Bariatric Surgery for the Treatment of Morbid Obesity

I am puzzled by the CMS's absurd position on the Sleeve Gastrectomy. They have approved multiple operations in several specialties with far less evidence than what is currently available on the Sleeve Gastrectomy.

Existing RCTs and other contemporaneous evidence clearly demonstrate that the Sleeve Gastrectomy has lower mortality and morbidity than the RNY GBP with equivalent results not just in terms of %EWL but also remission rates of several co-morbidities esp diabetes.

The Duodenal Switch and the Distal GBP are already on their list of "approved" surgery with NO recent RCTs. Their efficacy has been well established in the literature but primarily in the form of single institution retrospective studies. Available evidence on outcomes after the Sleeve Gastrectomy - which has been better studied than the DS or the Distal GBP suggest it is an effective operation - much more effective than the AGB; with less morbidity and less mortality than the DS/ Distal GBP. So why is CMS so resistant?

What are we going to tell the patients who would be recruited into the study - "We want to you to undergo a complex surgery with much higher mortality and morbidity even though the Sleeve could give you equivalent results, because that is what the government wants you to do?" What operation is going be the control - Prox RNYGBP or the AGB or "medical" management (which has clearly neven been shown to be a short-term or long-term solution to Morbid Obesity) ? How long are you going to run this study - 3 yrs ( we already have RCTs that have outlined this) or 10 yrs?

Having performed all types of bariatric surgery over the last 12 yrs, I can speak from my personal experience of several hundred sleeve gastrectomies both as a primary operation and as a revision that - pts have had excellent outcomes, with %EWL not substantially different from the Prox GBP.

It is time to review the additional evidence presented by the ASMBS and approve this life-saving operation promptly.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.
I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

[PHI Redacted] I am a certified bariatric nurse and a member of the National Association of Bariatric Nurses. Thank you for your consideration

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.
2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.
3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.
4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. We need this option to take care of Medicare patients just like I do for other patients.
I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Our program has performed vertical sleeve gastrectomy on 419 patients since January 1, 2008. Their outcomes and weight loss is consistent with that of a gastric bypass patient. I am afraid you've only considered Medicare patients as those who are age 65 or older; however, the majority of Medicare patients we see pursuing bariatric surgery are doing so because they have become disabled due to their severe obesity. We at Centennial Center for the Treatment of Obesity respectfully request your review of the above literature as a resource to approve the bariatric surgery procedure vertical sleeve gastrectomy as a Medicare covered procedure consistent with the current Medicare coverage of other bariatric surgery procedures.

Thank you,
Pamela R. Davis, RN, CBN
Bariatric Program Director
Centennial Center for the Treatment of Obesity
Nashville, TN.

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I have done many sleeve gastrectomies and published on the subject. I find weight loss to be the same as gastric bypass and long term outcomes more free of complications. I have also had to tell many Medicare patients who requested the operation that it was not available to them.

I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.
2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.
3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.
4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients. The government should not be restricting treatment options based on a fear of increased cost—there are better ways to control cost.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy should become a covered benefit for Medicare patients who need it and are desirous of the same treatment options as other Americans.

Sincerely yours,
Milt Owens MD FACS FASMBS

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If this randomized trial goes through as you purpose, if my understanding is correct the Vertical Sleeve (if the collected data proves favorable), would be approved at the earliest 2018. Those of us who have Medicare and need this surgery cannot hold out that long. Many of us have already endured for years holding out for VSG approval as it is.

A careful review and comparison of the VSG to the currently approved bariatric procedures quite clearly shows it has all the perks associated with weight loss surgery and almost none of the drawbacks (ie complications) that are inherent with the RNY, Lapband, and DS. It does not take a PhD to see the plain truth in this. As numerous doctors have already pointed out to you, the "missing" data your looking for in a randomized trial already exists. All you need do is review it.

I humbly implore CMS to scrap their proposal for a randomized trial and approve the VSG based on the existing medical data. Given our nations alarming epidemic of obesity, the Vertical Sleeve is needed now more than ever before.

I thank you for your time and considerate reflection upon my thoughts.

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Bariatric surgery is currently a covered service under medicare, but only adjustable gastric banding and gastric bypass are allowed. The recent decision to limit sleeve gastrectomy to prospective trials is really not necessary. Sleeve gastrectomy is part of nearly all bariatric surgeons' practice, and there are certain advantages to the procedure that actually may make it the BEST operation for the medicare population. For example, the small intestine is not involved with this operation, so patients with prior surgery may be candidates for the sleeve when a bypass might be technically impossible due to adhesion of the small intestine. additionally, the sleeve is the better option for patients who are extremely obese because of the fact that the operation all takes place in the upper abdomen, it is technically easier to achieve working space in these cases. Finally, the sleeve typically has a shorter OR time than gastric bypass, which is a desirable feature when you have an older patient that would be best served by getting off of the OR table sooner.

For the above reasons, I don't think medicare has made a compelling case for why gastric bypass is a covered operation but not the sleeve.

Also, given that private insurance companies often follow the trend set by medicare, the decision that medicare makes on this potentially impacts the access for millions of additional non-medicare patients. Nobody would disagree that obesity is an epidemic in the U.S. and it will cost our country dearly to pay for the complications of the disease. sleeve gastrectomy is an excellent option for a large portion of patients interested in bariatric surgery, and should be covered by all insurance, medicare and private. We will all reap the benefits of the improved overall health of patients undergoing sleeve gastrectomy.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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To Whom It May Concern:

Please allow me to comment on the proposed decision for CMS coverage of the sleeve gastrectomy. Ih the Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2), the proposed decision memo had an incomplete review of available evidence and did not consider the entire Medicare population.

Ultimately, I am concerned that this will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

In general, Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Sincerely,

Don J. Selzer, MD, MS
Associate Professor of Surgery
Interim Director, Section of General Surgery
Indiana University School of Medicine

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(Letter also submitted via e-mail to CMS/CAG. Available upon request from sphilli7@its.jnj.com.)

April 28, 2012

Louis Jacques, MD
Director, Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mail Stop S3-02-01
7500 Security Boulevard
Baltimore, MD 21244

Dear Dr. Jacques:

I am pleased to provide comments regarding the Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00252R2) issued by the Center for Medicare and Medicaid Services (CMS) on March 29, 2012.

Johnson & Johnson (J&J) is the world’s most comprehensive and broadly-based manufacturer of health care products for the consumer, pharmaceutical and medical devices and diagnostics markets. For 120 years, J&J Companies have supplied hospitals with a broad range of products and has led the way in innovation, beginning with the first antiseptic bandages and sutures. These comments reflect the opinion of Ethicon Endo-Surgery, a part of the Johnson & Johnson family of companies, that provides instruments used in bariatric and metabolic surgery.

We encourage CMS to issue a positive National Coverage Determination for Laparoscopic Sleeve Gastrectomy without a requirement for Coverage with Evidence Development (CED). Our rationale for this recommendation is based on the evidence we present in our comments below. New clinical evidence for laparoscopic sleeve gastrectomy directly pertaining to this issue has recently been published but, due to the timing of the Proposed Decision Memo, was not considered by CMS. We identify other important studies for your consideration, and describe analysis of recent Medicare discharge data on bariatric surgery utilization. We believe this information provides much of the evidence CMS found lacking in the Proposed Decision. Therefore, a CED policy is unnecessary.

New/recent Evidence for Sleeve Gastrectomy

We are concerned that the CMS Analysis of Laparoscopic Sleeve Gastrectomy (LSG) for the treatment of obesity (BMI>35 kg/m² ) had an incomplete review of the available evidence. The following evidence, which demonstrates that LSG for Medicare beneficiaries with BMI> 35 improves health outcomes, should be factored in the CMS decision in the coverage of LSG.

1. New England Journal of Medicine, March 26, 2012, Schauer and others published Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes (endnote 1), a randomized controlled study comparing 150 patients with laparoscopic sleeve gastrectomy, lap gastric bypass and intensive medical management. The sleeve gastrectomy procedure was found to be equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, in achieving an HbA1c level of 6% or less. The sleeve procedures was superior to medical management in improving patient outcomes such as weight loss and decreasing the use of drugs to lower glucose, lipid and blood pressure levels. Note that the average age of the patients participating in the Schauer study was 48 ± 8 years. Based on an analysis by Direct Research, LLC, this is the age range of most Medicare beneficiaries that receive a bariatric surgery procedure (see our comments below, Generalizability of Clinical Evidence to the Medicare Population).
2. In the April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment. The 60-patient study (mean age 53 and 56, respectively, of each cohort) confirms the efficacy of LSG in the treatment of morbidly obese type 2 diabetic patients when compared with medical treatment. Comparing results in both groups the LSG treatment group saw significant differences regarding excess weight loss, decreases in BMI and triglycerides and increase of HDL. Decreases in levels of Fasting Plasma Glucose and Hemoglobin A1c were significantly different only in patients with T2DM duration of more than 10 years.
3. Himpens in Annals of Surgery 2010, Long-term Results of Laparoscopic Sleeve Gastrectomy for Obesity, presents his 6-plus year results of 30 patients (median age 44, range 28-71) that received a sleeve gastrectomy. The 2010 study demonstrates the durability of sleeve gastrectomy originally presented in his 2006 Obesity Surgery paper with good weight loss outcomes at six years. Himpens also reported that patient acceptance of LSG is still quite good as indicated by a mean BAROS of 5, which suggests a good quality of life even more than 6 years postoperatively.
4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that in 197 consecutive patients all three weight loss surgeries (band, bypass, sleeve) were effective in patients ≥65 years of age (mean age 67), producing significant EWL, reduction in daily medication use and improvement in QOL. All surgeries were associated with a zero 30 day-mortality rate and a low morbidity profile. Again, as we note in the section below on Generalizability of Clinical Evidence to the Medicare Population, we are finding that the majority of Medicare beneficiaries that are getting a bariatric surgery procedure are under age 65.

There are several other noteworthy LSG prospective studies that CMS may want to consider that provide additional insight into the outcomes of this procedure. These include the published studies from Leyba (endnote 2) and Nocca (endnote 3). We recommend that CMS review these studies as part of their analysis of the available evidence showing the effectiveness of LSG compared to gastric bypass surgery.

Finally, since 2008 more than 210 LSG studies have been published in the peer-reviewed literature. Additionally, the ASMBS has a position paper on the procedure: http://s3.amazonaws.com/publicASMBS/GuidelinesStatements/PositionStatement/ASMBS-SLEEVE-STATEMENT-2011_10_28.pdf .

Generalizability of Clinical Evidence to the Medicare Population
Medicare patients that receive bariatric surgery are generally under age 65; therefore the sleeve gastrectomy evidence we describe above is relevant to most of the Medicare population. The typical patient in the general population that has a bariatric procedure has an average age in the mid-40’s and ranging between 30 and 65 years of age. According to an analysis we asked Direct Research, LLC to provide us; we have the following observations from the 2010 MedPAR database about Fee-for-Service Medicare beneficiaries that had bariatric surgery:

1. About 14,500 Fee-for-Service Medicare beneficiaries had a bariatric surgery procedure in 2010. This represents about 0.04% of all Fee-for-Service Medicare beneficiaries.
2. 68% (or 9900 beneficiaries) were age <65, and 70% of these patients were between the age 45-64 which is the typical bariatric surgery patient age range in the general population.
3. The complication and morbidity rates for all bariatric patients under Fee-for-service Medicare appear little different from the complication and morbidities for other common surgical procedure such as colectomy, hysterectomy and cholecystectomy.
4. About 600 Fee-for-Service Medicare patients received a laparoscopic sleeve gastrectomy in 2010. (endnote 4)

This analysis suggests that the Laparoscopic Sleeve Gastrectomy studies that appear in the peer reviewed literature for adults in the general population between the ages of 45 to 64 can be generalized to the Fee-for-Service Medicare population between the ages of 45 to 64 who are the typical Medicare beneficiaries that receive a bariatric surgery procedure.

Coverage with Evidence Development (CED) for LSG
We encourage CMS to issue a positive National Coverage Determination for Laparoscopic Sleeve Gastrectomy. CMS’s proposed NCD to cover LSG under CED in randomized controlled trials (RCT) will negatively impact patient access to care by imposing burdensome and unnecessary data collection requirements. Moreover, LSG has already been demonstrated reasonable and necessary (such as Schauer and Himpens mentioned above) among the age group 45 to 64, which is the age range of almost 70% of the 15,000 Medicare beneficiaries that typically have a bariatric surgery procedure each year.

Going forward, we encourage CMS to include stakeholders early on to determine the need for CED for specific technologies, to define the method to collect evidence as well as the type of evidence to collect under a CED. Stakeholders include manufacturers, health care providers and facilities, professional societies, foundations and health plans.

In conclusion, full CMS coverage of Laparoscopic Sleeve Gastrectomy is warranted based on the evidence presented above.

J & J greatly appreciates the opportunity to submit these comments and recommendations to CMS.

Sincerely,

Steve Phillips
Senior Director, Health Policy & Reimbursement
J&J Worldwide Government Affairs & Policy

Endnotes:

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I am a bariatric surgeon with 12 years’ experience treating over 2000 Morbidly Obese patients. Medicare patients comprise 20% of my population and I am concerned that your proposed decision regarding sleeve gastrectomy will continue the limited access to care for many Medicare patients who are particularly vulnerable. They suffer from obesity yet are not eligible or are not good candidates for the gastric bypass or the adjustable gastric band. For example, many obese Medicare patients who are on dialysis and trying to lose weight in order to become candidates for renal transplantation struggle to lose weight with the gastric band. The transplantation community does not want a gastric bypass because of the increased risk of nephrolithiasis following gastric bypass which would put the transplanted kidney at risk. For this group the sleeve gastrectomy is an excellent operation with great weight loss and minimal risk of nephrolithiasis. Patients with osteoporosis and steroid dependent conditions such as rheumatoid arthritis, Crohn’s disease and severe asthma also are not good candidates for the gastric band or gastric bypass. The FDA approval for the gastric band specifically excludes patients with chronic steroid use. The currently available oral treatments for osteoporosis exclude patients who have a narrowing of the upper intestinal tract; a condition present in both the gastric band and gastric bypass. The laparoscopic sleeve gastrectomy is an excellent operation for this high risk group of patients since the gastric mucosa remains intact without narrowing and patients tolerate both steroids and oral medication needed for osteoporosis quite well.

I have had the gratifying experience to perform the sleeve gastrectomy on two Medicare patients who were young but on total disability because of their obesity and related comorbidities. The operations were funded by local charities. Both of these patients made a contract that if they lost their excess weight and comorbidities, they would get jobs. I am proud to say that both patients are productive members of society and no longer Medicare beneficiaries.

I am also concerned that some recent excellent literature which strongly supports the safety and efficacy of laparoscopic sleeve gastrectomy was not included in your literature review. Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

In summary it has been my experience that the sleeve gastrectomy has a much lower morbidity than the gastric bypass. The weight loss and resolution of comorbidities is similar to the gastric bypass and superior to the adjustable gastric band. I therefore strongly believe that the sleeve gastrectomy should be a covered benefit under Medicare as it is with all other local payors in Maryland. I therefore ask CMS to review the new evidence and determine that laparoscopic sleeve gastrectomy become a covered benefit for morbidly obese Medicare beneficiaries; both those older than 65 and those on Medicare because of disability related to their obesity.

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I would like to comment and ask that you reconsider with regard to your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I treat a large African American patient population that as you know is disproportionately affected by obesity and its related co-morbid conditions. As the obesity incidence continues its upward trend, more and more Americans, and especially those of African descent, continue to be plagued by this increasing healthcare problem. In effect there has been little success in bridging the gap in the current state of healthcare disparities.

I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks, especially in the African American community. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Titus D. Duncan, M.D.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

As a bariatric surgeon, those of us who have performed Sleeve Gastrectomy and followed patients after this operation are by our experience, convinced it is a safe and very effective, operation. This operation was done based on the wise coverage decisions made by other third party payers who obviously are convinced as we, bariatric surgoens are. We have the expertise and experience to compare it to all the other options. I am absolutely convinced that Medicare will eventually cover this and harm patients who are not given benefits for the safest most appropriate weight loss surgery available.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Thank you for your time and consideration

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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Given the weight of the clinical evidence in favor of the procedure, for them to decree that M/C cases must be done as part of a research study is unarguably COERCIVE. One of the fundamental tenants of human subjects’ research is voluntary participation in research trials. Since most M/C patient have no other means to access this type of surgical care (out of pocket, other insurance) it is an unacceptable decision. The admonishments against coercion of humans into research studies is well laid out in many documents, from the Belmont report to the Code of Federal Regulations.

CMS could be within their rights to deny coverage if their assessment of the data is that the evidence of safety and efficacy is insufficient which is not the case . But to deny coverage as standard of care and instead indicate that coverage would be provided if done within an RCT is unbelievable.

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Dear Sir,

We would like that CMS review the new literature evidence submitted in the aforementioned ASMBS and ACS letter including Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes;Obesity, Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment; and SLEEVEPASS: A randomized prospective multicenter study comparing laparoscopic sleeve gastrectomy and gastric bypass in the treatment of morbid obesity: preliminary results. We believe that these studies provide evidence that laparoscopic vertical sleeve gastrectomy is safe and effective in a randomized trial basis with both medical therapy and covered bariatric surgeries as controls.
Regards,
Dr Rajat Goel

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

As a bariatric surgeon for 12 years I see the sleeve gastrectomy as having a very important role in the treatment of Medicaid and Medicare patients. It is much more efficacious than the band and safer than the bypass both of which are now covered.

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Regarding the proposed CMS decision to limit sleeve gastrectomy to those willing to participate in randomized trials, I believe that this position may well be unethical. Given the weight of the clinical evidence in favor of the procedure, for CMS to decide that M/C cases must be done as part of a research study is unarguably COERCIVE. One of the fundamental tenants of human subjects’ research is voluntary participation in research studies. Since most M/C patient have no other means to access this type of surgical care (out of pocket, other insurance) it is an unacceptable decision. The admonishments against coercion of humans into research studies is well laid out in many documents, from the Belmont report to the Code of Federal Regulations.

To deny coverage when a realistic assessment of many well done studies indicates that the evidence of safety and efficacy is sufficient in 2012 is not reasonable.

Thanks for your reconsideration.

Tom Inge, MD, PhD
Cincinnati, OH

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

I currently practice in a hospital employed practice with one other bariatric surgeon in an ASMBS center of excellence facility. I have felllowship training in minimally invasive surgery and bariatrics. We provide a comprehensive program to our patients including extensive education pre-surgery and support post surgery. We follow our patients life long.

In my practice we have performed over 360 laparoscopic sleeve gastrectomies over the past 5 years with excellent results. An average excess body weight loss of 57% and Major complication rate at 30 days of 2.4%. Our long term -major complication rate is 3.4%. Mortality has been 0%.

We have 28 patients in the over 60 age group. They have excellent results also. There have been only 2 major complications in this age group. One renal insufficency that resolved within a few days without dialysis and one bleeding episode that was supported with transfusion. There have been zero deaths and no significant cardiac or pulmonary events. Several of these patient were in a fairly high risk group with significant metabolic disease requiring high doses of insulin for diabetes, multiple medications for high blood pressure and CPAP machines for sleep apnea. Most had some limitations of mobility as well related to joint or back problems. They have done outstanding as a group with excess body weight loss ranging from 40-65% and very quick improvement and resoluction of their metabolic disease. It has significantly improved mobility and quality of life as well as decreased medications and utilization of health care resources. Many of these patient had some contraindication to other weight loss procedures offered including significant ulcer risk, bone disease, or long term diabetes.

The elderly population and disabled population are actually best suited for the laparoscopic sleeve gastrectomy compared with other current weight loss procedures.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients. I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Thank you for your consideration of this critical matter.
Sincerely

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2).

As a bariatric surgeon, I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need.

I believe CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients.
For instance: Some patients, such as patient in need of aspirin, Coumadin, or NSAIDs for various medical conditions are at higher lifelong risk of marginal ulcers and bleeding after gastric bypass. Some of these patients are not ideal candidates for band, either, due to higher Body Mass Index. Depriving these patients from sleeve gastrecomty will deprive them from the only reasonable surgical weight loss option they could have.

As a bariatric surgeon I need this option to take care of Medicare patients just like I do for other patients.
I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Thank you for attending to our patients’ needs,
Fariba Dayhim MD, FACS, FASMBS

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I have had the opportunity to witness the many benefits patients have had since having a gastric sleeve gastrectomy.Due to mutiple health problems and previous surgires they may have only one weight loss surgery option and that would be lap gastric sleeve.For most patients the benefits of having this surgery far out weight the risk and I stongly believe this surgical procedure should be included in the fight againist the number one health problem in the United States and slowly becoming the world Thank You

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

I have many patients who have waited to have Medicare cover sleeve gastrectomy. The sleeve gastrectomy is the better option for a variety of patients and has been shown to be effective.

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April 27, 2012

Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

To Whom it may concern:

I would like to thank the CMS for their decision to improve access for weight loss surgery through a National Coverage Decision. However I feel there is already enough scientific evidence to justify approval of Gastric Sleeve surgery for Obese Medicare Patients.

[PHI Redacted]

The research I've done indicates that the Gastric Sleeve has fewer complications and food restrictions and cost less than the Gastric bypass and after surgery results with the Gastric Sleeve seem to be near the same as with the Gastric bypass and better than the Lap-band, which have both been approved by Medicare.

Please continue your efforts to expand coverage for the treatment of severe obesity and the many health problems that it causes or contributes too. I respectively request that you consider providing coverage of Gastric Sleeve surgery for Medicare and Medicaid patients.

Sincerely,

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Gastric sleeve surgery is an effective weight loss operation with safety profile, results, lower long term risks than either gastric bypass, duodenal switch or Lap band. This is based on experience with approximately 550 gastric sleeve operations done over a 5 year period. I am aware that existing evidence-based data is limited in some respects but so it is with most other operations.

Specific circumstances make this operation a better choice than the other operations. For example, small bowel adhesions that preclude or make a bypass operation much more risky; the use of certain medications is better tolerated by sleeve patients than Lap Band or bypass patients (i.e. prednisone, aspirin, certain antibiotics, etc.); pregnancy is less risky for sleeve patients than Lap Band or bypass patients.

It is disconcerting that we may be faced with the choice of either proceeding with a gastric sleeve in a Medicare patient because it is the best choice at that moment or abort a weight loss operation because payment will be denied for all parties involved. My ethical responsibility is to proceeed with the correct operation as dictated by my judgement but this generates significant problems with the hospital and anesthesia because they will not get paid.

Please consider approving gastric sleeve as an effective weight loss operation.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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My name is James A. Foote, MD and I am a Bariatric surgeon in a private practice in Michigan I have been performing the Vertical Sleeve Gastrectomy since 2005. I have performed 2749 bariatric surgery procedures and of that I have performed 670 vertical sleeve Gastrectomy procedures.

I have 65 vertical sleeve patients that I have performed surgery on that qualify for Medicare, however many paid cash or used their secondary insurance to pay for this operation. Of those 65 patients, all of them are over the age of 65 and 46 of them had data available at one year post op.

The data on my patients who are at least one year post op from surgery and age 65 are as follows:

-The data below represents 46 patients
-The average weight loss of these patients is 82.23 pounds
-The average excess body weight loss percentage is 55.26% *
-The average age of these patients is 68.35
-The average pre op weight of these patients is 314.86

*We used the Metropolitan Chart for Ideal weight to calculate the excess body weight loss using the large frame high end of the chart.

There are no surgical mortalities with this group of patients and the weight loss surpasses that of our banding patients in this same age group. We have not calculated the reduction in co morbidities at this point and time but we are working on that as a continuation of this study.

In summary, we are asking you to please reverse your decision for nonpayment of the vertical sleeve procedure as we have proven this is an effective procedure for this group of patients.

James A. Foote, MD
Vice President, Grand Health Partners
Medical Director, North Ottawa Community Hospital

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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April 27, 2012

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop S3-02-01
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Dr. Jacques:

The American Society of Metabolic and Bariatric Surgery would like to respond to your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). We are concerned that the proposed decision memo reached its conclusions with an incomplete review of available evidence, lack of generalizability to the entire Medicare population, diminished access to care for vulnerable populations and no prior precedence for the level of review and scope of remedy. In addition, we believe the proposed remedy for coverage involving a randomized control trial for laparoscopic sleeve gastrectomy (LSG) is redundant, cost-ineffective and in conflict with CMS published standards of scientific integrity and relevance. We ask you to review carefully and come to the more appropriate conclusion that CMS provide laparoscopic sleeve gastrectomy as a covered benefit. We hope you agree that Medicare beneficiaries should receive the same level of obesity treatment coverage as over 100 million other Americans enjoy.

In the proposed decision memo, it is stated that there are little either randomized trial or long-term data to support coverage for LSG. Since your literature review end date of 12/2011, several clinical studies on sleeve gastrectomy have recently been published including two randomized trials and one prospective cohort study. These studies provide clear and compelling evidence that the laparoscopic vertical sleeve gastrectomy is safe and effective on a randomized trial basis with both medical therapy and CMS-covered bariatric surgeries as controls.

Specifically, the studies include:

1. In the March 26, 2012 issue of the New England Journal of Medicine, Schauer et a published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” In this randomized controlled trial, the efficacy of intensive medical diabetes management alone versus laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy in 150 obese patients with uncontrolled type 2 diabetes was performed. The results were enlightening. In this specific population, the sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit. At the end of the one-year trial, hemoglobin A1C was 7.5 for intensive medical diabetes management, 6.4 for Roux-en-Y gastric bypass, and 6.6 for sleeve gastrectomy. As expected, weight loss outcomes had similar results namely, an end-point BMI (kg/m²) of 34.4 for intensive medical diabetes management, 26.8 for Roux-en-Y gastric bypass, and 27.2 for sleeve gastrectomy. Of note, when examining serious adverse events requiring hospitalizations, intensive medical diabetes management and sleeve gastrectomy hospitalizations were equivalent! (9 vs. 8 %, respectively). This trial was published in the New England Journal of Medicine, which leads all general medical journals in its impact factor. There is no question that this trial is of the highest methodological quality and should be part of the External Technology Assessment of the proposed decision memo.
2. In the April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment. From trial initiation to trial end at 18 months, the medical treatment control group gained weight and saw modest declines in Fasting Plasma Glucose (BMI, 39 to 39.8 kg/m²) and saw modest declines in Fasting Plasma Glucose (FPG) (183 to 150 mg/dL). In contradistinction, the LSG group saw substantial declines in both weight, BMI 41.3 to 28.3 kg/m²) and FPG (166 to 97 mg/dL). Cardiac risk factor assessment showed consistent superiority of Laparoscopic Sleeve Gastrectomy over medical therapy particularly for Triglycerides, mg/dl (LSG, 169 to 97; Medical, 199 to 173).
3. In the April 2012 issue of Surgical Endoscopy, Helmio et al. published SLEEVEPASS: A randomized prospective multicenter study comparing laparoscopic sleeve gastrectomy and gastric bypass in the treatment of morbid obesity: preliminary results. In this study of 240 patients, early safety outcomes for the sleeve gastrectomy were superior to Roux-en-Y gastric bypass with no deaths in either group. Overall morbidity was significantly less after sleeve vs. bypass (13.2% vs. 26.5%, p=0.01).
4. The decision memo cites the Himpens et al. 2006 study as meeting criteria for support of the coverage decision and notes need for longer-term follow-up. However, the proposed decision memo excludes the long-term follow up study published by Himpens et al. in Annals of Surgery in 2010. This six- year study demonstrates durability of the three year results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss (EWL) at six years. Three-year results were also presented by Kehagias and colleagues in Obesity Surgery 2011 with a 68% EWL. Long-term results are also present in Obesity Surgery 2012 where Prasad et al. published An Analysis of 1–3-Year Follow-up Results of Laparoscopic Sleeve Gastrectomy demonstrating longevity of results with 66% EWL at three years.

The Proposed Decision Memo focuses on exclusively on Medicare beneficiaries whose age is >65. This emphasis on a single population ignores other Medicare beneficiaries whose age is < 65 and are disabled, have End-Stage Renal Disease or beneficiaries who are dual eligible for both Medicare and Medicaid. The over-all Medicare population aged < 65 is conservatively at least 20% of the over-all Medicare population (Mathematica Policy Research, May 2001, Volume 2). In our previous October 2011 letter in support of coverage for laparoscopic sleeve gastrectomy, for patients < 65, we cited published studies in NEJM 2009 (Flum et al.), JAMA 2010 (Birkmeyer et al.), Annals of Surgery 2011 (Hutter et al.) and data from over 268,000 bariatric surgeries in the BOLD registry that overwhelmingly demonstrated that the laparoscopic sleeve gastrectomy was positioned exactly between the two covered bariatric surgeries of gastric band and gastric bypass for both complications and weight loss.

Furthermore, the disabled Medicare population age < 65 is disproportionately at risk for being or becoming obese with significantly more comorbidities than the average bariatric population or, in general, they would not have been categorized as disabled. Similarly, ESRD patients age < 65 may be disenfranchised from kidney transplantation because of their weight. In addition, the Medicare SSI (disability) population represents a very high-risk group who would benefit from the LSG as a lower risk procedure than RYGB, which is currently covered by CMS. Coverage of the LSG could lower the total cost of management of the high risk Medicare patient (such as those with obesity hypoventilation syndrome, chronic congestive heart failure (CHF), re- or post transplant patients), while providing a more effective procedure, especially for T2DM, than the gastric band, also covered by CMS. The laparoscopic gastric band was never required to show efficacy in RCTs with other bariatric surgical procedures in the CMS population nor show data longer than three-year follow-up when approved by the Food and Drug Administration and then accepted by CMS as a covered procedure.

According to CMS's own MedPAR data for 2010, we have the following observations about Medicare patients that have had bariatric surgery. Namely, bariatric surgery in Medicare beneficiaries is rare with 14,500 Medicare beneficiaries having a bariatric surgery procedure in 2010 representing only about 0.04% of all Medicare beneficiaries. Bariatric surgery in Medicare beneficiaries occurs most commonly in age < 65 with 68% (or 9900 beneficiaries) of Medicare bariatric patients were age < 65, and 70% of these patients were between the ages of 45-64 which is the typical bariatric surgery patient age in the general population. Of note, about 600 Medicare patients have already received a laparoscopic sleeve gastrectomy in 2010. Source: Direct Research, LLC, Calculated from FY 2010 Medicare Provider Analysis and Review (MedPAR), Fee-for-Service Inpatient Discharges With Selected Procedures.

The Proposed Decision Memo also states that there are little data for patients older than 65. Given CMS’s lack of coverage for LSG in patients > 65 years of age, it is not surprising that data may not be as prominent as it is for LSG patients<65. However, there are three studies which demonstrate that laparoscopic sleeve gastrectomy results seen in patients <65 can be replicated in patients>65:

1. Ramirez and colleagues published Outcomes of Bariatric Surgery in Patients over 70 years of Age in SOARD 2012. This study demonstrated 55% reduction in all medications with no deaths for all three represented surgeries of banding, bypass and sleeve gastrectomy.
2. Specific to laparoscopic sleeve gastrectomy, Leivonen and colleagues demonstrated in Laparoscopic Sleeve Gastrectomy in Patients over 59 Years: Early Recovery and 12-Month Follow-Up in Obesity Surgery 2011 that patients older than 60 years of age compared to patients < 60 had similar weight loss and no mortality in either group.
3. O’Keefe et al. in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic?and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients ≥65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.
4. Finally, we accessed the ASMBS Bariatric Outcomes Longitudinal Database (BOLD). BOLD is the world’s largest repository of bariatric surgery outcomes and was established partly in response to the original Bariatric Surgery NCD. From 2007-2010, over 268,898 bariatric surgeries were entered and reviewed in BOLD. We specifically reviewed comparative outcomes for patients age >65 vs. <65 for the three procedures of gastric banding, sleeve gastrectomy and gastric bypass. These findings will be presented at the 2012 American Society of Metabolic and Bariatric Surgeons Annual Meeting this June.

14,476 patients who underwent bariatric surgery between June 2007 and December 2010 and were aged > 65 were identified. Compared to younger LSG patients, those aged >65 were more often male (39.9% vs. 25.4%), had a higher prevalence of diabetes (47.2% vs. 22.2%), hypertension (73.8% vs. 43.7%), CHF (6.0% vs. 1.7%) and a history of Venous Thromboembolism (VTE) disease (4.8% vs. 2.5%). Patients aged > 65 undergoing LRYGB had a similar risk profile as older LSG patients. The 30-day mortality rate for older LSG patients was higher than that of younger LSG patients (0.39% vs. 0.07%) as was the rate of serious complications (1.54% vs. 0.95%); however, both rates were lower than that seen in age>65 LRYGB patients (0.50% and 2.84%, respectively). Comparatively, LSG patients aged > 65 experienced less morbidity and mortality than older LRYGB patients.

The proposal for coverage within a randomized control trial is in conflict with the cited CMS standards of scientific integrity namely categories C-E.

3. The research study does not unjustifiably duplicate existing studies.

   Clearly, the call for a randomized control trial for laparoscopic sleeve gastrectomy does duplicate previous studies namely the NEJM STAMPEDE trial cited earlier in I.A. There are also four other randomized control trials answering the same question of whether sleeve gastrectomy is safe and effective in the affirmative (Helmio et al. 2012, Peterli et al. 2012, Karamanakos et al. 2011, Himpens et al. 2010).

4. The research study design is appropriate to answer the research questionbeing asked in the study.

   The proposed decision memo does not address what should be an appropriate control group, i.e., medical therapy, adjustable gastric banding, or Roux-en-Y gastric bypass. As standards of care already exist regarding candidacy for bariatric surgery, comparing Sleeve Gastrectomy to medical therapy will not address the real question of whether Sleeve Gastrectomy is an acceptable option to other bariatric surgery procedures in terms of safety and efficacy. With five randomized trials and almost 300,000 bariatric surgery registry patients supporting the conclusion that sleeve gastrectomy is comparable to other bariatric surgery procedures for safety and efficacy, the scientific standard should be that the procedure is at least as safe and effective and substantially equivalent to existing covered procedures similar to a 510 (k) submission to the FDA. The proposed randomized trial design is not optimal or even appropriate for determination of the incidence of infrequent complications over a period of years. A RCT for laparoscopic sleeve gastrectomy for age > 65 beneficiaries is unnecessarily costly and an inefficient use of resources for such a small patient population (<5000 pts.).

5. The research study is sponsored by an organization or individual capable of executing the proposed study successfully.

   It is not clear who will be administering the proposed study, who will approve each site, who will monitor adverse events, or propose a data collection model.

Given that the proposed decision memo did not include vital evidence, we are asking that CMS review the new evidence and reach the fitting and proper conclusion that laparoscopic sleeve gastrectomy become a covered benefit for all Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans. We look forward to your reply and welcome an opportunity to meet with you as soon as possible.

Sincerely,

Robin Blackstone, MD, FACS, FASMBS
President, American Society for Metabolic and Bariatric Surgery

John Morton, MD, FACS, FASMBS
Access to Care Chair, American Society for Metabolic and Bariatric Surgery

Scott Melvin, MD
President, Society of American Gastrointestinal and Endoscopic Surgeons

Patrick O’Neil, MD
President, The Obesity Society

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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The Obesity Action Coalition (OAC) appreciates the opportunity to respond to the Center for Medicare & Medicaid Services (CMS) March 29, 2012 Proposed National Coverage Decision (NCD) Memo regarding Bariatric Surgery for the Treatment of Severe Obesity (CAG-00250R2) specific to laparoscopic sleeve gastrectomy (LSG). We are concerned that CMS’ conclusions in the proposed decision memo were based on an incomplete review of available evidence with no prior precedence for the level of review and scope of remedy.

The OAC supports the comments of the surgical and medical organizations (American Society for Metabolic and Bariatric Surgery, American College of Surgeons, Society of American Gastrointestinal and Endoscopic Surgeons, The Obesity Society, and the American Society of Bariatric Physicians), which believe the proposed remedy for coverage involving a randomized control trial for LSG is redundant, cost-ineffective and in conflict with CMS published standards of scientific integrity and relevance.

We are also deeply troubled regarding the agency’s suggested path regarding coverage with evidence development (CED) given CMS’ failure to evaluate the majority of Medicare beneficiaries who could benefit from full coverage of LSG. Should CMS opt to finalize a CED approach, it will result in diminished access to care for the most vulnerable patients in the Medicare program – those beneficiaries under age 65 who are disabled, have End-Stage Renal Disease (ESRD) or who are dual eligible for both Medicare and Medicaid.

Numerous private health insurance plans adopted coverage of LSG throughout the last two years – affording this treatment option to more than 100 million Americans. A Medicare decision to adopt a CED approach to LSG will disadvantage Medicare beneficiaries and have a chilling effect on future, or even current private health plan coverage of this critical treatment option.

Given that the proposed decision memo did not include both recent and existing evidence, we are asking that CMS review these data and revaluate the evidence in the same fashion it would examine and determine coverage policy for treatment avenues for other chronic disease states. Healthcare professionals need an arsenal of treatments to address the millions of Americans affected by obesity. In the case of severe obesity, proven surgical interventions, combined with multi-disciplinary pre-op and post-op care, are critical treatment tools that all Medicare beneficiaries should be able to access. LSG is part of this arsenal and Medicare should provide full coverage for this proven safe and effective surgical intervention.

Sincerely,

Joe Nadglowski
President/CEO
Obesity Action Coalition
4511 N Himes Ave Suite 250
Tampa, FL 33614

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April 27, 2012

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicaid and Medicare Services

[submitted electronically]

Re: Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2)

Dear Dr. Jacques:

The American College of Surgeons (ACS) is a scientific and educational association of surgeons, founded in 1913, to improve the quality of care for the surgical patient by setting high standards for surgical education and practice. On behalf of the more than 75,000 members of the ACS, we appreciate the opportunity to support the American Society for Metabolic and Bariatric Surgery’s (ASMBS) comments dated April 25, 2012, on the proposed coverage decision for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2).

Specifically, the ACS echoes the concerns of the ASMBS with the Centers for Medicare and Medicaid Services’ (CMS) proposal to consider laparoscopic vertical sleeve gastrectomy a non-covered service. We believe that laparoscopic vertical sleeve gastrectomy is a reasonable and necessary procedure for the treatment of morbid obesity in the Medicare population.

The ACS asks that CMS review the new literature evidence submitted in the aforementioned ASMBS letter including Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes; Obesity, Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment; and SLEEVEPASS: A randomized prospective multicenter study comparing laparoscopic sleeve gastrectomy and gastric bypass in the treatment of morbid obesity: preliminary results. We believe that these studies provide evidence that laparoscopic vertical sleeve gastrectomy is safe and effective in a randomized trial basis compared with both medical therapy and covered bariatric surgery (gastric bypass) as controls.

Also, as stated in the ASMBS letter, the ACS recommends that CMS give additional consideration to the appropriateness of laparoscopic vertical sleeve gastrectomy to the entire Medicare population based on previously submitted evidence. We believe that this should include Medicare beneficiaries whose age is < 65 who are disabled, who have End-Stage Renal Disease, or who are dually eligible for both Medicare and Medicaid (“dual eligible”).

Given the new evidence submitted by the ASMBS, the ACS recommends that CMS reevaluate its current proposal and rather consider laparoscopic vertical sleeve gastrectomy a covered service. Medicare patients are a higher-risk patient population. Therefore, we believe that laparoscopic vertical sleeve gastrectomy is a reasonable and necessary procedure for the treatment of morbid obesity especially in the Medicare population and should be a covered service for Medicare beneficiaries.

Sincerely,

David B. Hoyt, MD, FACS
Executive Director

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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As a kidney transplant surgeon I see many patients with renal failure secondary to diabetes type 2 and hypertension. I believe the data is getting stronger and stronger that bariatric surgery (including sleave gastrectomy - see recent article in Arch Surg. Published online April 16, 2012. doi:10.1001/archsurg.2012.222) is being shown to be an good treatment modality for these patients. Since the risk of complications for sleave gastrectomies may be lower it seems to be more appropriate for my patients with organ failure.

I feel strongly that my patients need more access to the sleave gastrectomy procedure.

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April 27th 2012

To Whom it May Concern

I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Sincerely

Carrie A Perez RN, BSN
Bariatric Program Coordinator

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April 27th 2012

To Whom it May Concern

I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Sincerely

Joseph Cipriano, D.O.

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April 27th 2012

To Whom it May Concern

I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Sincerely

Jamie Adair, M.D.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need of these services. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

As a member of the Michigan Bariatric Surgery Collaborative (MBSC), my bariatric surgery program, along with 31 other bariatric surgery programs in Michigan, reports data on all bariatric surgery patients into a clinical registry that now includes data for over 35,000 patients. As a result, MBSC has robust data showing that sleeve gastrectomy is a safe and effective procedure to treat morbid obesity.

The Director of the MBSC has already provided CMS with a pre-publication copy of a comparative effectiveness analysis of laparoscopic sleeve gastrectomy (SG), gastric bypass (RYGBP) and adjustable gastric banding (LAGB). In this study, SG outcomes fall between RYGBP and LAGB. The overall complication rates among patients undergoing SG (6.3%) were significantly lower than for RYGB (10.0%, p< 0.0001) but higher than for LAGB (2.4%, p< 0.0001). Serious complication rates were similar for SG (2.4%) and RYGB (2.5%, p=0.736) but higher than for LAGB (1.0%, p< 0.0001). Weight loss over time was greatest for RYGB, followed by SG, and then LAGB. Weight loss for all three procedures was steep during the first year and then leveled off or rebounded slightly over the subsequent two years. Excess body weight loss at 1-year was 13% lower for SG (60%) than for RYGB (69%, p< 0.0001) but was 77% higher for SG than for LAGB (34%, p< 0.0001). SG was similarly closer to RYGB than LAGB with regard to resolution of obesity-related comorbidities, quality of life, and patient satisfaction.

Rates of complications increased with increasing age and rates of weight loss decreased with increasing age for all three procedures. Specifically, serious complications were approximately two times higher for patients in the 60+ age category than for patients in the < 30 age category for all three procedures. Excess body weight loss at 1 year was 5.7%, 8.1%, and 13.5% lower for patients in the 60+ age category than for patients in the < 30 age category for RYGB, SG, and LAGB, respectively.

The MBSC study adds to a growing body of evidence regarding the safety and efficacy of sleeve gastrectomy and addresses a number of CMS’s specific concerns with prior studies including the lack of comparison groups, selection bias, generalizability of single center studies, the lack of age-stratified results, and a lack of long-term outcomes. I am asking that CMS review the new evidence provided by MBSC and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Listed below are additional publications CMS should review as well.

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks and data shows that SG is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, SG should be an available surgical option for this group of high-risk patients. This will allow me to provide a full range of services to Medicare patients, just like I do for all of my other patients.

I am confident the information provided above will prove to be valuable in your discussion when drawing your final conclusion about sleeve gastrectomy coverage for Medicare patients.

Thank you for the opportunity for me to submit my comments.

Respectfully submitted,

Wayne J. English, M.D., F.A.C.S.
Clinical Assistant Professor, Department of Surgery
Michigan State University College of Human Medicine
Medical Director, Bariatric & Metabolic Institute
Marquette General Hospital
580 West College Avenue
Marquette, MI 49855

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I am a bariatric surgeon in Hackensack, New Jersey. I perform laparoscopic adjustable gastric banding, gastric bypass and sleeve gastrectomy. I have been doing the sleeve gastrectomy for two years. I have found it to be a remarkably safe and effective operation. My patients have been similarly satisfied. Sleeve gastrectomies now represent the majority of the bariatric procedures that my patients choose and that I perform.

I was shocked and disappointed that CMS did not approve the sleeve gastrectomy for Medicare patients. I urge you to reconsider. It is a very valuable tool in the armamentarium of the bariatric surgeon, and there are clearly patients for whom it is a better option than either the bypass or the band.

I would also state my agreement with and support for the "ASMBS Response to CMS Sleeve Coverage Decision."

Thank you for your consideration.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

While CMS is concerned about the lack of data regarding the use of Sleeve Gastrectomy in the over 65 population, review of the use of Bariatric surgery in Medicare patients reveals that the majority are disability patients under the age of 65 years. There is sufficient prospective data to support the use of Sleeve Gastrectomy in this population. (see articles above)

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo will result in diminished access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.
2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.
3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.
4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. As the valve at the bottom of the stomach is maintained there is reduced incidence of dumping and other malabsorption problems. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

[PHI Redacted] The physical and psychological benefits are far too numerous to list here. I would hate other patients to miss out on the benefits of this surgery because a federal program considers it to be controversial or experimental. It is not, it has been performed for years, even before it was proposed as a stand-alone surgery without subsequent RNY surgery. This procedure preserves much of the existing stomach structure, which reduces complications caused by RNY procedrures. Often a RNY is not the appropriate option for a patient. The Vertical Sleeve gastrectomy is a procedure approved by the National Institute of Health. I urge you to keep the decision of which procedure to use between the patient and their surgeon.

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Thank you very much for your efforts to allow people who are covered under Medicare to have weight loss surgery. I am concerned that only people who are able to participate in a clinical trial will be covered. As someone [PHI Redacted] who has worked in clinical trials for 14 years, I urge you to make this benefit available to all Medicare recipients.

[PHI Redacted] I’m afraid that many people who are older or disabled and have Medicare won’t be able to afford this surgery if the coverage is limited. [PHI Redacted]

[PHI Redacted]

Please continue to support treatment for severe obesity for those who need it.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

As a bariatric surgeon, I believe that the LSG is a very important tool in our armamentarium and this is especially true for medicare and medicaid patients who are either to fragile or old for a gastric bypass.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

It is unfathomable that CMS approves laparoscopic adjustable band but will not approve laparoscopic sleeve gastrectomy for Medicare patients. In my opinion, with over 5 years experience with the sleeve and band procedures, the sleeve gastrectomy is superior in weight loss, comorbid resolution and patient satisfaction.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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It is disappointing to see the recent CMS decision that would provide coverage for laparoscopic vertical sleeve gastrectomy, only under a randomized clinical study. This decision would reduce access to proper treatment for Medicare covered patients while the Proposed Decision Memo does not consider all available evidence nor include the entire Medicare population.

Sleeves have been performed throughout the world for years. Considering the thousands of articles, with weight loss data reported out more than 5 years, the accumulated results cannot be because of a placebo or Hawthorne effect. Recent randomized trials demonstrate the effectiveness of sleeve gastrectomy in the treatment of Type II Diabetes and Metabolic Syndrome.

Please review the following:

New England Journal of Medicine, March 26, 2012, Schauer et a published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment. Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

Himpens in Annals of Surgery 2010. This six- year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.
O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic?and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a Zero 30 day-mortality rate and a low morbidity profile.

When looking at sleeve compared to gastric bypass, the two procedures are not analogous with the gastric bypass requiring intestinal manipulation while the sleeve does not.

There are also substantial medical reasons where sleeve would be a preferential procedure for Medicare covered patients. For example:

Patients that require joint replacement and maintained on NSAIDS - Gastric bypass requires gastrojejunostomy and a disturbing late complication is marginal ulcer. This is not a rare occurrence and life long NSAIDS would be a concern for any bypass patients.

Similarly, patients with coronary artery or vascular disease require aspirin. This also can increase possibility of bleeding marginal ulcer.

Patients that have had a previous transplant are also best served by sleeve. Concentrations of the immunosuppressants can be altered by the bypass, especially those that require proper fat absorption for efficacy.
Other potential circumstances where sleeves maybe preferable are patients with multiple previous abdominal operations, history of inflammatory bowel disease, or other bowel resections.

In summary, the procedures are not identical. The sleeve involves only gastric manipulation, whereas gastric bypass requires both gastric and intestinal alteration. It should be allowed to do less, not more when objectives can be met with only gastric manipulation.

Looking at this from a research standpoint, any trial will be nearly impossible to enroll objective patients. Since there is coverage for rygb, lagb and ds, only patients that desire sleeve will submit to randomization. Therefore, it is likely that the only role of the trial would be a mechanism for coverage for patients who want sleeve. Patients that desire other bariatric procedures would not consent. Thus making this an expensive exercise with little value. There is a role for randomized trials, but not in every circumstance.

At present, there is zero question that sleeve is an effective weight loss procedure, with better efficacy than covered procedures such as lagb. There is also little question that its safety profile is similar to other stapling procedures and strong suggestion that is actually safer than operations that require intestinal manipulation.

I am asking that CMS review the new evidence and reach the conclusion that laparoscopic sleeve gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Brian Jacobs, MD, FACS

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I am a bariatric program manager and would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Sincerely,
C. Pontillo

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

You already cover adjustable gastric banding which in less effective than Laparoscopic Sleeve Gastrectomy and you cover Laparoscopic Roux-en-Y Gastric Bypass which has a higher risk profile. This forces many morbidly obese Medicare patients to choose an operation that is less than ideal for their particular set of diagnoses.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

I am asking that CMS review the evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans. I would also ask the reviewers to ask themselves this question: which operation would they want their obese parents to havesleeve, or gastric bypass? For those of us in the business, the answer is clear. Sleeve gastrectomy is the best option.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I am one of the few bariatric surgeons in a major metropolitan area who actually cares for weight loss surgery patients covered by medicare. Most of my patients are disabled, younger patients. It is hard to imagine that the committee has looked at the available evidence on sleeve gastrectomy and decided to exclude it from coverage. You cover lap bands but not sleeves? Really? We will not operate our way of the obesity epidemic, but there is clearly a role for surgery, and clearly a role for the sleeve in our surgical armamentarium.

I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

thanks - George Lynch, MD Nashvile

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.
I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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Regarding the recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2), it appears that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and certainly will diminish access to care for patients in need.

Most private insurance providers that cover bariatric surgery have been allowing patients and physicians to chose the sleeve gastrectomy for quite some now. CMS is already well behind the standard of care in this matter, and should quickly remedy the situation by providing the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

I personally have several Medicare patients that cannot have a gastric bypass or adjustable gastric band for various health and anatomic reasons, and they have been desperately waiting for a sleeve gastrectomy. Please do not force them to wait any longer!

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

I find there are several patients on multiple medications that cannot receive the gastric bypass procedure due to the decrease absorption of their medication and I feel this is an excellent alternative as the adjustable gastric band may be in select patients. Without this option of the sleeve gastrectomy I do not feel that we are giving our patients a fair choice to receive a proper tool for weight loss and maintain their health after surgery. Many younger patients may be on disability due to psychological issues or back, joint issues and need medication delivery that is accurate and reliable. I feel the gastric sleeve provides this option for these patients. I also feel that select patients that may need transplants of kidney or pancreas that a sleeve may be a better option.

Thank you.

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I am writing as a physician involved in the daily care of patients suffering from severe obesity and its related comorbidities, and as a witness to the life transforming stories of many of these patients who have undergone bariatric surgery. I suspect anyone making "policy decision" would be well served to spend just one day in bariatric surgeon's follow up clinic, because in doing so would truely understand the metamorphasis that occurs both in one's physical wellbeing as well as their mental wellbeing, and understand it is not only our ability to help these patients, but our responsibility.

As such, I have grave concerns about the surprising CMS decision to only approve the Sleeve Gastrectomy under "research protocol." I have used the sleeve gastrectomy successfully for years, and through my direct experience would say it is without doubt a tremendous weapon in our arsenal against obesity. I have used it successfully to help patients with end stage renal disease finally get the kidney transplant they so desparately needed. I have used it to help get the high risk supra-supra morbidly obese patient ambulatory again, eliminating the need for home health care. This is clearly an operation that is saving lives, and as an experienced bariatric surgeon fully participating in a Bariatric Surgery Center of Excellence program, we have not seen any short or long term consequences that would deem us to beleive there is anything unsafe or "experimental" with this operation.

More specifically, I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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As Director of Bariatric Surgery at Hackensack University Medical Center in New Jersey, I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). We are an ACS Level 1A Center of Excellence and provide life-saving bariatric care to many Medicare patients. I believe that this procedure is, in fact, likely the best choice of bariatric procedure for this group of patients. I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Hans J. Schmidt
Director, Bariatric Surgery
Hackensack University Medical Center
Hackensack, NJ
drhschmidt@yahoo.com

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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Dear Committee,

I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Thank you for your consideration.
Sincerely,
Crystal Twynham MD FACS

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Our staff appreciates the efforts being made to improve access to weight-loss surgery.

Our office sees patients from a wide variety of backgrounds with a broad spectrum of comorbidities. Many patients have researched the gastric sleeve and are interested in pursuing this surgical procedure. Because it is currently not a covered benefit under Medicare and various health insurances, patients are choosing to not pursue weight loss surgery and are incurring extensive medical bills with increased costs to insurance companies for continued management of their weight related illnesses.

Please consider this when evaluating the necessary treatment options for obesity.

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4/26/12

I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.
2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.
3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.
4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

The Slleeve gastrectomy is providing evidence of being a procedure that is much easier and less complications with more success in loosing weight to increase quality of life while decreasing health challenges from co morbids associated with obesity. This in turn produces increased savings to payors due to decreased health challenges.

It is a win win for payors and covered lives.

Respectfully,
Scott Sales
Administrator
Premier Metabolic and Bariatric Associates

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. Sleeve gasterectomy is shown to improve or resolve diabetes.

CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.
2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.
3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.
4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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Less

I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2).

[PHI Redacted]

I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

New England Journal of Medicine, March 26, 2012, Schauer et a published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment. Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

Himpens in Annals of Surgery 2010. This six- year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic?and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a Zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patient with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patient. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach conclusion that laparoscopic sleeve gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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To Medicare:
Although I am in strong support of the American Society for Bariatric Surgery (ASMBS) comment, which I have also signed, regarding the recent decision by CMS to limit coverage of the laparoscopic sleeve gastrectomy (LSG) to randomized, controlled studies, I feel obligated to emphasize a few of the points that were made.

The decision was totally focused on Medicare patients = 65 years of age. Many patients covered by CMS are < 65 with Social Security Insurance (SSI) as they have been classified as disabled. This population has significantly more comorbidities, such as obesity hypoventilation syndrome or congestive heart failure (CHF), than the average bariatric population or they would not have been categorized as disabled. This Medicare SSI (disability) population represents a very high-risk group who would benefit from the LSG as a lower risk procedure than RYGB or the Biliopancreatic Diversion with Duodenal Switch (BPD/DS), which are currently covered by CMS. Surgical complications in this population as a consequence of these high-risk procedures can be very expensive. Coverage of the LSG could lower the total cost of management of the high risk Medicare patient while providing a more effective procedure, especially for Type 2 Diabetes Mellitus (T2DM), than the gastric band, also covered by CMS. The laparoscopic gastric band was never required to show efficacy in RCTs with other bariatric surgical procedures in the CMS population nor show data longer than three-year follow-up when approved by the Food and Drug Administration and then accepted by CMS as a covered procedure. A much higher level of supporting evidence has already been achieved for the LSG.

According to CMS's own MedPAR data for 2010, we have the following observations about Medicare patients that have had bariatric surgery. Namely, bariatric surgery in Medicare beneficiaries is rare with 14,500 Medicare beneficiaries having a bariatric surgery procedure in 2010, representing only about 0.04% of all Medicare beneficiaries. Bariatric surgery in Medicare beneficiaries occurs most commonly in age <65 with 68% (or 9900 beneficiaries) of Medicare bariatric patients were age <65, and 70% of these patients were between the ages of 45-64 which is the typical bariatric surgery patient age in the general population. Of note, about 600 Medicare patients have already received a laparoscopic sleeve gastrectomy in 2010

In summary, even though I am no longer performing bariatric surgery, my reading of the literature finds that the published data, especially within the past year, has provided much more data than was required for approval of the adjustable band. It is a much more effective procedure than the band for patients with T2DM. The operation is almost as effective for weight loss and the control of co-morbidities as the RYGB but much easier to construct and it is safer than either the RYGB or the BPD/DS. It is an ideal procedure for the SSI severely obese patients who are < 65 years of age and severely disabled.

Sincerely yours,
Harvey J. Sugerman, MD
Emeritus Professor of Surgery
Virginia Commonwealth University

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It is with surprise and disappointment that I forward this response to CMS regarding the recent decision to provide coverage for laparoscopic vertical sleeve gastrectomy, only within a randomized clinical study. With a lengthy resume of professional experience in this area, I think that this decision is going to reduce access to proper treatment for Medicare covered patients, and not expand medical knowledge.

The role of a clinical trial should be to determine the effectiveness of a procedure, and compare it to other similar therapies. In both of these areas, there is no justification for a randomized trial. Sleeves have been performed throughout the world for years. My personal experience dates to 2003. With thousands of articles, with weight loss data reported out more than 5 years, the accumulated results cannot be because of a placebo or Hawthorne effect. Furthermore, several recent randomized trials demonstrate the effectiveness of sleeve gastrectomy in the treatment of Type II Diabetes and Metabolic Syndrome.

If the question is whether and how sleeve compares to gastric bypass, again this is not an area that justifies clinical trial. The two procedures are not analogous, as bypass requires intestinal manipulation and sleeve does not. There are substantial medical reasons were sleeve would be a preferential procedure for Medicare covered patients.

For example, for patients that require joint replacement and maintained on NSAIDS, sleeve is preferable. Gastric bypass requires gastrojejunostomy and a disturbing late complication is marginal ulcer. This is not a rare occurrence and life long NSAIDS would be a concern for any bypass patients. Similarly, patients with coronary artery or vascular disease require aspirin. This also can increase possibility of bleeding marginal ulcer. Patients that have had a previous transplant are also best served by sleeve. Concentrations of the immunosuppressants can be altered by the bypass, especially those that require proper fat absorption for efficacy. Other potential circumstances where sleeves maybe preferable are patients with multiple previous abdominal operations, history of inflammatory bowel disease, or other bowel resections.

In summary, these are not identical procedures. What is especially odd is that the sleeve involves only gastric manipulation, whereas gastric bypass requires both gastric and intestinal alteration. It should be allowed to do less, not more when objectives can be met with only gastric manipulation.

From a research standpoint, any trial will be impossible to enroll objective patients. As coverage exists for rygb, lagb and ds, only patients that desire sleeve will submit to randomization. This will mean that the only role of the trial will be a mechanism for coverage for patients who want sleeve. Patients that desire other bariatric procedures will never consent. Thus making this an expensive and useless exercise.

CMS must provide a balance between preventing patients from having the procedures that may be best for them and covering procedures that have not been shown to be effective and are really experimenting on patients. There is a role for randomized trials, but not in every circumstance.
At present, there is zero question that sleeve is an effective weight loss procedure, with better efficacy than covered procedures such as lagb. There is also little question that its safety profile is similar to other stapling procedures and strong suggestion that is actually safer than operations that require intestinal manipulation.

Additionally, there are known physiologic factors that would indicate that sleeve is a better choice than other covered procedures for Medicare beneficiaries. If this decision is not changed, I am certain that bariatric care is going to suffer and those in Medicare will get procedures that will wind up being more expensive, less effective, and have a higher complication rate. We do not need a randomized trial to demonstrate, only basic knowledge of gastric and intestinal physiology.

Mitchell S Roslin MD FACS
Chief of Bariatric Surgery
Lenox Hill Hospital/NSLIJ?Northern Westchester Hospital Center

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2).

Many surgeons will be writing to you asking you to review additional literature. I'd like to approach this from another view.

We all know that Gastric Banding is only successful in a small, very unique group of individual. The Gastric Bypass, the gold standard, produces phenomenal results, but at an increased risk to the patient.

As a nurse, I'm asking you to consider the outcomes for the thousands of the already at risk Medicare patients who are subjecting themselves to the additional risks of a Gastric Bypass when a less invasive sleeve gastrectomy would give them virtually the same result at a fraction of the risk.

Not only am I asking that CMS review the new evidence but also reach out to our medical community and personally MEET some of the recipients of the Sleeve Gastrectomy. THEN reach the conclusion that Laparoscopic Sleeve Gastrectomy should become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Thank you so much for your time. I would be more than welcome to speak further with you.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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First I want to thank CMS for helping to improve access through National Coverage.

[PHI Redacted] my understanding is that Medicare has not recognized the gastric sleeve surgery. I hope you can reconsider this decision. Any tools available to help improve the health of our citizens is a valuable step toward treating obesity.

My family and I hope that there will be continuing efforts made to expand the treatment of obesity in our country. It affects so many lives and families and we are so hopeful for more treatment options.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Sincerely,
Valerie J. Halpin, MD

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Morbid obesity is an epidemic in America. Unlike other epidemics, the policy decision to limit the use of all proven therapies shows significant prejudice on the part of the CMS decision makers. Although we can continue to work on non-surgical therapies, research has clearly shown that these therapies are ineffective. Surgical therapy has so far been shown to be the only effective therapy. Like most disease processes, there is never one therapy treats all presentations, and surgical therapy is no different. The use of gastric banding, gastric bypass, and sleeve gastrectomy has undergone extensive use in the past several years, and extensive research has shown that sleeve gastrectomy indeed has a place in the treatment options for morbid obesity and its comorbid diseases. There is ample research to show effective and significant weight loss and reduction of the severe and life threatening conditions that include diabetes, hypertension, sleep apnea, hyperlipidemia, degenerative disc and joint disease and many other conditions. CMS needs to allow its patients to access the options available and considered now standard by the experts representing bariatric surgery. The abundance of research available and growing monthly would be completely ignored if the decision to limit the access to sleeve gastrectomy prevails.

Sincerely,

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

I am the director of the Bariatric Care Center at Summa Health System. We are the safety net hospital for Summit County, OH and see a high percentage of CMS funded patients. The sleeve gastrectomy is often the best choice for patients with significant medical and psychological disability, allowing them to successfully lose weight, yet allowing their physicians to continue to care for them. We have performed over 100 sleeve gastrectomies, with excellent outcomes and very morbidities. Please, please reconsider this decision, and allow the sleeve gastrectomy as a weight loss surgical option as a covered benefit through CMS.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Thank You,
David Buchin, MD, FACS, FASMBS

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed. I have many patients with Medicare coverage requesting this procedure and who would benefit greatly by having this procedure by improved outcomes and reduced morbidity.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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As "obesity surgery" becomes more and more apparent to be in fact metabolic surgery and the treatment of disease states including diabetes, CMS must hone it's choices of covered benefits to those that are truly metabolic therapies of efficacy and safety. As a bariatric surgeon since 2000 and after 4000 gastric bypasses, I was reluctant to embrace the sleeve gastrectomy until late 2011 when the utter failure of the adjustable gastric band as a metabolic surgery (a CMS covered procedure) could no longer be ignored. After reviewing the enclosed data and performing more than 100 sleeves I request that you reconsider your decision to restrict the sleeve to randomized trials and support the performance of the sleeve to your clients as an approved therapy. The results in support of the sleeve from members of the American College of Surgeons and the American Society for Metabolic and Bariatric Surgey continue to accrue monthly and are quickly approximating those of the gastric bypass without the morbidities of re-operation for marginal ulcer and bowel obstruction. Substituting coverage for the sleeve in lieu of the adjustable band would provide needed treatment, conserve financial resources, and yield far more reliable and sustainable results.

Please review these additional studies that were not included in the ASMBS response by Drs. Robin Blackstone and John Morton on April 23rd:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.
2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.
3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.
4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am very concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed. Here are just a small sample of articles in the medical literature to support my position.

1. New England Journal of Medicine, March 26, 2012, Schauer et a published "Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes." The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment. Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six- year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O'Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic?and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients ?65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a Zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks for a number of reasons. Sleeve gastrectomy is associated with less morbidity yet near equivalent weight loss and resolution of comorbidities when compared to gastric bypass. Sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I have seen a number of Medicare patients who after a careful review of the available procedures have believed that the sleeve gastrectomy was the best option for them. The disappointment is evident when I tell them that due to their insurance coverage a sleeve gastrectomy is not an option unless they wish to pay cash for the operation. I often wonder if I am truly doing an informed consent when I consent the patient for their second choice when it comes to a weight loss operation. I need this option to take care of Medicare patients just like I do for my other patients.

I am asking that CMS review the new evidence and reach a conclusion that laparoscopic sleeve gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans. Thank you for your consideration.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your proposed Decision Memo for Bariatric Surgery for the treatment of Morbid Obesity (CAG-00250R2) I believe the decison memo is based on an incoplete review of available evidence for Laparoscopic Sleeve Gastrectomy. I belive CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit for Medicare patients seeking tretment for morbid obesity and related co morbid conditions. The following reports should be included in your review.

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.
2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.
3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.
4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

I ask that CMS review these reports and the informatin they provide and reach the conclusion that laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare Benmeficieries when they seek out treatment for Morbid Obesity.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Thank you for your consideration,
Alicia Allen
Dietitian

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I am a Bariatric and general surgeon who cares for patients with Medicare. I have seen that these patients often have a great need for weight loss surgery to improve their health and QOL. It is not infrequent that the gastric bypass is too high risk and the lap band is too ineffective to help them. They may also have specific situations like chronic steroid use or need for chronic NSAIDS where a sleeve gastrectomy would be a perfect option because it does not carry the risk of marginal ulceration that would be significant in patients on these medications with a gastric bypass. These patients often have limited mobility with arthritis exacerbated by their weight and just cannot exercise enough to lose weight with the lap band.

I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Evidence is present that shows sleeve gastrectomy to be an effective form of surgical weight loss. Limiting access to patients only in a clinical trial would only serve to delay the inevitable and hurt patients and increase costs in the long run.

Thank you for your consideration.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

As a practicing bariatric surgeon, I feel this is imperative. Many patients would greatly benefit from this surgery.
Thanks.

Farah A. Husain MD FACS

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4/25/2012

To Whom It May Concern,

I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Sincerely,

Teresa Fraker, MS, BSN, RN
Director, Outpatient Services
Genesis Health System
1227 East Rusholme Street
Davenport, IA 52803
fraker@genesishealth.com
Office, 563-421-6472

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

The research has already been completed, reviewed, published, and validated. I kindly request that you examine current literature before finalizing a decision.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

I personally have done over 500 Sleeve Gastrectomy and have been very impressed with the results. Please see our published study for your review:

Laparoscopic sleeve gastrectomy is a safe and effective bariatric procedure for the lower BMI (35.0-43.0 kg/m2) population.Obes Surg. 2011 Aug;21(8):1168-71

The laparoscopic vertical sleeve gastrectomy (LSG) is derived from the biliopancreatic diversion with duodenal switch operation (Marceau et al., Obes Surg 3:29– 35, 1993; Hess and Hess, Obes Surg 8:267–82, 1998; Chu et al., Surg Endosc 16:S069, 2002). Later, LSG was advocated as the first step of a two-stage procedure for super-obese patients (Regan et al., Obes Surg 13:861–4, 2003; Cottam et al., Surg Endosc 20:859–63, 2006). However, recent support is mounting that continues to establish LSG as the definitive procedure for surgical treatment of morbid obesity. We will report our experience with the LSG as a primary bariatric procedure and evaluate if this operation is suitable as a stand-alone procedure. Methods The study is a nonrandomized retrospective analysis of 204 patients from a single surgeon operated between July 2006 and April 2010. The study comprises of 155 women and 49 men with a mean age of 45 years (range, 19–70 years), a mean preoperative weight of 126.6 kg, and body mass index (BMI) of 45.7 kg/m2. Results The mean percent excess weight loss (%EWL) was 49.9% (n=159), 64.2% (n=138), 67.9% (n=77), 62.4% (n= 34), and 62.2% (n=9) at 3, 6, 12, 24, and 36 months, respectively. For patients with BMI =43.0, the mean postoperative %EWL was 58.9% (n=72), 74.1% (n=67), 75.8% (n=39), 72.1% (n=17), and 78.7% (n=5) at 3, 6, 12, 24, and 36 months, respectively. Operative complications include leak (0.0%), abscess (0.5%), hemorrhage (1.0%), sleeve stricture (1.0%), and severe gastroesphogeal reflux disease with need to convert to laparoscopic Roux-en-Y gastric bypass (0.5%).

Conclusions LSG yields excellent outcomes with low complication rates for morbidly obese patients. We advocate LSG as a safe and effective stand-alone procedure, especially with the lower BMI population (BMI 35.0– 43.0 kg/m2).

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April 25, 2012

VIA Electronic Mail to: CAGinquiries@cms.hhs.gov

Joseph Chin, MD, MS
Lead Medical Officer
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Mailstop S3-19-07
Baltimore, MD 21244-1850

Maria Ciccanti
Lead Analyst
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Mailstop S3-02-01
Baltimore, MD 21244-1850

RE: Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2)

Dear Dr. Chin and Ms. Ciccanti:

On behalf of Allergan, Inc., the manufacturer of the LAP-BAND® System, we are pleased to submit comments on the above-captioned Proposed Decision Memo. In these comments, we:

• Confirm our agreement with the agency’s characterization of the scientific evidence supporting the use of laparoscopic sleeve gastrectomy (LSG) in obese Medicare beneficiaries as “insufficient” to meet the “reasonable and necessary” standard as required by law
• Confirm our support for the agency’s decision to limit coverage for LSG to randomized controlled trials meeting certain requirements; and
• Provide a detailed overview of a recently-published article regarding LSG (the “STAMPEDE trial”) and conclude that it does not provide adequate clinical data responsive to the agency’s outstanding issues

As such, we encourage the Centers for Medicare & Medicaid Services (CMS) to finalize the Proposed Decision Memo as currently written.

Allergan agrees that the currently-available evidence is insufficient to conclude that LSG for the treatment of obesity (BMI = 35 kg/m²) improves long-term beneficiary health outcomes. In the comments that we submitted at the opening of the National Coverage Analysis (submitted October 30, 2011), we identified 16 studies that met search criteria. While these studies were generally supportive of LSG, we agree with CMS’s assessment (1) that there are no high quality studies or randomized controlled trials that specifically address the use of LSG in Medicare-eligible patients, (2) that the absence of such studies requires the generalization of data regarding younger adults to an older population, which may not be clinically appropriate, and (3) that no published study (regardless of study population demographics) reported long-term outcomes with an adequate number of participants. For your convenience, the following table lists publications that CMS and/or Allergan located during the NCA review period, and summarizes the reasons that CMS would not find such publications to be useful:

The Social Security Act only allows Medicare to establish coverage for LSG insofar as (1) CMS determines that the procedure is “reasonable and necessary” for the treatment of obesity, or (2) CMS establishes a coverage with evidence development (CED) program intended to provide the agency with the clinical data it needs to make a permanent coverage decision. Insofar as CMS interprets the “reasonable and necessary” standard for LSG to require RCTs with long-term follow-up in a Medicare-eligible population (among other requirements), we agree that the evidence is currently insufficient for LSG to be considered “reasonable and necessary”. Therefore, as a matter of law, Medicare may only provide coverage for LSG insofar as the procedure is performed in a clinical trial under the agency’s CED program.

Allergan supports CMS’s proposal to limit coverage for LSG to clinical trials performed under the auspices of the agency’s CED program. The agency’s proposal requires that such trials meet a series of design requirements (e.g., randomized controlled trial, patients are Medicare subjects who have BMI = 35 kg/m², follow-up of 3 years or longer, etc.); such requirements reasonably limit coverage to clinical trials capable of addressing the outstanding issues identified in the previous section, and the results of these trials will enable the agency to come to a clinically-appropriate, data-driven permanent coverage determination.

We believe that the proponents of expanded coverage for LSG intend to bring a recently-published article (the Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently (STAMPEDE) trial) to your attention. To help you evaluate this publication, we have (1) prepared an overview of the study’s key elements (with particular emphasis on the study’s findings with respect to LSG, and (2) analyzed whether the study addresses the key issues on which CMS believes it needs evidence to conclude that LSG is effective for the treatment of obesity (BMI = 35 kg/m²) in Medicare patients.

1. Overview

The following table summarizes the key elements of the STAMPEDE Trial.

2. The STAMPEDE Trial does not provide clinical data responsive to the agency’s outstanding questions

CMS proposes to limit coverage for LSG to clinical trials with the characteristics described in the Proposed Decision Memo. Because the agency (presumably) established these requirements to ensure that covered clinical trials will produce the information the agency needs to make a permanent coverage decision, we believe that CMS is likely to use the same criteria to evaluate clinical literature submitted during the current comment period.

As illustrated below, the design of the STAMPEDE trial does not meet several of the Decision Memo’s requirements, and thus, does not provide clinical data responsive to the agency’s outstanding questions:

The results of the STAMPEDE trial are promising. Nevertheless, the methodological shortcomings identified above – in particular, the exclusion of Medicare-eligible individuals from the study population and lack of long-term follow-up – limit the usefulness of these data to address the outstanding clinical questions raised by CMS in the Proposed Decision Memo as being necessary to make a permanent coverage determination.

Finally, we note that because the STAMPEDE trial includes a relatively high percentage of patients with BMI < 35 kg/m² – i.e., patients that would not meet the BMI requirement for coverage under the “Bariatric Surgery for the Treatment of Morbid Obesity” NCD – this publication may be more appropriately considered under the “Surgery for Diabetes” NCD.

I hope that you find the information in this letter to be helpful. If you have any questions, please contact me via e-mail at okerson_ted@allergan.com. Thank you in advance for your review and evaluation of the attached clinical literature.

Sincerely yours,

/s/

Ted Okerson, MD, FACP
Sr. Med. Dir. – Device, Global Medical Affairs, Allergan Inc.

Attachement

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To whom it may concern:

I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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To Whom It May Concern.

I would like to join many of my professional associates and physicians across the country to comment on your recent proposed decision memo for bariatric surgery for the treatment of morbid obesity (CAG-00250R2). I am concerned that the proposed memo is an incomplete review of available evidence. It does not consider that the population is aging and becoming more and more obese. In short, it does not consider the entire Medicare population and it will diminish access to care for patients in dire need. CMS should provide laparoscopic sleeve gastrectomy as a covered benefit so that this patient group can experience the same health advantage other Americans have enjoyed. This surgery not only treats obesity, but treats the associated illnesses.

Specifically CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior medical therapy in this randomized control trial.
2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.
3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.
4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risk. Many of these may have other health risks which prohibit them from having other bariatric surgery such as the roux-en-Y gastric bypass. Populations such as transplant patients, severe arthritis patients or other rheumatologic conditions and others are best served with laparoscopic sleeve gastrectomy. To prohibit this from Medicare beneficiaries is extremely short sighted. Please, carefully re-consider your decision.. The sleeve gastrectomy should be an available surgical option for this group of high risk patients. I need this option to take care of Medicare patients and provide the same level of care we provide for other patients. I am asking CMS to review the new evidence and reach the conclusion that laparoscopic sleeve gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desire the same treatment options as other Americans.

Kevin E. Wasco, M.D., F.A.C.S., F.A.S.M.B.S.
President of Wisconsin Obesity Coalition/Wisconsin Chapter of ASMBS

KEW/mlf

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients. Finally, this decision affects a number of other patient related issues that are too complicated to be discussed in detail. The sleeve operation is the ideal operation for patient who potentially will require transplantation subsequent to their weight loss. The sleeve operation is the ideal operation for patient with auto-immune disease who must take anti-inflammatory therapy. the sleeve operation is the ideal operation for patients who have giant incisional hernias. I could go on with many examples where the sleeve operation is the most ideal choice for our patients based upon their individual circumstances. Broad sweeping decisions miss the whole point of individualizing care for our patients to acheive the best outcomes for them. It is not the role of the insurer to tell us which operation is best, but to allow us the opportunity to use all of the tools at our disposal to best manage out patient conditions. I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I am writing to urge CMS to consider offering FULL COVERAGE of sleeve gastrectomy for Medicare beneficiaries. Newer available evidence that the committee should examine, in addition to the data already presented, includes:

1. New England Journal of Medicine, March 26, 2012, Schauer et al. "Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes."
2. Archives of Surgery, April 16, 2012, Leonetti et al. "Obesity, Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment."
3. Annals of Surgery, August 2010. Himpens et al. "Long-Term Results of Laparoscopic Sleeve Gastrectomy for Obesity."
4. Obesity Surgery, September 2010, O'Keefe et al. "Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence"

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with approximate equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

I am a bariatric surgeon with 10 years and 4000 patients experience. I have extensive experience with adjustable gastric banding, gastric bypass and sleeve gastrectomy. Sleeve gastrectomy has been a life-saving and cost-saving procedure for many high-risk patients who would not be candidates for gastric bypass and would not likely see good results with adjustable gastric banding.

Sleeve gastrectomy is especially beneficial for Medicare beneficiaries. Due to age, comorbidities and a high prevalence of medications such as NSAIDs common in this population, Medicare patients are at increased risk of complications related to gastric bypass, and sleeve gastrectomy mitigates these risks.

Sleeve gastrectomy has already been shown in at least one randomized trial to have superior results to adjustable gastric banding (see reference below) and as such can be expected to be more cost-effective, especially when taking into consideration the increased costs from adjustable gastric banding related to the device itself, band adjustments, and a high rate of re-operations due to problems such as slips, erosion and pouch or esophageal dilatation.

Please reconsider the decision to restrict sleeve gastrectomy to randomized trials as this this decision will sharply reduce the availability of this cost-saving, life-saving procedure to the patients who need it most.

Sincerely,
Hugh P. Babineau, MD, FACS, FASMBS
Tyler, Texas

ref: A prospective randomized study between laparoscopic gastric banding and laparoscopic isolated sleeve gastrectomy: results after 1 and 3 years.
Obes Surg. 2006; 16(11):1450-6 (ISSN: 0960-8923)

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2).

I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.”Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile. Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

The following article demonstrate the efficacy of sleeve gastrectomy in the treatment of morbid obesity:

1. New England Journal of Medicine, March 26, 2012, Schauer et a published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.
2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment. Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.
3. Himpens in Annals of Surgery 2010. This six- year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.
4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic?and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a Zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patient with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patient. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach conclusion that laparoscopic sleeve gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Thank you for your attention to this important issue

Sincerely,

John Angstadt, MD, FACS, FASMBS
New York Bariatric Group

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I am a fellowship trained bariatric surgeon and have been in practice for 8 years. I am an ACS COE surgeon as is my practice and hospital. I have been performed about 125 laparoscopic sleeves over the past 3 years.

The sleeve is a quick and relatively simple procedure to perform. It is about an 1hr quicker than a bypass and has fewer periop complications and almost no long term complications. Weight loss is comparable (about 60% excess wt loss at 1yr) to the bypass and far exceeds that of the band. It is ideally suited for the older medicare population that is often too high risk for a bypass and need more weight loss than the band.

I would urge you to consider coverage for the laparoscopic sleeve. Without sleeve coverage many Medicare recipients will be steered away from the bypass to the band. I honestly do not think it the band is very effective in the medicare population and would be in favor of eliminating coverage of the band in exchange for CMS coverage of the sleeve.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment in support of the Bariatric sleeve procedure. [PHI Redacted] had this procedure approximately one year ago. She needed the procedure as medical necessity due to other issues affecting her overall health. Since her surgery, she has lost approximately 80 pounds. Her overall health has improved immensely, taking her off virtually all her medications. She continues to exercise but is able to do much more and with little or no pain and continues to improve steadily.

[PHI Redacted]

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Hello,

As a busy bariatric surgeon, I would like to mention to you the important role that the sleeve gastrectomy plays in the safe management of high risk morbidly obese patients. Those taking aspirin for life or requiring steroids would have tremendous problems with the gastric bypass. The band is an alternative, but the outcomes are so poor long term that most of us are very hesitant to offer the band to patients that have limited mobility.

Please don't make the mistake of being penny wise and pound foolish. The patients receiving the band will ultimately play a large role in band removal and will cost more long term.

Thank you for your consideration.

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I wish to take this opportunity to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2).

I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

A recent New England Journal of Medicine, published March 26, 2012, by Schauer et al, “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial. Excess weight loss of only 13% for intensive medical therapy was seen as compared to 88% for Roux-en-Y gastric bypass and 81% for sleeve gastrectomy.

In an article published on April 16, 2012 in the Archives of Surgery, Leonetti and colleagues published Obesity, Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment. Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

Himpens, in an Annals of Surgery article in 2010, completed a six-year study demonstrating durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

In 2010, O’Keefe et al published an article in Obesity Surgery, Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic?and Bariatric Surgery Center of Excellence. All three weight loss procedures (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All procedures were also associated with a Zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patient with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patient. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach conclusion that laparoscopic sleeve gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Megan Gilmore, MD

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Would like to comment on the recent proposal by CMS for restricted coverage of laparoscopic sleeve gastrectomy only under clinical trials. I am in complete support of the response and comment submitted and signed by the American College of Surgeons, SAGES and ASMBS.
The points of my comments are:
1. CMS analysis didn’t include recent studies that can add to the data validation of this procedure.
2. CMS patients are in many instances not acceptable candidates to the options already accepted by CMS: sometimes too sick for gastric bypass and sometimes less complaint for the needed gastric band follow-up and adjustments. The sleeve gastrectomy has taken a role in some patients that need a stronger effect from the procedure that doesn’t limit their ability to obtain outcomes regardless of other psychosocial limitations.
3. Clinical trials are difficult to perform in private setting and the patient access will be extremely compromised. It is unrealistic to wait several years until some data is obtained, as more data has become available and will continue to be available in the near future.
I would encourage CMS to look at the new proposed ACS/ASMBS Accreditation and Quality Improvement Program that would enable us to collect data and improve quality, and a potential collaboration with CMS can address the need for specific answers to specific questions. Respectfully would state that being too restrictive in coverage is not the solution for a disease that causes a lot of health problems and cost.
Jaime Ponce, MD, FACS, FASMBS
Bariatric Surgeon
Dalton GA/Chattanooga TN

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed. This is an excellent alternative to the adjustable band operation which has a very high long term complication and failure rate. It is also probably the best operation for the patients that CMS serves ie disabled, elderly, or what we in surgery call "poor protoplasm" ie high risk.

I am asking that CMS review the new evidence below and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

By not doing so, you will lessen the options available to patients who do not want to have a malabsorptive procedure. CMS will furthermore incur more costs down the road with all the adjustments and removals and reoperations that bands require.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.
2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.
3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.
4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

The current situation is that medicare patients (usually higher risk) are not offered sleeve as an alternative to bypass, and thus can only choose between band and bypass, when a sleeve may be a safer option than the bypass in certain situations.

For instance, i recently had a superobese (BMI > 50) heavy smoker, s/p laparotomy for trauma and open cholecystectomy who was interestd in the sleeve. this would be a better option than the bypass b/c 1) lysis of adhesions required for bypass 2) smoking history portends higher risk of marginal ulcer 3)sleeve better option in superobese. b/c medicare only approves bypass, she has been unable to receive the care she needs most.

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Below is my comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). CMS should provide coverage for the Laparoscopic Sleeve Gastrectomy. The Medicare population is at an extreme disadvantage in that at the present time, they cannot enjoy the numerous health benefits that result from safe, dramatic weight loss that occurs after the Sleeve Gastrectomy.

Several articles have been recently published which demonstrate that the Sleeve Gastrectomy is superior to medical therapy in treating obesity-related comorbidities such as Type 2 diabetes, hypertension, and sleep apnea.

Schauer, et al's study entitled "Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes," published in NEJM March 26, 2012 showed that the Sleeve Gastrectomy was superior to medical therapy and as good as the Gastric Bypass in controlling blood sugar. Likewise, Leonetti et al published "Obesity, Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy versus Medical Treatment" in Archives of Surgery on April 16, 2012. These authors demonstrated that the Sleeve Gastrectomy was superior to medical treatment in causing a decline in fasting blood sugar.

Several Medicare patients would benefit from the Sleeve Gastrectomy. This surgery provides greater weight loss, on average, when compared to the Gastric Band, and has a lower risk profile when compared to the Gastric Bypass, while providing similar dramatic weight loss. It is a daily occurrence that I see a Medicare patient in my office who I believe is too high risk for the Gastric Bypass but who clearly would not acheive the mediacal benefits from the Gastric Band. I know these patients would be perfect candidates for the Sleeve Gastrectomy.

Please strongly consider covering the Sleeve Gastrectomy as an option for Medicare patients suffering from obesity.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I wish to take this opportunity to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2).

I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

A recent New England Journal of Medicine, published March 26, 2012, by Schauer et al, “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial. Excess weight loss of only 13% for intensive medical therapy was seen as compared to 88% for Roux-en-Y gastric bypass and 81% for sleeve gastrectomy.

In an article published on April 16, 2012 in the Archives of Surgery, Leonetti and colleagues published Obesity, Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment. Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

Himpens, in an Annals of Surgery article in 2010, completed a six-year study demonstrating durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

In 2010, O’Keefe et al published an article in Obesity Surgery, Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic?and Bariatric Surgery Center of Excellence. All three weight loss procedures (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All procedures were also associated with a Zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patient with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patient. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach conclusion that laparoscopic sleeve gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I am writing to urge CMS to consider offering FULL COVERAGE of sleeve gastrectomy for Medicare beneficiaries. Newer available evidence that the committee should examine, in addition to the data already presented, includes:

1. New England Journal of Medicine, March 26, 2012, Schauer et al. "Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes."
2. Archives of Surgery, April 16, 2012, Leonetti et al. "Obesity, Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment."
3. Annals of Surgery, August 2010. Himpens et al. "Long-Term Results of Laparoscopic Sleeve Gastrectomy for Obesity."
4. Obesity Surgery, September 2010, O'Keefe et al. "Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence"

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with approximate equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

New England Journal of Medicine, March 26, 2012, Schauer et a published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment. Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

Himpens in Annals of Surgery 2010. This six- year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic?and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a Zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patient with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patient. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach conclusion that laparoscopic sleeve gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I have read and whole heartedly agree with Dr Morton's Statement quoted below. I would like to second his motion will continue to support all efforst to promote the safety and efficacy of Bariatric Surgery.

"I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

New England Journal of Medicine, March 26, 2012, Schauer et a published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment. Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

Himpens in Annals of Surgery 2010. This six- year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic?and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a Zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patient with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patient. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach conclusion that laparoscopic sleeve gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

John Morton, MD, MPH, FACS
Associate Professor of Surgery
Section Chief, Minimally Invasive Surgery
Director of Quality, Surgery and Surgical Sub-Specialties
Director of Bariatric Surgery
Stanford School of Medicine
300 Pasteur Drive, H3680
Stanford, CA 94305
650-725-5247 Office
650-736-1663 Fax
morton@stanford.edu
http://med.stanford.edu/profiles/John_Morton"

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Sincerely,
Dr Anthony Maffei, FACS

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Please would ask you to reconsider your decision for restriction of Sleeve Gastrectomy to just RPT.

You will have plenty of info from others as to the literature or rationale as to why Sleeve produces reproducible, effective, and safe outcomes in morbid obese populations. I will not reiterate here

I will comment that RPT's do not often make sense or are feasible in the bariatric surgery realm. PRTs often make sense in surgery when you are refinig a technique of a particular focus that may improve that surgery. An example of that might be an RPT that compares two techniques of a gastric bypass. But they are very hard to carry out or unncessary for two completely separate surgeries with different risk profiles, experiences and expected outcomes. It could not work, for example for Lap Band, and yet this procedure emerged as an approved modality based on large experience and case series producing reproducible outcomes.

Such should be the case for Sleeve Gastrectomy.

Medicare patients should not be denied access to a procedure now available to much or our patient poplulation in Massachusetts. They should not be denied access to a true and safe alternative to gastric bypass. An alternative to gastric bypass is often necessary due to:
-patient request
-not want a foreign body (lap band), or contraindic to band
-gastric bypass not possible due to: inabililty to manipulate or use small intestine due to previous surgery, high risk of malabsorption complictions of nutrients or certain medications, high marginal ulcer risk

As a dedicated and hardworking surgeon for medicare patients, we desparately need more tools rather than less to help your patients. Lap Bands dont cut it for many. And gastric bypass is not always possible, safe, or indicated.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity. I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed. Furthermore, Medicare patients tend to have more co-morbidities making a procedure like the gastric bypass riskier in this patient population. The ideal procedure from a risk stand point on a Medicare patient with multiple co-morbidities is the sleeve gastrectomy. There is plenty of clinical evidence that support sleeve gastrectomy in the Medicare population. I have included a list of the studies to review.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.
2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.
3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.
4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.
I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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To whom it may concern,

I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed. We see many patients who are better candidates for sleeve gastrectomy based on their medical history or who are unwilling to undergo the more invasive bypass surgery and cannot get approval for the sleeve gastrectomy due to Medicare restrictions. It is not right to only offer this procedure to a small portion of patients who could truly benefit when there is now research showing its effectiveness in terms of improvement of obesity related comorbid illness, weight loss and quality of life.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.
2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.
3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.
4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Best regards,
Sara Tortorici, RN, NP
Center for Surgical Weight Loss
Lahey Clinic
Burlington,MA 02474

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With obesity being among the top health concerns in the United States, I feel CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit to medicare recipients.

Based on the decision memo, it appears an incomplete review of the literature has occurred and I would like to suggest that CMS specifically review the following:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.
2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.
3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.
4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

The sleeve gastrectomy procedure demonstrates excess weight loss and improvement or remission of obesity related illness that is comparable to gastric bypass, and with lower morbidity. It is a safe and effective treatment for the management of obesity without the malabsorptive concerns of the gastric bypass, and with more excess weight loss than is achieved with adjustable gastric banding. In my 10 years of clinical experience with bariatric surgery, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I am asking that CMS review the above cited evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries.

Thank you for your attention.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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Laparoscopic sleeve gastrectomy is a bariatric procedure that has withstood the scrutiny of peer reviewed analysis. There are numerous scientific publications that support the safety and efficacy of this bariatric procedure. In many circumstances it is the most appropriate bariatric procedure for a given patient. With supportive 5-year data and an affirmative position statement from The ASMBS, individual consideration should be given to selected patients who are contemplating this surgical approach.

Per the updated position statement on sleeve gastrectomy, some of the patients who would be considered appropriate for sleeve gastrectomy include those with a significant prior abdominal surgical history and resultant intra-abdominal adhesions, those with autoimmune conditions for whom gastric banding may be contraindicated, patients with a BMI greater than 60 kg/m2, patients who require continued use of specific medications (immunosuppressant or anti-inflammatory agents), pre-transplant weight loss, patient refusal to undergo anatomic rearrangement of their intestinal anatomy or placement of an implanted device, or patients who have experienced complications related to prior gastric restrictive procedures. This list represents a sample of potentially high-risk bariatric patients. There are other clinical scenarios that would support the performance of sleeve gastrectomy that would warrant individual consideration.

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To whom it may concern:

First of all let me say thank you for being an insurance provider to many patients in the United States and for the many procedures that you currently do cover. However, in regards to your decision to only cover the vertical sleeve as a randomized controlled trial, I do not agree. This surgery has been around for several years now and has been proven successful over those years. As a matter of fact, it is just as successful, if not more, than gastric bypass surgery.

[PHI Redacted]

I hope that you will give great consideration to covering this surgery for your patients as I believe it is a benefit they should not be denied. The long term benefits are far outreaching over what you will spend in medical cost by not allowing the procedure. I appreciate you taking the time to read my letter and looking forward to seeing this change rolled out by Medicare soon.

Sincerely,

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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it is absolutely inconceivable to me that medicare would NOT want to cover sleeve gastrectomy - there are multiple studies showing it's effectiveness:
The bottom line - as a surgeon that operates for morbid obesity, the sleeve gastrectomy is associated with similar weight loss to bypass, superior weight loss compared to lap band, and LESS long term complications that bypass! in the long term, it will likely be the operation of choice for morbid obesity. Please save the government money by extending coverage for an operation that is the most cost-effective compared to the options out there! It costs LESS than bypass or Lap Band AND is associated with fewer postoperative problems than both operations AND it has simialr weight loss to bypass - please cover it!!!! Enough inefficiency in healthcare! Please do something that makes sense!

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.
2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.
3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.
4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Currently, I am performing Sleeve gastrectomy on patients with high risk factors for complications because I know it will give them great resolution of their comorbidities at low risk. Unfortunately, I am forced to perform more complicated procedures such as gastric bypass or duodenal switch on the Medicare patients due to decisions of non-coverage. Does is make any sense that I am having to offer high risk procedures for my sick-high-risk medicare patients when I know that the Sleeve Gastrectomy would be the best alternative. I truly and sincerely want to provide the best medical solution for this medicare population.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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As a Nurse Practitioner who treats morbidly obese patients, I have seen the sleeve work as well or better than Lap-Band and/or Gastric Bypass in the last 3 years. I offer comment for your recent decision.

I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Less

I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Less

I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Our group recently presented data on over 3400 cases from the BOLD database at the recent SAGES meeting in March 2012. We found that sleeve gastrectomy done at BOLD centers was safe, effective and reproducible. Here are the details of the presentations

Kaul A, Sharma J, Sullivan T, Risucci D, Maffei A, Cerabona T. Leak After Sleeve Gastrectomy: Preliminary Results From) Bariatric Outcome Longitudinal Database (BOLD). Poster of distinction presentation at SAGES 2012 March 8-10, 2012 San Diego

Sharma J, Sullivan T, Risucci D, Maffei A, Cerabona T, Kaul A. Sleeve Gastrectomy: Preliminary Results From The Bariatric Outcome Longitudinal Database (BOLD). Poster presentation at SAGES 2012 March 8-10, 2012 San Diego

Our group has been doing sleeve gastrectomy since 2003 and we have over 600 sleeve cases done during that period. We presented our data at SAGES and found that at 3 years follow up our sleeve gastrectomy outcomes are as good as that of Roux-en-Y gastric bypasses. In our series with 2 year follow up after 874 bariatric cases the excess weight loss after sleeve gastrectomy was 64.2% with a starting BMI of 47.8 kg/m2.

I feel sleeve gastrectomy is the ideal procedure to be done on the elderly obese patient. To then deny an elderly obese this option is in my opinion an example of discrimination based on patients age and the persistent bias amongst society when it comes to taking care of the obese!!!

Specifically, CMS should also review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.
2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.
3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.
4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other America

Less

I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I have several concerns regarding the proposed decision memo. First, there is a cursory review of the available data. Asking for controls within every study borders on ridiculous since countless studies have demonstrated the expected weight loss in dietary controls. Second, critical studies were excluded including:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.
2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.
3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.
4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Finally, the Medicare/Medicaid population is unique in both their surgical and medical complexity. This decision relegates patients to a procedure that may expose them to unnecessary risk or inadequacy in addressing their comorbidities (band). Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients. These patients deserve the same standard of care that is enjoyed by most Americans. Further marginalization is not appropriate and places these patients at increased risk.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I am writing to urge CMS to consider offering FULL COVERAGE of sleeve gastrectomy for Medicare beneficiaries. Newer available evidence that the committee should examine, in addition to the data already presented, includes:

1. New England Journal of Medicine, March 26, 2012, Schauer et al. "Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes."
2. Archives of Surgery, April 16, 2012, Leonetti et al. "Obesity, Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment."
3. Annals of Surgery, August 2010. Himpens et al. "Long-Term Results of Laparoscopic Sleeve Gastrectomy for Obesity."
4. Obesity Surgery, September 2010, O'Keefe et al. "Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence"

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with approximate equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients.

Thank You for consideration of this matter,

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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Thanks for accepting my comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I believe this was an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Below are some literature evidence to support Sleeve

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.
2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.
3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.
4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

Please CMS, review the new evidence and see the realistic conclusion that Laparoscopic Sleeve Gastrectomy should be a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Thank you

Emeka Acholonu MD

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:
1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

Medicare currently covers laparoscopic adjustable gastric banding and has since 2006. This is a procedure that has a 15-30% chance of requiring reoperation, and the average percent excess weight loss is 30-40%. The current data on sleeve gastrectomy in the treatment of morbid obesity demonstrate a greater than 55% excess weight loss, and a much lower reoperation rate. It is a far better operation than the adjustable gastric band for most patients, and it is unethical to deny it to Medicare patients discriminating solely on the basis of age.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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It is becoming obvious to the trained and untrained that obesity surgery is about more than losing weight. It is life-saving and life-lengthening. It is the closest thing to a cure for Type II Diabetes that exists.

Physicians have performed sleeve gastrectomies for hundreds of years with negligible negative effects other than weight loss. For many patients, it is a better alternative than the Bypass, or a step in the right direction.

To limit gastrectomies to a select group for 5 years is ridiculous. Why is it that Medicare would rather pay for knee replacements, insulin pumps, kidney transplants, and amputations rather than a procedure that has been shown to be incredibly safe? Sleeve gastrectomies are a standard option in Bariatric clinics all over the country. What could you possibly learn from a 5-year trial that you don't already know.

It is another example of the government and the forest and the trees. I am not a Medicare recipient yet, but I urge you in the strongest of terms to follow the standard course of action and allow patients to have a life-saving option other than Bypass.

If you want to save money, eliminate coverage for the Band, which is much less effective than originally hoped.

Of course, paying for a personal trainer and nutrition coach for a year or two would cost even less.....

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I would like to comment on the Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am deeply concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have experienced.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL.

All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.
Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients. I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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[PHI Redacted]

All modalities of treatment for obesity need to be accessible to all of us who suffer from this disease. Limiting access to vertical sleeve gastrectomy surgeries will only increase the numbers of patients who continue to suffer multiple co-morbidities including Diabetes[PHI Redacted]. The JAMA reports and the American Diabetes Association supports weight loss surgery as a better means of controlling diabetes than medication, yet you are choosing to limit accessibility to one of these surgeries.
May I respectfully request that you take another look at your data and potentially revise your decision to include this surgery in the CMS as gastric bypass and gastric banding already are included?

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

? Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.
2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.
3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.
4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

I do feel that it is a cost effective alternative to other restrictive procedures. Complication rates are lower than with the lap gastric bypass. For any institution wishing to control costs and still provide effective care the sleeve gastrectomy is really an obvious choice.

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I strongly encourage and endorse the CMS to fully-approve laparoscopic vertical sleeve gastrectomy for the treatment of morbid obesity. The data strongly supports LVSG as an excellent adjunct, not only for successful long-term weight loss, but also in the long-term management of type II diabetes.

My patient population that has chosen LVSG as a weight loss tool has almost universally been completely satisfied with the results of the operation. A 5-year "trial period" is completely unnecessary, as the bariatric surgical community has already extensively studied and validated the LVSG as a viable alternative to Lap Banding or Gastric Bypass.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I wish to take this opportunity to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2).

I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

A recent New England Journal of Medicine, published March 26, 2012, by Schauer et al, “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial. Excess weight loss of only 13% for intensive medical therapy was seen as compared to 88% for Roux-en-Y gastric bypass and 81% for sleeve gastrectomy.

In an article published on April 16, 2012 in the Archives of Surgery, Leonetti and colleagues published Obesity, Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment. Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

Himpens, in an Annals of Surgery article in 2010, completed a six-year study demonstrating durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

In 2010, O’Keefe et al published an article in Obesity Surgery, Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic?and Bariatric Surgery Center of Excellence. All three weight loss procedures (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All procedures were also associated with a Zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patient with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patient. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach conclusion that laparoscopic sleeve gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I should like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I have several concerns that if unaddressed will diminish access to care for patients in need. I am concerned that the proposed decision memo had an incomplete review of available evidence. It did not consider the entire Medicare population as most of the patients who utilized Medicare coverage for NCD 100.1 were the young disabled under the age of 65. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group who desire a procedure (sleeve gastrectomy) that does not require frequent adjustments. They can experience the same health advantages that over 110 million other Americans with access to sleeve gastrectomy. I have personally spoken with the medical directors for United Health, Aetna, Cigna, HCSC, Wellpoint Anthem, who have reviewed the earlier data for sleeve coverage and agreed with coverage.

CMS should also consider that in the highest risk group, that the sleeve gastrectomy can performed as the first stage of a planned two stage operation.

The following articles provide further evidence that support the use of laparoscopic sleeve gastrectomy as a primary procedure. It has equivalent results to other covered procedures such as Laparoscopic Adjustable Gastric Banding, (LAGB).

1. New England Journal of Medicine, March 26, 2012, Schauer et a published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment. Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six- year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years better that LAGB which was the comparator procedure.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic?and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a Zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patient with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass, which is a covered procedure.

The Sleeve gastrectomy has better weight loss and resolution of comorbidities and lower long term complication rates compared to LAGB which is a covered procedure.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patient. I need this option to take care of Medicare patients just like I do for other patients. I am asking that CMS review the new evidence and reach conclusion that laparoscopic sleeve gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I am writing to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need.

I have treated many Medicare patients suffering from obesity who would benefit very substantially from the sleeve gastrectomy. Regrettably, this option was not available and it was necessary to offer them a different operation that was not as optimal for them.

CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

1. New England Journal of Medicine, March 26, 2012, Schauer et a published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment. Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six- year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic?and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a Zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patient with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patient. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach conclusion that laparoscopic sleeve gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

This is a critically important operation that must be made available for the Americans that need it most.

Sincerely,

Daniel M. Herron, MD, FACS
Professor of Surgery
Vice Chair of Surgical Technology
Chief, Section of Laparoscopic & Bariatric Surgery
Mount Sinai School of Medicine
1 Gustave L. Levy Place #1259
New York, NY 10029
212-241-5339

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed. It is safer than the Roux en Y gastric bypass and much more effective than the Lap Band.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.
2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.
3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.
4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Dale Sloan MD

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Sincerely,
Brent J. Bell, MD, JD

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I would like to comment on your proposed decision for the treatment of morbid obesity (CAG-00250R2). I am concerned that the proposed review may have an imcomplete review of available evidence, did not include the entire Medicare population, and will diminish access to care for patients in need with significant disease (morbid obesity.) CMS should provide the Laparoscopic Sleeve gastrectomy as a covered beneift os that this patient group can experience the same health advantage that over 100 million Americans enjoy.

Please, specifially review:

NEW ENGLAND JOURN OF MEDICINSE, March 26, 2012 Schauer et al published information on sleeve gastrectomy outcomes were equivalent to Roux en y gastric bypass and superior to medical management.

ARCHIVES OF SURGERY on April 16, 2012 Leonetti and colleagues publised a prospective chort study of laparoscopic sleeve gastrectomy vs medical management and significant improvement in weight and fasting glucose were seen in the surgical group that was not replicated in the medically treated group.

Himpens in ANNALS OF SURGERY 2010 followed patients in a 6 year study that demonstrated the durability of the sleeve gastrectomy study that were originaly presented in OBESITY SURGERY in 2006 with 53.3% excess weight lost.

BARIATRIC SURGERY OUTCOMES IN PATIENTS AGED 65 YEARS AND OLDER AT AN AMERICAN SOCIETY OF METABOLIC AND BARIATRIC SURGERY CENTER OF EXCELLENCE PUBLISEHD IN OBESITY SURGERY, found that all three weight loss surgeries were effective in patients > or = to 65 years of age producing significant excess weight loss and reduction of medication and improvement in quality of life.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeave gastrectomy is associated with lower morbidity with equivalancey in weight loss and resolution or improvement in co morbidities when compared to gastric bypass. Therefore, sleeve gastrectomy should be available as an option to Medicare beneficiaries who are in need of surgical treatment for morbid obesity. we need this option in our clinic to take care of Medicare patients just as we do for other patients.

I request that CMS review this additional information that is evidence based and reach the conclulsion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Thank you,
Leicia Teixeira, RD, LD

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I believe that the sleeve should be approved for bariatric surgery. Personally,speaking as a nurse working in bariatric surgery, it is much less invasive than the gastric bypass, but much more effective than the lap band. It helps with the co-morbidities, but patients don't have as many complications from mal-absorption.

Many lap band patients do not lose much weight and do not get over their medical problem and then end up converting to other procedures. Why would you not approve an effective, safe procedure such as the sleeve, but approve the lap band that has the end result of costing insurers more money long term?

Also, there is alot of research supporting the sleeve, as you can tell by the ASMBS statement from 6/07 on the sleeve:

"There are currently 15 published reports in the peer-reviewed literature describing shortterm outcomes in 775 patients after sleeve gastrectomy.2-16 A single study provides data to 3 years after the procedure and no follow-up beyond 3 years has been reported.7 The reports describe surgical treatment of patients with preoperative body mass index ranging from 35 to 69 kg/m2 and excess weight loss ranging from 33% to 83%. Comorbidity resolution 12 to 24 months after sleeve gastrectomy has been reported in 345 patients,3-6 demonstrating resolution rates of diabetes, hypertension, hyperlipidemia, and sleep apnea after sleeve gastrectomy are comparable to results of other restrictive procedures.
Similar to other forms of gastroplasty, perioperative risk for sleeve gastrectomy appears to be relatively low, even in high risk patients

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I have 6,000 bariatric patients in my practice. If you are going to approve coverage of any bariatric operations, then I can tell you that the most "sound" decision that Medicare could possibly make would be to approve coverage of Sleeve Gastrectomy. I have been performing Lap Band, Gastric Bypass, and Sleeve Gastrectomy, as well as revision and endoscopic procedures for the past 8 years. In my practice I only perform bariatric surgery and no longer perform general surgery procedures routinely. The complication rate after Sleeve Gastrectomy is only a fraction of the rates after Gastric Bypass and Lap Band. The success rate after Sleeve Gastrectomy is higher than that after Lap Band and roughly equivalent than that after Gastric Bypass. We actually will make less money after performing Sleeve Gastrectomy than Gastric Bypass under most policies. We will ultimately make less money after performing Sleeve Gastrectomy than Lap Band, when considering the "fills" or adjustments that Lap Band patients must have performed periodically under most policies.

Lastly, when any of my friends or family members come to me and ask "what operation should I have?" I will always respond Sleeve Gastrectomy, unless they have Diabetes when I will advise that they have a Gastric Bypass.

Please feel free to contact me at your convenience. My cell phone # is [PHI Redacted]. I would be flattered to put in my two cents or provide answers to any questions that you have. I would also invite you to come to our practice, which is the busiest bariatric practice in the most obese city in the U.S. (San Antonio), so that you can witness what I am trying to communicate to you.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on the decision (CAG-00250R2)regarding bariatric surgery, specifically the decision memo on the sleeve gastrectomy. The sleeve gastrectomy is the primary procedure that I use for my morbidly obese patients to lose weight. I have made this decision based on the effectiveness of the procedure (equal to the gastric bypass and superior to the gastric band) and safety (less procedure related complications than either banding or gastric bypass). My practice has published our results (Bayham et al, Diabetes Technology and Therapeutics, 2012;14(1)).

I would also request your agency review the recent publication (Schauer et al, New England Journal of Medicine, March 26, 2012) and reconsider the decision.

Thank you for your time.

Drake Bellanger, MD

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I am the coordinator of the bariatric surgery program at the Medical University of South Carolina, and an advanced practice nurse whose career is focused on severely obese individuals both before and after surgery. I have personally witnessed the profound change that the sleeve gastrectomy procedure has on these patients' lives. I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

1. New England Journal of Medicine, March 26, 2012, Schauer et a published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.
2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment. Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.
3. Himpens in Annals of Surgery 2010. This six- year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.
4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic?and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a Zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patient with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patient. I need this option to take care of Medicare patients just like I do for other patients.
I am asking that CMS review the new evidence and reach conclusion that laparoscopic sleeve gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed. I have seen first hand the positive results the sleeve gastrectomy has provided to other morbidly obese patients and believe this patient population deserves the same options, as deemed appropriate by a medical team.

1. New England Journal of Medicine, March 26, 2012, Schauer et a published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.
2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment. Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.
3. Himpens in Annals of Surgery 2010. This six- year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.
4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic?and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a Zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patient with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patient. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach conclusion that laparoscopic sleeve gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

[PHI Redacted] Each have their different benefits and outcomes but also different risks. [PHI Redacted] To deny this option puts the patient at risk and limits their available choices without a profound reason. The future benefits are obvious when you consider rising health care costs and the benefits of these surgeries reducing or eliminating the need to continue certain medications or levels of medication upon successful completion and weightless occurs.

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I have been doing bariatric surgery for 11 years now. I saw the onset of the Lap Band after the FDA studies and its subsequent acceptance by CMS along with Gastric Bypass. All evidence at 1, 3 and 5 or 6 years clearly shows that the Vertical Sleeve Gastrectomy is better than the Lap Band for weight loss and at least as effective, if not better in comorbidity resolution. Many studies have shown it to be nearly as effective as Gastric Bypass of both weight loss and comorbidity resolution. Its safety profile falls in the middle of the two covered CMS procedures.

Some weight regain is common with all bariatric surgeries and that does not mean that an operation is bad or inferior. Weight regain is a behavioral problem for the most part.

Many patients are on long term NSAIDS for osteoarthritis, and this is a problem with gastric bypass given the propensity for ulcer formation or GI bleeding. Sleeve patients can be easily surveyed and treated if they develop pain or bleeding which makes it the procedure of choice in pts with bad arthritis.

With diabetes and attendant increase in dialysis in this population, many patients may move towards transplant surgery. A sleeve does not greatly alter absorption of medications (immunosuppressives) given its relatively unchanged pathway. Most dialysis pts have CMS coverage.

Please consider reversing your decision on Sleeve Gastrectomy. A RCT will not show us anything we don't already know about its safety and clinical effectiveness.

J. Genaw, MD FACS

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with highe

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Less

I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Less

I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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Nissin C. Nahmias, M.D., F.A.C.S., F.A.S.M.B.S.
Michael B. Teiger, M.D., F.C.C.P.
Phone: 860-278-3812
Fax: 860-525-6054
Bariatric Surgery Center

To whom it may concern at the CMS Committee,
I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Sincerely,
Nissin Nahmias MD, FACS, FASMBS.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

Thank you,

Melissa Cooley, RN, BSN
Metropolitan Bariatric Program Director

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As a Patient Coordinator working for a hospital recognized as a Center of Excellence, working exclusively with patients who undergo weight loss surgery, I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patient. I need this option to take care of Medicare patients just like I do for other patients. I am asking that CMS review the new evidence and reach conclusion that laparoscopic sleeve gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans. In our Center of Excellence in Charleston, SC, we have personally seen many patients who have had the sleeve gastrectomy who have dramatically changed their lives because of surgery.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.
[PHI Redacted]

[PHI Redacted] Medicare needs to have the gastric sleeve as part of their coverage. To be able to have a chance as a healthy human being is up to insurance coverage. Without the coverage, so many will never be able to experience this life changing encounter. [PHI Redacted]
Thank you for your time and consideration.

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As a Registered Dietitian working exclusively with patients who undergo weight loss surgery, I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

1. New England Journal of Medicine, March 26, 2012, Schauer et a published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.
2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment. Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.
3. Himpens in Annals of Surgery 2010. This six- year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.
4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic?and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a Zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patient with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patient. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach conclusion that laparoscopic sleeve gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans. In our Center of Excellence in Charleston, SC, we have personally seen many patients who have had the sleeve gastrectomy who have dramatically changed their lives because of surgery.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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Thank you so much for the efforts CMS has made in the coverage of bariatric surgery by doing this it has improved and enhanced the lives of so many. [PHI Redacted]

[PHI Redacted] Barabara Bush said something about you can get over the test not passed, the job not done well, and the promation not gotten but you would always regret the time not spent with your family or a child. She is absolutely right. Bariatric surgery allows us not to have any more regrets becuse we fit in furniture, we can walk and we have the energy to get involved with family functions.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo is not based on the totality of data in the literature on sleeve gastrectomy, which has proven to be a very effective weight loss operation, actually superior to the gastric band in terms of weight loss and resolution of comorbid conditions-yet the band is covered and the sleeve is not. This does not seem to make sense and I would like to point out a few articles to be reviewed.

New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Sleevg gastrectomy is an excellent choice for patients in whom a restrictive procedure is desirable. The sleeve is superior to the band and, in nearly all trials, is close to the RYGB in terms of weight loss and resolution of comorbid conditions. Therefore, sleeve gastrectomy should be an available surgical option for this group of patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need of bariatric surgery treatment options.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to make a public comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. There is no doubt that the laparoscopic sleeve gastrectomy is an excellent surgical option ofr the obese medicare patient. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

1. New England Journal of Medicine, March 26, 2012, Schauer et a published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.
2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment. Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.
3. Himpens in Annals of Surgery 2010. This six- year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.
4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic?and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a Zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patient with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass. Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patient. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach conclusion that laparoscopic sleeve gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I am another concerned surgeon writing in regard to the CMS decision to only cover laparoscopic sleeve gastrectomy in a randomly controlled trial. There is already significant data regarding the success of sleeve gastrectomy as noted:

Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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I would like to comment on your recent Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). I am concerned that the proposed decision memo had an incomplete review of available evidence, did not consider the entire Medicare population, and will diminish access to care for patients in need. CMS should provide the Laparoscopic Sleeve Gastrectomy as a covered benefit so that this patient group can experience the same health advantages that over 100 million other Americans have enjoyed.

Specifically, CMS should review:

1. New England Journal of Medicine, March 26, 2012, Schauer et al published “Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.” The sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit, and superior to medical therapy in this randomized control trial.

2. April 16, 2012 issue of the Archives of Surgery, Leonetti and colleagues published Obesity, “Type 2 Diabetes Mellitus, and Other Comorbidities: A Prospective Cohort Study of Laparoscopic Sleeve Gastrectomy vs. Medical Treatment.” Unlike medical treatment, the Laparoscopic Sleeve Gastrectomy treatment group saw substantial declines in both weight and Fasting Plasma Glucose.

3. Himpens in Annals of Surgery 2010. This six-year study demonstrates durability of the three year randomized sleeve gastrectomy results originally presented in Obesity Surgery 2006 with a 53.3 % Excess Weight Loss at six years.

4. O’Keefe et al in Bariatric Surgery Outcomes in Patients Aged 65 Years and Older at an American Society for Metabolic and Bariatric Surgery Center of Excellence published in Obesity Surgery 2010 found that all three weight loss surgeries (band, bypass, sleeve) were effective in patients =65 years of age, producing significant EWL, reduction in daily medication use, and improvement in QOL. All surgeries also associated with a zero 30 day-mortality rate and a low morbidity profile.

Medicare beneficiaries tend to be a group of patients with higher operative risks. Sleeve gastrectomy is associated with lower morbidity with equivalency in weight loss and resolution of comorbidities compared to gastric bypass.

Therefore, sleeve gastrectomy should be an available surgical option for this group of high-risk patients. I need this option to take care of Medicare patients just like I do for other patients.

I am asking that CMS review the new evidence and reach the conclusion that Laparoscopic Sleeve Gastrectomy become a covered benefit for Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.

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