| First character of title | Commenter | Comment Information |
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Date: 10/25/2011
Dear Dr. Berwick,
Thank you for opening a National Coverage Determination for the Vertical Sleeve gastrectomy. As a practicing healthcare professional who treats those affected by morbid obesity, I can attest to the safety and efficacy of this procedure. Data exist to demonstrate that weight loss and complications for the vertical sleeve gastrectomy are comparable and fall between two CMS-approved weight loss surgeries --Roux-en-Y gastric bypass and adjustable gastric banding (NEJM 2009 Wolfe, JAMA 2010 Birkmeyer, Annals of Surgery 2011 Hutter).
Furthermore, Medicare coverage of vertical sleeve gastrectomy will afford those Medicare patients affected by obesity an additional treatment option for addressing their weight and obesity-related comorbidities while maintaining gastrointestinal continuity. In fact, there are circumstances where the vertical sleeve gastrectomy was an ideal treatment option for my patient:
CITE EXAMPLE
Expanding Medicare coverage for vertical sleeve gastrectomy will ensure that Medicare patients have access to the same treatment options that other non-Medicare patients already have. I wholeheartedly urge you to provide coverage for the vertical sleeve gastrectomy. This surgery has positively effected many of my patients.
Sincerely,
Emeka Acholonu MD FACS
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Title: Medical Director, Bariatric Surgery
Organization: Guthrie Health
Date: 10/28/2011
Dear Dr. Berwick,
Thank you for opening a National Coverage Determination for the vertical sleeve gastrectomy (VSG). As a practicing bariatric surgeon, I can attest to the safety and efficacy of this procedure. Data exist to demonstrate that weight loss and complications for the VSG are comparable and fall between two CMS-approved weight loss surgeries --Roux-en-Y gastric bypass and adjustable gastric banding (NEJM 2009 Wolfe, JAMA 2010 Birkmeyer, Annals of Surgery 2011 Hutter).
There are some patients for whom neither the Roux-en-Y gastric bypass nor the adjustable gastric band are ideal solutions for surgical weight loss. One patient example will suffice:
My patient, a 55-year old patient with diabetes, 120 pounds overweight, also suffered from significant joint pain, requiring NSAID analgesics frequently. NSAIDs are contraindicated with gastric bypass, but her significant weight loss need and diabetes suggested that adjustable gastric banding would not be sufficient to help with resolution of her co-morbid conditions. A VSG was an excellent alternative for her.
Expanding Medicare coverage for vertical sleeve gastrectomy will ensure that Medicare patients have access to the same treatment options that other non-Medicare patients already have. I wholeheartedly urge you to provide coverage for the vertical sleeve gastrectomy.
Sincerely,
Joshua B. Alley, MD, FACS
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Date: 10/29/2011
I am a Bariatric surgeon practicing in south Texas. Pleas considering adding sleeve gastectomy to the list of approved procedures for weight loss surgeries. My practice hase a large percentage of medicare and medicaid patients. I have many medicare patients for whom the sleeve gastrectomy is cleary the best procedure based on efficacy and safety. Since medicare does not currently cover this procedure and since I live in a poor area of the country (my patients can not pay out of pocket), they must choose between a less effective and slower weight loss procedure(lap band) and an effective but riskier gastric bypass. I am forced to offer a two tiered medical benefit program. If you have private insurance or medicaid, they can choose from three procedures. If they have medicare or tricare you can only choose from two. The lap band is less effective and takes more time to achieve weight loss and resolutin of diabetes and other comorbid conditons than the sleeve gastrectomy and the gastric bypass has a significant concern for acceleration of osteoporosis. For these reasons the sleeve gastrectomy is sometimes the best option but is not currently avalailble to medicare patients.
Respectfully,
Robert E. Alleyn, M.D.
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Title: MD, FACS, FASMBS
Date: 10/27/2011
Dear Dr. Berwick,
Thank you for opening a National Coverage Determination for the Vertical Sleeve gastrectomy. As a practicing healthcare professional who treats those affected by morbid obesity, I can attest to the safety and efficacy of this procedure. Data exist to demonstrate that weight loss and complications for the vertical sleeve gastrectomy are comparable and fall between two CMS-approved weight loss surgeries --Roux-en-Y gastric bypass and adjustable gastric banding (NEJM 2009 Wolfe, JAMA 2010 Birkmeyer, Annals of Surgery 2011 Hutter).
Furthermore, Medicare coverage of vertical sleeve gastrectomy will afford those Medicare patients affected by obesity an additional treatment option for addressing their weight and obesity-related comorbidities while maintaining gastrointestinal continuity. In fact, there are circumstances where the vertical sleeve gastrectomy was an ideal treatment option for my patient: middle aged female patient with BMI of 50, multiple comorbidities including Type 2 DM, HTN, hypercholesteremia, arthritis and with more than ten medications including insulin and oral pills for DM was referred to me for a surgical treatment. Patient underwent uneventful laparoscopic vertical sleeve gastrectomy operation and a year later she is now different person. She lost 75% of her EBW and she is taking only few vitamins for supplementation. Her DM is cured, her HTN is gone and her cholesterol is normal.
Expanding Medicare coverage for vertical sleeve gastrectomy will ensure that Medicare patients have access to the same treatment options that other non-Medicare patients already have. I wholeheartedly urge you to provide coverage for the vertical sleeve gastrectomy.
Sincerely,
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Title: Bariatric Surgeon
Organization: Desert Surgical & Bariatric Specialists
Date: 10/24/2011
Dear Dr. Berwick,
Thank you for opening a National Coverage Determination for the Vertical Sleeve gastrectomy. As a practicing healthcare professional who treats those affected by morbid obesity, I can attest to the safety and efficacy of this procedure. Data exist to demonstrate that weight loss and complications for the vertical sleeve gastrectomy are comparable and fall between two CMS-approved weight loss surgeries --Roux-en-Y gastric bypass and adjustable gastric banding (NEJM 2009 Wolfe, JAMA 2010 Birkmeyer, Annals of Surgery 2011 Hutter).
Furthermore, Medicare coverage of vertical sleeve gastrectomy will afford those Medicare patients affected by obesity an additional treatment option for addressing their weight and obesity-related comorbidities while maintaining gastrointestinal continuity. In fact, there are circumstances where the vertical sleeve gastrectomy was an ideal treatment option for my patient:
I have a Morbidly obese man with significant past abdmonial surgeries and a very hostile abdomen. Patient refuses gastric bypass for concern of intestinal bypass in light of his prior surgeries and adhesions. He has numerous weight health comorbities and is awaiting Mericare coverage for a sleeve. He would benifit greatly from this surgery.
Expanding Medicare coverage for vertical sleeve gastrectomy will ensure that Medicare patients have access to the same treatment options that other non-Medicare patients already have. I wholeheartedly urge you to provide coverage for the vertical sleeve gastrectomy.
Sincerely,
Ramy Awad, M.D
Desert Surgical And Bariatric Specialists.
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Title: Surgeon
Organization: Tyler Bariatrics
Date: 10/24/2011
Sleeve gastrectomy will be much more
Cost effective than lap-band for Medcare beneficiaries. It also has a significant safety advantage over gastric bypass, particularly in the elderly and/or disabled patient.
As a Bariatric surgeon I want to provide the best care for my patients and the sleeve gastrectomy has been an excellent option for many patients and for some is the only option.
Thank you for your consideration.
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Title: Richmond Bariatric Surgery Section Chief
Organization: The Permanente Medical Group
Date: 10/24/2011
Dear Dr. Berwick,
Thank you for opening a National Coverage Determination for the Vertical Sleeve gastrectomy. As a practicing healthcare professional who treats those affected by morbid obesity, I can attest to the safety and efficacy of this procedure. Data exist to demonstrate that weight loss and complications for the vertical sleeve gastrectomy are comparable and fall between two CMS-approved weight loss surgeries --Roux-en-Y gastric bypass and adjustable gastric banding (NEJM 2009 Wolfe, JAMA 2010 Birkmeyer, Annals of Surgery 2011 Hutter).
Furthermore, Medicare coverage of vertical sleeve gastrectomy will afford those Medicare patients affected by obesity an additional treatment option for addressing their weight and obesity-related comorbidities while maintaining gastrointestinal continuity. In fact, there are circumstances where the vertical sleeve gastrectomy was an ideal treatment option for many of my patients.
This includes patients who were awaiting transplant for liver and renal insufficiency. It includes patients who had already received a kidney transplant. It also includes patient on chronic NSAIDs and immune suppressives.
Expanding Medicare coverage for vertical sleeve gastrectomy will ensure that Medicare patients have access to the same treatment options that other non-Medicare patients already have. I wholeheartedly urge you to provide coverage for the vertical sleeve gastrectomy.
Sincerely,
Aaron G. Baggs
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Title: Attending surgeon
Organization: Gundersen Lutheran Medical Center
Date: 10/24/2011
Dear Dr. Berwick,
Thank you for opening a National Coverage Determination for the Vertical Sleeve gastrectomy. As a practicing healthcare professional who treats those affected by morbid obesity, I can attest to the safety and efficacy of this procedure. Data exist to demonstrate that weight loss and complications for the vertical sleeve gastrectomy are comparable and fall between two CMS-approved weight loss surgeries --Roux-en-Y gastric bypass and adjustable gastric banding (NEJM 2009 Wolfe, JAMA 2010 Birkmeyer, Annals of Surgery 2011 Hutter).
Furthermore, Medicare coverage of vertical sleeve gastrectomy will afford those Medicare patients affected by obesity an additional treatment option for addressing their weight and obesity-related comorbidities while maintaining gastrointestinal continuity. In fact, there are circumstances where the vertical sleeve gastrectomy was an ideal treatment option for a couple of my patients:
One had a vitamin D deficiency which would have worsened with the known calcium malabsorption associated with the gastric bypass procedure.
A second patient had gastric polyps that could not be followed after a gastric bypass procedure, but could after a sleeve gastrectomy.
Expanding Medicare coverage for vertical sleeve gastrectomy will ensure that Medicare patients have access to the same treatment options that other non-Medicare patients already have. I wholeheartedly urge you to provide coverage for the vertical sleeve gastrectomy.
Sincerely,
Matthew T. Baker, M.D.
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Title: Bariatric and General Surgeon
Date: 10/28/2011
The field of Bariatric Surgery is covered with surgical techniques that initially were felt to be the best approach, however later they were abandoned. Procedures that are not reversible, demonstrating some significant complications will require further time (close to 10 years) to see if it will still be considerate a viable option. A good example is the Vertical Band gastroplasty that initially was believed to be a great idea however years later it demonstrated to not work and surgeons stopped using it.
I have attended several sleeve courses to obtain further knowledge of the complications. The complications are not rare, and not easy to take care. Leaks are seen in up to 5% of the time and in a high pressure system that is the sleeve, it will not stop easily. Another complication that is under-appreciated is the reflux. A rate of 15% to 23% of patients will develop significant reflux. Several years of reflux can and will induce Barrett's esophagus and with more years the risk for cancer is significant. The problem is how can we correct the reflux. The Nissen fundoplication that is a well know procedure for reflux cannot be utilized since the stomach fundus was removed. The only option will be to perform a gastric bypass with a Roux-en-Y bypass. In my experience, the patients that are seeking gastric band or sleeve gastrectomy are not looking to have bypass surgery. We need to be more upfront with them and explain that the risk is quite significant.
A study that by Bohdjalian et al. on their sleeve gastrectomy 5 year follow-up of the initial 26 patients shows some concerns. The mean % EWL at 5 years was 55% (not converted, n = 21). Weight regain of more than 10 kg from nadir was observed in five (19.2%) of the 26 patients in this series and four of the patients (15.4%) were converted to gastric bypass due to severe reflux (n = 1) and weight loss failure (n = 3).
I believe sleeve gastrectomy is a viable option. However, patients must be screened for reflux and not encourage to have the surgery if they have reflux, since it can be aggravated. Patients must be informed that although without symptoms of reflux, that up to 1 in 5 patients may develop reflux and further surgery may be required to alleviate the problem. More years, up to 10 years will probably clarify how bad or good sleeve gastrectomy can be for the patients.
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Date: 10/25/2011
Dear Dr. Berwick,
Thank you for opening a National Coverage Determination for the Vertical Sleeve Gastrectomy. As a practicing Bariatric Surgeon who treats those affected by morbid obesity, I can attest to the safety and efficacy of this procedure. Data exist to demonstrate that weight loss and complications for the Vertical Sleeve Gastrectomy are comparable and fall between two CMS-approved weight loss surgeries --Roux-en-Y Gastric Bypass and Adjustable Gastric Banding (NEJM 2009 Wolfe, JAMA 2010 Birkmeyer, Annals of Surgery 2011 Hutter).
Furthermore, Medicare coverage of Vertical Sleeve Gastrectomy will afford those Medicare patients affected by obesity an additional treatment option for addressing their weight and obesity-related comorbidities while maintaining gastrointestinal continuity. In fact, there are circumstances where the Vertical Sleeve Gastrectomy is an ideal treatment option for our patients. Take, for example, the patient who, for any reason, cannot commit to the frequent follow up visits required for the proper management of the Adjustable Gastric Band. Many of these patients do not need or want an operation as extensive as the Gastric Bypass with its possible surgical and metabolic complications. Other patients are opposed to the implantation of any permanent device, yet desire a purely restrictive operation (ie.without the malabsorption created by Gastric Bypass).
Expanding Medicare coverage for Vertical Sleeve Gastrectomy will ensure that Medicare patients have access to the same treatment options that other non-Medicare patients already have. I wholeheartedly urge you to provide coverage for the Vertical Sleeve Gastrectomy.
Sincerely,
Joseph P. Barbalinardo, M.D., F.A.C.S.
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Date: 10/24/2011
Expanding Medicare coverage for vertical sleeve gastrectomy will ensure that Medicare patients have access to the same treatment options that other non-Medicare patients already have. I wholeheartedly urge you to provide coverage for the vertical sleeve gastrectomy.
Sincerely,
Christine Bauer,MSN,RN,CBN
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Title: Director, Weight Management Institute
Organization: Methodist Dallas Medical Center
Date: 10/26/2011
So many of our older Americans need drastic help to improve their health but are already too sick to safely have a Gastric Bypass. Unfortunately, the Band will not be effective enough to help most of them. The Sleeve Gastrectomy is the optimal solution for most of the Medicare population. The operation is shorter, less invasive, and has been shown to provide greater weight loss than the band and almost as much if not as much weight loss as the gastric bypass.
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Title: Bariatric Surgeon
Organization: Dean Clinic
Date: 10/25/2011
Dear Dr. Berwick,
Thank you for opening a National Coverage Determination for the Vertical Sleeve gastrectomy. As a practicing surgeon who treats those affected by morbid obesity, I can attest to the safety and efficacy of this procedure. Data exist to demonstrate that weight loss and complications for the vertical sleeve gastrectomy are comparable and fall between two CMS-approved weight loss surgeries --Roux-en-Y gastric bypass and adjustable gastric banding (NEJM 2009 Wolfe, JAMA 2010 Birkmeyer, Annals of Surgery 2011 Hutter).
Furthermore, Medicare coverage of vertical sleeve gastrectomy will afford those Medicare patients affected by obesity an additional treatment option for addressing their weight and obesity-related comorbidities while maintaining gastrointestinal continuity. In fact, there are circumstances where the vertical sleeve gastrectomy was an ideal treatment option for my patients, especially those who have had prior abdominal surgery.
Expanding Medicare coverage for vertical sleeve gastrectomy will ensure that Medicare patients have access to the same treatment options that other non-Medicare patients already have. I wholeheartedly urge you to provide coverage for the vertical sleeve gastrectomy.
Sincerely,
Frank Bendewald, MD
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Title: MD, FACS, FASMBS, Medical Director
Organization: Tallgrass General, Vascular & Bariatric Surgery/Turning Point
Date: 10/24/2011
Dear Dr. Berwick,
Thank you for opening a National Coverage Determination for the Vertical Sleeve gastrectomy. As a practicing healthcare professional who treats those affected by morbid obesity, I can attest to the safety and efficacy of this procedure. Data exist to demonstrate that weight loss and complications for the vertical sleeve gastrectomy are comparable and fall between two CMS-approved weight loss surgeries --Roux-en-Y gastric bypass and adjustable gastric banding (NEJM 2009 Wolfe, JAMA 2010 Birkmeyer, Annals of Surgery 2011 Hutter).
Furthermore, Medicare coverage of vertical sleeve gastrectomy will afford those Medicare patients affected by obesity an additional treatment option for addressing their weight and obesity-related comorbidities while maintaining gastrointestinal continuity. In fact, there are circumstances where the vertical sleeve gastrectomy was an ideal treatment option for my patient:
CITE EXAMPLE
Expanding Medicare coverage for vertical sleeve gastrectomy will ensure that Medicare patients have access to the same treatment options that other non-Medicare patients already have. I wholeheartedly urge you to provide coverage for the vertical sleeve gastrectomy.
Sincerely,
Bernita Berntsen, MD, FACS, FASMBS
Tallgrass General, Vascular & Bariatric Surgery
Medical Director,
Turning Point Surgical Weight Loss Solutions
6001 SW 6th Ave, Ste 220
Topeka, KS 66615
PH: 785-228-4773
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Title: Surgeon
Organization: ALSOM
Date: 10/24/2011
Dear Dr. Berwick,
Thank you for opening a National Coverage Determination for the Vertical Sleeve gastrectomy. As a practicing healthcare professional who treats those affected by morbid obesity, I can attest to the safety and efficacy of this procedure. Data exist to demonstrate that weight loss and complications for the vertical sleeve gastrectomy are comparable and fall between two CMS-approved weight loss surgeries --Roux-en-Y gastric bypass and adjustable gastric banding (NEJM 2009 Wolfe, JAMA 2010 Birkmeyer, Annals of Surgery 2011 Hutter).
Furthermore, Medicare coverage of vertical sleeve gastrectomy will afford those Medicare patients affected by obesity an additional treatment option for addressing their weight and obesity-related comorbidities while maintaining gastrointestinal continuity. In fact, there are circumstances where the vertical sleeve gastrectomy was an ideal treatment option for my patient:
He was 66 years old with 3 prior abdominal surgeries and crohns disease with diabetes. He could have benefitted from Vertical Sleeve Gastrectomy, and was not a candidate for the bypass given his prior procedures and scarring. His only option was banding which is far less rapid in effect and problematic in older patients with exercise issues.
Expanding Medicare coverage for vertical sleeve gastrectomy will ensure that Medicare patients have access to the same treatment options that other non-Medicare patients already have. I wholeheartedly urge you to provide coverage for the vertical sleeve gastrectomy.
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Title: bariatric coordinator
Organization: sharon regional health system
Date: 10/29/2011
The sleeve gastrectomy is a good surgical option. It provides almost as much excess body weight loss as the roux-en-y bypass without a malabsorptive component. It is less invasive than the gastic bypass yet has successful weight reduction statistics associated with it.
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Date: 10/27/2011
Dear Dr. Berwick,
Thank you for opening a National Coverage Determination for the Vertical Sleeve gastrectomy. As a practicing healthcare professional who treats those affected by morbid obesity, I can attest to the safety and efficacy of this procedure. Data exist to demonstrate that weight loss and complications for the vertical sleeve gastrectomy are comparable and fall between two CMS-approved weight loss surgeries --Roux-en-Y gastric bypass and adjustable gastric banding (NEJM 2009 Wolfe, JAMA 2010 Birkmeyer, Annals of Surgery 2011 Hutter).
Furthermore, Medicare coverage of vertical sleeve gastrectomy will afford those Medicare patients affected by obesity an additional treatment option for addressing their weight and obesity-related comorbidities while maintaining gastrointestinal continuity. In fact, there are circumstances where the vertical sleeve gastrectomy is an ideal treatment option.
To give a very concrete example, I work at the busiest renal transplant center in New Jersey, as you no doubt are aware most dialysis patients (hence most potential renal transplant patients) are covered by Medicare. At our transplant center one of the most common reasons for a potential transplant pt to be listed as "inactive" on the list is a Body Mass Index (BMI) of over 40. Such patients are referred to me for bariatric surgical evaluation and generally cannot be actively listed until there BMI is less than 30 or 35.
Under current Medicare guidelines I can only offer these patients either a Gastric Banding or Gastric Bypass, both procedures have significant drawbacks.
Gastric Banding is more properly suited for younger, healthier patients who can excercise (not the case with most dialysis patients). As a practical matter it is exceedingly rare that a dialysis patient will lose adequate weight with a gastric banding procedure to qualify for a transplant.
Gastric Bypass is less than ideal since it has a malabsorptive component which can make proper dosing of immuno-suppressive drugs difficult, and for this reason I am hestitant to offer this option. In addition, dehydration is a common complication after bypass. In a non-transplant patient this is a minor inconvenience, in a transplant patient it can jeopardize the transplant. For these reason I am forced to offer the band, as a first choice, even though it is rarely effective.
The sleeve gastrectomy addresses both of these issues quite effectively. Weight loss is much more effective than banding (without the necessity of daily excercise) and absorption is not effected, thus making management of immuno-suppressive drugs safer and easier. Dehydration is much less common and when seen, much less severe.
Expanding Medicare coverage for vertical sleeve gastrectomy will ensure that Medicare patients have access to the same treatment options that other non-Medicare patients already have. I wholeheartedly urge you to provide coverage for the vertical sleeve gastrectomy.
Sincerely,
Michael Bilof,MD
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Title: Associate Professor of Surgery
Organization: University of Michigan
Date: 10/30/2011
The Michigan Bariatric Surgery Collaborative is a statewide clinical outcomes registry and quality improvement program. Since 2007, our group has collected prospective information regarding the clinical care and outcomes of nearly 30,000 consecutive bariatric surgery patients. To date, our registry includes 3,502 patients that have undergone sleeve gastrectomy, with 1-year follow-up for 798. The rate of serious complications occurring within 30 days of surgery for patients undergoing sleeve gastrectomy (2.3%) is about half way between rates for patients undergoing laparoscopic adjustable gastric banding (1.0%) and gastric bypass (3.2%) procedures. However, weight loss at 12 months for sleeve gastrectomy (54% excess body weight loss) is closer to that for gastric bypass (66%) than for laparoscopic adjustable gastric band (37%) procedures. Resolution of obesity related comorbidites, health-related quality of life, and patient satisfaction for patients undergoing sleeve gastrectomy are similarly closer to gastric bypass than laparoscopic adjustable gastric band procedures. We believe that the sleeve gastectomy is a safe and effective bariatric procedure that should be covered for the treatment of morbid obesity by CMS as well as private payers. Blue Cross and Blue Shield of Michigan has recently decided to cover sleeve gastrectomy based on these findings. Our group would be pleased to supply you with any additional information that might assist you in your decision-making. Respectfully submitted on behalf of the Michigan Bariatric Surgery Collaborative.
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Title: President
Organization: American Society for Metabolic and Bariatric Surgery
Date: 10/29/2011
October 24, 2011
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
cc: Joseph Chin, MD, MS
Dear Dr. Berwick:
The American Society for Metabolic and Bariatric Surgery is pleased to support the recent decision by CMS to open a national coverage determination reconsideration in order to review the new evidence for the vertical sleeve gastrectomy (VSG) as a primary bariatric surgery. We are fully confident that CMS will find there is adequate evidence for evaluating health outcomes of the vertical sleeve gastrectomy for the indications listed in the current Bariatric Surgery for the Treatment of Morbid Obesity National Coverage Determination (NCD). We are aware of your particular interest in receiving evidence speaking to the health outcomes attributable to the use of VSG in the Medicare population and there is strong, supporting evidence submitted in this letter and in the attached ASMBS Vertical Sleeve Gastrectomy Position Statement. We believe it is fitting and proper that CMS support this National Care Determination for the vertical sleeve gastrectomy for the following reasons:
- The Medicare population is at risk for obesity and its consequences.
- The Vertical Sleeve Gastrectomy is safe and effective and comparable to CMS covered Gastric Bypass and Gastric Banding.
- The Vertical Sleeve Gastrectomy is a unique surgical intervention appropriate for at-risk patient populations.
- The Vertical Sleeve Gastrectomy is routinely covered by other payors.
The Medicare population is at risk for obesity and its consequences.
The Medicare population is specifically an at-risk population for obesity and its consequences. Eligibility for Medicare benefits include age >65 and disability including end-stage renal disease (ESRD). Numerous studies have detailed the impact of obesity leading to disability. In a 2008 Obesity Review article, Neovius and colleagues found that patients with a BMI>35 had a Three-Fold risk of being disabled. The same article highlighted the strong impact of bariatric surgery upon potential reversal of disability with a doubling of return to work for obese disabled patients who had surgical treatment for their obesity. Flegal in a 2010 JAMA article found a 12.1 % incidence of BMI>35 in the population age>60. Obesity has also been found to lead to increased waiting times for ESRD patients awaiting transplant leading to weight-related disparities in care for these Medicare patients in need (Segev, J Am Soc Nephrol, 2008).
The Vertical Sleeve Gastrectomy is safe and effective and comparable to CMS covered Gastric Bypass and Gastric Banding.
Since the implementation of the original National Care Determination for Bariatric Surgery, we have witnessed an American surgical success story regarding patient safety in the bariatric surgery population. Encinosa detailed in a 2009 Medical Care article the steep decline in in-patient, 30- day and 180 day complications respectively, 37%, 24%, and 21 %. In specific to the Medicare population, Nguyen in a 2010 Archives of Surgery noted a 33% reduction in mortality in Medicare beneficiaries following the NCD resulting in an overall bariatric surgery mortality rate 0.2%.
There are large, multi-center prospective studies to specifically compare the perioperative outcomes of the three main bariatric surgeries. In a 2010 JAMA article by Birkmeyer, a Michigan state-wide collaborative for bariatric surgery demonstrated a 30 day mortality rate of 0.14% for gastric bypass, 0.04% for gastric banding and ZERO % for sleeve gastrectomy. By utilizing the NSQIP database, Hutter in a 2011 article in Annals of Surgery found that the vertical sleeve gastrectomy was positioned between band and bypass for both complications and weight loss.
In order to respond to receiving evidence speaking to the health outcomes attributable to the use of VSG in the Medicare population, 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. Below in Table 1, the safety profile of the sleeve gastrectomy is between the two CMS-sanctioned bariatric procedures of gastric bypass and band. Similarly, resource utilization as measured by Length of Stay for the sleeve gastrectomy is less than the gastric bypass but more than the gastric band.
SAFETY: GASTRIC BAND>SLEEVE GASTRECTOMY>GASTRIC BYPASS
Table 1: 30-Day Outcomes, BOLD 2007-2010
| | Gastric Bypass (Roux-en-Y)
N=136036 |
Adjustable Gastric Banding
N=116898 |
Sleeve Gastrectomy
N=15964 |
|---|
| Deaths | 186 (0.14%) | 32 (0.03%) | 13 (0.08%) |
| Serious Complications | 1699 (1.25%) | 298 (0.25%) | 154 (0.96%) |
| Any Complications | 15425 (11.34%) | 4006 (3.43%) | 1336 (8.37%) |
| scope="row"Readmission | 6291 (4.62%) | 1611 (1.38%) | 576 (3.61%) |
| scope="row"Reoperation | 3710 (2.73%) | 759 (0.65%) | 272 (1.70%) |
| Index Length of Stay (days) |
| Mean(SD) | 2.3 (2.04) | 0.7 (1.01) | 1.9 (1.94) |
EFFICACY: GASTRIC BYPASS>SLEEVE GASTRECTOMY>GASTRIC BAND
In addition to assessing safety, efficacy must be taken into account. The main outcome for efficacy is weight loss. We are aware that weight loss closely tracks comorbidity resolution and subsequent survival benefit. As is demonstrated below in Table 2, the One-Year BMI reduction for the Sleeve Gastrectomy is more than Gastric Banding and slightly less than Gastric Bypass.
Table 2, One-Year Post-Operative BMI Reductions, BOLD 2007-2010
| | Gastric Bypass (Roux-en-Y)
N=136036 | Adjustable Gastric Banding
N=116898 | Sleeve Gastrectomy
N=15964 |
|---|
| Body Mass Index (kg/m2) |
| Mean(SD), Pre-op | 47.7 (7.90) | 45.1 (6.64) | 47.5 (9.01) |
| 1 Year Post-op |
31.2 (6.24) |
37.5 (6.65) |
34.1 (8.07) |
SPECIFIC MEDICARE BENEFICIARY OUTCOMES: AGE< 65 VS >65 LAPAROSCOPIC SLEEVE GASTRECTOMY COMPARABLE SAFETY AND EFFICACY
A current qualification for Medicare coverage includes age> 65. In examining this specific and Medicare relevant population, the safety and efficacy outcomes were equivalent for laparoscopic sleeve gastrectomy in ages >65 and < 65. Equally low rates of 30-day morbidity and mortality were seen for both groups with very similar, large reductions in BMI at one year post-operatively in Table 3.
Table 3: 30-Day Outcomes by Age, BOLD 2007-2010
| | Laparoscopic Sleeve Gastrectomy |
|---|
| | < 65
N=15445 | 65+
N=519 |
|---|
| Deaths | 11 (0.07%) | 2 (0.39%) |
| Serious Complications | 146 (0.95%) | 8 (1.54%) |
| Any Complications | 1298 (8.40%) | 38 (7.32%) |
| Readmission | 564 (3.65%) | 12 (2.31%) |
| Reoperation | 265 (1.72%) | 7 (1.35%) |
| Body Mass Index (kg/m2) |
| Mean(SD), Pre-op | 47.6 (9.05) | 46.1 (7.80) |
| 1 year Post-op | 34.1 (8.11) | 35.1 (7.06) |
LEVEL 1 EVIDENCE FOR SLEEVE GASTRECTOMY
There are multiple prospective randomized comparative trials for the vertical sleeve gastrectomy. As seen in table 4, the vertical sleeve gastrectomy compares very favorably to the two CMS-approved procedures. In these comparative effectiveness trials, the weight loss seen with the vertical sleeve gastrectomy exceeds gastric banding and is near equivalent to gastric bypass.
Table 4, Summary of RCTs Comparing Sleeve Gastrectomy to Gastric Bypass or Gastric Banding
| Author | Procedures | Follow-up | Weight Loss |
|---|
| Woelnerhanssen et al. | LSG vs.
LRYGB | 12 months | LSG 28% TBW
LRYGB 35% TBW |
| Kehagias et al. | LSG vs.
LRYGB | 36 months | LSG 68% EWL
LRYGB 62% EWL |
| Karamanakos et al. | LSG vs.
LRYGB | 12 months | LSG 69% EWL
LRYGB 60% EWL |
| Himpens et al. | LSG vs.
LAGB | 36 months | LSG 66% EWL
LAGB 48% EWL |
| Peterli et al. | LSG vs.
LRYGB | 3 months | LSG 39% EWL
LRYGB 43% EWL |
Legend: LSG (laparoscopic sleeve gastrectomy), LRYGB (laparoscopic roux-en Y gastric bypass), LAGB (laparoscopic gastric band), EWL (excess weight loss), TBW (total body weight)
The Vertical Sleeve Gastrectomy is a unique surgical intervention appropriate for at-risk patient populations.
Obesity affects over 60% of the national population with approximately 15 million people who qualify for weight loss surgery. Currently, the only effective and enduring treatment for severe obesity is bariatric surgery. With previous National Care Determinations, CMS has recognized the utility of gastric bypass and gastric banding. With these currently covered operations having sterling safety and efficacy profiles, the vertical sleeve gastrectomy offers another safe and effective therapy for patients in need.
Some potential advantages for the vertical sleeve gastrectomy include maintenance of gastrointestinal continuity with an intact pylorus which affords the premise of appropriate gastrointestinal transit with usual absorption of medications and continued ease of upper endoscopy, all without an implantable device. While the VSG is partly considered a restrictive procedure, the mechanisms of weight loss and improvement in comorbidities seen after VSG may also be related to neurohumoral changes related to gastric resection or expedited nutrient transport into the small bowel. The neurohormonal changes seen in VSG include early and progressive improvement in insulin sensitivity (insulin, GLP-1, PYY), adipokines (adiponectin, leptin), and satiety (Ghrelin) (Karamanakos, Ann Surg 2008 & Peterli, Ann Surg 2009).
In addition, it appears the vertical sleeve gastrectomy has lower incidence of both peptic ulcers and nutritional deficiencies (Kehagis, Obesity Surgery, 2011 and Gehrer, Obesity Surgery, 2010). All of these particular advantages of the Vertical Sleeve Gastrectomy hold import for select groups of Medicare patients who require normal absorption of needed medications (Transplant patients), endoscopic surveillance (Prior Gastrointestinal Reconstructive Surgical patients), and routine use of NSAIDS (Arthritis patients).
The Vertical Sleeve Gastrectomy is routinely covered by other payors.
We applaud the CMS reconsideration to include vertical sleeve gastrectomy as a covered benefit. The potential coverage decision will be in keeping with other payors and organizations and allows us to offer the same treatment to Medicare patients that other patients already enjoy.
For example, effective January 2010, the American Medical Association assigned a Current Procedural Terminology code to describe LSG as a primary single-stage restrictive weight loss procedure. Recently, on October 1, 2011, CMS decided to assign Laparoscopic Sleeve Gastrectomy to ICD 43.82 and Open Sleeve Gastrectomy to ICD 43.89. We appreciate CMS’s decision that provides for both of these ICD-9 codes to be grouped to DRG 619, 620 and 621, OR procedures for obesity.
Beyond this regulatory recognition, an overwhelming number of payors have chosen to provide vertical sleeve gastrectomy coverage to their beneficiaries. In sum, current national coverage for vertical sleeve gastrectomy extends to over 104 million patients. The long list of payors providing vertical sleeve gastrectomy coverage includes, but is not limited to the following: Aetna; Amerihealth; BC/BS Arkansas; BC/BS Nebraska; BS California; CareFirst BC/BS; Cigna; Emblem Health; Excellus BC/BS; HCSC (parent company for BC/BS Texas, Oklahoma, New Mexico, and Illinois); HealthNet; HMSA (BC/BS HI); Horizon BC/BS New Jersey; Federal BC/BS; Independence BC; BC/BS Texas; Medica; Michigan-BC/BS; Neighborhood Health Plan; Priority Health; QualCare; United Healthcare.
Conclusion
We believe the health outcomes evidence for the vertical sleeve gastrectomy is overwhelmingly favorable and clearly meets the indications listed in the current Bariatric Surgery for the Treatment of Morbid Obesity National Coverage Determination. The vertical sleeve gastrectomy is safe, effective and comparable to the current CMS approved bariatric surgery procedures. We urge its inclusion as a covered benefit so Medicare patients may equally profit with other insured obese patients. We welcome any and all opportunities to discuss this further with you as we all continue in our shared mission of providing optimal, safe, and effective care for our obese patients.
Sincerely,
American Society for Metabolic and Bariatric Surgery
Robin Blackstone, MD
President
Jaime Ponce, MD
President-Elect
Ninh Nguyen, MD
Secretary-Treasurer
John Morton, MD, MPH
Chair, Access to Care Committee
Stacy Brethauer, MD
Chair, Clinical Issues Committee
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Title: Vice President, Policy Initiatives and Advocacy
Organization: American Dietetic Association
Date: 10/30/2011
October 30, 2011
Donald M. Berwick, M.D.
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1503-P
Room 445-G, Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, D.C. 20201
RE: Reopened National Coverage Determination for Bariatric Surgery for the
Treatment of Morbid Obesity (CAG00250R2)
Dear Administrator Berwick,
The American Dietetic Association representing over 72,000 members urges the
Medicare program to expand coverage for surgical treatment of obesity to include
vertical sleeve gastrectomy. We applaud the Centers for Medicare & Medicaid
Services (CMS) for opening up a National Coverage Determination (NCD) to address
this specific treatment since there is inconsistency between Medicare and many
private health plans that provide coverage for this procedure resulting in disparity
with regard to patient access to treatment.
Currently the sleeve gastrectomy is offered to patients for whom other gastric
surgeries are contraindicated due to medical history or surgical risk factors. The
vertical sleeve gastrectomy has fewer nutrition and medical complications than the
Roux-en-Y gastric bypass and the duodenal switch/biliopancreatic diversion
procedures. Data suggest that weight loss with this less invasive procedure is
comparable to the adjustable band and Roux-en-Y gastric bypass making it a lowerrisk
option for many surgical candidates.
Expanding Medicare coverage for the sleeve gastrectomy procedure will ensure
consistent patient access to obesity treatment options across both the non-Medicare
and Medicare patient population. Currently for the Medicare population, patient
care is driven not by what is medically necessary or indicated, but rather by what is
covered.
ADA appreciates the opportunity to comment on this important initiative; please
contact either Jeanne Blankenship at 202-775-8277 ext. 6004 or by email at
jblankenship@eatright.org or Pepin Tuma at 202-775-8277 ext. 6001 or by email at
ptuma@eatright.org with any questions or requests for additional information.
Sincerely,
/s/
Jeanne Blankenship, MS RD
Vice President, Policy Initiatives and Advocacy
American Dietetic Association
/s/
Pepin Andrew Tuma, Esq.
Director, Regulatory Affairs
American Dietetic Association
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Title: Bariatric Surgeon
Date: 10/26/2011
Dear Dr. Berwick,
Thank you for opening a National Coverage Determination for the Vertical Sleeve gastrectomy. As a practicing healthcare professional who treats those affected by morbid obesity, I can attest to the safety and efficacy of this procedure. Data exist to demonstrate that weight loss and complications for the vertical sleeve gastrectomy are comparable and fall between two CMS-approved weight loss surgeries --Roux-en-Y gastric bypass and adjustable gastric banding (NEJM 2009 Wolfe, JAMA 2010 Birkmeyer, Annals of Surgery 2011 Hutter).
Furthermore, Medicare coverage of vertical sleeve gastrectomy will afford those Medicare patients affected by obesity an additional treatment option for addressing their weight and obesity-related comorbidities while maintaining gastrointestinal continuity. In fact, there are circumstances where the vertical sleeve gastrectomy was an ideal treatment option for my patient:
-Patients who suffer from severe gout and need to be on certain medications that they cannot take after a gastric bypass.
-Patients who suffer from iron deficiency anemia and need all of the iron that they can absorb.
-Patients with difficult to treat mental illnesses who have finally found a regimen that helps. The absorption of psych meds after gastric bypass is so variable that it is impossible to predict what will happen postop.
Expanding Medicare coverage for vertical sleeve gastrectomy will ensure that Medicare patients have access to the same treatment options that other non-Medicare patients already have. I wholeheartedly urge you to provide coverage for the vertical sleeve gastrectomy.
Sincerely,
Gregory Broderick-Villa, MD
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Title: Director of Bariatric Surgery
Organization: North Shore-LIJ Huntington Hospital
Date: 10/24/2011
Dear Dr. Berwick,
Thank you for opening a National Coverage Determination for the Vertical Sleeve gastrectomy. As a practicing healthcare professional who treats those affected by morbid obesity, I can attest to the safety and efficacy of this procedure. Data exist to demonstrate that weight loss and complications for the vertical sleeve gastrectomy are comparable and fall between two CMS-approved weight loss surgeries --Roux-en-Y gastric bypass and adjustable gastric banding (NEJM 2009 Wolfe, JAMA 2010 Birkmeyer, Annals of Surgery 2011 Hutter).
Furthermore, Medicare coverage of vertical sleeve gastrectomy will afford those Medicare patients affected by obesity an additional treatment option for addressing their weight and obesity-related comorbidities while maintaining gastrointestinal continuity. There are many patients in my practice that have received the sleeve gastrectomy due to the fact that they could not have an intestinal bypass or a lap band. Crohn's disease patients benefit greatly from a sleeve gastrectomy versus the other two procedures. In my practice, laparoscopic sleeve gastrectomies have become the procedure of choice by most patients within my practice. Medicare patients should also have the same opportunity to obtain this surgery.
Expanding Medicare coverage for vertical sleeve gastrectomy will ensure that Medicare patients have access to the same treatment options that other non-Medicare patients already have. I wholeheartedly urge you to provide coverage for the vertical sleeve gastrectomy.
Sincerely,
David Buchin, MD, FACS, FASMBS
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Title: MD
Organization: Meridian Surgical Group
Date: 10/30/2011
Dear Dr. Berwick,
Thank you for opening a National Coverage Determination for the Vertical Sleeve gastrectomy. As a practicing healthcare professional who treats those affected by morbid obesity, I can attest to the safety and efficacy of this procedure. Data exist to demonstrate that weight loss and complications for the vertical sleeve gastrectomy are comparable and fall between two CMS-approved weight loss surgeries --Roux-en-Y gastric bypass and adjustable gastric banding (NEJM 2009 Wolfe, JAMA 2010 Birkmeyer, Annals of Surgery 2011 Hutter).
Furthermore, Medicare coverage of vertical sleeve gastrectomy will afford those Medicare patients affected by obesity an additional treatment option for addressing their weight and obesity-related comorbidities while maintaining gastrointestinal continuity. In fact, there are circumstances where the vertical sleeve gastrectomy is an ideal treatment option for my patients. For example, a patient who is taking multiple medications and I do not want to affect the absorption of these medications. Or a high risk patient where a Sleeve Gastrectomy would be safer procedure than a gastric bypass and have better results than a Band. I personally have been forced to refuse Medicare patients a chance at weight loss surgery because I could not offer them a sleeve. These are patients who are too risky for a gastric bypass and on whom a gastric gand would not permit sufficient weight loss to make it worthwhile. The sleeve gastrectomy would have been the perfect procedure.
Expanding Medicare coverage for vertical sleeve gastrectomy will ensure that Medicare patients have access to the same treatment options that other non-Medicare patients already have. I wholeheartedly urge you to provide coverage for the vertical sleeve gastrectomy. Thank you for your consideration.
Sincerely,
Brenda M. Cacucci MD FACS
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Title: Associate Professor
Organization: University of Wisconsin School of Medicine and Public Health
Date: 10/26/2011
Dear Dr. Berwick,
I am an Associate Professor in the Department of Surgery at University of Wisconsin School of Medicine and Public Health and about 40% of my practice involves treating patients affected by morbid obesity.
I thank you for opening a National Coverage Determination for the Vertical Sleeve gastrectomy. As a practicing professional I can attest to the safety and efficacy of this procedure. Data exist to demonstrate that weight loss and resolution and remission of obesity associate diseases for the vertical sleeve gastrectomy are comparable and fall between two CMS-approved weight loss surgeries, i.e: Roux-en-Y gastric bypass and adjustable gastric banding.
Medicare coverage of vertical sleeve gastrectomy will afford those Medicare patients affected by morbid obesity an additional treatment option for addressing their weight and obesity-related diseases while maintaining gastrointestinal continuity and without the need for placement of an implantable device (band). In fact, there are many circumstances where the vertical sleeve gastrectomy is an ideal treatment option for patients such as patients with inflammatory bowel disease, patients receiving steroid medications for joint and bone diseases, patients with chronic renal or liver failure that may need organ transplant, among many others. I do use selectively in my practice the vertical sleeve gastrectomy as the procedure is covered by many private payors and now also in some cases by Wisconsin Medicaid.
Expanding Medicare coverage for vertical sleeve gastrectomy will ensure that Medicare patients have access to the same treatment options that other non-Medicare patients already have.
I support the initiative to provide coverage for the vertical sleeve gastrectomy. Please do not hesitate to contact me directly if I can be of any assistance or to provide more detailed information.
Sincerely,
Guilherme M. Campos, MD, FACS
Associate Professor of Surgery
University of Wisconsin School of Medicine and Public Health
600 Highland Avenue , H4/744 CSC
Madison, WI 53792-7375
Phone 608/263-1036
Fax 608/263-7502
mailto:campos@surgery.wisc.edu
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Date: 10/29/2011
Dear Dr. Berwick,
Thank you for opening a National Coverage Determination for the Vertical Sleeve gastrectomy. As a practicing healthcare professional who treats those affected by morbid obesity, I can attest to the safety and efficacy of this procedure. Data exist to demonstrate that weight loss and complications for the vertical sleeve gastrectomy are comparable and fall between two CMS-approved weight loss surgeries --Roux-en-Y gastric bypass and adjustable gastric banding (NEJM 2009 Wolfe, JAMA 2010 Birkmeyer, Annals of Surgery 2011 Hutter).
Furthermore, Medicare coverage of vertical sleeve gastrectomy will afford those Medicare patients affected by obesity an additional treatment option for addressing their weight and obesity-related comorbidities while maintaining gastrointestinal continuity. In fact, there are circumstances where the vertical sleeve gastrectomy was an ideal treatment option for several of my patients:
I have had to turn away several super morbidly obese patients due to contraindications to adjustable gastric banding secondary to autoimmune diseases. Additionally these patients had markedly increased risks to proceeding with Roux-en-Y gastric bypass including the requirement for lifelong use of steroids and multiple prior abdominal surgeries with dense intestinal adhesions making these patients ideal candidates for laparoscopic vertical sleeve gastrectomy. Furthermore, all of the other health insurance companies that our bariatric patients present with to our practice in Michigan cover vertical sleeve gastrectomy.
Expanding Medicare coverage for vertical sleeve gastrectomy will ensure that Medicare patients have access to the same treatment options that other non-Medicare patients already have. I wholeheartedly urge you to provide coverage for the vertical sleeve gastrectomy.
Sincerely,
Arthur M. Carlin, MD, FACS
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