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I have read so much conflicting stuff on the Gastric Sleeve....I am trying to have it done ...when is medicare going to approve it....I have done all the pre op stuff and am waiting for a phone call from USC doctors to procede........WHEN WILL IT BE APPROVED.....
Soon, ive heard.
A lot of surgeons are pressing for it...
View Public Comments for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2)
View Public Comments for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2)
Commenter:
Chlysta, Walter J. Chlysta MD
Date: 10/14/2011
Comment:
To whom it may concern: I am asking you to consider covering sleeve gastrectomy for medicare beneficiaries. I am a bariatric surgeon practicing bariatrics since 2002 and general surgery since 1999. I have been performing sleeves for about two years. There is ample literature available that shows the sleeve has comparable remission of comorbidities as the bypass specifically with respect to diabetes. I see this in my practice. The sleeve has many advantages over the bypass for certain patients. 1. There is a much lower risk of ulcers due to the fact that most of the acid producing part of the stomach is removed and there is no unopposed gastric stimulation as there is somewhat with the Gastric bypass. This is important in someone who is on a blood thinner(coumadin) as ulcers can bleed. I perform sleeves on patients on coumadin. This fact is also important for someone who has severe arthritic pain and requires NSAIDS. NSAID use in a bypass patient very frequently results in a marginal ulcer which can bleed or perforate or cause the need for PPI use and repeated endoscopy. This fact is also relevant for smokers. We require our patients to stop smoking preoperatively. Unfortunately many bypass patients start up again post op and develop marginal ulcers. (Marginal ulcers are very much associated with smoking after the gastric bypass). In a long time smoker who I believe will start up again, I offer them the sleeve. 2. There is a much lower risk of bowel obstruction postoperatively with the sleeve that with the bypass. No small bowel cutting is required for the sleeve so there are no internal hernia defects to close or to later open up again. There is no published episode of intussusception of a sleeve patient. This happens although infrequently in bypass patients. 3. In certain patients their bariatric surgery is more likely to be performed laparoscopically with a sleeve than with a bypass. This is because if someone has had extensive lower abdominal surgery, it can be difficult to laparoscopically (or even open) acces the small bowel to perform a bypass. With the sleeve, you don't have to acces the small bowel. You can operate superior to the adhesions and leave them undistubed. As you know, there is great benefit to the patient if you are able to perform their surgery laparoscopically as opposed to open. These benefits include lower incidence of wound infection, hernia, dehiscence, pneumonia, cardiopulmonary complications, and thromboembolism. All this is proven and in the literature. 4. The sleeve allows access to the bile duct endoscopically postopertively. 5. There is no endoscopically inaccessable distal stomach in the sleeve. If a bypass patient has anemia. Endoscopy is performed from above and below but the distal stomach can not easily be evaulated. There has been concern in the literature for the sleeve worsening symptoms of heartburn. That has not been my experience as I am very aggressive at fixing even small hiatal defects. With this the vast majority of my patients with preop heartburn do not have heartburn postop. To date I have performed over 325 bypasses, 80-09 sleeves and about 50 bands and 20-30 revisions. We have not had a PE or leak in a sleeve. Our excess weight loss for sleeves is 62% at one year and 77% for bypass. I ask you to consider coverage for sleeve gastrectomy as it is an excellent procedure for a bariatric surgeon to have in his armamentarium to offer patients. Thank you, Walter J. Chlysta MD, FACS
View Public Comments for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2)
View Public Comments for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2)
Commenter:
Castro, Manuel
Title: MD
Organization: New Beginnings Surgical Group
Date: 10/24/2011
Comment:
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 is a better treatment option for my patients: a) Patients with extensive small bowel adhesions from prior surgery, which limits mobilization of the bowel to complete a gastric bypass. b) Patients that take certain medications such as coumadin and others, whose absorption is markedly affected in the first few weeks after gastric bypass. This is much less of a problem with the vertical sleeve gastrectomy. c) Patients that cannot perform the required amount of exercise due to severe osteoarthritis, usually lose a greater amount of weight with the vertical sleeve gastrectomy than patients with adjustable gastric band. In fact, some older physically disabled patients may not lose any weight with the adjustable gastric band. d) Patients that need to take steroids chronically have a much lower incidence of gastric complications from these drugs after vertical sleeve gastrectomy. (The band is contraindicated and gstric bypass patients have a higher incidence of marginal ulcers with steroid use) e) Patients that live far from town frequently do not get the full benefit of the adjustable gastric band due to missing follow up appointments and band adjustments. In these patients, the vertical sleeve gastrectomy is a better option and we consistently see better results with the later operation. f) Patients with massive obesity, i.e. BMI of >60 or 70, the sleeve gastrectomy is a less risky option with results that are almost as good as patients with bypass. Moreover, adjustable gastric band in these patients falls short of the results achieved with gastric bypass or sleeve (i.e. inadequate weight loss and resolution of certain co morbid conditions such as diabetes). g) Patients with massive hepatomegaly. The only option under these circumstances may be the vertical sleeve gastrectomy because of poor access to the lesser curve side of the proximal stomach. 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, Manuel E. Castro, MD, PhD.
https://www.cms.gov/medicare-coverag...ReportType=nca
View Public Comments for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2)
Commenter:
Blackstone, Robin
Title: President
Organization: American Society for Metabolic and Bariatric Surgery
Date: 10/29/2011
Comment:
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%)
Readmission 6291 (4.62%) 1611 (1.38%) 576 (3.61%)
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
The list goes on and on, pages and pages: https://www.cms.gov/site-search/sear....html?q=sleeve