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Medicare insurance controversy

Medical associations unite to defend sleeve gastrectomy

The CMS are disagreeing with American medical associations over the utility of sleeve gastrectomy.
CMS proposes restricting coverage for LSG to operations that are part of a randomised control trial
ASMBS heads vigorous response from leading societies

The Centers for Medicaid and Medicare Services (CMS) has proposed coverage for laparoscopic sleeve gastrectomy (LSG) only as part of a randomised control trial, following a review of the published clinical studies. However, the proposal has resulted in an unprecedented display of unity with the ASMBS sending a response letter to the CMS that was also supported by the American College of Surgeons, American Society of Bariatric Physicians, Michigan Bariatric Surgery Collaborative, Obesity Action Coalition, SAGES, and The Obesity Society. 

The CMS proposal, published on 29th March 2012, stated: “The CMS proposes that the currently available evidence is insufficient to conclude that the bariatric surgery known as laparoscopic sleeve gastrectomy (LSG) for the treatment of obesity (BMI≥35) improves long-term beneficiary health outcomes. We therefore propose that coverage for LSG is not reasonable and necessary under section 1862 (a) (1) (A) of the Social Security Act.”

The statement also proposes to support the development of further research on the effectiveness of LSG for Medicare beneficiaries who have a BMI≥35 and at least one comorbidity “only when furnished in a randomized controlled trial under the coverage with evidence development paradigm.”

LSG has become a popular choice for obese individuals under 65 years. The CMS claims this proposed decision will allow certain eligible beneficiaries to receive LSG in controlled environments to ensure optimal care and will enhance the evidence base and aid Medicare patients and providers in important clinical decision making. The statement added that since LSG is now predominately done as a stand-alone procedure, LSG conducted as part of a planned two-stage surgery is “beyond the scope of this analysis and thus shall remain non-covered. LSG that converts to open sleeve gastrectomy is also non-covered”. The CMS recommendations for LSG randomised controlled trials are highlighted in the table below:

A randomized controlled trial under which there is Coverage with Evidence Development for LGS for the treatment of obesity (BMI ≥ 35) for patients with at least one comorbidity must address the following:

Prospectively, in Medicare subjects who have BMI≥35 and qualify under the patient criteria specified in Medicare’s Bariatric Surgery for the Treatment of Morbid Obesity National Coverage Determination what are the frequency and severity of the following outcomes and adverse events at 30 days, 90 days, one year, two year and three years or longer compared to subjects with the same patient criteria as above whose obesity treatment does not include laparoscopic sleeve gastrectomy:

Mortality Rate.

Re-Operation Rate.

Adverse Events including stroke, myocardial infarction, leaks, infections and others.

Short and long-term BMI.

Quality of Life.

Obesity-related comorbidities.

The study must adhere to the following standards of scientific integrity and relevance to the Medicare population:

The principal purpose of the research study is to test whether a particular intervention potentially improves the participants’ health outcomes.

The research study is well-supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.

The research study does not unjustifiably duplicate existing studies.

The research study design is appropriate to answer the research question being asked in the study.

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

Summary of the CMS’ proposed recommendations for LSG randomised controlled trials

 

Unified Response

The ASMBS Access to Care Response Team led by the Society’s president, Dr Robin Blackstone, and Dr John Morton, chair, access to care responded to CMS in a response letter regarding SG, vigorously defending the rightful coverage of LSG for CMS beneficiaries. In the letter, ASMBS cited evidence not previously reviewed by CMS including the recently published STAMPEDE trial and two other prospective, controlled trials regarding LSG. 

The letter also claimed that the CMS review focused exclusively on Medicare beneficiaries older then 65 ignoring other Medicare beneficiaries such as patients who are disabled, have End-Stage Renal Disease or beneficiaries who are dual eligible for both Medicare and Medicaid. Even for patient over 65, the ASMBS provided three studies and bariatric surgery registry data indicating the safe and effective use of LSG in this population. Finally, ASMBS said that additional RCTs would be redundant, cost-ineffective and in conflict with CMS published standards of scientific integrity and relevance.

The response stated: “We are concerned that the proposed decision memo reached its conclusions with an incomplete review of available evidence, lack of generalisability 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 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 LSG 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.”

The letter notes that the CMS’ literature review end date of December 2011 was before the publication of several clinical studies on sleeve gastrectomy, including two randomised trials and one prospective cohort study. These studies, the letter claims, 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'.

Clinical studies

Specifically, the letter refers to the 26 March 2012 issue of the New England Journal of Medicine, and a paper published by Schauer et al (Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes). In this randomised controlled trial, sleeve gastrectomy outcomes were equivalent to Roux-en-Y gastric bypass, a CMS covered surgical benefit. The letter also cites more recent paper by Leonetti et al. in the 16 April 2012 issue of the Archives of Surgery. 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) and in Fasting Plasma Glucose (FPG) (183 to 150mg/dL). In comparison the LSG group saw substantial declines in both weight, BMI 41.3 to) and FPG (166 to 97mg/dL). Cardiac risk factor assessment showed consistent superiority of LSG over medical therapy particularly for Triglycerides, mg/dl (LSG, 169 to 97; Medical, 199 to 173). 

The letter referenced a final study, in the April 2012 issue of Surgical Endoscopy, by Helmio et al. (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). Therefore, the ASMBS urges the consideration of these studies for inclusion in the CMS’ continued National Coverage Analysis for LSG.

Aged

The letter was also critical of the Proposed Decision Memo for its exclusive focus on on Medicare beneficiaries aged over 65, claiming that the CMS ignored patients who are aged under 65 and are disabled, have end-stage renal disease or beneficiaries who are dual eligible for both Medicare and Medicaid. Furthermore, the disabled Medicare population age under 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. 

Randomised clinical trial

The ASMBS Response Letter also disagreed with the proposal for coverage within a randomised control trial claiming that it is in conflict with the cited CMS standards of scientific integrity (Table 1). These are:

The research study does not unjustifiably duplicate existing studies.

ASMBS' response: “The call for a randomized control trial for laparoscopic sleeve gastrectomy does duplicate previous studies eg. Schauer et al. 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).”

The research study design is appropriate to answer the research question being asked in the study.

ASMBS' response: “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. The proposed randomized trial design is not optimal or even appropriate for determination of the incidence of infrequent complications over a period of years. An 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.). 

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

ASMBS' response: “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.”

The letter concludes; “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 LSG become a covered benefit for all Medicare beneficiaries who are in need and desirous of the same treatment options as other Americans.”

The CMS will complete its National Coverage Analysis for LSG by 27th June 2012.

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