Press Releases

MEDICARE PROPOSES NEW COVERAGE POLICY FOR BARIATRIC SURGERY PROCEDURES

The Centers for Medicare & Medicaid Services (CMS) announced today its proposal to modify Medicare coverage of bariatric surgery to help reduce significant health risks associated with obesity that may increase morbidity and mortality among the Medicare population.

Following an extensive evidence review, CMS proposes national coverage for Medicare beneficiaries under age 65 for open and laparoscopic Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding under certain clinical circumstances and when performed in a facility meeting evidence-based standards for bariatric surgery.

Further, in light of recent studies indicating significant surgical risks particularly in seniors aged 65 and over, CMS is proposing the non-coverage of these bariatric procedures.   CMS seeks comments on whether and how Medicare may cover these services for Medicare beneficiaries aged 65 and over, and support the development of better evidence of the safety and effectiveness of the surgery for Medicare beneficiaries. 

“This proposed limited coverage for bariatric surgery is part of Medicare’s ongoing commitment to ensure access to the most effective treatment alternatives for its beneficiaries, using the best and latest evidence,” said CMS Administrator Mark B. McClellan, M.D., Ph.D.

In the United States , more than 60 percent of the population is now classified as overweight or obese.   Overweight and obese persons have an increased risk of a number of serious diseases compared to normal weight and waist circumference.

Some of the most important, common, and costly co-morbidities include hypertension, dyslipidemia, type 2 diabetes, coronary heart disease, stroke, gallbladder disease, osteoarthritis, sleep apnea, respiratory problems, and endometrial, breast, prostate, and colon cancers.

Though diet and exercise are the mainstay of treatment, bariatric surgery may be a helpful treatment option for people with extreme obesity whose treatments have been unsuccessful and who have developed health problems from the obesity.   CMS is seeking comment on this evidence and its implications for coverage, and for the range of non-elderly patients who would be covered. 

“While the best proven ‘treatment’ is a nutritious diet and regular exercise, and medical treatments are also available, some beneficiaries may significantly reduce their health risks through surgery,” Dr. McClellan said. “We are seeking public comment on the best way to provide coverage for this surgery, to reduce the complications of obesity while limiting the risks of the surgical treatments.”

For the proposed coverage decision, CMS found that the evidence appears adequate to conclude that open and laparoscopicRoux-en-Y gastric bypass and laparoscopic adjustable gastric banding produce net health benefits in Medicare beneficiaries under age 65, who have at least one obesity-related health problem and have been previously unsuccessful with medical treatment for their obesity.  CMS is seeking comment on this evidence and its implications for coverage, and for the range of non-elderly patients who would be covered.

However, based in part on recent evidence on bariatric surgery in seniors that shows elevated risks, CMS is not proposing coverage for patients 65 and older.  In particular, a recent study by David R. Flum, Early Mortality Among Medicare Beneficiaries Undergoing Bariatric Surgical Procedures [JAMA. 2005; 294:1903-1908],  reported that patients 65 and older had two-to three-fold higher death rates after bariatric surgery compared with younger persons.  Based in part on recent evidence on bariatric surgery in seniors shows elevated risks, CMS is not proposing coverage for patients 65 and over.  Flum also reported higher death rates among persons over age 75 and among persons whose surgeon had less past experience with the operation.

While CMS is not proposing to cover surgery in older beneficiaries, CMS is seeking comment on expanding national coverage of bariatric surgery in the context of clinical trials.   This policy approach would be a form of coverage with evidence development (CED).  CMS is specifically asking for public comment on coverage of bariatric surgery under CED as well as the proposed decision itself. 

CMS is also proposing facility criteria, including a credentialing program for surgeons, a review of staff and consultant qualifications, an integrated program for patient care, written procedures for patient consent and adverse event reporting, and appropriate equipment for patient care.   CMS is also seeking comment on whether we should expand the facility criteria to also include specific bariatric surgery volume criteria for surgeons and/or facilities. 

In addition to today’s proposed decision, Medicare has taken other steps to help beneficiaries who are overweight or obese reduce the health risks by addressing obesity.   For example, beneficiaries also can benefit from the new “Welcome to Medicare” exam.  This new benefit can be used to screen Medicare beneficiaries for many illnesses and conditions.

Obesity also has a significant impact on Medicare beneficiaries’ quality of life.  By providing an initial physician examination for all newly enrolled Medicare beneficiaries, seniors and disabled Americans will have the opportunity to discuss with their physician the importance of preventive care and living a healthy lifestyle.  CMS also covers services other than bariatric surgery that treat complications of obesity.

The proposed decision memorandum, published today, is available on CMS’ Coverage website at http://www.cms.hhs.gov/coverage.   CMS encourages the public to respond to the Agency’s proposed decision by submitting public comments directly to the Coverage web site.  Comments will be accepted for 30 days following the posting of the proposed decision memorandum.  After careful consideration of the public comments, CMS will issue a final decision memorandum.