FDAnews Device Daily Bulletin


Nov. 29, 2005

The Centers for Medicare & Medicaid Services (CMS) has proposed extending coverage of bariatric surgery to Medicare beneficiaries under age 65 to help reduce significant health risks associated with obesity that may increase morbidity and mortality.

According to the recently proposed national coverage decision, the CMS would pay for open and laparoscopic Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding on patients who have a body mass index greater than 35 and at least one comorbidity related to obesity -- including hypertension, Type 2 diabetes, coronary heart disease, stroke, osteoarthritis and sleep apnea. Coverage would apply to patients who have been previously unsuccessful with medical treatment for obesity.

Meanwhile, the CMS also is proposing denying coverage for bariatric procedures in Medicare patients 65 and older. This proposal is based in part on recent evidence that finds patients 65 and older had two- to three-fold higher death rates after bariatric surgery compared with younger patients, according to the CMS, which cited a recent study in The Journal of the American Medical Association.

While the CMS is not proposing coverage in older beneficiaries, the agency is seeking comment on expanding national coverage of bariatric surgery in the context of clinical trials, the CMS said. This policy approach would be a form of coverage with evidence development (CED). In addition, the CMS is proposing a credentialing program for surgeons, as well as written procedures for patient consent and adverse event reporting.

The CMS is seeking public comment on coverage of bariatric surgery under CED as well as the proposed decision itself. The proposed decision memorandum is online at http://www.cms.hhs.gov/coverage/download/id160a.pdf (http://www.cms.hhs.gov/coverage/download/id160a.pdf). Comments will be accepted for 30 days following the posting of the memorandum.