Selected bariatric surgical procedures for reducing health risks associated with obesity are reasonable and necessary for certain Medicare beneficiaries under 65 years of age, according to CMS' proposed national coverage decision published Nov. 23.

Under the revised policy, payment for open and laparoscopic Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding would be extended to patients with a body-mass index ? 35 and at least one co-morbidity related to obesity.

The patient must have undergone medical treatment unsuccessfully before being considered for surgery, the agency adds. A reasonable trial period for medical treatment - which might consist of dietary manipulation, behavior modification and/or medication - is six to twelve months, CMS says.

In a tightening of existing policy, the decision would deny coverage of any kind to beneficiaries age 65 and older. Currently, CMS covers gastric bypass surgery in cases of extreme obesity, regardless of age, when "it is medically appropriate for the individual to have such surgery" and "the surgery is to correct an illness which caused the obesity or was aggravated by the obesity."

CMS cites data that has surfaced since its Medicare Coverage Advisory Committee suggested in November 2004 that results from bariatric surgery trials in younger patients could possibly be generalized to the senior population.

One study reported mortality rates in persons 65 years of age and older to be 2.8 times higher than that of the younger population at 30 days, three times higher at 90 days and 2.85 times higher at one year, according to CMS.

"Since there are no clinical trial data in the older population and the surgical risk is significantly higher, we believe that it is inappropriate to perform this surgery in this population and thus do not believe, with the data available, that any bariatric surgery procedure is reasonable and necessary for the Medicare population age 65 and older," the agency explains.

However, the agency requests public comment on the potential to revise its proposed noncoverage for seniors and instead pursue coverage with evidence development (CED). CMS issued a CED draft guidance in April and is currently finalizing the concept (¹ [A#01310200002], p. 4).

The agency also requests comment on using the CED approach to potentially broaden coverage for the under-65 population.

The bariatric surgery NCD was opened in May at the request of Inamed ( BioEnterics Lap-Band ), Johnson & Johnson/Ethicon Endo-Surgery ( Swedish Adjustable Gastric Band ), Tyco/U.S. Surgical, Medtronic/Transneuronix Corp., the American Society for Bariatric Surgery and the American Obesity Association (² Also see "Medicis May Inherit Medicare Coverage Of Obesity Intervention Devices" - Medtech Insight, 23 May, 2005., p. 18).

Seven bariatric procedures for which coverage was sought - open adjustable gastric banding, open and laparoscopic vertical banded gastroplasty, open and laparoscopic biliopancreatic diversion with or without duodenal switch, and open and laparoscopic sleeve gastrectomy - are non-covered under the proposed decision due to lack of evidence supporting their use, CMS explains.

The proposed decision would not affect the two existing noncoverage determinations in the National Coverage Determination Manual for gastric balloon and intestinal bypass interventions.

Noting that "experienced surgeons performing bariatric surgery have a lower rate of short-term mortality than inexperienced surgeons," the proposal would limit authorization to perform the surgeries to facilities "that have demonstrated competence in managing patients preoperatively, perioperatively and postoperatively," as defined by specified criteria.

CMS proposes requiring participating institutions to have a training and credentialing program for physicians, written policies to address and document adverse events, and a written informed consent process for patients.

The agency invites comments on these and other criteria, as well as on having the American College of Surgeons and the American Society of Bariatric Surgeons perform facility reviews. It also requests comments on the idea of including bariatric surgery volume criteria for both facilities and surgeons.

Additionally, CMS seeks comment on the evidence it used in its decision. Comments will be accepted for 30 days.

Proposed Decision Improves Bariatric Surgery Coverage For Patients Under 65

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