Reversing its November proposal, CMS has decided to include patients aged 65 and older in its national coverage of bariatric surgery for the treatment of morbid obesity.

The agency had originally proposed limiting coverage to patients under 65 who met certain conditions, citing data that showed higher mortality rates within the early post-operative period for older patients (¹ Also see "Proposed Decision Improves Bariatric Surgery Coverage For Patients Under 65" - Medtech Insight, 28 November, 2005., p. 10).

However, David Flum, MD, Department of Surgery, University of Washington, whose study was used as a reference by CMS, stressed in his comments on the proposal that surgeons with more experience have been able to achieve similar outcomes in Medicare beneficiaries of all ages.

Other bariatric surgeons who commented agreed that the benefits of surgery in reducing obesity-related disease outweighed the surgical risks. In addition, several professional societies pointed to the growing problem of morbid obesity in older people and urged CMS to cover those over 65.

Based on Flum's and others' input and a re-evaluation of the data on surgical risk, "we are revising our decision to provide coverage of identical procedures in the older population and younger population," CMS explains in its coverage decision memorandum.

The final decision, issued Feb. 21, provides nationwide Medicare payment for open and laparoscopic Roux-en-Y gastric bypass, laparoscopic adjustable gastric banding, and open and laparoscopic biliopancreatic diversion with duodenal switch (BPD/DS) to patients who have a body-mass index >35 and at least one co-morbidity related to obesity.

CMS' Medicare Coverage Advisory Committee awarded positive marks to the same procedures in November 2004, but questioned whether safety and efficacy data could be generalized to the over-65 Medicare population (² Also see "Gastric Banding Less Potent Than Bypass But Clinically Beneficial – MCAC" - Medtech Insight, 8 November, 2004., p. 10).

The BPD/DS procedure was not covered under CMS' original November proposal. But comments from surgeons extolling the technique's "superior effectiveness for maximal weight loss," as well as new data demonstrating a low short-term mortality rate when the procedure is performed by experienced surgeons, persuaded CMS to change its mind.

CMS Opts Not To Exercise CED Option

Though the agency had floated the idea of employing its coverage-with-evidence-development mechanism to gather more data on the use of bariatric surgery in some patient populations, CMS reported that it did not receive significant comments in support of conditioning coverage on a data collection system (³ Also see "Bariatric Surgery National Coverage Could Be Subject To CED – Phurrough" - Medtech Insight, 14 November, 2005., p. 7).

"Thus, we will not expand coverage using the CED concept," CMS says.

The new policy expands on CMS' previous coverage of weight-loss surgery. In the past, Medicare payment has been available only for the gastric bypass procedure, and only if the surgery was to correct an illness that caused or was aggravated by the patient's obesity.

Like the November proposal, the final decision requires a candidate for bariatric surgery to first undergo medical treatment - which might consist of dietary manipulation, behavior modification and/or medication - without success before turning to surgery.

But, as "there are no consistent standards in the literature regarding length of a medical treatment trial," CMS has revoked its proposed requirement that medical treatment be attempted for a trial period of six to 12 months, deferring instead to physician discretion.

All surgeons are expected "to be part of a comprehensive program for the treatment of co-morbid conditions related to obesity and to have applied principles of good medical care prior to surgery," CMS writes.

Coverage Contingent On Surgeon Experience

The decision mandates that bariatric surgery procedures be done by credentialed surgeons at certified facilities. To qualify, surgeons must perform at least 50 bariatric surgeries a year, with at least 125 bariatric surgery cases completed at initial certification.

A participating facility must be either certified by the American College of Surgeons (ACS) as a Level-1 Bariatric Surgery Center or designated by the American Society for Bariatric Surgery (ASBS) as a Bariatric Surgery Center of Excellence.

CMS has identified 117 institutions across 31 states as centers that have been certified by ACS and/or ASBS and therefore qualify to receive coverage for bariatric procedures.

Within the relatively new and growing market, Johnson & Johnson/Ethicon Endo-Surgery is developing the Swedish Adjustable Gastric Band to compete with Inamed/BioEnterics' currently available BioEnterics Lap-Band . J&J/Ethicon also offers its line of EndoPath endoscopic linear cutters for bariatric applications.

U.S. Surgical, a division of Tyco Healthcare, markets the Endo Gia Universal XL surgical stapler for use in laparoscopic bypass procedures.

Five bariatric procedures for which coverage was initially sought - open and laparoscopic vertical banded gastroplasty, open and laparoscopic sleeve gastrectomy and open adjustable gastric banding - are non-covered under the final decision due to insufficient evidence supporting their use.

The American Society for Bariatric Surgery - one of the requestors of the bariatric surgery national coverage determination, which CMS opened in May 2005 - may in the future seek coverage for sleeve gastrectomy as part of a staged bariatric procedure in patients who may be unable to tolerate more extensive intervention due to the severity of their illness, according to President Neil Hutcher, MD, Commonwealth Surgeons, Ltd.

Hutcher said that in extreme cases of morbid obesity some surgeons are already performing biliopancreatic diversion procedures in two stages, the first being sleeve gastrectomy. However, he acknowledged that data on staged bariatric intervention are limited.

Overall, the professional society is "very happy" with the coverage decision, Hutcher said. "We've gotten 99.9% of everything we requested from CMS," he noted, adding that the society is optimistic that private insurers will follow the agency's lead.

Seniors Covered In New Medicare Policy For Bariatric Surgery

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