CMS may issue national coverage for bariatric surgery on the condition that providers enroll beneficiaries in a clinical trial or registry to gather additional information on the procedure, according to CMS Coverage & Analysis Director Steve Phurrough, MD.

"We think bariatric surgery may be beneficial for our morbidly obese population over 65, but there are some concerns we have about the risk, so this may be an issue where [coverage-with-evidence development] would work," Phurrough said Nov. 10 at the Medical Device Manufacturers Association's Coverage & Reimbursement conference in Washington, D.C.

The agency's nascent coverage-with-evidence development (CED) policy allows CMS to issue national coverage decisions that require additional data collection to resolve outstanding questions. CMS issued a draft guidance on the process in April (¹ [A#01310200002], p. 4).

CMS opened the bariatric surgery NCD 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.

The decision will cover Roux-en-Y gastric bypass, adjustable gastric banding, biliopancreatic diversion and vertical banded grastoplasty. The agency expects to issue a proposed decision memo by Nov. 24.

Scarce Data On Bariatric Surgery In Elderly Patients

Phurrough noted that because trial data show a higher death rate in bariatric surgery in Medicare patients, "this has the potential of us saying 'we need some additional...information.'"

He also pointed out that bariatric surgery trials have included very few patients age 65 and older.

According to Inamed, the American Society of Bariat-ric Surgery found that 5% of bariatric surgery patients are over the age of 65. Inamed stressed that the NCD will affect disabled Medicare beneficiaries as well.

Recent CED decisions from CMS have dealt with procedures affecting large numbers of beneficiaries, such as PET scans to diagnose Alzheimer's and ICD implantation, for which CMS requires providers to enroll patients in a registry to receive reimbursement.

Despite the fact that the number of Medicare beneficiaries that will be affected by an NCD for bariatric surgery is relatively small, Phurrough stressed that "volume in and of itself...in general will not be the determining factor in whether we do CED or not."

"The beneficiary population eligible for bariatric surgery is less than the beneficiary population eligible for ICDs, for instance," he said. "But we have to make a decision. So if it fits CED, we would use it regardless."

Phurrough further noted that it is unlikely that CMS would leave coverage to the discretion of local carriers. "In general, if we're doing a national decision, we ought to make a national decision."

He emphasized that CED will likely be used in "very rare" cases. A second draft guidance outlining the policy is currently in the clearance process, he said.

FDA/CMS Parallel Reviews: FDA Will Issue A Notice

Phurrough and Ron Yustein, MD, clinical deputy director of CDRH's Office of Device Evaluation, also provided an update on FDA and CMS collaboration efforts.

In January, HHS published a task force report entitled "Moving Medical Innovations Forward," an initiative by former HHS Secretary Tommy Thompson that encourages inter-agency cooperation (² Also see "Cross-Agency Forum, Trial Standardization Pushed By HHS Innovation Report" - Medtech Insight, 17 January, 2005., p. 10).

This past summer, attorneys at FDA and CMS ironed out ways to make it easier for the two agencies to collaborate, according to Yustein. FDA's much tighter confidentiality policy has made collaboration difficult to date. He also acknowledged that changes in leadership at FDA have exacerbated the delay.

FDA is close to issuing a Federal Register document on a policy that would allow companies to request parallel reviews of medical technologies at CMS and FDA - one of the recommendations of the HHS task force, according to Yustein. The Federal Register notice likely will serve as the basis for a guidance document, he said.

"In the meantime, we're looking at a pilot program" to test the policy, Yustein added. The pilot will be specifically for devices, rather than drugs, he said.

FDA is also interested in sharing registries and other postmarket data with CMS and coordinating approval and coverage of products cleared under FDA's humanitarian device exemption process.

Phurrough further noted that CMS encourages device companies to interact with the agency early on in the FDA approval process. "In general, the kinds of endpoints that [CMS is] interested in are not so different from what the FDA is interested in," so adding them to FDA trials will not be that burdensome, he said.

The CMS official also reported that CMS' next guidance document will look at how the agency reviews evidence, including surrogate endpoints that FDA frequently allows for device trials.

Phurrough noted that CMS generally has concerns with surrogate endpoints, unless there is "good clinical data" supporting their value.

FDA And CMS Turn To Postmarket Data Collection

With FDA focused on quelling congressional and public concern over drug and device safety issues, and CMS interested in obtaining better evidence to support reimbursement, both agencies are relying on postmarket data collection.

Phurrough said that postmarket data collected through the CED process will allow CMS to determine whether appropriate patients are getting the covered technology; whether physicians have adequate training in using the technology; and whether real-world outcomes are similar to the short-term outcomes observed in the clinical trials used to support coverage.

Yustein noted that long-term outcomes are particularly important for devices, since product lifecycles are often much longer than the duration of the trial data used to approve the technologies.

Further, "the clinical pattern provided premarket is usually in a few highly esteemed clinical academic centers," he pointed out. "Once you introduce the technology out into the real world, it may not be used the same, or it may not be used with the same effectiveness or safety."

FDA might incorporate postmarket information into the product's labeling, or even public health notifications or recalls, Yustein posited.

Bariatric Surgery National Coverage Could Be Subject To CED – Phurrough

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