CMS plans to release its second coverage-with-evidence development (CED) guidance within the next couple of months, according to Acting Chief Medical Officer Barry Straube, MD.

The agency is "putting the final touches on a second draft document" and will release the delayed draft for public comment after Administrator Mark McClellan reviews it, Straube said in a recent interview.

He expects that after receiving public comments CMS will develop a final guidance, rather than issuing a third draft.

In April, the agency released an initial draft, which outlines its relatively recent strategy of issuing national coverage decisions requiring manufacturers to prospectively collect data to resolve any outstanding questions (¹ Also see "CMS Issues “Coverage With Evidence Development” Draft Guidance" - Medtech Insight, 11 April, 2005., p. 9).

Straube said that the device industry mistakenly believes that the CED process will be used to restrict coverage.

"If we didn't have coverage-with-evidence development, the device or therapy wouldn't be covered," he said. "We're not doing [CED] to not cover" a device - "we could have done that in the first place and saved everybody a lot of time and money."

Instead, the agency views CED as an opportunity to make new technologies available for Medicare beneficiaries and doctors while collecting additional information to better inform patient choice, Straube said.

"We're being responsible to the tax payers by not giving blanket coverage to something that may not be quite there in terms of the evidence base," he added.

In fact, CMS' greater concern is being able to narrowly define the criteria for CED decisions, so that only a few technologies qualify each year.

"If we don't start with that tight range, then we're going to get everybody wanting to have us do their research that a treatment is medically necessary," Straube said, adding that CMS could become a "research and development organization, as opposed to a federal regulatory agency."

CMS is also trying to assuage individual provider concerns that CED policies will add another level of burden and expense.

The agency is still determining who should pay for the CED requirements, but Straube said it will likely vary depending on the coverage decision. If an existing registry is available, the agency could require physicians to enter patients' information there.

If a registry is not in place, Straube suggested that manufacturers could pick up the tab or that providers could pay a user fee to fund a registry.

Following the spate of ICD recalls and fallout over Vioxx safety issues last year, Coverage & Analysis Group Director Steve Phurrough, MD, said that CMS would use CED to improve postmarket data collection (² Also see "CMS Will Push For More Postmarket Data Transparency – Phurrough" - Medtech Insight, 24 October, 2005., p. 6).

To that end, Straube said that senior FDA and CMS officials have begun preliminary discussions "about postmarket surveillance and how we might share information" that both agencies gather.

Although the discussions temporarily stopped after FDA Commissioner Lester Crawford abruptly resigned in September, Straube anticipates they will resume in the next six to 12 months.

The two agencies are also discussing ways to coordinate on parallel review, which would allow companies to request that FDA and CMS evaluate technologies simultaneously. The sister agencies expect to publish a parallel review document shortly in the Federal Register (³ Also see "FDA’s Gottlieb: Any FDA/CMS Collaboration Efforts Should Occur Postmarket" - Medtech Insight, 12 December, 2005., p. 5).

The agency is also grappling with ways to use data generated from CED decisions. If data were to show that Medicare patients have different outcomes than the clinical studies initially used to support coverage expansion, Straube suggested that CMS could stop Medicare coverage pending more rigorous trials.

Conversely, the agency could restrict coverage to specific centers of excellence or establish similar conditions to coverage.

Straube also floated the possibility that the Medicare Coverage Advisory Committee could be used to analyze registry data or clinical trial information garnered under CED policies, though the agency may first need to obtain statutory approval.

CMS’ Barry Straube Chats About Coverage-With-Evidence Development

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