The Centers for Medicare & Medicaid Services will release by year-end a draft guidance to aid regulators and manufacturers in determining levels of clinical evidence required for coverage decisions.

Currently circulating at CMS, the document will not outline specific thresholds for clinical effectiveness - as emphasized by drug trials - but will focus instead on degrees of evidence needed to fit the agency's standard of "reasonable and necessary," as reviewed on a case-by-case basis, according to the agency.

At a Medical Device Manufacturers Association conference Oct. 17 in Boston, MDMA Reimbursement Policy Counsel Dan Waldmann applauded CMS' progress on coverage review policy. He cautioned, however, that the document still would not address R&N sufficiently. "We would like to see much more in terms of elucidating what 'reasonable and necessary' means and retaining a lot of flexibility on what kind of evidence it would take to get there," he suggested.

CMS' only guidance for reviewing technologies is currently a list of Medicare Coverage Advisory Committee executive committee (EC) working group categories for evaluating effectiveness. The EC recently voted to add a new category, "substantially more effective" to that hierarchy (¹ Also see "“Substantial” Device Effectiveness Proposed As Coverage Decision Category" - Medtech Insight, 30 September, 2002., p. 11).

"The closest thing they have is [the MCAC document], but there's not a whole lot out there in terms of defining...the criteria that CMS uses in deciding whether they are going to cover something," Waldmann said.

"If all we get [in the guidance] is a very strict kind of standard about what kind of evidence [we] are going to have to show, those evidence requirements might not be appropriate for [many] specific technologies," he maintained.

Waldmann contrasted the situation to the one at FDA, where several different guidance documents outline data requirements for specific devices. "CMS doesn't have anything like" the wealth of guidances and regs that FDA has, he commented.

Closer coordination of CMS and FDA guidances may occur if the agencies adopt recommendations by the HHS Secretary's Advisory Committee on Regulatory Reform urging parallel clinical trial requirements (² Also see "FDA/CMS Device Trade Secret Memo Added To Regulatory Reform Wish List" - Medtech Insight, 16 September, 2002., p. 9).

The panel, which has also suggested an FDA-CMS memorandum of understanding preserving trade secrets and confidentiality, will hold its final meeting Nov. 21 in Washington, D.C.

Improving relations between the agencies also is a goal of incoming FDA Commissioner Mark McClellan (³ Also see "McClellan Outlines Vision For Device User Fees, Third-Party Inspections" - Medtech Insight, 14 October, 2002., p. 3). McClellan, CMS Administrator Tom Scully and HHS Secretary Tommy Thompson "are very close," CMS Center for Medicare Management Director Tom Grissom reported.

"I'm embarrassed to say that apparently in the past we would call up the FDA and ask for help and they wouldn't give it to us," Grissom said. "We're trying to overcome that and say, 'Hey, we work for the same people you do, we work for the same secretary. If you get something before we do, can you share it with us? And if we get something before you do, we'll share it with you.' It is beginning to happen now."

According to Waldmann, however, "CMS and FDA are two very different agencies: they have very, very different missions, and very, very different criteria, and I am very afraid of polluting the FDA review with lots of things that are relevant just to CMS."

"We don't want to get in the situation where your FDA approval is delayed...because we're trying to address questions that are only relevant to a federal program [for] people 65 and older," Waldmann warned.

Another obstacle the agencies may face in their collaboration is that of timing. Under the medical device user fee measure now awaiting the President's signature, FDA needs to meet specific review performance goals. In a parallel review setting, those goals may conflict with CMS timeframes.

Stakeholders should not expect CMS to push for its own user fee system anytime soon, however. "I really think we ought to be responsive to our beneficiaries and providers and not get into a situation where we get to the point where [industry has] to fund us in order for us to do our work," Grissom opined. "I would find that offensive to think that's something we should do; and the best way to avoid that is to try and do our job better."

CMS Coverage Guidance: Reasonable/Necessary Not Defined, But Approached

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