WASHINGTON Sean Tunis, chief medical officer of the Centers for Medicare & Medicaid Services (CMS; Baltimore, Maryland) and director of its Office of Clinical Standards and Quality, told attendees at the Medical Device Manufacturers Association (MDMA; Washington) annual meeting that the agency will soon be rolling out a series of guidance documents concerning the type of evidence it is looking for in its analysis of various types of products for reimbursement.

These guidance documents, he said, would focus on "key areas of technology developments," with the first ones likely to relate to molecular imaging and wound care systems. Other guidance documents, Tunis said, would relate more broadly to trial designs and expected outcomes as a "framework" for making decisions concerning CMS payment for new technologies.

Such guidance documents are intended to improve the transparency of CMS decision-making an issue oft-criticized by the industry and are likely to be welcomed considering the lack of specificity concerning the evidence that the agency is seeking, at least as described by Tunis at the MDMA meeting.

While he emphasized the need for better evidence concerning cost effectiveness and clinical outcomes, he also noted that the "threshold of evidence" varies and is not rigid but can move "higher or lower," depending on the type of product being reviewed for coverage.

As examples, he pointed to the high threshold of evidence being required for coverage of implantable cardioverter defibrillators (ICDs) and the resultant controversial determination to cover only a sub-population of the heart failure group ICDs are designed to treat. Conversely, he said that the threshold of evidence needed for other types of products products that are less invasive and at the same time products "hard to study" was often lower, using the coverage of an air-fluidized bed as an example of such a product that has won coverage.

Generally, he said also that potential applicants for coverages too often may have an "overly rigid understanding" of the type of evidence needed and so they assume that if they "don't have a randomized clinical trial, they don't show up at [our] door."

As an overview statement, he said that CMS is seeking evidence that "deemphasizes intuition" and that it has a "preference for systematic gathering of clinical data, [but] not a specific number [of patients] or a particular size. It varies as to the particular technology you're dealing with."

Tunis said that the first of the proposed guidances might be issued in "four to six weeks," which could result in such issuance sometime this month.

Don Long, Managing Editor

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