FDA and CMS will likely produce a memorandum of understanding soon after the HHS Secretary's Advisory Panel on Regulatory Reform holds its final meeting Oct. 1-2 in Washington, D.C.

The agreement would formalize collaborations between FDA and the Centers for Medicare & Medicaid Services in identifying data requirements for manufacturers during the approval and coverage determination processes.

As early as January, the two agencies began discussing plans for a "white paper" to coordinate regulatory and payment decisions (¹ Also see "Cancer Imaging Tech Forum May Lead To Further FDA/CMS Collaboration" - Medtech Insight, 4 February, 2002., p. 3).

More recently, FDA-CMS collaboration has been a priority issue for the HHS panel, which heard from several presenters, including CMS Administrator Tom Scully and Center for Devices & Radiological Health Director David Feigal during its June meeting in Minneapolis (² Also see "Unique Missions Of FDA, CMS Underscored In Presentations To HHS Panel" - Medtech Insight, 17 June, 2002., p. 5).

The outcomes of that meeting and subsequent break-out group discussions will figure in the HHS panel's final report to be released this fall.

Administrative attempts to align FDA and CMS decision-making processes occur in the background of legislative attention to the topic.

In 2001, Rep. Steve Buyer (R-Ind.) authored language in Medicare contractor reform legislation (HR 3391) that would require the agencies to share information on PMA applications. The HR 3391 provisions are now within HR 4954, the prescription drug reform bill that passed the House June 28.

Under the proposal, CMS and FDA would be required to report to the House Energy & Commerce Committee on the status of their efforts to shorten the time lag between review and coverage decisions.

Buyer's language further stipulates: "Nothing in this subsection shall be construed as changing the criteria for coverage of a medical device...nor premarket approval by [FDA], and nothing in this subsection shall be construed be to increase premarket approval application requirements."

Buyer, a fairly new member of Energy & Commerce, held a July 15 briefing in Indianapolis with representatives from roughly 18 companies to discuss medical device reforms, including user fees, third-party review and inspections, and device reprocessing issues.

Although Buyer's district is home to Guidant - a key supporter of the AdvaMed-backed user fee proposal - the congressman is sensitive to the concerns of several smaller manufacturers, represented at the briefing, who would be more comfortable with smaller fees than those contained in the current proposal circulating on the Hill.

Some companies indicated they would be amenable to a 510(k) user fee amount of $1,500-2,000 versus the $2,500 contained in the latest draft proposal.

At a separate briefing on Capitol Hill, the Indiana Medical Device Manufacturers Council presented on "The Need for FDA/CMS Harmonization." The event was co-sponsored by the House Medical Technology Caucus, the House Rural Health Care Coalition and the Senate Rural Health Caucus.

According to IMDMC General Counsel Brad Thompson of the Indianapolis law firm Baker & Daniels, CMS should collect "real outcomes data" for at least one year before developing coverage guidelines on an item or service. Such guidelines "would address classic insurance issues such as the appropriate clinical setting and frequency of use," would be developed publicly, and "would respect prior FDA decisions."

IMDMC member Cook Group also underscored the need for comprehensive outcomes data collection in CMS coverage policy development.

"Only after a period of use can the value of [an] innovation be fully recognized," Cook Executive VP Stephen Ferguson contended, since "users recommend improvements or refinements of the technology as they gain experience with a device."

According to Ferguson, such data can be collected only if new medical therapies are "immediately available to the Medicare population" upon receiving FDA approval. Ferguson acknowledged that statutory changes would be required in this case.

IMDMC plans to shop its proposal to House Ways & Means, Energy & Commerce and Senate Finance Committee staffers to shape the Medicare reform debate during the 2002 congressional elections.

MoU Or Statutory Fix? FDA/CMS “Harmonization” Strategies Are Under Review

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