The HHS Secretary's Advisory Committee on Regulatory Reform will consider proposals to coordinate CMS' coverage analysis process with FDA's evaluation of new technologies to prevent duplicative requirements.

At a subcommittee breakout session of the group's inaugural meeting Jan. 7-8 in Washington, D.C., Wellpoint Health Networks Chairman/CEO Leonard Schaeffer said urging CMS to cooperate with FDA in making coverage decisions is the "kind of thing that can be done right away."

"There has got to be a way to move forward in parallel, as opposed to waiting until [FDA] is done to start" the CMS coverage analysis process, explained Schaeffer, a former CMS administrator.

Subcommittee member Jeff Bloom, of the D.C.-based Patient and Consumer Coalition, agreed. "There is no reason why when FDA is [reviewing] a new technology that CMS can't also be participating in that [review] electronically at the same time instead of ex post facto," he maintained.

The seven-member Coordination Subcommittee will identify HHS regulations and procedures that overlap or conflict with rules imposed by states, third-party payers and federal agencies inside and outside of HHS.

One inefficiency that has been cited frequently by device makers is the duplication of FDA and CMS reviews of new technologies. The debate hinges on FDA's requirements that approved technologies be "safe and effective" while CMS covers procedures it deems "reasonable and necessary."

Device firms contend that national coverage decisions are often based on much of the same data submitted in support of FDA approval. Last year, CMS discussed plans to form a multi-agency committee, including FDA and the National Heart, Lung and Blood Institute, to help manufacturers design clinical trials for medical technologies. Modeled after an interagency council on biomedical imaging, the effort was seen as one way to streamline health outcomes data requirements across agencies (¹ Also see "HCFA Officials Looking To Expand Interagency Collaboration To NHLBI" - Medtech Insight, 19 March, 2001., p. 8).

Previously, CMS officials have rejected the notion that the agency's standards of evidence are too burdensome. Further, responding to industry's requests that FDA approval "trigger" national coverage decisions, CMS Coverage & Analysis Group Director Sean Tunis, MD, has suggested the lack of data indicating that such a proposal would reduce aggregate health care costs (² [A#01270110000], p. 3).

At the full committee meeting Jan. 7, Guidant CEO Ron Dollens, a member of the Coordination Subcommittee, identified CMS coverage and payment decisions for new technologies as the "biggest issue" for manufacturers.

Besides the Coordination Subcommittee, the HHS secretary's panel includes three other subcommittees: Data and Information; Flexibility in Regulations; and Communications and Oversight.

On Jan. 7, HHS Secretary Tommy Thompson asked the full committee to not only explore solutions to longer-term problems but also to "focus on problems that I can fix personally" without rulemaking or new legislation. "I don't want to wait nine months to hear good ideas," he said.

Other issues to be considered by the Coordination Subcommittee are the Medicare coverage appeals process, Medicare paperwork reduction, and streamlining state and federal audits, in addition to associated record-keeping requirements designed to deter fraud.

Chaired by Jack Rovner, a partner with the Chicago Health Law Practice Group, the Coordination Subcommittee will meet once a week via conference call for about 90 minutes to develop four or five proposals to be considered by the full committee at one of its regional public meetings.

The four subcommittee chairs, plus the chair of the full committee, Douglas Wood, MD, Mayo Clinic, will establish the agenda for the public meetings. In anticipation of the weekly conference calls, each panelist will receive a one-to-two page overview of the topic to be discussed, developed by HHS staffers at the committee's request. A listserve will facilitate communication for subcommittee members.

The panel's charter mandates that it meet at least three times a year; the committee currently has scheduled five regional meetings, beginning with Feb. 25-26 in Miami and March 20-21 in San Francisco. The panel is accepting regulatory reform comments through its website, ³ http://www.regreform.hhs.gov, as well as through a Jan. 4 Federal Register notice.

CMS Coverage, FDA Review Process Overlap Studied By HHS Secretary Panel

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