Analysis of the Operations of the Medicare Coverage
Advisory Committee (MCAC)

MCAC began operations in September, 1999, when it held its first panel meeting to evaluate new technologies for coverage under Medicare. Since that time, MCAC has experienced a variety of challenges in determining the exact process it will use in carrying out its work for HCFA. These issues hold implications both for the timing of evaluations and for the level of evidence that MCAC will require in reaching coverage recommendations.

• Timing/Procedures:
  Under HCFA's April, 1999, Notice, MCAC will review technologies through six panels focused on specific medical fields, such as medical/surgical proce-dures, laboratory and diagnostic testing, and diagnostic imaging. Once a panel completes its review, it will forward its recommendations to the MCAC Executive Committee, which then must review the recommendations before forwarding them to HCFA. Based on MCAC operations in late 1999 and early 2000, it appears that this process could significantly increase the time required for coverage review:
  a. Panel Review: The HCFA Notice sets no time limits for panel review. The panel has the authority to request a technology assessment, which HCFA estimates could take anywhere from 90-360 days. But the panel could take additional time beyond that in considering a technology. In ad-dition, on March 1, 2000, the MCAC Executive Committee concluded that HCFA should complete "evidence reports" which summarize data on the coverage request before the request is sent to the panel for evaluation. The MCAC document provided for as much as 180 days for completion of this report, in addition to 30 more days for review by independent experts. HCFA officials have indicated that the agency can complete these evi-dence reports in under 180 days.

  b. Re-Review: MCAC can-and has-sent panel recommendations back to the panel for reconsideration, thus increasing the review period. In its De-cember, 1999, meeting, MCAC's Executive Committee refused to ratify coverage recommendations from two of its panels which had met in Sep-tember and November, 1999. It concluded that the data underlying the recommendations were not rigorous enough. Thus, this two-step process has added time to the overall coverage review process for these technolo-gies.

  c. Technology Assessments: As noted above, MCAC has authority to request technology assessments on its own, even in those cases where HCFA has requested a separate technology assessment. It is possible that parallel as-sessments-which HCFA estimates could each take as long as one year-could be undertaken on new technologies.

• Evidence/Criteria
  The second major challenge involves the level of evidence that MCAC re-quires in evaluating medical technologies for coverage. Although HCFA has indicated that it will soon publish a regulation outlining the criteria that it will use in making coverage determinations, it has not yet done so. In the absence of this regulation, MCAC's March 1, 2000, guidance to its panels gave clear directions about the types of evidence they should seek in reviewing new technologies.

  The MCAC guidance concluded that randomized controlled clinical trials are the preferred form of evidence. Its initial draft stated this conclusion strongly, virtually to the exclusion of other types of evidence. In response to concerns from clinicians and manufacturers, however, MCAC modified its view by adding that other types of well-designed observational studies are acceptable as well.

  Given MCAC's strong views, it is possible that MCAC will ask for different types of studies than those agreed upon by HCFA and the manufacturer.