Medicare Issues Coverage Decision on Positron Emission Tomography (PET)

12/15/00 --The Health Care Financing Administration has acted to broaden coverage for PET scanning in a decision issued December 15. This coverage decision would permit PET for use in six cancers for which coverage had been requested. Several requested indications were referred for further review to a Medicare Coverage Advisory Committee panel dealing with imaging technology. The other requests were denied. A coverage request had been made on July 10, for broad coverage of 22 diseases, covering various oncological conditions, myocardial viability, and neurological conditions. The application was made by Drs. Michael Phelps and Sam Gambhir. Medicare already covers a series of specific situations where PET can be used.

In view of this coverage request, the Health Care Financing Administration (HCFA) considered the advice of the Medicare Coverage Advisory Committee (MCAC). MCAC's Executive Committee met on November 7 to consider guidelines it prepared for the evaluation of diagnostic tests and to use these draft guidelines in considering selected issues from the PET coverage request. During its full-day meeting, MCAC's Executive Committee discussed the draft guidelines for evaluating diagnostic tests, and concluded that the first step in assessing diagnostic technology should be to consider whether the test provides diagnostic information that the test is at least as effective as standard alternatives.

In applying these guidelines to PET and the coverage request, MCAC's Executive Committee evaluated the evidence that existed with respect to PET, specifically an analysis of literature and the PET submission, performed by the New England Medical Center of Tufts University, an Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality. This analysis raised some questions about the literature submitted with the request for coverage and identified several errors in the data that were abstracted from the studies. The Executive Committee did not vote formally on PET coverage, but discussion seemed to support some broadening of coverage. The committee also noted concern that HCFA coverage policy might prevent coverage of PET for some uses because of the absence of studies.

In its December 15 coverage decision, HCFA concluded that, while the evidence supported broad coverage for PET in diagnosing, staging, and restaging for six types of cancer, and for limited diagnostic use for two non-oncologic indications, "the currently available evidence does not support broad coverage for all of the proposed clinical indications listed in the July 10, 2000 request. Therefore use of PET for all other indications will remain non-covered." The Medicare coverage decision on PET can be found at: http://www.hcfa.gov/coverage/8b3-hh.htm The MCAC Executive Committee's draft Guidelines for evaluating diagnostic tests can be accessed at: http://www.hcfa.gov/coverage/8b1-i17.htm.