"preauthorize" care (as do many commercial insurers) the uncertainty cannot be dispelled in advance. Thus, patients considering whether to enter trials must assume that they may have to pay bills that Medicare rejects simply because they have enrolled in the trial.

This report recommends an explicit policy for reimbursement of routine patient care costs in clinical trials. It further recommends that HCFA provide additional support for selected clinical trials, and that the government support the establishment of a national clinical trials registry. These policies (1) should assure that beneficiaries would not be denied coverage merely because they have volunteered to participate in a clinical trial; and (2) would not impose excessive administrative burdens on HCFA, its fiscal intermediaries and carriers, or investigators, providers, or participants in clinical trials. Explicit rules would have the added benefit of increasing the uniformity of reimbursement decisions made by Medicare fiscal intermediaries and carriers in different parts of the country. Greater uniformity would, in turn, decrease the uncertainty about reimbursement when providers and patients embark on a clinical trial.

CONTEXT OF THE CURRENT STUDY

In the Balanced Budget Act of 1997 (P.L. 105–33, Section 4108), Congress directed HCFA to enter into a contract with the National Academy of Sciences for a "Study on Preventive and Enhanced Benefits" under Medicare. Five specific items were to be studied:

  1. nutrition therapy services, including parenteral and enteral nutrition and the provision of such services by a registered dietitian;

  2. skin cancer screening;

  3. medically necessary dental care;

  4. routine patient care costs for beneficiaries enrolled in approved clinical trial programs;

  5. elimination of time limitation for coverage of immunosuppressive drugs for transplant patients.

Three committees were established to carry out the tasks, including this one to focus exclusively on the clinical trial question.

The clinical trial committee is aware that the question of reimbursement for care in clinical trials is not a new issue. Clinical trial investigators, patients, and potential volunteers have increasingly seen as a problem the lack of coverage for routine patient care that would be covered if the patient were not in the trial. Cancer activists and organizations, including cancer centers, were the most active agents in bringing this issue into public view. Several draft bills have mandated that Medicare cover routine care costs in clinical trials. Some have



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