Clinical trials are integral to modern medical care and to the progress of medical science. Although HCFA has issued little explicit policy about payment for routine patient care for patients in clinical trials, the Medicare statute has been widely interpreted to exclude reimbursement for such care. However, evidence is ample to suggest that providers submit claims for routine care for Medicare beneficiaries in trials without noting the existence of the clinical trial, and HCFA's financial contractors usually pay them. The thrust of the committee's recommendations is that nothing should be done that would materially curtail Medicare's reimbursement for routine patient care costs for patients in clinical trials. On the contrary, HCFA should encourage such trials and even extend reimbursement in a limited number of specifically approved exceptional cases. To achieve these goals, the committee believes that HCFA should assure patients in clinical trials the same reimbursement of routine patient care that is available to patients who are not in trials. Extending reimbursement to certain procedures that represent modifications of current practice and distinguishing those from procedures for which risks and benefits are largely unknown will require some additional effort by HCFA, but it is an essential component of the committee's recommendations. The fundamental recommendation—reimbursement independent of trial participation—should be implemented relatively easily.

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