Abstract

Clinical research may be threatened by prospective payment systems (PPS), such as diagnosis-related groups (DRGs), since research protocols frequently entail greater hospital costs than traditional patterns of care. Higher costs often result from new procedures or protocols that extend or supplement, rather than replace, existing services.1 These have been partially funded through fee-for-service payments, thus providing a hidden subsidy of clinical research.' Fixed reimbursement under PPSs may be established at levels just adequate to cover the costs of care for a typical patient and may be insufficient to cover additional costs incurred in treating patients participating in clinical trials. As a result, research programs may be at risk as hospitals seek to eliminate services that cannot be managed efficiently.2 This study evaluates whether a hypothetical PPS equivalent to Medicare's DRGbased system would cover hospital costs for patients in General Clinical Research Centers (GCRCs), a patient-oriented re-

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