Reimbursement issues facing patients, providers, and payers

Abstract Escalating costs of health care delivery and the current constraints imposed by the federal budget deficit seriously threaten to compromise patient care and innovative biomedical research. Recent third‐party refusal to cover some patients treated in protocols has had considerable impact on trial research. 1,2 In addition, reimbursement for conventional care sometimes has been refused if delivered as part of a study (e.g., MOPP therapy versus ABVD therapy) or for an indication that is not specifically cited on the Food and Drug Administration label. Who should cover the patient care costs of patients participating in clinical trials? One approach would have patients cover these costs themselves. 3 A second approach is the reinstitution of patient care costs into research grants. A third possibility is that the pharmaceutical industry support patient care costs of clinical research. Historically, hospital expenses of patients participating in studies have been paid by health insurance policies. In the absence of a clinical trial, many patients would be treated with Food and Drug Administration‐approved therapies despite a lack of substantial benefit. Such marginal treatments are compensated by thirdparty payers routinely. The current system is arbitrary and expensive, compromises research and development, and equates new treatment with no treatment. By refusing to reimburse the patient care costs of investigational therapy, third‐party carriers are, in fact, making medical decisions. 4 There is a growing and legitimate concern that the pace of clinical research will be impeded significantly at a time when many exciting developments will be ready for clinical trials. 5 The molecular steps in carcinogenesis are being documented rapidly for common malignancies, such as colon cancer. Immunologic, biologic, and hormonal approaches, and emerging technologies, such as marrow transplant or antibody toxin conjugates, already are being studied in the clinic. Health policy legislation and decisions by the insurance industry have a direct impact on physicians, facilitating, or often impeding, the care physicians are able to provide. Who makes health policy decisions? Increasingly, these decisions are being made not by physicians, but by public health experts, economists, and, more recently, large industries grappling with the cost of providing insurance coverage (and its effects on competitive pricing in a world market). 4 Therefore, physicians need to position themselves to influence the development of medical policy, particularly as it relates to the prevention, diagnosis, and treatment of patients with cancer.