W P Peters1, M C Rogers. 1. Duke University Bone Marrow Transplant Program, Duke Comprehensive Cancer Center, Durham, NC 27710.
Abstract
BACKGROUND: The proper evaluation of new forms of technology depends on the results of clinical trials. However, the treatment of patients in grant-sponsored clinical trials of cancer therapy usually requires that the proposed treatment be approved in advance by an insurance carrier in a process called predetermination. METHODS: We examined the consistency of predetermination decisions by insurance companies for 533 patients enrolled in grant-supported clinical trials of high-dose chemotherapy and autologous bone marrow transplantation (ABMT) for breast cancer from 1989 through 1992. These decisions about coverage were compared with peer-reviewed decision making according to the study protocol and with clinical outcomes. RESULTS: Requests for insurance coverage for ABMT were approved in 77 percent of the cases. Of these patients, 23 percent did not undergo bone marrow transplantation for protocol-based or medical reasons. Insurance coverage for ABMT was denied in response to the other requests, primarily because the therapy was considered experimental; of these patients, 51 percent eventually underwent bone marrow transplantation despite the denial of insurance. In some instances, the patient had to hire an attorney to gain coverage. The frequency of approval was not influenced by the pretreatment clinical characteristics of the patients, the design or phase of the study, the year in which the predetermination request was made, or the response to induction therapy. There was substantial inconsistency in the frequency of approval of coverage both among insurers and between decisions made by some individual insurers, even for patients in the same study protocol. CONCLUSIONS: The predetermination process as applied to patients receiving care in clinical research trials of cancer therapy was arbitrary and capricious. Although most of the patients eventually received financial coverage for entry into clinical trials, the process of predetermination by insurers did not correlate with protocol-based medical decision making, and it was a barrier to obtaining treatment.
RCT Entities:
BACKGROUND: The proper evaluation of new forms of technology depends on the results of clinical trials. However, the treatment of patients in grant-sponsored clinical trials of cancer therapy usually requires that the proposed treatment be approved in advance by an insurance carrier in a process called predetermination. METHODS: We examined the consistency of predetermination decisions by insurance companies for 533 patients enrolled in grant-supported clinical trials of high-dose chemotherapy and autologous bone marrow transplantation (ABMT) for breast cancer from 1989 through 1992. These decisions about coverage were compared with peer-reviewed decision making according to the study protocol and with clinical outcomes. RESULTS: Requests for insurance coverage for ABMT were approved in 77 percent of the cases. Of these patients, 23 percent did not undergo bone marrow transplantation for protocol-based or medical reasons. Insurance coverage for ABMT was denied in response to the other requests, primarily because the therapy was considered experimental; of these patients, 51 percent eventually underwent bone marrow transplantation despite the denial of insurance. In some instances, the patient had to hire an attorney to gain coverage. The frequency of approval was not influenced by the pretreatment clinical characteristics of the patients, the design or phase of the study, the year in which the predetermination request was made, or the response to induction therapy. There was substantial inconsistency in the frequency of approval of coverage both among insurers and between decisions made by some individual insurers, even for patients in the same study protocol. CONCLUSIONS: The predetermination process as applied to patients receiving care in clinical research trials of cancer therapy was arbitrary and capricious. Although most of the patients eventually received financial coverage for entry into clinical trials, the process of predetermination by insurers did not correlate with protocol-based medical decision making, and it was a barrier to obtaining treatment.