Background The proper evaluation of new forms of technologydepends on the results of clinical trials. However, the treatmentof patients in grant-sponsored clinical trials of cancer therapyusually requires that the proposed treatment be approved inadvance by an insurance carrier in a process called predetermination.
Methods We examined the consistency of predetermination decisionsby insurance companies for 533 patients enrolled in grant-supportedclinical trials of high-dose chemotherapy and autologous bonemarrow transplantation (ABMT) for breast cancer from 1989 through1992. These decisions about coverage were compared with peer-revieweddecision making according to the study protocol and with clinicaloutcomes.
Results Requests for insurance coverage for ABMT were approvedin 77 percent of the cases. Of these patients, 23 percent didnot undergo bone marrow transplantation for protocol-based ormedical reasons. Insurance coverage for ABMT was denied in responseto the other requests, primarily because the therapy was consideredexperimental; of these patients, 51 percent eventually underwentbone marrow transplantation despite the denial of insurance.In some instances, the patient had to hire an attorney to gaincoverage. The frequency of approval was not influenced by thepretreatment clinical characteristics of the patients, the designor phase of the study, the year in which the predeterminationrequest was made, or the response to induction therapy. Therewas substantial inconsistency in the frequency of approval ofcoverage both among insurers and between decisions made by someindividual insurers, even for patients in the same study protocol.
Conclusions The predetermination process as applied to patientsreceiving care in clinical research trials of cancer therapywas arbitrary and capricious. Although most of the patientseventually received financial coverage for entry into clinicaltrials, the process of predetermination by insurers did notcorrelate with protocol-based medical decision making, and itwas a barrier to obtaining treatment.
Source Information
From the Duke University Bone Marrow Transplant Program (W.P.P.), the Duke Comprehensive Cancer Center (W.P.P.), and the Duke University Hospital (M.C.R.), Durham, N.C.
Address reprint requests to Dr. Peters at the Bone Marrow Transplant Program, 25101 Morris Bldg., DUMC Box 3961, Durham, NC 27710.
Mayer, M.
(2006). Listen to all the voices: an advocate's perspective on early access to investigational therapies. Clin Trials
3: 149-153
[Abstract]
Morreim, E. H.
(2003). A Dose of Our Own Medicine: Alternative Medicine, Conventional Medicine, and the Standards of Science. J Law Med Ethics
31: 222-235
Sampson, W.
(2002). Oncologist who stood up to US insurance companies lost work. BMJ
325: 167-167
[Full Text]
Welch, H G., Mogielnicki, J.
(2002). Presumed benefit: lessons from the American experience with marrow transplantation for breast cancer. BMJ
324: 1088-1092
[Full Text]
Mello, M. M., Brennan, T. A.
(2001). The Controversy Over High-Dose Chemotherapy With Autologous Bone Marrow Transplant For Breast Cancer. Health Aff (Millwood)
20: 101-117
[Abstract][Full Text]
Morreim, E. H.
(2001). From the Clinics to the Courts: The Role Evidence Should Play in Litigating Medical Care. Journal of Health Politics, Policy and Law
26: 409-428
Ramsey, S. D., Sullivan, S. D., Kaplan, R. M., Wood, D. E., Chiang, Y.-P., Wagner, J. L.
(2001). Economic analysis of lung volume reduction surgery as part of the national emphysema treatment trial. Ann. Thorac. Surg.
71: 995-1002
[Abstract][Full Text]
Morreim, E. H.
(2000). Quality of Life: Erosions and Opportunities Under Managed Care. J Law Med Ethics
28: 144-158
Bodenheimer, T., Casalino, L.
(1999). Executives with White Coats -- The Work and World View of Managed-Care Medical Directors- First of Two Parts. NEJM
341: 1945-1948
[Full Text]
Rowlings, P. A., Williams, S. F., Antman, K. H., Fields, K. K., Fay, J. W., Reed, E., Pelz, C. J., Klein, J. P., Sobocinski, K. A., Kennedy, M. J., Freytes, C. O., McCarthy, P. L. Jr, Herzig, R. H., Stadtmauer, E. A., Lazarus, H. M., Pecora, A. L., Bitran, J. D., Wolff, S. N., Gale, R. P., Armitage, J. O., Vaughan, W. P., Spitzer, G., Horowitz, M. M.
(1999). Factors Correlated With Progression-Free Survival After High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Metastatic Breast Cancer. JAMA
282: 1335-1343
[Abstract][Full Text]
Finkelstein, B. S., Silvers, J. B., Marrero, U., Neuhauser, D., Cuttler, L.
(1998). Insurance Coverage, Physician Recommendations, and Access to Emerging Treatments: Growth Hormone Therapy for Childhood Short Stature. JAMA
279: 663-668
[Abstract][Full Text]
Gaskin, D. J., Kong, J., Meropol, N. J., Yabroff, K. R., Weaver, C., Schulman, K. A.
(1998). Treatment Choices by Seriously III Patients: The Health Stock Risk Adjustment Model. Med Decis Making
18: 84-94
[Abstract]
Morreim, E. H.
(1995). Moral Justice and Legal Justice in Managed Care: The Ascent of Contributive Justice. J Law Med Ethics
23: 247-265
Halpern, J.
(1995). Can the Development of Practice Guidelines Safeguard Patient Values?. J Law Med Ethics
23: 75-81
Glasson, J., Plows, C. W., Clarke, O. W., Ruff, V., Fuller, D., Kliger, C. H., Wilkins, G. T. Jr, Cosgriff, J. H. Jr, Tenery, R. M. Jr, Johnson, K. B., Orentlicher, D., Harwood, K. M., Leslie, J.
(1995). Ethical Issues in Managed Care: Council on Ethical and Judicial Affairs, American Medical Association. JAMA
273: 330-335
[Abstract]
Annas, G. J.
(1994). When Should Preventive Treatment Be Paid for by Health Insurance?. NEJM
331: 1027-1030
[Full Text]
Krause, K. J., Cutler, C. M., Udvarhelyi, I. S., Winkenwerder, W., Erban, J. K., Templeton, K. M., Wingard, J. R., Khanna, V., Peters, W. P., Rogers, M. C.
(1994). Variations in Insurance Coverage for Autologous Bone Marrow Transplantation for Breast Cancer. NEJM
331: 329-331
[Full Text]
Light, D. W.
(1994). Life, Death, and the Insurance Companies. NEJM
330: 498-500
[Full Text]
Previous
