Hospice Benefits and Phase I Cancer Trials

  1. Ira Byock, MD; and
  2. Steven H. Miles, MD

    Abstract

    Medicare denies hospice coverage to patients with terminal illnesses who enroll as participants in phase I studies, which assess the toxicity and dosing of potential treatments for incurable diseases. Federal regulations require patients to forgo curative therapies, and they interpret phase I agents as treatment for the terminal condition for which hospice care was elected. Thus, by enrolling as a participant in a phase I trial, a patient otherwise eligible for hospice is rendered ineligible. Private insurers have similar provisions for children and adults younger than 65 years of age. Such exclusions are not defensible on ethical or clinical grounds. Policymakers, insurers, and institutional review boards all have a role in resolving this problem.

    Article and Author Information

    • Grant Support: By Promoting Excellence in End of Life Care, a national program of the Robert Wood Johnson Foundation. Dr. Miles received support from the Project on Death in America of the Open Society Institute of the Soros Foundation.

    • Requests for Single Reprints: Ira Byock, MD, The Practical Ethics Center, University of Montana, 1000 East Beckwith Avenue, Missoula, MT 59812; e-mail, ibyock{at}aol.com.

    • Current Author Addresses: Dr. Byock: The Practical Ethics Center, University of Montana, 1000 E. Beckwith Avenue, Missoula, MT 59812.

    • Dr. Miles: The Center for Bioethics, University of Minnesota, N504 Boynton Hall, 410 Church Street, Minneapolis, MN 55455.

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