1.

Record Nr.

UNINA9910970659603321

Titolo

Extending medicare reimbursement in clinical trials / / Committee on Routine Patient Care Costs in Clinical Trials for Medicare Beneficiaries ; Henry J. Aaron and Hellen Gelband, editors

Pubbl/distr/stampa

Washington, D.C., : National Academy Press, c2000

ISBN

9780309183888

030918388X

9780309558143

030955814X

9780309528542

0309528542

Edizione

[1st ed.]

Descrizione fisica

1 online resource (86 p.)

Altri autori (Persone)

AaronHenry J

GelbandHellen

Disciplina

338.4/33621/0973

Soggetti

Medicare

Clinical trials - United States

Medical care, Cost of - United States

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Description based upon print version of record.

Nota di bibliografia

Includes bibliographical references (p. 65-66).

Nota di contenuto

""Front Matter""; ""Acknowledgments""; ""Contents""; ""Executive Summary""; ""1 Clinical Trials in the United States""; ""2 Paying for Patient Care in Clinical Trials""; ""3 Recommendations for Medicare Clinical Trial Reimbursement""; ""References""; ""APPENDIX A Glossary, Acronyms, and Abbreviations""; ""APPENDIX B Committee Biographies""

Sommario/riassunto

Increasingly over the past five years, uncertainty about reimbursement for routine patient care has been suspected as contributing to problems enrolling people in clinical trials. Clinical trial investigators cannot guarantee that Medicare will pay for the care required, and they must disclose this uncertainty to potential participants during the informed consent process. Since Medicare does not routinely "preauthorize" care (as do many commercial insurers) the uncertainty cannot be dispelled in advance. Thus, patients considering whether to



enter trials must assume that they may have to pay bills that Medicare rejects simply because they have enrolled in the trial. This report recommends an explicit policy for reimbursement of routine patient care costs in clinical trials. It further recommends that HCFA provide additional support for selected clinical trials, and that the government support the establishment of a national clinical trials registry. These policies (1) should assure that beneficiaries would not be denied coverage merely because they have volunteered to participate in a clinical trial; and (2) would not impose excessive administrative burdens on HCFA, its fiscal intermediaries and carriers, or investigators, providers, or participants in clinical trials. Explicit rules would have the added benefit of increasing the uniformity of reimbursement decisions made by Medicare fiscal intermediaries and carriers in different parts of the country. Greater uniformity would, in turn, decrease the uncertainty about reimbursement when providers and patients embark on a clinical trial.