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J Natl Cancer Inst. 2010 Mar 17;102(6):376-90. doi: 10.1093/jnci/djq028. Epub 2010 Mar 2.

State payer mandates to cover care in US oncology trials: do science and ethics matter?

Author information

  • Children's Hospital Boston, Harvard Medical School, 300 Longwood Ave, Hun 106.3, Boston, MA 02115, USA. patrick.taylor@childrens.harvard.edu

Abstract

BACKGROUND:

In the United States, Medicare-eligible participants' costs for routine care and complications from cancer clinical trials are covered by Medicare, but other people depend on state insurance mandates to assure coverage.

METHODS:

State mandates were reviewed for requirements to assure trials' scientific and ethical soundness, whom they covered and omitted, scope, and coverage for participants' research-related injuries in addition to routine care costs.

RESULTS:

Twenty-six states mandated coverage. Four states (15%) required scientific peer review for all studies. For 20 states (80%), an approved investigational new drug qualified as scientific review. In 10 states (38%), institutional review board (IRB) approval could replace scientific review. Twenty-four states (92%) permitted trials without academic medical connection. All states covered privately insured patients; seven (27%) included government and Medicaid patients. Fourteen states (54%) covered phase I to phase IV trials. Sixteen states (62%) covered treatment trials only; one (4%) covered prevention, detection, treatment, and palliation. Thirteen states (50%) covered research-related injuries. Only seven states (27%) required IRB approval. Three states (12%) required commensurate risks and benefits; 23 (88%) had no standard. Eight states (31%) required clinical equipoise with standard care; eight (31%) had no standard; and remaining states (46%) had unique standards. Two states (8%) addressed publication or registries.

CONCLUSIONS:

Most states did not demand independent scientific review, IRB review, or basic ethical features of high-quality trials; provided partial coverage; omitted prevention, detection, and palliation research; and omitted mandated coverage for research-related injuries. Few required evaluation, independence in publication, or posting trial results. Further research on the impact of diverse state choices would improve policy making.

PMID:
20197514
[PubMed - indexed for MEDLINE]
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