August 10, 2001

Patients Rights Bills Contain Similar Provisions for Clinical Trials

The clinical trials provisions of the recently passed House's patients bill of rights legislation (H.R. 2563) mirror those in the Senate's version (S. 1052). The legislation is directed at individuals with serious or life-threatening illnesses who are covered by group health plans or other types of health insurance. It would apply only to clinical trials funded and approved by the National Institutes of Health (NIH), a cooperative group/center of the NIH, certain non-governmental entities supported by the National Cancer Institute (NCI), or the Food and Drug Administration (FDA). It would also apply to trials funded and approved by the Department of Veterans Affairs (VA) and the Department of Defense (DoD), as long as the quality and administration of the research met NIH standards.

Health plans could not deny coverage if an in-network referring physician determines that participation in a clinical trial would be appropriate. Specifically, the physician would have to agree that standard therapies were not effective, the patient was eligible to participate, and the trial could potentially offer the patient significant clinical benefits. In lieu of a participating physician's opinion, a patient could present medical or scientific information that establishes appropriateness.

The bill affords plans the option of requiring patients to participate in clinical trials via in-network investigators, as long as such an investigator is available and willing to accept the patient. Insurers would be expected to cover the costs of items and services related to trial participation, but would not be obligated to cover tests and measurements conducted primarily for the clinical trial itself. In-network providers would be reimbursed based on existing contracts. Health plans would be expected to pay comparable rates to out-of-network providers. Finally, insurers could not discriminate against an enrollee on the basis of clinical trial participation.

Last year, HCFA (now CMS) issued a final national coverage decision directing Medicare to cover the routine medical costs of participating in clinical trials.

Information: Christiane Mitchell, AAMC Office of Governmental Relations, 202-828-0526.