Equity In Access To Clinical Trials In Medicaid

The act authorizes the state medical assistance program (medicaid) to cover routine costs associated with phase I through phase IV clinical trials involving the prevention, detection, diagnosis, or treatment of life-threatening or debilitating diseases or conditions. The medicaid recipient's (recipient's) treating physician must determine that the recipient has a qualifying disease or condition and that the recipient meets the selection criteria for the clinical trial. The clinical trial must be an approved clinical trial, as described in the act, and must be conducted by agencies and organizations specified in the act.

As used in the act, "routine costs" include medically necessary items or services included under the medicaid program for a recipient, to the extent that the provision of such items or services to the individual outside the course of such participation would otherwise be covered under the medical assistance program, without regard to whether the recipient is participating in a clinical trial. Routine costs do not include items specified in the act, including the investigational item, device, or service itself; items and services provided solely to satisfy data collection and analysis needed for the clinical trial; and items, drugs, or services that would otherwise be provided by the clinical trial or provided for free to any individual participating in the clinical trial.

(Note: This summary applies to this bill as enacted.)