State Clinical Trials Law
The ACA requires that most, non-grandfathered, group health plans provide coverage for the routine costs when participating in clinical trials. Some states have more consumer protections. Click here for more information about clinical trials.
Ariz. Rev. Stat. §§20-826.01, 20-1057.07, 20-1342.03, 20-1402.01, 20-1404.01, 20-2328 (2005) – The statutes apply to hospital service corporations, medical service corporations, health care services organizations, disability insurers, group disability insurers, blanket disability insurers, and accountable health plans. These entities must pay covered patient costs directly associated with a cancer clinical trial (Phase I, II, II, or IV) that is offered within the state. The trial must be approved by one of the following: (1) NIH, (2) NIH cooperative group or center, (3) U.S. F.D.A. in the form of an investigational new drug application, (4) U.S. Dept. of Defense, (5) U.S. Dept. of Veterans Affairs, (6) a qualified research entity that meets NIH criteria for grant eligibility, or (7) a panel of qualified clinical research experts from academic health institutions in the state. Second, the trial must be reviewed and approved by a state IRB. Third, the personnel proving the treatment of conducting the study must be acting within the scope of their practice and experience, and must agree to accept reimbursement from the insurer. Fourth, a superior alternative non-investigational treatment must not exist. (Current as of 7/2011)