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.
The Michigan Consensus Agreement: (A unique coalition of patient advocate groups, employers, insurance companies, and the representation of health care providers of clinical trials from both the academic and community outpatient setting got together to agree on clinical trials. In a precedent-setting agreement, all 25 members of the Michigan Association of Health Plans agreed to work to increase participation in select cancer-related clinical trials by making payment for services within this context predictable. All member health plans stated a willingness to provide coverage for the routine care costs of patient participation in approved clinical trials.) Private insurance plans, HMO’s, and the state Medicaid program must provide coverage of routine patient care costs associated with Phase II or III cancer clinical trials, as well as the costs of paying for any side effects resulting from the investigational treatment. To qualify for coverage, the studies must be sponsored or approved by: (1) NIH, (2) NCI, (3) U.S. F.D.A., (4) U.S. Dept. of Defense, (5) U.S. Dept. of Veterans Affairs, (6) CMS, or (7) CDC. (Current 6/14/11) Note: this isn’t a statutory law, but an agreement between members of the group.