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.
Cal. Health & Safety Code Ann. §1370.6, Cal. Ins. Code Ann. §10145.4, Cal. Welfare & Inst. Code Ann. §§ 14087.11, 14132.98 – The statutes apply to most health plans licensed to do business in California, including health care service plan providers (not including specialized health care service plan contracts), disability insurers (ones that provide hospital, medical or surgical coverage in California), County Organized Health System plans, and Medi-Cal. These entities and programs must cover and pay for routine health care services related to Phase I, II, III, or IV clinical trials.
The trial must either: (1) involve a drug that is exempt under federal regulations from a new drug application, or (2) be approved by: (a) NIH, (b) U.S. F.D.A. in the form of an investigational new drug application, (c) U.S. Dept. of Defense, or (d) U.S. Dept. of Veterans Affairs. Second, the clinical trials must have a ‘therapeutic intent ‘ for patients and be recommended by the patient’s physician. Third, in many cases, the patient must get clinical trial care from a doctor or hospital within the state. However, health plans must pay for care at treatment centers outside the state if there is no provider in California taking part in the study.