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.
LA R.S. § 22:1044: Each policy or plan subject to the provisions of this Section shall provide coverage for patient costs incurred as a result of a treatment being provided in accordance with a clinical trial for cancer except any applicable copayment, deductible, or coinsurance amounts.The treatment must have: (1) “therapeutic or palliative intent” for cancer patients of the early detection of cancer; (2) only Phase II, III, and IV cancer clinical trials are covered; (3), the treatment must be approved by one of the following: (a) NIH, (b) NIH cooperative group, (c) U.S. Dept. of Defense, (d) U.S. Dept. of Veterans Affairs, (e) U.S. F.D.A in the form of an investigational new drug application, (f) a federally funded general clinical research center, or (g) the Coalition of National Cancer Cooperative Groups; (4) the protocol of the trial must be reviewed and approved by a state IRB (specifically, one that has a multiple project assurance contract approved by the U.S. Dept. of Health and Human Services, Office of Protection from Research Risks); (5) a clearly superior, non-investigational alternative approach must not exist; (6) clinical or preclinical data must provide a reasonable expectation that the treatment will be as effective as the non-investigational alternative; and (7) the patient must sign an IRB-approved informed consent form. (current 1/2011)