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.
NH Rev. Stat. §415:18-l – The statute applies to grp hospital and medical policies, health service corporations, HMOs, and manages care organizations. Medicare plans and SCHIP are excluded. Routine patient care costs are covered for insured participants of a Phase I, II, III, or IV clinical trial for cancer or any other life threatening condition. Note, coverage for a Phase I or II trial shall be decided on a case-by-case basis in this state. Coverage is required for reasonable and medically necessary services to administer the drug or device under evaluation in the clinical trial, provided the drug or device is FDA-approved. This mandate is enforced even whether the FDA has not approved the drug or device for use in treating the participant’s illness or condition.
The clinical trial must be approved by either: (1) NIH, (2) NIH cooperative group or center, (3) U.S. F.D.A., (4) U.S. Dept. of Defense, (5) U.S. Dept. of Veterans Affairs, or (6) a state IRB. Second, a superior, non-investigational alternative must not exist, or standard treatment is deemed ineffective. Third, the facility and personnel providing the experimental treatment must be experienced. Fourth, data related to the clinical trial must provide a reasonable expectation that the treatment will be at least as effective as the non-investigational alternative. (Updated 1/2011)
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