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.
N.M.S.A. §59A-22-43 – The statute applies to private insurers, non-profit health service providers, HMOs, managed care organizations, provider service organizations, and other state medical assistance programs. These entities must cover routine patient care costs arising from cancer clinical trials. Limited or specified disease policies are specifically excluded from the statute. The insurer is not bound to pay any out-of-state or out-of-network costs unless specifically set forth in the policy.
Coverage is limited to Phase II, III and IV cancer clinical trials. Next, the purpose of the trial must involve either the prevention of cancer re-occurrence, early detection, or treatment for which no equally or more effective standard treatment exists. Third, 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 qualified research entity that meets the criteria set forth by the NIH for grant eligibility. Additionally, an IRB must review and approve the trial to ensure protection of human subjects. Furthermore, the clinical trial must not be designed to test solely for the toxicity or disease pathophysiology, and it must have a therapeutic intent. The statute sets forth various requirements for the protocol of the study, including criteria for patient selection and reasonable expectation that the treatment will be at least as effective as standard cancer treatment, among others. A superior, non-investigational alternative must not exist. Moreover, the facility and personnel providing the experimental treatment must be experienced. No third party is liable for damages associated with the experimental treatment. (Current 6/9/2011)