State Clinical Trials Law
Who must cover the costs? Individual or group accident and sickness insurance, individual or group HMO contracts, individual or group hospital or medical service contracts, and other entities engaged in the business of insurance. However, accident-only, specified disease, short-term hospital medical, dental, vision, Medicare supplement, long-term care, and disability insurance are not included.
What must be covered? Routine patient care costs of cancer clinical trials
Requirements for Coverage: The trial must: (1) involve the scientific study of a new therapy for the treatment of cancer in humans and consist of a scientific plan of treatment that includes specified goals, a rationale, and background for the plan; criteria for patient selection; specific directions for administering therapy and monitoring patients; a definition of quantitative measures for determining treatment response; and methods for documenting and treating adverse reactions; (2) the treatment must be provided with therapeutic intent (that is, aimed at improving the patient’s survival or quality of life); (3) the proposed treatment must be reviewed and approved by the applicable qualified Institutional and Review Board; and (4), the available clinical or preclinical data must indicate that the treatment will be at least as effective as the standard therapy and is anticipated to constitute an improvement in therapeutic effectiveness for the treatment of the disease in question
Qualifying Trials: The trial must be authorized or approved by (1) the NIH, (2) US Food and Drug Administration, (3) US Dept of Defense or (4) US Dept of Veterans Affairs
(Last udpated 8/2022)