State Clinical Trials Law
DC ST § 31-2993.01
Who must cover the costs? Health insurance plans (not including Medicare and Medicaid)
What must be covered? routine patient care cost associated with clinical trials.
Qualifying Trials: To be an “approved clinical trial,” one of three options must be fulfilled; first, the trial must be fully funded or approved by one of the following: (1) NIH, (2) The Centers for Disease Control and Prevention, (3) The Agency for Health Care Research and Quality (4) The Centers for Medicare and Medicaid Services, (5) A bonafide clinical trial cooperative group, including the National Cancer Institute Clinical Trials Cooperative Group, the National Cancer Institute Community Clinical Oncology Program, (6) The Department of Defense, the Department of Veterans Affairs, or the Department of Energy or a qualified nongovernmental research entity to which the National Cancer Institute has awarded a support grant; second, the study or investigation can be approved by the Food and Drug Administration (“FDA”), including those conducted under an investigational new drug or device application reviewed by the FDA; or Third, the trial can be an investigation or study approved by an Institutional Review Board registered with the Department of Health and Human Services that is associated with an institution that has a federal-wide assurance approved by the Department of Health and Human Services specifying compliance with 45 C.F.R. Part 46.
(Last updated 8/2022)