Responsibility for Costs Associated With Clinical Trials

Medicare and coverage requirements in the Patient Protection and Affordable Care Act (ACA) have improved access to clinical trials, but major obstacles persist. First, access to participation in studies can be limited if networks established by insurance plans do not include providers involved in clinical trials. Second, certain details of the relationship between the clinical trials provisions of the ACA and state laws have not been defined. Third, consensus regarding the scope of insurance coverage for costs in clinical trials has not been reached. We discuss each of these problems and offer suggestions for resolution. These obstacles must be addressed to improve access for patients and to advance medical care through research.