Medicare Routine Clinical Trial Costs
CMS has issued an educational article clarifying issues related to Medicare payment of certain routine costs associated with clinical trials. The article focuses on the prohibition on payment for items or services which neither the beneficiary nor any other person or organization has a legal obligation to pay (i.e., items and services furnished gratuitously without regard to the beneficiary’s ability to pay and without expectation of payment from any source, such as free x-rays or immunizations provided by health organizations). CMS discusses the application of this policy in three scenarios: when a research sponsor says it will pay for routine costs if there is no reimbursement from any insurance company; when a research sponsor pays for the routine costs provided to an indigent non-Medicare patient; and when a research sponsor pays Medicare copayments for beneficiaries in a clinical trial.
