CMS – Copays in Clinical Trials

Source: 2018-05-16 Clarification of Medicare Payment for Routine Costs in a Clinical Trial


May a research sponsor pay Medicare copays for beneficiaries in a clinical trial?


If a research sponsor offers to pay cost-sharing amounts owed by the beneficiary, this could be a fraud and abuse problem.

In addition to CMS’ policy, the Office of Inspector General (OIG) advises that nothing in OIG rules or regulations under the Federal anti-kickback statute prohibits hospitals from waiving collection of charges to uninsured patients of limited means, so long as the waiver is not linked in any manner to the generation of business payable by a Federal health care program.

The citations include 42 U.S.C. 1320a-7(a)(i)(6); OIG Special Advisory Bulletin on Offering Gifts and Other Inducements to Beneficiaries  and OIG Special Fraud Alert on Routine Waivers of Copayments and Deductibles .