October 1, 2008
Clarification of Medicare payment for routine costs in a clinical trial
Effective Date: N/A
Implementation Date: N/A
Summary
This special edition article addresses concerns with routine costs associated with a clinical trial. In the article, these concerns have been formed into the following three questions:
• If a research sponsor says in writing that they will pay for routine costs if there is no reimbursement from any insurance company (including Medicare), does that fall into the "free of charge" category?
• If the research sponsor pays for the routine costs provided to an indigent non-Medicare patient (the provider has determined that the patient is indigent due to a valid financial hardship) may Medicare payment be made for Medicare beneficiaries?
• May a research sponsor pay Medicare copays for beneficiaries in a clinical trial?
Additional information is available on the CMS Web site. Here is the link to the MLN Matters article SE0822 
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.Source: CMS MLN Matters Special Edition Article SE0822
