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CMS – Letter – Primary Payor

In addition, a primary plan (in this instance, a liability insurance policy or plan (including a plan of self-insurance)) and an entity that receives payment from a primary plan are obligated to reimburse Medicare for any Medicare payments made once the primary plan's primary payment responsibility has been demonstrated. 42 U.S.C. 1395y(b)(2)(B)(ii). Any agreement by a trial sponsor to "pay for medically necessary services related to injuries receive[d] as a result of ... participation in this trial ... " constitutes a demonstration of primary payment responsibility. See id. Thus, if a trial sponsor (or its liability insurance policy or plan underwriter, if any) becomes aware of any situation where Medicare mistakenly made payment for services related to injuries that an individual received as a result of participation in such trials, is statutorily obligated to reimburse Medicare. Likewise, a provider, physician or other supplier that has received Medicare payment for such services is statutorily obligated to reimburse Medicare.

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While your e-mail to Mr. Olenick was phrased as a hypothetical question, we urge you to advise any of your clients that may have failed to make primary payments for services related to injuries sustained by Medicare beneficiaries in the course of their participation in clinical trials that CMS is willing to work with them to resolve their repayment obligations with minimal inconvenience to participants and their health care providers.

We appreciate your efforts in. bringing this matter to our attention. If you wish to discuss this matter further, you may call Tina Merritt on (410) 786-5233.



Gerald Walters


Financial Services Group

Office of Financial Management



All Regional Administrators

All Associate Regional Administrators for Financial Management

All Regional MSP Coordinators

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