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CMS Releases Final Rule Impacting Co-Pay Assistance Programs and Best Price

December 23, 2020

The Centers for Medicare and Medicaid Services (CMS) published a final rule on December 21, 2020, requiring pharmaceutical manufacturers to ensure the benefit of co-pay assistance programs goes only to patients in order to maintain the exclusion from best price reporting. This rule directly impacts co-pay accumulator scenarios, where PBMs do not count the value of manufacturer coupons toward patients’ cost-sharing obligation.

The portion of the rule impacting co-pay programs and best price has an effective date of January 1, 2023, to allow manufacturers time to adjust their programs accordingly.

Mercalis (formerly TrialCard) has led the way on this issue within the industry since the rule was first proposed months ago. From submitting comments to CMS on behalf of our pharmaceutical manufacturer clients to addressing the issue in industry forums, we are well-positioned to help you navigate the challenges it will present for co-pay assistance going forward.

Pharmaceutical manufacturers can reach out to Mercalis (formerly TrialCard) to discuss the implications of this rule with our team of industry experts. We can review your program and recommend potential program adjustments to ensure you are able to continue delivering patient assistance in a compliant manner when the rule becomes effective.

Contact for more information.

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