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U.S. District Court Strikes Down 2023 CMS Final Rule on Pharmaceutical Manufacturer Coupons and Best Price

May 18, 2022


By Mercalis Team

On Tuesday, May 17, 2022, the U.S. District Court for the District of Columbia issued a Memorandum Opinion granting a motion for summary judgment for the Pharmaceutical Research and Manufacturers of America (PhRMA) in its case challenging the CMS Final Rule on manufacturer copay offers and Best Price.

As a result, the rule – previously scheduled to go into effect on January 1, 2023 – is vacated.

Mercalis (formerly TrialCard) has been at the forefront of efforts to achieve this outcome since the rule was first proposed in 2020. From submitting public comments opposing the rule to CMS, to filing an amicus brief with the court in support of PhRMA’s position, to delivering educational sessions to the industry on the rule, we have worked tirelessly in support of our biopharmaceutical manufacturer clients and the patients they support.

It is important to note that health plans will continue to operate copay accumulator adjustment programs, pursuant to the most recent Notice of Benefit and Payment Parameters rule. This court opinion simply vacates the rule requiring manufacturers to ensure the benefit of their copay offers goes entirely to patients in order to avoid exclusion from Best Price calculations.

If you’d like to discuss in greater detail how this decision will impact your copay program going forward, please get in touch.

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