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CMS ‘Safe Harbor’ For Use Of Copay Accumulators In Private Insurance Challenged In Court

 
• By Cathy Kelly

Patient groups ‘left with no choice’ but to challenge federal regulation allowing commercial payers to bar manufacturer assistance with drug costs from being counted toward deductibles and out-of-pocket spending caps.

Tide May Be Turning Against Copay Accumulators, Maximizers • Source: Shutterstock

Three advocacy groups representing patients with diabetes, HIV and hepatitis are asking a federal court to strike down a Centers for Medicare and Medicaid Services rule that allows commercial insurers and pharmacy benefit managers to implement copay accumulator programs that prevent manufacturer assistance from being counted toward patient cost sharing requirements. 

The complaint targets a final rule issued in May 2020 known as the Notice of Benefit and Payment Parameters for 2021, which applies broadly to commercial insurance plans governed by the Affordable Care Act

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Medicare Negotiation Does Not Violate Due Process, Appeals Court Rules, Other Suits At Risk

 
• By Cathy Kelly

Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.

Most Favored Nation Pricing Policy Floated In Medicaid, Coming Back To Medicare?

 
• By Cathy Kelly

President Trump's ongoing interest in the policy, which would ensure the US government pays no more for prescription drugs than the lowest price available in comparable countries, continues to gain attention.

Brazil’s Drug Pricing Shake Up Calls For More Robust Evidence From Companies

 
• By Francesca Bruce

Brazil’s drug pricing authorities are planning to introduce, among other things, a new drug category for biosimilars to ensure the pricing procedures for such medicines are reflected in the official pricing framework.

Brazil To Upgrade Pricing Framework To Keep Up With Market Developments

 
• By Francesca Bruce

Brazil plans to clarify its medicine pricing framework, for example by outlining the procedures for setting medicine prices and bring it up to date with recent developments in the sector.

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Pink Sheet Podcast: A New Director For US FDA’s Biologics Center, Guidance Production Slowdowns

 
• By Derrick Gingery, Sue Sutter, and Nielsen Hobbs

Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.

US FDA Restoring Some Library Resources

 
• By Sue Sutter and Derrick Gingery

Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals, and laid off librarians have not been reinstated.

Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.