On October 2nd, the U.S. District Court for the District of Columbia struck down a Department of Health and Human Services (HHS) rule that allows certain commercial plans to not count the amount of assistance provided by manufacturer copay assistance programs toward a patient’s deductible and out-of-pocket maximum.

These so-called “copay accumulators” programs basically increase patient out-of-pocket costs – often surprisingly when a patient’s financial assistance has run out and they learn they have not met their deductible. They may be faced with a bill of thousands of dollars. This has spurred the All Copays Count coalition and led to 16 states to date to ban such programs.

This ban at a federal level is a major win for manufacturers over insurers and PBMs.  

Key Takeaway:

The decision is perceived as a major victory by nearly thirty patient groups which argued that the rule, first enacted under the Trump administration, restricted access to the most promising therapies and contradicted the cost-sharing principles that are central to the Affordable Care Act. As a result of the ruling:

  • Insurers will have to adhere to an earlier federal rule (2020) whereby copay accumulators are only allowable for brand-named therapies with a generic equivalent – if permitted by state law. 
  • HHS will be permitted to make any needed adjustments to the statutory language.

Increased attention on value and affordability 

While the federal ruling presents an immediate defeat for insurers and PBMs, manufacturers will need to carefully consider upcoming pricing and access decisions. 

  • For manufacturers with commercialized therapies, adjustments in financial assistance programs and near-term price increases can quickly be perceived as profit-driven.
  • Manufacturers preparing for regulatory approval should anticipate increased attention on patient discount programs and value discussions with stakeholders.
  • Manufacturers should also be prepared to speak about cost-sharing arrangements more broadly, and how much economics should or does factor into prescribing in their specific disease state.  

About the Author:

Patrick Rigby joined Syneos from the private sector where he specialized in corporate communication, government relations, and public affairs across the healthcare industry. Patrick served as Director of Communications and later as Chief of Staff for the New Jersey Office of Homeland Security and Preparedness under two administrations. He also served as an Advisor to the Chairman of the U.S. Senate Foreign Relations Committee. Prior to government service, Patrick held positions with Bloomberg L.P., the Council on Foreign Relations, U.S. House of Representatives, and in the financial services industry. Patrick brings with him over 15 years of managing large teams and directing complex communications and reputation management programs for businesses and government.