The U.S. Department of Health and Human Services has withdrawn its appeal in the copay assistance case.
January 29, 2024 – Alexandria, Virginia – The U.S. Department of Health and Human Services (HHS) has withdrawn their appeal of a decision handed down on December 22, 2023 by the U.S. District Court for the District of Columbia. The December decision reinstated policies in the 2020 Notice of Benefit and Payment Parameters (NBPP) final rule that require insurers to count copay assistance towards a patient’s out of pocket costs except for brand drugs with generic alternatives. The decision comes after three patient advocacy groups and three patients sued the Centers for Medicare and Medicaid Services (CMS) and HHS to invalidate rulemaking from the 2021 NBPP that had reversed the 2020 rule requiring health to implement copay accumulator programs. The U.S. District Court decision and the withdrawal of an appeal marks a significant milestone in the fight to improve patient access to treatments.
How and when the rule will be enforced now becomes the question. The Department of Health and Human Services has not yet issued guidance for health plans on implementing the rule that copay assistance must count towards beneficiary cost-sharing requirements. Further, the Department may decide to rewrite regulations to allow copay accumulator adjustment programs. If the Department fails to implement the 2020 rule and revises regulations to allow plans to use copay accumulators once again, it would be disastrous for patients living with psoriatic disease and other serious chronic conditions.
“We are pleased to see that the court has recognized what we have known to be true since our community first became exposed to copay accumulators: copay accumulators curtail a person’s access to treatment,” said Leah M. Howard, J.D., the President and CEO of NPF. “Now we have to keep up the pressure to be sure that HHS finishes the job of protecting patients from copay accumulators, and to work with Congress to pass the HELP Copays Act to cement these protections into law for the sake of the millions of people that rely on specialty prescription drugs.”
Copay accumulator adjustment programs have become an increasingly prevalent insurance practice since their introduction in 2017. Under copay accumulators, outside assistance in paying for prescriptions – such as manufacturer assistance or other third-party aid – is not counted toward a person’s cost sharing requirements such as their deductible and out-of-pocket maximum. People living with chronic illnesses that are treated by expensive medications are often met with formulary designs that require them to pay their out-pocket-maximum every year. This quickly becomes unaffordable, and creates an insurmountable barrier to a person’s ability to access lifechanging medications. All copays must count.
- U.S. Justice Department motion to dismiss.
- Legal briefs associated with the case.
- All Copays Count Coalition statement
About the National Psoriasis Foundation
Serving the community of people impacted by psoriatic disease for more than 55 years with patient support, advocacy, research, and education, the National Psoriasis Foundation is the leading nonprofit representing individuals with psoriasis and psoriatic arthritis. The mission of NPF is to drive efforts to cure psoriatic disease and improve the lives of more than 8 million individuals in the United States affected by this chronic immune-mediated disease. Learn more at psoriasis.org.