Patients’ Rights at Risk as Biden Administration Challenges Recent Drug Copay Assistance Court Win

Federal Appeal Challenges D.C. Court's Directive on Copay Assistance Inclusion in Deductibles

WASHINGTON (November 29, 2023) – The ALS Association on Wednesday condemned the federal government’s decision to appeal a recent court ruling that benefits all patients, including people living with ALS. At issue is a 2021 federal rule that allowed health insurers to not count drug manufacturer copay assistance towards a beneficiary’s out-of-pocket costs. On September 29, 2023, the U.S. District Court for the District of Columbia struck down that rule. Now, just a few weeks after a federal court ruled in favor of patients, the federal government has announced that it will appeal the decision.

“This is a devastating setback for people living with ALS and their families, many of whom have been forced to pay thousands of dollars more as a result of these predatory policies,” said Melanie Lendnal, Senior Vice President of Advocacy for the ALS Association. “We will do whatever it takes to ensure that people living with ALS get the affordable care they so desperately need as they navigate the final stages of their lives.”

The ALS Association is part of a large coalition of patient advocacy organizations supporting the effort to end “copay accumulator” policies, which allow health insurers to pocket the copay assistance patients receive, rather than allowing it to count toward deductibles. The policies mean that all patients, including people living with ALS, end up paying more for prescription drugs.

Insurers and Pharmacy Benefit Managers (PBMs) have increasingly implemented copay accumulators, a policy that allows them to collect the copay assistance but not count it towards a patient’s out-of-pocket costs. The U.S. District Court agreed with the patient community and confirmed that copay accumulators increase patient costs while simultaneously enhancing insurer profits.

Since 2022, the ALS Association has been on the frontlines advocating against copay accumulator policies at both the federal and state level. As of Fall 2023, 19 states (along with D.C. and Puerto Rico) have enacted prohibitions on the use of copay accumulator policies.

About ALS
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that afflicts approximately 27,000 people in the United States and a comparable number of patients in Europe. Approximately 6,300 new cases of ALS are diagnosed each year in the United States. The average life expectancy of a person with ALS is approximately two to five years after diagnosis and only approximately 10 percent of people with ALS survive for more than 10 years. Death is usually due to respiratory failure because of diminished strength in the skeletal muscles responsible for breathing. Few treatment options exist for these patients, resulting in a high unmet need for new therapies to address functional deficits and disease progression.

About The ALS Association
The ALS Association is the largest philanthropic funder of ALS research in the world. The Association funds global research collaborations, assists people with ALS and their families through its nationwide network of certified clinical care centers, and advocates for better public policies for people with ALS. The ALS Association is working to make ALS a livable disease while urgently searching for new treatments and a cure. For more information about The ALS Association, visit our website at