3 patient groups sue US over drug copay assistance rule

Three patient advocacy groups are suing the U.S. government to challenge the legality of a federal rule that allows health insurers to not apply drugmakers' copay assistance toward patients' out-of-pocket cost obligations. 

The HIV+Hepatitis Policy Institute, the Diabetes Leadership Council and the Diabetes Patient Advocacy Coalition filed the lawsuit Aug. 30 in the U.S. District Court for the District of Columbia  on behalf of more than 42 million Americans. 

HHS’ 2021 Notice of Benefit and Payment Parameters rule allows insurers and PBMs to have the policies, known as copay accumulator adjustment programs.

The advocacy groups argue that these policies increase costs for patients and violate cost-sharing caps set under the ACA, allowing insurers to "double dip" and receive payments from both the patient and drug manufacturers in the form of copay assistance. 

Editor's note: Becker's has reached out to HHS for comment on the lawsuit and will update the article when more information is available.

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