On September 29, 2023, the United States District Court for the District of Columbia held that the 2021 NBPP, which permitted the use of copay accumulators, would be set aside because it was arbitrary and capricious. In reaching this decision, the Court accepted the amicus brief filed by Aimed Alliance and fellow health policy and patient advocacy organizations explaining the impact of copay accumulators on patients.
The Court reasoned that the 2021 NBPP was arbitrary and capricious because HHS permitted two distinct interpretations of the same statutory text, and while HHS may interpret a text with some ambiguity, it may not interpret the same piece of text to have contradictory meanings.
When determining if the statutory definition of cost-sharing includes manufacturer copay assistance, the Court used the traditional canons of statutory interpretation, which include interpreting the text in light of its “plain meaning at the time of enactment.” The Court reasoned that the statutory text does not include any definition of cost-sharing as it relates to manufacturer copay assistance. However, the Court recognized it lacked the authority to pick a definition and thereby determine whether manufacturer copay assistance was intended to count towards “cost-sharing.” As such, the Court remanded the matter to HHS to decide whether manufacturer copay assistance is part of the statutory definition of “cost-sharing.” Read the full decision here.
Last Updated on October 2, 2023 by Aimed Alliance
