Court Overturns Accumulator Adjuster Rule

Court orders HHS to revise federal regulations permitting harmful copay accumulators 

In a preliminary victory for consumers, a federal judge in the District of Columbia set aside federal regulations that disadvantage people who rely on copay assistance to afford their medications. The ruling is welcome news for patient groups that have long opposed so-called “copay accumulator adjuster programs” (CAAPs): health plan strategies that prevent copay assistance from counting towards consumer cost-sharing obligations. 

The ruling comes in a lawsuit filed by the HIV and Hepatitis Policy Institute and two diabetes groups against the U.S. Department of Health and Human Services. Plaintiffs challenged HHS’s 2021 rule that allowed health plans to implement CAAPs. The 2021 rule, plaintiffs alleged, was internally inconsistent and conflicted with existing federal statutes and regulations. HFA and other patient advocates, led by the Aimed Alliance, filed an amicus curiae brief supporting the plaintiffs’ position.  

In the Sept. 29 ruling, the court accepted plaintiffs’ argument that HHS’s regulation relied on two contradictory and unsupported interpretations of the term “cost-sharing.” Because governing precedent holds that “it is not for the court to choose between competing meanings” of an ambiguous term, the court instead vacated the 2021 rule and remanded it to HHS for the agency to reconsider its interpretation of the relevant language. As a result, the full impact of this decision may not be known until CMS completes these revisions.