Bipartisan Group of Senators Asks HHS, DOL, and Department of Treasury to Enforce Rule Against Copay Accumulators
United States Senators Roger Marshall, MD, and Tim Kaine, members of the Senate Health, Education, Labor, and Pensions (HELP) Committee, recently sent a bipartisan letter, encouraging the United States Department of Health and Human Services (HHS), the Department of Labor (DOL), and the Department of the Treasury to lower out-of-pocket costs for prescription drugs by enforcing a rule that limits the use of “copay accumulators.” Copay accumulators often prevent copay assistance from counting toward a patient’s medical deductible or out-of-pocket maximum, which makes it more difficult for patients to afford their medications.
The letter comes on the heels of a decision from the United States District Court for the District of Columbia, HIV and Hepatitis Policy Institute et al. v. United States Department of Health and Human Services et al. In that decision, the D.C. District Court vacated the 2021 Notice of Benefit and Payment Parameters (NBPP) Final Rule provision that allowed for the use of copay accumulator adjustment programs (AAPs). The Court also remanded to HHS the need to interpret the definition of “cost sharing.”
In the letter, the Senators note that the Court’s decision “is an important step in the right direction for low-income and other eligible patients who rely on manufacturer and nonprofit copay assistance programs to alleviate affordability and access challenges for their medicines,” and express their disappointment that HHS opted to file a notice of appeal of the decision and that the agency further stated its intention to not take any enforcement action against health insurance issuers or health plans that fail to count copay assistance toward the patient’s maximum annual limitation on cost-sharing.
The Senators further note that patients have faced “financial hardship and barriers to their once-accessible life-saving medicine” as a result of copay accumulators, referencing a survey that showed “that between 25-36% of respondents discontinued therapy when they received an unexpected high charge of over $1,500 during the plan year as a result of AAPs.”
They point out that 19 states, the District of Columbia, and Puerto Rico have banned or limited the use of AAPs and that instead of appealing the D.C. Court’s decision, the agencies should adopt the 2020 NBPP Final Rule policy that required plans to count manufacturer copay assistance toward the annual limitation on cost-sharing for drugs that do not have a medically appropriate generic equivalent available.
Additionally, the Senators note that in the 2020 Final Rule, HHS “reasoned that it would be less likely that the manufacturer’s assistance would disincentivize a lower cost alternative and thereby distort the market” and the agency has also “acknowledged situations when a patient has been subject to significant out-of-pocket costs because the patient has not progressed through the deductible phase of the health plan due to AAPs not applying the value of the manufacturer-sponsored assistance to the patient’s deductible,” and that such situations can have a negative impact on the patient’s overall health.
In conclusion, the Senators note that Congress is working on a bipartisan, bicameral basis to pass legislation that would ensure copay assistance does count toward a patient’s maximum out-of-pocket costs, but that additional assistance from the agencies would help patients around the country, perhaps quicker than an act of Congress can. 17 bipartisan Senators also signed the letter, in addition to Senators Marshall and Kaine.