Jan 3 2024

WASHINGTON, D.C. – Senator Thom Tillis and his colleagues recently sent a letter urging the 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 limiting the use of harmful “copay accumulators.” Copay accumulators prevent copay assistance from counting towards a patient’s deductible or out-of-pocket maximum, which makes it harder for patients to afford their medications.

In the letter, the senators also push for their Help Ensure Lower Patient (HELP) Copays Act to permanently prohibit the use of copay accumulators and require health plans and Pharmacy Benefit Managers (PBMs) to count the value of copay assistance towards a patient’s deductible or out-of-pocket maximum.  

“We are writing in support of the recent decision from the U.S. District Court for the District of Columbia that vacated the 2021 Notice of Benefit and Payment Parameters (NBPP) Final Rule provision that permitted the use of copay accumulator adjustment programs (AAPs) and remanded to the U.S. Department of Health and Human Services (HHS) to interpret the definition of ‘cost-sharing.’ This 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. We are disappointed in HHS’s decision to file a notice of appeal of the decision and HHS’s articulated 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 wrote

“As you consider next steps, we strongly encourage you to support patients by reconsidering your appeal of the court’s ruling and instead adopting the 2020 NBPP policy. It 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. In the 2020 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. HHS itself 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,” the senators continued

“We also strongly believe that federal legislative action is also needed to restore this vital patient protection. In fact, Congress is currently working on a bipartisan, bicameral basis to advance legislation to ensure copay assistance counts toward the patient’s maximum annual limitation on cost-sharing. Thank you for your consideration of this request. We look forward to your reply and your plan to ensure patients receive cost-sharing protections,” the senators concluded.

Supportive Quotes:

“More patients than ever are reaching out to us because they’ve been negatively impacted by these programs. They are being caught in a financial bind because they can’t pay the full cost of their medications. Biologic medicines are expensive and there are no generic alternatives, so copay assistance is often a vital life line for them,” said Anna Hyde, Vice President of Advocacy and Access for the Arthritis Foundation

“Far too many of the 1 million Americans living with multiple sclerosis are unable to afford life-changing medications to reduce the number of relapses, delay the progression of disability, and limit new disease activity. The National Multiple Sclerosis Society is disappointed with the Biden Administration’s decision to appeal the court’s September 29th ruling and continue the use of copay accumulators that will negatively impact access to care. We urge the withdrawal of their recently filed appeal,” said Bari Talente, EVP, Advocacy & Healthcare Access, National MS Society.

“While serving a million people impacted by cancer each year, we at the Cancer Support Community have witnessed the adverse effects of copay accumulator adjustment programs (AAPs) on patients’ ability to access life-saving medications. CSC strongly opposes the use of AAPs and supports the adoption of the 2020 NBPP policy, protecting affordability and access to care for under-resourced patients who rely on manufacturer copay assistance programs. We are grateful to have leaders that share our commitment to breaking down barriers and improving healthcare for all,” said the Cancer Support Community.


Full text of the letter is available HERE.