Final Rule Regarding Copay Accumulator Programs May Increase Patients’ Out-of-Pocket Costs for Oral Cancer Drugs

Web Exclusives - Ovarian Cancer

Copay accumulator programs are a new utilization management tool being implemented by private health plans that exclude copay assistance from counting toward the accumulated total costs being applied to a patient’s deductible and out-of-pocket maximum.

These programs, which typically monitor the use of oral therapies dispensed by specialty pharmacies, have been quietly implemented by several private health insurers and pharmacy benefit managers. Patient advocacy groups and other organizations have voiced opposition to copay accumulator programs, pointing out that they unfairly negate the support provided by copay assistance programs and add to patients’ out-of-pocket cost burdens.

Nevertheless, in April 2019, the US Department of Health and Human Services (HHS) finalized a proposal allowing private insurance plans to exclude the value of certain direct manufacturer cost-sharing support (eg, copay coupons) from a patient’s annual cost-sharing limit. However, it also ruled that copay accumulator programs are permitted only for drugs for which there is a generic equivalent.

The HHS’s Final Rule is unclear regarding biologic therapies, which are frequently used to treat patients with cancer. Although biologics are drugs in the technical sense, the FDA evaluates them differently from other agents. Pharmaceuticals are evaluated by the agency’s Center for Drug Evaluation and Research, whereas biologics are reviewed by its Center for Biologics Evaluation and Research.

Although the HHS has not clarified its position regarding biologics, many legal experts agree with the interpretation that the federal ruling does not apply to these products because they are different from pharmaceuticals.

The ruling will affect patients who may not understand how copay coupons are now applied and may ultimately affect prescription compliance because of the adjustment in out-of-pocket expenses. According to the National Community Oncology Dispensing Association, “The impact is significant for cancer patients needing assistance to pay for pharmaceutical therapies.”

Importantly, the Final Rule does not preempt actions taken by individual states. Currently, legislation in several states curbs or prohibits the use of copay accumulator programs. In March 2019, Virginia and West Virginia banned the use of these programs, and California and Massachusetts have limited their use when generic equivalents are available. Arizona has also passed its own legislation that aligns with HHS provisions on generic equivalents. Advocacy groups are continuing to focus efforts on abolishing copay accumulator programs at the state and federal levels.

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Last modified: April 27, 2020