Patient Groups Sue U.S. Health Department Over Copay Assistance Rule


WASHINGTON — A trio of patient advocacy groups is challenging a Trump-era rule that allows insurers to prevent financial assistance from drug companies from counting toward a patient’s annual out-of-pocket costs.

Insurers argue that drug companies’ copay assistance programs allow drug companies to steer patients toward expensive brand-name drugs, driving up health costs for everyone.

But in a lawsuit filed Tuesday in the U.S. District Court for the District of Columbia, the HIV+Hepatitis Policy Institute, the Diabetes Leadership Council and the Diabetes Patient Advocacy Coalition argue that the rule disproportionately impacts people with chronic diseases, like diabetes and HIV, that require the use of costly drugs. The groups filed the suit against the Department of Health and Human Services and the Centers for Medicare and Medicaid Services.

The rule, which took effect in 2020, allows some insurers to implement so-called copay accumulator adjustment programs, and the groups argue that such programs effectively allow insurance companies to collect money from both patients and drugmakers without easing the financial burden on patients. 

“Patients are getting taken advantage of here,” said George Huntley, chief executive officer of the Diabetes Leadership Council. “Copay accumulator adjustment programs are, frankly, an evil money-grab by insurance plans and pharmacy benefit managers and are a blatant and we strongly believe illegal cost-shift back to patients.”

The lawsuit argues the rule violates the 2010 health care law, which sets annual limits for how much patients have to spend out of pocket and defined what counts as cost-sharing.

The groups also argue the rule’s policy of leaving it up to individual insurers to decide whether to include copay assistance programs toward an out-of-pocket maximum is arbitrary.

Drug companies often provide copay assistance to patients with insurance who might not be able to afford the copays for expensive drugs. But insurers argue those “coupons” steer patients to more expensive, name-brand drugs and ignore the role drug companies play in keeping the costs of drugs high.

The 2020 rule allows insurers to broadly exclude assistance from counting toward out-of-pocket maximums. Previous rules allowed exclusions to apply only to brand-name drugs.

“These accumulator programs also mean that the patient is no closer to reaching his or her deductible,” the lawsuit states. “Reaching that deductible is important because it would allow the patient to obtain more affordable drugs for the rest of the year. The accumulator programs thus deny patients the benefit of satisfying the deductible amount.”