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Patient groups sue feds to crack down on insurer, PBM copay adjustment programs

A collection of patient advocacy groups is suing to demand the federal government outlaw copay accumulator programs they say inflate healthcare costs.

The three groups filed the lawsuit Tuesday in the U.S. District Court for the District of Columbia challenging the legality of a Trump-era rule that allows insurers to avoid counting the value of drugmaker coupons toward patient out-of-pocket costs and deductibles.

These policies, referred to as copay accumulator adjustment programs, significantly increase patients' costs, the groups claim.

“It’s not every day that a patient community files a legal action against the federal government. We have been left with no choice,” said Carl Schmid, executive director of the HIV + Hepatitis Policy Institute, one of the three groups that filed the lawsuit, during a call with reporters Tuesday.

The Diabetes Leadership Council and the Diabetes Patient Advocacy Coalition are the other groups that joined the lawsuit.

A 2019 rule issued by the Trump administration blocks insurers from applying the drugmaker coupons to out-of-pocket limits like deductibles if there is a generic drug version on the market. However, the Trump administration decided to not enforce the rule in 2020 after complaints of confusion from stakeholders.

The 2021 Notice of Benefit and Payment Parameters rule—which outlines insurance regulations for Affordable Care Act exchange plans—enabled insurers to decide how to interpret cost-sharing. An insurer could “either include or exclude copay assistance from cost-sharing calculations,” according to a release on the lawsuit.

The groups also charged that the Department of Health and Human Services (HHS) abandoned the 2019 copay accumulator policy that enabled assistance to count toward a deductible or out-of-pocket cost responsibility except for a brand-name drug that has a generic version.

The complaint asserts that the HHS rule violates federal law and directly contradicts the government’s own definition of cost-sharing.

In the lawsuit, the groups allege that many insurers attempt to forbid a patient from counting assistance provided by a drug manufacturer as part of the copayment obligation.

"Unsurprisingly, copay accumulator adjustment programs can thus be expected to result in increased out-of-pocket costs to needy patients, decreased adherence to now-unaffordable prescription drug regimens, and greater systemic costs to the healthcare system," the groups wrote in the lawsuit.

HHS did not immediately return a request for comment on the lawsuit.

As groups battle in the courts over federal action, some states are adopting their own bans on copay accumulators. As of May, 14 states enacted laws banning the practice and affecting 10% of people enrolled in U.S. commercial plans, according to an analysis from the Urban Institute.


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