Copay accumulators and maximizers, and the rules that govern them

On Sept. 29, 2023, a federal judge in Washington struck down a federal rule that had let health insurers decide for themselves whether a drug manufacturer's copay help would count toward a patient's deductible and annual out-of-pocket limit. Judge John D. Bates wrote that the rule¹ "must be set aside" because the agencies had read the same statutory and regulatory language in contradictory ways.

The case, brought by three patients and three patient advocacy groups, was about programs known as copay accumulators and copay maximizers. More than three years after the ruling, the replacement rule the government said it would write has not appeared in the annual federal payment notices, and many states have passed laws of their own.

Generic drugs come into it more than people expect, because the one federal rule still standing turns on whether a brand drug has a generic equivalent.

How a copay accumulator works

Manufacturers of many brand-name drugs offer copay cards or coupons that pay part of a patient's cost share. Without an accumulator, the plan counts those payments toward the patient's deductible and out-of-pocket maximum, the same as cash. Under an accumulator, the patient can still use the coupon at the pharmacy, but the plan does not credit the coupon's value toward those limits. The court described it in those terms, citing the May 2020 federal rule³ that had allowed the practice.

To show the effect, the opinion used¹ a stylized example: a $6,000 annual cost-sharing maximum, $4,000 in manufacturer assistance and a drug that costs the patient $2,000 a month. GxRadar laid it out month by month.

Bates reached the same totals. With the accumulator, the patient pays $4,000 more before hitting the cap, and the insurer "collects $10,000 in cost-sharing payments as opposed to the $6,000 it would have collected in the absence of the copay accumulator," the opinion says¹.

How a copay maximizer differs

A maximizer reaches a similar result by a different route. HHS described it in a footnote to its 2025 payment notice⁴: "With a copayment maximizer, select drugs are categorized as non-EHBs, allowing plans to exclude drug manufacturer assistance payments from counting toward the patient's deductible and out-of-pocket limitation." EHB stands for essential health benefits, the categories of care the Affordable Care Act protects with its cost-sharing limits.

In the same rule, HHS wrote into regulation that prescription drugs a plan covers beyond its state's EHB benchmark are themselves EHB, and so count toward the annual limit on cost sharing. Commenters had told HHS that maximizers and so-called alternative funding programs were labeling covered drugs as non-EHB, the final rule records⁴. HHS said it would "consider copay maximizer programs, as relevant, in any subsequent policy making about drug manufacturer assistance programs."

Patient groups say that clarification does not reach far enough. In February 2026 the HIV+Hepatitis Policy Institute, one of the plaintiffs in the 2023 case, said the proposed 2027 payment notice lacked formal clarification⁶ that all drugs covered by large group and self-funded plans are essential health benefits.

Six years of federal rules

Federal policy has moved three times since 2019, and the provision the court reinstated is the oldest of them.

A later court order clarified that the ruling had reinstated the earlier provision from the 2020 payment notice, published in 2019, and the government said it would not enforce that rule until it writes a new one, according to the February 2026 statement⁶ from the plaintiff group. That provision is short. Amounts paid with manufacturer support "for specific prescription brand drugs that have an available and medically appropriate generic equivalent are not required to be counted toward the annual limitation on cost sharing," as the opinion quotes it¹.

That is where generics enter. Under the 2019 rule, a plan may decline to credit a coupon for a brand drug when an equivalent generic exists, and the same 2019 rulemaking² defined a generic as a drug approved under section 505(j) of the Food, Drug, and Cosmetic Act, the abbreviated pathway described in our guide to how a generic drug gets approved. How FDA rates a generic against its brand is covered in our explainer on therapeutic equivalence codes. Coupons are far less common for generics, whose cash prices are often low to begin with; see when the cash price beats the copay.

What the states have done

By January 2025, at least 21 states, the District of Columbia and Puerto Rico had enacted laws requiring insurers to count third-party payments such as copay assistance toward cost-sharing limits, according to written testimony⁸ filed that month on a North Dakota bill to do the same. State insurance law applies to the plans a state regulates. Whether a given employer plan falls under state rules or federal rules alone is a question for the plan's benefits office.

For a patient who uses a manufacturer coupon, a few questions put to the plan or the pharmacist can prevent a surprise: Does the plan use an accumulator or maximizer program for this drug? Is the drug classified as an essential health benefit under the plan? Does the coupon's value count toward the deductible and out-of-pocket maximum? Is there a generic equivalent, and would the plan treat the coupon differently if there is? Our guides to high-deductible plans, tiered formularies and patient assistance programs cover the surrounding rules, and more pieces on paying at the pharmacy are on our pharmacy counter desk.

On the federal side, the next vehicle is the 2028 payment notice; the 2027 notice was proposed in February 2026 and finalized in May. The patient group that won in court said in February that it was urging the administration "to act in the very near future," its statement said⁶.