As Biden Admin Winds Down, Will It Address Accumulators, Maximizers as Promised?

As President Joe Biden’s administration nears its end, two promised rules on copayment accumulators and maximizers have yet to be released. They stand to have a huge impact on whether pharma manufacturer-provided patient assistance — much of which is provided for specialty drugs — must be counted toward patients’ out-of-pocket responsibility.

The first concerns a lawsuit over the 2021 Notice of Benefit and Payment Parameters (NBPP) and its stance toward copay accumulators.

Health plans and PBMs several years ago began implementing accumulators to counter manufacturer copay assistance programs. Traditionally, that assistance would count toward beneficiaries’ annual out-of-pocket expenses. When those out-of-pocket maximums were reached, health plans would cover the remainder of members’ costs for the year. With accumulators, patients can still use that assistance, but it does not help reduce their out-of-pocket costs.

So once the assistance is depleted, which is usually fairly early in the year, beneficiaries must pay for often-costly drugs until they hit their out-of-pocket maximums, shifting payers’ financial responsibilities to their members and manufacturers.

The 2020 NBPP stated that plans could exclude manufacturer assistance from counting toward patients’ out-of-pocket limit for only “specific prescription brand drugs that have an available and medically appropriate generic equivalent.” That excluded many high-cost specialty drugs that did not have a generic equivalent.

But in the 2021 NBPP, CMS reversed course and said plans were not required to apply manufacturer assistance toward beneficiaries’ annual cost sharing, leaving members on the hook for numerous specialty medications once assistance ran out.

On Aug. 30, 2022, the HIV+Hepatitis Policy Institute, the Diabetes Patient Advocacy Coalition, the Diabetes Leadership Council and three people dependent on copay assistance whose health plans had copay accumulators in place filed a lawsuit (Case 1:22-cv-02604) against HHS, CMS and their respective leaders challenging the 2021 NBPP. The plaintiffs claimed that allowing the use of accumulators is at odds with how the Affordable Care Act (ACA) — as well as the agencies’ preexisting regulatory definition — defines “cost sharing” and charged that the 2021 NBPP is “arbitrary and capricious.”

On Sept. 29, 2023, U.S. District Judge John D. Bates of the U.S. District Court for the District of Columbia ruled in favor of the plaintiffs, ordering that the 2021 NBPP “must be set aside based on its contradictory reading of the same statutory and regulatory language and the fact that the agencies have yet to offer a definitive interpretation of this language that would support the rule.”

In response, on Nov. 27, HHS filed a conditional motion to clarify the scope of the court’s order, declaring that “defendants do not understand this Court’s order to require HHS to take enforcement action.”

It also revealed that the agency “intends to address, through rulemaking, the issues left open by the Court’s opinion, including whether financial assistance provided to patients by drug manufacturers qualifies as ‘cost sharing’ under the Affordable Care Act.” Until it issues that rule, said HHS, it had no intentions of taking “any enforcement action against issuers or plans based on their treatment of such manufacturer assistance.”

HHS filed a notice of appeal the following day, followed by the plaintiffs filing their own appeal on Dec. 11. In response to HHS’s motion for clarification, on Dec. 22, Bates stated that the 2020 NBPP is in effect.

On Jan. 16, the U.S. Department of Justice filed a motion to dismiss the government’s appeal. That was followed on Feb. 1 by the plaintiffs’ filing to dismiss their cross-appeal.

At the time, CMS did not respond to a request from AIS Health, a division of MMIT, for comment on whether it will issue a new rule addressing manufacturer-provided assistance.

Second Rule Concerns Copay Maximizers

The second rule stems from the final 2025 NBPP, which addressed copay maximizers.

These offerings work by declaring certain drugs non-essential health benefits (non-EHBs) to avoid covering them per the ACA. Rather than using all available manufacturer assistance as soon as possible, copay maximizers distribute 100% of available manufacturer copay offset funds over 12 months. Similar to accumulators, with next-generation maximizers, that assistance does not count toward patients’ out-of-pocket costs.

The final 2025 NBPP, issued earlier this year on April 2, closed what some have called a loophole in the ACA by declaring that “prescription drugs in excess of those covered by a State’s EHB-benchmark plan are considered EHB.”

But it addressed the use of maximizers in nongrandfathered individual and small group market plans only — not large group market plans and self-funded group plans.

In an FAQ issued the same day, the Departments of Labor, HHS and the Treasury said that they “intend to propose rulemaking that would align the standards applicable to large group market health plans and self-insured group health plans with those applicable to individual and small group market plans, so that all group health plans and health insurance coverage subject to sections 2711 and 2707(b) of the PHS [Public Health Service] Act, as applicable, would be required to treat prescription drugs covered by the plan or coverage in excess of the applicable EHB-benchmark plan as EHB for purposes of the prohibition of lifetime and annual limits and the annual limitation on cost sharing, which would further strengthen the consumer protections in the ACA.”

2026 NBPP Is Expected ‘Any Day Now’

The 2026 draft NBPP is “at the White House right now,” says Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. He tells AIS Health, a division of MMIT, that it has been there since July 17 and that he expects it to be released “any day now.”

Presumably, it will address the definition of cost sharing and HHS’s stance on accumulators. “We’re hoping that it’s going to be in there.”

He points out that it’s been almost one year since the court made its decision on the case in which his organization was a plaintiff. “Every day that they don’t issue a decision, people are being hurt.…There needs to be some outrage over this.”

“And this is coming from an administration that prides itself on patient affordability of prescription drugs,” he comments. Schmid says he’s had several meetings with the administration, as well as the Office of Management and Budget, to help impress upon them “what a big issue this is.”

He points to data from the IQVIA Institute for Human Data Science showing that patient out-of-pocket costs reached $91 billion in 2023, and as those costs rise, so do rates of prescription abandonment by patients. Manufacturer copay assistance offset patients’ costs last year by $23 billion, and accumulators and maximizers accounted for $4.8 billion of assistance in 2023 — an amount that was more than double the total for the programs in 2019, he says.

More than 20 states have enacted legislation banning the use of copay accumulators, but only for state-regulated health plans, including individual, fully insured large group and small group plans.

‘Clock Is Ticking on This Administration’

Schmid says that he also hopes that the 2026 draft NBPP aligns HHS’s stance against maximizers’ practice of declaring drugs non-EHB in nongrandfathered individual and small group market plans with large group market plans and self-funded group plans. If that isn’t included, “we have some real concerns,” he says. “The clock is ticking on this administration, and there are not many days left.”

While accumulators often apply to all drugs with assistance, maximizers are “really discriminatory.…They pick and choose which drugs” to exclude from coverage, and most of them are specialty drugs such as agents for HIV, hepatitis and cancer. “These employers are saying, ‘We’re providing health insurance.’ Well, it’s not really health insurance when you don’t cover” certain drugs.

“I know some of the drug companies pay more in copay assistance in a year than the cost of the drug,” he reveals, clarifying that he is referring to the list price. “This is just a scheme. It’s a travesty, and…there’s not enough attention on it.”

But some of the understanding on accumulators and maximizers is inaccurate, Schmid points out. In meetings with the National Association of Insurance Commissioners, many of the commissioners did not understand the issue.

And during a House of Representatives budgetary meeting in April, when Rep. Buddy Carter (R-Ga.) asked HHS Sec. Xavier Becerra why HHS was not complying with the accumulator ruling, he responded, “I can assure you that we will comply with the law. What we want to make sure at the same time is we don’t allow the Medicare program and Medicare beneficiaries to get gamed in the process and ultimately end up having to pay more out of pocket at the end of the day.”

But Medicare beneficiaries do not use accumulators and maximizers because per the Anti-Kickback Statute, they are not able to use drugmakers’ coupons.

When Carter said, “This impacts patient access to care,” Becerra replied, “It does not.…Patients will still have access to the drugs that they need….Under the Medicare program, they will have help with accessing the drugs they need.”

“Give me a case where a patient has been denied their drugs,” said Becerra. “Show me,” he repeated when Carter pushed back.

“That really bothered me,” says Schmid of Becerra’s perception. Afterwards Schmid was able to have a meeting with some of Becerra’s staff “to better educate” his office. “This issue, it’s not a small issue. I hope if he got that question again, he would answer it differently because it was, frankly, an embarrassment and really hurtful that the secretary didn’t know.”

Ultimately, says Becerra, if the 2026 NBPP addresses accumulators, “it has to be in a positive way.” And if it doesn’t, “the administration really needs to act very soon on these two issues. They promised that they would.”

This article was reprinted from AIS Health’s monthly publication Radar on Specialty Pharmacy.

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