Plan and PBM Use of Copay Adjustment Programs Has Increased Over Recent Years

In recent years, payers and pharmacy benefit managers (PBMs) have increasingly used copay adjustment programs (i.e., copay accumulators and copay maximizers) to limit plan sponsor exposure to prescription drug costs. Manufacturers often offer patient copay assistance programs to commercially insured patients to reduce their out-of-pocket (OOP) drug costs. Copay adjustment programs prevent this third-party assistance from counting toward patients’ deductibles and maximum out-of-pocket (MOOP) calculation. Research has shown that more than 83% of commercial market enrollees belong to plans that have implemented copay accumulator programs and 73% belong to plans that have implemented copay maximizer programs.

State and Federal Action Limiting Copay Adjustment Programs

Since 2019, state legislators have passed 21 bills aimed at banning the use of copay accumulator programs and ensuring that any third-party copay assistance used by a patient is counted toward the cost-sharing limits of their plan. As of March 2025, 21 states have enacted laws banning payer and PBM use of copay accumulator programs. These laws apply to state-regulated health plans, including the individual, fully insured large-group, and small-group markets (see Figure 1). As of January 1, 2025, at least 16% of the total US commercial market (approximately 31million individuals) are enrolled in plans that must count any form of copay assistance toward patient cost-sharing limits (note: certain states only limit bans in instances where a generic is not available).

Figure 1: Proposed and Enacted State Laws Limiting Copay Adjustment Programs

Note: As of March 2025

In September 2023, the US District Court for the District of Columbia struck down a federal rule that allowed plans and PBMs to omit manufacturer copay assistance from beneficiary cost-sharing calculations (e.g., MOOP totals). Current regulations permit plans to omit such assistance only in instances where a generic alternative is available. This ruling significantly limited the use of copay accumulators in federally regulated large group and self-insured plans, but did not limit the use of other adjustment programs like copay maximizers. However, as part of the 2023 District Court decision, HHS must provide clarification for consistent interpretation of the definition of “cost sharing” and the Trump administration may seek to provide broad latitude for use of accumulators as it did in previous rulemaking (i.e., 2021 Notice of Benefit and Payment Parameters).

Employers, Plans, and PBMs Are Utilizing Additional Tools for Managing Financial Exposure

As copay adjustment programs face increased scrutiny and restrictions from state and federal lawmakers, stakeholders have turned to alternative funding programs (AFPs) as an additional mechanism for managing specialty or high-cost drug exposure. These programs operate in agreement on behalf of plan sponsors and pharmacy benefit managers to “carve out” certain specialty products from a beneficiary’s prescription drug benefit. AFPs then facilitate patient acquisition of their drug via other channels, including the enrollment of patients taking these products into the specialty product manufacturer’s foundation or patient assistance program (PAP), non-manufacturer charitable foundations, or via international drug importation.

Stakeholder Implications

Copay adjustment programs and AFPs may slow patients from moving through their insurance OOP requirements (e.g., deductible, OOP maximum), resulting in higher overall patient cost and creating access challenges.

Several manufacturers have implemented strategies to mitigate the risk of being targeted by AFPs by updating the eligibility criteria or terms and conditions for their free product offerings (e.g., prohibiting any patients with insurance from receiving free product support). While such program changes may prevent AFPs from moving patients into manufacturer foundations or PAPs, patients subject to AFPs may face access challenges as a result. Manufacturers have also taken legal action to challenge both copay adjustment programs and AFPs seeking to curb their use in the market.

Looking Ahead

Patient access and affordability continue to be an area of considerable focus for stakeholders as the US healthcare landscape evolves. The Trump administration’s rulemaking in its first term indicated support for plan flexibility to implement copay accumulators and maximizers. Changes in leadership at HHS and CMS in the second term may result in different approaches to rulemaking such as the Notice of Benefit and Payment Parameters, which has implications for copay adjustment programs broadly.

Health plans are seeking to manage exposure to high-cost specialty drugs as their prices increase and they face increased liability under the Inflation Reduction Act. Plans and employers will likely continue to seek and utilize tools to manage drug spending.

Manufacturers continue to face challenges to their patient support and affordability programs, and will likely continue to revise eligibility and program structures as needed. Continuous monitoring and strategic action is required on behalf of all stakeholders to safeguard patient access to medication and treatment.

Avalere helps clients understand the evolving landscape of patient support, model the impacts of these policy changes, and identify solutions accounting for financial exposure while maximizing appropriate patient access. With its hands-on policy experience from the payer, manufacturer, and third-party vendor perspectives, Avalere is well positioned to help your organization respond to—or shape—the evolving copay adjustment program landscape.

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Appendix: Lives Impacted by Accumulator Bans Across States

Data sourced from AIS Enrollment Data, January 2025