Proposed 2027 Insurance Rule Omits Copay Assistance Protections, Advocates Warn

The Trump administration’s proposed 2027 Notice of Benefit and Payment Parameters rule does not include long-promised protections that would require insurers and pharmacy benefit managers to count manufacturer copay assistance toward patients’ out-of-pocket costs, leaving a regulatory gap that critics say allows billions of dollars in assistance to be diverted away from patients. The omission comes despite earlier court rulings and agency pledges to address the issue.

The rule fails to address whether copay assistance provided by drug manufacturers must count toward a patient’s deductible or other cost-sharing requirements. This has been a contentious issue as insurers and PBMs increasingly use “copay accumulator” programs that prevent such assistance from applying toward out-of-pocket limits. The controversy dates back nearly two and a half years to a federal court decision that struck down a prior rule allowing insurers to decide whether copay assistance counts. The court affirmed that a 2020 NBPP rule—requiring copay assistance to count, except for brand-name drugs with a generic equivalent—remains in effect, but the government has said it will not enforce that standard until new regulations are issued.

Annual maximum out-of-pocket limits are set to increase by 13 percent to $12,000 for individuals and $24,000 for families in 2027. According to IQVIA, drug manufacturers provided $21.4 billion in copay assistance to patients in 2024, but insurers and PBMs retained $7 billion, or 37 percent, of that total.

The proposed rule also fails to clarify that drugs covered by large group and self-funded health plans should be treated as essential health benefits. Some employers, working with PBMs and third-party vendors, classify drugs that come with manufacturer assistance as “non-essential,” even when they are covered. Because essential health benefits are subject to cost-sharing limits, this practice allows plans to capture copay assistance for themselves without crediting it to patients. The government closed this loophole for individual and small group plans in the 2025 NBPP rule and had promised to extend the fix to large group and self-funded plans, but that extension is absent from the 2027 proposal.

The executive director of the HIV+Hepatitis Policy Institute stated that every day the rule is delayed is another day that insurers and PBMs are pocketing billions of dollars meant for patients. While acknowledging the administration’s stated focus on drug affordability, advocates urge swift action to close the loophole.