HHS Notice of Benefit and Payment Parameters for 2026 Proposed Rule
On October 10, 2024, the Centers for Medicare & Medicaid Services (CMS), in collaboration with the U.S. Department of Health and Human Services (HHS), published the Notice of Benefit and Payment Parameters (NBPP) for the 2026 Proposed Rule. This rule signals that CMS, along with the Department of Treasury and the Department of Labor (collectively referred to as “the Tri-agencies”), plans to issue two additional rulemakings in the future:
- Clarifying that prescription drugs covered by employer-sponsored health plans are considered essential health benefits (EHBs) if the plans cover them.
- Addressing the applicability of drug manufacturer assistance to patients’ annual limitations on cost-sharing.
Comment Period for Stakeholders
Stakeholders are invited to submit comments to CMS regarding the Proposed Rule until November 12, 2024. [1]
Background on Essential Health Benefits (EHBs)
Earlier in 2024, HHS and CMS finalized NBPP 2025, determining that prescription drugs exceeding those listed in a state’s EHB-benchmark plan are considered EHBs for individual and small group health plans.[2] EHBs are a core aspect of the Affordable Care Act (ACA) aimed at standardizing essential items and services covered by non-grandfathered plans, including “prescription drugs.”[3] EHBs are subject to an annual cost-sharing limit under the ACA, offering protections to consumers.
Challenges Posed by Copay Adjustment Programs
Recent years have seen a rise in “copay maximizer programs,” where insurers set a patient’s cost-sharing to match the maximum amount of financial assistance provided by drug manufacturers. These programs, while maximizing insurer savings, often leave patients with significant deductibles and out-of-pocket costs for other necessary healthcare services.[3] As described in a recent report, these maximizer programs “ensure that the insurer captures as much financial assistance from pharmaceutical manufacturers or charitable assistance funds as possible without benefiting patients,” leaving them “subject to the deductible and cost-sharing for any other medications or health care services that they may need during the year.”[4]
Additionally, “copay accumulator programs” have become more common. In these arrangements, any manufacturer assistance received by a patient does not count toward their deductible or annual out-of-pocket maximum. Once this assistance is exhausted, patients may face higher costs, which can limit access to essential medications.[4]
In HIV & Hepatitis Policy Institute v. U.S. Department of Health & Human Services, the U.S. District Court for the District of Columbia reinstated a previous rule that permits manufacturer assistance to count toward cost-sharing for branded drugs without generic equivalents. If a generic is unavailable, financial assistance must contribute to the patient’s annual limit on cost-sharing.[5] However, HHS has not enforced regulations concerning copay accumulator programs and has indicated plans to further define “cost-sharing” in relation to manufacturer assistance through future rulemaking.[6]
Key Aspects of the NBPP 2026 Proposed Rule
The 2026 NBPP Proposed Rule, issued in October, stops short of expanding the EHB-related protections in NBPP 2025 to employer-sponsored health plans or explicitly defining “cost-sharing” regarding manufacturer assistance. However, CMS has committed to two Tri-agency rulemakings that would address:
- EHB Standardization Across Plans: The agencies “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… 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.”[1]
- Applicability of Manufacturer Assistance to Cost Sharing: The agencies stated they intend “to issue a future notice of proposed rulemaking [to] address the issues arising out of HIV and Hepatitis Policy Institute et al. v. U.S. Department of Health and Human Services… namely, the applicability of drug manufacturer support to the annual limitation on cost sharing.”[1]
Impact on Patients
Until these rulemakings are finalized, insurers can continue using copay accumulator and maximizer programs. As a result, patients may face ongoing challenges in affordability and access to their medications.[4]
How to Submit Comments
Comments on the NBPP 2026 Proposed Rule may be submitted until November 12, 2024. The assigned Federal Register Document Number is 2024-0311-0001. Refer to file code CMS-9888-P when submitting.
Comments can be sent through one of the following methods:
- Electronically: Visit Regulations.gov and follow the instructions to submit a comment.
- By Regular Mail: Address to “Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-9888-P, P.O. Box 8016, Baltimore, MD 21244-8016.”
- By Express or Overnight Mail: Send to “Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-9888-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.”
For further reading, access the full text of the NBPP 2026 Proposed Rule.
References: [1] CMS, “Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2026”
[2] CMS, “Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2025”
[3] CMS, “Information on Essential Health Benefits (EHB) Benchmark Plans”
[4] Long, Salaga, & Pestaina, “Copay Adjustment Programs: What Are They and What Do They Mean for Consumers?”
[5] The AIDS Institute, “Discriminatory Copay Policies Undermine Coverage for People with Chronic Illness”
[6] HIV and Hepatitis Policy Institute v. US Department of Health and Human Services
[7] HIV and Hepatitis Policy Institute v. US Department of Health and Human Services
