What Were Key 340B Developments in 2025, and What’s Ahead for 2026?

December 10, 2025

Summary

Significant 340B program changes in 2025 were driven by federal and state reforms, with major impacts on how hospitals, health centers, and pharmacies manage drug pricing, eligibility, patient access, and cash flow.
The Health Resources and Services Administration (HRSA) approved the 340B Rebate Pilot Program, launching a new rebate model for covered entities effective January 1, 2026, and involving multiple drug manufacturers and products subject to Medicare price caps.
Covered entities must adapt to new rebate processes, including platform registration and ongoing operational monitoring due to evolving workflows and vendor updates.
HRSA established clear guidance on rebate denials, requiring manufacturers to provide specific rationale and documentation for claim denials, with a defined escalation process for unresolved issues.

Introduction

Federal and state reform has shaped 340B developments this year. These developments could change how hospitals, health centers, and pharmacies manage drug pricing, eligibility, patient access, and cash flow. Below we share three major changes from 2025 and what we expect to see in 2026.

1. Rebate model

One of the biggest changes affecting covered entities in 2025 was the Health Resources and Services Administration’s (HRSA) approval of the 340B Rebate Pilot Program. This was announced on July 31, 2025. The rebates will apply to all outpatient uses of the drugs (retail, mixed-use, and contract pharmacy) and payers. The rebates will apply to all covered entity (CE) types beginning January 1, 2026.

Under the 340B Rebate Model Pilot, eight of the nine invited manufacturers were approved with an effective date of January 1, 2026. The ninth manufacturer was not initially approved but was later approved by HRSA with an effective date of April 1, 2026. Across the nine manufacturers, 10 drugs are included and are also subject to Medicare IRA–negotiated price caps when dispensed and paid under Medicare Part D.

VytlOne is working directly with our clients to assess financial and operational impacts. We continue to provide trusted partnership, strategic guidance, and unwavering support to help our clients deliver exceptional care to the communities they serve.

New rebate process: Covered entities should work with their vendor(s) to confirm new rebate processes are in place to participate in the rebate pilot, including registration with the Beacon platform, and then actively monitor their rebate model operations as this is a new process with evolving system workflows and vendor updates. Monitor closely.

Rebate denials: Manufacturers may not deny a 340B rebate claim solely for alleged 340B diversion compliance concerns; HRSA and Beacon platform guidance require that any manufacturer denial include a rationale and supporting documentation and be processed within 10 calendar days of data submission.

- If a rebate is not paid, first open a good faith inquiry in Beacon and engage the manufacturer; if no resolution, escalate to HRSA Office of Pharmacy Affairs (OPA) for review/assistance.

- During HRSA’s December 4, 2025, webinar, HRSA indicated it will provide a mechanism for covered entities to report denials through Apexus (the HRSA-designated prime vendor). Watch the Apexus Resource Center for forthcoming denial reporting tool details.

- Allowed denial reasons (examples):

- - Duplicate payment/claim (e.g., the same dispense was submitted by more than one covered entity, and payment has already been issued elsewhere).
  - Missing/invalid required data fields (per HRSA-approved data elements for pharmacy and medical claims).
  - MFP/340B deduplication: If a Medicare Maximum Fair Price (MFP) refund is already paid or in process on the same dispense (i.e., MFP is lower than 340B), then a 340B rebate would be duplicative and may be denied. (Context: MFPs apply in Part D starting January 1, 2026, and stakeholders are expected to prevent discount “stacking.”)

Temporary exclusions at contract pharmacies: As 340B partners develop system enhancements to comply with the rebate process, some contract pharmacies are temporarily excluding these products from 340B processing/dispensing. Confirm inclusion status and timing with your third-party administrator (TPA) and contract pharmacy network.

Manufacturer platform change (adjacent, not rebate-related): Some manufacturers have begun using Truzo to manage contract pharmacy policies; historically, 340B ESP was the primary platform used by manufacturers. This platform shift is unrelated to the 340B Rebate Model and pertains to other manufacturer policies restricting contract pharmacy claims that began in 2020. There will now be three 340B platforms used by manufacturers—Beacon, 340B ESP, and Truzo—which increases the need to track requirements separately (rebate workflows versus contract pharmacy restriction policies), and to align enrollment, data submission, and governance across all three.

2. State-level 340B legislative actions

In 2025, states started passing laws designed to increase transparency and cap drug costs.

340B Provider Reporting: States are increasingly requiring 340B CEs to report how they use program savings. These laws, 10 to date and nine pending as of early October, typically mandate annual disclosure of drug acquisition costs, reimbursements, and savings utilization along with payments to contract pharmacies.

Prescription Drug Affordability Boards (PDAB): Nine states have active PDABs. In early October, Colorado’s PDAB set an “Upper Payment Limit” of $600 per 50 mg unit for Enbrel®, marking the first U.S. state price cap on a specific drug. The limit applies to all dispenses and payers and will take effect on January 1, 2027.

Outpatient Drug Cap: Starting January 2026, Vermont hospitals (except unaffiliated Critical Access Hospitals) must limit outpatient drug charges to no more than 120% of the Average Sales Price with biannual updates.³ They are prohibited from raising prices on other services to offset revenue losses from these limits.

3. One Big Beautiful Bill Act (OBBB)

The OBBB, enacted on July 4, 2025, is a comprehensive budget reconciliation law that implements substantial funding reductions and policy modifications across multiple programs, including Medicaid.

The Congressional Budget Office projects that by 2034, 10.9 million people will be uninsured, and the Medicaid components of the OBBB would lead to 7.8 million beneficiaries losing their coverage. What else does the OBBB do?

Cuts Medicaid by about $1 trillion over 10 years, the largest reduction in the program’s history.

Adds work requirements (80 hours/month) for most adults under 65 in order for them to keep Medicaid coverage.

Imposes stricter eligibility checks and higher copays.

Restricts states’ ability to use provider taxes for Medicaid financing.

Requires states to conduct eligibility verifications more often (every six months versus annually), increasing the risk of coverage loss

States are expected to face challenges related to both operations and technology as they work to implement the OBBB.

What’s ahead in 2026?

Going into 2026, the 340B program will face many changes and shifts. These will affect how the program operates, how CEs participate, and how stakeholders respond. Below we explain some upcoming changes VytlOne is expecting next year:

CMS Part B Drug Acquisition Cost Survey (OPPS)

CMS will survey all OPPS hospitals for NDC‑level net acquisition costs for outpatient drugs with submissions January 1 to March 31, 2026. CMS intends to use the results to inform CY 2027 Part B reimbursement, potentially lowering rates for 340B‑acquired drugs; hospitals should prepare data extracts, internal validations, and response plans.

Medicare Part D identification of 340B claims (claims‑based + voluntary repository)

Beginning January 1, 2026, CMS will apply a data‑driven prescriber–pharmacy pairing methodology to flag and exclude 340B units from Inflation Reduction Act (IRA) inflation rebates and stand up a voluntary claims data repository for covered entities/TPAs to submit claim elements. Plan now for file standards, privacy review, and TPA integration for when claims submission becomes mandatory.

Wholesaler Acquisition Cost (WAC)/list‑price changes

Impacts on 340B prices and reimbursement. Manufacturers’ list price (WAC) reductions tied to IRA/MFP dynamics are likely to deflate gross‑to‑net and compress 340B spreads. Monitor manufacturer announcements and adjust accumulation, pricing verification, and reimbursement expectations accordingly.

340B Rebate Model go‑live

Watch for potential expansion to other manufacturers. As the pilot launches on January 1, 2026 (April 1 for Entresto), track HRSA/Beacon updates for additional manufacturers joining post‑launch—HRSA has signaled the pilot will inform future models, and legal analyses note manufacturers may join after launch with required notice and participation conditions. Establish monitoring and governance to adapt quickly.