Insights from the 2025 340B Coalition Summer Conference: Key Takeaways for Covered Entities

National Harbor, MD — July 21–23, 2025

The 340B Coalition Summer Conference brought together healthcare leaders, program stakeholders, and policy experts to examine the critical updates and challenges facing the 340B Drug Pricing Program. With growing legislative, regulatory, and financial pressures, this year’s conference focused on three dominant themes: manufacturer rebate models, the Inflation Reduction Act (IRA), CMS Medicare Transaction Facilitator (MTF), and state reporting mandates.

Manufacturer Rebates & Data Sharing

A recurring topic across sessions was the manufacturer-proposed rebate model as an alternative to traditional 340B purchasing models. These rebate frameworks require covered entities to purchase drugs at Wholesale Acquisition Cost (WAC) and then seek reimbursement (as opposed to the current 340B purchasing model) via complex third-party validation and data submission processes. While some manufacturers cite transparency and compliance as motivations, concerns remain:

• Significant cash flow burdens for covered entities
• Administrative complexity and delayed rebate payments
• Potential threats to patient access and hospital financial stability, particularly in rural and safety-net institutions

Legal challenges related to rebates are ongoing. Although HRSA’s oversight authority over rebate models has been upheld in recent court decisions, final guidance is still pending. Entities are advised to closely monitor these developments.

IRA, MFPs, and the CMS Medicare Transaction Facilitator (MTF)

The Inflation Reduction Act introduces Medicare drug price negotiation via the Maximum Fair Price (MFP) model, starting in 2026 (Part D) and 2028 (Part B). This legislation will have a profound impact on 340B savings:

• MFP will result in reduced reimbursement for negotiated drugs, and CEs will see reduced 340B margins for Medicare beneficiaries.
• Covered entities must choose between MFP and 340B pricing for eligible drugs—both discounts cannot apply to the same claim. Also, CEs must use MFP if the 340B price is higher than MFP.

The MTF system supports claims tracking, refund processing, and data reconciliation. While it enhances transparency, it also introduces new administrative burdens and potential challenges with manufacturer claim classification and reimbursement accuracy. Enrollment in the CMS Medicare Transaction Facilitator Data Module (MTF-DM) is mandatory for participation in Medicare Part D networks starting January 1, 2026. Enrollment opened in June, and CMS recommends enrolling by November 15, 2025, to avoid disruptions.

State Reporting Mandates: Transparency or Burden?

As scrutiny over the 340B program intensifies, many states have introduced or passed reporting requirements intended to evaluate how 340B savings are used. Key developments include:

• Ten states—Maine, Minnesota, Washington, Idaho, Indiana, Colorado, Hawaii, Ohio, Rhode Island, and Vermont—now mandate annual 340B reporting.
• Reports often require data on drug acquisition costs, reimbursement, contract pharmacy payments, and use of 340B savings.
• States like Minnesota have taken transparency further with the requirement of detailed public reporting and data publication.

Implications:

• Potential for increased compliance costs
• Risk of misinterpretation of data without context on patient impact
• Opportunity for proactive advocacy to shape balanced legislation

Additional Takeaways

1. H.R. 1 One Big Beautiful Bill impact was mentioned during several sessions. While the law does not include any 340B-specific provisions, the significant Medicaid funding reductions planned over the next ten years are expected to result in fewer Medicaid-eligible patients, fewer Medicaid inpatient days, and a decrease in a hospital’s disproportionate share (DSH) adjustment percentage. Hospitals that are already close to the threshold are especially at risk of losing eligibility if their DSH adjustment percentage drops below the minimum requirements for program participation. Speakers encouraged covered entities to closely monitor the impact within their organization and plan early for any necessary eligibility changes.

2. Federal Legislative Update: The 340B PATIENTS Act was reintroduced this week which would codify 340B providers’ ability to use contract pharmacies to dispense 340B discounted drugs. Regarding the draft SUSTAIN Act, the reformed working group is currently updating the draft. It is speculated that additional 340B legislation may be put forth in the second half of the year.

Looking Ahead

As 340B stakeholders navigate regulatory changes, operational challenges, and demands for data transparency, one thing is clear: preparedness and advocacy are essential. Covered entities must stay engaged with CMS updates, legal outcomes, and state-level policies while continuing to demonstrate the value and necessity of the 340B program in supporting underserved patient populations.