The 340B Drug Pricing Program is entering one of its most consequential periods in years. Congress is actively considering multiple reform proposals, HRSA is moving forward with a proposed rebate model, pharmaceutical manufacturers continue expanding claims data requirements, and litigation over contract pharmacies remains ongoing.
Against this rapidly changing backdrop, Advocates for Community Health (ACH) is working on multiple fronts to help policymakers understand how community health centers rely on 340B savings to care for millions of patients nationwide, and to ensure any reforms strengthen, rather than undermine, the program.
During yesterday’s federal policy update, ACH outlined the latest developments below and what they could mean for health centers.
The Pace of 340B Activity Is Accelerating
Several major policy developments are unfolding simultaneously, including:
- HRSA’s proposed 340B rebate model, starting 2027
- New manufacturer claims data requirements and Congressional pushback
- Multiple bipartisan legislative proposals in the House and Senate
- Continued litigation over state contract pharmacy laws, and other hotly contested areas of the program (e.g. patient definition)
Taken together, these developments represent one of the busiest periods for 340B policy in recent years.
As policymakers debate the future of the program, it’s important to keep its scale in perspective. According to HRSA’s latest data, total 340B purchases reached approximately $100 billion in 2025, yet community health centers accounted for just $5.92 billion, or just under 6%, of all 340B purchases nationwide. Despite representing a relatively small share of the program, health centers depend on those savings to keep clinics open, expand access to behavioral health, dental care, telehealth, mobile services, and affordable medications for patients in rural and underserved communities.
ACH is Focused on Stopping the Rebate Model
The most immediate issue is HRSA’s planned implementation of a rebate model for certain drugs covered under the Inflation Reduction Act.
HRSA is expected to publish additional implementation requirements in the Federal Register later this month, with the agency continuing to target January 1, 2027 for implementation.
ACH strongly opposes applying a rebate model to community health centers because it would delay access to critical 340B savings, create significant cash-flow challenges, and increase administrative burdens. In the near term, ACH is urging policymakers to exempt federally qualified health centers from the rebate model or, at minimum, delay implementation for FQHCs. Longer term, ACH supports a federally administered claims clearinghouse that would prevent duplicate discounts without requiring providers to operate under a rebate model. Throughout this process, ACH has engaged HRSA, congressional offices, and coalition partners to emphasize the real-world impact these changes would have on patient care.
Congress Is Actively Considering Multiple 340B Reform Proposals
Congress is weighing several proposals that could significantly reshape the future of the 340B program.
Senate HELP Committee Discussion Draft
Senate HELP Committee Chairman Bill Cassidy (R-LA) recently released a discussion draft proposing broad reforms to the 340B program.
While the proposal would allow covered entities to choose between receiving a discount or rebate, it also includes new requirements for accessing discounts and places substantial restrictions on contract pharmacy arrangements.
ACH believes the discussion draft fundamentally misunderstands how community health centers use the 340B program to expand access to care and is working with our members to develop detailed feedback before the August 28 stakeholder comment deadline.
The SECURE 340B Act
The newly introduced bipartisan SECURE 340B Act represents the first major House reform proposal in nearly two years.
ACH was encouraged to see many of our long-standing advocacy priorities reflected in the legislation, including provisions that balance transparency and accountability while promoting greater program stability. However, ACH continues to have concerns regarding portions of the patient definition language and plans to work with congressional offices to improve the bill.
SUSTAIN Act Expected Soon
ACH also expects the bipartisan Senate “Gang of Six” to release the long-awaited updated SUSTAIN Act later this month. The legislation has been delayed following changes in Senate membership but remains an important proposal to watch in the coming weeks.
Drug Manufacturers Continue Expanding Data Demands
Outside of Congress, several pharmaceutical manufacturers continue pushing forward with claims-level data reporting requirements.
Eli Lilly and a growing number of manufacturers have required covered entities to submit detailed claims information, and some hospitals have reportedly lost access to 340B pricing after declining to participate.
ACH continues engaging with manufacturers, HRSA, Congress, and national media to highlight the operational burdens these policies create for safety-net providers.
ACH Is Advancing a Practical Vision for 340B Reform
Throughout these policy discussions, ACH remains focused on protecting the core purpose of the 340B program while supporting reasonable transparency and accountability.
That work is guided by six core policy principles:
- Protect the core purpose of 340B
- Preserve access to contract pharmacies
- Reject the rebate model
- Prevent discriminatory PBM practices
- Support transparency without unnecessary administrative burden
- Maintain flexibility for community health centers
Those principles are reflected in ACH’s work to shape federal legislation, organize broad stakeholder coalitions, engage directly with policymakers and federal agencies, and elevate data demonstrating how health centers reinvest 340B savings to expand access to care in communities across the country.
Call to Action
With multiple legislative proposals under consideration, anticipated HRSA guidance expected within weeks, and continued manufacturer actions, the coming months will be pivotal for the future of the 340B program.
Now is the time for community health centers to make their voices heard. As Congress, HRSA, and other stakeholders consider significant changes to the program, the voices, experiences, and data from health centers will be more important than ever. ACH encourages members to stay engaged, respond to advocacy alerts, participate in opportunities to educate policymakers, and share how 340B savings strengthen patient care and improve health outcomes in their communities.
ACH will continue championing policies that protect patient access, preserve the original intent of the 340B program, and ensure reforms strengthen, not weaken, the program. While community health centers account for less than 6% of all 340B purchases, the savings they generate are indispensable to keeping clinics open, expanding access to behavioral health, dental care, telehealth, mobile services, and affordable medications in rural and underserved communities.
Every story shared, every lawmaker educated, and every voice raised helps reinforce what is at stake. Together, we can ensure policymakers understand that 340B is more than a drug pricing program; it is a vital investment in healthier communities, enabling health centers to reinvest every dollar of savings into better care, stronger communities, and healthier futures for millions of Americans.