Key Takeaways from the 340B Coalition Summer Conference 2026

July 30, 2026 Sponsored Content 340B Report Views

Where We Are Headed and How to Prepare

Manufacturer Data Requirements Continue to Expand

Manufacturer restrictions remain one of the most immediate challenges facing covered entities. Forty-four manufacturers now restrict access to 340B pricing through contract pharmacy arrangements, and at least 13 have expanded their policies to include claims from entity-owned pharmacies.

The requests are also becoming more complex. What began as basic contract pharmacy claim submissions has expanded to include in-house pharmacy claims, medical claims and, in at least one anticipated policy, patient encounter or diagnosis-related information.

CEs are also navigating manufacturer-created deadlines, including 45-day claim submission windows and unpublished “reasonable use” timeframes. These requirements can be especially difficult during program implementations, wholesaler account changes and TPA conversions. Even when a delay does not violate the 340B statute, missed submission windows can still result in lost access to 340B pricing.

To stay ahead, CEs should review new manufacturer policies quickly, confirm that purchasing and wholesaler accounts are aligned and keep eligible claim submissions current. Purchase and dispense misalignment remains one of the most common causes of pricing warnings and access loss.

Data submission is not necessarily an all-or-nothing decision. Some manufacturers may work with CEs on what they can operationally provide, and submitting data now does not eliminate the possibility of seeking restitution later if the restrictions are found unlawful.

CEs that cannot access a drug at the 340B ceiling price should also document the denial through HRSA’s reporting process or the Administrative Dispute Resolution process. Neither offers an immediate fix, but both create a formal record and bring the issue to HRSA’s attention.

State Protections Are Providing Meaningful Relief

States continue to be one of the most active battlegrounds for contract pharmacy access and manufacturer data requirements. Several state laws now prohibit manufacturers from requesting claims information beyond what the federal government requires, providing relief to CEs in roughly a dozen states.

340B providers should not assume these exemptions will be applied automatically. If a manufacturer continues to withhold pricing or request prohibited information, engaging your state attorney general or other appropriate state officials may help. This approach has already prompted manufacturers to recognize exemptions in some states.

Although most state legislatures have completed their 2026 sessions, advocacy should continue. Even where a broader contract pharmacy protection bill is not viable, a targeted claims-data protection measure may provide meaningful relief. Recent activity in Illinois and Washington also shows that states are exploring a wider range of approaches, including manufacturer reporting requirements.

A New Rebate Model Appears Likely

While the winter conference focused heavily on the withdrawal of the original 340B rebate pilot following a successful legal challenge, it’s clear that the rebate discussion had not ended. HRSA has continued gathering information and building an administrative record, and a revised pilot could be expected as early as January 1, 2027, although litigation is expected if the government moves forward.

CEs remain concerned about replacing prospective 340B pricing with a post-purchase rebate. Smaller organizations may be especially vulnerable because they would have to fund the full acquisition cost of medications while waiting for claims to be reviewed and reimbursed.

The operational burden also extends far beyond submitting claims data. Reconciliation, refund tracking, denial management and error resolution could require significantly more time than HRSA’s current estimates suggest. Experience with Maximum Fair Price refunds under the Inflation Reduction Act, including reported error and denial rates, adds to those concerns.

During future comment periods, CEs should provide specific, quantifiable information rather than relying on general opposition. Useful details could include staffing time, technology costs, expected claim and denial volumes, reconciliation work and the financial impact of carrying the full drug cost while awaiting reimbursement.

It will also be important to suggest practical changes that could reduce the burden. Even when an organization believes the model is flawed, offering workable alternatives creates a stronger administrative record and gives regulators specific options to consider.

Federal Proposals Offer a Preview of Future Reform

Federal 340B activity has increased, with several bills and discussion drafts now circulating. Comprehensive reform appears unlikely before the November 2026 elections, but the proposals still provide insight into the issues drawing congressional attention.

Current bills range from manufacturer-supported reform proposals to more targeted protections for community health centers and other grantees. Hospital stakeholders have raised concerns about language that could limit discharge, referral or child-site prescriptions.

Proposed orphan drug provisions also deserve close review. Depending on how exclusions are drafted, they could apply to CE types that have not historically been subject to them. Another proposal would restore 340B eligibility for rural emergency hospitals, which currently lose program access after converting to that designation. Even proposals that do not advance may influence future legislation, so it’s important that CEs understand the details and focus their advocacy accordingly.

Court Decisions Are Creating New Operational Considerations

With Congress and HRSA leaving key questions unresolved, the courts are playing a growing role in shaping 340B policy, including a recent decision addressing hospital child-site registration. A district court ruled that a site may use 340B drugs once it meets the statutory eligibility requirements, rather than only after HRSA registration. HRSA has appealed but did not request a stay, so the decision currently remains in effect.

Hospitals considering 340B use at an eligible but unregistered child site should proceed carefully. Policies should clearly document how the organization determined that the site is provider-based and part of the hospital, including reference to 42 CFR § 413.65. Medicaid claims also require additional attention because an unregistered location may create duplicate-discount audit concerns.

Policies and Procedures Must Keep Pace

The pace of change makes policy maintenance more than an administrative exercise. CEs should review their policies whenever they change purchasing practices, patient eligibility standards, contract pharmacy operations, in-house pharmacy processes or the use of child sites.

Policies should reflect actual practice and document the rationale behind key eligibility and purchasing decisions. That alignment will be critical if HRSA later reviews the program during an audit.

Hospitals should also begin preparing for Medicare provider-based attestation requirements. Beginning in 2028, off-campus hospital departments generally must have completed the required attestation process during the prior two years to remain part of the hospital. Locations that cannot demonstrate compliance may also lose their status as eligible 340B child sites.

Final Thoughts

The summer conference reinforced how quickly the 340B landscape is changing. Manufacturer requirements are expanding, a revised rebate model appears increasingly likely, and recent legislative and legal developments are reshaping how CEs should prepare.

There may be no single solution to the uncertainty surrounding 340B. But organizations that stay informed, document their decisions and keep their operations and policies aligned will be better positioned to adapt while continuing to serve the patients and communities the program was designed to support.