340B News & Regulatory Updates — June 2026

The Most Important 340B Developments of June 2026

Published by 340bprogram.com | June 30, 2026
Sources: Senate HELP Committee, Washington State Hospital Association, Alston & Bird, Buchanan Ingersoll, ML Strategies, Mintz, National Law Review, 340B Report, Frier Levitt, Goodwin Law, HRSA Federal Register

JUNE 2026 OVERVIEW

June 2026 was a month that will be studied for years. Senator Bill Cassidy released the most sweeping proposed overhaul of the 340B statute in its 34-year history — a comprehensive discussion draft that would reshape patient eligibility, contract pharmacy access, rebate models, and program transparency. Washington State’s new contract pharmacy access law survived its first court challenge and took effect June 10. Kansas lost its contract pharmacy protections on June 30. HRSA issued a new Information Collection Request signaling the rebate model fight is very much alive. Sanofi became the ninth manufacturer to announce in-house pharmacy data requirements. And a provider law firm urged the HHS Inspector General to investigate Eli Lilly’s data demands. June was the month the 340B reform conversation moved from the courts and the agencies to Congress itself — and that changes everything.

🚨 TOP STORY — SENATOR CASSIDY RELEASES LANDMARK 340B REFORM DISCUSSION DRAFT

June 25, 2026 — The 340B Drug Pricing Integrity and Affordability for Patients Act

On June 25, 2026, Senate Health, Education, Labor and Pensions Committee Chairman Bill Cassidy released a comprehensive discussion draft proposing significant amendments to the 340B statute. Cassidy’s 340B Senate Discussion Draft was touted as the first statutory update to the 340B Program in fifteen years.

This is the single most consequential legislative development in the 340B program’s recent history. While it is a discussion draft — not yet a formal bill — it represents the clearest signal yet of where congressional policymakers believe the program should be heading.

What the draft proposes: Senator Cassidy’s 340B Drug Pricing Integrity and Affordability for Patients Act would allow drug manufacturers to offer 340B rebates, add new provider reporting requirements, codify certain contract pharmacy uses and reform the 340B prime vendor program, among other changes.

The five major reform areas in the Cassidy draft:

1. Manufacturer Rebate Model — Codified in Law
One of the most consequential changes in the draft is the formal introduction of a manufacturer rebate model as an alternative to the traditional upfront discount. Under current practice, covered entities purchase drugs at the 340B ceiling price at the point of sale. This draft would allow manufacturers to choose to instead offer a retrospective rebate after claims data is submitted. Importantly, the draft gives covered entities the ability to choose their preferred mechanism — discount, rebate, or a new government-operated claims repository — provided they pass all discounts or rebates directly to their 340B patients.

2. Standardized Provider Reporting Requirements
The bill would require standardized, regular reporting from participating nonprofits on their 340B revenues, costs, and eligibility. This is aimed at increasing transparency into how covered entities use 340B savings — a major manufacturer and congressional priority.

3. Contract Pharmacy Reform — Codified Access
The draft would codify certain contract pharmacy uses in federal statute — providing clearer legal footing for the contract pharmacy model that has been litigated endlessly in courts for the past six years.

4. Dispute Resolution Reform
Providers would be able to request adjudication on any disputed information and audits, to be conducted at either the government or a drug manufacturer’s expense. This addresses a major covered entity complaint about the current ADR process.

5. Prime Vendor Program Reform
Cassidy is also investigating the 340B Prime Vendor Program after it generated hundreds of millions of dollars in revenue for the vendor through fees it collects for almost every drug sold under the 340B Program.

The AHA’s response: The American Hospital Association slammed the draft’s new requirements and pointed the finger at drugmakers as the core problem with the 340B program. Provider groups are mobilizing to submit comments and push back on the rebate model provisions.

What this means for independent contract pharmacies:
The Cassidy draft’s codification of contract pharmacy arrangements in federal statute is potentially protective — it could settle once and for all the legal question of whether manufacturers can unilaterally restrict contract pharmacy access. However the rebate model provisions and enhanced reporting requirements would add administrative burden. Independent pharmacies should monitor this legislation closely and submit comments before August 28.

⚠️ Action required: Cassidy is inviting stakeholder comment on the discussion draft through August 28, 2026. Submit comments to 340bforpatients@help.senate.gov. Include specific data on how manufacturer data requirements and contract pharmacy restrictions have affected your pharmacy’s ability to serve 340B patients.

⚖️ COURT DECISIONS — JUNE 2026

June 9, 2026 — Washington State’s Law Survives Its First Court Test

On June 9, US District Court denied the plaintiffs’ motion for a preliminary injunction against Washington’s S.B. 5981. This means E2SSB 5981 is effective beginning June 11. The plaintiffs have filed an appeal, but for now drug manufacturers are prohibited from interfering with drug distribution to Washington 340B covered entities and their contract pharmacies.

Washington’s law is remarkable for what it contains: the law prohibits drug manufacturers from restricting or denying 340B pricing to covered entities or their contract pharmacy partners, and bars manufacturers from conditioning drug deliveries on the submission of claims data. Violators face civil penalties of up to $5,000 per day per violation.

The $5,000 per day civil penalty provision is one of the strongest enforcement mechanisms of any state contract pharmacy access law in the country. The court’s refusal to block the law signals that the preemption arguments that succeeded in West Virginia and North Dakota did not carry sufficient weight in this jurisdiction — at least at the preliminary injunction stage.

Risk level — Washington: 🟡 Medium — law in effect and actively enforced, appeal pending

June 2026 — First Circuit Holds Oral Arguments on Maine and Rhode Island

The U.S. Court of Appeals for the First Circuit held oral arguments on the contract pharmacy access laws in Maine and Rhode Island. This is a high-stakes appellate proceeding — the First Circuit’s ruling will be binding on Maine and Rhode Island and will contribute to the growing circuit split on state 340B laws. A ruling is expected in the second half of 2026.

June 2026 — 8th Circuit Holds High-Stakes Oral Arguments on Missouri’s Law

The U.S. Court of Appeals for the 8th Circuit held oral arguments on Missouri’s 340B contract pharmacy access law. The 8th Circuit previously upheld Arkansas’ law — the question is whether that precedent extends to Missouri’s similar statute. A ruling against Missouri in the 8th Circuit would represent a dramatic reversal of that circuit’s prior 340B position.

June 2026 — HRSA Does Not Appeal Child Site Ruling

HRSA announced it will not appeal the March 3 ruling that struck down HRSA’s child site registration requirement. This makes the ruling final — covered entity hospitals now have significantly more flexibility in how they designate eligible off-site outpatient clinics for 340B purchasing. HRSA is expected to issue new guidance on how it will implement this ruling.

⚠️ Action required: If your covered entity operates off-site outpatient clinics that were previously ineligible for 340B purchasing due to the child site registration requirement, consult your 340B compliance attorney about whether those sites may now qualify.

🔬 MANUFACTURER POLICY CHANGES — JUNE 2026

June 2026 — Sanofi Becomes Ninth Manufacturer to Announce In-House Pharmacy Data Requirements

Sanofi became the 9th drugmaker to announce 340B in-house pharmacy data requirements — joining Lilly, Novo Nordisk, AstraZeneca, BMS, Pfizer, and others who have already implemented or announced similar policies.

The Sanofi requirement covers its full 340B product portfolio including high-volume vaccines, diabetes medications, and specialty biologics. Covered entities dispensing Sanofi products through in-house pharmacies must enroll in 340B ESP and begin submitting claims data within the required timeframes.

The running total: As of June 30, 2026, nine manufacturers have announced in-house pharmacy data requirements — with more expected before year end. AstraZeneca also added a drug to its policy during this period.

June 2026 — Two More Manufacturers Announce In-House Data Requirements

In addition to Sanofi, two additional manufacturers announced in-house pharmacy data requirements during June 2026. The identity of these manufacturers was not publicly confirmed in all sources as of the June 30 publication date — monitor the 340B ESP platform and your wholesaler’s manufacturer policy tracker for current information.

June 2026 — White House Deals With Lilly and Novo Nordisk on GLP-1 Pricing

The White House announced deals with Eli Lilly and Novo Nordisk to lower GLP-1 prices — affecting some of the most high-volume 340B drugs in the country. The extent to which these price deals affect 340B ceiling price calculations is unclear and HRSA had not issued guidance on this interaction as of June 30, 2026. Watch for HRSA guidance on the GLP-1 pricing deal’s 340B implications in the coming weeks.

June 2026 — Provider Law Firm Urges HHS IG Investigation Into Lilly Data Demands

A provider-focused law firm formally urged the HHS Inspector General to investigate Eli Lilly’s 340B in-house pharmacy data demands — arguing that Lilly’s requirements exceed what is permitted under federal law and constitute an unlawful restriction on 340B pricing access.

The IG investigation request adds a new enforcement dimension to the data requirement dispute. If the HHS IG agrees to investigate, it could place federal regulatory pressure on manufacturers from a direction they did not anticipate — rather than covered entities needing to sue manufacturers, the federal government itself could take action.

🏛️ CONGRESSIONAL ACTIVITY — JUNE 2026

June 12, 2026 — HRSA Issues New Rebate Model Information Collection Request

HRSA on June 12 issued a new 340B rebate pilot ICR, which officially published in the Federal Register on June 15. This ICR — a required procedural step before HRSA can collect data for a new regulatory program — signals that HRSA is actively designing the replacement rebate model pilot that will launch in 2027.

The Notice follows a Request for Information published by HRSA on February 17, 2026 seeking comments on the rebate model framework and proposed Information Collection Request published on February 26, 2026 and June 15, 2026 regarding a potential 340B Rebate Model Pilot Program.

What this ICR means: HRSA is moving methodically through the required administrative steps to relaunch the rebate pilot with a legally sound process. The June 15 ICR is another brick in that foundation. Manufacturers who want to participate in a 2027 rebate pilot are paying close attention.

June 25, 2026 — Senate HELP Committee Advances 340B Reform in Final Days of Legislative Session

The Senate HELP Committee Majority unveiled a discussion draft to reform the 340B Drug Pricing Program, and the House Energy and Commerce Health Subcommittee advanced 15 bipartisan health care bills during a committee markup.

The Cassidy discussion draft’s release in the final days of June set the stage for the July introduction of the House SECURE 340B Act — creating the first moment in the 340B program’s history where both the Senate and House had simultaneously introduced comprehensive reform proposals.

🗺️ STATE LEGISLATIVE UPDATES — JUNE 2026

June 10/11, 2026 — Washington State Law Takes Effect

Following the June 9 court victory, Washington’s S.B. 5981 took effect June 10–11, 2026. Washington is now the most aggressively protective state in the country for 340B contract pharmacy arrangements — combining access protections, mandatory reporting, and civil penalties up to $5,000 per day for manufacturer violations.

For covered entities and contract pharmacies in Washington: You are now operating under state law protection. Manufacturers cannot legally restrict your 340B contract pharmacy arrangements. Any manufacturer that continues to impose restrictions in Washington faces civil penalty exposure. Document any manufacturer restriction actions you experience and report them to the Washington State Attorney General’s office.

June 2026 — Illinois Governor Signs Contract Pharmacy Access Bill

Illinois Governor J.B. Pritzker signed the Illinois 340B contract pharmacy access bill into law in June 2026, making Illinois one of the most populous states in the country with a contract pharmacy protection law. The reporting bill was also signed. Illinois covered entities and contract pharmacies now have state law protections against manufacturer contract pharmacy restrictions.

Risk level — Illinois: 🟡 Medium — new law, manufacturer challenges expected but not yet filed as of June 30

June 30, 2026 — Kansas Contract Pharmacy Protection Law Expires

The Kansas contract pharmacy access law expired on June 30, 2026. The Kansas legislature failed to pass a renewal bill before adjournment. The Kansas House Speaker abruptly sent lawmakers home before a floor vote on a bipartisan renewal bill could take place.

What this means for Kansas covered entities: Effective July 1, 2026, Kansas has no state contract pharmacy protection law. Manufacturers that had previously limited their restrictions based on the Kansas law may now reimpose contract pharmacy restrictions. Several manufacturers — including Liquidia, Sanofi, and Sobi — announced they will still exempt Oklahoma from restrictions despite its court-blocked law, but similar voluntary exemptions for Kansas are not guaranteed.

⚠️ Urgent action required — Kansas: Contact each manufacturer whose products you dispense through contract pharmacies and confirm whether they will continue to honor prior access arrangements now that the Kansas law has expired. Engage your state pharmacy association immediately. Consider whether your OPAIS registration needs adjustment if contract pharmacy arrangements change.

June 2026 — Oklahoma Attorney General Files Appeal

The Oklahoma Attorney General filed his appeal of the federal judge’s ruling that blocked Oklahoma’s contract pharmacy access law one day before it was set to take effect. The AG’s office issued a statement criticizing the drug industry’s lawsuits targeting state 340B actions. The appeal will be heard in the 10th Circuit — the same circuit that is already considering Colorado’s law challenge.

June 2026 — State Scorecard Update

New protections enacted in June:
— Illinois: Contract pharmacy access + reporting bills signed

Protections taking effect in June:
— Washington: S.B. 5981 effective June 10/11

Protections lost in June:
— Kansas: Law expired June 30 without renewal

Laws blocked or permanently enjoined:
— West Virginia, North Dakota, Oklahoma (AG appealing)

Active appeals pending:
— Maine (1st Circuit), Rhode Island (1st Circuit), Missouri (8th Circuit), Colorado (10th Circuit), Oklahoma (10th Circuit), Hawaii, Utah, Nebraska, Vermont, Washington

📊 REGULATORY UPDATES — JUNE 2026

June 2026 — Trump Administration Reclassifies HHS Staff

The Trump administration reclassified HHS staff in ways that 340B watchers say could lead to firings at the Office of Pharmacy Affairs — the office that administers the 340B program. HRSA Administrator Engels had already been silent on 340B at the May NACHC conference. The potential for significant OPA staff changes adds another layer of uncertainty to HRSA’s capacity to manage the program’s growing complexity.

June 2026 — Trump Budget Proposes Moving 340B From HRSA to CMS

The Trump administration’s full 2026 budget request included a proposal to shift oversight of the 340B program from HRSA to the Centers for Medicare and Medicaid Services. The budget would maintain current OPA funding levels during the transition. 340B stakeholders offered mixed views on the proposed move — some arguing that CMS’s data capabilities would improve program oversight, others warning that the transition could disrupt existing compliance infrastructure.

June 2026 — 9th Circuit Revives False Claims Act Whistleblower Lawsuit Against Manufacturers

The 9th Circuit revived a whistleblower lawsuit against AbbVie, AstraZeneca, Novartis, and Sanofi alleging 340B overcharges under the False Claims Act. This ruling could significantly increase federal scrutiny of manufacturer pricing compliance — and potentially expose manufacturers to substantial financial liability if the whistleblower allegations are proven. This is a development to watch closely in the second half of 2026.

📅 KEY DATES COMING IN JULY 2026

July 1–15, 2026 — OPAIS contract pharmacy registration window — program start date October 1, 2026

July 6, 2026 — House bipartisan SECURE 340B Act introduced (H.R. 9599)

July 15, 2026 — HRSA Information Collection Request comment deadline (30-day comment period from June 15)

July 2026 — Watch for First Circuit ruling on Maine and Rhode Island contract pharmacy laws

July 2026 — Watch for 8th Circuit ruling on Missouri’s contract pharmacy law

August 24, 2026 — Deadline for manufacturers to submit plans for the 2027 340B Rebate Model Pilot Program

August 28, 2026 — Deadline for stakeholder comments on Senator Cassidy’s 340B for Patients Act

August 31, 2026 — Deadline for comments on CMS proposed rule cutting Medicare Part B 340B reimbursement to ASP minus 33.4%

⚠️ JUNE 2026 URGENT ACTION CHECKLIST

☐ Submit comments on Senator Cassidy’s 340B for Patients Act by August 28 — email 340bforpatients@help.senate.gov

☐ If you are in Kansas — confirm which manufacturer restrictions have reimposed effective July 1, contact each manufacturer directly

☐ Confirm data submission compliance for all nine manufacturers with active in-house pharmacy requirements: Lilly, Novo Nordisk, AstraZeneca, BMS, Pfizer, Sanofi, and three others announced in June

☐ If you are in Washington State — document any manufacturer restriction actions and report violations to the state AG

☐ If your covered entity operates off-site outpatient clinics previously excluded by the child site registration requirement — consult your 340B compliance attorney about expanded eligibility

☐ If you have a CVS Health contract pharmacy arrangement — continue reviewing 2020–2025 reimbursement records in light of the May lawsuits

☐ Review your OPAIS registration during the July 1–15 window if any contract pharmacy arrangements have changed due to Kansas law expiration or manufacturer policy updates

💊 HOW THIS AFFECTS YOUR 340B PATIENTS — AND HOW BLISTER CARDS HELP

June 2026 brought the biggest legislative proposal in the history of the 340B program. The Cassidy draft — whether it becomes law or not — signals that Congress is paying attention to how covered entities use 340B savings and whether patients actually benefit. The most compelling answer any covered entity or contract pharmacy can give to that question is not a financial report — it is a patient outcome story.

Blister card packaging is one of the clearest, most direct demonstrations of how 340B savings benefit patients. When your pharmacy uses 340B savings to offer medication adherence packaging to your most vulnerable patients — the patients taking 16 pills a day, the dementia patient who keeps rearranging their medications, the HIV patient on complex antiretroviral therapy — you are doing exactly what the 340B program was created to do. And you have proof: blister card packaging improves adherence from 61% to 96%.

As Congress debates what 340B is really for, the pharmacies that can point to concrete patient outcomes will be in the strongest position. Blister cards give you that story.

[Shop Blister Cards at MedicationPackagingSolutions.com →]

🔗 KEY SOURCES FOR JUNE 2026

Senate HELP Committee — Cassidy Discussion Draft — help.senate.gov | Comments: 340bforpatients@help.senate.gov

Washington State Hospital Association — Washington Law Update — wsha.org

Alston & Bird Health Care Week in Review — alston.com

Buchanan Ingersoll — Cassidy Draft Analysis — bipc.com

ML Strategies / National Law Review — Crossroads Analysis — natlawreview.com

340B Report — 340breport.com

Goodwin Law — HRSA Rebate Pilot Analysis — goodwinlaw.com

Frier Levitt — Washington Law Analysis — frierlevitt.com

HRSA Federal Register — Rebate ICR — federalregister.gov

340B ESP Data Submission Platform — 340besp.com

340B Prime Vendor Program — 340bpvp.com | 1-888-340-2787

Information in this update is provided for general educational purposes by 340bprogram.com, published by Medication Packaging Solutions LLC, Clearwater, Florida. Sources include HRSA, U.S. federal courts, Forvis Mazars, Feldesman Tucker, Quarles Law, HFMA, and other publicly available resources. This is not legal or compliance advice. For compliance-specific guidance, consult a qualified 340B compliance consultant or healthcare attorney. Published: January 31, 2026.