340B News & Regulatory Updates — September 2026

The Most Important 340B Developments of September 2026

Published by 340bprogram.com | September 30, 2026
Sources: HRSA Office of Pharmacy Affairs, AHA, Fierce Healthcare, ACI Monthly 340B, Health & Life Sciences News, 340B Report, McDermott Will & Emery, Mintz, Holland & Knight, Senate Finance Committee

SEPTEMBER 2026 OVERVIEW

September 2026 was the month everything converged at once. September’s updates point to one clear theme: covered entities are being asked to manage more data, from more sources, with higher operational stakes. HRSA announced the ten manufacturers approved for the January 1, 2027 rebate pilot — the largest approved participant list in the program’s history. The CMS Medicare Part D 340B data repository launched its voluntary testing phase. Congress advanced a nominee to a key HHS post who has publicly criticized the 340B program. Merck became the sixteenth manufacturer to announce in-house pharmacy data requirements. Courts continued reshaping the state contract pharmacy law landscape. And stakeholders at a major national pharmacy conference found themselves debating whether the 340B program should continue in its current form at all. September 2026 was not a month for passive monitoring. It demanded action — and January 1, 2027 is now less than 90 days away. aci340b

🚨 TOP STORY #1 — HRSA ANNOUNCES THE 10 APPROVED MANUFACTURERS FOR THE JANUARY 2027 REBATE PILOT

September 24, 2026 — HRSA Publishes Approved Rebate Pilot Manufacturer Plans

The Department of Health and Human Services’ Health Resources and Services Administration October 1 announced approval of 10 drug companies to participate in the 340B Rebate Model Pilot Program. The approved companies are AbbVie, Amgen, Astellas Pharma US, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim Pharmaceuticals, GlaxoSmithKline, Merck Sharp & Dohme, Pfizer and Teva Pharmaceuticals. aha

The scale of this pilot is larger than anything before it. HRSA has identified 10 drug manufacturers and 21 drugs that will participate in its revised 340B Rebate Model Pilot Program, which launches January 1. The list of approved participants and drugs is larger than the controversial pilot’s first attempted launch. fiercehealthcare

What this means operationally — the rebate model mechanics:
Under the pilot, rather than receive an upfront discount for a subset of drugs, hospitals will purchase a subset of drugs at the wholesale acquisition cost (WAC) and, after dispensing the drugs to 340B patients, submit claims to the manufacturers, which will issue a rebate equal to the difference between WAC and the 340B ceiling price. Participation is voluntary for manufacturers, but once HRSA approves a manufacturer’s plan, it becomes mandatory for all covered entities purchasing that manufacturer’s selected drugs. hklaw

The 21 drugs in the pilot — what covered entities are watching:
The pilot covers IRA-negotiated drugs for initial price applicability years 2026 and 2027 across all 10 approved manufacturers. Covered entities dispensing products from AbbVie, Amgen, AstraZeneca, BMS, Boehringer Ingelheim, GSK, Merck, Pfizer, Astellas, or Teva should identify which of their high-volume 340B drugs fall within the pilot’s scope and begin operational preparation immediately.

The 90-day notice clock:
Manufacturer plans must be submitted by August 24, 2026, with approvals by September 24, 2026, for a January 1, 2027, effective date. Manufacturers with approved plans must give covered entities 90 calendar days’ notice before implementation — meaning those notices are due now. Watch for formal manufacturer communications arriving at your covered entity in October. hklaw

The AHA’s response:
“To move forward with a 340B Rebate Model Pilot Program despite the overwhelming evidence that it will impose massive new administrative and financial burdens on hospitals that serve America’s most vulnerable patients,” was the response from an AHA spokesperson. Hospital groups are actively considering legal challenges. The AHA filed suit against HHS and HRSA over the rebate model — watch for developments on that litigation in October and November. fiercehealthcare

⚠️ Action required: Identify every drug on the pilot’s 21-drug list that your covered entity purchases at 340B pricing. Assess your cash flow capacity to purchase those drugs at WAC beginning January 1, 2027. Contact your third-party administrator or 340B software vendor immediately to confirm their platform will support rebate model claims submission by January 1.

🚨 TOP STORY #2 — CMS MEDICARE PART D 340B DATA REPOSITORY LAUNCHES

September 11, 2026 — CMS Releases Implementation Materials; Voluntary Launch October 1

CMS recently released new materials detailing the upcoming implementation of its new Medicare Part D 340B data repository. 340breport

CMS is set to begin accepting voluntary Medicare Part D 340B claims data from covered entities on October 1, 2026, through its new 340B data repository. aci340b

What the repository does: The CMS Medicare Part D 340B data repository is a new federal system that collects claim-level data on Medicare Part D prescriptions filled at 340B pricing. It operates separately from the 340B ESP platform used for manufacturer data submission requirements.

The confidentiality protection covered entities wanted: The agency also noted that repository data will not be shared outside CMS, including with manufacturers or Part D plans. This was a critical covered entity demand — that the data submitted to the CMS repository would not be made available to the manufacturers who have been using data requirements to impose restrictions. CMS honored that demand in its design. aci340b

Voluntary now — mandatory proposed for 2027: CMS will begin accepting voluntary Medicare Part D 340B claims data from covered entities through its new repository, with mandatory participation proposed for 2027. The October 1 launch is a testing period. CMS described the opening months as a “testing period” in which it will assess the usability and reliability of the data submitted to the repository. For providers, it said that it has designed the data repository “to facilitate submission with minimal burden” and to allow covered entities to “leverage data files they already have.” aci340bfiercehealthcare

⚠️ Action required: Review CMS’s Medicare Part D Claims Data 340B Repository resources. Begin voluntary data submission during the testing period — early participation gives you operational experience before mandatory participation potentially takes effect in 2027 and allows you to identify and resolve any data quality issues before they become compliance problems.

🏛️ CONGRESSIONAL ACTIVITY — SEPTEMBER 2026

September 15, 2026 — Senate Finance Committee Vets HHS Nominee Who Has Criticized 340B

The Senate Finance Committee today considered Ge Bai as President Donald Trump’s pick for HHS assistant secretary. Ge Bai has written research critical of the 340B program. 340breport

Senate committee recently advanced the nomination of Ge Bai, who has written research critical of the 340B program, for a key HHS post. Senate Finance Committee recently advanced President Donald Trump’s nominations for two key HHS posts. 340breport

Why this matters: The confirmation of a researcher who has publicly criticized 340B hospital practices to a senior HHS policy position signals continued executive branch pressure on the program. Covered entities should monitor any policy guidance or regulatory initiatives that emerge from the HHS Office of the Assistant Secretary following Ge Bai’s confirmation.

September 24, 2026 — House Lawmakers Co-Sponsor SECURE 340B Act

House lawmakers co-sponsored the SECURE 340B Act. Additional bipartisan House co-sponsors joining the bill introduced July 6 signals growing congressional momentum for comprehensive 340B reform. The SECURE 340B Act would pause manufacturer rebates, establish a new patient definition, and create new contract pharmacy oversight rules. 340breport

The three-bill landscape heading into October:

1. Cassidy Discussion Draft (Senate HELP) — Comment deadline August 28 has passed. Awaiting next steps.
2. SECURE 340B Act (House H.R. 9599) — Growing co-sponsorship. Committee consideration pending.
3. SUSTAIN 340B Act (Senate Bipartisan Working Group) — Would sunset HRSA’s rebate pilot. Competing directly with HRSA’s regulatory action.

The collision course: Track 1 — HRSA’s Rebate Model Pilot: a live regulatory action with binding near-term deadlines that will proceed unless a court intervenes again or Congress acts first. The executive branch and the legislative branch are now pulling in opposite directions simultaneously on the rebate model. mintz

September 22–25, 2026 — NASP inSPire2026 Conference — The Big Debate

A session on 340B program developments included a structured debate on whether the program should continue in its current form at NASP’s inSPire2026 conference, held September 22-25 in National Harbor, Maryland. ajmc

Opposing sides of the 340B debate converge on data clearinghouse, patient definition. Both manufacturers and covered entities at the conference found areas of common ground — specifically around the concept of a neutral, government-operated data clearinghouse as an alternative to both the rebate model and manufacturer-controlled data submission requirements. This convergence is potentially significant. If both sides support a clearinghouse approach, Congress could use it as the basis for a legislative compromise. ajmc

⚖️ COURT DECISIONS — SEPTEMBER 2026

September 1–7 — Illinois State Law Faces Five Simultaneous Manufacturer Lawsuits

In five cases brought by drug manufacturers and a trade association for drug manufacturers challenging an Illinois state law governing contract pharmacy arrangements, the defendant filed a combined response in opposition to the plaintiffs’ motions for preliminary injunction. healthlifesciencesnews

Illinois — which enacted its contract pharmacy access law in June 2026 — is now defending against five simultaneous legal challenges. Illinois filed a combined opposition to all five preliminary injunction motions. No ruling had been issued as of September 30.

Risk level — Illinois: 🟡 Medium — law in effect, preliminary injunction decision pending

September 8–14 — New Mexico Wins — Court Denies Manufacturer Preliminary Injunction

In a combined case brought by drug manufacturers challenging a New Mexico state law governing contract pharmacy arrangements, the court granted American Hospital Association’s, 340B Health’s, and the American Society of Health-System Pharmacists’ motions for leave to file amicus curia briefs and denied the plaintiffs’ motion for a preliminary injunction. healthlifesciencesnews

New Mexico’s contract pharmacy access law survives its first significant court challenge. The court’s denial of the preliminary injunction means the law remains in effect while the case proceeds to the merits. The AHA and 340B Health’s successful amicus interventions demonstrate the broad industry coalition supporting state contract pharmacy protection laws.

Risk level — New Mexico: 🟢 Favorable — preliminary injunction denied, law in effect

September 8–14 — Arkansas vs. Manufacturers — Removal to Federal Court

The parties involved in an action brought by the State of Arkansas against a group of drug manufacturers alleging that the manufacturers’ restrictive 340B policies violate state law filed a joint motion to remove the case to federal court. healthlifesciencesnews

Arkansas Attorney General Tim Griffin’s landmark lawsuit against thirteen drug manufacturers — filed in August 2026 — has been moved to federal court by joint motion. This is a significant procedural development. Federal court provides manufacturers with a more favorable venue for preemption arguments. Arkansas will now need to defend its state law enforcement action in a federal forum.

September 15–21 — Missouri Survives Manufacturer Rehearing Request

In a case brought by a drug manufacturer challenging a Missouri state law governing contract pharmacy arrangements, the court denied the petitions for a panel rehearing and rehearing en banc. healthlifesciencesnews

The Missouri appellate court denied manufacturers’ request for a full court rehearing of the ruling upholding Missouri’s contract pharmacy access law. This makes the favorable ruling more durable and signals the Missouri court’s confidence in its original decision.

Risk level — Missouri: 🟢 Strong — rehearing denied, 8th Circuit ruling still pending

September 15–21 — Mississippi Faces New Manufacturer Appeal

In a case brought by a drug manufacturer challenging a Mississippi state law governing contract pharmacy arrangements, the manufacturer filed an appeal. healthlifesciencesnews

Despite Mississippi’s three prior court victories, a manufacturer has filed yet another appeal of the state’s contract pharmacy protection law. Mississippi’s law continues to be one of the most repeatedly challenged — and repeatedly upheld — in the country.

September 15–21 — Rebate Pilot Litigation — First Circuit Rules on Manufacturer Intervention

In two appealed cases challenging the 340B Rebate Model Pilot Program, the First Circuit vacated the district court’s order denying intervention by a group of manufacturers and dismissed their appeal. healthlifesciencesnews

The First Circuit — the same court that blocked HRSA’s 2025 rebate pilot — issued a procedural ruling allowing manufacturers to intervene in the rebate pilot litigation. This sets up potential new legal challenges to the January 2027 pilot from the manufacturer side as well as the hospital side.

September 22–28 — Covered Entity Sues Manufacturer for Wrongful Denial of 340B Pricing

In a case by a covered entity against a drug manufacturer alleging that the covered entity is being wrongly denied access to 340B pricing, the drug manufacturer filed a motion to dismiss and an amicus brief was filed in support of the drug manufacturer’s motion to dismiss. healthlifesciencesnews

A covered entity directly suing a manufacturer for wrongful denial of 340B pricing access is one of the most direct legal confrontations of the year. If the covered entity prevails on the merits, it could establish precedent making it easier for other covered entities to challenge manufacturer pricing denials through direct litigation.

🔬 MANUFACTURER POLICY CHANGES — SEPTEMBER 2026

September 24, 2026 — Merck Becomes 16th Manufacturer to Announce In-House Pharmacy Data Requirements

Merck said Wednesday it will soon require 340B hospitals and health centers to submit in-house pharmacy claims data in order to access 340B pricing. 340breport

Merck joins fifteen prior manufacturers who have announced similar in-house pharmacy claims data requirements. The pace of manufacturer data requirement announcements has accelerated dramatically in 2026 — from a handful of manufacturers at the start of the year to sixteen by September’s end.

The running scorecard as of September 30, 2026:
Manufacturers with active in-house pharmacy data requirements include Lilly (February), Novo Nordisk (April), AstraZeneca (May), BMS (May), Pfizer (March), Sanofi (June), and now Merck (announced September, effective date TBD) — plus nine additional manufacturers. Every major pharmaceutical company has now either implemented or announced in-house pharmacy data requirements.

⚠️ Action required — Merck: Confirm your covered entity is enrolled in the 340B ESP platform. Identify all Merck products in your 340B formulary including high-volume diabetes medications. Merck’s effective date was not confirmed as of September 30 — monitor Merck’s 340B policy communications and 340besp.com for the specific implementation date and compliance requirements.

📊 REGULATORY UPDATES — SEPTEMBER 2026

September 8, 2026 — HRSA OPAIS Update Published

OPA Program Update — September 2026: 340B Program OPAIS Update published September 8, 2026. hrsa

HRSA’s September OPAIS updates are set to take effect on October 1, 2026. HRSA’s 340B OPAIS Online Help and Revision History provides current registration guidance and a running record of recent system and documentation updates. aci340b

⚠️ Action required: Review the September 8 OPAIS update at hrsa.gov/opa/updates before the October 1–15 registration window opens. Any OPAIS system changes affecting registration procedures need to be understood before you submit contract pharmacy registration applications.

September 11, 2026 — HHS Expected to Move 340B Oversight From HRSA to CMS by End of September

HHS leadership expected to move 340B oversight from HRSA to CMS by end of September. As of September 30, the transfer had not been formally announced. However the Trump administration’s budget proposal and internal HHS reorganization efforts continued to signal serious intent to move 340B administration from HRSA’s Office of Pharmacy Affairs to CMS. ajmc

What a HRSA-to-CMS transfer would mean: CMS has far greater data infrastructure, claims processing capability, and enforcement authority than HRSA. A transfer would likely mean more rigorous data-driven oversight, tighter audit processes, and potentially faster regulatory action on rebate model implementation. Covered entities and manufacturers alike are watching this development closely.

🗺️ STATE LEGISLATIVE UPDATES — SEPTEMBER 2026

September 2026 — State Scorecard

Actively protected — law in effect:
Arkansas (AG enforcement lawsuit active), Louisiana, Mississippi (new manufacturer appeal filed), Minnesota, Tennessee, Missouri (rehearing denied — strong), Washington, Illinois (preliminary injunction decision pending), Colorado, Hawaii, Idaho, South Dakota, Rhode Island, Maine, Vermont, Nebraska, Oregon, New Mexico (preliminary injunction denied — strong)

Currently blocked or expired:
West Virginia (4th Circuit blocked), North Dakota (permanently enjoined), Oklahoma (AG appealing), Maryland (4th Circuit vacated), Kansas (expired June 30)

No law enacted:
New York (advancing), California, Texas, Georgia, Ohio, Pennsylvania, Indiana, Virginia (vetoed twice)

📅 KEY DATES IN OCTOBER 2026

October 1, 2026 — CMS Medicare Part D 340B data repository opens for voluntary submissions

October 1, 2026 — HRSA OPAIS system updates take effect

October 1–15, 2026 — OPAIS contract pharmacy registration window — program start date January 1, 2027. This is the last registration window before the rebate pilot launches.

October 2026 — CMS expected to issue final rule on Medicare Part B 340B reimbursement (ASP minus 33.4% proposed rate)

October 2026 — Watch for 8th Circuit ruling on Missouri contract pharmacy law

October 2026 — Watch for AHA lawsuit against HRSA over rebate pilot — potential preliminary injunction filing

November/December 2026 — Manufacturer 90-day notice letters to covered entities for January 1, 2027 rebate pilot implementation

January 1, 2027 — 340B Rebate Model Pilot Program effective date for 10 approved manufacturers and 21 drugs

⚠️ SEPTEMBER 2026 URGENT ACTION CHECKLIST

☐ Identify the 21 pilot drugs — Determine which of the 10 approved manufacturers’ IRA-negotiated drugs your covered entity purchases at 340B pricing and will be subject to the rebate model beginning January 1, 2027

☐ Assess WAC cash flow capacity — Calculate how much capital your covered entity will need to purchase pilot drugs at WAC and how long you will wait for rebates to be processed and paid

☐ Contact your TPA or 340B software vendor — Confirm their platform supports rebate model claims submission and will be ready by January 1, 2027

☐ Register during October 1–15 OPAIS window — If any contract pharmacy arrangements have changed, this is the last window before January 1, 2027

☐ Begin voluntary CMS repository participation — Use the October testing period to identify and resolve any data quality issues

☐ Review Merck’s data requirement timeline — Confirm effective date and enroll in 340B ESP for Merck product submissions

☐ Monitor the AHA lawsuit against HRSA — A preliminary injunction could pause the January 1, 2027 pilot effective date. Watch for court filings in October

☐ Confirm Illinois preliminary injunction status — If your covered entity is in Illinois, monitor the court’s ruling on five simultaneous manufacturer challenges

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

September 2026 confirmed that the financial and administrative pressure on covered entities will reach a new peak on January 1, 2027 when the rebate pilot launches simultaneously with the CMS reimbursement cut’s potential finalization. The ten manufacturers approved for the pilot represent some of the highest-volume 340B drugs in the country — and covered entities will now need to front the full WAC cost of those drugs before receiving rebates.

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🔗 KEY SOURCES FOR SEPTEMBER 2026

HRSA Official Program Updates — hrsa.gov/opa/updates

AHA — HRSA Rebate Pilot Announcement and Statement — aha.org

Fierce Healthcare — HRSA Names 10 Drugmakers for Rebate Pilot — fiercehealthcare.com

ACI Monthly 340B — September 2026 — aci340b.com

Health & Life Sciences News — This Week in 340B (September 1–28) — healthlifesciencesnews.com

340B Report — Regulatory and Federal Archives — 340breport.com

Mintz — 340B Rebates 2.0 Analysis — mintz.com

Holland & Knight — HRSA Rebate Pilot Implications — hklaw.com

HRSA Federal Register — Rebate Model Pilot Notice — federalregister.gov

CMS Medicare Part D 340B Repository — cms.gov

340B ESP Data Submission Platform — 340besp.com

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

Published: September 30, 2026 | [← August 2026] | [October 2026 →] | [Back to 340B News & Updates →]

Information in this update is provided for general educational purposes by 340bprogram.com, published by Medication Packaging Solutions LLC, 2519 N McMullen Booth Road, Clearwater, FL 33761. Sources include HRSA, CMS, AHA, the 340B Report, ACI Monthly, Health & Life Sciences News, Fierce Healthcare, and multiple healthcare law firms. This is not legal or compliance advice. For compliance-specific guidance, consult a qualified 340B compliance consultant or healthcare attorney.