340B News & Regulatory Updates — January 2026

The Most Important 340B Developments of January 2026

Published by 340bprogram.com | January 31, 2026
Sources: HRSA.gov, U.S. District Court for the District of Maine, U.S. Court of Appeals for the First Circuit, HFMA, Forvis Mazars, Feldesman Tucker, Quarles Law, Cencora Manufacturer Tracker


JANUARY 2026 OVERVIEW

January 2026 was one of the most consequential months in the history of the 340B program. A federal rebate pilot program that would have fundamentally changed how 340B discounts are delivered collapsed in real time — blocked by two federal courts in the first weeks of the new year. Meanwhile new manufacturer data requirements took effect, the federal drug acquisition cost survey got underway, and covered entities across the country woke up to a 2026 that looked far more uncertain than anyone had anticipated.

Here is everything that happened, in the order it happened.


🚨 TOP STORY — THE 340B REBATE PILOT COLLAPSES AT THE STARTING LINE

January 1–12, 2026: The 340B Rebate Model Pilot Program Never Launches

Background — what the pilot was:
In August 2025, HRSA announced a voluntary 340B Rebate Model Pilot Program that would have fundamentally changed how covered entities receive their 340B discounts. Instead of paying a discounted upfront price at the point of drug purchase — which is how the program has worked since 1992 — covered entities would pay full price and then receive a rebate afterward. The pilot was limited to a defined set of drugs selected for Medicare price negotiation under the Inflation Reduction Act of 2022 and was scheduled to begin January 1, 2026.

The 10 drugs included in the pilot were: Eliquis, Enbrel, Farxiga, Imbruvica, Januvia, Fiasp, Jardiance, Stelara, Xarelto, and Entresto — all high-cost, high-volume drugs used heavily by 340B patient populations.


January 1, 2026 — The Pilot Never Takes Effect

On December 29, 2025, the U.S. District Court for the District of Maine issued a preliminary injunction blocking HHS from implementing the 340B Rebate Model Pilot Program, which was set to take effect January 1, 2026. The case — American Hospital Association v. Robert F. Kennedy, Jr. — was filed by hospital groups arguing that HRSA failed to follow required rulemaking procedures under the Administrative Procedure Act.

The result: January 1, 2026 came and went with the rebate pilot frozen. Manufacturers were still required to provide upfront 340B discounts on the affected drugs.

What this meant for covered entities: HRSA formally paused implementation of the 340B Rebate Model Pilot Program, requiring manufacturers in the meantime to continue offering up-front 340B discounts to covered entities on those drugs that were intended to be included in the rebate pilot.


January 7, 2026 — First Circuit Refuses to Lift the Block

The U.S. Court of Appeals for the First Circuit subsequently affirmed its denial for an emergency administrative stay by court order on January 7, 2026, noting that HHS failed to satisfy the burden of showing that it was likely to succeed on appeal. However, in doing so, the First Circuit also indicated its intent to review the full merits of the appeal and resolve it “without undue delay.”

What this meant: The federal government could not restart the rebate pilot even on an emergency basis. The pause was confirmed at both the district court and appellate court levels simultaneously — an unusually swift and decisive judicial rebuke of a federal program.


January 12, 2026 — HHS Signals It May Walk Away Entirely

On January 12, 2026, an attorney for the U.S. Department of Health and Human Services submitted a filing indicating the agency’s intention to dismiss the appeal and discuss a reconsideration of the rebate model. As such, the model remains paused indefinitely.

What this meant in plain English: The Trump administration signaled within two weeks of the program’s failed launch that it was reconsidering the entire rebate pilot concept. Rather than fight the court battle, HHS appeared ready to go back to the drawing board. This was a major victory for hospitals and covered entities — at least in the short term.

⚠️ What this does NOT mean: The rebate model debate is not over. Manufacturers have long pushed for a rebate-based system that gives them more visibility into 340B drug utilization. The legal and political pressure to revisit this will continue. Watch for HRSA’s Request for Information on rebate model design, which opened for public comment in February 2026.


What Covered Entities Should Do Right Now:

The rebate pilot pause means manufacturers must continue providing upfront 340B discounts on Eliquis, Enbrel, Farxiga, Imbruvica, Januvia, Fiasp, Jardiance, Stelara, Xarelto, and Entresto. However:

— Review your drug purchasing records to confirm you are receiving upfront 340B pricing on these drugs
— Contact your wholesaler account manager to confirm no rebate model billing processes were inadvertently activated
— Monitor HRSA’s website at hrsa.gov/opa for any new guidance on the rebate model’s future


⚖️ COURT DECISIONS — JANUARY 2026

The January 7 First Circuit Order — Full Recap

Case name: American Hospital Association et al. v. Robert F. Kennedy Jr. et al., No. 25-cv-600 (D. Me.)

What the court ruled: The U.S. District Court for the District of Maine issued a temporary restraining order blocking HRSA’s 340B Rebate Model Pilot Program from taking effect on January 1, 2026. Although the administration immediately appealed, both the District Court and the U.S. Court of Appeals for the First Circuit declined to stay the order while appeals proceeded.

The APA argument that won: Hospital plaintiffs successfully argued that HRSA failed to follow the Administrative Procedure Act’s notice-and-comment requirements before implementing the rebate pilot. The court found that HRSA moved too quickly, gave covered entities too little time to prepare, and did not meaningfully engage with the concerns raised during the public comment period. The court also noted that if CMS chooses to introduce the program again, it has agreed to do so in accordance with prescribed guidelines for proposed rulemaking and applications for program participants.

Risk level change: 🟢 Favorable for covered entities — in January 2026. However this is a procedural victory, not a substantive one. HRSA can relaunch the rebate pilot if it follows proper rulemaking procedures.


No New Contract Pharmacy State Court Decisions in January

No new appellate rulings on state contract pharmacy access laws were issued in January 2026. The major appellate decisions in the state law space came in later months — the 4th Circuit’s adverse rulings on Maryland and West Virginia, and the 5th Circuit proceedings on Louisiana, all developed later in 2026. January was defined entirely by the rebate pilot litigation.


🔬 MANUFACTURER POLICY CHANGES — JANUARY 2026

January 15, 2026 — Eli Lilly Expands Data Submission Requirements

The latest development came January 15, 2026, when Eli Lilly expanded its requirements for covered entities to submit claims-level data for its own pharmacies.

What Lilly now requires: Effective February 1, 2026 — announced in January — covered entities must submit claim-level data for pharmacy dispenses and medical claims for all Lilly products to the 340B ESP platform within 45 days of the dispense date. Covered entities that fail to submit complete and accurate data within this window risk losing access to 340B pricing for Lilly products.

Which states are currently exempt from Lilly’s requirements: At announcement, Lilly exempted covered entities in Colorado, Maine, Nebraska, North Dakota, Oregon, Rhode Island, South Dakota, Tennessee, Vermont, and West Virginia, as well as FQHCs in New Mexico. Check the 340B ESP platform and Lilly’s published policy for any updates to this exemption list.

⚠️ Action required: If your covered entity or contract pharmacy dispenses any Lilly product and is not in an exempt state, enroll in the 340B ESP data submission platform immediately. Failure to submit within 45 days will result in loss of 340B pricing.


January 1, 2026 — Puma Pharmaceuticals Creates New Contract Pharmacy Policy

A notice was received from Puma Pharmaceuticals for an effective date of January 1, 2026, creating a 340B contract pharmacy policy for all covered entity types.

What this means: Puma joins the growing list of manufacturers — now more than 40 — that have adopted contract pharmacy restrictions since Eli Lilly’s original July 2020 policy. Check Puma’s specific policy for details on which products are affected and what data submission or pharmacy-count limitations apply.


January 2026 — GSK and Eli Lilly Agree to Refund 340B Covered Entities for Overcharges

GSK and Eli Lilly agreed to refund 340B covered entities for overcharges — an important development for covered entities that were overbilled on affected drugs during a period of disputed pricing. If your covered entity purchases GSK or Lilly products and believes it was overcharged during 2023–2025, contact both manufacturers’ 340B pricing teams and your wholesaler to confirm whether you are owed a refund.


📊 REGULATORY & PROGRAM UPDATES — JANUARY 2026

The CMS Drug Acquisition Cost Survey Begins

As part of the 2026 Outpatient Prospective Payment System final rule, CMS finalized plans to conduct a hospital drug acquisition cost survey, collecting National Drug Code level data for outpatient drugs acquired between July 1, 2024 and June 30, 2025. The survey includes both 340B and non-340B drugs.

The survey launched in January 2026 with an original deadline of March 31, 2026 (later extended to April 7, 2026). CMS has indicated that survey results may inform outpatient drug payment policy beginning in calendar year 2027, though the agency has not committed to specific payment changes.

Why this matters: This survey is the foundational data collection that eventually led to CMS’s July 2026 proposed rule cutting Medicare Part B 340B reimbursement by nearly 40%. The survey data — showing that 340B drug acquisition costs were 33.4% below ASP — is the entire basis for that proposed cut. In January 2026 the survey was just beginning. By July 2026 its results would reshape the entire financial model of the 340B program for hospitals.

Should covered entities participate in the survey? Coverage entity analysts were split in January. Some urged participation to ensure the survey data accurately reflected real-world 340B drug costs. Others recommended caution given the survey’s potential to justify reimbursement cuts. If your hospital received a survey request and had not yet responded, consult your 340B compliance consultant or healthcare attorney before submitting.


January 2026 — 2026 OPAIS Registration Window Opens January 1–15

The first quarterly OPAIS contract pharmacy registration window of 2026 opened January 1 and closed January 15. Pharmacies and covered entities that registered during this window received an April 1, 2026 program start date.

If you missed this window: The next registration window opens April 1–15, 2026, with a program start date of July 1, 2026.

OPAIS reminder: The administrative burden and compliance risk presents an obstacle for pharmacists as they attempt to maintain access to 340B pricing under new models, especially where rebates or data submissions are involved. Make sure your OPAIS records are current and accurate. Outdated OPAIS records were the number one cause of audit findings in 2024.


🗺️ STATE LEGISLATIVE UPDATES — JANUARY 2026

No new state contract pharmacy access laws were enacted in January 2026. The state legislative session calendar means most new laws emerge in spring and fall. January was quiet on the state legislative front.

What was developing in January: The following states had active legislative efforts underway that would produce new laws or significant developments in the months ahead:

— Colorado — Contract pharmacy access law enacted in 2025 was facing AstraZeneca’s federal court challenge. Ruling expected in Q1 2026.
— Hawaii — AstraZeneca and other manufacturers had filed suit against Hawaii’s contract pharmacy access law. Federal judge would deny the bid to block the law in February 2026.
— Tennessee — AbbVie and PhRMA lawsuits against Tennessee’s contract pharmacy law were pending. Both would be dismissed in separate rulings in Q1 2026.
— Washington State — Contract pharmacy access bill advancing in the state legislature. Would be signed into law in March 2026 as the 22nd state protection law.


⚡ WHAT ALL OF THIS MEANS FOR INDEPENDENT CONTRACT PHARMACIES

January 2026 delivered an important short-term win — the rebate pilot collapse means you continue receiving upfront 340B discounts from manufacturers on the affected drugs for now. But the underlying pressure on the program continues to build from multiple directions simultaneously:

Manufacturer data requirements are expanding. Lilly’s January 15 announcement of expanded claims data requirements was not an isolated event. It was part of a systematic industry-wide move toward requiring covered entities and their contract pharmacies to submit detailed claims data as a condition of accessing 340B pricing. More than 40 manufacturers have now adopted contract pharmacy restrictions since Eli Lilly’s original July 2020 policy. Every new data requirement adds administrative burden and compliance risk to your program.

The rebate model debate is not over. The January court rulings blocked the specific pilot that HRSA designed. They did not resolve the underlying policy debate about whether a rebate model is legally permissible. HRSA issued a Request for Information on rebate model design in February 2026. The pressure to move toward a rebate-based system — favored by manufacturers and resisted by covered entities — will continue.

The CMS survey results will matter enormously. The drug acquisition cost survey that began in January 2026 became the basis for the July 2026 proposed rule cutting Medicare Part B 340B reimbursement by nearly 40%. The financial implications for hospitals and covered entities are profound. Monitor this carefully as the proposed rule’s comment period runs through August 31, 2026.


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

Regardless of how the rebate model litigation resolves, regardless of how the CMS survey results are used, and regardless of what new manufacturer data requirements emerge — the patients in your 340B program still need to take their medications correctly.

Medication non-adherence costs the US healthcare system $300 billion annually and contributes to 125,000 preventable deaths. For the complex, multi-medication 340B patients your pharmacy serves, pharmacy-grade blister card packaging improves adherence from 61% to 96% — and it costs your pharmacy almost nothing to offer.

As covered entities face growing financial and compliance pressure in 2026, the highest-ROI patient care investment available is also the simplest: better medication packaging.

[Shop Pharmacy-Grade Blister Cards at MedicationPackagingSolutions.com →]


📅 KEY DATES COMING UP IN FEBRUARY 2026

February 10, 2026 — U.S. District Court for the District of Maine expected to issue final ruling on the 340B Rebate Pilot (watch for vacatur and remand)

February 25, 2026 — HRSA extends comment deadline to April 20 for input on the 340B Rebate Model RFI

February 2026 — Eli Lilly’s expanded claims data requirements officially take effect (announced January 15)

February 2026 — Watch for First Circuit ruling on rebate pilot appeal

April 1–15, 2026 — Next OPAIS contract pharmacy registration window opens


🔗 KEY SOURCES FOR JANUARY 2026

HRSA Official 340B Rebate Model Pilot Page — hrsa.gov/opa/340b-model-pilot-program

American Hospital Association v. Kennedy — Case Documents — Available via PACER (U.S. District Court, District of Maine, Case No. 2:25-cv-00600)

Feldesman Tucker Alert — HRSA Pauses Rebate Pilot — feldesman.com

Quarles Law 340B Program Alert — quarles.com

Cencora Manufacturer Policy Tracker — cencora.com/340b-manufacturer-updates

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.

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