340B News & Regulatory Updates — February 2026

The Most Important 340B Developments of February 2026

Published by 340bprogram.com | February 28, 2026
Sources: HRSA Federal Register, U.S. District Court District of Maine, ASHP, NACHC, Quarles Law, Forvis Mazars

FEBRUARY 2026 OVERVIEW

February 2026 was defined by two major developments happening in rapid succession: the formal legal death of the 2025 rebate pilot on February 10, followed just three days later by HRSA immediately relaunching the rebate concept through a new Request for Information. February confirmed what January suggested — the rebate model fight is far from over, and HRSA intends to try again with a more legally defensible process. Meanwhile Eli Lilly’s expanded data submission requirements officially took effect February 1, adding real compliance burden to covered entities across the country.

🚨 TOP STORY — HRSA OFFICIALLY KILLS THE 2025 REBATE PILOT — THEN IMMEDIATELY STARTS OVER

February 6, 2026 — HHS Officially Drops the 340B Rebate Pilot

In a court filing in the lawsuit regarding the 340B Rebate Pilot Program, the U.S. Department of Health and Human Services stated that it will drop the current version of the rebate pilot and potentially restart a fresh rulemaking.

This was the formal confirmation of what HHS had signaled in January. After two federal court defeats, the administration abandoned its appeal and agreed to start the rebate model design process from scratch — this time following the proper Administrative Procedure Act notice-and-comment requirements that the courts said were missing from the 2025 pilot.

What this means for covered entities: Manufacturers who were approved for the 2025 rebate pilot — including the manufacturers of Eliquis, Enbrel, Farxiga, Imbruvica, Januvia, Fiasp, Jardiance, Stelara, Xarelto, and Entresto — must continue to provide upfront 340B discounts on those drugs. The rebate model for those drugs is dead for 2026.

February 10, 2026 — District Court Formally Vacates the Pilot

On February 10, 2026, the U.S. District Court for the District of Maine vacated and remanded to HHS the 340B Rebate Model Pilot Program Application Notice, effectively overturning HRSA’s Federal Register notice and manufacturer approvals due to the failure to follow requirements of the Administrative Procedure Act. As a result of the ruling, manufacturers must continue providing 340B pricing through upfront discounts.

This ruling did more than pause the pilot. It formally wiped it off the books — requiring HHS to start the entire rulemaking process from the beginning if it wants to implement a rebate model.

February 13, 2026 — HRSA Launches New Request for Information on Rebates

On February 13, 2026, HRSA released a Request for Information seeking stakeholder feedback on the potential impact of rebate models in the 340B Program space. The RFI comes just two days after the White House’s Office of Management and Budget completed its regulatory review of HRSA’s new 340B rebate proposal — which also occurred over the span of just a few days.

This was a remarkable turnaround — HRSA launched its new stakeholder outreach process just three days after the court formally killed the old one. HRSA is inviting stakeholder commentary regarding several rebate-related issues, including medication access concerns, anticipated cash-flow impacts, proposed alternatives and scope-limiting measures to inform the rebate pilot design, among others. Many requests expressly seek submission of detailed data to demonstrate expected impacts and operational costs, signaling HRSA’s intent to conduct a more detailed and granular review of its proposed model this time around.

The RFI was formally published in the Federal Register on February 17, 2026.

February 25, 2026 — HRSA Extends the Comment Deadline to April 20

In February 2026, HRSA extended the original 30-day comment period for the RFI and the comment deadline was extended to April 20, 2026. HRSA also suggested an expanded number of drugs to be included in any future rebate pilot.

NACHC announced it will submit comments on the detrimental impact of a rebate program to Community Health Centers and urged covered entity advocates to submit coordinated, data-driven responses.

⚠️ Action required: If your covered entity has not yet submitted comments on the 340B Rebate Model RFI, you have until April 20, 2026. Comments should address cash-flow impact, patient access concerns, operational costs of claims data submission, and alternatives to a rebate model. Submit via the Federal Register docket identified in the February 17, 2026 notice.

🔬 MANUFACTURER POLICY CHANGES — FEBRUARY 2026

February 1, 2026 — Eli Lilly Data Requirements Officially Take Effect

Effective February 1, 2026, all covered entity types are required to provide claims-level data for pharmacy dispenses and medical claims for all of Lilly’s portfolio of products to the 340B ESP platform within 45 days of product dispense.

Covered entities that fail to provide timely, complete, and accurate data for all products purchased at 340B ceiling prices face suspension of 340B pricing access for Lilly products until all outstanding required data has been fully submitted.

Exempt states as of February 1: Colorado, Maine, Nebraska, North Dakota, Oregon, Rhode Island, South Dakota, Tennessee, Vermont, and West Virginia. FQHCs and FQHC look-alikes in New Mexico are also exempt.

If your covered entity dispenses Lilly products and is not in an exempt state: You must be actively submitting claims data to the 340B ESP platform (340besp.com) for every Lilly dispense within 45 days. If you have not yet enrolled in 340B ESP, do so immediately.

February 2026 — Multiple Manufacturers Add New Mexico FQHC Exemptions

Several manufacturers, including AbbVie, Amgen, Biogen, GSK, Organon, Sanofi, and Sobi, added New Mexico to their lists of state-specific exemptions that apply exclusively to federally qualified health centers and FQHC look-alike organizations. The exemptions generally allow eligible FQHCs in New Mexico to utilize multiple or unlimited in-state contract pharmacy arrangements and in some instances waive claims data submission or proximity requirements.

This wave of New Mexico exemptions was a response to ongoing advocacy by New Mexico covered entities and their state-level legislative efforts. If your covered entity is an FQHC or FQHC look-alike in New Mexico, contact each manufacturer’s 340B pricing team to confirm your exemption status for specific products.

⚖️ COURT DECISIONS — FEBRUARY 2026

February 10 — The Maine District Court Vacatur

As detailed above, the February 10 vacatur of the rebate pilot by the District of Maine was the most significant court ruling of the month. No new state contract pharmacy law rulings were issued in February — the major state law appellate decisions came in March and April.

📊 REGULATORY UPDATES — FEBRUARY 2026

CMS Drug Acquisition Cost Survey Continues

The hospital drug acquisition cost survey launched in January continued through February, with CMS collecting NDC-level drug acquisition data from hospitals for outpatient drugs acquired between July 1, 2024 and June 30, 2025. The original survey deadline was March 31, 2026 (later extended to April 7). Covered entities that received survey requests and had not yet responded should consult their compliance teams immediately.

📅 KEY DATES COMING IN MARCH 2026

March 3, 2026 — Watch for federal district court ruling on HRSA’s child site registration requirement

March 25, 2026 — Washington State expected to sign contract pharmacy access law

March 31, 2026 — CMS drug acquisition cost survey deadline (original — later extended)

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

April 1, 2026 — Novo Nordisk claims data requirements take effect

April 20, 2026 — 340B Rebate Model RFI comment deadline

💊 BLISTER CARD CONNECTION

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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.