340B News & Regulatory Updates — March 2026

The Most Important 340B Developments of March 2026

Published by 340bprogram.com | March 31, 2026
Sources: Forvis Mazars, Feldesman LLP, ACI Monthly 340B, 340B Report, Federal Register

MARCH 2026 OVERVIEW

March 2026 delivered the most significant cluster of 340B court decisions since the program’s modern legal battles began. Three major rulings dropped in quick succession — a surprise win for covered entities overturning HRSA’s child site registration requirement, a major loss as the 4th Circuit blocked West Virginia’s contract pharmacy protection law, and Washington State becoming the 22nd state to enact a contract pharmacy access law on the very same day manufacturers filed suit against it. March also brought the CMS drug acquisition cost survey deadline and the approaching Novo Nordisk data requirement effective date. It was a defining month for the program’s trajectory in 2026.

🚨 TOP STORY — FEDERAL COURT OVERTURNS HRSA’S CHILD SITE REGISTRATION REQUIREMENT

March 3, 2026 — District Court Strikes Down HRSA Child Site Rule

On March 3, 2026, a federal district court issued a ruling overturning HRSA’s child site registration requirement. Before the ruling, these off-site facilities had to appear on a hospital’s Medicare cost report and be registered and listed in the Office of Pharmacy Affairs Information System (OPAIS) before they could purchase drugs at 340B prices.

What this means in plain English: HRSA had long required covered entity hospitals to formally register off-site outpatient clinics — called child sites — in OPAIS before those sites could participate in 340B purchasing. This registration requirement was a frequent source of compliance violations and audit findings. The March 3 ruling overturned that requirement, potentially giving hospitals significantly more flexibility in how they designate eligible outpatient sites.

What covered entities should do: Do not make immediate operational changes based on this ruling without consulting a 340B compliance attorney. HRSA may appeal the decision or issue new guidance. The ruling creates important opportunities but also uncertainty about how HRSA will respond.

⚖️ COURT DECISIONS — MARCH 2026

March 25, 2026 — Washington State Enacts the 22nd Contract Pharmacy Access Law

Washington became the 22nd state to enact a contract pharmacy access law when Governor Bob Ferguson signed S.B. 5981 on March 25, 2026 — the first state to do so in 2026, and notably the first to pair contract pharmacy protections with mandatory reporting requirements for both providers and manufacturers. The law takes effect June 10, 2026.

Washington’s law is notable for two reasons. First it is the first contract pharmacy access law passed in 2026 — demonstrating that the state legislative momentum is continuing despite manufacturer court challenges. Second it is the first state to require mandatory reporting from both covered entities and manufacturers simultaneously — a significant new approach that other states may follow.

AbbVie and Novartis filed suit the same day the law was signed. Litigation is ongoing. The law remains in effect while the challenge proceeds.

March 31, 2026 — 4th Circuit Blocks West Virginia’s 340B Contract Pharmacy Law

On March 31, 2026, the U.S. Court of Appeals for the Fourth Circuit, in a 2-1 decision, upheld a preliminary injunction blocking enforcement of West Virginia’s 340B contract pharmacy law. The statute prohibited drug manufacturers from restricting delivery of 340B-priced prescription drugs to pharmacies that contract with 340B covered entities for dispensing drugs to patients. The Fourth Circuit concluded that federal law likely preempts the West Virginia statute.

This is the first major appellate loss for state contract pharmacy protection laws. The 4th Circuit’s reasoning — that federal law preempts state contract pharmacy access laws — directly conflicts with the 8th Circuit’s 2024 ruling upholding Arkansas’ law. This creates a genuine federal circuit split that makes a Supreme Court case on state 340B laws increasingly likely within the next 12–24 months.

Which states are affected by the 4th Circuit’s jurisdiction: Maryland, West Virginia, Virginia, North Carolina, and South Carolina. If your covered entity or contract pharmacy is in any of these states, the 4th Circuit ruling creates real risk that state contract pharmacy protection laws may not be enforceable long-term.

Risk level changes:
— West Virginia: 🔴 High — law currently unenforceable
— Maryland: 🔴 High — 4th Circuit ruling creates serious jeopardy (separate ruling would follow in July 2026)

March 2026 — Tennessee Wins Twice — Both AbbVie and PhRMA Lawsuits Dismissed

A federal judge dismissed both AbbVie’s and PhRMA’s separate lawsuits challenging Tennessee’s contract pharmacy law within a three-week span. The court specifically found that the state’s prohibition on manufacturers requiring claims data not mandated under federal law is consistent with federal statute.

This was a significant win for covered entities and a direct counterpoint to the 4th Circuit’s West Virginia ruling. Tennessee’s law survived two separate manufacturer challenges in a single month — and the court’s reasoning about claims data requirements is potentially important precedent for other states.

Risk level change — Tennessee: 🟢 Low — dual court victories make the law more durable

🔬 MANUFACTURER POLICY CHANGES — MARCH 2026

March 31, 2026 — Pfizer Issues New Attestation and Claims Data Requirements

Pfizer issued new attestation and claims data requirements effective March 31, 2026, including validation that the covered entity has no wholly-owned pharmacy.

Pfizer joins the growing list of manufacturers requiring claims data submission as a condition of 340B pricing access. Covered entities dispensing Pfizer products through contract pharmacies should review the full requirements on the 340B ESP platform and confirm compliance before the March 31 effective date.

March 2026 — ADR Panel Sides with Novo Nordisk Against Wisconsin Hospital

A 340B Administrative Dispute Resolution panel rejected a hospital challenge to a drugmaker’s 340B contract pharmacy restrictions, marking the sixth consecutive time an ADR panel has sided with manufacturers under the updated process. The latest ruling dismissed a petition from Wisconsin-based St. Croix Regional Medical Center against Danish drugmaker Novo Nordisk’s contract pharmacy limitations, citing a January 2023 Philadelphia federal appeals court decision that upheld similar restrictions.

What this means: The ADR process — HRSA’s formal mechanism for covered entities to challenge manufacturer overcharges or restriction policies — has now sided with manufacturers six consecutive times under the current framework. Covered entities considering ADR challenges to manufacturer contract pharmacy restrictions should consult with their 340B compliance counsel before filing, given the track record.

📊 REGULATORY UPDATES — MARCH 2026

March 31, 2026 — CMS Drug Acquisition Cost Survey Deadline

The original March 31 deadline for the CMS hospital drug acquisition cost survey passed. CMS subsequently extended the deadline to April 7, 2026. The survey data collected will inform CMS’s future outpatient drug payment policy — and as we now know from the July 2026 proposed rule, that policy change will be significant. Covered entities that submitted survey responses should retain copies of all submitted data.

🗺️ STATE LEGISLATIVE UPDATES — MARCH 2026

Washington — Enacted (as above)

Virginia — Governor Youngkin vetoed contract pharmacy protection legislation for the second consecutive year. Virginia remains without state-level protection.

Kansas — The Kansas contract pharmacy access law remained in effect in March 2026, but faced a June 30, 2026 expiration date with no renewal bill advancing in the legislature. Covered entities in Kansas should begin contingency planning now.

Florida and Missouri — State lawmakers introduced provider-backed 340B bills in both states. Neither bill had advanced to a floor vote as of March 31.

📅 KEY DATES COMING IN APRIL 2026

April 1, 2026 — Novo Nordisk claims data requirements take effect for all covered entity types

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

April 7, 2026 — Extended CMS drug acquisition cost survey deadline

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

💊 BLISTER CARD CONNECTION

The 4th Circuit’s West Virginia ruling creates real uncertainty for covered entities in that circuit. The Tennessee wins show that courts are not uniformly siding with manufacturers. The Washington law shows that state legislatures are still fighting. In the middle of all of this legal and regulatory turbulence, the most stable thing your pharmacy can offer is consistent, reliable medication packaging for your 340B patients. Blister cards do not change with court rulings. They work the same way every time.

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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.