340B News & Regulatory Updates — April 2026

The Most Important 340B Developments of April 2026

Published by 340bprogram.com | April 30, 2026
Sources: ACI Monthly 340B Update April 2026, NACHC, Kodiak Solutions, 340B Report, HRSA Federal Register, NIH

APRIL 2026 OVERVIEW

April 2026 was the month of deadlines. The 340B Rebate Model RFI comment period closed April 20. The Novo Nordisk data submission requirement took effect April 1. The OPAIS registration window for a July 1 program start opened and closed. And the NIH SBIR program was officially reauthorized for five years. On the court front, April brought continued state law victories and one critical deadline warning for Kansas covered entities. For covered entities navigating the operational reality of 2026’s 340B landscape, April was defined by compliance deadlines that required real action — not just monitoring.

🚨 TOP STORY — NOVO NORDISK DATA REQUIREMENTS TAKE EFFECT APRIL 1

April 1, 2026 — Novo Nordisk Claims Data Submission Mandatory for All Covered Entities

Effective April 1, 2026, all 340B covered entity types are required to submit claim-level detail for in-house pharmacy dispenses, including hospital-owned retail and mixed-use locations, and medical claims for the Novo Nordisk product portfolio to the 340B ESP platform. Claims data must be submitted within 45 days of the dispense date. Failure to provide complete and accurate data within 45 days of dispense may result in suspension of access to 340B pricing.

Which Novo Nordisk products are affected: The requirement covers Novo Nordisk’s full 340B product portfolio. This includes high-volume diabetes medications — Ozempic, Victoza, Levemir, Tresiba, and others — that are among the most commonly dispensed 340B drugs in the country.

No state exemptions announced at launch: Unlike Lilly’s February data requirements, Novo Nordisk did not announce state-specific exemptions at the April 1 effective date. Covered entities in all states — including states with enacted contract pharmacy access laws — should assume the data submission requirement applies.

⚠️ Action required immediately:
— Confirm your covered entity is enrolled in 340B ESP (340besp.com)
— Set up automated reporting for all Novo Nordisk product dispenses
— Verify that your 340B software vendor or third-party administrator is capturing and transmitting the required data within 45 days
— Contact your wholesaler account manager to confirm Novo Nordisk 340B pricing access has not been suspended

⚖️ COURT DECISIONS — APRIL 2026

April 2026 — Hawaii Federal Judge Denies AstraZeneca’s Bid to Block State Law

A Hawaii federal judge denied AstraZeneca’s bid to block enforcement of the state’s 340B contract pharmacy access law. This followed AstraZeneca’s similar defeat in Colorado, where a federal court also denied the manufacturer’s attempt to halt enforcement of that state’s law.

Hawaii’s law remains in effect and enforceable. PhRMA and AbbVie had also filed suit in Hawaii — appeals court proceedings are ongoing but the law continues to apply in the meantime.

Risk level — Hawaii: 🟡 Medium — law in effect but litigation ongoing

April 2026 — ADR Process Continues to Favor Manufacturers

The 340B Administrative Dispute Resolution process sided with manufacturers again in April, maintaining a pattern of six consecutive manufacturer wins under the current ADR framework. Covered entities are in an unstable policy environment where rules may change with court decisions or new guidance.

April 2026 — Kansas Contract Pharmacy Law Expiration Warning

Covered entities in Kansas should assess contingency plans now given the June 30 expiration of the state’s contract pharmacy access law. The Kansas legislature failed to advance a renewal bill before adjournment. Unless a special session is called or emergency legislation is passed, Kansas covered entities will lose their state contract pharmacy protections effective July 1, 2026.

⚠️ If you are a covered entity or contract pharmacy in Kansas: Contact the Kansas Pharmacists Association and your state legislators immediately. Prepare contingency plans for operating without state-law protections after June 30. Review which manufacturers currently restrict contract pharmacy access in Kansas and assess which of your dispensing arrangements may be at risk.

🔬 MANUFACTURER POLICY CHANGES — APRIL 2026

April 2026 — Amgen and GSK Update Contract Pharmacy Policies

Amgen and GSK updated manufacturer policies, impacting contract pharmacy exemptions and specialty pharmacy network designations.

Amgen: Revised its contract pharmacy exemption list — removing its prior exemption for New Mexico providers while retaining other state exemptions. Covered entities in New Mexico that had relied on Amgen’s exemption for certain products should verify their current access status through the 340B ESP platform.

GSK: Updated its specialty pharmacy network designations — which affects how certain specialty drugs are distributed to 340B covered entities. Contact your GSK 340B account representative for specifics on products affected by the network redesignation.

April 20, 2026 — 340B Rebate Model RFI Comment Deadline

HRSA’s 340B Rebate Model Request for Information comment period closed April 20, 2026. NACHC, the American Hospital Association, and dozens of covered entity organizations submitted formal comments opposing a rebate model approach. Manufacturer groups submitted comments supporting the rebate model design. HRSA will use the comment record to design a new rebate pilot through proper APA rulemaking — watch for a proposed rule later in 2026.

What the comments focused on:
— Cash flow burden on covered entities that would have to pay full price and wait for rebates
— Technology and administrative costs of claims data submission
— Patient access concerns for low-income populations who depend on 340B savings
— Proposed alternatives to a full rebate model that preserve upfront discounts

📊 REGULATORY UPDATES — APRIL 2026

April 1–15, 2026 — OPAIS Registration Window

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

Missed this window? The next window opens July 1–15, 2026, with an October 1, 2026 program start date.

OPAIS compliance reminder: Make sure your pharmacy name, address, and covered entity contract information in OPAIS exactly matches your DEA registration and written contract documents. Mismatched records remain the number one cause of HRSA audit findings.

April 14, 2026 — NIH SBIR Program Officially Reauthorized for 5 Years

The NIH Small Business Innovation Research program was officially reauthorized for five years on April 14, 2026. This is relevant to pharmacies and covered entities pursuing federal grant funding for medication adherence innovation programs. The NIH’s National Heart, Lung and Blood Institute maintains specific SBIR funding opportunities focused on improving patient adherence — a direct fit for blister card packaging research and commercialization.

April 2026 — White House Completes Regulatory Review of HRSA’s New 340B Rebate Proposal

The White House’s Office of Management and Budget completed its initial regulatory review of HRSA’s new 340B rebate proposal. This rapid completion of regulatory review — the OMB review that took just a few days — signals that the Trump administration is actively supporting HRSA’s effort to relaunch a rebate pilot through proper rulemaking. Expect a proposed rule later in 2026.

🗺️ STATE LEGISLATIVE UPDATES — APRIL 2026

Active states to watch entering May 2026:

New York — Senate Finance Committee unanimously advanced S.1913, the “340B Prescription Drug Anti-Discrimination Act.” Full Senate floor vote pending.

Florida and Missouri — Provider-backed 340B bills remained under consideration but had not advanced to floor votes as of April 30.

Tennessee — Both manufacturer lawsuits dismissed (as detailed in March update). Tennessee’s law is now among the most litigation-tested and durable in the country.

Colorado — AstraZeneca’s appeal of the court ruling upholding Colorado’s law is pending at the 10th Circuit.

States with no protection laws and active legislative efforts: Ohio, Georgia, Arizona, and Iowa all had active 340B advocacy efforts underway, though none had introduced legislation that had advanced to a committee vote.

📅 KEY DATES COMING IN MAY 2026

May 1, 2026 — Bristol Myers Squibb claims data requirements take effect for all covered entity types

May 2026 — Watch for Colorado 10th Circuit ruling on AstraZeneca’s appeal

May 2026 — Kansas legislative session may or may not address the June 30 law expiration

June 10, 2026 — Washington State’s new contract pharmacy access law takes effect

June 30, 2026 — Kansas contract pharmacy protection law expires — contingency plans needed now

July 1–15, 2026 — Next OPAIS registration window

💊 BLISTER CARD CONNECTION

April 2026 reinforced a pattern that has defined the entire year: the 340B program’s financial and compliance landscape is becoming more complex and more uncertain simultaneously. As manufacturer data requirements multiply, court decisions create a patchwork of state-level protections, and the rebate model threat continues to evolve — the patients at the center of all of this still need to take their medications correctly every single day.

Blister card packaging does not require a compliance attorney, a 340B software platform, or a court ruling to work. It requires a foam filling template, a sealing roller, and five minutes. For the complex, multi-medication 340B patients your pharmacy serves, it may be the most practical and impactful thing you do this month.

[Shop Blister Cards at MedicationPackagingSolutions.com →]

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.