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340B Program Insights: Regulatory Updates and Compliance News

HRSA 340B rebate model RFI and ICR process, including comment deadlines and administrative burden estimates.

18 Mar HRSA Moves Forward on 340B Rebate Model

Posted at 11:17 AM in Uncategorized by Scott Ponaman

After a brief posting delay, HRSA’s Request for Information (RFI) on a potential new 340B rebate model is now officially open for comment. The RFI deadline has been extended to April 20, 2026. At the same time, HRSA released a separate Information Collection Request (ICR) estimating the administrative burden...

Gavel and court documents representing federal court decision on 340B program regulations.

12 Mar Federal Court Strikes Down HRSA’s 340B Child Site Registration Policy

Posted at 3:35 PM in Uncategorized by Peta Russell

A federal district court in Washington, D.C. has struck down HRSA’s policy requiring hospital outpatient clinics to appear on a Medicare cost report and be registered in OPAIS before accessing 340B pricing. In a March 3 decision, the court ruled that HRSA’s registration requirement conflicts with...

340B Program illustration with hospital, patient, medication, and financial elements.

10 Feb Update: Where Things Stand on the 340B Rebate Pilot

Posted at 11:34 AM in Uncategorized by Peta Russell

We want to share a brief update on developments since our last communication regarding the federal court’s decision to halt HRSA’s 340B rebate pilot. The pause remains in effect. Following the December 29 court order blocking the rebate pilot from taking effect, HRSA formally paused implementation on...

Hands holding assortment of pills representing 340B drug pricing program compliance.

13 Jan 340B Rebate Model Pilot: Temporary Restraining Order Issued

Posted at 12:20 PM in Uncategorized by Peta Russell

A major development has changed the near-term outlook for the 340B Rebate Model Pilot. On December 29, a federal district judge in Maine issued a temporary restraining order blocking HRSA from launching the 340B rebate pilot as planned on January 1. The order applies nationwide and...

Healthcare professional in gloves holding 340B drug medication blister packs.

19 Dec Beacon’s Final Data Validation Rules: What Will Get 340B Claims Accepted or Denied

Posted at 6:59 PM in Uncategorized by Peta Russell

Beacon has published the full Data Validations Overview, and this is the document that will determine whether rebate submissions are accepted or denied once the model goes live. It is the most detailed and definitive guidance Beacon has released to date, and several items differ from...

Beacon Rebate Model December pulse check and key updates with calendar and clock illustrating 340B

12 Dec Beacon Rebate Model: December Pulse Check and Key Updates to Know Before January 1

Posted at 6:42 PM in Uncategorized by Peta Russell

Below is your December pulse-check on all things Beacon and rebate. One more thing: Beacon quietly published its full Data Validations Overview, and it’s hefty. Watch for a separate update soon, we’ll walk you through what changed and what you may need to adjust before...

340B program compliance checklist and pharmacy management with doctor and medication

21 Nov

Posted at 9:31 AM in Uncategorized by Peta Russell

The Real Cost of the 340B Rebate Model: Why Cash Flow Planning Can’t Wait The 340B Rebate Model Pilot represents a major shift in how covered entities manage their pharmacy programs. Scheduled for January 1, 2026, certain high-cost drugs will no longer come with upfront 340B...

340B program support: healthcare professional and rebate model data analysis

14 Nov Beacon Rebate Pilot – Week 1 Update

Posted at 11:59 AM in Uncategorized by Peta Russell

HRSA’s 340B Rebate Model pilot remains on schedule for January 1, 2026, despite the ongoing federal government shutdown. Beacon Channel Management has issued updated manufacturer guidance, revised its FAQ on November 3, and opened registration for all covered entities. Key Program Updates Implementation Date: January 1, 2026...

06 Nov 340B Rebate Model: What to Know for 2026

Posted at 12:12 PM in Uncategorized by Peta Russell

The 340B Program is facing one of its biggest structural shifts in decades. Potentially starting January 1, 2026, or closely thereafter, HRSA and CMS plan to launch the 340B Rebate Model Pilot, aligning it with Medicare’s Drug Price Negotiation Program (MDPNP) under the Inflation Reduction...

Magnifying glass over 340B program data and charts illustrating audit scrutiny.

16 Oct Is Your 340B Program Audit-Ready? What Covered Entities Must Prepare for in 2025

Posted at 11:03 AM in Uncategorized by Peta Russell

The Audit Environment Is More Aggressive Than Ever HRSA and manufacturer audits of 340B programs are not slowing down in 2025, and covered entities continue to face increasing scrutiny. In some cases manufacturers have pursued their own. Whether you're a hospital, FQHC, or Ryan White clinic,...