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...
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...
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...
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...
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...
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...
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...
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...
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,...
