If you came here for the login, it is at the 340B OPAIS site and this post will not help you find it faster. What follows is for the person who has to keep the record behind that login accurate, because that record is read...
Two things are true at once and the gap between them is where compliance officers get into trouble. A federal court rejected HRSA’s narrow reading of who counts as a 340B patient. And HRSA still audits against the 1996 guidelines. If you are deciding today...
A pharmacy director asked us recently why a manufacturer had restricted their contract pharmacy access when nobody at the entity had done anything differently. The answer was a submission that had quietly stopped running four months earlier, when the analyst who owned it changed roles....
Most audit-readiness material tells covered entities to be ready. It does not tell them what “ready” means in evidence. Below is the other version. For each thing HRSA reviews, the record that answers it, taken from HRSA’s published audit scope and process rather than from...
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...