On March 3, 2026, the U.S. District Court for the District of Columbia (“Court”) issued a seismic ruling effectively vacating several components of Health Resources and Services Administration’s (“HRSA”) 340B registration requirements for qualifying off-site hospital facilities (“Order”). The Order represents a victory for 340B participating hospitals that will permit these entities to begin utilizing … Continue Reading
A little over a month after a federal circuit court blocked the Health Resources and Services Administration’s (HRSA) scheduled implementation of its 340B Rebate Model Pilot Program largely due to procedural deficiencies, HRSA appears to be performing additional diligence in hopes of avoiding similar setbacks in the future. In an announcement on February 13, 2026, … Continue Reading
Mere days before the Health Resources and Services Administration’s (HRSA) 340B Rebate Model Pilot Program’s (“Pilot”) scheduled January 1, 2026 effective date, a federal district court granted a preliminary injunction that temporarily halts the scheduled implementation of the Pilot approved rebate models. The decision, citing significant deficiencies in HRSA’s administrative processes when developing and implementing … Continue Reading
In a move that will fundamentally change how the 340B Drug Pricing Program (“340B Program”) operates for a subset of medications, HRSA’s Office of Pharmacy Affairs (“OPA”) opted late last week to approve eight manufacturer plans for participation in the 340B Rebate Model Pilot Program (“Pilot”). These approved plans, which will take effect on January … Continue Reading
The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting various types of 340B legislation.[1] On top of navigating these state-level laws, 340B Program participants are also assessing how recently passed federal legislation may indirectly … Continue Reading
