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
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
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
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
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
The 340B Program has continued to undergo significant upheaval in 2024 that has the potential to bring about impactful changes to how the 340B Program operates moving forward. These developments have left 340B stakeholders in a position of increasing uncertainty.
In a move long anticipated by 340B Program participants, the Department of Health and Human Services (HHS) recently published its finalized 340B Administrative Dispute Resolution (ADR) rule, establishing formal processes for resolving certain types of disputes between 340B covered entities and
Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts.
Litigation Update
Although 340B stakeholders still await the 7th Circuit and the DC
In a decision likely to send shockwaves through the 340B Program space, the United States District Court of South Carolina recently provided a favorable ruling to 340B-participating covered entities hoping to take a more expansive view of who can reasonably
After months of relative uncertainty, the Health Resources and Services Administration (HRSA) published a Notice today confirming the end to a COVID-19 pandemic-era flexibility that allowed unregistered child sites to utilize 340B Program benefits in some circumstances. However, HRSA also
