Topic
340B
257 published works
Hall, Render, Killian, Heath & Lyman, P.C. Blog
Ninth Circuit Permits 340B-Based FCA Claims to Proceed Despite Lack of Private Right of Action
By Hall Render
In a significant decision with implications for 340B enforcement and False Claims Act (“FCA”) whistleblower litigation, the United States Court of Appeals for the Ninth Circuit (the “Court”) held on…
Whistleblower Law Collaborative Blog and News
Ninth Circuit Expands Path for 340B Based False Claims Act Cases
On March 17, 2026, the U.S. Court of Appeals for the Ninth Circuit issued a landmark decision in United States ex rel. Adventist Health System of West v. AbbVie Inc.—a…
FCA Now
Ninth Circuit Permits 340B Program Enforcement Under the FCA
By Alex Hontos, Chris DeLong, Matthew Gillespie, Anna Ashley
Drug manufacturers participating in the Section 340B Drug Pricing Program now face a significant new litigation risk under the False Claims Act (“FCA”). In a recent decision, Adventist Health System…
Original Source
Ninth Circuit Opens Door to FCA Liability for Alleged 340B Overcharges
By Jaime L.M. Jones, Naomi A. Igra, Matt Bergs, Hannah Zobair
A recent decision from the U.S. Court of Appeals for the Ninth Circuit significantly reshapes the intersection of the False Claims Act (FCA) and the 340B Drug Pricing Program (340B…
To Be or Not to 340B Blog
340B Program Alert: Federal Court Ruling Vacates HRSA Notice Related to Child Site Registration Requirements
By Richard Davis, Michael French, Brenda Maloney Shafer, Jake Pallotta
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…
Triage Health Law
Back to the Drawing Board: HHS Scraps Initial 340B Rebate Pilot Program
In a joint motion filed February 5th with the U.S. District Court for the District of Maine, the U.S. Department of Health and Human Services (“HHS”) stated that it would…
Health Law Diagnosis
HRSA Requests Comments on Second Iteration of 340B Rebates
By Ivy Miller, Robinson+Cole's Health Law Group
On February 17, 2026, the Health Resources and Services Administration (HRSA) issued a Request for Information (RFI) regarding the use of rebates within the 340B Program. After an unsuccessful first…
To Be or Not to 340B Blog
340B Program Alert: Despite Recent Setbacks, HRSA Continues to Advance Potential 340B Rebate Model Pilot
By Brenda Maloney Shafer, Richard Davis, Michael French, Jake Pallotta
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…
Consumer Financial Services Law Monitor
Parties Seek Vacatur and Remand of 340B Rebate Pilot, Confirming Program Will Not Proceed on Existing Record
By Virginia Bell Flynn, Chad R. Fuller, Jessamyn Vedro, Tina Safi Felahi
In our January 14 blog, we explained that Chief Judge Lance Walker of the U.S. District Court for the District of Maine had entered a nationwide preliminary injunction in American…
Health Law Diagnosis
Government Withdraws Appeal in 340B Rebate Pilot Program Litigation, Signaling Shift
By Ivy Miller, Robinson+Cole's Health Law Group
The recent litigation concerning the government’s 340B Rebate Model Pilot Program (the Rebate Program), as further described below, took an unexpected turn as the federal government recently signaled that it…