Topic
340B
257 published works
To Be or Not to 340B Blog
340B Program Alert: HRSA Approves Manufacturer Rebate Models for Pilot Program Participation
By Brenda Maloney Shafer, Richard Davis, Michael French, Jake Pallotta
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…
Healthcare Law Blog
HRSA’s 340B Rebate Pilot Program: Industry Debates, Congressional Response, and Program Implications
By Amanda Bogle, John Herbstritt
A new chapter in the 340B Drug Pricing Program is unfolding as the Health Resources & Services Administration (“HRSA”) pursues its 340B Rebate Model Pilot Program (the “Pilot Program”)—a move…
Triage Health Law
HRSA to Test 340B Rebate Model in Pilot Program
On July 31, 2025, the U.S. Department of Health and Human Services Health Resources and Service Administration (HRSA) announced the availability of a new 340B Rebate Model Pilot Program (the…
Health Law Diagnosis
Appellate Court Gives Go-Ahead for 340B Contract Pharmacy Insulin Pricing Suit to Proceed
By Guest Contributor, Ivy Miller, Robinson+Cole's Health Law Group
This post was co-authored with Antitrust + Trade Regulation lawyer Jennifer Driscoll. On August 6, 2025, the U.S. Court of Appeals for the Second Circuit issued an opinion allowing a case…
Health Law Diagnosis
HRSA Publishes 340B Rebate Pilot Program FAQs
By Ivy Miller, Robinson+Cole's Health Law Group
As previously discussed in our prior blog post, on August 1, 2025, the Department of Health and Human Services (HHS) issued a Notice announcing a much-anticipated 340B Rebate Model Pilot…
Healthcare Law Blog
HRSA Launches and Seeks Comments on 340B Rebate Model Pilot Program
By Amanda Bogle, Todd Rosenberg
Post updated on 12/31/2025. On August 1, 2025, the Health Resources and Services Administration (“HRSA”) issued a Notice announcing the launch of the 340B Rebate Model Pilot Program (“Pilot Program”),…
To Be or Not to 340B Blog
Manufacturer Rebate Models: The Next 340B Program Battleground
By Richard Davis, Michael French, Brenda Maloney Shafer, Jake Pallotta
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…
Health Law Diagnosis
HHS Publishes 340B Guidance Proposing Rebate Pilot Program
By Guest Contributor, Robinson+Cole's Health Law Group
This post was co-authored by Paul Palma, legal intern at Robinson+Cole. Paul is not admitted to practice law. On July 31, 2025, the Department of Health and Human Services (HHS)…
Healthcare Law Blog
Federal District Court Upholds Authority of HHS to Pre-Approve 340B Rebate Programs; HRSA Submits Proposed 340B Rebate Guidance
By Amanda Bogle, Kendall Kohlmeyer, Margia Corner
A federal judge in D.C. recently ruled in favor of the U.S. Health Resources and Services Administration (“HRSA”), an administrative agency under the U.S. Department of Health and Human Services…
Hall Benefits Law Blog
Federal 340B Drug Pricing Program Failing Patients, Increasing Drug Costs
By Anne Hall
The American Benefits Council has released a new white paper calling for reforms to the federal 340B drug pricing program. According to the paper, the 340B program is failing to…