Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
On July 31, 2025, notice was published in the Federal Register by the Health Resources and Services Administration (“HRSA”) of a “340B Rebate Model Pilot Program” (“340B Pilot Program”). The 340B Pilot Program’s stated...more
Summary of Changes - In the fall of 2024, several pharmaceutical companies – specifically, Eli Lilly and Company, Sanofi-Aventis U.S. LLC, Bristol Myers Squibb Company, and Novartis Pharmaceuticals Corporation – reacted to...more
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more
Now approaching a year-long battle, drug manufacturers and 340B covered entities, which include hospitals and community health centers, participating in the 340B Drug Pricing Discount Program (“340B Participants”) continue to...more
In this episode of Triage, Andrew Ruskin and Victoria Hamscho provide an update on recent developments in the 340B Program and, in particular, on two recent legal challenges covered entities brought in response to drug...more
If you overheard Medicaid providers breathe audible sighs of relief on April Fool’s Day, it may be because on April 1, 2019, the Health Resources & Services Administration of the Department of Health and Human Services...more
This is the second episode in K&L Gates’ three-part series on the 340B Program with Chris Hatwig, President of Apexus, LLC. Apexus serves as HRSA’s Prime Vendor under the 340B Program, including by providing technical...more
This is the first episode in K&L Gates’ three-part series on the 340B Program with Chris Hatwig, President of Apexus, LLC. Apexus serves as HRSA’s Prime Vendor in administering the 340B Program, including by publishing...more
Over the past several months, the Health Resources and Services Administration (HRSA) has issued a number of guidance updates related to the agency's expectations for health care providers participating in the 340B drug...more
It is a time of change in the 340B Program. Manufacturers should closely monitor 340B Program developments and prepare to respond promptly and effectively to changes in legal requirements. This may make it necessary to devote...more
In a notice published on June 5, 2018, the Health Resources and Services Administration (HRSA) announced that the January 2017 340B Drug Pricing Program final rule (the “Final Rule”) will again be delayed. The Final Rule,...more
In the midst of the ongoing federal conversation surrounding the 340B Drug Pricing Program, individual states are implementing a number of regulatory efforts related to the 340B Program at an increasingly fast pace. These...more
The Health Resources and Services Administration recently surprised the 340B Drug Pricing Program community with the release of its regulations pertaining to drug manufacturer ceiling price calculations and civil monetary...more