Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
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 Program (Pilot Program). Subsequently,...more
Structure & Timing of the Pilot Program - On August 1, 2025, the Health Resources and Services Administration (HRSA), administrator of the 340B Drug Pricing Program, announced its voluntary 340B Rebate Model Pilot Program in...more
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
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....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
Find updates on 340B litigation from December 17, 2024 – January 6, 2025 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...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
A Quiet Healthcare Week on Capitol Hill. Congress was largely in recess this week, although the Senate returned briefly to complete consideration of a long-awaited foreign aid bill. Both chambers will return to session the...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
A periodic feature by Cornerstone Research, in which our affiliated experts, senior advisors, and professionals, talk about their research and findings. We interview Professor Sayeh Nikpay of the School of Public Health,...more
The 340B Drug Pricing Program has been making headlines. Two recent developments are difficult to square with one another. First, the Health Resources and Services Administration (HRSA), the federal agency that administers...more
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...more