HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 220: Healthcare Regulation Under the Trump Administration with Bob Coble of Maynard Nexsen
Podcast — Drug Pricing: How Might the Trump Administration Transform FDA Enforcement Activities?
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
12 Days of Regulatory Insights: Day 3 - State AG Oversight in the Health Care Industry — Regulatory Oversight Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 216: Patient Advocacy and Healthcare Policy Change with Melissa Horn of the Arthritis Foundation
Podcast — Drug Pricing: Takeaways From the Chicago Medicaid Drug Rebate Program Summit
Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
340B Drug Pricing Program Compliance
Inflation Reduction Act’s Drug Price Negotiation Provisions – What Now? – Diagnosing Health Care Podcast
Podcast: Inflation Reduction Act’s Drug Price Negotiation Provisions – What’s Next? - Diagnosing Health Care
Podcast: Chevron Deference: Is It Time for Change? - Diagnosing Health Care
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast
Podcast: IP(DC): Drug Prices, Political Pressures & Patents
Congress continues a quiet recess. Lawmakers will be back on September 2, 2025. CMS releases final FY 2026 payment regulations. The Centers for Medicare & Medicaid Services (CMS) updated payment rates in the final fiscal year...more
The Legislation combines spending and policy priorities from 11 congressional committees and will reshape federal policy across nearly every sector of the U.S. economy. With respect to healthcare, more than 35 provisions...more
The Administration issued Executive Order (“EO”) 14293: Regulatory Relief to Promote Domestic Production of Critical Medicines on May 5, 2025...more
In follow-up to the May 12th “Delivering Most Favored Nation Prescription Drug Pricing to American Patients” Executive Order, President Trump issued letters to seventeen manufacturers (Letters), reiterating the mandate for...more
Key Takeaways - HRSA’s 340B rebate pilot shifts financial and operational burden to covered entities, requiring upfront drug purchases with delayed, uncertain rebate recovery....more
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...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
This week, the U.S. House of Representatives will be out of session, as the chamber has adjourned for the August 2025 district work period. The U.S. Senate remains in session and continues to consider nominations to lead...more
With the reconciliation package signed into law, the U.S. House of Representatives is in recess and will return on July 14, 2025. In the interim, the U.S. Senate will focus on the appropriations bills for fiscal year (FY)...more
The Department of Justice and the Department of Health and Human Services announced the reinvigoration of a False Claims Act (“FCA”) Working Group, a joint effort between the two agencies. ...more
The U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced on July 2 their formation of a False Claims Act Working Group. The announcement and the formation of the Working Group...more
On July 2, 2025, the Department of Health and Human Services (HHS) and the Department of Justice (DOJ) announced the reinvigoration of their False Claims Act (FCA) enforcement efforts through the formation of a joint FCA...more
On July 2, 2025, the Department of Justice (“DOJ”) and the Department of Health and Human Services (“HHS”) announced a joint DOJ-HHS False Claims Act Working Group (the “Working Group”) that will focus on enhanced enforcement...more
On Wednesday, July 2, 2025, the U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) announced the creation of a DOJ-HHS False Claims Act Working Group. The Working Group is a procedural...more
Now in its sixth month, the second Trump administration has made clear that the False Claims Act (FCA) will remain a central tool in its efforts to combat fraud, waste, and abuse across federal programs....more
On July 2, 2025, the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced the creation of the DOJ-HHS False Claims Act Working Group, a high-level interagency initiative aimed at...more
Welcome to the seventh issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice. Iowa Governor Kim Reynolds signed Senate File 383 into law, placing new restrictions on pharmacy benefit...more
Some commentators are expecting that further details regarding the so-called most favored nation (MFN) pricing policy will be released in the coming days, while other sources indicate that no further information beyond a...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
In a May 15, 2025, opinion, Judge Dabney Friedrich of the US District Court for the District of Columbia denied drugmakers’ motions for summary judgment against the US Department of Health and Human Services and the Health...more
THIS WEEK’S DOSE - - House Passes Reconciliation Package. The package now moves to the Senate, where substantive changes, including in healthcare, will likely be made. - HHS Secretary Kennedy, FDA Commissioner Makary...more
The budget reconciliation package is expected to be considered by the full U.S. House of Representatives as soon as May 22, 2025. The House Committee on Rules is scheduled to meet on May 21, 2025, at which time additional...more
As part of a broader resurgence in pharmaceutical pricing reform and manufacturing policies in 2025, President Donald Trump and bipartisan congressional leaders have introduced contemporaneous proposals to lower prescription...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