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
The One Big Beautiful Bill Act takes a big step in the rare disease space by expanding the contours of the orphan drug exclusion, a once narrow exception that permitted manufacturers of rare disease drugs and biologics to be...more
The One Big Beautiful Bill Act ("OBBB") expands exemptions for orphan drugs from mandatory Medicare price negotiations and modifies their eligibility timeline....more
The proposed recast of European pharmaceutical law includes novel requirements to combat medicines shortages. Medicines shortages are a hot topic in the EU. Several stricter obligations for marketing authorization holders as...more
The Inflation Reduction Act (IRA) made changes to the way drugs are covered and reimbursed in Medicare. It has been anticipated that this could result in more restrictive formularies in drug plans or higher co-pays for...more
As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more
State laws seeking to regulate pharmacy benefit managers (PBMs) have increased significantly over the past few years. As it stands, all 50 states have laws that regulate PBMs in some way, but all are unique. However, most of...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
On June 12, 2025, Vermont Governor Phil Scott signed into law two major healthcare reform bills — H.266 and S.126 — marking a coordinated legislative effort to curb healthcare spending and enhance regulatory oversight in the...more
News Briefs - Healthcare Workforce Bounces Back, But Recovery Uneven -The U.S. healthcare workforce has bounced back from the massive job losses of early 2020, with employment now matching pre-pandemic projections, according...more
The U.S. House of Representatives Committee on Energy and Commerce's Subcommittee on Health held a recent hearing titled "Made in America: Strengthening Domestic Manufacturing and the Health Care Supply Chain." The hearing...more
Takeaways- • Republicans in the U.S. House of Representatives attempt to deliver on President Trump’s campaign promises in the One Big Beautiful Bill Act (BBB or the Act), which passed the House by a razor-thin margin of...more
Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: • Connecticut Law Aims to Weed Out Illegal Sales of...more
[embedded content] Host, Bridgette Keller is joined by Associate, David Gilboa to break down the highlights from our Spring 2025 PBM Policy and Legislative Update. In just five minutes, we cover the most impactful federal and...more
On April 16, 2025, Arkansas enacted Act 624 (the Act), an unprecedented law prohibiting pharmacy benefit managers (PBMs) from owning or operating pharmacies in the state. As we discussed in our May 2025 blog post, the law’s...more
As expected, the lawsuits have commenced following the enactment of the Arkansas legislation prohibiting pharmacy benefit managers (PBM’s) from owning or operating actual pharmacies within the state. Michigan has filed its...more
Indiana recently enacted significant new legislation that will impact how pharmacy benefit management services are provided in Indiana. Senate Bill 140 (SB 140), signed into law during the 2025 legislative session, imposes...more
We previously reported on an uptick in the passage of state drug price transparency legislation. What follows is an update to that report. As of April 2025, approximately 23 states had passed drug price transparency laws....more
Prescription Drug Affordability Boards (PDABs) are becoming a larger part of the state drug price regulatory landscape. The boards are regulatory bodies that review the affordability and cost of specific prescription drugs. ...more
In a first-of-its-kind move, Arkansas Governor Sarah Huckabee Sanders has enacted legislation prohibiting pharmacy benefit managers ("PBMs") from owning or operating pharmacies within the state. The law—Act 624—takes effect...more
The Maryland General Assembly’s 2025 legislative session concluded with a few impactful health care bills. The two bills below, signed into law by Gov. Wes Moore on Tuesday, represent significant steps in improving 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
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
On May 12, 2025, President Donald Trump signed the executive order (EO) “Delivering Most-Favored-Nation Prescription Drug Pricing To American Patients.” The EO sets forth policy positions that attempt to further rein in drug...more
Reconciliation Text Is Here - Late Sunday night, May 11, 2025, the House Committee on Energy and Commerce released the much-anticipated budget reconciliation bill text ahead of its scheduled markup on May 13, 2025. ...more
On April 16, 2025, Arkansas Governor Sarah Huckabee Sanders signed into law House Bill 1150, now Act 624 (the Act), making Arkansas the first state in the nation to prohibit pharmacy benefit managers (PBMs) from acquiring or...more