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
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
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
Looking Ahead: Fiscal Year 2026 Appropriations - This week, the U.S. House of Representatives and U.S. Senate return to Capitol Hill following the Memorial Day recess. The Senate is expected to begin work behind the scenes on...more
Over the past few years, Congress has attempted to pass “federal PBM reform.” Members of Congress have held numerous hearings related to PBMs and introduced numerous bills seeking to regulate PBMs (we regularly track these...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
THIS WEEK’S DOSE - - Key House Health Committees Advance Reconciliation, Bill Held Up in Budget Committee. The Energy and Commerce Committee and Ways and Means Committee passed their recommendations for reconciliation out of...more
When Congress adopted the Inflation Reduction Act (IRA) in 2022, creating the Medicare Drug Price Negotiation Program (MDPNP), the bill did not receive support from any Republican senators....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
The bipartisan legislative push could create big hurdles for drug development, with concerns mounting over limited patent protections and increased litigation risks, hears Marisa Woutersen. The US pharmaceutical industry...more
On April 15, 2025, President Trump signed an executive order titled “Lowering Drug Prices by Once Again Putting Americans First.” The order includes various provisions that are relevant to the pharmaceutical industry,...more
THIS WEEK’S DOSE - - Reconciliation Moves Forward with Senate Introduction of Concurrent Budget Resolution. This move initiates the next stage in the reconciliation process, which requires House and Senate passage of a...more
Reconciliation Watch - Reports indicate that the Senate will move as soon as Wednesday to begin advancing a unified budget plan. The Senate hopes to be able to advance the budget resolution by having the two chambers...more
CMS Finalizes New TCET Pathway. The final procedural notice, effective immediately, creates a new pathway that uses existing national coverage determination and coverage with evidence development (CED) processes to expedite...more
The Cozen Lens - While it’s becoming ever clearer Vice President Harris is likely to be the Democratic nominee following President Biden’s decision to step aside, it’s less clear what the impact will be on the presidential...more
House Ways & Means Committee Marks Up Telehealth and More. The bills considered in the markup support expanding access to telehealth as well as access to healthcare in rural areas. All six bills passed out of the committee,...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
House Energy & Commerce Health Subcommittee Holds Hearing on Cybersecurity. During the hearing, there was bipartisan concern about UnitedHealth Group’s response to the Change Healthcare cyberattack and consensus around the...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
Appropriations Update. On March 3, Congress released bill text for the CAA, 2024, which includes funding for six of the 12 appropriations bills: Agriculture-FDA, Military Construction-VA, Energy-Water, Transportation-HUD,...more