News & Analysis as of

Department of Health and Human Services (HHS)

Holland & Knight LLP

Holland & Knight Health Dose: June 10, 2025

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The U.S. Senate will likely release additional sections of the reconciliation package this week. It is unlikely the Senate Committee on Finance, which has jurisdiction over Medicaid, will hold a markup on its portion of the...more

Dinsmore & Shohl LLP

D.C. District Court Declines Manufacturers’ Unilateral Efforts to Move Forward with Proposed 340B Rebate Models

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Last month, the United States District Court for the District of Columbia (the “District Court”) evaluated Motions for Summary Judgment concerning drug manufacturers’ efforts to unilaterally pay 340B Program discounts in the...more

Morgan Lewis - As Prescribed

340B Under the Microscope: Key Trends and Takeaways for 2025

The 340B Drug Pricing Program (the Program) has long been a cornerstone for healthcare providers seeking to deliver affordable care to underserved communities. However, as the regulatory and compliance landscape evolves,...more

Cozen O'Connor

Cozen Currents: Trump the Uniter

Cozen O'Connor on

“The GOP is divided over key policy issues, such as Medicaid cuts, support for green energy, and changes to food assistance programs. But the consistent unifying force for both the party and the MAGA movement is President...more

McGuireWoods Consulting

Trump’s Health Care Budget Cuts: Part One

This is part one of a series on health care budget cuts. The Trump administration sent its budget – essentially its appropriation request to the Hill. While such a budget represents the administration’s wish list, in...more

Paul Hastings LLP

Biotech Spin-Off Transactions

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As we previously discussed (here and here), the biotech mergers and acquisitions market currently faces significant headwinds. These challenges include frozen capital markets, regulatory uncertainty at the Food and Drug...more

Alston & Bird

Health Care Week in Review | CMS Rescinds Biden-Era EMTALA Abortion Guidance; CBO Projects 16 Million Could Lose Coverage Under...

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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

Akin Gump Strauss Hauer & Feld LLP

Eliminating Waste, Fraud, and Abuse in Medicaid (Trump EO Tracker)

This memorandum directs the Secretary of Health and Human Services to take appropriate action to eliminate waste, fraud, and abuse in Medicaid, including by ensuring Medicaid payments rates are not higher than Medicare....more

McDermott+

McDermott+ Check-Up: June 6, 2025

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THIS WEEK’S DOSE - - Senate Begins Work on Reconciliation. Democrats prepared to file points of order to exclude certain provisions under the Byrd rule, while Republicans discussed key health provisions. - White House Sends...more

McDermott+

Breaking Down the New No Surprises Act FAQs Post-TMA III (June 2025 Update)

McDermott+ on

UPDATE: On May 30, 2025, the Fifth Circuit granted the TMA III plaintiffs’ petition for rehearing en banc, which was previously filed on December 16, 2024. Of note, the Fifth Circuit’s mandate has not yet been issued, so as a...more

King & Spalding

GAO Publishes Findings Regarding Prior Authorization of Behavioral Health Services

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Last week, the Government Accountability Office (GAO) published a report determining that there is a nontrivial risk that prior authorization requirements, together with internal coverage criteria, may undermine the Medicare...more

Bergeson & Campbell, P.C.

President’s FY 2026 Budget Requests Would Eliminate CSB, Reorganize CPSC

President Trump’s fiscal year (FY) 2026 budget request for the Chemical Safety and Hazard Investigation Board (CSB) states that the President’s budget proposes to eliminate funding for CSB as part of the Trump...more

Katten Muchin Rosenman LLP

HHS Rescinds 2022 EMTALA Guidance on State Law Preemption in Emergency Reproductive Healthcare

On May 29, 2025, the Department of Health and Human Services (“HHS”) rescinded its July 11, 2022 guidance (Ref. QSO-22-22-Hospitals) (the “2022 Guidance”) clarifying how the Emergency Medical Treatment and Labor Act of 1965...more

King & Spalding

Administrative, Congressional, and State Interest Signal a Potential Breakthrough Moment for Psychedelics

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The development of innovative pharmaceuticals targeting refractory mental health conditions has stagnated for decades. In recent years, however, psychedelics have garnered scientific and public attention for their potential...more

McDermott+

Filling in More Puzzle Pieces with HHS’s Newly Released Budget Documents

McDermott+ on

McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. Click here to subscribe to future blog posts. June 5, 2025 – On May 30, 2025, the US Department of Health and Human Services...more

Maynard Nexsen

In Surprise Move, DHHS Appeals District Court Decision to Strike Down Long Term Care Staffing Mandates

Maynard Nexsen on

On April 7, 2025, U.S. District Judge Matthew J. Kacsmaryk of the Northern District of Texas struck down the Biden administration’s final rule related to federally imposed minimum staffing requirements for long term care...more

WilmerHale

HHS Office of Inspector General Issues First Semiannual Report to Congress in this Administration

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On June 2, 2025, the Department of Health and Human Services Office of Inspector General (HHS-OIG) announced the release of its Spring 2025 Semiannual Report to Congress. Covering the period from October 1, 2024, to March 31,...more

Sheppard Mullin Richter & Hampton LLP

Federal District Court Upholds Authority of HHS to Pre-Approve 340B Rebate Programs; HRSA Submits Proposed 340B Rebate Guidance

A federal judge in D.C. recently ruled in favor of the U.S. Health Resources and Services Administration (“HRSA”), an administrative agency under the U.S. Department of Health and Human Services (“HHS”), by finding that drug...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - May 2025 #4

News Briefs - Judge Rules Against Administration's HHS Reorg, Reductions - California District Judge Susan Illston has granted a preliminary injunction against the Trump administration's recent reductions in force across...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2025

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more

Holland & Hart - The Benefits Dial

No Shoes, No Shirt, No Problems… But Nonenforcement Policy Doesn’t Make Mental Health Parity Compliance Optional

The Departments of Labor, Treasury, and Health and Human Services (the “Departments”) recently announced a nonenforcement policy with respect to the 2024 Mental Health Parity and Addiction Equity Act (“MHPAEA”) regulations or...more

Holland & Knight LLP

Holland & Knight Health Dose: June 3, 2025

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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

Akin Gump Strauss Hauer & Feld LLP

Five FDA Takeaways from the FY26 Budget

On May 30, 2025, the Department of Health and Human Services released additional information regarding the Trump administration’s Fiscal Year (FY) 2026 budget request. The release of these FY26 budget materials is timely as...more

Patrick Malone & Associates P.C. | DC Injury...

Better Health Care Newsletter - June 2025

Rain Man. Curious Incident of the Dog in the Night-Time. Temple Grandin. On the spectrum. Neurodivergent. Sound familiar? The likelihood that they do shows how, in a relatively short time, public awareness about autism...more

King & Spalding

Budget Reconciliation Bill Impacts Medicaid Financing, Programs, and Eligibility

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Last week, the House Energy & Commerce Committee marked up legislation that would significantly affect the Medicaid program, including changes to state Medicaid financing mechanisms, state directed payment programs that...more

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