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Constitutional Challenges Department of Health and Human Services (HHS)

Cozen O'Connor

HHS Advocates Mandated Placebo-Controlled Trials for New Vaccines: Implications for Clinical and Regulatory Practice

Cozen O'Connor on

The Department of Health and Human Services (“HHS”) recently proposed a policy that would require all new vaccines to undergo placebo-controlled clinical trials prior to FDA approval. The proposal, while controversial, is...more

Sheppard Mullin Richter & Hampton LLP

Recent Legal and Regulatory Developments Involving Gender-Affirming Care

On January 28, 2025, President Trump signed Executive Order 14187 (the “EO”), which directed the federal government to take steps to ensure that the federal government does not “sponsor, promote, assist, or support” the...more

Foley & Lardner LLP

Leaked Budget Proposal Suggests Major Restructuring of Federal Health and Safety Agencies, Including the Consumer Product Safety...

Foley & Lardner LLP on

A recently leaked and apparently genuine Office of Management and Budget (OMB) Budget “Passback” memorandum—the OMB’s official feedback mechanism for budget submissions from federal agencies—signals major changes to the...more

ArentFox Schiff

Gender-Affirming Care for Minors: Executive Order 14187 and Its Implications for Hospitals and Health Systems

ArentFox Schiff on

President Trump’s Executive Order (EO) 14187, “Protecting Children from Chemical and Surgical Mutilation,” represents a significant shift in federal policy regarding gender-affirming care (GAC) for minors....more

Brownstein Hyatt Farber Schreck

Reactions in the Wake of HHS Funding Cuts

In just over two months since President Donald Trump assumed office, the Department of Health and Human Services (HHS), now under the leadership of Secretary Robert F. Kennedy Jr., has undergone a profound shift in its...more

Jones Day

Constitutional Challenges to Inflation Reduction Act Head to Courts of Appeals

Jones Day on

No legislation has garnered more attention in the life sciences industry in recent past than the so-called Drug Price Negotiation Program of the Inflation Reduction Act (the "Program"). ...more

Polsinelli

DEI-Related Executive Orders Move Forward After Fourth Circuit Grants Stay of Preliminary Injunction; Federal Agency Actions

Polsinelli on

On March 14, 2025, the Fourth Circuit Court of Appeals issued a stay of the U.S. District Court’s preliminary injunction, which will allow the Trump administration to continue enforcing the Executive Orders (EOs) related to...more

Rivkin Radler LLP

The Status of Providing Gender-Affirming Care to Minors in NY

Rivkin Radler LLP on

In recent months, Executive Orders issued by the current Administration regarding gender-affirming care of minors have been the subject of much debate and litigation. The crux of these lawsuits is largely two Executive...more

Fennemore

Nursing Impact Litigation – A Tale of Two Matters

Fennemore on

This article highlights legal disputes central to APRNs’ ability to practice independently, the use of professional titles, insurance discrimination, and broader healthcare competition dynamics. Around the country, Advanced...more

Snell & Wilmer

Nationwide Preliminary Injunction Issued on Executive Order Limiting Gender-Affirming Care

Snell & Wilmer on

On March 4, 2025, a federal judge in Maryland issued a preliminary injunction to an executive order restricting access to gender-affirming care for individuals under the age of nineteen (the Executive Order)....more

McGuireWoods Consulting

Health Care Executive Orders And Legal Actions: Part One

This is part one of a series of executive orders related to health care. Transgender Care - Protecting Children from Chemical and Surgical Mutilation...more

Snell & Wilmer

Federal Judge Extends Block on Executive Orders Limiting Gender-Affirming Care

Snell & Wilmer on

On January 28, 2025, President Trump issued an executive order restricting access to gender affirming care for individuals under the age of nineteen (the Executive Order). Within two weeks of its issuance, two federal courts...more

Parker Poe Adams & Bernstein LLP

Georgia and 16 Other States Challenge Constitutionality of Section 504

Georgia and 16 other states recently joined a lawsuit challenging a rule finalized last year by the Biden administration that expanded the definition of Section 504 of the Rehabilitation Act, the federal law prohibiting...more

Latham & Watkins LLP

Update: Overview of Trump’s Executive Order on Pediatric Gender Dysphoria Matters

Latham & Watkins LLP on

Navigating the Trump administration executive order impacting pediatric gender dysphoria evidence, coverage, disclosures, regulation, legislation, and enforcement as well as grants to certain medical institutions, including...more

Shipman & Goodwin LLP

Two Federal Courts Issue Injunctions Temporarily Blocking Trump’s Executive Order Restricting Access to Gender Affirming Care

Shipman & Goodwin LLP on

On January 28, 2025, President Trump issued Executive Order 14187, directed at limiting gender-affirming care provided to children and teenagers under the age of nineteen, alerting that the federal government “will not fund,...more

Akin Gump Strauss Hauer & Feld LLP

Protecting Children from Chemical and Surgical Mutilation (Trump EO Tracker)

Summary - The Executive Order announces that the United States "will not fund, sponsor, promote, assist, or support the so-called ‘transition’ of a child from one sex to another and will rigorously enforce all laws that...more

Holland & Knight LLP

Holland & Knight Health Dose: January 21, 2025

Holland & Knight LLP on

Holland & Knight Health Dose 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

Groom Law Group, Chartered

Supreme Court to Decide Legality of ACA’s Preventive Services Mandate

On January 10, 2025, the Supreme Court agreed to hear an appeal in Becerra v. Braidwood Management, Inc. (“Braidwood”). The case (discussed in a prior Groom alert), on appeal from the Fifth Circuit, will determine if the...more

Mintz - Health Care Viewpoints

EnforceMintz —Could the Supreme Court’s Decision in Jarkesy Mean the End to HHS Civil Monetary Penalty Authorities as We Know...

Last June, the Supreme Court issued its decision in Securities and Exchange Commission v. Jarkesy, which holds that the Seventh Amendment entitles a defendant to a jury trial when the Securities and Exchange Commission (SEC)...more

Dorsey & Whitney LLP

The Supreme Court Update - January 13, 2025

Dorsey & Whitney LLP on

On January 10, 2025, the Supreme Court of the United States granted certiorari in three cases: Becerra v. Braidwood Management, Inc., No. 24-316: This case addresses the constitutionality of the U.S. Preventive Services...more

ArentFox Schiff

Investigations Newsletter: Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions

ArentFox Schiff on

Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions - In a brief filed earlier this week, the US federal government has urged the Eleventh Circuit Court of Appeals to uphold the...more

Genova Burns LLC

10th Birthday Wishes to the Affordable Care Act’s Employer Mandate

Genova Burns LLC on

The Patient Protection and Affordable Care Act (“ACA”) was signed into law by President Obama on March 23, 2010. ACA affected health insurance coverage, costs and preventive care. It also established the Health Insurance...more

Hall Benefits Law

Fifth Circuit Rules ACA Preventive Mandate Remains in Effect Nationwide – Except as to Plaintiffs

Hall Benefits Law on

The U.S. Court of Appeals for the Fifth Circuit has ruled in favor of Christian-owned businesses and individuals who sued over the Affordable Care Act (ACA) preventive care mandates. The appellate Court agreed with the...more

Mintz - Health Care Viewpoints

CMS 2026 IRA Price Negotiations Results Likely to Create Upstream and Downstream Effects

On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more

McGuireWoods LLP

A Failed Constitutional Challenge to the AKS Safe Harbor Provision – More to come?

McGuireWoods LLP on

This past summer, in United States v. Booker, a North Carolina district court ruled against a challenge to the constitutionality of Congress’s delegation of authority to promulgate safe harbors to the Anti-Kickback Statue...more

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