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Medicare Constitutional Challenges

Holland & Knight LLP

Holland & Knight Health Dose: July 8, 2025

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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

Goodwin

Health Headlines: June 2025

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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

Mintz - Health Care Viewpoints

Appeals Court Rejects AstraZeneca’s Challenge to Medicare Drug Price Negotiation Program

A federal appellate court has handed down the first appellate-level decision addressing the merits of drug manufacturers’ challenges to the Inflation Reduction Act of 2022's (IRA) Medicare Drug Negotiation Program...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

McCarter & English, LLP

Were All Those Nurse Staffing Seminars for Naught?

The contentious Nursing Home Minimum Staffing Rule (Rule), which established minimum staffing requirements for federally funded long-term care facilities (LTC) such as skilled nursing facilities (SNFs) for Medicare and...more

Polsinelli

Federal Court Finds False Claims Act Penalty Unconstitutionally Excessive

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On February 26, 2025, the U.S. District Court for the Northern District of Texas issued a significant False Claims Act (FCA) ruling in United States of America ex rel. Cheryl Taylor v. Healthcare Associates of Texas, LLC,...more

ArentFox Schiff

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

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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

McGuireWoods LLP

Fifth Circuit Concurrence Adds Voice to FCA Constitutionality Questions

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A first appellate circuit judge has questioned the False Claim Act’s constitutionality. In the Fifth Circuit’s decision last month in United States ex rel Montcrief v. Peripheral Vascular Assocs., P.A., No. 24-50176, — F....more

Jones Day

Constitutional Challenges to Inflation Reduction Act Head to Courts of Appeals

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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

Jones Day

Federal Court Rejects False Claims Act's Draconian Penalties

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Following a jury's verdict, a federal court slashed civil penalties under the False Claims Act ("FCA") as violative of the Constitution's 8th Amendment....more

Rivkin Radler LLP

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

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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

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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

Mintz - Health Care Viewpoints

Mintz IRA Update — A Circuit Win and the End of Chevron Deference Could Shift Tides in Drug Price Negotiation Program Challenges

As detailed in our previous updates, the IRA’s Medicare Drug Price Negotiation Program (the Negotiation Program or Program), which enables the federal government to negotiate prices for some of the costliest Medicare Part D...more

Alston & Bird

False Claims Act FY 2024 Update: Increase in Overall Recoveries, Decrease in Whistleblower Awards – Constitutional Questions...

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Our False Claims Act Team highlights key FCA enforcement trends in 2024, including the continued focus on health care fraud by the Department of Justice (DOJ)....more

King & Spalding

White House Rescinds Memorandum Freezing Federal Spending

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Two days after the White House Office of Management and Budget (OMB) issued a memorandum freezing all federal grants until at least February 10, 2025, the OMB issued a memorandum reversing the spending freeze....more

Husch Blackwell LLP

Are the qui tam provisions of the False Claims Act unconstitutional?

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The qui tam provisions of the False Claims Act allow individuals to file suit on behalf of the United States and to receive a share of the resulting financial settlement or judgment. Filing a qui tam case is not just a formal...more

ArentFox Schiff

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

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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

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

Mintz - Health Care Viewpoints

Mintz IRA Update — IRA Litigation Update: Courts Begin to Address Legal Challenges to the Medicare Drug Price Negotiation Program

The IRA’s Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”), which enables the federal government to negotiate prices for some of the costliest Medicare Part D drugs, has been subject to several...more

Burr & Forman

Medicare Announced First 10 Drugs for Upcoming Price Negotiations

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In 2024, Medicare will, for the first time, have authority under the Inflation Reduction Act passed in 2022 to negotiate drug prices with pharmaceutical manufacturers. On August 29, the Centers for Medicare and Medicaid...more

BakerHostetler

The CMS List of Selected Drugs: Developing Effective Arguments for Pricing of Selected Drugs Under the Inflation Reduction Act of...

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On Aug. 29, the Centers for Medicare & Medicaid Services (“CMS”) issued the inaugural list of drugs selected for price setting under the Inflation Reduction Act of 2022 (IRA). Those selected drugs are Eliquis, Jardiance,...more

Bass, Berry & Sims PLC

False Claims Act Fundamentals: Damages

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Having previously examined the falsity, materiality, and scienter elements of the False Claims Act (FCA) in our FCA Fundamentals series, we now turn to what damages can arise from violations of the False Claims Act...more

Kohrman Jackson & Krantz LLP

Healthcare Vaccine Mandate Deadline Pushed In 24 States

Following the United States Supreme Court’s recent decision to enforce the COVID-19 vaccine mandate over healthcare workers at facilities that participate in Medicare and Medicaid, the deadline to become fully vaccinated has...more

Ervin Cohen & Jessup LLP

Supreme Court Upholds Vaccine Mandate for Medicare and Medicaid-Certified Providers and Suppliers

On the same day that the United States Supreme Court imposed a stay of enforcement on OSHA’s vaccine mandate for private employers with over 100 employees, the Court ruled that the Centers for Medicare & Medicaid Services...more

Dorsey & Whitney LLP

U.S. Supreme Court Lifts Injunction Against CMS’ Health Care Facility Vaccine Mandate: What Does This Mean for Your Health Care...

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Health care employers are not alone in feeling overwhelmed by the constantly changing legal status of the various federal vaccine mandates. On Thursday afternoon, the Supreme Court made its rulings on two preliminary...more

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