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Constitutional Challenges Centers for Medicare & Medicaid Services (CMS)

Shipman & Goodwin LLP

Making a Speed Bump out of a Roadblock: CMS, ICE, and Several States Battle Over Medicaid Data Privacy

Shipman & Goodwin LLP on

In mid-June, the Department of Health and Human Services (HHS) ordered the Center for Medicare and Medicaid Services (CMS) to share the personal information of millions of Medicaid enrollees with the Department of Homeland...more

Davis Wright Tremaine LLP

EMTALA and Emergency Care for Pregnant Patients: Clarifications Evolve Gradually to Reconcile Conflicting Guidance Post-Dobbs

Since the U.S. Supreme Court's June 2022 decision in Dobbs v. Jackson Women's Health Organization (Dobbs), hospitals and their emergency department (ED) clinicians in some states have faced significant uncertainty about their...more

Goodwin

Health Headlines: July 2025

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Welcome to the sixth issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice....more

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

Foley Hoag LLP

Supreme Court Narrows Medicaid Beneficiaries’ Right to Sue: Key Takeaways from Medina v. Planned Parenthood South Atlantic

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The Supreme Court of the United States has issued a significant healthcare decision in Medina v. Planned Parenthood South Atlantic, a case which will likely have far-reaching implications for Medicaid beneficiaries and...more

Foley Hoag LLP

CMS Rescinds Post-Dobbs EMTALA Guidance, Raising New Questions for Emergency Departments

Foley Hoag LLP on

I. Key Takeaways - Federal enforcement under the Emergency Medical Treatment and Labor Act (EMTALA) may be changing after the Centers for Medicare & Medicaid Services (CMS) rescinded guidance issued under the Biden...more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On May 29, 2025, the Department of Health and Human Services (“HHS”) rescinded its July 11, 2022 guidance (Ref.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

Snell & Wilmer

Trump Administration Rescinds Emergency Abortion Guidance

Snell & Wilmer on

On June 3, 2025, the Trump administration announced (the Announcement) that it would no longer follow Biden-era guidance (the Guidance) that directed hospitals to provide emergency abortions to pregnant women in emergency...more

Goodwin

Third Circuit Affirms Rejection of AstraZeneca’s Challenges to IRA Drug Price Negotiation Program

Goodwin on

On May 8, 2025, the Court of Appeals for the Third Circuit affirmed the district court’s dismissal of AstraZeneca’s challenges to the Inflation Reduction Act’s Drug Price Negotiation Program and CMS’s Guidance implementing...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

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

Mintz - Health Care Viewpoints

Deregulatory Push by Trump Administration Picks Up Speed

It’s no secret that President Trump, his Cabinet, and other executive branch leaders are prioritizing deregulatory activities over more historical federal governance approaches. Indeed, one of President Trump’s earliest...more

King & Spalding

Texas Court Strikes Down Key Portions of Biden-Era Rule Imposing Minimum Nurse Staffing Requirements at Nursing Homes

King & Spalding on

On April 7, 2025, Judge Matthew Kacsmaryk of the Northern District of Texas vacated two provisions of a major 2024 CMS nurse staffing regulation requiring nursing homes to have an RN on site 24 hours a day, 7 days per week...more

Littler

DOJ Files a Statement of Interest in a Federal Lawsuit Against the NY Department of Health and Court Issues a Preliminary...

Littler on

As previously discussed, in Engesser v. McDonald, a class of Medicaid beneficiaries who receive personal care and home care services through New York’s CDPA Program (Consumers), and two independent living centers...more

ArentFox Schiff

FDA’s Attempt to Regulate Lab-Developed Tests Struck Down in Federal Court

ArentFox Schiff on

On March 31, a judge in the Eastern District of Texas vacated the US Food and Drug Administration’s (FDA) rule that sought to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and...more

Dickinson Wright

Federal Enforcement of Mental Health Parity: Key Updates and Challenges Ahead

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On January 17, 2025, the U.S. Departments of Labor, Health and Human Services, and the Treasury (“the Departments”) issued their 2024 Report to Congress on the enforcement and implementation of the Mental Health Parity and...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

Morgan Lewis

Manufacturers Challenge CMS’s Definitions of ‘QSSD’ and ‘Bona Fide Marketing'

Morgan Lewis on

Drug manufacturers remain steadfast in their efforts to challenge the constitutionality of the Inflation Reduction Act’s mandatory price negotiation provisions. Recently filed suits contend that CMS has impermissibly expanded...more

Falcon Rappaport & Berkman LLP

Disruptions to the Medicaid System, Alongside Trump Administration’s Freeze of Federal Funding to Agencies, Results in Lawsuit by...

On the evening of January 27, 2025, the Trump Administration’s Office of Management and Budget (OMB) issued a “Memorandum for Heads of Executive Departments and Agencies” titled, “Temporary Pause of Agency Grant, Loan, and...more

Holland & Knight LLP

Holland & Knight Health Dose: January 21, 2025

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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

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

Akerman LLP - Health Law Rx

Zafirov Decision Sets Stage for Appellate Showdown Over Constitutionality of FCA’s Qui Tam Provision

For the first time ever, a judge has ruled that the qui tam provision of the False Claims Act (FCA), which whistleblowers have used to recover $52 billion on behalf of the government since 1986, is unconstitutional....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

Burr & Forman on

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

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