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Loper Bright Enterprises v Raimondo Centers for Medicare & Medicaid Services (CMS)

Hogan Lovells

FDA to rescind laboratory developed test rule

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FDA decided to rescind the LDT rule after declining to appeal a district court decision vacating it. The rule reflected FDA’s latest attempt to regulate LDTs under the same framework as IVDs, which FDA considers medical...more

Troutman Pepper Locke

Federal Ruling on CMS Staffing Mandate Offers Relief for Long-Term Care Facilities

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Long-term care facilities, embattled by rising costs and potential Medicaid cuts, are seeing some relief on the horizon following a recent federal court ruling that struck down portions of the Centers for Medicare & Medicaid...more

McGuireWoods LLP

Court Strikes Down FDA Rule Regulating Laboratory-Developed Tests

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On March 31, 2025, the U.S. District Court for the Eastern District of Texas, in American Clinical Laboratory Association v. U.S. Food and Drug Administration, vacated the U.S. Food and Drug Administration’s (FDA’s) May 6,...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

Dinsmore & Shohl LLP

Stringent Federal Staffing Requirements for Skilled Nursing Facilities No Longer in Play

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On April 7, 2025, a Federal District Court in Texas vacated the controversial Centers for Medicare and Medicaid Services (“CMS”) proposal to require specific staffing requirements in skilled nursing facilities (“SNFs”).[1]...more

Morgan Lewis

Federal Court Blocks FDA’s Final Rule on LDTs: Key Considerations for Clinical Labs

Morgan Lewis on

The US District Court for the Eastern District of Texas issued a pivotal ruling in the consolidated lawsuit American Clinical Laboratory Association v. US Food and Drug Administration (FDA) challenging FDA’s final rule to end...more

Proskauer - Health Care Law Brief

Post‑Chevron Spotlight: Federal Court Nixes FDA Rule Reclassifying Laboratory Services as Medical Devices

In another rebuke to federal regulatory overreach, the U.S. District Court for the Eastern District of Texas (“District Court”) has vacated the Food and Drug Administration’s (“FDA”) 2024 final rule that sought to bring...more

Hanson Bridgett

Federal Judge Vacates Key Provisions of CMS’s Nursing Home Staffing Mandate

Hanson Bridgett on

Earlier last week, Hon. Matthew J. Kacsmaryk of the U.S. District Court for the Northern District of Texas vacated two key provisions of CMS’s 2024 nationwide staffing mandate, the requirements that skilled nursing facilities...more

Faegre Drinker Biddle & Reath LLP

Laboratory-Developed Tests (LDTs) Do Not Qualify as ‘Devices’ Under the Food, Drug and Cosmetic Act

On March 31, 2025, in the U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration’s (FDA) final rule, in which FDA attempted to assert regulatory authority over laboratory-developed...more

Foley Hoag LLP

HHS Under the Second Trump Administration

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On February 11, 2025, President Trump signed Executive Order (E.O.) 14210, Implementing The President’s “Department of Government Efficiency” Workforce Optimization Initiative, which instructed the newly formed Department of...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

Arnall Golden Gregory LLP

Insights From the 2025 American Health Law Association’s Long Term and Post-Acute Care Law and Compliance Conference

This year, health lawyers, providers, consultants, and government experts from across the country convened in Orlando, Florida, for the American Health Law Association’s Long Term and Post-Acute Care Law and Compliance...more

Whiteford

Navigating New Medicare Overpayment Rules and Practical Tips to Comply

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On November 1, 2024, the Centers for Medicare & Medicaid Services (CMS) finalized the Medicare regulations interpreting the federal 60-day overpayment refund requirement (the Overpayment Statute) for Medicare Parts A and B as...more

Wiley Rein LLP

Section 111 Bulletin: Mitigating Medicare Section 111 Reporting Risks - With Civil Money Penalties on the Line, Are You Certain...

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Under a long anticipated Centers for Medicare & Medicaid Services (CMS) final rule that took effect in October, casualty insurers face risks of incurring Civil Money Penalties (CMPs) if they fit the Section 111 definition of...more

Husch Blackwell LLP

Hospice Insights Podcast - What a Difference No Deference Makes: Courts No Longer Bow to Administrative Agencies

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The United States Supreme Court recently overruled decades-old precedent that favored an administrative agency’s interpretation of ambiguous statutes. This seismic shift in the role of the judiciary will affect every...more

Holland & Knight LLP

Election Implications for Telehealth, Health Equity, AI and Life Sciences

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In 2025, Republicans will hold the majority in both chambers of Congress, and the incoming Trump Administration will preside over the executive branch. For healthcare issues at the intersection of access and equity, this...more

Foley & Lardner LLP

Medicare Overpayments: CMS Issues Final Regulations Implementing Changes to 60-day Refund Rule

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On Friday, November 1, 2024, the Center for Medicare & Medicaid Services (CMS) issued the display copy of the final rule interpreting the 60-day Refund Rule for Medicare Parts A/B (Traditional Medicare) and C/D (Medicare...more

Ropes & Gray LLP

Hospital and Health Systems Reimbursement Check - NOVEMBER 2024

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Ropes & Gray attorneys share their analysis of administrative and court litigation, regulatory developments, key developments affecting federal program payments to hospitals and health systems, and other reimbursement-related...more

Whiteford

Preparing For 2025 Stark Enforcement Regarding Compensation and Productivity Bonuses

Whiteford on

In 2024, Stark enforcement remains a critical focus for healthcare providers and regulatory bodies, with a continued focus on excessive compensation and productivity bonuses. Compliance with Stark Law is essential to avoid...more

Foley & Lardner LLP

Loper Bright False Claims Act Developments

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In our July 15, 2024 post, we analyzed the Supreme Court’s landmark case Loper Bright Enterprises v. Raimondo and the opportunities the decision might offer False Claims Act (FCA) defendants. As a brief reminder, Loper Bright...more

Mintz - Health Care Viewpoints

Off-Cycle Nursing Facility Revalidations Are Starting: Is Your SNF Ready for the Required Disclosures?

Commencing October 2024, CMS will start off-cycle revalidations of all Skilled Nursing Facilities (SNFs). As part of the revalidation process, SNFs must disclose the additional information required under CMS’ final rule,...more

McGuireWoods LLP

Stark Law Regulations Under the Microscope in a Post-Chevron World

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Recently, in United States ex rel. Kyer v. Thomas Health Systems, the judge overseeinga whistleblower’s False Claims Act (FCA) suit against Thomas Health Systems Inc. stalled further decisions until both parties could file...more

Latham & Watkins LLP

Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry

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Recent Supreme Court decisions, such as the opinions in Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce that overruled the long-standing Chevron doctrine, will likely impact how federal agencies...more

Burr & Forman

Federal Agency Deference Eliminated, Now What?

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On June 28, 2024, the U.S. Supreme Court issued a decision that overrules the “Chevron doctrine.”  This means that federal agencies are limited in their ability to rely on their own interpretation of the laws they...more

Foley & Lardner LLP

The 340B Drug Pricing Program: Top Five Things to Know

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The 340B Drug Pricing Program continues to provide critical support for covered entities, although the program is subject to ongoing scrutiny and congressional, judicial, and industry pressures. Certain key guidance documents...more

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