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Administrative Procedure Act Healthcare

Jones Day

Judge Blocks FDA Regulation of Laboratory-Developed Tests

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On March 31, 2025, a judge in the Eastern District of Texas struck down a 2024 Final Rule (the "Final Rule") by the Food and Drug Administration ("FDA") that exerted jurisdiction over the regulation of laboratory-developed...more

Stevens & Lee

Presidential Memorandum Calls for Scrutiny and Fast-Track Repeal of Regulations

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President Trump issued a Memorandum on April 6 directing the heads of all executive departments and agencies to identify on a fast-track basis (60 days) certain categories of “unlawful and potentially unlawful” regulations...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

Littler

New York Court Issues Decision and Order Declaring the DOH’s August 2024 Reimbursement Rate Adjustment for Fiscal Intermediaries...

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On March 20, 2025, a New York Supreme Court Justice in Albany County issued a decision and order declaring the New York State Department of Health (NY DOH)’s August 2024 implementation of an administrative rate reimbursement...more

McDermott Will & Emery

NIH’s Mandatory 15% Indirect Rate – Next Steps Following Preliminary Injunction

On March 5, 2025, a US district court in Massachusetts issued a preliminary injunction blocking the National Institutes of Health (NIH) from implementing a February 7, 2025, “Supplemental Guidance” notice that would establish...more

Holland & Knight LLP

Holland & Knight Health Dose: March 4, 2025

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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

Bradley Arant Boult Cummings LLP

Backwards Down the Number Line: Assessing the State of Alabama’s Medical Cannabis Program Four Years After Its Enactment

Ronald Reagan famously asked voters, on the eve of the 1980 presidential election, to ask themselves whether they were better off than they were four years ago. It was a powerful question that asked Americans to take stock of...more

Arnall Golden Gregory LLP

Lawsuit Challenges Hospice Special Focus Program Rule and List

A group of four state associations and a hospice provider have filed a federal lawsuit in Texas challenging the Special Focus Program (“SFP”) Final Rule and the resulting list of hospices identified as poor performers. The...more

Seyfarth Shaw LLP

The Week in Weed: January 2025 # 3

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Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. This week, we give you an update on the DEA re-scheduling hearing. ...more

Sheppard Mullin Richter & Hampton LLP

Artificial Intelligence Infiltrating Healthcare in Illinois and its Effects on Insurers

On November 25, 2024, the Illinois State Legislature introduced House Bill 5918 IL HB5918, the Artificial Intelligence Systems Use in Health Insurance Act (“AI Act”). It provides the Illinois Department of Insurance (the...more

McDermott Will & Emery

Post-Chevron Insights and Resources

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On June 28, 2024, in Loper Bright Enterprises v. Raimondo, the US Supreme Court overruled the decades-old Chevron doctrine. This decision means that courts must now determine the meaning of federal statutes and effectively...more

Ballard Spahr LLP

ACA International files suit challenging CFPB medical debt advisory opinion

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ACA International, the association representing the accounts receivable industry, has filed suit against the CFPB, alleging that the bureau’s advisory opinion on medical debt was overtly political, issued in violation of the...more

Proskauer - Health Care Law Brief

Shortly After its Online Tracking Technologies Bulletin is Declared Unlawful, HHS-OCR Stands Down, Withdraws Appeal

On August 29, 2024, the Office for Civil Rights of the United States Department of Health and Human Services (“HHS-OCR”) withdrew its appeal of an order by the United States District Court for the Northern District of Texas’...more

Wiley Rein LLP

Finding Calm During the PBM Storm: What Health Plans Can Do As FTC Litigation Intensifies

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Tensions between the Federal Trade Commission (FTC) and pharmacy benefit managers (PBMs) continue to mount, bringing PBM practices and calls for reform back into the spotlight. On September 17, 2024, one of the largest PBMs,...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

Baker Donelson

60 Days After Loper: Health Care Impact of Chevron Deference's End

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The Supreme Court of the United States issued its highly anticipated ruling in a pair of cases challenging the long-standing Chevron doctrine on June 28, 2024. Foreshadowed by decisions in recent years slighting Chevron, it...more

Robinson+Cole Health Law Diagnosis

A Federal Court in Texas Strikes Down the FTC’s Nationwide Non-Compete Ban

On August 20, 2024, the United States District Court for the Northern District of Texas (Dallas Division) struck down the Federal Trade Commission’s (FTC) non-compete rule, 16 CFR § 910.1-6, that was set to take effect...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

Bass, Berry & Sims PLC

Healthcare Private Equity: What to Expect for the Rest of 2024

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Although the U.S. healthcare industry has weathered the storm over the past couple of years, we may be reaching calmer waters in the coming months. Dry powder held by U.S. private equity investors has reached an all-time...more

Keating Muething & Klekamp PLL

Benefits Monthly Minute - July 2024

The July Monthly Minute considers the impact of the Supreme Court’s Loper decision in overturning the longstanding Chevron deference standard, along with a district court case awarding penalties for failing to produce plan...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 3, July 2024

Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more

Schwabe, Williamson & Wyatt PC

Supreme Court decision overturning Chevron could have huge implications for health care

The recent U.S. Supreme Court decision overturning the Chevron Doctrine, which curtailed the power of the federal agencies to interpret the laws they administer, could prove to be disruptive in the health care realm, said two...more

Husch Blackwell LLP

The Overturning of Chevron Deference: Implications for AI in Medical Research

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In a landmark decision on June 28, 2024, the Supreme Court overturned a 40-year-old legal precedent known as Chevron deference. Established in 1984, Chevron deference mandated that judges defer to federal agencies concerning...more

McCarter & English, LLP

No Doubt, ‘Chevron’ Is Out; How Will This Impact Healthcare?

Through its recent decision in Loper Bright Enterprises v. Raimondo, No. 22-451 (S. Ct. June 28, 2024), the US Supreme Court overturned the landmark decision in Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc.,...more

Bradley Arant Boult Cummings LLP

The Overturn of Chevron: A New Design for Healthcare Law

On June 28, 2024, SCOTUS overturned the long-standing Chevron doctrine in its decision Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce. The Court’s ruling will have a significant impact on...more

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