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Dentons

Ep. 61 – Three Compliance Lessons from a False Claims Act Verdict

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In a recent False Claims Act case, a long-term care pharmacy and consulting services provider was found liable for submitting false claims to the government, resulting in a jury verdict of over $135 million in damages. The...more

Dickinson Wright

Breaking: FDA, HHS Seek Public Input on Cutting Rules

Dickinson Wright on

On May 13, 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced a public Request for Information to “identify and eliminate outdated or unnecessary...more

Baker Donelson

Proposed Rule for Nursing Homes: Key Updates for FY 2026

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I. Introduction - The Centers for Medicare & Medicaid Services (CMS) issued the proposed rule on April 11, 2025, for the skilled nursing facility (SNF) prospective payment system (PPS) fiscal year (FY) 2026 update (the...more

Goodwin

President Trump Issues Two Executive Orders Concerning the Affordability and Accessibility of Drugs

Goodwin on

In the past month, President Trump signed two executive orders concerning drug access and affordability, including for biologics and biosimilar drugs.  On April 15, 2025, President Trump signed Executive Order No. 14273 (“EO...more

McDermott+

President Trump Issues Most Favored Nations Drug Pricing Executive Order

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While much of Washington, DC’s attention this week has been focused on congressional action around budget reconciliation, including proposed changes to the Medicaid program, the White House also made news with release of a...more

Bass, Berry & Sims PLC

Indiana Enacts Legislation Affecting Health Care Transactions and Imposing Ownership Reporting Requirements

Bass, Berry & Sims PLC on

On May 6, 2025, Indiana Governor Mike Braun signed Indiana HB 1666 into law. This new law grants Indiana’s attorney general authority to investigate market concentration of health care entities, modifies existing requirements...more

McDermott Will & Emery

Hatch-Waxman or Not, Clinical Trials Aren’t Subject to Injunction

McDermott Will & Emery on

Analyzing the permissible scope of an injunction under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit reversed the district court’s prohibitions on an open-label extension (OLE) of a then-running...more

Sheppard Mullin Richter & Hampton LLP

Utah Enacts AI Amendments Targeted at Mental Health Chatbots and Generative AI

Utah is one of a handful of states that has been a leader in its regulation of AI. Utah’s Artificial Intelligence Policy Act (“UAIPA”) was enacted in 2024 and requires disclosures relating to consumer interaction with...more

Sheppard Mullin Richter & Hampton LLP

DOJ’s Updated Enforcement Policy: A Game-Changer for Corporate America?

On May 12, 2025, the U.S. Department of Justice (DOJ) announced a major overhaul of its corporate enforcement policy, aiming to incentivize companies to voluntarily self-disclose misconduct. Titled “Focus, Fairness, and...more

Akin Gump Strauss Hauer & Feld LLP

The Trump Administration Continues Focus on Drug Pricing with “Most-Favored-Nation Prescription Drug Pricing” Executive Order

On Monday, May 12, President Donald Trump signed an Executive Order (EO) titled, “Delivering Most-Favored-Nation Prescription Drug Pricing to Americans,” aimed at reducing prescription drug prices by implementing a...more

Amundsen Davis LLC

Marijuana Legalization Cut From Wisconsin Governor’s Proposed Budget

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Wisconsin Governor Tony Evers took another swing at legalizing cannabis in his proposed 2025-27 budget and struck out. On May 8, 2025, the Wisconsin Legislature’s Joint Finance Committee eliminated marijuana legalization from...more

Frost Brown Todd

U.S. EPA Announces Retainment of MCLs for PFOA and PFOS and Intent to Rescind and Reconsider MCLs for Other PFAS

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The United States Environmental Protection Agency (U.S. EPA) announced today that it will keep the current Maximum Contaminant Levels (MCLs) set by the National Primary Drinking Water Regulations for perfluorooctanoic acid...more

Bergeson & Campbell, P.C.

Registration Open until May 16, 2025, for Joint Regulatory Risk Assessors Summit on Advancing Safety and Sustainability Assessment...

On June 19 to June 20, 2025, the European Union (EU) Horizon Europe projects ACCORDs, iCare, MACRAMÉ, and nanoPASS are hosting a joint summit to address the needs of industry and regulators in assessing the safety and...more

Hogan Lovells

HHS & FDA Request Public Comment to Inform Agency’s Infant Formula Nutrient Review

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The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) are requesting public comment on nutrient requirements for infant formulas intended for healthy, full-term infants. FDA’s...more

Cooley LLP

Compliance Implications for Healthcare Companies Post-First Circuit Decision

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The US Court of Appeals for the First Circuit’s landmark decision in United States v. Regeneron Pharmaceuticals will have some implications for healthcare compliance and defense strategies. In the case, the First Circuit...more

Hogan Lovells

HHS, FDA Issue RFI on Deregulatory Plan to Lower Costs and Empower Providers

Hogan Lovells on

Earlier this week, the Department of Health and Human Services (HHS) published a broad request for information (RFI) seeking input on how to “dramatically deregulate across all areas the Department touches.”1 It specifically...more

Vedder Price

Trump Administration Issues Executive Order Aimed At Lowering Prescription Drug Pricing

Vedder Price on

On May 12, 2025, President Donald J. Trump signed an executive order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.” This executive order aims to lower the cost of prescription drugs...more

Mintz

Trump Signs Most-Favored-Nation Executive Order - Potential Impact on Drug Supply Chain

Mintz on

After significant fanfare and anticipation, President Trump issued his “Delivering Most-Favored Nation Prescription Drug Pricing to American Patients” Executive Order (Executive Order) this week. The Executive Order seeks to...more

Holland & Knight LLP

HHS, FDA Issue Request for Information to Support Administration's Deregulatory Agenda

Holland & Knight LLP on

The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) issued a Request for Information (RFI) on May 13, 2025, titled "Ensuring Lawful Regulation and Unleashing Innovation to...more

Ropes & Gray LLP

New York Fails to Pass Expanded Health Care Transaction Notice Requirements Bill

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On May 9, 2025, New York State (“NYS”) Governor Kathy Hochul signed legislation enacting the State Fiscal Year 2025-26 budget into law. Notably omitted from the final budget legislation was Part S of the Health and Mental...more

Holland & Knight LLP

Trump Administration Revives Most-Favored-Nation Drug Pricing: Here's What to Know

Holland & Knight LLP on

President Donald Trump on May 12, 2025, issued an executive order (EO) titled "Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients" and an accompanying Fact Sheet, "President Donald J. Trump...more

Ropes & Gray LLP

Insights from the Third Annual Ropes & Gray Rare Disease Forum

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Ropes & Gray recently hosted its Third Annual Ropes & Gray Rare Disease Forum on May 1, 2025 in Cambridge, Massachusetts. The event gathered legal, commercial, and patient advocacy experts in the rare disease community to...more

Fish & Richardson

How Trump’s Latest Drug Price EO Could Impact Pharma

Fish & Richardson on

On May 12, 2025, President Trump issued an executive order aimed at lowering prescription drug prices titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.” Generally, the order directs...more

Benesch

Updates to Reporting Requirement of Dental Support Organizations’ Mergers and Acquisitions in Indiana

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Indiana currently has a reporting requirement related to health care entity mergers and acquisitions that requires parties to covered health care entity transactions—including Dental Support Organization (“DSO”)...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - July 21st - 24th, Nashville, TN

Grounded in the OIG’s General Compliance Program Guidance and DOJ’s Evaluation of Corporate Compliance Programs, our immersive, three-and-a-half-day, classroom-style Healthcare Basic Compliance Academy equips compliance...more

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