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Fox Rothschild LLP

UPDATE: SNFs Receive Even More Time to Complete Off-Cycle Revalidation

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In October, we broke down the required off-cycle Medicare revalidation of all Skilled Nursing Facilities (SNFs) in an Alert and related blog post. We were happy to announce in November that CMS extended the deadline for SNFs...more

Wiley Rein LLP

Virginia Enacts Amendments to Consumer Protection Act

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Virginia recently amended its Consumer Protection Act (the Act) to provide enhanced protection for reproductive and sexual health information. These protections take effect on July 1, 2025. The amendment prohibits a...more

Axinn, Veltrop & Harkrider LLP

Federal Circuit Holds Generic’s Hatch-Waxman Litigation Expenses Deductible

A March 21 Federal Circuit decision in Actavis Laboratories FL, Inc. v. United States, No. 23-1320 (Fed. Cir. Mar. 21, 2025) marked a victory for generic drug developers, affirming that legal expenses incurred defending...more

Cozen O'Connor

Illinois Insights: An update from Cozen O'Connor (4/16)

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Gov. Pritzker, other Governors issue joint letter in response to CMS Proposed Rule - “Multiple governors, including Illinois Governor JB Pritzker, issued a join letter to the director of the Centers for Medicare & Medicaid...more

Morgan Lewis

FDA Drug Inspections Post–Workforce Reductions: Potential Implications and Practical Steps Forward

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The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time FDA employees is raising...more

Sheppard Mullin Richter & Hampton LLP

CMS to Withdraw Federal Medicaid Match for Workforce, Social Needs, and Infrastructure: What States, Health Care Providers and...

In a move signaling a major shift in federal priorities, the Centers for Medicare & Medicaid Services (“CMS”) recently announced it will limit federal funding for state Medicaid initiatives that support services beyond direct...more

McDermott Will & Emery

New Rx for High Drug Prices? Senate Judiciary Committee Advances Six Bills With Heavy Dose of Options

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The US Senate Judiciary Committee advanced to the full Senate six bills intended to reduce pharmaceutical prices and enhance market competitiveness. The package collectively targets several aspects of the pharmaceutical...more

BCLP

PFAS Air Emissions Restrictions

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When evaluating legal risk relating to per- and polyfluoroalkyl substances (“PFAS”), most businesses typically consider wastewater, groundwater, or soil impacts, not air emissions. However, state and federal regulatory...more

Husch Blackwell LLP

Navigating Compliance Risks in Laboratory Operations—Key Lessons from a Recent FCA Case

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A recent False Claims Act (FCA) litigation—Jensen ex rel. United States of America v. Genesis Laboratory—highlights critical compliance risks for laboratories. This case reinforces the need for laboratories to ensure...more

MG+M The Law Firm

Masks on for Spring Cleaning: New Study Reveals Household Dust may be an Additional PFAS Exposure Source

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A new study from the North Carolina State University’s GenX Exposure Study has detected airborne “forever chemicals” in everyday household dust in communities along the Cape Fear River Basin, North Carolina area. These...more

Pierce Atwood LLP

OSHA in 2025: Observations and Expectations

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The beginning of the second Trump administration has left employers asking myriad questions with respect to the Occupational Safety and Health Administration (OSHA). Are there plans to eliminate OSHA? Will inspections and...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

Davis Wright Tremaine LLP

Stay ADvised: 2025, Issue 8

New York State Bill Aims To Take a Bite Out of Junk Food Ads for Kids - New York state lawmakers recently introduced a bill to restrict false and misleading advertising of "junk" food to children. They say the purpose of...more

McDermott+

Inpatient Prospective Payment System (IPPS) Data Dashboard

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Updated to include Medicare claims data thru Q3 2024. What is the cost of a knee implant in the inpatient setting? How much does Medicare pay for different types of cardiac valve procedures? How have Medicare inpatient...more

Bass, Berry & Sims PLC

Healthcare Trends & Transactions Q1 2025

Bass, Berry & Sims PLC on

The healthcare mergers and acquisitions (M&A) market began 2025 with a slower start than expected given the easing headwinds and building momentum at the end of last year, with the number of deals reported in Q1 lower than...more

McDermott Will & Emery

European Commission Fines Teva €462.6 Million for Misusing Divisional patents and Disparaging Generic Competitors in the Copaxone...

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On October 31, 2024, the European Commission (the Commission) delivered its long-awaited decision in the Teva Copaxone case (which was published on April 8, 2025). Teva, a global pharmaceutical company, was fined EUR 462.6...more

Schwabe, Williamson & Wyatt PC

Regulatory Changes Address Surge of Food-As-Health Initiatives and Shift “Healthy” ‎Standard; Plus New Labeling Requirements

Food and beverage products that promote health and well-being have proliferated. Demand has surged for foods and drinks that are loaded with nutrients and offer health benefits. Their growth is partly driven by an increased...more

McDermott Will & Emery

This Week in 340B: April 8 – 14, 2025

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Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

McDermott+

FY 2026 Proposed Rules Are Out! Overview of the IPPS Proposed Rule

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Last Friday, the Centers for Medicare & Medicaid Services (CMS) officially launched the health policy community into reg season, releasing in one fell swoop all the fiscal year (FY) 2026 Medicare proposed regulations for...more

McDermott Will & Emery

Beyond Private Equity Transaction Oversight: Mass. H.5159 Includes New Licensing Requirements

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H.5159, An Act Enhancing the Market Review Process, was signed into law in January 2025. The primary focus of H.5159 is to expand the Commonwealth’s healthcare oversight mechanisms, particularly with respect to private equity...more

Littler

Blue States Push Back: Legislative Responses to Trump Administration Initiatives

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In the wake of Trump administration executive orders and regulatory actions, Democratic-led states across the nation have taken bold steps to counteract policies they view as regressive. There are 17 states that are led by...more

Littler

Australian Government Releases Work Health and Safety (Sexual and Gender-based Harassment) Code of Practice 2025

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As part of a suite of reforms intended to prevent sexual harassment and gender-based harassment, the Australian Government has released a detailed code of practice under work health and safety legislation. The government’s...more

Polsinelli

New Section 232 Trade Investigations on Pharmaceutical and Semiconductor Imports Could Lead to Tariffs Mid-Year

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On April 1, 2025, the Secretary of Commerce initiated, pursuant to President Trump’s directive, two new investigations under Section 232 of the Trade Expansion Act of 1962 (Section 232), one on imports of pharmaceuticals and...more

Knobbe Martens

U.S. Supreme Court Defers to Agency Decision-Making in FDA’s Denial of Premarket Approval of Flavored E-Cigarette Products

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We previously reported a decision by the U.S. Food and Drug Administration (FDA), denying the premarketing authorization of several flavored e-cigarette product. On April 2, 2025, the Supreme Court of the United States...more

K&L Gates LLP

Payroll Tax, Amnesties and Related Developments for Health Practices

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Health practices across Australia have been paying increasing attention to their potential exposure to payroll tax. The importance of doing so continues, particularly with new legislation bringing some further certainty....more

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