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CDF Labor Law LLP

COVID-19 Prevention Regulations Expired Effective Monday, With the Exception of Recordkeeping Requirement

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As of February 3, 2025, most of the Cal/OSHA’s COVID-19 Prevention Non-Emergency Regulations have formally come to an end, giving employers flexibility in how they approach COVID-19 in the workplace. However, subsection...more

Holland & Knight LLP

Government Contracts Enforcement: DOJ Publishes FY 2024 False Claims Act Statistics

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The U.S. Department of Justice (DOJ or the Department) has published statistics on False Claims Act (FCA) settlements and judgments for fiscal year (FY) 2024, a year in which the Department saw the highest number of qui tam...more

Holland & Knight LLP

Executive Order: Initial Rescissions of Harmful Executive Orders and Actions

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Date Issued: Jan. 20, 2025 This executive order revokes 78 actions and orders rolled out during the Biden Administration, intending to repair institutions and improve the economy under the policy plans of the Trump...more

McDermott Will & Emery

This Week in 340B: January 28 – February 3, 2025

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

Sheppard Mullin Richter & Hampton LLP

Healthcare Industry Leaders Predict Four Areas to Watch After the U.S. Election: Takeaways from the Business of Health Care...

The recent U.S. election has had profound implications for the healthcare industry, prompting industry leaders to reexamine their strategies and day-to-day operations. At the Miami Herbert Business School’s annual “The...more

Foley Hoag LLP - White Collar Law &...

New Massachusetts Healthcare Law Targets Private Equity, REITs, and MSOs; Expands State False Claims Act

On January 8, 2025, Governor Maura Healey signed House Bill 5159 into law, toughening the rules and increasing the risks for private equity (PE) companies, real estate investment trusts (REITs), and management services...more

McGuireWoods Consulting

What’s On The Table For Budget Reconciliation?

On Jan. 16, 2025, a 51-page document attributed to the House Budget Committee was released with policy options and associated budgetary impacts for congressional committees to consider as they work through the reconciliation...more

Maynard Nexsen

President Trump’s Latest Executive Orders Impacting Health Care

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In the first few days of his second presidential term, newly inaugurated President Trump signed a number of executive orders that will have an impact on the health care industry, some issuing new policies and some rescinding...more

Faegre Drinker Biddle & Reath LLP

Biden’s 11th-Hour Ethylene Oxide Decision Continues the Environmental Protection Agency’s Expansion Into Occupational Safety

On January 14, 2025, the Biden administration’s U.S. Environmental Protection Agency (EPA) posted a last-minute “interim” decision in the Federal Register for its review of ethylene oxide (EtO) under the Federal Insecticide,...more

Hogan Lovells

CMS Proposes Guidance on Use of Real World Data for Coverage with Evidence Development

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Real world data (RWD), which is data from actual patient treatments, provides valuable information on safety and effectiveness of innovative new health technologies, often at significantly lower cost than evidence generated...more

Robins Kaplan LLP

Novartis Pharms. Corp. v. Becerra

Robins Kaplan LLP on

Entresto® (sacubitril/valsartan) - Case Name: Novartis Pharms. Corp. v. Becerra, Civ. No. 24-cv-2234 (DLF), 2024 WL 4492072 (D.D.C. Oct. 15, 2024) (Friedrich, J.)  Drug Product and Patent(s)-in-Suit: Entresto®...more

Morgan Lewis - Health Law Scan

HHS OIG Sets Out Limited Guardrails for Patient Assistance Arrangements

In honor of Rare Disease Day on February 28, 2025, Morgan Lewis is publishing a series of posts on As Prescribed and Health Law Scan throughout the month of February on issues impacting the rare disease community....more

Lowenstein Sandler LLP

Robust False Claims Act Results for DOJ in 2024 Reveal Dynamic Enforcement Landscape

In January, the Department of Justice (DOJ) announced that settlements and judgments under the False Claims Act (FCA) exceeded $2.9 billion in fiscal year 2024, bringing the total amount of settlements and judgments under the...more

Goodwin

Medtech M&A and VC Signal Positive Momentum Entering 2025

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Medtech mergers and acquisitions (M&A) and venture capital (VC) showed signs of life in 2024, contributing to an overall optimistic outlook for the sector this year despite lingering headwinds. Strategic investments are...more

McDermott Will & Emery

Preparing for a New US Administration: Insights and Resources

President Donald Trump has taken office, and organizations can stay ahead of US policy changes and strategic shifts that may impact operations under the new presidential administration. McDermott’s cross-practice team, along...more

Fenwick & West LLP

Understanding the DEA’s New Telemedicine Rules: FAQ for Healthcare Providers and Telehealth Companies

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The U.S. Drug Enforcement Administration (DEA) recently announced new rules that will impact telemedicine practices, especially concerning remote prescribing of controlled substances....more

Bradley Arant Boult Cummings LLP

The False Claims Act in 2024: A Year in Review

In 2024, the government and whistleblowers were party to 558 False Claims Act (FCA) settlements and judgments, just slightly fewer cases than last year’s record. As a result, collections under the FCA exceeded $2.9 billion,...more

Venable LLP

Alvotech and Teva Announce First FDA Acceptance of aBLA for Simponi® / Simponi Aria® (golimumab) Biosimilar

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On January 27, 2025, Alvotech and Teva announced the FDA acceptance of an aBLA for AVT05, a proposed biosimilar of Janssen’s Simponi® / Simponi Aria® (golimumab)....more

Ropes & Gray LLP

New York's Health Information Privacy Act Aims to Strictly Regulate Consumer Health Data

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On January 22, 2025, the New York State Assembly and Senate rapidly passed the wide-ranging New York Health Information Privacy Act (“NY HIPA”). If not vetoed by Governor Kathy Hochul, NY HIPA would be the fourth enacted...more

Vicente LLP

Cannabis Rescheduling Hearings Postponed: How Did We Get Here and What Happens Next?

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The much-anticipated hearings on the proposed rulemaking to reschedule cannabis, which were scheduled to begin on January 21, have been postponed for at least three months as a result of an appeal granted by DEA...more

Bradley Arant Boult Cummings LLP

False Claims Act: 2024 Year in Review

Bradley’s Government Enforcement and Investigations Practice Group is pleased to present the False Claims Act: 2024 Year in Review, our annual review of significant False Claims Act (FCA) cases, developments and trends. ...more

Jones Day

DEA Releases Rules on Telemedicine Prescribing of Controlled Substances, Proposes Special Registrations

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The Drug Enforcement Administration ("DEA") announced three new regulations related to the prescription of controlled substances resulting from a telemedicine encounter, including the long-anticipated Proposed Rule on Special...more

Polsinelli

Federal Grant Funding: A Thaw in the Freeze?

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Last week was a roller coaster ride for health care providers and other recipients of federal grant funding. Here’s a quick recap of everything that’s happened since our last e-alert...more

Bodman

Resolutions for Healthcare Providers: Part 1 of 2 – Cybersecurity, Privacy and HIPAA Compliance

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As the new year begins, it is useful to review your practice’s processes and policies to ensure that the practice operates with efficiency and remains compliant with ever-changing healthcare regulations....more

Nelson Mullins Riley & Scarborough LLP

Gold Dome Report - Legislative Day 10 - January 2025

The Georgia General Assembly got off to a fast start on Monday with the State Senate taking up its first substantive measures of the session before both bodies filled the afternoon with committee hearings. But before...more

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