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Nelson Mullins Riley & Scarborough LLP

Gold Dome Report - Legislative Day 32 - March 2025

While we spend much of our time watching bills and budgets under the Gold Dome, lawmakers and elected officials spend much of their time honoring constituents and other notable figures....more

Knobbe Martens

District Court Finds the FDA Reasonably De-listed Eli Lilly’s Weight Loss Drug From Drug Shortage List

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Congress authorized the FDA to determine whether a drug is “in shortage in the United States.” The FDA’s determination of a drug shortage triggers mechanisms designed to alleviate the shortage. For example, a determination of...more

Holland & Hart LLP

E-mailing and Texting PHI: Beware HIPAA

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The HIPAA Privacy and Security Rules require covered entities (including healthcare providers and health plans) and their business associates to protect patient information stored or transmitted electronically, including...more

Holland & Knight LLP

CMMI Signals New Strategy and Terminates 4 Value-Based Care Models

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The Center for Medicare and Medicaid Innovation (CMMI) has released a statement on plans to unveil a new strategy focused on "improving the health of Americans through disease prevention via evidence-based practices,...more

Foley Hoag LLP - Cannabis and the Law

California Introduces Legislation to Curb Online Direct-to-Consumer Hemp Product Sales

Perhaps recognizing an enforcement gap in the evolving struggle to protect consumers from what Governor Newsom has characterized as a grave threat to public health and safety, the California legislature is taking steps to...more

McDermott Will & Emery

This Week in 340B: March 11 – 17, 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

ArentFox Schiff

RFK Jr. Takes Aim at GRAS Self-Affirmation Process

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On March 10, the US Department of Health and Human Services (HHS) announced that newly confirmed HHS Secretary Robert F. Kennedy Jr. has directed acting US Food and Drug Administration (FDA) Commissioner Dr. Sara Brenner to...more

Goodwin

FDA Approves Celltrion’s OMLYCLO® (omalizumab-igec)

Goodwin on

On March 9, 2025, Celltrion announced that the FDA has approved OMLYCLO® (omalizumab-igec), the first and only biosimilar of XOLAIR® (omalizumab)....more

McGuireWoods LLP

Bill Could Create Notification Requirement for Texas Healthcare Transactions

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On Feb. 12, 2025, the Texas House of Representatives introduced House Bill 2747, which would require entities to report certain healthcare transactions to the Texas attorney general. Currently, Texas does not require entities...more

Paul Hastings LLP

FDA Funding Changes Could Impact Biotech M&A

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With companies constantly developing new therapies and technologies, the biotech industry is a hotbed of innovation. This dynamic environment often leads to mergers and acquisitions (M&A) as a vehicle for larger companies to...more

Hogan Lovells

Early benefit assessment of medicinal products in Germany – first adaptions to AMNOG implementing the EU HTA Regulation

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First adaption of German AMNOG to the EU HTA Regulation: With the German Federal Ministry of Health's recent adoption of the respective ordinance in Germany (AMNutzenV), the German legislator took a first step to integrate...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Privacy Compliance Academy - March 24th - 27th, Chicago, IL

HCCA's Healthcare Privacy Compliance Academy is a three-and-a-half-day interactive education program with a focus on the vast body of privacy laws and regulations in place to help you protect PHI and other critical data. Our...more

Bennett Jones LLP

Pest Management Regulatory Agency Opens Pre-Consultation Period on Proposed Changes to the Pest Control Products Regulations

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On March 7, 2025, Health Canada’s Pest Management Regulatory Agency (PMRA) published two consultation documents as part of its ongoing work to clarify which categories of pest control products are subject to the Pest Control...more

Polsinelli

Medicare Telehealth Gets Another Temporary Lifeline – Will Congress Make it Permanent?

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On March 15, 2025, President Trump signed a continuing resolution to avert a government shutdown, which included a critical six-month extension of Medicare telehealth flexibilities through September 30, 2025. This six-month...more

Mandelbaum Barrett PC

New Jersey Officially Introduces Driver’s License Notation for Autistic Motorists

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Autistic motorists in New Jersey, as well as their parents/Guardians, are now able to request that their autism diagnoses be notated on their driver’s license. This notation will appear as a code in the “restrictions” column...more

Robinson+Cole Health Law Diagnosis

Medicare Telehealth Flexibilities Extended through September 30, 2025

On March 14, 2025, as part of a spending bill to avert a federal government shutdown, Congress extended COVID-era telehealth “waivers” applicable to Medicare until September 30, 2025.  These were originally scheduled to end...more

Venable LLP

DOJ Dismisses Lawsuit Over COVID Nasal Spray False Advertising

Venable LLP on

On March 10, the Department of Justice (DOJ) moved to drop a lawsuit filed on behalf of the Federal Trade Commission (FTC) against Xlear, which marketed a line of over-the-counter saline nasal spray products touted to treat...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - March 24th - 27th, Chicago, IL

Ideal for practitioners who want to build strong foundational knowledge of compliance program management in a healthcare setting and how to apply that knowledge in practice. Attendees will come away better prepared to...more

McDermott Will & Emery

Unclaimed Property Laws and the Health Industry: Square Peg, Round Hole

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Likely due to the tremendous number of healthcare mergers, acquisitions, and private equity deals that have been taking place, the industry has recently been the target of multistate unclaimed property audits. This increased...more

Bass, Berry & Sims PLC

CMS Terminates Four Value-Based Care Models Early and Signals New Strategy

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On March 12, the Centers for Medicare & Medicaid Services (CMS) announced that certain Medicare value-based payment models will terminate early and signaled a new strategy will be announced soon. Specifically, the Centers for...more

McDermott Will & Emery

Trending in Telehealth: February 2025

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Trending in Telehealth highlights monthly state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and...more

McGuireWoods Consulting

Marketplace Integrity And Affordability Rule Proposed

On March 10, 2025, the Centers for Medicare and Medicaid Services (CMS) proposed a rule that in many respects reverts to pre-Biden administration rules and definitions for health care marketplaces across the country. The...more

Groom Law Group, Chartered

This Week From the Hill (March 16 – 22, 2025)

Each week while Congress is in session, our Policy team delivers a key update to highlight a topical benefits, health, or retirement news item from the Hill, such as a newly introduced bill, a summary of a committee hearing,...more

Hogan Lovells

China’s first compliance guidelines to prevent corruption risks in the life sciences industry

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On January 14, 2025, China issued the final version of its compliance guidelines for health care companies to prevent commercial bribery risks (“Guidelines”), which took effect immediately. The Guidelines are applicable to...more

Pullman & Comley, LLC

Ten Immigration Compliance Tips for Health Care Providers and Businesses

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In today’s complex and rapidly evolving immigration landscape, health care providers and businesses that employ foreign nationals (more than 25% of physicians in the United States are foreign-born) must be proactive in...more

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