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IR Global

9th Circuit Finds That Stromal Vascular Fraction (SVF) Procedures Constitute Treatments As Drugs

IR Global on

In United States v. California Stem Cell Treatment Center, Inc.[1], the FDA brought a lawsuit against doctors who create and administer a stem cell mixture called stromal vascular fraction (SVF), alleging violations of the...more

Bass, Berry & Sims PLC

Athira Pharma Inc. Agrees to Settle False Claims Act Allegations

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On January 6, the Department of Justice (DOJ) announced that Athira Pharma Inc., a Washington-based biopharmaceutical company, agreed to pay over $4 million to settle allegations it violated the False Claims Act (FCA). The...more

Dentons

Ep. 44 – Three Ways to Reenergize Your Compliance Programming for 2025

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As we start a new year, January is a great time to plan ways to refresh your compliance programming for the upcoming year. Compliance training and activities can become stale. They often take a backseat to the day-to-day...more

McDermott+

McDermott+ Check-Up: January 10, 2025

McDermott+ on

119th Congress Begins. The new Congress began with key membership announcements for relevant healthcare committees. Cures 2.1 White Paper Published. The document outlines the 21st Century Cures 2.1 legislative proposal,...more

Burr & Forman

Failure to Return Credit Balances (Especially to Medicare and Medicaid) Can Create Significant Liability

Burr & Forman on

Every health care provider has “credit balances,” which occur when a provider receives more money than it is owed for services rendered. Credit balances can be caused by a number of factors, including incorrect coding,...more

Foley Hoag LLP

Health Care Fraud Enforcement in 2025

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We kick off our annual Year in Preview series with a comprehensive look at health care fraud enforcement in 2025. This post proceeds in three parts. First, we explore what the second Trump administration might bring, looking...more

Baker Donelson

Proposed HIPAA Security Rule Updates

Baker Donelson on

The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM) on December 27, 2024, to update the Health Insurance Portability and Accountability Act...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - January 2025 #1

News Briefs - Number of Official Physician Union Drives Soared Over Two Years - While fewer than 10 percent of U.S. physicians are unionized, the number of official union drives among private-sector doctors have skyrocketed...more

Alston & Bird

Updates to the Dietary Guidelines? HHS and USDA Request Public Input

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Our Food & Beverage Team discusses how looming changes to federal dietary guidelines and new Make America Healthy Again initiatives could impact the food and beverage industry in 2025....more

Alston & Bird

Health Care Week in Review: CMS Releases Advance Notice of MA and Part D Payment Methodologies and Senate Finance Chair Identifies...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Stikeman Elliott LLP

Federal Government Announces Policy on Canada Health Act Status of Payments to Regulated Healthcare Professionals Providing...

Stikeman Elliott LLP on

Friday, the Federal Government issued correspondence to the provinces and territories regarding its newly introduced Canada Health Act Services Policy. As set out in this correspondence from the Minister of Health, the CHA...more

McDermott Will & Emery

Trending in Telehealth: December 18, 2024 – January 6, 2025

McDermott Will & Emery on

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

Bass, Berry & Sims PLC

Massachusetts HB5159 Expands Oversight of Private Equity Investment in the Health Care Industry

Bass, Berry & Sims PLC on

On January 8, the governor of Massachusetts signed House Bill 5159 into law (Law). At a high level, the new Law expands Massachusetts’ existing health care transaction notice process and implements new reporting and oversight...more

Venable LLP

More States Consider Age Restrictions for Certain Weight Loss or Muscle-Building Products

Venable LLP on

On January 8, 2025, a bill prohibiting the sale of certain dietary supplements for weight loss and muscle building and other products to minors was formally introduced to the Virginia House of Delegates (House Bill No. 1585...more

Sheppard Mullin Richter & Hampton LLP

Building a Smarter Long-Term Care System in New York

New York State has a long-standing commitment to supporting its most vulnerable populations through Medicaid-funded services for older adults and those requiring long-term care. However, rising costs and an increasingly...more

Fenwick & West LLP

Some AI-Discovered Drugs Carry More IP Risks Than Others - Here's Why

Fenwick & West LLP on

AI is poised to revolutionize drug discovery, but uncertainty in developing protectable IP in this emerging field creates a host of potential risks for companies innovating in this space. Further complicating things: not all...more

Goodwin

Year in Review: Top Regulatory Developments of 2024

Goodwin on

As 2025 begins, we would like to reflect on last year’s regulatory developments in the biologics and biosimilars space. Here are some of the top regulatory developments from 2024....more

Hogan Lovells

FDA Issues Final “Healthy” Rule

Hogan Lovells on

On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued its long-awaited final rule updating the requirements for when the term “healthy” can be used as an implied nutrient content claim in food labeling. ...more

Tucker Arensberg, P.C.

2025 Medicare Final Rule Highlights

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CMS issued its Final Rule for the 2025 Medicare Physician Fee Schedule in November. Originally published in the Allegheny County Medical Society (ACMS) Bulletin - December 2024....more

Hogan Lovells

FDA Draft Guidance Addresses Management of Environmental Pathogen Hazards for Low-Moisture Ready-to-Eat Foods

Hogan Lovells on

On January 6, the U.S. Food and Drug Administration (FDA) issued long-awaited draft guidance regarding Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a...more

Morrison & Foerster LLP

FDA Issues Action Levels for Lead in Baby Food

On January 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance establishing action levels for lead in processed food intended for babies and young children. This is the first FDA guidance directly...more

Faegre Drinker Biddle & Reath LLP

FDA Makes Draft Guidance Available on Lifecycle Management and Marketing Submission Recommendations for AI-Enabled Device Software...

On January 7, 2025, FDA published “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff”...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

HHS Proposed Rule Would Increase Cybersecurity Requirements for Electronic Health Data

The U.S. Department of Health and Human Services (HHS) recently released a proposed rule to better protect electronic health data from cybersecurity threats. The proposed rule would apply to health plans, healthcare...more

Health Care Compliance Association (HCCA)

[Virtual Event] Healthcare Compliance Essentials Workshop - March 3rd - 6th, 8:00 am - 5:00 pm CT

Kick-start your compliance education with this comprehensive workshop - HCCA’s four-day Healthcare Compliance Essentials Workshop is designed to provide foundational education on the key elements of a compliance program...more

Morgan Lewis - ML Benefits

Welcome Healthcare Reporting Simplification Enacted

On December 23, 2024, President Biden signed into law two bills that will simplify employer reporting compliance under the Affordable Care Act (ACA). The new laws streamline the rules for employers furnishing ACA reporting...more

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