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Husch Blackwell LLP

DOJ Announces Largest-Ever National Healthcare Fraud Takedown and Launches New Data Fusion Center

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In June 2025, the Department of Justice (DOJ) announced its 2025 National Health Care Fraud Takedown, marking the largest coordinated healthcare fraud enforcement action in DOJ history. The sweep included charges against a...more

Hendershot Cowart P.C.

Qlarant, Novitas Audits Escalate as Medicare Skin Substitutes Spending Hits $1.6 Billion, CMS Seeks Evidence of Clinical...

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The wound care industry faces unprecedented scrutiny as Medicare Part B expenditures for skin substitutes exceeded $1.6 billion in the fourth quarter of 2023 alone. The spending surge has triggered a wave of skin substitute...more

Tucker Arensberg, P.C.

DOJ and HHS Launch New False Claims Act Working Group to Target Healthcare Fraud

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The U.S. Department of Health and Human Services (HHS) and the Department of Justice (DOJ) have jointly announced the launch of a reinvigorated DOJ-HHS False Claims Act Working Group aimed at enhancing interagency...more

Rivkin Radler LLP

OCR Announces $800,000 HIPAA Settlement with Florida Health System

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The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) has announced another settlement for alleged violations of HIPAA. OCR investigated BayCare Health System, which serves central Florida, after a...more

Blank Rome LLP

[Webinar] 180 Days of the Trump Administration—Quick Hits on Executive Orders, Actions, and Policies - July 17th - August 13th,...

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Blank Rome presents a new summer webinar series where our interdisciplinary team will unpack the most pressing legal, regulatory, and policy developments from the Trump Administration’s first 180 days. Each session offers...more

Greenbaum, Rowe, Smith & Davis LLP

Legal Risks and Challenges for Private Equity in Healthcare Acquisitions

Private Equity (PE) firms continue to be significant players in U.S. healthcare, acquiring assets across various sectors such as physician practices, home health, behavioral health, and urgent care. However, recent legal...more

Parker Poe Adams & Bernstein LLP

New FTC Consent Order Against Health Care-Focused Private Equity Firm Has Antitrust Implications

Last week, the Federal Trade Commission (FTC) approved a final consent order with a private equity firm focused on health care and technology to resolve allegations of anticompetitive practices in two anesthesiology markets...more

Paul Hastings LLP

Residency Match Programs for Healthcare Professionals Come Under Antitrust Scrutiny

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In recent months, private class action lawsuits have challenged residency match programs for pharmacists and veterinarians under antitrust laws. In addition, a congressional subcommittee has begun an inquiry into the...more

Hendershot Cowart P.C.

FDA Update: Current Guidelines for Semaglutide and Tirzepatide Compounding

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Weight loss clinics, telehealth companies, physicians, and pharmacies that have been prescribing or dispensing compounded GLP-1 medications must prepare for significant changes following the Food and Drug Administration’s...more

Sheppard Mullin Richter & Hampton LLP

FDA’s Semaglutide Shortage Resolution: Legal Implications and Risks for Compounding Pharmacies

Last month, the U.S. Food and Drug Administration (the “FDA”) announced in a Declaratory Order the resolution of the shortage of semaglutide injection products Wegovy and Ozempic (the “February Declaratory Order”). On March...more

ArentFox Schiff

FDA Announces End to Semaglutide Shortage, Impacting Compounders and Telehealth Providers Offering Injectable GLP-1 Drugs

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Last week, the US Food and Drug Administration (FDA) announced the end of a years-long shortage of semaglutide injection products — a popular glucagon-like peptide 1 (GLP-1) weight loss and diabetes medication. As a result,...more

Baker Donelson

The Office for Civil Rights Recently Settled Two Ransomware Related Investigations

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The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently settled two ransomware cases with covered entities. These cases signal the government's growing concern with health care...more

Health Care Compliance Association (HCCA)

An inside view of HIPAA enforcement

While many healthcare providers are generally aware of their obligations under HIPAA, most do not have a clear sense of what happens if they fail to meet these obligations. At best, most probably are familiar with headlines...more

BakerHostetler

FTC Continues Focus on Disclosure of Health Information to Third-Party Technologies

BakerHostetler on

A recently announced settlement with online alcohol addiction treatment service Monument Inc. demonstrates the Federal Trade Commission’s (FTC) continued focus on the use and disclosure of health data. The proposed settlement...more

Health Care Compliance Association (HCCA)

Hackers Increasingly Leveraging Threats to Patients to Pressure Health Organizations to Pay Ransom

Cyberhackers—potentially frustrated by their limited ability to extort ransom from health care entities in attacks—have started extorting the patients themselves, threatening them with the release of information or...more

Gardner Law

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

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Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

Health Care Compliance Association (HCCA)

Employees’ Misdeeds, Lack of Risk Analysis Cost NY Hospital $4.75M; OCR Issues Warning

Although the HHS Office for Civil Rights (OCR) described its recent $4.75 million agreement with a Bronx, New York, hospital as settling a “malicious insider cybersecurity investigation,” the agency considered a total of 11...more

Saul Ewing LLP

HHS OCR Issues Its Most Recent HIPAA Annual Report and a Second Ransomware Settlement

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On February 14, 2024, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) issued two reports to Congress as required by the Health Information Technology for Economic and Clinical Health...more

Mintz

EnforceMintz — COVID-19 Fraud Enforcement Unlikely to Slow Down in 2024

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The government continued to dedicate enormous resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs in 2023. While we observed some civil False Claims Act settlements, criminal enforcement...more

Health Care Compliance Association (HCCA)

Hospital Settles CMP Case Over Free APPs; 'Bona Fide' Use Shouldn't Inspire Fear, Lawyer Says

In a case that may hit a raw compliance nerve, Ascension Macomb Oakland Hospital in Michigan has agreed to pay $100,000 in a settlement with the HHS Office of Inspector General (OIG) over free services provided to certain...more

Dorsey & Whitney LLP

HIPAA on the Horizon in the New Year: Important Lessons from an Active 2023 and Regulatory Initiatives to Watch for in 2024

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2023 marked 20 years since the first compliance deadline under the Health Insurance Portability and Accountability Act’s (“HIPAA”) privacy rule. Despite the two decades of experience with HIPAA, compliance continues to remain...more

Quarles & Brady LLP

Indianapolis Health System to Pay $345 Million to Settle Stark Law Allegations

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Community Health Network, Inc. (“Community Health”) is a non-profit healthcare system with more than 200 hundred affiliated sites throughout central Indiana. As such, Community Health is one of the larger Midwest...more

Sheppard Mullin Richter & Hampton LLP

Overview of Recent Anti-Corruption Enforcement Actions in the Pharmaceutical Industry in China

On May 8, 2023, the National Health Commission of the People’s Republic of China (the “PRC”), along with 13 other government departments of the PRC, issued the “Key Highlights for Combating Corruption in the Medicine Purchase...more

Jones Day

DOJ Obtains First Divestitures in a Criminal Antitrust Case

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The U.S. Department of Justice Antitrust Division ("DOJ") recently resolved a criminal case with Teva Pharmaceuticals and Glenmark Pharmaceuticals via deferred prosecution agreements ("DPAs"), which include a novel remedy for...more

Epstein Becker & Green

The 2023 DOJ Health Care Fraud Enforcement (f/k/a “Takedown”): Big Dollars or Clever Packaging?

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On June 28, 2023, the U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services, Office of Inspector General (“HHS-OIG”), along with other federal and state law enforcement partners, announced a...more

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