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Enforcement Actions Health Care Providers Compliance

Hinshaw & Culbertson - Health Care

Emergency Alert! HHS Restricts Care for Immigrants—Health Centers Must Act Now

Overview of Key Changes and Immediate Impacts - Key Policy Shift: Section 330 Grants now treated as a “Federal Public Benefit” - The U.S. Department of Health and Human Services (HHS) now classifies the Health Center Program...more

Sheppard Mullin Richter & Hampton LLP

Inside the Ninth Circuit’s Interpretation of EKRA: Clarity for Kickback Law

On July 11, 2025, in United States v. Schena,[1] the Ninth Circuit adopted an expansive interpretation of the Eliminating Kickbacks in Recovery Act (EKRA), applying the law to any payment that could have the effect of...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

Ropes & Gray LLP

Navigating TRAIGA: Texas’s New AI Compliance Framework

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On June 22, 2025, Texas enacted the Texas Responsible Artificial Intelligence Governance Act (“TRAIGA”), putting it at the forefront of state-level AI regulation in the United States. TRAIGA becomes effective January 1, 2026....more

Jackson Lewis P.C.

OFCCP Extends Enforcement Moratorium for VAHBP Providers Until 2027

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In a move the Agency reported is designed to maintain healthcare access for active and retired service members and their families, the Office of Federal Contract Compliance Programs (OFCCP) has announced a two-year extension...more

Hendershot Cowart P.C.

GLP-1 Shortage Ended: Can You Still Legally Prescribe or Compound Semaglutide and Tirzepatide?

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For the past several years, physicians and compounding pharmacies have stepped in to address critical patient access gaps during U.S. Food and Drug Administration (FDA) shortage declarations for semaglutide (Ozempic, Wegovy)...more

Health Care Compliance Association (HCCA)

From $5,000 to $800,000: Days Apart, OCR Security Settlements Show Puzzling Math

A single incident that may have started as a personal vendetta or an extortion threat seven years ago has cost a Florida health care system $800,000, and comes on the heels of an unrelated breach suffered by a different...more

ArentFox Schiff

FCA Enforcement & Compliance Digest — Summer 2025 False Claims Act Newsletter

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Welcome to the Summer 2025 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and...more

Wiley Rein LLP

FTC Sends Warning Letters to 37 Eyeglass and Contact Lens Prescribers Over Possible Rule Violations

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On June 3, 2025, the Federal Trade Commission (FTC) announced its staff had sent warning letters to 37 contact lens prescribers that, according to the FTC, were the subject of consumer complaints concerning possible...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

Gardner Law

FDA’s Latest Untitled Letter: An Enforcement Tell?

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FDA’s Office of Prescription Drug Promotion (OPDP) is active throughout each year issuing letters challenging promotional labeling they deem noncompliant. Any communication from FDA regarding a promotional claim they disagree...more

Dentons

Ep. 61 – Three Compliance Lessons from a False Claims Act Verdict

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In a recent False Claims Act case, a long-term care pharmacy and consulting services provider was found liable for submitting false claims to the government, resulting in a jury verdict of over $135 million in damages. The...more

Roetzel & Andress

ADA Compliance for Medical and Dental Practices: Responding to Inquiries and Investigations

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Join us on the HealthLawHotSpot as host Ericka Adler and Michael Brohman, shareholder and member of Roetzel’s Employment Litigation Group, discuss ADA compliance for medical and dental practices. In this episode, you'll learn...more

Health Care Compliance Association (HCCA)

OCR Loses Staff, Faces Move to New ‘Enforcement’ Office; Will HIPAA Focus, Independence Suffer?

Today, the HHS Office for Civil Rights (OCR) stands shoulder-to-shoulder with the likes of the Office of Inspector General and Office of General Counsel, one of just a dozen or so agencies reporting directly to the secretary....more

Saul Ewing LLP

OCR Imposes $200,000 Civil Money Penalty Against HIPAA-Covered Entity

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On March 6, 2025, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced a civil money penalty (“CMP”) of $200,000 against Oregon Health & Science University (“OHSU”) for failing to...more

Health Care Compliance Association (HCCA)

$1.5M Warby Parker Fine a Holdover; OCR Focuses On Men in Sports, Antisemitism, ‘Biological Truth’

Nearly six years to the day that Warby Parker reported a breach affecting nearly 200,000 individuals, the HHS Office for Civil Rights (OCR) imposed a $1.5 million fine on the eyewear giant. Investigated by OCR under the Biden...more

ArentFox Schiff

Investigations Newsletter: FCA Enforcement & Compliance Digest — Winter 2025 False Claims Act Newsletter

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Welcome to the Winter 2025 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and...more

Rivkin Radler LLP

Provider and Beneficiaries Conspired to Defraud Louisiana’s Medicaid Program

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Healthcare fraud is prevalent within state Medicaid programs due to the massive amounts of money flowing through the system. In Louisiana, the Estate of Yolanda Burnom and her former company, Community Healthcare Solutions,...more

Dentons

Ep. 51 – Building Effective Compliance Committee Agendas

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Many healthcare organizations understand the importance of having a Compliance Committee but some struggle to use their committee effectively. The key to ensuring the Compliance Committee is effective is building smart...more

McDermott Will & Schulte

SB 5387 Aims to Codify Restrictive CPOM Doctrine in Washington

On January 21, 2025, the Washington state legislature introduced Senate Bill (SB) 5387, aiming to codify a restrictive state prohibition on the corporate practice of healthcare, commonly referred to as a corporate practice of...more

Robinson+Cole Health Law Diagnosis

Trump Administration Issues Executive Order Prioritizing Hospital Price Transparency Enforcement

On February 25, 2025, President Donald Trump issued an Executive Order titled “Making America Healthy Again by Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information” (the 2025 Order). The...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

Fox Rothschild LLP

End of Semaglutide Shortage Means Big Changes for Prescribers and Compounders

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On February 21, the FDA announced that the shortage of semaglutide injection products has been resolved. Semaglutide has appeared on the FDA’s Drug Shortage List since 2022 because demand for the drug exceeded the available...more

Kerr Russell

The Corporate Transparency’s Act’s Impact on Medical Practices: Understanding Physicians’ Obligations Amid Recent Judicial and...

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Medical practices across the United States are grappling with new compliance obligations under the Corporate Transparency Act (CTA). This article addresses the CTA’s applicability to medical practices, its current legal...more

Morrison & Foerster LLP

China Issues First Compliance Guidelines to Combat Commercial Bribery Risks - UPDATED February 2025

On January 10, 2025, China’s State Administration for Market Regulation (“SAMR”) put into effect its Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (“Compliance Guidelines”)....more

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