News & Analysis as of

Health Care Providers Enforcement

Arnall Golden Gregory LLP

“Longstanding and Clear”: OIG Continues Characteristic Close Scrutiny of Below-Market Benefits to Referral Sources

The United States Department of Health and Human Services, Office of Inspector General (“OIG”) recently released two unfavorable advisory opinions, OIG Advisory Opinion No. 25-04 and -08 (the “Opinions”) to medical device...more

Dinsmore & Shohl LLP

Recent Changes to Florida’s “Mobile Opportunity by Interstate Licensure Endorsement (MOBILE) Act” for Health Care Practitioners

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Last year, we reported on Florida’s adoption of the “Mobile Opportunity by Interstate Licensure Endorsement (MOBILE) Act” (Section 456.0145, Florida Statutes), which created a consistent regulatory framework for licensure by...more

Robinson+Cole Data Privacy + Security Insider

Purl v HHS: Resetting the Reproductive Health Privacy Landscape

Reproductive health privacy is once again in the legal spotlight with a recent federal district court decision that struck down nearly all of a recent rule under the Health Insurance Portability and Accountability Act (HIPAA)...more

Fenwick & West LLP

Supreme Court's McLaughlin Decision Creates New Uncertainty for Healthcare Text Message Compliance

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The Supreme Court's decision in McLaughlin Chiropractic Associates v. McKesson Corporation seismically shifts how courts will evaluate FCC interpretations of the TCPA, creating new compliance challenges for healthcare...more

King & Spalding

CMS Escalates Aggressive Rates Cut in Home Health Prospective Payment System Proposed Rule for CY 2026

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On June 30, 2025, CMS issued its annual Home Health Prospective Payment System Proposed Rule for Calendar Year (CY) 2026 (the Proposed Rule). The Proposed Rule continues the agency’s policy of using provisions of the...more

Cranfill Sumner LLP

Anesthesia in North Carolina Dentistry: Safety, Regulation, and Future Trends

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The administration of anesthesia in dental offices across North Carolina is under heightened scrutiny. A series of tragic patient deaths, public advocacy, and legislative interest have prompted the North Carolina State Board...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

Sheppard Mullin Richter & Hampton LLP

The One Big Beautiful Bill Act’s Proposed Moratorium on State AI Legislation: What Healthcare Organizations Should Know

Congress is weighing a sweeping proposal that could significantly reshape how artificial intelligence (AI) is regulated across the United States. At the end of May, the United States House of Representatives passed, by a vote...more

Robinson+Cole Health Law Diagnosis

CMS Issues Guidance and Requests Information to Promote Hospital Price Transparency Compliance and Enforcement Efforts

On May 22, 2025, the Centers for Medicare & Medicaid Services (CMS) took a series of actions to promote enhanced price transparency compliance by hospitals and identify challenges thereto, in order to inform future price...more

Cranfill Sumner LLP

Kickbacks and Causation: Supreme Court Could Soon Settle the Question of Anti-Kickback Statute and False Claims Act Causation...

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A decision by the First Circuit Court of Appeals has deepened the legal debate surrounding False Claims Act (FCA) actions based on violations of the Anti-Kickback Statute (AKS). This decision has increased speculation that...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

Dentons

Ep. 52 – Prioritize Hospital Price Transparency Compliance

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On February 25, 2025, President Trump signed an Executive Order directing federal agencies to “rapidly implement and enforce” federal healthcare price transparency regulations....more

ArentFox Schiff

Implications of New Federal Immigration Policies for Health Care Facilities, Part 2: Patient Privacy Concerns

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On January 20, the US Department of Homeland Security (DHS) rescinded 2021 guidelines that previously designated hospitals, clinics, and other health care facilities as “protected areas” and limited immigration enforcement...more

Verrill

Healthcare Costs Demystified: Trump's New Executive Order on Healthcare Price Transparency Explained

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President Trump’s Executive Order 14224 reinforces and expands a 2019 Executive Order which aimed to improve healthcare price transparency. On February 25, 2025, President Trump signed a new 2025 Executive Order entitled...more

Foley & Lardner LLP

The More Things Change… DOJ’s Latest Cyber Settlement Shows Continued False Claims Act Risk

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Although the change in administrations has heralded shifting enforcement priorities at the U.S. Department of Justice (DOJ), cybersecurity enforcement under the False Claims Act (FCA) appears to be alive and well. That is the...more

Foley & Lardner LLP

The Colorado AI Act: Implications for Health Care Providers

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Artificial intelligence (AI) is increasingly being integrated into health care operations, from administrative functions such as scheduling and billing to clinical decision-making, including diagnosis and treatment...more

Sheppard Mullin Richter & Hampton LLP

Finally, FDA’s Final Word on Unapproved Use Communications

On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...more

Holland & Knight LLP

Massachusetts to Require License for Office-Based Surgical Centers

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Many existing office-based surgical centers in Massachusetts will soon be required to obtain a new type of healthcare facility license. Massachusetts Gov. Maura Healey signed House Bill No. 5159 into law on Jan. 8, 2025,...more

Gardner Law

Sunshine Act Compliance: How to Take Action to Meet Reporting Requirements and Avoid Costly Penalties

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The clock is ticking for medical device and pharmaceutical companies to fulfill their obligations under the Physician Payments Sunshine Act (the "Sunshine Act"). With the reporting deadline of March 31 looming and CMS...more

McDermott Will & Schulte

Massachusetts H.5159 Seeks to Reshape Private Equity in Healthcare

On December 30, 2024, both the Massachusetts House of Representatives and the Massachusetts Senate enacted House Bill 5159 (H.5159), and Governor Maura Healey signed it on January 8, 2025. The bill seeks to strengthen...more

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

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

Ropes & Gray LLP

Massachusetts Passes Act Implementing Broad Oversight into For-Profit Investment in Health Care

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On January 8, 2025, Massachusetts Governor Maura Healey signed House Bill 5159, An Act Enhancing the Market Review Process (the “Act”) into law, effective April 8, 2025. The Act is a compromise redraft of the separate health...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

Second Circuit Expands Anti-Kickback Statute Liability: “At Least One Purpose” is Enough

In a significant ruling, the Second Circuit Court of Appeals recently expanded the scope of the Anti-Kickback Statute (AKS).The Court joined other circuit courts across the country in adopting, for the first time, the...more

Foley & Lardner LLP

Scientific Information on Unapproved Uses of Medical Products: FDA’s Final Guidance on Firm Communication to Health Care Providers

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The U.S. Food and Drug Administration (FDA) recently announced final guidance for firms in the medical device and product industry titled, “Communications From Firms to Health Care Providers Regarding Scientific Information...more

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