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Rivkin Radler LLP

Quality of Care Considerations in OIG’s Nursing Facility Compliance Guidance

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In November 2024, the U.S. Department of Health and Human Services’ Office of the Inspector General (“OIG”) published the long-awaited Industry Segment-Specific Compliance Program Guidance for Nursing Facilities (“Nursing...more

Venable LLP

Exploring the Future of GRAS: HHS’s Recent Directive and Its Potential Impact on the Food Industry

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On March 10, 2025, the U.S. Department of Health and Human Services (HHS) announced that HHS Secretary Robert F. Kennedy has directed the Food and Drug Administration (FDA or Agency) “to take steps to explore potential...more

Troutman Pepper Locke

Massachusetts Efforts to Ensure Safety in the Cannabis Industry: New Testing Requirements and Recent Advisories

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On February 3, the Massachusetts Cannabis Control Commission (CCC) issued two public health and safety advisories regarding potentially contaminated marijuana products sold by two separate licensees in Massachusetts....more

Rivkin Radler LLP

State Laws Target Healthcare Investments as Feds Deregulate

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Will the new administration’s federal deregulation be a boon for private equity investment in healthcare providers, or will the states be the “new sheriff in town”? In the short time he has been in office, President Trump...more

Whiteford

Understanding Price Transparency Laws and Gag Clauses: A Guide for Healthcare Providers

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Providers continually struggle to get the fair reimbursement they deserve from payers and often feel powerless to negotiate better rates. However, regulatory changes aimed at increasing price transparency and prohibiting gag...more

Holland & Hart LLP

Idaho's Abortion Statute: EMTALA Exception Narrowed

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Last week, the US District Court for the District of Idaho entered another preliminary injunction prohibiting enforcement of Idaho’s Total Abortion Ban (IC § 18-622) if the abortion is necessary to stabilize a pregnant woman...more

King & Spalding

Seventh Circuit Rules that Hospital Cannot Sue Their States to Enforce Medicaid Prompt Payment Obligations

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On March 14, 2025, the Seventh Circuit Court of Appeals ruled en banc (i.e., in a decision by the full court) that a Chicago hospital cannot sue the State of Illinois for injunctive/declaratory relief that would compel the...more

Foley & Lardner LLP

DEA Buprenorphine Rule Delayed to December 31, 2025

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The U.S. Department of Health and Human Services (HHS) and the Drug Enforcement Administration (DEA) have postponed the effective date of the final rule regarding telemedicine prescribing of buprenorphine (the final...more

Gardner Law

Why Compliance Audits Are Non-Negotiable

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In today’s heightened enforcement environment, compliance auditing isn’t just a best practice—it’s a necessity. Federal and state laws and industry guidance, including the Office of Inspector General (OIG) Compliance Program...more

Robins Kaplan LLP

Settlement Highlights Issue of Deliberate Indifference Involving Medical Need in Jails

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A recent $2.75 million settlement by Robins Kaplan LLP has drawn attention to a troubling case of deliberate indifference to medical needs at Anoka County Jail (the “Jail”). Deyonta Green, who struggled with addiction issues,...more

Epstein Becker & Green

The End of the Self-Affirmed GRAS Pathway?

Epstein Becker & Green on

On March 10, 2025, Robert F. Kennedy, Jr., Secretary of the U.S. Department of Health and Human Services (“HHS”), in a seismic shift, announced that the U.S. Food and Drug Administration (“FDA”) would “explore potential...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

Holland & Knight LLP

New York State Department of Health Issues Long-Awaited Guidance on Material Transactions Law

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The New York State Department of Health (DOH) has published a set of Frequently Asked Questions (FAQs) to provide guidance on the "Disclosure of Material Transactions" law that took effect on Aug. 1, 2023. Pursuant to Article...more

McDermott+

Healthcare Preview for the Week of: March 24, 2025

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Lawmakers are back in Washington, DC, after a week-long recess. Both chambers will be in town for three weeks before a two-week Easter recess in mid-April. With the government funded through the end of this fiscal year, focus...more

Groom Law Group, Chartered

Plaintiffs Double Down on Challenges to PBM Arrangements in Class Action Lawsuits Involving Johnson & Johnson and JPMorganChase

On March 10, 2024, the plaintiffs filed an amended complaint in a much-followed putative class action lawsuit against Johnson & Johnson (“J&J”) alleging that the plan fiduciaries for J&J’s group health plan violated ERISA by...more

McGuireWoods LLP

Texas House Bill 3749 Proposes Stricter Regulations for Medical Spas

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As the medical spa industry rapidly expands, states are increasing regulatory oversight to ensure patient safety and compliance with medical standards. Texas is the latest state to propose legislation targeting med spas,...more

Hogan Lovells

French supreme Court, March 20, 2025, Alexion Pharma France: a historic turnaround for the financial regulation of French...

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In a decision of 20 March 2025 (Appeal No. N 22-23.927), the FR supreme Court ruled that the “product clawbacks” negotiated with the Economic Committee for Health Products (‘CEPS’) on the price of pharmaceutical products...more

Baker Donelson

Looking Back at 2024: Key Health Care Regulatory Legal Developments in Fraud and Abuse, Compliance, and Enforcement

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The health care regulatory space realized significant regulatory and enforcement developments in 2024 that are influencing how providers and industry stakeholders approach various compliance measures and enforcement...more

Smart & Biggar

PMPRB announces Anie Perrault as acting Chairperson and releases latest expenditure report on private drug plan costs and...

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On March 6, 2025, the Patented Medicine Prices Review Board (PMPRB) announced that Thomas Digby stepped down from his role as Chairperson of the PMPRB. Vice-Chairperson Anie Perrault is now serving as acting Chairperson until...more

Hogan Lovells

State Licensing Spotlight – Medical Device Manufacturers & Distributors: Compliance Strategies for Avoiding or Reducing Penalties

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Medical device manufacturers and distributors have come under increasing scrutiny from state licensing agencies and operating without a required license may lead to severe consequences. These can include financial penalties;...more

Goodwin

Celltrion Wins Costco Formulary Listing for its Recently Launched Ustekinumab

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Last week, we reported Celltrion’s U.S. launch of STEQEYMA® (ustekinumab-stba), a biosimilar of Janssen’s STELARA® (ustekinumab).  According to Celltrion, STEQEYMA® is being sold at a wholesale acquisition cost (WAC) list...more

Morgan Lewis - Well Done

The Future of Artificial Colors in the US Food Supply Is Not So Bright

Only weeks after being confirmed, the Department of Health and Human Services (HHS) secretary has advised food companies to remove artificial colors from their food products. He recently met with several major food brand...more

Akin Gump Strauss Hauer & Feld LLP

HHS, FDA Announce Multiple Initiatives on Food Safety, Quality and Compliance Fronts

In the past week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS) announced three new initiatives related to food safety and food supply chain transparency....more

Kerr Russell

How to Handle Visits or Contacts by an ICE Agent

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It has been reported that dentists and other health care professionals have been visited/contacted by U.S. Immigration and Customs Enforcement agents seeking to carry out “immigration policies” and to remove those unlawfully...more

Stevens & Lee

U.S. HHS Announces Closure of Six Regional Locations of the Office of the General Counsel

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On March 11, 2025, the U.S. Department of Health and Human Services (HHS) announced plans for a “reorganization of the Office of the General Counsel” (OGC) “[a]s part of the department’s ongoing efforts to advance the...more

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