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Health Toxic Torts

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Epstein Becker & Green

Telehealth Cliff Averted, for Now (But September is Six Months Away)

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The potential plunge off the telehealth cliff that we warned you about in our March 3, 2025, blog post has been averted, for now....more

Akerman LLP - HR Defense

Hospital Leaders: Are You Fully Prepared For the Rising Wave of H-1B Onsite Inspections in Healthcare Systems Nationwide? Let’s...

In recent months, hospitals and healthcare systems across the country have seen an increase in random and unannounced worksite inspections by immigration officers, particularly targeting H-1B nonimmigrant worker visa holders....more

Robins Kaplan LLP

The Robins Kaplan Justice Report - Vol. 19, No. 1 - March 2025

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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

Nelson Mullins Riley & Scarborough LLP

Gold Dome Report - Legislative Day 35 - March 2025

Much like construction happening with the legislative offices, gutting and stuffing began in earnest today — the 35th day of the legislative session. But we aren’t talking about the Georgia Capitol renovations that are...more

Arnall Golden Gregory LLP

Step by Step: FDA Cracks Down on Unauthorized Medical Device Modifications

The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more

McDonnell Boehnen Hulbert & Berghoff LLP

Newman v. Moore -- Down to a "Battle of the Experts"?

The dispute between the Judicial Council of the Federal Circuit and The Honorable Pauline Newman, Circuit Judge for the U.S. Court of Appeals for the Federal Circuit has been waging for more than a year (see links below). The...more

Hogan Lovells

HHS Secretary Directs FDA to Explore Rulemaking to Eliminate Self-GRAS Pathway

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The Secretary of the U.S. Department of Health and Human Services (HHS), Robert F. Kennedy, Jr., recently issued a press release directing the Food and Drug Administration (FDA) to take steps to explore possible rulemaking to...more

McGuireWoods Consulting

Health Care Executive Orders And Legal Actions: Part Five

This is part five in a series of executive orders related to health care. Trump Recission of Biden Administration Executive Orders - Medicaid and the Affordable Care Act (ACA)...more

Knobbe Martens

Boston Scientific Agrees to Acquire Sonivie Ltd. For up to $540 Million

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Boston Scientific recently announced it entered into a definitive agreement to acquire SoniVie Ltd. According to the press release, SoniVie is a privately held medical device company that developed the TIVUS Intravascular...more

McDermott+

2026 Medicare Advantage and Part D Final Rate Notice: What to Expect

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Key Takeaways - - CMS is expected to issue the 2026 final rate notice for Medicare Advantage (MA) and Part D plans by April 7, 2025. - The January 2025 advance notice proposed policies that would increase payments to MA...more

Holland & Knight LLP

Holland & Knight Health Dose: March 25, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

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?

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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

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