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McDermott Will & Emery

OIG Nursing Facility Compliance Program Guidance: Renewed Focus on Fraud and Abuse

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The US Department of Health and Human Services Office of Inspector General’s (OIG’s) release of Nursing Facility Industry Segment-Specific Compliance Program Guidance (ICPG) for the first time since 2008 reemphasizes the...more

Sheppard Mullin Richter & Hampton LLP

Reminder: FDA Does, In Fact, Review DOF

When was the last time you thought about “data on file” (“DOF”)? Probably not recently, but last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted an untitled letter (the...more

A&O Shearman

First Circuit Ruling Requiring “But-For” Causation In FCA Kickback Claims Deepens Circuit Split

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In an opinion that may complicate the U.S. Department of Justice’s (“DOJ”) efforts to enforce the False Claims Act (“FCA”), the U.S. Court of Appeals for the First Circuit held in a unanimous opinion on February 18, 2025 that...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

A&O Shearman

Eastern District Of Pennsylvania Grants Defendants’ Motion To Dismiss Allegations Of Tying Discounted Drug Prices With Third-Party...

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On February 26, 2025, Judge Mia Perez of the United States District Court for the Eastern District of Pennsylvania granted defendants’ motion to dismiss plaintiff’s Sherman Act and Clayton Act claims, though the plaintiff had...more

McDermott Will & Emery

HHS OCR Investigates Medical Schools and Hospitals for Race- or Sex-Based Programs

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On March 7, 2025, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that it would begin investigating four medical schools and hospitals pursuant to President Donald Trump’s...more

Groom Law Group, Chartered

This Week From the Hill (March 9 – 15, 2025)

Each week while Congress is in session, our Policy team delivers a key update to highlight a topical benefits, health, or retirement news item from the Hill, such as a newly introduced bill, a summary of a committee hearing,...more

McDonnell Boehnen Hulbert & Berghoff LLP

Five Years Ago Today . . .

On March 11, 2020, World Health Organization Director-General Tedros Adhanom declared that the COVID-19 outbreak "can be characterized as a pandemic," and cautioned that the WHO has "rung the alarm bell loud and clear."  At...more

Frost Brown Todd

Proposed HIPAA Security Rule Requires AI Governance

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In terms of healthcare data breaches, 2024 was the worst year ever, with the records of at least 53% of the U.S. population involved and two of the biggest healthcare data breaches of 2024 ranking in the top 10 of all time. ...more

Bradley Arant Boult Cummings LLP

Georgia Legislature Considering Substantial Overhaul to Medical Marijuana, Hemp Laws

I’ve had Georgia on my mind these days. I needed to get that out immediately because otherwise I would have been hearing that song in my head the entire time I was writing. As is the case in many capitals around the...more

Stevens & Lee

Can Pennsylvania Certified Registered Nurse Practitioners Own a Medical Practice Solo?

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In Pennsylvania, Certified Registered Nurse Practitioners (CRNPs) do not have independence of practice. They may provide diagnoses and prescribe treatments only in collaboration with a physician, as per the details of their...more

Axinn, Veltrop & Harkrider LLP

GTCR / Surmodics: Four Key Takeaways for M&A Antitrust from the First FTC Merger Challenge Under Trump

In the FTC’s first merger challenge of the new administration, the FTC voted 4-0 last week to challenge the proposed acquisition of Surmodics by private equity firm GTCR BC Holdings (“GTCR”). As the Trump administration’s...more

ArentFox Schiff

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

ArentFox Schiff on

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

Whiteford

Client Alert: CMS Again Delays Updates to its Guidance to Surveyors for Long Term Care Facilities Under Appendix PP of the State...

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On March 10, 2025, the Centers for Medicare & Medicaid Services (“CMS”) announced a further delay in the implementation of proposed updates to its Guidance to Surveyors for Long-Term Care Facilities under Appendix PP of the...more

Mintz - Health Care Viewpoints

Health Law Diagnosed – Understanding the New Massachusetts Health Care Market Review Law

In the latest episode of Health Law Diagnosed, host Bridgette Keller discusses the new Massachusetts Health Care Market Review Law and what this means for health care providers, investors, and other key stakeholders. She is...more

Stikeman Elliott LLP

British Columbia and Prince Edward Island Sign Pharmacare Agreement with Canada Under New Pharmacare Act

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On February 27, 2025, the Government of Canada and Manitoba signed the first national pharmacare agreements under Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”), which received royal assent on October...more

Nelson Mullins Riley & Scarborough LLP

Gold Dome Report - Legislative Day 29 - March 2025

While many lawmakers and lobbyists crawled into the Georgia State Capitol on Monday after the double-whammy of Crossover Day and the return of Daylight Savings Time (to Senator Ben Watson’s chagrin), a few select legislators...more

Bradley Arant Boult Cummings LLP

Appellate Court Paves Way for Launch of Alabama Medical Cannabis Program: Watch What Happens Now

It takes a big person to admit when they are wrong. But I’ll raise my hand and say I was wrong when I predicted that the Alabama Court of Civil Appeals would rule in favor of the Alabama Medical Cannabis Commission in late...more

McDermott+

Healthcare Preview for the Week of: March 10, 2025

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This Friday is the deadline to pass a budget or enter a government shutdown. The House released a continuing resolution (CR) over the weekend and is scheduled to be in session only until Wednesday. The House Rules Committee...more

Bradley Arant Boult Cummings LLP

Federal Appeals Court Rules Against Doctor Seeking to Use Mushrooms to Aide Terminal Patients: How We Learned to Question the...

It’s funny how things work out – sometimes you find yourself living in a sort of butterfly effect where the tail seems to wag the dog. In 2023, when we first started writing about the traction psychedelics were gaining as...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, V 2, Issue 3, March 2025

Welcome to our third issue of 2025 of The Health Record -- our healthcare law insights e-newsletter. In this edition, we look at the possible expiration of telehealth flexibilities for Medicare patients, the potential...more

Goodwin

US Emerging as Top Global Medtech Destination

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For years, medtech firms around the globe (and certainly European companies) introduced their products in Europe, which requires obtaining a CE mark certifying compliance with relevant EU health and safety standards, prior to...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - March 2025 #1

News Briefs - Trump Signs Executive Order to Improve Health Price Transparency - U.S. President Donald Trump signed an executive order aiming to improve price transparency on healthcare costs by directing federal agencies to...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

K&L Gates LLP

First Circuit Adopts But-For Causation Standard for Kickback-Premised False Claims Act Actions

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On 18 February 2025, the First Circuit Court of Appeals issued its decision in United States v. Regeneron Pharmaceuticals, Inc., determining that “but-for” causation is the proper standard for False Claims Act (FCA) actions...more

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