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Stevens & Lee

Intent Required Under the Anti-Kickback Statute: Supreme Court Lets Stand Second Circuit’s Decision in the McKesson Case

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On Oct. 7, the U.S. Supreme Court denied a petition for review and let stand a widely watched Second Circuit Court of Appeals decision in which the court ruled that the term “willfully” as used in the Anti-Kickback Statute...more

Fenwick & West LLP

Heart of Healthcare Podcast: FTC Chair Lina Khan on Healthcare, Antitrust, and the Future of Competition

Fenwick & West LLP on

In a recent episode of the Heart of Healthcare podcast, co-hosts Michael T. Esquivel and Halle Tecco, sat down with Federal Trade Commission (FTC) Chair Lina Khan, who offered her perspective on the intersection of antitrust...more

King & Spalding

OIG Report Concludes That CMS Needs to Strengthen its Oversight of Remote Patient Monitoring

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On September 24, 2024, OIG released a report recommending that CMS exercise additional oversight of remote patient monitoring (RPM) services provided to Medicare beneficiaries. Medicare reimburses RPM for any chronic or acute...more

Foley & Lardner LLP

USC Announces Stem Cell Collaboration

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Treatment and prevention of heart failure are unmet medical needs in the United States. One in every eight deaths in the United States can be linked to this disease. The Keck School of Medicine at USC and the biotechnology...more

Fisher Phillips

Open Enrollment Season in the Workplace: 5 Legal Considerations + Employer Takeaways

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Open enrollment season can put a spotlight on the many complex rules applicable to employer-sponsored health and welfare plans. As you announce your benefit offerings for the upcoming plan year and tirelessly work to inform...more

Baker Botts L.L.P.

California Extends Privacy Law to Cover Neural Data

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On September 29, 2024, California took a significant step forward in data privacy protection by passing a law that extends the California Consumer Privacy Act (CCPA) to cover neural data—brain activity and related information...more

Morgan Lewis

February 2, 2026 Is Quickly Approaching—Are You QMSR Ready?

Morgan Lewis on

With the February 2, 2026 compliance deadline approaching, medical device manufacturers must prepare for FDA’s updated regulations. The new Quality Management System Regulation (QMSR) will replace the existing Quality System...more

Vinson & Elkins LLP

Supreme Court Declines to Revisit Limitations on Anti-Kickback Statute: What This Means for Enforcement of Corruption, Kickbacks...

Vinson & Elkins LLP on

On October 7, 2024, the U.S. Supreme Court declined to hear a case concerning the “willfulness” element of the Anti-Kickback Statute (the “AKS”). This decision leaves intact a recent Second Circuit holding, which established...more

Cozen O'Connor

Multistate Coalition Settles False Claims Allegations with Precision Diagnostics

Cozen O'Connor on

A multistate coalition of 44 AGs and the U.S. Department of Justice settled with Precision Toxicology, LLC d/b/a Precision Diagnostics, Inc. (Precision) to resolve allegations that it made false claims to multiple federal...more

BakerHostetler

Make no mistake, pharmacies can still deliver controlled substances to patients

BakerHostetler on

Under the federal Controlled Substances Act (CSA) and the Drug Enforcement Administration’s (DEA) implementing regulations, pharmacies must deliver controlled substances to the ultimate user. Common sense, as well as DEA’s...more

Proskauer - Health Care Law Brief

Fault Lines Expected to Deepen: Major False Claims Act Circuit Split

The health care industry is anxiously awaiting the First Circuit’s ruling on the standard of causation for actions brought under the False Claims Act (FCA) predicated on a federal Anti-Kickback Statute (AKS) violation. The...more

Morgan Lewis

Understanding the NewCo Model: A Trending Approach of Chinese Pharmaceutical Companies

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Inventive deal structures are on the rise within China’s life sciences industry, with the “NewCo” model having garnered significant interest among Chinese pharmaceutical companies in recent years. In 2024, several landmark...more

Orrick, Herrington & Sutcliffe LLP

Life Sciences Snapshot – Q3 2024 – A Quarterly Report on Financing Trends

This report series examines quarterly trends in life sciences venture investment. Key findings for Q2 2024 include: • Life sciences VC deal value reached $10.6 billion in Q2 2024, up more than 30% from Q1, which brings the...more

Brownstein Hyatt Farber Schreck

Health Care Policy Positions: Expectations for a Harris or Trump White House

With less than one month until the presidential election, health care policy issues are at the forefront of voters’ minds, including issues around drug pricing, federal research funding and reproductive rights....more

Manatt, Phelps & Phillips, LLP

CMS Releases Guidance Outlining Expectations for State Compliance with Medicaid & CHIP Renewal Requirements

On September 20, 2024, the Centers for Medicare & Medicaid Services (CMS) issued guidance detailing the timeline and expectations for states to fully comply with federal Medicaid and Children’s Health Insurance Program (CHIP)...more

Benesch

Dialysis & Nephrology Digest - October 2024

Benesch on

The House Ways and Means Committee has postponed discussions on several healthcare bills, including those related to physician pay, due to scheduling conflicts and disagreements over legislative language. This delay affects...more

Arnall Golden Gregory LLP

New OIG Report Suggests Medicare Remote Patient Monitoring Services May Face Increased Government Scrutiny

On September 24, 2024, the U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) posted a report entitled, “Additional Oversight of Remote Patient Monitoring in Medicare is Needed.”...more

WilmerHale

Texas Attorney General’s Office Reaches Settlement with AI Company Over Deceptive Claims

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On September 18, the Texas Attorney General (AG) announced a settlement agreement with Pieces Technologies, Inc. (“Pieces”), a Dallas-based healthcare artificial intelligence (AI) research and development firm, resolving...more

Faegre Drinker Biddle & Reath LLP

DOJ Targets Telemedicine Companies for Additional False Claims Act Recoveries

Telemedicine, which has been a fertile source of criminal prosecutions for federal prosecutors in recent years, is increasingly generating federal False Claims Act cases. This development is hardly surprising as the U.S....more

Hogan Lovells

Final FDA electronic systems guidance offers greater compliance flexibility

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) finalized its revised guidance summarizing how it intends regulate the use of electronic systems, records, and signatures in clinical investigations to account for advances in...more

McDermott Will & Emery

Tirzepatide Shortage Resolved

McDermott Will & Emery on

On October 3, 2024, the US Food and Drug Administration (FDA) revised its shortage categorization of tirzepatide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the...more

McGuireWoods LLP

Ounce of Prevention: Are You Providing Free Auxiliary Aids and Services to Individuals With Disabilities?

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Applicable Provider Types: All - Is Your Entity in Compliance? Recent regulatory language makes clear that most healthcare providers must provide free auxiliary aids and services for patients with disabilities....more

Downs Rachlin Martin PLLC

CMS – the Federal Agency that Administers Medicare and Medicaid – Recognizes Traumatic Brain Injury as a “Chronic Health...

For more than a decade this blog has covered the growing recognition by policy makers and in the peer reviewed literature that traumatic brain injuries (TBIs) of all kinds should not be treated as a static event from which...more

Orrick, Herrington & Sutcliffe LLP

California bans medical debt in credit reporting determinations

On September 24, the Governor of California approved SB 1061 (the “Act”), which prohibits consumer credit reporting agencies from including medical debt in consumer credit reports. In addition, a consumer reporting agency may...more

Ward and Smith, P.A.

Reopening Restaurants in Buncombe County after Helene: What We Know Today

Ward and Smith, P.A. on

Buncombe County's Environmental Health Supervisor Felissa Vazquez met with local restaurant owners at 12 Bones Brewing on the morning of October 8, 2024, to answer questions and advise them on how to reopen their businesses...more

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