News & Analysis as of

Medicare False Claims Act (FCA) Food and Drug Administration (FDA)

Greenbaum, Rowe, Smith & Davis LLP

First Circuit Decision Regarding Anti-Kickback Statute Standard Widens Circuit Split and Creates Potential for Supreme Court...

The U.S. Court of Appeals for the First Circuit, in United States v. Regeneron, has joined the Sixth and Eighth Circuits in adopting the “but-for” standard to find that a violation of the Anti-Kickback Statute (AKS) triggers...more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - July 2025

Latham & Watkins LLP on

On July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act, his signature policy legislation. Two aspects of this legislation are particularly relevant for drug pricing....more

Cooley LLP

Fourth Circuit Ruling Guts the Practice of Medicine Defense in FDA Cases

Cooley LLP on

Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson upheld a doctor’s conviction under Section 301(k) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 USC § 331(k) (Section 301(k)), for...more

Foley Hoag LLP

Health Care Fraud Enforcement in 2025

Foley Hoag LLP on

We kick off our annual Year in Preview series with a comprehensive look at health care fraud enforcement in 2025. This post proceeds in three parts. First, we explore what the second Trump administration might bring, looking...more

ArentFox Schiff

Investigation Newsletter: Teva Pharmaceuticals Agrees to Pay $450 Million to Resolve FCA Claims

ArentFox Schiff on

Teva Pharmaceuticals Agrees to Pay $450 Million to Resolve FCA Claims - On October 10, the US Department of Justice (DOJ) announced that Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc. will pay $450 million to...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | July 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more

ArentFox Schiff

Investigations Newsletter: Ultragenyx to Pay $6 Million To Settle False Claims Act Case

ArentFox Schiff on

Ultragenyx to Pay $6 Million To Settle False Claims Act Case - Ultragenyx Pharmaceutical Inc. recently agreed to pay $6 million to settle a qui tam action filed under the False Claims Act (FCA). Ultragenyx manufactures a...more

Foley & Lardner LLP

Remote Patient Monitoring: OIG Issues Consumer Alert

Foley & Lardner LLP on

On November 22, 2023, while many were preparing for the Thanksgiving holiday, the Office of Inspector General (OIG) posted a consumer alert (Alert) warning the public about a fraud scheme involving monthly billing for remote...more

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | July 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more

Husch Blackwell LLP

Georgia Physician Awaits $27+ Million Judgment Following False Claims Act Trial Loss

Husch Blackwell LLP on

On June 14, 2023, a federal jury found that a Georgia physician knowingly violated the False Claims Act following a two-week trial on allegations that he made false claims to the Medicare Program. Now, despite just $1.1...more

Warner Norcross + Judd

Second Circuit Rules Anti-Kickback Statute Means No “Corrupt Intent” Required for Liability

Warner Norcross + Judd on

On January 9, 2023, the U.S. Supreme Court denied Pfizer Inc.’s petition for a writ of certiorari. The denial brought the pharmaceutical company’s lawsuit challenging the breadth of the federal Anti-Kickback Statute (AKS) to...more

Wilson Sonsini Goodrich & Rosati

2022-2023 Medical Product and Service Regulatory Initiatives

The medical product and healthcare service industry is one of the most closely regulated sectors in the U.S. Several agencies actively exercise authority with constantly changing legislation and policies to keep pace with...more

Foley & Lardner LLP

Migraine Company Fails to Avoid Own Headache: Jet Medical and Others to Pay $745,000 to Resolve Allegations that Medical Device...

Foley & Lardner LLP on

On January 4, 2023, the Department of Justice issued a press release stating that Jet Medical Inc. has agreed to pay $200,000 to resolve criminal allegations relating to a migraine headache treatment. Jet Medical and two...more

ArentFox Schiff

Investigations Newsletter: Medical Device Company to Pay Over $700,000 To Resolve Criminal Allegations

ArentFox Schiff on

Medical Device Company to Pay Over $700,000 To Resolve Criminal Allegations - On January 4, 2023, a criminal information was filed in the Southern District of Illinois, in which Jet Medical Inc. (Jet), a medical device...more

ArentFox Schiff

Investigations Newsletter: Medical Technology Company President Convicted for Participation in $77 Million COVID-19 and Allergy...

ArentFox Schiff on

Medical Technology Company President Convicted for Participation in $77 Million COVID-19 and Allergy Testing Scheme - On September 1, 2022, the president of Arrayit Corporation, a medical technology company in Silicon...more

ArentFox Schiff

Investigations Newsletters: US Supreme Court Requests Solicitor General's Views in FCA Rule 9(b) Context

ArentFox Schiff on

US Supreme Court Requests Solicitor General’s Views in FCA Rule 9(b) Context - On May 16, 2022, the US Supreme Court requested a brief from the US Solicitor General on the level particularly required by Federal Rule of...more

Holland & Knight LLP

Healthcare Law Update: October 2021

Holland & Knight LLP on

Kathryn Isted In Harbor Healthcare System, L.P. v. United States, 5 F.4th 593 (5th Cir. 2021), the court of appeals ruled that the district court abused its discretion in refusing to exercise its equitable jurisdiction over a...more

Health Care Compliance Association (HCCA)

Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act

While the pandemic put many things on hold, it did not do the same for the False Claims Act (FCA). To find out what is happening in FCA activity we spoke with Patrick Hooper, Jordan Kearney and Alicia Macklin, partners at the...more

The Volkov Law Group

Alere Agrees to Pay $38.75 Million to Settle False Claims Act Violations (Part II of V)

The Volkov Law Group on

Alere, Inc. and its San Diego subsidiary, agreed to pay $38.75 million to resolve False Claims Act charges for billing the Medicare program for defective rapid point-of-care testing devices. ...more

MoFo Life Sciences

Ninth Circuit Weighs In On Fraud-On-The-FDA Theory, Marketing Devices For Off-Label Use, And Kickbacks

MoFo Life Sciences on

The Ninth Circuit recently weighed in on the appeal of a False Claims Act lawsuit from a relator against Medtronic. In this case, the relator alleges that Medtronic, Inc.: (1) Engaged in “fraud-on-the-FDA” when obtaining...more

Holland & Knight LLP

Healthcare Law Update: April 2021

Holland & Knight LLP on

William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more

Cozen O'Connor

1st Amendment Win For Credit Card Surcharges| Texas Sues Over Electricity Bills | Dodgy COVID Fees

Cozen O'Connor on

2022 AG Elections- Former South Dakota Attorney General Steps Back into Contention for AG’s Office- •Marty Jackley, who formerly served as U.S. Attorney for South Dakota, South Dakota AG, and President of the National...more

Cozen O'Connor

FTC Under New Management | First Assertion Of The BOTS Act | Ash Cleanup Costs Redistributed

Cozen O'Connor on

Breaking News- New Leadership at the FTC- •President Joseph R. Biden designated Federal Trade Commission (“FTC”) Commissioner Rebecca Kelly Slaughter as Acting Chair of the FTC . •As Commissioner, Chairwoman...more

Dorsey & Whitney LLP

In the First FCA Appellate Case of 2021, the Fourth Circuit Affirms the Dismissal of Relators’ Claims for Lack of Scienter and...

Dorsey & Whitney LLP on

On January 8, 2021, in the first appellate decision of the year addressing a False Claims Act case, the Fourth Circuit affirmed the summary judgment dismissal of relators’ claims that a manufacturer of allergenic extracts...more

Holland & Knight LLP

Healthcare Law Update: February 2020

Holland & Knight LLP on

Neurosurgeons' Compensation in Top 10 Percent Nationwide Gives Rise to Stark Act and FCA Claims - In United States ex re. Bookwalter v. UPMC, 946 F. 3d 162 (3d Cir. 2019), the court ruled that the relators stated a Stark...more

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