News & Analysis as of

Enforcement Actions Genetic Testing

Rivkin Radler LLP

Genetic Testing Marketing Companies and Executives Settle Medicare Fraud Allegations for $6 Million

Rivkin Radler LLP on

The U.S. Attorney’s Office for the Eastern District of Pennsylvania announced on April 23 that Genexe, LLC (doing business as Genexe Health) and its parent company, Immerge, Inc., along with two of their executive...more

Morrison & Foerster LLP

When Your Life Sciences Are on the Line: False Claims Act

Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the ninth episode of When Your Life Sciences Are on the...more

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - January 2025

Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more

Morrison & Foerster LLP

New HHS-OIG Guidance on Sponsored Genetic-Testing Programs

On December 17, 2024, the Department of Health & Human Services, Office of Inspector General (HHS-OIG) issued its second favorable advisory opinion involving an arrangement in which a drug manufacturer sponsors genetic...more

WilmerHale

FTC Calls Out Genetic Data as an Enforcement Priority

WilmerHale on

The Federal Trade Commission (FTC) recently published a post on their Business Guidance Blog discussing lessons learned from three enforcement actions against sellers of genetic testing products. These guidelines address...more

WilmerHale

FTC Announces Enforcement Action Against 1Health.io for Inadequate Protection of Genetic Data and Unfair Privacy Policy Changes

WilmerHale on

On June 16, the Federal Trade Commission (FTC) announced an enforcement action against 1Health.io Inc. (“1Health,” also known as Vitagene, Inc.), a genetic testing company that analyzes consumer-provided DNA samples and uses...more

Epstein Becker & Green

Beyond HIPAA: FTC’s Data Protection Authority Results in Settlement with Genetic Testing Company

Epstein Becker & Green on

A recent enforcement action by the Federal Trade Commission (“FTC”) against 1Health.io—which sells “DNA Health Test Kits” to consumers for health and ancestry insights—serves as a reminder that the FTC is increasingly...more

Bradley Arant Boult Cummings LLP

Genetic Testing Fraud: A New Wave of Medicine, a New Wave of Enforcement Actions

Genetic testing is a burgeoning area of preventative and predictive medicine. Such testing enables greater insight into a patient's unique genetic makeup and, in turn, more tailored and individualized medical decisions....more

Robinson+Cole Health Law Diagnosis

The DOJ Continues to Prosecute Providers for Fraudulent Telemarketing and Telehealth

A physician in Washington state pled guilty on September 28, 2022, to a criminal charge of conspiring to accept kickbacks related to fraudulent genetic testing. According to the Department of Justice (DOJ), the physician...more

The Volkov Law Group

False Claims Investigations and Criminal Prosecutions: Recent Examples of Criminal Charges – a Lab Owner, A Physician and a Nurse...

The Volkov Law Group on

A False Claims Act case can easily turn into a criminal prosecution.  The Federal Bureau of Investigation often initiates criminal investigations as part of its commitment to reducing health care fraud....more

The Volkov Law Group

Department of Justice Brings Criminal Charges Against 35 Individuals for Involvement in $2.1 Billion in Fraudulent Genetic Testing...

The Volkov Law Group on

The Justice Department, in coordination with HHS-OIG and the FBI recently announced the arrest and prosecution of 35 individuals for a massive genetic testing fraud scheme involving dozens of telemedicine companies and cancer...more

Mintz - Health Care Viewpoints

OIG Issues Fraud Alert Regarding Fraudulent Genetic Testing Schemes

Earlier this week the OIG took the somewhat unusual step of issuing a fraud alert directed to Medicare beneficiaries (rather than to Medicare providers) regarding “fraud schemes” that involve genetic testing. According to the...more

Akin Gump Strauss Hauer & Feld LLP

Checking In On FDA’s Enforcement Discretion Policy for Laboratory Developed Tests

• In a recent warning letter, the Food and Drug Administration (FDA) advised a laboratory to seek marketing authorization for its genetic tests that qualified as laboratory developed tests (LDTs)—which have largely benefited...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues Warning Letter to Lab Marketing Three Laboratory-Developed Tests

In an April 4, 2019 Press Release, the U.S. Food and Drug Administration (FDA) announced its issuance of a Warning Letter to Inova Genomics Laboratory (Inova) in Virginia for marketing genetic tests for predicting medication...more

Bass, Berry & Sims PLC

FDA Warns Against Direct-to-Consumer Lab Developed Tests

Bass, Berry & Sims PLC on

Despite it being a continual topic of discussion, the Food and Drug Administration (FDA) enforcement in the realm of laboratory developed tests (LDTs) has been relatively quiet in recent years. That is, until earlier this...more

Holland & Knight LLP

Holland & Knight's Israel Practice Newsletter - Winter 2017

Holland & Knight LLP on

Holland & Knight invites you to read our Winter 2017 Israel Practice newsletter, in which our authors discuss pertinent American-Israeli topics. As Israel has been a crossroads and a prolific source of new ideas for more than...more

16 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide