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Clinical Laboratories Enforcement Actions Health Care Providers

Morrison & Foerster LLP

China Issues First Compliance Guidelines to Combat Commercial Bribery Risks - UPDATED February 2025

On January 10, 2025, China’s State Administration for Market Regulation (“SAMR”) put into effect its Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (“Compliance Guidelines”)....more

Holland & Knight LLP

No Sunset on the Horizon for EKRA

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Recently, Holland & Knight healthcare attorneys have received questions as to whether the Eliminating Kickback in Recovery Act (EKRA) is still in effect, given the recent expiration of many provisions of the Substance...more

Health Care Compliance Association (HCCA)

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

Epstein Becker & Green

The 2023 DOJ Health Care Fraud Enforcement (f/k/a “Takedown”): Big Dollars or Clever Packaging?

Epstein Becker & Green on

On June 28, 2023, the U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services, Office of Inspector General (“HHS-OIG”), along with other federal and state law enforcement partners, announced a...more

WilmerHale

Attorneys General Bring Multistate Data Breach Settlement Against DNA Testing Lab

WilmerHale on

On February 17, 2023, the state attorneys general of Pennsylvania and Ohio reached a settlement with Ohio-based DNA Diagnostics Center (“DDC”) for a 2021 data breach that affected 2.1 million individuals nationwide and...more

Bass, Berry & Sims PLC

[Virtual Conference] Nashville Healthcare Fraud Conference - December 15th - 16th, 8:00 am - 1:00 pm CST

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Please join us for the 8th Annual Nashville Healthcare Fraud Conference hosted by Bass, Berry & Sims and the Tennessee Hospital Association. Eligible for more than seven hours of CLE credit (including ethics), this...more

Rivkin Radler LLP

DOJ Intervenes in Kickback Lawsuit Against Lab and Hospital Execs

Rivkin Radler LLP on

The U.S. Department of Justice (DOJ) recently intervened in an action filed in Texas against two laboratory CEOs, one hospital CEO, and numerous other executives, employees, and recruiters, seeking civil penalties and treble...more

Goodwin

DOJ False Claims Act Recoveries Exceed $5.6 Billion in 2021

Goodwin on

The U.S. Department of Justice (“DOJ”) recently announced that over $5.6 billion in False Claims Act (“FCA”) settlements and judgments had been reached during the 2021 fiscal year, with over $5 billion of those settlements...more

Davis Wright Tremaine LLP

[Ongoing Program] Healthcare Regulatory and Compliance Seminar: Telehealth, and Government Investigations of Health Care Providers...

Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance. This year’s seminar will take place virtually on March 15, March 17, March 22, and...more

Davis Wright Tremaine LLP

[Ongoing Program] Healthcare Regulatory and Compliance Seminar: Healthcare Privacy, Criminal and Civil Enforcement in Healthcare...

Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance. This year’s seminar will take place virtually on March 15, March 17, March 22, and...more

Davis Wright Tremaine LLP

[Ongoing Program] Healthcare Regulatory and Compliance Seminar: COVID-19 Enforcement Trends Panel, Medical Staff and the Quality...

Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance. This year’s seminar will take place virtually on March 15, March 17, March 22, and...more

Davis Wright Tremaine LLP

[Ongoing Program] Healthcare Regulatory and Compliance Seminar: Recent Developments and New Trends in Fraud & Abuse, and The No...

Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance. This year’s seminar will take place virtually on March 15, March 17, March 22, and...more

Davis Wright Tremaine LLP

[Webinar] 2021 DWT Healthcare Regulatory and Compliance Seminar - A Virtual Series - March 18th, 10:00 am - 12:00 pm PT

Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance... Registrants will have the option of selecting the sessions they would like to...more

Davis Wright Tremaine LLP

[Webinar] 2021 DWT Healthcare Regulatory and Compliance Seminar - A Virtual Series - March 16th, 10:00 am - 12:00 pm PT

Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance... Registrants will have the option of selecting the sessions they would like to...more

Davis Wright Tremaine LLP

[Webinar] 2021 DWT Healthcare Regulatory and Compliance Seminar - A Virtual Series - March 11th, 10:00 am - 12:00 pm PT

Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance... Registrants will have the option of selecting the sessions they would like to...more

Davis Wright Tremaine LLP

[Webinar] 2021 DWT Healthcare Regulatory and Compliance Seminar - A Virtual Series - March 9th, 10:00 am - 12:00 pm PT

Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance... Registrants will have the option of selecting the sessions they would like to...more

Bass, Berry & Sims PLC

Penalties for COVID-19 Reporting Failures and Other New CMS Rules on Mandatory Testing and Ordering Limits

Anyone conducting COVID-19 testing – whether using point of care or high complexity tests – should take note. On August 25, the Centers for Medicare & Medicaid Services (CMS) released an Interim Final Rule with comment period...more

Bricker Graydon LLP

Clinical trials and Medicare billing: Avoiding false claims liability

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Participating in clinical trials can leave health care providers vulnerable to false claims liability if Medicare rules are not closely followed. This publication reviews settlements involving clinical trials, provides an...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Annual Review 2019

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Bass, Berry & Sims is pleased to announce the release of the 2019 edition of its Healthcare Fraud & Abuse Annual Review. Compiled by the firm’s Healthcare Fraud Task Force, the Review is an in-depth and comprehensive analysis...more

Buchalter

Nation’s First Conviction under EKRA

Buchalter on

What appears to be the United States’ first conviction under the Eliminating Kickbacks in Recovery Act (“EKRA”) occurred last month when the United States District Court for the Eastern District of Kentucky accepted the...more

King & Spalding

DOJ Reports More Than $3 Billion Recovered from False Claims Act Cases in Fiscal Year 2019

King & Spalding on

On January 9, 2020, DOJ announced it recovered more than $3 billion in settlements and judgments from civil cases involving fraud and false claims against the government in the fiscal year ending September 30, 2019. DOJ...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

Holland & Knight LLP

FDA Commissioner Speaks Out on Compliance and Enforcement

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On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more

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