News & Analysis as of

Enforcement Actions Clinical Laboratories

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?

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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

Sheppard Mullin Richter & Hampton LLP

Laboratory and Pathology Information Blocking Concerns

Recently, we were invited to speak on a panel at the Executive War College on Diagnostics, Clinical Laboratory and Pathology Management. We spoke about the federal information blocking rules, and highlighted how some actors...more

WilmerHale

Attorneys General Bring Multistate Data Breach Settlement Against DNA Testing Lab

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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

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | December 2022 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between November 21 and December 31, 2022, including recent enforcement activity and a summary of the Office of Inspector...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

Robinson & Cole LLP

Clinical ColLABorative - Legal Insights in Laboratory Compliance

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What To Do When The Government Knocks On Your Lab’s Door - The volume of federal enforcement actions involving laboratories has increased dramatically over the last few years. Not a month seems to pass without a press...more

Holland & Knight LLP

The State of EKRA: Summer 2022

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Enacted in 2018, the Eliminating Kickbacks Recovery Act (EKRA) remains a source of anxiety and confusion in the clinical laboratory industry. In the four years since EKRA's enactment, U.S. Department of Justice (DOJ)...more

Bass, Berry & Sims PLC

OIG Declines to Approve Lab’s Payment of Specimen Collection Fees to Hospitals

On April 28, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-09, declining to approve a laboratory company’s proposal to pay hospitals a fair market...more

Rivkin Radler LLP

DOJ Intervenes in Kickback Lawsuit Against Lab and Hospital Execs

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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

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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

The Volkov Law Group

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

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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

Robinson+Cole ERISA Claim Defense Blog

Second Circuit Addresses Limitations Periods Governing Fraudulent Billing Claims Against Non-Participating Labs

In Connecticut General Life Ins. Co. v. BioHealth Labs., Inc., No. 20-2312-CV, — F.3d –, 2021 WL 476111 (2d Cir. Feb. 10, 2021), Cigna, as administrator of employee health plans, sued six out-of-network lab companies for...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

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