News & Analysis as of

Medicare Clinical Laboratories

Rivkin Radler LLP

NYC Man Pleads Guilty in $3.5 Million COVID-19 Kickback Scheme

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On February 26, David Weathers of the Bronx pleaded guilty in federal court in New Jersey for his role in a COVID-19 kickback conspiracy. The government had charged Weathers with soliciting kickbacks in return for referrals...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

ArentFox Schiff

Investigations Newsletter: Clinical Laboratory and CEO To Pay Over $13 Million to Settle False Claims Act Allegations

ArentFox Schiff on

Clinical Laboratory and CEO To Pay Over $13 Million to Settle False Claims Act Allegations - A New Jersey-based laboratory, RDx Bioscience Inc. (RDX), and its owner and CEO, Eric Leykin, agreed to pay $10,315,023 to the US...more

Akin Gump Strauss Hauer & Feld LLP

Unfinished Health Care Business: 10 Issues to Watch as Congress Rings in the New Year

Health care was one of the most active issue areas in 2023 and this trend is expected to continue when Congress returns in the New Year for the second session of the 118th Congress. The activity by the health committees of...more

Benesch

Opportunities and Challenges for Office-Based Labs and Ambulatory Surgery Centers: Six Main Takeaways from the Benesch Healthcare+...

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Six Main Takeaways from the Benesch Healthcare+ Nephrology & Dialysis Conference. Experts included Dapo Afolabi, M.D., President and CEO of Fort Worth Renal Group, Terry Litchfield, President of Access Solutions, Jason...more

Bass, Berry & Sims PLC

CY 2023 Medicare Physician Fee Schedule: Clinical Laboratory Update

Bass, Berry & Sims PLC on

On November 2, 2022, Centers for Medicare & Medicaid Services (CMS) filed its final rule implementing changes to the Medicare Physician Fee Schedule for CY 2023 (Final Rule). Embedded within this Final Rule are important...more

Benesch

Modern Vascular is the Latest Defendant in a Growing Trend of Qui Tam Relator Cases against Office-based Lab Companies

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Earlier this month a federal judge unsealed a federal qui tam relator complaint originally filed in January 2020 by Dr. Jay Radhakrishnan and Dr. William Julien against Arizona-based Modern Vascular and certain of its...more

King & Spalding

D.C. Circuit Issues Favorable Decision in Medicare Clinical Laboratory Case

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On July 15, 2022, the D.C. Circuit issued a decision in favor of the American Clinical Laboratory Association (ACLA) in American Clinical Laboratory Association v. Becerra. The decision is the latest chapter in long-pending...more

Mintz - Health Care Viewpoints

PAMA Laboratory Reporting In Flux: ACLA Wins HHS Lawsuit and Congress Introduces PAMA Amendment Legislation

Important developments related to required price reporting to Medicare for clinical laboratories under the Protecting Access to Medicare Act of 2014 (PAMA) have recently occurred. As a result, the clinical laboratory...more

Dorsey & Whitney LLP

How EKRA and AKS Impact Laboratories and Commission-Based Compensation

Dorsey & Whitney LLP on

With the enactment of the Eliminating Kickbacks in Recovery Act (“EKRA”) in 2018, the permissibility of commission-based compensation to laboratory sales representatives based on volume, revenue, or profit has come under...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

Womble Bond Dickinson

What to Expect as OIG and CMS Audits Focus on COVID-19 Testing?

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The COVID-19 pandemic has caused an enormous need for testing and has spawned the creation of new labs and specimen collection agencies to (try to) meet that need. In 2020 alone, Medicare spent $1.5 billion on COVID-19 tests....more

Alston & Bird

Alston & Bird Health Care Week in Review - January 2022 #3

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, 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...

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

Oberheiden P.C.

Eight Keys to Developing an OIG Compliance Program for Hospitals

Oberheiden P.C. on

The Office of Inspector General is a division of the U.S. Department of Health and Human Services that is tasked with combating fraud committed against Medicare, Medicaid, and other federally funded government programs. The...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

Oberheiden P.C.

EKRA Rules, Regulations & Compliance: 5 Tips that Health Care Providers Need to Know

Oberheiden P.C. on

Most health care providers have at least a basic understanding of the Anti-Kickback Statute. This federal law prohibits providers from offering, paying, soliciting, or accepting any form of “remuneration” for patient...more

Holland & Knight LLP

CMS Releases 2021 OPPS and ASC Payment System Final Rule

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The Centers for Medicare & Medicaid Services (CMS) has published the Calendar Year (CY) 2021 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule. Note that the...more

Jackson Walker

CMS Implements Stricter COVID-19 Testing Regulations on Nursing Homes

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As part of a broader Trump administration announcement made on August 25, 2020, the Centers for Medicare & Medicaid Services (CMS) issued sweeping oversight changes in the form of an Interim Final Rule with Comment Period...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

Health Care Compliance Association (HCCA)

CMS reveals new HCPCS code for coronavirus lab tests

Compliance Today (May 2020) - The Centers for Medicare & Medicaid Services (CMS) announced on March 6, 2020, in a special edition of MLN Connects[1] that the agency has taken “additional actions to ensure America’s...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

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