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Laboratories Clinical Laboratories

BCLP

Five years on: EKRA's legacy

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Five years ago Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”). Aimed at combating kickbacks in the addiction treatment industry, EKRA prohibits remunerations in return for patient referrals to...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

Benesch

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

Benesch on

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

Butler Snow LLP

Tennessee Governor Lee Releases Executive Order No. 59 with Focus on Health Care

Butler Snow LLP on

On August 28, 2020, Governor Bill Lee issued Executive Order 59 which extends the state of emergency related to the COVID-19 crisis until September 30, 2020. To help facilitate ongoing targeted regulatory flexibility to...more

Baker Donelson

OIG Nixes Arrangements Involving Free Tests

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Labs Attempt to Counter Exclusive Lab Arrangements - With increasing frequency, clinical laboratories have found themselves unable to receive any payments for tests performed for individuals whose third-party insurer...more

Baker Donelson

Laboratory Discount Arrangements Survive Antikickback Statute Scrutiny

Baker Donelson on

There has been question for some time whether in evaluating certain discount arrangements involving clinical laboratory tests under the federal antikickback statute (FAS), discount charges should be measured against the...more

Mintz - Health Care Viewpoints

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed False Claims Act (FCA) Cases: May 2014

Trends & Analysis: ..We have identified 58 health care–related qui tam cases that have been unsealed since our last Qui Tam Update. Of those, 33 cases were initiated after the start of 2012, with the remaining 25 cases...more

Foley & Lardner LLP

Is Next Generation Sequencing Ready for Personalized Medicine?

Foley & Lardner LLP on

Next generation sequencing (NGS) promises to transform the delivery of health care by providing in one test diagnostic and prognostic information that had previously only been available in multiple analyses. One application...more

McDermott Will & Emery

CMS Announces Plans to Modernize and Update the Clinical Laboratory Fee Schedule

McDermott Will & Emery on

On November 27, 2013, Centers for Medicare & Medicaid Services posted the final 2014 Medicare physician fee schedule and, in it, announced plans to change how and how much Medicare pays for clinical diagnostic laboratory...more

Bradley Arant Boult Cummings LLP

CMS Issues Proposed Rule to Reform "Unnecessary, Obsolete, or Excessively Burdensome" Medicare Participation Standards

On February 4, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to reform Medicare regulations that CMS views as unnecessary, obsolete, and/or excessively burdensome on hospitals and health care...more

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