Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
Changes in FDA, Cannabis Policies and AI Developments
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 181: South Carolina’s Life Sciences Economy with Ashely Teasdel, Deputy Secretary of SC Department of Commerce
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 166 — Christine Vannais, COO of Fujifilm Diosynth Biotechnologies
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Episode 150 - Jane Pine Wood, Senior Vice President & Chief Legal Officer, BioReference
Jones Day Talks Health Care: The Eliminating Kickbacks in Recovery Act
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
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
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
Introduction - On 6 December 2022, the Department of Health and Human Services Office of Inspector General (HHS-OIG) issued a report (Report) that summarized findings of HHS-OIG’s review of laboratories with questionably high...more
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
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
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
Eleventh Circuit Affirms “Exceptional Case” Ruling: Insurer Had No Duty to Defend Construction Debris Claim Where Amended Complaint Omitted Crucial Fact Implicating Pollution Exclusion The Eleventh Circuit, affirming the...more
I. INTRODUCTION - As discussed in recent alerts, federal and state authorities have focused their enforcement efforts on combatting fraud related to the COVID-19 pandemic....more
The Healthcare Fraud Prevention Partnership (“HFPP”) recently published its second white paper, entitled “Examining Clinical Laboratory Services,” which provides a comprehensive overview of practices that raise fraud and...more
According to a recently released report by the HHS Office of Inspector General (OIG), over 1,000 labs had unusually high billing for Medicare Part B Clinical Laboratory Services for dates of service in 2010. Increased...more
On June 25, the U.S. Department of Health & Human Services, Office of the Inspector General ("OIG") issued a Special Fraud Alert updating the previous guidelines concerning compensation by clinical laboratories to referring...more
The Health and Human Services Office of the Inspector General (OIG) recently issued a Special Fraud Alert on laboratory payments to referring physicians. Specifically, the alert is concerned with Specimen Processing...more
On June 25, 2014, the Office of the Inspector General (OIG) issued a Special Fraud Alert addressing the issue of remuneration offered and paid by laboratories to referring physicians. The Special Fraud Alert expands upon...more
On June 25, 2014, the Office of Inspector General (OIG) published a Special Fraud Alert titled “Laboratory Payments to Referring Physicians” in which it addresses compensation arrangements and potential anti-kickback statute...more
On Wednesday, June 25, 2014, the Office of Inspector General (OIG) issued a Special Fraud Alert (the Alert) addressing compensation paid by laboratories to referring physicians. The latest in a series of guidance documents...more
The laboratory market has become quite competitive in recent years, raising compliance concerns and investigations into lab relationships with referring physicians. Accordingly, on June 25, 2014, the OIG released a Special...more
The Office of the Inspector General (OIG) for the Department of Health and Human Services recently issued a Special Fraud Alert regarding laboratory payments to referring physicians. The Special Fraud Alert reaffirms OIG’s...more