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
In June 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced a new item in its Work Plan: “Medicare Payments for Clinical Diagnostic Laboratory Tests in 2024.” This annual review,...more
A recent False Claims Act (FCA) litigation—Jensen ex rel. United States of America v. Genesis Laboratory—highlights critical compliance risks for laboratories. This case reinforces the need for laboratories to ensure...more
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
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
The U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) is tasked with combating fraud under Medicare, Medicaid, and other federally funded healthcare programs. ...more
On November 10, 2016, the Office of Inspector General (“the OIG”) of the U.S. Department of Health and Human Services (“DHHS”) is charged with ensuring the integrity of more than 100 programs administered by DHHS, including...more
On October 3, 2016, OIG released a report monitoring CMS’s progress on preparing for the implementation of the new payment system for clinical laboratory tests. The new payment system was mandated by the Protecting Access to...more
The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has released its Work Plan for Fiscal Year 2016. The annual work plan can provide valuable insights into the OIG’s planned areas of...more
As required by a 2014 statute, CMS has issued proposed regulations (Proposed Rule) implementing new requirements for laboratory reporting of, and eventually basing Medicare payment on, rates for clinical laboratory services...more
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
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
Perhaps not coincidentally, immediately following the release of the Questionable Laboratory Payments Special Fraud Alert by the OIG, posted yesterday on the Med Law Blog, the OIG has followed up with Audit Report OIG –...more
On April 1, the Protecting Access to Medicare Act of 2014 was enacted into law (Pub. L. 113-93). Section 216, entitled Improving Medicare Policies for Clinical Diagnostic Laboratory Tests, modernizes the Medicare payment...more
The Office of Inspector General of the Department of Health and Human Services recently posted an Advisory Opinion describing a proposed arrangement by a clinical laboratory. ...more