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 May 1, 2026, CMS published three interconnected Federal Register notices that set the stage for how Medicare will price clinical laboratory tests in calendar year 2027. They announce the rechartering and new membership of...more
Grounded in the OIG’s General Compliance Program Guidance and DOJ’s Evaluation of Corporate Compliance Programs, our immersive, three-and-a-half-day, classroom-style Healthcare Basic Compliance Academy equips compliance...more
On February 18, 2026, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 26-02 (AO 26-02), concluding that a proposed arrangement involving a management services...more
Management service organizations (MSOs) with affiliated clinical labs and urgent care clinics should take note of newly identified guardrails that will facilitate their compliance with the federal Anti-Kickback Statute (AKS)....more
LongueVue Capital (LVC) has announced a strategic investment in Apex Dental Laboratory Group in partnership with Swaney Group Capital (SGC). Apex, founded in 2015 and headquartered in Waco, Texas, operates a network of 16...more
During and after the COVID-19 Public Health Emergency, the Centers for Medicare & Medicaid Services (CMS) provided certain flexibilities and exercised enforcement discretion with respect to regulations affecting...more
Key Takeaways - First Circuit strengthens False Claims Act defenses for clinical laboratories. In United States ex rel. Omni Healthcare Inc. v. MD Spine Solutions LLC, the court held that laboratories may generally rely on...more
The US Department of Health and Human Services Office of Inspector General (OIG) recently issued Advisory Opinion No. 26-02, concluding that a proposed arrangement under which an urgent care management entity would operate an...more
The Consolidated Appropriations Act of 2026, HR 7148 (the Act), just signed into law on February 3, 2026, ended a brief government shutdown and includes multiple provisions with a critical impact on health care organizations....more
The Health and Human Services Office of Inspector General (HHS-OIG) recently issued a favorable advisory opinion (AO-26-02) stating that it would not sanction an urgent-care management company for operating a separate...more
On February 3, 2026, President Trump signed H.R. 7148, the Consolidated Appropriations Act, 2026 (the “Bill”) into law. In addition to funding portions of the government through September 30, 2026, the Bill also includes...more
Every sector of the healthcare industry relies upon laboratory testing. Lab tests are used to diagnose virtually all illnesses and conditions ranging from the common flu to cancer. The average American receives their first...more
On February 3, 2026, President Trump signed into law the Consolidated Appropriations Act, 2026 (H.R.7148), an appropriations act that provides funding for various agencies including the Department of Health and Human...more
After uncertainty over the last few months, the last few weeks saw potential changes to the Protecting Access to Medicare Act of 2014 (PAMA) under section 6226 of the Consolidated Appropriations Act of 2026. On January 20,...more
Recently, the Ninth Circuit Court of Appeals affirmed a conviction of a lab operator for violations of the Eliminating Kickbacks in Recovery Act (“EKRA”) in United States v. Schena. Originally Published in Healthcare...more
The final quarter of 2025 saw continued enforcement actions against clinical labs and other related healthcare entities. The Office of Inspector General (OIG) and Department of Justice (DOJ) heavily focused on False Claims...more
The Eliminating Kickbacks in Recovery Act (EKRA), enacted in 2018 as part of the SUPPORT Act, established a criminal statute prohibiting payments for patient referrals related to recovery homes, clinical treatment facilities,...more
Plaintiffs’ firms are adapting the California Invasion of Privacy Act (CIPA), a 1960s-era wiretapping statute, to modern web technologies such as pixels, chatbots, and session replay tools. For laboratories, the practical...more
Addressing an issue of first impression, the First Circuit has clarified the burden to satisfy the knowledge element required in False Claims Act (FCA) cases in the context of laboratory testing and Medicare fraud....more
On December 1, 2025, the First Circuit Court of Appeals delivered a decision that should bring welcome relief to clinical laboratories facing False Claims Act (FCA) allegations. In United States ex rel. OMNI Healthcare,...more
A clinical lab in Anderson, South Carolina, and its founder and CEO have agreed to pay a minimum of $6.8 million to settle a federal qui tam case based on allegations for paying illegal kickbacks to physicians in exchange for...more
Key Takeaways - Reliance on Physician Orders: Clinical laboratories may generally rely on physician orders to establish medical necessity and are not required to independently reassess clinical judgment....more