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
Though responsible and ethical use of artificial intelligence (AI) has been a hot topic for the past few years, there has not yet been significant adoption of laws or regulations aimed specifically at regulating the use of AI...more
Thin Lizzy famously declared in their 1976 hit, “The Boys are Back in Town.” The same is true almost 50 years later, as the U.S. Food and Drug Administration has announced its plan to phase out its general enforcement...more
The U.S. Food and Drug Administration (FDA) is reaffirming its plans to actively regulate certain laboratory developed tests (LDTs) that the FDA has historically treated with enforcement discretion. On June 25, 2024, the FDA...more
On May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory developed tests (LDTs), the U.S. Food and Drug Administration (FDA) published its...more
The U.S. Food and Drug Administration (FDA) issued a final rule on April 29, 2024, that significantly changes the regulatory framework for laboratory developed tests (LDTs). LDTs are in vitro diagnostic products (IVDs) that...more
The U.S. Food and Drug Administration (FDA or Agency) announced on April 29, 2024, in a forthcoming and long-awaited final rule that laboratory developed tests (LDTs) will be regulated as medical devices....more
On November 6, 2023, OIG released new General Compliance Program Guidance (General CPG). The General CPG applies to all individuals and entities involved in the healthcare industry. The release of the General CPG was not...more
Get the latest strategies and insights for healthcare research compliance - Whether you missed this year’s in-person Research Compliance Conference or are looking for additional insights from research colleagues and...more
Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...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
The Eliminating Kickbacks in Recovery Act (EKRA) was enacted by Congress in October of 2018 as part of the SUPPORT Act. While its initial focus was to address patient brokering and kickback schemes within recovery homes and...more
Please join us for the 8th Annual Nashville Healthcare Fraud Conference hosted by Bass, Berry & Sims and the Tennessee Hospital Association. Eligible for more than seven hours of CLE credit (including ethics), this...more
The tragedy of the COVID-19 pandemic is something we all agree we wish we could have avoided. However, the fact of the matter is that many respiratory and clinical labs have seen a boon to their bottom line due to the...more
Clinical laboratories such as respiratory and clinical labs that bill Medicare, Department of Health and Human Services (“DHHS”) programs, and other federal programs are subject to oversight by the Office of Inspector General...more
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
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
Compliance Today (March 2020) - According to the Centers for Medicare & Medicaid Services (CMS) MLN Connects, “For Clinical Diagnostic Laboratory Tests (CDLTs) that are not Advanced Diagnostic Laboratory Tests (ADLTs),...more
HCCA's Health Care Research Compliance Academy is a three-and-a-half-day intensive training program focuses on compliance issues related solely to research. Its faculty is made up of experts in the field. With a wide range of...more
Clinical laboratories will see significant changes to their Medicare payments for clinical diagnostic laboratory tests (CDLTs) starting January 1, 2017, but the basis for new payment rates will come from “applicable data”...more
Latest Healthcare False Claims Act Roundup and Top 3 Best Practices to Reduce Exposure - As the legal landscape in healthcare becomes increasingly complex, healthcare companies that receive federal program funds face...more
Craig Holden co-presented "New Compliance Red Flags Workshop," a workshop hosted by G2 Intelligence. Over the past five years, the Departments of Justice and Health and Human Services have recovered $19.2 billion from...more