False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 195: Life Sciences and Healthcare Workforce Development with Dr. John Hauser of Gaston College
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
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
340B Drug Pricing Program Compliance
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 171: Laura Gunter, President of the NC Life Sciences Organization
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 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 163: David Ellison, Chief Data Scientist for Lenovo’s Infrastructure Solutions Group
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
The Massachusetts law permitting pharmacies and pharmaceutical manufacturers to offer drug discounts to consumers, which was set to expire on January 1, 2023, has recently been extended to January 1, 2026....more
On January 25, in a 2-1 decision in U.S. ex rel. Sheldon v. Allergan Sales, LLC, 2022 WL 211172, the Fourth Circuit became the most recent federal appellate court to hold that the objective scienter standard in the Supreme...more
On November 30, 2020, the United States Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule (“Final Rule”) that makes significant changes to the federal Antikickback Statute...more
In this episode, Macy Flinchum and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent guidance by the Centers for Medicare and Medicaid Services on best practices for states to...more
Late last year, we noted that the Massachusetts Medicaid program had proposed regulations to address issues related to the prohibition on duplicate discounts in the 340B program. The Massachusetts solution was relatively...more
In today’s blog post, I want to look at some of the more unusual bribery schemes from Foreign Corrupt Practices Act (FCPA) enforcement actions in 2019. Some of these schemes were not unusual but they were accomplished with...more
On 14 March 2019, the UK Competition and Markets Authority (CMA) decided to close its investigation into a discount scheme by Merck Sharp & Dohme Limited (MSD). The CMA concluded that there were no grounds for it to take...more
Last week, the OIG posted favorable advisory opinion (16-07) regarding a proposed discount program for Part D beneficiaries who are prescribed a statutorily excluded erectile dysfunction drug. The OIG concluded that while...more
Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more
Brand name drugs cost a lot. So to make them more attractive, drug manufacturers issue coupons for discounts on the copayment portion of the price. They work the same as the dollar-off coupons offered by cereal manufacturers....more