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 Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-07 (the “Opinion”), to a nonprofit tax-exempt grant-making...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including guidance regarding hospital...more
On June 20, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 24-04, a favorable opinion analyzing a refund and discount program designed to alleviate the...more
On June 17, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 24-03, approving an arrangement under which a pharmaceutical manufacturer provides travel, lodging, and...more
On June 17, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted a favorable Advisory Opinion 24-03 (“AO 24-03”) involving a pharmaceutical manufacturer’s proposed patient...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for March 2024. We summarize a US Court of Appeals for the Second Circuit decision interpreting the intent standard under the federal...more
The United States District Court for the Eastern District of Virginia recently dismissed an appeal by the Pharmaceutical Coalition for Patient Access (“PCPA”) that challenged a negative opinion issued by the U.S. Department...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new Innovation in...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for October 2023. We discuss several enforcement actions that involve violations of the False Claims Act (FCA) and the...more
On Oct. 25, 2023, the Office of Inspector General (OIG) for the Department of Health and Human Services (DHHS) issued an unfavorable opinion in response to a manufacturer’s proposal to offer and provide a free compatible...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for August 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more
In our July 18, 2023, webinar titled “False Claims Act 2023: What Every Health Care Entity Working with the Government Needs to Know,” Manatt posed the following hypothetical and asked three questions about it in our live...more
On June 28, 2023, the U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services, Office of Inspector General (“HHS-OIG”), along with other federal and state law enforcement partners, announced a...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for May 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act (FCA)...more
Without fanfare or any significant discussion, the Bipartisan Budget Act (Act) contains the first legislative action related to provider-based status—and it is a sweeping action with negative financial consequences to many...more
On August 12, 2015, the Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion No. 15-11, finding that a program to supply a limited amount of free cancer drugs to federal health...more
Last month, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services released a comprehensive report and data brief detailing its concerns about the ability of Medicare Part D sponsors – as...more
The update to the Fiscal Year 2015 Annual Work Plan includes new initiatives that may affect pharmaceutical companies and Medicare Part D payors and pharmacies. Annually, the Department of Health and Human Services...more
In recent years, copayment coupon programs have become standard promotional practices for both large and small pharmaceutical manufacturers. Copayment coupons are typically offered to commercially insured patients in order...more
Last week, the U.S. Department of Health and Human Services Office of Inspector General (OIG) released a Special Advisory Bulletin titled, Pharmaceutical Manufacturer Copayment Coupons (Bulletin), and a report titled,...more
For the past 18 months, health care providers and the pharmaceutical industry have been hoping for some clarity regarding 340B Drug Discount Program operations. But things just keep getting murkier....more
In an effort to address new concerns about the independence of charity patient assistance programs (PAPs), the Office of Inspector General (OIG) released its Supplemental Special Advisory Bulletin: Independent Charity Patient...more
On May 21, 2014, the Office of the Inspector General ("OIG") of the Department of Health and Human Services issued a Supplemental Special Advisory Bulletin ("Supplemental Bulletin") addressing the risks that Independent...more
The healthcare industry has been an innovative leader in developing compliance tools and strategies. They have come by it honestly – prosecutors and HHS-OIG have been pounding on pharmaceutical companies, medical device...more