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
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
News Briefs - Physicians Responsible for Meeting CMS Information Blocking Rules - The Centers for Medicare & Medicaid Services and Office of the National Coordinator for Health Information Technology issued a final rule that...more
Welcome to our fourth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we address a variety of topics including a recent SCOTUS ruling and the potential impact on CMS, issues of patient...more
On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more
CMS Finalizes New TCET Pathway. The final procedural notice, effective immediately, creates a new pathway that uses existing national coverage determination and coverage with evidence development (CED) processes to expedite...more
The Centers for Medicare & Medicaid Services (CMS) released the Part D national average bid amount and Part D base beneficiary premiums for 2025. These figures set the premium costs and government subsidies for Medicare...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
The Centers for Medicare & Medicaid Services (CMS) finalized the second part of its guidance on implementation of the IRA’s Medicare Prescription Payment Plan (MPPP), known informally as Part D monthly out of-pocket...more
Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more
Senate HELP Committee Holds Hearing on Medical Debt. The hearing examined the negative impacts of medical debt and explored potential solutions to address the growing issue. Senators and witnesses highlighted the disparity...more
On June 17, CMS and the Office of the National Coordinator for Health Information Technology (ONC) issued a final rule implementing new standards for e-prescribing under Medicare Part D. ...more
Executive Summary- The Inflation Reduction Act (IRA) makes significant changes to the Medicare Part D prescription drug benefit and also directs the Centers for Medicare and Medicaid Services (CMS) to enforce...more
House Oversight Subcommittee Hearing with Fauci. The hearing aimed to gather more information on the response to the COVID-19 pandemic by Anthony Fauci, MD, former National Institute of Allergy and Infectious Diseases...more
House Ways & Means Committee Marks Up Telehealth and More. The bills considered in the markup support expanding access to telehealth as well as access to healthcare in rural areas. All six bills passed out of the committee,...more
A Quiet Healthcare Week on Capitol Hill. Congress was largely in recess this week, although the Senate returned briefly to complete consideration of a long-awaited foreign aid bill. Both chambers will return to session the...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
New guidance released by the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) on April 1, 2024, clarified that hospitals will not be eligible for Medicare or Medicaid...more
Appropriations Update. On March 3, Congress released bill text for the CAA, 2024, which includes funding for six of the 12 appropriations bills: Agriculture-FDA, Military Construction-VA, Energy-Water, Transportation-HUD,...more
Appropriations Update. As appropriators continue to finalize the 12 funding bills for fiscal year (FY) 2024 – which began on October 1, 2023 – a series of stopgap CRs have been needed to avoid a government shutdown. This...more