Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
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
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
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
Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...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
ACI’s Advanced Forum on Managed Care Disputes and Litigation offers an unparalleled learning experience, specifically designed for the MCO legal community. Attend and develop winning legal strategies and business best...more
News Briefs - 2024 FDA Guidance Likely to Include AI, Cybersecurity - The Food and Drug Administration is ramping up production of medtech guidance, adding 18 draft documents to the list of priorities for its 2024 financial...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...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
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
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal...more
Health Care fraud is a growing national issue. The National Heath Care Anti-Fraud Association estimates that health care fraud costs the nation about $68 billion annually — about 3 percent of the nation's $2.26 trillion in...more
On December 14, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule regarding Contract Year 2024 Policy and Technical Changes to the Medicare Advantage (MA) and Medicare Prescription Drug Benefit...more
In the second of a three-part webinar series on the recently enacted Inflation Reduction Act of 2022 (IRA), Hogan Lovells partners Alice Valder Curran and Ken Choe, as well as David Chan, President and General Manager of...more
After several years without any enforcement, the U.S. Department of Justice (“DOJ”) recently penalized medical device and life sciences companies for violating the U.S. Provider Payments Sunshine Act (“Sunshine Act”) (42...more
CMS Releases Proposed Physician Fee Schedule for 2022: On July 13, 2021, the Centers for Medicare and Medicaid Services (CMS) released the proposed Physician Fee Schedule (PFS) for 2022 (link). Among other issues, the PFS...more
Report on Medicare Compliance 30, no. 22 (June 14, 2021) - CMS’ supplemental medical review contractor (SMRC) is now doing postpayment reviews of Medicare claims for electrodiagnostic (EDX) testing axial muscles and...more
On July 20, 2020, the Department of Health and Human Services published a Notice of Proposed Rulemaking proposing to amend the Vaccine Injury Table by removing Shoulder Injury Related to Vaccine Administration (“SIRVA”),...more
The COVID-19 pandemic has created many new enforcement priorities for the U.S. Department of Justice (DOJ). From selling ineffective personal protective equipment (PPE) to companies fraudulently seeking loan forgiveness under...more
In part two, Wiley Health Care Practice partners Dot Powell-Woodson and Rachel Alexander continue their discussion of the Most-Favored Nations (MFN) Rule and the Rebate Rule and look at the potential impacts of these Final...more
In part one, Wiley Health Care Practice partners Dot Powell-Woodson and Rachel Alexander break down the background, substance, and procedural issues of the two Final Drug Pricing Rules released on November 30, 2020: the...more
On November 20, 2020, the Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services Office of the Inspector General (“OIG”) released their highly-anticipated final rules to modernize and...more
In a completely unexpected move, on November 20, 2020, the Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services (“HHS”) Office of the Inspector General (“OIG”) published advance...more
CMS announced today that in acknowledgment of the extreme circumstances posed by COVID-19, it will exercise enforcement discretion with respect to any Physician Payments Sunshine Act Open Payments reporting that is submitted...more
In this episode, Ryan Severson and Victoria Hamscho discuss recent developments in pharmaceutical pricing and the 340B Drug Pricing Program heading into 2020, including reimbursement cuts for 340B drugs under the Outpatient...more
Information Collection Request. On November 27, 2019, 340B Health, a nonprofit membership organization comprised of hospitals and health systems that participate in the federal 340B drug pricing program (“340B Program”),...more