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
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
Welcome to our second issue of The Health Record - our healthcare law insights e-newsletter! SCOTUS Agrees to Review Medicare DSH Payments Case - “The suit, Advocate Christ Medical Center v. Becerra, was originally filed in...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
We are pleased to bring you our 12th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more
Ballard Spahr attorneys from the firm’s Life Sciences and Health Care Industry Teams were on the ground for the 42nd Annual J.P. Morgan Healthcare Conference (JPM24) from January 7-10. While still less crowded than...more
On October 8, 2023, California Governor Gavin Newsom signed Assembly Bill 1286 into law. The new law, sponsored by Assemblymember Matt Haney and the California Board of Pharmacy, aims to reduce medication errors and...more
After steadying during Q2, it appears the overall volume of deals in the healthcare industry declined in Q3 compared with Q2, and year-to-date 2023 is still down from last year. A slumping economy has no doubt played a large...more
On August 15, 2023, the U.S. Court of Appeals for the Tenth Circuit issued an opinion in Pharmaceutical Care Management Association v. Glen Mulready, in his official capacity as Insurance Commissioner of Oklahoma, Oklahoma...more
The healthcare M&A market appears to be steadying. Although deal activity through the year appears slightly below the high-water marks for the corresponding period of 2022, deal activity is generally up from the first quarter...more
There have been several noteworthy False Claims Act (FCA) settlements in the second quarter of 2023. Four of these settlements have come in over $20 million. This post summarizes key settlements of interest....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
We are pleased to bring you our 11th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more
We always focus on foreign bribery — the FCPA and corporate bribery of foreign officials. It is certainly a problem that undermines economic development and human rights. ...more
Prosecutions related to the submission of claims to Tricare for compounded pain creams continue. The Eleventh Circuit Court of Appeals affirmed convictions against a Florida pharmacist, physician, and Navy veteran for their...more
Civil lawsuits are an unavoidable and expected consequence of operating in a heavily regulated industry. While CEOs and other pharmaceutical executives may lose sleep over the outcome of civil trials and the potential...more
On March 30, 2022, the United States Department of Justice (DOJ) announced that Manual J. Bojorquez, the owner of a marketing company, was sentenced to 36 months’ probation and ordered to pay restitution of $3.3 million for...more
Earnest v. Sanofi U.S. Services et al, U.S. Circuit Court of Appeals for the Fifth Circuit, No. 20-30184 (Feb. 10, 2022) - The plaintiff sued Sanofi U.S. Services, Inc. and Sanofi-Aventis U.S., LLC in the Eastern District...more
Bass, Berry & Sims and Deloitte presented the 2021 Health Care Investors Conference virtually on November 16... Here are some of the most significant takeaways for healthcare investors from the stimulating discussions and...more
On November 19, 2021, the U.S. House of Representatives (“the House”) narrowly passed the Build Back Better Act (H.R. 5376, or “the Act”), a spending bill appropriating nearly $2 trillion for measures to expand the country’s...more
In mid-August, the Eastern District of Kentucky granted a preliminary injunction in favor of an interventional pain management physician (Physician) against CVS Pharmacy (CVS) based on allegations that CVS was refusing to...more
Although Big Pharma has taken deserved heat for selling its drugs by slathering doctors with cheesy tchotchkes, lavish or even cheap meals, and pricey trips, as well as lucrative consulting and speaking opportunities, medical...more
On November 30, 2020, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a final rule (“Final Rule”) that removes safe harbor protection under the discount safe harbor to...more
If I printed a tee shirt for the 2020 J.P. Morgan Healthcare Conference, what would it say? In past years, it would have been “Big Data,” Analytics, Artificial Intelligence, ACA, Risk, Medicare Advantage or Quality. This...more
Editors’ Note: This is the second in our start-of-year series examining important trends in white collar law and investigations in the coming year. Our previous entry discussed SEC enforcement in 2020. Up next: a look at...more