Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 218: Artificial Intelligence in Drug Development with John Van Hoy of PPD & Thermo Fisher
Podcast — Drug Pricing: How Might the Trump Administration Transform FDA Enforcement Activities?
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 217: Japanese Investment in North Carolina’s Life Sciences Industry with David Robinson of Maynard Nexsen
12 Days of Regulatory Insights: Day 3 - State AG Oversight in the Health Care Industry — Regulatory Oversight Podcast
Hospice Insights Podcast - What a Difference No Deference Makes: Courts No Longer Bow to Administrative Agencies
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 216: Patient Advocacy and Healthcare Policy Change with Melissa Horn of the Arthritis Foundation
AGG Talks: Home Health & Hospice Podcast - Episode 7: OIG Report Reveals Gaps in Hospice PRF Compliance: What Providers Need to Know
Health Policy Update: Impact of the 2024 U.S. Elections – Diagnosing Health Care
Updating the Research Compliance Handbook
Preparing for CMS Staffing Mandates — Assisted Living and the Law Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 215: Bioactives for Human Health with Jan-Willem van Klinken of Brightseed
From Innovation to Commercialization: Turning Research Into Tangible Outcomes With John Bamforth
Harnessing Generative AI: Innovations and Best Practices — The Good Bot Podcast
Hospice Insights Podcast - Meet the New Laws, Same as the Old Laws: Overpayment Recoupment Update
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 214: Pharma Manufacturing in North Carolina with Ed Hernandez of Eli Lilly
AI Discrimination and Emerging Best Practices – Part 2 - The Good Bot Podcast
Year-End and Trending Tax Considerations for Health Care Practices
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 213: AI Transformations in Life Sciences and Beyond with Igor Jablokov of Pyron
When I investigated and litigated False Claims Act (FCA) cases at the U.S. Department of Justice (DOJ) over the last 10 years, I was often surprised by just how little I knew about the broad array of government agencies and...more
On December 20th, 2024, the Court of Appeals for the Federal Circuit issued an important decision in Teva Branded Pharmaceutical Products R&D v. Amneal Pharmaceuticals that impacts Orange Book (OB) listings for patents...more
The House Task Force on Artificial Intelligence (AI) released a comprehensive 253-page report providing a roadmap for Congress as it develops policies to regulate and optimize the use of this rapidly advancing technology. The...more
On December 11, 2024, the US Food and Drug Administration (FDA) updated its Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products. As discussed in our previous On the Subject, FDA...more
The US Internal Revenue Service (IRS) has released its 2025 cost-of-living adjustments applicable to employee benefit plans. A year-to-year comparison of limitations is below....more
Exeltis USA, Inc. and other parties (Exeltis) recently prevailed against Lupin Ltd. and Lupin Pharmaceuticals, Inc. (Lupin) in a patent infringement suit brought in the District of Delaware. After a three-day bench trial, the...more
Investment in the healthcare industry requires careful consideration, as it involves numerous distinct areas of the law. Venable's Private Equity Investment in Healthcare webinar series explores the unique issues and timely...more
With 2024 coming to a close, here is a roundup of Cal/OSHA updates from the recent Standard Board meetings and Cal/OSHA’s triannual advisory committee meeting:...more
On November 20, 2024, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued the Nursing Facility Industry Segment-Specific Compliance Program Guidance (Nursing Facility ICPG). This...more
Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the seventh episode of When Your Life Sciences Are on...more
Certain telehealth flexibilities, including geographic requirements, have officially been extended. Just before midnight on Friday, December 20, 2024, by a vote of 366-34, the U.S. House of Representatives passed the American...more
Closing out 2024, the Centers for Medicare & Medicaid Services (CMS) has issued a proposed rule entitled “Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit...more
Legislation signed by Ohio Governor Mike DeWine on December 20, 2024 will significantly expand mandatory reporting duties for professionals and facilities. These changes, and others from Ohio Substitute Senate Bill 109, not...more
US Congress on December 20, 2024 passed a last-minute temporary government funding bill that keeps the government open for three months. As part of this package, a number of existing telehealth flexibilities were also...more
Ozempic's meteoric rise has reshaped the landscape of healthcare, retail, and consumer behavior. Its initial popularity as a weight loss medication has sparked a broader conversation around health, wellness, and body image....more
In November, we wrote about Massachusetts legislative and regulatory updates that impact both nursing homes and assisted living residences....more
By a 3-2 vote on November 11, the Board of Supervisors of Cecil Township in Western Pennsylvania increased the setback distance for fracking operations to 2,500 feet from protected structures like residences and businesses,...more
On December 11, 2024, the Texas Health and Human Services Commission filed a complaint in the United States District Court for the Western District of Texas. The complaint seeks to block the enforcement of a May 9, 2014,...more
SB 1120 (the “Bill”), which takes effect on January 1, 2025, amends existing California law to adopt guardrails around the use of artificial intelligence tools for the purpose of utilization management. As discussed in a...more
After much uncertainty, Congress has extended many Medicare telehealth flexibilities through March 31, 2025, in its end-of-year appropriations bill. However, several important flexibilities, such as first-dollar coverage of...more
This week’s post covers the period of December 15-20. Here’s what’s happening....more
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule regulations have been updated to impose additional requirements on covered entities to safeguard the privacy of reproductive health related...more
The latest Special Fraud Alert from the U.S. Department of Health and Human Services Office of Inspector General (OIG) warns about marketing schemes involving questionable payments and referrals among Medicare Advantage...more
The finalization of information blocking exceptions were announced just in the "St. Nick" of time by the U.S. Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy (ASTP), formerly known as...more
On December 20, 2024, the U.S. Court of Appeals for the Federal Circuit issued a significant ruling in the Teva v. Amneal case following oral arguments before the Federal Circuit, which we discussed in our previous article. ...more