New Developments in Health Information Policy
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 220: Healthcare Regulation Under the Trump Administration with Bob Coble of Maynard Nexsen
Podcast - Rewriting the Narrative of Private Equity in Healthcare
Hospice Insights Podcast - A Year in Review: Reflections and Hopes for the Future
Key Takeaways From the OIG's New Compliance Guidance for Nursing Facilities — Assisted Living and the Law Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 219: The Evolving Nursing Industry with Terry McDonnell of Duke University Health System
AGG Talks: Healthcare Insights Podcast - Episode 7: National MultiPlan Litigation: A Guide for Healthcare Providers
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
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
On January 15, 2025, FDA announced an order revoking the listings providing for the use of the color additive FD&C Red No. 3 in both foods (including dietary supplements) and ingested drugs. The order is in response to a 2022...more
On January 13, 2025, California Attorney General (“AG”) Rob Bonda issued an advisory describing providers’ and businesses’ obligations related to the development, sale, and use of artificial intelligence (“AI”) and automated...more
The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting requirements for a nonprescription drug product with an “additional condition for...more
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more
The American Relief Act, 2025, signed into law on December 21, included a short-term extension of certain telehealth waivers that went into effect in the early days of the COVID-19 Public Health Emergency. These waivers, for...more
Private equity sponsors and their healthcare portfolio companies are expected to ride the tailwind of an M&A rebound. Long-term capital gains tax rates will likely remain unchanged, or possibly drop. As a result, sellers may...more
Recent enforcement actions, audit activity, proposed rulemakings, and guidance issued by the U.S. Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) highlight the agency’s focus on health data...more
On January 7, 2025, FDA announced the availability of a final guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more
If you are looking for a high-level summary of California laws regulating artificial intelligence (AI), check out the two legal advisories issued by California Attorney General Rob Bonta. The first advisory is directed at...more
The qui tam provisions of the False Claims Act allow individuals to file suit on behalf of the United States and to receive a share of the resulting financial settlement or judgment. Filing a qui tam case is not just a formal...more
On January 1, 2025, Amgen launched the first interchangeable biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab), Wezlana™ (ustekinumab-auub), as a private label product through Optum Health’s Nuvaila....more
When considering the health care enforcement landscape in 2024 and where it might be headed in 2025, we would be remiss if we did not address the enforcement activities of state and federal agencies beyond those typically...more
Earlier this month, the U.S. Food and Drug Administration (FDA) announced a public meeting entitled “Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act”...more
The HHS Office of Inspector General (OIG), in connection with its enforcement responsibilities, must exclude a party from the federal health care programs if the party is found to have violated certain federal laws. This type...more
The US Department of Health and Human Services (HHS) on January 6, 2025 issued a notice of proposed rulemaking (NPRM) seeking feedback on proposed updates to the Security Standards for the Protection of Electronic Protected...more
Value-based care (VBC) is a health care delivery model that has grown increasingly common in recent years. Perhaps unsurprisingly, this growth seems to have attracted the attention of government enforcement agencies...more
Mental illness in the United States is more common than most people may think. More than one in five U.S. adults live with a mental illness and one in six U.S. youth aged 6 to 17 experience a mental health disorder each year....more
As government scrutiny and enforcement targeting the Medicare Advantage (Medicare Part C) program continued in 2024, the industry’s response to agency actions escalated. Last year also resulted in the first sizable Part D...more
Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. This week, we give you an update on the DEA re-scheduling hearing. ...more
In this episode of Real Talk, Real Growth, host Linda Ostovitz welcomes Shaun Eddy, CEO and partner at Oxford Planning Group. Shaun, a certified financial planner with a master's degree in financial analysis, explores the...more
In a press release issued on January 15, 2025, the US Department of Justice released its annual statistics and announced that recoveries from False Claims Act settlements and judgments in fiscal year 2024 topped $2.9...more
In 2024, the Department of Justice (DOJ) pursued significant enforcement activity under its Civil Cyber-Fraud Initiative (CCFI). As our readers know, the Deputy Attorney General announced the creation of the CCFI in October...more
The FDA has shared its first draft guidance on how sponsors should assess the credibility of artificial intelligence (AI) models to support FDA decisions regarding drug safety, effectiveness or quality. The agency noted an...more
In 2024, the Department of Justice (DOJ) resolved several noteworthy False Claims Act (FCA) cases against hospitals and health systems. In particular, DOJ obtained a number of large recoveries in cases where Stark Law and...more
In past years we have discussed how opioid-related enforcement efforts have remained a top federal and state priority (here, here, and here). In 2024, opioid-related enforcement efforts continued across the entire opioid...more
