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
The HHS Office of Inspector General (“OIG”) released a Special Fraud Alert to inform health care professionals (“providers”) and Medicare Advantage Organizations (“MAOs”) about the OIG’s view of potentially abusive marketing...more
The Mental Health Parity and Addiction Equity Act (MHPAEA) generally requires group health plans and health insurance issuers to ensure that financial requirements (such as copays and deductibles), quantitative treatment...more
Effective as of December 26, 2024, each nursing home facility (“Facility”) in New York State will be required to post its overall Centers for Medicare & Medicaid Services (“CMS”) rating, as well as its ratings for (i) health...more
On December 5, 2024, just in time for the holidays, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Expedited Program for Serious Conditions: Accelerated Approval of Drugs and...more
What is your favorite part about practicing healthcare law at McDermott? The lawyers and other professionals here, first and foremost. We have an amazingly talented team with a wealth of experience advising sophisticated...more
On November 25, 2024, the Illinois State Legislature introduced House Bill 5918 IL HB5918, the Artificial Intelligence Systems Use in Health Insurance Act (“AI Act”). It provides the Illinois Department of Insurance (the...more
The Centers for Medicare and Medicaid Services (CMS) finalized material changes to the overpayment rules for Medicare Parts A, B, C, and D effective January 1, 2025. These changes create new ambiguity and practical challenges...more
On December 18, 2024, the U.S. Equal Employment Opportunity Commission (EEOC) published new guidance for healthcare providers on what information to provide patients seeking childbirth- and pregnancy-related workplace...more
Following consultation starting in 2022, on November 29, 2024, Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) were registered. These Regulations amend the Food and Drug...more
Cyber, Privacy, and Technology Report - Welcome to your monthly rundown of all things cyber, privacy, and technology, where we highlight all the happenings you may have missed....more
While the authors are not huge fans of the rock band Def Leppard, its 1983 “Photograph” hit came to mind recently, when we read a recent Warning Letter issued, in part, because of a company’s refusal to allow photographs...more
Yesterday, FDA released the final rule that updates the definition for “healthy” nutrient content claims. In an update that may be long overdue, manufacturers who use the term “healthy” (or derivative terms: “health,”...more
China’s main healthcare regulatory bodies, including the National Medical Products Administration, released draft administrative measures for pharmaceutical representatives intended to strengthen anti-corruption efforts and...more
UPDATE: The stop-gap spending bill has been revised to remove the provision discussed herein. However, life sciences companies should nonetheless take note of efforts by congress to enact patent-related reforms such as this....more
FDA issued a final rule today updating the requirements food must meet to be marketed as “healthy.” FDA says that a “healthy” claim “implies that the nutrient content of the food may help consumers maintain healthy dietary...more
Recognizing that healthcare providers often play a key role in the reasonable accommodation process, the United States Equal Employment Opportunity Commission (“EEOC”) issued guidance on December 18, 2024, explaining how...more
The listing of patents in the Orange Book has an important role in intellectual property protection for pharmaceuticals. Patents listed in the Orange Book can include, without question, patents covering compositions or...more
News Briefs - Congress Taking on Healthcare Policies Set to Expire - Congress has begun discussions on important healthcare policies set to expire on December 31....more
Nebraska AG Mike Hilgers filed a lawsuit against Change Healthcare Inc. and its owners and operators (collectively, “Change”)—which provide a data clearinghouse used by healthcare providers, pharmacies, and insurers—alleging...more
The 135th General Assembly finished yesterday with both houses enacting two pieces of legislation of primary interest to boards of education and their administrators, HB 8 and HB 206. Both pieces of legislation are on their...more
McKinsey & Company, Inc., has entered into a deferred prosecution agreement (DPA) to resolve a federal criminal investigation into its advice to Purdue Pharma L.P. (Purdue) on how to increase sales of OxyContin, and a civil...more
Cal/OSHA announced in a press release on December 12, 2024, that it had issued its first willful heat violation citation, highlighting its increased emphasis on heat illness prevention. The citation imposed $276,425 in...more
On December 5, 2024, the U.S. Food and Drug Administration (“FDA”) issued a much anticipated draft guidance for industry on accelerated approval that provides additional clarity on FDA’s expectations for accelerated approval...more
Welcome back to the Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. This week, we check in on Nebraska, of course. We also report on the situation with Minnesota’s licensing lottery. We...more
On December 18, 2024, Governor Newsom proclaimed a State of Emergency to streamline and expedite the state’s response to Avian influenza A (H5N1), commonly known as “Bird Flu.” This may give many employers flashbacks to the...more
