Insights on Health Care

ArentFox Schiff’s Gayland Hethcoat on navigating the line between wellness and medical devices in the longevity era.

On April 29, the US Food and Drug Administration (FDA) published a Request for Information (RFI) seeking public comment on a proposed pilot program to test the use of artificial intelligence (AI) in early-stage clinical trials for drugs and biologics. Comments are due June 29.

Headlines that Matter for Companies and Executives in Regulated Industries

Headlines that Matter for Companies and Executives in Regulated Industries

On May 13, the Centers for Medicare & Medicaid Services (CMS) implemented two separate nationwide moratoria that halt the Medicare enrollment of new home health agencies (HHAs) and hospice providers. The moratoria took effect immediately.

Mail and telemedicine access to mifepristone — used together with misoprostol to end an early pregnancy — is in flux following a Fifth Circuit Court of Appeals ruling that restricts mail-order distribution of the medication nationwide, and the US Supreme Court’s subsequent administrative stay restoring the status quo ante on a temporary basis.

On May 1, the US Food and Drug Administration (FDA) announced that it is proposing to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List. If finalized, this proposal would close the last remaining regulatory pathway for large-scale compounding of these popular GLP-1 receptor agonists by 503B outsourcing facilities.

Headlines that Matter for Companies and Executives in Regulated Industries

Michelle J. Shapiro will speak on the “Health Care Fraud Enforcement: Examining the Current Era” panel at the Boston Bar Association’s (BBA) 2026 White-Collar Crime Conference.

False Claims Act Investigations & Litigation attorneys Jacques Smith, Pat Naples, and John Keblish authored a piece for Chief Healthcare Executive on the key regulatory developments and emerging areas of risk in cybersecurity-specific False Claims Act (FCA) settlements.

Headlines that Matter for Companies and Executives in Regulated Industries

Everyone is talking about peptides. Your doctor, your trainer, that guy at the dinner party who swears that BPC-157 rebuilt his knee — peptides have officially entered the zeitgeist. But for every breathless testimonial, there is a thicket of regulations that most market participants barely understand.

On April 18, President Trump signed an executive order (EO) directing multiple federal agencies to accelerate research and expand access to psychedelic drugs as potential treatments for serious mental health conditions. The EO represents a notable shift in federal policy toward psychedelic substances and their potential therapeutic use.

The Federal Trade Commission (FTC) is signaling that health care and life sciences companies should expect heightened regulatory scrutiny related to consumer protection and competition.

Headlines that Matter for Companies and Executives in Regulated Industries

Health care enforcement targeting diagnostic and laboratory services accelerated in 2025 and shows no signs of slowing down in 2026.

Welcome to the April 2026 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month. We bring you the most recent and significant insights in an accessible format, concluding with our main takeaways — aka “And the Fox Says…” — on what you need to know.

In a recent ruling out of the District of Minnesota, a federal magistrate judge directed UnitedHealthcare (UHC) to turn over an expansive set of documents in the class action Estate of Lokken v. UnitedHealth Group, Inc., alleging that the health insurer used an artificial intelligence (AI) algorithm to improperly withhold post-acute care coverage from Medicare Advantage enrollees.

Headlines that Matter for Companies and Executives in Regulated Industries

Pat Naples was featured on a recent proposal from the US Treasury Department that would share monetary penalties with healthcare whistleblowers.

Headlines that Matter for Companies and Executives in Regulated Industries

While Section 232 tariffs have so far been largely a metals-and-autos story, pharma has now officially joined the narrative.

Headlines that Matter for Companies and Executives in Regulated Industries

ArentFox Schiff’s Pat Naples discusses with Medical Economics the US Centers for Medicare & Medicaid Services’ (CMS) expanded anti‑fraud enforcement and its impact on health care providers.

Michelle J. Shapiro to speak at Executive Women in Bio (EWIB) virtual program – Implementing Lessons Learned From Enforcement Developments to Improve Corporate Compliance.