Health Care Counsel Blog
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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.
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.
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.
Health care enforcement targeting diagnostic and laboratory services accelerated in 2025 and shows no signs of slowing down in 2026.
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
Headlines that Matter for Companies and Executives in Regulated Industries
On March 9, a federal court in Connecticut issued a decision in Abira Medical Laboratories LLC v. Aetna Inc. et al. that underscores the continuing importance of clear and comprehensive assignment-of-benefits language in payer disputes.
The rapidly expanding consumer biomarker testing market — a major pillar of the longevity ecosystem — has produced its first major lawsuit between competitors.
Headlines that Matter for Companies and Executives in Regulated Industries
The Centers for Medicare & Medicaid Services (CMS) has released detailed payment amounts, performance targets, and reporting requirements for the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model, applicable to care periods beginning July 5 through December 31, 2027.
Massachusetts proposed amendments to the regulations that govern skilled nursing facilities (SNFs). Here is what operators, real property owners, and investors need to know as they acquire facilities, change managers, and navigate licensure renewals in Massachusetts.
Headlines that Matter for Companies and Executives in Regulated Industries
On January 27, the US Department of Health and Human Services Office of Inspector General (OIG) issued a Special Advisory Bulletin providing significant guidance for pharmaceutical manufacturers offering prescription drugs through direct-to-consumer (DTC) programs to patients enrolled in federal health care programs.
Headlines that Matter for Companies and Executives in Regulated Industries
With 2026 underway, the AFS Health Care team highlights some of the most pressing legal issues facing the health care industry this year.
Headlines that Matter for Companies and Executives in Regulated Industries
The enforcement landscape entering 2026 points to sustained False Claims Act activity across traditional health care fraud, AI-enabled misconduct, civil rights–based claims, customs and tariff fraud, and expanding theories of investor liability.
As we approach the end of the first year of the second Trump Administration, many in the health care sector continue to closely watch federal enforcement trends to identify government priorities going forward.
For the past several years, the use of contract sales forces by pharmaceutical and device manufacturers and other suppliers has been under a heightened enforcement spotlight.
The California Department of Public Health (CDPH) denied two petitions to amend the hospital licensing regulations in Title 22 of the California Code of Regulations to allow advanced practice providers to be members of organized medical staffs in general acute care hospitals.
The Centers for Medicare & Medicaid Services (CMS) Innovation Center has announced the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model, a 10‑year voluntary payment model that introduces outcome‑aligned payments (OAPs) to expand access to technology‑supported care for Medicare beneficiaries with common chronic conditions.