Insights on Health Care

ArentFox Schiff is pleased to announce the launch of its Longevity & Healthspan Industry Group, a cross-sector initiative supporting the rapidly expanding ecosystem of companies advancing anti-aging innovation, wellness, and preventive health.

False Claims Act Investigations Partners Hillary Stemple (Health Care) and Nadia Patel (Litigation) will host a Continuing Education webinar on recent trends in health care fraud enforcement for the Health Care Compliance Association on January 27, 2026.

Headlines that Matter for Companies and Executives in Regulated Industries

Pascal Naples was quoted on a recent “unfavorable” opinion published by the Office of Inspector General (OIG) for the US Department of Health and Human Services that sign-on bonuses for caregivers providing in-home care for Medicaid recipients would fall under the anti-kickback statute.

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

On January 6, the US Food and Drug Administration (FDA) released two significant updates potentially important for companies operating in the consumer health technology space.

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.

The telehealth industry is entering a new phase of scrutiny marked by intensified enforcement actions across civil and criminal fronts that reflect a coordinated, whole-of-government approach.

Last month, a federal court in Maine halted the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) 340B Rebate Model Pilot Program in its tracks — a mere four days before it was to go into effect.

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.

On December 18, President Trump issued an executive order (EO) directing the Attorney General to complete rulemaking to reschedule “marijuana” from Schedule I to Schedule III under the Controlled Substances Act (CSA) and to expand federal research and policy development on medical marijuana and hemp derived cannabinoids.

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.

The past year has been unusually active on the health care antitrust front. Providers are pressing price-fixing and information-exchange theories against payers and claims intermediaries and a landmark class settlement moving into its implementation phase.

Headlines that Matter for Companies and Executives in Regulated Industries

Public-facing debates over pharmaceutical drugs and life sciences products are as pronounced as ever. Although the ongoing scuffle over Tylenol has received the most attention, similar controversies abound. Just last month, Aurinia Pharmaceuticals filed a defamation complaint against a now-resigned US Food and Drug Administration (FDA) official over critical statements made about one of its drugs.

In recent months, three federal courts have refused to enforce expansive US Department of Justice (DOJ) administrative subpoenas issued to providers of gender-affirming care, concluding the subpoenas were issued for an improper purpose or exceeded the government’s statutory authority. These rulings are significant.

On December 12, the Eleventh Circuit heard the much-anticipated oral arguments in United States ex rel. Zafirov v. Florida Medical Associates LLC concerning the constitutionality of the False Claims Act’s (FCA) qui tam provisions.

Headlines that Matter for Companies and Executives in Regulated Industries

Federal regulators are taking a coordinated step to accelerate the responsible integration of digital health technologies into routine care.

Headlines that Matter for Companies and Executives in Regulated Industries

Judge Kathryn Kimball Mizelle’s ground-breaking decision in Zafirov v. Florida Medical Associates LLC and Justice Clarence Thomas’ solo dissent in US ex rel. Polansky v. Executive Health Resources Inc. have revived what many had viewed as a settled constitutional question.