Much of the national discussion around artificial intelligence regulation has centered on whether legislatures need to pass new, AI-specific laws to address the technology’s risks. In health care, though, AI is already regulated in important ways.
Duane Morris Health Law
Duane Morris Health Law, published by Duane Morris LLP, covers legal issues related to healthcare regulation and compliance. The blog addresses topics such as Medicare and Medicaid policies, telehealth reimbursement, healthcare fraud and abuse including False Claims Act enforcement, drug enforcement regulations, and antitrust matters in the healthcare sector. It provides updates on government rules, court decisions, and legislative developments affecting healthcare providers, payers, and related entities. The content is aimed at legal professionals and stakeholders navigating the complex regulatory environment of the healthcare industry.
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Webinar: HHS Section 504 Compliance Deadline on May 11, 2026
By Duane Morris
Website accessibility is no longer a technical or marketing issue—it is an enterprise risk with growing regulatory and litigation exposure. Federal investigations and private lawsuits are increasing and becoming more costly, and post-hoc remediation is rarely a defensible position. Join Colin…
Medicare Telehealth Claims Reimbursement and Flexibilities Face Limits During the Government Shutdown
By Duane Morris
By Erin Duffy, Neville Bilimoria and Victoria (Tori) Hawekotte Due to the U.S. government shutdown, the Centers for Medicare and Medicaid Services have paused reimbursement payments for nonbehavioral health telehealth Medicare claims, pending congressional action. Further, a new congressional bill,…
CMS Issues Final Rule on Returning Medicare and Medicaid Overpayments
By Duane Morris
By Daniel R. Walworth, Christopher H. Casey, Frederick R. Ball, Erin M. Duffy and Arti Fotedar The Centers for Medicare & Medicaid Services (CMS) issued a Final Rule as part of the 2025 Physician Fee Schedule, which revises requirements for reporting and returning overpayments of Medicare…
First Circuit Embraces More Restrictive View of False Claims Act Kickback Enforcement Provision
By Duane Morris
By Daniel R. Walworth, Christopher H. Casey, Frederick R. Ball, Erin M. Duffy and Joseph R. Welsh The United States Court of Appeals for the First Circuit’s opinion in United States v. Regeneron Pharmaceuticals, Inc. has sharpened the circuit split for demonstrating the…
U.S. Drug Enforcement Administration Proposes Permanent Tele-Prescribing Rules, Offering Registration Framework for Remote Prescription of Controlled Substances
On January 17, 2025, the U.S. Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (Notice) to allow for remote prescription of certain controlled substances within the telemedicine exception provided by the Ryan Haight Act (Act). The Act generally…
Federal and State Antitrust Enforcers Reiterate Focus on Healthcare
Federal and state antitrust enforcers are keenly focused on potential anticompetitive conduct in the healthcare space. Federal Trade Commission Chair Lina Kahn recently noted that “the FTC is squarely focused on tackling illegal business practices that deprive Americans of access…
CMS Rules for Coding Emergency Department Claims
By Duane Morris
By Gregory A. Brodek and Arti Fotedar The Centers for Medicare and Medicaid Services (CMS) has consistently authorized hospitals to establish and utilize their own coding guidelines for emergency department facility claims. CMS makes clear that “[a]s long as the…
FTC Wields Health Breach Notification Rule for First Time in Quest to Protect Consumer Health Information
By Duane Morris
By Samantha Dalmass and Melissa Sobel Snyder The Federal Trade Commission (“FTC”) is seeking enforcement under the Health Breach Notification Rule for the first time since the rule was adopted in 2009. The Health Breach Notification Rule (16 C.F.R. Part…
340B Hospital Reimbursement Update: D.C. District Court Remands Underpayment Remedy to HHS
By Duane Morris
On Tuesday, January 10, 2023, the United States District Court for the District of Columbia issued an important ruling allowing the U.S. Department of Health and Human Services (HHS) to propose an appropriate retrospective remedy for underpayments made from 2018…