This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new Innovation in Behavioral Health Model (IBH) released by the Centers for Medicare & Medicaid Services (CMS), amendments to New York’s Section 1115 Medicaid waiver, new final rules related to prior authorization and conscience rights, and the Food & Drug Administration’s (FDA) approval of Florida’s drug importation program. We also discuss four favorable Office of Inspector General (OIG) Advisory Opinions and several criminal and civil enforcement actions pertaining to healthcare fraud, including alleged violations under the False Claims Act (FCA), federal Anti-Kickback Statute (AKS) and Physician Self-Referral Law (Stark Law).
