Resources
for You and Your Team
A Welcome Produce Alert: OIG Signals a Practical Path Forward for Food as Medicine Programs in Advisory Opinion 26-16
In OIG Advisory Opinion 26-16, regulators declined to sanction an FQHC’s Food as Medicine program, offering crucial guidance for digital health companies, health systems, and payors. While free produce triggers Anti-Kickback Statute (AKS) and Beneficiary Inducements CMP risks, OIG exercised enforcement discretion due to strict clinical oversight, financial-need screening, and operational safeguards. Nixon Law Group breaks down the 5 key compliance principles needed to safely structure Food as Medicine and SDOH initiatives.
OIG Advisory Opinion 26-10: What Digital Health Companies Should Know Before Paying Clinician Royalties
Can digital health companies pay physicians and other clinicians royalties tied to platform revenue, product sales, or adoption? In OIG Advisory Opinion 26-10, the Office of Inspector General rejected a proposed clinician royalty arrangement despite fair market value safeguards, finding that physician influence over product utilization created Anti-Kickback Statute concerns. This article explains the OIG's reasoning, key compliance lessons, and what digital health, clinical AI, RPM, RTM, telehealth, and health tech companies should know before structuring clinician compensation arrangements.
MSO-PC Models: Digital Health Compliance and Scaling
Navigating the complex legal landscape of digital health requires a robust and compliant corporate structure. In this video, Nixon Law Group Senior Counsel Reema Taneja provides a comprehensive 101 on the Managed Service Organization (MSO) – Professional Corporation (PC) model, focusing on the critical regulatory hurdles of the Corporate Practice of Medicine (CPOM) and the Anti-Kickback Statute (AKS).