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).

Whether you're a digital health startup, a multi-state provider group, or an investor, learn how to:

  • Structure your MSO-PC relationship compliantly to avoid fee-splitting and CPOM violations.

  • Understand the key legal and operational components of the "Friendly PC" model.

  • Identify the latest regulatory changes and state-level scrutiny (including updates in California and Oregon).

  • Strategically scale your model for multi-state expansion, identifying barriers and outsourcing opportunities.

⚠️ Legal Disclaimer: This video is for informational purposes only and does not constitute legal advice. You should consult with qualified legal counsel regarding your specific situation.

Timeline:

  • 00:00 Introduction and Agenda

  • 01:30 MSO-PC Model 101: When, What, and Why

  • 02:40 The Rise of the MSO-PC Model in Virtual Care (2015-Present)

  • 03:45 Defining MSO vs. PC Roles and Responsibilities

  • 05:40 The Purpose of the MSO-PC Model: CPOM, Licensure, and Fee Splitting

  • 07:45 Diagram: Compliant MSO-PC Structure and Revenue Flow

  • 09:50 The Regulatory Environment: Federal (OIG/AKS) & State-Level Scrutiny

  • 12:15 New State CPOM Laws (California, Oregon, etc.) and Ownership Restrictions

  • 14:40 Compliance as a Strategic Differentiator

  • 15:30 The Evolution of Operational Models within MSO-PC (DTC, Telepharmacy, AI)

  • 18:10 Barriers vs. Opportunities: The Ecosystem of Telehealth Adjacent Businesses

  • 21:00 Scaling the MSO-PC Model: Timeline, Goals, and Primary Offering

  • 23:00 Outsourcing and Partnering Opportunities (PC Owner Services, Platform, Credentialing)

  • 24:45 The Importance of Expert Legal Counsel (Avoid Generic Templates)

  • 26:15 Conclusion and Resources

Summary List of Topics

  • MSO-PC Model 101: Definition, historical foundation (1950s adoption of CPOM), recent acceleration (2015-2023).

  • Key Entity Roles: Management Services Organization (MSO) for administrative/non-clinical support; Professional Corporation (PC) for exclusive clinical decision-making/operations.

  • Friendly PC: The physician-owned entity whose success is tied to the MSO's performance.

  • Foundational Legal Doctrines:

    • Corporate Practice of Medicine (CPOM): Restricts non-physicians from practicing medicine or controlling clinical decisions.

    • Fee Splitting/Kickback Laws: Prohibits sharing professional fees with unlicensed entities; requires the MSO's management fee to be flat and based on Fair Market Value (FMV), not a percentage of revenue or volume.

  • Regulatory Environment: OIG guidance on Anti-Kickback Statute (AKS) safe harbor; increasing state-level scrutiny.

  • Recent State Legislative Action: Stricter CPOM laws and reporting requirements in states like California and Oregon (e.g., prohibiting common ownership).

  • Evolution of Operations: Expansion into Direct-to-Consumer (DTC), diagnostics, remote monitoring, and asynchronous care, involving a broader mix of clinicians.

  • Scaling and Strategy: Barriers to multi-state launch; opportunities via telehealth adjacent businesses (staffing, licensure, tech vendors); necessity of a realistic 3-6 month timeline; defining your primary offering (clinical care vs. proprietary tech).

  • Risk Mitigation: The importance of bespoke, expert legal counsel to tailor documents and governance structures, avoiding generic templates.

Previous
Previous

2026 Medicare Final Rule Part 3: Rapid-Fire Q&A on FQHC and RHC Bundled Code Unbundling

Next
Next

FDA Launches TEMPO: What Digital Health Innovators Need to Know Now