Digital Mental Health Technology - The Quick Breakdown

Are you a founder of a digital mental health company navigating the complexities of U.S. healthcare policy? In this rapid-fire breakdown, Nixon Law Group Senior Counsel Reema Taneja and Digital Health Expert Michael Schellhous cut through the noise to explain the critical shifts in Digital Mental Health Treatment (DMHT) codes.

They cover what the DMHT codes actually reimburse, how they fundamentally differ from Remote Patient Monitoring (RPM) and Remote Therapeutic Monitoring (RTM), and the strict FDA/CMS requirements your device must meet. They unpack the major hurdles—from the lack of a national payment amount (MAC contractor pricing) to provider uptake challenges—and advise founders on how to position their companies for success despite these limitations.

This video is an essential resource for founders looking to understand the pathway to reimbursement and influence the future of digital mental healthcare policy.

What you will learn:

• DMHT vs. RPM/RTM: How Digital Mental Health Treatment codes cover direct intervention, not just passive monitoring.

• Eligibility Essentials: The FDA clearance pathways, indications (Depression, Anxiety, Insomnia, Substance Abuse, ADHD), and billing requirements.

• The 3 Major Hurdles: Understanding MAC-based pricing negotiation, narrow FDA eligibility, and provider cost-incurrence requirements.

• Strategic Imperative: Why, despite the complexities, these codes are a major step forward and how to advocate for broader adoption.

Disclaimer: This video provides general information and does not constitute legal advice. Please consult with a qualified attorney for advice regarding your specific situation.

💡 Summary List of Topics

A quick-reference list of the core topics covered in the video:

• Introduction to Digital Mental Health Technology (DMHT) Codes: Overview and context by Reema Taneja and Michael Schellhous.

• DMHT Code Definition and Scope: What DMHT codes cover (direct delivery of software-based mental health intervention).

• DMHT vs. RPM/RTM Distinction: DMHT is for a single course of treatment, unlike RPM/RTM's focus on passive, month-to-month monitoring.

• Device Eligibility Requirements:

  • FDA clearance under specific regulations.

  • Covered indications: Depression, Anxiety, Insomnia, Substance Abuse, and ADHD (2026 expansion).

  • Patient must have a formal diagnosis.

  • Device must be ordered/prescribed by the billing provider.

  • Billing provider must incur the cost of furnishing the device.

  • Use must align strictly with FDA-cleared indications.

• Three Primary Limitations/Hurdles for Founders:

  1. Narrow FDA Eligibility: Difficulty for many devices to achieve clearance under the identified, restrictive regulations.

  2. MAC Contractor Pricing: Absence of a national payment amount, requiring individual price negotiation with each Medicare Administrative Contractor (MAC).

  3. Provider Cost Incurrence: Requirement for the provider to front the device cost, slowing uptake and requiring significant education.

• Overall Policy View: Despite hurdles, DMHT codes are a crucial win; stakeholders must continue advocating to payors, providers, and CMS.