New Reimbursement Opportunities for Digital Mental Health Treatment in 2025: CMS’ Final Rule
CMS issued its 2025 Medicare Physician Fee Schedule (the “2025 MPFS” or “Final Rule”) on November 1, 2024. In doing so, it finalized the first-ever reimbursement for Digital Mental Health Treatment (“DMHT”) devices and services and set a promising precedent for reimbursement of digital therapeutics more broadly.
The Final 2025 MPFS contains some modifications and clarifications to several elements of the original proposal released in July 2024 (the “Proposed Rule”), which we discussed in this earlier post.
Key Changes and Clarifications from the Proposed Rule
DMHT Devices
CMS modified its original proposal for payment of DMHT devices under HCPCS code G0552, stating that such devices “must be cleared under section 510(k) of the FD&C Act or granted De Novo authorization by FDA and in each case must be classified under 21 CFR 882.5801 for mental or behavioral health treatment.” This requirement is more stringent than the payment policy for Remote Therapeutic Monitoring, which merely requires that the device used meet the FDA’s definition of a device.
In comments submitted to CMS, some stakeholders expressed concern that limiting DMHT devices to those classified under 21 CFR 882.5801 that have been “cleared” would unduly limit the types of devices used and the behavioral health conditions that could be treated. While CMS extended its policy to include devices with “de novo” approval, concerns remain that many DMHT devices and use cases will be excluded.
Finally, CMS elected to use contractor pricing for reimbursement of HCPCS code G0552, the supply of DMHT devices, citing the considerable variability in device costs and ongoing technological advancements in digital mental health.
Treatment Management Services
CMS addressed several comments from behavioral health stakeholders by modifying the code descriptors for treatment management codes G0553 and G0554. Those code descriptors now emphasize reviewing “information related to the use” of the DMHT device as a therapeutic intervention. This change is intended to address the broader applicability of DMHT and distinguish the DMHT codes from the existing Remote Therapeutic Monitoring (“RTM”) codes intended to monitor a response to therapeutic intervention through data collected from an RTM device.
CMS also addressed complex patient scenarios by allowing the concurrent use of multiple DMHT devices for co-occurring mental health conditions without specific limitations, acknowledging the potential benefits for patients with complex mental health needs.
Eligible Billing Providers
CMS addressed several comments requesting clarification of who is eligible to prescribe or order DMHT devices by stating that DMHT devices may be ordered by a physician or other practitioner when that individual is authorized to diagnose, evaluate, and treat a mental health disorder; the individual performs the prescribing/ordering within their State prescriptive authority; and the intended prescribing/ordering is permitting under the device’s specific FDA clearance.
Summary of the Digital Mental Health Treatment Codes
HCPCS G0552 covers the supply of a DMHT device, along with initial education and onboarding for a single treatment course. Eligibility is limited to devices meeting specific FDA requirements, ensuring the device’s therapeutic impact and safety.
HCPCS G0553 and G0554 allow monthly billing for DMHT-related treatment management services, requiring direct patient or caregiver interaction. These codes provide structure for ongoing device-based treatment.
HCPCS G052 has been assigned “contractor pricing” described in more detail below.
HCPCS G0553 has an estimated reimbursement rate of $20.06 for the first 20 minutes of treatment management each month, based on a Work RVU of 0.62 and the 2025 Medicare Conversion Factor of $32.35.
HCPCS G0554 has an estimated reimbursement rate of $19.73 for each additional 20 minutes of treatment management, with a Work RVU of 0.61.
Understanding Contractor Pricing for HCPCS G0552
Unlike G0553 and G0554, the reimbursement rate for G0552—which covers the supply of the DMHT device and initial onboarding—is set by “contractor pricing.” This means that the Medicare Administrative Contractors (“MACs”), which administer Medicare for different regions, have the discretion to establish reimbursement rates for this code. Rather than CMS setting a national rate, each MAC will set regional pricing, allowing flexibility based on local costs and market conditions. However, this also means that reimbursement for G0552 could vary across the country, affecting providers operating in multiple regions.
CMS often uses contractor pricing for new services or technology-driven treatments where data on costs and utilization may still be evolving. Over time, as CMS collects more data, they may establish a national rate, but for now, practitioners should refer to their regional MAC for G0552 reimbursement specifics.
Key Takeaways
The new DMHT codes represent a step forward in enabling patient access to innovative digital therapeutics, helping fill gaps in health care access and supporting diverse patient needs. However, CMS’s narrow eligibility criteria may exclude emerging devices that lack the specific FDA clearances required by CMS but have shown promise as a device under alternative FDA pathways such as 510(k) exempt status or the FDA’s enforcement discretion. Likewise, devices already on the market with FDA clearances that were classified under regulations other than 882.5801 will be excluded from the new DMHT codes and may need to reassess their regulatory strategy to incorporate these new codes.
Additionally, CMS’s approach to contractor pricing reflects the current uncertainty around setting national pricing for digital therapeutics. For practitioners, this means reimbursement levels could vary across contractors, which might impact adoption of DMHT and other digital therapeutics.
At the end of the day, these new DMHT codes represent a step in the right direction but may create additional questions for many digital health companies. Whether it’s assisting you with understanding the details of implementing the new DMHT codes with your currently FDA-cleared device or talking through how to develop an updated regulatory strategy to incorporate these new codes into your business model, we’re here to help! Contact us to set up an appointment.