CMS Proposes Expanded Coverage for Digital Mental Health Devices—And Seeks Input on Broader Digital Therapeutics Use Cases
As part of the 2026 Medicare Physician Fee Schedule (MPFS) Proposed Rule, CMS is signaling growing support for digital mental health treatment (DMHT) while laying important groundwork for the future of digital therapeutics (DTx) across a range of clinical use cases.
For DTx innovators, this is a critical moment. CMS is not only expanding the scope of current DMHT coverage but also actively soliciting input on how to shape future reimbursement frameworks for digital tools, including those that fall outside of FDA-regulated device pathways.
Expanded DMHT Coverage for ADHD
In a significant policy expansion, CMS proposes to extend payment eligibility under HCPCS codes G0552–G0554 to include devices classified under CFR § 882.5803, “Digital therapy device for Attention Deficit Hyperactivity Disorder.” Coverage for DMHT established in the 2025 Medicare Physician Fee Schedule was limited to devices classified under CFR § 882.5801, “Computerized Behavioral Therapy Device for Psychiatric Disorders).”
To qualify for reimbursement under the proposed expansion, ADHD devices must meet FDA special control requirements, including the use of validated measures of effectiveness, and be used as an adjunct to clinician-supervised treatment.
The inclusion of DTx devices under § 882.5803 signals CMS’ willingness to broaden the clinical applicability of DMHT coverage beyond what was finalized in the CY 2025 rule. CMS notes that it is also considering requests to expand coverage to other DTx devices — see the list below. CMS has emphasized that a key factor in determining whether to expand DMHT coverage to additional device types is the presence of FDA-mandated special controls—specifically, requirements that the device’s behavioral therapy model be validated through clinical data. Both § 882.5801 and § 882.5803 devices meet this standard, and CMS is likely to prioritize similar validation requirements when evaluating other digital therapeutics for future reimbursement.
Utilization Challenges: Why Are Claims Volumes for DMHT Low?
Despite finalizing G0552–G0554 in the CY 2025 final rule, CMS acknowledges that claims volume remains low. The agency posits that this may be because the billing practitioner must incur the cost of furnishing the DMHT device to the patient.
Our take: There is another, even bigger reason behind the low volume of claims. To date, CMS has not assigned reimbursement for the DTx device to be used with DMHT, deferring to the MACs to establish contractor pricing for each device. Many DTx companies – much less practitioners -- simply don’t know how to approach the Medicare Administrative Contractors (MACs) to secure contractor-based pricing, which remains the only reimbursement pathway in the absence of a national rate for G0552. For the vast majority of digital health stakeholders, the MAC process is opaque, inconsistently applied, and logistically difficult to navigate.
Despite this significant barrier to adoption, CMS proposes retaining the contractor-pricing status for G0552, citing the diversity of technologies in this space and the challenge of establishing a uniform national rate at this stage.
Additional Expansions of DTx Reimbursement: CMS Wants Your Input
CMS is also exploring whether to further expand coverage to additional FDA-authorized digital therapeutics. Specifically, the agency is requesting public comment on potential inclusion of devices classified under:
§ 876.5960 – Computerized behavioral therapy for gastrointestinal conditions
§ 882.5705 – Digital therapy for sleep disturbance in psychiatric conditions
§ 882.5804 – Computerized behavioral therapy for fibromyalgia symptoms
These proposed expansions present a clear opportunity for companies with FDA-authorized products in these therapeutic areas to help shape future policy through public comment.
Future Payment for Digital Tools Without FDA Clearance?
CMS is also actively soliciting feedback on whether to establish separate billing codes for digital tools used in behavioral health care that do not require FDA clearance or authorization. These tools could include apps or platforms used to support treatment adherence, monitor patient progress, or encourage healthy behaviors as part of a behavioral health plan of care.
CMS is requesting input on:
The clinical evidence supporting use of these tools
Their role in mental health treatment plans
Whether CMS should create lower-intensity billing codes for them
Appropriate valuation methods and payment crosswalks
CMS acknowledges that these tools may justify lower reimbursement than FDA-authorized DMHT devices and is interested in comments about how to set appropriate payment rates.
Submit your comments by September 12, 2025
DTx stakeholders should seize this opportunity to provide their feedback to CMS on its proposals. Please contact Nixon Law Group soon if you would like assistance in drafting and submitting your comments!