What are the DMHT codes?
Medicare added three HCPCS codes for digital mental health treatment (DMHT) devices, effective January 1, 2025: G0552 (supply of the device and initial onboarding) and G0553 and G0554 (monthly treatment management). For CY 2026, CMS expanded the codes to devices for ADHD classified under 21 CFR 882.5803.
Sources: CMS MLN909432; CMS MM14315; CY 2026 PFS final rule (CMS-1832-F, 90 FR 49266).
Who can bill, and under what conditions
- The device must be FDA-cleared under 510(k) or granted De Novo under 21 CFR 882.5801 (computerized behavioral therapy device for psychiatric disorders) or, from 2026, 882.5803 (ADHD).
- Incident to behavioral health services. The device is furnished incident to the billing practitioner's behavioral health treatment, under an ongoing plan of care.
- The practitioner bears the device cost billed under G0552.
- Monthly codes need active use of the device plus at least one interactive communication with the patient during the month.
On pricing: G0552 is contractor-priced, while G0553 and G0554 are nationally priced. We do not list amounts here; check the the CMS Physician Fee Schedule Look-Up Tool or your MAC for current figures.
Sources: CMS MLN909432; CMS MM14315. This is a summary, not billing or legal advice.
Examples of devices under 882.5801 and 882.5803
The table is a partial list of FDA authorizations under the two regulations, checked on FDA's databases on Oct 27, 2026. It is not a list of billable products: being classified under these regulations is necessary, not sufficient, and we have not confirmed current marketing status. Over-the-counter products such as EndeavorOTC fall outside the prescription, incident-to model the codes assume. Products originally from Pear Therapeutics (reSET, reSET-O, Somryst) are listed for their authorizations only. A 510(k) clearance or De Novo grant is not FDA approval.
| Device | Number | Regulation (21 CFR) | Decision date |
|---|---|---|---|
| reSet | DEN160018 (De Novo) | 882.5801 | 2017-09-14 |
| reSET-O | K173681 | 882.5801 | 2018-12-10 |
| Somryst | K191716 | 882.5801 | 2020-03-23 |
| Rejoyn | K231209 | 882.5801 | 2024-03-30 |
| MamaLift Plus | K223515 | 882.5801 | 2024-04-22 |
| Sleepio® | K233577 | 882.5801 | 2024-08-05 |
| Daylight | K233872 | 882.5801 | 2024-08-30 |
| Motivista (CT-155) | K254038 | 882.5801 | 2026-07-30 |
| EndeavorRx | DEN200026 (De Novo) | 882.5803 | 2020-06-15 |
| EndeavorRx | K231337 | 882.5803 | 2023-12-13 |
| EndeavorOTC | K233496 | 882.5803 | 2024-06-14 |
| Prismira | K243729 | 882.5803 | 2025-06-13 |
Sources: 21 CFR 882.5801; 21 CFR 882.5803; FDA 510(k) database; FDA De Novo database.
What it means for digital mental health startups
Our reading (editorial, not from a source):
- Regulatory path decides billing eligibility. If you want these codes, plan a 510(k) or De Novo under 882.5801 or 882.5803.
- Design for the practitioner workflow. The codes assume a treating practitioner who buys the device, tracks use and communicates with the patient monthly.
- Capture use data. Active-use requirements mean your product should report engagement in a form a practice can document.
Related resources
Frequently asked questions
What are G0552, G0553 and G0554?
Medicare HCPCS codes for digital mental health treatment devices, effective January 1, 2025. G0552 covers supply of the device and onboarding; G0553 and G0554 cover monthly treatment management.
Which devices qualify for DMHT codes?
Devices cleared under 510(k) or granted De Novo under 21 CFR 882.5801, and from CY 2026 under 882.5803 for ADHD, furnished incident to behavioral health services.
How much does Medicare pay for DMHT?
G0552 is contractor-priced and G0553 and G0554 are nationally priced. Check the CMS Physician Fee Schedule Look-Up Tool or your MAC for current amounts.
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