Effective January 1, 2025, CMS established HCPCS code G0552 for the supply of digital mental health treatment (DMHT) device, including initial education and onboarding, per course of treatment that augments a behavioral therapy plan.

Payment remains contractor priced in calendar year 2026, until CMS establishes a national rate.

Requirements for HCPCS Code G0552

Documentation shall support the following applicable Medicare requirements for DMHT device and service to be considered for reimbursement.

1. Device classification. The DMHT device furnished to the beneficiary must be cleared under section 510(k) of the Federal Food, Drug, and Cosmetic Act, or granted De Novo marketing authorization by the Food and Drug Administration (FDA) and must be classified under 21 CFR 882.5801 (Computerized behavioral therapy device for psychiatric disorders) or beginning January 1, 2026, under 21 CFR 882.5803 (Digital therapy device for Attention Deficit Hyperactivity Disorder). FDA clearance or authorization under a different device classification does not satisfy this requirement.
2. Practitioner incurs the cost. The billing practitioner must incur the cost of acquiring and furnishing the DMHT device to the beneficiary as a supply. Medicare shall not pay G0552 when the billing practitioner incurs no cost in furnishing the device, or when the beneficiary independently procures the device.
3. Incident to ongoing treatment. The DMHT device must be furnished incident to the billing practitioner's professional behavioral health services and used in conjunction with ongoing treatment under a behavioral health treatment plan of care.
4. Prescription or order. The billing practitioner must prescribe or order the DMHT device, but need not be the one who originally made the mental health condition diagnosis.
5. Diagnosis. Payment may only be made for DHMT devices for mental health treatment in accordance with the use indicated under their FDA classification under 21 CFR 882.5801 or 21 CFR 882.5803.
6. Practitioner scope of practice. The billing practitioner must be a physician or other qualified non-physician practitioner legally authorized, under applicable state prescriptive authority and the device's FDA clearance or authorization, to diagnose, evaluate, and treat the mental health disorder, and to prescribe or order the DMHT device.

Monthly Treatment Management

When providing monthly treatment management directly related to the patient's therapeutic use of the DMHT device, use the applicable HCPCS code(s):

• G0553: First 20 minutes of monthly treatment management services directly related to the patient's therapeutic use of the digital mental health treatment (DMHT) device that augments a behavioral therapy plan, physician/other qualified health care professional time reviewing information related to the use of the DMHT device, including patient observations and patient specific inputs in a calendar month and requiring at least one interactive communication with the patient/caregiver during the calendar month.
• G0554: Each additional 20 minutes of monthly treatment management during the calendar month. (Add-on code)