Article Detail - JF Part A

Starting with calendar year (CY) 2025, CMS added coverage for digital mental health treatment.

Devices must have FDA clearance under 21 Code of Federal Regulations (CFR) 882.5801. These computerized behavioral therapy devices are prescription-only devices intended to provide computerized versions of condition-specific behavioral therapy, in conjunction with outpatient treatments.

Digital mental health treatment (DMHT) uses devices provided "incident to" professional behavioral health services with treatment under a behavioral health or therapy plan of care.

• Billing practitioner must prescribe or order DMHT device cleared under section 510(k) of the Food, Drug, and Cosmetic Act
• Patient can use DMHT devices at home or in an outpatient setting, if FDA classification allows

HCPCS Codes

• G0552: Supply of digital mental health treatment device and initial education and onboarding, per course of treatment that augments a behavioral therapy plan Contractor pricing
• G0553: First 20 minutes of monthly treatment management services related to the device's use.
• G0554: Each additional 20 minutes of monthly treatment management services related to device's use.

POS 02 and 10 cannot be used for these non-face-to-face services and are excluded from the list of reimbursable telehealth services.

Resource

• CMS Medicare Learning Network (MLN) 1986542 Medicare and Mental Health Coverage