The Evolution of Digital Health Policy: A 2024 Retrospective and 2025 Outlook

In a long-needed win for the digital therapeutics sector, new Healthcare Common Procedure Coding System (HCPCS) codes were introduced specifically for digital mental health treatment (DHMT) devices, including G0552 (for 2025) for reimbursing physicians providing FDA-cleared DTx devices for mental health, G0553 for the first 20 minutes of managing a patient’s digital therapeutic device each month and G0554 for each additional 20 minutes of management. These codes can encourage DTx adoption by reimbursing providers for management of these solutions. Notably, there is also a supply code that allows DTx manufacturers to indirectly bill through a buy-and-bill model. However, these codes cover only products that treat psychiatric conditions under FDA regulation 882.5801 and do not cover DTx solutions for other therapeutic areas.

Medigy Insights

New HCPCS codes were introduced for wearable health devices, including GWD01 for continuous glucose monitors, GWD02 for smartwatches with health tracking capabilities and GWD03 for wearable ECG monitors. This change allows for distinct codes to be used for different types of wearable devices, ensuring more precise billing and better support for the integration of these technologies into patient care. Before 2024, existing codes could not distinguish between device types, limiting adoption.

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