Summary

Adds prescription digital therapeutics to Medicare Part B and to the list of items covered under Medicaid beginning January 1, 2026. Requires the Department of Health and Human Services to create a new Medicare payment framework with coding, payment rules, manufacturer reporting, confidentiality protections, and penalties, with specific deadlines for a payment methodology and product-specific codes. Establishes manufacturer reporting obligations starting January 1, 2026, and gives CMS 1 year to set an initial payment methodology and 2 years to issue HCPCS codes for individual products; Medicaid coverage is updated to reference the new statutory definition of prescription digital therapeutics.

Key Points

• Establishes prescription digital therapeutics as a covered Medicare Part B service and a covered Medicaid item starting January 1, 2026.
• Creates a new Medicare statutory payment authority (1834B) requiring CMS to set payment rules and issue product-specific HCPCS codes.
• CMS must publish an initial payment methodology within 1 year and product-specific HCPCS codes within 2 years of enactment.
• Manufacturers must begin reporting required data to CMS on January 1, 2026, subject to confidentiality protections and penalties for noncompliance.
• Medicaid coverage is updated by adding prescription digital therapeutics to the list of covered items in 1905(a), referencing the statutory definition.
• Implementation will require administrative work by CMS, Medicare contractors, state Medicaid agencies, providers, and manufacturers.
• The change may expand patient access to regulated software-based therapies but will also create new federal reporting and payment obligations.

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