Digital Health Technologies: Diagnostic Applications

This policy covers FDA‑cleared or approved standalone software-as-a-medical-device (SaMD) prescribed by a healthcare provider for diagnostic applications—detecting presence/absence of a condition, assessing future risk, or monitoring treatment response—including FDA‑cleared tools used in evaluation or diagnosis of autism spectrum disorder (ASD) using DSM‑5 criteria and in the context of recommended pediatric developmental screening. Coverage is contingent on the member’s benefit plan and state contract and excludes software that is not standalone SaMD, is not prescribed, lacks FDA clearance/approval (De Novo/510(k)/PMA), is used for non‑diagnostic purposes, or is deemed experimental/investigational.

"FDA-cleared/approved software-as-a-medical-device (SaMD) prescribed by a healthcare provider for diagnostic applications (detecting presence/absence of a condition)."