Digital Health Technologies for Attention Deficit/Hyperactivity Disorder

Covers FDA-cleared standalone digital therapeutics (Software as a Medical Device), including computer‑game–based therapies prescribed by a licensed provider to improve attention in children ages 8–12 with primarily inattentive or combined‑type ADHD. Coverage requires FDA marketing clearance (de novo, 510(k), or PMA), prescription, demonstrated real‑world clinical benefit on validated attention measures, HIPAA compliance and usability; it excludes non‑standalone software, non‑prescribed or investigational products (including EndeavorRx, which the policy deems experimental/unproven) and is limited to the specified age group, ADHD subtypes, and outcome measures.

"Standalone software intended for a medical therapeutic purpose (meets definition of Software as a Medical Device)."

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