Digital therapeutics
The US pays for some digital therapies. Medicare introduced billing codes for eligible digital mental-health treatment in 2025 and extended the policy to devices for attention deficit hyperactivity disorder (ADHD) for 2026. Coverage is still narrow, because a product has to be eligible, a clinician has to be involved and the therapy has to be part of ongoing care.
Research snapshot · updated Nov 12, 2026
US DTx commercial pathway requires federal reimbursement framework that doesn't yet exist
The Access to PDT Act lapsed in 2024 and was reintroduced in May 2025 (H.R.3288) but has not passed. State Medicaid coverage in MA + CT + NY + CO is emerging but insufficient. Without a permanent federal CMS code, US DTx companies depend on employer-benefit and cash-pay channels with structural growth ceilings. Pear's 2023 bankruptcy remains the cautionary tale.
European national schemes sustain DTx commercially where the US does not
Around 55 DiGA-listed apps in Germany are reimbursable by statutory health insurance - the only mature DTx channel. France's PECAN fast-track (live since 2023, DiGA-modelled) has underdelivered: by early 2025 no DTx had secured reimbursement and HAS had issued four negative PECAN assessments. UK NHS deploys Big Health Sleepio + Daylight. The DACH channel functions; France is not yet a reliable route; the US has none.
State of the art (2026)
Medicare has paid for some digital mental-health treatment since 2025. CMS created three codes in the 2025 Physician Fee Schedule: G0552 for supplying the device and getting the patient started, and G0553 and G0554 for managing treatment. For 2026 it extended the policy to devices for ADHD. The route covers a limited set of products and needs a clinician to be involved. Standalone prescription apps have struggled commercially, and Pear Therapeutics went bankrupt in 2023. Germany's DiGA scheme remains the longest-running national route to reimbursement.
Big Pharma partnerships provide regulatory + clinical validation without commercial scale
Click Therapeutics partnerships with Otsuka + Boehringer Ingelheim + Sanofi. Cognoa adjacencies with companies. Big pharma DTx co-development validates clinical efficacy but pharma sales channels don't unlock new payer reimbursement. Useful but not transformative for category.
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Signal stack
Evidence stacked leading → lagging
9 signals
Signal stack
Evidence stacked leading → lagging
Technology-native KPIs
Metrics that predict trajectory, tracked over time
5 tracked
Technology-native KPIs
Metrics that predict trajectory, tracked over time
Landscape map
Who builds what, and who depends on whom
150 players · 6 layers
Landscape map
Who builds what, and who depends on whom
Catalyst calendar
Dated events that will move the position
7 ahead
Catalyst calendar
Dated events that will move the position
Technology roadmap
Milestones on the path to maturity
7 milestones
Technology roadmap
Milestones on the path to maturity
Watchlists
Companies, people and papers, each with a condition for removing it
20 · 20
Watchlists
Companies, people and papers, each with a condition for removing it
Decision frameworks
What our view means for your job
Locked
Decision frameworks
What our view means for your job
Thesis changelog
When our view changed, and why
9 updates
Thesis changelog
When our view changed, and why
Change our mind
5 disconfirming conditions
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