Digital Health Technologies for Attention Deficit/Hyperactivity Disorder
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This policy governs coverage of FDA-cleared prescription digital therapeutics (specifically EndeavorRx) intended to improve attention in children with ADHD and applies to Blue Cross Blue Shield - Rhode Island members under Medicare Advantage and Commercial products as described.
No material clinical or coverage changes in this revision.
Coverage Determination and Evidence
Coverage determination
Covered when ALL of the following are met:
Medicare Advantage policy statement
Commercial products policy statement
Evidence limitations described in background and trial summaries
For Commercial products, the use of EndeavorRx for all indications, including attention‑deficit/hyperactivity disorder (ADHD), is not covered and is considered a contract exclusion.
HCPCS code A9291 (Prescription digital cognitive and/or behavioral therapy, FDA‑cleared, per course of treatment) is not covered for Medicare Advantage plans. The same code, A9291, is listed as non‑covered and a contract exclusion for Commercial products.
The evidence is considered insufficient to determine that EndeavorRx improves net health outcomes. The pivotal randomized trial (STARS‑ADHD) showed improvement on a computerized attention test but did not demonstrate superior parent or clinician‑rated behavioral outcomes versus control. Key limitations include a trial population that excluded children taking ADHD medication (not representative of intended real‑world use), a short 4‑week study duration inadequate to assess long‑term effects on impairment and functioning, and uncertainty about the clinical significance of computerized test improvements without observable behavioral change. Consequently, additional studies — including trials in children on stimulant medication and longer‑term assessments — are needed to establish clinical benefit.
Billing Codes and Status
| A9291 | Prescription digital cognitive and/or behavioral therapy, FDA-cleared, per course of treatment |
| A9291 | Prescription digital cognitive and/or behavioral therapy, FDA-cleared, per course of treatment |
Provider Requirements and Impact
Prior authorization not required; HCPCS A9291 not covered
Prior authorization does not apply for this policy. However, note that HCPCS code A9291 (Prescription digital cognitive and/or behavioral therapy, FDA-cleared, per course of treatment) is explicitly listed as not covered for Medicare Advantage and as a contract exclusion for Commercial products.
- Prior authorization: Not applicable
- Coding note: A9291 listed as not covered (Medicare Advantage) and non-covered/contract exclusion (Commercial)
No step therapy required; device used within therapeutic program
EndeavorRx is intended to be used as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs. The policy specifies no step therapy requirements for use of the device.
- Intended use: part of a broader therapeutic program (clinician-directed therapy, medication, and/or educational programs)
- Step therapy: No step therapy requirements specified
Product indication — EndeavorRx (prescription device, ages 8–12)
EndeavorRx is a prescription device indicated to improve attention function as measured by computer-based testing in children ages 8-12 years with primarily inattentive or combined type ADHD who have a demonstrated attention issue; it requires a prescription from a healthcare provider.
- Indication age range: 8-12 years
- Target population: children with primarily inattentive or combined type ADHD and a demonstrated attention issue
- Measurement: improvement demonstrated on computerized testing (TOVA)
Noncoverage and contract exclusion triggers (including HCPCS A9291)
Use of EndeavorRx is not covered for Medicare Advantage plans and is not covered and considered a contract exclusion for Commercial products; the HCPCS code A9291 is listed as not covered (Medicare Advantage) and as non-covered/contract exclusion (Commercial).
- Medicare Advantage: EndeavorRx not covered for all indications
- Commercial: EndeavorRx not covered and considered a contract exclusion
- Billing code impact: A9291 listed as not covered / contract exclusion
Digital Therapeutic Device
Prescription digital therapeutic (EndeavorRx)
Product description:
FDA indication and intended use
Key Definitions
Clinical Background
Attention‑deficit/hyperactivity disorder (ADHD) is a chronic neurodevelopmental condition characterized by symptoms of hyperactivity, impulsivity, and inattention that impact functioning across settings. EndeavorRx is a prescription digital therapeutic developed to target cognitive control networks and was cleared by the FDA via the De Novo pathway for use in children. Clinical evidence includes the STARS‑ADHD randomized controlled trial, which found improvement on a computerized measure of attention but did not show corresponding improvements on parent or clinician behavioral assessments. Trial design limitations — including exclusion of children on ADHD medication and short follow‑up — limit generalizability to routine clinical practice. Given these uncertainties, the policy treats the device as investigational/noncovered pending further evidence demonstrating meaningful behavioral and functional benefits.
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