CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Digital Health Technologies for Attention Deficit/Hyperactivity Disorder

This policy addresses coverage of FDA-cleared prescription digital therapeutics (software as a medical device) intended to improve attention in children with ADHD, focusing on devices prescribed by a healthcare provider and marketed through FDA De Novo or 510(k)/PMA pathways.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyDigital Health Technologies for Attention Deficit/Hyperactivity Disorder

Policy CodePolicy N/A

Change TypeAdministrative review — no material changes

Effective DateJan 2, 2026

Next Review DateN/A

Key ActionDo not bill or authorize HCPCS A9291 for Commercial or Medicare Advantage — the device is non-covered/contract exclusion.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

A9291HCPCS code not covered

Ages 8-12FDA age range

De NovoRegulatory pathway

Not coveredCommercial coverage

Not coveredMedicare Advantage

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Coverage Determination

Overall Coverage Determination

Covered when ALL of the following are met:

Coverage determination: EndeavorRx and similar FDA-cleared prescription digital therapeutics for ADHD are not covered for Medicare Advantage (evidence insufficient) and are a contract exclusion for Commercial products; benefits may vary by contract.

Policy cites limitations in trial generalizability, short duration, and uncertain clinical significance of computerized attention test improvements without behavioral change.

For Commercial products, the use of EndeavorRx for all indications, including attention‑deficit/hyperactivity disorder (ADHD), is not covered and is treated as a contract exclusion. The policy explicitly lists HCPCS code A9291 (Prescription digital cognitive and/or behavioral therapy, FDA‑cleared, per course of treatment) as non‑covered and a contract exclusion for Commercial Products.

For Medicare Advantage plans, the use of EndeavorRx for all indications, including ADHD, is not covered because the evidence is judged insufficient to determine effects on health outcomes. The policy also specifies that HCPCS code A9291 is not covered for Medicare Advantage.

The available evidence is insufficient to demonstrate an improvement in net health outcome. The pivotal randomized controlled trial showed greater improvement on a computerized test of attention for EndeavorRx versus a digital control, but parent and clinician assessments improved similarly in both groups. Key limitations include trial populations that excluded children on stimulant medication, a short 4‑week duration that does not address long‑term ADHD outcomes, and uncertainty about the clinical significance of improved computerized attention testing without observable behavioral improvement. An open‑label adjunct study design also prevents conclusions about additive benefit when used with stimulant medication.

Billing and Codes

Not Covered / Contract ExclusionHCPCSNot Covered

A9291

Prescription digital cognitive and/or behavioral therapy, FDA-cleared, per course of treatment

Provider Requirements and Operational Notes

Prior Authorization

Prior authorization: Not applicable — service/code non‑covered

Prior authorization and medical criteria are listed as “Not applicable” in the policy; however, HCPCS code A9291 is explicitly listed as not covered. Because the service/code is non-covered, there are no prior authorization requirements to submit for coverage of EndeavorRx.

Policy: “Not applicable” for medical criteria and prior authorization.
HCPCS A9291 is listed as not covered for Medicare Advantage and as a contract exclusion for Commercial products.

Step Therapy

Step therapy / adjunctive use: No step therapy specified

No step therapy requirements are specified in the policy. The policy states EndeavorRx is intended to be used as part of a therapeutic program and may be adjunctive to clinician-directed therapy, medication, and/or educational programs.

No prerequisite trials or step-up medication/therapy sequences are required by this policy.

Clinical Background

Attention‑deficit/hyperactivity disorder (ADHD) is a chronic condition characterized by symptoms of hyperactivity, impulsivity, and inattention that affect functioning across settings. EndeavorRx is a prescription, game‑like digital therapeutic cleared by the FDA (De Novo DEN200026) for children ages 8–12 years with primarily inattentive or combined‑type ADHD and a demonstrated attention issue. It is intended to be used as part of a broader therapeutic program that may include clinician‑directed therapy, medication, and educational supports, but its trials excluded children on stimulant medication and the clinical benefit beyond computerized attention measures remains uncertain.

Key Definitions

Software as a medical device (SaMD) — definition and scope

DefinitionSoftware intended to be used for a medical purpose without being part of a hardware medical device or merely storing/transmitting medical information.

Regulatory requirementMust have received FDA marketing clearance or approval (De Novo, 510(k), or PMA) to be considered under this policy.

Prescribing requirementMust be prescribed by a healthcare provider to fall within scope of the policy.

Scope limitationThis policy reviews only digital technologies intended for therapeutic application (prescription digital therapeutics).

EndeavorRx indication — indicated age range and intended effect

Indicated age rangeChildren ages 8-12 years.

Care Setting and Level Criteria

Therapeutic Modalities

Prescription digital therapeutic (EndeavorRx)

Covered when ANY of the following are met:

Intended adjunctive use: EndeavorRx is intended to be used as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs.

FDA-cleared for children ages 8-12 to improve attention on computerized testing; however, evidence limitations affect coverage determinations.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyDigital Health Technologies for Attention Deficit/Hyperactivity Disorder

Policy CodePolicy N/A

Change TypeAdministrative review — no material changes

Effective DateJan 2, 2026

Next Review DateN/A

Key ActionDo not bill or authorize HCPCS A9291 for Commercial or Medicare Advantage — the device is non-covered/contract exclusion.

SourceLink

On This Page

Intended use: part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs.

Documentation Required

Documentation expectations: FDA‑marketed SaMD and EndeavorRx labeling

Document that the device is an FDA‑marketed software-as-a-medical-device prescribed by a healthcare provider; for EndeavorRx, note the FDA De Novo clearance and the indicated age/clinical population per labeling.

SaMD requirement: software intended for a medical purpose and prescribed by a healthcare provider (per policy overview).
EndeavorRx specifics: FDA De Novo (DEN200026) clearance; indicated to improve attention function in children ages 8–12 with a demonstrated attention issue.

Denial Risk

Coverage denial triggers: Non‑coverage / contract exclusion and non‑covered HCPCS code

Use of EndeavorRx is a coverage exclusion in Commercial products (contract exclusion) and is not covered for Medicare Advantage plans due to insufficient evidence; billing HCPCS A9291 will be considered not covered.

Commercial: “The use of EndeavorRx … is not covered and is considered a contract exclusion.”
Medicare Advantage: “The use of EndeavorRx … is not covered as the evidence is insufficient.”
HCPCS A9291 is listed as not covered for Medicare Advantage and as non-covered/contract exclusion for Commercial products.

Intended effectImprove attention function as measured by computer-based testing (improvements in TOVA sustained and selective attention).

PopulationChildren with primarily inattentive or combined-type ADHD who have a demonstrated attention issue.

Use contextIntended to be used as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs.

Regulatory pathway (example)EndeavorRx cleared by FDA through De Novo process (DEN200026).