DraftBlue Cross Blue Shield - Rhode IslandPolicy N/A

Digital Health Technologies for Attention Deficit/Hyperactivity Disorder (EndeavorRx)

Policy governs coverage of prescription digital therapeutic software (EndeavorRx) intended to improve attention in children with ADHD for Blue Cross Blue Shield - Rhode Island members; distinguishes Medicare Advantage and Commercial product stances.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyDigital Health Technologies for Attention Deficit/Hyperactivity Disorder (EndeavorRx)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionDo not submit prior authorization; EndeavorRx is not covered for Medicare Advantage and is a contract exclusion for Commercial products.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

8-12FDA age

ExclusionCommercial stance

A9291HCPCS code

STARS-ADHDKey trial

Coverage Determinations

Coverage determinations

Coverage determination summary

Medicare Advantage stance: Use of EndeavorRx for all indications including attention-deficit/hyperactivity disorder is not covered because the evidence is insufficient to determine the effects of the technology on health outcomes.

Commercial products stance: Use of EndeavorRx for all indications including attention-deficit/hyperactivity disorder is not covered and is considered a contract exclusion for Commercial Products.

For members covered under Commercial products, the policy states that the use of EndeavorRx is not covered and is treated as a contract exclusion. The associated HCPCS code A9291 (Prescription digital cognitive and/or behavioral therapy, FDA-cleared, per course of treatment) is listed as a non-covered/contract exclusion for Commercial Products.

For Medicare Advantage plans, the use of EndeavorRx for all indications, including attention-deficit/hyperactivity disorder (ADHD), is not covered. The rationale cites insufficient evidence that the technology improves net health outcomes — noting limitations of the pivotal randomized trial (STARS-ADHD), including a selective trial population (excluded children on ADHD medication), short duration (4 weeks) inadequate to assess long-term functional outcomes, and uncertain clinical significance because improvement was seen on a computerized attention test without corresponding parent or clinician-rated behavioral improvements.

Coding and Eligibility

Not Covered / Contract ExclusionHCPCSNot Covered

A9291

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

Age — FDA-indicated patient age for EndeavorRx

FDA-indicated age rangeChildren ages 8-12 years

Clinical populationChildren with primarily inattentive or combined type ADHD who have a demonstrated attention issue

Outcome measure specified in indicationImprovement in attention function as measured by computer-based testing (TOVA)

Provider Requirements and Operational Notes

Prior Authorization

Prior authorization — Not applicable per policy.

Step Therapy

Step therapy / Adjunct Use

EndeavorRx is intended to be used as part of a therapeutic program and may be prescribed alongside clinician-directed medication and/or educational programs. Providers should consider this device as an adjunct to comprehensive ADHD care rather than a standalone substitute for pharmacologic or behavioral therapies.

Intended use: adjunct to clinician-directed medication and/or educational programs
Evidence notes: pivotal trials enrolled medication‑naïve children; adjunctive effectiveness with stimulant medication remains uncertain

Documentation Required

Required Device Qualifications & Prescription

Required device qualifications & prescription — EndeavorRx meets the definition of Software as a Medical Device (SaMD), received FDA De Novo clearance (DEN200026), and is a prescription-only digital therapeutic. Coverage and use require that the product is an FDA‑cleared/approved SaMD and is prescribed by a licensed healthcare professional.

SaMD definition: software intended for a medical purpose
Regulatory status: FDA De Novo clearance (EndeavorRx)
Prescription requirement: must be prescribed by a healthcare provider

Denial Risk

Coverage Denial Triggers and Coding

Coverage denial triggers — Not covered for Medicare Advantage (insufficient evidence) and not covered for Commercial products (contract exclusion). Billing implications: HCPCS A9291 (Prescription digital cognitive and/or behavioral therapy, FDA‑cleared, per course of treatment) is listed as not covered for Medicare Advantage and is a contract exclusion / non‑covered for Commercial Products.

Medicare Advantage: EndeavorRx not covered — A9291 not covered for Medicare Advantage Plans
Commercial Products: EndeavorRx not covered — A9291 non‑covered and considered a contract exclusion

Prescription Digital Therapeutic

Prescription digital therapeutic (EndeavorRx)

FDA-cleared indication: Children ages 8-12 with primarily inattentive or combined type ADHD and a demonstrated attention issue; EndeavorRx is a prescription device intended to improve attention function as measured by computer-based testing and is intended to be used as part of a therapeutic program that may include clinician-directed medication and/or educational programs.8-12 years

Key Definitions

Software as a Medical Device (SaMD) — definition and requirement for FDA marketing clearance/approval

Definition of SaMDSoftware intended to be used for a medical purpose without being part of a hardware medical device

Marketing requirementMust have received FDA marketing clearance or approval (De Novo, 510(k), or PMA)

Prescription requirementMust be prescribed by a healthcare provider to fall within scope of this policy

EndeavorRx indication — prescription device indicated to improve attention in children ages 8-12 years

Device typeEndeavorRx — prescription digital therapeutic (Akili Interactive Labs)

Indicated effectIndicated to improve attention function as measured by computer-based testing

Target populationChildren ages 8-12 years with primarily inattentive or combined type ADHD and a demonstrated attention issue

Intended use contextIntended to be used as part of a therapeutic program that may include clinician-directed medication and/or educational programs

Clinical Background

Attention-deficit/hyperactivity disorder (ADHD) is a chronic pediatric condition characterized by symptoms of inattention, hyperactivity, and impulsivity that impair functioning across settings. EndeavorRx is a prescription digital therapeutic developed to target cognitive control networks and was evaluated in clinical studies of children ages 8-12 years. Randomized trial data showed improvement on a computerized test of attention but did not demonstrate corresponding improvements on parent or clinician assessments; trial design limitations (selective sample and short duration) leave uncertainty about meaningful, durable clinical benefit.