Medical Coverage Policy | Digital Health Technologies for Attention Deficit/Hyperactivity Disorder
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Policy governs coverage and medical necessity determinations for FDA-cleared prescription digital therapeutic EndeavorRx for treatment of attention-deficit/hyperactivity disorder in children and applies to Medicare Advantage and Commercial products through Blue Cross Blue Shield - Rhode Island.
No material clinical or coverage changes in this revision.
Coverage Determinations
Coverage stance
Coverage determinations:
Medicare Advantage explicit noncoverage.
Commercial explicit not medically necessary.
FDA indication and key evidence
FDA indication and evidence summary (informational):
Intended as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs.
Open-label study comparing EndeavorRx plus stimulant medication versus EndeavorRx alone does not permit conclusions about adjunctive benefit; additional studies in adolescents and children on stimulant medication are completed but not yet published.
Benefits and coverage may differ between groups and contracts. Refer to the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement to determine whether EndeavorRx (or related digital therapeutics) is an applicable covered or not medically necessary/not covered benefit for that specific contract.
For Commercial products, the use of EndeavorRx for all indications, including attention-deficit/hyperactivity disorder, is considered not medically necessary because the evidence is insufficient to determine the effects of the technology on health outcomes.
Billing and Codes
| A9291 | Prescription digital cognitive and/or behavioral therapy, FDA-cleared, per course of treatment |
Provider Requirements and Operational Notes
Prior authorization required
Not applicable
Coverage denial risk — EndeavorRx
The use of EndeavorRx is not covered / not medically necessary for the indicated populations below. For Medicare Advantage Plans: EndeavorRx is not covered. For Commercial Products: EndeavorRx is considered not medically necessary.
- Medicare Advantage Plans: EndeavorRx not covered
- Commercial Products: EndeavorRx not medically necessary
Step therapy and adjunctive treatment notes
No formal step therapy requirements are specified. Evidence gaps remain regarding adjunctive use of EndeavorRx with stimulant medication; available studies do not adequately assess additive benefit. Clinicians should document rationale when using EndeavorRx as adjunctive therapy and be aware payers may deny coverage for adjunctive use due to insufficient evidence.
- No step therapy specified
- Adjunctive use with stimulant medication: evidence insufficient
Key Definitions
Prescription Digital Therapeutic — Treatment Context
Prescription digital therapeutic (EndeavorRx)
No evidence showing additive benefit when combined with stimulant medication due to study design limitations.
Clinical Background
Attention-deficit/hyperactivity disorder (ADHD) is a chronic condition characterized by symptoms of hyperactivity, impulsivity, and inattention that impair functioning across settings. EndeavorRx is a prescription digital therapeutic cleared by the FDA through the De Novo pathway (DEN200026) to improve attention function as measured by computer-based testing in children ages 8-12 with primarily inattentive or combined type ADHD who have a demonstrated attention issue. Clinical evidence includes a pivotal randomized controlled trial that showed improvement on a computerized attention test (Test of Variables of Attention, TOVA) for participants using EndeavorRx, but parent and clinician assessments did not show corresponding behavioral improvements; the clinical significance of improved computerized test performance without detectable behavioral change is uncertain. EndeavorRx is intended to be used as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs.
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