CurrentBlue Cross Blue Shield - Rhode IslandPolicy 3.03.03

Medical Coverage Policy Prescription Digital Health Therapies for Attention Deficit/Hyperactivity Disorder

Policy addresses coverage of prescription digital health therapies for attention-deficit/hyperactivity disorder (ADHD) for Medicare Advantage and commercial products, evaluating medical necessity and coverage status of such digital therapeutics (e.g., EndeavorRx).

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy Prescription Digital Health Therapies for Attention Deficit/Hyperactivity Disorder

Policy CodePolicy 3.03.03

Change TypeNo material change

Effective DateJan 1, 2022

Next Review Date

Key ActionVerify member-specific benefits in the Benefit Booklet/Evidence of Coverage/Subscriber Agreement and confirm coverage before providing prescription digital therapy for ADHD.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes — policy remains unchanged.

1Coverage Stance: Not Covered Indications

0Associated Billing Codes

Coverage Summary

This policy addresses coverage of prescription digital health therapies for attention-deficit/hyperactivity disorder (ADHD), with a focus on the prescription digital therapeutic device EndeavorRx. The target population described is children with ADHD (specifically ages 8-12 years with primarily inattentive or combined type). The policy's high-level stance is that such prescription digital therapies (including EndeavorRx) are not covered / not medically necessary for Medicare Advantage and commercial products due to insufficient evidence to determine effects on health outcomes.

Coverage Determination

Coverage statements as provided in the policy:

ALL of the following

Medicare Advantage Plans: Prescription digital therapy for the treatment of attention-deficit/hyperactivity disorder is not covered as the evidence is insufficient to determine the effects of the technology on health outcomes.
Commercial Products: Not medically necessary as the evidence is insufficient to determine the effects of the technology on health outcomes.

Medical-Necessity Rationale & Evidence

FDA clearance: EndeavorRx (Akili Interactive Labs) received De Novo marketing clearance (DEN200026) in April 2020 as a prescription device indicated to improve attention function in children ages 8-12 years with primarily inattentive or combined type ADHD; improvements were measured by computerized tests (e.g., TOVA).

Policy evidence assessment: The policy concludes there is insufficient evidence to determine the effects of the technology on health outcomes; therefore the therapy is not covered for Medicare Advantage plans and considered not medically necessary for commercial products.

EndeavorRx: A prescription digital therapeutic (computer game) cleared by the FDA via De Novo (DEN200026) intended to improve attention function in children ages 8-12 years with primarily inattentive or combined type ADHD; effectiveness was demonstrated on digitally assessed measures (e.g., TOVA) of sustained and selective attention.

Provider Actions & Billing Impact

Documentation Required

Benefit verification required

Benefits may vary between groups and contracts; providers should refer to the member's Benefit Booklet/Evidence of Coverage/Subscriber Agreement for applicable coverage determinations and verify member-specific benefits.

Denial Risk

Service not covered / not medically necessary

Claims for prescription digital therapy for ADHD may be denied because the service is considered not covered / not medically necessary per this policy due to insufficient evidence.

There is no billing code for this non-covered service. Claims may be denied because the service is considered not covered / not medically necessary per this policy. Providers may not bill members for non-covered services unless the member was informed and agreed in writing in advance per participation/subscriber agreements; verify member-specific benefits in the member's Benefit Booklet/Evidence of Coverage/Subscriber Agreement.

Background

ADHD is characterized by symptoms of hyperactivity, impulsivity, and inattention that are excessive for the person's age. Established treatments for children with ADHD include educational, environmental, psychological/behavioral interventions, and medication. In April 2020, the FDA granted De Novo marketing clearance (DEN200026) for EndeavorRx, a prescription digital therapeutic intended to improve attention function in children ages 8-12 with primarily inattentive or combined type ADHD; benefits were measured by computerized attention tests, and the device is intended to be used as part of a therapeutic program that may include clinician-directed medication and/or educational programs.