CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

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

Policy governs coverage determination for prescription digital therapies intended to treat attention-deficit/hyperactivity disorder (ADHD) for Medicare Advantage and commercial products offered by Blue Cross Blue Shield - Rhode Island. It summarizes clinical background, regulatory status (FDA clearance for EndeavorRx), and declares coverage stance.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

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

Policy CodePolicy N/A

Change Typeclarified

Effective DateJan 1, 2022

Next Review Date

Key ActionBenefits may vary between groups and contracts; providers must refer to the appropriate Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for member-specific coverage determinations.

SourceLink

POLICY UPDATE CHANGES

Policy states prescription digital therapy for ADHD is not covered for Medicare Advantage and not medically necessary for commercial products due to insufficient evidence.

MAMedicare Advantage - Not Covered

CommercialCommercial - Not Medically Necessary

EndeavorRxFDA-cleared device mentioned (EndeavorRx)

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This policy governs coverage determinations for prescription digital therapies intended to treat attention-deficit/hyperactivity disorder (ADHD) for Medicare Advantage and commercial products offered by Blue Cross Blue Shield - Rhode Island. Effective date: 01/01/2022; last review: 09/01/2021. The policy highlights the FDA-cleared prescription digital therapeutic EndeavorRx, which received De Novo clearance (DEN200026) in April 2020 and is indicated to improve attention function on computer-based testing in children ages 8-12 with primarily inattentive or combined-type ADHD.

Key Facts

Medicare AdvantageNot Covered

CommercialNot Medically Necessary

FDA-cleared device mentionedEndeavorRx (De Novo DEN200026, April 2020)

Effective date2022-01-01

Policy last review2021-09-01

Medical-Necessity and Coverage Determinations

Medicare Advantage Coverage Determination

Prescription digital therapy for the treatment of attention-deficit/hyperactivity disorder is not covered

Reason: evidence is insufficient to determine the effects of the technology on health outcomes

Commercial Products Coverage Determination

Prescription digital therapy for the treatment of attention-deficit/hyperactivity disorder is considered not medically necessary

Reason: evidence is insufficient to determine the effects of the technology on health outcomes

Not Covered / Experimental Therapies

Policy conclusion: prescription digital therapy for ADHD is not covered for Medicare Advantage members and is considered not medically necessary for commercial products because the evidence is insufficient to determine effects on health outcomes. The policy specifically references the FDA-cleared device EndeavorRx (De Novo, April 2020) but finds available evidence inadequate to establish meaningful health outcome benefits.

Provider Actions & Billing Impact

Documentation Required

Refer to Benefit Booklet/Subscriber Agreement

Benefits may vary between groups and contracts; providers must refer to the appropriate Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for member-specific coverage determinations.

Denial Risk

Claims for prescription digital therapy may be denied

Claims for prescription digital therapy for ADHD are not covered for Medicare Advantage members and are considered not medically necessary for commercial members; submitters risk denial or nonpayment.

Background, Evidence & Definitions

Background: ADHD is a chronic condition characterized by symptoms of hyperactivity, impulsivity, and inattention. Established treatments include educational, environmental, psychological/behavioral interventions, and medication; many children receive stimulant medication and/or behavioral therapy. In the regulatory context, EndeavorRx (Akili) obtained FDA De Novo marketing clearance in April 2020 as a prescription digital therapeutic indicated to improve attention on computer-based testing in children ages 8-12 with primarily inattentive or combined-type ADHD.

Source	Summary
FDA clearance	EndeavorRx cleared by FDA via De Novo (DEN200026) April 2020
Evidence statement	Policy conclusion: evidence insufficient to determine effects on health outcomes

Definitions

EndeavorRxA prescription digital therapeutic (video-game based) indicated to improve attention function as measured by computer-based testing in children ages 8-12 with primarily inattentive or combined type ADHD.

Revision History

policy_clarification (draft)Latest

DRAFT document contains coverage determinations. Policy states prescription digital therapy for ADHD is not covered for Medicare Advantage and considered not medically necessary for commercial products due to insufficient evidence to determine effects on health outcomes. Change marked DRAFT and identified as non-material.

2022-01-01effective_date

Policy effective date 01/01/2022 (policy marked DRAFT).

2021-09-01last_review

Policy last updated/reviewed 09/01/2021.

coverage_details

Benefits may vary by contract; there is no specific billing code for this non-covered service and providers should refer to the applicable Benefit Booklet, Evidence of Coverage, or Subscriber Agreement.

regulatory_note

Notes FDA De Novo (DEN200026) clearance for EndeavorRx (April 2020) and its indication to improve attention function on computer-based testing in children ages 8-12, but policy still finds evidence insufficient for coverage decisions.