CurrentBlue Cross Blue Shield - MassachusettsPolicy 947

EndeavorRx (prescription digital therapeutic) — Investigational for all indications

This policy governs coverage of the prescription digital therapeutic EndeavorRx (a Software as a Medical Device) for therapeutic use, specifying investigational status and applicability to commercial and Medicare members of Blue Cross Blue Shield Massachusetts.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyEndeavorRx (prescription digital therapeutic) — Investigational for all indications

Policy CodePolicy 947

Change TypeNo material change

Effective DateDec 1, 2021

Next Review DateDec 1, 2025

Key ActionPrecertification/preauthorization is required for inpatient services described in this policy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Investigationalcoverage stance for EndeavorRx

Ages 8-12age range evaluated

No codescoding availability

Precert requiredauthorization when inpatient

Not coveredoutpatient coverage

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Coverage Criteria

Investigational — All indications

Policy statement

Policy stance: The use of EndeavorRx is considered INVESTIGATIONAL for all indications including attention-deficit/hyperactivity disorder.

Applies to Commercial and Medicare products listed.

For outpatient settings, EndeavorRx is not a covered service for the products listed. Specifically, outpatient use is not covered for Commercial Managed Care (HMO and POS), Commercial PPO and Indemnity, Medicare HMO Blue SM, and Medicare PPO Blue SM members. Providers should expect outpatient claims for this service to be denied under these products.

The available clinical evidence is insufficient to demonstrate a net health benefit for EndeavorRx. The pivotal randomized controlled trial (STARS-ADHD) showed improvement on a computerized attention test in children ages 8–12, but there was no difference on parent- or clinician-rated assessments. The trial excluded children taking ADHD medication and had a short duration (4 weeks), limiting generalizability to routine clinical practice and the ability to assess long-term functional outcomes. An open-label adjunct study (STARS-Adjunct) compared EndeavorRx plus stimulant medication with EndeavorRx alone, a design that does not permit conclusions about adjunctive benefit. Given these limitations and uncertainty about clinical significance, the evidence does not establish that EndeavorRx improves symptoms, functioning, or quality of life; therefore it is considered investigational.

Coding and Billing

Covered CPT CodesCPT

No codes listed

General coding guidancemixed

No codes listed

Provider Actions and Authorization

Prior Authorization

Inpatient prior authorization — Precertification required for inpatient services

Precertification/preauthorization is required for all inpatient services described in this policy across products. Providers must obtain prior authorization before performing the procedure in an inpatient setting to avoid claim denials or retroactive denials.

Applies to all products when procedure is performed inpatient

Denial Risk

Outpatient noncoverage — outpatient use not a covered service across products

Outpatient use of the services described in this policy is not a covered benefit for Commercial Managed Care (HMO and POS), Commercial PPO and Indemnity, Medicare HMO Blue SM, and Medicare PPO Blue SM. Do not bill outpatient claims expecting coverage; verify member contract benefits for any exception.

Commercial Managed Care (HMO and POS), Outpatient = Not a covered service

Treatment Modalities

Prescription digital therapeutic (EndeavorRx)

Evidence summary: Pivotal RCT showed improvement on a computerized attention test but no difference on parent or clinician assessments; open-label adjunct study design limits conclusions; evidence insufficient for net health benefit.

STARS-ADHD and STARS-Adjunct referenced; trial enrolled children ages 8-12 not taking ADHD medication; short duration limits generalizability.

Definitions

SaMD — definition

TermSoftware as a Medical Device (SaMD)

DefinitionSoftware intended to be used for one or more medical purposes that performs those purposes without being part of a hardware medical device.

Scope inclusion criteriaIncluded SaMD for review are therapeutic digital technologies intended for medical use, not software that only stores or transmits medical information.

ExamplesStandalone medical software such as an application that tracks lesion size and estimates melanoma risk.

Regulatory noteSaMD may have previously been referred to as standalone software, medical device software, or health software; definition aligns with IMDRF/FDA wording.

BCBSA evaluation criteria for digital health technologies — approval and evidence expectations

Background

EndeavorRx is a prescription digital therapeutic — a software-based medical intervention marketed to improve attention in children with attention-deficit/hyperactivity disorder. The pivotal randomized trial evaluated children ages 8–12 who were not taking stimulant medication and demonstrated benefit on a computerized test of attention but not on parent or clinician ratings. Because this device is intended to be used as part of a broader therapeutic program (which may include clinician-directed therapy, medication, and educational supports), and because trial populations and duration were limited, current evidence is insufficient to confirm meaningful clinical benefit in routine practice.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyEndeavorRx (prescription digital therapeutic) — Investigational for all indications

Policy CodePolicy 947

Change TypeNo material change

Effective DateDec 1, 2021

Next Review DateDec 1, 2025

Key ActionPrecertification/preauthorization is required for inpatient services described in this policy.

SourceLink

On This Page

Commercial PPO and Indemnity, Outpatient = Not a covered service

Medicare HMO Blue SM, Outpatient = Not a covered service

Medicare PPO Blue SM, Outpatient = Not a covered service

Billing Rule

Precertification and coding guidance — providers should precertify inpatient services and report using specified codes where applicable

Providers should precertify inpatient services and report all services using current industry-standard procedure, revenue, and diagnosis codes, including applicable modifiers. Follow payer-specific precertification procedures and include documentation as required by the authorizing process to support medical necessity determinations.

Report services with up-to-date CPT/HCPCS/Revenue/ICD-10 codes and modifiers where applicable
Follow Blue Cross Blue Shield — Massachusetts precertification process for inpatient services

Step Therapy

No step therapy stated — absence of step therapy requirements and trial exclusions noted

No step therapy requirements are specified in this policy. There are no stated trial or step-therapy prerequisites for authorization in the source policy text.

No step therapy stated in policy — absence of step therapy requirements and trial exclusions noted

Denial Risk

Investigational therapy denial — investigational status as basis for claim denial

The use of EndeavorRx is considered investigational for all indications (including ADHD); claims may be denied on the basis of investigational status. Verify coverage and clinical evidence before submitting for authorization.

EndeavorRx considered investigational for all indications including ADHD
Investigational status may be basis for claim denial

Requirement: Regulatory ApprovalTechnology must have final approval or clearance from the appropriate governmental regulatory body (eg, FDA).

Requirement: Evidence of Health OutcomesScientific evidence must permit conclusions about the technology's effect on health outcomes and demonstrate improvement in net health outcome.

Requirement: Comparable to AlternativesThe technology must be as beneficial as any established alternatives.

Requirement: Real-world UsabilityImprovements must be attainable outside investigational settings and demonstrate usability in real-world settings.

Requirement: Information ProtectionThe technology must assure protection of sensitive patient health information consistent with HIPAA requirements.