CurrentBlue Cross Blue Shield - MassachusettsPolicy 175

Prescription digital diagnostic technologies for autism spectrum disorder (ASD)

This policy governs coverage and utilization management for prescription Software as a Medical Device (SaMD) cleared by the FDA as a diagnostic aid for autism spectrum disorder (Canvas Dx specifically referenced) for applicable Blue Cross Blue Shield Massachusetts products. It addresses prior authorization, inpatient/outpatient distinctions, and evidence summary for children aged 18–72 months.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyPrescription digital diagnostic technologies for autism spectrum disorder (ASD)

Policy CodePolicy 175

Change TypeNo material change

Effective DateDec 1, 2022

Next Review Date

Key ActionObtain precertification/preauthorization for inpatient use; outpatient use is not a covered service.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18-72 monthsage range evaluated

68%indeterminate proportion

98.4%sensitivity

80.8%PPV

Investigational

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Determinations

Not covered / Investigational

Covered when ALL of the following are met:

Investigational coverage determination: Prescription digital health technologies cleared by the FDA as diagnostic aids for autism spectrum disorder (example: Canvas Dx) are considered investigational and not covered; current evidence is insufficient to determine that these technologies improve net health outcome.

Policy history and coverage stance: investigational; see evidence limitations below.

Evidence summary notes: Single prospective multicenter study in children 18–72 months with developmental delay concerns; 68% of participants received an ‘indeterminate’ result from Canvas Dx; determinate outputs showed 98.4% sensitivity and 80.8% positive predictive value, but study limitations (missing data, high dropout, limited generalizability, unclear role in clinical pathway, and lack of usability data outside trial) prevent demonstration of clinical utility.

Evidence is insufficient to construct a chain of evidence showing improved net health outcomes.

Outpatient use of the services described in this policy is not a covered service for the following product lines: Commercial Managed Care (HMO and POS), Commercial PPO and Indemnity, Medicare HMO Blue, and Medicare PPO Blue. Refer to precertification requirements for inpatient settings; outpatient claims for these services are excluded from coverage under the listed products.

The available evidence for the diagnostic Software as a Medical Device (Canvas Dx) is limited to a single prospective, double-blind, multicenter clinical-validity study in children aged 18–72 months. In that study, 68% of participants were classified as “indeterminate” by Canvas Dx, and determinate outputs (the remaining ~32%) demonstrated high sensitivity (reported as 98.4%) and a positive predictive value of 80.8% PPV. However, major limitations — including high rates of indeterminate results, missing data, potential selection and generalizability concerns, unclear placement of the test within the clinical diagnostic pathway (i.e., whether it is a rule-in or rule-out test), and lack of usability data outside the trial setting — prevent construction of a chain of evidence showing clinical usefulness. Therefore the evidence is insufficient to demonstrate that Canvas Dx improves net health outcome, and the technology is considered investigational.

Coding and Billing

CPT CodesCPT

No codes listed

HCPCS/ICD/Modifiers guidancemixed

No codes listed

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

For services described in this policy, precertification/preauthorization is required for all products when the procedure is performed inpatient. Providers must obtain prior authorization before scheduling inpatient services to avoid claim denials or delays.

Preauthorization required for ALL products if performed inpatient
Obtain prior authorization before inpatient admission to prevent denials

Denial Risk

Outpatient Not Covered

Outpatient services described in this policy are not covered for the listed product lines. Do not submit claims for outpatient procedures under these products as they will be considered not covered.

Commercial Managed Care (HMO and POS) — Outpatient: Not a covered service
Commercial PPO and Indemnity — Outpatient: Not a covered service

Clinical Background

Autism spectrum disorder (ASD) is a neurodevelopmental condition characterized by deficits in social communication and restricted, repetitive behaviors. Diagnosis typically involves developmental screening followed by a comprehensive diagnostic evaluation; early identification in infancy and toddlerhood can improve outcomes. This policy evaluates prescription digital diagnostic SaMD intended to aid ASD assessment, with the primary clinical evidence for Canvas Dx drawn from children aged 18–72 months.

Key Definitions

Software 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 (Software as a Medical Device, SaMD).

FDA clearance/approval requirementMust have received marketing clearance or approval by the U.S. Food and Drug Administration (via de novo, 510(k), or premarket approval).

Prescription requirementMust be prescribed by a healthcare provider for use as a diagnostic aid to be within the scope of this policy.

Scope — diagnostic applications onlyScope is limited to digital technologies intended for diagnostic applications (detect presence/absence of a condition, risk of future condition, or treatment response).

Distinction from other softwareExcludes software that is part of a hardware medical device or software whose primary function is storage or transmission of medical information; previously referred to as standalone medical device software or health software.

Diagnostic Software (SaMD) Details

Diagnostic SaMD (Canvas Dx)

Covered when ALL of the following are met:

Device-specific scope: Canvas Dx (prescription Software as a Medical Device intended as a diagnostic aid for ASD) is the technology evaluated; only SaMD that meet the policy scope — FDA marketing clearance/approval and prescription by a healthcare provider — are considered under this policy.

Policy limits review to SaMD that are FDA-cleared/approved and prescribed by a healthcare provider.

Clinical evidence and limitations: Evaluation is based on a single double-blind, multicenter, prospective clinical validity study in 18–72 month-olds; the study found a high rate of indeterminate results (68%), determinate outputs had high sensitivity (98.4%) and PPV (80.8%), but substantial limitations (missing data, 40% estimated dropout, site reductions, unclear applicability to home settings, and unclear placement in clinical diagnostic pathway) render evidence insufficient for clinical utility.

See full study limitations in policy summary.