CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Prescription Digital Diagnostic Technologies for Autism Spectrum Disorder (ASD)

This policy governs coverage determinations for prescription digital health technologies intended as diagnostic aids for autism spectrum disorder (ASD) that are FDA-marketed and prescribed by a healthcare provider, and describes payer stance for Medicare Advantage and commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyPrescription Digital Diagnostic Technologies for Autism Spectrum Disorder (ASD)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 2, 2023

Next Review DateN/A

Key ActionFile claims for these digital diagnostic technologies with an unlisted code; prior authorization is not applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Canvas DxTechnology highlighted

Not covered / NMNCoverage stance

Unlisted codeBilling

18–72 moAge range cited

Coverage determinations

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 decision and rationale

Covered when ALL of the following are met:

Medicare Advantage stance: Canvas Dx is not covered for Medicare Advantage plans because evidence is insufficient to determine the effects of the technology on health outcomes.

Supports denial for Medicare Advantage

Commercial products stance: Canvas Dx is considered not medically necessary for commercial products because evidence is insufficient to determine the effects of the technology on health outcomes.

Supports NMN determination for commercial lines

Evidence limitations: Available clinical validity data are limited (single prospective study; specialist—not primary care—used the clinician module; studies enrolled preselected high‑risk children; unclear how the test integrates into the recommended screening/diagnostic pathway; lack of general population and real‑world usability data), preventing demonstration of clinical utility.

Rationale for NMN/not covered decisions

Prescription digital health technologies that have received FDA marketing clearance specifically as a diagnostic aid for autism spectrum disorder (Canvas Dx) are addressed by this policy. For Medicare Advantage plans, such technologies are not covered. For commercial products, they are considered not medically necessary. These determinations apply to FDA-cleared, prescription digital diagnostic software marketed for ASD and referenced here as Canvas Dx.

For commercial products, Canvas Dx is considered not medically necessary because the available evidence is insufficient to determine the effects of the technology on health outcomes. This rationale supports a not medically necessary determination for commercial lines of business.

Provider requirements and billing guidance

Prior Authorization

Prior authorization — Not applicable.

Step Therapy

Step therapy — No step therapy requirements specified for prescription digital diagnostic technologies.

Billing Rule

Billing Guidance

Billing guidance — There is no specific code for this procedure. Claims should be filed with an unlisted code.

Denial Risk

Coverage Denial Risk for Canvas Dx

Coverage denial risk for Canvas Dx — Prescription digital health technologies cleared by the U.S. Food and Drug Administration as a diagnostic aid for autism spectrum disorder (Canvas Dx) are not covered for Medicare Advantage members and are considered not medically necessary for Commercial members due to insufficient evidence of clinical benefit. Claims for Canvas Dx may therefore be denied.

Clinical background

Autism spectrum disorder (ASD) is a neurodevelopmental condition diagnosed through a staged process that begins with developmental screening and proceeds to a comprehensive diagnostic evaluation when screening or clinical concern suggests possible ASD. Early identification and intervention can improve outcomes. Digital health technologies intended as software as a medical device (SaMD) have been developed to assist in the diagnostic pathway for young children (discussed in studies including subjects in the 18–72 months range), but available clinical validity and utility data for FDA‑cleared tools like Canvas Dx are limited and do not establish clear benefit when integrated into current screening and diagnostic workflows.

Key definitions

Software as Medical Device (SaMD) — definition and policy scope

DefinitionSoftware as a Medical Device (SaMD): software intended to be used for a medical purpose without being part of a hardware medical device and not merely storing or transmitting medical information.

Scope requirementPolicy applies only to digital technologies intended for diagnostic application that meet the SaMD definition, have FDA marketing clearance or approval, and are prescribed by a healthcare provider.

Regulatory pathwaysFDA marketing authorization may be by De Novo, 510(k), or premarket approval (PMA) pathways for technologies meeting this SaMD definition.

Clinical roleSaMD in this policy is intended to detect presence/absence of a condition, risk of developing a condition, or treatment response (diagnostic application).

ExclusionsTechnologies that only store or transmit medical information or are not intended for a medical purpose do not meet the SaMD definition in this policy.

ASD diagnostic pathway — screening then diagnostic evaluation

Two-step pathwayDiagnosis of ASD generally occurs in two steps: developmental screening followed by a comprehensive diagnostic evaluation if screened positive.

AAP screening scheduleAmerican Academy of Pediatrics recommends general developmental screening at 9, 18, and 30 months and specific ASD screening at 18 and 24 months.

Purpose of diagnostic evaluationComprehensive diagnostic evaluation follows screening to confirm ASD using standardized criteria (DSM-5) and assess level of support needed.

Importance of early diagnosisDiagnosis and treatment in the first few years can strongly impact functioning by enabling intervention during a window of developmental plasticity.

Variation in age at diagnosisMedian age of earliest known ASD diagnosis varies by region (example: 36 months in California to 63 months in Minnesota per ADDM data), indicating ongoing gaps in early identification.

Digital diagnostic technologies

Digital diagnostic technologies (SaMD)

Intended use criteria for reviewed technologies: Policy scope is limited to digital technologies intended for diagnostic application that meet three criteria: (1) meet the definition of Software as a Medical Device (SaMD), (2) have received marketing clearance or approval by the U.S. Food and Drug Administration (eg, de novo, 510(k), or PMA), and (3) are prescribed by a healthcare provider.

Defines SaMD diagnostic technologies included in this policy