Prescription Digital Diagnostic Technologies (Canvas Dx) — Autism Spectrum Disorder Coverage
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This policy governs coverage determinations for prescription digital health technologies intended as diagnostic aids for autism spectrum disorder (ASD), specifically addressing the FDA-cleared Canvas Dx product, and applies to Blue Cross Blue Shield - Rhode Island members.
No material clinical or coverage changes in this revision.
Coverage determinations for Canvas Dx
Coverage determinations
Coverage determinations for Canvas Dx (prescription digital diagnostic for ASD):
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This policy addresses coverage for the prescription digital diagnostic application Canvas Dx, intended as an aid in diagnosing autism spectrum disorder. For Medicare Advantage members, Canvas Dx is not covered because the available evidence is insufficient to determine its effect on health outcomes. For Commercial products, Canvas Dx is classified as not medically necessary for the same reason — insufficient evidence to demonstrate clinical benefit.
For commercial members, the Canvas Dx prescription digital diagnostic application is considered not medically necessary. This determination is based on an assessment that the evidence is insufficient to establish that use of the technology favorably affects health outcomes; therefore claims for Canvas Dx may be denied on the basis of medical necessity.
Billing and coding guidance
| unlisted code | No specific code exists; claims should be filed with an unlisted code as instructed in policy |
Provider requirements, authorization, and billing risks
Prior Authorization
Prior authorization — prior authorization not applicable for this policy.
Step Therapy
Step therapy — no step therapy requirements specified.
Billing documentation
Billing documentation — there is no specific code for this procedure. Claims should be filed with an unlisted code. Include supporting documentation explaining the FDA-cleared diagnostic software used, the clinical indication, prescribing provider information, and any test results or interpretation to justify medical necessity.
- File claims with an appropriate unlisted procedure code (no specific CPT/HCPCS exists).
- Include documentation: prescription/order for the digital diagnostic software; FDA clearance reference (e.g., Canvas Dx if applicable); clinical indication and rationale; provider notes and test results; date(s) of service and place of service.
Commercial coverage denial risk
Commercial coverage denial risk — Canvas Dx considered not medically necessary for commercial products; claims may be denied.
- Canvas Dx — considered not medically necessary for commercial products; expect potential claim denial.
Medicare Advantage coverage denial risk
Medicare Advantage coverage denial risk — Canvas Dx not covered for Medicare Advantage; claims may be denied.
- Canvas Dx — not covered for Medicare Advantage plans; expect potential claim denial.
Clinical background
Autism spectrum disorder (ASD) is a neurodevelopmental condition characterized by persistent deficits in social communication and interaction and by restricted, repetitive patterns of behavior. Diagnosis typically involves developmental surveillance and screening followed by a comprehensive diagnostic evaluation; early and accurate identification can improve access to interventions and outcomes. Prescription digital diagnostic technologies reviewed by this policy (software as a medical device, such as Canvas Dx) are intended to support diagnostic assessment, but their clinical role must be evaluated against evidence demonstrating impact on diagnostic accuracy and downstream health outcomes.
Key definitions
Prescription digital diagnostic technologies (SaMD) — scope
Prescription digital diagnostic technologies (SaMD)
Scope and required attributes for prescription digital diagnostic technologies (software as a medical device):
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