CurrentBlue Cross Blue Shield - MassachusettsPolicy 175

Prescription digital health technologies for ASD diagnosis (Canvas Dx)

Defines Blue Cross Blue Shield of Massachusetts coverage position for FDA-cleared prescription digital health technologies intended as diagnostic aids for autism spectrum disorder (Canvas Dx), application across commercial and Medicare products, and prior authorization requirements for inpatient/outpatient settings.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyPrescription digital health technologies for ASD diagnosis (Canvas Dx)

Policy CodePolicy 175

Change TypeAnnual review; policy statements unchanged

Effective DateDec 1, 2022

Next Review Date

Key ActionPrecertification/preauthorization is required for all products when the service is performed inpatient.

SourceLink

POLICY UPDATE CHANGES

Initial policy created describing investigational indications for prescription digital health technologies for ASD (Canvas Dx).

Annual policy reviews performed with description, summary, and references updated in 9/2024 and 3/2026; policy statements unchanged.

1Investigational device named

0Covered indications

68%Indeterminate rate in study

Coverage Summary

This policy (Policy Number 175) defines Blue Cross Blue Shield of Massachusetts's position on FDA-cleared prescription digital health technologies intended as diagnostic aids for autism spectrum disorder (Canvas Dx). The policy scope is limited to diagnostic Software as a Medical Device (SaMD) that is FDA-cleared and prescribed by a healthcare provider. Current policy status: CURRENT and the coverage stance treats Canvas Dx as investigational / not covered for the described diagnostic application.

Policy dates and headline conclusion

Effective date2022-12-01

Last review2026-03-01

Policy conclusionEvidence insufficient to demonstrate improvement in net health outcome; test considered investigational.

Investigational device named (count)1

Medical Necessity / Coverage Determinations

Coverage Determination

Policy statement:

Prescription digital health technologies for diagnostic application that have received clearance for marketing by the U.S. Food and Drug Administration as a diagnostic aid for autism spectrum disorder (Canvas Dx) are considered INVESTIGATIONAL.

Site-specific prior authorization requirements

Precertification / prior authorization rules by setting:

Inpatient requirement: Precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.

Outpatient coverage by product

Commercial Managed Care (HMO and POS), Outpatient = This is not a covered service.
Commercial PPO and Indemnity, Outpatient = This is not a covered service.
Medicare HMO Blue SM, Outpatient = This is not a covered service.
Medicare PPO Blue SM, Outpatient = This is not a covered service.

Provider Actions & Billing Impact

Prior Authorization

Inpatient precertification required

Precertification/preauthorization is required for all products when the service is performed inpatient.

Applies to all products when inpatient

Denial Risk

Outpatient not covered

Claims for outpatient use of prescription digital health diagnostic technologies for ASD (Canvas Dx) for Commercial Managed Care, Commercial PPO/Indemnity, Medicare HMO Blue SM, and Medicare PPO Blue SM are not covered and may be denied.

Commercial Managed Care (HMO and POS)
Commercial PPO/Indemnity
Medicare HMO Blue SM
Medicare PPO Blue SM

Documentation Required

Coding and documentation guidance

Providers should report services using most up-to-date procedure, revenue, and diagnosis codes; absence of a specific CPT/HCPCS code for the service does not imply coverage.

No specific CPT/HCPCS codes exist for this service; report most up-to-date procedure, revenue, and diagnosis codes.

Coding

CPT CodesCPT

No codes listed

References to ICD/CPT/HCPCSmixed

There are not any specific codes for this service. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement.

Absence of a specific CPT or HCPCS code for this service does not imply coverage or reimbursement. Providers should report services using the most up-to-date procedure, revenue, and diagnosis codes, and follow the policy's coding and documentation guidance; precertification/preauthorization requirements still apply as described in the policy.

Background & Evidence Summary

Software as a Medical Device (SaMD) is defined as software intended to be used for one or more medical purposes that perform those purposes without being part of a hardware medical device. The policy scope is limited to diagnostic SaMD that are standalone, FDA-cleared (de novo, 510(k), or PMA), and prescribed by a healthcare provider. Evidence for Canvas Dx consists of a single prospective, double-blind, multicenter clinical validity study in children aged 18 to 72 months; however, the study classified 68% (290/425) of outputs as indeterminate and the evidence was judged insufficient to demonstrate clinical utility or an improvement in net health outcome.

Evidence summary

Study populationChildren aged 18 to 72 months

Indeterminate outputs (Canvas Dx)68% (290/425)

Sensitivity (determinate results)98.4% (95% CI, 91.6% to 100%)

Specificity (determinate results)78.9% (95% CI, 67.6% to 87.7%)

Policy conclusionPrescription digital health diagnostic aid for ASD (Canvas Dx) is considered investigational; evidence insufficient to demonstrate improvement in net health outcome.

Revision History

2022-12-01policy_created

Initial policy created describing investigational indications for prescription digital health technologies for ASD (Canvas Dx); effective 12/1/2022.

2024-09-01annual_review

Annual policy reviews performed with description, summary, and references updated; policy statements unchanged.

2026-03-01annual_reviewLatest

Annual policy review completed; no changes to policy statements (policy statements remained investigational).