DESCRIPTION
Digital health technologies are a broad term that can include multiple categories (i.e., mobile health, health information technology, wearable devices, telehealth and telemedicine, and personalized medicine) that have a wide range of uses, from applications in general wellness to companion diagnostics. The scope of this policy is to include only those digital technologies intended to be used for diagnostic application (i.e., detecting the presence or absence of a condition, risk of developing a condition, or treatment response) and that meets three criteria:
Must be software that is intended to be used for a medical purpose, without being part of a hardware medical device or software that stores or transmits medical information.
Must have de novo, premarket or 510 (K) FDA approval or marketing clearance
Must be prescribed by a physician.
An example of a digital health technology that meets the current scope of this policy is Canvas DX (formerly known as Cognoa App) that was given FDA clearance in 2021 for use by physicians as an aid in diagnosing autism spectrum disorder in individuals ages 18-72 months at risk for developmental delays. It is a prescription only device and described as an artificial intelligence application (app) for use by physicians. The caregiver uses a smartphone application to fill out a questionnaire regarding the child’s behavior and development. The caregiver can also video the child’s behavior at home using the app. A video analyst then reviews the videos taken by the caregiver and completes an online questionnaire using a healthcare provider portal. Finally, a health care professional meets with the child and caregiver and completes his online questionnaire. Canvas Dx then takes the 3 individual inputs and produces one of 3 outputs. 1.) Positive for ASD with physician confirmation that the individual’s clinical presentation is consistent with ASD. 2.) Negative for ASD with physician confirmation that the individual’s clinical presentation is not consistent with ASD. 3.) No result due to the available information has not allowed the algorithm to produce a result.
POLICY
Prescription digital health technologies for diagnostic applications as a diagnostic aid (e.g., Canvas Dx for autism) are considered investigational.
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g., statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
Evidence for the Canvas Dx has not directly demonstrated that the test is clinically useful, and a chain of evidence cannot be constructed to support utility. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
SOURCES
Abbas, H., Garberson, F., Glover, E., & Wall, D.P. (2018). Machine learning approach for early detection of autism by combining questionnaire and home video screening. Journal of the American Medical Informatics Association, 25 (8), 1000-1007. (Level 4 evidence)
American Academy of Pediatrics. Caring for children with autism spectrum disorder: A practical resource tool kit for clinicians, 3rd edition. Retrieved April 21, 2023 from https://publications.aap.org/toolkits/pages/Autism-Toolkit.
BlueCross BlueShield Association. Evidence Positioning System. (8.2022). Digital Health Technologies: Diagnostic Applications(3.03.01). Retrieved April18, 2023 from www.bcbsaoca.com/eps/. (33 articles and/or guidelines reviewed)
DuBay, M., Watson, L.R., Mendez, L., & Rojevic, C. (2021). Psychometric comparison of the English and Spanish western-hemisphere versions of the modified checklist for autism in toddlers-revised. Journal of Developmental & Behavioral Pediatrics, 42 (9), 717-725. Abstract retrieved April 24, 2023 from PubMed database.
Hyman, S.L., Levy, S.E., & Myers, S.M. (2020). Identification, evaluation, and management of children with autism spectrum disorder. The American Academy of Pediatrics, 145 (1), e20193447. (Level 5 evidence)
Lipkin, P.H., & Macias, M.M. (2020). Promoting optimal development: identifying infants and young children with developmental disorders through developmental surveillance and screening. The American Academy of Pediatrics, 145 (1), e20193449. (Level 5 evidence)
Maenner, M J., Shaw, K A., Baio, J., EdS., Washington, A., Patrick, M., et al. (2020). Prevalence of autism spectrum disorder among children aged 8 years – autism and developmental disabilities monitoring network, 11 sites, united states, 2016. Centers for Disease Control and Prevention, 69 (4), 1-12. (Level 4 evidence)
National Institute for Health and Care Excellence (NICE). (2018, December). Evidence standards framework for digital health technologies. Retrieved April 24, 2023 from https://www.nice.org.uk/.
Pierce, K., Gazestani, V., Bacon, E., Courchesne, E., Cheng, A., Barnes, C.C., et al. (2021). Get set early to identify and treatment refer autism spectrum disorder at 1 year and discover factors that influence early diagnosis. The Journal of Pediatrics, 236, 179-188. (Level 3 evidence)
Salisbury, L.A., Nyce, J.D., Hannum, C.D., Sheldrick, C.R., & Perrin, E.C. (2018). Sensitivity and specificity of 2 autism screeners among referred children between 16 and 48 months of age. Journal of Developmental & Behavioral Pediatrics, 39 (3), 254-258. Abstract retrieved April 24, 2023 from PubMed database.
U.S. Food and Drug Administration. (2020, June). Center for Devices and Radiological Health, De Novo classification request for cognoa diagnosis ASD aid. DEN200069. Retrieved April 20, 2023 fromhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200069.
U.S. Preventive Services Task Force (USPSTF) (2016, February). Autism spectrum disorder in young children: screening. Retrieved April 20, 2023 from https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/autism-spectrum-disorder-in-young-children-screening.
Winifred S. Hayes, INC. Evolving Evidence Review. (2021, October). Canvas Dx (Cognoa Inc.) for diagnosis of autism spectrum disorder. Retrieved April 21, 2023 from www.Hayesinc.com/subscribers. (13 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 8/30/2023
MOST RECENT REVIEW DATE: 8/30/2023
ID_BA
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.