DESCRIPTION
Substance use disorder is defined by the World Health Organization as “the harmful or hazardous use of psychoactive substance,” which include alcohol, cocaine, marijuana, stimulants, benzodiazepines, and opiates. Treatments for drug addiction can be given as part of a cognitive-behavioral approach that includes behavioral counseling and skills training. A prescription mobile app (e.g., reSet®, reSet-O®) has been developed and proposed to supplement or replace individual or group therapy. It delivers a cognitive behavioral approach in a series of interactive lessons specifically for substance abuse.
POLICY
Digital health therapies for the treatment of substance use disorders is 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
Mobile digital Technology is proposed as an adjunct to outpatient treatment; however, there are several limitations in the current evidence base that limit any conclusions regarding efficacy. Further studies in well-designed trials are needed to determine the effects of prescription digital therapeutics on relevant outcomes in individuals with substance use disorder.
Vorvida® and Modia® (Orexo) provide support for individuals with problematic drinking and opioid use disorder. These digital technologies have not received marketing clearance by the FDA. They are currently available in the U.S. through the Enforcement Policy for digital health devices for treating psychiatric disorders during COVID19.
SOURCES
American Society of Addiction Medicine (ASAM). National practice guideline for the treatment of opioid use disorder 2020 focused update. Retrieved March 16, 2023 from https://www.asam.org/quality-care/clinical-guidelines/national-practice-guideline.
BlueCross BlueShield Association. Evidence Positioning System. (8.2022). Digital Health Therapies for Substance Use Disorders (5.01.35). Retrieved March 16, 2023 from https://www.evidencepositioningsystem.com/. (31 articles and/or guidelines reviewed)
Bonfiglio, NS., Mascia, ML., Cataudella, S., & Penna, MP. (2022). Digital help for substance users {SU}: A systematic review. International Journal of Environmental Research and Public Health, 19 (18), 11309. (Level 3 evidence)
Campbell, A N.C., Nunes, V.E., Matthews, A.G., Stitzer, M., Miele, G.M, Polsky, D., et al. (2014). Internet-delivered treatment for substance abuse: A multi-site randomized controlled clinical trial. The American Journal of Psychiatry, 171 (6), 683-690. (Level 2 evidence)
Maricich, Y.A., Gerwien, R., Kuo, A., Malone, D.C., Fulton, F.V., Imbert, B., et al. (2021). Real-world use and clinical outcomes after 24 weeks of treatment with a prescription digital therapeutic for opioid use disorder. Current Medical Research And Opinion, 37(2), 175-183. (Level 4 evidence)
Maricich, Y.A., Nunes, E.V., Campbell, A.N C., Botbyl, J.D., & Luderer, H.F. (2022) Safety and efficacy of a digital therapeutic for substance use disorder: Secondary analysis of data from a NIDA clinical trials network study. Substance Abuse, 43 (1), 937-942. (Level
Maricich, Y.A., Xiaorui, X., Gerwien, R., Kuo, A., & Fulton, F.V. (2021). Real-world use and clinical outcomes after 24 weeks of treatment with a prescription digital therapeutic for opioid use disorder. Hospital Practice, 49 (5), 348-355. (Level 4 evidence)
Marino, L.A., Campbell, ANC., Pavlicova, M., Hu, M., & Nunes, EV. (2019). Social functioning outcomes among individuals with substance use disorders receiving internet-delivered community reinforcement approach. Substance Use & Misuse, 54 (7), 1067–1074. Abstract retrieved March 22, 2023 from PubMed database.
National Institute on Drug Abuse (NIDA). Principals of drug addiction treatment: A research - based guide (third edition). Retrieved March 16, 2023 from https://www.drugabuse.gov/.
U.S. Food and Drug Administration. (2016, May). Center for Devices and Radiological Health. 510 (k) Premarket Notification Database. K173681. Retrieved March 17, 2023 from https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN160018.pdf.
U.S. Food and Drug Administration. (2019, August). Center for Devices and Radiological Health, De Novo classification request for ReSet. DEN160018. Retrieved March 17, 2023 from https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN160018.pdf.
Valez, F.F., Ruetsch, C., & Maricich, Y. (2021). Evidence of long-term real-world reduction in healthcare resource utilization following treatment of opioid use disorder with reSET-O, a novel prescription digital therapeutic. Expert Review Of Pharmacoeconomics & Outcomes Research, 21 (4), 519-520. (Level 5 evidence)
Winifred S. Hayes, INC. Health Technology Assessment. (2021, May). Mobile medical applications for substance use disorders. Retrieved March 16, 2023 from www.Hayesinc.com/subscribers. (37 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 8/1/2023
MOST RECENT REVIEW DATE: 8/1/2023
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.
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