mp-736
print Print Back Back

Digital Health Therapies for Substance Abuse

Policy Number: MP-736

Latest Review Date: July 2021                                                                                                                                                                      

Category: DME                                                         

Policy Grade: A

POLICY:

Prescription digital therapeutics Digital health therapies for patients with substance use disorder is considered investigational.

DESCRIPTION OF PROCEDURE OF SERVICE:

The World Health Organization defines substance abuse as “the harmful or hazardous use of psychoactive substances”, which include alcohol, cocaine, marijuana, stimulants, benzodiazepines and opiates. Treatments for drug addiction include behavioral counseling and skills training, which can be given as part of a cognitive-behavioral approach. The first prescription mobile app, developed to supplement or replace individual or group therapy, delivers a cognitive-behavioral approach developed specifically for substance use disorder in a series of interactive lessons.

Substance Use Disorder

The World Health Organization defines substance abuse as “the harmful or hazardous use of psychoactive substances, including alcohol and illicit drugs”, which include alcohol, cocaine, marijuana, stimulants, benzodiazepines and opiates. The American Psychiatric Association, in the Diagnostic and Statistical Manual of Mental Disorders, details 11 problematic patterns of use that lead to clinically significant impairment or distress. Mild substance use disorder (SUD) is defined as meeting 2 to 3 criteria, moderate as 4 to 5 criteria, and severe as 6 or more criteria.

  1. Often taken in larger amounts or over a longer period than was intended.
  2. A persistent desire or unsuccessful efforts to cut down or control use.
  3. A great deal of time is spent in activities necessary to obtain, use, or recover from the substance’s effects.
  4. Craving or a strong desire or urge to use the substance.
  5. Recurrent use resulting in a failure to fulfill major role obligations at work, school, or home.
  6. Continued use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by its effects.
  7. Important social, occupational, or recreational activities are given up or reduced because of use.
  8. Recurrent use in situations in which it is physically hazardous.
  9. Continued use despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance.
  10. Tolerance.
  11. Withdrawal.

Treatment

Treatments for drug addiction include behavioral counseling, skills training, medication, treatment for withdrawal symptoms, treatment for co-occurring mental health issues, and long-term follow-up to prevent relapse. For patients with primary opioid use disorder (OUD), medication assisted treatment is the most common approach. U.S. Food and Drug Administration (FDA)-approved drugs for opioid use treatment include a full opioid agonist (methadone), a partial opioid agonist (buprenorphine), and an opioid antagonist (naltrexone). These are used to suppress withdrawal symptoms and reduce cravings, and may be used in combination with counseling and behavioral therapies.

One common psychosocial intervention is cognitive-behavioral therapy (CBT). CBT is an established therapy based on social learning theory that addresses a patient’s thinking and behavior. CBT has proven positive effects for the treatment of SUD. There are two main goals of CBT: first, recognize thoughts and behaviors that are associated with substance abuse, and second, expand the repertoire of effective coping responses. Specific goals for SUD and OUD include a better understanding of risk factors for use, more accurate attributions of cause and effect, increased belief in the ability to address problems, and coping skills. Specific skills may include motivation, drink/drug refusal skills, communication, coping with anger and depression, dealing with interpersonal problems, and managing stress.

The community reinforcement approach (CRA) is a form of CBT that has a goal of making abstinence more rewarding than continued use. CRA increases non-drug reinforcement by teaching skills and encouraging behaviors that help improve employment status, family/social relations and recreational activities. CRA was originally developed for alcohol dependence and cocaine use, and has been shown to be more effective than usual care in reducing the number of substance use days.

Contingency management may also be a component of addiction treatment. Contingency management, also known as motivational incentives, provides immediate positive reinforcement to encourage abstinence and attendance. Positive reinforcement may range from a verbal/text acknowledgement of completion of a task to monetary payment for drug-negative urine specimens. Contingency management is based on the principles of operant conditioning as formulated by B.F. Skinner, which posits that rewarding a behavior will increase the frequency of that behavior. Contingency management is typically used to augment a psychosocial treatment such as CRA.

The combination of CRA plus contingency management was shown in a 2018 network meta-analysis of 50 RCTs to be the most efficacious and accepted intervention among 12 structured psychosocial interventions, including contingency management alone, in individuals with cocaine or amphetamine addiction.  Positive reinforcement with voucher draws (e.g., from a fishbowl) of variable worth that range from a congratulatory message to an occasional high dollar value are as effective as constant monetary vouchers. Studies conducted by the National Drug Abuse Treatment Clinical Trials Network have shown that intermittent reinforcement with incentives totaling $250 to $300 over 8 to 12 weeks both increases retention in a treatment program and reduces stimulant drug use during treatment.

Software as a Medical Device

The International Medical Device Regulators Forum, a consortium of medical device regulators from around the world which is led by the FDA, distinguishes between 1) software in a medical device and 2) software as a medical device (SaMD). The Forum defines SaMD as "software that is intended to be used for one or more medical purposes that perform those purposes without being part of a hardware medical device". FDA's Center for Devices and Radiological Health is taking a risk-based approach to regulating SaMD. Medical software that "supports administrative functions, encourages a healthy lifestyle, serves as electronic patient records, assists in displaying or storing data, or provides limited clinical decision support, is no longer considered to be and regulated as a medical device". Regulatory review will focus on mobile medical apps that present a higher risk to patients.

  • Notably, FDA will not enforce compliance for lower risk mobile apps such as those that address general wellness.
  • FDA will also not address technologies that receive, transmit, store, or display data from medical devices.

The agency has launched a software pre-cert pilot program for SaMD that entered its test phase in 2019. Key features of the regulatory model include the approval of manufacturers prior to evaluation of a product, which is based on a standardized "Excellence Appraisal" of an organization, and its commitment to monitor product performance after introduction to the U.S. market. Criteria include excelling in software design, development, and validation. Companies that obtain pre-certification participate in a streamlined pre-market review of the SaMD. Pre-certified organizations might also be able to market lower-risk devices without additional review. In 2017, FDA selected 9 companies to participate in the pilot program, including Pear Therapeutics.

KEY POINTS:

This evidence review was created with a search of the PubMed database through June 6, 2021.

Author, year, country

Study Design

Population Characteristics

Interventions

Comparators

Clinical Outcomes, Length of Follow-Up

Campbell et al (2014) FDA

Summary DEN160018

RCT

507 adult patients with self-report of drug use, with a subset of 305 who did not have primary use of opioids treated at community health centers

12 weeks of TAU + CCRA (62 modules on a desktop) + CM for module completion and negative drug screen (n=255)

12 weeks of TAU consisting > 2 individual or group therapy sessions per week (n=252)

TES reduced drop-out from the treatment program (hazard ratio=.72 [95% CI: 0.57 to 0.92], P=.010), and the odds of achieving abstinence was 1.62 fold greater in the group with CCRA and contingency management group (p=.010). TES benefit was only observed in pts who were not abstinent at baseline.

6 month follow up

Christensen et al (2014)

FDA summary

K173681

RCT

170 opioid-dependent adults

12 weeks of CCRA (69 modules on a desktop in the clinic) + CM + buprenorphine/ naloxone (n=92)

12 weeks of CM + buprenorphine/ naloxone (n=78)

9.7 more days of abstinence in 84 days, in the CCRA group (67.1 days) than in the control group (57.4 days, P=.01), No significant difference between the two groups in the longest abstinence (5.5 days P=.214). No significant improvement on the overall Addiction Severity Index (P>16).

12 week follow up

Summary of Evidence:

For individuals with SUD who receive a prescription digital therapeutic, the evidence includes 2 pivotal RCTs and analysis of data of more than 3000 patients from the mobile app. Relevant outcomes are symptoms, morbid events, change in disease status, quality of life, and medication use. Mobile digital technology is proposed to increase access to evidence-based cognitive-behavioral treatments, particularly in rural areas or where there are other limitations to specialist care. Although it is theoretically appealing to replace in-person counseling with computer-based therapy, there are a number of limitations in the current evidence base that limit any conclusions regarding efficacy. Specifically, 1 of the trials assessed the combined intervention of computer-based learning and a reward for abstinence. Since reward for abstinence alone has been shown to increase both abstinence and retention, the contribution of the web-based program to the overall treatment effect cannot be determined. The treatment effect on abstinence was not observed at follow-up, raising further questions about the relative effects of the rewards and the web program. The second trial, conducted in patients with primary opioid use disorder, did not meet a primary objective of longest days of abstinence. While both RCTs reported a positive effect on the intermediate outcome of retention, the relationship between retention and relevant health outcomes in these trials is uncertain. In addition, both trials were conducted with an earlier technology (a desktop in a clinic) and were unblinded, so there are issues of possible performance bias and questions about generalizability of these results. The observational study shows that participants who complete more modules with the mobile app have greater abstinence during weeks 9 to 12, but the lack of a control group with comparable motivation limits interpretation of results. Given all of these limitations, further study in well-designed trials is needed to determine the effects of prescription digital therapeutics on relevant outcomes in patients with SUD and OUD. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements:

National Institute on Drug Abuse

The 2018 Principles of Drug Addiction and Treatment from the National Institute on Drug Abuse describes evidence-based approaches to drug addiction treatment. Behavioral therapies include cognitive-behavioral therapy (alcohol, marijuana, cocaine, methamphetamine, nicotine), contingency management (alcohol, stimulants, opioids, marijuana, nicotine), community reinforcement approach plus vouchers (alcohol, cocaine, opioids), motivational enhancement therapy (alcohol, marijuana, nicotine), the matrix model (stimulants), 12-step facilitation therapy (alcohol, stimulants, opiates) and family behavior therapy.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

reSET-O®, reSET®, substance use disorder, prescription mobile app,deprexis, vorvida, Modia, cognitive behavioral therapy, CBT

APPROVED BY GOVERNING BODIES:

In 2017, reSET® (Pear Therapeutics), received de novo marketing clearance from the FDA to provide CBT as an adjunct to contingency management, for patients with substance use disorder who are enrolled in outpatient treatment under the supervision of a clinician (DEN160018). This is the first prescription digital therapeutic to be approved by the FDA.

In 2018, reSET-O® (Pear Therapeutics) was cleared for marketing by the FDA through the 510(k) pathway as a prescription-only digital therapeutic to “increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management” (K173681). FDA determined that this device was substantially equivalent to existing devices. The predicate device was reSET®.

In July 2020, deprexis®(Orexo Digital Therapuetics) received FDA EUA approval. Deprexis is a 12 week digital cognitive behavorial therapy program for mild to moderate to severe depression.

In July 2020, VORV!DA®(Orexo Digital Therapuetics) received FDA EUA approval. VORV!DA is a 24 week digital cognitive behavorial therapy program for problematic drinking.

Modia™ (Orexo Digital Therapuetics) is currently in development for use in patients with opioid use disorder. This includes a 24 week digital therapy support program.

Vorvida® and Modia® (Orexo) provide support for individuals with problematic drinking and OUD. These digital technologies have not received marketing clearance by U.S. Food and Drug Administration and are not reviewed here. They are currently available in the U.S. through the Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During COVID19.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.

ITS: Covered if covered by the Participating Home Plan

FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING:

E1399

Durable Medical Equipment Miscellaneous

REFERENCES:

  1. American Psychological Association. What is cognitive behavioral therapy? Clinical practice guideline for the treatment of posttraumatic stress disorder. July 2017. Accessed June 9, 2020. https://www.apa.org/ptsd-guideline/patients-and-families/cognitive-behavioral.pdf.
  2. Beevers CG, Pearson R, Hoffman JS, Foulser AA, Shumake J, Meyer B. Effectiveness of an internet intervention (deprexis) for depression in a United States adult sample: a parallel-group pragmatic randomized controlled trial. J Consult Clin Psychol. 2017;85(4):367-380. doi:10.1037/ccp0000171.
  3. Berger T. Evaluating an e-mental health program ("deprexis") as adjunctive treatment tool in psychotherapy for depression: results of a pragmatic randomized controlled trial. J Affect Disord. 2017;227:455-462.
  4. Bickel WK, Marsch LA, Buchhalter AR, et al. Computerized behavior therapy for opioid-dependent outpatients: a randomized controlled trial. Exp Clin Psychopharmacol. Apr 2008; 16(2): 132-43.
  5. Bücker L, Bierbrodt J, Hand I, Wittekind C, Moritz S. Effects of a depression-focused internet intervention in slot machine gamblers: a randomized controlled trial [published correction appears in PLoS One. Aug 23, 2018;13(8):e0203145]. PLoS One. 2018;13(6):e0198859. doi:10.1371/journal.pone.0198859.
  6. Campbell AN, Nunes EV, Matthews AG, et al. Internet-delivered treatment for substance abuse: a multisite randomized controlled trial. Am J Psychiatry. Jun 2014; 171(6): 683-90.
  7. Christensen DR, Landes RD, Jackson L, et al. Adding an Internet-delivered treatment to an efficacious treatment package for opioid dependence. J Consult Clin Psychol. Dec 2014; 82(6): 964-72.
  8. De Crescenzo F, Ciabattini M, D'Alo GL, et al. Comparative efficacy and acceptability of psychosocial interventions for individuals with cocaine and amphetamine addiction: A systematic review and network meta-analysis. PLoS Med. Dec 2018; 15(12): e1002715.
  9. Denis CM, Cacciola JS, Alterman AI. Addiction Severity Index (ASI) summary scores: comparison of the Recent Status Scores of the ASI-6 and the Composite Scores of the ASI-5. J Subst Abuse Treat. Nov-Dec 2013; 45(5): 444-50.
  10. Dennis BB, Sanger N, Bawor M, et al. A call for consensus in defining efficacy in clinical trials for opioid addiction: combined results from a systematic review and qualitative study in patients receiving pharmacological assisted therapy for opioid use disorder. Trials. Jan 06 2020; 21(1): 30.
  11. Drug Abuse Treatment Outcome Studies (DATOS) Treatment retention findings. 2008 http://www.datos.org/adults/adults- retention.html. Accessed June 7, 2021.
  12. Fischer A, Schröder J, Vettorazzi E, et al. An online programme to reduce depression in patients with multiple sclerosis: a randomised controlled trial. Lancet Psychiatry. 2015;2(3):217-223. doi:10.1016/S2215-0366(14)00049-2.
  13. International Medical Device Regulators Forum. Software as a Medical Device (SaMD): Key Definitions. 2013. http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-samd-key-definitions-140901.pdf Accessed May 5, 2020.
  14. Jördis M. Zill, Eva Christalle, Björn Meyer, Martin Härter, and Jörg Dirmaier The Effectiveness of an Internet Intervention Aimed at Reducing Alcohol Consumption in Adults: Results of a Randomized Controlled Trial (Vorvida) Dtsch Arztebl Int 2019; 116: 127–33. DOI: 10.3238/arztebl.2019.0127
  15. Kiluk BD, Nich C, Buck MB, et al. Randomized Clinical Trial of Computerized and Clinician-Delivered CBT in Comparison With Standard Outpatient Treatment for Substance Use Disorders: Primary Within-Treatment and Follow-Up Outcomes. Am J Psychiatry. Sep 01 2018; 175(9): 853-863.
  16. Klein JP, Berger T, Schröder J, et al. Effects of a psychological internet intervention in the treatment of mild to moderate depressive symptoms: results of the EVIDENT study, a randomized controlled trial. Psychother Psychosom. 2016;85(4):218-228. doi:10.1159/000445355.
  17. Maricich YA, Xiong X, Gerwien R, et al. Real-world evidence for a prescription digital therapeutic to treat opioid use disorder.Curr Med Res Opin. Feb 2021; 37(2): 175-183.
  18. Marino LA, Campbell ANC, Pavlicova M, et al. Social functioning outcomes among individuals with substance use disorders receiving internet-delivered community reinforcement approach. Subst Use Misuse. 2019; 54(7): 1067-1074.
  19. Marsden J, Gossop M, Stewart D, et al. The Maudsley Addiction Profile (MAP): a brief instrument for assessing treatment outcome. Addiction. Dec 1998; 93(12): 1857-67.
  20. McHugh RK, Hearon BA, Otto MW. Cognitive behavioral therapy for substance use disorders. Psychiatr Clin North Am. Sep 2010; 33(3): 511-25. PMID 20599130
  21. Meyer B, Bierbrodt J, Schröder J, et al. Effects of an internet intervention (deprexis) on severe depression symptoms: Randomized controlled trial. Internet Interventions. 2015;2(1):48-59. doi:10.1016/j.invent.2014.12.003.
  22. Moritz S, Schilling L, Hauschildt M, Schröder J, Treszl A. A randomized controlled trial of internet-based therapy in depression. Behav Res Ther. 2012;50(7-8):513-521. doi:10.1016/j.brat.2012.04.006.
  23. National Institute on Drug Abuse. Principles of Drug Addiction Treatment: A Research-BasedGuide(ThirdEdition).2018. https://www.drugabuse.gov/publications/principles-drug-addiction-treatment-research-based-guide-third-edition/principles- effective-treatment. Accessed June 7, 2021.
  24. Stitzer ML, Petry NM, Peirce J. Motivational incentives research in the National Drug Abuse Treatment Clinical Trials Network. J Subst Abuse Treat. Jun 2010; 38 Suppl 1: S61-9.
  25. U.S. Food and Drug Administration. Enforcement policy for digital health devices for treating psychiatric disorders during thecoronovirus disease 2019 (COVID-19) public health emergency. Guidance for industry and Food and Drug Administration Staff.April 2020. https://www.fda.gov/media/136939/download. Accessed June 8, 2021.
  26. U.S. Food and Drug Administration. Digital health innovation action plan. https://www.fda.gov/media/106331/download. Accessed June 5, 2021.
  27. U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration. Data and Dissemination. https://www.samhsa.gov/data.  Accessed June 5, 2021.
  28. U.S. Food and Drug Administration. De Novo Classification Request for reSET. https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN160018.pdf. May 16, 2016. Accessed June 5, 2021.
  29. U.S. Food and Drug Administration. 510K Summary. 2019. https://www.accessdata.fda.gov/cdrh_docs/pdf17/K173681.pdf. Accessed June 7, 2021.
  30. Zwerenz R, Becker J, Knickenberg RJ, et al. Online self-help as an add-on to inpatient psychotherapy: efficacy of a new blended treatment approach. Psychotherapy and Psychosomatics. 2017; 86(6):341-350.

POLICY HISTORY:

Medical Policy Panel, August 2020

Medical Policy Group, September 2020 (6): New medical policy. On draft through October 24, 2020.

Medical Policy Group, March 2021 (6): Updates to Governing Bodies, Key Words and References to include the following: deprexis, vorvida, modia, cognitive behavioral therapy, CBT.

Medical Policy Panel, July 2021

Medical Policy Group, July 2021 (6): Updates to Policy title, Policy statement to include new verbiage “Digital Health Therapies”, Key Points, Governing Bodies and References.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent 

therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.