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Digital Health Therapies for Substance Use

Policy Number: MP-736

Latest Review Date: August 2022                                                                                                                                                         

Category: DME                                                         

POLICY:

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

DESCRIPTION OF PROCEDURE OF SERVICE:

The World Health Organization defines substance use 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 substance use disorder 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-certification 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.

BCBSA Evaluation Framework for Digital Health Technologies

SaMDs, as defined by FDA, are subject to the same evaluation standards as other devices; the Blue Cross and BlueShield Association Technology Evaluation Criterion are as follows:

The technology must have final approval from the appropriate governmental regulatory bodies.

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

The technology must improve the net health outcome.a

The technology must be as beneficial as any established alternatives.

The improvement must be attainable outside the investigational settings.b

a The technology must assure protection of sensitive patient health information as per the requirements of The Health Insurance Portability and Accountability Act of 1996 (HIPAA)

b The technology must demonstrate usability in a real-world setting

Other regulatory authorities such as the United Kingdom's National Institute for Health and Care Excellence (NICE) have proposed standards to evaluate SaMD.

KEY POINTS:

This evidence review was created with a search of the PubMed database through June 6, 2022.

Author, year, country

Study Design

Population Characteristics

Interventions

Comparators

Clinical Outcomes, Length of Follow-Up

Marichich et al  (2021)

Observational Study

3144 patients with buprenorphine medication for OUD who were under the care of a clinician and filled a 12-weekprescription for reSET-O

 

Four 30 min modules per week for a total of 31 core modules and 36 supplemental modules on a mobile device;

Total treatment time 12 weeks

None

12 weeks

Marichich et al (2021)

Observational Study

643 individuals from the above cohort who had completed a 12-week prescription

 

Same as above; with a total treatment time of 24 weeks

None

24 weeks

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 other than OUD who receive a prescription digital therapeutic, the evidence includes 1 pivotal CT and secondary analyses of data from the trial. Relevant outcomes are symptoms, morbid events, change in disease status, quality of life, and medication use. Mobile digital technology is proposed as an adjunct to outpatient treatment; however, there are a number of limitations in the current evidence base that limit any conclusions regarding efficacy. The RCT 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. While the RCT reported a positive effect on the intermediate outcome of retention, the relationship between retention and relevant health outcomes in this trial is uncertain. A retrospective secondary analyses of data from the trial reported an association between engagement with the app and abstinence at 9 to 12 weeks, but study design limitations preclude drawing conclusions from this study. Given these limitations, further study in well-designed trials is needed to determine the effects of prescription digital therapeutics on relevant outcomes in individuals with SUD. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with OUD who receive a prescription digital therapeutic, the evidence includes 1 pivotal RCT 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 as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management; however, there are a number of limitations in the current evidence base that limit any conclusions regarding efficacy. The RCT did not meet a primary objective of longest days of abstinence. While there was a positive effect on the intermediate outcome of retention, the relationship between retention and relevant health outcomes in this trial is uncertain. Retrospective observational studies found that participants who completed more modules with the mobile app had greater abstinence during weeks 9 to 12 and, in a subgroup of individuals who received a refill prescription, during weeks 21 to 24, but the retrospective design and lack of a control group with comparable motivation limits interpretation of these results. Given these limitations, further study in well-designed trials is needed to determine the effects of prescription digital therapeutics on relevant outcomes in individuals with OUD. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements:

American Society of Addiction Medicine

In 2020, the American Society of Addiction Medicine (ASAM) published a focused update of their National Practice Guideline for the Treatment of Opioid Use Disorder.

The guideline recommended that psychosocial treatment should be considered in conjunction with pharmacological treatment for opioid use disorder and noted, "At a minimum, the psychosocial treatment component of the overall treatment program should include assessment of psychosocial needs; individual and/or group counseling; linkages to existing support systems; and referrals to community-based services. “They also noted that "psychosocial treatment may also include more intensive individual counseling and psychotherapy, contingency management, and mental health services" and, "while questions remain about which specific psychosocial therapies work best with which pharmacological treatments, there is widespread support for recommending psychosocial treatment as an important component of a patient’s opioid use disorder treatment plan." The guideline did not address digital health therapies.

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:

CPT Codes :

0702T

Remote therapeutic monitoring of a standardized online digital cognitive behavioral therapy program ordered by a physician or other qualified health care professional; supply and technical support, per 30 days (Effective 01/01/2022)

0703T

Remote therapeutic monitoring of a standardized online digital cognitive behavioral therapy program ordered by a physician or other qualified health care professional; management services by physician or other qualified health care professional, per calendar month (Effective 01/01/2022)

HCPCS:

A9291 Prescription digital behavioral therapy, fda cleared, per course of treatment (Effective 04/01/22)

E1399

Durable Medical Equipment Miscellaneous

 

REFERENCES:

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  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.
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  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.
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  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.
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  17. Luderer HF, Campbell ANC, Nunes EV, et al. Engagement patterns with a digital therapeutic for substance use disorders: Correlations with abstinence outcomes. J Subst Abuse Treat. Jan 2022; 132: 108585.
  18. Maricich YA, Nunes EV, Campbell ANC, et al. Safety and efficacy of a digital therapeutic for substance use disorder: Secondary analysis of data from a NIDA clinical trials network study. Subst Abus. 2022; 43(1): 937-942.
  19. 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.
  20. Maricich YA, Gerwien R, Kuo A, et al. Real-world use and clinical outcomes after 24 weeks of treatment with a prescription digital therapeutic for opioid use disorder. Hosp Pract (1995). Dec 2021; 49(5): 348-355.
  21. 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.
  22. 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.
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  26. 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.
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  30. U.S. Food and Drug Administration. 510K Summary. 2019.https://www.accessdata.fda.gov/cdrh_docs/pdf17/K173681.pdf Accessed June 9, 2022.
  31. 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.
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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.

Medical Policy Group, November 2021: 2022 Annual Coding Update. Added CPT 0702T-0703T.

Medical Policy Group, March 2022 Quarterly Coding Update. Added HCPCS A9291 to Current Coding section.

Medical Policy Panel, July 2022

Medical Policy Group, August 2022 (6): Updates to Key Points, Practice Guidelines and References. Title modified to Digital Health Therapies for Substance Use.

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.