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L.5.01.599
The World Health Organization defines substance use disorder 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 use disorder 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 is defined as meeting 2 to 3 criteria, moderate as 4 to 5 criteria, and severe as 6 or more criteria.
Often taken in larger amounts or over a longer period than was intended.
A persistent desire or unsuccessful efforts to cut down or control use.
A great deal of time is spent in activities necessary to obtain, use, or recover from the substance’s effects.
Craving or a strong desire or urge to use the substance.
Recurrent use resulting in a failure to fulfill major role obligations at work, school, or home.
Continued use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by its effects.
Important social, occupational, or recreational activities are given up or reduced because of use.
Recurrent use in situations in which it is physically hazardous.
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.
Tolerance.
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, 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. Cognitive-behavioral therapy is an established therapy based on social learning theory that addresses a patient’s thinking and behavior. Cognitive-behavioral therapy has proven positive effects for the treatment of substance use disorder. There are 2 main goals of cognitive-behavioral therapy: first, recognize thoughts and behaviors that are associated with substance abuse, and second, expand the repertoire of effective coping responses. Specific goals for substance use disorder and opioid use disorder 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 is a form of cognitive-behavioral therapy that has a goal of making abstinence more rewarding than continued use. Community reinforcement approach increases non-drug reinforcement by teaching skills and encouraging behaviors that help improve employment status, family/social relations and recreational activities. Community reinforcement approach 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 community reinforcement approach.
The combination of community reinforcement approach 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 (eg, 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."
The 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, the FDA will not enforce compliance for lower risk mobile apps such as those that address general wellness.
The 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, the FDA selected 9 companies to participate in the pilot program, including Pear Therapeutics.
BCBSA Evaluation Framework for Digital Health Technologies
SaMDs, as defined by the FDA, are subject to the same evaluation standards as other devices; the Blue Cross and Blue Shield 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
aThe technology must assure protection of sensitive patient health information as per the requirements of The Health Insurance Portability and Accountability Act of 1996 (HIPAA)bThe 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.
In 2017, reSET® (Pear Therapeutics), received de novo marketing clearance from the FDA to provide cognitive-behavioral therapy 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. reSET is indicated as a 12-week (90 days) prescription-only treatment intended to increase abstinence from a patient's substances of abuse during treatment, and increase retention in the outpatient treatment. FDA product code: PWE
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 in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management” (K173681). The FDA determined that this device was substantially equivalent to existing devices. The predicate device was reSET.
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 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 COVID-19.
The evidence base in the policy concerns two tests produced by Pear Therapeutics. As of April 7th, 2023, neither the ReSET nor the ReSET-O digital applications are commercially available.
Related medical policies –
Digital health therapies for individuals with substance use disorders are considered investigational.
Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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 U.S. Food and Drug Administration and are not reviewed in this policy. They are currently available in the U.S. through the Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During COVID19 (U.S. Food and Drug Administration, 2020).
The evidence base in the policy concerns two tests produced by Pear Therapeutics. As of April 7th, 2023, neither the ReSET nor the ReSET-O digital applications are commercially available.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
07/01/2023: New policy added. Approved by the Medical Policy Advisory Committee.
10/10/2023: Policy description and Policy Guidelines updated regarding the availability of the tests addressed in this policy. Policy statement unchanged.
02/15/2024: Policy updated to change the policy number from “A.5.01.35” to “L.5.01.599.”
07/24/2024: Policy reviewed; no changes.
12/20/2024: Code Reference section updated to revise description for CPT code 98978 and to add new HCPCS codes G0552, G0553, and G0554 effective 01/01/2025.
03/27/2025: Policy reviewed; no changes.
Blue Cross Blue Shield Association policy # 5.01.35
This may not be a comprehensive list of procedure codes applicable to this policy.
Investigational Codes
Code Number | Description |
CPT-4 | |
98978 | Remote therapeutic monitoring (eg, therapy adherence, therapy response, digital therapeutic intervention); device(s) supply for data access or data transmissions to support monitoring of cognitive behavioral therapy, each 30 days (Revised 01/01/2025) |
HCPCS | |
A9291 | Prescription digital cognitive and/or behavioral therapy, FDA-cleared, per course of treatment |
G0552 | Supply of digital mental health treatment device and initial education and onboarding, per course of treatment that augments a behavioral therapy plan (New 01/01/2025) |
G0553 | First 20 minutes of monthly treatment management services directly related to the patient's therapeutic use of the digital mental health treatment (dmht) device that augments a behavioral therapy plan, physician/other qualified health care professional time reviewing information related to the use of the dmht device, including patient observations and patient specific inputs in a calendar month and requiring at least one interactive communication with the patient/caregiver during the calendar month (New 01/01/2025) |
G0554 | Each additional 20 minutes of monthly treatment management services directly related to the patient's therapeutic use of the digital mental health treatment (dmht) device that augments a behavioral therapy plan, physician/other qualified health care professional time reviewing data generated from the dmht device from patient observations and patient specific inputs in a calendar month and requiring at least one interactive communication with the patient/caregiver during the calendar month (New 01/01/2025) |
ICD-10 Procedure | |
ICD-10 Diagnosis |
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