CurrentOptumPolicy BH727CBTBCP112025

Computer Based Treatment for Cognitive Behavioral Therapy (CBTCBT) for Substance Use Disorders

This policy governs coverage and medical necessity assessment of computer-based CBT (CBTCBT) interventions for outpatient treatment of substance use disorders for Optum members, referencing member-specific benefit documents and applicable laws.

Policy Summary

PayerOptum

PolicyComputer Based Treatment for Cognitive Behavioral Therapy (CBTCBT) for Substance Use Disorders

Policy CodePolicy BH727CBTBCP112025

Change TypeNo material change

Effective Date

Next Review DateNov 18, 2025

Key ActionConfirm member eligibility and review the member-specific benefit document before approving services.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12-weekreSET duration

5RCTs (AUD iCBT)

405CBT4CBT participants

20Systematic review studies

25,475Total sample (2022 review)

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Coverage Determinations for Computer‑Based CBT

Investigational / Not accepted as standard outpatient therapy

Policy coverage stance for CBTCBT in outpatient SUD treatment

Investigational determination: CBTCBT for the treatment of substance use disorders is considered investigational due to insufficient evidence of safety and effectiveness

Limited evidence of benefit as adjunctive therapy only; short-term benefits observed but replication and durability not established

This policy addresses computer-based delivery of cognitive behavioral therapy for outpatient substance use disorder treatment. Examples of FDA-cleared prescription digital therapeutics include reSET® and reSET-O®, which are intended to be used in conjunction with standard outpatient treatment under the care of a health care professional. These applications are not intended as stand-alone definitive therapy; documentation and treatment should reflect concurrent outpatient care and clinician oversight.

reSET® is a 12-week, FDA-cleared prescription digital therapeutic intended to be used with standard outpatient treatment for stimulant-, cannabis-, cocaine-, and alcohol-related substance use disorders and is explicitly not intended as a stand-alone treatment or to treat opioid dependence. reSET-O® received FDA pre-market safety clearance and is intended to be used as an adjunct to outpatient opioid use disorder treatment alongside buprenorphine and contingency management; the FDA review noted it did not demonstrate improved abstinence in trials and therefore had safety-only clearance.

The policy determines that computer-based CBT (CBTCBT) for substance use disorders is investigational because the clinical literature does not support CBTCBT as a safe and effective outpatient therapy. While some short-term benefits and adjunctive effects have been observed, the evidence is limited, heterogeneous, and lacks replicated, durable outcomes necessary to establish effectiveness.

Current guideline guidance reflects uncertainty about computer-delivered behavioral treatments. The ASAM 2023 Clinical Practice Guideline states there is insufficient evidence to recommend CBT4CBT as a standalone treatment for stimulant use disorder. The VA/DoD 2021 guideline similarly reports there is insufficient evidence to recommend for or against computer-delivered behavioral treatments, alone or combined with usual care, for substance use disorders.

Billing and Diagnosis Codes

Procedure CodesHCPCS

A9291

Prescription digital cognitive and/or behavioral therapy, FDA-cleared, per course of treatment.

Diagnosis CodesICD-10

F10.10	Alcohol abuse, uncomplicated.
F10.20	Alcohol dependence, uncomplicated.
F11.1-F11.9	Opioid abuse and dependence.
F12.10	Cannabis abuse, uncomplicated.
F12.20	Cannabis dependence, uncomplicated.
F14.10	Cocaine abuse, uncomplicated.
F14.20	Cocaine dependence, uncomplicated.
F15.10	Other stimulant abuse, uncomplicated.
F15.20	Other stimulant dependence, uncomplicated.
F19.10	Other psychoactive substance abuse, uncomplicated.

1–10 of 11

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Provider Responsibilities, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Per plan requirements, prior authorization is required for FDA-cleared prescription digital CBT devices (e.g., reSET®, reSET-O®). Submit authorization requests using code A9291 (Prescription digital cognitive and/or behavioral therapy, FDA-cleared, per course of treatment) and include clinical justification linking the prescription to the member's treatment plan and diagnosis. Authorization must confirm the device is being used as an adjunct to outpatient treatment under the direction of a qualified behavioral health provider.

A9291 — Prescription digital CBT, per course of treatment
Include member-specific benefit verification prior to authorization

Denial Risk

Coverage Basis and Denial Triggers

Coverage is determined by the member-specific health benefit plan document and applicable federal/state law. Inclusion of A9291 or other codes in this policy does not guarantee coverage. Deny or non-authorize services that are inconsistent with the member's benefit document or that are investigational per this Policy (e.g., CBTCBT for substance use disorders when not meeting plan terms).

Clinical and Evidence Background

Computer-based delivery of CBT via web, mobile apps, or other digital platforms has been evaluated across substance use disorders as either adjunctive therapy or standalone interventions. The evidence shows some short-term improvements in outcomes such as abstinence, reduced use, and retention, but overall the literature is heterogeneous with many studies small, variably designed, and lacking long-term follow-up. As a result, current data support potential adjunctive benefit but do not establish CBTCBT as a proven standalone outpatient treatment.

Key Definitions and Product Examples

inv-17: reSET® — 12-week FDA-cleared prescription digital therapeutic intended as adjunct

ProductreSET® (Pear Therapeutics)

Intended duration12-week prescription digital therapeutic

Intended useTo be used in conjunction with standard outpatient treatment for stimulant-, cannabis-, cocaine-, and alcohol-related substance use disorders; not intended as a stand-alone treatment

Not for opioid dependenceApplication is not intended to be used to treat opioid dependence

DeliveryFDA-cleared mobile application prescribed and provided for outpatient use

inv-18: reSET-O® — FDA-cleared mobile app prescription CBT intended for adjunctive use in OUD treatment

Applicable Level of Care

Digital Treatment Modalities Considered

Digital therapeutic (reSET®, reSET-O®, CBT4CBT, TES)

These modalities are intended for adjunctive outpatient use and are not established as standalone definitive therapy.

Intended use: These digital therapeutics are intended as adjuncts to standard outpatient care (reSET®, reSET-O®) or as components combined with clinician support in trials (CBT4CBT, TES); not established as standalone definitive therapy

Device labeling and FDA statements indicate adjunctive use; reSET is not intended as standalone or to treat opioid dependence; reSET-O received only safety marketing clearance for opioid use disorder and is intended to be combined with buprenorphine and contingency management

Prescription digital CBT (e.g., reSET, reSET-O)

Prescription digital CBT apps cleared or reviewed by the FDA should be used as adjuncts to outpatient treatment under clinician supervision.

Guideline caution and device labeling: Prescription digital CBT (e.g., reSET, reSET-O) is intended to be used in conjunction with outpatient therapy under the care of a health care professional and is not established as a standalone treatment; clinical guidelines report insufficient evidence to recommend computer-delivered behavioral treatments as standalone for stimulant use disorder or broadly for SUDs

Policy Summary

PayerOptum

PolicyComputer Based Treatment for Cognitive Behavioral Therapy (CBTCBT) for Substance Use Disorders

Policy CodePolicy BH727CBTBCP112025

Change TypeNo material change

Effective Date

Next Review DateNov 18, 2025

Key ActionConfirm member eligibility and review the member-specific benefit document before approving services.

SourceLink

On This Page

Listing of codes does not imply coverage or reimbursement
When plan language limits/excludes the service, the plan document governs

Documentation Required

Required Pre-Review and Provider Qualification

Before authorization, confirm member eligibility, identify the applicable member benefit document (e.g., Evidence of Coverage), and ensure the prescribing provider is a properly qualified behavioral health provider per plan and state law. If there is any conflict between this Policy and the member's benefit document, the member's document governs; if conflict exists between the benefit document and law, applicable law governs.

Verify member eligibility and benefit limits
Confirm provider qualification and applicable state/federal requirements

Note

Adjunctive Use Noted

FDA-cleared digital therapeutics covered by prior authorization are intended to be used as adjuncts to standard outpatient treatment and not as standalone therapies. Document in the record that the digital therapeutic is prescribed in addition to (not in place of) active outpatient treatment and, when applicable, combined with other required treatments (e.g., buprenorphine and contingency management for reSET‑O®).

reSET® — 12-week, adjunct to standard outpatient treatment (not for opioid dependence)
reSET‑O® — adjunct to outpatient OUD treatment with buprenorphine and contingency management

Documentation Required

Prescription and Treatment Documentation

When prescribing and documenting treatment with FDA-cleared digital CBT, include: diagnosis(es) supporting use, treatment plan describing adjunctive role of the digital therapeutic, expected duration (course), concurrent treatments (e.g., medication-assisted treatment, counseling, contingency management), and ongoing monitoring/engagement plans. Retain documentation of member consent and device prescription; include clinical progress and rationale for continued use if requesting renewal authorization.

Document diagnosis and clinical rationale
Include treatment plan, expected course length, and concurrent therapies
Maintain progress notes and consent; provide documentation for renewals

ProductreSET-O® (Pear Therapeutics)

Regulatory statusFDA 510(k) pre-market safety clearance (marketing clearance) granted in December 2018

Intended usePrescription cognitive behavioral therapy mobile app intended to be used in addition to outpatient opioid use disorder treatment under the care of a health care professional

Required combination therapyDesigned to be combined with buprenorphine treatment and contingency management within an outpatient OUD program

Effect on abstinence in trialClinical trial data did not demonstrate improved abstinence from opiates or decreased illicit drug use; clearance was for safety/marketing only

inv-19: Prescription digital therapeutic — examples reSET / reSET-O

DefinitionPrescription digital therapeutic—FDA-cleared mobile applications (examples: reSET®, reSET-O®) that deliver CBT modules for SUDs

Intended roleIntended to be used as adjuncts to outpatient therapy and clinician oversight rather than as standalone treatments

Examples & scopereSET® cleared for alcohol, cocaine, marijuana, and stimulant SUDs; reSET-O® cleared for use with outpatient OUD programs but had safety-only clearance regarding abstinence outcomes

Prescription deliveryApplications are downloaded to a mobile device after a prescription from the treating physician and used during participation in outpatient programs

reSET is a 12-week FDA-cleared prescription digital therapeutic intended as adjunctive outpatient treatment; reSET-O had safety-only clearance for opioid use disorder and should be combined with buprenorphine and contingency management