CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Prescription digital therapeutics for substance use disorder — coverage criteria

This policy describes BCBSRI coverage stance for prescription digital therapeutics (FDA-cleared software like reSET and reSET-O) intended as adjunctive cognitive behavioral therapy for patients with substance use disorder, and indicates applicability to Medicare Advantage and commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyPrescription digital therapeutics for substance use disorder — coverage criteria

Policy CodePolicy N/A

Change TypeMinor / no material change

Effective Date04/06/2022

Next Review DateN/A

Key ActionDo not authorize prescription digital therapeutics for Medicare Advantage (not covered) and consider commercial coverage not medically necessary due to insufficient evidence; follow the member's benefit booklet for contract-specific determinations.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

reSET / reSET-OFDA-cleared products referenced

Not coveredMedicare Advantage stance

Not medically necessaryCommercial stance

A9291New HCPCS code

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inv-01: Medicare Advantage - Not Covered

Covered when ALL of the following are met:

Medicare Advantage stance: Prescription digital therapeutics for patients with substance use disorder are not covered because evidence is insufficient to determine effects on health outcomes.

FDA clearances are acknowledged but trials have limitations (older technology, unblinded, combined interventions) that limit conclusions about clinical benefit.

inv-02: Commercial - Not Medically Necessary

Covered when ALL of the following are met:

Commercial products stance: Prescription digital therapeutics are considered not medically necessary for commercial products due to insufficient evidence to determine effects on health outcomes; benefits may vary by contract and the member's benefit booklet controls.

Coding guidance lists CPT codes 0702T and 0703T and HCPCS code A9291 (effective 4/01/2022).

Benefits for prescription digital therapeutics may vary by group and contract. The member's governing plan documents — the Benefit Booklet, Evidence of Coverage, or Subscriber Agreement — determine applicable coverage and benefits. When a service is identified as non-covered under those documents, the provider must not bill the member except as permitted by the subscriber agreement or applicable regulations.

The policy finds insufficient evidence to support coverage of prescription digital therapeutics (examples: reSET, reSET-O) for substance use disorders. Although randomized trials reported improvements in intermediate outcomes such as retention, limitations — including use of earlier technology, unblinded study designs, possible performance bias, and uncertain links between retention and meaningful health outcomes — prevent concluding a net clinical benefit. For Medicare Advantage the technology is therefore not covered, and for commercial products it is considered not medically necessary for the same reason.

Billing Codes and Status

Covered CPT Codes (listed)CPT

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

Not covered / not medically necessary codesCPTNot Covered

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

HCPCS / New codesHCPCS

A9291

Prescription digital behavioral therapy, FDA cleared, per course of treatment (New code effective 4/01/2022)

Provider Requirements and Risks

Prior Authorization

Coding and prior authorization note

Coding for prescription digital behavioral therapy and related remote therapeutic monitoring is specified below. Benefits may vary by contract; providers should check the member’s Benefit Booklet / Evidence of Coverage for applicable coverage and medical necessity determinations. Prior authorization requirements may apply per contract—confirm and obtain authorization when required before rendering services.

Affected codes: 0702T, 0703T, A9291
Note: Benefits vary by group/contract — refer to Benefit Booklet/Evidence of Coverage

Step Therapy

Step therapy

Step therapy/adjunct use: Prescription digital therapeutics (PDTs) are intended as adjuncts to clinician-supervised outpatient treatment and contingency management and, for opioid use disorder (OUD), in combination with medication‑assisted treatment (eg, transmucosal buprenorphine) per FDA clearances. Coverage may be limited to adjunctive use; PDTs are not intended as standalone replacements for counseling, medication, or contingency management interventions. Where step therapy policies exist, requirements to trial and document adjunctive/combined therapies (contingency management, MAT) should be followed.

PDTs intended as adjunct to outpatient treatment and contingency management
For OUD: adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management

Documentation Required

Supporting documentation

Supporting documentation should indicate the PDT is prescribed as an adjunct under clinician supervision and include documentation of concurrent outpatient treatment, contingency management when applicable, and any medication‑assisted treatment for OUD. Cite FDA clearances where relevant (reSET — de novo clearance; reSET‑O — 510(k) clearance) to support device status.

Document clinician supervision and enrollment in outpatient treatment
If OUD, document concurrent transmucosal buprenorphine and contingency management

Denial Risk

Coverage denial triggers

Coverage denial triggers: Medicare Advantage — prescription digital therapeutics (eg, reSET) are not covered when evidence is insufficient to demonstrate improved health outcomes. Commercial products may be considered not medically necessary when clinical evidence is insufficient or when PDTs are used as standalone therapies outside FDA‑cleared adjunct indications.

Medicare Advantage: PDTs not covered (insufficient evidence)
Commercial Products: Not medically necessary when used outside evidence-based adjunct indications

Clinical Background

Substance use disorders (SUD) are conditions involving the harmful or hazardous use of psychoactive substances and are classified by diagnostic criteria that indicate severity (from mild to severe) based on the number of criteria met. Recommended treatments include behavioral counseling (notably cognitive behavioral therapy and community reinforcement approaches), contingency management (motivational incentives), medication-assisted treatment for opioid use disorder, management of withdrawal symptoms, and long-term follow-up. Prescription digital therapeutics are designed to deliver CBT-based interventions as an adjunct to outpatient treatment under clinician supervision, rather than as standalone therapy.

Key Definitions

Prescription digital therapeutic / SaMD — definition and examples

DefinitionSoftware-as-a-Medical-Device (prescription digital therapeutic / SaMD) intended to deliver cognitive-behavioral therapy (CBT) or related interventions for substance use disorder and cleared by the FDA to be used as an adjunct to outpatient treatment under clinician supervision.

Examples (FDA-cleared)reSET (Pear Therapeutics) — de novo marketing clearance to provide CBT as an adjunct to contingency management; reSET-O — FDA-cleared for use as an adjunct for opioid use disorder.

Intended useDelivered as an adjunct to clinician-supervised outpatient treatment, often alongside counseling, contingency management, or medication-assisted treatment (for OUD).

Therapeutic approachPrimarily cognitive-behavioral therapy (CBT) and skills training delivered via interactive lessons or modules through a prescription app or online program.

Regulatory noteThese products have received FDA clearance for adjunctive use; clinical trials cited in the policy had limitations (older technology, unblinded, combined interventions) affecting evidence on health outcomes.

Appropriate Level of Care

inv-14: Outpatient (adjunctive use with clinician supervision)

These products are intended to be used as adjuncts to outpatient treatment under clinician supervision; use is appropriate only when all of the following apply:

Outpatient adjunctive use: Patient is enrolled in outpatient treatment under the supervision of a clinician.

Consistent with FDA clearance language for reSET and reSET-O.

Adjunct to standard care: Digital therapeutic is used as an adjunct to evidence-based outpatient treatments (for example, cognitive behavioral therapy, contingency management, and, where indicated, medication-assisted treatment for opioid use disorder).

These products are not intended as standalone replacements for clinician-delivered care.

Clinical oversight and integration: Clinical team supervises and integrates the digital therapeutic into the patient's treatment plan, including monitoring engagement and outcomes.

Operational placement: outpatient setting with clinician supervision; documentation should reflect adjunctive role and supervision.

Digital Therapeutic Modalities

inv-15: Digital CBT adjuncts (reSET, reSET-O)

Prescription digital cognitive behavioral therapy products (examples: reSET, reSET-O) may be considered only as adjuncts to outpatient care under clinician supervision when ALL of the following conditions are met:

Adjunctive use: Prescription digital therapeutics are intended to be used as adjuncts to outpatient treatment, which may include CBT, contingency management, and medication-assisted treatment for OUD.

FDA clearances specify adjunctive use under clinician supervision; clinical trials show improvements in intermediate outcomes (retention) but limitations prevent definitive conclusions about health outcomes.