ModifiedPremera BluecrossPolicy N/A

Prescription Digital Therapeutics for Substance Use Disorders

Defines coverage stance and evidence for prescription digital therapeutics (PDTs) intended to prevent, manage, or treat substance use disorders for Premera members; informs providers about when PDTs for SUD may be considered.

Policy Summary

PayerPremera Bluecross

PolicyPrescription Digital Therapeutics for Substance Use Disorders

Policy CodePolicy N/A

Change TypeModified (coding and related-policy updates)

Effective DateNov. 1, 2025

Next Review DateN/A

Key ActionDo not submit claims for PDTs for SUD without documentation of FDA clearance; services are considered investigational and may be denied.

SourceLink

POLICY UPDATE CHANGES

New policy created and approved January 9, 2024 stating prescription digital therapeutics for individuals with substance use disorders are considered investigational.

Coding update adding new HCPCS code A9294 effective April 1, 2026.

Minor update to related policy section and updated policy number for Drug Testing in Pain Management and Substance Use Disorder Treatment Settings.

Annual review completed October 13, 2025; literature search completed September 26, 2025; policy statements unchanged.

InvestigationalCoverage stance

A9294New HCPCS

1 RCTKey evidence (non-OUD)

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Coverage Criteria — Prescription Digital Therapeutics for SUD

Investigational / Not covered with criteria

Covered when ALL of the following are met:

Investigational stance for PDTs for SUD: Prescription digital therapeutics for individuals with substance use disorders (including OUD and non-OUD SUD) are considered investigational.

Evidence includes pivotal randomized controlled trials and observational analyses but is insufficient to demonstrate improvement in net health outcome (see evidence summaries).

Not medically necessary / Investigational

Policy determination

Investigational determination: Prescription digital therapeutics for individuals with substance use disorders are considered investigational.

New policy approved January 9, 2024; annual review October 13, 2025 with literature search completed September 26, 2025; coding update April 1, 2026 adding HCPCS A9294.

This policy does not address non-prescription digital therapies. Examples of such consumer-facing apps include Vorvida and Modia, which do not require a prescription and are explicitly excluded from the scope of this medical policy.

This medical policy does not apply to Medicare Advantage plans. Additionally, there is no Medicare National Coverage Determination for prescription digital therapeutics for substance use disorders.

The available evidence for prescription digital therapeutics for substance use disorders (both non‑OUD SUD and OUD) is limited. Pivotal randomized trials and observational analyses have methodological limitations — including inability to isolate the effect of the software from adjunctive components (e.g., contingency rewards), failure to meet primary objectives in some trials, reliance on intermediate outcomes such as retention, and retrospective designs without appropriate controls. Given these limitations, the evidence is insufficient to determine that prescription digital therapeutics improve net health outcomes for SUD or OUD.

Based on current evidence and review, prescription digital therapeutics for individuals with substance use disorders are considered investigational and are not covered under this policy.

Coding and Regulatory Identifiers

CPTCPT

99199

Unlisted special service, procedure or report (CPT)

HCPCSHCPCS

A9291	Prescription digital cognitive and/or behavioral therapy, FDA cleared, per course of treatment (HCPCS)
A9294	Prescription digital cognitive and/or behavioral therapy, biofeedback, FDA cleared, per course of treatment (HCPCS) (new code effective 04/01/26)
A9999	Miscellaneous DME supply or accessory, not otherwise specified (HCPCS)
E1399	Durable medical equipment, miscellaneous (HCPCS)

Updated HCPCSHCPCS

A9294

New HCPCS code added April 1, 2026 (as noted in history)

FDA device clearances / identifiersmixed

DEN160018	FDA de novo marketing clearance identifier for reSET (2017)
K173681	FDA 510(k) clearance identifier for reSET-O (2018)
PWE	FDA product code for reSET

Provider Actions, Billing, and Documentation

Denial Risk

Investigational Determination and Documentation Required

Prescription digital therapeutics (PDTs) for substance use disorders are classified as investigational under this policy. Claims for these services may be denied on the basis of the investigational determination. When billed, include supporting regulatory documentation (e.g., FDA clearance/de novo or 510(k) numbers) and clinical justification that the PDT is being used as an adjunct to outpatient treatment supervised by a clinician.

Investigational classification may affect claims processing and eligibility for coverage; services may be denied on this basis.
When billing, include FDA pathway documentation when applicable (e.g., DEN160018, K173681) and clinical documentation that the PDT is being used as an adjunct to outpatient treatment.
PDTs are proposed as adjuncts to outpatient treatment (e.g., reSET indicated as a 12‑week prescription treatment to increase abstinence and retention; reSET-O as adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management).

Background

Substance use disorder (SUD) refers to the harmful or hazardous use of psychoactive substances, including alcohol, stimulants, benzodiazepines, opioids and other drugs. Standard treatment approaches include behavioral counseling and skills training (for example, cognitive behavioral therapy and community reinforcement approach), contingency management, medications for opioid use disorder when indicated, and long‑term follow‑up. Prescription digital therapeutics are mobile software applications intended to augment these clinician‑supervised interventions but remain under study for SUD.

Definitions

Prescription digital therapeutic (PDT) / Software as a Medical Device (SaMD) — definition and intended use

DefinitionMobile software applications intended to prevent, manage, or treat medical and behavioral health conditions; when intended for medical purposes and regulated, they may be considered software as a medical device (SaMD).

Intended useSaMD performs medical purposes without being part of a hardware medical device and is regulated by FDA's risk-based framework focusing on higher-risk mobile medical apps.

Regulatory approachFDA's CDRH uses a risk-based approach and has a precertification pilot for SaMD that streamlines pre-market review for pre-certified organizations.

Substance use disorder severity — DSM-based severity levels

Mild SUDMeets 2–3 DSM criteria.

Moderate SUD

Policy Revision History

2026-04-01coding updateLatest

Added new HCPCS code A9294 effective April 1, 2026.

2026-02-06related policy update

Minor update to related policy section; updated related policy number to 2.04.522 for Drug Testing in Pain Management and Substance Use Disorder Treatment Settings.

2025-11-01annual review

Annual review approved October 13, 2025; literature search completed September 26, 2025; policy statements unchanged.

Policy Summary

PayerPremera Bluecross

PolicyPrescription Digital Therapeutics for Substance Use Disorders

Policy CodePolicy N/A

Change TypeModified (coding and related-policy updates)

Effective DateNov. 1, 2025

Next Review DateN/A

Key ActionDo not submit claims for PDTs for SUD without documentation of FDA clearance; services are considered investigational and may be denied.

SourceLink

On This Page

Billing Rule

Billing and Coding Guidance

Billing for PDTs should follow applicable CPT/HCPCS and miscellaneous/unlisted coding guidance. Use of unlisted or miscellaneous codes may be necessary when a specific covered code is not available.

CPT: 99199 (Unlisted special service, procedure or report) when no specific CPT exists.
HCPCS: A9291 (Prescription digital cognitive and/or behavioral therapy, FDA cleared, per course of treatment).
HCPCS: A9294 (Prescription digital cognitive and/or behavioral therapy, biofeedback, FDA cleared, per course of treatment) — new code effective 04/01/26.
HCPCS: A9999 (Miscellaneous DME supply or accessory) and E1399 (Durable medical equipment, miscellaneous) as alternatives where applicable.

Note

PDTs as Adjuncts to Outpatient and Psychosocial Treatments

PDTs are intended to be used as adjuncts to outpatient treatment supervised by a clinician and are not standalone replacements for established psychosocial or pharmacologic treatments. Providers should document how the PDT complements behavioral counseling, skills training, medication-assisted treatment (for OUD), contingency management, or other psychosocial interventions.

Document that the PDT is being used in conjunction with outpatient treatment and, when applicable, with medication-assisted treatment (e.g., transmucosal buprenorphine for OUD).
Document the specific psychosocial components available to the patient (e.g., CBT, contingency management, CRA) and how the PDT augments these services.
Vorvida and Modia (non-prescription digital therapies) are not addressed by this policy and do not require a prescription.

Prior Authorization

Prior Authorization and Billing Documentation

Prior authorization or other pre‑billing requirements may apply depending on member benefits and contract language. When submitting claims for PDTs, include required clinical documentation and any prior authorization approvals; absence of these may result in claim denial or delay.

Verify member benefits and prior authorization requirements before initiating PDT services.
Attach clinical documentation supporting medical necessity, supervisory clinician involvement, and FDA clearance information when applicable.
Billing may require submission of predicate FDA documentation (e.g., DEN160018, K173681) to substantiate device status.

Documentation Required

Regulatory and Coding Documentation

Regulatory status matters for billing and clinical justification. Include FDA clearance pathway information (de novo, 510(k), or other) when available and relevant to the service billed.

When billing HCPCS A9291 or A9294, include documentation that the product is FDA cleared and specify the clearance number.
If an unlisted CPT (99199) or miscellaneous HCPCS (A9999, E1399) is used, provide supporting FDA and clinical documentation to justify the service.
Keep records of product ownership/transfer (e.g., acquisition of reSET/reSET-O by PursueCare in Dec 2023) as part of regulatory/device lineage where relevant.

Meets 4–5 DSM criteria.

Severe SUDMeets 6 or more DSM criteria.

Definition — prescription-only software-based therapeutic cleared by FDA (example: reSET/reSET-O)

DefinitionA prescription-only software-based therapeutic cleared by the FDA to provide behavioral interventions (example: reSET and reSET-O delivering cognitive behavioral therapy and contingency management) as adjuncts to clinician‑supervised outpatient treatment.

reSET (DEN160018)De novo marketing clearance (2017); indicated as a 12-week (90 days) prescription-only treatment to increase abstinence and retention in outpatient SUD treatment; FDA product code PWE.

reSET-O (K173681)510(k) marketing clearance (2018) as a prescription-only digital therapeutic to increase retention for patients with opioid use disorder when used as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management.

2024-01-09policy creation

New policy created and approved January 9, 2024 stating prescription digital therapeutics for individuals with substance use disorders are considered investigational.