CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Prescription Digital Therapeutics for Substance Use Disorder — Coverage Criteria

This policy addresses coverage and medical necessity for prescription digital therapeutics (e.g., reSET®, reSET-O®) for individuals with substance use disorder under Blue Cross Blue Shield - Rhode Island 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 TypeNo material change

Effective DateJun 1, 2021

Next Review DateFeb 10, 2024

Key ActionVerify member-specific benefits and prior authorization requirements via the benefit booklet or provider call center before ordering or billing these services.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

reSET® DEN160018FDA status

reSET‑O® K173681FDA status

98978Not covered codes

10/02/2024Last review

Coverage Determination and Rationale

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Overall coverage determination

Coverage stance differs by product:

Medicare Advantage coverage stance: Prescription digital therapeutics (eg, reSET®) for individuals with substance use disorder are not covered for Medicare Advantage plans because the evidence is insufficient to determine effects on health outcomes.

Commercial products coverage stance: Prescription digital therapeutics (eg, reSET®) for individuals with substance use disorder are considered not medically necessary for Commercial products due to insufficient evidence to determine effects on health outcomes.

Rationale / Evidence limitations

Evidence summary supporting noncoverage:

Evidence limitations: Pivotal randomized trials have limitations: trials combined web-based therapy with contingency rewards (confounding the contribution of the software); one trial in primary opioid use disorder did not meet its primary objective; both trials showed retention effects but the relationship between retention and meaningful health outcomes is uncertain; trials used earlier desktop technologies and were unblinded, raising concerns about performance bias and generalizability.

The policy lists specific billing codes that are excluded from coverage. Code 98978 (Remote therapeutic monitoring — device supply with scheduled recordings and/or programmed alerts to monitor cognitive behavioral therapy, each 30 days) is identified as not covered for Medicare Advantage plans. The policy also notes that A9291 (Prescription digital behavioral therapy, FDA cleared, per course of treatment) can be used for reSET®/reSET‑O and is listed as not medically necessary for Commercial products.

Services that are determined to be not medically necessary, or in some cases services that are medically necessary but are designated as non‑covered benefits, are excluded from payment under this policy. Providers may not bill the member for such services unless the member has been informed in advance and has provided written agreement to accept financial responsibility, and participation agreements may impose additional terms.

For Commercial products, prescription digital therapeutics (for example, reSET®) are considered not medically necessary. The policy states the rationale is insufficient evidence to determine the effect of these technologies on health outcomes, and therefore coverage is not supported for Commercial lines.

The policy explicitly identifies the following billing codes as excluded from coverage or identified as not medically necessary: 98978 — Remote therapeutic monitoring for monitoring cognitive behavioral therapy (each 30 days), and A9291 — Prescription digital behavioral therapy, FDA cleared, per course of treatment. These code determinations apply as detailed elsewhere in the policy to the specified product lines.

A determination that a service is not medically necessary affects coverage and billing: such services are excluded from payment and generally cannot be billed to the member unless the member has been informed and has agreed in writing to accept financial responsibility. Providers should confirm member benefits and any applicable participation agreement provisions before delivering services that may be non‑covered.

Provider Responsibilities, Prior Authorization, and Billing Risk

Prior Authorization

Prior Authorization and Coverage Codes

Prior authorization is not applicable for this policy. However, prior authorization requirements and benefits may vary by contract; providers should verify member-specific requirements before rendering services.

Prior authorization: Not applicable (verify via member benefit documents)
Coverage codes noted in policy: 98978, A9291

Documentation Required

Confirm Prior Authorization via Member Benefit Documents

Coverage and payment are governed by the member's subscriber agreement, evidence of coverage, or employer agreement. Providers must confirm prior authorization and coverage via member benefit documents or by calling the provider call center.

Verify member eligibility and benefits in the Benefit Booklet, Evidence of Coverage, or Subscriber Agreement
Contact the provider call center for member-specific prior authorization requirements

Note

Medicare Advantage: prescription digital therapeutics

Medicare Advantage: Prescription digital therapeutics (for example, reSET®) for substance use disorder are not covered; Commercial: prescription digital therapeutics (for example, reSET®) are considered not medically necessary.

Medicare Advantage — prescription digital therapeutics (reSET®): Not covered
Commercial — prescription digital therapeutics (reSET®): Not medically necessary

Denial Risk

Member Financial Liability Risk

If services are determined to be not medically necessary or are non-covered benefits, providers may not bill the member unless the member has been informed and has agreed in writing in advance to be financially responsible. Refer to the provider participation agreement for applicable provisions.

Do not bill members for non-covered or not medically necessary services unless there is a written, advance member agreement
Check participation agreement for billing and member liability provisions

Note

Benefits May Vary Between Groups and Contracts

Benefits and coverage may vary between groups and contracts. Always consult the appropriate Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for the member's specific coverage details.

Verify group- and contract-specific benefits before scheduling or billing services
Member-specific documents supersede this medical policy

Clinical Context

Substance use disorder (SUD) refers to the harmful or hazardous use of psychoactive substances (including alcohol, stimulants, benzodiazepines, opioids, cannabis, and others). Severity is defined by DSM criteria based on the number of diagnostic criteria met: mild (2–3 criteria), moderate (4–5 criteria), and severe (6 or more criteria). Treatments commonly include behavioral counseling (notably cognitive‑behavioral therapy), contingency management, medication‑assisted treatment for opioid use disorder, and long‑term follow‑up; prescription digital therapeutics are intended to deliver CBT and support contingency management as adjuncts to outpatient care.

Key Terms

Substance use disorder — definition and examples

DefinitionHarmful or hazardous use of psychoactive substances including alcohol, cocaine, marijuana, stimulants, benzodiazepines and opiates; DSM lists 11 problematic patterns of use with severity defined as mild (2–3), moderate (4–5), or severe (6+).

Common examplesAlcohol, cocaine, marijuana, stimulants, benzodiazepines, opiates.

Clinical severityDSM-defined severity: mild (2–3 criteria), moderate (4–5), severe (6+).

Typical treatmentsBehavioral counseling and skills training (notably cognitive-behavioral therapy), contingency management, medication-assisted treatment for opioid use disorder, and long-term follow-up.

Software as a Medical Device (SaMD) — definition and regulatory note

DefinitionSoftware intended for one or more medical purposes that performs those purposes without being part of a hardware medical device (Software as a Medical Device, SaMD).

Regulatory approachFDA (via IMDRF leadership) applies a risk-based regulatory approach to SaMD; higher-risk mobile medical apps receive regulatory review while lower-risk wellness apps are not enforced as devices.

Precertification pilotFDA launched a SaMD precertification pilot (begun 2019) to evaluate organizations for streamlined premarket review and post-market performance monitoring; Pear Therapeutics was among selected participants in 2017.

Prescription digital therapeutic — definition and regulatory context

DefinitionA prescription digital therapeutic is an FDA-reviewed software-based intervention prescribed to treat substance use disorders, delivering interventions such as cognitive-behavioral therapy and supporting contingency management.

Regulatory contextRegulatory documentation cited includes FDA De Novo summary for reSET (DEN160018) and 510(k) summary for reSET-O (K173681).

Evidence sourcesClinical trials, safety/efficacy analyses, engagement studies, and real-world economic and utilization studies are cited as the evidence base for prescription digital therapeutics for SUD.

Digital Therapeutics and Related Therapies

Prescription digital therapeutics (reSET®, reSET-O®)

Digital therapeutic role: Prescription digital therapeutics (reSET®, reSET-O®) are intended to deliver cognitive-behavioral therapy and to be used as an adjunct to contingency management and outpatient treatment under clinician supervision; reSET® received FDA de novo clearance as adjunct to contingency management in outpatient settings, and reSET-O® was cleared to increase retention in outpatient OUD treatment as an adjunct to transmucosal buprenorphine and contingency management.

Prescription digital therapeutics (internet-delivered behavioral therapies)

Evidence base: References include randomized trials, real-world evidence, engagement analyses, and economic and budget-impact studies evaluating internet-delivered behavioral therapies and prescription digital therapeutics for substance use disorders.

OpenPayer