Digital Health Therapies for Substance Use Disorders — Coverage Criteria
Customize your policy alerts
Sign up for all Blue Cross Blue Shield - Rhode Island policy alerts
Know when Blue Cross Blue Shield - Rhode Island releases new policies or updates existing guidance.
Monitor payer policy activity
Coverage policy for prescription digital therapeutics and related billing for treatment of substance use disorders for Blue Cross Blue Shield - Rhode Island members, describing coverage stance for Medicare Advantage and Commercial products.
No material clinical or coverage changes in this revision.
Coverage decisions and determinations
Coverage decisions
Coverage stance and evidence summary
Supported by evidence summary noting limitations of pivotal RCTs, inability to isolate the effect of the web-based program from contingency management rewards, and uncertain relation between intermediate outcomes (eg, retention) and patient-important health outcomes.
Policy explicitly states these products are a contract exclusion for Commercial Products.
For Commercial products, prescription digital therapeutics (for example, reSET) for treatment of substance use disorder are not covered and are considered a contract exclusion.
If services are determined to be not medically necessary (or are non-covered benefits), providers may not bill or charge the member for those services unless the member has been informed in advance and has provided prior written agreement to continue the treatment at their own expense.
The evidence is insufficient to determine that prescription digital therapeutics (including reSET and reSET-O) improve net health outcomes for substance use disorder (SUD) or opioid use disorder (OUD). Key limitations include reliance on a single pivotal randomized trial for each indication, inability to separate effects of contingency rewards from the web-based program, failure to meet some primary endpoints, and observational or retrospective analyses that cannot establish causation. Consequently, these technologies are not covered for Medicare Advantage and are not supported by sufficient evidence overall.
Services determined to be not medically necessary or otherwise non-covered may not be billed to the member unless the member has been notified in advance and has agreed in writing to assume financial responsibility for the services.
Billing and coding guidance
| 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 (Text Revised Effective 1/1/2025) |
| A9291 | Prescription digital cognitive and/or behavioral therapy, FDA-cleared, per course of treatment |
| 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 (Text Revised Effective 1/1/2025) |
| A9291 | Prescription digital cognitive and/or behavioral therapy, FDA-cleared, per course of treatment |
Actions, prior authorization, and billing risks for providers
Prior authorization — Not applicable
Prior authorization is not applicable for this policy.
Check member benefit documents for prior authorization
Determine whether prior authorization is required by checking the member's subscriber agreement/member certificate or employer agreement and, for member-specific information, contact the provider call center.
- Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement.
- For information on member-specific benefits, call the provider call center.
Provider note — verify coverage and payment
Provider note: This policy is informational and not a guarantee of payment—verify member-specific coverage before prescribing or billing.
- Medical policy availability does not substitute for clinical judgment.
- Member benefit documents supersede this medical policy.
Provider note — confirm group/contract-specific benefits
Provider note: Do not rely solely on this policy for member eligibility—confirm applicable benefits and any contract exclusions with the member's benefit documents or the provider call center.
- Benefits may vary between groups and contracts; refer to the Benefit Booklet, Evidence of Coverage, or Subscriber Agreement.
- Contact the provider call center for member-specific information.
Benefit variance notice
Benefits may vary between groups and contracts; refer to the appropriate Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for applicable not covered benefits/coverage.
Verify member benefits and eligibility
Verify member benefits and eligibility by reviewing the member's subscriber/member certificate or employer agreement and contacting the provider call center for member-specific information.
- Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement.
- For information on member-specific benefits, call the provider call center.
Coverage denial conditions — reSET / reSET-O and commercial exclusions
Coverage denial risk: reSET and reSET-O are not covered for Medicare Advantage (insufficient evidence) and prescription digital therapeutics are a contract exclusion for Commercial Products.
- Medicare Advantage: "Prescription digital therapeutics, ie. reSET ®, for individuals with substance use disorder is not covered as the evidence is insufficient to determine the effects of the technology on health outcomes."
- Commercial Products: "Prescription digital therapeutics, ie. reSET ®, for individuals with substance use disorder is not covered and is considered a contract exclusion."
Billing code non-coverage — 98978 not covered
Billing code 98978 (Remote therapeutic monitoring) is listed as not covered.
- 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 (Text Revised Effective 1/1/2025).
Billing risk — member billing prohibition without written agreement
Do not bill members for services determined to be not medically necessary or non-covered benefits unless the member has been informed and has agreed in writing in advance to continue at their own expense.
- If services are determined to not be medically necessary (or are non-covered benefits), you may not charge the member unless they have agreed in writing in advance to pay out-of-pocket.
Digital therapeutic products and modalities
Prescription digital therapeutics (reSET, reSET-O)
Covered uses and clinical context for prescription digital therapeutics
Regulatory clearances specify adjunctive use under clinician supervision; as of April 7, 2023 these specific apps were not commercially available.
Clinical program descriptions and FDA clearances frame use alongside clinician-supervised outpatient care and medication for OUD where applicable.
Given these limitations, current evidence is insufficient to conclude improvement in net health outcomes.
CBT, community reinforcement approach, and contingency management are established components of SUD treatment and the digital therapeutics are described as adjuncts to these approaches.
Key definitions and regulatory terms
Clinical background
Substance use disorder (SUD) refers to the harmful or hazardous use of psychoactive substances and is defined using DSM criteria that categorize severity as mild (2–3 criteria), moderate (4–5 criteria), or severe (6 or more criteria). Treatment approaches include behavioral counseling and skills training—most notably cognitive behavioral therapy and community reinforcement approaches—medication-assisted treatment for opioid use disorder, contingency management (motivational incentives), management of withdrawal symptoms, and long-term follow-up to reduce relapse risk.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.