CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

2020 Prescription Digital Therapeutics for Substance Abuse.pdf

Defines Blue Cross & Blue Shield of Rhode Island coverage position for prescription digital therapeutics (software/SaMD) used to treat substance use disorder (including opioid use disorder) for Medicare Advantage and commercial products, including regulatory context and evidence summary.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

Policy2020 Prescription Digital Therapeutics for Substance Abuse.pdf

Policy CodePolicy N/A

Change Typeclarified

Effective DateJan 6, 2021

Next Review Date

Key ActionBenefits may vary between groups and contracts; providers must refer to the applicable Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for member-specific coverage determinations.

SourceLink

POLICY UPDATE CHANGES

Policy states prescription digital therapeutics for substance use disorder are not covered for Medicare Advantage and not medically necessary for commercial products due to insufficient evidence.

0Covered Indications

2Payer Positions Listed

2017-2018FDA clearances referenced

Coverage Summary

Scope: Defines Blue Cross & Blue Shield of Rhode Island coverage position for prescription digital therapeutics (software/SaMD) used to treat substance use disorder, including opioid use disorder, for Medicare Advantage and commercial products. Subject: Prescription digital therapeutics for substance use disorder. Effective date: 01|06|2021. Last review: 01|06|2021.

Regulatory context: Notes FDA clearances for reSET (de novo DEN160018) and reSET-O (510(k) K173681) as prescription digital therapeutics intended to provide CBT adjunctive to outpatient treatment.

Headline conclusion: Prescription digital therapeutics for substance use disorder are not covered for Medicare Advantage and considered not medically necessary for commercial products because the evidence is insufficient to determine effects on health outcomes.

Key items

PayerBlue Cross & Blue Shield of Rhode Island

PolicyPrescription digital therapeutics for substance use disorder

Coverage stancenot_covered_cosmetic

SubjectPrescription digital therapeutics for substance use disorder

Effective date2021-01-06

Last review2021-01-06

Payer positions listed2

Notable FDA clearances referenced2017-2018

Medical Necessity / Coverage Determination

Coverage determination

Coverage/medical necessity determination for prescription digital therapeutics for substance use disorder:

ALL of the following

Medicare Advantage Plans: Prescription digital therapeutics for patients with substance use disorder is not covered because the evidence is insufficient to determine the effects of the technology on health outcomes.
Commercial Products: Prescription digital therapeutics for patients with substance use disorder is considered not medically necessary because the evidence is insufficient to determine the effects of the technology on health outcomes.

Not Covered / Insufficient Evidence

Policy conclusion in plain language: For Medicare Advantage plans, prescription digital therapeutics for patients with substance use disorder are not covered. For commercial products, prescription digital therapeutics for patients with substance use disorder are considered not medically necessary.

Rationale and regulatory context: This determination is made despite FDA marketing authorizations for reSET (de novo DEN160018) and reSET-O (510(k) K173681). The available clinical evidence, summarized in the brief, does not adequately demonstrate that these prescription digital therapeutics improve relevant health outcomes.

Evidence summary (brief): The body of evidence includes pivotal randomized trials but has important limitations; overall the evidence is judged insufficient to determine effects on health outcomes.

Technology	Regulatory status referenced	Policy conclusion
Prescription digital therapeutics (software/SaMD) delivering cognitive behavioral therapy and adjuncts (e.g., contingency management) for substance use disorder (including reSET, reSET-O).	reSET: FDA de novo marketing clearance (DEN160018); reSET-O: FDA 510(k) clearance (K173681).	Not covered for Medicare Advantage; considered not medically necessary for commercial products due to insufficient evidence to determine effects on health outcomes. No specific billing code; service non-covered.

Provider Actions

Documentation Required

Benefit verification

Benefits may vary between groups and contracts; providers must refer to the applicable Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for member-specific coverage determinations.

Denial Risk

Coverage not available — denial risk for claims

Prescription digital therapeutics for substance use disorder are not covered for Medicare Advantage and are considered not medically necessary for commercial products because the evidence is insufficient to determine effects on health outcomes. Claims for these prescription digital therapeutics risk denial. No prior authorization or medical criteria apply, and there is no specific billing code for this non-covered service.

No prior authorization applicable
No specific billing code exists for this non-covered service

Background & Evidence Summary

Background — clinical context: Substance use disorder (SUD) is the harmful or hazardous use of psychoactive substances (including alcohol, cocaine, marijuana, stimulants, benzodiazepines, and opiates). The APA DSM characterizes SUD by a set of criteria (mild: 2–3 criteria; moderate: 4–5; severe: 6 or more). Treatment approaches include behavioral counseling, skills training, medication (including methadone, buprenorphine, naltrexone for OUD), treatment for withdrawal, co-occurring mental health issues, and long-term follow-up.

Behavioral treatments: Cognitive-behavioral therapy (CBT) is an established psychosocial intervention with demonstrated positive effects for SUD; goals include identifying thoughts/behaviors linked to use and building coping skills. The community reinforcement approach (CRA) is a CBT-based intervention that increases non-drug reinforcement to support abstinence. Contingency management (motivational incentives) provides immediate positive reinforcement (from verbal acknowledgement to monetary incentives) to encourage abstinence and attendance and is often used to augment CRA; combinations of CRA plus contingency management have been shown to be particularly effective in some settings.

Regulatory context for SaMD: Software as a Medical Device (SaMD) is defined as "software that is intended to be used for one or more medical purposes that perform those purposes without being part of a hardware medical device" (IMDRF definition). FDA has a risk-based approach to regulating SaMD, focusing review on higher-risk mobile medical apps; lower-risk wellness apps are generally not enforced as medical devices. The agency has piloted a pre-certification program to streamline review for validated software manufacturers.

FDA-cleared products referenced: reSET received de novo marketing clearance in 2017 to provide CBT as an adjunct to contingency management for SUD (DEN160018). reSET-O was cleared via 510(k) in 2018 as a prescription digital therapeutic to increase retention in outpatient OUD treatment when used as an adjunct to transmucosal buprenorphine and contingency management (K173681).

Evidence summary: The evidence includes two pivotal randomized controlled trials. Limitations cited include combined interventions (web-based program plus incentives) making it impossible to isolate the web program’s contribution, trials conducted with older technology (desktop-based in clinic settings), unblinded designs with potential performance bias, and uncertainty about whether intermediate outcomes such as retention translate to meaningful health outcomes.

Overall determination: Given these limitations and uncertainties, the evidence is judged insufficient to determine the effects of prescription digital therapeutics for substance use disorder on health outcomes.

Revision History

2021-01-06policy_updateLatest

Policy clarifies that prescription digital therapeutics for substance use disorder are not covered for Medicare Advantage and are considered not medically necessary for commercial products because evidence is insufficient to determine effects on health outcomes; no prior authorization or medical criteria apply and there is no specific billing code for this non-covered service. Has_material_change: false.