CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

2021 Prescription Digital Therapeutics for Substance Abuse.pdf

Defines coverage position for prescription digital therapeutics (software/SaMD) intended to treat substance use disorder for Medicare Advantage and commercial products, including clinical background, regulatory status, evidence appraisal, and specific coding not covered.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

Policy2021 Prescription Digital Therapeutics for Substance Abuse.pdf

Policy CodePolicy N/A

Change TypeNo material change

Effective Date01/06/2021

Next Review Date

Key ActionVerify member-specific benefits and eligibility in the appropriate Benefit Booklet, Evidence of Coverage, Subscriber Agreement or employer agreement because benefits may vary between groups and contracts.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes.

2CPT codes not covered / not medically necessary

Not covered / Not medically necessaryCoverage stance

Coverage Summary

Prescription digital therapeutics (Software as a Medical Device) for substance use disorder are not covered for Medicare Advantage plans and are considered not medically necessary for commercial products because the evidence is insufficient to determine effects on health outcomes. Effective date: 01/06/2021. Last review: 01/06/2021.

Coverage Determination / Medical Necessity

Coverage determination

Coverage statements 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 as the evidence is insufficient to determine the effects of the technology on health outcomes.
Supported by regulatory and evidence assessment noting limitations of pivotal RCTs and insufficient evidence.
Commercial Products: Prescription digital therapeutics for patients with substance use disorder is considered not medically necessary as the evidence is insufficient to determine the effects of the technology on health outcomes.
Includes coding guidance that related CPT codes are not covered / not medically necessary.

Regulatory and evidence context (supporting details): FDA cleared products (reSET de novo; reSET-O 510(k)) exist, but trials had limitations (combined interventions, unblinded, earlier technology) and retention outcomes do not clearly translate to health outcomes; overall evidence insufficient to determine effects on health outcomes.

Provider Actions

Documentation Required

Benefits and eligibility verification

Verify member-specific benefits and eligibility in the appropriate Benefit Booklet, Evidence of Coverage, Subscriber Agreement or employer agreement because benefits may vary between groups and contracts.

Denial Risk

Coverage denial for Medicare Advantage

Claims for prescription digital therapeutics for substance use disorder under Medicare Advantage are not covered due to insufficient evidence and are subject to denial.

0702T
0703T

Denial Risk

Commercial not medically necessary

Claims for prescription digital therapeutics for substance use disorder for commercial products are considered not medically necessary due to insufficient evidence and are subject to denial.

0702T
0703T

Background and Evidence

Substance use disorder (SUD) encompasses harmful or hazardous use of psychoactive substances (including alcohol, cocaine, marijuana, stimulants, benzodiazepines and opiates) and is defined in DSM criteria with severity levels: mild (2–3 criteria), moderate (4–5), and severe (6 or more). Treatments include behavioral counseling, skills training, medication (including medication-assisted treatment for opioid use disorder), management of withdrawal, treatment for co-occurring mental health issues, and long-term follow-up.

Common psychosocial treatments include cognitive-behavioral therapy (CBT), the community reinforcement approach (CRA), and contingency management. CBT targets thoughts and behaviors linked to substance use and teaches coping skills; CRA enhances non-drug reinforcement (employment, social relations, recreation) and has shown greater effectiveness than usual care for certain substances; contingency management uses immediate positive reinforcement (including modest monetary incentives) to increase abstinence and retention and is often combined with other psychosocial approaches.

Regulatory context: Software as a Medical Device (SaMD) is software intended for medical purposes without being part of a hardware device. FDA’s Center for Devices and Radiological Health applies a risk-based approach to SaMD and has piloted a Software Pre-Cert program to streamline review for pre-certified organizations.

FDA status for relevant prescription digital therapeutics: reSET (Pear Therapeutics) received de novo marketing clearance in 2017 as a prescription digital therapeutic providing CBT as an adjunct to contingency management for outpatient SUD (DEN160018). reSET‑O was cleared via 510(k) in 2018 as a prescription digital therapeutic to increase retention in outpatient treatment for opioid use disorder when used with transmucosal buprenorphine and contingency management (K173681).

Definitions

TermSaMD

DefinitionSoftware as a Medical Device: software intended to be used for one or more medical purposes that performs those purposes without being part of a hardware medical device (per IMDRF).

Pivotal RCTs: Two pivotal randomized controlled trials exist but have important limitations—combined interventions that make it unclear how much the digital therapeutic contributed, earlier/desktop technologies and unblinded designs raising performance and generalizability concerns, and uncertain linkage between improved retention and meaningful health outcomes. Overall, the evidence is insufficient to determine the effects of prescription digital therapeutics for SUD on health outcomes.

OpenPayer

2021 Prescription Digital Therapeutics for Substance Abuse.pdf

Coverage Summary

Coverage Determination / Medical Necessity

Coding

Provider Actions

Background and Evidence

Revision History

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
0703T	Remote therapeutic monitoring of a standardized online digital behavioral program Ordered by a physician or other qualified health care professional; management services by physician or other qualified health care professional, per calendar month