DraftBlue Cross Blue Shield - Rhode IslandPolicy N/A

Digital Health Technologies — Therapeutic Applications (Coverage Criteria)

Defines coverage stance for FDA-cleared/approved therapeutic digital health software (Software as a Medical Device) prescribed by a healthcare provider, with specific determinations for Freespira and NightWare and HCPCS A9291. Applies to Blue Cross Blue Shield - Rhode Island members.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyDigital Health Technologies — Therapeutic Applications (Coverage Criteria)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionVerify member-specific benefits and eligibility with the benefit booklet or subscriber agreement before ordering or billing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2named technologies not covered (Commercial/MA)

A9291HCPCS code not covered

3required scope criteria

Not applicableprior auth

Coverage determinations and criteria

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Coverage determinations

Covered when ALL of the following are met:

Scope inclusion criteria: Software must (1) meet the Software as a Medical Device (SaMD) definition, (2) have FDA marketing clearance or approval (de novo, 510(k), or PMA), and (3) be prescribed by a healthcare provider.all three required

Defined in background; technologies outside this scope are not considered here.

Specific technologies with explicit noncoverage: Freespira and NightWare are explicitly listed as not covered for specified plan types (Freespira not covered for Medicare Advantage and Commercial; NightWare not covered for Medicare Advantage and is a commercial contract exclusion).1+

Policy states evidence is insufficient to determine clinical benefit for these technologies.

Evidence requirement: The evidence for Freespira (single-arm studies with high loss to follow-up and lack of control groups) and NightWare (single pivotal trial that did not meet the primary endpoint and was likely underpowered) is insufficient to demonstrate improvement in net health outcome; well-designed blinded randomized trials are needed.N/A

Used to justify noncoverage decisions.

Per the policy, NightWare is listed as a contract exclusion for Commercial products. For Medicare Advantage plans, both Freespira and NightWare are specifically listed as not covered because the available evidence is insufficient to demonstrate improvement in net health outcomes.

The policy identifies key limitations in the evidence base that drive the noncoverage stance: for Freespira, the supporting studies are primarily single-arm designs with high loss to follow-up (24%–58%) and no control groups; for NightWare, the single pivotal trial did not meet its primary efficacy endpoint and failed to recruit adequately (likely underpowered). The policy concludes that well-designed blinded randomized controlled trials with predefined hypotheses and adequate follow-up are required to determine whether these technologies improve net health outcomes.

Billing codes and coding-related coverage decisions

Not covered / Contract exclusionHCPCSNot Covered

A9291

Prescription digital cognitive and/or behavioral therapy, FDA-cleared, per course of treatment

Study follow-up and power — evidence limitations

Follow-up completenessFreespira studies had high loss to follow-up (24%–58%), limiting confidence in outcomes

Control group absenceFreespira evidence is based on single-arm studies without control groups, reducing ability to attribute effects to the intervention

Pivotal trial powerNightWare had a single pivotal trial that did not meet its primary efficacy endpoint and failed to achieve planned recruitment (likely underpowered)

Recommendation for evidenceWell-designed, blinded randomized controlled trials with prespecified hypotheses are needed for both technologies to determine net health benefit

Provider steps, verification, and denial risks

Prior Authorization

Prior authorization not required (verify benefits)

Prior authorization is not required for these services through the medical policy; however, benefits and coverage may vary by contract. Providers must verify member-specific benefits, eligibility, and any prior authorization requirements with Blue Cross Blue Shield of Rhode Island before rendering services.

Verify member eligibility and benefits prior to service.
Contact the BCBSRI provider call center for member-specific prior authorization and coverage information.

Documentation Required

Required product characteristics and benefit verification

Covered digital therapeutics must meet product and benefit requirements before coverage is considered. Confirm all of the following when verifying benefits: the software meets the definition of Software as a Medical Device (SaMD); the product has U.S. FDA marketing clearance or approval (de novo, 510(k), or PMA as applicable); and the product is prescribed by a healthcare provider. Additionally, coverage may be affected by plan-specific contract exclusions (see Noncoverage triggers).

Confirm the product is SaMD: intended for one or more medical purposes and functions without being part of a hardware medical device.
Confirm FDA marketing clearance or approval (de novo, 510(k), or premarket approval) documentation is available.
Confirm the product is prescribed by a licensed healthcare provider when required by the product labeling.
Verify plan contract for exclusions or limitations that may apply to prescription digital therapeutics.
HCPCS A9291 may be listed as non-covered under certain products/lines of business; verify code-level coverage in the member's contract.

Digital therapeutic apps and specific technologies

digital therapeutic apps (Freespira, NightWare)

Covered when ANY of the following (technology-specific) criteria are met:

Freespira (capnometry-guided respiratory intervention): Intended for panic disorder and PTSD by training respiratory control and normalizing ETCO2 and respiratory rate; current evidence consists of single-arm studies with high loss to follow-up (24%–58%) and other design limitations, therefore evidence is insufficient to support coverage.

NightWare (wearable sleep intervention): Intended for nightmare disorder and PTSD-associated nightmares using an AI-driven algorithm with wrist vibration via smartwatch; the single pivotal trial did not meet the primary efficacy endpoint and was likely underpowered, therefore evidence is insufficient to support coverage.

Key definitions used in this policy

Software as a Medical Device (SaMD) — definition summary

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

Synonymous termsPreviously referred to as standalone software, medical device software, or health software

Regulatory originDefinition referenced from the International Medical Device Regulators Forum and aligned with FDA framing

Technologies in scope — SaMD, FDA clearance/approval, prescription requirement

In-scope criteriaTherapeutic digital technologies must meet the SaMD definition, have FDA marketing clearance or approval (de novo, 510(k), or PMA), and be prescribed by a healthcare provider

Examples in policyTechnologies reviewed include Freespira (capnometry-guided respiratory biofeedback for panic disorder/PTSD) and NightWare (AI-driven wearable vibration for nightmares)

Intended use requirementScope limited to software intended for therapeutic application (treatment) rather than non-therapeutic or administrative uses

Background and context

Software that functions independently to achieve medical purposes without being part of a hardware medical device is considered Software as a Medical Device (SaMD). This policy applies to therapeutic digital applications that meet three conditions: they satisfy the SaMD definition, have received FDA marketing authorization (de novo, 510(k), or PMA), and are prescribed by a healthcare provider. Technologies outside this scope are not addressed by this policy.