CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Digital Health Therapeutics — Prescription Digital Therapeutics and Biofeedback (Freespira, NightWare)

This policy addresses coverage determinations for FDA-cleared prescription digital therapeutics and biofeedback technologies (including Freespira and NightWare) for panic disorder, PTSD, and nightmare disorder for Blue Cross Blue Shield - Rhode Island members.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyDigital Health Therapeutics — Prescription Digital Therapeutics and Biofeedback (Freespira, NightWare)

Policy CodePolicy N/A

Change TypeMinor revision — no material coverage changes

Effective DateJan 2, 2026

Next Review DateN/A

Key ActionDo not bill or expect coverage for Freespira or NightWare — they are listed as not covered or contract exclusions; verify member benefits for contract-specific rules.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2named technologies considered not covered

A9291, A9294HCPCS codes listed as not covered / contract exclusion

3SaMD scope criteria for technologies reviewed

single-arm / single trialevidence types noted as insufficient

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Coverage Determinations

Not covered due to insufficient evidence

Coverage stance and evidence summary

Not covered technologies: Freespira and NightWare are not covered due to insufficient evidence to determine improvement in net health outcome for indicated uses.

Medicare Advantage: listed as not covered; Commercial: contract exclusion

For Commercial Products, Freespira and NightWare are not covered and are listed as contract exclusions. The policy explicitly states Freespira is not covered for all indications including treatment of panic disorder and/or post-traumatic stress disorder, and NightWare is not covered for all indications including treatment of nightmare disorder or nightmares from posttraumatic stress disorder. The HCPCS codes A9291 and A9294 are identified in the policy as non-covered / contract exclusion codes for Commercial Products, which impacts claims processing and billing for these services.

The evidence base for both Freespira and NightWare is limited and described as insufficient to determine a net health benefit. For Freespira, available data are from several single-arm studies (two in panic disorder and one pilot in PTSD) that reported symptom improvement but had substantial limitations, notably high loss to follow-up (ranging from 24% to 58%) and lack of control groups. For NightWare, the body of evidence consists of a single pivotal trial that did not meet its primary efficacy endpoint, failed to reach recruitment goals, and was likely underpowered. The policy concludes that well-designed blinded randomized controlled trials with pre-specified hypotheses are needed for both technologies.

Billing and Coding

Not covered HCPCS codes (Medicare Advantage)HCPCSNot Covered

A9291	Prescription digital cognitive and/or behavioral therapy, FDA-cleared, per course of treatment
A9294	Prescription digital cognitive and/or behavioral therapy, biofeedback, fda cleared, per course of treatment (New Code Effective 4/1/2026)

Non-covered / contract exclusion codes (Commercial)HCPCSNot Covered

A9291	Prescription digital cognitive and/or behavioral therapy, FDA-cleared, per course of treatment
A9294	Prescription digital cognitive and/or behavioral therapy, biofeedback, fda cleared, per course of treatment (New Code Effective 4/1/2026)

What Providers Need to Know

Prior Authorization

Prior authorization status and code impact

Prior authorization is Not applicable for these services. However, listed HCPCS codes below are not covered or are contract exclusions — do not submit prior authorization requests for non-covered items.

Prior authorization status: Not applicable
Do not submit prior auth for codes listed as not covered or contract exclusions

Note

Benefit variation and contract-level rules

Benefits and coverage may vary by group and contract. Always verify member-specific coverage rules in the appropriate plan documents before delivering or billing for services.

Refer to the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for applicable coverage and exclusions

Documentation Required

SaMD scope and documentation expectations

This policy applies only to Software as a Medical Device (SaMD) intended for therapeutic use that meets all of the following: (1) meets the SaMD definition (software intended for a medical purpose without being part of hardware), (2) has FDA marketing authorization (de novo, 510(k), or PMA), and (3) is prescribed by a healthcare provider. Documentation should demonstrate the SaMD designation, FDA clearance/approval, and that the product was prescribed by an authorized provider.

Scope limited to therapeutic SaMD products
Documentation expectations: proof of SaMD status, FDA marketing authorization, and provider prescription

Denial Risk

Non-covered digital therapeutic services and codes

The following digital therapeutic services are not covered. For Medicare Advantage Plans these are considered not covered due to insufficient evidence; for Commercial Products they are contract exclusions. Affected HCPCS codes are listed below.

Freespira — not covered for all indications (including treatment of panic disorder and/or PTSD)
NightWare — not covered for all indications (including treatment of nightmare disorder or nightmares from PTSD)
Affected HCPCS codes (Medicare Advantage & Commercial as noted): A9291 — Prescription digital cognitive and/or behavioral therapy, FDA-cleared, per course of treatment (not covered)
A9294 — Prescription digital cognitive and/or behavioral therapy, biofeedback, FDA-cleared, per course of treatment (not covered; new code effective 4/1/2026)

Background and Scope

This policy reviews therapeutic digital applications that meet the definition of Software as a Medical Device (SaMD) and are intended to be prescribed by a clinician as prescription digital therapeutics. Digital health technologies encompassed by the policy include mobile health applications, wearable devices, and algorithm-driven software that interact with consumer devices (for example, NightWare’s use of Apple Watch and iPhone data). Freespira is defined in the policy as a capnometry-guided respiratory biofeedback program delivered over a 4-week training period to target panic symptoms and PTSD-related breathing abnormalities; NightWare is an AI-driven algorithm that analyzes sleep heart rate and motion to deliver brief sleep-period vibrations as an adjunct to standard therapy for nightmare disorder or PTSD-associated nightmares. The scope is limited to FDA-cleared SaMD intended for medical purposes and evaluated for clinical benefit in the treated populations.

Key Definitions

Software as a Medical Device (SaMD)

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.

Scope criteria (1)Must meet the SaMD definition (intended for a medical purpose and not part of a hardware medical device).

Scope criteria (2)Must have received FDA marketing clearance or approval (De Novo, 510(k), or PMA).

Scope criteria (3)Must be prescribed by a healthcare provider to be considered under this policy's review scope.

Freespira — capnometry-guided respiratory intervention

InterventionFreespira — a capnometry-guided respiratory biofeedback program that provides breath-to-breath end-tidal CO2 (ETCO2) feedback and paced breathing training administered as twice-daily ~17-minute sessions over a 4-week program.

Intended useTargeted for individuals with panic disorder and considered for PTSD-associated panic symptoms to normalize ETCO2 and respiratory rate via biofeedback.

Evidence summaryEvidence consists of single-arm studies (two in panic disorder, one pilot in PTSD) reporting symptom improvements but limited by 24%–58% loss to follow-up and lack of randomized controls; benefit is uncertain.

NightWare — AI-driven wearable algorithm

InterventionNightWare — an AI-driven algorithm that uses Apple Watch/iPhone-collected heart rate and motion data to detect abnormal sleep activity and delivers short vibrations via the watch to disrupt nightmares while the patient sleeps.

Intended useIntended to reduce nightmares in individuals with nightmare disorder and PTSD-associated nightmares as an adjunct to standard therapy; device worn only during sleep.

Evidence summaryEvidence includes a single pivotal trial that did not meet its primary efficacy endpoint and was likely underpowered; benefit is uncertain due to trial limitations.

Reviewed Treatment Modalities

Prescription digital therapeutics (biofeedback, wearable AI)

Freespira: Respiratory biofeedback/ETCO2-guided paced breathing program intended for panic disorder and PTSD; evidence insufficient.

Evidence includes single-arm studies with high loss to follow-up; benefit uncertain.

NightWare: Wearable AI-driven vibration therapy for nightmares used adjunctively; evidence insufficient.

Single pivotal trial did not meet primary efficacy endpoint and was likely underpowered; benefit uncertain.