Medical policy: Audio Visual Neuromodulation for Neuropathic Pain

Policy number: MP 6.065

Effective date: 11/1/2026

Policy

The use of U.S. Food and Drug Administration-authorized prescription audiovisual digital therapeutics for neuropathic pain is considered investigational. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Product variations

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Please see additional information below.

FEP PPO - Refer to Section VI of the FEP Medical Policy Manual. The FEP Medical Policy Manual can be found at: FEP Medical Policy Manual.

Description/Background

Scope of review

This review addresses a specific subset of U.S. Food and Drug Administration (FDA)-authorized prescription digital therapeutics (PDTs) that deliver their primary therapeutic effect through integrated hardware-software systems utilizing visual and/or auditory stimulation. Covered products may have received De Novo classification or 510(k) clearance, depending on the availability of a legally marketed predicate device.

The scope of this review is restricted to prescription audiovisual therapeutics for management of neuropathic pain that meet the following 3 criteria:

• Must be a PDT: software that performs one or more medical purposes as the primary therapeutic component of a hardware-software system, excluding software used solely to store or transmit medical information.
• Must have received marketing clearance or approval by the FDA and,
• Must be prescribed by a healthcare provider.

BCBSA evaluation framework for digital health technologies

FDA-authorized PDTs are subject to the same evaluation standards as other devices; the Blue Cross and Blue Shield Association Technology Evaluation Criterion are as follows:

• The technology must have final approval from the appropriate governmental regulatory bodies.
• The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.
• The technology must improve the net health outcome.^a
• The technology must be as beneficial as any established alternatives.
• The improvement must be attainable outside the investigational settings.^b
  • The technology must assure protection of sensitive patient health information as per the requirements of The Health Insurance Portability and Accountability Act of 1996 (HIPAA).
  • The technology must demonstrate usability in a real-world setting.

Regulatory status

In January 2026, the U.S. Food and Drug Administration (FDA) granted De Novo marketing authorization (DEN250005) for the Sana Device (Sana Health, Inc.) for the adjunctive treatment of neuropathic pain.

The Sana Device is currently the only FDA-authorized prescription audiovisual therapeutic indicated for neuropathic pain management in the United States.

Rationale

Summary of evidence

For individuals with neuropathic pain who receive the Sana Device, the evidence includes a single pivotal double-blind, sham-controlled RCT (N=75). Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The Sana Device received FDA De Novo authorization in January 2026. The pre-specified primary endpoint for the pivotal trial was the between-group comparison of neuropathic pain symptom severity at week 14 (off-treatment follow-up); this endpoint was met (mean difference 8.75, 95% CI 1.30 to 16.20, calculated from reported standard errors; p=.021). Both active (Sana Device) and sham groups improved significantly within-group at week 10 (end of treatment) with no significant between-group difference. Only the active group maintained improvement at week 14; the sham group returned toward baseline. Active participants also showed significant reductions in use of multiple pain medication classes compared to sham. A responder analysis based on an anchor-derived minimum clinically important difference (MCID) threshold showed a significantly higher response rate in the active arm (67%) versus sham (32%; NNT=2.89; χ²=4.44, p=0.035). No significant between-group differences were observed for secondary outcomes assessing mood, anxiety, sleep quality, or quality of life. The evidence base is limited to a single trial with no independent replication, an externally validated MCID (threshold and the result claiming success drawn from the same trial data), and baseline imbalance across key prognostic variables (age, sex, pain severity, and pain duration) not controlled for in the primary model. It is unknown whether neuroplastic changes observed at Week 14 are sustained, whether repeated treatment cycles are needed to maintain benefit, and what retreatment intervals if any would be appropriate. The evidentiary standard for moving from investigational to a determination of improved net health outcome would require, at minimum: independent replication with prognostic variables controlled as covariates; a prospectively established MCID derived from an external cohort independent of the pivotal trial; and controlled follow-up of at least 6 to 12 months to establish durability of effect. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as permitted by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These policies are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the members’ benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding information

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement.

Investigational; therefore, not covered

References

1. Food and Drug Administration (FDA). Sana Device. January 16, 2026.
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15. Tabacof et al (2026). Audio-visual stimulation therapy for chronic neuropathic pain: a sham-controlled randomized clinical trial. BMC Neurology. Published: 17 March 2026.
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