Medical policy: Audio Visual Neuromodulation for Neuropathic Pain

Número de política: MP 6.065

Fecha de entrada en vigor: 11/1/2026

Política

The use of U.S. Food and Drug Administration-authorized prescription audiovisual digital therapeutics for neuropathic pain is considered investigational. No hay pruebas suficientes para apoyar una conclusión general con respecto a los resultados o beneficios para la salud asociados con este procedimiento.

Variaciones del producto

Esta política solo se aplica a ciertos programas y productos administrados por Capital Blue Cross y está sujeta a variaciones en los beneficios. Consulte la información adicional a continuación.

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.

Descripción/Antecedentes

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.

Situación reglamentaria

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.

Fundamento

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). Los resultados pertinentes son los síntomas, los resultados funcionales, la calidad de vida y la morbilidad relacionada con el tratamiento. 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. Las pruebas son insuficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

Exención de responsabilidad

Las políticas médicas de Capital Blue Cross se utilizan para determinar la cobertura de tecnologías, procedimientos, equipos y servicios médicos específicos. Estas políticas médicas no constituyen un consejo médico y están sujetas a cambios según lo permita la ley o la evidencia clínica aplicable de las pautas de tratamiento independientes. Los proveedores que brindan tratamiento son individualmente responsables de los consejos médicos y el tratamiento de los miembros. Estas políticas no son una garantía de cobertura o pago. El pago de las reclamaciones está sujeto a la determinación del programa de beneficios del miembro y la elegibilidad en la fecha del servicio, y a la determinación de que los servicios son médicamente necesarios y apropiados. El procesamiento final de una reclamación se basa en los términos del contrato que se aplican al programa de beneficios de los miembros, incluidas las limitaciones y exclusiones de beneficios. Si un proveedor o miembro tiene alguna pregunta sobre esta política médica, debe comunicarse con Servicios para proveedores o Servicios para miembros de Capital Blue Cross.

Información de codificación

Nota: esta lista de códigos puede no ser exhaustiva y los códigos están sujetos a cambios en cualquier momento. La identificación de un código en esta sección no denota cobertura, ya que la cobertura está determinada por los términos de la información de beneficios del miembro. Además, no todos los servicios cubiertos son elegibles para un reembolso por separado.

Investigational; therefore, not covered

Referencias

1. Food and Drug Administration (FDA). Sana Device. January 16, 2026.
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