POLICY NUMBER

A.3.03.07

DESCRIPTION

This policy addresses prescription digital therapeutics (PDTs) that deliver therapeutic benefit through audiovisual (AV) hardware-software systems indicated for the management of neuropathic pain. Unlike software-only PDTs, the products reviewed here require dedicated hardware, a wearable AV stimulation device, through which proprietary software delivers the primary therapeutic intervention. To be within scope, a product must: 1) be a PDT in which software 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; 2) have received marketing clearance or approval by the U.S. Food and Drug Administration (FDA); and 3) be prescribed by a healthcare provider.

Scope of Policy

This policy 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 policy is restricted to prescription audiovisual therapeutics for management of neuropathic pain that meet the following 3 criteria:

1. 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).

2. Must have received marketing clearance or approval by the FDA.

3. Must be prescribed by a healthcare provider.

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, as summarized in the table below.

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

Prescription Audiovisual Therapeutics for Neuropathic Pain

AVS: audiovisual stimulation; CBT: cognitive behavioral therapy

POLICY

The use of U.S. Food and Drug Administration-authorized prescription audiovisual digital therapeutics for neuropathic pain is considered investigational.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

08/01/2026: New policy added. Approved by the Medical Policy Advisory Committee.

SOURCE(S)

Blue Cross Blue Shield Association policy # 3.03.07

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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