II-177-007

Medical Policy:

II-177-007

Topic:

Nerve Fiber Density Measurement

Section:

Medicine

Effective Date:

September 30, 2019

Issued Date:

October 30, 2023

Last Revision Date:

September 2019

Annual Review:

October 2023

This Policy version was replaced on October 28, 2024. To find the newest version, go to https://www.bluecrossmn.com/providers/medical-management, select 'See Medical and Behavioral Health Policies', then 'Blue Cross and Blue Shield of Minnesota Medical and Behavioral Health Policies'. This will bring up the Medical Policy search screen. Enter the policy number without the version number (last three digits).

Skin biopsy is used to assess the density of epidermal (intraepidermal) and sweat gland (sudomotor) nerve fibers using antibodies to a marker found in peripheral nerves. This procedure is proposed as an objective measure of small fiber neuropathy by identifying a reduction in the density of nerve fibers.

A specific test to assess intraepidermal nerve fiber (IENF) density and sweat gland nerve fiber (SGNF) density using skin biopsy and immunostaining of the tissue has been developed that allows the identification and counting of intraepidermal and sudomotor nerve fibers. Assessment of nerve fiber density typically involves a 3-mm punch biopsy of skin from the calf, foot, or thigh. After sectioning by microtome, the tissue is immunostained with anti-protein-gene-product 9.5 (PGP 9.5) antibodies and examined with immunohistochemical or immunofluorescent methods.

Assessment of intraepidermal nerve fiber (IENF) and sweat gland nerve fiber density with PGP 9.5 is commercially available from samples obtained with an in-house biopsy kit, although IENF-density measurement (ie, tissue preparation, immunostaining with PGP 9.5, and counting) may also be done by local research pathology labs.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

I. Epidermal/Intraepidermal Nerve Fiber (IENF) Density Measurement

Skin biopsy with epidermal nerve fiber density measurement for the diagnosis of small fiber neuropathy may be considered MEDICALLY NECESSARY AND APPROPRIATE when ALL of the following criteria are met:

Individual presents with symptoms of painful sensory neuropathy; AND
No history of a disorder known to predispose to painful neuropathy (e.g., diabetic neuropathy, toxic neuropathy, HIV neuropathy, celiac neuropathy, inherited neuropathy); AND
Physical examination shows no evidence of findings consistent with large-fiber neuropathy, such as reduced or absent muscle-stretch reflexes or reduced proprioception and vibration sensation; AND
Electromyography and nerve-conduction studies are normal and show no evidence of large-fiber neuropathy; AND
The test is ordered by a neurologist.

II. Skin biopsy with epidermal nerve fiber density measurement is considered EXPERIMENTAL/INVESTIGATIVE for the monitoring of disease progression or response to treatment due to the lack of clinical evidence demonstrating an impact on improved health outcomes.

III. Skin biopsy with epidermal nerve fiber density measurement is considered EXPERIMENTAL/INVESTIGATIVE for ALL other indications including but not limited to the following, due to a lack of clinical evidence demonstrating an impact on improved health outcomes:

Fibromyalgia
Sarcoidosis

IV. Sweat Gland/Sudomotor Nerve Fiber (SGNF) Density Measurement

Measurement of sweat gland nerve fiber density is considered EXPERIMENTAL/INVESTIGATIVE due to lack of evidence demonstrating an impact on improved clinical outcomes.

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Denial Statements

No additional statements.

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