POLICY NUMBER

A.2.01.106

DESCRIPTION

Percutaneous electrical nerve field stimulation involves the transmission of electrical impulses to cranial nerve bundles in the ear targeting brain areas involved in processing pain. In the case of patients with abdominal pain-related disorders of gut-brain interaction, nerves processing pain for the abdominal region are targeted.

Abdominal Pain-Related Disorders of Gut-Brain Interaction

The Rome IV diagnostic criteria (published in 2016) provide definitions for the abdominal pain-related disorders of gut-brain interaction (Table 1). This family of conditions has historically been called functional gastrointestinal disorders, but the Rome IV criteria proposed updated terminology based on newer understanding of pathophysiology and lack of clarity about the word "functional". The Rome V diagnostic criteria are expected to be released in 2026.

Table 1. Abdominal Pain-Related Disorders of Gut-Brain Interaction According to Rome IV Criteria

Irritable Bowel Syndrome

Irritable bowel syndrome (IBS) is estimated to affect 5% to 10% of the population globally, and accounts for between 2.4 and 3.5 million physician visits in the United States each year. Up to two-thirds of patients with IBS are female, and it is most common in patients less than 50 years of age. The cause of IBS remains unknown, but is believed to be due to a dysfunction in gut-brain interaction. Symptoms of IBS can include diarrhea, constipation, or both. Abdominal pain and bloating are also common IBS symptoms. These symptoms decrease patient quality of life and create a significant healthcare burden. The American College of Gastroenterology (ACG) recommends that patients diagnosed with IBS are categorized by subtypes: IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), IBS with mixed symptoms (IBS-M), or IBS without abnormal stools (IBS-U).

Treatment

First-line treatment of patients with IBS generally involves dietary changes. If dietary changes fail to achieve therapeutic goals, there are numerous pharmacotherapeutic options for patients with IBS. Pharmacologic treatment is based on the IBS subtype, and the predominance of either constipation or diarrhea (Table 2). Notably, many IBS treatments are not Food and Drug Administration (FDA)-approved for children or adolescents. The American College of Gastroenterology recommends that gut-directed psychotherapy such as cognitive-behavior therapy and gut-directed hypnotherapy may be beneficial for global IBS symptoms.

Table 2. Pharmacologic Treatment of Irritable Bowel Syndrome

HT: hydroxytryptamine (serotonin); IBS-C: irritable bowel syndrome with constipation; IBS-D: irritable bowel syndrome with diarrhea; SSRI: selective serotonin reuptake inhibitor; TCA: tricyclic antidepressant.

Functional Dyspepsia

According to the Rome IV criteria, functional disorders are diagnosed based on symptoms reported by the patient, rather than based on objective structural or motility findings. Dyspepsia affects about 12% of the US population. The most common symptoms are postprandial gastrointestinal distress (feeling full during or after a meal) as well as epigastric pain. The American College of Gastroenterology published guidelines for management of dyspepsia in 2017. Treatment of dyspepsia includes empiric proton pump inhibitor therapy or treatment for Helicobacter pylori infection in patients with H. pylori infection. If first-line treatment is not effective, prokinetic or tricyclic antidepressant therapy are second-line options.

Percutaneous Electrical Nerve Field Stimulation

Because there are few pharmacologic treatments for children and adolescents with abdominal pain-related disorders of gut-brain interaction, nonpharmacologic options are commonly explored. Percutaneous electrical nerve field stimulation (PENFS) is a potential treatment option for these patients. PENFS involves a non-implantable device which stimulates nerves remotely from the site of pain and has been studied for a variety of musculoskeletal or neuropathic pain conditions or for patients with opioid withdrawal. The IB-Stim device is a type of PENFS that is intended for use only in patients with IBS. The device is disposable and battery-operated. Key components of the device include a percutaneous electrical nerve field stimulator placed behind the ear which connects to a multi-wire electrode array consisting of 4 leads. The electrodes have thin needles and attach to the ear at points (preauricular, lobule and superior crus) where cranial nerve peripheral branches are located just beneath the skin. A pen light included with the device is used to visualize the neurovasculature features and aid in proper electrode placement.

In 2019, the IB-Stim device (previously known as Neuro-Stim; Innovative Health Solutions, Inc.) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the de novo 513(f)(2) process (DEN180057). Both the IB-Stim and the similar NSS-2 BRIDGE device (Innovative Health Solutions, Inc.) are derivatives of the Electro Auricular Device (Navigant Consulting, Inc.). As of October 2025, the IB-Stim device (NeurAxis) is indicated for patients 8 years of age and older with functional abdominal pain associated with IBS and functional dyspepsia when combined with other therapies. It is intended to be used for 120 hours per week for 4 consecutive weeks. The expanded indication for use in adults was based on extrapolation of clinical data. The First Relief v1 (DyAnsys, Inc.) device was deemed substantially equivalent to the IB-Stim device in 2020 and the TEA Device (Transtimulation Research, Inc.) was deemed substantially equivalent to the IB-Stim device in 2023. FDA product code: QHH.

Related medical policies –

• Percutaneous Electrical Nerve Stimulation, Percutaneous Neuromodulation Therapy, and Restorative Neurostimulation Therapy

• Cranial Electrotherapy Stimulation (CES) and Auricular Electrostimulation

POLICY

Percutaneous electrical nerve field stimulation for abdominal pain in individuals with disorders of gut-brain interaction, including but not limited to irritable bowel syndrome and functional dyspepsia, 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.

The Rome IV diagnostic criteria provide definitions for abdominal pain-related disorders of gut-brain interaction. See Table 1.

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

11/01/2023: New policy added. Approved by the Medical Policy Advisory Committee.

09/09/2024: Policy reviewed; no changes.

11/21/2025: Policy reviewed; no changes.

01/01/2026: Code Reference section updated to add new CPT code 64567.

03/05/2026: Policy description updated regarding devices. Policy statement unchanged.

09/28/2026: Policy title changed from "Percutaneous Electrical Nerve Field Stimulation for Irritable Bowel Syndrome" to "Percutaneous Electrical Nerve Field Stimulation for Disorders of Gut-Brain Interaction." Policy description updated regarding abdominal pain-related disorders of gut-brain interaction, functional dyspepsia, and devices. Policy statement updated to include disorders of gut-brain interaction and functional dyspepsia as investigational. Policy Guidelines updated regarding the Rome IV diagnostic criteria.

SOURCE(S)

Blue Cross Blue Shield Association policy # 2.01.106

CODE REFERENCE

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

Investigational Codes

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