Description
IB-STIM^® is a percutaneous electrical nerve field stimulator (PENFS) system is intended to be used in patients 11 – 18 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-STIM is intended to be used for 120 hours per week up to 4¹ consecutive weeks, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination, as an aid in the reduction of pain when combined with other therapies for IBS. The IB-STIM procedure is typically performed in an office setting. 

This nonsurgical device works by sending electrical impulses into the cranial nerve bundles located in the ear. The stimulation targets the brain areas that are involved with processing pain, and aids in the reduction of functional abdominal pain, that is associated with inflammatory bowel syndrome (IBS).

Policy
IB-STIM^® may be considered MEDICALLY NECESSARY in children and adolescents when ALL of the following criteria is met:

• The patient is 11 – 18 years of age. 
• Patient must be diagnosed with a ROME IV defined-functional gastrointestinal disorder. These include functional abdominal pain, functional abdominal pain syndrome, irritable bowel syndrome, functional dyspepsia, and abdominal migraine.
• Organic GI disease must have been ruled out.
• The problem has been present for at least 9 months.
• The patient has tried and failed medications in all 3 categories: Acid suppression (H2-blockers or PPIs), antispasmodics or motility medications (hyoscyamine, dicyclomine, erythromycin/linaclotide, prucalopride) and neuromodulators (amitriptyline/nortriptyline/gabapentin/periactin/aprepitant), in addition to diet modification.

All other uses of IB-STIM device is considered investigational/unproven therefore is considered NOT MEDICALLY NECESSARY.

Rationale
Percutaneous Electrical Nerve Field Stimulation (PENFS) is a noninvasive treatment option for pediatric patients with functional bowel disorders including irritable bowel syndrome. This noninvasive device delivers percutaneous electrical nerve field stimulation to the external ear and is a safe and effective therapy for pediatric abdominal pain-related functional gastrointestinal disorders in pediatric patients with functional abdominal pain disorders. Studies showed that PENFS modulates central pain pathways and attenuates visceral hyperalgesia.

The current standard for children with functional abdominal pain is to use off-label medications, most of which have serious side-effects and black-box warnings. These medications include tricyclic antidepressants (amitriptyline), selective serotonin reuptake inhibitor (SSRIs), prokinetics, gabapentin and cyproheptadine.

The evidence includes 2 randomized, double-blind, sham-controlled trial. Auricular neurostimulation reduces abdominal pain scores. PENFS has proven to be an effective and safe treatment for pediatric patients with abdominal pain disorders. Studies concluded that PENFS improves overall wellbeing in adolescents with abdominal pain. PENFS with Neuro-stim (IB-STIM) showed an 81% improvement in overall symptoms, and approximately 59% of test subjects showed at least a 30% reduction in their worst pain. Kovacic (2017); Krasaelap (2020)

Clinical input obtained in 2021 was in agreement that PENFS is medically necessary for the management of functional gastrointestinal disorders. There are no other IBS approaches that attain the level of clinical efficacy of IB-STIM. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

References

1. Gupta, S., Schaffer, G., & Saps, M. Pediatric irritable bowel syndrome and other functional abdominal pain disorders; an update of non-pharmacological treatments. Expert Review of Gastroenterology & Hepatology. 2018; 12(5): 447-456.
2. Kovacic, K, Hainsworth, M., et al. Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial. The Lancet: Gastroenterology & Hepatology. 2017; 2(10): 727-737.
3. Madani, S., Parikh, S., et al. Long-term study of children with ROME III functional gastrointestinal disorders managed symptomically in a biophysical model. Gastroenterol Res. 2017;10(2): 84-91.
4. Walker, L.S., Dengler-Crish, C.M., et al. Functional abdominal pain in childhood and adolescence inreases risk for chronic pain in adulthood. Pain. 2010; 150(3); 568-572
5. Non-implanted nerve stimulator for functional abdominal pain relief. Regulatory Class: Class II Device. https://www.accessdata.fda.gov/cdrh_docs/pdf18/DEN180057.pdf
6. Amornluck Krasaelap, Manu R Sood, B U K Li et al. Efficacy of Auricular Neurostimulation in Adolescents with Irritable Bowel Syndrome in a Randomized, Double-Blind Trial. Clin Gastroenterol Hepatol. 2020 Aug;18(9):1987-1994.e2. 
7. Katja Kovacic, Jacek Kolacz, Gregory F. Lewis et al. Impaired Vagal Efficiency Predicts Auricular Neurostimulation Response in Adolescent Functional Abdominal Pain Disorders. Am J Gastroenterol 2020 Sep;115(9):1534-1538.
8. de Bruijn CMA, et al. Antidepressants for functional abdominal pain disorders in children and adolescents. Cochrane Database Syst Rev. 2021. 
9. Gottfried-Blackmore A et al. Noninvasive vagal nerve stimulation for gastroenterology pain disorders. Pain Manag. 2021 Jan;11(1):89-96.

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

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