Description

Percutaneous electrical nerve stimulation (PENS) and percutaneous neuromodulation therapy (PNT) are therapies that combine the features of electroacupuncture and transcutaneous electrical nerve stimulation (TENS). PENS is performed with needle electrodes while PNT uses very fine needle-like electrode arrays that are placed in close proximity to the painful area to stimulate peripheral sensory nerves in the soft tissue. Percutaneous electrical nerve field stimulation (PENFS) differs from PENS in that with PENFS, a “field” of pain is targeted, instead of targeting a specific nerve.

Background

Percutaneous electrical nerve stimulation (PENS) and percutaneous neuromodulation therapy (PNT) have been evaluated for the treatment of a variety of chronic musculoskeletal or neuropathic pain conditions including low back pain, neck pain, diabetic neuropathy, chronic headache, and surface hyperalgesia that present a substantial burden to patients, adversely affecting function and quality of life. These chronic pain conditions have typically failed other treatments, and percutaneous electrical nerve stimulation and percutaneous neuromodulation therapy have been evaluated as treatments to relieve unremitting pain.

PENS is similar in concept to TENS but differs in that needles are inserted either around or immediately adjacent to the nerves serving the painful area and are then stimulated. PENS is generally reserved for patients who fail to get pain relief from TENS. PENS is also distinguished from acupuncture with electrical stimulation. In electrical acupuncture, needles are also inserted just below the skin, but the placement of needles is based on specific theories regarding energy flow throughout the human body. In PENS the location of stimulation is determined by proximity to the pain.

Percutaneous neuromodulation therapy is a variant of PENS in which fine filament electrode arrays are placed near the area causing pain. Some use the terms PENS and PNT interchangeably. It is proposed that PNT inhibits pain transmission by creating an electrical field that hyperpolarizes C-fibers, thus preventing action potential propagation along the pain pathway.

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. 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).

Because there are few pharmacologic treatments for children and adolescents with IBS, 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.^6, 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.

Functional abdominal pain disorders (FAPDs) are the most common cause of chronic abdominal pain in children and adolescents, and involve a complex interplay among regulation of the enteric and central nervous systems. FAPD includes several pain-predominant functional gastrointestinal (GI) disorders: functional dyspepsia, irritable bowel syndrome, abdominal migraine and FAP-not otherwise specified. Symptoms associated with FAPD may include visceral hyperalgesia and a reduced threshold for pain, and may adversely affect mental health.

Regulatory Status

In 2002, the Percutaneous Neuromodulation Therapy^™ (Vertis Neuroscience) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The labeled indication is: "… for the symptomatic relief and management of chronic or intractable pain and/or as an adjunctive treatment in the management of post-surgical pain and post-trauma pain."

In 2006, the Deepwave^® Percutaneous Neuromodulation Pain Therapy System (Biowave) was cleared for marketing by FDA through the 510(k) process. The FDA determined that this device was substantially equivalent to the Vertis neuromodulation system and a Biowave neuromodulation therapy unit. The Deepwave^® system includes a sterile single-use percutaneous electrode array that contains 1014 microneedles in a 1.5-inch diameter area. The needles are 736 μm (0.736 mm) in length; the patch is reported to feel like sandpaper or Velcro.

In 2019, the IB-Stim device (previously known as Neuro-Stim; Innovative Health Solutions, Inc.) was cleared for marketing by the FDA through the de novo 513(f)(2) process. 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.). The IB-Stim device (NeurAxis) is now indicated for patients 8 to 21 years of age with functional abdominal pain associated with IBS when combined with other IBS therapies. It is intended to be used for 120 hours per week for 4 consecutive weeks. The First Relief v1 (DyAnsys, Inc.) device was deemed substantially equivalent to the IB-Stim device in 2020.

Related Policies

Transcutaneous Electrical Nerve Stimulation (TENS)

Temporomandibular Joint Dysfunction (TMJD)

Neurostimulation, Electrical

Cranial Electrotherapy Stimulation (CES) and Auricular Electrostimulation

***Note: This Medical Policy is complex and technical. For questions concerning the technical language and/or specific clinical indications for its use, please consult your physician.

Policy

Percutaneous Electrical Nerve Stimulation (PENS) and Percutaneous Neuromodulation Therapy (PNT) are considered investigational for all applications. BCBSNC does not provide coverage for investigational services or procedures.

Percutaneous Electrical Nerve Field Stimulation (PENFS), including IB-stim, is considered investigational for all applications. BCBSNC does not provide coverage for investigational services or procedures.

Benefits Application

This medical policy relates only to the services or supplies described herein. Please refer to the Member's Benefit Booklet for availability of benefits. Member's benefits may vary according to benefit design; therefore member benefit language should be reviewed before applying the terms of this medical policy.

When Percutaneous Electrical Nerve Stimulation (PENS) or Neuromodulation Therapy and Percutaneous Electrical Nerve Field Stimulation (PENFS) is covered

Not applicable.

When Percutaneous Electrical Nerve Stimulation (PENS) or Neuromodulation Therapy and Percutaneous Electrical Nerve Field Stimulation (PENFS) is not covered

Percutaneous electrical neurostimulation and percutaneous neuromodulation therapy are considered investigational. BCBSNC does not cover investigational services.

Percutaneous electrical nerve field stimulation is considered investigational. BCBSNC does not cover investigational services.

Policy Guidelines

PENS/PNT

For individuals who have chronic pain conditions (eg, back, neck, neuropathy, headache, hyperalgesia) who receive PENS, the evidence includes primarily small controlled trials and 2 systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and medication use. Two systematic reviews have not revealed consistent benefit from PENS in musculoskeletal pain disorders. One review concluded that PENS could decrease pain intensity but not related disability, while the other found no significant differences between PENS and TENS in mitigation of pain. These conclusions are uncertain due to important methodological limitations in individual trials included in these reviews, such as high heterogeneity with regard to application methods. In the highest quality trial of PENS conducted to date in chronic low back pain, no difference in outcomes was found between the active (30 minutes of stimulation with 10 needles) and the sham (5 minutes of stimulation with 2 needles) treatments. Smaller trials, which have reported positive results, are limited by unclear blinding and short-term follow-up. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have chronic pain conditions (eg, knee osteoarthritis) who receive PNT, the evidence consists of one randomized controlled trial. Relevant outcomes are symptoms, functional outcomes, quality of life, and medication use. The single trial is limited by lack of investigator blinding, unclear participant blinding, and short-term follow-up. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

PENFS

For individuals with irritable bowel syndrome (IBS) who receive percutaneous electrical nerve field stimulation (PENFS), the evidence includes a subgroup analysis of a single randomized controlled trial (RCT). Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The RCT (N=115) included a heterogeneous population of adolescent patients age 11 to 18 years with pain-related functional gastrointestinal disorders. Treatment was administered for 3 weeks, and reductions in pain were observed with the active device compared with a sham PENFS device at end of treatment and end of follow-up (maximum of 12 weeks). The subgroup of patients with IBS also had improved pain at the end of treatment with the active device compared with the sham device. However, the trial is limited by its small sample size, heterogeneous population of gastrointestinal disorders, lack of bowel habit measurement, and the short duration of follow-up. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Billing/Coding/Physician Documentation Information

This policy may apply to the following codes. Inclusion of a code in this section does not guarantee that it will be reimbursed. For further information on reimbursement guidelines, please see Administrative Policies on the Blue Cross Blue Shield of North Carolina web site at www.bcbsnc.com. They are listed in the Category Search on the Medical Policy search page.

Applicable service codes: 64567, A4438

Providers may submit claims for these services using the unlisted code 64999. Providers should not be using 64553-64565, or 64590 to bill this service as these codes are not appropriate.

BCBSNC may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included. 

Scientific Background and Reference Sources

Percutaneous Electrical Nerve Stimulation

BCBSA Medical Policy Reference Manual - 11/1996

Medical Policy Advisory Group Review - 3/1999

Specialty Matched Consultant Advisory Panel - 11/1999

Medical Policy Advisory Group - 12/1999

Percutaneous Electrical Nerve Stimulation (PENS) or Neuromodulation Therapy

BCBSA Medical Policy Reference Manual [Electronic Version], 7.01.29. 1/8/2009

Senior Medical Director Review - 3/2009

BCBSA Medical Policy Reference Manual [Electronic Version], 7.01.29. 2/11/2010

Chou R, Qaseem A, Snow V et al. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med 2007; 147(7):478-91.

Specialty Matched Consultant Advisory Panel – 11/2010

BCBSA Medical Policy Reference Manual [Electronic Version], 7.01.29. 8/11/2011

Specialty Matched Consultant Advisory Panel – 11/2011

BCBSA Medical Policy Reference Manual [Electronic Version], 7.01.29. 8/9/2012

Senior Medical Director – 10/2012

Specialty Matched Consultant Advisory Panel – 10/2012

BCBSA Medical Policy Reference Manual [Electronic Version], 7.01.29. 7/11/2013

Senior Medical Director – 8/2013

Specialty Matched Consultant Advisory Panel – 10/2013

BCBSA Medical Policy Reference Manual [Electronic Version], 7.01.29. 7/10/2014

Specialty Matched Consultant Advisory Panel – 10/2014

BCBSA Medical Policy Reference Manual [Electronic Version], 7.01.29. 7/9/2015

Specialty Matched Consultant Advisory Panel – 10/2015

Specialty Matched Consultant Advisory Panel – 10/2016

BCBSA Medical Policy Reference Manual [Electronic Version], 7.01.29. 3/9/2017

Specialty Matched Consultant Advisory Panel – 10/2017

BCBSA Medical Policy Reference Manual [Electronic Version], 7.01.29. 6/14/2018

Specialty Matched Consultant Advisory Panel – 10/2018

BCBSA Medical Policy Reference Manual [Electronic Version], 7.01.29. 6/13/2019

Specialty Matched Consultant Advisory Panel – 10/2019

BCBSA Medical Policy Reference Manual [Electronic Version], 7.01.29. 6/18/2020

Specialty Matched Consultant Advisory Panel – 10/2020

Percutaneous Electrical Nerve Stimulation (PENS) or Neuromodulation Therapy and Percutaneous Electrical Nerve Field Stimulation (PENFS)

Kovacic K, Hainsworth K, Sood M, et al. Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial. Lancet Gastroenterol Hepatol. 2017 Oct;2(10):727-737.

Krasaelap A, Sood MR, Li BUK, 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.

BCBSA Medical Policy Reference Manual [Electronic Version], 7.01.29. 6/10/2021

Specialty Matched Consultant Advisory Panel – 10/2021

Specialty Matched Consultant Advisory Panel – 4/2022

Medical Director Review – 4/2022

Specialty Matched Consultant Advisory Panel – 4/2023

Medical Director Review – 4/2023

Specialty Matched Consultant Advisory Panel – 4/2024

Medical Director Review – 4/2024

Specialty Matched Consultant Advisory Panel – 4/2025

Medical Director Review – 4/2025

IBS Facts and Statistics. International Foundation for Gastrointestinal Disorders. https://aboutibs.org/what-is-ibs/facts-about-ibs/.

Definition & Facts for Irritable Bowel Syndrome. National Institute of Diabetes and Digestive and Kidney Diseases. https://www.niddk.nih.gov/health-information/digestive-diseases/irritable-bowel-syndrome/definition-facts. Updated November 2017.

Lacy BE, Pimentel M, Brenner DM, et al. ACG Clinical Guideline: Management of Irritable Bowel Syndrome. Am J Gastroenterol. Jan 01 2021; 116(1): 17-44. PMID 33315591

Specialty Matched Consultant Advisory Panel – 4/2026

Medical Director Review – 4/2026

Policy Implementation/Update Information

3/80 Original Policy: Generally accepted medical practice for chronic intractable pain.

6/83 Reaffirmed

Percutaneous Electrical Nerve Stimulation

8/88 Reviewed: Eligible for coverage for patients in whom failure of TENS is thought to be due to physical barrier to electrical stimulation.

2/97 Reaffirmed. National Association reviewed 11/30/96.

3/99 Reviewed by MPAG. Reaffirmed.

7/99 Reformatted, Medical Term Definitions added.

12/99 Reaffirmed, Medical Policy Advisory Group.

4/01 System changes.

7/1/01 Policy archived.

Percutaneous Electrical Nerve Stimulation (PENS) or Neuromodulation Therapy

4/13/09 Policy from archive. Original name of policy, "Percutaneous Electrical Nerve Stimulation" has been changed to "Percutaneous Electrical Nerve Stimulation (PENS) or Neuromodulation Therapy". Senior Medical Director Review 3/16/09. "Description" section updated. "Policy" statement indicates; "BCBSNC will not provide coverage for Percutaneous Electrical Nerve Stimulation (PENS) or Percutaneous Neuromodulation Therapy (PNT) because they are considered investigational." References added. Notification date 4/13/09. Effective date of policy 7/20/09.

6/22/10 Policy Number(s) removed (amw)

12/21/10 Specialty Matched Consultant Advisory Panel review 11/29/10. “Description” section revised. Reworded “Policy” statement, no change to intent. Added comment to “Billing/Coding” section to indicate; “Providers should not be using 64553-64565, or 64590 to bill this service as these codes are not appropriate.” References added. (btw)

10/11/11 Reference added. (btw)

1/10/12 Specialty Matched Consultant Advisory Panel review 11/30/11. No change to policy intent. (btw)

10/30/12 Description section revised. Medical Director review 10/14/2012. Specialty Matched Consultant Advisory Panel review 10/17/12. Reference added. (btw)

9/10/13 Description and Policy Guidelines sections updated. Senior Medical Director review 8/29/2013. Reference added. (btw)

11/12/13 Specialty Matched Consultant Advisory Panel review 10/16/2013. No change to policy. (btw)

9/30/14 Reference added. (sk)

11/25/14 Specialty Matched Consultant Advisory Panel review 10/28/2014. No change to policy. (sk)

9/1/15 Reference added. (sk)

11/24/15 Specialty Matched Consultant Advisory Panel review 10/29/2015. (sk)

11/22/16 Specialty Matched Consultant Advisory Panel review 10/26/2016. (sk)

5/26/17 Reference added. Description updated. Policy Guidelines updated. (sk)

11/10/17 Specialty Matched Consultant Advisory Panel review 10/25/2017. (sk)

11/9/18 Reference added. Specialty Matched Consultant Advisory Panel review 10/24/2018. (sk)

8/27/19 Reference added. (sk)

11/26/19 Specialty Matched Consultant Advisory Panel review 10/16/2019. (sk)

11/10/20 Reference added. Specialty Matched Consultant Advisory Panel review 10/21/2020. (sk)

Percutaneous Electrical Nerve Stimulation (PENS) or Neuromodulation Therapy and Percutaneous Electrical Nerve Field Stimulation (PENFS)

6/15/21 Policy statement added that PENFS, including IB-stim, is considered investigational. Policy Guidelines updated. References added. Medical Director review. Title changed from Percutaneous Electrical Nerve Stimulation (PENS) or Neuromodulation Therapy to Percutaneous Electrical Nerve Stimulation (PENS) or Neuromodulation Therapy and Percutaneous Electrical Nerve Field Stimulation (PENFS). Notification given 6/15/2021 for policy effective date 8/24/2021. (sk)

3/31/22 Reference added. Policy Guidelines updated. Specialty Matched Consultant Advisory Panel review 10/20/2021. (sk)

5/3/22 References updated. Specialty Matched Consultant Advisory Panel review 4/2022. Medical Director review 4/2022. No change to policy statement. (tt)

6/14/22 Added CPT code 0720T to Billing/Coding section. Effective 7/1/2022. (tt)

6/13/23 Related policies updated. References updated. Specialty Matched Consultant Advisory Panel review 4/2023. Medical Director review 4/2023. No change to policy statement. (tt)

4/1/24 Added HCPCS code A4438 to Billing/Coding section, effective 4/1/24. (tt)

5/1/24 Policy Guidelines updated for clarity. References updated. Specialty Matched Consultant Advisory Panel review 4/2024. Medical Director review 4/2024. No change to policy statement. (tt)

5/14/25 References updated. Specialty Matched Consultant Advisory Panel review 4/2025. Medical Director review 4/2025. No change to policy statement. (tt)

12/31/25 Updated Billing/Coding section to remove 0720T and add 64567, effective 1/1/2026. (tt)

5/6/26 Description, regulatory status, related policies, and policy guidelines updated. References added. Specialty Matched Consultant Advisory Panel review 4/2026. Medical Director review 4/206. No change to policy statement. (tt)