Medical policy: Percutaneous Electrical Nerve Stimulation (PENS) and Percutaneous Neuromodulation Therapy (PNT)
Policy number: MP 6.050
Clinical benefit
- Minimize safety risk or concern.
- Minimize harmful or ineffective interventions.
- Assure appropriate level of care.
- Assure appropriate duration of service for interventions.
- Assure that recommended medical prerequisites have been met.
- Assure appropriate site of treatment or service.
Effective date: 9/1/2026
Policy
Percutaneous electrical nerve stimulation (PENS) is considered investigational as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.
Percutaneous neuromodulation therapy (PNT) is considered investigational as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.
Policy Guidelines
The correct CPT code to use for percutaneous electrical nerve stimulation (PENS) and percutaneous neuromodulation therapy (PNT) is the unlisted CPT code 64999. CPT codes for percutaneous implantation of neurostimulator electrodes (i.e., 64553-64561) are not appropriate, because PENS and PNT use percutaneously inserted needles and wires rather than percutaneously implanted electrodes. The stimulation devices used in PENS and PNT are not implanted, so CPT code 64590 is also not appropriate.
Cross-References:
- MP 1.034 Vagus Nerve and Implantable Peripheral Nerve Stimulators
- MP 2.092 Cranial Electrotherapy Stimulation and Auricular Electrostimulation
- MP 6.020 Transcutaneous Electrical Nerve Stimulation and Transcutaneous Afferent Patterned Stimulation
- MP 6.046 Threshold Electrical Stimulation as a Treatment of Motor Disorders
- MP 6.047 Interferential Current Stimulation
- MP 6.049 H-Wave Electrical Stimulation
- MP 6.051 Functional Neuromuscular Electrical Stimulation
Product variations
This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Please see additional information below.
FEP PPO: Refer to FEP Medical Policy Manual. The FEP Medical Policy manual can be found at:
Description/Background
Percutaneous electrical nerve stimulation (PENS) and percutaneous neuromodulation therapy combine the features of electroacupuncture and transcutaneous electrical nerve stimulation. Percutaneous electrical nerve stimulation is performed with needle electrodes while PNT uses very fine needle-like electrode arrays placed near the painful area to stimulate peripheral sensory nerves in the soft tissue.
Chronic Pain
A variety of chronic musculoskeletal or neuropathic pain conditions, including low back pain, neck pain, diabetic neuropathy, chronic headache, and surface hyperalgesia, present a substantial burden to patients, adversely affecting function and quality of life.
Treatment
These chronic pain conditions have typically failed other treatments, and percutaneous electrical nerve stimulation (PENS) and percutaneous neuromodulation therapy (PNT) have been evaluated as treatments to relieve unremitting pain.
Percutaneous electrical nerve stimulation is similar in concept to transcutaneous electrical stimulation (TENS) (see MP 6.020) 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.
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.
FDA product code: NHI.
Rationale
Summary of evidence
For individuals who have chronic pain conditions (e.g., 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 (e.g., knee osteoarthritis) who receive PNT, the evidence consists of a randomized controlled trial (RCT). 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.
Definitions
N/A
Disclaimer
Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as permitted by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These policies are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the member’s benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.
Coding information
Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement.
Investigational for PENS and PNT; therefore, not covered:
Procedure Codes |
||||
|
64999 |
|
|
|
|
References
- Dworkin RH, Turk DC, Farrar JT, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. Jan 2005; 113(1-2): 9-19. PMID 15621359
- Dworkin RH, Turk DC, Wyrwich KW, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. Feb 2008; 9(2): 105-21. PMID 18055266
- Gewandter JS, Dworkin RH, Turk DC, et al. Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations. Pain. Jul 2015; 156(7): 1184-1197. PMID 25887465
- Plaza-Manzano G, Gómez-Chiguano GF, Cleland JA, et al. Effectiveness of percutaneous electrical nerve stimulation for musculoskeletal pain: A systematic review and meta-analysis. Eur J Pain. Jul 2020; 24(6): 1023-1044. PMID 32171035
- Beltran-Alacreu H, Serrano-Muñoz D, Martín-Caro Álvarez D, et al. Percutaneous Versus Transcutaneous Electrical Nerve Stimulation for the Treatment of Musculoskeletal Pain. A Systematic Review and Meta-Analysis. Pain Med. Aug 01 2022; 23(8): 1387-1400. PMID 35167691
- Ghoname EA, Craig WF, White PF, et al. Percutaneous electrical nerve stimulation for low back pain: a randomized crossover study. JAMA. Mar 03 1999; 281(9): 818-23. PMID 10071003
- Ghoname ES, Craig WF, White PF, et al. The effect of stimulus frequency on the analgesic response to percutaneous electrical nerve stimulation in patients with chronic low back pain. Anesth Analg. Apr 1999; 88(4): 841-6. PMID 10195535
- Hamza MA, Ghoname EA, White PF, et al. Effect of the duration of electrical stimulation on the analgesic response in patients with low back pain. Anesthesiology. Dec 1999; 91(6): 1622-7. PMID 10598602
- Weiner DK, Rudy TE, Glick RM, et al. Efficacy of percutaneous electrical nerve stimulation for the treatment of chronic low back pain in older adults. J Am Geriatr Soc. May 2003; 51(5): 599-608. PMID 12752833
- Topuz O, Ozfidan E, Ozgen M, Ardic F. Efficacy of transcutaneous electrical nerve stimulation and percutaneous neuromodulation therapy in chronic low back pain. J Back Musculoskelet Rehabil. 2004;17:127-133.
- Yokoyama M, Sun X, Oku S, et al. Comparison of percutaneous electrical nerve stimulation with transcutaneous electrical nerve stimulation for long-term pain relief in patients with chronic low back pain. Anesth Analg. Jun 2004; 98(6): 1552-1556. PMID 15155304
- Weiner DK, Perera S, Rudy TE, et al. Efficacy of percutaneous electrical nerve stimulation and therapeutic exercise for older adults with chronic low back pain: a randomized controlled trial. Pain. Nov 30 2008; 140(2): 344-357. PMID 18930352
- Perez-Palomares S, Olivan-Blazquez B, Magallon-Botaya R, et al. Percutaneous electrical nerve stimulation versus dry needling: effectiveness in the treatment of chronic low back pain. J Musculoskelet Pain. 2010;18:23-30.
- Weiner DK, Rudy TE, Morone N, et al. Efficacy of periosteal stimulation therapy for the treatment of osteoarthritis-associated chronic knee pain: an initial controlled clinical trial. J Am Geriatr Soc. Oct 2007; 55(10): 1541-7. PMID 17908057
- Weiner DK, Morone CG, Morone NE, et al. Efficacy of periosteal stimulation for chronic pain associated with advanced knee osteoarthritis: a randomized, controlled clinical trial. Clin Ther. Nov 2013; 35(11): 1703-20.e5. PMID 24184053
- da Graca-Tarragó M, Deitos A, Patrícia Brietzke A, et al. Electrical Intramuscular Stimulation in Osteoarthritis Enhances the Inhibitory Systems in Pain Processing at Cortical and Cortical Spinal System. Pain Med. May 01 2016; 17(5): 877-891. PMID 26398594
- Elbadawy MA. Effectiveness of Periosteal Stimulation Therapy and Home Exercise Program in the Rehabilitation of Patients With Advanced Knee Osteoarthritis. Clin J Pain. Mar 2017; 33(3): 254-263. PMID 27513639
- Dunning J, Butts R, Henry N, et al. Electrical dry needling as an adjunct to exercise, manual therapy and ultrasound for plantar fasciitis: A multi-center randomized clinical trial. PLoS One. 2018; 13(10): e0205405. PMID 30379937
- da Graca-Tarragó M, Lech M, Angoleri LDM, et al. Intramuscular electrical stimulus potentiates motor cortex reorganization effects on pain and descending inhibitory systems in knee osteoarthritis: a randomized, factorial, sham-controlled study. J Pain Res. 2019; 12: 209-221. PMID 30655690
- León-Hernández JV, Martín-Pintado-Zugasti A, Frutos LG, et al. Immediate and short-term effects of the combination of dry needling and percutaneous TENS on post-needling soreness in patients with chronic myofascial neck pain. Braz J Phys Ther. Jul 11 2016; 20(5): 422-431. PMID 27410163
- Sumen A, Sarsan A, Alkan H, et al. Efficacy of low level laser therapy and intramuscular electrical stimulation on myofascial pain syndrome. J Back Musculoskelet Rehabil. 2015; 28(1): 153-8. PMID 25061034
- Medeiros LF, Caumo W, Dussán-Sarria JA, et al. Effect of Deep Intramuscular Stimulation and Transcranial Magnetic Stimulation on Neurophysiological Biomarkers in Chronic Myofascial Pain Syndrome. Pain Med. Jan 2016; 17(1): 122-35. PMID 26408420
- Botelho L, Angoleri L, Cortea M, et al. Insights About the Neuroplasticity State on the Effect of Intramuscular Electrical Stimulation in Pain and Disability Associated With Chronic Myofascial Pain Syndrome (MPS): A Double-Blind, Randomized, Sham-Controlled Trial. Front Hum Neurosci. 2018; 12: 388. PMID 30459575
- Dunning J, Butts R, Young J, et al. Periosteal Electrical Dry Needling as an Adjunct to Exercise and Manual Therapy for Knee Osteoarthritis: A Multicenter Randomized Clinical Trial. Clin J Pain. Dec 2018; 34(12): 1149-1158. PMID 29864043
- Yoshimizu M, Teo AR, Ando M, Kiyonara K, Kawamura T. Relief of chronic shoulder and neck pain by electro-acupuncture and transcutaneous electrical nerve stimulation: A randomized crossover trial. Med Acupunct. 2012;24(2):97-103.
- Ng MM, Leung MC, Poon DM. The effects of electro-acupuncture and transcutaneous electrical nerve stimulation on patients with painful osteoarthritic knees: a randomized controlled trial with follow-up evaluation. J Altern Complement Med. Oct 2003; 9(5): 641-9. PMID 14629842
- Tsukayama H, Yamashita H, Amagai H, et al. Randomised controlled trial comparing the effectiveness of electroacupuncture and TENS for low back pain: a preliminary study for a pragmatic trial. Acupunct Med. Dec 2002; 20(4): 175-80. PMID 12512791
- Cheng RSS, Pomeranz B. Electrotherapy of chronic musculoskeletal pain: Comparison of electroacupuncture and acupuncture-like transcutaneous electrical nerve stimulation. Cochrane Library. Clin J Pain 1986;2(3):1439.
- Lehmann TR, Russell DW, Spratt KF, et al. Efficacy of electroacupuncture and TENS in the rehabilitation of chronic low back pain patients. Pain. Sep 1986; 26(3): 277-290. PMID 2946016
- Ghoname EA, White PF, Ahmed HE, et al. Percutaneous electrical nerve stimulation: an alternative to TENS in the management of sciatica. Pain. Nov 1999; 83(2): 193-9. PMID 10534590
- White PF, Craig WF, Vakharia AS, et al. Percutaneous neuromodulation therapy: does the location of electrical stimulation affect the acute analgesic response?. Anesth Analg. Oct 2000; 91(4): 949-54. PMID 11004055
- Hamza MA, White PF, Craig WF, et al. Percutaneous electrical nerve stimulation: a novel analgesic therapy for diabetic neuropathic pain. Diabetes Care. Mar 2000; 23(3): 365-70. PMID 10688687
- Ahmed HE, White PF, Craig WF, et al. Use of percutaneous electrical nerve stimulation (PENS) in the short-term management of headache. Headache. Apr 2000; 40(4): 311-5. PMID 10759936
- Raphael JH, Raheem TA, Southall JL, et al. Randomized double-blind sham-controlled crossover study of short-term effect of percutaneous electrical nerve stimulation in neuropathic pain. Pain Med. Oct 2011; 12(10): 1515-22. PMID 21883874
- Kang RW, Lewis PB, Kramer A, et al. Prospective randomized single-blinded controlled clinical trial of percutaneous neuromodulation pain therapy device versus sham for the osteoarthritic knee: a pilot study. Orthopedics. Jun 2007; 30(6): 439-45. PMID 17598487
- Bril V, England J, Franklin GM, et al. Evidence-based guideline: Treatment of painful diabetic neuropathy [RETIRED]: report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. Neurology. May 17 2011; 76(20): 17521482920
- Price R, Smith D, Franklin G, et al. Oral and Topical Treatment of Painful Diabetic Polyneuropathy: Practice Guideline Update Summary. Report of the AAN Guideline Subcommittee. Neurology. Jan 04 2022; 98(1): 31-43. PMID 34965987
- 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. Oct 02 2007; 147(7): 478-91. PMID 17909209
- Qaseem A, Wilt TJ, McLean RM, et al. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. Apr 04 2017; 166(7): 514-530. PMID 28192789
- Benzon HT, Connis RT, De Leon-Casasola OA, et al. Practice guidelines for chronic pain management: an updated report by the American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology. Apr 2010; 112(4): 810-33. PMID 20124882
- Manchikanti L, Sanapati MR, Soin A, et al. Comprehensive Evidence-Based Guidelines for Implantable Peripheral Nerve Stimulation (PNS) in the Management of Chronic Pain: From the American Society Of Interventional Pain Physicians (ASIPP). Pain Physician. Nov 2024; 27(S9): S115-S191. PMID 39565237
- Strand N, D'Souza RS, Hagedorn JM, et al. Evidence-Based Clinical Guidelines from the American Society of Pain and Neuroscience for the Use of Implantable Peripheral Nerve Stimulation in the Treatment of Chronic Pain. J Pain Res. 2022; 15: 2483-2504. PMID 36039168
- National Institute for Health and Care Excellence (NICE). Percutaneous electrical nerve stimulation for refractory neuropathic pain [IPG450]. 2013; https://www.nice.org.uk/guidance/ipg450.
- National Institute for Health and Care Excellence. 2022 Neurostimulation of lumbar muscles for refractory nonspecific chronic low back pain: Interventional Procedures Guidance. https://www.nice.org.uk/guidance/ipg739.
- Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Assessing Patient's Suitability for ELECTRICAL NERVE STIMULATION Therapy (160.7.1). 2006; https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=63&ncdver=2&CoverageSelection=National&KeyWord=Electrical+Nerve+Stimulation&Key.
Policy history |
|
|
MP 6.050 |
09/08/2020 Consensus Review. No changes to policy statements. References updated. |
|
12/03/2021 Minor Review. PENS now MN with criteria. Updated FEP, background, rationale, coding table, and references. |
|
|
06/10/2022 Administrative Update. New code 0720T added effective 07/01/22. |
|
|
12/30/2022 Consensus Review. Updated references. 0720T removed as it is housed in MP 2.092. |
|
|
10/04/2023 Consensus Review. Updated references. No changes to coding. |
|
|
11/04/2024 Minor Review. PENS is no longer MN. Updated clinical benefit, cross references, background, rationale and references. |
|
|
04/16/2025 Consensus Review. No changes to the policy statement. References reviewed. No coding changes. |
|
|
07/16/2025 Administrative Update. Removed Benefit Variations Section and updated Disclaimer. |
|
|
05/29/2026 Consensus Review. No changes to policy statement. Updated formatting, cross-references, product variations, background, rationale, definitions, disclaimer, and references. No coding changes. |
|