Peripherally Implanted Nerve Stimulation (PNS), Peripheral Subcutaneous Field Stimulation (PSFS) Form

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Peripherally Implanted Nerve Stimulation (PNS),
Peripheral Subcutaneous Field Stimulation (PSFS) - Medical Policy
Updated Revision Effective: January 1, 2026 Policy Number:

UM570POL

Approval Date: 5/13/2025

Line(s) of Business:

Commercial
Medicare Advantage
Medicaid (BeHealthy)

Description

Implantable peripheral nerve stimulation (PNS) is a type of neuromodulation therapy in which electrodes are surgically placed next to a selected peripheral nerve considered the source of chronic pain. These electrode(s) deliver electrical impulses to the affected nerve, which is thought to disrupt the normal transmission of pain signals leading to reduced levels of pain. During the trial period, the electrode is connected to an external device, and if the trial is successful, a small generator is implanted into the patient’s body. PNS has been proposed for the treatment of chronic, refractory pain that is nonresponsive to conservative treatments (e.g., neuropathic shoulder pain, back pain, carpal tunnel syndrome, causalgia, complex regional pain syndrome, failed back syndrome, fibromyalgia, hemiplegic shoulder pain, brachial plexus injuries, post-trauma pain, subacromial impingement syndrome, post-amputation pain, post-herpetic neuralgia, stroke, testicular pain, and trigeminal neuropathy).

Peripheral nerve field stimulation (PNFS), also known as peripheral subcutaneous field stimulation, is a recent technology proposed for the treatment of chronic cervical, thoracic, or lumbar pain. Electrode leads are placed in subcutaneous tissue around the painful area, and electrical current is applied to create stimulation in the area, or "field," of pain. This technique is different from peripheral nerve stimulation (PNS), in which specific peripheral nerves are targeted. In peripheral nerve field stimulation, a field of pain is targeted rather than specific nerves.

In both PNS and PNFS, electrode leads are connected to an external pulse generator if temporary or implanted when permanent.

Percutaneous electrical nerve field stimulator (PENFS) system (IB-STIM) 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).

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 Line of Business

Commercial:

• Refer to criteria under the Policy section in this medical policy.

Medicaid – BeHealthy:

• Refer to criteria under the Policy section in this medical policy.

• There are no MassHealth guidelines for non-diagnostic Peripheral nerve stimulation (PNS) or Peripheral Nerve Field Stimulation (PNFS) or Percutaneous electrical nerve field stimulator (PENFS) system.

Medicare:

• Refer to criteria under the Policy section in this medical policy.

• For Implanted Peripheral Nerve Stimulators Health New England follows National Coverage Determination (NCD) Electrical Nerve Stimulators (160.7) for Medicare line of business. https://www.cms.gov/medicare-coverage-database/search.aspx

Policy

I. Criteria for approval of Peripheral nerve stimulation (PNS) or Peripheral Nerve Field Stimulation (PNFS):

A. Peripheral nerve stimulation (PNS) or Peripheral Nerve Field Stimulation (PNFS) with a FDA approved peripheral nerve stimulator may be considered MEDICALLY NECESSARY when ALL of the following criteria are met:

1. Members have chronic intractable pain for minimum of 3 months that is refractory to at least two less invasive treatment modalities as appropriate to alleviate or cure the underlying condition causing the pain; examples include but are not limited to PT, braces, local injections, analgesics such as gabapentin, pregabalin, acupuncture, OR postsurgical and posttraumatic acute pain (FDA approved). AND
2. Appropriate documented patient education, discussion and disclosure of risks and benefits;
3. No active substance abuse issues; AND
4. Formal psychological screening by a mental health professional with documentation of no psychological contraindications to using this treatment; AND
5. Objective evidence of pathology (e.g. on nerve conductions study/electromyogram); AND

6. Lack of surgical contraindications including infections and/or medical risks.

   B. Permanent implantable stimulator is considered MEDICALLY NECESSARY after a successful stimulation trial with greater than or equal to 50% reduction in pain intensity before (e.g. Stimwave/StimQ and Nalu); (trial not required for a temporary stimulator (e.g. Sprint), AND above criteria from (A) 2-6 are being met.

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C. What is Not Covered:

1. PNS or PNFS for treatment of post-herpetic neuralgia, fibromyalgia, phantom limb pain, diffuse polyneuropathy or angina pectoris, or non-FDA approved indications is considered INVESTIGATIONAL.

2. PNS or PNFS when above criteria is not met are considered NOT MEDICALLY NECESSARY.

3. Percutaneous electrical stimulation of a peripheral nerve using needle[s] or needle electrode[s].

4. Additional (second or more) lead of a peripheral nerve stimulator is considered EXPERIMENTAL and INVESTIGATIONAL.

   D. Contraindications:

5. Body mass index (BMI) > 40

6. Prior Lumbar surgery

7. Implanted electronic device

8. Pregnancy

   II. Criteria for approval of Percutaneous electrical nerve field stimulator (PENFS) system:

   A. PENFS system (IB-STIM®) may be considered MEDICALLY NECESSARY in children and adolescents when ALL of the following criteria is met:

9. 11-21 years of age; AND
10. Patients 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); AND
11. Organic GI disease must have been ruled out (These include IBD, GERD, Peptic Ulcer Disease, Celiac disease, Gallstones, Gastrointestinal Cancers etc.); AND
12. The problem has been present for at least 9 months AND

13. 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.

    B. PENFS system for all other indications other than criteria above are considered EXPERIMENTAL and IVESTIGATIONAL.

    III. Medicare does not have a National Coverage Determination (NCD) or a Local Coverage Determination (LCD) for Percutaneous electrical nerve field stimulator (PENFS) system. The above criteria apply.

    IV. There are no MassHealth guidelines for Peripheral nerve stimulation (PNS) or Peripheral Nerve Field Stimulation (PNFS) or Percutaneous electrical nerve field stimulator (PENFS) system. The above criteria apply.

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Policy Guidelines and Definitions

Policy Guidelines:

I) Required Documentation:

A. Clinical notes from treating providers that reference the above criteria. B. Pertinent CPT codes. C. If pain is effectively controlled by percutaneous stimulation and implantation of electrodes is warranted. The physician should be able to determine and document whether the member is likely to derive a significant therapeutic benefit from continuing use of an implanted nerve stimulator within a trial period of minimum 1 month.

II) Examples of indications that may be covered are:

A. PNS for occipital nerve for occipital neuralgia, post-surgical neuropathic pain, cervicogenic headaches and treatment of resistant migraine.
B. PNS/PNFS of nerves in the upper and lower extremities of complex regional pain syndromes (type 1 and 2), pain due to peripheral nerve injury, post-surgical scar formation, nerve entrapment, painful mononeuropathy and painful amputation neuromas. C. PNS/PNFS of intercostal and ilio-inguinal nerves for post-surgical and posttraumatic neuropathic pain involving these nerve distributions; D. PNFS of the trunk/ lower back for cases of severe post-surgical neuropathic pain (continuous, burning, and unresponsive to less invasive procedures)

III) Type of Peripheral nerve stimulators:

There are four different types of peripheral nerve stimulators with external pulse generators currently available: Sprint® (SPR Therapeutics), Stimrouter® (Bioventus), StimQ (Stimwave), and NaluTM. These are all approved by Food and Drug Administration (FDA) for chronic intractable pain of peripheral nerve origin. In addition, Sprint is approved for postsurgical and posttraumatic acute pain. It should be noted that the use of these peripheral nerve stimulators for the pain of cranial or facial nerve origin is not yet approved by the FDA.

IV) Unique characteristics of Peripheral nerve stimulators:

A. Sprint (SPR): Temporary for 60 days; external pulse generator and battery. B. Stimrouter: Permanent; external pulse generator and battery. C. Stimwave/StimQ: Permanent; up to 14 days of trial; internal pulse generator and external battery. D. Nalu: Permanent; up to 14 days for trial; internal pulse generator and external battery.

Coding Guidance

Code
Description
PA Required 64555 Percutaneous implantation of neurostimulator electrode array; peripheral nerve (excludes sacral nerve) PA Required 64567 Percutaneous electrical nerve field stimulation, cranial nerves, without implantation PA Required

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Code
Description
PA Required 64590 Insertion or replacement of peripheral, sacral, or gastric neurostimulator pulse generator or receiver, requiring pocket creation and connection between electrode array and pulse generator or receiver PA Required 64596 Insertion or replacement of percutaneous electrode array, peripheral nerve, with integrated neurostimulator, including imaging guidance, when performed; initial electrode array PA Required 64598 Revision or removal of neurostimulator electrode array, peripheral nerve, with integrated neurostimulator PA Required 64999 Unlisted procedure, nervous system
Experimental/Investigational when used to describe percutaneous electrical stimulation of a peripheral nerve using needles[s] or needle electrode[s] [eg, PENS, PNT]

CPT® Copyright 2026 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Note: CPT/HCPCS codes are included for informational purposes and may not be all-inclusive. Inclusion or exclusion of a CPT/HCPCS code(s) does not signify or imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member’s specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee of payment. Other policies and coverage determination guidelines may apply.

References

Peripheral nerve stimulation (PNS) or Peripheral Nerve Field Stimulation (PNFS) 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) Manchikanti et al. Pain Physician, 2024 Nov;27(S9):S115-S191. PMID: 39565237. https://pubmed.ncbi.nlm.nih.gov/39565237/

The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interventional Treatments for Low Back Pain. Sayed et al.
J Pain Res. 2022 Dec 6;15:3729–3832. doi: 10.2147/JPR.S386879. PMCID: PMC9739111, PMID: 36510616. https://pmc.ncbi.nlm.nih.gov/articles/PMC9739111/

Percutaneous 60-day peripheral nerve stimulation implant provides sustained relief of chronic pain following amputation: 12-month follow-up of a randomized, double-blind, placebo-controlled trial. Gilmore et al. Reg Anesth Pain Med. 2019 Nov 17:rapm-2019-100937. doi: 10.1136/rapm-2019-100937. PMID: 31740443.

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Percutaneous 60-day peripheral nerve stimulation implant provides sustained relief of chronic pain following amputation: 12-month follow-up of a randomized, double-blind, placebo-controlled trial - PubMed

A review of prospective studies regarding percutaneous peripheral nerve stimulation treatment in the management of chronic pain. Pritzlaff et al. Pain Manag. 2024;14(4):209-222. doi: 10.1080/17581869.2024.2352398. PMID: 38939963, PMCID: PMC11234914 https://pubmed.ncbi.nlm.nih.gov/38939963/

Pain intensity and opioid consumption after temporary and permanent peripheral nerve stimulation: a 2-year multicenter analysis. West et al. Reg Anesth Pain Med. 2024 Jul 26:rapm-2024-105704. doi: 10.1136/rapm-2024-105704. PMID: 39060006. Pain intensity and opioid consumption after temporary and permanent peripheral nerve stimulation: a 2-year multicenter analysis - PubMed

Peripheral Nerve Stimulation, LCD L37360.

https://www.cms.gov/medicare-coverage- database/view/lcd.aspx?lcdid=37360&ver=17&keyword=&keywordType=starts&areaId=all&docType=6,3,5, 1,F,P&contractOption=all&hcpcsOption=code&hcpcsStartCode=64555&hcpcsEndCode=64555&sortBy=title &bc=1

Electrical Nerve Stimulators, NCD 160.7.

NCD - Electrical Nerve Stimulators (160.7) (cms.gov)

Deer T et al 2020, A Systematic Literature Review of Peripheral Nerve Stimulation Therapies for the Treatment of Pain, Journal of Pain Medicine 2020; 21(8):1590-1603.

A Systematic Literature Review of Peripheral Nerve Stimulation Therapies for the Treatment of Pain - PubMed (nih.gov)

Wilson RD et al (2017), The Effect of Peripheral Nerve Stimulation on Shoulder Biomechanics: A Randomized Controlled Trial in Comparison to Physical Therapy, American Journal Phys Med Rehab. 2017 Mar; 96(3): 191–198, PMID 28099193.

The Effect of Peripheral Nerve Stimulation on Shoulder Biomechanics: A Randomized Controlled Trial in Comparison to Physical Therapy - PubMed (nih.gov)

Percutaneous peripheral nerve stimulation for the treatment of chronic neuropathic post amputation pain: a multicenter, randomized, placebo-controlled trial, Reg Anesth Pain Med. 2019 Jun; 44(6):637-645. doi: 10.1136/rapm-2018-100109., PMID 30954936.

Percutaneous peripheral nerve stimulation for the treatment of chronic neuropathic postamputation pain: a multicenter, randomized, placebo-controlled trial - PubMed (nih.gov)

Van Gorp, E-J, Teernstra, O, et al Long-Term Effect of Peripheral Nerve Field Stimulation as Add-On Therapy to Spinal Cord Stimulation to Treat Low Back Pain in Failed Back Surgery Syndrome Patients: A 12-Month Follow-Up of a Randomized Controlled Study, Neuromodulation. 2019 Dec;22(8):970-977, PMID: 29608807.
Long-Term Effect of Peripheral Nerve Field Stimulation as Add-On Therapy to Spinal Cord Stimulation to Treat Low Back Pain in Failed Back Surgery Syndrome Patients: A 12-Month Follow-Up of a Randomized Controlled Study - PubMed (nih.gov)

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Eldabe, S, Taylor, R, A Randomized Controlled Trial of Subcutaneous Nerve Stimulation for Back Pain Due to Failed Back Surgery Syndrome: The SubQStim Study, Neuromodulation. 2019 Jul;22(5):519-528. doi: 10.1111/ner.12784. Epub 2018 Apr 28, PMID  29704437.

A Randomized Controlled Trial of Subcutaneous Nerve Stimulation for Back Pain Due to Failed Back Surgery Syndrome: The SubQStim Study - PubMed (nih.gov)

A Comparison of Various Peripheral Nerve Stimulators Available Currently on the Market. https://www.asra.com/news-publications/asra-newsletter/newsletter-item/asra-news/2022/11/01/a- comparison-of-various-peripheral-nerve-stimulators-available-currently-on-the- market#:~:text=There%20are%20four%20different%20types,pain%20of%20peripheral%20nerve%20or igin.

Percutaneous electrical nerve field stimulator (PENFS) system

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.

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.

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.

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.

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.

Non-implanted nerve stimulator for functional abdominal pain relief. Regulatory Class: Class II Device. https://www.accessdata.fda.gov/cdrh_docs/pdf18/DEN180057.pdf.

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.

de Bruijn CMA, et al. Antidepressants for functional abdominal pain disorders in children and adolescents. Cochrane Database Syst Rev. 2021.

Gottfried-Blackmore A et al. Noninvasive vagal nerve stimulation for gastroenterology pain disorders. Pain Manag. 2021 Jan;11(1):89-96.

Policy Implementation

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Approved by the Medical and Pharmacy Policy Committee

Kate McIntosh MD MBA

Chief Medical Officer

Saad Usmani MD MBA

Medical Director

Date Update 6/2022 Initial policy effective date 12/2023 Moved to new template. Coding updated, no significant changes to criteria.
1/2024 Line of Business section added. 2/2025 References updated. Minor formatting changes.

04/2025 Percutaneous electrical nerve field stimulator (PENFS) system criteria added. No significant criteria changes to Peripheral nerve stimulation (PNS) or Peripheral Nerve Field Stimulation (PNFS). Coding table updated added 0702T and updated 64999 to include PENFS for MassHealth. References updated.

11/2025 Effective 1/1/2026 removed CPT 0702T, updated CPT 64999 and added CPT 64567

Medical Criteria Disclaimer

Property of Health New England. All rights reserved. The treating physician or primary care provider must submit to Health New England the clinical evidence that the patient meets the criteria for the treatment, testing or surgical procedure. Without this documentation and information, Health New England will not be able to properly review the request for prior authorization. The clinical review criteria reflect how Health New England determines whether certain services or supplies are medically necessary. Health New England established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors).
Health New England expressly reserves the right to revise these conclusions as clinical information changes and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by Health New England, as some programs exclude coverage for services or supplies that Health New England considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication. Health New England has adopted the herein policy in providing management, administrative and other services to its Health Plan.