Printer Friendly Version
Printer Friendly Version
Printer Friendly Version
A.1.01.31
Peripheral nerve stimulation (PNS) is a percutaneous system consisting of leads, electrodes, and a pulse transmitter that delivers electrical impulses to peripheral nerves. Leads are placed using ultrasound guidance and can be placed for temporary or permanent use in an outpatient procedure.
Peripheral Neuropathic Chronic Pain
Chronic, noncancer pain is responsible for a high burden of illness and can be defined as persistent pain that lasts for more than 3 months. Chronic pain of peripheral origin may be caused by damage to peripheral nerves impacting the upper and lower extremities.
Peripheral Nerve Stimulation
Peripheral nerve stimulation (PNS) has been used to treat chronic pain. It is a percutaneous system consisting of leads, electrodes, and a pulse transmitter that delivers electrical impulses to peripheral nerves. Leads are placed using ultrasound guidance and can be placed for temporary or permanent use in an outpatient procedure.
A number of PNS devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. These are listed in the table below.
Two PNS devices by Stimwave Technologies Inc., the StimQ Peripheral Nerve Stimulator (PNS) System and the Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit, were recalled in Sept 2020 for the product containing a non-functional component not referenced in product labeling.
FDA-Cleared Peripheral Nerve Stimulation Devices (FDA Product Codes: GZF, NHI)
Device Name | Manufacturer | Cleared | 510(k) | Indications |
SPRINT Peripheral Nerve Stimulation System | SPR Therapeutics, Inc. | July 2018 | K181422 | The SPRINT Peripheral Nerve Stimulation (PNS) System is indicated for up to 60 days in the back and/or extremities for: Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain; Symptomatic relief of post-traumatic pain; Symptomatic relief of post-operative pain. The SPRINT PNS System is not intended to treat pain in the craniofacial region. |
Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits | Nalu Medical, Inc. | March 2019 | K183579 | This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region. |
IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 | Nalu Medical, Inc. | Sept 2019 | K191435 | This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region. |
StimRouter Neuromodulation System | Bioness, Inc. | Oct 2019, March 2020, Feb 2022 | K190047, K200482, K211965 | The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (eg, medications). The StimRouter is not intended to treat pain in the craniofacial region. |
Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit | Micron Medical Corporation | Aug 2020 | K200848 | Moventis PNS is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Moventis PNS is not intended to treat pain in the craniofacial region. |
Neuspera Neurostimulation System (NNS) | Neuspera Medical, Inc. | Aug 2021 | K202781 | The Neuspera Neurostimulation System (NNS) is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region. |
Neuspera Nuity System | Neuspera Medical, Inc. | April 2023 | K221303 | The Neuspera Nuity™ System (NNS) is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region. |
Related medical policies -
Peripheral nerve stimulation as a treatment for chronic pain is considered investigational.
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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Spinal cord and dorsal root ganglion stimulation are covered in the Spinal Cord and Dorsal Root Ganglion Stimulation medical policy and are not reviewed in this policy.
The Nalu Medical, Inc. and Neuspera Medical Inc. device indications state "trial devices are solely for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device."
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.
07/18/2024: New policy added.
12/19/2024: Code Reference section updated to add new HCPCS code C9807 effective 01/01/2025.
08/27/2025: Policy description updated regarding devices. Policy statement unchanged.
Blue Cross Blue Shield Association policy # 1.01.31
This may not be a comprehensive list of procedure codes applicable to this policy.
Investigational Codes
Code Number | Description |
CPT-4 | |
64555 | Percutaneous implantation of neurostimulator electrode array; peripheral nerve (excludes sacral nerve) |
64585 | Revision or removal of peripheral neurostimulator electrode array |
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 |
64595 | Revision or removal of peripheral, sacral, or gastric neurostimulator pulse generator or receiver, with detachable connection to electrode array |
64596 | Insertion or replacement of percutaneous electrode array, peripheral nerve, with integrated neurostimulator, including imaging guidance, when performed; initial electrode array |
64597 | Insertion or replacement of percutaneous electrode array, peripheral nerve, with integrated neurostimulator, including imaging guidance, when performed; each additional electrode array (List separately in addition to code for primary procedure) |
64598 | Revision or removal of neurostimulator electrode array, peripheral nerve, with integrated neurostimulator |
64999 | Unlisted procedure, nervous system |
HCPCS | |
A4438 | Adhesive clip applied to the skin to secure external electrical nerve stimulator controller, each |
C1767 | Generator, neurostimulator (implantable), non-rechargeable |
C1778 | Lead, neurostimulator (implantable) |
C1816 | Receiver and/or transmitter, neurostimulator (implantable) |
C1883 | Adaptor/extension, pacing lead or neurostimulator lead (implantable) |
C1897 | Lead, neurostimulator test kit (implantable) |
C9807 | Nerve stimulator, percutaneous, peripheral (e.g., sprint peripheral nerve stimulation system), including electrode and all disposable system components, non-opioid medical device (must be a qualifying medicare non-opioid medical device for post-surgical pain relief in accordance with section 4135 of the caa, 2023) (New 01/01/2025) |
L8679 | Implantable neurostimulator, pulse generator, any type |
L8681 | Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only |
ICD-10 Procedure | |
ICD-10 Diagnosis |
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.