Latest Review Date:   December 2022

Category:  Surgery                                                                 

POLICY:

Peripheral nerve stimulation of the trunk or limbs may be considered medically necessary for the treatment of chronic intractable pain that is refractory to all other pain therapies, when all of the following criteria, clearly documented in the patient’s record, are met:

• The stimulator is utilized in accordance with FDA guidelines and indications; AND
• The implantation of the stimulator is used only as a late or last resort for patients with chronic pain (present for ≥ three months); and
• Other treatment modalities (pharmacological, surgical, physical or psychological therapies) have been tried and did not prove satisfactory or are judged unsuitable or contraindicated for the given patient; and
• There is objective evidence of pathology (e.g., electromyography), and
• All of the facilities, equipment, and professional and support personnel required for the proper diagnosis, treatment, training, and follow-up of the patient must be available; and
• Demonstration of pain relief with either a temporarily implanted electrode that precedes permanent implantation (revision or replacement of the pulse generator, electrodes or receiver does not require a trial) or for restorative neurostimulation, a palpable contraction of the multifidus muscle after electrode positioning is performed intraoperatively prior to permanent placement.

Peripheral nerve stimulation does not meet medical criteria for coverage and is considered investigational for post-herpetic neuralgia because its effectiveness for this indication has not been established.

Peripheral nerve stimulation of the trunk or limbs does not meet medical criteria for coverage for the treatment of pain that does not meet the previously listed criteria.

• Please refer to Policy #328 ‘Spinal Cord and Dorsal Root Ganglion Stimulation’ for coverage information on spinal cord stimulation.

• Please refer to Policy # 375 ‘Transcutaneous Electrical Nerve Stimulation (TENS)’ for coverage information on TENS.

• Please refer to Policy #406 ‘Percutaneous Electrical Nerve Stimulation Applications for coverage information on PENS, PNT, and PENFS.'

• Please refer to Policy # 411 ‘Peripheral Nerve Stimulation of the Head and Neck for Treatment of Pain’ for coverage information on the stimulation of occipital, infraorbital/supraorbital, and trigeminal nerves.

• Please refer to Policy #526 ‘Peripheral Subcutaneous Field Stimulation’ for coverage information on stimulation of peripheral field.

DESCRIPTION OF PROCEDURE OR SERVICE:

Peripheral nerve stimulation is the implantation of electrodes around a selected peripheral nerve. The stimulating electrode is connected by an insulated lead to a receiver unit that is inserted subcutaneously at a depth not greater than half an inch. Stimulation is elicited by a generator that is connected to an antenna that is attached to the skin surface over the receiver unit.

As with other types of implantable nerve stimulation, implantation of the peripheral nerve stimulator is typically done in a two-step process. Initially, the electrode is temporarily implanted, allowing a trial period of stimulation. Once treatment effectiveness is confirmed, the electrodes and radio receiver/transducer are permanently implanted.

Chronic, noncancer pain is responsible for a high burden of illness. Common types of chronic pain are lumbar and cervical back pain, chronic headaches, and abdominal pain. All of these conditions can be challenging to treat. Medications are typically the first-line treatment for chronic pain, and several classes of medications are available. These include analgesics (opioid and nonopioid), antidepressants, anticonvulsants, and muscle relaxants. There are also a variety of nonpharmacologic treatments, including physical therapy, exercise, cognitive-behavioral interventions, acupuncture, chiropractic, and massage.

Neuromodulation is another form of nonpharmacologic therapy that is usually targeted toward patients with chronic pain that is refractory to other modalities. Some forms of neuromodulation, such as spinal cord stimulation is an established method of chronic pain treatment. Peripheral nerve stimulation, which involves placement of an electrical stimulator on a peripheral nerve, has also been proposed as a non-destructive surgical option for patients with refractory neuropathic pain affecting the trunk or limbs.

KEY POINTS:

The most recent literature update was performed through October 17, 2022.

Summary of Evidence

Based on review of the peer reviewed medical literature the evidence is limited to a small number of randomized controlled trials and case series that suggests implantable peripheral nerve stimulation is safe and works as intended to treat chronic pain of peripheral nerve origin. However, results need confirmation in additional randomized controlled trials (RCTs) with longer follow-up to draw conclusions on safety and efficacy. Further studies should also compare implantable peripheral nerve stimulation with other neuromodulation therapy such as spinal cord stimulation and alternative treatments.

Practice Guidelines and Position Statements

Currently, there are no evidence based clinical practice guidelines that recommend the use of implantable peripheral nerve stimulation for the treatment of chronic pain of peripheral nerve origin. 

KEY WORDS:

Neurostimulator, implantable peripheral nerve stimulator, electrical nerve stimulators, implantable electrical nerve stimulators, PNS, peripheral nerve stimulator, StimRouter® neuromodulation; neuromuscular control; restorative neurostimulation; Reactiv8; SPRINT® Peripheral Nerve Stimulation (PNS) System; StimQ PNS System and Nalu Neurostimulation Systems

APPROVED BY GOVERNING BODIES:

The implantable stimulation system used for PNS (i.e., generator, electrodes, leads) includes basically the same components used for spinal cord stimulation. The surgical leads used for PNS have received 510(K) marketing clearance for peripheral nerve stimulation for treatment of intractable chronic pain.

The U. S. Food and Drug Administration (FDA) has approved the StimQ Peripheral Nerve Stimulator (PNS) system for use in adults with “severe intractable chronic pain of peripheral origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.”

Another device, the StimRouter Neuromodulation System, gained 510(k) clearance for “pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications).”

The SPRINT peripheral nerve stimulation device received FDA clearance as a temporary implant for the treatment of post-traumatic pain, post-operative pain, and chronic, intractable pain.

In June 2020, the ReActiv8 Implantable Neurostimulation System (Mainstay Medical, Brooklyn Center, MN) received premarket approval from the FDA (P190021). The FDA approved the system for:

Bilateral stimulation of the L2 medial branch of the dorsal ramus as it crosses the transverse process at L3 as an aid in the management of intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing in adults who have failed therapy including pain medications and physical therapy and are not candidates for spine surgery.

The system contains a programmable implantable pulse generator and percutaneous leads.

In March 2021, the Nalu Neurostimulation System (Nalu Medical, Carlsbad, California) was cleared by the FDA (K203547) for both spinal cord stimulation and peripheral nerve stimulation. The peripheral nerve stimulation indication is for adults with “severe intractable chronic pain of peripheral nerve origin”. The clearance states that the Nalu system is “not intended to treat pain in the craniofacial region”. Use of the device involves up to 30 days of trial stimulation to determine efficiency prior to permanent implantation.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING:

CPT Codes:

HCPCS Codes:

REFERENCES:

1. American Society of Addiction Medicine (ASAM). Definitions related to the use of opioids for the treatment of pain. Public Policy of ASAM. Chevy Chase, MD: ASAM; February 2001. Available at: http://www.asam.org/ppol/paindef.htm.
2. Dahlhamer J, Lucas J, Zelaya, C, et al. Prevalence of Chronic Pain and High-Impact Chronic Pain Among Adults — United States, 2016. MMWR Morb Mortal Wkly Rep 2018;67:1001-1006.
3. Deer, T., Pope, J., Benyamin, R., Vallejo, R., Friedman, et al. Prospective, multicenter, randomized, double-blinded, partial crossover study to assess the safety and efficacy of the novel neuromodulation system in the treatment of patients with chronic pain of peripheral nerve origin. Neuromodulation: Technology at the Neural Interface; 2016: 19:91–100.
4. Department of Health and Human Services Food and Drug Administration. StimQ Peripheral Nerve Stimulator (PNS) System. Stimwave. StimQ PNS System.
5. ECRI. Product Brief StimRouter Neuromodulation System (Bioness, Inc.) for Treating Peripheral Nerve Pain. Published April 2018.
6. Food and Drug Administration. K152178: StimQ Peripheral Nerve Stimulator (PNS) System. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf15/K152178.pdf.  Accessed on October 18, 2022.
7. Food and Drug Administration. K181422: SPRINT Peripheral Nerve Stimulation System. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181422.pdf. Accessed on October 18, 2022.
8. Food and Drug Administration. K190047: StimRouter Neuromodulation System. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190047. Accessed on October 18, 2022.
9. Food and Drug Administration. K203547: Nalu Neurostimulation System. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf20/K203547.pdf.  Accessed on October 18, 2022.
10. Food and Drug Administration. P190021: ReActiv8 Implantable Neurostimulation System. Available at: https://www.fda.gov/medical-devices/recently-approved-devices/reactiv8-implantable-neurostimulation-system-p190021. Accessed on October 18, 2022.
11. Gilligan C, Volschenk W, Russo M et al. ReActiv8-B investigators. An implantable restorative-neurostimulator for refractory mechanical chronic low back pain: a randomized sham-controlled clinical trial. Pain. 2021; 162(10):2486-2498.
12. Herschkowitz D and Kubias J. Wireless peripheral nerve stimulation for complex regional pain syndrome type I of the upper extremity: a case illustration introducing a novel technology. Scand J Pain 2018 Jul 26; 18(3):555-560.
13. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
14. Leak WD, Ansel AE. Neural stimulation: Spinal cord and peripheral nerve stimulation. In: Pain Medicine. A Comprehensive Review. PP Raj, ed. St. Louis, MO: Mosby; 1996; Ch. 32: 327-333.
15. Lerman IR, Chen JL, Hiller D, et. al. Novel high-frequency peripheral nerve stimulator treatment of refractory postherpetic neuralgia: a brief technical note. Neuromodulation 2015 Aug;18(6):487-93.
16. Lynch, P. J., McJunkin, T., Eross, E., Gooch, S. and Maloney, J. Case report: successful epiradicular peripheral nerve stimulation of the C2 dorsal root ganglion for postherpetic neuralgia. Neuromodulation 2011; 14:58–61.
17. Nayak R and Banik R. Current innovations in peripheral nerve stimulation. Pain Res Treat 2018; 2018:9091216.
18. Picarelli H, Sterman-Neto H, Lima De-Oliveira et. al. Neuromodulation in treating complex regional pain syndrome: a critical review of the evidence. Journal of Neurology and Neuroscience 2017 Vol. 8: No. 1:173
19. Shaw, A., Sharma, M., Zibly, Z., Ikeda, D., Deogaonkar, M et al. Sandwich technique, peripheral nerve stimulation, peripheral field stimulation and hybrid stimulation for inguinal region and genital pain. British Journal of Neurosurgery. 2016 Dec; 30(6):631-636.
20. Slavin KV. Peripheral nerve stimulation for the treatment of neuropathic craniofacial pain. Acta Neurochir Suppl. 2007; 97(Pt 1):115-120.
21. Stidd DA, Wuollet AL, Bowden K, et. al. Peripheral nerve stimulation for trigeminal neuropathic pain. Pain Physician 2012 Jan-Feb 15(1):27-23.
22. Yakovlev AE and Peterson AT. Peripheral nerve stimulation in treatment of intractable postherpetic neuralgia. Neuromodulation 2007 Oct: 10(4):373-5.

POLICY HISTORY:

Medical Policy Group,  March  2016 (2): New policy created.

Medical Policy Administration Committee, April 2016

Available for comment March 31 through May 14, 2016

Medical Policy Group, September 2018 (3): Updates to Description, Key Points, and References. No change to policy statement or intent.

Medical Policy Group, November 2019 (3): 2019 Updates to Key Points. No changes in policy statement or intent.

Medical Policy Group, August 2021 (3): Updates to Key Points, Governing Bodies, Practice Guidelines and References. No change to policy intent.

Medical Policy Group, November 2021:  2022 Annual Coding Update. Revised CPT 64575.

Medical Policy Group, October 2022 (3): 2022 Updates to Key Points, Approved By Governing Bodies, References, and Key Words: added neuromodulation; neuromuscular control; restorative neurostimulation; Reactiv8; SPRINT® Peripheral Nerve Stimulation (PNS) System; StimQ PNS System and Nalu Neurostimulation Systems. Updated policy criteria to clarify criteria for the use of restorative neurostimulation and changed chronic intractable neurogenic pain to chronic intractable pain.

Medical Policy Group, December 2022 (3): Clarification made to ensure stimulators are used in accordance with FDA guidelines and indications.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.