Latest Review Date: May 2024

Category:  Medical                                                    

POLICY:

Peripheral subcutaneous field stimulation is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Peripheral subcutaneous field stimulation is a form of neuromodulation intended to treat chronic neuropathic pain. Applications of peripheral subcutaneous field stimulation being evaluated are craniofacial stimulation for headache and migraine, craniofacial pain, or occipital neuralgia. Peripheral subcutaneous field stimulation is also being investigated for low back pain, neck and shoulder pain, inguinal and pelvic pain, thoracic pain, abdominal pain, fibromyalgia, and postherpetic neuralgia.

Chronic Pain

Chronic, non-cancer 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.

Treatment

Pharmacologic agents are typically the first-line treatment for chronic pain, and several classes of medications are available. They include analgesics (opioid and non-opioid), antidepressants, anticonvulsants, and muscle relaxants. A variety of non-pharmacologic treatments also exist, including physical therapy, exercise, cognitive-behavioral interventions, acupuncture, chiropractic, and therapeutic massage.

Neuromodulation, a form of non-pharmacologic therapy, is usually targeted toward patients with chronic pain refractory to other modalities. Some forms of neuromodulation, such as transcutaneous electrical nerve stimulation and spinal cord stimulation (SCS), are established methods of chronic pain treatment. Peripheral nerve stimulation, which involves placement of an electrical stimulator on a peripheral nerve, is also used for neuropathic pain originating from peripheral nerves.

Peripheral Subcutaneous Field Stimulation

Peripheral subcutaneous field stimulation (PSFS) is a modification of peripheral nerve stimulation. In PSFS, leads are placed subcutaneously within the area of maximal pain. The objective of PSFS is to stimulate the region of affected nerves, cutaneous afferents, or the dermatomal distribution of the nerves, which then converge back on the spinal cord. Combination spinal cord stimulation (SCS) plus PSFS is also being evaluated.

Similar to SCS or peripheral nerve stimulation, permanent implantation is preceded by a  trial of percutaneous stimulation trial with at least 50% pain reduction. Currently, there is no consensus regarding the indications for PSFS. Criteria for a trial of PSFS trial may include a clearly defined, discrete focal area of pain with a neuropathic or combined somatic/neuropathic pain component with characteristics of burning and increased sensitivity, and failure to respond to other conservative treatments including medications, psychological therapies, physical therapies, surgery, and pain management programs.

The mechanism of action in  PSFS is not known. Theories include an increase in endogenous endorphins and other opiate-like substances, modulation of smaller A-delta and C  nerve fibers with stimulation of large-diameter A-beta fibers, local stimulation of nerve endings in the skin, local anti-inflammatory and membrane depolarizing effect, or a central action via antegrade activation of A-beta nerve fibers. Complications of PSFS include lead migration or breakage and infection of the lead or neurostimulator.

KEY POINTS:

The most recent literature review was updated through February 8, 2024.

Summary of Evidence

For individuals who have chronic neuropathic pain who receive peripheral subcutaneous field stimulation, the evidence includes 2 RCTs, a nonrandomized comparative study, and case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. One RCT, McRoberts et al (2013), which used a crossover design, did not compare peripheral subcutaneous field stimulation with alternatives. Rather, it compared different methods of peripheral subcutaneous field stimulation. Among trial participants, 24 (80%) of 30 patients had at least a 50% reduction in pain with any type of peripheral subcutaneous field stimulation. However, because the RCT did not include a sham group or comparator with a different active intervention, this trial offers little evidence for efficacy beyond that of a prospective, uncontrolled study. An open-label RCT found that peripheral subcutaneous field stimulation plus medical management had a greater rate of pain reduction compared to medical management alone at 9 months follow-up. Secondary outcomes found benefits in several quality-of-life indices over medical management alone. The trial had a high loss to follow-up and was terminated early as a result of recruitment challenges, which impacted the durability and certainty of these findings. Case series are insufficient to evaluate patient outcomes due to the variable nature of pain and the subjective nature of pain outcome measures. Larger, prospective controlled trials comparing peripheral subcutaneous field stimulation with placebo or alternative treatment modalities are needed to determine the efficacy of peripheral subcutaneous field stimulation for chronic pain. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Society of Pain and Neuroscience

In 2022, the American Society of Pain and Neuroscience published consensus clinical guidelines for the use of implantable peripheral nerve stimulation in the treatment of chronic pain based on a review of the literature through March 2021. Recommendations for best practices are listed below in Table 1.

Table 1. American Society of Pain and Neuroscience Best Practices Peripheral Nerve Stimulation Guidelines

CRPS: complex regional pain syndrome; DOR: degree of recommendation; LOE: level of evidence; PNS: peripheral nerve stimulation; SCS: spinal cord stimulator.

The National Institute for Health and Care Excellence (NICE)

In 2013, NICE issued guidance peripheral subcutaneous field stimulation for chronic low back pain, which stated:

“Current evidence on the efficacy of peripheral nerve-field stimulation (PNFS) for chronic low back pain is limited in both quantity and quality, and duration of follow-up is limited. Evidence on safety is also limited and there is a risk of complications from any implanted device."

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Peripheral subcutaneous field stimulation, PSFS

APPROVED BY GOVERNING BODIES:

Peripheral subcutaneous field stimulation is an off-label use of peripheral nerve stimulation system that have been approved by the FDA for the treatment of chronic pain by targeting one or more peripheral nerves associated with pain.

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.

CURRENT CODING:

CPT Codes:

There are no specific CPT codes for peripheral subcutaneous field stimulation.

REFERENCES:

1. Eldabe SS, Taylor RS, Goossens S, et al. A Randomized Controlled Trial of Subcutaneous Nerve Stimulation for Back Pain Due to Failed Back Surgery Syndrome: The SubQStim Study. Neuromodulation. Jul 2019; 22(5): 519-528.
2. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
3. Kloimstein H, Likar R, Kern M, et al. Peripheral nerve field stimulation (PNFS) in chronic low back pain: a prospective multicenter study. Neuromodulation. Feb 2014; 17(2):180-187.
4. McRoberts WP, Wolkowitz R, Meyer DJ et al. Peripheral nerve field stimulation for the management of localized chronic intractable back pain: results from a randomized controlled study. Neuromodulation 2013; 16(6):565-75.
5. Mironer YE, Hutcheson JK, Satterthwaite JR, et al. Prospective, two-part study of the interaction between spinal cord stimulation and peripheral nerve field stimulation in patients with low back pain: development of a new spinal-peripheral neurostimulation method. Neuromodulation. Mar-Apr 2011; 14(2):151-154; discussion 155. 
6. National Institute for Health and Care Excellence (NICE). Peripheral nerve-field stimulation for chronic low back pain[IPG451]. 2013; www.nice.org.uk/guidance/ipg451.
7.  Sator-Katzenschlager S, Fiala K, Kress HG et al. Subcutaneous target stimulation (STS) in chronic noncancer pain: a nationwide retrospective study. Pain Pract 2010; 10(4):279-86.
8. 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.
9. Verrills P, Rose R, Mitchell B, et al. Peripheral nerve field stimulation for chronic headache: 60 cases and long- term follow-up. Neuromodulation. Jan 2014; 17(1):54-59.
10. Verrills P, Vivian D, Mitchell B et al. Peripheral nerve field stimulation for chronic pain: 100 cases and review of the literature. Pain Med 2011; 12(9):1395-1405.

POLICY HISTORY:

Medical Policy Panel, March 2013

Medical Policy Group, March 2013 (2) New policy

Medical Policy Administration Committee, April 2013

Available for comment April 18 through June 5, 2013

Medical Policy Panel, March 2014

Medical Policy Group, March 2014 (1): Update to Key Points and References; no change to policy statement

Medical Policy Panel, March 2015

Medical Policy Group, March 2015 (6):  Update to Key Points; no change to policy statement

Medical Policy Panel, April 2016

Medical Policy Group, April 2016 (6):  Update to Description and Key Points; no change to policy statement.

Medical Policy Group, December 2016: 2017 Annual Coding Update. Created previous coding section and moved deleted CPT codes 0282T - 0285T to this section; added existing CPT code 64999 to current coding.

Medical Policy Panel, April 2017

Medical Policy Group, April 2017 (6): Update to Description and Key Points: no change to policy statement.

Medical Policy Panel, April 2018

Medical Policy Group, May 2018 (6): Updates to Key Points.

Medical Policy Panel, April 2019

Medical Policy Group, May 2019 (3): 2019 Updates to Key Points, Approved by Governing Bodies, References and Key Words: added SPRINT® Peripheral Nerve Stimulation System. No changes to policy statement or intent.

Medical Policy Panel, April 2020

Medical Policy Group, May 2020 (3): 2020 Updates to Key Points and References. No changes to policy statement or intent.

Medical Policy panel, April 2021

Medical Policy group, April 2021 (3): 2021 Updates to Key Points. Policy statement updated to remove “not medically necessary,” no change to policy statement or intent.

Medical Policy Panel, April 2022

Medical Policy Group, April 2022 (3): 2022 Updates to Key Points and References. No changes to policy statement or intent.

Medical Policy Panel, April 2023

Medical Policy Group, April 2023 (3): 2023 Updates to Key Points, Approved by Governing Bodies, Benefit Applications, Practice Guidelines and Position Statements, and References. Previous coding section removed. No changes to policy statement or intent.

Medical Policy Panel, April 2024

Medical Policy Group, May 2024 (3): Updates to Key Points, Approved by Governing Bodies and References. Update Key Words removed SPRINT® Peripheral Nerve Stimulation System. No changes to policy statement or intent.

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.