mp-526 - Medical Policies - Alabama
Peripheral Subcutaneous Field Stimulation
Policy Number: MP-526
Latest Review Date: April 2022
Peripheral subcutaneous field stimulation is considered investigational.
DESCRIPTION OF PROCEDURE OR SERVICE:
Peripheral subcutaneous field stimulation (PSFS, also called peripheral nerve field stimulation or target field stimulation) is a form of neuromodulation that is intended to treat chronic neuropathic pain. Applications of PSFS being evaluated are craniofacial stimulation for headache/migraines, craniofacial pain, or occipital neuralgia. Also being investigated is PSFS for low back pain, neck and shoulder pain, inguinal and pelvic pain, thoracic pain, abdominal pain, fibromyalgia, and post-herpetic neuralgia.
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.
Pharmacologic agents are typically the first-line treatment for chronic pain, and several classes of medications are available. They include analgesics (opioid and nonopioid), antidepressants, anticonvulsants, and muscle relaxants. Varieties of nonpharmacologic treatments also exist, including physical therapy, exercise, cognitive-behavioral interventions, acupuncture, chiropractic, and therapeutic massage.
Neuromodulation, a form of nonpharmacologic 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 SCS plus PSFS is also being evaluated.
Similar to SCS or peripheral nerve stimulation, permanent implantation is preceded by a percutaneous stimulation trial with at least 50% pain reduction. Currently, there is no consensus regarding the indications for PSFS. Criteria for a 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 PSFS is not known. Theories include an increase in endogenous endorphins and other opiate-like substances, modulation of smaller A-delta and C 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.
The most recent literature review was updated through March 1, 2022.
Summary of Evidence
For individuals who have chronic neuropathic pain who receive peripheral subcutaneous field stimulation (PSFS), the evidence includes two randomized controlled trials (RCTs), one 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 PSFS to alternatives. Rather, it compared different methods of PSFS. Among trial participants, 24 (80%) of 30 patients had at least a 50% reduction in pain with any type of PSFS. 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 additional RCT by Johnson et al (2021) compared sham to external non-invasive peripheral electrical nerve stimulation, but found no significant differences in pain scores between groups after intervention. Case series are insufficient to evaluate patient outcomes due to the variable nature of pain and the subjective nature of pain outcome measures. Prospective controlled trials comparing PSFS with placebo or alternative treatment modalities are needed to determine the efficacy of PSFS for chronic pain. The evidence is insufficient to determine the effects of the technology on health outcomes.
Practice Guidelines and Position Statements
In 2013, the National Institute for Health and Care Excellence issued guidance peripheral subcutaneous field stimulation for chronic low back pain. The guidance 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. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.”
U.S. Preventive Services Task Force Recommendations
Peripheral subcutaneous field stimulation, PSFS, SPRINT® Peripheral Nerve Stimulation System
APPROVED BY GOVERNING BODIES:
In July 2018, the U.S. Food and Drug Administration (FDA) cleared the SPRINT Peripheral Nerve Stimulation System (SPR Therapeutics, Inc) for marketing through the 510(k) process (K181422). FDA determined that this device was equivalent to existing devices for use in pain management. FDA has approved PSFS an off-label use of SCS devices for the treatment of chronic pain. (See policy #328-Spinal Cord Stimulation)
The U.S. Food and Drug Administration (FDA) has not approved a device specifically for peripheral subcutaneous field stimulation (PSFS). PSFS is an off-label use of spinal cord stimulation devices or peripheral nerve stimulation devices (e.g. the SPRINT® PNS System) that have been FDA approved for the management of pain.
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.
There are no specific CPT codes for peripheral subcutaneous field stimulation.
unlisted procedure, nervous system
Percutaneous of open implantation of neurostimulator electrode array(s), subcutaneous (peripheral subcutaneous field stimulation), including imaging guidance, when performed, cervical, thoracic or lumbar, for trial, including removal at the conclusion of trial period (Deleted 12/31/16)
Percutaneous of open implantation of neurostimulator electrode array(s), subcutaneous (peripheral subcutaneous field stimulation), including imaging guidance, when performed, cervical, thoracic or lumbar, permanent, with implantation of a pulse generator (Deleted 12/31/16)
Revision or removal of pulse generator or electrodes, including imaging guidance, when performed, including addition of new electrodes, when performed (Deleted 12/31/16)
Electronic analysis of implanted peripheral subcutaneous field stimulation pulse generator, with reprogramming when performed (Deleted 12/31/16)
- Johnson S, Marshall A, Hughes D, et al. Mechanistically informed non-invasive peripheral nerve stimulation for peripheral neuropathic pain: a randomised double-blind sham-controlled trial. J Transl Med. Nov 06 2021; 19(1): 458.
- 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.
- 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.
- 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.
- National Institute for Health and Care Excellence (NICE). Peripheral nerve-field stimulation for chronic low back pain [IPG451]. 2013; https://www.nice.org.uk/guidance/ipg451. Accessed February 24, 2020.
- 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.
- 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.
- 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.
- Warner NS, Schaefer KK, Eldrige JS, et al. Peripheral Nerve Stimulation and Clinical Outcomes: A Retrospective Case Series. Pain Pract. Apr 2021; 21(4): 411-418.
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.
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.