Medical Policy: 07.01.70 

Original Effective Date: December 2015 

Reviewed: November 2017 

Revised: November 2017 

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

Peripheral subcutaneous field stimulation (PSFS), also called peripheral nerve field stimulation (PNFS) 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/migraine, craniofacial pain or occipital neuralgia. PSFS is also being investigated for low back pain, neck and shoulder pain, inguinal and pelvic pain, thoracic pain, abdominal pain, fibromyalgia, and post-herpetic neuralgia. 

 

Chronic, non-cancer pain is responsible for a high burden of illness. Common types of chronic pain include lumbar and cervical pain, chronic headaches and abdominal pain. All 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. These include analgesics (opioid and non-opioid), antidepressants, anticonvulsants, and muscle relaxants. There also are a variety of non-pharmacologic treatments, including physical therapy, exercise, cognitive-behavioral interventions, acupuncture, chiropractic, and therapeutic massage. 

 

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

 

PSFS is a modification of peripheral nerve stimulation. In PSFS, leads are placed subcutaneously within the area of maximal pain. The objective 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. 

 

The mechanism of PSFS is unknown. Theories include an increase in endogenous endorphins and other opiate-like substances; modulation of smaller A delta and C nerve fibers by stimulated 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. 

 

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. 

 

As with other types of implantable nerve stimulation, implantation of the PSFS is typically a two-step process, the electrode is temporarily implanted, allowing a trial period of stimulation. Once treatment effectiveness is confirmed from the trial stimulation which is defined as at least 50% reduction in pain, the electrodes and neurostimulator are then permanently implanted.  

 

Summary

Neuromodulation is another form of non-pharmacologic therapy that is usually targeted toward patients with chronic pain that is refractory to other modalities. Some forms of neuromodulation, such as transcutaneous electrical nerve stimulation (TENS) and spinal cord stimulation (SCS), are established methods of chronic pain treatment. Peripheral subcutaneous field stimulation (PSFS); also called peripheral nerve field stimulation (PNFS) or target field stimulation is being investigated in the treatment of chronic neuropathic pain. Based on review of the peer reviewed medical literature the evidence for the effectiveness of PSFS based on controlled studies is lacking. The literature includes one randomized controlled trial, one nonrandomized comparative study and case series. Further randomized controlled trials are needed comparing PSFS with placebo or alternative treatment modalities to evaluate the efficacy of this treatment for chronic pain as either a stand-alone procedure or adjunct therapy with SCS for chronic neuropathic pain. Therefore, the evidence is insufficient to determine the effects on net health outcomes and peripheral subcutaneous field stimulation (PSFS) is considered investigational for all indications. 

 

Also, no complete PSFS stimulation system has received U.S. Food and Drug Administration (FDA) approval.  See Regulatory Status information below.   

 

Practice Guidelines and Position Statements

 

National Institute for Health and Care Excellence

In 2013 the National Institute for Health and Care Excellence issued guidance on Peripheral Nerve Field Stimulation for Chronic Low Back Pain. The guidance indicated: 

 

“Current evidence on the efficacy of peripheral nerve 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 for research.”    

 

Regulatory Status

No devices have been approved by the U.S. Food and Drug Administration (FDA) specifically for peripheral subcutaneous field stimulation (PSFS). PSFS is an off label use of spinal cord stimulation devices that have been approved by the FDA for the treatment of chronic pain. 

 

Prior Approval:

 

Not applicable

 

Policy:

See also Medical Policy 07.01.61 Spinal Cord Stimulation

 

Peripheral subcutaneous field stimulation (PSFS) (also called peripheral nerve field stimulation (PNFS) or target field stimulation) to include temporary and permanent placement is considered investigational for all indications including but not limited to the following:

  • Occipital neuralgia
  • Chronic headaches/migraines
  • Craniofacial pain
  • Low back pain
  • Thoracic pain
  • Neck pain (cervical)
  • Shoulder pain
  • Inguinal and pelvic pain
  • Pain following hernia surgery
  • Abdominal pain
  • Fibromyalgia
  • Post-herpetic pain
  • Failed back syndrome or post laminectomy syndrome
  • Complex regional pain syndrome Type I or Type II (formerly known as reflex sympathetic dystrophy (RSD))
  • Diabetic peripheral neuropathy
  • Peripheral vascular disease neuropathy
  • Painful peripheral neuropathy
  • Intercostal neuralgia
  • Radiculopathy
  • Lumbosacral arachnoiditis 
  • Post-thoracotomy syndrome
  • Trigeminal neuralgia
  • Trigeminal neuropathic pain

 

Based on review of the peer reviewed medical literature the evidence for the effectiveness of PSFS based on controlled studies is lacking. Further randomized controlled trials are needed comparing PSFS with placebo or alternateiv treatment modalities to evaluate the efficacy of this treatment for chronic pain as either a stand-alone procedure or adjunct therapy with spinal cord stimulation (SCS). The evidence is insufficient to determine the effects on net health outcomes.  Also, no complete PSFS stimulation system has received FDA approval. Therefore, peripheral subcutaneous field stimulation (PSFS) (also called peripheral nerve field stimulation (PNFS) or target field stimulation) is considered investigational for all indications. 

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes and / or diagnosis codes.

  • 64999 Unlisted procedure nervous system

 

Selected References:

  • National Institute for Health and Care Excellence IPG451 Peripheral Nerve Stimulation for Chronic Low Back Pain: Guidance 2013.
  • American Society of Anesthesiologists: Practice Guidelines for Chronic Pain Management, an Updated Report by American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology 2010; 112:1-1
  • ECRI. Hotline Response Implantable Peripheral Nerve Stimulation Devices for Treating Chronic Pain. March 2013.
  • Medtronic 2013 Press Release Medtronic Initiates U.S. Trial to Evaluate the use of Subcutaneous Peripheral Nerve Stimulation for Chronic Back Pain.
  • Eldabe Sam, Kern Michael, et. al. Study Protocol – Assessing the Effectiveness and Cost Effectiveness of Subcutaneous Nerve Stimulation in Patients with Predominate Back Pain due to Failed Back Surgery Syndrome (SubQStim Study): Study Protocol for a Multicenter Randomized Controlled Trial. Eldabe et al. Trials 2013, 14:189
  • Manchikanti Laxmaiah, Abdi Salahadin, et. al., An Update of Comprehensive Evidence-Based Guidelines for Interventional Techniques in Chronic Spinal Pain. Part II: Guidance and Recommendations. Pain Physician 2013; 16:S49-S283
  • Sator-Katzenschlager S, Fiala K, et. al. Subcutaneous Target Stimulation (STS) in Chronic Non-Cancer Pain: A Nationwide Retrospective Study. Pain Pract 2010 Jul-Aug;10(4):279-86. PMID 20230450
  • Mironer YE, Hutcheson JK, 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 2011 Mar-Apr; 14(2):151-4 . PMID 21992203
  • McRoberts WP, Wolkowitz R. et. al,  Peripheral Nerve Field Stimulation for the Management of Localized Chronic Intractable Back Pain: Results from a Randomized Controlled Study. Neuromodulation 2013 Nov-Dec;16(6):565-74. PMID 23577773
  • Klomstein H, Likar R, et.al. Peripheral Nerve Field Stimulation (PNFS) in Chronic Low Back Pain: A Prospective Multicenter Study. Neuromodulation 2014 Feb; 17(2):180-7. PMID 24320718
  • Verrills P, Rose R, Mitchell B, Vivian D, Bernard A, Peripheral Nerve Field Stimulation for Chronic Headache: 60 Cases and Long Term Follow Up. Neuromodulation 2014 Jan;17(1):54-9. PMID 24165152
  • Winkelmueller Matthias, Kolodzeij Malgorzata Anna, et. al. Subcutaneous Peripheral Nerve Field Stimulation for the Treatment of Chronic Back Pain: Patient Selection and Technical Aspects. Journal of Neurological Surgery Part A November 14, 2014.
  • International Neuromodulation Society Subcutaneous Peripheral Field Stimulation. March 4, 2012.

 

Policy History:

  • November 2017 - Annual Review, Policy Revised
  • November 2016 - Annual Review, Policy Renewed
  • December 2015 - New policy

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.