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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. One application of PSFS that is being evaluated is occipital or 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 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. These 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, 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 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
Similar to spinal cord stimulation or peripheral nerve stimulation, permanent implantation is preceded by a trial of percutaneous stimulation with at least 50% pain reduction. Currently, there is no consensus regarding the indications for PSFS. Criteria for a trial of PSFS 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 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.
No devices have been approved by the U.S. Food and Drug Administration (FDA) specifically for 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.
Peripheral subcutaneous field stimulation is 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.
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.
07/18/2013: Approved by Medical Policy Advisory Committee.
04/29/2014: Policy reviewed; no changes.
04/06/2015: Policy description and statement unchanged. Policy guidelines updated to revise investigative definition.
08/04/2015: Code Reference section updated for ICD-10.
05/31/2016: Policy number added.
06/27/2016: Policy description updated. Policy statement unchanged.
Blue Cross and Blue Shield Association Policy # 7.01.139
This may not be a comprehensive list of procedure codes applicable to this policy.