Coverage Policy Manual - Arkansas Blue Cross and Blue Shield

Coverage Policy Manual
Policy #:	2010005
Category:	Surgery
Initiated:	January 2010
Last Review:	July 2023

Peripheral Nerve Stimulation

Description:

Percutaneous electrical nerve stimulation (PENS), percutaneous neuromodulation therapy (PNT), and restorative neurostimulation therapy (ReActiv8) combine the features of electroacupuncture and transcutaneous electrical nerve stimulation. Percutaneous electrical nerve stimulation is performed with needle electrodes while PNT uses very fine needle-like electrode arrays placed near the painful area to stimulate peripheral sensory nerves in the soft tissue. ReActiv8 is an implantable electrical neurostimulation system that stimulates the nerves that innervate the lumbar multifidus muscles.

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/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.

A variety of chronic musculoskeletal or neuropathic pain conditions, including low back pain, neck pain, diabetic neuropathy, chronic headache, and surface hyperalgesia, present a substantial burden to patients, adversely affecting function and quality of life. Certain racial and ethnic groups are at a higher risk of developing diabetes, which may also put them at higher risk of developing complications from diabetes, such as diabetic neuropathy. According to a 2018 to 2019 National Health Interview Survey and data from the Indian Health Service National Data Warehouse, American Indians and Alaska Natives had the highest reported rate of diagnosed diabetes at 14.5% (CDC, 2022). This was followed by 12.1% of Black individuals, 11.8% of Hispanic individuals, 9.5% of Asian individuals, and 7.4% of White individuals having diagnosed diabetes in 2018 or 2019.

These chronic pain conditions have typically failed other treatments, and percutaneous electrical nerve stimulation (PENS) and percutaneous neuromodulation therapy (PNT) have been evaluated as treatments to relieve unremitting pain.

Percutaneous electrical nerve stimulation (PENS) is similar in concept to transcutaneous electrical nerve stimulation (TENS, see policy No.1998154), but differs in that needles are inserted either around or immediately adjacent to the nerve serving the painful area and are then stimulated. PENS is generally reserved for patients who fail to get pain relief from TENS. PENS must be distinguished from acupuncture with electrical stimulation. In electrical acupuncture, needles are also inserted just below the skin, but the placement of needles is based on specific theories regarding energy flow throughout the human body. In PENS the location of stimulation is determined by proximity to the pain rather than the theories of energy flow that guide placement of stimulation for acupuncture.

Percutaneous neuromodulation therapy is a variant of PENS in which fine filament electrodes are temporarily placed at specific anatomical landmarks in the deep tissues near the area of the spine that is causing pain (with or without radiating lower extremity pain). Treatment regimens consist of 30- minute sessions, once or twice a week for 8 to 10 sessions. Some use the terms PENS and PNT interchangeably. It is proposed that PNT inhibits pain transmission by creating an electrical field that hyperpolarizes C fibers, thus preventing action potential propagation along the pain pathway.

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. Combined spinal cord stimulation and PSFS is also being evaluated. 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.

Regulatory Status

In 2002, the Percutaneous Neuromodulation Therapy™ (Vertis Neuroscience) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The labeled indication is: "… for the symptomatic relief and management of chronic or intractable pain and/or as an adjunctive treatment in the management of post-surgical pain and post-trauma pain."

In 2006, the Deepwave® Percutaneous Neuromodulation Pain Therapy System (Biowave) was cleared for marketing by FDA through the 510(k) process. The FDA determined that this device was substantially equivalent to the Vertis neuromodulation system and a Biowave neuromodulation therapy unit. The Deepwave® system includes a sterile single-use percutaneous electrode array that contains 1014 microneedles in a 1.5-inch diameter area. The needles are 736 μm (0.736mm) in length; the patch is reported to feel like sandpaper or Velcro.

Peripheral implanted nerve stimulator (PINS) involves the surgical implantation of electrodes to stimulate a peripheral nerve for treatment of chronic pain. The process of implantation usually involves two phases – a temporary test, followed by implantation of the programmable generator and/or battery pack if testing is successful.

In February 2015 the U.S. Food and Drug Administration (FDA) granted 510 (k) marketing clearance for the StimRouter™ Neuromodulation System (Bioness®). (K142432). It is not intended to treat pain in the craniofacial region.

In March 2016, the FDA determined the StimQ Peripheral Nerve Stimulator (PNS) System (StimQ™ LLC and Stimwave™ LLC, Pompano Beach, FL) was substantially equivalent to predicate devices (K152178). It is not intended to treat pain in the craniofacial region.

In 2018, the FDA reviewed the Cala ONE™ TENS device (Cala Health) via the de novo pathway and granted approval for the device as an aid in the transient relief of hand tremors following stimulation in the affected hand of adults with essential tremor. This prescription device is contraindicated for use in patients with an implanted electrical medical device, those that have suspected or diagnosed epilepsy or other seizure disorder, those who are pregnant, and patients with swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions. In October 2020, the FDA granted breakthrough device designation to the Cala Trio™ device for the treatment of action tremors in the hands of adults with Parkinson's disease (Cala Health news release, 2021).

In 2020, the ReActiv8 (Mainstay Medical) was FDA approved through the Premarket Approval (PMA) process (PMA P190021) for individuals with intractable chronic low back pain associated with multifidus dysfunction for whom available low back pain treatments do not provide sufficient or durable symptom relief (FDA, 2020).

In July 2018, the SPRINT® Peripheral Nerve Stimulation System (SPR Therapeutics, Inc) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process (K181422). The FDA determined that this device was substantially equivalent to existing devices for use in pain management. PSFS is an off-label use of spinal cord stimulation devices that have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic pain.

FDA product codes: NHI, QLK.

The correct CPT code to use for percutaneous electrical nerve stimulation (PENS) and percutaneous neuromodulation therapy (PNT) is the unlisted CPT code 64999.

CPT/HCPCS codes used for reporting peripheral implanted nerve stimulator (PINS):

64555 Percutaneous implantation of neurostimulator electrode array; peripheral nerve (excludes sacral nerve)
64575 Incision for implantation of neurostimulator electrode array; peripheral nerve (excludes sacral nerve)
64585 Revision or removal of peripheral neurostimulator electrode array
64590 Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, direct or inductive coupling
64595 Revision or removal of peripheral or gastric neurostimulator pulse generator or receiver
L8679 Implantable neurostimulator, pulse generator, any type
L8680 Implantable neurostimulator electrode, each
L8681 Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only
L8682 Implantable neurostimulator radiofrequency receiver
L8683 Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver
L8685 Implantable neurostimulator pulse generator, single array, rechargeable, includes extension
L8686 Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension
L8687 Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension
L8688 Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension
L8689 External recharging system for battery (internal) for use with implantable neurostimulator, replacement only

Policy/
Coverage:

Effective October 2023, coverage policies 2010005 (Electrical Stimulation, Percutaneous Electrical Nerve Stimulation [PENS] or Percutaneous Neuromodulation Therapy [PNT]) and 2013013 (Peripheral Subcutaneous Field Stimulation) were combined into one policy. Policy 2013013 is now archived.

Effective October 2023

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Percutaneous electrical neurostimulation (PENS) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

For members with contracts without primary coverage criteria, percutaneous electrical neurostimulation (PENS) is considered investigational. Investigational services are exclusions in most member benefit certificate of coverage.

Percutaneous neuromodulation therapy (PNT) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

For members with contracts without primary coverage criteria percutaneous neuromodulation therapy (PNT) is considered investigational. Investigational services are exclusions in most member benefit certificate of coverage.

Restorative neurostimulation therapy (e.g., ReActiv8) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

For members with contracts without primary coverage criteria, restorative neurostimulation therapy (e.g., ReActiv8) is considered investigational. Investigational services are exclusions in most member benefit certificate of coverage.

Peripheral implanted nerve stimulation (PINS) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

For members with contracts without primary coverage criteria, peripheral implanted nerve stimulation (PINS) is considered investigational. Investigational services are exclusions in most member benefit certificate of coverage.

Neuromodulation or Transcutaneous Afferent Patterned Stimulation for the treatment of essential tremor, including but not limited to Cala Trio, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.

For members with contracts without primary coverage criteria, Neuromodulation or Transcutaneous Afferent Patterned Stimulation for the treatment of essential tremor, including but not limited to Cala Trio, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Peripheral subcutaneous field stimulation for the treatment of chronic neuropathic pain or any other indication does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

For members with contracts without primary coverage criteria, peripheral subcutaneous field stimulation for the treatment of chronic neuropathic pain or any other indication is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Effective August 2023 - September 2023

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Percutaneous electrical neurostimulation (PENS) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

Percutaneous neuromodulation therapy (PNT) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

Restorative neurostimulation therapy (e.g., ReActiv8) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

Peripheral implanted nerve stimulation (PINS) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

Effective September 2022 through July 2023

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Percutaneous electrical neurostimulation (PENS), percutaneous neuromodulation therapy (PNT), and peripheral implanted nerve stimulation (PINS) do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

For members with contracts without primary coverage criteria, percutaneous electrical neurostimulation (PENS), percutaneous neuromodulation therapy (PNT), and peripheral implanted nerve stimulation (PINS) are considered investigational. Investigational services are exclusions in most member benefit certificate of coverage.

Effective October 2019 through August 2022

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Effective September 2011 – September 2019

Percutaneous electrical neurostimulation or neuromodulation does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.

For members with contracts without primary coverage criteria, percutaneous electrical neurostimulation or neuromodulation is considered investigational. Investigational services are exclusions in the member benefit certificate of coverage.

Effective prior to September 2011

Percutaneous electrical neurostimulation or neuromodulation is an exclusion in the member certificate of coverage in most benefit certificates.

For member benefit certificates without this specific contract exclusion, percutaneous electrical neurostimulation or neuromodulation is considered investigational. Investigational services are exclusions in the member benefit certificate of coverage.

Rationale:

A Blue Cross and Blue Shield TEC Assessment of percutaneous electrical nerve stimulation (PENS) for the treatment of chronic pain was completed in 1996. The objective of the 1996 Assessment was to determine if the effects of PENS exceed placebo effects. No clinical studies of PENS were identified by the 1996 Assessment, thus no conclusions about effectiveness could be reached.

The following study selection criteria were used in the 1996 TEC Assessment .

the study contained original empirical data;
the study design included a treatment group and a control group;
the study reported on a health outcome relevant to the pain condition treated; and
the study used a random assignment, control group design

A literature search revealed 8 randomized trials meeting the cited criteria above. Of the 8, a total of 5 addressed use of PENS in treating chronic back pain. A single study focused on each of these conditions: chronic neck pain (Weiner, 2003), chronic diabetic neuropathy (Yokoyama, 2004), and chronic headache (Weiner, 2008). All were designed as randomized crossover studies in which sham PENS was compared with between 1 and 3 types of active PENS, in addition to alternative treatments such as transcutaneous electrical nerve stimulation (TENS) or exercise therapy. Patients would undertake 30-minute treatment sessions, 3 times per week for 2 or 3 weeks. The order of treatments was random. On completing a treatment, a 1-week washout period would follow, then the patient would proceed to another treatment until all patients had received all treatments. Post-treatment outcome was assessed either immediately after completing the last session of a treatment or up to 3 days later. All 8 studies were conducted at 1 institution, the University of Texas Southwestern Medical Center in Dallas.

Chronic Low Back Pain

Ghoname et al compared sham PENS, active PENS, and TENS in 64 patients. Active PENS achieved better outcomes than sham PENS on visual analogue scale (VAS) pain scores, and daily oral analgesic requirement. Active PENS was better than sham PENS and TENS on physical activity, quality of sleep, and preference. Ghoname et al administered sham PENS, active PENS, TENS, and exercise therapy in 60 patients (Ghoname, 1999). Active PENS resulted in better outcomes than all other modalities in terms of VAS pain, analgesic requirements, physical activity, quality of sleep, and preference. Hamza et al varied the duration of active electrical stimulation at 3 levels (15, 30, and 45 minutes) and compared them with sham stimulation in 75 patients (Hamza, 1999). These investigators confirmed that sham PENS had the least effect, and results were best when the stimulation lasted 30 or 45 minutes. Ghoname et al varied the frequency of the active electrical stimulus at 3 levels, also comparing it with sham stimulation, in 68 patients (Ghoname, 1999). One level involved active stimulation with alternating 15-Hz and 30-Hz frequencies, while the other active levels had frequencies of 4 Hz and 100 Hz. The alternating frequency technique had the best results, superior to sham PENS. White et al did not include sham PENS in a study of 72 patients (White, 2001). Rather, this study compared 4 montages, or patterns of needle placement. They found that a bottle-shaped pattern achieved the best results, compared with 3 other patterns. In addition, a 2003 study focused on chronic low back pain in community dwelling older adults (Weiner, 2003). Patients were randomized to receive twice weekly PEN or sham PENS for 6 weeks. At 3-month follow-up, the treatment group reported a significant reduction in pain intensity and disability while the control group did not.

While these studies suggest that active PENS has effects that exceed placebo PENS in the short term, it is unclear whether the study designs included adequate blinding. It is also unclear whether patients withdrew from these studies. Furthermore, the objective of treating chronic low back pain is long-term improvement of pain and functional outcomes, which none of these studies addresses.

Two clinical trials on the use of PENS for chronic back pain were identified. Yokoyama et al found patients randomized to PENS treatment twice per week for 8 weeks had significantly decreased pain levels, physical impairment, and NSAID use, which continued to be present 1 month after treatment completion compared to a second group that received PENS for 4 weeks followed by TENS for 4 weeks and a third group that received only TENS for 8 weeks (Yokoyama, 2004). While PENS treatment for 8 weeks seemed to demonstrate greater effectiveness in controlling pain for up to 1 month after treatment when compared to the other treatment groups, the beneficial effects were not found at the 2-month follow-up. Weiner and colleagues reported a trial with 200 older adults that had been funded by the National Institutes of Health (Weiner, 2008). Subjects with chronic lower back pain were randomized to PENS or sham-control treatment, with or without physical conditioning/aerobic exercise, twice a week for 6 weeks. Thus, the 4 treatment groups were PENS alone, sham PENS alone, PENS plus physical conditioning, or sham PENS plus physical conditioning. The sham control condition consisted of 10 acupuncture needles in identical locations, depth and duration (30 minutes) as the PENS needles, with brief (5-minute) stimulation at 2 additional needles. Primary and secondary outcome measures were collected at baseline, 1 week, and 6 months after treatment by a research associate who was unaware of the treatment. There were no significant adverse effects, and also no differences between the PENS and sham PENS groups in any outcome measure at 1-week or 6-month follow-up. All 4 groups reported reduced pain of a similar level (improvement ranging from 2.3 to 4.1 on the McGill Pain Questionnaire), reduced disability (range of 2.1 to 3.0 on the Roland scale) and improved gait velocity (0.04 to 0.07 m/s) that was maintained for 6 months. Although the authors concluded that minimal electrical stimulation (5 minutes at 2 electrodes) is as effective as usual PENS (30 minutes of stimulation from 10 electrodes), the lack of benefit of this treatment over sham control does not provide support for use of PENS in patients with chronic low back pain.

Chronic Neck Pain

One study of 68 patients by White et al compared 2 locations of active stimulation with sham stimulation in 68 patients (White, 2000). Local stimulation involved needle insertion at the neck, while remote stimulation entailed needles placed in the lower back. The sham condition received needles with no electrical stimulation at the neck. Outcomes were assessed immediately after completion of a 3-week treatment period. The local placement of active needles resulted in better pain relief, physical activity, quality of sleep, and analgesic use than local sham treatment or remote active treatment. The authors stated that no side effects were observed at needle insertion sites. The study was described as investigator blinded, but no details were given about the method of blinding. Withdrawals were not noted, and no long-term outcome data were presented. This single study, in which blinding is of uncertain adequacy, does not permit conclusions about the effectiveness of PENS for treating chronic neck pain.

Diabetic Neuropathy

In a crossover study by Hamza et al. , 50 patients with diabetic neuropathic pain for at least 6 months were randomized to receive either sham PENS or active PENS first in a 7-week study. Outcome was assessed 1 day after completion of a 3-week treatment period (Hamza, 2000). Active PENS resulted in better outcomes on VAS pain, activity, sleep, and analgesic use, compared with sham PENS. The authors describe the study as investigator blinded, without providing details of how blinding was attempted. Thus, it is uncertain whether blinding was adequate. Withdrawals were not mentioned. Also, no long-term outcome data were presented, so long-term effects are unknown. This single study, which may not have been adequately blinded, does not allow conclusions about the effects of PENS for treating diabetic neuropathy.

Headache

Ahmed et al conducted a crossover study in 30 patients with longstanding headaches of 3 types: tension, migraine, and post-traumatic injury (Ahmed, 2000). Two-week courses of active and sham PENS were compared. Outcomes were assessed at the completion of each treatment. Active PENS achieved better outcomes than sham PENS in terms of VAS pain, physical activity, and quality of sleep. Results did not vary by headache type. The investigators stated that the study was single-blinded, but gave no details about blinding methods or whether withdrawals occurred. The report offers no long-term outcome data. This study does not establish the effectiveness of PENS for treatment chronic headache.

Osteoarthritis of the Knee

In 2007, Kang et al reported a single-blinded trial that included 70 patients with knee osteoarthritis randomized to stimulation (at the highest tolerable intensity) or placement of electrodes (without stimulation) (Kang, 2007). Patients in the sham group were informed that they would not perceive the normal “pins and needles” with this new device. Patients received 1 treatment and were followed up for 1 week. The neuromodulation group had 100% follow-up; 7 of 35 (20%) patients from the sham group dropped out. VAS pain scores improved immediately after active (from 5.4 to 3.2), but not sham (5.6 to 4.9) treatments. VAS scores (4.6 vs. 5.2) were not significantly different for the two groups at 48 hours after treatment. Changes in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) were significantly better for the category of stiffness (1-point change vs. 0-point change) but not for pain or function at 48 hours. Measures of patient satisfaction were significantly higher in the neuromodulation group (e.g., 77% vs.11% good to excellent) at up to 1-week follow-up. Interpretation is limited by the discrepancy between patient satisfaction ratings and 48-hour VAS pain scores, and the differential loss to follow-up in the two groups. These results raise questions about the effectiveness of the blinding, the contribution of short-term pain relief and placebo effects, and the duration of the treatment effects.

Percutaneous Neuromodulation

From its description, neuromodulation appears to be a variant of PENS, varying in length of the needle and its placement at specific anatomical landmarks in the back, instead of specifically at the site of pain. A literature search identified 1 abstract focusing on neuromodulation. This study was an uncontrolled case series of 83 patients with low back pain. While pain improved at 5-week follow-up, the lack of a control group precludes scientific assessment (Condon, 2002).

A search of the clinical trials database in January 2010 identified a randomized controlled trial comparing Vertis neuromodulation therapy with TENS (NCT00290238). The study began in 2005 with an estimated enrollment of 122 patients. A posting from May 2009 lists the study as terminated due to slow recruitment and high dropout rates.

Joint clinical practice guidelines on the diagnosis and treatment of low back pain from the American College of Physicians and the American Pain Society in 2007 indicates that there is uncertainty over whether PENS should be considered a novel therapy or a form of electroacupuncture (Chou, 2007). The guidelines conclude that PENS is not widely available. (The guidelines also conclude that TENS has not been proven effective for chronic low back pain.

Medicare Coverage Policy

The Centers for Medicare and Medicaid Services (CMS) currently has the following national coverage policy on PENS:

35-46 ASSESSING PATIENT'S SUITABILITY FOR ELECTRICAL NERVE STIMULATION THERAPY

“Electrical nerve stimulation is an accepted modality for assessing a patient's suitability for ongoing treatment with a transcutaneous or an implanted nerve stimulator. Accordingly, program payment may be made for the following techniques when used to determine the potential therapeutic usefulness of an electrical nerve stimulator:

B. Percutaneous Electrical Nerve Stimulation (PENS).--This diagnostic procedure which involves stimulation of peripheral nerves by a needle electrode inserted through the skin is performed only in a physician's office, clinic, or hospital outpatient department. Therefore, it is covered only when performed by a physician or incident to physician's service. If pain is effectively controlled by percutaneous stimulation, implantation of electrodes is warranted.

As in the case of TENS (described in subsection A), generally the physician should be able to determine whether the patient is likely to derive a significant therapeutic benefit from continuing use of an implanted nerve stimulator within a trial period of 1 month. In a few cases, this determination may take longer to make. The medical necessity for such diagnostic services that are furnished beyond the first month must be documented.

NOTE: Electrical nerve stimulators do not prevent pain but only alleviate pain as it occurs. A patient can be taught how to employ the stimulator, and once this is done, can use it safely and effectively without direct physician supervision. Consequently, it is inappropriate for a patient to visit his/her physician, physical therapist, or an outpatient clinic on a continuing basis for treatment of pain with electrical nerve stimulation. Once it is determined that electrical nerve stimulation should be continued as therapy and the patient has been trained to use the stimulator, it is expected that a stimulator will be implanted or the patient will employ the TENS on a continual basis in his/her home. Electrical nerve stimulation treatments furnished by a physician in his/her office, by a physical therapist or outpatient clinic are excluded from coverage by §1862(a)(1) of the Act. (See §160.7 for an explanation of coverage of the therapeutic use of implanted peripheral nerve stimulators under the prosthetic devices benefit. See §280.13 for an explanation of coverage of the therapeutic use of TENS under the durable medical equipment benefit.)”

2011 Update

A literature review was conducted through August 2011. There was no new literature identified that would prompt a change in the coverage statement.

2012 Update

A search of the MEDLINE database was conducted through September 2012. The following is a summary of literature reviewed:

In 2011 Raphael et al. reported a multicenter double-blinded randomized crossover trial of a single PENS treatment compared with a sham treatment in 30 patients with surface hyperalgesia due to a variety of chronic pain conditions. The duration of pain ranged from 1 to 35 years, with a mean of 8.1 years. Subjective pain on a numerical scale and a pressure pain threshold were measured prior to and 1 week after the single treatment, with a washout period of 4 weeks between treatments. T he median numerical rating scale improved from 7.5 to 0.5 after active PENS and did not change after sham treatment (7.5 pre, 7.5 post). The mean pain pressure threshold improved from 202 gm to 626 gm after active PENS and did not change significantly after sham treatment (202 gm pre, 206 gm post). Blinding was maintained after the first treatment, but not after the second due to the tingling sensation with active PENS. Analysis of the first treatment showed a significant difference in change of the numerical rating scale (3.9 vs. 0.1) and in the pain pressure threshold (310 gm vs. 8 gm) for the active compared to sham treatment. Longer term follow-up in a larger sample of patients is needed to evaluate the efficacy of this treatment approach to chronic hyperalgesia.

Wanich and colleagues (2011) published the results of a small (n=23) single-blinded randomized controlled trial that assessed the efficacy of PNT to control acute pain after total knee replacement. Twice daily PNT or sham treatments were begun following removal of the epidural at 36 to 48 hours post-surgery and continued until hospital discharge. The average length of stay was 4.36 days in the PNT group and 3.9 days in the control group. All patients randomized to the control group completed the study, while 2 participants from the experimental group withdrew due to unwillingness to comply with twice daily treatments. Before and after each treatment, patients completed a Brief Pain Inventory, which included a VAS pain score. The VAS pain score decreased from 28 to 19 after PNT (32% decrease), but did not change significantly in the control group (26 pre- and 25 post-treatment). Limitations of the study included: not reporting the results for the Brief Pain Inventory, the lack of investigator blinding, and measurement of outcomes immediately after treatment. The authors indicate that a larger trial is planned.

There was no published literature found that would prompt a change in the coverage statement.

2013 Update

A search of the MEDLINE database did not reveal any new information that would prompt a change in the coverage statement.

2014 Update

A literature search conducted through June 2014 did not reveal any new information that would prompt a change in the coverage statement.

2015 Update

A literature search conducted through May 2015 did not reveal any new information that would prompt a change in the coverage statement.

2017 Update

A literature search conducted using the MEDLINE database did not reveal any new literature that would prompt a change in the coverage statement.

2018 Update

A literature search was conducted through June 2018. There was no new information identified that would prompt a change in the coverage statement.

2019 Update

Annual policy review completed with a literature search using the MEDLINE database through June 2019. No new literature was identified that would prompt a change in the coverage statement.

2020 Update

Annual policy review completed with a literature search using the MEDLINE database through September 2020. No new literature was identified that would prompt a change in the coverage statement.

2021 Update

Annual policy review completed with a literature search using the MEDLINE database through September 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.

The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommends that chronic pain trials should consider assessing outcomes representing 6 core domains: pain, physical functioning, emotional functioning, participant ratings of improvement and satisfaction with treatment, symptoms and adverse events, and participant disposition (Dworkin, 2005). The benchmarks for interpreting changes in chronic pain outcomes are as follows (Dworkin, 2008):

Pain intensity measured by a 0 to 10 numeric rating scale
Physical functioning measured by the Multidimensional Pain Inventory Interference Scale and Brief Pain Inventory Interference Scale
Emotional functioning measured by the Beck Depression Inventory
Profile of Mood States measured by Total Mood Disturbance and Specific Subscales
Global Rating of Improvement measured by Patient Global Impression of Change

Regarding optimal timing of outcome assessment, this varies with pain setting (Gewandter, 2015). Per IMMPACT, recommended assessment timing includes at 3, 6, and 12 months in patients with chronic low back pain, 3 to 4 months after rash onset in postherpetic neuralgia, 3 and 6 months in patients with painful chemotherapy-induced peripheral neuropathy, and at various timepoints in the chronic post-surgical pain setting (ie, 24 to 48 hours after surgery; 3, 6, and 12 months; or surgery-specific times based on the natural history of acute to chronic pain transition).

Plaza-Manzano et al evaluated the effects of PENS alone or as an adjunct to other interventions on pain and related disability in adults with musculoskeletal pain conditions (Plaza-Manzano, 2020). This systematic review and meta-analysis included a total of 19 RCTs. Overall, the results revealed poor quality of evidence (dependent upon the presence of study limitations, indirectness of evidence, unexplained heterogeneity or inconsistency of results, imprecision of results, and high probability of publication bias), suggesting that PENS alone is associated with a large effect compared with sham and a moderate effect when compared with other interventions for decreasing pain intensity in the short term. Additionally, the combination of PENS with other interventions had a similar poor quality of evidence for a moderate effect for reducing pain intensity than comparative intervention alone. No clear effects of PENS, either alone or in combination, on related disability were seen. None of the included trials were able to blind therapists. Ten of the trials rated a high risk of bias in the item of allocation concealment and 17 in the item of blinding of participants. Beyond these 2 items, the risk of bias in the included trials was low. Of note, the quality of included evidence was negatively impacted by the presence of heterogeneity in the data and an insufficient number of participants to meet the desired significance and power in some RCTs.

2022 Update

Annual policy review completed with a literature search using the MEDLINE database through June 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.

Beltran-Alacreu et al evaluated the effectiveness of PENS compared to transcutaneous electrical nerve stimulation (TENS) on the reduction of musculoskeletal pain (Beltran-Alacreu, 2022). This systematic review and meta-analysis included a total of 9 RCTs in the qualitative analysis, with 7 in the quantitative analysis (N=527). Overall, there was low-quality evidence for increased pain intensity reduction with PENS over TENS, but the difference found was not deemed to be clinically significant. When only studies with low risk of bias were meta-analyzed, there was a moderate quality of evidence that there is no difference between TENS and PENS for pain intensity. Six out of the 9 studies presented high risk for the blinding of participants, and 7 out of 9 were high risk for blinding of personnel. Beyond these 2 items, the risk of bias in the included trials was either low or unclear. Protocols and parameters for the application of PENS and TENS were heterogenous across all trials.

2023 Update

Annual policy review completed with a literature search using the MEDLINE database through June 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.

Restorative neurostimulation therapy with the ReActiv8 system has been evaluated in 1 multicenter, sham-controlled RCT enrolling 204 individuals with chronic, refractory low back pain (ReActiv8-B, NCT02577354). Control group participants received treatment with theReActiv8 system set to deliver low-level stimulation. The primary endpoint was the difference in proportions of responders in the treatment and control groups. Response was defined as the composite of 30% or greater reduction in VAS and no increase in pain medications, assessed at 120 days. Following the 120-day randomized phase, participants in the control group were given the option to cross over to the intervention group and were followed along with the participants from the intervention group for up to 3 years. Primary study results were reported by Gilligan et al (Gilligan, 2021). Information on the RCT is also included in the FDA Summary of Safety and Effectiveness Data conducted as part of the premarket approval process (FDA, 2020).

At 120 days, there was no difference between groups on the primary endpoint of treatment response (57.1% intervention vs 46.6% sham; p =.1377) or the individual components of the primary endpoint. The study investigators conducted prespecified secondary analyses of the primary outcome data, including the between-group difference in VAS at 120 days, a review of participants with increased pain medications, and a cumulative-proportion-of-responders analysis, which graphically displays the proportion of responders across the range of all possible cutoffs and is described as having greater statistical power than the comparison of proportions of the dichotomized primary outcome. The VAS mean change from baseline to 120 days favored the intervention group (-3.3 vs -2.4; p =.032), but it is unclear if the difference between groups (0.9 points) was clinically meaningful. The cumulative proportion-of-responders analysis similarly favored the intervention group (p =.0499). Nine participants in both the intervention and control groups had an increase in pain medication at 120 days, but the increase was unrelated to low back pain in 6 of 9 participants in the treatment group versus 0 of 9 in the control group.

Most importantly, the controlled phase was only 120 days. In the longer-term, uncontrolled follow-up phase of the trial, there was continued improvement in VAS scores over time in those who were assessed, but the lack of a control group and high attrition limits drawing conclusions from these results. Data was available for 176 of 204 participants at 1 year (86.3%), 156 of 204 participants (79%) at 2 years, and 130 of 204 (63.7%) at 3 years (Gilligan, 2021; Gilligan, 2023; Gilligan, 2023).

Nonrandomized studies of restorative neurostimulation therapy for chronic low back pain are at high risk of bias due to lack of blinding, small sample sizes, high attrition, and no sham control, but are briefly discussed here for completeness. A prospective single-arm trial (ReActiv8-A; NCT01985230) was conducted at 9 sites in the United Kingdom, Belgium, and Australia to assess technical feasibility, performance, and safety of the ReActiv8 system. Participants were followed at 45, 90, 180, and 270 days, then annually for 4 years. Results at 1 year, 2 years, and 4 years have been published (Deckers, 2018; Thomson, 2021; Mitchell, 2021). Of 53 participants enrolled, 33completed 4-year follow-up. Of these, 73% had a clinically meaningful improvement of 2 points or greater on the low back pain Numeric Rating Scale and 76% had an improvement of 10 points or greater on the Oswestry Disability Scale (Mitchell, 2021). A case series (N = 44) published in 2022 reported the experience of a single surgeon in Germany (Ardeshiri, 2022). After 1 year of therapy, 68% of individuals with refractory chronic low back pain who received treatment with the Reactive8 device had moderate (30%or greater) reductions in pain and 52% had substantial (greater than 50%) reductions in pain.

In September 2022, NICE published guidance on neurostimulation of lumbar muscles with the ReActiv8 system for refractory non-specific chronic low back pain (Nice, 2022).

The guidance was based on a rapid review conducted in July 2021 and included the following statements:

"Evidence on the efficacy and safety of neurostimulation of lumbar muscles for refractory non-specific chronic low back pain is limited in quantity and quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research."

"Further research should include suitably powered randomised controlled trials comparing the procedure with current best practice with appropriate duration. It should report details of patient selection and long-term outcomes."

October 2023 Update

The literature on peripheral subcutaneous field stimulation (PSFS) was searched through February 2023. Relevant literature identified includes 2 small comparative trials, 2 large retrospective case series from outside of the U.S., and a number of small case series.

Case series are insufficient to evaluate pain outcomes due to the variable nature of pain and the subjective nature of the outcome measures. Randomized controlled trials with adequate blinding are needed to control for the variable natural history of pain, as well as for the expected placebo effect in research on pain treatment.

A prospective comparative study of combined use of SCS and PSFS in patients with low back pain was reported by Mironer et al. in 2011 (Mironer, 2011). In the first part of the study, 20 patients with failed back surgery syndrome or spinal stenosis underwent a trial with both SCS and PSFS and selected the type of stimulation they found most efficacious (Program 1: SCS alone, Program 2: PSFS alone, or Program 3: combined SCS and PSFS). Patients were blinded to the difference between the programs (randomized order of presentation) and were encouraged to try each program for at least 8 hours; 79% percent of patients preferred the simultaneous use of SCS and PSFS. In the second part of the study, 20 patients were implanted with SCS and PSFS electrodes and selected which program they preferred (SCS and PSFS used simultaneously, SCS as anode and PSFS as cathode, or SCS as cathode and PSFS as anode). The programs were presented in a random order, and patients were blinded to the difference between the programs. Communication between SCS and PSFS was reported to provide wider coverage of axial pain, with an overall success rate (>50% pain relief) of 90%. The most effective program was SCS as cathode and PSFS as anode.

Two large case series have been identified. Sator-Katzenschlager et al. reported in 2010 a retrospective multicenter study of the use of PSFS (Sator-Katzenschlager, 2010). A total of 111 patients with chronic pain were treated, including 29 patients with low back pain, 37 with failed back surgery syndrome, 15 with cervical neck pain, and 12 patients with postherpetic neuralgia. The median duration of chronic pain was 13 years and the median number of previous surgeries was 2.7. For permanent implantation of the leads, patients had to have achieved at least 50% improvement in pain on a numerical rating scale during the trial period. After permanent implantation, pain intensity decreased in 102 patients (92%). Mean pain intensity decreased from 8.2 at baseline to 4.0 at follow-up with a reduction in consumption for analgesics and antidepressants. Lead dislocation or fracture occurred in 20 patients (18%).

In 2011, Verrils et al. reported on a series of 100 patients treated with PSFS for chronic neuropathic pain. Indications included chronic pain in occipital/craniofacial (n=40), lumbosacral (n=44), thoracic (n=8), groin/pelvis (n=5), or abdominal (n=3) regions (Verrills, 2011). Selection criteria included a clearly defined, discrete focal area of pain with a neuropathic component 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. Outcomes were assessed at a mean of 8.1 months after implantation (range, 1 to 23 months) with a combination of numerical pain scores, patient answered questionnaires, and patient medical histories. For the entire cohort, pain decreased from 7.4 at baseline to 4.2 at follow-up. About 34% of patients had at least a 75% improvement in pain scores, and 69% improved by at least 50%. Analgesic use decreased in 40% of patients following PSFS. Adverse events were reported in 14% of patients, including unpleasant sensations, lead erosions and lead or battery migration.

Johnson et al conducted a 2-part study comprised of a double-blind, sham controlled RCT followed by an open-label mechanistic study to determine the impact of external non-invasive peripheral electrical nerve stimulation (ENPENS) in adults with chronic moderate to severe peripheral nerve injury pain (Johnson, 2021). Patients were randomized to either active ENPENS or sham for 3 months (minimum 10 minutes daily). The primary outcome was change in average pain intensity (on a 0 to 10 Likert scale) after ENPENS or sham. Seventy-six patients were randomized (38 per group), with 65 (31 active, 34 sham) included in the intention-to-treat analysis. After adjusting for baseline scores, pain scores were 0.3 units lower in the active group, but not significantly different from the sham group (p=.30). Nineteen patients continued on to the open-label ENPENS mechanistic study after the RCT. In the open-label phase, primary outcomes of mechanical pain sensitivity (p=.006) and mechanical allodynia (p=.043) significantly improved, indicating reduced sensitivity to pain with low-frequency nerve stimulation. Results from the RCT failed to reach significance and the results from the open-label portion were limited by the small sample size and lack of a comparator group.

A retrospective case series by Warner et al reported on adults undergoing peripheral nerve stimulation implantation at an academic medical center (Warner, 2021). The primary outcomes were changes in numeric rating scale pain scores, opioid use in oral morphine milligram equivalent (MME), and self-reported patient functioning at 6 months post-implantation. A total of 72 patients underwent peripheral nerve stimulation implantation. The most common indication for stimulation was occipital neuralgia (47.3%) followed by lower-extremity neuropathies (16.5%). Peripheral nerve stimulation implantation was associated with a 6-month reduction in pain scores (median baseline score 7 vs median score 4 at 6 months; p<.001) and opioid utilization (median 60 MME at baseline vs median 18 MME among those with baseline opioid use [n=25]; p<.001). All patients reported improvement in daily functioning, with median improvement of 73% post-implantation.

CPT/HCPCS:

64555	Percutaneous implantation of neurostimulator electrode array; peripheral nerve (excludes sacral nerve)
64596	Insertion or replacement of percutaneous electrode array, peripheral nerve, with integrated neurostimulator, including imaging guidance, when performed; initial electrode array
64597	Insertion or replacement of percutaneous electrode array, peripheral nerve, with integrated neurostimulator, including imaging guidance, when performed; each additional electrode array (List separately in addition to code for primary procedure)
64598	Revision or removal of neurostimulator electrode array, peripheral nerve, with integrated neurostimulator
64999	Unlisted procedure, nervous system

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