Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Percutaneous Electrical Nerve Stimulation (PENS) and Percutaneous Neuromodulation Therapy (PNT)

Policy #:05.00.75

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin 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 Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

PERCUTANEOUS ELECTRICAL NERVE STIMULATION (PENS)

Percutaneous electrical nerve stimulation, when used as a treatment for pain, is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published literature.

Percutaneous electrical nerve stimulation to assess a member's suitability for implantation of an electrical nerve stimulator and electrodes is considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support its use.

PERCUTANEOUS NEUROMODULATION THERAPY (PNT)

Although the US Food and Drug Administration (FDA) has approved devices for percutaneous neuromodulation therapy, the Company has determined that the safety and/or effectiveness of this service, when used as a treatment, cannot be established by review of the available published peer-reviewed literature. Therefore, percutaneous neuromodulation therapy, when used as a treatment for pain, is considered experimental/investigational by the Company and not covered.

Although the US Food and Drug Administration (FDA) has approved devices for percutaneous neuromodulation therapy, the Company has determined that the available published peer-reviewed literature does not support its use in assessing a member's suitability for implantation of an electrical nerve stimulator and electrodes. Therefore, percutaneous neuromodulation therapy is considered not medically necessary by the Company and not covered.

PLACE OF SERVICE

Percutaneous electrical nerve stimulation and percutaneous neuromodulation therapy are performed in a professional provider’s office, clinic, or hospital outpatient department setting.

Percutaneous electrical nerve stimulation and percutaneous neuromodulation therapy do not meet the Company's definition of durable medical equipment (DME) because it is inappropriate for home use.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

BENEFIT APPLICATION

Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The FDA does not regulate percutaneous electrical nerve stimulation as a treatment. However, the agency does approve for marketing the acupuncture needles and needle electrodes used in the procedures.

Percutaneous Neuromodulation Therapy™ (Vertis Neurosciences) received FDA approval in September 2002. The Deepwave Percutaneous Neuromodulation Pain Therapy System (Biowave) received FDA approval in December 2005.

Description

Percutaneous electrical nerve stimulation (PENS) is a minimally invasive, non-surgical procedure in which needle-like electrodes are temporarily inserted (to a depth of one to four centimeters) into the deep tissues (muscles, ligaments, tendons) around or immediately adjacent to the nerve serving the painful area in order to electrically stimulate the peripheral nerve fibers. The intensity of the electrical stimulation is adjusted to produce the highest tolerable or comfortable electrical sensation without evidence of muscle contraction. A PENS unit consists of one or more electric signal generators, a battery, and a set of electrodes. Frequencies used during PENS include, low-frequency (2 to 4 Hz), intermediate-frequency (10 to 30 Hz), and high-frequency (75 to 200 Hz). Treatment regimens consist of 30- minute sessions, one to three times per week for 3 to 4 weeks.

PENS is generally reserved for individuals who fail to get pain relief from transcutaneous electrical nerve stimulation (TENS), due to physical barriers that inhibit the electrical stimulation (e.g., skin resistance, scar tissue, obesity). Contraindications to PENS are the same as those for electrical stimulation in general: avoid pregnant individuals, individuals who have carcinoma, and stimulation over the thorax in individuals with pacemakers. PENS is not the same as acupuncture with electrical stimulation (i.e., electroacupuncture). In electrical acupuncture, needles are inserted below the skin, but placement is based on specific theories regarding energy flow throughout the human body (i.e., meridians and acupoints). However, in PENS, the needles are placed not at acupoints, but along dermatomes, myotomes, and scleratomes to activate peripheral nerves. Thus, the location of stimulation using PENS is determined by proximity to the pain rather than the theories of energy flow that guide placement of stimulation for acupuncture.

Percutaneous neuromodulation therapy (PNT) is a variation of PENS in which fine filament electrode arrays are placed near the area that is causing pain. Some use the terms PENS and PNT interchangeably.

Although PENS and PNT are minimally invasive procedures, a number of potential adverse events may occur, such as bruising, bleeding, vascular or nerve damage, pneumothorax, interaction with a cardiac pacemaker if used above the waistline, seizures if used near the head, possible effects if used during pregnancy, dislodgement (with loss of effect), unpleasant tingling sensations, and collection of blood under the skin. Given the potential problems, PENS and PNT should be performed in a professional provider’s office, clinic, or hospital outpatient department under the guidance of a specialist in pain management.

REGULATORY STATUS

Percutaneous Neuromodulation Therapy™ (Vertis Neurosciences) received approval to market by the U.S. Food and Drug Administration (FDA) through the 510(k) process in 2002. The labeled indication reads as follows, “Percutaneous neuromodulation therapy (PNT) is indicated 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.” The Deepwave Percutaneous Neuromodulation Pain Therapy System (Biowave) received 510(k) approval in 2005, listing the Vertis Neuromodulation system and a Biowave TENS unit as predicate devices. The Deepwave system includes a sterile single-use percutaneous electrode array that contains 1,014 microneedles in a 1.5-inch diameter area. The needles are 736 microns (0.736 millimeters) in length; the patch is reported to feel like sandpaper or Velcro.

PEER-REVIEWED LITERATURE

Clinical reports exist concerning the use of PENS or PNT for various types of conditions such as low back pain (LBP), neck pain, osteoarthritic pain, headache, diabetic neuropathic pain, acute herpes zoster, cancer pain, irritable bowel syndrome, acute postoperative pain, and chronic surface hyperalgesia.

PERCUTANEOUS ELECTRICAL NERVE STIMULATION
Chronic Low Back Pain (LBP)

In 2008, Weiner and colleagues reported the results from a randomized controlled trial which included 200 men and women (> 64 years of age) with chronic low back pain (CLBP). The purpose of this study was to evaluate the efficacy of percutaneous electrical nerve stimulation (PENS) with and without general conditioning and aerobic exercise (GCAE), for reducing pain and improving physical function. Individuals were randomized to one of the following four groups (50 individuals per group): (1) PENS [47 completed; 94%], (2) control-PENS (brief electrical stimulation to control for treatment expectancy) [48 completed; 96%], (3) PENS+GCAE [45 completed; 90%], or (4) control-PENS+GCAE [44 completed; 88%]. Overall drop-out was 8%. All interventions were administered twice a week for 6 weeks. All primary and secondary outcome measures were collected at baseline, within one week of completing the 6 week intervention, and 6 months later. All four groups experienced significantly reduced pain, improved self-reported disability, sustained at 6 months. The GCAE groups experienced significantly fewer fear avoidance beliefs immediately post-intervention and at 6 months than non-GCAE groups. There were no significant side effects. The authors stated that "[b]ecause treatment expectancy was comparable among the four randomized groups, one cannot exclude the possibility that treatment expectancy accounted for the change in outcomes observed." Since brief electrical stimulation (i.e., control-PENS, 5 minutes) facilitated comparably reduced pain and improved function at 6 months as compared with PENS (30 minutes), the exact dose of electrical stimulation needed for analgesia could not be determined. GCAE was more effective than PENS alone in reducing fear avoidance beliefs, but not in reducing pain or in improving physical function.

Yokoyama et al. (2004) investigated the long-term effect of percutaneous electrical nerve stimulation (PENS) on chronic low back pain (LBP). The authors evaluated the number of sessions for which PENS should be performed to alleviate chronic LBP and how long analgesia is sustained. Individuals were randomized to the following treatment groups: Group A (n = 18) received PENS twice a week for 8 weeks, Group B (n = 17) received PENS twice a week for the first 4 weeks and transcutaneous electrical nerve stimulation (TENS) twice a week for the second 4 weeks, and Group C (n = 18) received TENS twice a week for 8 weeks. Pain level, degree of physical impairment, and the daily intake of nonsteroidal antiinflammatory drugs (NSAIDs) were assessed before the first treatment, 3 days after Week 2, Week 4, and Week 8 treatments, and at 1 and 2 months after the sessions. Individuals in Group A (PENS only) had significantly decreased pain levels, physical impairment, and nonsteroidal anti-inflammatory drug (NSAID) use, which continued to be present 1 month after treatment completion compared to Group B (PENS+TENS) and Group C (TENS only). 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. Limitations of this study include: lack of a sham-PENS group, blinding was not reported, and concomitant placebo effects, hypnotic effects, or individuals’ psychological expectations may have contributed to the results.

Weiner et al. (2003) evaluated the efficacy of PENS on chronic low back pain in community-dwelling older adults. Thirty-four individuals were randomized to receive twice-weekly PENS and physical therapy or sham PENS and physical therapy for 6 weeks. The primary outcome measures were assessed at baseline, immediately after the 6-week intervention period, and 3 months later. Individuals randomized to PENS plus physical therapy displayed significant reductions in pain intensity measures from pre- to post-treatment, but the sham PENS plus physical therapy individuals did not. These pain reduction effects were maintained at 3-months follow-up. Significant reductions in pain-related disability were observed at post-treatment for the PENS plus physical therapy individuals and were maintained at follow-up, but the sham PENS plus physical therapy individuals did not show reductions in pain-related disability. Psychosocial function, timed chair rise, and isoinertial lifting endurance also improved significantly at post-treatment for the PENS plus physical therapy individuals, and their improvement was sustained at 3-months follow-up, but the sham PENS plus physical therapy did not display significant changes on these measures after treatment. The authors noted that "[l]arger studies with longer duration of follow-up are needed to validate these findings and support the use of PENS in clinical practice."

Hsieh and Lee (2002) investigated the therapeutic effects of low-frequency PENS to TENS in 133 individuals with low back pain. Individuals were randomized to three groups: medication only (Group 1), one shot of PENS plus medication (Group 2), or one shot of TENS plus medication (Group 3). Therapeutic effects were measured using a visual analog scale, body surface score, pain pressure threshold, and the Quebec Back Pain Disability Scale. Immediately after one-shot treatment, the visual analog scale improved 1.53 units and the body surface score improved 3.06 units in Group 2. In Group 3, the visual analog scale improved 1.50 units and the body surface score improved 3.98 units. The improvements did not differ between the two groups. There were no differences in improvement at three days or one week after the treatment among the three groups. The authors concluded that "[s]imple one-shot treatment with percutaneous electrical nerve stimulation or transcutaneous electrical nerve stimulation provided immediate pain relief for low back pain individuals. One-shot transcutaneous electrical nerve stimulation treatment is recommended due to the rarity of side effects and its convenient application." Limitations of this study include: lack of a sham-PENS or TENS group, the article did not report whether any individuals withdrew from the study before its completion, the study was not blinded, and a possible placebo effect resulting from the placement of the needles.

Ghoname EA, White PF et al. (1999) reported the results from a randomized, single-blinded, cross-over study evaluating sham PENS, active PENS, and TENS in 64 individuals with sciatica due to lumbar disc herniation. Each treatment modality was administered for a period of 30 minutes three times per week for 3 weeks, with 1 week off between each modality. 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. The authors concluded that "PENS was more effective than TENS when administered at a stimulation frequency of 4 Hz in providing short-term pain relief and improved functionality in individuals with sciatica." Limitations of the study included: individual withdrawal from the study before its completion was not reported, lack of individual blinding, and a possible placebo effect.

Ghoname EA, Craig WF et al. (1999) compared the effectiveness of sham PENS, active PENS, TENS, and flexion-extension exercise therapies in 60 individuals with long-term lower back pain secondary to degenerative disk disease. The study was a randomized, single-blinded, sham-controlled, crossover study. Individuals were randomized to 4 therapeutic modalities (sham-PENS, PENS, TENS, and exercise therapies) which were each administered for 30 minutes 3 times a week for 3 weeks. Active PENS resulted in better outcomes than all other modalities in terms of VAS pain, analgesic requirements, physical activity, quality of sleep, and preference. Limitations of this study included: individual withdrawal from the study before its completion was not reported, lack of individual blinding, and a possible placebo effect.

In a randomized, sham-controlled, crossover study, Hamza et al. (1999) evaluated the effect of differing durations (0, 15, 30, and 45 minutes) of electrical stimulation on the analgesic response to PENS in 75 individuals with low back pain over the course of an 11-week study period. All active PENS treatments were administered using alternating frequencies of 15 and 30 Hz three times per week for 2 consecutive weeks. PENS produced short-term improvements in the visual analog scale pain, physical activity, and quality of sleep scores, and a reduction in the oral analgesic requirements. The 30 and 45 minute durations of electrical stimulation produced similar hypoalgesic effects and were significantly more effective than either 15 or 0 minutes. The 30 and 45 minute treatments were also more effective in improving physical activity and sleep scores over the course of the 2-week treatment period. In contrast to the sham treatment (0 minutes), the health status survey short form revealed that electrical stimulation for 15 to 45 minutes three times per week for 2 weeks improved individual function. Limitations of this study included: individual withdrawal from the study before its completion was not reported, lack of individual blinding, and a possible placebo effect.

In a randomized, sham-controlled, crossover study, Ghoname ES et al. (1999) evaluated the effect of four different frequencies of electrical stimulation (4 Hz, alternating 15 Hz and 30 Hz (15/30 Hz), 100 Hz, and 0 Hz (sham-PENS)), on the analgesic response to PENS therapy in 68 individuals with low back pain secondary to degenerative lumbar disc disease. Each treatment was administered for a period of 30 minutes three times per week for 2 weeks. The sham-PENS (0 Hz) treatments failed to produce changes in the degree of pain, physical activity, sleep quality, or daily intake of oral analgesic medications. In contrast, 4-Hz, 15/30-Hz, and 100-Hz stimulation all produced significant decreases in the severity of pain, increases in physical activity, improvements in the quality of sleep, and decreases in oral analgesic requirements. Of the three frequencies, 15/30 Hz was the most effective in decreasing pain, increasing physical activity, and improving the quality of sleep. Limitations of this study included: individual withdrawal from the study before its completion was not reported, lack of individual blinding, and a possible placebo effect.

Chronic Neck Pain

One prospective, randomized, single-blinded, sham-controlled, crossover study by White et al. (2000) compared two locations of active stimulation with sham stimulation in 68 individuals with nonradiating chronic neck pain. 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. All treatments were given for 30 minutes, three times per week for three weeks, with one week off between treatments. Outcomes were assessed immediately after completion of a three-week treatment period. Due to the nature of the treatment, individual blinding was not possible. In an attempt to minimize investigator bias, all individual assessments were performed by individuals not involved in administering the treatments. However, details as to whether this blinding was successful were not reported. 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. 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 PNT for treating chronic neck pain.

Diabetic Neuropathy

In a prospective, randomized, single-blinded, sham-controlled, crossover study by Hamza et al. (2000), 50 individuals with type 2 diabetes and peripheral neuropathic pain for at least 6 months were randomized to receive either sham PENS (needles only) or active PENS (needles with electrical stimulation). Treatment lasted 30 minutes, and was performed three times a week for three consecutive weeks. There was a one week washout period between the two different treatments. Active PENS resulted in better outcomes on VAS pain, activity, sleep, and analgesic use, compared with sham PENS. The post-treatment physical and mental components of the SF-36, the BDI, and the POMS all showed a significantly greater improvement with active versus sham treatments. Active PENS treatment improved the neuropathic pain symptoms in all individuals. 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 also not mentioned. In addition, 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

In 1999, Ghoname et al. reported the results of a non-randomized, single-blinded, sham-controlled, crossover study comparing sham PENS to active PENS in five individuals with post-electroconvulsive therapy (ECT) head pain. Each treatment was administered for 30 minutes. Due to the nature of the treatment, double-blinding was not possible. In an attempt to minimize investigator bias, all individual assessments were performed by individuals not involved in administering the treatments. However, details as to whether blinding was successful were not reported. In this sham-controlled preliminary evaluation the authors stated that, “PENS therapy proved to be a useful alternative to opioid analgesics for the acute treatment and/or prevention of ECT-induced headache." Furthermore, the authors noted the need for prospective, RCTs to determine the relative efficacy of PENS and serotonin agonist therapies in the prophylactic management of ECT-induced headaches.

In 2000, Ahmed et al. conducted a prospective, randomized, single-blinded, sham-controlled, crossover study in 30 individuals with longstanding (at least six months duration) headaches of three types: tension, migraine, and post-traumatic injury. Treatment consisted of active and sham PENS. All treatments were administered for 30 minutes, three times a week for two consecutive weeks with one week off between the two different treatments. 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.

These two studies do not establish the effectiveness of PENS for treatment of ECT-induced headaches or chronic headaches.

Chronic Surface Hyperalgesia

Raphael and colleagues (2011) conducted a multicenter randomized double-blind sham-controlled crossover trial on 31 individuals with surface hyperalgesia due to a variety of chronic pain conditions to investigate the efficacy of PENS. The pain diagnoses included surgical scar pain, occipital neuralgia, post-traumatic neuropathic pain, stump pain, inflammatory neuropathic pain, chronic low back pain, complex regional pain syndrome, pain following total knee arthroplasty (TKA), chronic cervical pain, and post-herpetic neuralgia. 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. For the active PENS therapies, the median numerical rating scale for pain changed from 7.5 to 0.5 (range 0-8.5) after therapy, but did not change after sham treatment. The mean pain pressure threshold changed from 202 gm before therapy to 626 gm after PENS therapy, but did not change significantly after sham treatment. There was a statistically significant difference between the changes in NRS (3.9 vs 0.1) and PPT (310 gm vs 8 gm) for the active compared with the sham treatment. Blinding was maintained after the first treatment, but not after the second due to the tingling sensation with active PENS. The authors concluded that "PENS therapy appears to be effective in providing short-term pain relief in chronic pain conditions. Studies, involving larger sample sizes and longer follow-up are recommended."

Acute Herpes Zoster

In a prospective, randomized, single-blinded, controlled study by Ahmed et al. (1998), 50 individuals with the recent (< 72 hours) acute onset of herpes zoster lesions were randomly assigned to either the control group (which received famciclovir 500mg three times a day for one week) or the experimental group (which received PENS therapy for 30 minutes three times a week for two weeks). The PENS group experienced more rapid resolution of the vesicles and complete healing of the lesions. The VAS pain scores were lower in the PENS group during the two week observation period. On the global assessment questionnaire, the percent decrease in the VAS pain score was 67% in the PENS group compared with 45% in the control group. The percentage improvement in the VAS physical activity and quality of sleep scores was greater in the PENS group versus the control group at the end of the second week. PENS therapy was associated with a decrease in the severity of postherpetic neuralgia at three and six months, but not at nine months. 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 also not mentioned. In addition, this study did not include a placebo (or sham) group. This single study, which may not have been adequately blinded, does not allow conclusions about the effects of PENS for treating postherpetic neuralgia during acute herpes zoster.

Cancer Pain

In 1998, Ahmed et al. evaluated the use of PENS in the management of opioid-resistant cancer pain in three individuals. PENS therapy was administered on three or more occasions using acupuncture-like needle probes that were stimulated for 30 minutes at frequencies of 4-100 Hz. Two of the three individuals achieved good to excellent pain relief that lasted 24-72 hours after each treatment session. This small (n=3) single case series does not allow conclusions about the effects of PENS for treating cancer pain.

Irritable Bowel Syndrome (IBS)

In 2002, Dr. Gerald W. Grass evaluated the use of PENS in the treatment of IBS in a single individual. PENS therapy was administered once a week for 15 weeks for 30 minutes at frequencies of 4 and 8 Hz. Following 15 treatment sessions, the individual reported dramatic and long-lasting diminution of symptoms. This single case report does not allow conclusions about the effects of PENS for treating irritable bowel syndrome.

PERCUTANEOUS NEUROMODULATION THERAPY
Chronic Low Back Pain

In Borg-Stein et al (2003), the authors evaluated the safety, tolerability, and clinical efficacy of PNT in 59 individuals with subacute low back pain with radiation to the lower extremity. Individuals were treated with PNT 1 to 2 times per week for at least 4 weeks. Mean VAS scores significantly improved as follows: leg/buttock pain decreased by 37%; low back pain decreased by 26%; activity levels improved by 38%; and sleep improved by 27%. The Oswestry Low Back Pain Disability scores significantly improved by 24%. Pain relief was sustained over a 3-month observation period. Limitations of this study included: lack of a control group, absence of follow-up data on individuals who withdrew from the study, and a possible placebo effect.

Seroussi RE et al (2003) reported the effects of PNT on 31 individuals with chronic and severe levels of LBP. The individuals were treated with PNT 2 times per week for 4 weeks. Baseline VAS scores of LBP, physical activity, sleep, and the Oswestry Questionnaire were recorded. The final assessment was made 48 hours after the last treatment. After 4 sessions, the individuals completed a “responder screen” questionnaire whereby, to continue treatment, they had to indicate both a perceived benefit and improvement in LBP and/or activity levels. Of the 18 individuals (58% of 31) who passed the responder screen, 14 (78% of 18, 45% of 31) had ≥30% improvement in LBP and/or activity levels. Mean LBP scores significantly decreased by 37%; activity scores significantly improved by 39%; and sleep scores significantly improved by 40%. In addition, Oswestry scores significantly improved. Limitations of this study included: lack of a control group, absence of follow-up data on individuals who withdrew from the study, and a possible placebo effect.

In a randomized, single-blinded, crossover study, White PF, Ghoname EA et al. (2001) compared 4 montages, or patterns of needle placement, on the acute analgesic response to PNT when applied at the same dermatomal levels in 72 individuals with low back pain. All of the PNT treatments were administered at identical alternating stimulation frequencies of 15 and 30 Hz for a period of 30 min, three times per week for two consecutive weeks, with one week "off" between each modality. All four montages produced significant improvements in pain, physical activity, and quality of sleep, as well as reductions in the daily oral analgesic usage. The authors found that a bottle-shaped pattern achieved the best results, compared with 3 other patterns. The author stated that the "data suggest that the pattern of stimulation (i.e., montage) can influence the acute analgesic response to PNT". Limitations of this study include: lack of a control group and a possible placebo effect.

Osteoarthritic Pain

One prospective, randomized, single-blinded, sham-controlled study by Kang et al. (2007) compared stimulation (at the highest tolerable intensity) to placement of electrodes (without stimulation) in 70 individuals with knee osteoarthritis. Seven individuals (all in the sham group) were lost to follow-up. Of the 63 completed individuals, 28 individuals were randomly assigned to the sham group and 35 individuals were randomly assigned to the live treatment group. Individuals in the sham group were informed that they would not perceive the normal “pins and needles” with this new device (Deepwave Percutaneous Neuromodulation Pain Therapy System [Biowave Corporation]). Individuals received one treatment and were followed up for one week. 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 individual satisfaction were significantly higher in the PNT group (e.g., 77% vs. 11% good to excellent) at up to one-week follow-up. Interpretation is limited by the discrepancy between individual 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 and the contribution of short-term pain relief and placebo effects to these results. Questions also remain about the duration of the treatment effects. Larger double-blinded studies with a more effective sham condition and longer follow-up are needed. Therefore, this single study does not permit conclusions about the effectiveness of PNT for treating osteoarthritic pain of the knee.

Acute Postoperative Pain

In 2011, Wanich and colleagues assessed the efficacy of PNT in reducing the severity of acute pain and opioid use in individuals following total knee replacement (TKR) surgery. The authors conducted a single-blinded randomized controlled trial on 23 individuals who underwent primary TKR. The individuals were randomized into two groups--experimental or control group. Following TKR, individuals underwent twice daily PNT or sham treatments. All individuals randomized to the control group completed the study, while two individuals in the experimental group withdrew due to an unwillingness to comply with the twice daily treatments. Before and after each treatment, individuals completed a Brief Pain Inventory questionnaire and the amount of all pain medications taken were recorded. The average length of stay was 4.36 days in the PNT group and 3.9 days in the control group. The VAS pain score decreased significantly after PNT, but did not change significantly in the control group, with a trend toward decreased opioid use in the PNT group but this was not significant. Post-hoc power analysis indicated that the study was underpowered. Additional limitations are the lack of investigator blinding and measurement outcomes immediately after treatment. The authors indicated that a larger trial is planned.

PRACTICE GUIDELINES AND POSITION STATEMENTS

The United Kingdom’s National Institute for Health and Care Excellence published guidance on PENS in 2013. NICE concluded that the current evidence on the safety of percutaneous electrical nerve stimulation (PENS) for refractory neuropathic pain raises no major safety concerns and there is evidence of efficacy in the short term, and that this procedure may be used with normal arrangements for clinical governance, consent and audit. The authors further stated that patient selection and treatment using PENS for refractory neuropathic pain should be carried out by teams specializing in pain management.

The American Academy of Neurology, American Association of Neuromuscular and Electrodiagnostic Medicine, and American Academy of Physical Medicine and Rehabilitation published an evidence-based guideline on the treatment of painful diabetic neuropathy in 2011. The guideline concluded that, based on a Class I study, electrical stimulation is probably effective in lessening the pain of painful diabetic neuropathy and improving quality of life and recommended that PENS be considered for the treatment of painful diabetic neuropathy (level B).

SUMMARY

Percutaneous electrical nerve stimulation (PENS) and percutaneous neuromodulation therapy (PNT) are minimally invasive, non-surgical procedures in which needle-like electrodes are temporarily inserted into the deep tissues around or immediately adjacent to the nerve serving the painful area. The literature evaluating PENS and PNT consists primarily of small uncontrolled and controlled trials with short follow-up periods and uncertainty regarding blinding and placebo effect. Recommendations from guidelines were mixed regarding the use of PENS and PNT to treat a number of conditions.
References


Ahmed HE, Craig WF, White PF, et al. Percutaneous electrical nerve stimulation: an alternative to antiviral drugs for acute herpes zoster. Anesth Analg. 1998;87:911-914.

Ahmed HE, Craig WF, White PF, et al. Percutaneous electrical nerve stimulation (PENS): a complementary therapy for the management of pain secondary to bony metastasis. Clin J Pain. 1998;14(4):320-323.

Ahmed HE, White PF, Craig WF, et al. Use of percutaneous electrical nerve stimulation (PENS) in the short-term management of headache. Headache. 2000;40(4):311-315.

Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Transcutaneous electric nerve stimulation (TENS) or percutaneous electric nerve stimulation (PENS) in the treatment of chronic and postoperative pain TEC Assessments. 1996;Volume 11, Tab 21.

Borg-Stein J, Seroussi RE, Gomba L, et al. Safety and efficacy of percutaneous neuromodulation therapy in the management of subacute radiating low back pain. Pain Practice. 2003;3(2):125-134.

Bril V, England J, Franklin GM, et al. Evidence-based guideline: Treatment of painful diabetic neuropathy: report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. Neurology. 2011;76(20):1758-65.

Chou R, Qaseem A, Snow V, et al. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. Oct 2 2007;147(7):478-491.

Chou, R. Subacute and chronic low back pain: Nonpharmacologic and pharmacologic treatment. 08/29/18. [UpToDate Web site]. Available at:
https://www.uptodate.com/contents/subacute-and-chronic-low-back-pain-nonpharmacologic-and-pharmacologic-treatment?search=chronic%20pain&source=search_result&selectedTitle=5~150&usage_type=default&display_rank=5#H35 [via subscription only]. Accessed February 11, 2019.

Condon JE, Borg-Stein J, Revord J, et al. A multicenter trial of percutaneous neuromodulation therapy for low back pain patients with a subacute duration of lower extremity pain. Paper presented at: American Academy of Pain Medicine Annual Meeting 2002; San Francisco, CA.

Feldman, EL, McCulloch DK. Treatment of diabetic neuropathy. 11/27/18. [UpToDate Web site]. Available at:https://www.uptodate.com/contents/treatment-of-diabetic-neuropathy?search=Percutaneous%20electrical%20nerve%20stimulation&source=search_result&selectedTitle=2~90&usage_type=default&display_rank=2#H20. Accessed February 11, 2019.

Ghoname EA, Craig WF, White PF, et al. Percutaneous electrical nerve stimulation for low back pain: a randomized crossover study. JAMA. 1999;281(9):818-823.

Ghoname EA, Craig WF, White PF. Use of percutaneous electrical nerve stimulation (PENS) for treating ECT-induced headaches. Headache. 1999;39:502-505.

Ghoname EA, White PF, Ahmed HE, et al. Percutaneous electrical nerve stimulation: an alternative to TENS in the management of sciatica. Pain. 1999;83(2):193-199.

Ghoname ES, Craig WF, White PF, et al. The effect of stimulus frequency on the analgesic response to percutaneous electrical nerve stimulation in patients with chronic low back pain. Anesth Analg. 1999;88(4):841-846.

Grass GW. Percutaneous electrical nerve stimulation in the treatment of irritable bowel syndrome: a case report. Medical Acupuncture. 2002;13(2):12-14.

Hamza MA, Ghoname EA, White PF, et al. Effect of the duration of electrical stimulation on the analgesic response in patients with low back pain. Anesthesiology. 1999;91(6):1622-1627.

Hamza MA, White PF, Craig WF, et al. Percutaneous electrical nerve stimulation: a novel analgesic therapy for diabetic neuropathic pain. Diabetes Care. 2000;23(3):365-370.

Hsieh RL, Lee WC. One-shot percutaneous electrical nerve stimulation vs. transcutaneous electrical nerve stimulation for lower back pain. Am J Phys Med Rehabil. 2002;81(11):838-843.

Johnson M, Martinson M. Efficacy of electrical nerve stimulation for chronic musculoskeletal pain: a meta-analysis of randomized controlled trials. Pain. 2007;130:157-165.

Kang RW, Lewis PB, Kramer A, et al. Prospective randomized single-blinded controlled clinical trial of percutaneous neuromodulation pain therapy device versus sham for the osteoarthritic knee: a pilot study. Orthopedics. 2007;30(6):439-445.

National Institute for Health and Care Excellence (NICE). IPG 450. Percutaneous electrical nerve stimulation for refractory neuropathic pain. March 2013. Available online at: http://www.nice.org.uk/guidance/ipg450. January 18, 2018.

Perret DM, Rim J, Cristian A. A Geriatrician’s guide to the use of the physical modalities in the treatment of pain and dysfunction. Clin Geriatr Med. 2006;22:331-354.

Pinsker MC. Percutaneous electrical nerve stimulation or acupuncture. Anesth Analg. 1999;89(4):1065.

Raphael JH, Raheem TA, Southall JL, et al. Practice guidelines for chronic pain management: an updated report by the American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology. Apr 2010;112(4):810-833. Randomized double-blind sham-controlled crossover study of short-term effect of percutaneous electrical nerve stimulation in neuropathic pain. Pain Med. 2011;12(10):1515-22.

Rozen D, Grass GW. Intradiscal electrothermal coagulation and percutaneous neuromodulation therapy in the treatment of discogenic low back pain. Pain Practice. 2005;5(3):228-243.

Seroussi RE, Gliner BE, Steinitz E, et al. Effectiveness of percutaneous neuromodulation therapy for patients with chronic and severe low back pain. Pain Practice. 2003;3(1):22-30.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. 510(k) Summary of Safety and Effectiveness. Percutaneous Neuromodulation Therapy
(PNT) Nerve Stimulation System [FDA Web site]. 09/11/02. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf2/K022241.pdf. Accessed February 8, 2019.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. 510(k) Summary for the Biowave Deepwave Neuromodulation Pain Therapy Device [FDA Web site]. 12/13/05. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/K052289.pdf. Accessed February 8, 2019.

Wanich T, Gelber J, Rodeo S, et al. Percutaneous neuromodulation pain therapy following knee replacement. J Knee Surg. 2011;24(3):197-202.

Weiner DK, Ernst E. Complementary and alternative approaches to the treatment of persistent musculoskeletal pain. Clin J Pain. 2004;20(4):244-255.

Weiner DK, Perera S, Rudy TE, et al. Efficacy of percutaneous electrical nerve stimulation and therapeutic exercise for older adults with chronic low back pain: a randomized controlled trial. Pain. 2008;140(2):344-57.

Weiner DK, Rudy TE, Glick RM, et al. Efficacy of percutaneous electrical nerve stimulation for the treatment of chronic low back pain in older adults. J Am Geriatr Soc. 2003;51(5):599-608.

White PF, Craig WF, Vakharia AS, et al. Percutaneous neuromodulation therapy: does the location of electrical stimulation affect the acute analgesic response? Anesth Analg. 2000;91(4):949-954.

White PF, Ghoname EA, Ahmed HE, et al. The effect of montage on the analgesic response to percutaneous neuromodulation therapy. Anesth Analg. 2001;92(2):483-487.

White PF, Li S, Chiu JW. Electroanalgesia: its role in acute and chronic pain management. Anesth Analg. 2001;92:505-513.

Yokoyama M, Sun X, Oku S, et al. Comparison of percutaneous electrical nerve stimulation with transcutaneous electrical nerve stimulation for long-term pain relief in patients with chronic low back pain. Anesth Analg. 2004;98(6):1552-1556.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

THE FOLLOWING CODE IS USED TO REPRESENT PERCUTANEOUS ELECTRICAL NERVE STIMULATION (PENS) OR PERCUTANEOUS NEUROMODULATION THERAPY (PNT):


64999



Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

N/A


HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

05.00.75
03/13/2019The policy has been reviewed and reissued to communicate the Company’s continuing position on Percutaneous Electrical Nerve Stimulation (PENS) and Percutaneous Neuromodulation Therapy (PNT).
03/14/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on Percutaneous Electrical Nerve Stimulation (PENS) and Percutaneous Neuromodulation Therapy (PNT).


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 09/30/2014
Version Issued Date: 09/30/2014
Version Reissued Date: 03/13/2019

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