Medical Policies - Medicine


Percutaneous and Implanted Nerve Stimulation and Neuromodulation

Number:MED205.032

Effective Date:10-15-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Percutaneous electrical nerve stimulation (PENS), percutaneous neuromodulation therapy (PNT), and peripheral implanted nerve stimulation (PINS), used alone or in combination with any other type of nerve stimulation, are considered experimental, investigational and/or unproven for treatment of any condition, including but not limited to pain.

NOTE 1: See specific policies in Medical Policy listing on web site for coverage of stimulation of phrenic nerve, sacral nerve, spinal cord, vagus nerve, deep brain, pelvic floor, and peripheral subcutaneous field stimulation (PSFS).

Description:

Nerve stimulation (neurostimulation) is a therapeutic activation of part of the nervous system using microelectrodes. The electrodes are used to interface with excitable tissue in order to either restore sensation or control a sensation.

Neuromodulation is the direct stimulation of the nervous system with electrical signals. The signals are used to manage pain conditions and/or movement disorders.

Background

Percutaneous electrical nerve stimulation (PENS) is similar in concept to transcutaneous electrical nerve stimulation (TENS), but differs in that needles are inserted either around or immediately adjacent to the nerves serving the painful area and are then stimulated. PENS is generally reserved for patients who fail to get pain relief from TENS. PENS is also 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 (PNT) is a variant 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. 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.

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.

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 2006, 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 1014 microneedles in a 1.5-inch diameter area. The needles are 736 μm (0.736 mm) in length; the patch is reported to feel like sandpaper or Velcro. FDA product code: NHI.

Rationale:

This policy was created in 2006 and originally based on the 1996 Blue Cross Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) Assessment of percutaneous electrical nerve stimulation (PENS) for the treatment of chronic pain. (1) The policy has been periodically updated with searches in the MedLine database through January 5, 2017. The following is a summary of the key literature.

The objective of the 1996 BCBSA TEC Assessment was to determine if the effects of PENS exceed placebo effects. The following study selection criteria were used in the 1996 TEC Assessment:

Study contained original empirical data;

Study design included a treatment group and a control group;

Study reported on a health outcome relevant to the pain condition treated; and

Study used a random assignment, control group design.

No clinical studies of PENS were identified by the 1996 BCBSA TEC Assessment, thus no conclusions about effectiveness could be reached.

Literature Review

The literature review revealed 8 randomized trials meeting their cited criteria. 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, (2) chronic diabetic neuropathy, (3) and chronic headache. (4) 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. All 8 studies were conducted at 1 institution, the University of Texas Southwestern Medical Center in Dallas, Texas.

Percutaneous Electrical Nerve Stimulation (PENS)

Chronic Low Back Pain

In 2008, Weiner et al. reported a trial with 200 older adults, which had been funded by the National Institutes of Health. (5) 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, 2.1-3.0, on the Roland scale) and improved gait velocity (0.04-0.07 m/s) that was maintained for 6 months Although the authors concluded that minimal electrical stimulation (5 minutes at 2 needles) is as effective as usual PENS (30 minutes of stimulation from 10 needles), 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.

Yokoyama et al. found patients randomized to PENS treatment twice per week for 8 weeks 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 with 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. (6) While PENS treatment for 8 weeks seemed to demonstrate greater effectiveness in controlling pain for up to 1 month after treatment when compared with the other treatment groups, the beneficial effects were not found at the 2-month follow-up.

Ghoname et al. (7) compared sham PENS, active PENS, and TENS in 64 patients. Active PENS achieved better outcomes than sham PENS on visual analog 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. (8) administered sham PENS, active PENS, TENS, and exercise therapy in 60 patients. 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. (9) varied the duration of active electrical stimulation at 3 levels (15, 30, 45 minutes) and compared them with sham stimulation in 75 patients. 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. (10) varied the frequency of the active electrical stimulus at 3 levels, also comparing it with sham stimulation, in 68 patients. 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. (11) did not include sham PENS in a study of 72 patients. 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. (12) Patients were randomized to receive twice weekly PENS 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.

Section Summary: Chronic Low Back Pain

The highest quality trial on PENS for chronic low back pain found no difference between the active (30 minutes from 10 needles) and sham PENS (5 minutes from 2 needles) at 1 week or 6 months after treatment. While other studies suggest that active PENS has effects that exceed placebo PENS in the short term, they did not address long-term improvement of pain and functional outcomes, the objective of treating chronic low back pain. It is also unclear whether these study designs included adequate blinding or whether patients withdrew from these studies.

Chronic Neck Pain

One study by White et al. (2) compared 2 locations of active stimulation with sham stimulation in 68 patients. 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 adverse 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., (3) 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. 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. (4) conducted a crossover study in 30 patients with longstanding headaches of 3 types: tension, migraine, and post-traumatic injury. 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 of chronic headache.

Chronic Surface Hyperalgesia

Raphael et al. (13) 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 pain diagnoses included surgical scar pain, occipital neuralgia, posttraumatic 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. The duration of pain ranged from 1 to 35 years, with a mean of 8.1 years. Subjective pain on a numeric rating scale (NRS) and a pressure pain threshold were measured before and 1 week after the single treatment, with a washout period of 4 weeks between treatments. The median NRS 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 g to 626 gm after active PENS and did not change significantly after sham treatment (202 g pre, 206 g 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 NRS (3.9 versus 0.1) and in the pain pressure threshold (310 g versus 8 g) for the active compared with 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.

Percutaneous Neuromodulation Therapy (PNT)

Chronic Low Back Pain

From its description, PNT appears to be a variant of PENS, varying in length and number of the needles. A literature search identified 1 abstract focusing on neuromodulation for chronic low back pain. (14) 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.

Osteoarthritis of the Knee

In 2007, Kang et al. (15) 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). 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 versus 5.2, respectively) were not significantly different for the 2 groups at 48 hours after treatment. Changes in the Western Ontario and McMaster Osteoarthritis Index were significantly better for the category of stiffness (1-point change versus 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% versus 11% good to excellent, respectively) 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 2 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.

Acute Postoperative Pain

A small (N=23) single-blinded randomized controlled trial (RCT) was published in 2011 that assessed the efficacy of PNT to control acute pain after TKA. (16) 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). Results for the Brief Pain Inventory were not reported. There was a trend (p=0.09) for decreased opioid use in the PNT group compared with controls. Post-hoc power analysis indicated that the study was underpowered. Additional limitations are the lack of investigator blinding and measurement of outcomes immediately after treatment. The authors indicate that a larger trial is planned.

Peripheral Implanted Nerve Stimulation (PINS)

The American Society of Anesthesiologists’ (ASAHQ) Practice Guidelines on Chronic Pain Management states that the literature is suggestive of the analgesic benefit effects, but is equivocal regarding the beneficial or adverse effects, of PINS. A Medline search of peer-reviewed literature failed to locate large, randomized, double-blinded clinical trials that permit conclusions about the efficacy and long-term benefit of peripheral implanted nerve stimulation for treatment of pain. (17)

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this policy are listed in Table 1.

Table 1. Summary of Key Trials

NCT Number

Trial Name

Planned Enrollment

Completion Date

Unpublished

NCT00290238a

Percutaneous Neuromodulation Therapy with Chronic Low Back Pain Patients With or Without Lower Extremity Pain – A Randomized, Controlled, Parallel Groups Study

122

Terminated (enrollment, dropouts)

Table Key:

NCT: National Clinical Trial;

a: Denotes industry-sponsored or cosponsored trial.

Practice Guidelines and Position Statements

National Institute for Health and Care Excellence (NICE)

The U.K.’s NICE published guidance on PENS in 2013. (18) NICE concluded that the current evidence on the safety of PENS for refractory neuropathic pain raises no major safety concerns, that 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.

American Academy of Neurology (AAN) et al.

The AAN, American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM), and American Academy of Physical Medicine and Rehabilitation (AAPMR) published an evidence-based guideline on the treatment of painful diabetic neuropathy in 2011. (19) 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).

American Society of Anesthesiologists (ASAHQ) and American Society of Regional Anesthesia and Pain Medicine (ASRAPM)

The 2010 Practice guidelines for chronic pain management from the ASAHQ Task Force on Chronic Pain Management and the ASRAPM state that subcutaneous PINS may be used in the multimodal treatment of patients with painful peripheral nerve injuries who have not responded to other therapies (category B2 evidence, observational studies). (17)

American College of Physicians (ACP) and American Pain Society (APS)

Joint clinical practice guidelines on the diagnosis and treatment of low back pain from the ACP and the APS in 2007 indicate that there is uncertainty over whether PENS should be considered a novel therapy or a form of electroacupuncture. (20) 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.)

Summary of Evidence

The literature on percutaneous electrical nerve stimulation (PENS) and percutaneous neuromodulation therapy (PNT) consists primarily of small controlled trials with unclear blinding and short follow-up. In the highest quality trial of PENS conducted to date, no difference in outcomes was found between the active (30 minutes of stimulation at 10 needles) and the sham (5 minutes of stimulation at 2 needles) treatments. Literature searches have identified only 2 small trials on PNT. Literature searches for peripheral implanted nerve stimulation (PINS) is lacking. The available evidence is insufficient to permit conclusions concerning the effect of this procedure on health outcomes.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

The correct CPT code to use for percutaneous electrical nerve stimulation (PENS) and percutaneous neuromodulation therapy (PNT) is the unlisted CPT code 64999. CPT codes for percutaneous implantation of neurostimulator electrodes (i.e., 64553-64565) are not appropriate, because PENS and PNT use percutaneously inserted needles and wires rather than percutaneously implanted electrodes. The stimulation devices used in PENS and PNT are not implanted, so CPT code 64590 is also not appropriate.

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

64555, 64565, 64575, 64580, 64585, 64590, 64595, 64999, 95970, 95971, 95972

HCPCS Codes

A4595, L8679, L8680, L8681, L8682, L8683, L8685, L8686, L8687, L8688, L8689, L8695

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position.

A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Transcutaneous Electric Nerve Stimulation (TENS) or Percutaneous Electric Nerve Stimulation (PENS) in the Treatment of Chronic and Postoperative Pain. Chicago, Illinois: Blue Cross and Blue Shield Association Technology Evaluation Center Assessments (1996) Volume 11, Tab 21.

2. White PF, Craig WF, Vakharia AS, et al. Percutaneous neuromodulation therapy: does the location of electrical stimulation effect the acute analgesic response? Anesth Analg. Oct 2000; 91(4):949-54. PMID 11004055

3. Hamza MA, White PF, Craig WF, et al. Percutaneous electrical nerve stimulation: a novel analgesic therapy for diabetic neuropathic pain. Diabetes Care. Mar 2000; 23(3):365-70. PMID 10868867

4. Ahmed HE, White PF, Craig WF, et al. Use of percutaneous electrical nerve stimulation (PENS) in the short-term management of headache. Headache. Apr 2000; 40(4):311-5. PMID 10759936

5. 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. Nov 30 2008; 140(2):344-57. PMID 18930352

6. 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. Jun 2004; 98(6):1552-6, table of contents. PMID 15155304

7. Ghoname EA, White PF, Ahmed HE, et al. Percutaneous electrical nerve stimulation: an alternative to TENS in the management of sciatica. Pain. Nov 1999; 83(2):193-9. PMID 10534590

8. Ghoname EA, Craig WF, White PF, et al. Percutaneous electrical nerve stimulation for low back pain: a randomized crossover study. JAMA. Mar 3 1999; 281(9):818-23. PMID 10071003

9. 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. Dec 1999; 91(6):1622-7. PMID 10598602

10. 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. Apr 1999; 88(4):841-6. PMID 10195535

11. White PF, Ghoname EA, Ahmed HE, et al. The effect of montage on the analgesic response to percutaneous neuromodulation therapy. Anesth Analg. Feb 2001; 92(2):483-7. PMID 11159255

12. 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. May 2003; 51(5):599-608. PMID 12752833

13. Raphael JH, Raheem TA, Southall JL, et al. Randomized double-blind sham-controlled crossover study of short-term effect of percutaneous electrical nerve stimulation in neuropathic pain. Pain Med. Oct 2011; 12(10):1515-22. PMID 21883874

14. 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.

15. 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. Jun 2007; 30(6):439-45. PMID 17598487

16. Wanich T, Gelber J, Rodeo S, et al. Percutaneous neuromodulation pain therapy following knee replacement. J Knee Surg. Sep 2011; 24(3):197-202. PMID 21980881

17. ASAHQ – Practice Guidelines for Chronic Pain Management. A Report of the American Society of Anesthesiologists Task Force on Pain Management, Chronic Pain Section. American Society of Anesthesiologist. Anesthesiology. Apr 1997; 86:995-1004. Available at <http://www.asahq.org> (accessed January 5, 2017).

18. NICE – Percutaneous Electrical Nerve Stimulation for Refractory Neuropathic Pain. National Institute for Health and Care Excellence IPG 450 (June 2013). Available at: <http://www.nice.org.uk> (accessed January 5, 2017).

19. 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. May 17 2011; 76(20):1758-65. PMID 21482920

20. 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. 2010; 112(4):810-33.

21. 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):478-91. PMID 17909209

22. CMS – Assessing Patient's Suitability for Electrical Nerve Stimulation Therapy 160.7.1. (June 19, 2006). Centers for Medicare and Medicaid. Medicare Coverage Issues Manual. Available at: <http://www.cms.gov> (accessed January 5, 2017).

23. Percutaneous Electrical Nerve Stimulation (PENS) and Percutaneous Neuromodulation Therapy. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (July 2015) Surgery 7.01.29.

Policy History:

DateReason
10/15/2018 Reviewed. No changes.
2/15/2017 Document updated with literature review. Coverage unchanged.
1/1/2015 Reviewed. No changes.
12/1/2013 Document updated with literature review. Coverage unchanged.
10/15/2013 The following change was made to Coverage: Peripheral nerve field stimulation (PNFS) was moved to new Medical Policy MED205.036 Peripheral Subcutaneous Field Stimulation (PSFS).
1/1/2012 The following change was made to Coverage: Peripheral nerve field stimulation (PNFS) is considered experimental, investigational and unproven. CPT/HCPCS codes updated.
8/1/2011 Document updated with literature review. The following was added to Coverage: Clarification was added that PENS, PNT and PINS are experimental, investigational and unproven whether used alone or in combination with any other type of nerve stimulation. Posterior tibial nerve stimulation was moved from this document to MED202.035, Posterior Tibial Nerve Stimulation (PTNS).
1/1/2009 Revised/Updated Entire Document. This policy is no longer scheduled for routine literature review and update.
3/12/2006 Revised/Updated Entire Document
1/15/2006 New Medical Document

Archived Document(s):

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