Percutaneous and Implanted Nerve Stimulation and Neuromodulation
© Blue Cross and Blue Shield of Montana
Current Effective Date:
October 25, 2013
Original Effective Date:
September 14, 2010
October 25, 2013
October 19, 2012; September 25, 2013
Percutaneous electrical nerve stimulation (PENS) is similar in concept to surface electrical stimulation, such as transcutaneous electrical nerve stimulation (TENS), but differs in that, instead of electrodes applied to the skin, stimulation is delivered via needles that are inserted to a depth of 1-4 cm either around or immediately adjacent to the nerve serving the painful area. PENS is generally reserved for patients who fail to get pain relief from TENS, apparently due to obvious physical barriers to the conduction of the electrical stimulation (e.g., scar tissue, obesity).
PENS must be distinguished from electrical stimulation acupuncture. 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. Thus, 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.
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.
Percutaneous neuromodulation therapy (PNT) is a variant of PENS in which up to ten fine filament electrodes are temporarily placed at specific anatomical landmarks in the back. Treatment regimens consist of 30-minute sessions, once or twice a week for 8-10 sessions.
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 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.
Refer to ICD-9-CM Manual.
Refer to ICD-10-CM Manual.
64555, 64565, 64575, 64580, 64585, 64590, 64595, 64999, 95970, 95971, 95972, 95973, A4595, L8679, L8680, L8681, L8682, L8683, L8685, L8686, L8687, L8688, L8689, L8695
- 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.
- White PF, Craig WF, Vakharia AS et al. Percutaneous neuromodulation therapy: does the location of electrical stimulation effect the acute analgesic response? Anesth Analg 2000; 91(4):949-54.
- 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):365-70.
- 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):311-5.
- 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 2008; 140(2):344-57.
- 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):1552-6, table of contents.
- 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):193-9.
- Ghoname EA, Craig WF, White PF et al. Percutaneous electrical nerve stimulation for low back pain: a randomized crossover study. JAMA 1999; 281(9):818-23.
- 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):1622-7.
- 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):841-6.
- 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):483-7.
- 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.
- 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 2011; 12(10):1515-22.
- 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 Meeting2002; San Francisco, CA.
- 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):439-45.
- Wanich T, Gelber J, Rodeo S et al. Percutaneous neuromodulation pain therapy following knee replacement. J Knee Surg 2011; 24(3):197-202.
- National Institute for Health and Care Excellence (NICE). IPG 450. Percutaneous electrical nerve stimulation for refractory neuropathic pain. 2013. Available online at: www.nice.org.uk Last accessed June, 2013.
- 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.
- 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.
- 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 2007; 147(7):478-91.
- Centers for Medicare and Medicaid. Medicare Coverage Issues Manual: Assessing Patient's Suitability for Electrical Nerve Stimulation Therapy 160.7.1. 2006. Available online at: www.cms.gov Last accessed July, 2012.
- Practice Guidelines for Chronic Pain Management. A report of the American Society of Anesthesiologists task force on pain management, chronic pain section. Anesthesiology. (1997) 86:995-1004. Available at http://www.asahq.org . Last accessed 6/21/2005.
- Percutaneous Electrical Nerve Stimulation (PENS) and Percutaneous Neuromodulation Therapy. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (July 2013) Surgery 7.01.29.
||Medical Policy Development Meeting. Previously part of the neuromuscular stimulators medical policy. |
||Medical Policy Physician's Committee Meeting/approved.|
||Policy updated with literature review through June 2012; references 13 and 16 added; policy statement unchanged. Clinical input reviewed. |
||Policy formatting and language revised. Policy statement unchanged. Title changed from "Percutaneous Electrical Nerve Stimulation (PENS) and Percutaneous Neuromodulation Therapy (PNT)" to "Percutaneous and Implanted Nerve Stimulation and Neuromodulation". Added codes 64555, 64565, 64575, 64580, 64585, 64590, 64595, 95970, 95971, 95972, 95973, A4595, L8680, L8681, L8682, L8683, L8685, L8686, L8687, L8688, L8689, and L8695. |