Percutaneous Electrical Nerve Stimulation and Percutaneous Neuromodulation Therapy

Transcription

1 MEDICAL POLICY Percutaneous Electrical Nerve Stimulation and Percutaneous Neuromodulation Therapy BCBSA Ref. Policy: Effective Date: June 1, 2017 Last Revised: May 2, 2017 Replaces: N/A RELATED MEDICAL POLICIES: Electrical Stimulation Devices Cranial Electrotherapy Stimulation and Auricular Electrostimulation Select a hyperlink below to be directed to that section. POLICY CRITERIA CODING RELATED INFORMATION EVIDENCE REVIEW REFERENCES HISTORY Clicking this icon returns you to the hyperlinks menu above. Introduction Using mild electrical current is one way to treat nerve pain. It s believed that the electrical signals interfere with the way nerves relay information about pain to the brain. TENS, which uses electricity transferred through the skin, has been in use for decades and is well proven. Newer ways of delivering small electrical impulses are being studied. Percutaneous electrical nerve stimulation (PENS) uses small needles placed just below the skin, with electricity delivered by a battery-powered stimulator. In percutaneous neuromodulation therapy (PNT), fine needle electrodes are placed in deep tissues. Because more high-quality studies are needed to determine if PENS and PNT are effective, they are both still considered unproven. Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered. Policy Coverage Criteria

2 Procedure Percutaneous electrical neurostimulation or neuromodulation Investigational Percutaneous electrical neurostimulation or neuromodulation is considered investigational. Guidelines Percutaneous electrical neurostimulation (PENS) and percutaneous neuromodulation (PNT) use needle and wire electrodes that are inserted into the skin above a nerve, rather than having electrodes implanted on the skin. The stimulation devices used in PENS and PNT are also not implanted. Coding CPT Unlisted procedure, nervous system Note: CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS). Related Information N/A Evidence Review Description Percutaneous electrical nerve stimulation (PENS) and percutaneous neuromodulation therapy (PNT) combine the features of electroacupuncture and transcutaneous electrical nerve stimulation. PENS is performed with needle electrodes while PNT uses very fine needle-like Page 2 of 9

3 electrode arrays placed in close proximity to the painful area to stimulate peripheral sensory nerves in the soft tissue. Background Percutaneous electrical nerve stimulation (PENS) and percutaneous neuromodulation therapy (PNT) have been evaluated for the treatment of a variety of chronic musculoskeletal or neuropathic pain conditions including low back pain, neck pain, diabetic neuropathy, chronic headache, and surface hyperalgesia. Chronic pain presents a substantial burden to patients, adversely affecting function and quality of life. These chronic pain conditions have typically failed other treatments, and the goal of treatment with PENS and PNT is to relieve unremitting pain. Percutaneous electrical nerve stimulation (PENS) is similar in concept to transcutaneous electrical nerve stimulation or TENS (see Related Policies) 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 different from acupuncture with electrical stimulation (see Related Policies). 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 needles are placed close to the nerves serving the painful area rather than depending on the theories of energy flow that guide placement of needles 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. Summary of Evidence For individuals who have chronic pain conditions (eg, back, neck, neuropathy, headache, hyperalgesia, knee osteoarthritis) and receive percutaneous electrical nerve stimulation (PENS), the evidence includes primarily small controlled trials. Relevant outcomes are symptoms, functional outcomes, quality of life, and medication use. In the highest quality trial of PENS conducted to date, no difference in outcomes was found between the active (30 minutes of stimulation with 10 needles) and the sham (5 minutes of stimulation with 2 needles) treatments. Page 3 of 9

4 Smaller trials, which have reported positive results, are limited by unclear blinding and short-term follow-up. The evidence is insufficient to determine the effects of the technology on health outcomes. For individuals who have chronic pain conditions (eg, back, neck, neuropathy, headache, hyperalgesia, knee osteoarthritis) who receive percutaneous neuromodulation therapy, the evidence only consists of 1 randomized controlled trial. Relevant outcomes are symptoms, functional outcomes, quality of life, and medication use. The single trial is limited by lack of investigator blinding, unclear participant blinding, and short-term follow-up. The evidence is insufficient to determine the effects of the technology on health outcomes. Clinical Input Received From Physician Specialty Societies and Academic Medical Centers While the various physician specialty societies and academic medical centers may provide appropriate reviewers who collaborate with and make recommendations during this process, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted. In response to requests, input was received from 5 physician specialty societies and 2 academic medical centers while this policy was under review in The input was mixed regarding whether PENS and PNT should be considered investigational or medically necessary. Practice Guidelines and Position Statements National Institute for Health and Care Excellence (NICE) The U.K. s NICE (National Institute for Health and Care Excellence) published guidance on PENS in 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. Page 4 of 9

5 American Academy of Neurology et al. The American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation published an evidence-based guideline on the treatment of painful diabetic neuropathy in The guideline concluded that, based on a Class I study, electrical stimulation is probably effective in lessening the pain of diabetic neuropathy and improving quality of life. It wasrecommended that PENS be considered for the treatment of painful diabetic neuropathy (level B). American Society of Anesthesiologists et al The 2010 practice guidelines for chronic pain management from the American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine state that subcutaneous peripheral nerve stimulation 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 and American Pain Society 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 indicate that there is uncertainty over whether PENS should be considered a novel therapy or a form of electroacupuncture. 18 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 National Coverage The Centers for Medicare and Medicaid Services (CMS) currently has the following national coverage policy on PENS 19 : 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: Page 5 of 9

6 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 for an explanation of coverage of the therapeutic use of implanted peripheral nerve stimulators under the prosthetic devices benefit. See for an explanation of coverage of the therapeutic use of TENS under the durable medical equipment benefit.) Regulatory Status Percutaneous Neuromodulation Therapy (Vertis Neurosciences) received approval to market by FDA through the 510(k) process in 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. Page 6 of 9

7 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 μm (0.736 mm) in length; the patch is reported to feel like sandpaper or Velcro. FDA product code: NHI. References 1. 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 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 ;140(2): PMID 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): PMID 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): , table of contents. PMID 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): PMID Ghoname EA, Craig WF, White PF, et al. Percutaneous electrical nerve stimulation for low back pain: a randomized crossover study. JAMA. Mar ;281(9): PMID 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): PMID 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): PMID 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): PMID 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): PMID 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): PMID 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): PMID 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. Page 7 of 9

8 14. 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): PMID National Institute for Health and Care Excellence (NICE). Percutaneous electrical nerve stimulation for refractory neuropathic pain [IPG 450]. 2013; Accessed May 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 ;76(20): PMID 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): PMID 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 ;147(7): PMID Centers for Medicare and Medicaid. National Coverage Determination (NCD) for Assessing Patient's Suitability for ELECTRICAL NERVE STIMULATION Therapy ( ). 2006; ookup=title&keywordsearchtype=and&list_type=ncd&bc=gaaaabaaaaaa&. Accessed May History Date Comments 03/13/12 New policy. Add to Surgery section. Removed from /26/12 Replace Policy. Rationale section revised based on literature review through June References 13 and 16 added; other references renumbered or removed. Policy statement unchanged. 11/20/12 Update Related Policies. Add /14/13 Update Related Policies, title has changed to policy /11/13 Update Related Policies. Add /27/13 Replace policy. Policy updated with literature review through June 4, 2013; reference 17 added; policy statement unchanged. 03/21/14 Update Related Policies. Delete and replace with /23/14 Annual Review. Policy updated with literature review through June 6, 2014; policy statement unchanged. 03/13/15 Update Related Policies. Remove as it was archived. 04/17/15 Update Related Policies. Remove as it was archived. 09/08/15 Annual Review. Removed CPT codes and descriptions from Policy Guidelines section. Policy updated with literature review through June 9, 2015; no references added. Policy Page 8 of 9

9 Date Comments statement unchanged. 09/01/16 Annual Review, approved August 9, Policy updated with literature review; no references added. Policy statement unchanged. 06/01/17 Annual Review, approved May 2, Policy moved to new format. Policy updated with literature review through January 26, 2017; some references removed. Minor edits to the Policy section; policy statement otherwise unchanged. Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA) Premera All Rights Reserved. Scope: Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This medical policy does not apply to Medicare Advantage. Page 9 of 9

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Es posible que este aviso contenga información importante acerca de su solicitud o cobertura a través de LifeWise Health Plan of Washington. Es posible que haya fechas clave en este aviso. Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura médica o ayuda con los costos. Usted tiene derecho a recibir esta información y ayuda en su idioma sin costo alguno. Llame al Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng LifeWise Health Plan of Washington. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos. May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag sa ไทย (Thai): ประกาศน ม ข อม ลส าค ญ ประกาศน อาจม ข อม ลท ส าค ญเก ยวก บการการสม ครหร อขอบเขตประก น ส ขภาพของค ณผ าน LifeWise Health Plan of Washington และอาจม ก าหนดการในประกาศ น ค ณอาจจะต องด าเน นการภายในก าหนดระยะเวลาท แน นอนเพ อจะร กษาการประก นส ขภาพของค ณ หร อการช วยเหล อท ม ค าใช จ าย ค ณม ส ทธ ท จะได ร บข อม ลและความช วยเหล อน ในภาษาของค ณโดยไม ม ค าใช จ าย โทร (TTY: ) Український (Ukrainian): Це повідомлення містить важливу інформацію. Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через LifeWise Health Plan of Washington. Зверніть увагу на ключові дати, які можуть бути вказані у цьому повідомленні. Існує імовірність того, що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того, щоб зберегти Ваше медичне страхування або отримати фінансову допомогу. У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові. 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