National Medical Policy

National Medical Policy Subject: Policy Number: Percutaneous Electrical Nerve Stimulation (PENS) and Percutaneous Neuromodulation Therapy (PNT) NMP60 Effective Date*: October 2003 Updated: May 2017 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State s Medicaid manual(s), publication(s), citation(s), and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link X National Coverage Determination (NCD) Assessing Patient's Suitability for Electrical Nerve Stimulation Therapy (160.7.1): http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx National Coverage Manual Citation Local Coverage Determination (LCD)* Article (Local)* Other None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage Percutaneous Electrical Nerve Stimulation (PENS) (PNT) May 17 1

determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement Percutaneous electrical nerve stimulation (PENS), also known as percutaneous neuromodulation therapy (PNT), is considered medically necessary for patients with severe, acute or chronic pain that is significant, constant or frequent when all of the following are met: 1. Patient has tried TENS and failed to obtain pain relief due to the presence of obvious physical barriers to conduction of an electrical stimulus, such as in extremely obese individuals or those with scar tissue at the point of stimulation 2. Patient has been unresponsive to conservative measures and/or has diminished effectiveness or intolerance of medications or has a history of substance abuse 3. Pain limits ability to perform rehabilitation (e.g., exercise programs, physical therapy treatment) 4. Pain relief from temporarily placed peripheral nerve stimulation needles has been documented prior to permanent placement. 5. Treatment is used only as a last resort; other non-surgical treatments have been tried and failed, or are judged to be unsuitable or contraindicated. Not Medically Necessary Health Net Inc. considers PENS not medically necessary for any of the following: 1. Management of pain related to (unstable) angina pectoris; or 2. PENS during pregnancy; or 3. Patient has an implantable electrical device such as a pacemaker or defibrillator; or 4. Patient has a convulsive disorder; or 5. Presence of radiculopathies; or 6. Inability, either mentally or physically, to understand new procedures and the use of the PENS unit for pain control; or 7. Pain requiring placement of PENS over the eyes or anterior neck; or 8. Continued use of PENS after lack of benefit during the first month of use; or 9. The treatment of a weak pelvic floor with pelvic organ Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures have been replaced by ICD-10 code sets. Percutaneous Electrical Nerve Stimulation (PENS) (PNT) May 17 2

ICD-9 Codes Too numerous to list (May not be all inclusive) 338.1-338.19 Acute pain 338.2 338.4 Chronic Pain ICD-10 Codes Too numerous to list (May not be all inclusive) G89.1-G89.8 Acute pain, not elsewhere classified G89.2-G89.4 Chronic pain, not elsewhere classified R52 Pain, unspecified CPT Codes 64553 Percutaneous implantation of neurostimulator electrodes; cranial nerves 64555 Peripheral nerve (excludes sacral nerve) 64561 Sacral nerve (transforaminal placement), including image guidance, if performed 64590 Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, direct or inductive coupling HCPCS Codes A4556 A4557 A4595 A4630 C1787 C1816 E0720 E0730 E0731 E0761 L8680 L8682 L8683 L8684 L8685 L8686 Electrodes (e.g., Apnea monitor), per pair Lead wires (e.g., Apnea monitor), per pair Electrical stimulator supplies, 2 lead, per month, (eg. TENS, NMES) Replacement batteries for medically necessary transcutaneous electrical nerve stimulator (TENS) owned by patient Patient programmer, neurostimulator Receiver and/or transmitter, neurostimulator (implantable) Transcutaneous electrical nerve stimulation (TENS) device, two lead, localized stimulation Transcutaneous electrical nerve stimulation (TENS) device, four or more leads, for multiple nerve stimulation Form-fitting conductive garment for delivery of TENS or NMES (with conductive fibers separated from the patient's skin by layers of fabric Non-thermal pulsed high frequency radiowaves, high peak power electromagnetic energy treatment device Implantable neurostimulator electrode, each Implantable neurostimulator radiofrequency receiver Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver Radiofrequency transmitter (external) for use with implantable sacral root neurostimulator receiver for bowel and bladder management replacement Implantable neurostimulator pulse generator, single array, rechargeable, includes extension Implantable neurostimulator pulse generator, single array, non rechargeable, includes extension Percutaneous Electrical Nerve Stimulation (PENS) (PNT) May 17 3

L8687 L8688 Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension Scientific Rationale Update January 2014 According to a National Institute of Clinical Evidence (NICE) guidance: Percutaneous electrical nerve stimulation for refractory neuropathic pain (Mar 2013), 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. Therefore this procedure may be used with normal arrangements for clinical governance, consent and audit. Slotty et al (2013) investigated the predictive value of PENS in peripheral nerve stimulation (PNS) for chronic neuropathic pain. Twelve patients being evaluated for PNS for chronic neuropathic pain were included in this survey. Stimulation with acupuncture needles was applied with continuous high frequency stimulation. Position, polarity, frequency and amperage threshold of perception, and adverse effects were noted. Additional stimulation side effects were documented. A StimScore was developed to evaluate effects in a standardized manner. This StimScore comprises coverage of the painful area, therapeutic range, and amperage required for successful stimulation. StimScore was determined during PENS, during test stimulation, and under final stimulation. PNS was well tolerated by all patients. Seven of the 12 patients (58%) were classified as successfully treated, and 5/12 patients (42%) as unsuccessful. The mean overall pain reduction in the first group was 4.0 points (SD = 2.87, P = 0.010) and 2.4 points (SD = 1.29, P = 0.014), respectively, on the visual analogue scale. In the successful stimulation group, a mean StimScore of 13.14 (SD 11.19-15.0) was calculated vs. 10.4 (95% CI 8.52-12.28) in the unsuccessful stimulation group (P = 0.033, 95% CI = 0.265-5.220). Investigators concluded predicting response to PNS is crucial to reduce the number of patients implanted in vain. To adopt PENS via electroacupuncture needles as a percutaneous simulation method for PNS seemed to be feasible. The technique presented herein bears the potential to improve patient selection combined with reduced invasiveness. The presented results are encouraging and deliver a starting point for further trials. Kopsky et al (2013) conducted a pilot study to evaluate the feasibility and effect of PENS in spinal cord injury (SCI) patients with chronic neuropathic pain. In 18 weeks, 12 PENS treatments were scheduled. Assessment with questionnaires was performed at baseline (T0), after 8 weeks (T8), 18 weeks (T18), and 12 weeks posttreatment (T30). From 26 screened patients, 17 were included. In total, 91.2% questionnaires were returned, 2 patients dropped out, and 4.2% of the patients reported minor side effects. Pain scores on the week pain diary measured with the numerical rating scale improved significantly at T8, from 6.5 at baseline to 5.4, and were still significantly improved at T18. Pain reduction of 30% directly after a session was reported in 64.6% sessions. In total, 6 patients experienced reduction in size of the pain areas at T18 and T30, with a mean reduction of 45.8% at T18 and 45.3% at T30. Investigators concluded PENS is feasible as an intervention in SCI patients and might have a positive effect on pain reduction in a part of this patient group. Percutaneous Electrical Nerve Stimulation (PENS) (PNT) May 17 4

Scientific Rationale August 2008 Pelvic floor stimulation (PFS) involves the electrical stimulation of the pelvic floor muscles using a probe wired to a device controlling the electrical stimulation. It is believed that electric or magnetic stimulation leads to PFS, which in turn stimulates the pudendal nerve to improve urethral closure by activating the pelvic musculature by enhancing the process of re-innervation. PFS is an off-label use for electrical stimulation devices. Electrical stimulation has been employed in the treatment of urinary incontinence, especially in Europe. The mechanism of action of electrostimulation is still unclear, but it probably serves to provide a kind of muscular training similar to that of pelvic floor exercise. (2007) American College of Obstetricians and Gynecologists (ACOG) notes the following recommendations and conclusions, based on good and consistent scientific evidence, for pelvic organ prolapse (Level A- Recommendations are based on good and consistent scientific evidence): The only symptom specific to prolapse is the awareness of a vaginal bulge or protrusion. For all other pelvic symptoms, resolution with prolapse treatment cannot be assumed. Pessaries can be fitted in most women with prolapse, regardless of prolapse stage or site of predominant prolapse. Cadaveric fascia should not be used as graft material for abdominal sacral colpopexy because of a substantially higher risk of recurrent prolapse than with synthetic mesh. Stress-continent women with positive stress test results (prolapse reduced) are at higher risk for developing postoperative stress incontinence after prolapse repair alone compared with women with negative stress test results (prolapse reduced). For stress-continent women planning abdominal sacral colpopexy, regardless of the results of preoperative stress testing, the addition of the Burch procedure substantially reduces the likelihood of postoperative stress incontinence without increasing urgency symptoms or obstructed voiding. For women with positive prolapse reduction stress test results who are planning vaginal prolapse repair, tension-free vaginal tape (TVT) midurethral sling (rather than suburethral fascial plication) appears to offer better prevention from postoperative stress incontinence. The following recommendations for pelvic organ prolapse are based primarily on consensus and expert opinion of ACOG (Level C - Recommendations are based primarily on consensus and expert opinion): Clinicians should discuss with women the potential risks and benefits in performing a prophylactic anti-incontinence procedure at the time of prolapse repair. Women with prolapse who are asymptomatic or mildly symptomatic can be observed at regular intervals, unless new bothersome symptoms develop. For women who are at high risk for complications with reconstructive procedures and who no longer desire vaginal intercourse, colpocleisis can be offered. Cystoscopy should be performed intraoperatively to assess for bladder or ureteral damage after all prolapse or incontinence procedures during which the bladder or ureters may be at risk of injury. Percutaneous Electrical Nerve Stimulation (PENS) (PNT) May 17 5

(2000) Electrical pelvic floor stimulation was noted in a study by BlueCross/ BlueShield Association Technology Evaluation Center (TEC) assessment that reviewed the published peer-reviewed literature focusing on the safety and effectiveness of electrical pelvic floor stimulation compared to placebo and compared to other forms of behavioral therapies, including pelvic floor muscle exercises and the use of vaginal cones. The specific etiologies of stress incontinence, urge incontinence, and post-prostatectomy incontinence were considered. The assessment offered the following conclusions: Eleven controlled trials, of which all but one were randomized, reported outcomes of pelvic floor stimulation in the treatment of stress incontinence. These trials do not provide strong and consistent evidence that pelvic floor stimulation reduces the frequency and severity of incontinent episodes. Two randomized controlled trials investigated pelvic floor stimulation in women with urge or mixed incontinence. No conclusions can be drawn from either trial. One 1997 trial did not report the key clinical outcomes, i.e., improvement and cure as measured by voiding diaries or pad testing. The second trial found no significant difference between pelvic floor stimulation and the sham treatment arm. There was no significant difference in results between the patients receiving pelvic floor stimulation plus pelvic muscle exercises compared to those undergoing muscle exercises alone. In summary, neither ACOG nor TEC BC/ BS recommends percutaneous electrical nerve stimulation (PENS) for the treatment of weakened pelvic floors with organ prolapse. There is minimal information in the published peer-reviewed literature to support PENS for this scenario. There are no short or long term outcomes to determine the safety or efficacy of this procedure, nor are there any comparison studies to compare this technology with the current treatment. Therefore at this time, PENS for the treatment of weakened pelvic floors with organ prolapse, remains investigational and therefore not medically necessary. Scientific Rationale Update May 2008 Percutaneous neuromodulation therapy (PNT) is a minimally invasive form of pain therapy that has been used for the treatment of a variety of pain syndromes that are unresponsive to conservative measures. PNT is a variant of percutaneous electrical nerve stimulation (PENS) in which up to 10 fine filament electrodes are temporarily placed at specific anatomical landmarks near the nerve serving the painful area. Treatment regimens consist of thirty-minute sessions, once or twice a week for 8 to 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. Scientific Rationale Initial Percutaneous electrical nerve stimulation (PENS) is used to relieve pain and is essentially the same as TENS. PENS is generally reserved for individuals who fail to get pain relief from TENS. PENS is an electronic stimulus generator that transmits electrical impulses to surgically implanted electrodes either around, or immediately Percutaneous Electrical Nerve Stimulation (PENS) (PNT) May 17 6

adjacent, to the nerve serving the painful area. When implanted, the stimulating electrodes are connected by an insulated lead to a receiver unit that is placed under the skin. Stimulation is induced by a generator, which is attached to the skin surface over the receiver unit. The mechanism of action is unknown, but it is purported that the electrical pulses block the transmission of pain to nerve fibers or may stimulate the release of endorphins or serotonin. PENS units, which are usually battery operated, have been used to relieve chronic intractable pain, post-surgical pain and pain associated with active or post-trauma injury unresponsive to other standard pain therapies. Ghoname and colleagues randomized 60 patients with chronic low back pain to PENS, sham PENS, TENS, or exercise therapy in a crossover study. The PENS therapy consisted of placement of needle probes into the soft tissue and/or muscle in the lower back area to a depth of 2 to 4 cm according to the dermatomal distribution of the pain. The sham PENS group received the same distribution of needle probes but without electrical stimulation. All patients completed pre and several post treatment Health Status Survey Short Form (SF-36) and visual analog scales for physical activity, pain level, and sleep. Compared with pre-study values, PENS therapy was associated with a 50% reduction in the daily oral analgesic requirement. TENS therapy decreased pain medication use in only 6 days, out of the 3-week study period. Sham PENS and exercise therapies did not alter pain medication use. After 3 to 4 PENS treatments patients began reporting significant improvement in pretreatment VAS scores for pain, activity, and sleep compared with baseline values. Hamza and colleagues randomized 50 adult patients with painful diabetic peripheral neuropathy of greater than 6 months duration to PENS or sham PENS. The protocol was similar to the Ghoname study, in that patients were treated for 30 minutes three times each week during a three-week study period. This study was also a crossover study with a one-week washout period between therapies. With active PENS therapy VAS scores for pain, activity, and sleep were improved significantly compared to the baseline scores. For sham PENS the VAS scores were unchanged from baseline. Review History October 16, 2003 December 2005 April 2006 March 2007 May 2008 August 2008 April 2011 January 2012 January 2013 January 2014 January 2015 January 2016 May 2017 Medical Advisory Council initial approval Revised to include PNT Code updates, no revision to policy Code Updates Update. Added Percutaneous Tibial Nerve Stimulation to the Subject. Added as investigational, the continued use of PENS after lack of benefit during the first month of use. Coding Updates. Revised policy to add the treatment of a weak pelvic floor with pelvic organ prolapse as investigational. Update. Added Medicare Table with link to NCD and article. No revisions. Update no revisions Update no revisions. Code updates. Update no revisions Update no revisions. Code updates. Update no revisions. Code updates. Update no revisions 1. This policy is based on the following evidence-based guideline: Percutaneous Electrical Nerve Stimulation (PENS) (PNT) May 17 7

1. Brosseau L, Wells GA, Finestone HM, et al. Clinical practice guidelines for transcutaneous electrical nerve stimulation (TENS). Top Stroke Rehabil 2006 Spring;13(2):61-3. 2. American College of Obstetricians and Gynecologists (ACOG). Pelvic organ prolapse. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2007 Feb. 13 p. Reaffirmed 2011 3. National Institute of Clinical Evidence (NICE). Percutaneous electrical nerve stimulation for refractory neuropathic pain. March 2013. Available at: http://publications.nice.org.uk/percutaneous-electrical-nerve-stimulation-forrefractory-neuropathic-pain-ipg450 References Update January 2016 1. Chou R. Subacute and chronic low back pain: Pharmacologic and noninterventional treatment. UpToDate. Updated June 10, 2015. References Update January 2015 1. Deogaonkar M, Slavin KV. Peripheral nerve/field stimulation for neuropathic pain. Neurosurg Clin N Am. 2014 Jan;25(1):1-10 2. Goroszeniuk T, Pang D. Peripheral neuromodulation: a review. Curr Pain Headache Rep. 2014 May;18(5):412. References Update February 2014 1. Kopsky DJ, Ettema FW, van der Leeden M, et al. Percutaneous Nerve Stimulation in Chronic Neuropathic Pain Patients due to Spinal Cord Injury: A Pilot Study. Pain Pract. 2013 Apr 16. 2. Slotty PJ, Vesper J, Pohlmeier K, Wille C. Predicting Outcome in Peripheral Nerve Stimulation for Chronic Neuropathic Pain. Neuromodulation. 2013 Aug 6. References Update January 2013 1. Chae J, Wilson RD, Bennett ME, et al. Single-Lead Percutaneous Peripheral Nerve Stimulation for the Treatment of Hemiplegic Shoulder Pain: A Case Series. Pain Pract. 2012 Mar 26 2. Gavronsky S, Koeniger-Donohue R, Steller J, Hawkins JW. Postoperative pain: acupuncture versus percutaneous electrical nerve stimulation. Pain Manag Nurs. 2012 Sep;13(3):150-6. References Update January 2012 1. Gaj F, Andreuccetti J, Speziali F, et al. Chronic pelvic pain treatment with posterior tibial nerve stimulation. Clin Ter. 2011 Jul-Aug;162(4):e111-4 2. Raphael JH, Raheem TA, Southall JL, et al. Randomized double-blind shamcontrolled crossover study of short-term effect of percutaneous electrical nerve stimulation in neuropathic pain. Pain Med. 2011 Oct;12(10):1515-22. 3. Wanich T, Gelber J, Rodeo S, Windsor R. Percutaneous neuromodulation pain therapy following knee replacement. J Knee Surg. 2011 Sep;24(3):197-202 References Updated April 2011 1. Wegener JT, Boender ZJ, Preckel B, et al. Comparison of percutaneous electrical nerve stimulation and ultrasound imaging for nerve localization. Br J Anaesth. 2011 Jan;106(1):119-23. Epub 2010 Oct 25. 2. Aló KM, Abramova MV, Richter EO. Percutaneous peripheral nerve stimulation. Prog Neurol Surg. 2011;24:41-57. Epub 2011 Mar 21. Percutaneous Electrical Nerve Stimulation (PENS) (PNT) May 17 8

3. Marcelissen T, Leong R, Serroyen J, et al. Is the screening method of sacral neuromodulation a prognostic factor for long-term success? J Urol. 2011 Feb;185(2):583-7. Epub 2010 Dec 18. References Updated August 2008 1. Wein - Campbell-Walsh Urology, 9th ed. Conservative Management of Urinary Incontinence:Behavioral Pelvic Floor Therapy, Urethral and Pelvic Devices. 2007 2. Bradley CS, Zimmerman MB, Qi Y, et al. Natural history of pelvic organ prolapse in postmenopausal women. SO Obstet Gynecol. 2007 Apr;109(4):848-54. 3. TEC Assessment: Pelvic Floor Stimulation in the Treatment of Urinary Incontinence, 2000; BlueCross and BlueShield Association Technology Evaluation Center Vol 15, Tab 2. 4. Sung MS, Hong JY, Choi YH et al. FES-biofeedback versus intensive pelvic floor muscle exercise for the prevention and treatment of genuine stress incontinence. J Korean Med Sci 2000;15(3):303-8. 5. TEC Assessment: Magnetic Stimulation in the Treatment of Urinary Incontinence in Adults, 2000; BlueCross and BlueShield Association Technology Evaluation Center Vol 15, Tab 8 6. Meschia M, Pifarotti P, Spennacchio M, et al. A randomized comparison of tension-free vaginal tape and endopelvic fascia plication in women with genital prolapse and occult stress urinary incontinence. Am J Obstet Gynecol. 2004;190(3):609-613. References Updated May 2008 1. Bernstein CA, Paicius RM, Barkow SH, et al. Spinal Cord Stimulation in Conjunction With Peripheral Nerve Field Stimulation for the Treatment of Low Back and Leg Pain: A Case Series. Neuromodulation: journal of the International Neuromodulation Society - Volume 11, Issue 2 (April 2008) 2. Shimohi K, Takahashi N, Yasuyuki N, et al. Pain Relief by Transcutaneous Electric Nerve With Bidirectional Modulated Sine Waves in Patients With Chronic Back Pain: A Randomized, Double-Blind, Sham-Controlled Study. Neuromodulation: journal of the International Neuromodulation Society - Volume 10, Issue 1 (January 2007) References Initial 1. 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 May;51(5):599-608 2. St. Anthony's Complete Guide to Medicare Coverage Issues. Assessing Individual's Suitability for Electrical Nerve Stimulation Therapy. 2001;Sections 35-46 & 45-19. 3. White PF, Li S, Chiu JW. Electroanalgesia: Its role in acute and chronic pain management. Anesthesia and Analgesia. 2001;92(2):505-13. 4. 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 5. Ahmed HE, White PE, Craig WF, et al. Use of percutaneous electrical nerve stimulation (PENS) in short-term management of headache. Headache. 2000;40(4):311-5. 6. 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. Percutaneous Electrical Nerve Stimulation (PENS) (PNT) May 17 9

7. Ghoname EA, Craig WF, White PF, et al. Percutaneous electrical nerve stimulation for low back pain. JAMA 1999; 281(9): 818-823 8. 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. Anesthesia and Analgesia. 1999;88(4):841-6. 9. Hamza MA, Ghoname EA, White PF, Craig WF, 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. 10. Schwartz, R.G. Electric Sympathetic Block: Current Theoretical Concepts and Clinical Results. Journal of Back and Musculoskeletal Rehabilitation. 1998;10:31-46. 11. American Society of Anesthesiologist Task Force. Practice guidelines for chronic pain management. Anesthesiology. 1997;86(4):995-1004. Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, prior notice or website posting is required before an amendment is deemed effective. No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Percutaneous Electrical Nerve Stimulation (PENS) (PNT) May 17 10

Policy Limitation: Member s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member s contract shall govern. The Policies do not replace or amend the Member s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Reconstructive Surgery CA Health and Safety Code 1367.63 requires health care service plans to cover reconstructive surgery. Reconstructive surgery means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Reconstructive Surgery after Mastectomy California Health and Safety Code 1367.6 requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation. Percutaneous Electrical Nerve Stimulation (PENS) (PNT) May 17 11