National Medical Policy

Transcription

1 National Medical Policy Subject: Trigeminal Neuralgia, Interventional Treatments Policy Number: NMP73 Effective Date*: October 2003 Updated: February 2016 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 National Coverage Determination (NCD) National Coverage Manual Citation X Local Coverage Determination (LCD)* Stereotactic Body Radiation Therapy: Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SBRT); Cranial Stereotactic Radiosurgery (SRS) and Cranial Stereotactic Radiotherapy: Article (Local)* Other None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Trigeminal Neuralgia, Interventional Treatments Feb 16 1

2 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 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 Health Net Inc, considers all of the following surgical procedures medically necessary for the treatment of trigeminal neuralgia (also known as tic douloureux) when all of the criteria below are met: 1. Percutaneous glycerol rhizotomy (or injections) 2. Percutaneous radiofrequency rhizolysis/rhizotomy/ cryoanalgesia 3. Balloon microcompression 4. Microvascular decompression 5. Stereotactic Radiosurgery (Gamma Knife Radiosurgery) Criteria: 1. Patient has pain characteristic of trigeminal neuralgia for > 6 months; and 2. Pharmacotherapies that often provide significant benefit are contraindicated, have led to intolerable side effects or have failed (e.g., carbamazepine (Tegretol), clonazepam (Klonopin), phenytoin, and baclofen). 3. There is documentation that the pain can be abolished by local anesthetic injection, but not by placebo injection. Not Medically Necessary Health Net, Inc. considers pulsed radiofrequency for the treatment of trigeminal neuralgia not medically necessary due to lack of evidence in the peer review literature demonstrating its safety and efficacy for this indication. Definitions TN Trigeminal neuralgia MVD Microvascular decompression GKS Gamma knife surgery CRF Continuous radiofrequency PRF Pulsed radiofrequency RF-TR Radiofrequency trigeminal rhizotomy BTN Bilateral trigeminal neuralgia ITN Idiopathic trigeminal neuralgia 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 non- Trigeminal Neuralgia, Interventional Treatments Feb 16 2

3 covered 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. ICD-9 Codes Trigeminal neuralgia Other specified trigeminal neuralgia disorders Postherpetic trigeminal neuralgia ICD-10 Codes G50.0 Trigeminal neuralgia B02.22 Postherpetic trigeminal neuralgia CPT Codes Stereotactic radiosurgery (particle beam, gamma ray or linear accelerator); 1 simple cranial lesion Stereotactic radiosurgery (particle beam, gamma ray or linear accelerator); each additional cranial lesion, simple (List separately in addition to code for primary procedure) Stereotactic radiosurgery (particle beam, gamma ray or linear accelerator); 1 complex cranial lesion Stereotactic radiosurgery (particle beam, gamma ray or linear accelerator); each additional cranial lesion, complex (List separately in addition to code for primary procedure) Application of stereotactic headframe for stereotactic radiosurgery (List separately in addition to code for primary procedure) Stereotactic radiosurgery (particle beam, gamma ray or linear accelerator); 1 spinal lesion Stereotactic radiosurgery (particle beam, gamma ray or linear accelerator); each additional spinal lesion (List separately in addition to code for primary procedure) Injection, anesthetic agent; trigeminal nerve, any division or branch Destruction by neurolytic agent; other peripheral nerve or branch Unlisted procedure, nervous system (No specific code for pulsed radiofrequency neurolysis HCPCS Codes N/A Scientific Rationale - Update February 2015 There are no clinical trials on pulsed radiofrequency for trigeminal neuralgia. There is a paucity of peer-reviewed medical literature to support the efficacy, safety and the long term outcomes of this therapy. Scientific Rationale Update February 2013 Liu et al (2012) analyzed the clinical efficacy of radiofrequency thermocoagulation in the treatment of idiopathic trigeminal neuralgia, and discussed the method, skill of radiofrequency thermocoagulation and complications. 648 patients with idiopathic Trigeminal Neuralgia, Interventional Treatments Feb 16 3

4 trigeminal neuralgia, who were treated by radiofrequency thermocoagulation via foramen infraorbitale approach, lateral approach, anterior approach and other approach from July 2001 to March 2011 in one hospital, were observed and the clinical efficacy was evaluated. After the first treatment of the 648 patients, the rate of pain control was 98.3% via foramen infraorbitale approach, 91.0% via lateral approach and 95.5% via former approach. The overall response rate was 96.0%. 395 patients were followed up from 6 months to 2 years. The recurrent rate within one year was 9.6%, 20.5% within two years. Good response was achieved after retreatment with radiofrequency thermocoagulation in recurrent patients. Investigators concluded the clinical efficacy of radiofrequency thermocoagulation in the treatment of idiopathic trigeminal neuralgia is good and reliable. The operation is simple, the indication is wide, and the complication is fewer. CT location can improve the accuracy of puncture, and reduce complications. Tang et al (2012) evaluated the curative effects and complications when using microvascular decompression (MVD) or gamma knife surgery (GKS) to treat trigeminal neuralgia (TN) and investigated the prognosis for TN after these treatments. Sixty-one TN patients treated using MVD and eighty-six TN patients treated using GKS were enrolled by means of telephone, letter or out-patient recheck; the patients had originally presented from December 1996 to June A chi-square test was applied to follow-up data on pain relief after 1 month, 6 months and 12 months, and at the final follow-up. One hundred and two patients were followed for months. Cumulative pain relief rates at 1, 6, 12 months and at end times were 90.48%, 95.24%, 92.86%, and 95.24%, respectively, for forty-two MVD-treated patients, and 23.33%, 83.33%, 86.67% and 90% for sixty GKS-treated patients, respectively. The effects of two methods for treatment of TN was not statistically different (χ(2) = 2.053, P=0.152). Pain relief rates in the short-term (first month) demonstrated statistically significant differences (P<0.01), but pain relief rates in the long-term showed no significant differences (P>0.05). Investigators concluded immediate pain relief with MVD treatment is higher than with GKS, but in the long term both treatments were comparable. Li et al (2012) conducted a prospective randomized controlled study to evaluate whether continuous radiofrequency (CRF) combined with pulsed radiofrequency (PRF) to the Gasserian ganglion (GG) decreases the side effects of CRF while preserving efficacy. Sixty patients diagnosed with classic trigeminal neuralgia (TN) were treated with either 75 C CRF for 120 s to 180 s (SCRF group), 75 C CRF for 240 s to 300 s (LCRF group), or 42 C PRF for 10 minutes (min) followed by 75 C CRF for 120 s to 180 s (PCRF group). Patients were assessed for pain intensity, quality of life (QOL), and intensity of facial dysesthesia before (baseline), and at seven days, three months, six months, and 12 months after the procedure. The efficacy in pain relief was most significant on the seventh day after treatment and there were no significant differences between groups. After 12 months, >70% of patients in each group had complete pain relief, and the QOL in all three groups had increased significantly compared to baseline. The intensity of facial dysesthesia was mildest in the SCRF group and most severe in the PCRF group on the seventh day after the procedure, but most persistent in the LCRF group. Investigators concluded patients who receive PRF combined with CRF to the GG can achieve comparable pain relief to those who receive CRF alone, and shorter exposure of CRF could result in less destruction of the target tissue. Bozkurt et al (2012) evaluated the effectiveness of percutaneous controlled radiofrequency trigeminal rhizotomy (RF-TR) in patients with bilateral trigeminal Trigeminal Neuralgia, Interventional Treatments Feb 16 4

5 neuralgia (BTN). Patients were analyzed after RF-TR in terms of outcome, safety and complications. Eighty-nine BTN patients underwent 186 RF-TR procedures. Eightyseven patients had idiopathic trigeminal neuralgia (ITN) and two patients had multiple sclerosis (2.2%). Fifty-six (62.9%) were women and 33 (37.1%) were men. Ages ranged from 29 to 85 years. Anesthesia was administered at a determined optimal level, allowing patient cooperation for controlled and selective lesioning. The mean follow-up period was ± 77.7 months. Familial occurrence was seen in two (2.2%) patients. Synchronized pain was observed in 25 (28.2%) patients. Pain occurrence on the contralateral side was observed with an average duration of ± months. Fifty-four of the 89 patients underwent 146 RF-TR procedures for both sides and 35 underwent 40 RF-TR procedures for one side. Complete pain relief or partial satisfactory pain relief was achieved on the medically treated side in 35 patients. During follow-up, 36 patients required the second procedure and 7 required the third procedure. Acute pain relief was reported in 86 (96.6%) patients. Early (<6 months) pain recurrence was observed in 11 (12.3%) and late (>6 months) recurrence in 25 (28.0%) patients. Complications included diminished corneal reflex in four (2.1%) patients, keratitis in two (1.1%), masseter dysfunction in four (2.1%), dysesthesia in two (1.1%), and anesthesia dolorosa in one (0.5%). Investigators concluded RF-TR is an effective, selective, well-controlled, and effortlessly repeatable procedure for treating BTN, especially in the elderly, in terms of low morbidity and mortality rates and high rate of satisfactory pain relief. Scientific Rationale Update February 2011 A 2011 Cochrane review (Zakrzewska and Akram) assessed the efficacy of neurosurgical interventions for classical trigeminal neuralgia in terms of pain relief, quality of life and any harms. They searched randomised controlled trials and quasirandomised controlled trials of neurosurgical interventions used in the treatment of classical trigeminal neuralgia. Two authors independently assessed trial quality and extracted data. Eleven studies involving 496 participants met some of the inclusion criteria stated in the protocol. One hundred and eighty patients in five studies had peripheral interventions, 229 patients in five studies had percutaneous interventions applied to the Gasserian ganglion, and 87 patients in one study underwent two modalities of stereotactic radiosurgery (Gamma Knife) treatment. No studies addressing microvascular decompression (which is the only non-ablative procedure) met the inclusion criteria. All but two of the identified studies had a high to medium risk of bias because of either missing data or methodological inconsistency. It was not possible to undertake meta-analysis because of differences in the intervention modalities and variable outcome measures. Three studies had sufficient outcome data for analysis. One trial, which involved 40 participants, compared two techniques of radiofrequency thermocoagulation (RFT) of the Gasserian ganglion at six months. Pulsed RFT resulted in return of pain in all participants by three months. When this group were converted to conventional (continuous) treatment these participants achieved pain control comparable to the group that had received conventional treatment from the outset. Sensory changes were common in the continuous treatment group. In another trial, of 87 participants, investigators compared radiation treatment to the trigeminal nerve at one or two isocentres in the posterior fossa. There were insufficient data to determine if one technique was superior to another. Two isocentres increased the incidence of sensory loss. Increased age and prior surgery were predictors for poorer pain relief. Relapses were nonsignificantly reduced with two isocentres (risk ratio (RR) 0.72, 95% confidence intervai (CI) 0.30 to 1.71). A third study compared two techniques for RFT in 54 participants for 10 to 54 months. Both techniques produced pain relief (not significantly in favour of neuronavigation (RR 0.70, 95% CI 0.46 to 1.04) but relief was more sustained and Trigeminal Neuralgia, Interventional Treatments Feb 16 5

6 side effects fewer if a neuronavigation system was used. The remaining eight studies did not report outcomes as predetermined in our protocol. Chua et al (2011) evaluated the efficacy of Pulsed Radiofrequency (PRF) treatment in chronic pain management in randomized clinical trials (RCTs) and well-designed observational studies. Six RCTs that evaluated the efficacy of PRF, one against corticosteroid injection, one against sham intervention, and the rest against conventional RF thermocoagulation. Two trials were conducted in patients with lower back pain due to lumbar zygapophyseal joint pain, one in cervical radicular pain, one in lumbosacral radicular pain, one in trigeminal neuralgia, and another in chronic shoulder pain. The reviewers noted that from the available evidence, the use of PRF to the dorsal root ganglion in cervical radicular pain is compelling. With regards to its lumbosacral counterpart, the use of PRF cannot be similarly advocated in view of the methodological quality of the included study. PRF application to the supracapular nerve was found to be as efficacious as intra-articular corticosteroid in patients with chronic shoulder pain. The use of PRF in lumbar facet arthropathy and trigeminal neuralgia was found to be less effective than conventional RF thermocoagulation techniques. Scientific Rationale Update April 2008 Pulsed radiofrequency has been investigated in patients with neuropathic pain syndromes that have been poorly controlled with other oral and invasive treatments. Pulsed radiofrequency applies short bursts of radiofrequency energy to the target nerve at a lower temperature, stunning the nerve rather than destroying nerve tissue. The available peer review literature regarding the use of pulsed radiofrequency for the treatment of trigeminal neuralgia is limited. One small, short-term, prospective randomized study (Erdine et al) compared the effect of pulsed radiofrequency (PRF) to conventional radiofrequency (CRF) in the treatment of idiopathic trigeminal neuralgia. The investigator reported, at the end of 3 months, conventional radiofrequency was performed on the group initially treated with pulsed radiofrequency because all patients in this group still had intractable pain. This led the investigator to conclude that pulsed radiofrequency is not an effective method of pain treatment for idiopathic trigeminal neuralgia. At the present time, clinical advantages and mechanisms of this treatment remain unclear. Large prospective, randomized studies with long term-follow up are necessary to validate the clinical value of this approach. Scientific Rationale Trigeminal neuralgia (TN), also known as tic douloureux, is a disorder of the fifth cranial (trigeminal) nerve that causes episodes of intense, stabbing pain in the face. Although trigeminal neuralgia is initially treated medically, with the anti-epileptic drug carbamazepine (Tegretol) being the drug of choice in a substantial number of cases, drug treatment is either ineffective or the adverse effects become intolerable (poor liver function, confusion, ataxia, drowsiness, and allergic responses). Upon failure of further attempts at pharmaceutical control, neurosurgical options include microvascular decompression, balloon compression, and rhizotomy. Studies have shown that cryoanalgesia provides temporary pain relief or cure with minimal morbidity (e.g., no permanent sensory loss) in patients with refractory TN. Trigeminal Neuralgia, Interventional Treatments Feb 16 6

7 Surgical treatment can be divided into percutaneous and open interventions. The former approaches include radiofrequency rhizolysis, glycerol injection, balloon microcompression techniques and cryoanalgesia. The principal open approach is microvascular decompression, which entails posterior fossa craniotomy and has a small incidence of serious neurological morbidity. In general, elderly or medically debilitated patients, patients with multiple sclerosis, or individuals who have failed to attain pain relief from the open approach are encouraged to use the percutaneous approaches, while the open approach is recommended for younger and healthier subjects. Stereotactic Radiosurgery (SRS), also referred to as Gamma Knife Radiosurgery, has been investigated as an alternative to these neurosurgical treatments without making an incision. Two hundred-one beams of cobalt-60 radiation are focused precisely on a specific region in the brain. In the case of TN, the target area is the trigeminal nerve, just where it leaves the brain. The treatment does not require general anesthesia, and the patient stays in the hospital for less than five hours. Any patient with trigeminal neuralgia who has pain or has difficulty with the medicines used to relieve the pain is an excellent candidate for SRS. The patient's age or medical condition does not affect the decision to have SRS. Even the elderly or medically infirm can undergo this treatment. Patients who are receiving anticoagulants for other medical conditions do not have to stop or reverse the anticoagulation therapy prior to SRS. Those who have had previous procedures for TN may also undergo SRS. Patients who are concerned about the possibility of numbness are particularly good candidates for SRS, because the chance of postoperative numbness occurring is very small. Patients who poorly tolerate medicines given for sedation and relief of pain during a procedure are also very suitable for SRS because these medications are not necessary. Excellent or good pain relief occurs in approximately 85 to 90 percent of patients. Onset of pain relief may occur one day to four months after the procedure. About half of patients will experience pain relief within four weeks. Recurrent pain occurs within three years in 10 percent of patients. Gamma Knife radiosurgery can be repeated, but not until at least four months after the original procedure. Major complications have not been reported. Additional numbness in the face or new facial sensations occur in less than 10 percent of patients. There are theoretical possibilities of delayed complications such as brain damage or brain tumor formation, but these are rare and have not been reported to occur in any patients treated for trigeminal neuralgia. Review History October 2003 April 2006 April 2008 April 2011 February 2012 February 2013 February 2014 February 2015 February 2016 Medical Advisory Council Update no revisions Added pulsed radiofrequency for treatment of trigeminal neuralgia as investigational and therefore not medically necessary. Update. Added Medicare Table with links to LCDs and article. Codes updated. No revisions. Update no revisions Update no revisions. Code updates Update no revisions. Code updates Update no revisions. Codes updated Update no revisions. Codes updated Trigeminal Neuralgia, Interventional Treatments Feb 16 7

8 This policy is based on the following evidence-based guidelines: 1. Gronseth G, Cruccu G, Alksne J, Argoff C, Brainin M, Burchiel K, Nurmikko T, Zakrzewska JM. Practice parameter: the diagnostic evaluation and treatment of trigeminal neuralgia (an evidence-based review). Report of the Quality Standards Subcommittee of the American Academy of Neurology and the European Federation of Neurological Societies. Neurology 2008 Oct 7;71(15): IRSA. Stereotactic radiosurgery for patients with intractable typical trigeminal neuralgia who have failed medical management. Harrisburg (PA): IRSA; 2009 Jan. 11 p. Available at: UpdatedJan2009.pdf References Update February Temple ZJ, Chivukula S, Monaco EA 3rd, et al. The results of a third Gamma Knife procedure for recurrent trigeminal neuralgia. J Neurosurg. 2015;122(1): References Update February Zakrzewska JM, Linskey ME. Trigeminal neuralgia. BMJ 2014; 348:g Zhang J, Yang M, Zhou M, et al. Non-antiepileptic drugs for trigeminal neuralgia. Cochrane Database Syst Rev 2013; 12:CD References Update February Bajwa ZH, Ho CC, Khan SA. Trigeminal neuralgia. UpToDate. February Updated September 3, Updated July 27, References Update February Bozkurt M, Al-Beyati ES, Ozdemir M, et al. Management of bilateral trigeminal neuralgia with trigeminal radiofrequency rhizotomy: a treatment strategy for the life-long disease. Acta Neurochir (Wien) May;154(5): Chen JC..Microvascular decompression for trigeminal neuralgia in patients with and without prior stereotactic radiosurgery. World Neurosurg Jul;78(1-2): Fraioli MF, Strigari L, Fraioli C, et al. Preliminary results of 45 patients with trigeminal neuralgia treated with radiosurgery compared to hypofractionated stereotactic radiotherapy, using a dedicated linear accelerator. J Clin Neurosci Oct;19(10): Ibrahim S. Trigeminal neuralgia: diagnostic criteria, clinical aspects and treatment outcomes. A retrospective study. Gerodontology Oct Lazzara BM, Ortiz O, Bordia R, et al. Cyberknife radiosurgery in treating trigeminal neuralgia. J Neurointerv Surg Jan 1;5(1): Lee JK, Choi HJ, Ko HC, et al..long term outcomes of gamma knife radiosurgery for typical trigeminal neuralgia-minimum 5-year follow-up. J Korean Neurosurg Soc May;51(5): Li X, Ni J, Yang L, et al. A prospective study of Gasserian ganglion pulsed radiofrequency combined with continuous radiofrequency for the treatment of trigeminal neuralgia. J Clin Neurosci Jun;19(6): Li P, Wang W, Liu Y, Zhong Q, Mao B. Clinical outcomes of 114 patients who underwent γ-knife radiosurgery for medically refractory idiopathic trigeminal neuralgia. J Clin Neurosci Jan;19(1):71-4. Trigeminal Neuralgia, Interventional Treatments Feb 16 8

9 9. Liu C, Zhou ZG, Yuan CY. Treatment of primary trigeminal neuralgia with radiofrequency thermocoagulation: report of 648 consecutive cases. Shanghai Kou Qiang Yi Xue Aug;21(4): Luo F, Meng L, Wang T, et al. Pulsed radiofrequency treatment for idiopathic trigeminal neuralgia: A retrospective analysis of the causes for ineffective pain relief. Eur J Pain Jan Tang X, Wang Y, Shu Z, Hou Y. Efficacy and prognosis of trigeminal neuralgia treated with surgical excision or gamma knife surgery. Zhong Nan Da Xue Xue Bao Yi Xue Ban Jun;37(6): Trojnik T, Ŝmigoc T. Percutaneous trigeminal ganglion balloon compression rhizotomy: experience in 27 patients. ScientificWorldJournal. 2012;2012: Tuleasca C, Carron R, Resseguier N, et al. Patterns of pain-free response in 497 cases of classic trigeminal neuralgia treated with Gamma Knife surgery and followed up for least 1 year. J Neurosurg Dec;117 Suppl: Zakrzewska JM, Coakham HB. Microvascular decompression for trigeminal neuralgia: update. Curr Opin Neurol Jun;25(3): References Update February Bender M, Pradilla G, Batra S, et al. Effectiveness of Repeat Glycerol Rhizotomy in Treating Recurrent Trigeminal Neuralgia. Neurosurgery Nov 3 2. Campos WK, Linhares MN. A prospective study of 39 patients with trigeminal neuralgia treated with percutaneous balloon compression. Arq Neuropsiquiatr Apr;69(2A): Chakravarthi PS, Ghanta R, Kattimani V. Microvascular decompression treatment for trigeminal neuralgia. J Craniofac Surg May;22(3): Chen JC. Microvascular Decompression for Trigeminal Neuralgia in Patients with and without Prior Stereotactic Radiosurgery: A Retrospective Review of a Consecutive Single-Surgeon Experience. World Neurosurg Nov Chen JF, Tu PH, Lee ST. Repeated Percutaneous Balloon Compression for Recurrent Trigeminal Neuralgia: A Long-Term Study. World Neurosurg Nov 7 6. Chua NH, Vissers KC, Sluijter ME. Pulsed radiofrequency treatment in interventional pain management: mechanisms and potential indications-a review. Acta Neurochir (Wien) Apr;153(4): Harries AM, Mitchell RD. Percutaneous glycerol rhizotomy for trigeminal neuralgia: safety and efficacy of repeat procedures. Br J Neurosurg Apr;25(2): Li P, Wang W, Liu Y, Zhong Q, Mao B. Clinical outcomes of 114 patients who underwent Gamma-knife radiosurgery for medically refractory idiopathic trigeminal neuralgia. J Clin Neurosci Jan;19(1): Park KJ, Kondziolka D, Berkowitz O, et al. Repeat Gamma Knife Radiosurgery for Trigeminal Neuralgia. Neurosurgery Aug Yen CP, Schlesinger D, Sheehan JP. Gamma Knife radiosurgery for trigeminal neuralgia. Expert Rev Med Devices Nov;8(6): Zakrzewska JM, Akram H. Neurosurgical interventions for the treatment of classical trigeminal neuralgia. Cochrane Database Syst Rev Sep 7;9:CD References Update April Kouzounias K, Lind G, Schechtmann G, et al. Comparison of percutaneous balloon compression and glycerol rhizotomy for the treatment of trigeminal neuralgia. J Neurosurg Feb 26. [Epub ahead of print] Trigeminal Neuralgia, Interventional Treatments Feb 16 9

10 2. Azar M, Yahyavi ST, Bitaraf MA, et al. Gamma knife radiosurgery in patients with trigeminal neuralgia: Quality of life, outcomes, and complications. Clin Neurol Neurosurg. 2009;111(2): Adler JR Jr, Bower R, Gupta G, et al. Nonisocentric radiosurgical rhizotomy for trigeminal neuralgia. Neurosurgery. 2009;64(2 Suppl):A84-A Fontaine D, Hamani C, Lozano A. Efficacy and safety of motor cortex stimulation for chronic neuropathic pain: Critical review of the literature. J Neurosurg. 2009;110(2): Fariselli L, Marras C, De Santis M, et al. CyberKnife radiosurgery as a first treatment for idiopathic trigeminal neuralgia. Neurosurgery. 2009;64(2 Suppl):A96-A101. References Update April Sekula RF, Marchan EM, Fletcher LH, et al. Microvascular decompression for trigeminal neuralgia in elderly patients. J Neurosurg Apr;108(4): Guo S, Chao ST, Reuther AM, et al. Review of the Treatment of Trigeminal Neuralgia with Gamma Knife Radiosurgery. Stereotact Funct Neurosurg Mar 12;86(3): Onoda K, Agari T, Date I. Microvascular decompression for trigeminal neuralgia in older patients. No Shinkei Geka Jan;36(1): Fountas KN, Smith JR, Lee GP, et al. Gamma Knife stereotactic radiosurgical treatment of idiopathic trigeminal neuralgia: long-term outcome and complications. Neurosurg Focus. 2007;23(6):E8 5. Sindou M, Leston J, Decullier E, et al. Microvascular decompression for primary trigeminal neuralgia: long-term effectiveness and prognostic factors in a series of 362 consecutive patients with clear-cut neurovascular conflicts who underwent pure decompression. J Neurosurg Dec;107(6): Cheshire WP. Trigeminal neuralgia: for one nerve a multitude of treatments. Expert Rev Neurother Nov;7(11): Racz GB, Ruiz-Lopez R. Radiofrequency procedures. Pain Pract Mar;6(1): Cahana A, Van Zundert J, Macrea L, et al. Pulsed radiofrequency: current clinical and biological literature available. Pain Med Sep-Oct;7(5): Erdine S, Ozyalcin NS, Cimen A, et al. Comparison of pulsed radiofrequency with conventional radiofrequency in the treatment of idiopathic trigeminal neuralgia. Eur J Pain Apr;11(3): Munglani R. The longer term effect of pulsed radiofrequency for neuropathic pain. Pain Mar;80(1-2): References Initial 1. Barker FG, et al. The long-term outcome of microvascular decompression for trigeminal neuralgia. N Engl J Med. 1996;334: Brisman R. Surgical treatment of trigeminal neuralgia. Semin Neurol. 1997;17(4): Cappabianca P, et al. Percutaneous retrogasserian glycerol rhizolysis for treatment of trigeminal neuralgia. Technique and results in 191 patients. J Neurosurg. 1995;39(1): Chilton JD. Gamma knife radiosurgery: Indications, techniques, and results in 200 patients treated at the Midwest gamma knife center. Missouri Med. 1997;94(7): Das B, Saha SP. Trigeminal neuralgia: Current concepts and management. J Indian Med Assoc. 2001;99(12): Trigeminal Neuralgia, Interventional Treatments Feb 16 10

11 6. Eide PK, Stubhaug A. Relief of trigeminal neuralgia after percutaneous retrogasserian glycerol rhizolysis is dependent on normalization of abnormal temporal summation of pain, without general impairment of sensory perception. Neurosurg. 1998;43(30): Kondziolka D, et al. Gamma knife radiosurgery for trigeminal neuralgia. Neurosurg Clin North Am. 1997;8(1): Kondziolka D, Lunsford LD, Flickinger JC. Stereotactic radiosurgery for the treatment of trigeminal neuralgia. Clin J Pain. 2002;18(1): Mendoza N, Illingworth RD. Trigeminal neuralgia treated by microvascular decompression: A long-term follow-up study. Br J Neurosurg. 1995;9: Pollock BE, et al. The Mayo Clinic gamma knife experience: Indications and initial results. Mayo Clin Proc. 1999;74: Rand RW. Leksell gamma knife treatment of tic douloureux. Neurosurg Clin North Am. 1997;8(1): Sindou M, Mertens P. Microsurgical vascular decompression (MVD) in trigeminal and glosso-vago-pharyngeal neuralgias. A twenty-year experience. Acta Neurochir. 1993;58: Tan LK, et al. Glycerol versus radiofrequency rhizotomy -- A comparison of their efficacy in the treatment of trigeminal neuralgia. Br J Neurosurg. 1995;9(2): Wilkinson HA. Trigeminal nerve peripheral branch phenol/glycerol injections for tic douloureux. J Neurosurg. 1999;90(5): Young RF, et al. Gamma knife radiosurgery for treatment of trigeminal neuralgia: Idiopathic and tumor related. Neurology. 1997;48(3): 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. Trigeminal Neuralgia, Interventional Treatments Feb 16 11

12 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. 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 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 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. Trigeminal Neuralgia, Interventional Treatments Feb 16 12