Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Migraine Deactivation Surgery

Policy #:11.15.24a

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

Migraine deactivation surgery is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, migraine deactivation surgery is not eligible for payment under the medical benefits of the Company’s products because the service is considered experimental/investigational and, therefore, not covered.

Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

Description

Migraines are classified in the International Headache Classification (ICHD III) as a primary headache disorder. The ICHD III defines six different types of migraine disorders, further delineated into subtypes. It is estimated that more than 35,000,000 Americans (12% of the population) experience migraines, and, according to the World Health Organization (WHO), migraine ranks among the world's most disabling medical illnesses. There is no known cure for migraines, and findings from migraine studies suggest the disorder is under-recognized and under-treated. Typical features of migraine headaches include unilateral location, pulsating quality, moderate or severe intensity, and associated symptoms such as nausea, photophobia, and/or phonophobia.

Current treatments for migraines include interventions to prevent migraine episodes, as well as to lessen the intensity and/or duration of migraine episodes after symptoms start. Preventive measures involve 1) avoidance of known physical and/or psychological triggers and 2) use of pharmacologic intervention. In 2010, the FDA also approved the use of Botox for the prevention of chronic migraine headaches. Over-the-counter and prescription medications are recommended during acute episodes.

Non-pharmacologic approaches to migraine management have also been investigated. These approaches include complementary and alternative medicine methods, such as acupuncture, biofeedback, and chiropractic adjustment; occipital nerve blocks; and surgical interventions, including occipital nerve stimulation, patent foramen ovale (PFO) closure, and surgical deactivation.

Migraine deactivation surgery (MDS) encompasses a variety of invasive procedures performed to neutralize the suspected anatomic migraine trigger site(s) for an individual. Surgery to remove wrinkles from the forehead and between the eyebrows (rhytidectomy); open nasal passage(s) (inferior turbinate excision or resection); fix a deviated nasal septum (septoplasty); lift eyebrow (brow ptosis repair); and relieve nerve compression (neuroplasty) are some of the surgical techniques used in MDS. Due to the possible involvement of multiple trigger sites, a combination of surgical techniques are often performed as part of MDS. The migraine trigger sites are deactivated by removing and/or manipulating the small muscles, nerves, and anatomic contact points hypothesized to initiate migraine symptoms. The interventions include removal of the glabellar muscle group to relieve compression of the supraorbital and supratrochlear nerves, removal of the zygomaticotemporal branch of the trigeminal nerve to prevent its compression by the temporalis muscle, removal of the semispinalis capitis muscle surrounding the greater occipital nerve, and/or alteration of contact points.

Subjective reports of migraine relief by patients who had undergone forehead rejuvenation surgery for cosmetic reasons form the basis for the clinical studies published since 2000. These studies ranged from retrospective chart reviews to randomized controlled trials (RCT). The RCTs are summarized below.

The first randomized controlled trial to investigate the efficacy of surgical deactivation of migraine headache trigger sites was published in 2005 by Guyuron et al. Subjects with neurologist-confirmed migraine headaches were randomized 4:1 to the treatment or control arms of the study. Trigger site(s) in the treatment arm (n = 100) were determined by a Botox response algorithm, whereas the control arm (n = 25) received saline injections. A total of 91 patients had a positive study response to the Botox injection(s) and proceeded to surgery. Follow-up information was successfully completed for 89 (98%) of these subjects. Lower follow-up adherence was noted among the control arm; 19 out of 25 (76%) subjects fulfilled the follow-up requirement.

The study endpoints included total composite scores, as well as pre- and post-frequency, intensity, and duration values. The monthly frequency of migraine headache in the treatment group was 3.8 0.4, compared with 10.2 1.7 (p < 0.001) for the control group. The Migraine Headache Index was 12.6 3.1 in the treatment group, compared with 90.6 33.6 in the control group (p = 0.03). Reduction from baseline values of at least 50% in frequency, intensity, or duration was experienced by 82 subjects (92%), 31 of whom reported elimination of their migraine symptoms, compared to 3 of the 19 control subjects with a 50% reduction from baseline values (p < 0.001). A 50% or greater reduction in the Migraine Index Scores for 89 treatment (93.3%) and 8 control (42.1%) subjects was also noted (p < 0.001). Although the treated group had a statistically significant rate of improvement, the positive results noted by the control group, who did not have any intervention, minimizes the treatment effect noted in this study population.

The study design by Guyuron et al., however, does not disclose the parameters used for sample size calculation or account for the rationale behind the unequal randomization allocation. Additional design flaws include the absence of a priori power analysis, the lack of an active comparator in the control group, and the comparison between unblinded study arms. Lastly, the potential for recall bias and temporal effect on migraine symptoms is significant, in that the follow-up period ranged from 233 to 629 days with a mean of 396 days. These factors highlight the need for more rigorous study designs to assess if the aforementioned outcomes can be reproduced in the clinical setting.

Another important factor is the number of trigger sites treated. In this sample, the majority (64.9%) of the subjects had three or four sites treated. Although the metrics for improvement and elimination were not reported related to the number of sites treated, the authors suggest that there may be additional trigger sites not identified or yet to be discovered, which could eventually improve the elimination rate. The addition of nasal surgery as needed in this RCT and the plans to improve accuracy of trigger identification highlight the evolving nature of this intervention.

Lastly, the findings from this RCT supplement the safety profile for deactivation surgery for migraines, including the addition of adverse events specifically related to the intra-nasal manipulation. The reported complications were: temporary nasal dryness (n = 12); rhinorrhea (n = 11); slight recurrence of septal deviation (n = 8); intense itching (n = 7); minor hair loss (n = 5); abnormal intraoperative bleeding (n = 4); short-term neck stiffness (n = 3); epistaxis requiring desmopressin (n = 3); sinus infection (n = 3); long-term neck stiffness (n = 1); hematoma (n = 1); unilateral airway reduction (n = 1); and significantly major hair loss (n = 1).

The same authors collected long-term adverse sequelae as part of their five-year follow-up of the subjects in this study. The follow-up, however, does not include results for the control arm subjects because they were offered surgery after one year (17 of the 19 control subjects accepted the offer of surgery). Five-year outcome data was available for 79 of the 89 originally treated subjects; however, 10 of the 79 underwent additional deactivation surgery in the interim and were also excluded from the analysis. The reported results remained favorable, as evidenced by the five-year maintenance of reductions in mean values from baseline in the frequency, intensity, duration, and migraine headache index scores. Overall, 88% (n = 61) of the subjects experienced significant improvement (at least 50% decrease in frequency, intensity, or duration), with 20 of the subjects (29%) reporting complete elimination of their migraines (compared to 35% of the subjects [n = 31] without symptoms at the one-year follow-up).

A second RCT, also conducted by Guyuron et al., represents the seminal work to date on migraine deactivation surgery. The study design incorporated sham surgery versus actual surgery to the predominant Botox-responsive trigger site (frontal, temporal, or occipital). Among the 317 patients who were screened for initial study eligibility, 130 had Botox injected to determine responsiveness and further eligibility. A total of 76 subjects underwent surgery as part of this RCT; however, results are reported on 75 due to failure of one patient to complete the one-year follow-up. The stratification for the predominant trigger site for the actual (n = 49) and sham (n = 26) arms for frontal, temporal, and occipital were 19 and 10; 19 and 9; and 11 and 7, respectively.

The potential for placebo effect due to surgical manipulation in both study arms, as well as authors’ concern about study participants exaggerating their preoperative symptoms to improve chances for study selection decreases the validity of the study results. Furthermore, the findings from the analysis of pre-treatment and one-year follow-up data for the treatment arms were statistically significant. Improvement was documented for 41 out of the 49 subjects (83.7%) who received actual deactivation surgery, compared with 15 of the 26 subjects (57.7%) who received sham surgery (p = 0.014). Complete elimination was experienced in 28 of the 49 (57.1%) actual surgery subjects and 1 (3.8%) of the 26 sham surgery patients (p < 0.00010). Despite 42.3% (n = 11) of the sham arm reporting no change, 16.3% (n = 8) of the real deactivation arm also experienced no change (p = 0.02), thus requiring additional investigation to gauge superior effective treatment between responders and non-responders. The authors acknowledge that the lack of desired effect among the real deactivation arm could be the treatment restriction of only treating one trigger site in this study, which may not be the only trigger site. The potential for no benefit, therefore, must continue to be weighed against the known risks and recovery associated with surgery.

In 2016, Omranifard et al., published an RCT comparing surgical deactivation of migraine trigger sites to medical treatment in 50 individuals from a single center in Iran. The trial did not include a sham control and individuals were not blinded to treatment group. Individuals met diagnostic criteria for migraine headache and were asked about their most common migraine trigger sites. All individuals received injections of botulinum toxin into the frontal, temporal, and occipital trigger sites. Investigators did not state how they evaluated individuals' responses to botulinum toxin or how their responses to botulinum toxin affected their eligibility to participate in the trial. Individuals in the medical treatment group (n=25) were prescribed propranolol and amitriptyline. Individuals assigned to the surgery group (n=25) underwent decompression surgery in one or any combination of four trigger sites (frontal, temporal, septum, and/or occipital) they identified as relevant to their pattern of headaches. Surgical procedures were similar to those used in the Guyuron et al. RCTs except that a septal surgery option was added. For individuals with frontal headaches, the glabellar muscles were removed. For individuals with temporal headaches, a segment of the zygomaticotemporal branch of the trigeminal nerve was removed. For individuals with occipital headaches, a segment of the semispinalis capitis muscle was removed, and the occipital artery was removed if it was entangled with the nerve. For individuals with migraines originating at the septum, septoplasty and/or turbinectomy procedures were performed. All 12-month outcomes were significantly better in the surgery group compared with the medical treatment group. No adverse effects were reported. The trial, however, was subject to methodological limitations. Interpreting trial findings is influenced by the lack of individual blinding, which raises concerns about subjective and individual reported outcome measures. The reported results could be affected by the placebo effect. Moreover, it is not clear how individual outcomes data were collected (trialists did not mention participant diaries). Furthermore, surgeries differed by individual's trigger sites, which makes it difficult to evaluate any particular surgical procedure. Additional multicenter and sham controlled randomized studies are needed.

Despite a variety of study designs with promising results, including reductions in frequency, duration, and/or intensity of migraine headaches, the following issues limit the strength of the findings: absence of a well-defined population that might benefit from the surgery; the use of multiple surgical techniques within the studies; the identification of multiple potential trigger sites; the utilization of small sample sizes and invalidated endpoints to measure improvement; and the dearth of comparative data in relation to established alternatives, including Botox injections. These design limitations diminish the reliability and validity of the findings. Additional appropriately powered, double-blind RCTs are needed to further establish safety and efficacy.
References


American Headache Society. American Headache Society Urges Caution in Using Any Surgical Intervention in Migraine Treatment. [American Headache Society Web site]. 04/13/2012. Available at: https://americanheadachesociety.org/news/american-headache-society-urges-caution-in-using-any-surgical-intervention-in-migraine-treatment/. Accessed February 12, 2018.

Behin F, Behin B, Bigal ME, et al. Surgical treatment of patients with refractory migraine headaches and intranasal contact points. Cephalalgia. 2005;25(6):439-43.

Bigal ME, Lipton RB. The epidemiology, burden, and comorbidities of migraine. Neurol Clin. 2009;27(2):321-34.

Chepla KJ, Oh E, Guyuron B. Clinical outcomes following supraorbital foraminotomy for treatment of frontal migraine headache. Plast Reconstr Surg. 2012;129(4):656e-662e.

Chmielewski LI, Liu MT, Guyuron B. The role of occipital artery resection in the surgical treatment of occipital migraine headaches. Plast Reconstr Surg. 2013;131(3):351e-6e.

Dirnberger F, Becker K. Surgical treatment of migraine headaches by corrugator muscle resection. Plast Reconstr Surg. 2004;114(3):652-657; discussion 658-659.

Ducic I, Felder JM, 3rd, Khan N, et al. Greater occipital nerve excision for occipital neuralgia refractory to nerve decompression. Ann Plast Surg. 2014;72(2):184-187.

Guyuron B, Harvey D, Reed D. A prospective randomized outcomes comparison of two temple migraine trigger site deactivation techniques. Plast Reconstr Surg. 2015;136(1):159-165.

Guyuron,B, Kriegler JS, Davis J, Amini SB. Comprehensive surgical treatment of migraine headaches. Plast Reconstr Surg. 2005;115(1):1-9.

Guyuron B, Kriegler JS, Davis J, Amini SB. Five-year outcome of surgical treatment of migraine headaches. Plast Reconstr Surg. 2011;127(2):603-608.

Guyuron B, Lineberry K, Nahabet EH. A retrospective review of the outcomes of migraine surgery in the adolescent population. Plast Reconstr Surg. 2015;135(6):1700-1705.

Guyuron B, Reed D, Kriegler JS, et al. A placebo-controlled surgical trial of the treatment of migraine headaches. Plast Reconstr Surg. 2009;124(2):461-468.

Guyuron B, Tucker T, Davis J. Surgical treatment of migraine headaches. Plast Reconstr Surg. 2002;109(7):2183-2189.

Guyuron B, Varghai A, Michelow B J, et al. Corrugator supercilii muscle resection and migraine headaches. Plast Reconstr Surg. 2000;106(2):429-434; discussion 435-427.

Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013;33(9) 629–808.

Holland S, Silberstein SD, Freitag F, et al. Evidence-based guideline update: NSAIDs and other complementary treatments for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. 2012;78(17):1346-1353.

International Headache Society (IHS). 2nd Edition of the International Headache Classification (ICHD-2): MIGRAINE. [IHS Web site]. 2016. Available at: http://ihs-classification.org/en/02_klassifikation/02_teil1/01.00.00_migraine.html. [The link to this reference is no longer active on the IHS Web site]. Accessed April 17, 2017.

International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38(1):1-211.

Kurlander DE, Punjabi A, Liu MT, et al. In-depth review of symptoms, triggers, and treatment of temporal migraine headaches (Site II). Plast Reconstr Surg. 2014;133(4):897-903.

Larson K, Lee M, Davis J, Guyuron B. Factors contributing to migraine headache surgery failure and success. Plast Reconstr Surg. 2011;128(5):1069-1075.

Lee M, Lineberry K, Reed D, Guyuron B. The role of the third occipital nerve in surgical treatment of occipital migraine headaches. J Plast Reconstr Aesthet Surg. 2013;66(10):1335-9.

Liu MT, Chim H, Guyuron B. Outcome comparison of endoscopic and transpalpebral decompression for treatment of frontal migraine headaches. Plast Reconstr Surg. 2012;129(5):1113-1119.

Liu MT, Armijo BS, Guyuron B. A comparison of outcome of surgical treatment of migraine headaches using a constellation of symptoms versus botulinum toxin type A to identify the trigger sites. Plast Reconstr Surg. 2012;129(2):413-9.

Loder E, Weizenbaum E, Frishberg B, et al. Choosing wisely in headache medicine: the American Headache Society's list of five things physicians and patients should question. Headache. 2013;53(10):1651-1659.

Mathew PG. A critical evaluation of migraine trigger site deactivation surgery. Headache. 2014;54(1):142-52.

Omranifard M, Abdali H, Ardakani MR, et al. A comparison of outcome of medical and surgical treatment of migraine headache: In 1 year follow-up. Adv Biomed Res. 2016;5:121.

Poggi JT, Grizzell BE, Helmer SD. Confirmation of surgical decompression to relieve migraine headaches. Plast Reconstr Surg. 2008;122(1):115-122; discussion 123-114.

Silberstein SD, Holland S, Freitag F, et al. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. 2012;78(17):1337-1345.

Silberstein SD, Tfelt-Hansen P, Dodick DW, et al.Guidelines for controlled trials of prophylactic treatment of chronic migraine in adults. Cephalalgia. 2008;28(5):484-495.

U.S. Food and Drug Administration. FDA approves Botox to treat chronic migraine. 10/15/2010. Available at: http://www.prnewswire.com/news-releases/fda-approves-botox-to-treat-chronic-migraine-105069589.html. Accessed February 12, 2018.

World Health Organization (WHO). Headache disorders. [WHO Web site]. Updated April 2016. Available at: http://www.who.int/mediacentre/factsheets/fs277/en/. Accessed February 12, 2018.

World Health Organization, Lifting the Burden. “Atlas of Headache Disorders and Resources in the World 2011.” Geneva. World Health Organization. May, 2011.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

THE FOLLOWING CODES ARE USED TO REPRESENT MIGRAINE DEACTIVATION SURGERY:


30999 , 64999, 67999, 96999



Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

This service is experimental/investigational for all diagnoses.


HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

Revisions from 11.15.24a
04/25/2018This policy has undergone a routine review, and no revisions have been made.

Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date: 03/11/2015
Version Issued Date: 03/11/2015
Version Reissued Date: 04/25/2018

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Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.