Medical Policy: 02.01.52 

Original Effective Date: December 2013 

Reviewed: July 2021 

Revised: July 2021 

 

Notice:

This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy 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 will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

Acute/chronic migraine and acute/chronic non-migraine headaches are common conditions and available treatments are not always effective. A proposed treatment options include blocking the sphenopalatine ganglion (SPG) nerve by applying an intranasal topical anesthetic or peripheral nerve injections/nerve blocks may also be used at various locations around the face and neck (occipital nerve, trigeminal nerve, supraorbital nerve and stellate ganglion) to reduce pain and inflammation using injectable anesthetic, steroids or other agents to manage headaches

 

As many as 90% of all primary headaches fall under a few categories including migraine, tension-type, and cluster headache. While episodic tension-type headache (TTH) is the most frequent headache type in population-based studies, migraine is the most common diagnosis in patients. Cluster headache typically leads to significant disability and most of these patients will seek medical attention.

 

Chronic Daily Headaches

Chronic daily headache (CDH) is a descriptive term that encompasses several different specific headache diagnoses characterized by frequent headaches. Primary CDH subtypes of long duration (i.e., four hours or more) include chronic migraine and chronic tension-type headache. Primary headache types of shorter duration that can be chronic and occur daily are chronic cluster headache, chronic paroxysmal hemicrania and primary headache disorders such as cervicogenic headache.

  • Chronic Migraine: Migraine is a common disabling primary headache disorder. Chronic migraine headache is defined as greater than or equal to 15 days per month lasting 4 hours a day or longer in an adult patient.
  • Chronic tension type headache: Frequent episodic tension type headache, with daily or very frequent episodes of headache, typically bilateral, pressing to tightening in quality and of mild to moderate intensity, lasting hours, to days or unremitting. The pain does not worsen with routine physical activity, but may be associated with mild nausea, photophobia or phonophobia.
  • Chronic cluster headache: Chronic cluster headaches is one of the trigeminal autonomic cephalagias (TACs), a group of primary headache disorders characterized by unilateral trigeminal distribution pain that occurs in association with ipsilateral cranial autonomic features. Cluster headache is characterized by attacks of severe unilateral, orbital, supraorbital or temporal pain. In the episodic form, attacks occur daily, usually one to eight times a day for several weeks, followed by a period of remission. The chronic form of cluster headaches occur for more than 1 year without remissions, or with remission periods lasting less than 1 month.
  • Cervicogenic headache: The clinical features of cervicogenic headache may mimic those associated with primary headache disorders (e.g., tension-type headache, migraine, or hemicranias continua), making it difficult to distinguish among headache types. Cervicogenic headaches is characterized by continuous, unilateral head pain radiating from the occipital areas to the front area, with associated neck pain and ipsilateral shoulder or arm pain. The headache is moderate in intensity with non-throbbing character. It is described as dull, boring, dragging pain that can fluctuate in intensity. The duration of the headache may range from a few hours to several days, and in some cases several weeks. The pain can be exacerbated by neck movements and is usually caused by neck trauma.
    • The anatomic point for cervicogenic headache is the trigeminocervical nucleus in the upper cervical spinal cord, where sensory nerve fibers in the descending tract of the trigeminal nerve are believed to interact with sensory fibers from the upper cervical roots. This functional intersection of upper cervical and trigeminal sensory pathways is through to allow bidirectional transmission of pain signals between the neck and the trigeminal sensory receptor fields of the face and head.
    • Cervicogenic headache is typically caused by a disorder of the cervical spine and its component bony, disc and/or soft tissue elements, usually but not invariably accompanied by neck pain. 

 

A variety of medications are used to treat acute/chronic migraine episodes. They include medications taken at the onset of an attack to abort the attack (triptans, ergotamines) and medications to treat the pain and other symptoms of migraines once they are established (nonsteroidal anti-inflammatory drugs, antiemetics). Prophylactic medication therapy may be appropriate for people with migraines that occur more than 2 days per week. In addition to medication, behavioral treatments (eg, relaxation, cognitive therapy) are used to manage migraine headache. Botulinum toxin type A injections are FDA-approved treatment for chronic migraine.

 

Severe acute/chronic cluster headaches may be treated with abortive therapy including breathing 100% oxygen, and triptan medications. Other medications used to treat cluster headaches include steroids, calcium channel blockers, and nerve pain medications. Due to the severity of pain associated with cluster headaches, patients may seek emergency treatment. Tension-type headaches are generally treated with over the counter pain medication. 

 

Sphenopalatine Ganglion (SPG) Block(s) and Application of Injections/Nerve Blocks to the Occipital Nerve, Trigeminal Nerve, Supraorbital Nerve and Stellate Ganglion for Headache Management

Clinical Context and Therapy Purpose

Sphenopalatine Ganglion (SPG) Block(s)

The purpose of sphenopalatine ganglion (SPG) block(s) in patients who have chronic headaches (chronic migraine, chronic tension type headache, chronic cluster headache and cervicogenic headache (primary headache disorder) is to provide a treatment option that is an alternative to or an improvement to existing therapies. 

 

The SPG is a group of nerve cells located behind the bony structures of the nose. The nerve bundle is linked to the trigeminal nerve which are associated with the sensory nerves associated with pain perception. SPG blocks involve topical application of local anesthetic to mucosa overlying the SPG. The rationale for using SPG blocks to treat headaches is that local anesthetics in low concentrations could block the sensory fibers and thereby reduce pain while maintaining autonomic function.

 

The proposed procedure for SPG block is to insert an intranasal catheter that is attached to a syringe carrying local anesthetic (e.g., lidocaine, bupivacaine). Once the catheter is in place, the local anesthetic is applied to the posterior wall of the nasal cavity, reaching the SPG. Three catheter devices are commercially available for performing SPG blocks: SpenoCath, Allevio SPG Nerve Block Catheter and Tx360 Nasal Applicator device. The company marketing Tx360 Nasal Applicator device proposes its use in the context of the MiRX protocol. This is a two- part protocol which includes a medical component for immediate pain relief and a physical component to reduce headache recurrences. The medical component involves clinical evaluation and if the patient is considered eligible, an SPG block procedure. The physical component can include any number of treatment approaches such as physical therapy, ergonomic modifications, message, and dietary recommendations.

 

The optimal number and frequency of SPG blocks is unclear. Randomized controlled trials have described a course of treatment for migraines consisting of SPG blocks twice a week for 6 weeks, for a total of 12 treatments.

 

Application of Injections or Nerve Blocks to the Occipital Nerve, Trigeminal Nerve, Supraorbital Nerve and Stellate Ganglion

Peripheral nerve injections/nerve blocks may also be used at various locations around the face and neck (occipital nerve, trigeminal nerve, supraorbital nerve and stellate ganglion) to reduce pain and inflammation using injectable anesthetic, steroids or other agents to manage headaches

 

Although clinicians commonly utilize these peripheral nerve injections/nerve blocks to manage headaches the procedure has yet to be standardized for this indication. 

 

Population

The relevant population of interest is individuals with acute/chronic headaches (chronic migraine, chronic tension type headache, chronic cluster headache and cervicogenic headache (primary headache disorder).

 

Interventions

The therapy being considered is Sphenopalatine ganglion (SPG) block(s) and peripheral nerve injections/ nerve blocks.

 

SPG block(s) are proposed for both short and long- term treatment of chronic headaches and chronic migraines. When used in the emergency department setting in patients with severe acute headaches, the goal of treatment is to abort the current headache while the patient is in the emergency department setting.

 

Peripheral nerve injections/nerve blocks may also be used at various locations around the face and neck (occipital nerve, trigeminal nerve, supraorbital nerve and stellate ganglion) to reduce pain and inflammation using injectable anesthetic, steroids or other agents to manage headaches.

 

Comparators

The following therapies and practices are currently being used to treat chronic headaches (chronic migraine, chronic tension type headache, chronic cluster headache and cervicogenic headache (primary headache disorder): medications, self-management [exercise, relaxation/message], physical therapy, ergonomic modifications and dietary recommendations).

 

Outcomes

The general outcomes of interest are reductions in headache frequency, intensity, and medication use. Treatment-related adverse events are minor. A series of injections may be given over several weeks, with follow-up over months to monitor for treatment effect and durability.   

 

Summary of Evidence

Based on review of the peer reviewed medical literature regarding the use of sphenopalatine ganglion (SPG) block(s) for the treatment of migraine and non-migraine headaches the evidence includes randomized controlled trials (RCTs) and case series. Sphenopalatine blocks are being proposed as preventative for chronic migraines and evidence demonstrating reduced migraine frequency, severity or other objective outcomes from robust trails are still needed. For non-migraine headaches additional studies preferably randomized controlled trials (RCTs) are needed to evaluate SPG blocks for this indication. The evidence is insufficient to support a conclusion concerning the net health outcomes or benefits associated with this procedure.

 

Based on review of the peer reviewed medical literature regarding peripheral nerve injections/nerve blocks used at various locations around the face and neck (occipital nerve, trigeminal nerve, supraorbital nerve and stellate ganglion) to reduce pain and inflammation using injectable anesthetic, steroids or other agents to manage headaches (migraine or non-migraine headaches) is limited. There is considerable variability among clinicians as to injection site(s) and medication selection, indicating a substantial gap in the literature to guide practice and supports the need for further research (controlled clinical trials) in this area. The evidence is insufficient to support a conclusion concerning the net health outcomes or benefits associated with this procedure.

 

Practice Guidelines and Position Statements

European Headache Society

In 2019, the European Headache Foundation issued an update: Aides to management of headache in primary care (2nd edition) and this updated management guide does not mention the use sphenopalatine ganglion nerve block or any other types of nerve blocks in the treatment of headaches or trigeminal neuralgia.

 

American Headache Society

The American Headache Society (AHS) Special Interest Section for Peripheral Nerve Blocks and Other Interventional Procedures cited the paucity of evidence for treatment of most headache disorders and cranial neuralgias, excluding cluster headaches.

 

The Institute for Clinical Systems Improvement’s clinical guideline on “Diagnosis and treatment of headache” (2013) did not mention trigeminal nerve block as a therapeutic option.

 

An updated consensus statement for treating migraine was released in December 2018 by the American Headache Society.

 

Use evidence-based treatment at the first sign of a migraine attack. Use NSAIDs (including aspirin), nonopioid analgesics, acetaminophen, or caffeinated analgesic combinations for mild-to-moderate attacks and migraine-specific agents (triptans, dihydroergotamine) for moderate or severe attacks and mild-to-moderate attacks that respond poorly to NSAIDs or caffeinated combinations.

 

Use a nonoral option for select patients, including those with nausea or vomiting or those who have trouble swallowing.

 

Options for outpatient rescue include SC sumatriptan, DHE injection or intranasal spray, or corticosteroids. Inpatient options may include parenteral formulations of triptans, DHE, antiemetics, NSAIDs, anticonvulsants (eg, valproate sodium and topiramate, except in women of childbearing age who are not using reliable birth control), corticosteroids, and magnesium sulfate.

 

Regulatory Status

The Tx360 Nasal Applicator Device (Tian Medical, the Allevio SPG Nerve Block Catheter (JET Medical), and the SpenoCath (Dolor Technologies) are considered class I devices by the U.S. Food and Drug Administration (FDA) and are exempt from 510(k) requirements. This classification does not require submission of clinical data on efficacy but only notification of FDA prior to marketing. All 3 devices are used to apply local anesthetic intranasally.

 

Prior Approval:

Not applicable.

 

Policy:

See Related Medical Policies

  • 07.01.66 Ablative Treatments for Occipital Neuralgia, Chronic Headaches and Atypical Facial Pain
  • 02.01.04 Biofeedback

 

Sphenopalatine ganglion (SPG) block(s) are considered investigational for the treatment of migraines and non-migraine headaches because the evidence is insufficient to support a conclusion concerning the net health outcomes or benefits associated with this procedure.

 

Nerve block(s)/injection therapy of local anesthetic steroids or other agents to the stellate ganglion, supraorbital nerve, occipital nerve, or trigeminal nerve is considered investigational for the treatment of migraines and non-migraine headaches because the evidence is insufficient to support a conclusion concerning the net health outcomes or benefits associated with this procedure.

 

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • 30999 Unlisted procedure, nose
  • 64400 Injection(s), anesthetic agent(s) and/or steroid; trigeminal nerve, each branch (i.e., ophthalmic, maxillary, mandibular)
  • 64405 Injection(s), anesthetic agent(s) and/or steroid; greater occipital nerve
  • 64505 Injection, anesthetic agent, sphenopalatine ganglion
  • 64510 Injection, anesthetic agent; stellate ganglion (cervical sympathetic)
  • 64999 Unlisted procedure, nervous system

 

Selected References:

  • American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 3334
  • Levin M. Nerve blocks in the treatment of headache. Neurotherapeutics, 7(2): 197-203  2010.
  • Bogduk N. Role of anesthesiologic blockade in headache management. Curr Pain Headache Rep, 8(5): 399-403  2004.
  • Tian Medical Inc. Use of the Tx360 Nasal Applicator in the Treatment of Chronic Migraine Clinical Trials. Bethesda (MD): National Library of Medicine (US). 2012
  • International Headache Society. The International Classification of Headache Disorders, 2nd edition May, 2005. Web site. Accessed. November  2013.
  • Krusz JC. Aggressive interventional treatment of intractable headaches in the clinic setting. Clinics in Family Practice, 7(3)2005.
  • Khan, S; Schoenen, J; Ashina, M. "Sphenopalatine ganglion neuromodulation in migraine: What is the rationale?" Cephalalgia 2014;34(5):382–391
  • Journal of Headache and Pain 2013, 14:86  doi:10.1186/1129-2377-14-86
  • Schoenen, J; Jensen, RH; Lantéri-Minet, M; Láinez, MJ; Gaul, C; Goodman, AM; Caparso, A; May, A. "Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: a randomized, sham-controlled study." Cephalalgia. 2013 Jul;33(10):816-30.
  • Khan, S; Schoenen, J; Ashina, M. "Sphenopalatine ganglion neuromodulation in migraine: What is the rationale?" Cephalalgia 2014;34(5:382–391.
  • Martelletti, P; Jensen, RH; Antal, A; Arcioni, R; Brighina, F’ de Tommaso, M; Franzini, A; Fontaine, D; Heiland, M; Jürgens, TP; Leone, M; Magis, D; Paemeleire, K; Palmisani, S; Paulus, W; May, A. "Neuromodulation of chronic headaches: position statement from the European Headache Federation." J Headache Pain 2013;14(1):86.
  • Piagkou, M; Demesticha, T; Troupis, T; Vlasis, K; Skandalakis, P; Makri, A; Mazarakis, A; Lappas, D; Piagkos, G; Johnson, EO. "The pterygopalatine ganglion and its role in various pain syndromes: from anatomy to clinical practice." Pain Pract. 2012;12(5):399-412.
  • Roger Cady, Joel Saper, Kent Dexter and Heather R. Manley A Double-Blind, Placebo-Controlled Study of Repetitive Transnasal Sphenopalatine Ganglion Blockade With Tx360® as Acute Treatment for Chronic Migraine Headache: The Journal of Head and Face Pain 55  Article first published online: 23 OCT 2014 | DOI: 10.1111/head.12458
  • Zarembinski C, Graff-Radford S. An Unusual Challenge in Performing Sphenopalatine Ganglion Block with Enlarged Coronoid Process: Jacob's Disease. Pain Med. 2014 Feb;15(2):329-32.
  • Practice Guidelines for Chronic Pain Management. An Updated Report by the American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology 2010; 112:1–1.
  • American Migraine Foundation. Sphenopalatine Ganglion Blocks in Headache Disorders. 2016
  • American Academy of Neurological Surgeons (AANS). Occipital Neuralgia. November 2006. Updated 2013.
  • Blumenfeld A, Ashkenazi A, Napchan U, et al. Expert consensus recommendations for the performance of peripheral nerve blocks for headaches--a narrative review. Headache. 2013; 53(3): 437 - 446.
  • Cho SJ, Song TJ, Chu MK. Treatment update of chronic migraine. Curr Pain Headache Rep. 2017;21(6):26.
  • Ambrosini A, Schoenen J. Invasive pericranial nerve interventions. Cephalalgia. 2016 Mar 22 [Epub ahead of print].
  • Mehta, D. , Leary, M. C., Yacoub, H. A., El‐Hunjul, M. , Kincaid, H. , Koss, V. , Wachter, K. Malizia, D. , Glassman, B. and Castaldo, J. E. (2018), The Effect of Regional Anesthetic Sphenopalatine Ganglion Block on Self‐Reported Pain in Patients With Status Migrainosus. Headache: The Journal of Head and Face Pain. . doi:10.1111/head.13390
  • Puledda F, Goadsby PJ, Prabhakar P. Treatment of disabling headache with greater occipital nerve injections in a large population of childhood and adolescent patients: a service evaluation. The Journal of Headache and Pain. 2018;19(1):5. doi:10.1186/s10194-018-0835-5.
  • Pringsheim, T., Davenport, W. J., Marmura, M. J., Schwedt, T. J. and Silberstein, S. (2016), How to Apply the AHS Evidence Assessment of the Acute Treatment of Migraine in Adults to your Patient with Migraine. Headache, 56: 1194–1200. doi:10.1111/head.12870
  • Tobin J, Flitman S. Occipital nerve blocks: when and what to inject? Headache. 2009 Nov-Dec; 49(10):1521-33.
  • American Headache Society. The American Headache Society Position Statement on Integrating New Migraine Treatments into Clinical Practice. Headache. 2019 Jan;59(1):1–18. 
  • Brauser, D. AHS Releases Updated Guidance on Migraine Treatment. Medscape Medical News. January 10, 2019. 
  • UpToDate, Inc. Tension-type headache in adults: preventive treatment.  Updated December 2018.
  • Krebs, K, Rorden, C, and Androulakis, XM. Resting State Functional Connectivity After Sphenopalatine Ganglion Blocks in Chronic Migraine With Medication Overuse Headache: A Pilot Longitudinal fMRI Study. Headache. 2018;58(5):732-743
  • Binfalah M, Alghawi E, Shosha E, Alhilly A, Bakhiet M. Sphenopalatine ganglion block for the treatment of acute migraine headache. Pain Research and Treatment. 2018;2018:2516953. doi:10.1155/2018/2516953
  • Gupta, R., Fisher, K. & Pyati, S. Chronic Headache: a Review of Interventional Treatment Strategies in Headache Management. Curr Pain Headache Rep 23, 68 (2019). 
  • Slullitel A, Santos IS, Machado FC, Sousa AM. Transnasal sphenopalatine nerve block for patients with headaches. Journal of clinical anesthesia. 2018;47:80-81. doi:10.1016/j.jclinane.2018.03.025.
  • Crespi J, Bratbak D, Dodick D, et al. Measurement and implications of the distance between the sphenopalatine ganglion and nasal mucosa: a neuroimaging study. J Headache Pain 2018; 19:14
  • European Headache Foundation. Aids to management of headache disorders in primary care (2nd edition) on behalf of the European Headache Federation and lifting the burden: The global campaign against headache. Journal of Headache and Pain 2019 20:57

 

Policy History:

  • July 2021 - Annual Review, Policy Revised
  • July 2020 - Annual Review, Policy Renewed
  • July 2019 - Annual Review, Policy Revised
  • August 2018 - Annual Review, Policy Revised
  • August 2017 - Annual Review, Policy Revised
  • August 2016 - Annual Review, Policy Revised
  • September 2015 - Annual Review, Policy Revised
  • October 2014 - Annual Review, Policy Renewed
  • December 2013 - New Policy

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

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