Medical Policy: 02.01.52
Original Effective Date: December 2013
Reviewed: October 2014
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.
A sphenopalatine ganglion (SPG) block has been introduced as a quick, minimally invasive procedure. A local anesthetic, currently Marcaine but historically Lidocaine, is introduced intranasally for topical administration. Access to this structure can be gained via a small area of mucosa just posterior and superior to the tail of the middle turbinate on the lateral nasal wall. At this aspect, there is no bony boundary to the SPG.
The introduction of a new medical device specific for medication delivery to the nasal passageway was recently introduced. The Tx360 nasal applicator was developed by Tian Medical in 2011. Use of anesthetic delivered topically to the specific area of mucosa associated with the SPG via nasal applicator is in clinical trial. No results have been posted pertaining to this trial. The use of Marcaine by topical administration is outside the FDA approved routes of administration at this time.
Intranasal application of Marcaine (bupivacaine) has side effects: including a burning sensation or numbness in the nose or in and around the eyes. Most seriously, it can also produce numbness in the throat, creating a sensation of gagging. If the patient eats or drinks, aspiration in the pharynx, and misdirection of the food into the lungs can readily occur, with the possible consequence of aspiration pneumonia. There is also the possibility of an allergic reaction to Marcaine and other local anesthetic agents. It is also known that repeated local administration of local anesthetic agents can be toxic to mucosal cells.
Bupivacaine hydrochloride is used for infiltration anesthesia and for peripheral, sympathetic nerve, and epidural (including caudal) block anesthesia. A 0.75% solution of the drug in 8.25% dextrose is used for spinal anesthesia. Bupivacaine is not used for obstetric paracervical block or topical anesthesia per product label. Marcaine is not FDA approved for the treatment of migraine or headache.
The efficacy of local anesthesia used topically, outside of product approved routes of administration, has not been established in well designed clinical trials. Efficacy of Marcaine for the treatment of migraine or headache is not an FDA approved indication. There is a lack of evidence at this time proving long term safety and health benefits for this procedure.
The administration of topical anesthesia to block nerves of the sphenopalantine ganglion is considered investigational.
The efficacy of local anesthesia used topically, outside of product approved routes of administration, or product indications has not been established in well designed clinical trials. There is a lack of evidence at this time proving long term safety and health benefits for this procedure.
Procedure Codes and Billing Guidelines:
- 64505 Injection, anesthetic agent, sphenopalatine ganglion
- 30999 Unlisted procedure, nose
- 64999 Unlisted procedure, nervous system
Wellmark's policy is based on:
- 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
Date Reason Action
December 2013 New policy
October Annual review Policy renewed
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
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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.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.