Medical Policy: 02.01.52
Original Effective Date: December 2013
Reviewed: August 2016
Revised: August 2016
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. Depending on the type of headache disorder being treated, the procedure may be repeated in the other nostril. Recently, better catheters have been developed, including the Sphenocath®, Tx360®, and AllevioTM devices. The duration of pain relief varies from a few weeks to months. The procedure is repeated as required.
The introduction of a medical device specific for medication delivery to the nasal passageway was recently introduced. The Tx360 nasal applicator was developed by Tian Medical in 2011. Recently, a number of catheter-based nasal applicators (Sphenocath, Tx360, Allevio) have been developed and approved for use when performing SPG blocks. 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.
Although excellent international guidelines for organisation of headache service and management have been introduced [3-5] there is no single standard of care for patients presenting with primary chronic headache symptoms. For example, treatment choices for acute migraine are based on headache severity, attack frequency, associated symptoms, and co-morbidities. Despite significant improvement in management of migraine, achieving a satisfactory treatment outcome is still a challenge because of inadequate response of medications and difficulty in predicting individual response to a specific agent or dose.
The medical treatment of patients with chronic primary headache syndromes (such as chronic migraine, chronic cluster headache, chronic tension-type headache or hemicrania continua) is particularly challenging as valid studies are few and in many cases even higher doses of preventative medication is ineffective and adverse side effects frequently complicate the course of medical treatment.
The administration of topical anesthesia to block nerves of the sphenopalantine ganglion is considered investigational for all indications.
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.
To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
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.
*CPT® is a registered trademark of the American Medical Association.