Subject: Electrical Stimulation (Salitron System) for Xerostomia
Date: June 5, 2012
Important NoteThis Clinical Policy Bulletin expresses our determination of whether certain services or supplies are medically necessary. We have reached these conclusions based on a review of currently available clinical information including:
Each benefits plan defines which services are covered, excluded and subject to dollar caps or other limits. Members and their dentists will need to consult the member's benefits plan to determine if any exclusions or other benefits limitations apply to this service or supply. The conclusion that a particular service or supply is medically necessary does not guarantee that this service or supply is covered (that is, will be paid for by Aetna) for a particular member. The member's benefits plan determines coverage. Some plans exclude coverage for services or supplies that we consider medically necessary. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the federal government or CMS for Medicare and Medicaid members.
PolicyAetna considers electric reflex salivary stimulation (Salitron System) experimental and investigational for the treatment of xerostomia (dry mouth) or for any other indications because its effectiveness has not been established.
BackgroundChronic xerostomia can be caused by Sjogren's syndrome, certain medications or therapeutic irradiation. It can cause difficulty in eating dry foods, swallowing and wearing dentures; and susceptibility to dental caries, oral pain and frequent infections. Proponents of electrostimulation as a treatment option postulate that stimulating the tongue and the roof of the mouth simultaneously will result in impulses to all residual salivary tissues, major and minor, in the oral and pharyngeal regions, thus causing salivation.
The role of electrical stimulation in the management of patients with xerostomia awaits the outcomes of randomized, double-blind, controlled clinical studies with large sample sizes and long-term follow up. In many reviews on the management of patients with xerostomia (Cooke, 1996; Fox, 1997; Davies, 1997; Mariette, 2002; Fox, 2003), salivary electrostimulation was not mentioned as a method to manage patients with this condition.
Strietzel et al (2007) evaluated the safety and effectiveness of a recently developed electro-stimulating device mounted on an individualized intra-oral removable appliance. The device, containing electrodes, a wetness sensor, an electronic circuit and a power source, was tested on patients with xerostomia in a cross-over, randomized, sham-controlled, double-blind, multi-center study (n = 23; 10 with primary Sjogren's syndrome, 7 with medication-induced xerostomia, and 6 with idiopathic xerostomia). Electrical stimulation and also sham were delivered for 10 minutes to the oral mucosa, in the mandibular third-molar region. Oral dryness was measured by the sensor. As the primary outcome, sensor dryness and xerostomia symptom changes as a result of device wearing were assessed, and compared between active and sham modes. In addition, side-effects were recorded. Electrostimulation resulted in a significant decrease in sensor dryness, leading to a beneficial effect on patients' subjective condition. No significant adverse events were observed. However, 30.4 % patients reported the sham mode to be more effective than the active mode. The authors stated that these findings are encouraging enough to continue developing and investigating the miniature electrostimulating device mounted on a dental implant.
CPT Codes / HCPCS Codes / ICD-9 Codes*
|HCPCS codes not covered for indications listed in the CPB:|
|E0755||Electronic salivary reflex stimulator (intraoral/noninvasive)|
|ICD-9 codes not covered for indications listed in the CPB (not all-inclusive):|
|521.00 - 521.09||Dental caries|
|527.7||Disturbance of salivary secretion (xerostomia)|
|528.9||Other and unspecified diseases of oral soft tissues|
|710.2||Sicca syndrome [Sjogren's disease]|
|990||Effects of radiation, unspecified|
|V15.3||Personal history of irradiation|
The above policy is based on the following references:
Revision DatesOriginal policy: November 4, 2004
Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna 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 Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
*Current Procedural Terminology (CPT®) 2010 copyright
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