Dental Policy Bulletins

Number: 022
(Updated)

Subject: Electrical Stimulation (Salitron System) for Xerostomia

Date: June 5, 2012

Important Note

This 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:
  • Clinical outcome studies in the peer-reviewed published medical and dental literature
  • Regulatory status of the technology
  • Evidence-based guidelines of public health and health research agencies
  • Evidence-based guidelines and positions of leading national health professional organizations
  • Views of physicians and dentists practicing in relevant clinical areas
  • Other relevant factors
We expressly reserve the right to revise these conclusions as clinical information changes, and welcome further relevant information.

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.

Policy

Aetna 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.

Background

Chronic 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.

Although the FDA approved the Salitron System in 1988 to treat xerostomia secondary to Sjogren's syndrome, the Agency for Health Care Policy and Research (AHCPR) advised in a 1991 assessment that there were “insufficient data to determine the clinical effectiveness of this modality of salivary production, or to identify those xerostomic patients who would benefit from the procedure.” (Erlichman, 1991). One published study (Weiss et al, 1986) reported some degree of response after three stimulation sessions of three minutes each in 24 patients with xerostomia related to Sjogren's, radiation therapy, drugs or unknown etiology. However, there was no control group, information on the duration of response, quantitative assessment of salivary response, or intermediate or long-term assessment of effectiveness.

Another report, a double-blind study (Steller et al, 1988) noted a statistically significant mean increase in post-stimulation whole saliva flow between subjects (n = 29) using active and placebo stimulators. However, this was due mainly to the responses of three subjects who showed marked increases in their whole saliva flow rate during the study. Of the active study arm, only one subject showed evidence of a cumulative response over the four weeks of the study. Further research of electrical stimulation of salivary flow is needed to ascertain its role in the treatment of Sjogren's patients with xerostomia.

Talal and colleagues (1992) reported that electrical stimulation improves salivary function of patients with Sjogren's syndrome. In this placebo controlled study, patients received three treatments (2 weeks apart, over a 4-week period) with an active device (n = 34) or a placebo device (n = 37). Patients using active devices showed a statistically greater increase in salivary production than patients using placebo devices. Moreover, patients demonstrated significant improvement in other symptoms such as difficulty in swallowing as well as burning tongue. There were three major shortcomings of this study:
  1. It is unclear whether the control group was age-matched
  2. Lack of long-term assessment of effectiveness
  3. The number of patients in the active device group who did not respond to treatment was not disclosed, and the range or standard deviation for pre- and post-stimulation whole salivary flow rates was not given.

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]
787.2 Dysphagia
990 Effects of radiation, unspecified
V15.3 Personal history of irradiation


The above policy is based on the following references:

  1. Weiss WW Jr, Brenman HS, Katz P, Bennett JA. Use of electronic stimulation for the treatment of dry mouth. J Oral Maxillofacial Surg. 1986;44(11):845-850.
  2. Steller M, Chou L, Daniels TE. Electrical stimulation of salivary flow in patients with Sjogren's syndrome. J Dental Res. 1988;67(10):1334-1337.
  3. Erlichman M. Salivary electrostimulation in Sjogren's syndrome. AHCPR Health Technology Assessment Report No. 8. AHCPR Pub. No. 91-0009. Rockville, MD: Agency for Health Care Policy and Research (AHCPR); March 1991.
  4. Talal N, Quinn JH, Daniels TE. The clinical effects of electrostimulation on salivary function of Sjogren's syndrome patients. Rheumatol Int. 1992;12(2):43-45.
  5. Cooke C. Xerostomia -- A review. Palliative Med. 1996;10(4):284-292.
  6. Fox PC. Management of dry mouth. Dent Clin North Am. 1997;41(4):863-875.
  7. Davies AN. The management of xerostomia: A review. Eur J Cancer Care. 1997;6(3):209-214.
  8. Mariette X. Current and potential treatments for primary Sjogren's syndrome. Joint Bone Spine. 2002;69(4):363-366.
  9. Fox RI. Sjogren's syndrome: Evolving therapies. Expert Opin Investig Drugs. 2003;12(2):247-254.
  10. Strietzel FP, Martín-Granizo R, Fedele S, et al. Electrostimulating device in the management of xerostomia. Oral Dis. 2007;13(2):206-213.

Revision Dates

Original policy: November 4, 2004
Updated: September 25, 2006, August 26, 2008; November 16, 2009; January 20, 2011; June 5, 2012
Revised
Medical Policy Bulletin #0302: June 22, 2012



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
2010 American Medical Association. All Rights Reserved.

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