Xerostomia: Selected Treatments

Coverage Summary

Scope: This Clinical Policy Bulletin defines Aetna's coverage position on selected treatments for xerostomia (dry mouth), specifying interventions considered experimental/investigational, providing applicable CPT/HCPCS/ICD-10 code listings, and summarizing background evidence. This document is Part 1 of 3 in the policy series and addresses policy scope, experimental and investigational determinations, code lists, and background evidence for several interventions (including electrical stimulation, ALTENS, TENS, fat grafting, acupuncture, and artificial saliva).

Status: mixed coverage stance; Policy Number 0302. Effective date: 2004-02-06; Last review: 2023-05-08; Next review: 2024-03-14.

Policy metadata

Policy Number0302

PayerAetna

StatusCURRENT

Effective Date2004-02-06

Last Review2023-05-08

Next Review2024-03-14

Experimental/Investigational items (count)9

High-level position: The policy identifies a set of interventions as Experimental and Investigational because effectiveness has not been established (see list under the Experimental and Investigational title). The listed interventions include electrical stimulation, acupuncture, ALTENS, ASC (adipose-derived mesenchymal stem cell) therapy, fat grafting to salivary glands, hyperbaric oxygen, low-level laser/light therapy (photo-biomodulation), TENS, and Venalot Depot.

Note: This bulletin is Part 1 of 3 per the scope summary and covers the policy scope, the 'Experimental and Investigational' determinations, code lists, and background evidence for multiple non-pharmacologic and novel interventions for xerostomia.

Medical Necessity / Determinations

Experimental and Investigational

The following interventions are considered experimental and investigational because effectiveness has not been established:

Interventions considered experimental/investigational

Electrical stimulation (e.g., the Salitron System and the Saliwell Crown device) for the prevention or treatment of xerostomia (dry mouth) or for any other indications
Acupuncture for the treatment of xerostomia
ALTENS: Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) for the treatment of xerostomia
Adipose-derived MSC therapy: Adipose tissue-derived mesenchymal stem cell therapy for the treatment of xerostomia

Codes and Billing Status

CPT codes listed in policy (codes not covered for indications listed in the CPB)CPTNot Covered

0552T	Low-level laser therapy, dynamic photonic and dynamic thermokinetic energies, provided by a physician or other qualified health care professional.
15769	Grafting of autologous soft tissue, other, harvested by direct excision (eg, fat, dermis, fascia).
15773	Grafting of autologous fat harvested by liposuction technique to face, eyelids, mouth, neck, ears, orbits, genitalia, hands, and/or feet; 25 cc or less injectate.
+15774	each additional 25 cc injectate, or part thereof (List separately in addition to code for primary procedure).
97810	Acupuncture.
97811	Acupuncture, with stimulation, any type.
97812	Acupuncture, with electrostimulation, initial area.
97813	Acupuncture, with electrostimulation, each additional area.
97814	Acupuncture, with biofeedback/other modalities (listed as part of series).
99183	Physician or other qualified health care professional attendance and supervision of hyperbaric oxygen therapy, per session.

HCPCS codes listed in policy (codes not covered for indications listed in the CPB)HCPCSNot Covered

E0755	Electronic salivary reflex stimulator (intraoral/noninvasive).
G0277	Hyperbaric oxygen under pressure, full body chamber, per 30 minute interval.
S8948	Application of a modality (requiring constant provider attendance) to one or more areas; low-level laser; each 15 minutes.

ICD-10 codes listed as not covered for indications in the CPB (not all-inclusive)ICD-10Not Covered

K02.3 - K02.9 K03.89	Dental caries and other specified diseases of hard tissues of teeth.
K11.7	Disturbance of salivary secretion (xerostomia).
K12.1 K13.1 K13.4 K13.6 - K13.79	Other and unspecified diseases of oral soft tissues.
M35.00 - M35.09	Sicca syndrome [Sjögren].
R13.10 - R13.19	Dysphagia.
R68.2	Dry mouth, unspecified.
T66.xx+	Effects of radiation, unspecified [radiation-induced xerostomia].
Z92.3	Personal history of irradiation.

Provider Actions & Documentation

Documentation Required

Use applicable diagnosis codes for claims

Claims for interventions related to xerostomia should include the appropriate ICD-10 diagnosis codes listed in the policy. The policy identifies a set of ICD-10 codes that are noted as not covered when used for indications in this clinical policy bulletin; use the listed codes as applicable to the billed service and note the policy's not-covered code list when submitting claims.

K11.7
R68.2
T66.xx+
Z92.3
M35.00 - M35.09

Documentation Required

Consideration of treatment risks and benefits

When considering preventive or treatment interventions for radiation-induced xerostomia, providers should weigh the evidence of short- to medium-term benefits against potential harms and costs. For example, low-quality evidence suggests amifostine may reduce moderate-to-severe xerostomia at the end of radiotherapy and up to 3 months, but it is associated with increased vomiting, hypotension, nausea, and allergic reactions; these risks and the agent's cost should be considered in decision-making.

Background & Evidence Summary

Background: Chronic xerostomia has multiple etiologies, including Sjögren's syndrome, certain medications, and therapeutic irradiation, and can lead to functional impairment (difficulty eating dry foods, swallowing, wearing dentures) and dental complications (increased dental caries, oral pain, infections).

Quality of evidence for non-pharmacologic interventions: Evidence for electrical stimulation and many other non-pharmacologic approaches is limited — studies are often small, variable in quality, and produce mixed results. Systematic reviews (including Cochrane and other reviews) found many trials at high or unclear risk of bias and concluded there is insufficient or low-quality evidence to establish effectiveness for several non-pharmacologic interventions, indicating a need for larger, well-designed randomized controlled trials with longer follow-up.

Study / Evidence	Key Finding
{"text":"Salitron FDA approval year","status":""},{"text":"1988 approval; AHCPR 1991 concluded insufficient data for clinical effectiveness","status":""}
{"text":"Wong et al 2015 (RTOG 0537)","status":""},{"text":"Phase III: ALTENS vs pilocarpine — primary endpoint (XeQOLS at 9 months) not significantly different; less toxicity with ALTENS","status":""}
{"text":"Garcia et al 2019","status":""},{"text":"Phase III RCT: true acupuncture reduced radiation-induced xerostomia score at 1 year vs standard care (statistically significant)","status":""}
{"text":"Cochrane review (Furness et al 2013)","status":""},{"text":"Insufficient/low-quality evidence for electrostimulation; acupuncture no difference vs placebo for dry mouth symptoms in pooled trials","status":""}
{"text":"LLLT randomized trial (Fidelix 2018, n=66)","status":""},{"text":"No significant improvement in xerostomia inventory scores or salivary flow (p=0.301 and p=0.643)","status":""}
{"text":"Photo-biomodulation systematic reviews/meta-analyses","status":""},{"text":"Some meta-analyses reported short-term improvements in salivary flow or QOL; heterogeneity and high risk of bias limit conclusions","status":""}
{"text":"TENS evidence (meta-analyses and systematic reviews)","status":""},{"text":"Mixed results: a meta-analysis (369 participants) not statistically significant; other reviews report some studies with increased saliva and confirm safety; further high-quality RCTs needed","status":""}
{"text":"Topical malic acid 1% spray (meta-analysis, 5 studies, 244 patients)","status":""},{"text":"Improved dry mouth symptom scores and increased unstimulated and stimulated saliva flow after 2 weeks","status":""}
{"text":"Amifostine (prevention in radiotherapy)","status":""},{"text":"Low-quality evidence it may reduce moderate-to-severe xerostomia at end of RT and up to 3 months; associated with increased vomiting, hypotension, nausea, allergic responses","status":""}
{"text":"Adipose-derived MSCs (ASC) randomized phase I/II (n=30)","status":""},{"text":"Increased unstimulated saliva flow at 1 and 4 months (33% and 50%) and improved symptom scores without detected AEs","status":""}

Definitions

ALTENS: Acupuncture-like transcutaneous electrical nerve stimulation.

TENS: Transcutaneous electrical nerve stimulation.

Xerostomia: Subjective sensation of dry mouth, often associated with reduced salivary flow (hyposalivation).

LLLT / Photo-biomodulation: Low-level laser or light therapy applied to salivary glands with proposed biomodulatory effects.

TENS / ALTENS: Transcutaneous electrical nerve stimulation or acupuncture-like TENS used to electrically stimulate salivary flow.

ASC: Adipose tissue–derived mesenchymal stem cell therapy, investigated for radiation-induced xerostomia.

Revision History

2004-02-06effective_date

Policy effective

2023-05-08last_review

Last review completed

2024-03-14next_reviewLatest

Next review scheduled