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Dental - Clinical Policy Bulletins

Number: 006
(Revised)

Subject: Brush Biopsy -- Transepithelial Sample Collection

Reviewed: September 21, 2007

Important Note

This Clinical Policy Bulletin expresses Aetna's determination of whether certain services or supplies are medically necessary. We have reached these conclusions based upon 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, and 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, which are excluded and which are subject to dollar caps or other limits. Members and their dentists will need to consult the member's benefits plan to determine if there are any exclusions or other benefits limitations applicable to this service or supply. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty 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 Aetna considers 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

There is insufficient evidence or research to indicate a high degree of accuracy for the diagnosis of dysplastic and/or early minimally invasive disease. Aetna considers oral brush biopsy experimental and investigational for screening or diagnosis of cancerous or precancerous oral lesions.

Background

Each year, there are approximately 9,000 oral cancer-related deaths in the United States.¹ It is presumed that with early screening, potentially precancerous oral lesions could be detected. Precancerous lesions may first be detected in the oral cavity as asymptomatic lesions. The most definitive, accurate and reliable method for diagnosing oral mucosal abnormalities, however, remains the scalpel biopsy.

Oral Brush Biopsy With Computer-Assisted Analysis

The oral brush biopsy is defined in the CDT-2007-2008 as “collection of oral disaggregated transepithelial cells via rotational brushing of the oral mucosa.”⁶ The oral brush biopsy coupled with computer-assisted analysis (Oral Dx, CDx Laboratories, Suffern, NY) was developed as an alternative technique for evaluating unexplained, clinically detectable alterations of the surface epithelium of the oral mucosa where cancer or precancerous lesions are suspected (Sciubba, et al., 2003).¹Obtaining and sampling cells is central to the consistent and accurate diagnosis of early oral and oropharyngeal cancer or precancerous lesions. The goal of the oral brush biopsy is to provide a highly sensitive and specific technique that is simpler to perform than a scalpel or punch biopsy. 

The oral brush biopsy, using a specially designed circular bristled brush, was designed to access and sample all epithelial layers, including the basal cell layer and the most superficial aspects of the lamina propria (Sciubba, et al., 2003).¹ Thus, the cellular material obtained represents all epithelial layers in a disaggregated form spread over the surface of an ordinary glass slide.

Only one large-scale study has been published about the use of this technique in the oral cavity (Sciubba, et al., 1999). The study reported that the technique had zero false-negatives in 945 opportunities. The analysis, however, must be considered incomplete, as 517 of the 699 negative brush samples (73.9 percent) were not followed with definitive incisional biopsy for diagnostic confirmation.³

There are some reports of significant rates of false negatives from brush biopsy. Potter, et al. (2003) examined all diagnoses of oral squamous cell carcinoma from a university oral pathology service over a two-year period to determine if any had previously undergone brush biopsy reported to be "negative for epithelial abnormality." Those cases identified were further investigated to determine the time lapse between brush biopsy and definitive tissue diagnosis. Potter, et al. (2003) found 4 of 115 squamous cell carcinomas that were reported to be negative on brush biopsy, a false negative rate of 3.5 percent.¹

The false-negative rate may be unacceptably high for a diagnostic test. Potter, et al. (2003) explains:

It has been argued that a 3.5 percent false-negative rate may be acceptable, particularly if one compares this result with a screening modality like mammography, which has a false-negative rate that varies from approximately 6 percent to 25 percent. This analogy, however, is flawed. Mammography is a screening test directed toward at-risk populations without known disease. The brush biopsy technique, on the other hand, is directed toward clinically obvious pathologic change, and thus a comparison of false-negative rates with mammography or other screening tests is inappropriate.

Potter, et al., (2003) concluded that “it seems that the most likely probability may be that the technique may not be of adequate sensitivity to detect all clinically dysplastic or malignant lesions.”¹

Oral brush biopsy has been criticized for adding time and cost to the diagnosis of oral lesions without additional benefit to the patient. Because the brush biopsy detects only cellular atypia, positive oral brush biopsy results must be confirmed with a scalpel biopsy for definitive diagnosis. This results in the need for two procedures, rather than one, to establish a diagnosis. The need to perform two procedures may significantly delay diagnosis. In the study described above, Potter, et al. (2003) reported an “undeniably unacceptable” average delay in diagnosis of squamous cell carcinoma of 117.25 days (range 5 to 292 days) with oral brush biopsy. The investigators stated that this delay “can be potentially disasterous.”¹

The oral brush biopsy technique may also delay diagnosis if the results are negative. If oral brush biopsy results are negative, no diagnosis is rendered, making it difficult to determine appropriate treatment or anticipate whether an additional procedure is necessary.   

There is insufficient evidence to support the use of oral brush biopsy as a general screening technique for persons without oral lesions. The National Cancer Institute, the Canadian Task Force on the Periodic Health Examination and the U.S. Preventive Services Task Force have recommended against routine screening for oral cancer using a brush biopsy or other methods (NCI, 2004).³ A Cochrane evidence review found that there is no evidence from prospective clinical trials that screening with brush biopsy reduces mortality (Kujan, et al., 2004).⁴Although the American Dental Association has issued a contrary recommendation regarding oral cancer screening, CDx Laboratories corporate sponsorship of the ADA's oral cancer campaign has been a subject of controversy (Engber, 2002; Potter, et al., 2002).⁵

Codes⁶

D7288 -- Brush biopsy- transepithelial sample collection

Revision Dates

Original policy:  September 13, 2005
Updated: 
Revised:  December 5, 2005: September 21, 2007

The above policy is based on the following references:

¹Sciubba JJ. Oral brush biopsy with computer-assisted analysis. eMedicine Dermatology Topic 701. San Francisco, CA: eMedicine.com; updated August 11, 2003. Available at: http://www.emedicine.com/derm/topic701.htm. Accessed March 5, 2004.

²Sciubba JJ and the U.S. Collaborative OralCDx Study Group. Improving detection of precancerous and cancerous oral lesions: Computer-assisted analysis of the oral brush biopsy. U.S. Collaborative OralCDx Study Group. J Am Dent Assoc. 1999; 130:1445-1457.

³National Cancer Institute (NCI). Screening for oral cancer. Oral Cancer (PDQ^®): Screening. Bethesda, MD: NCI; updated February 20, 2004. Available at: http://www.cancer.gov/cancerinfo/pdq/screening/oral/
healthprofessional/. Accessed March 5, 2004.

⁴Kujan O, Glenny AM, Duxbury AJ, et al. Screening programs for the early detection and prevention of oral cancer (Cochrane Review). In: The Cochrane Library, Issue 1, 2004. Chichester, UK: John Wiley & Sons, Ltd. Update available at: O. Kujan, A. Glenny, R. Oliver, N. Thakker and P. Sloan. Cochrane Database Syst Rev. 2006. 3: CD004150. Accessed November 1, 2007.

⁵Potter TJ, Campbell JH, Summerlin DJ,et al.  Oral cancer campaign [letter].  J Am Dent Assoc. 2002; 133(3):272, 274, 276.

⁶American Dental Association. Current Dental Terminology, CDT-2007-2008: 52.*

⁷Sciubba JJ.  Oral leukoplakia. Crit Rev Oral Biol Med. 1995;6(2):147-160.

⁸Svirsky JA, Burns JC, Carpenter WM, et al.  Comparison of computer-assisted brush biopsy results with follow-up scalpel biopsy and histology. Gen Dent. 2002; 50:500.

⁹Christian DC. Computer-assisted analysis of oral brush biopsies at an oral cancer screening program.  J Am Dent Assoc.  2002; 357-362.

¹⁰Potter TJ, Summerlin DJ, Campbell JH.  Oral malignancies associated with negative transepithelial brush biopsy.  J Oral Maxillofac Surg.  2003; 61(6):674-677.

¹¹Eisen D, Frist S.  Efficacy of oral brush biopsy [letter].  J Oral Maxillofac Surg.  2003; 61:1237-1239.

¹²Svirsky,A, Burns JC, Carpenter WM, et al.  Comparison of computer-assisted brush biopsy results with follow up scalpel biopsy and histology.  Gen Dent.  2002; 50(6). 

¹³Engber D.  Dentally unsound.  Salon.  2002; 3(26).  Available at: http://www.salon.com/mwt/feature/2002/03/26/oral_cancer/. Accessed March 5, 2004.

¹⁴Hawkins RJ, Wang EE, Leake JL. Preventive health care, 1999 update: prevention of oral cancer mortality. Canadian Task Force on Preventive Health Care. J Can Dent Assoc. 1999; 65(11):617.   Available at: http://www.ctfphc.org/. Accessed March 5, 2004.

¹⁵Weinberg MA, Estefan DJ.  Assessing oral malignancies.  Am Fam Physician.  2002; 65(7):1379-1386.  Available at: http://www.aafp.org/afp/20020401/1379.html.  Accessed March 5, 2004.

¹⁶Potter TJ, Summerlin DJ, Campbell JH.  Oral Malignancies associated with negative transepithelial brush biopsies.  J Oral Maxillofac Surg 2003 Oct; 61:1237.

*Copyright 2006 American Dental Association. All rights reserved.

Property of Aetna. All rights reserved. Dental Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical/dental advice. This Dental 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 health care professionals are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating health care professionals are solely responsible for medical/dental advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.