I'm a member
You will be redirected to myBlue. Would you like to continue?
Please wait while you are redirected.
Please enter a username and password.
Printer Friendly Version
Chromoendoscopy refers to the use of dyes or stains during endoscopy to enhance tissue differentiation or characterization. When used with colonoscopy, the intent is to increase the sensitivity of the procedure by facilitating the identification of mucosal abnormalities. There are two types of chromoendoscopy: one involves actual spraying of dyes or stains through the working channel of an endoscope; the other, known as virtual chromoendoscopy, uses a computer algorithm to simulate different colors of light that results from dye or stain spraying.
Colonoscopy, a procedure during which colonic and rectal polyps can be identified and removed, is considered the criterion standard test for colorectal cancer screening and diagnosis of colorectal disease. However, colonoscopy is an imperfect procedure. A systematic review pooled findings from tandem (i.e. back-to-back) colonoscopy studies and found that 22% of polyps were missed on the first colonoscopy. Most of the missed polyps were small and thus had a lower-risk of becoming cancerous. The pooled miss rate by polyp size was 2% for polyps 10 mm and larger, 13% for polyps 5-10 mm, and 26% for polyps 1-5 mm.
Several adjunct endoscopic techniques, including chromoendoscopy, could enhance the sensitivity of colonoscopy. Chromoendoscopy, also known as chromoscopy and chromocolonoscopy, refers to the application of topical stains or dyes during endoscopy to enhance tissue differentiation or characterization and facilitate identification of mucosal abnormalities. Chromoendoscopy may be particularly useful for detecting flat or depressed lesions. Standard colonoscopy uses white light to view the colon. In chromoendoscopy, stains are applied, resulting in color highlighting of areas of surface morphology of epithelial tissue. The dyes or stains are applied via a spray catheter that is inserted down the working channel of the endoscope. Chromoendoscopy can be used in the whole colon (pan-colonic chromoendoscopy) on an untargeted basis or can be directed to a specific lesion or lesions (targeted chromoendoscopy). Chromoendoscopy differs from endoscopic tattooing in that the former uses transient stains, whereas tattooing involves the use of a long-lasting pigment for future localization of lesions.
Stains and dyes used in chromoendoscopy can be placed in the following categories:
Indigo carmine, a contrast stain, is the most commonly used stain with colonoscopy to enhance the detection of colorectal neoplasms. Several absorptive stains are also used with colonoscopy. Methylene blue, which stains the normal absorptive epithelium of the small intestine and colon, has been used to detect colonic neoplasia and to aid in the detection of intraepithelial neoplasia in patients with chronic ulcerative colitis. In addition, crystal violet (also known as gentian violet) stains cell nuclei and has been applied in the colon to enhance visualization of pit patterns (i.e. superficial mucosal detail). Reactive stains are primarily used to identify gastric abnormalities and are not used with colonoscopy.
Potential applications of chromoendoscopy as an adjunct to standard colonoscopy include:
The equipment used in regular chromoendoscopy is widely available. Several review articles and technology assessments have indicated that, although the techniques are simple, the procedure (e.g. concentration of dye and amount of dye sprayed) is variable, and thus classification of mucosal staining patterns for identifying specific conditions is not standardized.
Virtual chromoendoscopy (also called electronic chromoendoscopy) involves imaging enhancements with endoscopy systems that could be an alternative to dye spraying. One system is the Fujinon Intelligent Color Enhancement feature (Fujinon, Inc.). This technology uses post-processing computer algorithms to modify the light reflected from the mucosa from conventional white light to various other wavelengths.
In August 2014, the Fujifilm EPX-4440HD Digital Video Processor with Fujinon Intelligent Color Enhancement (FICE®) and Light Source was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. FDA documents stated that FICE® could be used to supplement white-light endoscopy but is not intended to replace histopathologic sampling as a means of diagnosis.
In April 2003, the i-scan™ (Pentax), used for virtual chromoendoscopy, was cleared for marketing by FDA through the 510(k) process. This digital image enhancement technology and is part of the Pentax EPK-i5010 Video Processor. The i-scan has several modes that digitally enhance images in real-time during endoscopy. FDA documents state that i-scan is intended as an adjunct following white-light endoscopy, but is not intended to replace histopathologic analysis.
No dye or stain product has been specifically approved by the FDA for use in chromoendoscopy.
Chromoendoscopy is considered investigational as an adjunct to diagnostic or surveillance colonoscopy.
Virtual chromoendoscopy is considered investigational as an adjunct to diagnostic or surveillance colonoscopy.
Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
07/19/2012: Approved by Medical Policy Advisory Committee.
05/07/2013: Policy reviewed; no changes.
04/24/2014: Policy reviewed; description updated regarding FDA approval of devices. Policy statement unchanged.
12/31/2014: Code Reference section updated to revise the description of the following CPT code: 44799. Added the following new 2015 HCPCS code: G6021.
04/01/2015: Policy description updated regarding devices. Policy statements unchanged. Policy guidelines updated to revise the definition of investigative.
07/09/2015: Code Reference section updated for ICD-10.
01/06/2016: Policy description updated. Policy statements unchanged.
06/01/2016: Policy number A.2.01.84 added.
12/02/2016: Policy description updated. Policy statements unchanged.
Blue Cross Blue Shield Association policy # 2.01.84
This may not be a comprehensive list of procedure codes applicable to this policy.
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.