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Chromoendoscopy refers to the application 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 type, 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 test. A recent 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, though, were small and, thus, lower-risk of becoming cancerous. The pooled miss rate by polyp size was 2% for polyps 10mm and larger, 13% for polyps 5-10mm and 26% for polyps 1-5mm.
Several adjunct endoscopic techniques, including chromoendoscopy, could potentially 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 and facilitate the 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:
Reactive stains are primarily used to identify gastric abnormalities and are not used with colonoscopy. 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 individuals 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).
Potential applications of chromoendoscopy as an alternative to standard colonoscopy include:
The equipment used in regular chromoendoscopy is widely available. Several authors of review articles and technology assessments have stated that, although the techniques are simple, procedures, e.g. concentration of dye and amount of dye sprayed, is variable and 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 potentially be an alternative to dye spraying. One system is the Fujinon® Intelligent Color Enhancement (FICE®) 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.
The Fujinon® endoscope series EPX-4400 and EPX-4400HD (Fujinon, Inc.) have been cleared for marketing by the Food and Drug Administration (FDA) through the 510(k) process. The FDA determined that this device was substantially equivalent to existing devices for use in endoscopic observation, diagnosis, treatment and image recording. The Fujinon EPX-4400 and 4400HD systems include FICE™. This feature is intended to enhance the appearance of images and is used for virtual chromoendoscopy. On February 7, 2011, the FDA sent an Urgent Medical Device Corrective Action letter advising users that the FICE feature should no longer be used since this feature was not reviewed under the premarket notification/510k process. In August 2014, the FujiFilm EPX-4440HD Digital Video Processor with FICE and Light Source was cleared by FDA through the 510(k) process. FDA documents state that FICE can be used to supplement white light endoscopy but is not intended to replace histopathologic sampling as a means of diagnosis.
The i-scan™ (Pentax), used for virtual chromoendoscopy, was cleared by FDA in April 2013. This is a 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 and 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.
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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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.
Blue Cross Blue Shield Association policy # 2.01.84
This may not be a comprehensive list of procedure codes applicable to this policy.