Latest Review Date: November 2024

Category: Radiology                                                          

POLICY:

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.

DESCRIPTION OF PROCEDURE OR SERVICE:

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, known as virtual chromoendoscopy uses a computer algorithm to simulate different colors of light that results from dye or stain spraying.

Colonoscopy

Colonoscopy, a procedure during which colonic and rectal polyps can be identified and removed, is considered the criterion standard test for colorectal cancer (CC) screening and diagnosis of colorectal disease. However, colonoscopy is an imperfect procedure. A systematic review and meta-analysis by Zhao et al (2019) pooled findings from more than 15,000 tandem (i.e., back-to-back)colonoscopies in 43 publications and found a miss rate of 26% for adenomas, 9% for advanced adenomas, and 27% for serrated polyps. Miss rates were higher for proximal advanced adenomas (14%), serrated polyps (27%), flat adenomas (34%), and in individuals at high risk for CC (33%).

Adjunctive Procedures

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. A 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 (pancolonic 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:

• Absorptive these stains are preferentially absorbed by certain types of epithelial cells.
• Contrast these stains seep through mucosal crevices and highlight surface topography.
• Reactive these stains undergo chemical reactions when in contact with specific cellular constituents which results in a color change.

Indigo carmine, a contrast stain, is one of the most commonly used stains with colonoscopy to enhance the detection of colorectal neoplasms. Several absorptive stains are also used with colonoscopy. Methylene blue is widely used; it stains the normal absorptive epithelium of the small intestine and colon, and 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). 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:

• Diagnosis of colorectal neoplasia in symptomatic individuals at increased risk of colorectal cancer due to a family history of colorectal cancer, a personal history of adenomas, etc.
• Identification of mucosal abnormalities for targeted biopsy as an alternative to multiple random biopsies in individuals with inflammatory bowel disease (IBD)
• Screening the general population for colorectal cancer

The equipment used in regular chromoendoscopy is widely available. Several review articles and technology assessments have indicated 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.

KEY POINTS:

The most recent literature review was updated through September 23, 2024.

Summary of Evidence

Chromoendoscopy

For individuals who have an average risk of colorectal cancer (CC) who receive chromoendoscopy, the evidence includes randomized controlled trials (RCTs) and a meta-analysis of RCTs. Relevant outcomes are overall survival (OS), disease-specific survival (DSS), test validity, and change in disease status. The meta-analysis demonstrated that dye-based chromoendoscopy increased the adenoma detection rate and adenomas per colonoscopy in patients at average or increased risk of CC compared to standard or high-definition white light colonoscopy. However, limitations included unclear indication of colonoscopy in the studies (which included patients with screening and surveillance), and some heterogeneity in mean adenomas per patient. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have an increased risk of CC who receive chromoendoscopy, the evidence includes systematic reviews and a recent RCT. Relevant outcomes are OS, DSS, test validity, and change in disease status. A Cochrane systematic review of trials comparing chromoendoscopy with standard colonoscopy in high-risk patients (but excluding those with inflammatory bowel disease [IBD]) found significantly higher rates of adenoma detection and rates of 3 or more adenomas with chromoendoscopy than with standard colonoscopy. The evidence for detecting larger polyps, defined as greater than 5 mm or greater than 10 mm, is less robust. While 1 study reported a significantly higher detection rate for polyps greater than 5 mm, no studies reported increased detection of polyps greater than 10 mm. A recent RCT and systematic review involving patients with Lynch syndrome also found equivocal results. Results from the RCT showed similar neoplasia detection rates with chromoendoscopy and conventional white-light colonoscopy, while the systematic review concluded that chromoendoscopy is associated with significantly improved detection of certain lesions; however, the odds of having an adenoma detected were not significantly different between the modalities. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have IBD who receive chromoendoscopy, the evidence includes meta-analyses and RCTs. Relevant outcomes are OS, DSS, test validity, and change in disease status. Several meta-analyses found a statistically significant higher yield of chromoendoscopy over standard white-light colonoscopy for detecting dysplasia. The evidence supported improved polyp detection rates with chromoendoscopy; however, the studies had limitations such as lack of information regarding the timing of the screening modalities A recent RCT found increased detection of dysplasia with chromoendoscopy compared to white-light endoscopy, although the benefit was only observed in a a subgroup analysis in the second half of the study follow-up period. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Virtual Chromoendoscopy

For individuals who have an average risk of CC who receive virtual chromoendoscopy, the evidence includes several RCTs and systematic reviews with meta-analyses. The relevant outcomes are OS, DSS, test validity, and change in disease status. The available RCTs have not found that virtual chromoendoscopy improves the detection of clinically important polyps compared with standard white-light colonoscopy. Moreover, there is a lack of studies on the impact of virtual chromoendoscopy on CC incidence or mortality rates compared with standard colonoscopy. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have an increased risk of CC who receive virtual chromoendoscopy, the evidence includes RCTs. The relevant outcomes are OS, DSS, test validity, and change in disease status. The available RCTs have not found that virtual chromoendoscopy improves the detection of clinically important polyps compared with standard white-light colonoscopy. Moreover, there is a lack of studies on the impact of virtual chromoendoscopy on CC incidence or mortality rates compared with standard colonoscopy. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have IBD who receive virtual chromoendoscopy, the evidence includes 2 meta-analyses and 2 RCTs. Relevant outcomes are OS, DSS, test validity, and change in disease status. One meta-analysis showed superiority of virtual chromoendoscopy over high-definition white light colonoscopy for dysplasia per biopsy, and ranked virtual chromoendoscopy as the best option for screening among the different modalities in comparison. The second meta-analysis found no difference between dye-based chromoendoscopy and virtual chromoendoscopy for dysplasia detection. One RCT found a significantly greater likelihood that virtual chromoendoscopy would correctly identify the extent of disease inflammation than standard colonoscopy but no significant difference in the likelihood of identifying disease activity. The other RCT found that there was no significant difference in the detection of neoplasia between high definition white light versus high-definition virtual chromoendoscopy in patients with long-standing IBD. There is a lack of studies assessing the impact of virtual chromoendoscopy on CC incidence and mortality rates compared with standard colonoscopy. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Gastroenterological Association

In 2021, the American Gastroenterological Association (AGA) published a clinical practice update on the surveillance and management of colorectal dysplasia in patients with inflammatory bowel disease (IBD). This was an expert review that underwent internal peer review by the AGA Clinical Practice Updates Committee and external peer review through standard procedures undertaken by the publishing journal (Gastroenterology). Table 1 summarizes relevant best practice statements.

Table 1. Best Practice Advice on Surveillance and Management of Dysplasia in Patients With Inflammatory Bowel Disease

American Society for Gastrointestinal Endoscopy and the American Gastroenterological Association

In 2015, the American Society for Gastrointestinal Endoscopy (ASGE) and the American Gastroenterological Association (AGA)published a SCENIC consensus statement on the surveillance and management of dysplasia in patients with IBD. This statement, developed by an international multidisciplinary group representing a variety of stakeholders, incorporated systematic reviews of the literature. Table 2 summarizes relevant recommendations.

Table 2. Recommendations on Surveillance and Management of Dysplasia in Patients with Inflammatory Bowel Disease

LOA: level of agreement; QOE: quality of evidence; SOR: strength of recommendation.

Panelists did not reach consensus on the use of chromoendoscopy in random biopsies of patients with IBD undergoing surveillance.

Commentaries in 2 gastroenterology journals questioned whether the SCENIC guidelines would be accepted as the standard of care in IBD surveillance. Both commentaries noted that the guidelines considered the outcome of the detection of dysplasia and not disease progression or survival. Moreover, the commentators noted the lack of longitudinal data on clinical outcomes in patients with dysplastic lesions detected using chromoendoscopy. Two other articles published in 2022 comment on how the approach to dysplasia surveillance in IBD has changed significantly since the publication of the SCENIC guidelines, and therefore, updates to the recommendations are warranted based on findings from recent meta-analyses and randomized trials (discussed in this review).

Then ASGE (2015) issued guidelines on endoscopy in the diagnosis and treatment of IBD, which made the following recommendations about chromoendoscopy: "Chromoendoscopy with pancolonic dye spraying and targeted biopsies is sufficient for surveillance in inflammatory bowel disease; consider 2 biopsies from each colon segment for histologic staging."

The ASGE (2015) also published a systematic review and meta-analysis assessing narrow-band imaging, i-SCAN, and Fujinon Intelligent Color Enhancement for predicting adenomatous polyp histology of small or diminutive colorectal polyps to determine whether they have met previously established criteria or thresholds to incorporate into clinical practice.

The ASGE assessment confirmed that:

"....The thresholds have been met for narrow-band imaging with endoscopists who are experts in using these advanced imaging technologies and when assessments are made with high confidence. The ASGE Technology Committee endorsed the use of NBI[narrow band imaging] for both the ‘diagnose-and-leave’ strategy for diminutive (≤5 mm) rectosigmoid hyperplastic polyps and the‘resect-and-discard’ strategy for diminutive (≤5 mm) adenomatous polyps."

The report addressed the “trepidation” of patients, endoscopists, and pathologists with the “diagnose-and-leave” strategy, indicating there are challenges for implementation for the use of these strategies in clinical practice.

U.S. Multi-Society Task Force on Colorectal Cancer

In 2020, the Multi-Society Task Force issued guidelines on the endoscopic removal of colorectal lesions. Regarding lesion assessment and description, the Task Force suggested "proficiency in the use of electronic- (e.g., NBI, i-SCAN, and Fuji Intelligent Chromoendoscopy, or blue light imaging) or dye (chromoendoscopy)-based image-enhanced endoscopy techniques to apply optical diagnosis classifications for colorectal lesion histology [conditional recommendation, moderate-quality evidence)." The Task Force also suggested "careful examination of the post-mucosectomy scar site using enhanced imaging, such as dye-based (chromoendoscopy) or electronic-based methods, as well as obtaining targeted biopsies of the site. Post-resection scar sites that show both normal macroscopic and microscopic (biopsy) findings have the highest predictive value for long-term eradication [conditional recommendation, moderate-quality evidence]."

The 2012 Multi-Society Task Force guidelines on colonoscopy surveillance after screening and polypectomy (consensus update) stated that chromoendoscopy and NBI might enable endoscopists to accurately determine if lesions are neoplastic and if there is a need to remove them and send specimens to pathology. The guidelines noted that these technologies currently do not have an impact on surveillance interval.

U.S. Preventive Services Task Force Recommendations

The U.S. Preventive Services Task Force (2021) recommendations on screening for colorectal cancer do not mention chromoendoscopy.

KEY WORDS:

Chromoendoscopy, Chromoscopy, Chromocolonoscopy. Virtual chromoendoscopy, FICE, i-scan, NBI

APPROVED BY GOVERNING BODIES:

In August 2014, the EPX-4440HD Digital Video Processor with Fujinon Intelligent Color Enhancement (FICE®) and Light Source (FujiFilm) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process (K140149). The 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 June 2012, the i-SCAN™ (Pentax), used for virtual chromoendoscopy, was cleared for marketing by the FDA through the 510(k) process. This is a digital image enhancement technology and is part of the Pentax EPK-i5010 Video Processor. This digital image enhancement technology is part of the Pentax EPK-i5010 Video Processor. The i-SCAN™ has several modes that digitally enhance images in real-time during endoscopy. The FDA documents stated that i-SCAN™ is intended as an adjunct following white-light endoscopy but not intended to replace histopathologic analysis.

No dye or stain product has been specifically approved by the FDA for use in chromoendoscopy.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING: 

There is no specific coding for chromoendoscopy. The additional work of the chromoendoscopy would probably be reported with the unlisted CPT code 44799 (unlisted procedure, intestine) or 78299 (unlisted gastrointestinal procedure, diagnostic nuclear medicine).

REFERENCES:

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POLICY HISTORY:

Medical Policy Group, March, 2012 (4)

Medical Policy Administration Committee, March, 2012

Available for comment April 13 through May 28, 2012

Medical Policy Panel, March 2013

Medical Policy Group, April 2013 (3): 2013 Updates to Key Points and References; no change in policy statement

Medical Policy Panel, March 2014

Medical Policy Group, March 2014 (3):  2014 Updates to Key Points, Governing Bodies, & References; no change in policy statement

Medical Policy Panel, March 2015

Medical Policy Group, March 2015 (4): Updates to Key Points, Coding, and References. No change to policy statement.

Medical Policy Panel, November 2015

Medical Policy Group, November 2015 (4): Updates to Key Points and References; no change to policy statement.

Medical Policy Panel, November 2016

Medical Policy Group, January 2017 (4): Updates to Description, Key Points and References; no change to policy statement.

Medical Policy Panel, November 2017

Medical Policy Group, December 2017 (4):  Updates to Key Points and References, no change to policy statement.

Medical Policy Panel, December 2018

Medical Policy Group, December 2018 (4): Updates to Key Points. No change to policy statement.

Medical Policy Panel, November 2019

Medical Policy Group, November 2019 (5): Updates to Description, Key Points, Approved by Governing Bodies, and Practice Guidelines and Position Statements. No change to Policy Statement.

Medical Policy Panel, November 2020

Medical Policy Group, December 2020 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. No change to Policy Statement.

Medical Policy Panel, November 2021

Medical Policy Group, November 2021 (5): Updates to Description, Key Points, Practice Guidelines, Governing Bodies, USPSTF and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Panel, November 2022

Medical Policy Group, November 2022 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. No change to Policy Statement.

Medical Policy Panel, November 2023

Medical Policy Group, November 2023 (11): Updates to Key Points, Benefit Application, and References. No change to Policy Statement.

Medical Policy Panel, November 2024

Medical Policy Group, November 2024 (11): Updates to Description, Key Points, and References. No change to Policy Statement.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.