Subject:
In Vivo Analysis of Colorectal Polyps
Description:
_______________________________________________________________________________________
IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
__________________________________________________________________________________________________________________________
During a colonoscopy or sigmoidoscopy as a screening test for colorectal cancer, the physician must often decide which polyp should be removed for histologic diagnosis. While hyperplastic polyps are considered benign without malignant potential, adenomatous polyps are thought to represent one of the earliest stages in the progression to a malignancy. Identification of these premalignant lesions is considered one of the cornerstones of colorectal cancer prevention. The physician must thus balance the time and potential morbidity of removing all polyps, many of which will be benign, versus removal of those polyps most likely to be adenomatous. Techniques have been developed as adjuncts to colonoscopy that are intended to distinguish between normal and precancerous tissue.
The first system developed was based on the observation that benign and malignant tissues emit different patterns and wavelengths of fluorescence after exposure to a laser light. One such device was approved by the U.S. Food and Drug Administration (FDA) in 2000, the Optical Biopsy System (SpectraScience, Minneapolis MN). This system consists of an optical fiber emitting a laser that is directed against three different regions of the same polyp. The subsequent fluorescent signal is collected, measured, and analyzed by a proprietary system software, and classifies a polyp as "suspicious" (i.e., adenomatous) or "not suspicious" (i.e., hyperplastic).
Narrow band imaging (NBI) is another technique that allows visualization of the mucosal surface and capillary vessels and thus may assist in the differentiation of abnormal from normal mucosa during colonoscopy. Two NBI systems are available. The NBI color chip system is used in the United States; in this system a single filter with a 2-band pass characteristic is used to generate central wavelengths at 415 nm (blue) and 540 nm (green and red). The NBI red-green-blue sequential illumination system uses narrow spectra of red, green, and blue light and a video endoscopic system with a frame sequential lighting method. The light source unit consists of a xenon lamp and a rotation disk with 3 optical filters. The rotation disk and monochrome charge-coupled device are synchronized and sequentially generate image in 3 optical filter bands. By use of all 3 band images, a single color endoscopic image is synthesized by the video processor. NBI has limited penetration into the mucosal surface and has enhanced visualization of capillary vessels and their fine structure on the surface layer of colonic tissue.
The FDA-labeled indication for the Optical Biopsy System reads as follows: "The SpectraScience Optical Biopsy System is indicated for use as an adjunct to lower gastrointestinal endoscopy. The device is intended for the evaluation of polyps less than 1 cm in diameter that the physician has not already elected to remove. The device is only to be used in deciding whether such polyps should be removed (which includes submission for histological examination)."
NBI received FDA clearance through the 510(k) process in 2005. This clearance (K051645) added NBI with the EVIS EXERA 160A System (Olympus Medical Systems Corp) to existing endoscopic equipment. FDA indications are for endoscopic diagnosis, treatment, and video observation.
Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
In vivo analysis of colorectal polyps is considered investigational.
Medicare Coverage:
There is no National Coverage Determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of Local Medicare Carriers. Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has not issued a determination for this service. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy.
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE-SNP:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
[RATIONALE: Literature review on the Optical Biopsy System and Narrow Band Imaging (NBI):
Optical Biopsy System
The U.S. Food and Drug Administration (FDA) approval for the Optical Biopsy System was based on a prospective, nonrandomized Phase II study involving 101 subjects from 5 sites. The data from this trial have not been published in a peer-reviewed journal but are available as an FDA summary of safety and effectiveness. Patients who participated in the study had undergone a prior lower gastrointestinal endoscopic procedure with at least 1 polyp identified, and were referred for an additional colonoscopy exam, in which fiberoptic analysis of the polyps was performed. At the time of the colonoscopy, the physicians documented whether or not the polyp was considered hyperplastic or adenomatous, and whether or not they would remove the polyp. The fiberoptic probe was then applied to 3 different portions of the polyp and a segment of normal adjacent mucosa. The physician did not know the results of the analysis and thus the test did not affect patient treatment. The effectiveness of the analysis was then calculated as its ability to correctly identify adenomatous polyps (i.e., sensitivity) and to correctly identify hyperplastic polyps (i.e., the specificity), either alone or in conjunction with physician assessment. The sensitivity and specificity of the physician assessment alone was 82.7% and 50%, respectively, compared to a combined sensitivity and specificity of 96.3% and 33%, respectively. In other words, fiberoptic analysis identified additional adenomatous polyps that the physician had classified as hyperplastic and presumably would not have removed based on visual assessment alone. This increase in sensitivity comes at the price of a decrease in specificity, as more hyperplastic polyps will undergo biopsy. However, according to the FDA, the risk of taking biopsies of additional hyperplastic polyps is minimal.
The clinical significance of these results and their effect on patient management is difficult to interpret from the data presented. It is not clear how the physician decided to select additional polyps for fiberoptic analysis (it is not entirely clear whether all polyps were analyzed and then underwent biopsy), or whether the same results could be obtained by simply randomly taking a biopsy of a subset of polyps that were considered hyperplastic on visual assessment. While adenomatous polyps are considered premalignant lesions, the evolution to cancer is a slow process requiring 7 to 8 years, and thus the immediate removal of all adenomatous polyps is not required. In addition, the finding of an adenomatous polyp serves as a marker that the patient should undergo more frequent endoscopic exams. It is well known that the current practice of visual inspection of polyps will certainly miss some adenomatous polyps, but this lack of sensitivity is considered acceptable if at least 1 adenomatous polyp is identified and the patient undergoes more frequent screening.
Few data have been published on the SpectraScience Optical Biopsy System since 2002. A feasibility study of fiberoptic analysis of normal, adenomatous, and cancerous tissue in 11 patients was published in 2003. (Mayinger B et al, 2003) No additional literature on the Optical Biopsy System was found, but a report in 2006 detailed the results of spectral scattering to different colonic lesions in a small series of 45 patients. (Dhar A et al, 2006)
Narrow Band Imaging
Several studies from both outside and inside the United States have evaluated the NBI system. These studies are a mixture of those evaluating its overall detection rates for colonic polyps and those specifically examining its ability to differentiate between neoplastic and non-neoplastic lesions. Data from 4 randomized trials of NBI versus white-light colonoscopy failed to show any advantage in total detection rate for NBI. Published randomized trials differed from the conventional approach to the assessment of diagnostic tests. In these trials patients were randomized to one test or the other (i.e., they received only one test). In general, when comparing diagnostic tests we would have each patient receive both tests and compare the test results.
Adler and colleagues published 2 trials. The first trial (2008) enrolled 401 participants where the majority of the patients (89%) were enrolled for a diagnostic colonoscopy and evaluated by expert endoscopists (>500 per provider). The second trial (2009) enrolled 1,256 participants evaluated with a screening colonoscopy in a private practice setting by 6 endoscopists with substantial lifetime experience (>10,000 total colonoscopies). Both trials randomized participants to receive NBI or white-light colonoscopy; neither trial showed a benefit of NBI over white-light for overall polyp detection rate. In a similar study, with the same conclusion, Rex and colleagues (2007) enrolled 434 participants, in a population split between 60% screening colonoscopy and 40% returning for surveillance. Each participant was randomized to either NBI or white-light colonoscopy. No benefit of NBI for the detection of adenomas was observed over white-light colonoscopy. Kaltenback and colleagues (2008) randomized 434 participants to receive both NBI and a white-light colonoscopy, or 2 white-light colonoscopies. Participants were screened by experienced endoscopists. With the first test, all visible polyps were removed, then the second test was performed to pick up any additional “missed” polyps; from this difference, the polyp miss rate was calculated. The major limitation with this method is that removing polyps with the first test eliminates the opportunity for the second test to “miss” any polyps that were already removed. NBI did not improve what was termed the “neoplasm miss rate” compared with white light. Inoue and colleagues (2009), in a randomized, controlled trial of 243 patients in Japan, presented data showing that NBI did improve overall adenoma detection rates over conventional colonoscopy, as well as improving the number of small (<5 mm) adenomas detected, while the number of patients with at least one adenoma remained the same. Participants in this trial had a previous positive colonoscopy or positive fecal occult blood test; approximately 80% were undergoing polyp surveillance. All testing was performed at an endoscopy center by 6 experienced endoscopists. Differences in results may be attributed to different study populations and/or differences in the version of NBI system used.
One randomized trial addressed both total detection rate and differentiation of neoplastic from non-neoplastic lesions. Pohl and colleagues (2009) conducted a randomized multicenter trial of virtual chromoendoscopy with the “Fujinon intelligent colour enhancement” system (FICE or NBI) versus standard colonoscopy with targeted indigocarmine chromoscopy. This German trial included 764 patients in the final analysis and reported that FICE/NBI was not superior to control for overall adenoma detection rates; it was comparable on the differentiation of neoplastic and non-neoplastic lesions. The sensitivity of FICE/NBI was 92.7% versus 90.4% for the control. Additional data on NBI for the differentiation of neoplastic from non-neoplastic lesions comes from nonrandomized studies of various sizes where the conclusion often is that NBI may be more accurate than conventional colonoscopy for the differentiation of lesions.
For example, Hirata (2008) evaluated 148 colorectal lesions and concluded that determination of pit patterns of colorectal neoplasia by NBI magnification was nearly the same as that by standard magnification with chromoendoscopy and that NBI can distinguish neoplastic and non-neoplastic lesions without chromoendoscopy. Rastogi and colleagues (2009), after evaluating 100 patients with 236 detected polyps, concluded that NBI without magnification was significantly superior to high-definition white-light colonoscopy for the real-time prediction of adenomas. van den Broek (2009) reported sensitivity, specificity, and overall accuracy of NBI for differentiation of 90%, 70%, and 79%, respectively, and while the specificity and overall accuracy were superior to high-resolution endoscopy, endoscopic trimodal imaging and autofluorescence imaging, the test characteristics were disappointing for the diagnostic accuracy for polyp differentiation. These studies only reported on the accuracy of the NBI system in the in vivo evaluation of colonic polyps. None of the studies evaluated the impact of this technology on outcomes including whether or not there would be an improvement in the selection of polyps for removal during colonoscopy.
In an editorial, Soetikno (2007)mentions the need for a user-friendly classification system for use of these devices. The editorial also comments on the need for high-definition recording devices to allow further research. As noted, without these devices, the details of lesions cannot be seen beyond the fleeting moment during the procedure and patterns cannot be fully correlated with pathology. Current technology allows for images to be saved and reviewed at a later time, but development of a standardized system for the classification of the different patterns seen on NBI is needed. (Lee MM, 2009)
While other technologies are under investigation, including chromocolonoscopy,Third Eye Retroscope, and autofluorescence, there is no evidence that current studies of these technologies overcome the issues referenced. Randomized trial data, in which participants receive both screening tests, and histologic confirmation of disease is matched to screening test results for each polyp are required to evaluate this technology.
Since the impact of this technology on health outcomes is not known, it is considered investigational.
Technology Assessments, Guidelines and Position Statements
Neither the U.S. Preventive Services Task Force nor the National Comprehensive Cancer Network (NCCN) mentions NBI in their current policy statements or screening guidelines. The American Gastroenterological Association in 2008 published a technology assessment of image-enhanced endoscopy, which mentions optical and electronic devices potentially playing a role in colon screening in the future, but currently, more data are needed. (Kaltenback T et al, 2008)]
________________________________________________________________________________________
Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
___________________________________________________________________________________________________________________________
Index:
In Vivo Analysis of Colorectal Polyps
Optical Biopsy System
Narrow Band Imaging
NBI
References:
1. Optical Biopsy System: Summary of Safety and Effectiveness. www.fda.gov
2. Mayinger B, Jordan M, Horner P et al. Endoscopic light-induced autofluorescence spectroscopy for the diagnosis of colorectal cancer and adenoma. J Photochem Photobiol B. 2003; 70(1):13-20.
3. Dhar A, Johnson KS, Novelli MR et al. Elastic scattering spectroscopy for the diagnosis of colonic lesions: initial results of a novel optical biopsy technique. Gastrointest Endosc 2006; 63(2):1257-61.
4. Inoue T, Murano M, Murano N et al. Comparative study of conventional colonoscopy and pan-colonic narrow-band imaging system in the detection of neoplastic colonic polyps: a randomized, controlled trial. J Gastroenterol 2008; 43(1):45-50.
5. Matsumoto T, Esaki M, Fujisawa R et al. Chromoendoscopy, narrow-band imaging colonoscopy and autofluorescence colonoscopy for detection of diminutive colorectal neoplasia in familial adenomatous polyposis. Dis Colon Rectum 2009; 52(6):1160-5.
6. Huneburg R, Lammert F, Rabe C et al. Chromocolonoscopy detects more adenomas than white light colonoscopy or narrow band imaging colonoscopy in hereditary nonpolyposis colorectal cancer screening. Endoscopy 2009; 41(4):316-22.
7. Adler A, Pohl H, Papanikolaou IS. A prospective randomised study on narrow-band imaging versus conventional colonoscopy for adenoma detection: does narrow-band imaging induce a learning effect? Gut 2008; 57(1):59-64.
8. Adler A, Aschenbeck J, Yenerim T et al. Narrow-band versus white-light high definition television endoscopic imaging for screening colonoscopy: A prospective randomized trial. Gastroenterology 2009; 136(2):410-6.
9. Togashi K, Osawa H, Koinuma K et al. A comparison of conventional endoscopy, chromoendoscopy, and the optimal-band imaging system for the differentiation of neoplastic and non-neoplastic colonic polyps. Gastrointest Endosc 2009; 69(3):734-41.
10. Pohl J, Lotterer E, Balzer C et al. Computed virtual chromoendoscopy versus standard colonoscopy with targeted indigocarmine chromoscopy: a randomised multicentre trial. Gut 2009; 58(1):73-8.
11. van den Broek FJ, Fockens P, Van Eeden S et al. Clinical evaluation of endoscopic trimodal imaging for the detection and differentiation of colonic polyps. Clin Gastroenterol Hepatol 2009; 7(3):288-95.
12. Hirata M, Tanaka S, Oka S et al. Magnifying endoscopy with narrow band imaging for diagnosis of colorectal tumors. Gastrointest Endosc 2007; 65(7):988-95.
13. Tischendorf JJ, Wasmuth HE, Koch A et al. Value of magnifying chromoendoscopy and narrow band imaging (NBI) in classifying colorectal polyps: a prospective controlled study. Endoscopy 2007; 39(12):1092-6.
14. Kaltenbach T, Friedland S, Soetikno R. A randomised tandem colonoscopy trial of narrow band imaging versus white light examination to compare neoplasia miss rates. Gut 2008; 57(10):1406-12.
15. Rex DK. Narrow band imaging without optical magnification for histologic analysis of colorectal polyps. Gastroenterology 2009; 136(4):1174-81.
16. Rastogi A, Keighley J, Singh V et al. High accuracy of narrow band imaging without magnification for the real-time characterization of polyp histology and its comparison with high-definition white light colonoscopy: a prospective study. Am J Gastroenterol 2009; 104(10):2422-30.
17. Rex DK, Helbig CC. High yields of small flat adenomas with high-definition colonoscopes using either white light or narrow band imaging. Gastroenterology 2007; 133(1):42-7.
18. Rogart JN, Jain D, Siddiqui UD. Narrow band imaging without high magnification to differentiate polyps during real-time colonoscopy: improvement with experience. Gastrointest Endosc 2008; 68(6):1136-45.
19. Sikka S, Ringold DA, Jonnalagadda S et al. Comparison of white light and narrow band high definition images in predicting colon polyp histology, using standard colonoscopes without optical magnification. Endoscopy 2008; 40(10):818-22.
20. Soetikno R, Kaltenbach T. The beginning of a new paradigm in colonoscopy? Gastrointest Endosc 2007; 65(7):996-7.
21. Lee MM, Enns R. Narrow band imaging for the detection of neoplastic lesions of the colon. Can J Gastroenterology 2009; 23(1):15-18.
22. Triadafilopoulos G, Li J. A pilot study to assess the safety and efficacy of the Third Eye retrograde auxiliary imaging system during colonoscopy. Endoscopy 2008; 40(6):478-82
23. Matsuda T, Saito Y, Fu KI et al. Does autofluorescence imaging videoendoscopy system improve the colonoscopic polyp detection rate?--a pilot study. Am J Gastroenterol 2008; 103(8):1926-32.
24. Kaltenbach T, Sano Y, Friedland S et al. American Gastroenterological Association (AGA) Institute technology assessment on image-enhanced endoscopy. Gastroenterology 2008; 134(1):327-40.
25. Yeung TM, Mortensen NJ. Advances in endoscopic visualization of colorectal polyps. Colorectal Dis. 2011;13(4):352-359.
26. Sabbagh LC, Reveiz L, Aponte D, et al. Narrow-band imaging does not improve detection of colorectal polyps when compared to conventional colonoscopy: A randomized controlled trial and meta-analysis of published studies. BMC Gastroenterol. 2011;11:100.
27. Nagorni A, Bjelakovic G, Petrovic B. Narrow band imaging versus conventional white light colonscopy for the detection of colorectal polyps. Cochrane Database Syst Rev. 2012;1:CD008361.
28. Dinesen L, Chua TJ, Kaffes AJ, et al. Meta-analysis of anrrow band imaging versus conventional colonoscopy for adenoma detection. Gastrointest Endosc. 2012;75(3):604-611.
29. Ussui VM, Wallace MB. Confocal endomicroscopy of colorectal polyps. Gastroenterol Res Pract. 2012;2012:545679.
30. Repici A, Hassan C, Radaelli F, etal. Accuracy of narrow-band imaging in predicting colonoscopy surveillance intervals and histology of distal diminutive polyps: results from a multicenter, prospective trial. Gastrointest Endosc 2013 Jul;78(1):106-14.
31. Parikh ND, Perl D, Lee MH, et al. In vivo diagnostic accuracy of high-resolution microendoscopy in differentiating neoplastic from non-neoplastic colorectal polyps: a prospective study. Am J Gastroenterol 2014 Jan;109(1):68-75.
32. Bergholt MS, Lin K, Wang J et al. Simultaneous fingerprint and high-wavenumber fiber-optic Rahman spectroscopy enhances real-time in vivo diagnosis of adenomatous polyps during colonoscopy. J Biophotonics. 2015 Apr 7;9999(9999). [Epub ahead of print]
33. Lopez-Ceron M, Sanabria E, Pellise M. Colonic polyps: is it useful to characterize them with advance colonoscopy? World J Gastroenterol. 2014 Jul 14;20(26):8449-57.
34. Schachschal G, Mayr M Treszl A et al. Endoscopic versus histological characterization of polyps during screening colonoscopy. Gut. 2014 Mar;63(3):458-65.
35. UpToDate. Tests for screening for colorectal cancer: Stool tests, radiologic imaging and endoscopy. Literature review current through May 2016. Topic last updated April 29, 2016.
36. Kim B, Kim YH, Park SJ, et al. Probe-based confocal laser endomicroscopy for evaluating the submucosal invasion of colorectal neoplasms. Surg Endosc 2016 Jun 20. [Epub ahead of print]
37. Stefanescu D, Streba C, Cartana ET, et al. Computer Aided Diagnosis for Confocal Laser Endomicroscopy in Advanced Colorectal Adenocarcinoma. PLoS One 2016 May 4;11(5):e0154863.
38. Macrae FA. Approach to the patient with colonic polyps. In: UpToDate, Rutgeerts P, Grover S (Eds), UpToDate, Waltham, MA (Accessed on June 2, 2017.)
39. Doubeni C. Screening for colorectal cancer: Strategies in patients at average risk. In: UpToDate, Lamont T, Elmore JG, Melin JA (Eds), UpToDate, Waltham, MA (accessed on June 2, 2017.)
40. Doubeni C. Tests for screening for colorectal cancer: Stool tests, radiologic imaging and endoscopy. In: UpToDate, Lamont T, Elmore JG, Melin JA (Eds), UpToDate, Waltham, MA (Accessed on June 2, 2017.)
41. Doubeni C. Tests for screening for colorectal cancer: Stool tests, radiologic imaging and endoscopy. In: UpToDate, Melin JA (Eds), UpToDate, Waltham, MA (Accessed April 25, 2018.)
42. Doubeni C. Tests for screening for colorectal cancer: Stool tests, radiologic imaging and endoscopy. In: UpToDate, Lamont JT, Elmore JG, Melin JA (Eds), UpToDate, Waltham, MA (Accessed May 3, 2019.)
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
_________________________________________________________________________________________
Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
____________________________________________________________________________________________________________________________ |