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Effective Date: 03/01/2013 |
Title: Optical Endomicroscopy
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Revision Date: 04/01/2016
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Document: BI392:00
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CPT Code(s): 43206, 43252, 0397T
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Public Statement
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Effective Date:
a)
This policy
will apply to all services performed on or after the above revision date which
will become the new effective date.
b)
For all
services referred to in this policy that were performed before the revision
date, contact customer service for the rules that would apply.
QualChoice
considers optical Endomicroscopy, confocal laser Endomicroscopy, Fuji
Intelligent Chromo Endoscopy, and other similar techniques to be experimental
and investigational, and these techniques are not covered.
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Medical Statement
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Optical
Endomicroscopy is a technique that was developed for visually recognizing
dysplasia and early cancer in the gastrointestinal tract. In this technique,
various methods are used to examine the lining of the esophagus or stomach to
identify abnormalities that might warrant biopsy. While theoretically
promising, these techniques require additional study to determine their actual
effect on important outcomes. These techniques have been suggested primarily
for surveillance in patients with Barrett’s esophagus, but also for diagnostic
purposes in gastroscopy.
Codes Used in This Policy:
43206 Esophageal optical Endomicroscopy
43252 Upper GI optical Endomicroscopy
0397T
ERCP with optical Endomicroscopy
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Background
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Confocal
laser Endomicroscopy utilizes an intravenously administered contrast material,
such as fluorescein, which is then excited with monochrome blue light. The
endoscopist then acquires images by applying the confocal window of the probe to
the mucosa. The use of contrast with extreme magnification permits better
identification of tissue abnormalities.
In a
prospective, multi-center, randomized, clinical trial, Wallace and colleagues
(2012) evaluated if use of pCLE in addition to high-definition white light (HDWL)
could aid in determination of residual BE. After an initial attempt at
ablation, patients were followed-up either with HDWL endoscopy or HDWL plus pCLE,
with treatment of residual metaplasia or neoplasia based on endoscopic findings
and pCLE used to avoid over-treatment. Main outcome measurements included the
proportion of optimally treated patients, defined as those with residual BE who
were treated and had complete ablation plus those without BE who were not
treated and had no evidence of disease at follow-up. The study was halted at
the planned interim analysis based on a priori criteria. After enrollment was
halted, all patients who had been randomized were followed to study completion.
Among the 119 patients with follow-up, there was no difference in the proportion
of patients achieving optimal outcomes in the 2 groups (15/57, 26 % for HDWL;
17/62, 27 % with HDWL + pCLE). Other outcomes were similar in the 2
groups. The authors concluded that this study yielded no evidence that the
addition of pCLE to HDWL imaging for detection of residual BE or neoplasia can
provide improved treatment.
Bertani et al
(2012) stated that many endoscopic imaging modalities have been developed and
introduced into clinical practice to enhance the diagnostic capabilities of
upper endoscopy. In the past, detection of dysplasia and carcinoma of esophagus
had been dependent on biopsies taken during standard white-light endoscopy
(WLE). Recently high-resolution (HR) endoscopy enables us to visualize
esophageal mucosa but resolution for glandular structures and cells is still
low. Probe-based confocal laser Endomicroscopy is a new promising diagnostic
technique by which details of glandular and vascular structures of mucosal layer
can be observed. However, the clinical utility of this new diagnostic tool has
not yet been fully explored in a clinical setting. Bisschops, in an editorial
published in 2011, stated, “From a technical viewpoint, confocal laser
Endomicroscopy is probably the ultimate endoscopic imaging tool; however, there
are no clear indications to make the investment and to implement it in a general
endoscopy unit at this time.” Similarly, Falk (2011) stated, “Although the
conceptual paradigm of replacing conventional surveillance biopsies with virtual
optical biopsies is exciting, data to date suggest that it is still premature to
change our current practice.”
According to
the manufacturer of the Fuji Intelligent Chromo Endoscopy system, "[a]s a basic
principle, F.I.C.E. imaging is implemented based on Spectral Estimation
Technology. Spectral Estimation Technology takes an ordinary endoscopic image
from the video processor and arithmetically processes, estimates and produces an
image of a given, dedicated wavelength of light. Now, for the first time ever,
this technology is put to practical use in the field of endoscopy by Fujinon.
The expected advantage of this new digital processing system is a dramatic
enhancement in the detection and identification of pathologic changes. The
F.I.C.E. system is expected to enable doctors to supplement differences in
experiences and to diagnose clinical findings more accurately than ever before.
In contrast to a system in which an optical filter is used, this digital
processing system is able to switchover between an ordinary image and a F.I.C.E.
image in a split second."
In a review
on advanced imaging of the gastro-intestinal tract Goetz and Kiesslich (2009)
stated that digital chromo endoscopy techniques such as narrow band imaging,
i-scan, or FICE offer new possibilities of easily and reversibly obtaining
enhanced tissue contrast. Advanced imaging techniques have provided the
endoscopist with an armamentarium of novel modalities for detection,
characterization and microscopy of lesions during endoscopy. In addition,
functional and molecular imaging give insight into dynamic processes of tissues
in their natural surroundings.
According to
ClinicalTrials.gov, a service of the National Institutes of Health, a clinical
trial on the role of the FICE for the detection of dysplasia in BE and in
post-ablation BE was suspended recently (2011).
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Reference
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1.
Goetz M,
Kiesslich R. Advanced imaging of the gastrointestinal tract: Research vs.
clinical tools? Curr Opin Gastroenterol. 2009;25(5):412-421.
2.
Wallace MB,
Crook JE, Saunders M, et al. Multicenter, randomized, controlled trial of
confocal laser Endomicroscopy assessment of residual metaplasia after mucosal
ablation or resection of GI neoplasia in Barrett`s esophagus. Gastrointest
Endosc. 2012 Jun 28. [Epub ahead of print]
3.
Bertani H,
Pigò F, Dabizzi E, et al. Advances in endoscopic visualization of Barrett`s
esophagus: The role of confocal laser Endomicroscopy. Gastroenterol Res Pract.
2012;2012:493961.
4.
Bisschops R.
Confocal laser Endomicroscopy: finally ready to change clinical practice?.
Gastro Endo. 2011:7(4): 781-3.
5.
Falk G.
Probe-based confocal Endomicroscopy in Barrett’s esophagus: the real deal or
another tease? Gastro Endo. 2011:7(3) 473-6.
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Application to Products
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This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
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Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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