mp-311 - Medical Policies - Alabama
Optical Coherence Tomography of the Anterior Eye Segment
Policy Number: MP-311
Latest Review Date: March 2021
Policy Grade: C
Scanning computerized ophthalmic (e.g., optical coherence tomography) imaging of the anterior eye segment is considered investigational.
DESCRIPTION OF PROCEDURE OR SERVICE:
Optical coherence tomography (OCT) is a noninvasive, high-resolution imaging method that can be used to visualize ocular structures. OCT of the anterior segment (AS) is being evaluated as a noninvasive diagnostic and screening tool for detecting angle-closure glaucoma, for presurgical evaluation, surgical guidance, and for assessing complications following surgical procedures. It is also being studied as a tool to evaluate the pathologic processes of dry eye syndrome, tumors, uveitis, and infections.
Optical Coherence Tomography
Optical coherence tomography (OCT) is a noninvasive, high-resolution imaging method that can be used to visualize ocular structures. OCT creates an image of light reflected from the ocular structures. In this technique, a reflected light beam interacts with a reference light beam. The coherent (positive) interference between the two beams (reflected and reference) is measured by an interferometer, allowing construction of an image of the ocular structures. This method allows cross-sectional imaging at a resolution of six to 25 μm.
The Stratus OCT, which uses a 0.8-μm wavelength light source, was designed to evaluate the optic nerve head, retinal nerve fiber layer, and retinal thickness in the posterior segment. The Zeiss Visante OCT and AC Cornea OCT use a 1.3-μm wavelength light source designed specifically for imaging the anterior eye segment. Light of this wavelength penetrates the sclera, permitting high-resolution cross-sectional imaging of the anterior chamber (AC) angle and ciliary body. The light is, however, typically blocked by pigment, preventing exploration behind the iris. Ultrahigh resolution OCT can achieve a spatial resolution of 1.3 μm, allowing imaging and measurement of corneal layers.
An early application of OCT technology was the evaluation of the cornea before and after refractive surgery. Because this noninvasive procedure can be conducted by a technician, it has been proposed that this device may provide a rapid diagnostic and screening tool for detecting angle-closure glaucoma.
Other Diagnostic Tools
Optical coherence tomography of the anterior eye segment is being evaluated as a noninvasive diagnostic and screening tool with a number of potential applications. One proposed use of anterior segment optical coherence tomography is to determine whether there is a narrowing of the anterior chamber angle, which could lead to angle-closure glaucoma. Another general area of potential use is as a presurgical and postsurgical evaluation tool for anterior chamber procedures. This could include assessment of corneal thickness and opacity, calculation of intraocular lens power, guiding surgery, imaging intracorneal ring segments, and assessing complications following surgical procedures such as blockage of glaucoma tubes or detachment of Descemet membrane following endothelial keratoplasty. A third general category of use is to image pathologic processes such as dry eye syndrome, tumors, noninfectious uveitis, and infections. It is proposed that anterior segment optical coherence tomography provides better images than slit-lamp biomicroscopy/gonioscopy and ultrasound biomicroscopy due to higher resolution; in addition, anterior segment optical coherence tomography does not require probe placement under topical anesthesia.
Alternative methods of evaluating the anterior chamber are slit-lamp biomicroscopy or ultrasound biomicroscopy. Slit-lamp biomicroscopy is typically used to evaluate the anterior chamber; however, the chamber angle can only be examined with specialized lenses, the most common being the gonioscopic mirror. In this procedure, a gonio lens is applied to the surface of the cornea, which may result in distortion of the globe. Ultrasonography may also be used for imaging the anterior eye segment. Ultrasonography uses high-frequency mechanical pulses (10 to 20 MHz) to build a picture of the front of the eye. An ultrasound scan along the optical axis assesses corneal thickness, anterior chamber depth, lens thickness, and axial length. Ultrasound scanning across the eye creates a two-dimensional image of the ocular structures. It has a resolution of 100 μm but only moderately high intraobserver and low interobserver reproducibility. Ultrasound biomicroscopy (»50 MHz) has a resolution of 30 to 50 μm. As with slit-lamp biomicroscopy with a gonioscopic mirror, this technique requires placement of a probe under topical anesthesia.
Classification and Assessment of Glaucoma
Glaucoma is characterized by degeneration of the optic nerve.
The classification of glaucoma as open-angle or angle-closure relies on assessment of the anterior segment anatomy, particularly that of the anterior chamber angle. Angle-closure glaucoma is characterized by obstruction of aqueous fluid drainage through the trabecular meshwork (the primary fluid egress site) from the eye’s anterior chamber. The width of the angle is a factor affecting the drainage of aqueous humor. A wide unobstructed iridocorneal angle permits sufficient drainage of aqueous humor, whereas a narrow-angle may impede the drainage system and leave the patient susceptible to an increase in intraocular pressure and angle-closure glaucoma.
A comprehensive ophthalmologic examination for glaucoma includes assessment of the optic nerve and retinal nerve fiber layer. The presence of characteristic changes in the optic nerve or abnormalities in visual field, together with increased intraocular pressure, is sufficient for a definitive diagnosis of glaucoma.
The most recent literature review was updated through January 27, 2021.
Summary of Evidence
For individuals who are being evaluated for angle-closure glaucoma who receive anterior segment optical coherence tomography, the evidence includes case series and cohort studies. Relevant outcomes are test accuracy, symptoms, change in disease status, and morbid events. Current literature consists primarily of assessments of qualitative and quantitative imaging and detection capabilities. Ideally, a diagnostic test should be evaluated based on its diagnostic accuracy and clinical utility. Studies have shown that anterior segment optical coherence tomography detects more eyes with narrow or closed angles than gonioscopy, suggesting that the sensitivity of optical coherence tomography is higher than that of gonioscopy. However, because of clinical follow-up and validation studies, it is not clear to what degree these additional cases are true-positives or false-positives and, therefore, the specificity and predictive values cannot be determined. The evaluation of diagnostic performance depends, therefore, on evidence that the additional eyes identified with narrow-angle by anterior segment optical coherence tomography are at higher risk for primary angle-closure glaucoma. Results from a study with mid-term follow-up have shown that some patients identified with angle-closure on anterior segment optical coherence tomography will develop angle-closure on gonioscopy after several years, but that there may also be a large number of false-positive results. Longer-term studies are needed to determine whether eyes classified as closed-angle by anterior segment optical coherence tomography are at higher risk of developing primary angle-closure glaucoma. It is also not known whether early detection of angle-closure will improve outcomes in individuals who do not have symptoms of angle-closure. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who are being evaluated for anterior eye surgery or postsurgical complications who receive anterior segment optical coherence tomography, the evidence includes case series. Relevant outcomes are test accuracy, symptoms, change in disease status, and morbid events. Use of anterior segment optical coherence tomography has been reported for presurgical evaluation, surgical guidance, and monitoring for postsurgical complications. There is some evidence that the high-resolution images provided by anterior segment optical coherence tomography are superior to results from slit-lamp examination or gonioscopy for some indications. However, current literature is very limited. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have anterior eye segment disease or pathology who receive anterior segment optical coherence tomography, the evidence includes case series. Relevant outcomes are test accuracy, symptoms, change in disease status, and morbid events. The evidence related to the use of anterior segment optical coherence tomography for anterior segment disease or pathology (e.g., dry eye syndrome, tumors, uveitis, infections) is limited, and does not support improvements in imaging compared with alternative diagnostic techniques. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
Practice Guidelines and Position Statements
American Academy of Ophthalmology
In 2020, the American Academy of Ophthalmology published a preferred practice pattern on primary angle closure disease. The Academy stated that gonioscopy of both eyes should be performed on all patients in whom primary angle closure disease is suspected to evaluate the angle anatomy, including the presence of iridotrabecular contact and/or peripheral anterior synechiae, and plateau iris configuration. Anterior segment imaging may be a useful adjunct to gonioscopy and is particularly helpful when the ability to perform gonioscopy is precluded by corneal disease or poor patient cooperation. Although anterior segment optical coherence tomography can be very useful, it has limitations in evaluating the angle. Neither the posterior aspect of the iris nor the ciliary body are well imaged with anterior segment optical coherence tomography, reducing the utility of this approach in evaluating plateau iris configuration or ciliary body abnormalities. Isolated peripheral anterior synechiae or small tufts of neovascularization may be missed if not in the plane imaged by anterior segment optical coherence tomography.
U.S. Preventive Services Task Force Recommendations
Scanning computerized ophthalmic, optical coherence tomography, OCT, Stratus OCT™, Zeiss OCT™, Visante OCT non-contact, high resolution tomographic and biomicroscopic device, anterior imaging techniques, AC Cornea OCT, Bioptigen Envisu™, SOCT Copernicus HR, RTVue® (Optovue), Slit-Lamp OCT (SL-OCT, Heidelberg Engineering), ReScan 700 (Zeiss), Haag-Streit iOCT®
APPROVED BY GOVERNING BODIES:
Multiple optical coherence tomography systems have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. Examples of approved systems are the Visante™ OCT (Carl Zeiss Meditec; FDA product code: HLI); the RTVue® (Optovue; FDA product code: OBO) and the Slitlamp optical coherence tomography (SL-OCT; Heidelberg Engineering; FDA product code: MXK).
The microscope-integrated optical coherence tomography devices for intraoperative use include the ReScan 700 (Zeiss; FDA product code: OBO) and the iOCT® system (Haag-Streit).
Portable devices for intraoperative use include the Bioptigen Envisu™ (Bioptigen; FDA product code: HLI) and the Optovue iVue® (Optovue; FDA product code: OBO). Ultrahigh-resolution optical coherence tomography devices include the SOCT Copernicus HR (Optopol Technologies; FDA product code OBO).
Commercially available laser systems, such as the LenSx® (Alcon), Catalys® (OptiMedica), and VICTUS® (Technolas Perfect Vision), include optical coherence tomography to provide image guidance for laser cataract surgery. FDA product code: OOE.
Custom-built devices, which do not require FDA approval, are also used.
The anterior chamber Cornea optical coherence tomography (Ophthalmic Technologies) is not cleared for marketing in the United States.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP contracts: FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
Scanning computerized ophthalmic diagnostic imaging, anterior segment, with interpretation and report, unilateral or bilateral.
- Agarwal A, Ashokkumar D, Jaco S et al. High speed optical coherence tomography for imaging anterior chamber inflammatory reaction in uveitis: clinical correlation and grading. Am J Ophthalmol 2009; 147(3):413-6.
- American Academy of Ophthalmology. Preferred Practice Pattern: Primary angle closure disease. 2020; https://www.aao.org/preferred-practice-pattern/primary-angle-closure-disease-ppp. Accessed January 27, 2021.
- Baskaran M, Iyer JV, Narayanaswamy AK, et al. Anterior Segment Imaging Predicts Incident Gonioscopic Angle Closure. Ophthalmology. Dec 2015; 122(12):2380-2384.
- Bianciotto C, Shields CL, Guzman JM et al. Assessment of anterior segment tumors with ultrasound biomicroscopy versus anterior segment optical coherence tomography in 200 cases. Ophthalmology 2011; 118(7):1297-302.
- Cauduro RS, Ferraz Cdo A, Morales MS et al. Application of anterior segment optical coherence tomography in pediatric ophthalmology. J Ophthalmol 2012; 2012:313120.
- Ehlers JP, Dupps WJ, Kaiser PK, et al. The Prospective Intraoperative and Perioperative Ophthalmic Imaging with Optical Coherence Tomography (PIONEER) Study: 2-Year Results. Am J Ophthalmol. Nov 2014; 158(5):999-1007 e1001.
- Ehlers JP, Kaiser PK, Srivastava SK. Intraoperative optical coherence tomography using the RESCAN 700: preliminary results from the DISCOVER study. Br J Ophthalmol. Oct 2014; 98(10):1329-1332.
- Garcia JP Jr, Rosen RB. Anterior segment imaging: optical coherence tomography versus ultrasound biomicroscopy. Ophthalmic Surg Lasers Imaging. 2008 Nov-Dec; 39(6):476-84.
- Jiang C, Li Y, Huang D et al. Study of anterior chamber aqueous tube shunt by fourier-domain optical coherence tomography. J Ophthalmol 2012; 2012:189580.
- Kalev-Landoy M, Day AC, Cordeiro MF et al. Optical coherence tomography in anterior segment imaging. Acta Ophthalmol Scand 2007; 85(4):427-30.
- Leung CK, Li H, Weinreb RN, et al. Anterior chamber angle measurement with anterior segment optical coherence tomography: A comparison between slit lamp OCT and visante OCT. Invest Ophthalmol Vis Sci 2008; 49: 3469-3474.
- Mansouri K, Sommerhalder J, Shaarawy T. Prospective comparison of ultrasound biomicroscopy and anterior segment optical coherence tomography for evaluation of anterior chamber dimensions in European eyes with primary angle closure. Eye (Lond) 2010; 24(2):233-9.
- Maram J, Pan X, Sadda S, et al. Reproducibility of Angle Metrics Using the Time-Domain Anterior Segment Optical Coherence Tomography: Intra-Observer and Inter-Observer Variability. Curr Eye Res. Jun 23 2014:1-5.
- Medina CA, Plesec T, Singh AD. Optical coherence tomography imaging of ocular and periocular tumors. Br J Ophthalmol. Jul 2014; 98 Suppl 2:ii40-46.
- Moutsouris K, Dapena I, Ham L et al. Optical coherence tomography, Scheimpflug imaging, and slit-lamp biomicroscopy in the early detection of graft detachment after descemet membrane endothelial keratoplasty. Cornea 2011; 30(12):1369-75.
- Narayanaswamy A, Sakata LM, He MG et al. Diagnostic performance of anterior chamber angle measurements for detecting eyes with narrow angles: an anterior segment OCT study. Arch Ophthalmol 2010; 128(10):1321-7.
- Nguyen P, Chopra V. Applications of optical coherence tomography in cataract surgery. Curr Opin Ophthalmol 2013; 24(1):47-52.
- Nolan W. Anterior segment imaging: Ultrasound biomicroscopy and anterior segment optical coherence tomography. Curr Opin Ophthalmology, March 2008; 19(2): 115-121.
- Nolan WP, See JL, Chew PT et al. Detection of primary angle closure using anterior segment optical coherence tomography in Asian eyes. Ophthalmology 2007; 114(1):33-9.
- Pekmezci M, Porco TC, Lin SC. Anterior segment optical coherence tomography as a screening tool for the assessment of the anterior segment angle. Ophthalmic Surg Lasers Imaging. 2009 Jul-Aug; 40(4):389-98.
- Shih CY, Ritterband DC, Palmiero PM et al. The use of postoperative slit-lamp optical coherence tomography to predict primary failure in Descemet stripping automated endothelial keratoplasty. Am J Ophthalmol 2009; 147(5):796-800.
- Steven P, Le Blanc C, Velten K et al. Optimizing descemet membrane endothelial keratoplasty using intraoperative optical coherence tomography. JAMA Ophthalmol 2013; 131(9):1135-42.
- Takezawa Y, Suzuki T, Shiraishi A. Observation of retrocorneal plaques in patients with infectious keratitis using anterior segment optical coherence tomography. Cornea. Oct 2017; 36(10):1237-1242.
- Thomas BJ, Galor A, Nanji AA, et al. Ultra high-resolution anterior segment optical coherence tomography in the diagnosis and management of ocular surface squamous neoplasia. Ocul Surf. Jan 2014; 12(1):46-58.
- Venincasa MJ, Osigian CJ, Cavuoto KM, et al. Combination of anterior segment optical coherence tomography modalities to improve accuracy of rectus muscle insertion location. J AAPOS. Jun 2017; 21(3):243-246.
- Wang D, Pekmezci M, Basham RP, et al. Comparison of different modes in optical coherence tomography and ultrasound biomicroscopy in anterior chamber angle assessment. J Glaucoma, Aug 2009; 18(6): 472-478.
- Wolffsohn JS, Peterson RC. Anterior ophthalmic imaging. Clin Exp Optom 2006; 89(4):205-14.
Medical Policy Group, December 2007 (2)
Medical Policy Administration Committee, January 2008
Available for comment January 5-February 20, 2008
Medical Policy Group, December 2008 (1)
Medical Policy Group, December 2009 (1)
Medical Policy Group, December 2010 (1): Description, Key Points updated, Key word added and info to Approved by Governing Body added, no policy change
Medical Policy Group, December 2010; 2011 coding update
Medical Policy Group, January 2011: Key Points, References
Medical Policy Panel February 2011
Medical Policy Panel, July 2011 (2): Key Points updated
Medical Policy Group, September 2012 (1): Update to Description, Key Points and References related to MPP update; no change to policy statement
Medical Policy Panel, February 2013
Medical Policy Group, February 2013 (2): Update to Description, Key Points, Governing bodies and References related to MPP update; no change to policy statement
Medical Policy Panel, February 2014
Medical Policy Group, February 2014 (1) Update to Key Points and References; no change to policy statement
Medical Policy Panel, February 2015
Medical Policy Group, February 2015 (6): 2015 Updates to Key Points, Key Words, Approved by Governing Bodies and References; no change in policy statement.
Medical Policy Panel, August 2016
Medical Policy Group, August 2016 (6): Updates to Key Points, Key Words, Summary, Approved by Governing Bodies and References. Clarified policy statement to include “of the anterior eye segment”
Medical Policy Panel, March 2017
Medical Policy Group, March 2017 (6): Updates to Description, Key Points, Summary, Approved by Governing Bodies; no change in policy statement.
Medical Policy Panel, April 2018
Medical Policy Group, April 2018 (6): Updates to Key Points and References; no change in policy statement.
Medical Policy Panel, March 2019
Medical Policy Group, March 2019 (6): Updates to Description, Key Points and Approved by Governing Bodies. Policy Title changed to “Optical Coherence Tomography of the Anterior Eye Segment”. No change to policy statement.
Medical Policy Panel, March 2020
Medical Policy Group, March 2020 (6): Updates to Description and Key Points.
Medical Policy Panel, March 2021
Medical Policy Group, March 2021 (9): 2021 Updates to Key Points, Description, References. Policy statement updated to remove “not medically necessary,” no change to policy intent.
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.