Clinical UM Guideline
|Guideline #:||CG-MED-47||Current Effective Date:||06/28/2016|
|Status:||Reviewed||Last Review Date:||05/05/2016|
This document addresses the uses of fundus photography. Fundus photography uses a retinal camera to photograph regions of the vitreous, retina, choroid, and optic nerve to document abnormalities related to disease processes affecting the eye or to follow the progress of the disease in response to therapy. The photographs can be taken with a 35mm camera or digitally.
Note: Please see the following related document for additional information:
A. Fundus photography is considered medically necessary to document abnormalities or disease processes (not screening) affecting the eye or to follow the progress of such eye disease when the results of fundus photography will be used to direct therapy and improve clinical outcomes. Examples include, but are not limited to the following:
B. Repeat or sequential fundus photographs are considered medically necessary only if they document a condition with the potential to change in appearance or size of the eye, and where such change would alter treatment.
Not Medically Necessary:
A. Fundus photography is considered not medically necessary when the criteria outlined above are not met and for all other conditions, including screening for ocular disorders.
B. Fundus photography is considered not medically necessary for retinopathy screening in individuals treated with chloroquine and hydroxychlorquine anti-malarial therapies.
C. Use of computer-based technology designed to superimpose a series of time-lapsed retinal images (for example, MatchedFlicker) is considered not medically necessary for monitoring the progression of retinal disease and for all other indications.
The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
|92250||Fundus photography with interpretation and report|
|0380T||Computer-aided animation and analysis of time series retinal images for the monitoring of disease progression, unilateral or bilateral, with interpretation and report|
|Including, but not limited to:|
|A50.01||Early congenital syphilitic oculopathy|
|A50.30||Late congenital syphilitic oculopathy, unspecified|
|A50.44||Late congenital syphilitic optic nerve atrophy|
|A51.43||Secondary syphilitic oculopathy|
|A52.15||Late syphilitic neuropathy|
|A52.71||Late syphilitic oculopathy|
|B20||Human immunodeficiency virus [HIV] disease|
|C69.00-C69.92||Malignant neoplasm of eye and adnexa|
|C79.49||Secondary malignant neoplasm of other parts of nervous system|
|D09.20-D09.22||Carcinoma in situ of eye|
|D31.00-D31.92||Benign neoplasm of eye and adnexa|
|D33.3||Benign neoplasm of cranial nerves|
|D49.81||Neoplasm of unspecified behavior of retina and choroid|
|G93.2||Benign intracranial hypertension [pseudotumor cerebri]|
|H30.81-H30.93||Other chorioretinal inflammations|
|H33.001-H33.059||Retinal detachments and breaks|
|H33.20-H33.23||Serous retinal detachment|
|H33.40-H33.43||Traction detachment of retina|
|H33.8||Other retinal detachments|
|H53.50-H53.59||Color vision deficiencies|
|M32.19||Other organ or system involvement in systemic lupus erythematosus|
|M32.8-M32.9||Systemic lupus erythematosus, unspecified|
|P35.0-P35.9||Congenital viral diseases|
|P37.0-P37.9||Other congenital infectious and parasitic diseases|
|Q14.0-Q14.9||Congenital malformation of posterior segment of eye|
|R94.110-R94.118||Abnormal results of function studies of eye|
|S05.00XA-S05.92XS||Injury of eye and orbit|
Imaging of the fundus is useful to check its status and assess for any changes from a healthy condition of the eye. Fundus imaging can focus on the structure or function of the retina or diagnose ocular diseases. Because of the architecture of the retina and its function, diseases of the eye and diseases which affect circulation and the brain can start in the retina. Ocular diseases including glaucoma, age-related macular degeneration (AMD), diabetic retinopathy and systemic diseases such as multiple sclerosis can affect the retina.
Diabetic retinopathy is characterized by damage to the blood vessels in the retina. Diabetic retinopathy is the most common eye disease in diabetics and is a leading cause of blindness in American adults. It is caused by changes in the blood vessels of the retina. A 2013 study by Ku and colleagues reported on 360 individuals (706 eyes) who had fundus photographs and self-reported diabetes. Upon clinical grading of the photographs, 163 eyes had diabetic retinopathy and 51 eyes had vision-threatening diabetic retinopathy. The sensitivity for detecting diabetic retinopathy was 74% with a specificity of 92%; for vision-threatening diabetic retinopathy, sensitivity was 86% and specificity was 95%. The authors concluded that fundus photography was a valid screening tool for diabetic retinopathy.
The American Academy of Ophthalmology (AAO) 2016 Preferred Practice Pattern® (PPP) for diabetic retinopathy reports that the use of fundus photography has little value in the cases of minimal diabetic retinopathy or when the diabetic retinopathy is unchanged from prior photographs, but fundus photography may be useful for documenting disease progression and treatment response. This PPP also encourages annual dilated eye screening exams for those with Type 2 diabetes mellitus who have not developed retinopathy or fundus photography screening stating:
Given the known gap in accessibility of direct ophthalmologic screening, fundus photographic screening programs may help increase the chances that at-risk individuals will be promptly referred for more detailed evaluation and management.
In summary, the AAO's support of fundus photography in screening for diabetic retinopathy is only in light of potential inaccessibility to ophthalmic exams; evidence demonstrating its efficacy over screening in improving clinically relevant outcomes is lacking.
Glaucoma is a group of diseases that damage the optic nerve of the eye and can lead to vision loss and blindness. The AAO has published a PPP Summary Benchmark for primary open-angle glaucoma (2015) and primary open-angle glaucoma suspect (2015) and both recommend examination of the retinal nerve fiber layer of the fundus to include photography. While the most desirable techniques for evaluating the optic nerve head and retinal nerve fiber layer are stereophotography or computer-based imaging, a nonstereoscopic photograph is an alternative.
AMD is a disorder of the macula which generally affects older adults and is characterized by loss of vision in the macula (center of the field of vision) caused by damage to the retina. There are both 'dry' and 'wet' forms of AMD and it constitutes a major cause of blindness and visual deficits in developed countries. It was estimated that approximately 1.75 million people over the age of 40 in the United States (U.S.) were affected in at least one eye in 2004, with estimates of nearly 3 million to be affected by 2020 (AAO, 2015). The AAO PPP for AMD (2015) recommends, "Color fundus photographs may be obtained when angiography is performed, because they are useful in finding landmarks, evaluating serous detachments of the neurosensory retina and RPE [retinal pigment epithelium], and determining the etiology of blocked fluorescence." There is no recommendation by the AAO for fundus photography use as a screening tool in AMD.
Recommendations by the AAO (Marmor, 2011) do not advise the use of fundus photography for screening for chloroquine and hydroxychloroquine retinopathy from anti-malarial medication. They state that fundus photography should be used for documentation and monitoring purposes, but if bull's eye maculopathy is visible, this is considered to be a late change and the goal of screening is to find toxicity at an earlier stage.
MatchedFlicker® (EyeIC, Wayne, PA) received U.S. Food and Drug Administration (FDA) 501(k) premarket approval (PMA) in 2009 and is described as "a software program that is intended for use by health care professionals to collect, store, and spatially calibrate (i.e. register and align) images of the posterior segment of the human eye" (FDA, 2009). The majority of the literature on MatchedFlicker consists of small case studies or are non-comparative in nature. Although there are a handful of moderately large published studies that suggest comparability to standard of care or even superior inter-rater reliability, the role of MatchedFlicker in the clinical setting, demonstrated through improved clinical outcomes, remains undefined (Cymbor, 2009; Syed 2012; VanderBeek, 2010). No specialty guidelines recommend the use of MatchedFlicker technology in fundus photography analysis.
Choroid: The vascular layer of the eye that lies between the retina and the sclera. It provides nourishment to outer layers of the retina.
Fundus: The interior surface of the eye, opposite the lens. The fundus includes the retina, optic disc, macula, fovea, and posterior pole.
Glaucoma: A disease characterized by destruction of the nerve fiber layer of the optic disc.
Optic nerve: The nerve that carries images of what is seen from the eye to the brain.
Retina: The light-sensitive layer of tissue that lines the inside of the eye and sends visual messages through the optic nerve to the brain.
Vitreous body: A transparent jellylike substance that fills the posterior segment of the eye, delimited by the hyaloid membrane.
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
|Websites for Additional Information|
|Reviewed||05/05/2016||Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Discussion/General Information and References sections. Removed ICD-9 codes from Coding section.|
|Revised||05/07/2015||MPTAC review. Added MatchedFlicker to NMN Criteria. Updated Description, Coding, Discussion/General Information and References sections.|
|Reviewed||05/15/2014||MPTAC review. Updated General Information/Background, References and History sections.|
|New||05/09/2013||MPTAC review. Initial document development.|