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DESCRIPTIONDigital imaging systems use a digital fundus camera to acquire a series of standard field color images and/or monochromatic images of the retina of each eye. This type of retinopathy screening and risk assessment is proposed as an alternative to conventional dilated fundus examination, particularly in diabetic individuals who are not compliant with the recommended periodic retinopathy screening. The digital images that are captured may then be evaluated on site and stored for comparison with subsequent retinal images of the same individual or they may be transmitted via the internet to a remote center for interpretation by trained readers, storage, and subsequent comparison.
Diabetic retinopathy is the leading cause of blindness among adults aged 20–74 years in the United States. The major risk factors for developing diabetic retinopathy are duration of diabetes and severity of hyperglycemia. After 20 years of disease, almost all patients with type 1 and >60% of patients with type 2 diabetes will have some degree of retinopathy. Other important risk factors include hypertension and elevated serum lipid levels.
Diabetic retinopathy progresses, at varying rates, from asymptomatic, mild nonproliferative abnormalities to proliferative diabetic retinopathy (PDR) with new blood vessel growth on the retina and posterior surface of the vitreous. The two most serious complications for vision are diabetic macular edema and proliferative diabetic retinopathy. At its earliest stage (nonproliferative retinopathy), the retina develops microaneurysms, intraretinal hemorrhages, and focal areas of retinal ischemia. With disruption of the blood-retinal barrier, macular retinal vessels become permeable, leading to exudation of serous fluid and lipids into the macula (macular edema). As the disease progresses blood vessels that provide nourishment to the retina are blocked, triggering the growth of new and fragile blood vessels (proliferative retinopathy). The new blood vessels that occur in PDR may fibrose and contract, resulting in tractional retinal detachments with significant vision loss. Severe vision loss with proliferative retinopathy arises from vitreous hemorrhage. Moderate vision loss can also arise from macular edema (fluid accumulating in the center of the macula) during the proliferative or nonproliferative stages of the disease. Although proliferative disease is the main blinding complication of diabetic retinopathy, macular edema is more frequent and is the leading cause of moderate vision loss in people with diabetes.
The value of screening is well established since diabetic retinopathy has few visual or ocular symptoms until vision loss develops. With early detection, diabetic retinopathy can be treated with modalities that can decrease the risk of severe vision loss. Tight glycemic and blood pressure control is the first line of treatment to control diabetic retinopathy, followed by laser photocoagulation for patients whose retinopathy is approaching the high-risk stage. Although laser photocoagulation is effective at slowing the progression of retinopathy and reducing visual loss, it results in collateral damage to the retina and does not restore lost vision. Focal macular edema may be treated with focal laser photocoagulation, while diffuse macular edema (characterized by generalized macular edema on fluorescein angiography) may be treated with grid laser photocoagulation. Corticosteroids may reduce vascular permeability and inhibit vascular endothelial growth factor (VEGF) production, but are associated with serious adverse effects including cataracts and glaucoma with damage to the optic nerve. Corticosteroids also can worsen diabetes control. VEGF inhibitors (e.g., ranibizumab, bevacizumab, and pegaptanib), which reduce permeability and block the pathway leading to new blood vessel formation (angiogenesis), are being evaluated for the treatment of diabetic macular edema and proliferative diabetic retinopathy.
Because treatments are aimed primarily at preventing vision loss, and retinopathy can be asymptomatic, it is important to detect disease and begin treatment early in the process. Annual dilated, indirect ophthalmoscopy coupled with biomicroscopy or 7-standard field stereoscopic 30° fundus photography have been considered to be the screening techniques of choice. Because these techniques require a dedicated visit to a competent eye care professional, typically an ophthalmologist, there is underutilization of this screening recommendation by at-risk members. The under-use has resulted in the exploration of remote retinal imaging, using film or digital photography, as an alternative to direct ophthalmic examination of the retina.
A number of photographic methods have been evaluated that allow images of the retina to be captured and then interpreted by expert readers who may not be located conveniently to the patient. One approach is mydriatic standard field 35-mm stereoscopic color fundus photographs. Digital fundus photography has also been evaluated as an alternative to conventional film photography. Retinal imaging can be performed using digital retinal photographs with (mydriatic) or without (nonmydriatic) dilating the pupil. Digital imaging has the advantage of easier acquisition, transmission, and storage. In addition, the potential for digital images of the retina to be acquired in a primary care setting and evaluated by trained readers in a remote location with retinal specialist consultation exists.
Several digital camera and transmission systems are currently available:
POLICYRetinal telescreening with digital imaging and manual grading of images may be considered medically necessary as a screening technique for the detection of diabetic retinopathy.
Retinal telescreening is considered investigational for all other indications, including the monitoring and management of disease in individuals diagnosed with diabetic retinopathy.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
The 2011 diabetic retinopathy screening recommendation of the American Diabetic Association includes:
POLICY HISTORY07/27/2006: Approved by Medical Policy Advisory Committee (MPAC)
1/22/2007: Code Reference section updated. Added ICD-9 codes 250.00-250.43, 250.60-250.93, and 362.03-362.06
08/11/2011: Policy title changed from "Digital Imaging Systems for the Detection and Evaluation of Diabetic Retinopathy" to "Retinal Telescreening for Diabetic Retinopathy." Policy description and guidelines updated regarding disease prevalence and screeing recommendations. Revised the first policy statement to indicate that retinal telescreening with digital imaging and manual grading of images may be considered medically necessary as a screening technique for the detection of diabetic retinopathy. It previously stated that digital imaging systems may be considered medically necessary as a screening technique for the detection and interpretation of diabetic retinopathy. Added the following investigational policy statement: Retinal telescreening is considered investigational for all other indications, including the monitoring and management of disease in individuals diagnosed with diabetic retinopathy.
12/01/2011: Policy reviewed; no changes.
11/30/2012: Policy reviewed; no changes.
01/22/2014: Policy reviewed; no changes.
SOURCE(S)Blue Cross Blue Shield Association policy # 9.03.13
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is perforemd according to the "Policy" section of this document.