Retinal Telescreening for Diabetic Retinopathy

POLICY NUMBER

L.9.03.411

DESCRIPTION

Retinopathy telescreening and risk assessment with digital imaging systems are proposed as an alternative to conventional dilated fundus examination in diabetic individuals. Digital 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. Captured digital images may be transmitted via the Internet to a remote center for interpretation, storage, and subsequent comparison.

Diabetic Retinopathy

Diabetic retinopathy is the leading cause of new blindness among adults aged 20 to 74 years in the United States. The major risk factors for developing diabetic retinopathy are the duration of diabetes and severity of hyperglycemia. The risk increases with diabetes duration, affecting over half of individuals over time. Other factors that contribute to the risk of retinopathy include kidney disease, hypertension, and elevated serum lipid levels.

Diabetic retinopathy progresses, at varying rates, from asymptomatic, mild non-proliferative abnormalities to proliferative diabetic retinopathy, 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 (non-proliferative retinopathy), the retina develops microaneurysms, intraretinal hemorrhages, and focal areas of retinal ischemia. With the 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, retinal blood vessels are blocked, triggering the growth of new and fragile blood vessels (proliferative retinopathy). The new blood vessels that occur in proliferative diabetic retinopathy 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 non-proliferative stages of the disease. Although proliferative disease is the main cause of blinding in diabetic retinopathy, macular edema is more frequent and is the leading cause of moderate vision loss in people with diabetes.

Treatment

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 causes collateral damage to the retina and does not restore lost vision. Focal macular edema(characterized by leakage from discrete microaneurysms on fluorescein angiography) 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 production, but are associated with serious adverse events, including cataracts and glaucoma with damage to the optic nerve. Corticosteroids can also worsen diabetes control. Vascular endothelial growth factor inhibitors (e.g., ranibizumab, bevacizumab, and pegaptanib), which reduce permeability and block the pathway leading to new blood vessel formation (angiogenesis), are also used for the treatment of diabetic macular edema and proliferative diabetic retinopathy.

Digital Photography and Transmission Systems for Retinal Imaging

A number of photographic methods have been evaluated that capture images of the retina to be interpreted by expert readers, who may or may not be located proximately to the patient. Retinal imaging can be performed using digital retinal photographs with (mydriatic) or without (non-mydriatic) dilating of the pupil. One approach is mydriatic standard field 35-mm stereoscopic color fundus photography. Digital fundus photography has also been evaluated as an alternative to conventional film photography and has become the standard in major clinical trials. Digital imaging has the advantage of easier acquisition, transmission, and storage. Digital images of the retina can also be acquired in a primary care setting and evaluated by trained readers in a remote location, in consultation with retinal specialists.

Several digital camera and transmission systems (see Table 1 for examples) have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. Digital image storage and data communication systems that are designed to be utilized with a variety of cameras have also been cleared for marketing by the FDA. FDA product codes: HKI and NFJ

Many artificial intelligence analysis systems are in use around the world. As of January 2022, two have received marketing clearance from the FDA (Table 2). In 2018, the FDA gave de novo clearance for the automated retinal analysis system (IDx-DR®) that uses artificial intelligence (DEN180001). IDx-DR is indicated "for use by health care providers to automatically detect more than mild diabetic retinopathy in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. IDx-DR is indicated for use with the Topcon NW400." EyeArt® retinal analysis software (Eyenuk) received marketing clearance through the FDA's 510(k) pathway in 2020. It is indicated for use with the Canon CR-2 AF and Canon CR-2 Plus AF cameras in both primary care and eye care settings. Use of automated retinal analysis of images obtained with other cameras would be considered off-label. FDA product code: PIB

Table 1. Examples of Digital Camera and Transmission Systems Cleared by the FDA for Retinal Telescreening:

Table 2. Automated Analysis Systems

POLICY

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.

Digital retinal imaging with image interpretation by artificial intelligence software that is approved by the U.S. Food and Drug Administration (eg, IDX-DR, EyeArt) may be considered medically necessary for screening for 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 EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

07/27/2006: 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 screening 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.

03/27/2014: Removed deleted HCPCS code S0625 from the Code Reference section. Added CPT code 92227 and 92228 to the Code Reference section.

03/19/2015: Policy description updated regarding devices. Policy statements unchanged.

05/21/2015: Removed CPT code 92228 from the Covered Codes table.

08/14/2015: Medical policy revised to add ICD-10 codes.

05/27/2016: Policy number A.9.03.13 added. Policy Guidelines updated to add medically necessary and investigative definitions.

07/06/2016: Policy description updated regarding digital photography and transmission systems for retinal imaging. Policy statements unchanged. Policy Guidelines updated to add the 2016 diabetic retinopathy screening recommendations.

09/30/2016: Code Reference section updated to add new ICD-10 diagnosis codes: E08.3551 - E08.3559, E08.3591 - E08.3599, E09.3551 - E09.3559, and E09.3591 - E09.3599.

03/31/2017: Policy description updated regarding devices. Policy statements unchanged.

04/11/2018: Policy reviewed; no changes.

04/09/2019: Policy description updated regarding devices. Policy statements unchanged. Policy Guidelines updated regarding diabetic retinopathy screening recommendations.

03/24/2022: Policy description updated regarding systems cleared by the FDA for retinal telescreening. Added policy statement that digital retinal imaging with image interpretation by artificial intelligence software that is approved by the U.S. Food and Drug Administration (eg, IDX-DR, EyeArt) may be considered medically necessary for screening for diabetic retinopathy. Policy Guidelines updated to remove the diabetic retinopathy screening recommendations. Code Reference section updated to move CPT code 92228 from the investigational codes table to the medically necessary codes table. Added CPT code 92229 to the medically necessary codes table.

05/20/2022: Policy description updated regarding devices. Policy statements unchanged.

12/21/2022: Code Reference section updated to revise the description for CPT code 92229, effective 01/01/2023.

04/18/2023: Policy description updated. Policy statements unchanged.

04/24/2024: Policy reviewed; no changes.

04/25/2025: Policy description updated regarding diabetic retinopathy. Policy statements unchanged.

06/15/2025: Policy number changed from "A.9.03.13" to "L.9.03.411."

SOURCE(S)

Blue Cross Blue Shield Association policy # 9.03.13 

CODE REFERENCE

This 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 performed according to the "Policy" section of this document.  

Medically Necessary Codes

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