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.

1)    QualChoice considers diabetic retinopathy tele screening systems medically necessary for diabetic retinopathy screening as an alternative to retinopathy screening by an ophthalmologist or optometrist.

2)    QualChoice considers tele screening systems experimental and investigational for any other indications because of insufficient evidence of their clinical value for these indications (not an all-inclusive list):

a)    Following the progression of disease in members who are diagnosed with diabetic retinopathy;

b)    Screening or evaluating retinal conditions other than diabetic retinopathy, including, but not limited to macular degeneration/edema;

c)    Screening for retinopathy of prematurity. 

1)    Remote imaging for detection of retinal disease is covered once every 12 months, without prior authorization for members with:

a)    Type I diabetes OR Type II diabetes AND

b)    No history of diabetic retinopathy or any other type of retinal disease AND

c)    The imaging technique is performed with a U.S. Food and Drug Administration (FDA) approved device for retinal tele screening; AND

d)    The final images are graded for diabetic retinopathy using a manual process by an Ophthalmologist.

2)    Remote imaging for monitoring and management of any active retinal disease, including diabetic retinopathy, is not covered.

Codes Used In This BI:

92227       Imaging of retina for detection or monitoring of disease; with remote clinical staff review and report, unilateral or bilateral (code revised eff 01-01-2021)

92228       Imaging of retina for detection or monitoring of disease; with remote physician or other qualified health care professional interpretation and report, unilateral or bilateral (code revised eff 01-01-2021)

Retinal tele screening systems use specialized digital imaging cameras to photograph the retina to obtain wide-field stereoscopic retinal images. The retinal images can be stored and transferred to a central imaging evaluation center for reading by a trained eye provider. The results are subsequently transmitted back to the physician`s office. The imaging can be performed in conjunction with a primary care physician office visit. This technology is an alternative to conventional ophthalmologic examination of the retina. Individuals who live in rural areas may have limited access to ophthalmology specialists and this may result in lower rates for screening for diabetic retinopathy. This technology is an alternative to conventional ophthalmologic examination of the retina.

Diabetic retinopathy is a disorder of the retina that eventually will develop to some extent in nearly all individuals with long-standing diabetes. Diabetic retinopathy is estimated to be the most frequent cause of new cases of blindness among adults aged 20-74 years in the United States. It is a highly specific vascular complication occurring in type 1 and type 2 diabetes, with the prevalence being highly dependent upon the duration of the disease. Nearly all individuals with type 1 diabetes and over 60% of individuals with type 2 diabetes who have had lengthy courses of this disease will have some degree of retinopathy. Laser photocoagulation surgery and anti-VEGF therapy are established treatments for diabetic retinopathy.

An estimated 4.1 million Americans are affected by retinopathy with 899,000 affected by vision-threatening retinopathy. For those individuals with type 1 diabetes, the American Diabetes Association (2017) recommends retinopathy screening with yearly retinal examinations within 5 years after diagnosis and for those individuals with type 2 diabetes, screening is recommended shortly after the diagnosis of diabetes.

Clinical manifestations begin with retinal micro aneurysms and hemorrhages progressing to retinal capillary non-perfusion, occlusion of retinal vessels, pathological proliferation of fragile retinal vessels (neovascularization), and macular edema. Visual loss results primarily from macular edema, macular capillary non-perfusion, vitreous hemorrhage, and distortion or traction detachment of the retina.

Diabetic retinopathy has few symptoms until vision loss occurs. Ongoing evaluation for retinopathy is of critical importance to allow for early treatment. The "gold standards" for diabetic retinopathy screening include ophthalmological exam by a trained professional using pupillary dilation and stereoscopic 7-field fundus photography by a trained photographer and interpreted by an experienced grader. In a 2014 Clinical Statement by the American Academy of Ophthalmology (AAO) for Screening for Diabetic Retinopathy, it is stated that "Appropriately validated digital imaging technology can be a sensitive and effective screening tool to identify patients with diabetic retinopathy for referral for ophthalmic evaluation and management." However, it is also noted that "Further studies will be required to assess the implementation of programs that are based on single-field fundus photography in a real clinical setting to confirm the clinical effectiveness and cost-effectiveness of these techniques in improving population visual outcomes."

Access to the specialist equipment and expertise may not always be available and retinal tele screening systems have emerged as a way to increase screening for diabetic retinopathy.

An analysis of the literature shows high-resolution digital stereoscopic fundus photographs are comparable in accuracy to plain film stereoscopic fundus photographs (the gold standard). One study with 290 diabetic participants analyzed the detection of threshold events requiring referral, which consisted of an Early Treatment Diabetic Retinopathy Study (EDTRS) severity level greater than or equal to 53, questionable or definite clinically significant macular edema in either eye, or ungradable images (Fransen, 2002). The sensitivity of digital photography in detecting threshold events was 98.2% and the specificity was 89.7%. The positive predictive value was 69.5% and the negative predictive value was 99.5% for this sample. Zimmer-Galler (2006) reported on 2,771 individuals with diabetes who had not undergone an eye examination in the past year who were imaged with the Digi Scope (EyeTel Imaging, Inc., Centreville, VA) in the primary care physician`s office. The authors stated that their study "indicates that implementation of the Digi Scope in the primary care setting is practical and allows screening of patients with diabetes who are otherwise not receiving recommended eye examinations." The evidence supporting these conclusions includes well-designed cross-sectional studies.

The "gold standard" of 35 mm film photography has been shown in studies to be equivalent or superior to conventional ophthalmoscopy in detecting diabetic retinopathy. Thus, the relative equivalence of digital imaging to plain film photography shows retinal tele screening systems, if they meet the criteria for medical necessity, can be a valid alternative to conventional exams by an eye specialist. In a 2015 literature review and analysis by Shi and colleagues, 20 articles involving 1960 participants were reviewed to determine the diagnostic accuracy of telemedicine in diabetic retinopathy. In detecting the absence of diabetic retinopathy, low- or high-risk proliferative diabetic retinopathy, the pooled sensitivity was 80%. In the detection of mild or moderate non-proliferative diabetic retinopathy, the sensitivity exceeded 70%. It was also noted that the diagnostic accuracy was higher when the digital images were obtained through mydriasis than through non-mydriasis. While there were some limitations in this literature review, including heterogeneity, three of the included studies had unavailable raw data, and the data was only from published papers, telemedicine can be used widely for diabetic retinopathy screening.

Farley and colleagues (2008) reported on a screening program for diabetic retinopathy using single-field nonmydriatic retinal photographs. This study assessed the accuracy of the primary care physicians in reading the single-image retinal photographs and in correctly determining which participants needed referral. All images were also read by an ophthalmologist. There were 20 primary care physicians trained to read the photographs prior to program implantation. The clinicians were tested using 100 standardized images of non-dilated eyes from 50 people. The overall sensitivity and specificity of the 20 clinicians in reading the photographs was 88% and 92% respectively. After the primary care physicians were trained, a total of 1040 participants were then screened for diabetic retinopathy over a 3-year period at six different health center clinics. Diabetic retinopathy was found in 113 participants; 46 were severe enough to warrant a referral to an ophthalmologist. The ophthalmologists found 344 participants with diabetic retinopathy who needed referral. Of these, the primary care physicians failed to refer 35 of them. The overall sensitivity for the primary care clinicians` ability to appropriately refer patients was 89.8%. There were also several limitations to this study including inadequate financial ability of this participant population to try to obtain care from an eye care specialist. Also there were many inadequate photographs, attributed to not using mydriatic agents during the study. There were also some variances between the six different health clinics; some only had a camera available twice a year as opposed to having a permanent camera available which led to variances in remembering to refer the participants for retinal photography. Some of the clinics were more aggressive with follow-up phone calls and sending out reminder cards about screening whereas other clinics were less so. Even with the variances, using a telemedicine approach and single-image photographs may be a way to help reduce vision loss in those diabetic individuals who have limited access to ophthalmologists.

In a 2013 study by Ku and colleagues, the authors assessed the accuracy of grading diabetic retinopathy using a single-field digital fundus photograph compared to clinical grading from a dilated slit-lamp fundus exam. A total of 360 participants (706 eyes) had fundus photographs available that were able to be graded. On clinical grading, 163 eyes had diabetic retinopathy. A total of 51 eyes had vision-threatening diabetic retinopathy. The sensitivity and specificity for detecting diabetic retinopathy were 74% (95% confidence interval [CI], 67%-80%) and 92% (95% CI, 90%-94%), respectively. The sensitivity and specificity for detecting vision-threatening diabetic retinopathy were 86% (95% CI, 77%-96%) and 95% (95% CI, 93%-97%), respectively.

In a 2015 study by Mansberger and colleagues, 567 participants were randomized to receive either telemedicine with a nonmydriatic camera in a primary care clinic (n=296) or traditional surveillance with an eye care professional (n=271) and were followed for 5 years. After 2 years, telemedicine was offered to all participants. During the 6-month or less time period, the telemedicine group participants were more likely to receive a diabetic retinopathy screening examination when compared with the traditional surveillance group (94.6% [280/296] vs 43.9% [119/271]; 95% CI, 46.6%-54.8%; p<0.001). The telemedicine group was also more likely to receive diabetic retinopathy screening exams in the 6-18 month timeframe (53.0% [157/296] vs 33.2% [90/271]; 95% CI, 16.5%-23.1%; p<0.001). After 2 years when telemedicine was offered to both groups, there was no difference between the groups in the percentage of diabetic retinopathy screening examinations. These results suggest that primary care clinics can use telemedicine to screen for diabetic retinopathy and monitor for worsening of disease.

Modern digital cameras can produce quality images with a smaller pupil diameter often eliminating the need to have the pupils dilated. Bragge and colleagues (2011) reported a meta-analysis which examined how pupil dilation and the qualifications of those taking the retinal photographs affect the accuracy of screening for diabetic retinopathy. The analysis included 20 studies which measured the sensitivity and specificity of tests for diabetic retinopathy. Variations in photographer medical qualification did not influence sensitivity. Specificity of detection of diabetic retinopathy was significantly higher for those methods that use a photographer with specialist eye or medical qualifications. Sensitivity or specificity to detect diabetic retinopathy was not influenced by variations in pupillary dilation status. Murgatroyd (2004) reported on the effect of pupillary dilation on screening for diabetic retinopathy. A total of 398 individuals (794) eyes were included. When the pupils were dilated, the proportion of ungradable photographs went from 26% down to 5%. And although un-dilated pupils led to a higher percentage of photographs which could not be graded, the sensitivity and specificity of those photographs which could be graded were no different for dilated versus undilated pupils.

Digital retinal imaging can be obtained by a trained non-physician photographer in the primary care physician`s office, thus obviating the need for separate annual ophthalmology evaluation for diabetic retinopathy. This may increase an individual`s adherence to annual retinal exams, a critical component of diabetic care. Digital imaging appears to be a highly sensitive test and may be considered an important option for increasing the screening rate. However, it should be noted retinal tele screening is not a substitute for a comprehensive ophthalmologic examination.

1.    Bragge P, Gruen RL, Chau M, et al. screening for presence or absence of diabetic retinopathy: a meta-analysis. Arch Ophthalmol. 2011; 129(4):435-444.

2.    Farley TF, Mandava N, Prall FR, Carsky C. Accuracy of primary care clinicians in screening for diabetic retinopathy using single-image retinal photography. Ann Fam Med. 2008; 6(5):428-434.

3.    Fransen SR, Leonard-Martin TC, Feuer WJ, et al. Clinical evaluation of patients with diabetic retinopathy: accuracy of the Inoveon diabetic retinopathy-3DT system. Ophthalmology. 2002; 109(3):595-601.

4.    Ku JJ, Landers J, Henderson T, Craig JE. The reliability of single-field fundus photography in screening for diabetic retinopathy: the Central Australian Ocular Health Study. Med J Aust. 2013; 198(2):93-96.

5.    Lim JI, Labree L, Nichols T, et al. Comparison of nonmydriatic digitized video fundus images with standard 35-mm slides to screen for and identify specific lesions of age-related macular degeneration. Retina. 2002; 22(1):59-64.

6.    Mansberger SL, Sheppler C, Barker G, et al. Long-term comparative effectiveness of telemedicine in providing diabetic retinopathy screening examinations: a randomized clinical trial. JAMA Ophthalmol. 2015; 133(5):518-525.

7.    Murgatroyd H, Ellingford A, Cox A, et al. Effect of mydriasis and different field strategies on digital image screening of diabetic eye disease. Br J Ophthalmol. 2004; 88(7):920-924.

8.    Osareh A, Mirmehdi M, Thomas B, et al. Automated identification of diabetic retinal exudates in digital color images. Br J Ophthalmol. 2003; 87(10):1220-1223.

9.    Rudnisky CJ, Hinz BJ, Tennant MTS, et al. High-resolution stereoscopic digital fundus photography versus contact lens bio microscopy for the detection of clinically significant macular edema. Ophthalmology. 2002; 109(2):267-274.

10.   Saari JM, Summanen P, Kivela T, Saari KM. Sensitivity and specificity of digital retinal images in grading diabetic retinopathy. Acta Ophthalmol Scand. 2004; 82(2):126-130.

11.   Shi L, Wu H, Dong J, et al. Telemedicine for detecting diabetic retinopathy: a systematic review and meta-analysis. Br J Ophthalmol. 2015; 99(6):823-831.

12.   Tu KL, Palimar P, Sen S, et al. Comparison of optometry vs. digital photography screening for diabetic retinopathy in a single district. Eye (Lond). 2004; 18(1):3-8.

13.   Van Leeuwen R, Chakravarthy U, Vingerling JR, et al. Grading of age-related maculopathy for epidemiological studies: is digital imaging as good as 35-mm film? Ophthalmology. 2003; 110(8):1540-1544.

14.   Whited JD. Accuracy and reliability of tele ophthalmology for diagnosing diabetic retinopathy and macular edema: a review of the literature. Diabetes Technol Ther. 2006; 8(1):102-111.

15.   Zimmer-Galler I, Zeimer R. Results of implementation of the Digi Scope for diabetic retinopathy assessment in the primary care environment. Telemed J E Health. 2006; 12(2):89-98. American Academy of Ophthalmology (AAO). Clinical Statement. Screening for diabetic retinopathy (2014). For additional information visit the AAO website: http://www.aao.org/. Accessed on January 9, 2017.

16.   American Academy of Ophthalmology (AAO). Preferred Practice Pattern®. Diabetic Retinopathy. 2016. For additional information visit the AAO website: http://www.aao.org/. Accessed on January 9, 2017.

17.   American Academy of Ophthalmology (AAO). Ophthalmic Technology Assessment. Single-field fundus photography for diabetic retinopathy screening. 2004; 111(5):1055-1062.

18.   American Diabetes Association. Standards of medical care in diabetes--2017. Diabetes Care. 2017; 40 Suppl 1:S1-S135. Available at:  http://professional.diabetes.org/sites/professional.diabetes.org/files/media/dc_40_s1_final.pdf. Accessed on January 9, 2017.

19.   Fong DS, Aiello L, Gardner TW, et al. American Diabetes Association position statement: retinopathy in diabetes. Diabetes Care. 2004; 27(Suppl 1):S84-S87.

20.   U.S. Food and Drug Administration 510(k) Premarket Notification Database. Digi scope ophthalmic camera. Summary of Safety and Effectiveness. No. K990205. Rockville, MD: FDA. March 26, 1999. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/k990205.pdf. Accessed on January 9, 2017.

21.   National Eye Institute. U.S. National Institutes of Health. Facts about diabetic eye disease. Last updated September 2015. Available at: https://www.nei.nih.gov/health/diabetic . Accessed on January 9, 2017

Addendum:

1)    Effective 01/01/2019: Diabetic tele-retinal eye exam are covered once every year under preventive benefit for diabetics without any known eye complications.

2)    Effective 01/01/2021: Updated codes 92227 and 92228.