Clinical UM Guideline
|Subject:||Retinal Telescreening Systems|
|Guideline #:||CG-MED-35||Current Effective Date:||02/11/2016|
|Status:||Revised||Last Review Date:||02/04/2016|
This document addresses retinal telescreening, including its use for the detection of diabetic retinopathy.
Note: Please see the following related document for additional information:
Retinal telescreening systems are considered medically necessary for annual diabetic retinopathy screening as an alternative to retinopathy screening by an ophthalmologist or optometrist when all of the following criteria are met:
Not Medically Necessary:
All other uses of retinal telescreening systems are considered not medically necessary, including, but not limited to those listed below:
The following codes for treatments and procedures applicable to this document 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.
|92227||Remote imaging for detection of retinal disease (eg, retinopathy in a patient with diabetes) with analysis and report under physician supervision, unilateral or bilateral|
|92228||Remote imaging for monitoring and management of active retinal disease (eg, diabetic retinopathy) with physician review, interpretation and report, unilateral or bilateral|
Retinal telescreening 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 technician. 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 without referral to an ophthalmologist or optometrist. 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. Outreach clinics are a way to screen those individuals without access to specialized equipment and expertise. Community-based, outreach models for diabetic retinopathy screening have been applied in rural and remote areas of Australia, Canada, and the United Kingdom. The model consists of a photograph being taken instead of a direct exam. The photographic images are taken without pupil dilation. The outreach model has the potential to increase the screening of at-risk individuals in areas where direct access to ophthalmologic specialists is limited. 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 is an established treatment 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 (2015) 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 microaneurysms and hemorrhages progressing to retinal capillary nonperfusion, occlusion of retinal vessels, pathological proliferation of fragile retinal vessels (neovascularization) and macular edema. Visual loss results primarily from macular edema, macular capillary nonperfusion, 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 telescreening 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 DigiScope (EyeTel Imaging, Inc., Centreville, VA) in the primary care physician's office. The authors stated that their study "indicates that implementation of the DigiScope 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 telescreening 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 nondilated 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 undilated 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 telescreening is not a substitute for a comprehensive ophthalmologic examination.
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
|Websites for Additional Information|
Diabetic Retinopathy Telescreening
DigiScope Ophthalmic Camera
Digital Fundus Photography
Fundus Photography, Digital
VISUPAC™ Digital Imaging System
The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.
|Revised||02/04/2016||Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Clinical Indications to remove requirement of Diabetic Retinopathy Study seven standard fields (DRS7) from the Medically Necessary and Not Medically Necessary statements. Updated Description, Discussion/General Information and Reference sections.|
|Reviewed||11/05/2015||MPTAC review. Updated Description, Discussion/General Information and Reference sections. Removed ICD-9 codes from Coding section.|
|Revised||11/13/2014||MPTAC review. Updated Discussion/General Information and References.|
|Reviewed||11/14/2013||MPTAC review. Updated Description and References.|
|Reviewed||11/08/2012||MPTAC review. Updated Discussion/General Information, References and Index.|
|Revised||11/17/2011||MPTAC review. Removal from medical necessity statement "Pharmacologic dilation of the pupils takes place prior to image capture." Removal from not medically necessary statement "To evaluate the retina through undilated pupils." Updated Discussion/General Information and References. Updated Coding section; removed S0625 deleted 12/31/2011.|
|Reviewed||11/18/2010||MPTAC review. Updated Discussion/General Information, References and Index. Updated Coding section with 01/01/2011 CPT changes.|
|Reviewed||02/25/2010||MPTAC review. Updated References and Web Sites.|
|Reviewed||02/26/2009||MPTAC review. Updated References and Web Sites. Removed Place of Service.|
|10/01/2008||Updated Coding section with 10/01/2008 ICD-9 changes.|
|Reviewed||02/21/2008||MPTAC review. References updated.|
|New||03/08/2007||MPTAC review. Initial document development. Transferred content from MED.00052 Retinal Telescreening Systems; Investigational/Not Medically Necessary indications changed to Not Medically Necessary. References updated.|