0563 Retinopathy Telescreening Systems...type 2 diabetes. The prevalence of retinopathy is strongly...
Transcript of 0563 Retinopathy Telescreening Systems...type 2 diabetes. The prevalence of retinopathy is strongly...
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(https://www.aetna.com/)
Retinopathy TelescreeningSystems
Clinical Policy Bulletins Medical Clinical Policy Bulletins
Policy History Last
Review
08/15/2019
Effective: 09/28/2001
Next Review:
06/12/2020
Review History
Definitions
Additional Information
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Number: 0563
Policy *Please see amendment for Pennsylvania Medicaid at the end of this CPB.
Aetna considers retinopathy telescreening systems medically necessary for
screening diabetic retinopathy and retinopathy of prematurity as an alternative to
retinopathy screening by an ophthalmologist or optometrist.
Aetna considers retinopathy telescreening systems experimental and
investigational for the following because of insufficient evidence of their clinical
value for these indications (not an all-inclusive list):
Following the progression of disease in members who are diagnosed with
diabetic retinopathy
Screening or evaluating retinal conditions other than diabetic retinopathy or
retinopathy of prematurity, including, but not limited to macular
degeneration/edema.
See also
CPB 0344 - Optic Nerve and R etinal Imaging Methods (../300_399/0344.html).
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B ac kgro und
Diabetic retinopathy is a highly specific vascular complication of both type 1 and
type 2 diabetes. The prevalence of retinopathy is strongly related to the duration of
diabetes. After 20 years of diabetes, nearly all patients with type 1 diabetes and
more than 60 % of patients with type 2 diabetes have some degree of retinopathy.
Diabetic retinopathy poses a serious threat to vision. Overall, diabetic retinopathy
is estimated to be the most frequent cause of new cases of blindness among adults
aged 20 to 74 years.
Vision loss due to diabetic retinopathy results from several mechanisms. First,
macular edema or capillary non-perfusion may impair central vision. Second, the
new blood vessels of proliferative diabetic retinopathy and contraction of the
accompanying fibrous tissue can distort the retina and lead to tractional retinal
detachment, producing severe and often irreversible vision loss. Third, the new
blood vessels may bleed, adding the further complication of pre-retinal or vitreous
hemorrhage.
One of the main motivations for screening for diabetic retinopathy is the established
efficacy of laser photocoagulation surgery in preventing visual loss. Two large
National Institutes of Health sponsored trials, the Diabetic Retinopathy Study and
the Early Treatment Diabetic Retinopathy Study, provide the strongest support for
the therapeutic benefit of photocoagulation surgery. Timely laser photocoagulation
therapy can prevent loss of vision in a large proportion of patients with severe
diabetic retinopathy and/or macular edema. Since some patients with vision-
threatening pathologies may not have symptoms, ongoing evaluation for
retinopathy is a valuable and required strategy.
The American Diabetes Association recommends retinopathy screening with yearly
retinal examinations beginning at the time of diagnosis of diabetes for all patients
age 30 years and older. For patients under age 30 years, annual retinal
examinations are recommended beginning within 3 to 5 years after diagnosis of
diabetes once the patient is 10 years old or older.
Diabetic retinopathy telescreening systems involve taking digital pictures of the
retina of diabetic patients in the primary care physician's office, and electronically
transmitting these pictures to a reading center for evaluation for diabetic retinopathy
and macular edema by trained non-physician technicians. Because diabetic
retinopathy telescreening can be performed in conjunction with a primary care
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physician office visit without referral to an ophthalmologist or optometrist, these
systems have the potential to improve compliance with retinopathy screening. A cost-
effectiveness analysis performed by the British National Health Service Centre for
Reviews and Dissemination concluded that screening using a digital camera may
be more accurate than screening by the general practitioner, and offers an
opportunity to reduce costs of diabetic screening, especially as the costs of digital
cameras come down. The UK NHS National Coordinating Centre for Health
Technology Assessment (NCCHTA) has initiated a primary research project on the
value of digital imaging in diabetic retinopathy.
The Inoveon System of retinopathy screening (iScore, Inoveon Corp., Oklahoma
City, OK) involves 7-standard field stereoscopic 30° digital fundus photographs
through dilated pupils obtained by a trained photographer located in or near the
primary care physician's office, electronic transmission of these digital photographs,
examination and grading of these images by non-physician technicians, and
rereading of a selected sample of images for assessment of inter- and intra-rater
reliability. In addition, any image sets with questionable pathology or non-typical
findings are referred to Inoveon's ophthalmologist medical director for secondary
evaluations following initial technician reader evaluation. If images are not
adequate to allow the technician readers to make an assessment of the patient's
diabetic retinopathy or macular edema status, Inoveon recommends to the primary
care physician that the patient be referred for further evaluation by an
ophthalmologist or optometrist. According to Inoveon Corp., these quality
assurance protocols meet or exceed HEDIS specifications for reading centers
providing diabetic retinopathy evaluation services.
In a study comparing high-resolution digital stereoscopic fundus photographs
(Inoveon System) to plain film stereoscopic fundus photographs (the gold
standard), Fransen et al (2002) reported that the digital photographs provided
highly accurate diabetic retinopathy referral decisions. Seven standard field
stereoscopic retinal photographs were obtained in 290 adult patients with diabetes
by a trained photographer using both a 35-mm plain film camera and a digital
camera. In this double-masked study, each image was independently graded by
trained technicians for retinopathy severity (ETDRS severity scale) and for macular
edema. A third technician was used to adjudicate any discrepancies between
independent readings. The primary endpoint was the detection of threshold events
requiring referral, which was defined as an ETDRS retinopathy severity level
greater than 52, questionable or definite clinically significant macular edema, or
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ungradable images. The prevalence of threshold events in the study population
was 19.3 %. The investigators found that the sensitivity of the digital photography
system in detecting threshold events, compared to plain film photography, was
98.2 % (confidence interval [CI]: 90.5 % to 100%) and the specificity was 89.7 %
(CI: 85.1 % to 93.3 %). The positive-predictive value was 69.5 % and the negative-
predictive value was 99.5 % for this sample.
Rudnisky and colleagues (2002) found high-resolution stereoscopic digital
photography comparable to contact lens biomicroscopy in diagnosing clinically
significant macular edema. A total of 120 patients with diabetes underwent clinical
examination with contact lens biomicroscopy by a retinal specialist (the gold
standard), and on the same day received digital photographs of the macula. The
stereoscopic digital images were evaluated by a single masked grader for the
presence or absence of macular edema. Agreement between digital photographs
and contact lens biomicroscopy was 83.6 % for clinically significant macular edema
(CSME), 83.6 % for CSME type 1, 96.1 % for CSME type 2, 88.5 % for CSME type
3, 75 % for macular edema, 77.9 % for microaneurysms, 83.7 % for intraretinal
hemorrhage, and 73.1 % for hard exudates. Sensitivity for CSME overall was 90.6
%. Specificity ranged from 90.0 % for macular edema to 99.0 % for CSME type 2.
The DigiScope Diabetic Retinal Evaluation Service (EyeTel Imaging Corp.,
Centreville, VA) employs a DigiScope, a specialized digital camera, to obtain high-
resolution, wide-field stereoscopic digital images of the retina through dilated
pupils. Trained office personnel use the DigiScope to obtain retinal images. The
DigiScope automatically centers on the pupil, illuminates, focuses, and estimates
visual acuity. The DigiScope images 15 slightly overlapping fields providing a 55 to
60 degree overall view that centered on the macula. The images are transmitted
over phone lines to a central reading center, where the images are evaluated for
diabetic retinopathy and macular edema by trained technicians. The findings are
transmitted to the physician and patient.
An image validation study has demonstrated high correlations between the
DigiScope and 7-field stereo color fundus photography as a gold standard
(Schiffman et al, 2005). In a masked prospective study, 111 patients with diabetes
(222 eyes) were imaged with the DigiScope and with 7-field stereo color fundus
photography. There was close agreement between the DigiScope and 7-field
stereo color fundus photography between “no diabetic retinopathy” and “any
diabetic retinopathy” (Kappa statistic 0.97 for the right eye (OD) and 0.94 for the left
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eye (OS)). This was reflected in very high sensitivities (0.99 OD, 1.00 OS) and
specificities (1.00 OD, 0.92 OS). As referral on the basis of any retinopathy, no
matter how mild, may result in an unnecessarily high number of referrals, the study
evaluated a second threshold level of very mild non-proliferative diabetic
retinopathy to reduce the number of unnecessary referrals. Using this threshold,
there was substantial agreement based on “microaneurysms or less
retinopathy” (which includes no diabetic abnormalities and microaneurysms only)
versus retinal hemorrhages or worse retinopathy" (Kappa stastistic 0.78 OD, 0.88
OS), with corresponding sensitivities (0.95 OD, 0.98 OS) and specificities (0.81 OD,
0.87 OS). The investigators concluded that this image validation study showed that
the DigiScope has excellent agreement, sensitivity, and specificity compared with
the “gold-standard” 7-field color stereo photography for identifying patients with any
or low levels of diabetic retinopathy who should be under the care of an
ophthalmologist. The authors noted, however, that the DigiScope is not designed
as a diabetic retinopathy disease management tool or to replace a comprehensive
eye examination.
Recent techniques permit the acquisition of high-quality photographs through
undilated pupils and the acquisition of images in digital format. Although this may
eventually permit undilated photographic retinopathy screening, no rigorous studies
to date validate the equivalence of these photographs with 7-standard field
stereoscopic 30° fundus photography for assessing diabetic retinopathy. The use of
the non-mydriatic camera for follow-up of patients with diabetes in the physician's
office might be considered only in situations where dilated eye examinations can
not be obtained.
Salcone et al (2010) stated that retinopathy of prematurity (ROP) is a vision-
threatening vaso-proliferative condition of premature infants worldwide. As survival
rates of younger and smaller infants improve, more babies are at risk for the
development of ROP and blindness. Meanwhile, fewer ophthalmologists are
available for bedside indirect ophthalmoscopy screening examinations. Remote
digital imaging is a promising method with which to identify those infants with
treatment-requiring or referral-warranted ROP quickly and accurately, and may help
circumvent issues regarding the limited availability of ROP screening providers.
The Retcam imaging system is the most common system for fundus photography,
with which high-quality photographs can be obtained by trained non-physician
personnel and evaluated by a remote expert. It has been shown to have high
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reliability and accuracy in detecting referral-warranted ROP, particularly at later post-
menstrual ages. Additionally, the method is generally well-received by parents and is
highly cost-effective.
An UpToDate review on "Retinopathy of prematurity" (Paysse, 2013) states that
"screening evaluation consists of a comprehensive eye examination performed by
an ophthalmologist with expertise in neonatal disorders".
An American Academy of Ophthalmology Preferred Practice Pattern on Diabetic
Retinopathy (AAO, 2014) states: "Some studies have shown that screening
programs using digital images taken with or without dilation may enable early
detection of diabetic retinopathy along with an appropriate referral. Digital cameras
with stereoscopic capabilities are useful for identifying subtle neovascularization
and macular edema .... Studies have found a positive association between
participating in a photographic screening program and subsequent adherence to
receiving recommended comprehensive dilated eye examinations by a clinician. Of
course, such screening programs are more relevant when access to ophthalmic
care is limited. Screening programs should follow established guidelines. 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."
An UpToDate review on “Age-related macular degeneration: Clinical presentation,
etiology, and diagnosis” (Arroyo, 2013) does not mention the use of retinopathy
telescreening systems as a management tool.
Telescreening for Retinopathy of Prematurity
In a retrospective analysis, Wang and colleagues (2015) reported the 6-year results
of the Stanford University Network for Diagnosis of Retinopathy of Prematurity
(SUNDROP) initiative in the context of telemedicine screening initiatives for
retinopathy of prematurity (ROP). Subjects were premature newborns requiring
ROP screening at 6 neonatal intensive care units (NICUs) from December 1, 2005,
to November 30, 2011. Infants were evaluated via remote retinal photography by
an ROP specialist. A total of 608 preterm infants meeting ROP examination criteria
were screened with the RetCam II/III (Clarity Medical Systems, Pleasanton, CA).
Primary outcomes were treatment-warranted ROP (TW-ROP) and adverse
anatomical events. During the 6 years, 1,216 total eyes were screened during
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2,169 examinations, generating 26,970 retinal images, an average of 3.56
examinations and 44.28 images per patient; 22 (3.6 %) of the infants screened met
criteria for TW-ROP. Compared with bedside binocular ophthalmoscopy, remote
interpretation of RetCam II/III images had a sensitivity of 100 %, specificity of 99.8
%, positive predicative value (PPV) of 95.5 %, and negative predicative value
(NPV) of 100 % for the detection of TW-ROP. No adverse anatomical outcomes
were observed for any enrolled patient. The authors concluded that the 6-year
results for the SUNDROP telemedicine initiative were highly favorable with respect
to diagnostic accuracy. These investigators stated that telemedicine appeared to
be a safe, reliable, and cost-effective complement to the efforts of ROP specialists,
capable of increasing patient access to screening and focusing the resources of the
current ophthalmic community on infants with potentially vision-threatening disease.
On behalf of the AAO, American Academy of Pediatrics (AAP), and American
Association of Certified Orthoptists (AACO), Fierson an Capone (2015) noted that
ROP remains a significant threat to vision for extremely premature infants despite
the availability of therapeutic modalities capable, in most cases, of managing this
disorder. It has been shown in many controlled trials that application of therapies at
the appropriate time is essential to successful outcomes in premature infants
affected by ROP. Bedside binocular indirect ophthalmoscopy has been the
standard technique for diagnosis and monitoring of ROP in these patients.
However, implementation of routine use of this screening method for at-risk
premature infants has presented challenges within the existing care systems,
including relative local scarcity of qualified ophthalmologist examiners in some
locations and the remote location of some NICUs. Modern technology, including
the development of wide-angle ocular digital fundus photography, coupled with the
ability to send digital images electronically to remote locations, has led to the
development of telemedicine-based remote digital fundus imaging (RDFI-TM)
evaluation techniques. These techniques have the potential to allow the diagnosis
and monitoring of ROP to occur in lieu of the necessity for some repeated on-site
examinations in NICUs. The authors reviewed the currently available literature on
RDFI-TM evaluations for ROP and outlined pertinent practical and risk
management considerations that should be used when including RDFI-TM in any
new or existing ROP care structure.
Wood and co-workers (2016) noted that ROP is a leading cause of childhood
blindness. The incidence of ROP is rising, placing greater demands on the
healthcare providers that serve these patients and their families. Telemedicine
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remote digital fundus imaging (TM-RDFI) plays a pivotal role in ROP management,
and has allowed for the expansion of ROP care into previously underserved areas.
These researchers carried out a broad literature review through the PubMed index
with the goal of summarizing the current state of ROP and guidelines for its
screening. Furthermore, all currently used telemedicine remote digital fundus
imaging devices were analyzed both via the literature and the companies'
websites/brochures. Finally, the PanoCam LT and PanoCam Pro created by
Visunex Medical were analyzed via the company website/brochures. The authors
concluded that the PanoCam LT and PanoCam Pro have recently been approved
for use within the U.S. and CE marked for international commercialization in
European Union and other countries requiring CE mark. These wide-field imaging
systems have the intended use of ophthalmic imaging of all newborn babies and
meet the requirements for ROP screening, thereby serving as competition within
the ROP screening market previously dominated by one camera imaging system.
Wongwai and associates (2018) evaluated the diagnostic accuracy of a digital
fundus photographic system that consists of taking fundus photographs by a trained
technician using a RetCam shuttle and interpreting fundus images by an expert to
detect ROP requiring treatment (ROP-RT, which defined as type I ROP according
to the Early Treatment for ROP study (ETROP). A total of 100 infants were
examined by an expert ophthalmologist experienced in ROP care using indirect
ophthalmoscopy; digital wide-field imaging by a trained technician using a RetCam
shuttle and images were sent remotely for interpretation by 2 ophthalmologists
experienced in ROP care (Reader A, and Reader B); and local ophthalmologists
using indirect ophthalmoscopy. The diagnostic accuracy consisting of sensitivity,
specificity, PPV, NPV, positive likelihood ratio (LR+), and negative likelihood ratio
(LR-) were calculated. Agreement between all examiners and readers were
evaluated. A total of 100 infants (mean gestational age [GA] of 31.1 weeks, mean
birth weight of 1,511.1 g) participated in the study; 9 infants were classified as
ROP-RT. Reader A and B had very good agreement in detection of ROP- RT
(Kappa 1.00, 95 % CI: 1.00 to 1.00). For reader A, diagnostic performance
parameters (95 % CIs) for detecting ROP-RT were; sensitivity 100.0 % (66.4 to
100.0), specificity 97.8 % (92.1 to 99.7), PPV 81.8 % (48.2 to 97.7), NPV 100.0 %
(95.8 to 100.0), LR+ 44.5 (11.3 to 175.2), and LR- 0.1 (0.0 to 0.8). For reader B
these were; sensitivity 100.0 % (66.4 to 100.0), specificity 95.6 % (89.0 to 98.8),
PPV 69.2 % (38.6 to 90.9), NPV 100.0 % (95.8 to 100.0), LR+ 22.5 (8.6 to 58.6),
LR- 0.1 (0.0 to 0.8). No adverse events (AEs)were reported. The authors
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concluded that diagnosis of ROP-RT from RetCam images taken by trained
technicians and evaluated remotely by an expert ophthalmologist had good
diagnostic accuracy for screening purposes.
Karkhaneh and colleagues (2019) evaluated sensitivity and specificity of digital
retinal image reading in the diagnosis of referral-warranted ROP. Infants referred
to the ROP clinic underwent fundus examination through indirect ophthalmoscopy.
Fundus photographs were acquired using RetCam (shuttle 2; Clarity medical
systems, Pleasanton, CA). Four retinal specialists who were blind to patients'
information reviewed the RetCam fundus photographs. By comparing the results of
photographs' readings with that of indirect ophthalmoscopy as the gold standard,
the sensitivity and specificity of telescreening was determined. A total of 147
treatment-naïve patients met the inclusion criteria and were enrolled in the study.
Mean GA was 28.6 ± 2.0 weeks. Digital retinal imaging had sensitivity of 85 % and
specificity of 35 % in detecting referral-warranted ROP in this study; PPV of digital
photography was 80 %, and NPV was 43 %. The authors concluded that
considering the large number of ROP patients to be screened, telescreen digital
photography could improve the management of patients, prevent significant
deleterious visual sequels, and facilitate research. However, based on the findings
of the study, digital imaging cannot be proposed as a substitute for indirect
ophthalmoscopy; further study including more patients and graders is needed.
Furthermore, an UpToDate review on “Retinopathy of prematurity: Pathogenesis,
epidemiology, classification, and screening” (Coats, 2019) states that
“Telemedicine systems can be used to identify infants with potentially severe ROP.
The process involves using wide-angle ocular digital fundus photography to create
digital retinal images. Up to 6 standard images may be taken. The images are
then transmitted to a remote location for interpretation. Initially, telemedicine was
used to provide screening for remote locations without access to an
ophthalmologist skilled in ROP screening; however, telemedicine is increasingly
used as the primary mode of screening even in locations with access to an
ophthalmologist skilled in ROP screening. When a telemedicine screening
approach is used, the AAP/AAO/AAPOS/AACO joint statement suggests that it
follow the same schedule as ophthalmoscopic screening (as described above) and
that infants at risk undergo indirect ophthalmoscopy by a qualified ophthalmologist
at least once before initiating treatment or terminating screening”.
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CPT Codes / HCPCS Codes / ICD-10 Codes
Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+":
Code Code Description
CPT codes covered if selection criteria are met::
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
CPT codes not covered for indications listed in the CPB:
92228 Remote imaging for monitoring and management of active retinal
disease (eg, diabetic retinopathy) with physician review, interpretation
and report, unilateral or bilateral
Other HCPCS codes related to the CPB:
S3000 Diabetic indicator; retinal eye exam, dilated, bilateral
ICD-10 codes covered if selection criteria are met:
E10.10 -E10.29
E10.40 - E10.9
E11.00 - E11.29
E11.40 - E11.9
E13.00 - E13.29
E13.40 - E13.9
Diabetes (except with ophthalmic manifestations)
H35.101 -
H35.179
Retinopathy of prematurity
Z13.5 Encounter for screening for eye and ear disorders [screening for
retinopathy of prematurity]
ICD-10 codes not covered for indications listed in the CPB (not all-inclusive):
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Code Code Description
E08.311,
E08.3211 -
E08.3219,
E08.3311 -
E08.3319,
E08.3411 -
E08.3419,
E08.3511 -
E08.3559,
E09.311,
E09.3211 -
E09.3219,
E09.3311 -
E09.3319,
E09.3411 -
E09.3419,
E09.3511 -
E09.3559,
E10.311,
E10.3211 -
E10.3219,
E10.3311 -
E10.3319,
E10.3411 -
E10.3419,
E10.3511 -
E10.3559,
E11.311,
E11.3211 -
E11.3219,
E11.3311 -
E11.3319,
E11.3411 -
E11.3419,
E11.3511 -
E11.3559,
Diabetic retinopathy [not covered for following the progression of
disease in members who are diagnosed with diabetic retinopathy]
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H35.389
H35.81
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P07.00 - P07.18
The above policy is based on the following references:
1. American Diabetes Association. Position statement: Diabetic retinopathy.
Clinical Practice Guidelines 2001. Diabetes Care. 2001; 24 Supp 1:S73-S76.
2. Aiello LP, Gardner TW, King GL, et al. Diabetic retinopathy. Technical Review.
Diabetes Care. 1998;21:143-156.
3. Schiffman JS, Li HK, Tang RA. Telemedicine enters eye care: Practical
experience. J Ophthalmic Nurs Technol. 1998;17(3):102-106.
4. Liesenfeld B. A telemedical approach to the screening of diabetic retinopathy:
Digital fundus photography. Diabetes Care. 2000;23(3):345-348.
5. Yogesan K. Telemedicine screening of diabetic retinopathy using a hand-held
fundus camera. Telemed J. 2000;6(2):219-223.
6. NHS Centre for Reviews and Dissemination. Complications of diabetes:
Screening for retinopathy; Management of foot ulcers. Effective Health Care.
1999;5(4):1-12.
7. Prasad S, Bannon P, Clearkin LG, et al. Digital fundus imaging: A quality and
cost comparison with 35-mm film. Acta Ophthalmol Scand. 1999;77(1):79-82.
8. Sharp PF, Olson J, Strachan F, et al. The value of digital imaging in diabetic
retinopathy. Health Technol Assess. 2003;7(30):1-132..
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9. American Academy of Ophthalmology (AAO). Diabetic retinopathy. Preferred
Practice Pattern. San Francisco, CA: AAO; 2003.
10. Rudnisky CJ, Hinz BJ, Tennant MT, et al. High-resolution stereoscopic digital
fundus photography versus contact lens biomicroscopy for the detection of
clinically significant macular edema. Ophthalmology. 2002;109(2);267-274.
11. 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.
12. Inoveon Corp. Inoveon iScore Diabetic Retinopathy Evaluation Service.
Quality assurance program at the Inoveon Evaluation Center, Nashville,
Tennessee. Oklahoma City, OK: Inoveon; 2002.
13. National Institute for Clinical Excellence (NICE). Management of type II
diabetes. Retinopathy - screening and early management - guideline. London,
UK: NICE; 2002.
14. Health Technology Board for Scotland (HTBS). Organisation of services for
diabetic retinopathy screening. Health Technology Assessment - consultation
report. Glasgow, Scotland: HTBS; April 2002.
15. Williams GA, Scott IU, Haller JA, et al. Single-field fundus photography for
diabetic retinopathy screening: A report by the American Academy of
Ophthalmology. Ophthalmology. 2004;111(5):1055-1062.
16. Schiffman RM, Jacobsen G, Nussbaum JJ, et al. Comparison of a digital
retinal imaging system designed for detection of diabetic retinopathy in the
primary care physician’s office to stereo seven-field color fundus photography.
Ophthalmol Surg Lasers Imag. 2005;36(1):46-56.
17. Schneider S, Aldington SJ, Kohner EM, et al. Quality assurance for diabetic
retinopathy telescreening. Diabet Med. 2005;22(6):794-802.
18. Mundy L, Merlin T, Braunack-Mayer A, Hiller JE. Retinal photography and the
detection of diabetic retinopathy. Adelaide Health Technology Assessment
(AHTA) on behalf of National Horizon Scanning Unit (HealthPACT and
MSAC). Adelaide, SA: Department of Public Health, University of Adelaide;
2004.
19. Whited JD, Datta SK, Aiello LM, et al. A modeled economic analysis of a
digital teleophthalmology system as used by three federal healthcare agencies
for detecting proliferative diabetic retinopathy. Telemed J E-Health. 2005;11
(6):641-651.
20. Zimmer-Galler I, Zeimer R. Results of implementation of the DigiScope for
diabetic retinopathy assessment in the primary care environment. Telemed J
E Health. 2006;12(2):89-98.
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21. Johansen MA, Fossen K, Norum J, et al. The potential of digital monochrome
images versus colour slides in telescreening for diabetic retinopathy. J
Telemed Telecare. 2008;14(1):27-31.
22. Neubauer AS, Kernt M, Haritoglou C, et al. Nonmydriatic screening for
diabetic retinopathy by ultra-widefield scanning laser ophthalmoscopy
(Optomap). Graefes Arch Clin Exp Ophthalmol. 2008;246(2):229-235.
23. Bek T, Lund-Andersen H, Hansen AB, et al. The prevalence of diabetic
retinopathy in patients with screen-detected type 2 diabetes in Denmark: The
ADDITION study. Acta Ophthalmol. 2009;87(3):270-274.
24. 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.
25. Joshi GD, Sivaswamy J. DrishtiCare: A telescreening platform for diabetic
retinopathy powered with fundus image analysis. J Diabetes Sci Technol.
2011;5(1):23-31.
26. Paysse EA. Retinopathy of prematurity. UpToDate [serial online]. Waltham,
MA: UpToDate; reviewed April 2013.
27. Arroyo JG. Age-related macular degeneration: Clinical presentation, etiology,
and diagnosis. UpToDate [serial online]. Waltham, MA: UpToDate; reviewed
April 2013.
28. Liu L, Geng J, Wu J, et al. Prevalence of ocular fundus pathology with type 2
diabetes in a Chinese urban community as assessed by telescreening. BMJ
Open. 2013;3(12):e004146.
29. Kirkizlar E, Serban N, Sisson JA, et al. Evaluation of telemedicine for
screening of diabetic retinopathy in the Veterans Health Administration.
Ophthalmology. 2013;120(12):2604-2610.
30. Raman R, Bhojwani DN, Sharma T. How accurate is the diagnosis of diabetic
retinopathy on telescreening? The Indian scenario. Rural Remote Health.
2014;14(4):2809.
31. Surendran TS, Raman R. Teleophthalmology in diabetic retinopathy. J
Diabetes Sci Technol. 2014;8(2):262-266.
32. Bashshur RL, Shannon GW, Smith BR, Woodward MA. The empirical
evidence for the telemedicine intervention in diabetes management. Telemed
J E Health. 2015;21(5):321-354.
33. American Academy of Ophthalmology (AAO), Retina/Vitreous Panel. Diabetic
retinopathy. Preferred Practice Pattern. San Francisco, CA: AAO; November
2014.
http://www.aetna.com/cpb/medical/data/500_599/0563.html 08/28/2019
Page 15 of 16
34. Peng JJ, Huang JN, Lu LN, Zou HD. Research advances in diabetic
retinopathy telescreening systems. Zhonghua Yan Ke Za Zhi. 2016;52
(11):868-871.
35. Bhaskaranand M, Ramachandra C, Bhat S, et al. Automated diabetic
retinopathy screening and monitoring using retinal fundus image analysis. J
Diabetes Sci Technol. 2016;10(2):254-261.
36. Jani PD, Forbes L, Choudhury A, et al. Evaluation of diabetic retinal
screening and factors for ophthalmology referral in a telemedicine
network. JAMA Ophthalmol. 2017;135(7):706-714.
37. Wang SK, Callaway NF, Wallenstein MB, et al. SUNDROP: Six years of
screening for retinopathy of prematurity with telemedicine. Can J
Ophthalmol. 2015;50(2):101-106.
38. Fierson WM, Capone A Jr; American Academy of Pediatrics Section on
Ophthalmology; American Academy of Ophthalmology, American
Association of Certified Orthoptists. Telemedicine for evaluation of
retinopathy of prematurity. Pediatrics. 2015;135(1):e238-e254.
39. Wood EH, Moshfeghi AA, Nudleman ED, Moshfeghi DM. Evaluation of
Visunex Medical's PanoCam(TM) LT and PanoCam(TM) Pro wide-field
imaging systems for the screening of ROP in newborn infants. Expert Rev
Med Devices. 2016;13(8):705-712.
40. Wongwai P, Suwannaraj S, Asawaphureekorn S, et al. Diagnostic accuracy
of a digital fundus photographic system for detection of retinopathy of
prematurity requiring treatment (ROP-RT). PLoS One. 2018;13
(7):e0201544.
41. Karkhaneh R, Ahmadraji A, Riazi Esfahani M, et al. The accuracy of digital
imaging in diagnosis of retinopathy of prematurity in Iran: A pilot study. J
Ophthalmic Vis Res. 2019;14(1):38-41.
42. Coats DK. Retinopathy of prematurity: Pathogenesis, epidemiology,
classification, and screening. UpToDate [online serial]. Waltham, MA:
UpToDate; reviewed March 2019.
http://www.aetna.com/cpb/medical/data/500_599/0563.html 08/28/2019
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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan
benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial,
general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care
services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in
private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible
for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to
change.
Copyright © 2001-2019 Aetna Inc.
http://www.aetna.com/cpb/medical/data/500_599/0563.html 08/28/2019
AETNA BETTER HEALTH® OF PENNSYLVANIA
Amendment to Aetna Clinical Policy Bulletin Number: 0563 Retinopathy
Telescreening Systems
There are no amendments for Medicaid.
www.aetnabetterhealth.com/pennsylvania revised 08/15/2019