0563 Retinopathy Telescreening Systems...type 2 diabetes. The prevalence of retinopathy is strongly...

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Page 1 of 16 (https://www.aetna.com/) Retinopathy Telescreening Systems 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 http://www.aetna.com/cpb/medical/data/500_599/0563.html 08/28/2019 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 Retinal Imaging Methods (../300_399/0344.html).

Transcript of 0563 Retinopathy Telescreening Systems...type 2 diabetes. The prevalence of retinopathy is strongly...

Page 1: 0563 Retinopathy Telescreening Systems...type 2 diabetes. The prevalence of retinopathy is strongly related to the duration of diabetes. After 20 years of diabetes, nearly all patients

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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

http://www.aetna.com/cpb/medical/data/500_599/0563.html 08/28/2019

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

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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.

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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