Prior Authorization Review Panel MCO Policy Submission€¦ · Multiple sclerosis Penetration of...

Prior Authorization Review Panel MCO Policy Submission

A separate copy of this form must accompany each policy submitted for

review. Policies submitted without this form will not be considered for review.

Plan: Aetna Better Health Submission Date: 09/04/2018

Policy Number: 0539 Effective Date: Revision Date: 06/14/2018

Policy Name: Fundus Photography

Type of Submission – Check all that apply: New Policy Revised Policy* Annual Review – No Revisions

*All revisions to the policy must be highlighted using track changes throughout the document. Please provide any clarifying information for the policy below:

CPB 0539 Fundus Photography

Clinical content was last revised 06/14/2018. Additional non-clinical updates were made by Corporate since the last PARP submission, as documented below.

Revision and Update History since last PARP submission: 04/13/2018 - This CPB has been updated with additional coding. 06/14/2018 - This CPB has been revised to state that fundus photography is considered medically necessary for age-related macular degeneration and congenital glaucoma. 05/23/2019 – Tentative next scheduled review date by Corporate.

Name of Authorized Individual (Please type or print):

Dr. Bernard Lewin, M.D.

Signature of Authorized Individual:

www.aetnabetterhealth.com/pennsylvania Updated 04/13/2018

http://www.aetnabetterhealth.com/pennsylvania

Fundus Photography - Medical Clinical Policy Bulletins | Aetna Page 1 of 21

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Fundus Photography

Number: 0539 *Please see amendment for Pennsylvania Medicaid at the end of this CPB.

Policy

I. Aetna considers fundus photography medically necessary for any of the

following indications:

▪ Abnormal electro-oculogram (EOG)

▪ Abnormal oculomotor studies

▪ Abnormal retinal function studies

▪ Abnormal visually evoked potential

▪ Age-related macular degeneration

▪ Benign neoplasm of choroid, cranial nerves, eyeball, or retina

▪ Carcinoma in situ of eye

▪ Chorioretinal inflammation, scars, and other disorders of choroid

▪ Color vision deficiencies

▪ Congenital anomalies of posterior segment of eye

▪ Congenital glaucoma

▪ Congenital rubella

▪ Diabetes mellitus (diabetic retinopathy)

▪ Disorders of aromatic amino-acid metabolism affecting the fundus

▪ Disorders of globe

▪ Disorders of optic nerve and visual pathways

▪ Endophthalmitis

▪ Glaucoma and glaucoma suspects

Poli cy Hi story

Last

Review

06/14/2018

Effective: 06/29/200

Next

Review: 05/23/2019

Review

History

Definitions

Additional Information

http://qawww.aetna.com/cpb/medical/data/500_599/0539_draft.htmlhttp://www.aetna.com/)



▪ Hamartoses involving the eye

▪ Histoplasmosis

▪ Human immunodeficiency virus (HIV) disease

▪ Initial baseline evaluation and periodical follow-up of individuals being

treated with ethambutol (Myambutol)

▪ Lupus erythematosus

▪ Malignant neoplasm of eye

▪ Monitoring of members for toxicity by anti-malarials such as chloroquine

(Aralen), hydroxychloroquine (Plaquenil) and drugs acting on other blood

protozoa

▪ Multiple sclerosis

▪ Penetration of eyeball with magnetic or non-magnetic foreign body

▪ Peters anomaly

▪ Pseudotumor cerebri

▪ Retinal detachment and defects

▪ Rheumatoid arthritis and other inflammatory polyarthropathies

▪ Sickle-cell anemia

▪ Syphilitic retrobulbar neuritis

▪ Systemic lupus erythematosus

▪ Toxoplasmosis

▪ Tuberous sclerosis

▪ Other retinal disorders where the results of fundus photography will

change the treatment of the member.

II. Frequency of Testing:

Clinical

Policy

Bulletin

Notes

Aetna considers fundus photography medically necessary no more than two

times per year. Justification for more frequent testing must be documented

in the medical record.

III. Aetna considers fundus photography experimental and investigational for

screening in asymptomatic persons without signs or symptoms of disease

and for all other indications (e.g., toxocariasis) because there is insufficient

evidence that this test affects management for these other indications such

that clinical outcomes are improved.

http://qawww.aetna.com/cpb/medical/data/500_599/0539_draft.html



Note: Fundus photography of a normal retina is considered not medically

necessary.

IV. Aetna considers computer-aided animation and analysis of time series

retinal images (e.g., MatchedFlicker) experimental and investigational for

monitoring disease progression and for all other indications.

Background

Fundus photography involves the use of a retinal camera to photograph the regions

of the vitreous, retina, choroid, and optic nerve. The resultant images may be either

photographic or digital and become part of the member's medical record. Fundus

photographs are usually taken through a dilated pupil in order to enhance the quality

of the photographic record, unless unnecessary for image acquisition or clinically

contraindicated.

Fundus photography is indicated to document abnormalities related to disease

processes affecting the eye or to follow the progress of the disease, and is

considered medically necessary for such conditions such as macular degeneration,

retinal neoplasms, choroid disturbances and diabetic retinopathy, or to identify

glaucoma, multiple sclerosis, and other central nervous system abnormalities.

Fundus photographs are only considered medically necessary where the results

may influence the management of the patient. In general, fundus photography is

performed to evaluate abnormalities in the fundus, follow the progress of a disease,

plan the treatment for a disease, and assess the therapeutic effect of recent surgery

(e.g., photocoagulation). Fundus photographs are not medically necessary simply to

document the existence of a condition. However, photographs may be medically

necessary to establish a baseline to judge later whether a disease is progressive.

A CGS Administrators, LLC Medicare Local Coverage Determination (LCD) allows

coverage of fundus photography (L34399) for diagnosis of conditions such as

macular degeneration. Fundus photography is usually medically necessary no more

than two times per year. Fundus photography of a normal retina will be

considered not medically necessary.

A First Coast Service Options, Inc. Medicare Local Coverage Determination (LCD)

also allows coverage of fundus photography (L33670) and states that “fundus

photos may be of value in the documentation of rapidly evolving diabetic retinopathy.




In the absence of prior treatment, studies would not generally be performed for this

indication more frequently than every 6 months.”

A National Government Services, Inc. Medicare Local Coverage Determination

(LCD) allows coverage of fundus photography (L33567) which states that “fundus

photography may be used for the diagnosis of conditions such as macular

degeneration, retinal neoplasms, choroid disturbances and diabetic retinopathy,

glaucoma, multiple sclerosis or other central nervous system anomalies.” It is not

covered if study is performed as a “screening” service. Fundus photography is

usually medically necessary no more than two times per year. Fundus photography

of a normal retina will be considered not medically necessary.

Sequential series of photographs are considered medically necessary only if they

document a clinically relevant condition that is subject to change in extent,

appearance or size, and where such change would directly affect the management.

Repeat fundus photography may be medically necessary when an examination of

the fundus reveals that the disease of condition of the fundus has progressed, such

that prior fundus photographs no longer depict the pathology at the present time.

Repeated fundus photographs of the same disease or condition, without any

meaningful change, are not considered medically necessary. In addition to disease

progression, repeat fundus photographs may be necessary if there is a new disease

affecting the fundus, or for planning for additional surgical treatment. Routine

images to embellish the record, but a succession of which would not influence

treatment, are not considered medically necessary. When performed concurrently,

the medical necessity of fundus photography and scanning computerized diagnostic

imaging of the posterior segment should be documented in the medical record.

Documentation in the patient's medical record should include a current, pertinent

history and physical examination, and progress notes describing and supporting the

covered indication for fundus photography, and pertinent prior diagnostic testing and

completed report(s), including, when appropriate, previous fundus photographs.

Fundus photographs should be properly labeled as to which eye they represent, the

date they were taken, and the date they were reviewed. The medical records should

document the findings of the fundus photography, including a description of changes

from prior fundus photographs (if any), and an interpretation of those findings, and

the implications of the photographic evidence, including whether any chages in the

treatment plan will be instituted as a result of the photographs. Fundus photographs

without an interpretation are considered not medically necessary. All documentation




must be maintained in the member’s medical record. The record must be legible

and include appropriate patient identification information (e.g., complete name,

dates of service(s)), as well as the physician or non-physician practitioner

responsible for and providing the care of the patient.

When indicated for glaucoma, the interpretation of the fundus photographs should

include a report of the vertical and horizontal cup/disc ratio based upon vessel

pattern and/or coloration, the presence or absence of diffuse or focal pallor, the

presence or absence of asymmetry, and the presence or absence of progression

regarding any of the above parameters. If the fundus photographs include red-free

images, commentary on the status of the retinal nerve fiber layer should accompany

the images.

The American Academy of Ophthalmology (Marmor et al, 2011) does not

recommend the use of fundus photography for screening of chloroquine and

hydroxychloroquine retinopathy. It is not sensitive enough for screening because

recognizable bull's-eye retinopathy signifies relatively advanced chloroquine or

hydroxychloroquine toxicity.

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 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, 2012) does not

mention the use of digital imaging or fundus photography. It states that "screening

evaluation consists of a comprehensive eye examination performed by an

ophthalmologist with expertise in neonatal disorders".




An UpToDate review on “Toxocariasis: visceral and ocular larva migrans” (Weller

and Leder, 2013) does NOT mention the use of fundus imaging/photography.

Computer-aided animation and analysis of time series retinal images (e.g.,

MatchedFlicker) has been proposed for use in monitoring glaucoma and other retinal

diseases. According to the manufacturer of the MatchedFlicker (EyeIC, Wayne, PA),

the technology automatically aligns and registers two images of the same object

taken at different points in time, and generates a superimposed view that is

alternated back and forth (i.e., a flicker). In so doing, areas of change present

between the two images appear as motion.

MatchedFlicker has been cleared by the FDA based upon 510(k) premarket

notification as a class II device.

The manufacturer states that MatchedFlicker helps to improve both the speed and

accuracy of image diagnostic evaluations, resulting in more efficient workflow, more

accurate patient diagnosis, and ease of documentation (EyeIC, 2014).

Studies have compared computer-aided animation and analysis of time series retinal

images to side-by-side comparison of photographic images in a number of retinal

diseases, including detection of glaucoma and screening of premature infant eyes

for retinopathy of prematurity. Clinical utility studies are ongoing.

Screening for Diabetic Retinopathy:

van Ballegooie and van Everdingen (2000) stated that early detection and adequate

treatment of complications of diabetes mellitus (DM) are important for many patients

in maintaining independence and ability to work. Diabetic retinopathy (DR) cannot

be prevented. Limitation of damage is possible by aiming for normoglycemia and

normotension. While exudative as well as proliferative retinopathy can occur without

any visual symptom, regular ophthalmological examination is necessary for timely

laser coagulation. Fundus photography for screening is applicable under certain

conditions; fluorescence angiography can be useful in patients with understood

deterioration of visual acuity or diabetic maculopathy. In many patients foot disease

can be prevented by simple measures: examining the foot at least once-yearly,

recognition of the foot with a high level of risk, education of patient and family,

adapted shoes and preventive foot care. Treatment of a foot ulcer consists of relief

of mechanical pressure, repair of disturbed skin circulation, treatment of infection




and edema, optimal metabolic control, frequent local wound care and education.

Patients with a diabetic foot have to be thoroughly followed-up for the rest of their

lives. For patients with diabetic nephropathy cardiovascular complications are the

main causes of morbidity and mortality. Of all patient with DM older than 10 years,

urine has to be examined for loss of albumin at least once-yearly. Treatment of

nephropathy consists of non-smoking, sufficient physical exercise, reduction of over-

weight, well-composed nutrition and particularly treatment of hypertension.

Diagnosing cardiovascular diseases in patients with DM is in principle the same as

for other patients. Treatment of hyper-cholesterolemia has to be based on an

absolute risk of 20 % for cardiovascular disease in the following 10 years. The limit

for treatment will be reached earlier in the presence of micro-albuminuria, persistent

high HbA1c greater than 8.5 %, triglyceride concentration greater than 2.0 mmol/L,

or a positive family history with myocardial infarction less than 60 years. In proven

cardiovascular disease one needs to strive for optimization of the glucose

metabolism, non-smoking and if necessary drug therapy.

Massin et al (2003) compared the results of fundus photography using a new non-

mydriatic digital camera with the results of reference standard of Early Treatment

Diabetic Retinopathy Study (ETDRS) retinal photographs, for the detection of DR.

Fundus color photographs were taken with a Topcon non-mydriatic camera of 147

eyes of 74 diabetic patients, without pupillary dilation (5 overlapping fields of 45

degrees; posterior pole, nasal, temporal, superior and inferior). Three retinal

specialists classified the photographs in a masked fashion, as showing no DR or

mild non-proliferative DR (NPDR) not requiring referral, moderate or more severe

NPDR and/or macular edema, or as non-gradable image requiring referral; ETDRS

35-mm color slides served as reference images for DR detection. For moderately

severe to severe DR, the sensitivities of detection reported by the 3 observers were

92, 100 and 92 %, respectively, and the specificities, 87, 85, and 88 %, respectively.

For 4 levels of DR severity (none or mild NPDR, moderate NPDR, severe NPDR

and proliferative DR), the percentages of exact agreement between the 3 observers

on the retinopathy grades assigned to the non-mydriatic photographs and to the

ETDRS reference slides were 94.6, 93 and 87.6 %, respectively (kappa 0.60 to

0.80); 16 eyes of 9 patients (11%) were judged un-gradable by at least 1 observer.

In a second series of 110 patients, evaluated in the setting of a screening

procedure, fewer photographs were un-gradable (less than 6 %). The authors

concluded that these findings suggested that fundus photographs taken by the

Topcon TRC-NW6S non-mydriatic camera, without pupillary dilation, are suitable for

DR screening.




In a prospective study, Aptel et al (2008) evaluated the sensitivity and specificity of

1- and 3-field, non-mydriatic and mydriatic, and 45 degrees digital color photography

compared with mydriatic indirect ophthalmoscopy for DR screening. A group of 79

patients (158 eyes) were included. Color fundus photographs were taken with a

Topcon TRC-NW6S digital camera, using 4 different techniques: (i) single-field non-

mydriatic; (ii) 3-field non-mydriatic; (iii) single-field mydriatic; and (iv) 3-field

mydriatic; followed by dilated ophthalmoscopy. Two independent

ophthalmologists classified blinded photographs according to the presence or

absence of specific diabetic retinal findings. The sensitivity, specificity and

agreement (kappa analyses) of the 4 methods were calculated for the presence or

absence of DR and for all diabetic retinal findings. The sensitivity and specificity of

digital photography compared with ophthalmoscopy for detection of DR were

respectively: 77 and 99 % using single-field non-mydriatic; 92 and 97 % using 3-field

non-mydriatic; 90 and 98 % using single-field mydriatic; and 97 and 98 % using

3- field mydriatic. The degrees of agreement for the 4 methods were 0.82, 0.90, 0.90

and 0.95, respectively. For specific retinal findings, sensitivity was greater for

detection of hard exudates, nerve fiber layer hemorrhage and venous beading, and

lower for detection of micro-aneurysms, dot-blot hemorrhage, cotton wool spots and

intra-retinal microvascular anomalies. The authors concluded that the 3-field

strategy without pupil dilation represents a good compromise, with reasonable

sensitivity and good comfort (short examination duration, able to drive after

photography) favoring patient compliance with the screening program.

Polak and colleagues (2008) noted that the revised evidence-based guideline

“Diabetic retinopathy: Screening, diagnosis and treatment” contained important

recommendations concerning screening, diagnosis and treatment of DR. Regular

screening and the treatment of risk factors, such as hyperglycemia, hypertension,

obesity and dyslipidemia, can prevent retinopathy and slow down its development.

Fundus photography is recommended as a screening method. If necessary,

diagnosis by biomicroscopy and a treatment consisting of photocoagulation and/or

vitrectomy should be performed by the ophthalmologist. The re-assessment of

responsibilities is a vital component of the implementation of the guideline bearing in

mind that the screening in particular, can be performed by personnel other than

ophthalmologists.

In a cross-sectional study, Germain and associates (2011) compared the efficiency

of the DR screening with digital camera by endocrinologists with that by specialist

and resident ophthalmologists in terms of sensitivity, specificity, and level of "loss of




chance". A total of 500 adult diabetic patients (1,000 eyes) underwent 3-field retinal

photography with a digital fundus camera following pupillary dilatation; 5

endocrinologists and 2 ophthalmology residents underwent 40 hours of training on

screening and grading of DR and detection of associated retinal findings. A κ test

compared the accuracy of endocrinologist and ophthalmology resident screening

with that performed by experienced ophthalmologists. Screening efficiency of

endocrinologists was evaluated in terms of "loss of chance", namely, missed

diagnoses that required ophthalmologist referrals. The mean weighted κ of DR

screening performed by endocrinologists was similar to that of ophthalmology

residents (0.65 versus 0.73). Out of 456 DR eyes, both endocrinologists and

ophthalmology residents mis-diagnosed only stage 1 DR (36 and 14, respectively),

which did not require ophthalmologist referral. There were no significant differences

between endocrinologists and ophthalmology residents in terms of diabetic

maculopathy and incidental findings except for papillary cupping and choroidal

lesions, which were not the main purpose of the study or of the training. The

authors concluded that endocrinologist with specific training for DR detection using a

3-field digital fundus camera with pupillary dilatation could perform a reliable DR

screening without any loss of chance for the patients when compared with identical

evaluation performed by experienced ophthalmologists.

Guigui et al (2012) reviewed the current screening methods for DR, with a focus on

non-mydriatic digital fundus photography. Articles from Medline were reviewed from

1976 to November 2011 for different combinations of the words "diabetic

retinopathy", "screening", "fundus photography" and "nonmydriasis". Current

research has proven that pupillary dilation is not a necessary step in the fundus

examination, although it reduces the number of unnecessary referrals to

ophthalmologists. Automated grading systems, while saving time and reducing

human error, still need refinement before they can replace manual grading by

trained ophthalmologists. The authors concluded that non-mydriatic digital fundus

photography with manual grading by a trained technician is an acceptable method of

screening for DR.

Ku and colleagues (2013) evaluated the accuracy of grading DR using single-field

digital fundus photography compared with clinical grading from a dilated slit-lamp

fundus examination in Indigenous Australians living in Central Australia. Main

outcome measures included sensitivity and specificity of grading using digital

photography compared with the clinical gold standard of slit-lamp fundus

examination. Of the 1,884 participants recruited for the study, 1,040 had self-




reported DM and, of those, 360 had fundus photographs available (706 eyes) that

were able to be graded. On clinical grading, 163 eyes had any DR and 51 eyes had

vision-threatening DR (VTDR). The sensitivity and specificity for detecting any DR

were 74 % (95 % confidence interval [CI]: 67 % to 80 %) and 92 % (95 % CI: 90 %

to 94 %), respectively. The sensitivity and specificity for detecting VTDR were 86 %

(95 % CI: 77 % to 96 %) and 95 % (95 % CI: 93 % to 97 %), respectively. The

authors concluded that single-field digital fundus photography is a valid screening

tool for DR in remote communities of central Australia and may be used to provide

eye care services to this region with acceptable accuracy.

An UpToDate review on “Diabetic retinopathy: Screening” (McCulloch, 2016) states

that “Ophthalmoscopy is a reasonable screening method when performed by well-

trained personnel on dilated fundi. The accuracy of ophthalmoscopy is substantially

lower when performed by primary care physicians. As an alternative, 7-field

stereoscopic fundus photography is another acceptable method, but also requires

both a trained photographer and a trained reader. Fundal photography compares

favorably with ophthalmoscopy (performed by an experienced ophthalmologist,

optometrist, and ophthalmic technician) …. In patients with diabetes, we recommend

screening for diabetic retinopathy (DR) (Grade 1B). Screening must be performed

by those with expertise and can be accomplished with dilated fundus examination or

retinal photography”.

Diagnosis and Management of Diabetic Retinopathy:

The Institute for Clinical Systems Improvement’s clinical practice guideline on

“Diagnosis and management of type 2 diabetes mellitus in adults” (Redmon et al,

2014) stated that “A dilated eye examination for diabetic eye disease performed by

an ophthalmologist or optometrist is recommended annually for patients with T2DM.

Less frequent exams (every 2 to 3 years) may be considered in the setting of a

normal eye exam. The role of fundus photography is still being considered but

doesn't replace a comprehensive exam”.

Monitoring of Ethambutol-Induced Optic Neuropathy:

Chung and associates (1989) reported the case of a 54-year old Chinese woman

with miliary choroidal tuberculosis who was followed for more than 3 years. She had

had tuberculous meningitis for about 1 month before an ophthalmologic examination

for blurred vision OU (oculus uterque meaning both eyes). There were 50 to 60

choroidal tubercles OU which were located mostly at the posterior poles including




the macular areas. The meningitis and tubercular lesions resolved with anti-

tuberculous medications. In a series of fundus photographs and fluorescein

angiograms, a macular subretinal neovascularization was noted in association with

the tubercular lesions, which resulted in disciform maculopathy. The authors stated

that this case had the largest number of tubercles reported in this century, and the

association of macular subretinal neovascularization with choroidal tuberculosis has

never been reported.

In a prospective, longitudinal, cohort study, Han and colleagues (2015) evaluated

longitudinal analysis of peri-papillary retinal nerve fiber layer (RNFL) and peri-foveal

ganglion cell-inner plexiform layer (GCIPL) thickness in patients being treated with

ethambutol (EMB). This study enrolled 37 patients who were treated with EMB for

pulmonary tuberculosis. Best-corrected visual acuity (BCVA), color vision test,

automated perimetry, fundus photography, and RNFL and GCIPL thickness were

measured at baseline and at 4 and 6 months after the start of EMB treatment, using

Cirrus optical coherence tomography (OCT). Among 37 patients, EMB-induced

optic neuropathy occurred in 1 patient (2.7 %). In this patient, thickening of the

RFNL and thinning of the GCIPL were noted at the onset of symptoms. After

discontinuation of EMB, RNFL and GCIPL thickness progressively normalized.

Changes in RNFL and GCIPL thickness were not statistically significant in the 36

patients who did not exhibit EMB-induced optic neuropathy-related symptoms during

follow-up (all p > 0.05). The authors concluded that thickening of the peri-papillary

RNFL and thinning of the peri-foveal GCIPL is an effective quantitative and early

marker for diagnosis of EMB-induced optic neuropathy.

Furthermore, the American Optometric Association recommends fundus

photography for initial baseline evaluation and periodical follow-up of individuals

being treated with ethambutol. .

Age-Related Macular Degeneration:

Holz and colleagues (2017) summarized the results of 2 consensus meetings

(Classification of Atrophy Meeting [CAM]) on conventional and advanced imaging

modalities used to detect and quantify atrophy due to late-stage non-neovascular

and neovascular age-related macular degeneration (ARMD) and to provide

recommendations on the use of these modalities in natural history studies and

interventional clinical trials. A panel of retina specialists participated in a systematic

debate on the relevance of distinct imaging modalities held in 2 consensus




meetings. During the CAM, a consortium of international experts evaluated the

advantages and disadvantages of various imaging modalities on the basis of the

collective analysis of a large series of clinical cases. A systematic discussion on the

role of each modality in future studies in non-neovascular and neovascular ARMD

was held. Main outcome measures were advantages and disadvantages of current

retinal imaging technologies and recommendations for their use in advanced ARMD

trials. Imaging protocols to detect, quantify, and monitor progression of atrophy

should include color fundus photography (CFP), confocal fundus auto-fluorescence

(FAF), confocal near-infrared reflectance (NIR), and high-resolution OCT volume

scans. These images should be acquired at regular intervals throughout the study.

In studies of non-neovascular ARMD (without evident signs of active or regressed

neovascularization [NV] at baseline), CFP may be sufficient at baseline and end-of-

study visit. Fluorescein angiography (FA) may become necessary to evaluate for

NV at any visit during the study. Indo-cyanine green angiography (ICG-A) may be

considered at baseline under certain conditions. For studies in patients with

neovascular ARMD, increased need for visualization of the vasculature must be

taken into account. Accordingly, these studies should include FA (recommended at

baseline and selected follow-up visits) and ICG-A under certain conditions. The

authors concluded that a multi-modal imaging approach is recommended in clinical

studies for the optimal detection and measurement of atrophy and its associated

features. Specific validation studies will be necessary to determine the best

combination of imaging modalities, and these recommendations will need to be

updated as new imaging technologies become available in the future.

Fleckenstein and associates (2018) noted that geographic atrophy (GA) is an

advanced form of ARMD that leads to progressive and irreversible loss of visual

function. Geographic atrophy is defined by the presence of sharply demarcated

atrophic lesions of the outer retina, resulting from loss of photoreceptors, retinal

pigment epithelium (RPE), and underlying choriocapillaris. These lesions typically

appear first in the peri-foveal macula, initially sparing the foveal center, and over

time often expand and coalesce to include the fovea. Although the kinetics of GA

progression are highly variable among individual patients, a growing body of

evidence suggested that specific characteristics may be important in predicting

disease progression and outcomes. This review synthesized current understanding

of GA progression in ARMD and the factors known or postulated to be relevant to

GA lesion enlargement, including both affected and fellow eye characteristics. In

addition, the roles of genetic, environmental, and demographic factors in GA lesion

enlargement were discussed. Overall, GA progression rates reported in the




literature for total study populations ranged from 0.53 to 2.6 mm2/year (median of

approximately 1.78 mm2/year), assessed primarily by color fundus photography or

FAF imaging. Several factors that could inform an individual's disease prognosis

have been replicated in multiple cohorts: baseline lesion size, lesion location, multi-

focality, FAF patterns, and fellow eye status. Because BCVA does not correspond

directly to GA lesion enlargement due to possible foveal sparing, alternative

assessments are being explored to capture the relationship between anatomic

progression and visual function decline, including micro-perimetry, low-luminance

VA, reading speed assessments, and patient-reported outcomes. The authors

concluded that understanding GA progression and its individual variability is critical

in the design of clinical studies, in the interpretation and application of clinical trial

results, and for counseling patients on how disease progression may affect their

individual prognosis.

Appendix

Note on Optomap coding: The Optos Optomap is image-assisted ophthalmoscopy

for evaluation of ocular health. Optomap meets the criteria for the CPT code for

fundus photography (92250).

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:

92250 Fundus photography with interpretation and report [includes Optomap]

CPT codes not covered if selection criteria are met:

0380T Computer-aided animation and analysis of time series retinal images for

the monitoring of disease progression, unilateral or bilateral, with

interpretation and report Other HCPCS code related to the CPB:

Ethambutol - no specific code :

ICD-10 codes covered if selection criteria are met:

A52.15

B20

B39.4

B39.5

Late syphilitic neuropathy

Human immunodeficiency virus (HIV) disease

Histoplasmosis capsulati, unspecified

Histoplasmosis duboisii





B39.9

B50.0 - B54

B58.01

B58.09

C69.00 - C69.92

Histoplasmosis, unspecified

Malaria

Toxoplasma chorioretinitis

Other toxoplasma oculopathy

Malignant neoplasm of eye and adnexa C79.40 - C79.49 Secondary malignant neoplasm of other and unspecified parts of nervous

system

D09.20 - D09.22

D31.20 - D31.22

D31.30 - D31.32

D31.40 - D31.42

D33.3

D49.81

D57.00 -

D57.819

Carcinoma in situ of eye

Benign neoplasm of retina

Benign neoplasm of choroid

Benign neoplasm of ciliary body

Benign neoplasm of cranial nerves

Neoplasm of unspecified behavior of retina and choroid

Sickle-cell disorders

E08.00 - E13.9

E70.20 - E70.9

G35

G93.2

H27.10 -

H27.119

Diabetes mellitus

Disorders of aromatic amino-acid metabolism

Multiple sclerosis

Benign intracranial hypertension [pseudotumor cerebri]

Subluxation of lens

H27.131 -

H27.139

Posterior dislocation of lens

H30.001 -

H30.93

Chorioretinal inflammation

H31.00 - H31.9

H32

Other diseases of choroid

Chorioretinal disorders in diseases classified elsewhere

H33.001 - H33.8 Retinal detachment and breaks

H34.00 - H34.9

H35.00 - H35.9

Retinal vascular occlusions

Other retinal disorders





H36 Retinal disorders in diseases classified elsewhere

H40.001 - H40.9 Glaucoma

H42

H43.00 - H43.9

Glaucoma in diseases classified elsewhere

Disorders of vitreous body

H44.001 - H44.9 Disorders of the globe

H44.511 -

H44.519

Absolute glaucoma

H46.00 - H47.9 Disorders of optic nerve and visual pathways

H53.50 - H53.59 Color vision deficiencies

H59.031 -

H59.039

Cystoid macular edema following cataract surgery

L93.0 - L93.2 Lupus erythematosus

M05.00 -

M14.89

Inflammatory polyarthropathies

M32.0 - M32.9 Systemic lupus erythematosus (SLE)

P35.0 Congenital rubella syndrome

Q13.4 Other congenital corneal malformations [Peter’s anomaly]

Q14.0 - Q14.9 Congenital anomalies of posterior segment of eye

Q15.0 Congenital glaucoma

Q85.1 Tuberous sclerosis

Q85.8 - Q85.9 Other and unspecified phakomatoses, not elsewhere classified

Q87.1 - Q87.89 Other specified congenital malformation syndromes affecting multiple

systems

Q89.8 Other specified congenital malformations

Q99.2 Fragile X chromosome

R94.110 Abnormal electro-oculogram (EOG)

R94.111 Abnormal electroretinogram [ERG]

R94.112 Abnormal visually evoked potential [VEP]

R94.113 Abnormal oculomotor study




The above policy is based on the following references:

1. Xact Medicare Services. Fundus Photography. Medicare Medical Policy

Bulletin No. M-37. Camp Hill, PA: Xact; April 28, 1997. Available at:

http://www.eyecare.org/ecbc/medicare/fundfoto.html. Accessed March 24,

2000.

2. Louisiana Medicare Services. Fundus photography. Medicare Part B

Medical Policy. Baton Rouge, LA: Louisiana Medicare; June 21, 1991.

Available at: http://www.lamedicare.com/provider/medpol/fundpho.asp.

Accessed March 24, 2000.

3. Highmark Medicare Services, Inc. Fundus photography. Medicare Local

Coverage Determination (LCD) L27498. Medicare Administrative Contractor

(MAC) Parts A and B. Camp Hill, PA: Highmark Medicare Services;

November 2, 2009.

4. American Academy of Ophthalmology (AAO). Age-related macular

degeneration. Preferred Practice Pattern. San Francisco, CA: AAO; 2008.

5. American Academy of Ophthalmology (AAO). Primary open-angle

glaucoma. Preferred Practice Pattern. San Francisco, CA: AAO; 2010.

6. American Academy of Ophthalmology (AAO). Primary open-angle glaucoma

suspect. Preferred Practice Pattern. San Francisco, CA: AAO; 2010.

7. American Academy of Ophthalmology (AAO). Primary angle closure.

Preferred Practice Pattern. San Francisco, CA: AAO; 2010.

8. American Academy of Ophthalmology (AAO). Diabetic retinopathy.

Preferred Practice Pattern. San Francisco, CA: AAO; 2008.


S05.50x+ -

S05.52x+

Penetrating wound with foreign body of eyeball

T37.2x1+ -

T37.2x4+

Poisoning by antimalarials and drugs acting on other blood protozoa

[hydroxychloroquine toxicity]

T37.3x1+ -

T37.3x4+

ICD-10 codes not covered for indications listed in the CPB: (not all inclusive):

Visceral larva migrans

Poisoning by other antiprotozoal drugs

B83.0

http://qawww.aetna.com/cpb/medical/data/500_599/0539_draft.htmlhttp://www.eyecare.org/ecbc/medicare/fundfoto.htmlhttp://www.eyecare.org/ecbc/medicare/fundfoto.htmlhttp://www.lamedicare.com/provider/medpol/fundpho.asp



9. American Academy of Ophthalmology. Posterior vitreous detachment,

retinal breaks, and lattice degeneration. Preferred Practice Pattern. San

Francisco, CA: AAO; 2008.

10. Wong D. The fundus camera. In: Duane's Clinical Ophthalmology. Vol. 1.

Rev. ed. W Tasman, EA Jaeger, eds. Philadelphia, PA: Lippincott Williams &

Wilkins; 1999; Ch. 61:1-14.

11. Chang DF. Ophthalmologic examination. In: General Ophthalmology. 15th

ed. D Vaughan, T Asbury, P Riordan-Eva, eds. Stamford, CT: Appleton &

Lange; 1999; Ch. 2:27-56.

12. Mardin CY, Junemann AG. The diagnostic value of optic nerve imaging in

early glaucoma. Curr Opin Ophthalmol. 2001;12(2):100-104.

13. Shiba T, Yamamoto T, Seki U, et al. Screening and follow-up of diabetic

retinopathy using a new mosaic 9-field fundus photography system.

Diabetes Res Clin Pract. 2002;55(1):49-59.

14. Larsen M, Godt J, Larsen N, et al. Automated detection of fundus

photographic red lesions in diabetic retinopathy. Invest Ophthalmol Vis Sci.

2003;44(2):761-766.

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. Marmor MF, Carr RE, Easterbrook M, Farjo AA, Mieler WF; American

Academy of Ophthalmology. Recommendations on screening for

chloroquine and hydroxychloroquine retinopathy: A report by the

American Academy of Ophthalmology. Ophthalmology 2002;109(7):1377-

1382.

17. Davis MD, Bressler SB, Aiello LP, et al; Diabetic Retinopathy Clinical

Research Network Study Group. Comparison of time-domain OCT and

fundus photographic assessments of retinal thickening in eyes with

diabetic macular edema. Invest Ophthalmol Vis Sci. 2008;49(5):1745-1752.

18. Polak BC, Hartstra WW, Ringens PJ, Scholten RJ. Revised guideline 'Diabetic

retinopathy: Screening, diagnosis and treatment'. Ned Tijdschr Geneeskd.

2008;152(44):2406-2413.

19. American Diabetes Association. Position statement: Standards of medical

care in diabetes - 2010. Diabetes Care. 2010;33(Suppl. 1):S11-S61.

20. Jain N, Farsiu S, Khanifar AA, et al. Quantitative comparison of drusen

segmented on SD-OCT versus drusen delineated on color fundus

photographs. Invest Ophthalmol Vis Sci. 2010;51(10):4875-4883.




21. Marmor MF, Kellner U, Lai TY, et al; American Academy of Ophthalmology.

Revised recommendations on screening for chloroquine and

hydroxychloroquine retinopathy. Ophthalmology. 2011;118(2):415-422.

22. Salcone EM, Johnston S, VanderVeen D. Review of the use of digital imaging

in retinopathy of prematurity screening. Semin Ophthalmol. 2010;25

(5-6):214-217.

23. American Diabetes Association (ADA). Standards of medical care in

diabetes. VI. Prevention and management of diabetes complications.

Diabetes Care 2011;34(Suppl 1):S27-S38.

24. Paysse EA. Retinopathy of prematurity. UpToDate [online serial]. Waltham,

MA: UpToDate; reviewed March 2012.

25. Weller PF, Leder K. Toxocariasis: visceral and ocular larva migrans.

UpToDate [online serial]. Waltham, MA: UpToDate; reviewed April 2013.

26. Ku JJ, Landers J, Henderson T, et al. 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.

27. Syed ZA, Radcliffe NM, De Moraes CG, et al. Automated alternation flicker

for the detection of optic disc haemorrhages. Acta Ophthalmol. 2012;90

(7):645-650.

28. EyeIC Inc. MatchedFlicker [website]. Wayne, PA: EyeIC; 2014. Available at:

http://www.eyeic.com/index.php. Accessed December 10, 2014.

29. VanderBeek BL, Smith SD, Radcliffe NM. Comparing the detection and

agreement of parapapillary atrophy progression using digital optic disk

photographs and alternation flicker. Graefes Arch Clin Exp Ophthalmol.

2010;248(9):1313-1317.

30. Myung JS, Gelman R, Aaker GD, et al. Evaluation of vascular disease

progression in retinopathy of prematurity using static and dynamic retinal

images. Am J Ophthalmol. 2012;153(3):544-551.

31. Radcliffe NM, Smith SD, Syed ZA, et al. Retinal blood vessel positional shifts

and glaucoma progression. Ophthalmology. 2014;121(4):842-848.

32. Marlow ED, McGlynn MM, Radcliffe NM. A novel optic nerve photograph

alignment and subtraction technique for the detection of structural

progression in glaucoma. Acta Ophthalmol. 2014;92(4):e267-e272.

33. Syed ZA, Radcliffe NM, De Moraes CG, et al. Detection of progressive

glaucomatous optic neuropathy using automated alternation flicker with

stereophotography. Arch Ophthalmol. 2011;129(4):521-522.

34. Radcliffe NM, Sehi M, Wallace IB, et al. Comparison of stereo disc

photographs and alternation flicker using a novel matching technology for

http://qawww.aetna.com/cpb/medical/data/500_599/0539_draft.htmlhttp://www.eyeic.com/index.phphttp://www.eyeic.com/index.php



detecting glaucoma progression. Ophthalmic Surg Lasers Imaging. 2010;41

(6):629-634.

35. Cymbor M, Lear L, Mastrine M. Concordance of flicker comparison versus

side-by-side comparison in glaucoma. Optometry. 2009;80(8):437-441.

36. Berger JW, Patel TR, Shin DS, et al. Computerized stereochronoscopy and

alternation flicker to detect optic nerve head contour change.

Ophthalmology. 2000;107(7):1316-1320.

37. Vicchrilli S. Testing services, Part one: Selecting the CPT code. Savy Coder:

Coding & Reimbursement. EyeNet. San Francisco, CA: American Academy

of Ophthalmology; May 2012.

38. van Ballegooie E, van Everdingen JJ. CBO guidelines on diagnosis,

treatment, and prevention of complication in diabetes mellitus:

Retinopathy, foot ulcers, nephropathy and cardiovascular diseases. Dutch

Institute for Quality Assurance. Ned Tijdschr Geneeskd. 2000;144(9):413-

418.

39. Massin P, Erginay A, Ben Mehidi A, et al. Evaluation of a new non-mydriatic

digital camera for detection of diabetic retinopathy. Diabet Med. 2003;20

(8):635-641.

40. Aptel F, Denis P, Rouberol F, Thivolet C. Screening of diabetic retinopathy:

Effect of field number and mydriasis on sensitivity and specificity of digital

fundus photography. Diabetes Metab. 2008;34(3):290-293.

41. Polak BC, Hartstra WW, Ringens PJ, Scholten RJ. Revised guideline 'Diabetic

retinopathy: Screening, diagnosis and treatment'. Ned Tijdschr Geneeskd.

2008;152(44):2406-2413.

42. Germain N, Galusca B, Deb-Joardar N, et al. No loss of chance of diabetic

retinopathy screening by endocrinologists with a digital fundus camera.

Diabetes Care. 2011;34(3):580-585.

43. Guigui S, Lifshitz T, Levy J. Screening for diabetic retinopathy: Review of

current methods. Hosp Pract (1995). 2012;40(2):64-72.

44. 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.

45. Redmon B, Caccamo D, Flavin P, et al. Diagnosis and management of type 2

diabetes mellitus in adults. Bloomington, MN: Institute for Clinical Systems

Improvement (ICSI); July 2014.

46. McCulloch DK. Diabetic retinopathy: Screening. UpToDate [online

serial]. Waltham, MA: UpToDate; reviewed March 2016.




47. Chung YM, Yeh TS, Sheu SJ, Liu JH. Macular subretinal neovascularization in

choroidal tuberculosis. Ann Ophthalmol. 1989;21(6):225-229.

48. Han J, Byun MK, Lee J, et al. Longitudinal analysis of retinal nerve fiber layer

and ganglion cell-inner plexiform layer thickness in ethambutol-induced

optic neuropathy. Graefes Arch Clin Exp Ophthalmol. 2015;253(12):2293-

2299.

49. Holz FG, Sadda SR, Staurenghi G, et al; CAM group. Imaging protocols in

clinical studies in advanced age-related macular degeneration:

Recommendations from Classification of Atrophy Consensus Meetings.

Ophthalmology. 2017;124(4):464-478.

50. Fleckenstein M, Mitchell P, Freund KB, et al. The progression of geographic

atrophy secondary to age-related macular degeneration. Ophthalmology.

2018;125(3):369-390.

51. Centers for Medicare & Medicare Services (CMS). Local Coverage

Determination (LCD): Ophthalmology: Posterior segment imaging

(extended ophthalmoscopy and fundus photography) (L34399). CGS

Administrators, LLC – MAC Part B. Medicare Coverage Database. Baltimore,

MD: CMS; effective January 1, 2016.


Determination (LCD): Fundus photography (L33670). First Coast Service

Options, Inc - MAC Part B. Medicare Coverage Database. Baltimore, MD:

CMS; effective October 1, 2015.


Determination (LCD): Ophthalmology: Posterior segment imaging

(extended ophthalmoscopy and fundus photography) (L33567). National

Government Services, Inc. – MAC Part B. Medicare Coverage Database.

Baltimore, MD: CMS; effective October 1, 2015.




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 © 2001-2018 Aetna Inc.


AETNA BETTER HEALTH® OF PENNSYLVANIA

Amendment to Aetna Clinical Policy Bulletin Number:

0539 Fundus Photography

There are no amendments for Medicaid.

www.aetnabetterhealth.com/pennsylvania Updated 04/13/2018

http://www.aetnabetterhealth.com/pennsylvania

A separate copy of this form must accompany each policy submitted for review.Number: 0539Screening for Diabetic Retinopathy:Diagnosis and Management of Diabetic Retinopathy:Monitoring of Ethambutol-Induced Optic Neuropathy:Age-Related Macular Degeneration:AppendixThe above policy is based on the following references:

Amendment toThere are no amendments for Medicaid.

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