Description:
Ocular photoscreening is proposed to detect risk factors for amblyopia, with the goal of facilitating earlier diagnosis and treatment of amblyopia. This policy only addresses ocular photoscreening in the setting of the primary care physician’s office.

Amblyopia is a disorder of visual development, manifested as decreased visual acuity in one eye. It affects more than 2 percent of the population and is the leading cause of monocular vision loss in children and adults. However, if detected before 8 to 10 years of age, it can be effectively treated by occlusion of the sound eye. A variety of organizations have recommended routine vision screening throughout childhood. Organizations include the American Academy of Pediatrics, the U.S. Preventive Services Task Force, the American Academy of Ophthalmology, the American Optometric Association, and the American Association for Pediatric Ophthalmology and Strabismus. Detection of amblyopia itself requires assessment of visual acuity, which is difficult in preverbal children. Ocular photoscreening has been investigated as an alternative screening method, not to detect amblyopia but to detect risk factors for amblyopia, which include strabismus, high refractive errors, anisometropia and media opacities.

Ocular photoscreening is based on the principle of photorefraction in which the refractive state of the eye is assessed via the pattern of light reflected through the pupil. The images can then be analyzed based on the position of the corneal light reflex, as well as the overall reflection of light from the fundus, which provides information on the child’s fixation pattern and the presence or absence of strabismus. Patients are photographed in a darkened room while looking at the camera. The photographs can be sent to a central laboratory for analysis, either by ophthalmologists or specifically trained personnel. Results are typically graded as pass, fail or repeat photoscreening.

The American Academy of Pediatrics, in conjunction with the American Academy of Ophthalmology, the American Association for Pediatric Ophthalmology and Strabismus and the American Association of Certified Orthoptists, issued a 2012 policy statement that recommends ocular photoscreening or automated-refraction as an alternative to visual acuity screening with vision charts for children ages 3 through 5 to detect conditions that may lead to amblyopia. After age 5, visual acuity screening with vision charts becomes more efficient.

The U.S. Preventive Services Task Force (USPSTF, 2011) recommends vision screening for all children at least once between the ages of 3 and 5 years, to detect the presence of amblyopia or its risk factors. The USPSTF recommendation states that various screening tests to identify visual impairment in children are feasible in the primary care setting. These tests include visual acuity tests using vision charts, stereoacuity tests, the cover-uncover test and the Hirschberg light reflex test as well as the use of auto-refractors and photoscreeners (grade B recommendation).

Note: Ocular photoscreening can be performed in several settings. For example, photoscreening can be performed in a public health setting or as part of school screening programs. In addition, photoscreening may be performed by ophthalmologists as an adjunct to an ophthalmologic exam. This policy only addresses the use of photoscreening in the setting of the primary care physician’s office, where it is performed as an adjunct or alternative to the standard visual exam. It is anticipated that the results of photoscreening would be used by the primary care physician to determine whether the patient required referral to a pediatric ophthalmologist for further evaluation.

Regulatory Status
In April 1994, the MTI Photoscreener (Medical Technology and Innovations Inc.; Cedar Falls, Iowa) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The FDA determined that this device was substantially equivalent to existing devices for use as an ophthalmic camera.

In January 2001, the iScreen Vision Screener was cleared for marketing by the FDA through the 510(k) process. The FDA determined that this device was substantially equivalent to existing devices for use in screening vision problems.

Policy:
Instrument-based ocular screening using photoscreening or automated-refraction is MEDICALLY NECESSARY to screen children 3 to 5 years of age who are unable to cooperate for visual acuity screening by standard vision charts (e.g., preverbal or nonverbal children, preliterate children, children with developmental delays and/or children with severe behavioral disorders) in the primary care physician's office setting.

Instrument-based ocular screening using photoscreening or automated-refraction is NOT SEPARATELY REIMBURSABLE for eye care specialty providers.

Policy Guidelines
Since 2008, there has been a category I CPT code for this test:

99174: Ocular photoscreening, with interpretation and report, bilateral 

The CPT book also indicates that the above code should not be used with CPT codes 92002 – 92014 (ophthalmological service codes), or 99172 – 99173 (vision screening tests).

Between July 2004 and January 2008, there was a category III CPT code for this test:

0065T: Ocular photoscreening, with interpretation and report, bilateral

It is likely that ocular photoscreening would be performed by office staff, with the resulting images either interpreted by the physician or sent to a central site for interpretation.

Benefit Application
BlueCard/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all devices approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational. Thus, these devices may be assessed only on the basis of their medical necessity.

Rationale:
As noted in the Description, this policy only addresses ocular photoscreening when performed in the primary care physician’s office, either as an adjunct or as an alternative to standard visual assessment. Aside from assessment of visual acuity using Snellen charts, letters or other techniques, primary care physicians typically assess fixation and following movements and perform the red reflex test. Specifically, the red reflex test can detect visual opacities in the visual axis and abnormalities of the back of the eye, such as retinoblastoma or retinal detachment. When the red reflex is assessed simultaneously, potentially amblyopic conditions, such as asymmetric refractive errors and strabismus, can also be identified. The test is performed in a darkened room, with the direct ophthalmoscope focused on each pupil individually and then both eyes simultaneously. The family and clinical history may also identify a child at higher risk of amblyopia. For example, high-risk children include those with a family history of strabismus, ambylopia, high refractive errors or childhood eye disorders. Children born prematurely, or those with neurologic and developmental conditions, are also at higher risk.¹

It is assumed that the results of photoscreening would be used to prompt referral to an ophthalmologist for further evaluation. Therefore, assessment of photoscreening in this setting requires population-based studies to determine whether the results of photoscreening result in a higher referral rate to ophthalmologists compared to standard visual assessment, with an associated improvement in sensitivity and specificity for detection of amblyogenic factors that lead to earlier diagnosis and treatment with a decrease in vision-impairing amblyopia.

An initial literature search was performed in 2004. The policy was updated regularly with a literature review using MEDLINE, most recently for the period October 2009 through October 2010. Following is a summary of the literature to date.

Early published literature focused on the technical feasibility of ocular photoscreening. Tong and colleagues from the Wilmer Eye Institute published a series of three feasibility studies with the MTI PhotoScreener. The first study of 100 children, published in 1998, was designed to determine whether health care professionals or lay volunteers could interpret and grade photoscreening photographs.² A total of 18 volunteers, including both pediatric ophthalmologists and lay personnel, interpreted the photoscreening results, which included 26 children with normal ophthalmologic exams and 74 with abnormalities. Results from the graders varied, with sensitivities ranging from 37 – 88 percent and specificity from 40-80 percent. No single grader achieved both sensitivity and specificity greater than 70 percent.

Two subsequent studies were published in 2000. The first included 392 preverbal children who were referred to an ophthalmologist for examination; 103 had normal examination findings, while the remaining 284 children had conditions of interest for pediatric screening. Five children were excluded.³ The photographs were graded by a representative of the manufacturer, MTI Photoscreener, and the results compared with the results of the ophthalmologic exam. The overall sensitivity was 65 percent and the specificity was 87 percent. The results were further analyzed according to the abnormality present, i.e., external examination abnormality (e.g., ptosis), media opacity, strabismus and refractive error. The sensitivity for refractive error was low (33 percent), while the sensitivity for strabismus was 55 percent. The other study investigated a new grading system for hyperopia, based on the conclusions from the previous study that the criteria for hyperopia indicating a failing grade were too low and would result in an undesirably high referral rate.⁴ This study re-examined the 392 photographs from the previous study and developed new grading criteria that resulted in a sensitivity and specificity of 100 percent and 88 percent, respectively.

Several studies have evaluated the accuracy of ocular photoscreening; however, none of these addressed photoscreening in a primary care physician’s office. The Vision in Preschoolers (VIP) study, a multicenter prospective trial sponsored by the National Eye Institute, evaluated screening tests for identifying preschool children in need of comprehensive eye examinations.⁵ The trial evaluated screening tests administered by eye care professionals (in Phase I) and nurses and lay screeners (in Phase II) in a community-based setting. In Phase I, a total of 2,588 children aged 3 to 5 years in Head Start were screened with 11 tests, including 2 photoscreening tests using a mobile unit designed for the study.⁶ When overall specificity was set to either 90 percent or 94 percent, non-cycloplegic retinoscopy, Retinomax, SureSight and Lea Symbols VA performed the best in detecting children who had at least one of the targeted conditions (amblyopia, strabismus, significant refractive error and/or unexplained reduced visual acuity), as well as those with the most severe conditions. Non-cycloplegic retinoscopy, Retinomax and SureSight performed significantly better than static photoscreeners, including the MTI Photoscreener and the iScreen Photoscreener. Phase II used the best performing tests from Phase I, which did not include photoscreening.

Another study, conducted by Simons and colleagues, studied the MTI Photoscreener in 100 children, aged 4 months to 12 years, who were recruited either from a pediatric ophthalmologic referral practice or a day care center, or who were suspected to have developmental delay or a behavior disorder.⁷ All 100 photographs were independently graded by 6 observers, including 4 pediatric ophthalmologists, a nurse and a research coordinator, and compared to the results of a complete ophthalmologic examination. For detecting any abnormal results, the sensitivity ranged from 80-91 percent and the specificity ranged from 20 – 67 percent. This study included mainly verbal children, who presumably could participate in visual acuity tests. It should be noted that studies that include patients recruited from a pediatric ophthalmology practice or similar settings tend to have a high incidence of patients with pathologic conditions. While these populations are useful to determine the initial sensitivity of photoscreening, this population does not duplicate the general population of children presenting to the primary care physicians’ office.

A recent study evaluated photoscreening using an infrared camera (the Plusoptix S04) in children between 3 and 5 years of age seen at one pediatric ophthalmology practice in the U.S.⁸ Chart review for a 6-month period identified 153 patients who had received screening and a comprehensive pediatric ophthalmology examination on the same day; all children also had a cycloplegic refraction procedure within the previous 6 months. Photoscreening was done by either a certified orthoptist or an ophthalmic technician before the patient was examined. The ophthalmologist was not blinded to findings from the photoscreening. No amblyopia risk factors and no amblyopia were found in 60 of 153 (39 percent) by photoscreening and in 72 (47 percent) by examination. The photoscreener was found to have a sensitivity of 99 percent, specificity of 82 percent, false-positive rate of 18 percent, false-negative rate of 1.2 percent and positive predictive value of 86 percent. The authors noted that the population in this study likely had a higher prevalence of amblyopia than the general population, which would result in a higher positive predictive value.

Only one study was identified that examined the use of photoscreening in the primary care setting, and this was a survey of physicians, not a clinical trial.⁹ Kemper and Clark conducted a national survey of 377 pediatricians (55 percent response) to determine the rate of acuity screening in preschool children. It was reported that vision screening was conducted in 35 percent, 73 percent and 66 percent, of 3-, 4- and 5-year olds, respectively. Few (8 percent) of the respondents reported using either autorefraction or photoscreening.

Other published studies in the literature generally describe the diagnostic yield of screening programs. The screening has been conducted in settings other than the primary care physician’s office, i.e., community or public health settings, or in ophthalmology clinics.^10,11 The largest studies conducted in the community setting report on programs sponsored by Lions Clubs. Recently, Longmuir and colleagues described findings from a photoscreening program in Iowa in which lay volunteers screened 147,809 children who were at least 6 months old at 9,746 sites using the MTI PhotoScreener.¹² The screenings were conducted by lay volunteers, and the program was supervised by a volunteer pediatric ophthalmologist. The mean age of children screened was 4.7 years. Photoscreens were evaluated in a central location by professional photo readers, and children who failed the screen were referred to an ophthalmic professional. A total of 6,247 of 147,809 children (4.2 percent) were referred for additional testing and, for 4,781, the evaluation took place and findings were recorded. The additional evaluation found that 3,925 of the 4,781 (82 percent) children had an amblyopia risk factor. Donahue reported on a similar Lions Club-sponsored program that screened 15,000 preschool children in Tennessee.¹³ This program also used lay volunteers to take the photographs and had professional photo readers to interpret them. The positive predictive value ranged from 84 percent, when a diagnosis of strabismus was suggested by the photoscreen, to 41 percent for astigmatism. An additional publication, a retrospective case series, reported on outcomes in children identified in the Tennessee screening program and subsequently treated. Of 901 children referred to a pediatric ophthalmology practice, 551 had amblyopiogenic risk factors without amblyopia, 185 were diagnosed with amblyopia and 165 had false-positive screenings.¹⁴ Of the 185 children with amblyopia, 125 met inclusion criteria (lack of developmental delay and/or organic eye disease and sufficient documentation in clinical records). Ninety-seven of the 125 (78 percent) children were successfully treated (at least 3 lines of improvement in reading and/or 20/30 or better vision in the amblyopic eye). While the vision screening took place in a public health setting, and, thus, these studies are not applicable to the policy, it is anticipated that ocular photoscreening may be predominantly used in a community-based or public health setting.

No published studies have evaluated the clinical utility of photoscreening in the primary care physician’s office compared to standard visual assessment. A Cochrane review, last updated in 2009, focused on the role of screening for amblyopia in general.¹⁵ The investigators searched the literature through August 2008 and noted that there have been no trials comparing the prevalence of amblyopia in screened versus unscreened populations; therefore, it is difficult to analyze the impact of screening programs on the prevalence of amblyopia.

Summary
Empirical studies on ocular photoscreening have been conducted in settings other than primary care, such as community-based screening or screening in an ophthalmology clinic. No population-based studies were identified that evaluated whether the results of ocular photoscreening lead to higher referral rates to ophthalmologists, earlier diagnosis and treatment or a decrease in vision-impairing amblyopia, compared to standard visual assessment. The evidence is thus insufficient that ocular photoscreening in the primary care physician’s office improves the net health outcome, and, thus, the test is considered investigational.

Technology Assessments, Guidelines and Position Statements
American Academy of Pediatrics (AAP): In 2008, the AAP reaffirmed its policy statement on photoscreening, which was originally issued in 2002.^16,17 The document noted the following:

• Photoscreening does not represent a single technique or piece of equipment. Different optical systems can be used for photoscreening. Interpretation of screened images may be performed in the physician's office, office in a reading center or with an automated system.
• Each photoscreening system may have its own advantages and disadvantages, and it appears that results published in the literature for one system are not necessarily valid for others.
• It is difficult to compare efficacies of various vision-screening methods, such as stereoacuity testing, autorefraction, red reflex testing and cover testing, and then determine if photoscreening has better positive and negative predictive values. This is attributable in part to a lack of uniformity in pass-fail criteria for significant refractive errors.
• Photoscreening needs to be studied more extensively. The AAP favors additional research of photoscreening devices and other vision-screening methods in large, controlled studies to elucidate validity of results, efficacy and cost effectiveness to identify amblyogenic factors in different age groups, as well as subgroups of children.

American Association for Pediatric Ophthalmology and Strabismus (AAPOS) and American Academy of Ophthalmology (AAO)

In 2007, the organizations issued a joint statement on vision screening for infants and children. The statement recommends screening for vision problems and says that photoscreening may be "a valuable adjunct to the traditional screening process, particularly in preliterate children." The statement did not recommend any particular venue for photoscreening.¹⁸

References:

1. Simon JW, Kaw P. Vision screening performed by the pediatrician. Pediatr Ann 2001; 30(8):446-52.
2. Tong PY, Enke-Miyazaki E, Bassin RE et al. Screening for amblyopia in preverbal children with photoscreening photographs. National Children’s Eye Care Foundation Vision Screening Study Group. Ophthalmology 1998; 105(5):856-63.
3. Tong PY, Bassin RE, Enke-Miyazaki E et al. Screening for amblyopia in preverbal children with photoscreening results: II. Sensitivity and specificity of the MTI photoscreener. Ophthalmology 2000; 107(9):1623-9.
4. Tong PY, Macke JP, Bassin RE et al. Screening for amblyopia in preverbal children with photoscreening photographs. III. Improved grading criteria for hyperopia. Ophthalmology 2000; 107(9):1630-6.
5. Vision In Preschoolers Study (VIP Study). 
6. Vision in Preschoolers (VIP) Study Group. Optom Vis Sci 2009; 86(6):619-23.
7. Simons BD, Siatkowski RM, Schiffman JC et al. Pediatric photoscreening for strabismus and refractive errors in a high-risk population. Ophthalmology 1999; 106(6):1073-80.
8. Matta NS, Singman EL, Silbert DI. Performance of the plusoptiX S04 photoscreener for the detection of amblyopia risk factors in children aged 3 to 5. J AAPOS 2010; 14(2):147-9.
9. Kemper AR, Clark SJ. Preschool vision screening in pediatric practices. Clin Pediatr (Phila) 2006; 45(3):263-6.
10. Savage HI, Lee HH, Zaetta D et al. Pediatric Amblyopia Risk Investigation Study (PARIS). Am J Ophthalmol 2005; 140(6):1007-13.
11. Kemper AR, Keating LM, Jackson JL et al. Comparison of monocular autorefraction to comprehensive eye examinations in preschool-aged and younger children. Arch Pediatr Adolesc Med 2005; 159(5):435-9.
12. Longmuir SQ, Pfeifer W, Leon A et al. Nine-year results of a volunteer lay network photoscreening program of 147,809 children using a photoscreener in Iowa. Ophthalmology 2010; 117(10):1869-75.
13. Donahue SP. Relationship between anisometropia, patient age, and the development of amblyopia. Am J Ophthalmol 2006; 142(1):132-40.
14. Teed RG, Bui CM, Morrison DG et al. Amblyopia therapy in children identified by photoscreening. Ophthalmology 2010; 117(1):159-62.
15. Powell C, Hatt SR. Vision screening for amblyopia in childhood. Cochrane Database Syst Rev 2009; (3):CD005020.
16. Committee on Practice and Ambulatory Medicine and Section on Ophthalmology; American Academy of Pediatrics. Use of photoscreening for children’s vision screening. Pediatrics 2002; 109(3):524-5. 
17. American Academy of Pediatrics. AAP publications reaffirmed and retired, February and May 2008. Pediatrics 2008; 122(2):450.
18. American Association for Pediatric Ophthalmology and Strabismus (AAPOS) and American Academy of Ophthalmology. Policy Statement: Vision screening for infants and children.
19. 19. Nelson H, Nygren P, Huffman L et al. Screening for Visual Impairment in Children Younger than Age 5 Years. Update of The Evidence from Randomized Controlled Trials, 1999 – 2003. U.S. Preventive Services Task Force, 05/04.
20. U.S. Preventive Services Task Force (USPSTF). Screening for Visual Impairment in Children Younger than Age 5 Years, Recommendation Statement Agency for Healthcare Research and Quality, Rockville, MD, 05/04.
21. U.S. Preventive Services Task Force (USPSTF). Screening for visual impairment in children ages 1 to 5 years. Recommendations of the U.S. Preventive Services Task Force. Rockville, MD: Agency for Healthcare Research and Quality (AHRQ); January 2011

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

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