Table of Contents

• Provider Claim Codes
• Section Title

1. 0469T Retinal Polarization Scan
2. 0506T Heterochromatic Flicker Photometry Measurement of Macular Pigment Density
3. 0509T Pattern Electroretinography (PERG)
4. 0514T Intraoperative Visual Axis Identification
5. 0604T, O605T, 0606T Remote Optical Coherence Tomography (OCT)
6. 0616T, 0617T, 0618T, C1839 Iris Prosthesis and Insertion
7. 0687T, 0688T, 0704T, 0705T, 0706T, A9292 Digital Amblyopia Therapy

Retinal Polarization Scan Section Effective Date: 06/22/2023
Page: 1 of 15

Code Compendium (Ophthalmology) Policy Number: HUM-0571-009 Page: 2 of 15

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Section Revision Date: 06/22/2023

Section Review Date: 06/22/2023

Change Summary: Updated References

Description

0469T
Retinal polarization scan, ocular screening with on-site automated results, bilateral
Not Covered

Vision screening is generally recommended at least once in children 3 to 5 years of age to detect amblyopia (lazy eye). Devices using polarized light to scan the nerve fibers surrounding the foveas in each eye purportedly provide automated detection of amblyopia and microstrabismus (imperceptible misalignment of the eyes). One example of a US Food & Drug Administration (FDA)-approved device is the blinq pediatric vision scanner.

Coverage Determination

Humana members may NOT be eligible under the Plan for ocular screening using retinal polarization scan. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

References

1. American Academy of Ophthalmology (AAO). Joint Policy Statement. Vision screening for infants and children: a joint statement of the American Association for Pediatric Ophthalmology and Strabismus and the American Academy of Ophthalmology. https://www.aao.org. Published June 1991. Updated October 2022. Accessed June 2, 2023.
2. American Academy of Ophthalmology (AAO). Preferred Practice Pattern. Amblyopia. https://www.aao.org. Published September 9, 2022. Accessed June 2, 2023.
3. American Academy of Ophthalmology (AAO). Preferred Practice Pattern. Pediatric eye evaluation. https://www.aao.org. Published September 9, 2022. Accessed June 2, 2023.
4. American Academy of Pediatrics (AAP). Policy Statement. Visual system assessment in infants, children, and young adults by pediatricians. https://www.aap.org. Published January 2016. Updated October 2021. Accessed June 1, 2023.
5. ClinicalKey. Bosque L, Yamarino C, Salcedo N, et al. Evaluation of the blinq vision scanner for detection of amblyopia and strabismus. J AAPOS. 2021;25:214.e1-214.e7. https://www.clinicalkey.com. Accessed June 1, 2022.
6. ClinicalKey. Silverstein E, Donahue S. Vision screening. In Lyons CJ, Lambert SR. Taylor and Hoyt’s Pediatric Ophthalmology and Strabismus. 6th ed. Elsevier;2023:1099-1103. https://www.clinicalkey.com. Accessed June 2, 2023.
7. Gramatikov B. Detecting central fixation by means of artificial neural networks in a pediatric vision screener using retinal birefringence scanning.

8. BioMed Eng OnLine. 2016;15:15. https://link.springer.com/journal/12938. Accessed December 11, 2017.
9. Loudon SE, Rook CA, Nassif DS, et al. Rapid, high accuracy detection of strabismus and amblyopia using the pediatric vision scanner. Invest Ophthalmol Vis Sci. 2011;52:5043-5048. https://iovs.arvojournals.org. Accessed January 3, 2019.
10. US Food & Drug Administration (FDA). De novo summary: Pediatric vision scanner. https://www.fda.gov. Published December 13, 2013. Accessed October 24, 2017.
11. US Preventive Services Task Force (USPSTF). Recommendation Statement. Vision screening in children aged 6 months to 5 years. https://www.uspreventiveservicestaskforce.org. Published September 5, 2017. Accessed June 2, 2023.

Change Summary: Updated References

Description

Flicker photometry compares the brightness of two lights using the principle that flicker between two alternating lights of different color is at a minimum when the brightness of the two is equal. In heterochromatic flicker photometry (HFP), the two lights are alternated at frequencies typically between 10 and 20 hertz (Hz). The person administering the test adjusts the time-averaged luminance of one of the lights until the perception of flicker is absent or minimized.

The macula is a small, thin area at the center of the retina responsible for detailed central vision. Macular pigment is the yellow area in the central retina, made up of two carotenoids (lutein and zeaxanthin), that protects the retina from harmful blue light and maintains normal function of the macula in detailed central vision.

Measurement of the macular pigment optical density (MPOD) by HFP is accomplished by viewing a small circular light stimulus that alternates between a test wavelength that is absorbed by the macular pigment (typically - blue, 460 nm) and a reference wavelength that is not absorbed (typically - green, 540 nm). The individual being tested reportedly sees a flicker at the moment when the macular pigment is saturated by the absorbed (blue) light and presses a response button on the device, generating a MPOD measurement. Low MPOD is being studied as a possible risk factor for age-related macular degeneration (AMD).

Coverage Determination

Humana members may NOT be eligible under the Plan for heterochromatic flicker photometry measurement of macular pigment optical density for any indication. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

References

1. American Academy of Ophthalmology (AAO). Preferred Practice Pattern. Age- related macular degeneration. https://www.aao.org. Published September 7, 2019. Accessed December 9, 2022.

2. Bartlett H, Howells O, Eperjesi F. The role of macular pigment assessment in clinical practice: a review. Clin Exp Optom. 2010;93(5):300-308. https://www.onlinelibrary.wiley.com. Accessed May 30, 2018.
3. De Kinkelder R, van der Veen RLP, Verbaak FD, Faber, DJ, van Leeuwen TG, Berendschot TTJM. Macular pigment optical density measurements: evaluation of a device using herterochromatic flicker photometry. Eye. 2011;25:105-112. https://www.ncbi.nlm.nih.gov/pmc. Accessed May 30, 2018.

Hayes, Inc. Search & Summary (ARCHIVED). Heterochromatic flicker photometry for measurement of macular pigment optical density in patients with macular degeneration. https://evidence.haysesinc.com. Published June 14, 2018. Accessed December 29, 2020.

4. Suarez-Berumen K, Davey PG. Macular pigments optical density: a review of techniques of measurements and factors influencing their levels. JSM Ophthalmol. 2014;2(3):1-4. https://www.jscimedcentral.com. Accessed November 30, 2018.

Pattern Electroretinography Section

Effective Date: 02/02/2023
Section Revision Date: 02/02/2023
Section Review Date: 02/02/2023

Change Summary: Updated References

Description

0509T
Electroretinography (ERG) with interpretation and report, pattern (PERG)
Not Covered

An electroretinography (ERG) test, also known as an electroretinogram, measures the electrical response of the light-sensitive cells in the retina. Pattern electroretinography (PERG) is recorded in response to an alternating black-and-white checkerboard pattern. It is proposed clinically to determine the presence of a central retinal disorder as well as detect and monitor dysfunction of retinal ganglion cells caused by conditions such as glaucoma, optic neuropathies and primary ganglion cell diseases.

Coverage Determination

Humana members may NOT be eligible under the Plan for pattern electroretinography (PERG) for any indication. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

References

1. American Academy of Ophthalmology (AAO). Ophthalmic Technology Assessment. Assessment of visual function in glaucoma. https://www.aao.org. Published May 2011. Updated 2016. Accessed December 9, 2022.
2. ClinicalKey. Misra P, Lee P, Stein J. Screening for glaucoma. In: Yanoff M, Duker J. Ophthalmology. 6th ed. Elsevier;2023;953-057.e2. https://www.clinicalkey.com. Accessed December 12, 2022.
3. ECRI Institute. Hotline Response. Pattern electroretinography for detecting central retinal damage from diabetes. https://www.ecri.org. Published January 21, 2020. Accessed December 1, 2022.
4. ECRI Institute. Hotline Response. Pattern electroretinography for detecting central retinal damage from glaucoma. https://www.ecri.org. Published January 21, 2020. Accessed December 1, 2022.
5. Hayes, Inc. Evidence Analysis Research Brief (ARCHIVED). Pattern electroretinography for diagnosis of retinal function. https://evidence.haysesinc.com. Published July 17, 2020. Accessed December 1, 2022.
6. Hayes, Inc. Health Technology Assessment. Pattern electroretinography for diagnosis of glaucoma. https://evidence.hayesinc.com. Published April 6, 2021. Updated March 28, 2022.

Intraoperative Visual Axis Identification Using Patient Fixation

0514T
Intraoperative visual axis identification using patient fixation
Not Covered

Intraoperative visual axis identification using patient fixation purports to assist in creating a more precise circular incision when performing cataract removal by having the individual focus (fixate) on a specified point. This purportedly centers the capsulotomy based on an individual’s visual axis, rather than the center of the pupil or capsular bag. The procedure using this technology may be referred to as precision pulse capsulotomy. One example of a US Food & Drug Administration (FDA)- approved device is the Zepto capsulotomy system.

Coverage Determination

Humana members may NOT be eligible under the Plan for intraoperative visual axis identification using patient fixation during cataract surgery. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

References

1. ClinicalKey. Waltz K, Thompson V, Quesada G. Precision pulse capsulotomy: initial clinical experience in simple and challenging cataract surgery cases. J Cataract Refract Surg. 2017;43:606–614. https://www.clinicalkey.com. Accessed January 9, 2019.
2. Gundersen K, Potvin R. Clinical results after precision pulse capsulotomy. Clin Ophthalmol. 2020;14:4533-4540. https://www.pubmed.ncbi.nlm.nih.gov. Accessed January 7, 2021.
3. Hayes, Inc. Health Technology Assessment. Precision pulse capsulotomy (Zepto Capsulotomy System) for anterior capsulotomy during cataract surgery. https://evidence.haysesinc.com. Published March 23, 2020. Updated March 7, 2022. Accessed December 1, 2022.
4. US Food & Drug Administration (FDA). 510(k) summary: Zepto. https://www.fda.gov. Published June 2, 2017. Accessed January 7, 2019.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Change Summary: Updated References

Remote Optical Coherence Tomography (OCT)

• 0604T Optical coherence tomography (OCT) of retina, remote, patient-initiated image capture and transmission to a remote surveillance center unilateral or bilateral; initial device provision, set-up and patient education on use of equipment - Not Covered
• 0605T Optical coherence tomography (OCT) of retina, remote, patient-initiated image capture and transmission to a remote surveillance center unilateral or bilateral; remote surveillance center technical support, data analyses and reports, with a minimum of 8 daily recordings, each 30 days - Not Covered
• 0606T Optical coherence tomography (OCT) of retina, remote, patient-initiated image capture and transmission to a remote surveillance center unilateral or bilateral; review, interpretation and report by the prescribing physician or other qualified health care professional of remote - Not Covered

Optical coherence tomography (OCT) is a noninvasive, transpupillary imaging technology that measures the echo time delay and intensity of back-reflected near-infrared light to produce high-resolution, cross-sectional images of retinal anatomy. It is used to diagnose and monitor conditions that affect the retina, such as age-related macular degeneration (AMD or ARMD).

Notal Vision's Home OCT was designated a Breakthrough Device by the US Food & Drug Administration (FDA) as a complement to traditional office-based disease monitoring strategies for individuals with AMD. To initiate home monitoring, the individual receives the device as well as education and training on its use. Images are captured by the individual at home, on a regular basis, as instructed and sent to a remote surveillance center for data analysis before the health care provider completes the interpretation and report. Home OCT purports to lengthen the interval between office visits, while ensuring that disease status is regularly monitored. Current home monitoring techniques include checking monocular near vision by reading or the use of Amsler grid (or equivalent).

Code Compendium (Ophthalmology) Policy Number: HUM-0571-009 Page: 9 of 15

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Coverage Determination

Humana members may NOT be eligible under the Plan for remote OCT at home for age-related macular degeneration (AMD, ARMD) or any other indications. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

References

1. American Academy of Ophthalmology (AAO). Clinical Statement. Telemedicine for ophthalmology. https://www.aao.org. Published February 2018. Accessed December 9, 2022.
2. American Academy of Ophthalmology (AAO). Preferred Practice Pattern. Age-related macular degeneration. https://www.aao.org. Published September 7, 2019. Accessed December 9, 2022.
3. ClinicalKey. Clinical Overview. Macular degeneration. https://www.clinicalkey.com. Published January 1, 2022.

Iris Prosthesis and Insertion Section

Effective Date: 06/22/2023
Section Revision Date: 06/22/2023
Section Review Date: 06/22/2023

Change Summary: Updated References

Description

• 0616T Insertion of iris prosthesis, including suture fixation and repair or removal of iris, when performed; without removal of crystalline lens or intraocular lens, without insertion of intraocular lens - Not Covered
• 0617T Insertion of iris prosthesis, including suture fixation and repair or removal of iris, when performed; with removal of crystalline lens and insertion of intraocular lens - Not Covered
• 0618T Insertion of iris prosthesis, including suture fixation and repair or removal of iris, when performed; with secondary intraocular lens placement or intraocular lens exchange - Not Covered

C1839 Iris prosthesis - Not Covered

An iris prosthesis (artificial iris) is intended for implantation as a replacement for the natural iris of the eye if it is absent, damaged or has been removed. The prosthesis reduces light sensitivity and glare associated with aniridia through the artificial pupil at the center of the prosthesis but does not include optical power for refractive correction. The artificial iris also provides cosmetic improvement by altering the appearance of the eye to look more natural by matching the other eye as closely as possible. The CustomFlex Artificial Iris is an example of a US Food & Drug Administration (FDA)-approved iris prosthesis. Occasionally iris replacement may be combined with another surgical procedure, such as removal of the native lens, or insertion or exchange of an intraocular lens.

For information regarding intraocular lens implants, please refer to Intraocular Lens Implants Medical Coverage Policy.

Coverage Determination

Humana members may NOT be eligible under the Plan for an iris prosthesis for aniridia. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

References

1. ClinicalKey. Ayres B, Fant B, Landis Z, et al. Results of the United States Food and Drug Administration clinical trial of the CustomFlex artificial iris. Ophthalmology. 2022;129:614-625. https://www.clinicalkey.com. Accessed June 7, 2023.
2. ClinicalKey. Snyder ME, Schockman SL. Iris reconstruction surgery. In Mannis M, Holland E. Cornea. 5th ed. Elsevier; 2022:1522.e1-1530.e1. https://www.clinicalkey.com. Accessed June 7, 2023.
3. ECRI Institute. Clinical Evidence Assessment. CustomFlex artificial iris prosthesis (HumanOptics AG) for repairing iris defects. https://www.ecri.org. Published October 7, 2021. Accessed June 6, 2023.
4. Hayes, Inc. Evolving Evidence Review. CustomFlex artificial iris (HumanOptics AG, Clinical Research Consultants Inc.) for aniridia. Code Compendium (Ophthalmology) Policy Number: HUM-0571-009 Page: 11 of 15 https://evidence.hayesinc.com. Published March 10, 2022. Updated May 8, 2023. Accessed June 7, 2023.
5. US Food & Drug Administration (FDA).

Summary of Safety and Effectiveness Data

CustomFlex Artificial Iris. Published May 30, 2018. Accessed November 26, 2019.

Digital Amblyopia Therapy Section

Effective Date: 06/22/2023
Section Revision Date: 06/22/2023
Section Review Date: 06/22/2023

Change Summary: Updated Title, Description, References

• 0688T Treatment of amblyopia using an online digital program; assessment of patient performance and program data by physician or other qualified health care professional, with report, per calendar month - Not Covered
• 0704T Remote treatment of amblyopia using an eye tracking device; device supply with initial set-up and patient education on use of equipment - Not Covered
• 0705T Remote treatment of amblyopia using an eye tracking device; surveillance center technical support including data transmission with analysis, with a minimum of 18 training hours, each 30 days - Not Covered
• 0706T Remote treatment of amblyopia using an eye tracking device; interpretation and report by physician or other qualified health care professional, per calendar month - Not Covered
• A9292 Prescription digital visual therapy, software-only, - Not Covered

Code Compendium (Ophthalmology) Policy Number: HUM-0571-009 Page: 12 of 15

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Standard treatment for amblyopia (lazy eye) involves placing a patch over an individual’s strong eye, making the brain recognize input from the weaker eye forcing it to work and therefore become stronger. Therapy outcome is largely dependent upon adherence, which is a barrier for some individuals, particularly children. Virtual reality headsets and digital applications for smartphones, tablets and other devices have been developed as a compliment or alternative to patching.

Luminopia One, classified through the US Food & Drug Administration (FDA) De Novo process, is a digital therapy device that combines the use of a virtual reality headset (also called a head-mounted display [HMD]) with a compatible proprietary software application to support online amblyopia therapy at home. The individual selects a television show or movie; software algorithms modify the content presenting it differently to each eye forcing the brain to combine images. Luminopia One operates over WiFi and is available only by prescription.

CureSight-CS100 is another FDA-approved home treatment device available by prescription only. This digital amblyopia treatment uses a proprietary system that includes customized three-dimensional (3D) glasses and a tablet-like device supported by an integrated wireless cloud platform. While wearing the glasses and watching a video, eye-tracking technology blurs images in the center of vision for the dominant eye while the weaker eye sees clear content, encouraging the eyes to learn to work together. During the video, the system purportedly collects eye- tracking data and combines it with artificial intelligence (AI) algorithms to automatically adjust treatment according to the individual’s progress. Real-time monitoring and progress reports are available to healthcare providers and parents through a mobile health application or a cloud-based platform.

Coverage Determination

Humana members may NOT be eligible under the Plan for digital amblyopia therapy using Luminopia One, CureSight-CS100 or any other device.

This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

References

1. American Academy of Ophthalmology (AAO). Ophthalmic Technology Assessment. Binocular treatment of amblyopia. https://www.aao.org. Published February 2020. Accessed June 6, 2023.
2. Code Compendium (Ophthalmology) Policy Number: HUM-0571-009 Page: 13 of 15

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

2. American Academy of Ophthalmology (AAO). Preferred Practice Pattern. Amblyopia. https://www.aao.org. Published September 9, 2022. Accessed June 2, 2023.
3. Hayes, Inc. Emerging Technology Report. CureSight for amblyopia in children. https://evidence.hayesinc.com. Published April 11, 2022. Updated October 13, 2022. Accessed June 5, 2023.
4. Hayes, Inc. Evidence Analysis Research Brief. CureSight for treatment of amblyopia in children. https://evidence.hayesinc.com. Published November 8, 2022. Accessed June 5, 2023.
5. Hayes, Inc. Evolving Evidence Review. Luminopia One (Luminopia Inc.) for treatment of amblyopia in children. https://evidence.hayesinc.com. Published April 14, 2023. Accessed June 5, 2023.
6. UpToDate, Inc. Amblyopia in children: management and outcome. https://www.uptodate.com. Updated May 2023. Accessed June 2, 2023.
7. US Food & Drug Administration (FDA). 510(k) summary: Curesight-CS100. https://www.fda.gov. Published September 29, 2022. Accessed June 5, 2023.
8. US Food & Drug Administration (FDA). De novo summary: Luminopia One. https://www.fda.gov. Published March 1, 2021. Accessed June 5, 2023.
9. Wyganski-Jaffe T, Kushner B, Moshkovitz A, Belkin M, Yehezkel O. An eye-tracking-based dichoptic home treatment for amblyopia. Ophthalmology. 2023;130(3):274-285. https://www.aaojournal.org. Accessed June 6, 2023.

Provider Claims Codes

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.

Code Compendium (Ophthalmology) Policy Number: HUM-0571-009 Page: 14 of 15

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

CPT® Category III Code(s)

Code Compendium (Ophthalmology) Policy Number: HUM-0571-009 Page: 15 of 15

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.