Medical policy: Intraocular Lenses, Spectacle Correction and Iris Prosthesis

Número de política: MP 6.058

Fecha de entrada en vigor: 3/1/2026

Política

Intraocular lens implant (IOL)

Initial IOL implant

A standard monofocal intraocular lens (IOL) implant is medically necessary when the eye’s natural lens is absent including the following:

• Following cataract extraction
• Trauma to the eye which has damaged the lens
• Congenital cataract
• Congenital aphakia
• Lens subluxation/displacement

A standard monofocal intraocular lens (IOL) implant is medically necessary for anisometropia of three diopters or greater, and uncorrectable vision with the use of glasses or contact lenses.

Premium intraocular lens implants including but not limited to the following are investigational for any indication, including aphakia, because each is intended to reduce the need for reading glasses:

• Presbyopia correcting IOL (examples include but are not limited to: Array® Model SA40, ReZoom™, AcrySof® ReSTOR®, Tecnis® Multifocal IOL, Tecnis Symfony and Tecnis Symfony Toric, IntraOcular Lens Displacement Aspheric Optic™)
• Astigmatism correcting IOL (examples include but are not limited to: AcrySof IQ Toric IOL [Alcon] and Tecnis Toric Aspheric IOL)
• Phakic IOL (examples include but are not limited to: Artisan®, Staar Vision ICL™)

Replacement IOLs

Replacement of a medically necessary IOL is medically necessary when anatomical change, inflammatory response, or mechanical failure renders a previously implanted intraocular lens ineffective or nonfunctional.

Spectacle correction (eyeglasses/contacts) for aphakia (those who do not have an IOL)

Initial

For aphakia that is due to the congenital absence of a lens or following the removal of a cataract without the insertion of an IOL, the following are medically necessary for the first pair of glasses or aphakic contact lenses, or combination of lenses:

• Bifocal lenses in frames; or
• Trifocal lenses in frames; or
• Lenses in frames for far vision and lenses in frames for near vision; or
• Contact lens(es) for far vision (including cases of binocular and monocular aphakia)

Note: Contact lenses and lenses in frames for near vision to be worn either at the same time as the contact lens(es) and lenses in frames, or to be worn when the contacts have been removed may be considered medically necessary.

The following additions to lenses may be considered medically necessary:

• Anti-reflective coating (V2750), a clear lens treatment to decrease glare and internal/external reflections
• Tinted lenses (V2744, V2745) (unless to be used as sunglasses prescribed in addition to un-tinted prosthetic lenses)
• Polycarbonate lenses (V2784, S0580) for individuals with functional vision in only one eye
• Oversize lenses (V2780)
• UV protection (V2755)

Replacement lenses for spectacle correction due to aphakia (those who do not have an IOL)

For aphakia, an additional pair of lens(es), either eyeglass or contact lenses, are medically necessary each time the member’s prescription changes. Please reference the member’s certificate of coverage/benefits booklet.

Spectacle correction for pseudophakia (those who have an IOL)

One pair of eyeglasses or contact lenses is medically necessary after each cataract surgery with insertion of an IOL.

Note: When an individual has a cataract extraction with IOL insertion in one eye, subsequently has a cataract extraction with IOL insertion in the other eye and does not receive eyeglasses or contact lenses between the two surgical procedures, only one pair of eyeglasses or contact lenses after the second surgery is medically necessary. If an individual has a pair of eyeglasses, and has a cataract extraction with IOL insertion, and receives new lenses but not new frames after the surgery, the benefit will not cover new frames at a later date (unless it follows subsequent cataract extraction in the other eye).

Replacement lenses for spectacle correction due to pseudophakia

Reference the member’s certificate of coverage/benefits booklet for information on replacement frames, eyeglass lenses and contact lenses for members with pseudophakia (those who have an IOL).

The following are considered investigational for lenses due to pseudophakia or aphakia:

• Any lens customization such as, but not limited to:
  • Tinted lenses (V2745) including photochromatic lenses (V2744), used as sunglasses, which are used in addition to regular prosthetic lenses
  • Scratch resistant coating (V2760)
  • Mirror coating (V2761) reflective lens treatments
  • Polarization (V2762)
  • Deluxe lens feature (V2702) (includes services and features such as lens edge treatments and lens drilling)
  • Progressive lenses (V2781) (a multifocal lens that gradually changes in lens power from the top to the bottom eliminating the line that would otherwise be seen in a bifocal or trifocal lens)
  • Use of polycarbonate or similar material (V2784) or high index glass or plastic (V2782, V2783) to decrease weight or thickness of the lens
  • Specialty occupational multifocal lenses (V2786)
• Deluxe frames (V2025)
• Eyeglass cases (V2756)
• Contact lens cleaning solution and normal saline for contact lenses
• Low vision aids (V2600–V2615)

Prótesis de iris

An iris prosthesis may be considered medically necessary for:

• Aniridia
• Traumatic injury to the eye
• Albinism (achromasia)
• Melanoma of the eye

All other indications of iris prosthesis other than those described in the policy section are considered investigational, as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Cross-references:

• MP 2.103 Off label use of medications and other interventions
• MP 6.031 Gas permeable scleral contact lens and therapeutic soft contact lens

Variaciones del producto

Esta política solo se aplica a ciertos programas y productos administrados por Capital Blue Cross y está sujeta a variaciones en los beneficios. Consulte la información adicional a continuación.

FEP PPO - Consulte el Manual de Políticas Médicas de FEP.

Descripción/antecedentes

Intraocular lenses (IOL)

Aphakia is the absence of the lens of the eye due to surgical removal (as in surgery for cataract extraction), a perforating wound or ulcer, or congenital anomaly. It causes a loss of accommodation, far sightedness (hyperopia), and a deep anterior chamber.

When the natural lens is absent, much of the eye's focusing ability is lost. To restore vision, lost focusing power is usually replaced by one of three methods. The first method is the use of glasses (spectacles). The required lens power is high and the corrective lens quite thick. The second option is to wear a contact lens. This option can be utilized for cataract surgery on one or both eyes. The third option is to place a permanent IOL inside the eye. An intraocular lens implant is a synthetic, artificial lens placed inside the eye that replaces the focusing power of a natural lens.

Types of intraocular lenses

Standard monofocal IOL

Monofocal IOLs have a fixed or single focal point and are the current standard of treatment for lens replacement. A standard monofocal IOL is a lens that provides good vision at one focal point which can be set for distance, intermediate or near vision. With a fixed focusing power set for one specific distance, typically distance vision, eyeglasses are commonly required for reading or near vision tasks.

Premium IOLs

Premium IOLs are used for patients with the goal of reducing their dependency on glasses. Currently available premium IOLs include the toric, multifocal, and accommodative IOLs.

Toric IOLs

Toric IOLs are used for patients with significant astigmatism who desire less dependency on glasses. Because they also correct patients' astigmatism, toric IOLs will allow improved distance vision without glasses or improved reading vision without glasses.

Multifocal IOLs

Multifocal IOLs use either diffractive or refractive techniques to allow for two focal points: one for distance and one for reading. Multifocal IOLs are used for patients who desire both good distance and good reading vision without glasses.

With refractive multifocal IOLs, smaller pupil sizes may limit the amount of light passing through the different refractive rings, thus limiting the multifocal effect of the IOL. Furthermore, given the loss of contrast inherent in a multifocal IOL, they generally do not work well in patients with corneal disease, macular disease, glaucoma, or other ocular pathology.

Accommodative IOLs

Accommodative IOLs use materials and design techniques that allow the IOL to flex via contraction of the ciliary body, thus shifting the focal point from distance to intermediate, and from intermediate to near. Accommodative IOLs are used for patients whose goals include good uncorrected distance and intermediate vision, but who find it acceptable to wear glasses for extended periods of reading.

Anisometropia

Anisometropia is a condition where there is unequal refraction between a person's eyes. Common symptoms include blurred vision, double vision, sensitivity to light, nausea, fatigue, and disorientation. Anisometropia with a difference between the eyes of greater than 3D should be treated in children as soon as possible, as it can lead to amblyopia. Refractive surgical procedures are typically performed in adults. However, in select cases of severe refractive error, refractive surgery may be performed in children to prevent amblyopia, treat amblyopia that is not responding to standard therapy, or as a component of the treatment of amblyopia (e.g., in children with severe anisometropia and bilateral severe abnormal refraction who cannot or will not wear refractive correction). Though anisometropia typically develops in childhood, it can also occur after cataract surgery in adults.

Patients with a significant postoperative refractive error following cataract surgery typically have three options for its correction. The first is IOL exchange, which is best performed early in the postoperative period. The second option is corneal refractive surgery. The third option is the implantation of a piggyback IOL. Piggyback IOL implantation was first introduced in 1993 by Gayton and Sanders and involves the placement of another IOL in the bag or more recently, in the sulcus. Higher safety profile, easier technique, and the potential of removing the second lens are the advantages of piggyback IOL implantation over IOL exchange.

Types of iris prosthesis

CustomFlex artificial iris implants

CustomFlex artificial iris implants, from HumanOptics AG, is the only FDA approved stand-alone prosthetic iris. It is made of thin, foldable medical-grade silicone, and can be sized and colored for each individual patient. The CustomFlex artificial iris implant can be used to treat congenital and traumatic aniridia. It can also be used to treat iris defects due to other reasons or conditions, such as albinism, or surgical removal due to melanoma.

This product is restricted by the FDA to practitioners who have been trained and have experience in the surgical management and treatment of aniridia. The manufacturer has an online certification course that must be completed before a provider can order the device.

Fundamento

N/D

Definiciones

Amblyopia refers to reduced vision in an eye not correctable by a manifest refraction and with no obvious pathologic or structural cause.

Albinism (achromasia) is a rare group of genetic disorders that cause the skin, hair, or eyes to have little or no color. Albinism is also associated with vision problems. According to the National Organization for Albinism and Hypopigmentation, about 1 in 18,000 to 20,000 people in the United States have a form of albinism.

Aniridia is an eye disorder where the iris (colored ring structure of the eye that forms the pupil) is malformed. In some cases, other structures of the eye are poorly developed. The word aniridia implies that there is “no iris,” but in fact there is a small ring of iris tissue present which is variable in size. Because the iris tissue is so small, the pupil is very large and may be irregularly shaped. Aniridia is a bilateral condition, meaning it is present in both eyes. However, the two eyes may be affected differently by the disease.

Aphakia refers to the absence of the lens of an eye, occurring congenitally or as a result of trauma or surgery.

Congenital refers to a condition present at birth, whether inherited or caused by the environment, especially the uterine environment.

Cornea refers to the transparent anterior portion of the sclera (the fibrous outer layer of the eyeball), about one sixth of its surface; the first part of the eye that refracts light.

Intraocular lens is a mechanical transplant used in ophthalmology to replace the natural lens of the eye that has ceased to function due to disease (e.g., cataract) or otherwise functionally disrupted.

Photophobia, or light sensitivity, is an intolerance of light.

Exención de responsabilidad

Las políticas médicas de Capital Blue Cross se utilizan para determinar la cobertura de tecnologías, procedimientos, equipos y servicios médicos específicos. Estas políticas médicas no constituyen asesoramiento médico y están sujetas a cambios según lo exija la ley o las pruebas clínicas aplicables de las directrices de tratamiento independientes. Los proveedores que brindan tratamiento son individualmente responsables de los consejos médicos y el tratamiento de los miembros. Estas políticas no son una garantía de cobertura o pago. El pago de las reclamaciones está sujeto a la determinación del programa de beneficios del miembro y la elegibilidad en la fecha del servicio, y a la determinación de que los servicios son médicamente necesarios y apropiados. El procesamiento final de una reclamación se basa en los términos del contrato que se aplican al programa de beneficios de los miembros, incluidas las limitaciones y exclusiones de beneficios. Si un proveedor o miembro tiene alguna pregunta sobre esta política médica, debe comunicarse con Servicios para proveedores o Servicios para miembros de Capital Blue Cross.

Información de codificación

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. La identificación de un código en esta sección no denota cobertura, ya que la cobertura está determinada por los términos de la información de beneficios del miembro. Además, no todos los servicios cubiertos son elegibles para un reembolso por separado.

Investigational; therefore, not covered: premium intraocular lens implants

Investigational; therefore, not covered: spectacle correction (eyeglasses/contacts)

Investigational; therefore, not covered: low vision aids

Covered when medically necessary: intraocular lens implant (IOL)

Covered when medically necessary: spectacle correction (eyeglasses)

Covered when medically necessary: contacts

Covered when medically necessary for iris prosthesis

Referencias

1. Graham R. Helping patients select the best IOL. July 16, 2009. [Website]
2. Intraocular lens implant (IOL). American Association for Pediatric Ophthalmology and Strabismus. Updated 04/2020 [Website]
3. Ong H, Evans J, Allan A. Accommodative intraocular lens versus standard monofocal intraocular lens implantation in cataract surgery. Cochrane Database Syst Rev. 2014 May 1;5:CD009667. doi:10.1002/14651858.CD009667.pub2. Review. PMID:24788900
4. Olson R, Braga-Mele R. Cataract in the adult eye. Preferred practice pattern. 2021. American Academy of Ophthalmology
5. American Academy of Ophthalmology. Cosmetic iris implants carry risk of permanent eye damage, vision loss. 29 de octubre de 2014
6. Mayer CS, Reznikoff L, Hoffmann AE. Pupillary reconstruction and outcome after artificial iris implantation. Ophthalmology. 2016 May;123(5):1011-8. doi:10.1016/j.ophtha.2016.02.016. Epub 2016 Feb 28
7. Thompson CG, Fawzy K, Bryce JG, Noble BA. Implantation of a black diaphragm intraocular lens for traumatic aniridia. J Cataract Refract Surg. 1999 Jun;25(6):808-13
8. Tripathy K and Salini B. Aniridia. Actualización: 21 de febrero de 2022
9. Grant MK, Bobliew AM, Pierce JE, DeWitte J, Lauderdale JD. Structural brain abnormalities in 12 persons with aniridia. F1000Res. 2017;6:255. Published 2017 Mar 13. doi:10.12688/f1000research.11063.2
10. The U.S. Food and Drug Administration: FDA News Release. FDA approves first artificial iris. 30 de mayo de 2018
11. The U.S. Food and Drug Administration. Intraocular lens. Ophthalmic devices. Updated 7/3/2023
12. Department of Health and Human Services. CMS Recognized Presbyopia-Correcting (PC) IOLs and Astigmatism-Correcting (AC) IOLs. Last updated April 2022
13. iLase. What are the advantages and disadvantages of piggyback lens implants. iNVISION. Guide to advanced treatment options. Last updated January 2022
14. Rubenshtein J. Piggyback IOLs for residual refractive error after cataract surgery. Cataract and Refractive Surgery Today
15. Pandey SK, Sharma V. Piggyback IOL implantation: indications, surgical techniques, and complications. Adv Ophthalmol Vis Syst. 2018;8(2):135-137
16. Karjou Z, Jafarinasab MR, Seifi MH, Hassanpour K, Kheiri B. Secondary piggyback intraocular lens for management of residual ametropia after cataract surgery. J Ophthalmic Vis Res. 2021 Jan 20;16(1):12-20. doi:10.18502/jovr.v16i1.8244. PMID:33520123; PMCID: PMC7841270
17. Coats DK and Paysse EA. Refractive errors in children. In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; updated September 29, 2020. Literature review current through July 2022
18. Centers for Medicare and Medicaid Services. Local Coverage Determination L33793 Refractive Lenses
19. Centers for Medicare and Medicaid Services. National Coverage Determination 80.12 Intraocular lenses
20. Landsend ES, Utheim ØA, Pedersen HR, Lagali N, Baraas RC, Utheim TP. The genetics of congenital aniridia-a guide for the ophthalmologist. Surv Ophthalmol. 2018 Jan-Feb;63(1):105-113. doi:10.1016/j.survophthal.2017.09.004. Epub 2017 Sep 18
21. Behar-Cohen F, Baillet G, de Ayguavives T, Garcia PO, Krutmann J, Peña-García P, Remé C, Wolffsohn JS. Ultraviolet damage to the eye revisited: eye-sun protection factor (E-SPF), a new ultraviolet protection label for eyewear. Clin Ophthalmol. 2014;8:87-104. doi:10.2147/OPTH.S46189. Epub 2013 Dec 19. PMID:24379652; PMCID: PMC3782277
22. Kuo IC. How to protect your eyes from UV damage. News and publications from Johns Hopkins Medicine. 24 de julio de 2019
23. Hampel U, Effert HM, Kakkassery V, Heindl LM, Schlotzer AK. UV-strahlenexpositionsbedingte Veränderungen am vorderen Augenabschnitt [Alterations of the anterior segment of the eye caused by exposure to UV radiation]. Ophthalmologe. 2022;119(3):234-239. doi:10.1007/s00347-021-01531-0
24. Delcourt C, Cougnard-Grégoire A, Bonal M, et al. Lifetime exposure to ambient ultraviolet radiation and the risk for cataract extraction and age-related macular degeneration: the Alienor Study. Invest Ophthalmol Vis Sci. 2014;55(11):7619-7627. Published 2014 Oct 21. doi:10.1167/iovs.14-14471
25. Mayer CS, Hoffmann A.M., Prahs P, et al. Functional outcomes after combined iris and intraocular lens implantation in various iris and lens defects. BMC Ophthalmol. 2020;370 (2020)
26. Romano D, Bremond-Gignac D, Barbany M, et al. Artificial iris implantation in congenital aniridia: a systematic review. Survey of Ophthalmology. 2023;68(4):794-808
27. Sengör T, Gençg A, Atakan T. Management of contact lenses for visual development in pediatric aphakia. Turk J Ophthalmol. 2024;54(2):90-102. PMID 38645732 PMCID PMC11034540
28. Gardiner M. Overview of eye injuries in the emergency department. In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; Updated July 29, 2025. Literature review current through August 2025
29. Patel V, Pakravan P, Lai J, et al. Intraocular lens exchange: indications, comparative outcomes by technique, and complications. Clin Ophthalmol. 2023;17:941-951. Published 2023 Mar 23. doi:10.2147/OPTH.S399857