Description/Scope

This document addresses the use of presbyopia-correcting intraocular lenses (IOLs) and astigmatism-correcting IOLs.

Note: Please see the following related document for additional information:

• CG-SURG-77 Refractive Surgery

Position Statement

Not Medically Necessary:

The use of presbyopia-correcting intraocular lenses is considered not medically necessary for all indications.

The use of astigmatism-correcting intraocular lenses is considered not medically necessary for all indications.

Rationale

Conventional monofocal IOLs are designed with a fixed optical power to provide primarily distance vision, and thus these lenses are not designed to simultaneously correct the presbyopia, which is part of the natural process of aging seen in most adults undergoing cataract surgery. Therefore, individuals after cataract surgery who have presbyopia may continue to wear glasses or contact lenses for near vision and individuals with pre-existing astigmatism may require glasses or contact lenses for optimal vision following cataract extraction as well. Intraocular lenses are now available for the visual correction of presbyopia, and more recently IOLs have been developed for the visual correction of astigmatism following cataract surgery. The use of presbyopia-correcting IOLs and astigmatism-correcting IOLs as alternatives to monofocal IOLs is considered to be predominately for comfort and convenience, that is, to eliminate the need for spectacles or contact lenses.

Some individuals may not like eyeglasses following cataract surgery because the unaffected eye may still retain some accommodative ability. A study by Mesci and colleagues (2010) attempted to determine whether a unilateral multifocal IOL had an additive effect on binocular vision (the ability to use both eyes to see a single image). Four groups of individuals (n=87) had implants following cataract surgery. The safety and efficacy of 4 different types of implants were studied; 24 individuals had monofocal implants (group 1), 21 individuals had accommodating implants (group 2), 22 individuals had diffractive multifocal implants (group 3), and 20 individuals had refractive multifocal implants (group 4). Follow-up exams occurred postoperatively at 1 week, 2 weeks, 1, 3, 6, 9, 12, 14, and 18 months. Eighteen (18) months after surgery, refractions, monocular distance and near best-corrected visual acuity was measured along with distance-corrected near and intermediate visual acuity, monocular and binocular distance, and intermediate and near uncorrected visual acuity. Between groups 2, 3, and 4, there was no difference observed in the distance and near best-corrected visual acuities. The multifocal groups (3 and 4) had better near vision than groups 1 and 2. No difference was observed in the near visual acuity of groups 3 and 4. And while this study showed the multifocal groups (3 and 4) had higher rates of eyeglass independence, better stereopsis and satisfactory vision than the monofocal and accommodating IOLs (groups 1 and 2), this study is limited by the lack of randomization and the small number of individuals participating in each arm of the study.

In 2012 Agresta and colleagues reported on a systematic review which evaluated the efficacy of multifocal IOLs in individuals with presbyotic cataracts. A total of 29 studies met inclusion criteria. Uncorrected distance visual acuity was reported by 26 studies and uncorrected near visual acuity was reported by 25 studies. Gains in improvement for uncorrected distance visual acuity were greater than uncorrected near visual acuity. Limitations of the studies included differences in measurements of quality of life, spectacle independence and visual disturbances. There was a lack of consistency in reporting these outcomes and a lack of a validated instrument to measure these outcomes. And while this systematic review analyzed studies which reported improvements in uncorrected visual acuity in participants with cataracts and presbyopia, further analysis is needed to report on spectacle independence and quality of life with consistent measurement of outcomes.

Crystalens^™
The Crystalens (Eyeonics, Inc., Aliso Viejo, CA) received Food and Drug Administration (FDA) approval through the premarket approval (PMA) process on November 14, 2003. The FDA-labeled indication reads as follows: “The Crystalens is an accommodating intraocular lens (IOL) that is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.” Insertion of the accommodating intraocular lens requires a distinct surgical procedure. The FDA approval was based on a prospective nonrandomized study of 324 subjects followed for 1 year; 90% of the population was Caucasian with a mean age of 69.7 years (FDA, 2003). The device was not studied in younger adults or children. The clinical effectiveness endpoint was visual performance at near, intermediate and distance. A total of 93.5% achieved visual acuities of 20/32 or better, uncorrected at near, distance or intermediate 1 year after surgery. Individuals were surveyed regarding their use of spectacles; 73% stated they either did not wear spectacles or only wore them rarely. No long-term follow up is available. Eyeonics was acquired by Bausch & Lomb (Rochester, NY) in January 2008.

AcrySof^® ReSTOR^®
The AcrySof ReSTOR Apodized Diffractive Optic Posterior Chamber multifocal IOL (Alcon Research Ltd., Fort Worth, TX) received approval through the PMA process on March 21, 2005. This device, implanted in the capsular bag, is intended for the visual correction of aphakia secondary to removal of a cataractous lens in adults with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. The FDA approval was based on a study of 802 individuals enrolled in a trial to determine the safety of the ReSTOR IOL. A total of 760 individuals were evaluated at 1 year. Of these, 566 first eyes were implanted with the ReSTOR IOL and 194 first eyes were implanted with a monofocal control IOL. Of the first eyes implanted with each lens model, the fellow eye was also implanted with the same lens model in 549 eyes and 181 eyes (monofocal control). Mean contrast acuities and contrast sensitivity were clinically equivalent between the ReSTOR IOL and the monofocal control group. Glare/flare, problems with night vision, and halos were reported significantly (p<0.05) more often by the ReSTOR individuals compared to monofocal control group.

ReZoom^™
The ReZoom IOL (Advanced Medical Optics, Inc. Santa Ana, CA) is a second-generation refractive, multifocal lens, which received supplemental approval through the PMA process on March 23, 2005. This lens distributes light over five optic zones arranged in concentric circles to provide near and distant vision. The device, implanted in the capsular bag, is intended for visual correction of aphakia in persons 60 years or older in whom a cataractous lens has been removed and who desire near vision without reading spectacles and increased spectacle independence over a range of distances. FDA approval was based on a clinical trial of a first generation multifocal lens, the ARRAY^® Multifocal Silicone Posterior Chamber Lens. Using a prospective, nonrandomized design, 456 eyes (456 individuals) were implanted with the ARRAY IOL. Both historic and prospective controls (n=102) were used. Results indicate the ARRAY provides comparable distance and intermediate vision compared to monofocal IOL with increased near vision. Under low contrast conditions, i.e., driving at night or in poor visibility, visual acuity is reduced compared to a monofocal lens. The supplemental approvals beginning in 2008 now show ReZoom as the trade name. The ReZoom has not been clinically evaluated. Advanced Medical Optics (AMO) was acquired by Abbott (Park, Illinois) in February 2009.

Astigmatism-Correcting IOLs
In a 2002 study by Till, 81 individuals had cataract surgery and implantation of an astigmatism-correcting IOL. After a mean follow-up of 23 weeks, an estimated 20% of the individuals with astigmatism achieved good vision and reduced their need for distance glasses. Mendicute and colleagues (2008) evaluated the results of astigmatism-correcting IOL implantation following cataract surgery in individuals with preexisting astigmatism. They studied 30 eyes of 15 individuals. The eyes in this study had a 70% reduction in astigmatism after astigmatism correcting IOL implantation. However, the authors also concluded that further studies with larger sample sizes and longer follow-up should continue to evaluate the efficacy of this IOL in cataract surgery.

Background/Overview

Clouding of the lens of the eye is common in older persons and rarely is seen in newborn children. This condition is generally known as “cataracts,” but more specifically as “adult cataracts” when present in previously unaffected adults and as “congenital cataracts” when present in newborn infants. The only available treatment for cataracts at this time is surgical replacement of the affected lens with a prosthetic lens.

Presbyopia-correcting intraocular lenses (IOLs), including, but not limited to, accommodating and multifocal IOLs, are designed to restore a fuller range of near, intermediate and far distance vision as compared to monofocal IOLs. Astigmatism-correcting lenses are designed to reduce the need for glasses for clear distance vision following cataract surgery.

Standard Intraocular Lenses
Standard prosthetic intraocular lenses are small polymer discs designed to have the same optical properties as an individual’s natural lens, and are used to replace diseased lenses removed during cataract surgery. The normal lens is attached to muscles in the eye, which alter the shape of the lens to focus the eye on objects at various distances. Standard prosthetic lenses cannot duplicate this function (accommodation).

Accommodating Lenses
Accommodating intraocular lenses (AIOLs) have been proposed as an alternative to standard lens prostheses. AIOLs are designed to work with the muscles of the eye to reproduce the focusing function of the lens, by changing the position of the lens rather than changing its shape. AIOLS are made of similar polymers as standard lens prostheses, and have additional features, referred to as “hinges”, allowing the prosthesis to move with the eye naturally to provide visual focusing for near, intermediate, and distance vision. At this time, AIOLs have not been discussed as an alternative treatment for congenital cataracts and only adult cataracts have been studied. The majority of individuals with adult cataracts also require corrective lenses to correct the presbyopia (lack of accommodation) created by a fixed monofocal prosthetic lens. The use of AIOLs may simultaneously correct presbyopia and thus eliminate the need for reading glasses.

Multifocal Lenses
The AcrySof ReSTOR IOL uses apodized diffractive technology which responds to how wide or small the pupil might be to provide near, intermediate, and distance vision. Twelve concentric steps of gradually decreasing step heights allocate energy based on lighting conditions and activity, creating a full range of quality vision. ReZoom is a multifocal refractive IOL that distributes light over five optical zones to provide near, intermediate, and distance vision.

Definitions

Accommodation: The ability of the eye to increase its focusing power. As an object is viewed closer up, greater focusing power is needed to continue to see it clearly.

Apodization: The gradual reduction or blending of the diffractive step heights.

Astigmatism: A common form of visual impairment in which part of an image is blurred, due to an irregularity in the curvature of the front surface of the eye, the cornea.

Cataract: Cloudiness of the natural lens inside the eye which can blur vision.

Cornea: The clear, transparent cover over the iris and pupil on the front part of the eye. The cornea is the first part of the eye that bends (or refracts) the light and provides most of the focusing power of the eye.

Crystalline (natural) lens: The eye’s natural lens that bends light (refracts) to provide some of the focusing power of the eye. The eye's natural lens is able to change shape allowing the eye to focus at different distances.

Diffraction: The spreading of light, occurring when light passes through discontinuities (i.e., steps or edges). In an optical system, light can be diffracted to form multiple focal points or images.

Intraocular lens: A lens made of silicone, plastic or acrylic material surgically implanted inside the eye.

Presbyopia: A type of age-associated refractive error resulting in progressive loss of focusing power of the lens of the eye which can cause difficulty seeing objects at near distance, or close-up.

Stereopsis: The ability to see objects as three-dimensional and the judge their distance in space by putting together mental imagines from both eyes.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Not Medically Necessary:

HCPCS
V2787	Astigmatism correcting function of intraocular lens
V2788	Presbyopia correcting function of intraocular lens
ICD-10 Diagnosis
	All diagnoses

References

Peer Reviewed Publications:

1. Agresta B, Knorz MC, Kohnen T, et al. Distance and near visual acuity improvement after implantation of multifocal intraocular lenses in cataract patients with presbyopia: a systematic review. J Refract Surg. 2012; 28(6):426-435.
2. Chiam PJ, Chan JH, Aggarwal RK, et al. ReSTOR intraocular lens implantation in cataract surgery: quality of vision. J Cataract Refract Surg. 2006; 32(9):1459-1463.
3. Cumming JS, Colvard DM, Dell SJ, et al. Clinical evaluation of the Crystalens AT-45 accommodating intraocular lens: results of the U.S. Food and Drug Administration clinical trial. J Cataract Refract Surg. 2006; 32(5):812-825.
4. Kohnen T, Allen D, Boureau C, et al. European multicenter study of the AcrySof ReSTOR apodized diffractive intraocular lens. Ophthalmology. 2006; 113(4):574-584.
5. Macsai MS, Padnick-Silver L, et al. Visual outcomes after accommodating intraocular lens implantation. J Cataract Refract Surg. 2006; 32(4):628-633.
6. Marchini G, Mora P, Pedrotti E, et al. Functional assessment of two different accommodative intraocular lenses compared with a monofocal intraocular lens. Ophthalmology. 2007; 114(11):2038-2043.
7. Mendicute J, Irigoyen C, Aramberri J, et al. Foldable toric intraocular lens for astigmatism correction in cataract patients. J Cataract Refract Surg. 2008; 34(4):601-607.
8. Mesci C, Erbil HH, Olgun A, Yaylali SA. Visual performances with monofocal, accommodating, and multifocal intraocular lenses in patients with unilateral cataract. Am J Ophthalmol. 2010; 150(5):609-618.
9. Pepose JS, Qazi MA, Davies J, et al. Visual performance of patients with bilateral vs combination Crystalens, ReZoom, and ReSTOR intraocular lens implants. Am J Ophthalmol. 2007; 144(3):347-357. 
10. Souza CE, Muccioli C, Soriano ES, et al. Visual performance of AcrySof ReSTOR apodized diffractive IOL: a prospective comparative trial. Am J Ophthalmol. 2006; 141(5):827-832.
11. Till JS, Yoder PR Jr, Wilcox TK, Spielman JL. Toric intraocular lens implantation: 100 consecutive cases. J Cataract Refract Surg. 2002; 28(2):295-301.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Academy of Ophthalmology. Preferred Practice Pattern^®. For additional information visit the AAO website: http://one.aao.org/CE/PracticeGuidelines/Snippet.aspx?cid=49fa4bc8-537e-4f60-8293-34faaff897a8. Accessed on March 5, 2018.
   • Cataract in the Adult Eye (October 2016)
   • Refractive Errors & Refractive Surgery (November 2017)
2. Centers for Medicare and Medicaid Services. CMS Ruling. Ruling Requirements for Determining Payment Made for Insertion of Astigmatism-Correcting Intraocular Lenses following Cataract Surgery. Ruling No. 1536-R Date January 22, 2007. Available at: http://www.cms.hhs.gov/Rulings/downloads/CMS1536R.pdf. Accessed on March 1, 2018.
3. Centers for Medicare and Medicaid Services. CMS Ruling. Requirements for Determining Coverage of Presbyopia-Correcting Intraocular Lenses that Provide Two Distinct Services for the Patient: (1) Restoration of Distance Vision Following Cataract Surgery, and (2) Refractive Correction of Near and Intermediate Vision with Less Dependency on Eyeglasses or Contact Lenses. Ruling No. 05-01 Date: May 3, 2005. Available at: http://www.cms.hhs.gov/Rulings/downloads/CMSR0501.pdf. Accessed on March 1, 2018.
4. Centers for Medicare and Medicaid Services. National Coverage Determination: Intraocular Lenses (IOLs). NCD #80.12. Effective May 19, 1997. Available at: http://www.cms.gov/mcd/index_chapter_list.asp. Accessed on March 1, 2018.
5. de Silva SR, Evans JR, Kirthi V, et al. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev. 2016 (9):CD003169.
6. Ong HS, Evans JR, Allan BD. Accommodative intraocular lens versus standard monofocal intraocular lens implantation in cataract surgery. Cochrane Database Syst Rev. 2014; 5:CD009667.
7. U.S. Food and Drug Administration Summary of Safety and Effectiveness. crystalens Model AT-45 Accommodating Posterior Chamber Intraocular Lens. No. P030002. Rockville, MD: FDA. November 14, 2003. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030002b.pdf. Accessed on March 5, 2018.
8. U. S. Food and Drug Administration Summary of Safety and Effectiveness. Model SA40N AMO Array Multifocal Ultraviolet-Absorbing Silicone Posterior Chamber Intraocular Lens. No. P960028. Rockville, MD: FDA. September 5, 1997. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/P960028.pdf. Accessed on March 1, 2018.
9. U.S. Food and Drug Administration Summary of Safety and Effectiveness. AcrySof ReSTOR Apodized Diffractive Optic Posterior Chamber Intraocular Lenses. No. P040020. Rockville, MD: FDA. March 21, 2005. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040020b.pdf Accessed on March 1, 2018.

Websites for Additional Information

1. National Library of Medicine. Medical Encyclopedia: Cataracts. Updated August 24, 2013. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/001001.htm. Accessed on March 1, 2018.

Index

Accommodating Intraocular Lens
ACRYSOF Toric Posterior Chamber Intraocular Lens
Astigmatism-Correcting Intraocular Lens
Crystalens
Multifocal Intraocular Lens
Presbyopia-Correcting Intraocular Lens
ReSTOR
ReZoom
Staar Toric (astigmatism correcting) IOL implant
TECNIS Multifocal Foldable Silicone and Acrylic Intraocular Lenses
TECNIS Symfony^®

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History

Status	Date	Action
Reviewed	03/22/2018	Medical Policy & Technology Assessment Committee (MPTAC) review. The document header wording updated from “Current Effective Date” to “Publish Date.” Updated Rationale and References sections.
Reviewed	05/04/2017	MPTAC review. Updated References and Index sections.
Reviewed	05/05/2016	MPTAC review. Updated Description/Scope, Background/Overview, and References sections. Removed ICD-9 codes from Coding section.
Reviewed	05/07/2015	MPTAC review. Updated References.
Reviewed	05/15/2014	MPTAC review. Updated Index.
Reviewed	05/09/2013	MPTAC review. Updated Rationale and References.
Reviewed	05/10/2012	MPTAC review. Updated References.
Reviewed	05/19/2011	MPTAC review. Updated Rationale, References and Index.
Reviewed	05/13/2010	MPTAC review. No change to Position Statement.
Revised	05/21/2009	MPTAC review. Added cross reference to SURG.00009. Updated Rationale, Definitions, Coding, References and Web Sites. Title change to Presbyopia and Astigmatism-Correcting Intraocular Lenses. Revision of not medically necessary statement to include astigmatism-correcting intraocular lenses.
Reviewed	05/15/2008	MPTAC review. References updated.
Reviewed	05/17/2007	MPTAC review. Rationale and References updated. Coding updated; removed HCPCS code V2702.
Revised	06/08/2006	MPTAC review. Title changed to Presbyopia-Correcting Intraocular Lenses. Multifocal Lenses added as an example of presbyopia-correcting IOLs. Position revised from investigational/not medically necessary to not medically necessary.
	11/18/2005	Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).
Reviewed	09/22/2005	MPTAC review. Revision based on Pre-Merger Anthem and Pre-Merger WellPoint Harmonization.

Pre-Merger Organizations	Last Review Date	Document Number	Title
Anthem, Inc.	10/28/2004	SURG.00061	Accommodating Intraocular Lens
WellPoint Health Networks, Inc.			No Document