Accommodating Intraocular Lens

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National Medical Policy

Subject: Accomodating Intraocular Lens (i.e.

Crystalens, ReStore, Synchrony, ReZoom,

TECNIS Multifocal Lens)

Policy Number: NMP178

Effective Date*: October 2004

Updated:

March 2016

This National Medical Policy is subject to the terms in the

IMPORTANT NOTICE at the end of this document

For Medicaid Plans: Please refer to the appropriate State’s Medicaid manual(s), publication(s), citation(s), and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net

Medical Policies

The Centers for Medicare & Medicaid Services (CMS)

For Medicare Advantage members please refer to the following for coverage guidelines first:

Use Source Reference/Website Link

X National Coverage Determination

(NCD)

Intraocular Lenses (IOLs) [80.12]

National Coverage Manual Citation

Local Coverage Determination (LCD) *

Article (Local) *

X Other Medicare Learning Matters Network. Instructions for Implementing the Centers for Medicare &

Medicaid (CMS) Ruling CMS 1536-R;

Astigmatism-Correcting Intraocular Lens (A-C

IOLs): http://www.cms.gov/MLNMattersArticles/downlo ads/MM5527.pdf

CMS Ruling #1536-R: http://www.cms.gov/Rulings/downloads/CMS15

36R.pdf http://www.cms.gov/Medicare/Medicare-Fee-for-

Service-Payment/ASCPayment/NTIOLs.html http://www.cms.gov/Outreach-and-

Education/Medicare-Learning-Network-

MLN/MLNProducts/downloads/VisionServices_FactShe et_ICN907165.pdf

http://www.cms.gov/Medicare/Medicare-Fee-for-

Service-

Payment/HospitalOutpatientPPS/Downloads/PCIOL-

Accommodating Intraocular Lens Mar 16 1

ACIOL.pdf

CMS Manual System. Department of Health & Human

Services (DHHS). Pub 100-04 Medicare Claims

Processing. Transmittal 914. Date: APRIL 21, 2006

Change Request 4361. SUBJECT: Additional $50

Payment for New Technology Intraocular Lenses

(NTIOLs) Furnished in Ambulatory Surgical Centers

(ASCs): https://www.cms.gov/Regulations-and-

Guidance/Guidance/Transmittals/downloads/R914CP.

pdf

None Use Health Net Policy

Instructions

 Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions.

 Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under “Reference/Website” and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS

Manual Chapter 4 Section 90.2)

 If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual.

 If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance.

Current Policy Statement

Health Net, Inc. considers the use of premium multifocal intraocular lenses (IOLs), presbyopic-correcting lenses, astigmatism-correcting lenses (aspheric, toric), or accommodating IOLs following cataract extraction not medically necessary. These lenses do not offer a superior medical benefit for these lenses over the monofocal

IOL other than decreasing the need for corrective eye wear.

NOTE: Health Net will provide reimbursement for the cost of conventional

(standard) or monofocal IOLs post cataract extraction. However, members may choose to receive a premium lens but must agree to assume liability for the additional expense related to these lenses.

Codes Related To This Policy

NOTE:

The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive.

On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures have been replaced by ICD-10 code sets.

ICD-9

366.00– 366.90 Cataract

743.30- 743.39 Congenital cataract and lens anomalies

Accommodating Intraocular Lens Mar 16 2

ICD- 10 Codes

E08.36

E09.36

E10.36

E11.36

E13.36

H25.011-H25.9

H26.001-H26.09

H26.101-H26.139

H26.20

H26.211-H26.219

H26.221-H26.229

H26.231-H26.239

H26.411-H26.419

H26.30-H26.33

H26.40

H26.491-H26.499

H26.8

Diabetes mellitus due to underlying conditions with diabetic cataract

Drug or chemical induced diabetes mellitus with diabetic cataract

Type 1 diabetes mellitus with diabetic cataract

Type 2 diabetes mellitus with diabetic cataract

Other specified diabetes mellitus with diabetic cataract

Age related cataract, code range

Infantile and juvenile cataract, code range

Traumatic cataract, code range

Unspecified complicated cataract

Cataract with neovascularization

Cataract secondary to ocular disorders (degenerative)

(inflammatory)

Glaucomatous flecks (subcapsular)

Soemmering’s ring

Drug-induced cataract

Unspecified secondary cataract

Other secondary cataract

Other specified cataract

H26.9

H28

Unspecified cataract

Cataract in diseases classified elsewhere

CPT Codes

66982 Extracapsular cataract removal with insertion of intraocular lens prosthesis

(one stage procedure), manual or mechanical technique (e.g., irrigation and aspiration or phacoemulsification), complex, requiring devices or techniques not generally used in routine cataract surgery (e.g., iris expansion device, suture support for intraocular lens, or primary posterior capsulorrhexis) or performed on patients in the amblyogenic developmental stage

66983 Intracapsular cataract extraction with insertion of intraocular lens

prosthesis (one stage procedure)

66984 Extracapsular cataract removal with insertion of intraocular lens prosthesis

(one stage procedure), manual or mechanical technique (e.g., irrigation and aspiration or phacoemulsification)

66985 Insertion of intraocular lens prosthesis (secondary implant), not associated

with concurrent cataract removal

66986 Exchange of intraocular lens

HCPCS Codes

C1780 Lens, intraocular (new technology)

Q1004 New technology intraocular lens category 4 as defined in Federal Register notice

Q1005 New technology intraocular lens category 5 as defined in Federal Register

V2630 notice

Anterior chamber intraocular lens

V2631 Iris supported intraocular lens

V2632 Posterior chamber intraocular lens

Premium Lenses

S0596 Phakic intraocular lens for correction of refractive error

V2787 Astigmatism-correcting function of an intraocular lens

Accommodating Intraocular Lens Mar 16 3

V2788 Presbyopia correcting function of intraocular lens

Definitions

Monofocal intraocular lens (IOL) are standard replacement lenses implanted after cataract surgery and usually have a fixed focusing power designed for either near or distance vision. The placement of a monofocal IOL usually requires corrective lenses or eyeglasses after surgery.

Premium Lenses

Multifocal IOLs are designed to provide near and far vision simultaneously thru the use either diffrative or refractive techniques to distribute light to distance, intermediate or near focal points depending on the amount of ambient light.

Intermediate vision is usually compromised and issues regarding glare, halos, variable loss of clarity and low contrast acuity have been reported by patients.

Presbyopia correcting lenses (e.g. multifocal, pseudoaccommodating) with or without additional features (e.g., toric, aspheric, ultraviolet protection), have been developed to improve visual acuity and may be referred to as premium IOLs.

Examples of P-C

IOLs include various models of TECNIS multifocal acrylic and silicone lens, ReZoom,

Acrysof ReSOTR.

Toric IOL are astigmatism-correcting intraocular lenses that provide correction or reduction of pre-existing astigmatism by incorporating a special curvature into the

IOL. Examples of A-C IOLs include various models of TENSIS Toric, Acrysof IQ Toric,

Trulign Toric and STAAR Toric.

Accommodating IOLs have hinges on both ends of the lens to facilitate flexion/contraction of the ciliary body by changing the position the lens (rather than shape) with the intent of allowing focus for distance, intermediate to near vision.

Crystalens is an example of an accommodating IOL.

Scientific Rationale – Update March 2014

Dhital et al (2013) compared visual acuity, intraocular lens (IOL) movement, and depth of focus with the Crystalens HD single-optic accommodating IOL and the

Tecnis ZCB00 aspheric monofocal IOL at a single center in a prospective randomized controlled trial. Patients with bilateral symptomatic cataract had bilateral sequential cataract surgery within 6 weeks with randomized implantation of the accommodating or monofocal IOL in both eyes. Exclusion criteria included other ocular conditions and corneal astigmatism greater than 2.00 diopters. The primary outcome was uniocular distance-corrected near visual acuity (DCNVA). Secondary measures were IOL movement, depth of focus, intermediate and distance vision, objective refraction, and pupil size at distance and near fixation. Results from 3 months postoperatively are presented. Three months postoperatively, 64 patients (32 in each group) were available for study. The distance vision was not statistically significantly different between the accommodating IOL and monofocal IOL (mean 0.05 logMAR versus 0.06 logMAR). The mean DCNVA (0.48 logMAR ± 0.15 [SD] versus 0.61 ± 0.13 logMAR) and intermediate visual acuity (0.08 ± 0.1 logMAR versus 0.20 ± 0.09 logMAR) were significantly better with the accommodating IOL (P<.001). Neither IOL had clinically significant movement, and near vision did not directly correlate with movement of the accommodating IOL. The accommodating IOL provided greater depth of focus.

Investigators concluded near and intermediate acuities were better with the accommodating IOL. This effect was not directly linked to IOL movement but was at least partly due to depth of focus.

Ang et al (2013) compared the visual acuity and quality of vision achieved with three widely-usedIOLs in subjects with bilateral cataracts. This three-arm, parallel,

Accommodating Intraocular Lens Mar 16 4

prospective, partially masked, single-surgeon study randomized 78 subjects to receive bilateral Crystalens Advanced Optics (AO) accommodating IOLs, AcrySof IQ

ReSTOR +3.0 multifocal IOLs, or TECNIS Multifocal IOLs. Examinations were assessed through days 120 to 180. The Crystalens AO group had statistically significantly better monocular and binocular, high-contrast (HC) and low-contrast

(LC) uncorrected intermediate visual acuity, HC and LC distance-corrected intermediate visual acuity, and significantly fewer monocular and binocular halos and starbursts than did the ReSTOR and TECNIS groups. Monocular and binocular, HC and LC uncorrected near visual acuity exhibited no significant differences among the three lenses. For monocular and binocular HC distance-corrected near visual acuity, the Crystalens AO performed significantly better than the TECNIS and was not significantly different from the ReSTOR. For monocular and binocular LC distancecorrected near visual acuity, the Crystalens AO performed significantly better than both the ReSTOR and the TECNIS. Contrast sensitivity was clinically similar between groups. The Crystalens AO produced statistically fewer halos and starbursts.

Investigators concluded all three IOLs had excellent uncorrected acuity results at all distances and had good safety, confirming the established safety and effectiveness of these IOLs. Distance and near vision were similar between all three IOLs, and the

Crystalens AO provided statistically significantly better intermediate vision.

Zamora-Alejo et al (2013) performed an evaluation of accommodation with a bilateral accommodating IOL versus monofocal IOLs. Patients received accommodating IOL (Crystalens HD) bilaterally after cataract surgery. These were compared to a matched group receiving monofocal IOLs. Preoperative and postoperative distance corrected distance, intermediate, and near vision were evaluated. Objective accommodation was measured with the WAM-5500 Binocular

Autorefractor/Keratometer (Grand Seiko, Pty Ltd., Hiroshima, Japan). Nineteen patients were included. Ten received the Crystalens HD in both eyes and nine received one of three monofocal lenses in each eye. Mean postoperative distance corrected distance visual acuity was not statistically different between the two groups. Mean distance corrected intermediate vision was better in the Crystalens HD group (logMAR 0.24 ± 0.11 [control], logMAR 0.11 ± 0.10 [Crystalens HD], P =

.033). The groups did not differ significantly for mean distance corrected near vision

(logMAR 0.54 ± 0.12 [control], logMAR 0.42 ± 0.15 [Crystalens HD], P = .087).

However, a significantly greater proportion of Crystalens HD eyes achieved 0.4 or

0.3 logMAR for near wearing their distance correction (P = .013). With distance correction, the mean spherical equivalent failed to show any myopia with accommodative effort in either group. Low contrast and low luminance contrast acuity were not significantly different. Investigators concluded the Crystalens HD showed some benefit for intermediate visual function compared to the monofocal

IOLs with both groups wearing full correction for distance. There were no significant signs of accommodation in either group.

Beiko et al (2013) compared near vision and quality of vision after controlling for pseudoaccommodation in patients with single-optic accommodating IOLs or monofocal IOLs targeted for mini-monovision in a prospective randomized controlled clinical trial. Patients were randomized to bilateral implantation of the Crystalens HD silicone accommodating IOL, the Tetraflex acrylic accommodating IOL, or the Tecnis

1-piece monofocal (nonaccommodating) control IOL. The target refraction for the control group was mini-monovision (-0.25 diopter [D] and -0.75 D). In the accommodating IOL groups, manufacturer recommendations were followed; that is, a target refraction of mini-monovision (-0.25 D and -0.75 D) in the acrylic accommodating group and +0.25 D in the silicone accommodating group. Pupil size and anterior corneal spherical aberration were measured preoperatively. Main outcome measures were binocular target refraction corrected near vision and contrast sensitivity 3 months postoperatively. There were no statistically significant

Accommodating Intraocular Lens Mar 16 5

differences between the 3 groups in age, photopic or mesopic pupil size, anterior corneal spherical aberration, corneal astigmatism, or the power of the IOLs implanted. Binocular distance visual acuity at 4 m was 20/20(-) in all groups, intermediate vision was approximately 20/25, and near vision was 20/40 to 20/50.

There were no statistically significant differences between the 3 groups in visual acuity or contrast sensitivity. Investigators concluded single-optic accommodating

IOLs did not offer a significant advantage in near visual acuity over mini-monovision with a monofocal (nonaccommodating) IOL.

Scientific Rationale – March 2012

Lubinski et al (2011) evaluated 3 and 6 months binocular visual outcomes after cataract surgery using a multifocal IOL "mix and match" approach, with a refractive

(ReZoom) IOL in the dominant eye and a diffractive (Tecnis) IOL in the fellow eye.

Three and 6 months after bilateral cataract surgery, 40 eyes of 20 patients were evaluated for binocular UDVA, UNVA and UIVA (logMAR), spectacle independence, contrast sensitivities (CS), stereoscopic vision, subjective symptoms, patient satisfaction and complications. Three months after surgery mean binocular UDVA did not differ from the six-month follow-up. All patients achieved binocular UNVA of

0.0 at both follow-ups. Mean binocular UIVA improved significantly from 0.06 to 0.01

(p<0.027), 6 months after surgery. All patients had very function at good visual all distances and were totally spectacle independent. CS under various conditions was within normal age-matched limits at both follow-ups. For some spatial frequencies six months postoperative results were significantly better than for the 3 months follow-up (p<0.05). Stereoscopic vision was normal. A low degree of glare/halo was detected in 75% of subjects. Overall patient satisfaction was very high (9.6/10).

There were no postoperative complications. The investigators concluded mixing and matching multifocal IOLs in selected cataract patients provides an excellent visual outcome, a high level of patient satisfaction and spectacle-free visual function. A period of neuroadaptation lasting at least six months is necessary to obtain better visual function results.

Altaie et al (2011) evaluated the efficacy, safety, and predictability of apodized, diffractive multifocal IOLs following phacoemulsification for cataract or clear lens extraction in a prospective, observational study of consecutive patients undergoing cataract or clear lens extraction (CLE) with insertion of the AcrySof Natural ReSTOR

IOL (SN60D3). Assessment included: manifest/cycloplegic refraction, corneal topography, biometry (Zeiss Humphrey IOLmaster), monocular and binocular uncorrected (UCVA) and best spectacle corrected (BCVA) distance and near visual acuity. Main outcome measures were visual acuity, spectacle dependence. 363 eyes of 203 patients underwent surgery (54.8% cataract, 45.2% CLE). Mean preoperative BCVA 0.30LogMAR, (6/12) [cataract] and 0.0LogMAR, (6/6) [CLE]. 161

(98.2%) of the CLE group were hyperopic and presbyopic (mean SEQ +4.25 ±

3.5D). Post-operatively UCVA was ≥6/12 in 96.5% of eyes (51.9 % ≥ 6/6) and ≥N5 in 95% of eyes. At six months 97.2% of the eyes were ≤1.00 D and 182 (91.4%)

[cataract] and 137 (83.5%) [CLE] eyes ≤0.50 D of target SEQ. 81.9% (n = 168) reported spectacle independence. 10.2% reported minor halos or other visual phenomena. No subjects required IOL exchange. Safety index at 6 months was 2.5 and 1.17 for cataract and CLE respectively. Investigators concluded the apodized, diffractive multifocal IOL predictably provided excellent near UCVA and good distance

UCVA following cataract and CLE surgery with a high rate of spectacle independence.

A minority of subjects note halos and other visual phenomena that may be related to

IOL design.

Accommodating Intraocular Lens Mar 16 6

Scientific Rationale – April 2011

Astigmatism-correcting intraocular lenses (IOLs), also known as toric IOLs provide correction or reduction of pre-existing astigmatism by incorporating a special curvature into the IOL. Prior to the advent of toric IOLs, pre-existing astigmatism could only be corrected by making limbal relaxing incisions into the cornea during cataract surgery to change its curvature, or by wearing astigmatism correcting eyeglasses after surgery.

Other recent technological advancements to intraocular lens development include the development of aspheric lenses, toric lenses and ultraviolet absorbing lenses. Several of these features may be applied to either monofocal or multifocal lenses, and in some cases, to accommodating IOLs. Aspheric lenses are slightly flatter and improve contrast sensitivity, decrease halos and improve optical quality, such as night driving performance. Toric lenses decrease eyeglass dependence due to astigmatism

(American Academy of Ophthalmology, 2006). Ultraviolet (UV) light absorbing lenses are made out of special materials that absorb UV and blue light, which are intended to protect the retina from the harmful effects of UV light.

In a 2002 study by Till, eighty-one patients had cataract surgery and implantation of an astigmatism-correcting IOL. After a mean follow-up of 23 weeks, an estimated

20% of the patients 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 patients. The eyes in this study had a 70% reduction in astigmatism after astigmatism correcting IOL implantation.

However, the authors also concluded "Further studies with larger samples and longer follow-up should continue to evaluate the efficacy and safety of this IOL in cataract surgery." At this time, there is insufficient evidence from the available peer-reviewed literature to conclude that astigmatism-correcting IOLs are superior to the use of monofocal IOLs in conjunction with conventional eyewear.

Scientific Rationale – Update April 2008

Published data supporting accommodating intraocular lens technology continues to be limited. Study population numbers have been low with short-term results. There lacks sufficient evidence in the published, peer-reviewed literature to support longterm patient outcomes regarding safety and improved visual acuity. At the present time, it is unclear if the accommodating technology is superior to monofocal or multifocal intraocular lens (IOLs).

Based on a review of the current evidence, the National Institute of Health and

Clinical Excellence (NICE) issued guidance (2007) on implantation of accommodating intraocular lenses noting that accommodating lenses are at a relatively early stage of development and the technology is evolving. They report the current evidence suggests that there is evidence of short-term efficacy in correcting visual acuity, however, there is inadequate evidence that the procedure achieves accommodation. They reported no major safety concerns associated with the implantation of accommodating lenses for cataract.

Scientific Rationale

Crystalens is a single-focus posterior chamber accommodating intraocular lens (IOL) composed of a solid silicon called Biosil. It was developed to address the loss of intermediate and near focusing ability after cataract surgery. The design element that makes Crystalens the state-of-the-art replacement lens are "hinges" which are designed to allow the lens to move, or accommodate, to focus on objects near, far and all distances in-between seamlessly, thus functioning more like the eye's natural

Accommodating Intraocular Lens Mar 16 7

lens. This device was shown to successfully restore 20/40 vision, or better, far away vision and near point vision in approximately 88.4% of patients in a clinical study, compared to 35.9% of patients who were implanted with a standard IOL. During clinical trials, the adverse events experienced were minimal and included persistent iritis (<1.0%), persistent cystoid macular edema (<1.0%), and cumulative cystoid macular edema (3.7%).

In the clinical studies with 324 patients over the age of 50, 100% could see images at intermediate distances (24"-36'), 98.4% could read print the size of the stock quotes in the newspaper or phone numbers in the telephone book and 98.4% could see distant objects all without glasses. 100% could see well enough without their glasses to pass their driver's test. It was also shown in the clinical studies that significantly more patients implanted with a crystalens (88.4%) could see better at all distances than patients implanted with a standard IOL (35.9%).

At this point, the FDA has approved the Crystalens for the treatment of presbyopia or loss of focus flexibility in cataract patients, although they may be implanted in patients without cataracts in what is considered an off-label use. Another IOL awaiting FDA approval, known as the ReStore lens from AMO, is a pseudoaccomodative lens that gives simultaneous near and distance vision. Additionally, the

Synchrony IOL from Visiogen is a dual-optic accommodative lens and is currently in overseas clinical trials. It is expected that the FDA will eventually approve the

Crystalens for people who don’t have cataracts, but wish to have their refractive errors corrected.

Even though preliminary studies have shown increased accommodative range and better near visual acuity than a control group with conventional IOLs, further research is necessary to confirm these results in masked, randomized, prospective studies and to confirm further the accommodative power of this group of new IOLs.

Review History

October 12, 2004

April 18, 2006

March 2007

April 2008

April 2010

April 2011

March 2012

March 2013

March 2014

March 2015

Medical Advisory Council

Update with no changes

Code updates

Update with no changes

Update with no changes

Update with Medicare table and added toric lenses

Update – no revisions

Update – no revisions. Codes updated.

Update – no revision

Review to consider member buy up

May 2015

March 2016

Added option for member buy up to premium lenses

Update – no revision. Codes updated.

This policy is based on the following evidence-based guidelines:

1.

Philippine Academy of Ophthalmology. Clinical practice guideline for the management of cataract among adults. Philippines: Philippine Academy of

Ophthalmology; 2001.

2.

American Academy of Ophthalmology (AAO), Anterior Segment Panel. Cataract in the adult eye. San Francisco (CA): American Academy of Ophthalmology (AAO);

2001. Update 2011. Available at: http://one.aao.org/preferred-practicepattern/cataract-in-adult-eye-ppp--october-2011

3.

National Institute of Health and Clinical Excellence (NICE) Implantation of accommodating intraocular lenses for cataract. Feb 2007.

Accommodating Intraocular Lens Mar 16 8

References – Update March 2016

1.

Lipson MJ. Overview of contact lenses. UpToDate. September 11, 2015.

2.

Tomás-Juana J, Murueta-Goyena LA. Axial movement of the dual-optic accommodating intraocular lens for the correction of the presbyopia: Optical performance and clinical outcomes. J Optom. 2015 Apr-Jun; 8(2): 67–76. doi:

10.1016/j.optom.2014.06.004.

References – Update March 2014

1.

Ang R, Martinez G, Cruz E, et al. Prospective evaluation of visual outcomes with three presbyopia-correcting intraocular lenses following cataract surgery. Clin

Ophthalmol. 2013;7:1811-23.

2.

Beiko GH. Comparison of visual results with accommodating intraocular lenses versus mini-monovision with a monofocal intraocular lens. J Cataract Refract

Surg. 2013 Jan;39(1):48-55

3.

Dhital A, Spalton DJ, Gala KB. Comparison of near vision, intraocular lens movement, and depth of focus with accommodating and monofocal intraocular

4.

lenses. J Cataract Refract Surg. 2013 Dec;39(12):1872-8.

Pérez-Vives C, Montés-Micó R, López-Gil N, et al. Crystalens HD intraocular lens analysis using an adaptive optics visual simulator. Optom Vis Sci. 2013

Dec;90(12):1413-23.

5.

Zamora-Alejo KV, Moore SP, Parker DG, et al. Objective accommodation measurement of the Crystalens HD compared to monofocal intraocular lenses. J

Refract Surg. 2013 Feb;29(2):133-9.

References – Update March 2013

1.

Jacobs DS. Cataract in adults. UpToDate. August 3, 2012.

2.

Yeu E. Vision Correction Procedures. Bope & Kellerman: Conn's Current Therapy

2013, 1st ed. Saunders, An Imprint of Elsevier.

References – Update March 2012

1.

Altaie R, Ring CP, Morarji J, et al. A Prospective Analysis of Visual Outcomes

Using Apodized, Diffractive Multifocal Intraocular lenses Following

Phacoemulsification for Cataract or Clear Lens Extraction. Clin Experiment

Ophthalmol. 2011 Aug 22. doi: 10.1111/j.1442-9071.2011.02671.x

2.

Lichtinger A, Rootman DS. Intraocular lenses for presbyopia correction: past,

3.

present, and future. Curr Opin Ophthalmol. 2012 Jan;23(1):40-6

Lubiński W, Podboraczyńska-Jodko K, Gronkowska-Serafin J, Karczewicz D.

Visual outcomes three and six months after implantation of diffractive and refractive multifocal IOL combinations. Klin Oczna. 2011;113(7-9):209-15.

4.

Swiątek B, Michalska-Małecka K, Dorecka M, et al. Results of the AcrySof Toric intraocular lenses implantation. Med Sci Monit. 2012 Jan;18(1):PI1-4.

References – Updated April 2011

1.

Bauer NJ, et al. Astigmatism management in cataract surgery with AcrySof toric intraocular lens. J Cataract Refract Surg 2008 Sep;34(9):1483-8.

2.

Horn JF. Status of toric intraocular lenses. Curr Opin Ophthalmol 2007

Feb;18(1):58-61.

3.

Jampaulo M, et al. Long-term Starr toric intraocular lens rotational stability. Am J

Ophthalmol 2008 Oct;146 (4):550-3.

4.

Mendicute J, et al. Toric intraocular lens versus opposite clear corneal incisions to correct astigmatism in eyes having cataract surgery. J Cataract Refract Surg

2009 Mar;35(3):451-8.

5.

Souza CE, Muccioli C, Soriano ES, Chalita MR, Oliveira F, Freitas LL, Meire LP,

Tamaki C, Belfort R Jr. Visual performance of AcrySof ReSTOR apodized

Accommodating Intraocular Lens Mar 16 9

6.

diffractive IOL: a prospective comparative trial. Am J Ophthalmol. 2006

May;141(5):827-32,epub 2006 Mar 20.

Harman FE, Maling S, Kampougeris G, Langan L, Khan I, Lee N, Bloom PA.

Comparing the 1CU accommodative, multifocal, and monofocal intraocular lenses: a randomized trial. Ophthalmology. 2008 Jun;115(6):993-1001.

7.

Gierek-Ciaciura S, Cwalina L, Bednarski L, Mrukwa-Kominek E. A comparative clinical study of the visual results between three types of multifocal lenses.

Graefes Arch Clin Exp Ophthalmol. 2010;248(1):133-140

8.

Marshall J, Cionni RJ, Davison J, et al. Clinical results of the blue-light filtering

AcrySof Natural foldable acrylic intraocular lens. J Cataract Refract Surg.

9.

2005;31(12):2319-2323.

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

10.

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.

References – Updated April 2010

1.

Martínez Palmer A, Gómez Faiña P, España Albelda A, et al. Visual function with bilateral implantation of monofocal and multifocal intraocular lenses: A prospective, randomized, controlled clinical trial. J Refract Surg. 2008;24(3):257-

264.

2.

National Institute for Health and Clinical Excellence (NICE). Implantation of multifocal (non-accommodative) intraocular lenses during cataract surgery.

Interventional Procedure Guidance 264. London, UK: NICE; June 2008. Available at: http://www.nice.org.uk/nicemedia/pdf/IPG264Guidance.pdf.

References – Update April 2008

1.

Harman FE, Maling S, Kampougeris G, et al. Comparing the 1CU

Accommodative, Multifocal, and Monofocal Intraocular Lenses A Randomized

2.

Trial. Ophthalmology. 2007 Nov 19.

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 Sep;144(3):347-357

3.

Marchini G, Mora P, Pedrotti E, et al. Functional assessment of two different accommodative intraocular lenses compared with a monofocal intraocular lens.

Ophthalmology. 2007 Nov;114(11):2038-43. Epub 2007 Jun 6.

4.

Findl O, Leydolt C. Meta-analysis of accommodating intraocular lenses. J

Cataract Refract Surg. 2007 Mar;33(3):522-7

5.

Galand A. Accommodating intraocular lenses. Rev Med Liege. 2006

Apr;61(4):245-8

6.

Cumming JS, Colvard DM, Dell SJ, et al. Clinical evaluation of the Crystalens AT-

7.

9.

45 accommodating intraocular lens: results of the U.S. Food and Drug

Administration clinical trial. J Cataract Refract Surg. 2006 May;32(5):812-25.

Macsai MS, Padnick-Silver L, Fontes BM. Visual outcomes after accommodating intraocular lens implantation. J Cataract Refract Surg. 2006 Apr;32(4):628-33.

8.

Buratto L, Di Meglio G. Accommodative intraocular lenses: short-term visual results of two different lens types. Eur J Ophthalmol. 2006 Jan-Feb;16(1):33-9.

Dogru M, Honda R, Omoto M, et al. Early visual results with the 1CU accommodating intraocular lens. J Cataract Refract Surg. 2005 May;31(5):895-

902.

References

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U.S. Department of Health and Human Services, Public Health Service, Agency for Health Care Policy and Research. Cataract in Adults: Management of

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Functional Impairment. Clinical Practice Guideline no. 4, AHCPR Publication no.

93-0544. Rockville, MD: Agency for Health Care Policy and Research, February

1993.

American Academy of Ophthalmology. Cataract in the adult eye. San Francisco,

CA: AAO; 1996.

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U.S. Department of Health and Human Services. Health Care Financing

Administration. Medicare Program; Limitations on Medicare Coverage of Cataract

Surgery. Federal Register. Friday, October 6, 1995; 60(194):52396-52403.

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American College of Eye Surgeons. Outpatient Ophthalmic Surgery Society,

Society for Excellence in Eye Care, Society for Geriatric Ophthalmology, and the

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Ophthalmic Anesthesia Society. Alternate Guidelines for Cataract Surgery.

Bellevue, WA: McIntyre Eye Clinic and Surgical Center, February 1993.

Mamalis N, Crandall AS, Linebarger E, et al. Effect of intraocular lens size on posterior capsule opacification after phaecoemulsification. J Cataract Refract

Surg. 1995;21(1):99-102.

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Young TL, Bloom JN, Ruttum M, et al. The IOLAB, Inc pediatric intraocular lens study. AAPOS Research Committee. American Association for Pediatric

Ophthalmology and Strabismus. J AAPOS. 1999;3(5):295-302.

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Foster CS, Stavrou P, Zafirakis P, et al. Intraocular lens removal patients with

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uveitis. Am J Ophthalmol. 1999;128(1):31-37.

Teichmann KD. Landmarks in the evolution of cataract surgery. Surv Ophthalmol.

2000;44(6):541.

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Castells X, Alonso J, Castilla M, et al. Outcomes and costs of outpatient and inpatient cataract surgery: A randomised clinical trial. J Clin Epidemiol.

2001;54(1):23-29.

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Verhulst E, Vrijghem JC. Accuracy of intraocular lens power calculations using the

Zeiss IOL master. A prospective study. Bull Soc Belge Ophtalmol. 2001;(281):61-

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2001;27(6):861-867.

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Eyeonics, Inc. Imagine Crystalens. Aliso Viejo, CA; Eyeonics; 2003.

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Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net’s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are

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