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«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 ...»

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National Medical Policy

Subject: Capsular Tension Rings

Policy Number: NMP89

Effective Date*: January 2004

Updated: February 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), citations(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 National Coverage Determination (NCD) National Coverage Manual Citation Local Coverage Determination (LCD)* Article (Local)* Other X 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) Capsular Tension Rings Feb 16 1  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 capsular tension rings medically necessary for adult members undergoing cataract extraction with intraocular lens implantation and are determined to have weak or partially absent zonules. Conditions associated with

weak or partially absent zonules may include:

 Primary zonular weakness (e.g., Marfan’s Syndrome)  Secondary zonular weakness (e.g., trauma or vitrectomy)  Cases of zonulysis  Cases of pseudoexfoliation  Cases of Marchesani’s Syndrome.

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 non- covered 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 Codes 379.32 Primary zonular weakness (e.g., Marfan’s Syndrome 090.49) 379.39 Secondary zonular weakness (e.g., trauma or vitrectomy) cases of zonulysis 366.11 Pseudoexfoliation, lense capsule 759.89 Marchesani (-Weill) Syndrome.

ICD-10 Codes H25-H28 Disorders of lens Q87.0 Congenital malformation syndromes predominantly affecting facial appearance Q87.42 Marfan’s syndrome with ocular manifestations CPT Codes 66982 Extracapsular cataract removal with insertion of intraocular lens prosthesis (1-stage procedure), manual or mechanical technique (eg, irrigation and aspiration or phacoemulsification), complex, requiring devices or techniques not generally used in routine cataract surgery (eg, iris expansion device, suture support by intraocular lens or primary posterior capsulorrhexis) or performed on patients in the amblyogenic developmental stage 66999 Unlisted Procedure, anterior segment of eye Capsular Tension Rings Feb 16 2 HCPCS Codes L8699 Prosthetic implant, not otherwise specified Scientific Rationale – Update February 2016 Celik et al (2015) sought to reveal the indications, clinical outcomes and complications of capsular tension ring (CTR) implantation in a series of consecutive phacoemulsification surgeries during a three-year interval. A review of all patients undergoing cataract surgery with insertion of a CTR between 2010 and 2013 was conducted at our tertiary teaching ophthalmology department. The demographic details of patients, indications and clinical outcomes of CTR implantation were evaluated. Between 2010 and 2013, 4316 phacoemulsification surgeries were performed and of these surgeries CTR implantation was done in 41 eyes of 36 patients. The indications of CTR implantation were zonular dehiscence or weakness associated with mature cataract (29.2%), trauma (24.3%), pseudoexfoliation syndrome (19.5%), retinitis pigmentosa (14.6%), degenerative myopia (9.7%), and lens coloboma (2.4%). Posterior chamber intraocular lens (PCIOL) was implanted into the capsular bag in all eyes. Dislocation of PCIOL was not observed in any case.

Transient IOP increased in 5 eyes (12%) and corneal edema in 14 eyes were noted.

Posterior capsular opasification in 1 eye (2.4%), anterior capsule phimosis in 1 eye (2.4%) and cystoid macular edema in 1 eye (2.4%) were detected as late complications. The authors concluded in complicated cataract surgeries, CTR implantation seems to improve clinical outcomes.





Scientific Rationale – Update February 2014 Wang et al (2013) sought to determine preoperative indications, intraoperative procedures, and outcomes of capsular tension ring (CTR) insertion during cataract surgery. A review of all patients undergoing cataract surgery with insertion of a CTR between July 2000 and June 2010 was conducted at a large tertiary teaching hospital in Australia. Information relating to each patient's demographic details, preoperative assessment, surgical procedure, and postoperative assessment were obtained.

Eighty-four eyes of 82 patients were included in this study. The main indications for CTR insertion were previous trauma, pseudoexfoliation syndrome, and mature cataracts. Twenty-one eyes (25.0%) did not have any obvious preoperative indication. A posterior capsule tear was the most common intraoperative complication (3.6%). An intraocular lens was successfully implanted in the bag in 72 eyes (85.7%). Postoperatively, the most common complications were a decentered intraocular lens (8.3%) and persistent corneal edema (6.0%). Overall, 61 eyes (72.6%) had better postoperative visual acuity compared with preoperative acuity, with 67 patients (79.8%) achieving vision of 20/40 or better. Investigators concluded for the majority of cases, CTR use in complex cataract surgeries is associated with improved postoperative outcomes. CTR implantation is most commonly required in patients with known risk factors for zonular instability.

Bayyoud et al (2013) described the long-term clinical outcomes after cataract surgery with and without capsular tension ring (CTR) in 52 eyes (46 patients) with retinitis pigmentosa (RP) in a retrospective study. Primary and secondary outcomes included visual acuity, secondary cataract, capsular contraction syndrome (CCS), intraocular pressure, cystoid macular edema (CME), intraocular lens dislocation and endophthalmitis. The mean age at surgery was about 53 years and the overall mean follow-up was 26 months (range 3-60 months). The mean preoperative logarithm of the minimal angle of resolution of the best corrected visual acuity (LogMAR BCVA) in the entire group was 1.45±0.85 (95% CI 1.21 to 1.69) and had increased to Capsular Tension Rings Feb 16 3

1.32±0.95 (95% CI 1.06 to 1.58, p=0.02). The mean preoperative and the mean postoperative LogMAR BCVA in the non-CTR group (group 1) improved from

1.16±0.8 (95% CI 0.83 to 1.48) to 0.98±0.88 (95% CI 0.62 to 1.33, p=0.02) and in the CTR group (group 2) from 1.74±0.81 (95% CI 1.42 to 2.07) to 1.66±0.90 (95% CI 1.3 to 2.03, p=0.31), respectively. Secondary cataract was observed in a total of 23 eyes (44%), of which 13 (50%) were belonged to group 1 and 10 (38%) to group

2. CCS was seen in a total of two eyes (4%) all under group 1. CME was noted in two eyes (4%), of which one belonged to group 1 and a second one to group 2.

Endophthalmitis was not observed in any group. Investigators concluded both surgical approaches were beneficial to the RP patients. Eyes under group 2 showed less long-term postoperative complications. This includes secondary cataract and CCS. Eyes under group 1 performed significantly better in respect of visual acuity.

Further research would include insights into the genetic subsets.

Scientific Rationale – Initial It is estimated by the World Health Organization that 12 to 15 million people go blind from cataracts and 8 million cataract operation are carried out world-wide each year.

Last year, approximately 2.7 million Americans underwent cataract surgery. Most cataract surgeries are now performed using microscopic size incisions, advanced ultrasonic equipment to fragment cataracts into tiny fragments, and folded intraocular lenses (IOLs) inserted into the capsular bag to maintain small incision size. Over 98% of cataract surgeries are successfully completed without surgical complications, and more than 95% of patients have improved vision.

Weak or broken zonules affect approximately one to three percent of all cataract surgery patients and can rarely be anticipated prior to surgery. Zonules are the small fibers that regulate the shape of the lens, relaxing and expanding to allow the lens to increase its curvature and refract (bend) light rays for near vision, and contract to flatten the curve of the lens to focus on distant objects. Some complications of cataract surgery with weakened zonules include dislocation of the nucleus, vitreous loss, lens subluxation into the vitreous, the need to position the intraocular lens in another part of the eye, and ultimately the loss of optimal visual acuity.

Capsular tension rings (CTRs) have been widely used in Europe, Australia and other countries for a number of years. The rates of the worldwide sales of the rings over the past decade had produced few complaints, in part because use of the device was restricted to unusual conditions. Review of current medical literature indicated that the majority of clinical studies have been performed outside the United States, though clinical trials have been occurring in the US since 1996.

In January of 2002, the FDA granted conditional approval of the CTR. In the Phase 1 and II trials, 540 CTRs were inserted by eleven surgeons at participating 5 sites.

Primary efficacy measures were intraocular lense (IOL) centration, long-term stability, and reduction of vitreous loss at surgery. Despite the lack of a reliable methodology for measuring IOL centration, only 10% of eyes reported clinically detectable decentration at two years, and 7.6% or 6.4 % in the two groups investigated at one year. Other adverse event complications of Core Phase I and Core Phase II patients included glaucoma, uveitis, cystoid macular edema, retinal detachment, branch retinal vein occlusion, phthisis, broken eyelets, and device explantation. In the September 2003 Journal of Cataract and Refractive Surgery, Capsular Tension Rings Feb 16 4 Cionni et al reported similar results in a study of 90 CTRs at the Cincinnati Eye Institute.

One study evaluated the effectiveness of the CTR in influencing the formation of capsule opacification but data is currently limited. The results were compared with a control group of 36 eyes that did not have a capsular tension ring but had similar surgery. The results indicated that in the group with the capsular tension ring and implantation, 7.7% of patients had moderate or severe posterior capsule opacification, compared with 36.1% in the control group. Further studies are underway.

In conclusion, intracapsular tension rings appear to have some use during cataract surgery to provide additional zonular support of the lens, helping to maintain the central position of the lens post-operatively, and may also assist in intra-operative placing of the lens. However, there is conflicting evidence as to whether these rings prevent the occurrence of capsular bag shrinkage, and the use of these rings may not be appropriate in children as there appears to be the potential for retardation of the eye’s axial growth (although whether this is a direct result of the intracapsular ring is not clear). With further research into the occurrence and dynamics of capsular bag shrinkage and growth retardation, intracapsular rings have the potential to significantly assist in intraocular lens placement.

Review History January 13, 2004 Medical Advisory Council Review April 2006 Update - no changes April 2008 Update – no changes. Codes reviewed.

February 2012 Update. Added revised Medicare table. No revisions.

February 2013 Update – no revisions. Code updates.

February 2014 Update – no revisions February 2015 Update – no revisions February 2016 Update – no revisions References – Update February 2016

1. Canović S, Kovačević S, Kolega MŠ, et al. Capsular tension ring in damaged zonules. Coll Antropol. 2015 Mar;39(1):237-8.

2. Celik E, Koklu B, Dogan E, et al. Indications and clinical outcomes of capsular tension ring implantation in phacoemulsification surgery at a tertiary teaching hospital: A review of 4316 cataract surgeries. J Fr Ophtalmol. 2015 Dec;38(10):955-9.

3. Date RC, Olson MD, Shah M, et al. Outcomes of a modified capsular tension ring with a single black occluder paddle for eyes with congenital and acquired iris defects: Report 2. J Cataract Refract Surg. 2015 Sep;41(9):1934-44.

References – Update February 2015

1. Keles S, Kartal B, Apil A, et al. Nd: YAG laser posterior capsulotomy rates in myopic eyes after implantation of capsular tension ring. Med Sci Monit. 2014 Aug 18;20:1469-73.

2. Ma X, Li Z. Capsular tension ring implantation after lens extraction for management of subluxated cataracts. Int J Clin Exp Pathol. 2014 Jun 15;7(7):3733-8

3. Weber CH, Cionni RJ. All about capsular tension rings. Curr Opin Ophthalmol.

2015 Jan;26(1):10-5.

–  –  –

References – Update February 2014

1. Bayyoud T, Bartz-Schmidt KU, Yoeruek E. Long-term clinical results after cataract surgery with and without capsular tension ring in patients with retinitis pigmentosa: a retrospective study. BMJ Open. 2013 Apr 26;3(4).



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