Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Implantation of Intrastromal Corneal Ring Segments (ICRS)

Policy #:11.05.11c

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

The implantation of intrastromal corneal ring segments (ICRS) prescription inserts for the treatment of myopia is considered a benefit contract exclusion for all Company products and groups. Therefore, this service is not covered or eligible for reimbursement consideration.

MEDICALLY NECESSARY

The implantation of any FDA-approved ICRS (e.g., INTACS) is considered medically necessary and, therefore, covered for the treatment of keratoconus. As per the US Food and Drug Administration (FDA) humanitarian device exemption (HDE) designation, this device is indicated for the reduction or elimination of myopia and/or astigmatism in individuals with keratoconus who are no longer able to achieve adequate vision with contact lenses or eyeglasses, so that their functional vision may be restored and the need for corneal transplantation may be deferred. Individuals with keratoconus who may be treated with INTACS prescription inserts are those who meet all of the following criteria:
  • The individual has experienced a progressive deterioration in vision, such that they can no longer achieve adequate functional vision on a daily basis with either contact lenses or eyeglasses.
  • The individual is 21 years of age or older.
  • The individual has clear central corneas.
  • The individual has a corneal thickness of 450µm or greater at the proposed incision site.
  • Corneal transplantation is the only remaining option to improve functional vision.

EXPERIMENTAL/INVESTIGATIONAL

The use of ICRS for any other indication not listed above is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of those uses cannot be established by review of the available published peer-reviewed literature.

A HUD may only be used in facilities that have an institutional review board (IRB) to oversee the clinical application of such devices. The IRB must approve the application of the device to ensure that it will be used in accordance with the FDA-approved indication(s). In addition, documentation of IRB approval may be requested by the Company to ensure compliance with the FDA-approved HUD indication(s).

ABSOLUTE CONTRAINDICATIONS

The following are absolute contraindications for INTACS prescription inserts for keratoconus:
  • Individuals who have abnormally thin corneas or who have corneal thickness of 449µm or less at the proposed incision site
  • Individuals with collagen, vascular, autoimmune, or immunodeficiency diseases
  • Individuals who are pregnant or nursing
  • The presence of ocular conditions, such as recurrent corneal erosion syndrome or corneal dystrophy, that may predispose the individual to future complications
  • Individuals who are taking one or more of the following medications: isotretinoin (Accutane) and amiodarone hydrochloride (Cordarone)
  • Individuals who have Fuchs’ dystrophy or have suspected endothelial cell deficiency

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, the implantation of ICRS for the treatment of myopia is a benefit contract exclusion for the Company's products. Therefore, this service is not covered or eligible for reimbursement consideration.

Subject to the terms and conditions of the applicable benefit contract, the implantation of ICRS for the treatment of keratoconus is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in the medical policy are met.

Subject to the terms and conditions of the applicable benefit contract, devices that are used for the FDA-approved humanitarian device exemption (HDE) indications listed in this policy are covered under the medical benefits of the Company's products.

However, when the implantation of intrastromal corneal ring segments (ICRS) is performed on an individual who has any of the absolute contraindications listed in the policy, it is considered not medically necessary and, therefore, not covered.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

KeraVision Intacs™ (KeraVision, Inc.; Fremont, CA) were approved as a treatment for myopia by the US Food and Drug Administration (FDA) on April 9, 1999. INTACS® Prescription Inserts for Keratoconus (0.25 mm, 0.30 mm, 0.35 mm) (Addition Technology; Des Plaines, IL) received a humanitarian device exemption (HDE) designation as a treatment for keratoconus by the FDA on July 26, 2004. On March 23, 2010, the FDA expanded the HDE to include additional sizes (0.21, 0.40mm, 0.45mm) INTACS.

Description

Myopia, also known as nearsightedness, is an error of visual focusing that causes distant objects to appear blurred. With this condition, the cornea is too steep, and light rays are focused in front of the retina, rather than directly on its surface. Traditional treatment options for myopia are eyeglasses or contact lenses, which correct vision by shifting the focus point of the eye to the retina. Surgical options, such as Lasik, also exist, which reshape the retina.

Keratoconus, a condition that causes decreased visual acuity, is common in individuals with myopia. It deteriorates the corneal structure by gradually bulging the cornea's normal round shape into a cone shape. The most common initial treatment for keratoconus is hard contact lenses. For individuals who develop an intolerance to contact lenses (hard or soft), the next treatment option is a procedure called penetrating keratoplasty (PK) (i.e., corneal grafting), which typically improves visual acuity. However, PK puts individuals at risk for perioperative complications and can lead to endothelial cell loss over time, which is of particular concern for younger individuals. In 2016, the FDA approved Photrexa® Viscous, Photrexa® and the KXL® System for corneal cross linking (CXL) in the treatment of progressive keratoconus. CXL is a technique which uses UV-A light and riboflavin to strengthen corneal collagen, stabilizing the progression of keratoconus with the possibility of improving visual acuity.

The implantation of intrastromal corneal ring segments (ICRS) has emerged as a treatment option for both myopia and keratoconus. Intrastromal corneal ring segments consist of two arc-shaped segments made of polymethylmethacrylate (PMMA) that are inserted through a radial incision, created either mechanically using a rotating lamellar dissector or by using a femtosecond laser, and placed in the peripheral corneal stroma of the eye at two-thirds depth. ICRS are manufactured with variable thickness (i.e., 0.25 mm, 0.30 mm, 0.35 mm) and diameter that directly relate to the amount of correction achieved. Thicker, smaller diameter ICRS result in increased amounts of correction.

In April 1999, INTACS Prescription Inserts received US Food and Drug Administration (FDA) premarket approval (PMA) for the reduction or elimination of mild myopia (-1.00 diopter to -3.00 diopters spherical equivalent [SE] at the spectacle plane) in individuals:
  • Who are 21 years of age or older
  • Who have a documented stability of refraction as demonstrated by a change of less than or equal to 0.50 diopter for at least 12 months prior to the preoperative examination
  • Who have an astigmatic component of +1.00 diopter or less

In individuals with keratoconus, INTACS are used to reinforce the cornea and prevent further deterioration. In July 2004, INTACS received humanitarian device exemption (HDE) designation from the FDA for the reduction or elimination of myopia and/or astigmatism in individuals with keratoconus who are no longer able to achieve adequate vision with contact lenses or eyeglasses, so that their functional vision may be restored and the need for corneal transplantation may be deferred.

HUMANITARIAN DEVICE EXEMPTION (HDE)

In rare instances, certain medical devices intended to be used for humanitarian purposes are evaluated by the US Food and Drug Administration (FDA) through the Humanitarian Device Exemption (HDE) process. The FDA’s humanitarian use device (HUD) designation permits the use of certain medical devices when there is no comparable device available to treat or diagnose a disease or condition affecting fewer than 4,000 individuals annually. Since clinical investigation demonstrating the efficacy of the device is not feasible (given the low prevalence of the disease in the population), an HDE grants manufacturers an exemption to the usual premarket approval process and allows marketing of the device only for the FDA-labeled HDE indication(s).

Under FDA requirements, an HUD may only be used after institutional review board (IRB) approval has been obtained for the use of the device in accordance with the FDA-labeled indication(s) under the HDE.
References


Addition Technology, Inc. FDA Approves Larger Size Intacs® Corneal Implants for Keratoconus [Press Release]. 4/7/2010. Available at: http://www.vision-institute.com/UserFiles/File/FDA%20Approves%20Larger%20Size%20Intacs.pdf. Accessed January 3, 2018.

Addition Technology, Inc. Intacs® Corneal Implants. Professional Use Information Manual for Correction of Myopia and Astigmatism Associated with Keratoconus Using Intacs® Prescription Inserts. Physician Booklet. 2004. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf4/h040002c.pdf. Accessed January 3, 2018.

Addition Technology. Professional Use Information Manual for Correction of Myopia and Astigmatism Associated with Keratoconus Using Intacs® Corneal Implants. Physician Booklet. 2010. Available at:
http://intacsforkeratoconus.com/wp-content/uploads/2015/05/Intacs-for-Keratoconus-11400-116001.pdf. Accessed on January 3. 2018.

Alfonso JF, Lisa C, Merayo-Lloves J, Cueto LF, Montes-Mico R. Intrastromal corneal ring segment implantation in paracentral keratoconus with coincident topographic and coma axis. J cataract Refract Surg. 2012;38:1576-1582.

Alio JL, Shabayek MH, Artola A. Intracorneal ring segments for keratoconus correction: Long-term follow-up. J Cataract Refract Surg. 2006;32(6):978-985.

Alio JL, Shabayek MH, Belda JI, et al. Analysis of results related to good and bad outcomes of Intacs implantation for keratoconus correction. J Cataract Refract Surg. 2006;32(5):756-761.

American Academy of Ophthalmology. EyeWiki™. Intrastromal Corneal Ring Segments (ICRS). Last modified 11/28/2017. Available at: http://eyewiki.aao.org/Intrastromal_Corneal_Ring_Segments_(ICRS). Accessed January 3, 2018.

Arriola-Villalobos P, Diaz-Valle D, Guell JL, et al. Intrastromal corneal ring segment implantation for high astigmatism after penetrating keratoplasty. J Cataract Refract Surg. 2009;35(11):1878-1884.

Bedi R, Touboul D, Pinsard L, et al. Refractive and topographic stability of Intacs in eyes with progressive keratoconus: five-year follow-up. J Refract Surg. 2012;28(6):392-6.

Beniz LA, Queiroz GH, Queiroz CF, et al. Intrastromal corneal ring segments delay corneal grafting in patients with keratoconus. Arq Bras Oftalmol. 2016;79(1):30-32.

Boxer Wachler BS, Christie JP, Chandra NS, et al. INTACS for keratoconus. Ophthalmology. 2003;110(5):1031-1040. Erratum in Ophthalmology. 2003;110:(8)1475.

Colin J. European clinical evaluation: Use of Intacs for the treatment of keratoconus. J Cataract Refract Surg. 2006;32(5):747-755.

Colin J, Cochener B, Savary G, Malet F, Holmes-Higgin D. INTACS inserts for treating keratoconus: One-year results. Ophthalmology. 2001;108(8):1409-1414.

Colin J, Malet FJ. Intacs for the correction of keratoconus: two-year follow-up. J Cataract Refract Surg. 2007;33(1):69-74.

Company Benefit Contracts.

Coscarelli S, Ferrara G, Alfonso JF, et al. Intrastromal corneal ring segment implantation to correct astigmatism after penetrating keratoplasty. J Cataract Refract Surg. 2012;38(6):1006-1013.

Fernandez-Vega Cueto L, Lisa C, Poo-Lopez A, et al. Intrastromal corneal ring segment implantation in 409 paracentral keratoconic eyes. Cornea. 2016;35(11):1421-1426.

Ferrer C, Alio JL, Montanes AU, et al. Causes of intrastromal corneal ring segment explantation: clinicopathologic correlation analysis. J Cataract Refract Surg. 2010;36(6):970-977.

Heikal MA, Abdelshafy M, Soliman TT, et al. Refractive and visual outcomes after Keraring intrastromal corneal ring segment implantation for keratoconus assisted by femtosecond laser at 6 months follow-up. Clin Ophthalmol. 2017;11:81-86.

Kanellopoulos AJ, Pe LH, Perry HD, Donnenfeld ED. Modified intracorneal ring segment implantations (INTACS) for the management of moderate to advanced keratoconus: efficacy and complications. Cornea. 2006;25(1):29-33.

Kymionis GD, Siganos CS, Tsiklis NS, et al. Long-term follow-up of Intacs in keratoconus. Am J Ophthalmol. 2007;143(2):236-244.

Kubaloglu A, Sari ES, Cinar Y, et al. A single 210-degree arc length intrastromal corneal ring implantation for the management of pellucid marginal corneal degeneration. Am J Ophthalmol. 2010;150(2):185-92 e1.

Levinger S, Pokroy R. Keratoconus managed with intacs: One-year results. Arch Ophthalmol. 2005;123(10):1308-1314.

Medline Plus. Medical Encyclopedia. Keratoconus. [MedlinePlus Web site]. 10/20/06. Updated 8/20/2016. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/001013.htm. Accessed January 3, 2018.

Medline Plus. Medical Encyclopedia. Nearsightedness. [MedlinePlus Web site]. 08/22/08. Updated 8/20/2016. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/001023.htm. Accessed January 3, 2018.

Miraftab M, Hashemi H, Hafezi F, et al. Mid-term results of a single intrastromal corneal ring segment for mild to moderate progressive keratoconus. Cornea. 2017;36(5):530-34.

National Institute for Health and Care Excellence (NICE). Guidance on corneal implants for keratoconus [IPG227]. 7/25/2007. Minor maintenance 01/14/2012. Available at: http://www.nice.org.uk/nicemedia/pdf/IPG227guidance.pdf. Accessed January 3, 2018.

Ozerturk Y, Sari ES, Kubaloglu A, et al. Comparison of deep anterior lamellar keratoplasty and intrastromal corneal ring segment implantation in advanced keratoconus. J Cataract Refract Surg. 2012; 38(2):324-32.

Pinero DP, Alio JL, Morbelli H, et al. Refractive and corneal aberrometric changes after intracorneal ring implantation in corneas with pellucid marginal degeneration. Ophthalmology. 2009;116(9):1656-1664.

Rabinowitz YS. Intacs for Keratoconus. Int Ophthalmol Clin. 2006;46(3):91-103.

Rabinowitz YS, Li X, Ignacio TS, Maguen E. INTACS inserts using the femtosecond laser compared to the mechanical spreader in the treatment of keratoconus. J Refract Surg. 2006;22(8):764-771.

Samimi S, Leger F, Touboul D, et al. Histopathological findings after intracorneal ring segment implantation in keratoconic human corneas. J Cataract Refract Surg. 2007;33(2):247-253.

Schanzlin DJ, Abbott RL, Asbell PA, et al. Two-year outcomes of intrastromal corneal ring segments for the correction of myopia. Ophthalmology. 2001;108(9):1688-1694.

Shetty R, Kaweri L, Pahuja N, et al. Current review and a simplified “five-point management algorithm for keratoconus. Indian J Ophthamol. 2015;63(1):46-53.

Siganos CS, Kymionis GD, Kartakis N, et al. Management of keratoconus with Intacs. Am J Ophthalmol. 2003;135(1):64-70.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. ICRS® (intrastromal corneal ring segments). Summary of safety and effectiveness data. [FDA Web site]. 08/30/1999. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/P980031b.pdf. Accessed January 3, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. ICRS® (intrastromal corneal ring segments). Summary of safety and Probable Benefit. [FDA Web site]. 07/26/2004. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf4/h040002b.pdf. Accessed January 3, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. INTACS® Prescription Inserts for Keratoconus (0.25 mm, 0.30 mm, and 0.35 mm). HDE approval letter. [FDA Web site]. 07/26/04. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf4/h040002a.pdf. Accessed January 3, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. INTACS® Prescription Inserts for Keratoconus (0.21 mm, 0.40 mm, and 0.45 mm). HDE supplement approval letter. [FDA Web site]. 03/23/10. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=375772. Accessed January 3, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. KeraVision Intacs™. Premarket approval letter. [FDA Web site]. 04/09/99. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/P980031a.pdf. Accessed January 3, 2018.

Vega-Estrada A, Alio JL, Brenner LF, et al. Outcomes of intrastromal corneal ring segments for treatment of keratoconus: Five-year follow-up analysis. J Cataract Refract Surg. 2013;39(8):1234-1240.

Vega-Estrada A, Alio JL, Plaza-Puche AB. Keratoconus progression after intrastromal corneal ring segment implantation in young patients: Five-year follow-up. J Cataract Refract Surg. 2015;41:1145-1152.

Ziaei M, Barsam A, Shamie N, et al. Reshaping procedures for the surgical management of corneal ectasia. J Cataract Refract Surg. 2015;41(4):842-872.

Zare MA, Mehrjardi HZ, Afarideh M, Bahrmandy H, Mohammadi S. Visual, Keratometric and Corneal Biomechanical Changes after Intacs SK Implantation for Moderate to Severe Keratoconus. J Ophthalmic Vis Res. 2016;11(1):17-25.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

65785


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

MEDICALLY NECESSARY

H18.601 Keratoconus, unspecified, right eye
H18.602 Keratoconus, unspecified, left eye
H18.603 Keratoconus, unspecified, bilateral
H18.609 Keratoconus, unspecified, unspecified eye
H18.611 Keratoconus, stable, right eye
H18.612 Keratoconus, stable, left eye
H18.613 Keratoconus, stable, bilateral
H18.619 Keratoconus, stable, unspecified eye
H18.621 Keratoconus, unstable, right eye
H18.622 Keratoconus, unstable, left eye
H18.623 Keratoconus, unstable, bilateral
H18.629 Keratoconus, unstable, unspecified eye

BENEFIT CONTRACT EXCLUSION

H52.10 Myopia, unspecified eye
H52.11 Myopia, right eye
H52.12 Myopia, left eye
H52.13 Myopia, bilateral



HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

Revisions from 11.05.11c

03/28/2018

This policy has undergone a routine review, and no revisions have been made.


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 09/07/2016
Version Issued Date: 09/07/2016
Version Reissued Date: 03/28/2018

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