Implantation of Intrastromal Corneal Ring Segments Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 01|01|2016 POLICY LAST REVIEWED: 01|08|2025 OVERVIEW Intrastromal corneal ring segments (ICRS) are composed of microthin soft plastic inserts of variable thickness that are placed in the periphery of the cornea. Intrastromal corneal ring segments have been investigated as a means of improving vision in diseases such as keratoconus and pellucid marginal degeneration, and for astigmatism following penetrating keratoplasty.
MEDICAL CRITERIA Medicare Advantage Plans and Commercial Products Implantation of intrastromal corneal ring segments may be considered medically necessary for the treatment of keratoconus in patients 21 years of age or older who meet the following criteria: • The patient has experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision with contact lenses or spectacles; AND • Corneal transplantation is the only alternative to improve their functional vision; AND • The patient has a clear central cornea with a corneal thickness of 450 microns or greater at the proposed incision site. PRIOR AUTHORIZATION Medicare Advantage Plans and Commercial Products Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products and is obtained via the online tool for participating providers for the treatment of keratoconus. See the Related Policies section. POLICY STATEMENT Medicare Advantage Plans and Commercial Products Implantation of intrastromal corneal ring segments may be considered medically necessary for the treatment of keratoconus when the medical criteria above have been met. Implantation of intrastromal corneal ring segments is not covered and is a contract exclusion as a treatment of myopia. Medicare Advantage Plans Implantation of intrastromal corneal ring segments is not covered for all other conditions as the evidence is insufficient to determine the effects of the technology on health outcomes. Commercial Products Implantation of intrastromal corneal ring segments is considered not medically necessary for all other conditions as the evidence is insufficient to determine the effects of the technology on health outcomes. COVERAGE Benefits may vary between groups/contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for applicable surgery and not medically necessary/not covered benefits/coverage.
Medical Coverage Policy | Implantation of Intrastromal Corneal Ring Segments d

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

BACKGROUND Vision Disorders Keratoconus is a progressive bilateral dystrophy characterized by paracentral steepening and stromal thinning that impairs visual acuity.

Pellucid marginal degeneration is a noninflammatory progressive degenerative disease, typically characterized by bilateral peripheral thinning (ectasia) of the inferior cornea. Deterioration of functional vision results from the irregular astigmatism induced by asymmetric distortion of the cornea, and visual acuity typically cannot be restored by using spherocylindrical lenses.

Treatment Initial treatment for keratoconus often consists of hard contact lenses. A penetrating keratoplasty (ie, corneal grafting) was traditionally considered the next line of treatment in patients who developed intolerance to contact lenses. While visual acuity is typically improved with penetrating keratoplasty, perioperative complications are an associated risk; long-term topical steroid use is required; and endothelial cell loss occurs over time, which is a particular concern in younger patients. As an alternative, a variety of keratorefractive procedures have been attempted, broadly divided into subtractive and additive techniques. Subtractive techniques include photorefractive keratectomy or laser in situ keratomileusis (LASIK), although, generally, results of these techniques have been poor. In deep anterior lamellar keratoplasty, pathologic corneal stromal tissue is selectively removed to the level of the Descemet membrane, followed by transplantation of a donor graft. Implantation of intrastromal corneal ring segments (ICRS) represents an additive technique, in which the implants are intended to reinforce the cornea, prevent further deterioration, and potentially obviate the need for penetrating keratoplasty.

Rigid gas permeable contact lenses may be used to treat pellucid marginal degeneration. ICRS, crescentic lamellar keratoplasty, penetrating keratoplasty, and corneal wedge excision have also been proposed as treatments.

ICRS correct myopia by flattening the center of the cornea and represent an alternative to LASIK and other refractive surgeries. A proposed advantage of ICRS is that their insertion does not affect the central cornea and, thus, their effect is not related to the healing process in the cornea. No corneal tissue is removed, and the implants may be removed or replaced. However, mild myopia is effectively treated with spectacles or contact lenses.

Intrastromal Corneal Ring Segments ICRS are composed of microthin soft plastic inserts of variable thickness that are placed in the periphery of the cornea. They are inserted through an incision made in the cornea, into which channels have been created by rotating a lamellar dissector or by using a femtosecond laser. One or 2 segments are implanted in each channel, and various implants with a range of thicknesses are available for different degrees of correction. They affect refraction in the eye by physically changing the shape of the cornea (flattening the front of the eye), thereby correcting the irregular corneal shape and restoring a degree of functional vision. If required, the implants can be removed or replaced at a later date.

Intacs®, an intrastromal corneal ring, was approved by the U.S. Food and Drug Administration (FDA) for 2 indications. In 1999, Intacs® (KeraVision, now Addition Technology) was approved by FDA through the premarket approval process for the following labeled indication: “The KeraVision Intacs are intended for the reduction or elimination of mild myopia (-1.00 to -3.00 diopters spherical equivalent at the spectacle plane) in patients: • Who are 21 years of age or older; • With 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; and • Where the astigmatic component is +1.00 diopter or less.”

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

In 2004, Intacs® received additional approval by FDA through the humanitarian device exemption process for the following indication: “This device is indicated for the reduction or elimination of myopia and astigmatism in patients with keratoconus, who are no longer able to achieve adequate vision with their contact lenses or spectacles, so that their functional vision may be restored and the need for a corneal transplant procedure may potentially be deferred. The specific set of keratoconic patients proposed to be treated with Intacs prescription inserts are those patients: • Who have experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with their contact lenses or spectacles; • Who are 21 years of age or older; • Who have clear central corneas; • Who have a corneal thickness of 450 microns or greater at the proposed incision site; AND • Who have corneal transplantation as the only remaining option to improve their functional vision.”

For individuals who have pellucid marginal degeneration who receive ICRS, most case series report have assessed devices not available in the United States. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have astigmatism after penetrating keratoplasty who receive ICRS, the evidence includes a few case series. Two case series used devices not available in the United States. The evidence is insufficient to determine the effects of the technology on health outcomes.

CODING Medicare Advantage Plans and Commercial Products The following CPT code is considered medically necessary when the medical criteria above are met: 65785 Implantation of intrastromal corneal ring segments

RELATED POLICIES Preauthorization via Web-Based Tool for Procedures

PUBLISHED Provider Update, March 2025 Provider Update, April 2024 Provider Update, April 2023 Provider Update May 2022 Provider Update, September 2021

REFERENCES

1. Zadnik K, Money S, Lindsley K. Intrastromal corneal ring segments for treating keratoconus. Cochrane Database Syst Rev. 2019 May;5:CD011150. PMID 31087649
2. 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. Aug 2013;39(8):1234-1240. PMID 23747207
3. 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. May 2006;32(5):756-761. PMID 16765791
4. Boxer Wachler BS, Christie JP, Chandra NS, et al. Intacs for keratoconus. Ophthalmology. May 2003;110(5):1031-1040. PMID 12750109
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7. Siganos CS, Kymionis GD, Kartakis N, et al. Management of keratoconus with Intacs. Am J Ophthalmol. Jan 2003;135(1):64-70. PMID 12504699

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 4 (401) 274-4848 WWW.BCBSRI.COM

8. Ziaei M, Barsam A, Shamie N, et al. Reshaping procedures for the surgical management of corneal ectasia. J Cataract Refract Surg. Apr 2015;41(4):842-872. PMID 25840308
9. Beniz LA, Queiroz GH, Queiroz CF, et al. Intrastromal corneal ring segments delay corneal grafting in patients with keratoconus. Arq Bras Oftalmol. Feb 2016;79(1):30-32. PMID 26840163
10. 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. Jan 2017;11:81-86. PMID 28096650
11. 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. May 2017;36(5):530-534. PMID 27984365
12. Colin J, Malet FJ. Intacs for the correction of keratoconus: two-year follow-up. J Cataract Refract Surg. Jan 2007;33(1):69-74. PMID 17189796
13. 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. Jun 2012;28(6):392-396. PMID 22589292
14. Kymionis GD, Siganos CS, Tsiklis NS, et al. Long-term follow-up of Intacs in keratoconus. Am J Ophthalmol. Feb 2007;143(2):236-244. PMID 17184717
15. Fernandez-Vega Cueto L, Lisa C, Poo-Lopez A, et al. Intrastromal corneal ring segment implantation in 409 paracentral keratoconic eyes. Cornea. Nov 2016;35(11):1421-1426. PMID 27490048
16. Izquierdo L, Mannis MJ, Mejias Smith JA, et al. Effectiveness of Intrastromal Corneal Ring Implantation in the Treatment of Adult Patients With Keratoconus: A Systematic Review. J Refract Surg. 2019 Mar;35(3). PMID 30855097
17. Kang MJ, Byun YS, Yoo YS, et al. Long-term outcome of intrastromal corneal ring segments in keratoconus: Five-year follow up. Sci Rep. 2019 Jan;9(1). PMID 30670787
18. Nguyen N, Gelles JD, Greenstein SA, et al. Incidence and associations of intracorneal ring segment explantation. J Cataract Refract Surg. 2019 Feb;45(2). PMID 30509748
19. Pinero DP, Alio JL, Morbelli H, et al. Refractive and corneal aberrometric changes after intracorneal ring implantation in corneas with pellucid marginal degeneration. Ophthalmology. Sep 2009;116(9):1656-1664. PMID 19643482
20. 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. Aug 2010;150(2):185-192 e181. PMID 20570241 21. 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. Nov 2009;35(11):1878-1884. PMID 19878819
21. Coscarelli S, Ferrara G, Alfonso JF, et al. Intrastromal corneal ring segment implantation to correct astigmatism after penetrating keratoplasty. J Cataract Refract Surg. Jun 2012;38(6):1006-1013. PMID 22624900
22. Ferrer C, Alio JL, Montanes AU, et al. Causes of intrastromal corneal ring segment explantation: clinicopathologic correlation analysis. J Cataract Refract Surg. Jun 2010;36(6):970-977. PMID 20494769
23. Kanellopoulos AJ, Pe LH, Perry HD, et al. Modified intracorneal ring segment implantations (INTACS) for the management of moderate to advanced keratoconus: efficacy and complications. Cornea. Jan 2006;25(1):29-33. PMID 16331037
24. Samimi S, Leger F, Touboul D, et al. Histopathological findings after intracorneal ring segment implantation in keratoconic human corneas. J Cataract Refract Surg. Feb 2007;33(2):247-253. PMID 17276265

25. National Institute for Health and Care Excellence (NICE). Corneal implants for keratoconus [IPG227]. 2007; https://www.nice.org.uk/guidance/IPG227. Accessed January 27, 2020.i

    This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association. CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS