Medicare Advantage

Medical Policy

Notification

Refractive Keratoplasty, Keratoprosthesis, and Corneal Collagen Cross-Linking

Notification Issue Date:

This version of the policy will become effective 11/18/2019.

Policy language addressing radial keratotomy and keratoplasty was

revised

for clarity. However, there was no change in coverage position.

Title:

Refractive Keratoplasty, Keratoprosthesis, and Corneal Collagen Cross-Linking

Policy #:

MA11.008g

Policy

This policy uses coverage criteria primarily based on applicable Medicare statutes, regulations, NCDs, LCDs, CMS manuals and other applicable Medicare coverage documents. In the absence of fully established coverage criteria from these Medicare coverage documents for a specific medical service or item, the criterion/indication/service indicated by an asterisk below (*) is based on internal coverage criteria developed by the Company in consideration of peer-reviewed medical literature, clinical practice guidelines, regulatory status, and/or expert opinion.

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.

MEDICALLY NECESSARY

REFRACTIVE KERATOPLASTY

Keratoplasty is considered medically necessary and, therefore, covered when used to treat lesions of the cornea causing abnormalities in the eye (e.g., phototherapeutic keratectomy that removes scar tissue from the visual field).

KERATOPROSTHESIS

The Boston (Dohlman-Doane) Keratoprosthesis (Boston KPro) is considered medically necessary for the surgical treatment of corneal opacification in individuals who meet the following criteria *(Ahmad et al., 2016; Rudnisky et al., 2016; Lee et al., 2015; Srikumaran et al., 2014; Ciolino et al., 2013; Rudnisky et al., 2012; Dunlap et al., 2010):

Cadaveric corneal transplants have failed or have a very low likelihood of success.
The cornea is severely opaque and vascularized, AND
Best-corrected visual acuity is 20/400 or less in the affected eye and 20/40 or less in the contralateral eye, AND
No end-stage glaucoma or retinal detachment is present, AND
The individual has one of the following indications:
- History of one or more corneal transplant graft failures
- Stevens-Johnson syndrome
- Ocular cicatricial pemphigoid
- Autoimmune conditions with rare ocular involvement
- Ocular chemical burns
- An ocular condition unlikely to respond favorably to primary corneal transplant surgery (eg., limbal stem cell compromise or postherpetic anesthesia)

CORNEAL COLLAGEN CROSS-LINKING

Corneal collagen cross-linking epithelium-off using riboflavin and ultraviolet A is considered medically necessary and, therefore, covered when used as a treatment of the following indications after refractive surgery:

Progressive keratoconus *(Cortina et al., 2024; Knutsson et al., 2018; McAnena et al., 2017; Hersh et al., 2017; Toprak et al., 2017; Badawi, 2017; Padmanabhan et al., 2017; Papaioannou et al., 2016; Raiskup et al., 2015; National Institute for Health and Care Excellence [NICE], 2013; Caporossi et al., 2010; Raiskup-Wolf et al., 2008)

Corneal ectasia *(Cortina et al., 2024; Amaral et al., 2024; Margines et al., 2023; Hersh et al., 2017; Wittig-Silva et al., 2014; NICE, 2013; Wittig-Silva et al., 2008)

NOT COVERED

Radial keratotomy and keratoplasty for the purpose of refractive error compensation is considered a substitute or alternative to eyeglasses or contact lenses, which are specifically excluded by Medicare because they are considered to be cosmetic. Therefore, radial keratotomy and keratoplasty to treat refractive defects in place of eyeglasses or contact lenses are not covered.

An exception to this may occur in certain cases in connection with cataract surgery.

Radial keratotomy and keratoplasty that do not meet the medical necessity criteria listed in this policy are considered cosmetic services. Services that are cosmetic are excluded for the Company’s Medicare Advantage plans because they are not covered by Medicare. Therefore, they are not eligible for reimbursement consideration.

EXPERIMENTAL/INVESTIGATIONAL

All other uses for keratoplasty are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

Although the US Food and Drug Administration (FDA) has approved devices for corneal cross-linking epithelium-on, the Company has determined that the safety and/or effectiveness of this procedure cannot be established by review of the available published peer-reviewed literature. Therefore, corneal cross-linking epithelium-on is considered experimental/investigational by the Company and not covered.

All other uses for corneal collagen cross-linking epithelium-off are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

Keratoprosthesis with any other device other than the Boston KPro is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

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

This policy is consistent with Medicare’s coverage determination. The Company’s payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, refractive keratoplasty is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

Subject to the terms and conditions of the applicable Evidence of Coverage, corneal collagen cross-linking is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

Services that are cosmetic are excluded for the Company’s Medicare Advantage plans because they are not covered by Medicare. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The Boston KPro (Dohlman-Doane keratoprosthesis; Massachusetts Eye and Ear Infirmary) was approved by the FDA through the premarket approval process on January 21, 1992, for use in patients with severe corneal opacity. The device is used when standard corneal transplant has failed or would be unlikely to succeed. There are two types of Boston KPro. Type I is used in eyes when eyelids, blink mechanism, and tear film are intact. Type II is used with severe dry eye and in eyes with mucosal keratinization and obliteration of normal conjunctival fornices.

The ViewPoint® CK System was approved by the FDA on April 11, 2002.

In late 2011, the FDA awarded orphan drug status to Avedro for its formulation of riboflavin ophthalmic solution to be used in conjunction with the company's particular UVA irradiation system. In 2015, however, the FDA withdrew its approval, citing a need for more data.

Riboflavin 5′-phosphate in 20% dextran ophthalmic solution (Photrexa Viscous®; Avedro) and riboflavin 5′-phosphate ophthalmic solution (Photrexa®; Avedro) were approved by the FDA on April 15, 2016, for use with KXL System in corneal collagen cross-linking for the treatment of progressive keratoconus and corneal ectasia after refractive surgery.

Riboflavin 5′-phosphate ophthalmic solution 0.239% (Epioxa HD; Glaukos) and riboflavin 5′-phosphate ophthalmic solution 0.177% (Epioxa; Glaukos) were approved by the FDA on October 17, 2025, for use with O2n System and Boost Goggles in corneal collagen cross-linking for the treatment of progressive keratoconus and corneal ectasia after refractive surgery.

Description

Refractive keratoplasty is surgery to reshape the cornea of the eye to correct vision problems such as myopia (nearsightedness) and hyperopia (farsightedness). Refractive keratoplasty procedures include keratomileusis, in which the front of the cornea is removed, frozen, reshaped, and stitched back on the eye to correct either near or farsightedness; keratophakia, in which a reshaped donor cornea is inserted in the eye to correct farsightedness; and radial keratotomy, in which spoke-like slits are cut in the cornea to weaken and flatten the normally curved central portion to correct nearsightedness.

Collagen cross-linking of the cornea (CXL) is a photochemical procedure that is approved by the US Food and Drug Administration (FDA) for the treatment of progressive keratoconus and corneal ectasia. Keratoconus is a naturally occurring dystrophy of the cornea characterized by progressive deformation (steepening) of the cornea while corneal ectasia is keratoconus that occurs after refractive surgery. Both lead to functional loss of vision and need for corneal transplantation. CXL is performed with the photosensitizer riboflavin (vitamin B₂) and ultraviolet A (UVA) irradiation. There are two protocols for CXL.

Epithelium-off CXL (also known as “epi-off”): In this method, a portion of the central corneal epithelium is removed under topical anesthesia to allow better diffusion of the photosensitizer riboflavin into the stroma.
Epithelium-on CXL (also known as “epi-on” or transepithelial): In this method, the corneal epithelial surface is left intact (or may be partially disrupted) and a longer riboflavin loading time is needed

CXL Epithelium-on method, with the use of Epioxa, is FDA approved as of October, 2025. FDA approval is based on the results of two prospective, randomized, multicenter, double-masked phase 3 trials. In both studies by Hersh et. al., the study of CXL treatment for Corneal Ectasia after Refractive Surgery and CXL treatment for Keratoconus, the results suggests short-term improvements in keratometric values and visual acuity. However, there are several limitations beginning with its design. A 1 year follow up is not adequate enough to evaluate the course of treatment for a chronic, progressive condition such as keratoconus and corneal ectasia. Second, the control group only received riboflavin without epithelial removal, which does not represent a true sham equivalent to the procedural steps of CXL, limiting validity of comparative effectiveness. Both of these raise the possibility of performance bias and may overestimate the treatment effect. The primary efficacy points of both studies was a change in maximum keratometry, which does not demonstrate clinical benefit clearly; clearer long-term endpoints would be to measure the reduction in corneal transplantation rates or prevention of progression to advanced disease stages. A 2024 study by Khan et al. reported there was no difference found between epi-on and standard epi-off CXL in terms of reducing keratometric values and there was a higher risk of progression in individuals treated with Epi-On CXL, with an increased rate of patients requiring re-treatment. Therefore, the current reliable evidence is not suitable to establish effectiveness and clinical benefit of this technology due to the lack of robust studies and the availability of longer-term data.

A keratoprosthesis is an artificial cornea intended to restore vision in individuals with severe bilateral corneal disease for whom the standard surgical intervention (a corneal transplant, performed via penetrating keratoplasty [PK]) is contraindicated. A keratoprosthesis consists of a central optic held in a cylindrical frame. The device replaces the section of the cornea that has been removed, and, along with being held in place by the surrounding tissue, may be covered by a membrane to further anchor the prosthesis. There are currently two FDA-approved keratoprostheses: the Boston (Dohlman-Doane) keratoprosthesis (Boston KPro), and the AlphaCor® (Chirila) keratoprosthesis. Available outcomes data for the two devices suggest that the Boston KPro is associated with fewer complications.

In 2015, the American Academy of Ophthalmology (AAO) published the findings of a systematic review into the safety and efficacy of the Boston KPro. The study’s inclusion criteria were language of publication (English) and, in the case of retrospective studies, a collective sample size of at least 25 eyes. The search ultimately yielded 22 observational studies but no randomized controlled trials. Regarding outcomes, the study found that the proportion of patients with visual acuity of 20/200 after surgery ranged from 54% to 84% in the 10 studies reporting this outcome. Five studies reported that 11% to 39% of treated eyes attained visual acuities of 20/40 or better. In terms of safety and durability outcomes, the review found 14 studies reporting on retention rates (eyes retaining the KPro device without loss, extrusion or dehiscence of the device); retention rates ranged from 65% to 100% (mean, 88%). The most common reasons for KPro loss were corneal melts with device exposure or extrusion, endophthalmitis, infectious keratitis, or corneal ulceration. The most common complication was retroprosthetic membrane formation, which ranged from 1% to 65% (mean, 30%) in the 13 studies reporting complications.
A 2011 study by Jerásková et al. reported on the long-term results of AlphaCor implantations (n=15). The survival rate of the device at 1, 2, and 3 years was 87%, 58%, and 42%, respectively. Postoperative visual acuity ranged from hand movement to 0.8. The most significant complications were stromal melt (n=9), optic deposition (n=3), and retrospective membrane formation (n=3). The most common device-unrelated complication was trauma (n=3). All complications were managed without eye loss. The authors concluded that AlphaCor provides a treatment option for individuals with corneal blindness in whom donor tissue graft would not succeed.

References

Abad JC, Vargas A. Gaping of radial and transverse corneal incisions occurring early after CXL. J Cataract Refract Surg. 2011;37(12):2214-2217.

Ahmad S, Mathews PM, Lindsley K, et al. Boston Type 1 Keratoprosthesis versus repeat donor keratoplasty for corneal graft failure: a systematic review and meta-analysis. Ophthalmology. 2016;123(1):165-177.

Amaral DC, Menezes AHG, Vilaça Lima LC, et al. Corneal Collagen Crosslinking for Ectasia After Refractive Surgery: A Systematic Review and Meta-Analysis. Clin Ophthalmol. 2024;18:865-879.

American Academy of Ophthalmology Cornea/External Disease Panel. Preferred Practice Pattern® Guidelines. Corneal Ectasia. San Francisco, CA: American Academy of Ophthalmology; 2023. Available at: https://www.aao.org/education/preferred-practice-pattern/corneal-ectasia-ppp-2023. Accessed August 4, 2025.

American Academy of Ophthalmology. Corneal Cross-Linking. October 10, 2024. Available at: https://www.aao.org/eye-health/treatments/corneal-cross-linking-2. Accessed August 4, 2025.

American Academy of Ophthalmology. EyeWiki™. Corneal Cross-Linking. (Review 01/26/2025). Available at: https://eyewiki.org/Corneal_Cross-Linking. Accessed August 4, 2025.

Asri D, Touboul D, Fournie P, et al. Corneal collagen crosslinking in progressive keratoconus: multicenter results from the French National Reference Center for Keratoconus. J Cataract Refract Surg. 2011;37(12):2137-2143.

Avedro Inc. Photrexa® Viscous and Photrexa® Prescribing Label. 07/2016. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203324s000lbl.pdf. Accessed August 4, 2025.

Avedro Inc. Avedro Briefing Package for Joint Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Device Panel of the Medical Devices Advisory Committee NDA 203324: Photrexa Viscous and Photrexa (riboflavin ophthalmic solution) and KXL System (UVA light source) Avedro, Inc. 2016. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203324. Accessed August 4, 2025.

Awdeh RM, Abbey AM, Vroman DT, et al. Phototherapeutic keratectomy for the treatment of subepithelial fibrosis and anterior corneal scarring after descemet stripping automated endothelial keratoplasty. Cornea. 2012;31(7):761-763.

Badawi AE. Accelerated corneal collagen cross-linking in pediatric keratoconus: One year study. Saudi J Ophthalmol. 2017;31(1):11-18.

Brooks NO, Greenstein S, Fry K, et al. Patient subjective visual function after corneal collagen crosslinking for keratoconus and corneal ectasia. J Cataract Refract Surg. 2012;38(4):615-619.

Caporossi A, Mazzotta C, Baiocchi S, et al. Long-term results of riboflavin ultraviolet a corneal collagen cross-linking for keratoconus in Italy: the Siena eye cross study. Am J Ophthalmol. 2010;149(4):585-593.

Caporossi A, Mazzotta C, Baiocchi S, et al. Riboflavin-UVA-induced corneal collagen cross-linking in pediatric patients. Cornea. 2012;31(3):227-231.

Center for Drug Evaluation and Research: FDA. Summary Review: Application Number 203324Orig2s000. July 15, 2016. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/203324Orig2s000SumR.pdf. Accessed August 4, 2025.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 80.7: Refractive keratoplasty. [CMS Web site]. 05/01/97. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=72&ncdver=1&bc=BAABAAAAAAAA&. Accessed August 4, 2025.

Chan CC, LoVerde L, Qiang J, et al. Incidence, Risk Factors, and Surgical Management of Boston Type 1 Keratoprosthesis Corneal Melts, Leaks, and Extrusions. Cornea. 2016;35(8):1049-1056.

Chunyu T, Xiujun P, Zhengjun F, et al. Corneal collagen cross-linking in keratoconus: a systematic review and meta-analysis. Sci Rep. 2014;4:5652.

Ciolino JB, Belin MW, Todani A, et al. Retention of the Boston keratoprosthesis type 1: multicenter study results. Ophthalmology. 2013;120(6):1195-1200.

Colliardo P, Taloni A, Taloni M, et al. Follow-up Extension Up to 43 Years of Modified Osteo-Odonto-Keratoprosthesis. Ophthalmology. 2023;130(9):995-997.

Cortina MS, Greiner MA, Kuo AN, et al. Safety and Efficacy of Epithelium-Off Corneal Collagen Cross-Linking for the Treatment of Corneal Ectasia: A Report by the American Academy of Ophthalmology. Ophthalmology. 2024;131(10):1234-1242.

Crawford GJ, Hicks CR, Lou X, et al. The Chirila Keratoprosthesis: phase I human clinical trial. Ophthalmology. 2002;109(5):883-889.

Davis LJ, Schechtman KB, Wilson BS, et al. Longitudinal changes in visual acuity in keratoconus. Invest Ophthalmol Vis Sci. 2006;47(2):489-500.

De La Paz MF, De Toledo JA, Charoenrook V, et al. Impact of clinical factors on the long-term functional and anatomic outcomes of osteo-odonto-keratoprosthesis and tibial bone keratoprosthesis. Am J Ophthalmol. 2011;151(5):829-839.

Dunlap K, Chak G, Aquavella JV, et al. Short-term visual outcomes of Boston type 1 keratoprosthesis implantation. Ophthalmology. 2010;117(4):687-692.

Falcinelli G, Falsini B, Taloni M, et al. Modified osteo-odonto-keratoprosthesis for treatment of corneal blindness: long-term anatomical and functional outcomes in 181 cases. Arch Ophthalmol. 2005;123(10):1319-1329.

Farid M, Rhee MK, Akpek EK, et al. Corneal Edema and Opacification Preferred Practice Pattern(R). Ophthalmology. 2019;126(1):P216-P285.

Gkika M, Labiris G, Kozobolis V. Corneal collagen cross-linking using riboflavin and ultraviolet-A irradiation: a review of clinical and experimental studies. Int Ophthalmol. 2011;31(4):309-319.

Gokhale NS. Corneal endothelial damage after collagen cross-linking treatment. Cornea. 2011;30(12):1495-1498.

Goldman DR, Hubschman JP, Aldave AJ, et al. Postoperative posterior segment complications in eyes treated with the Boston type I keratoprosthesis. Retina. 2013;33(3):532-541.

Hersh PS, Greenstein SA, Fry KL. Corneal collagen crosslinking for keratoconus and corneal ectasia: One year results. J Cataract Refract Surg. 2011;37(1):149-160.

Hersh PS, Stulting RD, Muller D, et al. United States multicenter clinical trial of corneal collagen crosslinking for keratoconus treatment. Ophthalmology. 2017;124(9):1259-1270.

Hersh PS, Stulting RD, Muller D, et al. U.S. multicenter clinical trial of corneal collagen crosslinking for treatment of corneal ectasia after refractive surgery. Ophthalmology. 2017;124(10):1475-1484.

Hicks CR, Crawford GJ, Lou X, et al. Corneal replacement using a synthetic hydrogel cornea, AlphaCor: device, preliminary outcomes and complications. Eye (Lond). 2003;17(3):385-392.

Hoffart L, Carles G, Matonti F. Lamellar corneal lenticule graft to treat keratolysis after AlphaCor keratoprosthesis implantation. Eur J Ophthalmol. 2015;25(1):1-7.

Holland G, Pandit A, Sánchez-Abella L, et al. Artificial Cornea: Past, Current, and Future Directions. Front Med (Lausanne). 2021;8:770780.

Hughes EH, Mokete B, Ainsworth G, et al. Vitreoretinal complications of osteoodontokeratoprosthesis surgery. Retina. 2008;28(8):1138-1145.

Jirásková N, Roszival P, Burova M, et al. AlphaCor artificial cornea: clinical outcome. Eye (Lond). 2011;25(9):1138-1146.

Khan, M., & Ageed, A. (2024). Advances in the Treatment of Keratoconus: Epithelial-On (EPI-On) Corneal-Collagen Cross-Linking (CXL) and CXL-Plus Procedures. Cureus. 16(1), e51565. Available at: https://doi.org/10.7759/cureus.51565. Accessed February 10, 2026

Knutsson KA, Paganoni G, Matuska S, et al. Corneal collagen cross-linking in paediatric patients affected by keratoconus. Br J Ophthalmol. 2018;102(2):248-252.

Kohanim S, Palioura S, Saeed HN, et al. Acute and Chronic Ophthalmic Involvement in Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis - A Comprehensive Review and Guide to Therapy. II. Ophthalmic Disease. Ocul Surf. 2016;14(2):168-88.

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Lee WB, Shtein RM, Kaufman SC, et al. Boston keratoprosthesis: outcomes and complications: a report by the American Academy of Ophthalmology. Ophthalmology. 2015;122(7):1504-1511.

Liu C, Okera S, Tandon R, et al. Visual rehabilitation in end-stage inflammatory ocular surface disease with the osteo-odonto-keratoprosthesis: results from the UK. Br J Ophthalmol. 2008;92(9):1211-1217.

Margines JB, Rabinowitz YS, Li X, et al. Results of corneal collagen cross-linking in patients with corneal ectasia after laser refractive surgery-A prospective study. Photodiagnosis Photodyn Ther. 2023;42:103521.

Matthaei M, Sandhaeger H, Hermel M, et al. Changing Indications in Penetrating Keratoplasty: A Systematic Review of 34 Years of Global Reporting. Transplantation. 2017;101(6):1387-1399.

McAnena L, Doyle F, O'Keefe M. Cross-linking in children with keratoconus: a systematic review and meta-analysis. Acta Ophthalmol. 2017;95(3):229-239.

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Meiri Z, Keren S, Rosenblatt A, et al. Efficacy of corneal collagen cross-linking for the treatment of keratoconus: a systematic review and meta-analysis. Cornea. 2016;35(3):417-428.

Mian SI, Viriya ET, Ahmad S, et al. Corneal Edema and Opacification Preferred Practice Pattern®. Ophthalmology. 2024;131(4):P247-P305.

Michael R, Charoenrook V, de la Paz MF, et al. Long-term functional and anatomical results of osteo- and osteoodonto-keratoprosthesis. Graefes Arch Clin Exp Ophthalmol. 2008;246(8):1133-1137.

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Nonpassopon M, Niparugs M, Cortina MS. Boston Type 1 Keratoprosthesis: Updated Perspectives. Clin Ophthalmol. 2020;14:1189-1200.

Odorcic S, Haas W, Gilmore MS, et al. Fungal infections after Boston Type 1 Keratoprosthesis Implantation: literature review and in vitro antifungal activity of hypochlorous acid. Cornea. 2015;34(12):1599-1605.

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Padmanabhan P, Rachapalle Reddi S, Rajagopal R, et al. Corneal collagen cross-linking for keratoconus in pediatric patients-long-term results. Cornea. 2017;36(2):138-143.

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Wittig-Silva C, Whiting M, Lamoureux E, et al. A randomized controlled trial of corneal collagen cross linking in progressive keratoconus: preliminary results. J Refract Surg. 2008;24(7):S720-725.

Xu W, Ye P, Yao K, et al. Conductive keratoplasty for the treatment of astigmatism induced by corneal trauma or incision. J Refract Surg. 2010;26(1):33-42.

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Coding

CPT Procedure Code Number(s)

MEDICALLY NECESSARY
0402T, 65770

NOT COVERED
65760, 65765, 65767, 65771

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

Report the most appropriate diagnosis code in support of medically necessary criteria as listed in the policy.

HCPCS Level II Code Number(s)

MEDICALLY NECESSARY
C1818 Integrated keratoprosthesis
L8609 Artificial cornea
S0812 Phototherapeutic keratectomy (PTK)

NOT COVERED
S0800 Laser in situ keratomileusis (LASIK)
S0810 Photorefractive keratectomy (PRK)

Revenue Code Number(s)

276 Medical/Surgical Supplies and Devices-Intraocular Lens

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From MA11.008g:

07/27/2026

This version of the policy will become effective 07/27/2026.

The title of the policy has been changes FROM:

Refractive Keratoplasty

TO:

Refractive Keratoplasty, Keratoprosthesis, and Corneal Collagen Cross-Linking

The following policy criteria have been revised:

Corneal collagen cross-linking epithelium-off using riboflavin and ultraviolet A is considered medically necessary for the treatment of progressive keratoconus and corneal ectasia following refractive surgery.
All other uses for corneal collagen cross-linking epithelium-off are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

The following policy criteria have been added to this policy:

Although the US Food and Drug Administration (FDA) has approved devices for corneal collagen cross-linking epithelium-on using riboflavin and ultraviolet A, the Company has determined that the safety and/or effectiveness of this procedure cannot be established by review of the available published peer-reviewed literature. Therefore, corneal collagen cross-linking epithelium-on using riboflavin and ultraviolet A is considered experimental/investigational by the Company and not covered.

Updated information distinguishing epithelium-off from epithelium-on corneal collagen cross-linking and FDA approvals have been included.

Revisions From MA11.008f:

12/29/2025

This version of the policy will become effective 12/29/2025.

This policy has been updated to communicate that corneal collagen cross-linking using riboflavin and ultraviolet A is considered medically necessary for the treatment of progressive keratoconus and corneal ectasia following refractive surgery.

Coverage of the following CPT code has been changed from Experimental/Investigational to Medically Necessary: 0402T.

Revisions From MA11.008e:

06/26/2024	This policy has been reissued in accordance with the Company’s annual review process.
01/01/2024	Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.
03/22/2023	This policy has been reissued in accordance with the Company’s annual review process.
07/01/2022	This policy has been identified for the CPT code update, effective 07/01/2022. The following CPT narrative has been revised in this policy: 0402T

Revisions From MA11.008d:

05/18/2022	This policy has been reissued in accordance with the Company’s annual review process.
06/02/2021	The policy has been reviewed and reissued to communicate the Company’s continuing position on Refractive Keratoplasty.
12/02/2020	The policy has been reviewed and reissued to communicate the Company’s continuing position on Refractive Keratoplasty.
11/18/2019	Policy language addressing radial keratotomy and keratoplasty was revised for clarity. However, there was no change in coverage position.

Revisions From MA11.008c:

07/01/2019

This policy has been identified for the CPT code update, effective 07/01/2019.

The following CPT narrative has been revised in this policy: 0402T

Revisions From MA11.008b:

03/28/2018	This policy has undergone a routine review, and no revisions have been made.
08/02/2017	The intent of this policy remains unchanged. The following CPT code has been added to this policy: 65770 The following HCPCS codes have been added to this policy: C1818, L8609 The following revenue code has been added to this policy: 0276

Revisions From MA11.008a:

01/01/2017

This version of the policy will become effective 01/01/2017. Collagen cross-linking of the cornea for the treatment of keratoconus, and Keratoprostheses implantation in the treatment of individuals with corneal opacities have been added to the policy.

Procedure code 0402T with an existing and continued experimental/investigational position has been added to the policy.

Revisions From MA11.008:

03/02/2016	The policy has been reviewed and reissued to communicate the Company’s continuing position on Refractive Keratoplasty.
12/31/2015	This policy has been reissued in accordance with the Company’s annual review process.
01/01/2015	This is a new policy.

Version Effective Date:

7/27/2026

Version Issued Date: