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Refractive Keratoplasty, Keratoprosthesis, and Corneal Collagen Cross-Linking
11.05.01h

Policy

MEDICALLY NECESSARY
​ 
REFRACTIVE KERATOPLASTY
Refractive keratoplasty is considered medically necessary and, therefore, covered when performed by corneal relaxing incision, corneal wedge resection, or conductive keratoplasty for the correction of astigmatism resulting from trauma or previous eye surgery (e.g., cataract surgery, penetrating keratoplasty).

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:
  • 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 (e.g., 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 progressive keratoconus or corneal ectasia after refractive surgery.

EXPERIMENTAL/INVESTIGATIONAL

All other uses for refractive 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 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. ​

 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 device cannot be established by review of the available published peer-reviewed literature.

NOT ELIGIBLE FOR REIMBURSEMENT

For most plans, all other refractive keratoplasty procedures and related services performed for the correction of refractive defects (e.g., myopia, hyperopia, or astigmatism) in order to eliminate or reduce the need for prescription or corrective vision lenses are not covered by the Company because they are a benefit contract exclusion. Therefore, they are not eligible for reimbursement consideration.


Coverage for services varies by benefit plan, therefore, individual benefits must be verified.


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, refractive keratoplasty may be covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met. However, services that are identified in this policy as experimental/investigational are not eligible for coverage or reimbursement by the Company. Certain Company benefit contracts may exclude the surgical treatments and procedures performed solely to eliminate the need for or reduce the Prescription of corrective vision lenses including, but not limited to radial keratotomy and refractive keratoplasty. Individual benefits must be verified, as coverage may vary between products and/or groups.

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.​
BILLING GUIDELINES

There is no specific procedure code for conductive keratoplasty. When the procedure is performed for the correction of astigmatism resulting from trauma or previous eye surgery, providers should report the nonspecific Current Procedural Terminology (CPT) code 66999.

Description

The cornea is the part of the eye that helps focus light in order to create an image on the retina. It works in much the same way that the lens of a camera focuses light to create an image on film.

The bending and focusing of light by the cornea is known as refraction. When a refractive error occurs, it is usually because of imperfections in the shape of the cornea and/or the eye that cause the image on the retina to become out of focus (blurred) or distorted. Eyeglasses or contact lenses are designed to compensate for the eye's imperfections.

Refractive keratoplasty is a generic term that includes surgical procedures that reshape the cornea to correct vision problems such as myopia (nearsightedness), hyperopia (farsightedness), and astigmatism (a distortion of the image on the retina caused by irregularities in the cornea or lens of the eye).

Refractive keratoplastic procedures include the following:
  • Corneal relaxing incisions (CRIs): A subset of astigmatic keratotomy (AK) (the other subset is limbal relaxing incisions [LRIs]), in which partial thickness incisions are made at the corneal periphery for the treatment of corneal astigmatism.
  • Corneal wedge resection: A procedure performed to correct posttransplant-induced astigmatism. In this procedure, a wedge resection is designed to steepen the flattest corneal meridian by removing a wedge of corneal tissue and suturing the edges together.
  • Conductive keratoplasty (CK): Radiofrequency energy is applied to heat points around the edge of the cornea, thus shrinking and tightening the collagen in the eye and increasing the curvature of the eye over the cornea to correct hyperopia or astigmatism (i.e., the ViewPoint® CK System).
  • Epikeratoplasty: A donor cornea is applied to the anterior surface of the cornea from which the epithelium has been removed to correct hyperopia.
  • Keratomileusis: The front of the cornea is removed, frozen, reshaped, and stitched back onto the eye to correct myopia or hyperopia.
  • Keratophakia: A reshaped donor cornea is inserted in the eye to correct hyperopia.
  • Laser in situ keratomileusis (LASIK): LASIK is a laser procedure that permanently reshapes the inner layers of the cornea to correct myopia or hyperopia.
    • Wavefront-guided LASIK is an enhanced laser procedure in which data are translated into a mathematical formula that is programmed into the laser to create a computer-generated map that vaporizes corneal tissue to correct myopia or astigmatism (e.g., the LADARWave Customized Ablation System and the VISX CustomVue System).
  • Photorefractive keratectomy (PRK): An excimer laser is used to remove a thin layer of the cornea (epithelium) to correct or reduce astigmatism (e.g., the LADARVision® System and the LASERScan LSX System).
  • Radial keratotomy (RK): Spoke-like slits are cut in the cornea to weaken and flatten the normally curved central portion to correct myopia.
    • AK, which is similar to RK, is performed to reduce astigmatism.
  • Collagen cross-linking of the cornea (CXL): 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.
      1. 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.
      2. 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 Jirásková et al. reported 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

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U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health. Boston Keratoprosthesis, Type I and Type II. 510(k) summary. [FDA Web site]. 05/10/2013. Available at:  http://www.accessdata.fda.gov/cdrh_docs/pdf12/K121203.pdf. Accessed August 4, 2025​.

U.S. Food and Drug Administration (FDA). Center for Drug Evaluation and Research (CDER). Epioxa [FDA Web site]. Page Last Updated: 10/17/2025. Available at: Epioxa (riboflavin 5’-phosphate ophthalmic solution) 0.177%. Accessed February 10, 2026.​


Wittig-Silva C, Chan E, Islam FM, et al. A randomized, controlled trial of corneal collagen cross-linking in progressive keratoconus: three-year results. Ophthalmology. 2014;121(4):812-821.

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.

Ye PP, Xu W, Xu HS, et al. Conductive keratoplasty: an approach for the correction of residual hyperopia in post-lasik pseudophakia. Int J Ophthalmol. 2012;5(5):630-633.​

Coding

CPT Procedure Code Number(s)
MEDICALLY NECESSARY
0402T, 65770, 65772, 65775


THE FOLLOWING CODE IS USED TO REPRESENT CONDUCTIVE KERATOPLASTY:
66999

NOT ELIGIBLE FOR REIMBURSEMENT
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


NOT ELIGIBLE FOR REIMBURSEMENT
S0800   Laser in situ keratomileusis (LASIK)
S0810   Photorefractive keratectomy (PRK)
S0812   Phototherapeutic keratectomy (PTK)

Revenue Code Number(s)
276 Medical/Surgical Supplies and Devices-Intraocular Lens​


​

Coding and Billing Requirements

Policy History

Revisions From 11.05.01h:
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 e​pithelium-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 E/I statement has 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 11.05.01g:
​12/10/2025
​This policy has been reissued in accordance with the Company's annual review process.​​
​​​​​06/26/2024
​​This policy has been reissued in accordance with the Company's annual review process.​
​​03/22/2023
​This policy has been reissued in accordance with the Company's annual review process.​
07/01/2022This 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 11.05.01f:
05/18/2​0​22​​​​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.​
​11/06/2019​​​​
​​The policy has been reviewed and reissued to communicate the Company’s continuing position on Refractive Keratoplasty.
07/01/2019This 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 11.05.01e:
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.
7/27/2026
7/27/2026
11.05.01
Medical Policy Bulletin
Commercial
No
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