Corneal Remodeling for Refractive Errors Form

1 Corneal Remodeling for Refractive Errors - Medical Policy Updated Revision Effective: January 1, 2026 Policy Number: UM671POL Approval Date: Line(s) of Business: Commercial
Medicare Advantage
Medicaid (BeHealthy) Description Refractive error (ametropia) is present when parallel rays of light entering the non-accommodating eye do not focus on the retina. The errors are defects in the functioning power of the eye due to an imperfectly shaped eyeball, cornea or lens, so that viewed objects are focused either in front of or behind the retina, resulting in blurred vision. Refractive errors include myopia, or nearsightedness; hyperopia, or farsightedness; astigmatism, in which an uneven curvature of the cornea blurs vision for both near and far objects; and presbyopia, which is associated with aging and loss of flexibility of the lens, limiting the ability of the eye to change its point of focus from far to near.
Keratoconus is a non-inflammatory degenerative condition in which collagen fibers within the cornea weaken and progressively thin. As a result of the thinning, the fibers can no longer maintain the normal round shape of the cornea. Consequently, the cornea bulges outward, steepens and develops a progressive conical shape. This abnormality prevents light that is entering the eye from focusing directly on the retina, resulting in irregular astigmatism and progressive myopia or visual loss.
Corneal ectasia, also known as keratectasia or iatrogenic keratoconus, is caused by irregularities in the cornea that lead to disturbances of vision as a result of astigmatism. The term corneal ectasia can refer to a group of conditions, most notably keratoconus, but can also be related to irregular astigmatism that can develop after a patient undergoes refractive surgery (laser in situ keratomileusis [LASIK] or photorefractive keratectomy [PRK]). Corneal ectasia after laser refractive surgery is a keratoconus-like focal biomechanical disorder characterized by progressive distortion of the corneal shape and optical quality. The cornea can continue to bulge, leading to a worsening of vision (American Academy of Ophthalmology [AAO], 2018).
Refractive surgery refers to surgical procedures designed to correct refractive errors by reshaping the corneal surface, and to improve the focusing power of the eye, thus reducing or eliminating the need for corrective lenses. According to the AAO, refractive surgery is an elective procedure which may be considered by those who wish to become less dependent on spectacles or contact lenses or when there is an occupational or cosmetic reason to not wear spectacles (AAO, 2022).
11/11/2025

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The need to correct refractive errors depends on the patient’s symptoms and visual needs. Those with low refractive errors may not need correction. Small changes in refractive corrections in asymptomatic patients are usually not recommended. The major reasons for treating refractive errors are to improve visual acuity, function and comfort. Other reasons for treatment include enhancing binocular vision and decreasing strabismus. Patients with high refractive errors generally require correction to achieve satisfactory vision. Options for correcting refractive errors include spectacles, contact lenses or surgery. Spectacles should be considered before contact lenses or refractive surgery. The majority of adults can tolerate up to 3.0 D of difference in eyeglass refractive correction. Occasionally, individuals may tolerate more than 3.0 D of difference (AAO, 2018).

Refractive Procedures

Corneal collagen crosslinking (CXL) is proposed to minimize or stop the keratoconus disease process by strengthening and stabilizing the collagen lamellae by mimicking the age-related crosslinking that occurs in the cornea over time. Ideally, the treatment results in mechanical stiffening of the cornea, decreasing the disease progression (e.g., decreasing keratometry readings, increasing corneal thickness) (Hersh, et al., 2017).

The 2018 American Academy of Ophthalmology (AAO) Summary Benchmark for Preferred Practice Pattern® Guidelines on corneal ectasia includes a discussion of the initial and follow-up evaluation of the condition. The guideline listed collagen crosslinking as a treatment option that can improve corneal rigidity by increasing bonds between fibers.

In the 2022 Refractive Surgery Preferred Practice Pattern, the AAO stated that options for the treatment of corneal ectasia after LASIK include corneal crosslinking. Studies have shown that CXL induced by topical riboflavin and ultraviolet irradiation may arrest keratectasia, as demonstrated by preoperative and postoperative corneal topography/tomography and a reduction in maximum keratometric readings. Long-term stability after CXL therapy for treatment of post-refractive corneal ectasia has been reported and has received FDA approval.

Intrastromal Corneal Ring Segments (INTACS) involves inserting a flexible ring beneath the surface of the cornea to elevate the edge of the cornea to flatten the front of the eye, decreasing nearsightedness. Different size rings are used to correct different degrees of nearsightedness. Intrastromal corneal ring segments have been investigated for two indications—as a refractive procedure to correct mild myopia and as a treatment of keratoconus.

In addition, intrastromal corneal ring segments have been investigated as a treatment for corneal ectasia after LASIK. According to the AAO, reported techniques vary in the size, number, and symmetry of the implants as well as the location of the incision. Although early results show potential, long-term efficacy for this procedure remains to be determined (AAO, 2022). Treatment for post- LASIK ectasia is not an FDA-approved indication for intrastromal corneal ring segments.

Corneal Relaxing Incisions/Corneal Wedge Resection (Astigmatic Keratotomy [AK]) are a type of incisional treatment used in the management of astigmatism, and include astigmatic keratotomy (AK) and limbal relaxing incisions (LRIs). In AK, either transverse or arcuate incisions are made in the paracentral cornea to change its curvature in order to reduce or eliminate corneal astigmatism by allowing the cornea to become more rounded when it heals. AK is often performed for the correction of surgically induced astigmatism and following medically indicated cataract removal or corneal transplant surgery. Variations of AK include the Ruiz Procedure and the Troutman Wedge Resection, also referred to as a corneal wedge resection. The wedge resection, often used with corneal relaxing incisions, effectively decreases astigmatism. However, clinical results have been reported to be unpredictable, therefore, the technique is typically reserved for the correction of post-keratoplasty astigmatism of high degree.

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Limbal Relaxing Incisions (LRIs) or peripheral corneal relaxing incisions, are a variant of astigmatic keratotomy (AK) (see above) in which incisions are placed just on the far peripheral aspect of the cornea. LRIs may be used to treat low to moderate degrees of astigmatism and have been performed alone or combined with cataract extraction and intraocular lens implantation to reduce preoperative corneal astigmatism (AAO, 2022). As such, the use of LRIs to treat astigmatism that is not surgically induced is considered not medically necessary.

 Line of Business

Commercial:

• Refer to the criteria under the Policy section in this medical policy.

Medicaid – BeHealthy:

• Refer to the criteria under the Policy section in this medical policy. There are no MassHealth guidelines for Corneal Remodeling for Refractive Errors.

Medicare:

• Health New England follows National Coverage Determination (NCD) 80.7, Refractive Keratoplasty (NCD

• Refractive Keratoplasty (80.7)for Medicare line of business.

  • Refer to the criteria under the Policy section in this medical policy for other corneal remodeling procedures.

  Policy

  Corneal Crosslinking

  I. Criteria for Approval for all lines of business:

  A. Conventional, epithelium-off, corneal collagen crosslinking (C-CXL) using a U.S. Food and Drug Administration (FDA) approved drug/device system (e.g., Photrexa® Viscous or Photrexa® with the KXL® System) (CPT Code® 0402T) is considered MEDICALLY NECESSARY for the treatment of EITHER of the following:

  1. Progressive keratoconus; OR

  2. Corneal ectasia following refractive surgery;

                                                                                  AND

  3. When ALL the following criteria are met:
     a. Age 14–65 years; AND
     b. Progressive deterioration in vision ; AND c. Absence of visual disturbance from a significant central corneal opacity or other eye disease (e.g., herpetic keratitis, neurotrophic keratopathy).

  B. C-CXL is considered NOT MEDICALLY NECESSARY for any other indication including when combined with a second refractive procedure.

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C. All other corneal collagen crosslinking procedures (e.g., epithelium-on/trans-epithelial) are considered EXPERIMENTAL and INVESTIGATIONAL. Intrastromal Corneal Ring Segments

I. Criteria for Approval for all lines of business:

A. The insertion of intrastromal corneal ring segments (CPT® code 65785) (e.g., INTACS® prescription inserts) is considered MEDICALLY NECESSARY when provided in accordance with the Humanitarian Device Exemption (HDE) specifications of the U.S. Food and Drug Administration (FDA) for the treatment of myopia and astigmatism in patients with keratoconus who meet ALL of the following criteria:

1. Progressive deterioration in vision, such that adequate functional vision on a daily basis with contact lenses or spectacles can no longer be achieved; AND
2. Age 21 years of age or older; AND
3. Clear central corneas; AND
4. Corneal thickness of 450 microns or greater at the proposed incision site; AND

5. Corneal transplantation is the only other remaining option for improving functional vision.

   B. Intrastromal corneal ring segments (CPT® code 65785) (e.g., INTACS® prescription inserts) are considered NOT MEDICALLY NECESSARY for any other indications.

   Corneal Relaxing/Corneal Wedge Resection

   I. Criteria for Approval for all lines of business:

   A. Correction of surgically induced astigmatism 3.00 diopters (D) or greater with a corneal relaxing incision (CPT® code 65772) or corneal wedge resection (CPT® code 65775) (i.e., astigmatic keratotomy [AK]), post-cataract or post-corneal transplant surgery is considered MEDICALLY NECESSARY in an individual who is intolerant of glasses or contact lenses.

   B. Corneal relaxing incision (CPT® code 65772) or corneal wedge resection (CPT® code 65775) (i.e., astigmatic keratotomy [AK]) is considered NOT MEDICALLY NECESSARY for any other indication.

   Other Procedures

   I. The following refractive procedures are considered NOT MEDICALLY NECESSARY:

   A. Conductive keratoplasty (CPT® code 66999), B. Lamellar keratoplasty (non-penetrating keratoplasty) (CPT® codes 65710; 66999), C. Laser thermokeratoplasty (LTK) (CPT® code 66999), D. Limbal relaxing incisions for non-surgically induced astigmatism (CPT® code 66999),
   E. Penetrating keratoplasty (PK) (corneal transplantation, perforating keratoplasty) (CPT® codes 65730; 65750; 65755; 66999). F. Laser epithelial keratomileusis (LASEK) (CPT® code 66999). G. Orthokeratology in all cases (HCPCS code V2599).

   II. The following refractive procedures are considered EXPERIMENTAL and INVESTIGATIONAL:

   A. Automated lamellar keratomileusis (ALK) (i.e. standard keratomileusis) for the treatment of all refractive errors (CPT® code 65760), B. Corneal inlay (CPT® code 66999), C. Hexagonal keratotomy in all cases (CPT® code 66999), D. Keratophakia for the correction of all refractive errors (CPT® code 65765),

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E. Minimally-invasive radial keratotomy (mini-RK) in all cases (CPT® code 66999), F. Scleral expansion surgery (CPT® code 66999). Coding Guidance

E&I = experimental/investigational, NMN= not medically necessary Conventional, epithelium-off, corneal collagen crosslinking

CPT Codes
Description
Coverage PA 0402T Collagen crosslinking of cornea including removal of the corneal epithelium, when performed, and intraoperative pachymetry, when performed Covered Yes Corneal Relaxing Incision/Corneal Wedge Resection

CPT Codes
Description
Coverage

65772 Corneal relaxing incision for correction of surgically induced astigmatism Covered Yes 65775 Corneal wedge resection for correction of surgically induced astigmatism Covered Yes Intrastromal Corneal Ring Segments

CPT Codes
Description
Coverage

65785 Implantation of intrastromal corneal ring segments Covered Yes Other Procedures

CPT Codes
Description
Coverage

65710
Keratoplasty (corneal transplant); anterior lamellar
NMN No 65730 Keratoplasty (corneal transplant); penetrating (except in aphakia or pseudophakia)
NMN No 65750 Keratoplasty (corneal transplant); penetrating (in aphakia) NMN No 65755 Keratoplasty (corneal transplant); penetrating (in pseudophakia) NMN No 65756 Keratoplasty (corneal transplant); endothelial NMN No 66999 Unlisted procedure, anterior segment of eye (when used to describe procedures in the not medically necessary section of this policy)
NMN No 65760
Keratomileusis
E&I No 65765
Keratophakia
E&I No 66999
Unlisted procedure, anterior segment of eye (when used to describe procedures in the experimental and investigational section of this policy) E&I No HCPCS Codes Description Coverage

V2599 Contact lens, other type Not covered when used to describe procedures in the experimental and investigational No

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section of this policy Prior Authorization (PA). Not Medically Necessary (NMN). *Experimental and Investigational (E&I).

ICD 10 codes applicable to CPT codes 65710, 65730, 65750, 65755, 65765, 66999 Code Description H52.0 Hypermetropia H52.1 Myopia H52.2 Astigmatism H52.3 Anisometropia and aniseikonia H52.4 Presbyopia H52.6 Other disorders of refraction H52.7 Unspecified disorder of refraction

CPT® Copyright 2024 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Note: CPT/HCPCS codes are included for informational purposes and may not be all inclusive. Inclusion or exclusion of a CPT/HCPCS code(s) does not signify or imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member’s specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee of payment. Other policies and coverage determination guidelines may apply.

References

1. Aixinjueluo W, Usui T, Miyai T, Toyono T, Sakisaka T, Yamagami S. Accelerated transepithelial corneal crosslinking for progressive keratoconus: a prospective study of 12 months. Br J Ophthalmol. 2017 Sep;101(9):1244-1249. (10.1136/bjophthalmol-2016-309775)

2. Al Fayez MF, Alfayez S, Alfayez Y. Transepithelial Versus Epithelium-Off Corneal Collagen Crosslinking for Progressive Keratoconus: A Prospective Randomized Controlled Trial. Cornea. 2015 Oct;34 Suppl 10:S53-6.

3. American Academy of Ophthalmology (AAO). Preferred Practice Pattern. Corneal Ectasia. Oct 2018.
   https://www.aao.org/preferred-practice-patterns

4. American Academy of Ophthalmology (AAO). Cornea/external disease summary benchmarks – 2022. Dec 2022. https://www.aao.org/preferred-practice-patterns

5. American Academy of Ophthalmology (AAO). Refractive Errors Preferred Practice Pattern. 2022. https://www.aao.org/preferredpractice-patterns

6. American Academy of Ophthalmology (AAO). Refractive Surgery Preferred Practice Pattern. 2022. https://www.aao.org/preferredpractice-patterns

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7. American Academy of Ophthalmology (AAO). Corneal Collagen Cross-Linking. Oct 27, 2022. Corneal Cross- Linking - EyeWiki

8. American Academy of Ophthalmology (AAO). Corneal inlays. Jul 8, 2023. Corneal Inlays - EyeWiki

9. American Association for Pediatric Ophthalmology and Strabismus (AAPOS). AAPOS Home - American Association for Pediatric Ophthalmology and Strabismus

10. Beer SMC, Werner L, Nakano EM, et al. A 3-year follow-up study of a new corneal inlay: clinical results and outcomes. Br J Ophthalmol. 2020;104(5):723-728.

11. Bower KS. Laser refractive surgery. In: UpToDate, Givens J (Ed.). Aug 15, 2022. UpToDate, Waltham, MA.

12. Boxer Wachler BS, Christis JP, Chandra NS, Chou B, Korn T, Nepomuceno R. Intacs for keratoconus. Ophthalmology. 2003 May;110(5):1031-1040.

13. Burcel MG, Lacraru IC, Dascalescu DMC, Corbu MC, Potop V, Coviltir V. Assessment of twoyear clinical outcomes after keratoconus treatment using two different crosslinking protocols. Eur Rev Med Pharmacol Sci. 2022 Feb;26(3):906-916.

14. Chan TCY, Ng ALK, Chan KKW, Cheng GPM, Wong IYH, Jhanji V. Combined application of prophylactic corneal crosslinking and laser in-situ keratomileusis - a review of literature. Acta Ophthalmol. 2017 Nov;95(7):660-664.

15. Charm J, Cho P. High myopia-partial reduction ortho-k: a 2-year randomized study. Optom Vis Sci. 2013 Jun;90(6):530-9.

16. Chunyu T, Xiujun P, Zhengjun F, Xia Z, Feihu Z. Corneal collagen crosslinking in keratoconus: a systematic review and meta-analysis. Sci Rep. 2014 Jul 10;4:5652

17. Craig JA, Mahon J, Yellowlees A, Barata T, Glanville J, Arber M, et al. Epithelium-off photochemical corneal collagen crosslinkage using riboflavin and ultraviolet a for keratoconus and keratectasia: a systematic review and meta-analysis. Ocul Surf. 2014 Jul;12(3):202-14.

18. D'Oria F, Palazón A, Alio JL. Corneal collagen cross-linking epithelium-on vs. epithelium-off: a systematic review and meta-analysis. Eye Vis (Lond). 2021 Sep 1;8(1):34.

19. Hersh PS, Stulting RD, Muller D, Durrie DS, Rajpal RK; United States Crosslinking Study Group. United States Multicenter Clinical Trial of Corneal Collagen Crosslinking for Keratoconus Treatment. Ophthalmology. 2017 Sep;124(9):1259-1270.

20. Scleral surgery for the treatment of presbyopia: where are we today? Hipsley, A., Hall, B. & Rocha, K.M.
    https://eandv.biomedcentral.com/articles/10.1186/s40662-018-0098-x
21. Scleral expansion surgery for presbyopia https://www.nice.org.uk/guidance/ipg70/documents/interventional-procedure-consultation-document-scleral- expansion-surgery-for-presbyopia

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Policy Implementation

Approved by the Medical and Pharmacy Policy Committee

Kate McIntosh MD MBA

Chief Medical Officer

Saad Usmani MD MBA

Medical Director

Date Update 11/2023 New policy in place of Corneal Cross-Linking and Intacs Corneal Implants. PA added to 65772 The following codes will deny as not medically necessary when billed with a diagnosis of refractive disorder: 65710, 65730, 65750,65755 65760 added to policy (currently experimental/investigational) 65765 will deny experimental/investigational when billed with a diagnosis of refractive disorder

1/2024 Updated Line of Business Section 09/2024 Annual Review. No criteria changes. 09/2025 Annual Review, reviewed and updated references.

Medical Criteria Disclaimer

Property of Health New England. All rights reserved. The treating physician or primary care provider must submit to Health New England the clinical evidence that the patient meets the criteria for the treatment, testing or surgical procedure. Without this documentation and information, Health New England will not be able to properly review the request for prior authorization. The clinical review criteria reflect how Health New England determines whether certain services or supplies are medically necessary. Health New England established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors).
Health New England expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by Health New England, as some programs exclude coverage for services or supplies that Health New England considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication. Health New England has adopted the herein policy in providing management, administrative and other services to its Health Plan.