OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

CurrentAetnaPolicy 0023

Corneal Remodeling

Customize your policy alerts

Sign up for Aetna Policy 0023 alerts

Get alerted when Policy 0023 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Defines medical necessity, experimental/investigational status, and coding guidance for corneal remodeling procedures (e.g., corneal relaxing incisions, PTK, keratoplasty, collagen cross-linking, refractive surgeries) for Aetna members.

Policy Summary

PayerAetna

PolicyCorneal Remodeling

Policy CodePolicy 0023

Change TypeNo material changes

Effective DateAug 3, 1995

Last ReviewJun 7, 2023

Next Review DateJan 11, 2024

Key ActionObtain prior authorization when requesting corneal relaxing incisions or corneal wedge resection and document selection criteria (time since surgery, astigmatism ≥3.00 D, intolerance of corrective lenses).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

400 μmCXL standard threshold

3.00 DMinimum astigmatism

60 moPost-PK timeframe

36 moPost-cataract timeframe

01/11/2024Next review

Coverage Criteria

Post-Cataract Post-Transplant Corneal Surgery

Post-cataract or post-penetrating keratoplasty correction of surgically induced astigmatism is covered when ALL of the following are met:

Post-surgical astigmatism correction criteria

Astigmatism magnitude and intolerance: The degree of astigmatism is 3.00 diopters or greater AND the member is intolerant of glasses or contact lenses.>= 3.00 D
Prior surgery timeframe: Member had prior penetrating keratoplasty within the past 60 months OR prior cataract surgery within the past 36 months.penetrating keratoplasty ≤ 60 months OR cataract surgery ≤ 36 months
Both surgery timing and clinical thresholds must be met.

Policy Summary

PayerAetna

PolicyCorneal Remodeling

Policy CodePolicy 0023

Change TypeNo material changes

Effective DateAug 3, 1995

Last ReviewJun 7, 2023

Next Review DateJan 11, 2024

SourceLink

On This Page

Operational note: Prior authorization may be required for CPT codes 65772 (corneal relaxing incision) or 65775 (corneal wedge resection) when seeking coverage; documentation should support the clinical thresholds above.

See coding and prior authorization guidance.

Phototherapeutic Keratectomy (PTK)

Phototherapeutic keratectomy (PTK) is considered medically necessary when the member has ANY of the following conditions:

PTK indications: Corneal scars and opacities (post‑traumatic, post‑infectious, post‑surgical, or secondary to pathology); OR epithelial membrane dystrophy; OR irregular corneal surfaces due to Salzmann's nodular degeneration or keratoconus nodules; OR recurrent corneal erosions when conservative measures (e.g., lubricants, hypertonic saline, patching, bandage contact lenses, gentle debridement) have failed; OR superficial corneal dystrophy (including granular, lattice, and Reis‑Bückler's dystrophy).

Conservative measures should be attempted and documented for recurrent erosions prior to PTK.

PTK investigational exclusions: PTK is considered experimental and investigational for treatment of infectious keratitis and for indications not listed above.

Collagen Cross-Linking (CXL) for Keratoconus/Keratectasia

Collagen cross-linking is covered when performed as epithelium-off photochemical CXL with riboflavin and UVA for the following:

CXL indication: Keratoconus OR keratectasia.

Epithelium-off (standard/Dresden) riboflavin + UVA technique is the established method supported by guidance; epithelium-on (transepithelial) CXL and CXL combined with other procedures (CXL‑plus) are considered experimental/investigational for other indications.

Technique and documentation: When performing conventional epithelium‑off CXL, document corneal thickness (≥ 400 μm) and procedural parameters (e.g., riboflavin saturation and UVA 370 nm at 3 mW/cm2 for 30 minutes, cumulative dose 5.4 J/cm2) as applicable.>= 400 μm; 5.4 J/cm2 (370 nm, 3 mW/cm2 × 30 min)

Epithelium‑on CXL has inadequate evidence of safety and efficacy per NICE and may require additional justification or be considered investigational.

Refractive Surgery (general stance)

Refractive surgical procedures coverage stance:

General NMN stance for refractive surgery: Refractive procedures performed solely to correct refractive errors (e.g., PRK, LASIK, RK, astigmatic keratotomy, keratomileusis, epikeratophakia, intrastromal corneal ring segments) are considered not medically necessary when correction can be achieved with spectacles or contact lenses.

Specific FDA/AAO‑accepted indications and plan contractual exclusions may further define applicability; some procedures (e.g., astigmatic keratotomy) are medically necessary when performed to correct surgically induced astigmatism after cataract removal or corneal transplant.

FDA/AAO limits referenced: LASIK, PRK and related procedures are considered not medically necessary for many refractive ranges outside accepted FDA indications; see device‑specific FDA/AAO guidance for approved refractive ranges.

Policy references FDA/AAO ranges and recommends using spectacle/contact lens correction when appropriate.

Covered when selection criteria are met vs Refractive surgery NMN

Overall stance and conditional coverage

Mixed coverage stance: Some corneal procedures (certain keratoplasty types, INTACS under HDE criteria, epithelium‑off CXL with CPT 0402T, keratoprosthesis) may be covered when explicit selection criteria are met, while refractive surgical procedures are generally considered not medically necessary for routine refractive correction.

Coverage is contingent on meeting documented clinical selection criteria and plan contract provisions; appropriate CPT/HCPCS/ICD documentation should accompany requests.

Procedural selection criteria (background-derived)

Procedural indications and selection notes extracted from clinical background and regulatory guidance:

Dermal graft use: Split‑thickness dermal grafts may be used to repair non‑infectious corneal/scleral defects when adjacent conjunctiva is inadequate or prior reconstructions have failed; consider when traditional methods are inappropriate.

Supported by small case series (Mauriello & Pokorny).

INTACS candidate criteria: INTACS may be appropriate for keratoconus patients who are ≥21 years old, have progressive deterioration with inability to achieve functional vision with glasses/contact lenses, have clear central corneas, have corneal thickness ≥450 μm at the proposed incision site, and for whom corneal transplant is the remaining option.>= 450 μm; age ≥ 21

Reflects FDA HDE criteria.

Phakic IOL selection notes: Phakic intraocular lenses require documented refractive stability, device‑specific biometric criteria (e.g., anterior chamber depth ≥ ~3.0–3.2 mm), and adherence to approved indication ranges.>= 3.0–3.2 mm anterior chamber depth

Device‑dependent FDA guidance should be followed.

Keratoprosthesis candidacy summary: Keratoprosthesis (e.g., Boston K‑Pro, OOKP) can be considered for patients with prior failed grafts or ocular surface disease that makes donor grafting unlikely to succeed; practice varies regarding number of prior graft failures required before K‑Pro consideration.

Document prior graft history and rationale; compare alternatives such as repeat donor transplantation.

Keratoprosthesis candidate considerations

Clinical considerations influencing coverage decisions include:

Keratoprosthesis candidate considerations: Keratoprosthesis may be considered when ALL apply: (1) prior donor corneal transplant(s) have failed or donor graft is unlikely to succeed; (2) alternatives have been evaluated (including repeat donor grafting); (3) pre‑operative glaucoma status and management plan are documented given high prevalence and risk of progression; (4) informed consent documents device retention rates and potential complications.

Centers vary in whether one or multiple graft failures are required; document clinical justification.

Endothelial keratoplasty

Endothelial keratoplasty (DSEK/DSAEK/DMEK) considerations:

Endothelial keratoplasty candidates: Patients with corneal endothelial dysfunction (e.g., Fuchs dystrophy, bullous keratopathy, failed penetrating graft) may be considered for endothelial keratoplasty (DSEK/DSAEK/DMEK), which typically offers faster rehabilitation and better refractive stability than penetrating keratoplasty; risks include graft dislocation and endothelial cell loss.

AAO and NICE assessments support EK but note potential complications and varying long‑term data.

Collagen crosslinking

Corneal collagen crosslinking (CXL) coverage considerations:

CXL candidate criteria: Progressive keratoconus or keratectasia documented by objective measures; use of epithelium‑off (standard/Dresden protocol) riboflavin+UVA CXL is preferred given established evidence of safety and efficacy; epithelium‑on (transepithelial) techniques and unvalidated topical pharmacologic cross‑linkers are considered experimental/investigational.>= 400 μm corneal thickness for conventional CXL

NICE (2013) and CADTH assessments favor epithelium‑off CXL; combination 'CXL‑plus' procedures lack sufficient evidence.

CXL and related techniques

Evidence-based considerations and coverage stance for corneal cross-linking and related remodeling procedures

Conventional epithelium-off CXL: Conventional (Dresden) epithelium‑off CXL is supported by guidance (e.g., NICE) and evidence showing stabilization of keratoconus when performed with standard parameters.>= 400 μm; UVA 370 nm, 3 mW/cm2 for 30 min (5.4 J/cm2)

Document procedural parameters and corneal thickness when billing/authorization requested.

Epithelium-on (transepithelial) CXL: Epithelium‑on CXL has inadequate evidence of safety and efficacy per NICE and should be considered investigational or limited to research contexts unless further supportive data are provided.none

May require prior authorization and additional documentation.

Accelerated and novel CXL protocols: Accelerated CXL protocols and 'CXL‑plus' combination procedures have limited short‑term evidence; longer‑term randomized data are needed before routine coverage.none

Topical pharmacologic CXL agents are experimental and not medically necessary for routine use.

Post-LASIK epithelial ingrowth management

Management options for post-LASIK epithelial ingrowth and flap complications

Flap lift, debridement and suturing: Mechanical debridement of epithelial ingrowth with flap lift, scraping, and flap suturing has been reported to control clinically significant epithelial ingrowth with low recurrence in retrospective series.

Document prior treatments and extent of ingrowth; consider based on severity.

Flap amputation with PTK and MMC: In severe cases with keratolysis or failed prior removal attempts, flap amputation followed by PTK with intraoperative mitomycin‑C has been reported as a salvage option (limited evidence: case report).

Considered salvage; limited data.

Debridement with fibrin adhesive: Debridement combined with fibrin tissue adhesive has been used in case series to manage recurrent ingrowth and interface fluid syndrome.

Alternative to suturing in selected cases.

Observation for mild ingrowth: Mild epithelial ingrowth may be observed; intervention is indicated for clinically significant ingrowth affecting vision or causing complications.

Use clinical judgment and document follow‑up.

Endothelial keratoplasty options

Endothelial keratoplasty approaches for endothelial decompensation and acute corneal hydrops

DMEK for TASS-related endothelial decompensation: DMEK has shown improved BCVA and reduced corneal thickness in small series for TASS‑related endothelial decompensation; consider when appropriate with documented indication and prior management.

Evidence limited to small retrospective series.

Mini‑DMEK for acute corneal hydrops: Mini‑DMEK tailored to defect size has been used in small case series for acute corneal hydrops in keratoconus with clinical improvement; further study needed to define selection.

Consider when conservative measures or gas tamponade are unlikely to succeed.

UT‑DSAEK for severe hydrops with posterior stromal ridge: Ultrathin DSAEK has been reported to resolve edema and improve vision in selected severe hydrops with posterior stromal changes; selection should be guided by AS‑OCT findings and clinician expertise.

Limited case reports/series; document imaging and rationale.

Tissue-additive and laser reshaping techniques

Novel and tissue-additive procedures for keratoconus

Crescent excimer keratectomy: Excimer crescent keratectomy has been reported in very small series to improve VA and topography at 1 year but lacks standardized nomograms and wider validation.

Preliminary technique; further standardization and evidence needed.

Femtosecond‑assisted stromal keratophakia (lenticule implantation): Femtosecond‑assisted lenticule implantation (stromal keratophakia) has shown promise in systematic reviews/meta‑analysis (small heterogeneous studies) to increase stromal volume and improve refractive/visual metrics, but technique standardization and long‑term data are lacking.

Considered investigational pending larger standardized studies.

Genetic susceptibility testing

Genetic testing and predisposition

Genetic polymorphism testing (ALDH3A1, LOX, SPARC): Small genetic association studies have identified SNPs in ALDH3A1, LOX, and SPARC associated with keratoconus predisposition in specific populations; these findings require further validation across populations before clinical diagnostic use.

Not established as a clinical diagnostic or predictive test pending broader validation.

Procedures performed solely to correct refractive errors (for example, many uses of penetrating or lamellar keratoplasty, photorefractive keratectomy [PRK], LASIK, radial keratotomy [RK], and related refractive procedures) are excluded or considered not medically necessary unless the member’s benefit plan explicitly includes coverage for refractive surgery. The policy distinguishes PTK (a therapeutic use of the excimer laser for corneal disease) from PRK (a refractive procedure) to emphasize that surface-laser procedures intended only to change refractive status are not covered under standard benefits.

Refractive surgical procedures intended to correct refractive error (e.g., PRK, LASIK, RK, astigmatic keratotomy, keratomileusis, epikeratophakia, intrastromal ring implants) are considered not medically necessary for routine refractive correction because spectacles or contact lenses provide more accurate and predictable refractive outcomes. Where a plan does not explicitly exclude refractive surgery, these procedures remain not medically necessary or investigational except for FDA/AAO-accepted indications; clinical examples and evidence supporting limited accuracy of surgical refractive correction versus lenses are noted.

Methods of thermokeratoplasty other than FDA‑approved conductive keratoplasty (for selected presbyopia/hyperopia indications) — such as holmium:YAG laser thermokeratoplasty (LTK), the hot‑needle technique, and other historical thermokeratoplasty methods — and orthokeratology are not proven effective for routine correction of refractive errors or for keratoconus and are reported as abandoned or not recommended due to unpredictable wound healing, scarring, and instability. Scleral expansion surgery for presbyopia likewise lacks robust evidence and is not recommended.

Guidance and systematic reviews indicate that evidence supporting epithelium-on (transepithelial) CXL is inadequate to establish its safety and efficacy compared with the established epithelium‑off (Dresden) technique. NICE (2013) concluded that most evidence relates to epithelium‑off CXL and that epithelium‑on approaches and ‘‘CXL‑plus’’ combinations have limited supporting data; therefore transepithelial CXL should be considered limited or investigational unless further robust evidence is provided.

Several procedures and combination approaches are considered to have insufficient evidence for routine coverage and are described as investigational or experimental. These include elective combined PRK with prophylactic CXL for mild keratoconus (reports of progressive remodeling have been published), epithelium‑on (transepithelial) CXL, ‘‘CXL‑plus’’ combination techniques without supporting randomized data, and topical pharmacologic cross‑linking agents or other unvalidated CXL delivery methods. When such procedures are proposed, documentation and justification should be provided; absent convincing evidence, they are generally not supported for routine reimbursement.

This Clinical Policy Bulletin provides a partial description of plan benefits related to corneal remodeling procedures and is intended to assist in administering plan provisions. It does not guarantee coverage, does not replace a member’s benefit contract, and specific coverage decisions should be based on the member’s plan documents and any prior authorization determinations.

No explicit set of additional coverage criteria or changes beyond those summarized in this policy excerpt are provided in the document segment; reviewers should refer to the full policy and the member’s benefit plan for any additional criteria or exclusions.

Phototherapeutic keratectomy (PTK) is considered experimental and investigational for the treatment of infectious keratitis and for indications not listed as medically necessary in this policy. PTK is medically necessary only for the specific corneal surface conditions enumerated (e.g., corneal scars/opacities, epithelial membrane dystrophy, Salzmann’s nodular degeneration, recurrent erosions after failed conservative therapy, and superficial corneal dystrophies).

Refractive surgical procedures are considered not medically necessary primarily because spectacles or contact lenses provide more accurate and reversible correction of refractive errors. The policy notes lower precision of surgical refractive outcomes and potential for optical complications; therefore, coverage for elective refractive surgery is generally not supported unless the member’s plan specifically includes refractive benefits or exceptional medical indications exist.

Orthokeratology and scleral expansion surgery are not recommended for routine use. Orthokeratology has not been proven effective and is considered unpredictable and poorly controlled; scleral expansion surgery for presbyopia lacks quality evidence and was recommended by NICE not to be used.

There is an evidence gap comparing artificial corneas (keratoprostheses) with repeat donor corneal transplantation: no randomized controlled trials directly compare outcomes and complications between keratoprosthesis devices and repeat donor grafting. This lack of high‑quality comparative data may affect coverage decisions and supports careful documentation of prior graft failures and rationale when considering an artificial cornea.

Topical pharmacologic cross‑linking agents and other nonstandard or unvalidated CXL delivery methods (including experimental agents identified in early reports) remain investigational. Although preclinical and early clinical work has identified candidate compounds and novel delivery strategies, further controlled trials are required before these approaches are considered medically necessary for routine care.

Within this document segment there are no additional explicit statements labeled as 'not medically necessary' beyond the refractive surgery exclusions and investigational procedure listings already summarized. Providers should consult the full policy and member benefit contract for any further 'not medically necessary' provisions.

Coding

Post-Cataract Post-Transplant Corneal SurgeryCPTCovered

65772	Corneal relaxing incision for correction of surgically induced astigmatism.
65775	Corneal wedge resection for correction of surgically induced astigmatism.

Refractive Surgery / LASIKmixed

65760	Keratomileusis.
S0800	Laser in situ keratomileusis (LASIK).

Refractive Surgery / LASIK - Not Medically Necessary ExamplesmixedNot Covered

S0810	Photorefractive keratectomy (PRK).
S0596	Phakic intraocular lens for correction of refractive error (HCPCS) - listed as not covered in CPB.

Phototherapeutic Keratectomy (PTK)HCPCSCovered

S0812

Phototherapeutic keratectomy (PTK).

Other corneal procedures (varied coverage)CPT

65771	Radial keratotomy.
65767	Epikeratoplasty.
65710	Keratoplasty (corneal transplant); anterior lamellar.

Example ICD-10 codes for covered indicationsICD-10

H52.201 - H52.229	Astigmatism.
H18.601 - H18.629	Keratoconus.
H17.00 - H17.9	Corneal scars and opacities.
Z94.7	Corneal transplant status.
Z98.41 - Z98.49	Cataract extraction status.

Related HCPCS (vision aids)HCPCS

V2100 - V2499	Spectacle lenses.
V2500 - V2599	Contact lens.

Mixed HCPCS/CPT/ICD examplesmixed

V2599	Contact lens.
H52.10 - H52.13	Myopia.
H52.201 - H52.229	Astigmatism.
65760	Keratomileusis.

Penetrating keratoplasty and PRK codesmixed

65730	Keratoplasty; penetrating (except in aphakia or pseudoaphakia).
S0810	Photorefractive keratectomy (PRK).
65760	Keratomileusis.

Endothelial keratoplasty and CXLmixedCovered

65756	Keratoplasty (Corneal Transplant); endothelial.
65757	Backbench preparation of corneal endothelial allograft prior to transplantation (list separately).
0402T	Collagen cross-linking of cornea (including removal of the corneal epithelium and intraoperative pachymetry when performed).
J2787	Riboflavin 5'-phosphate, ophthalmic solution, up to 3 mL.

INTACS and contact lens service codesmixed

65785	Implantation of intrastromal corneal ring segments (INTACS).
92070	Fitting of contact lens for treatment of disease, including supply of lens.
92310 - 92326	Contact lens services.

Keratoprosthesis codesmixedCovered

65770	Keratoprosthesis.
C1818	Integrated keratoprosthesis.
L8609	Artificial cornea.

Intraocular lens / clear lens extraction codes (not covered list present)mixedNot Covered

66840	Removal of lens material; aspiration technique, 1 or more stages.
66940	Extracapsular (other than 66840, 66850, 66852).
66985	Insertion of intraocular lens prosthesis (secondary implant).
C1780	Lens, intraocular (new technology).
Q1004	New technology intraocular lens category 4.
Q1005	New technology intraocular lens category 5.

Genetic polymorphism testingneutralNot Covered

ALDH3A1/LOX/SPARC testing

ALDH3A1, LOX, and SPARC polymorphism testing – no specific CPT code; listed as not covered.

inv-41: Astigmatism magnitude — minimum threshold for eligibility

Astigmatism magnitude>= 3.00 diopters

Requirement contextRequired for correction of surgically induced astigmatism after penetrating keratoplasty or cataract surgery

Additional conditionMember must be intolerant of glasses or contact lenses

inv-42: Time since penetrating keratoplasty — eligibility timeframe

Time since penetrating keratoplasty<= 60 months

ContextOne of the allowable prior surgeries for eligibility to correct surgically induced astigmatism

Related requirementDegree of astigmatism >= 3.00 D and intolerance of spectacles/contact lenses also required

inv-43: Time since cataract surgery — eligibility timeframe

Time since cataract surgery<= 36 months

ContextAllows correction of surgically induced astigmatism after cataract surgery when other criteria met

Related requirementDegree of astigmatism >= 3.00 D and intolerance of spectacles/contact lenses also required

inv-44: LASIK FDA refractive ranges — approved refractive ranges

LASIK myopia range (FDA)-1.0 to -15.0 diopters

LASIK hyperopia range (FDA)Up to +6.0 diopters

LASIK astigmatism limit (FDA)Up to 5.0 diopters

inv-45: Radial Keratotomy indicated range — myopia correction range

RK indicated myopia range-2.00 to -8.00 diopters

Indication noteRK considered for low-to-moderate myopia per AAO guidance

Not indicatedNot proven effective for myopia > -8.00 D

inv-46: Minimum corneal thickness for INTACS incision site — FDA constraint

Minimum corneal thickness at incision site (INTACS)450 microns

Age constraint (FDA)Patient age >= 21 years for INTACS keratoconus indication

Other INTACS criteriaClear central cornea and progressive deterioration with inability to achieve functional vision with glasses/contact lenses

inv-47: Anterior chamber depth for phakic IOLs (device-dependent) — biometric requirement

Anterior chamber depth for phakic IOLs>= 3.0–3.2 mm (device-dependent)

Device examplesArtisan: ACD >= 3.2 mm; Visian ICL: ACD >= 3.0 mm

Other biometric requirementDocumented refractive stability (device-specific interval) required

inv-48: PRK/PTK refractive limits (FDA) — refractive limits for procedures

PRK/PARK hyperopia limit (FDA)Up to +6.0 diopters

PRK/PARK myopia limit (FDA)Up to -10.0 diopters

PRK/PARK astigmatism limit (FDA)Up to 4.0 diopters

inv-49: Minimum corneal thickness — conventional CXL corneal thickness threshold

Minimum corneal thickness for conventional (Dresden) CXL>= 400 μm

ContextRequired threshold prior to performing epithelium-off riboflavin+UVA CXL

DocumentationCorneal thickness should be documented when reporting conventional CXL

inv-50: Conventional CXL cumulative UVA dose — procedural parameter

Conventional CXL cumulative UVA dose5.4 J/cm2 (370 nm, 3 mW/cm2 for 30 minutes)

Protocol nameDresden protocol (epithelium-off)

Accelerated option noteAccelerated protocols use higher irradiance for shorter time (e.g., 9 mW/cm2 for ~10 min) but evidence limited

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required for PTK

Prior authorization is required for phototherapeutic keratectomy (PTK, HCPCS S0812). Submit documentation that demonstrates the indication meets medical necessity (e.g., corneal scars/opacities, epithelial membrane dystrophy, recurrent erosions after conservative therapy has failed, Salzmann's nodules, superficial corneal dystrophy). Conservative measures (lubricants, hypertonic saline, patching, bandage contact lenses, gentle debridement) should be attempted and documented prior to PTK.

Affected code: HCPCS S0812
Document prior conservative therapy and lack of response

Prior Authorization

Prior authorization required for covered corneal procedures

Prior authorization is required for covered corneal procedures and will be contingent on meeting the policy's selection and documentation criteria. Provide relevant operative reports, prior treatment history, and diagnoses supporting medical necessity.

Include applicable CPT/HCPCS and ICD-10 codes when submitting requests
Examples: keratoplasty, endothelial keratoplasty codes (e.g., 65756, 65757), KPro (65770) when indicated

Prior Authorization

Keratoprosthesis prior authorization and required documentation

For keratoprosthesis (e.g., Boston K‑Pro, OOKP), prior authorization is required. Authorization should document prior graft attempts, ocular comorbidities, and peri‑operative glaucoma management plan.

Document number and timing of prior graft failures
Provide indications (failed grafts, high‑risk ocular surface disease) and prior donor/autogenous graft attempts

Prior Authorization

Glaucoma evaluation required prior to KPro authorization

A glaucoma evaluation and documentation of peri‑operative glaucoma management are required before authorization for keratoprosthesis. Because glaucoma is common and may progress after KPro, document baseline glaucoma status and planned monitoring/management (medical and/or surgical).

Document pre‑op intraocular pressure assessment, optic nerve status, visual fields/imaging if available
Plan for glaucoma drainage device or other interventions if indicated

Prior Authorization

Prior authorization for limited‑evidence CXL techniques

Prior authorization is required for collagen cross‑linking (CXL) techniques that have limited, mixed, or insufficient evidence (for example, epithelium‑on/transepithelial approaches, novel accelerated or 'CXL‑plus' combinations). These techniques may be considered investigational or require additional documentation to support medical necessity.

Document rationale for using a limited‑evidence technique vs. conventional epithelium‑off (Dresden) CXL
Reference to NICE and CADTH findings on evidence limitations

Note

Prior authorization guidance and provider responsibility

This bulletin provides guidance to help administer benefits but does not itself establish coverage. Use the prior authorization requirements described here to support benefit determinations; providers remain responsible for clinical decision‑making and treatment.

Prior authorization requirements referenced in this section should be followed when applicable
Clinical Policy Bulletins are not guarantees of coverage

Denial Risk

Coverage exclusions: refractive surgery

Refractive surgical procedures (e.g., LASIK, PRK, radial keratotomy, phakic IOL solely for refractive correction) are considered not medically necessary for routine correction of refractive error; spectacles or contact lenses are the preferred corrective modalities. When requesting authorization for procedures with refractive intent, include justification showing medical necessity per policy criteria.

Examples of excluded/Not Medically Necessary procedures: routine refractive surgery (LASIK/PRK)
If procedure is for post‑surgical astigmatism after graft or cataract meeting timing and criteria, reference applicable policy criteria and codes (e.g., 65772, 65775)

Documentation Required

INTACS indication constraints — documentation required

INTACS candidacy should meet FDA/clinical criteria: age ≥21, progressive deterioration with inadequate vision using spectacles/contact lenses, clear central cornea, corneal thickness ≥450 μm at the incision site, and corneal transplantation considered the only remaining option. Include these data when requesting authorization for INTACS.

Document age, central cornea clarity, corneal thickness at site (≥450 μm), and failed conservative/optical measures
Note limited evidence for INTACS in ectasias not secondary to keratoconus

Denial Risk

Evidence gaps may affect authorization

Evidence gaps (for example, absence of randomized controlled trials comparing keratoprosthesis versus repeat donor grafts, or limited comparative data for artificial corneas) may affect authorization and coverage decisions. Provide detailed clinical rationale and supporting literature when evidence is limited.

For artificial cornea (KPro) requests, document prior graft history and rationale for selecting prosthesis vs repeat graft
Acknowledge that lack of RCTs may prompt case‑by‑case review

Denial Risk

Epithelium‑on CXL — evidence limitation and authorization expectations

Epithelium‑on (transepithelial) CXL has limited evidence of safety and efficacy compared with the conventional epithelium‑off (Dresden) technique. When epithelium‑on CXL is proposed, prior authorization should include justification and supporting data; preference is given to conventional epithelium‑off CXL when criteria are met.

Document why epithelium‑on technique is selected instead of Dresden protocol
Include any available outcome data or justification for accelerated/modified protocols

Note

No automatic denial triggers in this document segment

There are no explicit denial triggers listed within this document segment; administrative review and clinical judgment will guide individual coverage decisions. Providers should nevertheless supply complete documentation to avoid delays.

Complete clinical documentation reduces administrative delays
Follow prior authorization instructions in this bulletin

Billing Rule

Coding and diagnosis documentation required

When submitting prior authorization requests or claims, include appropriate coding and diagnosis documentation. Use the applicable CPT/HCPCS codes and ICD‑10 diagnosis codes that match the procedure and indication.

Examples: PTK S0812; corneal relaxing incision 65772; corneal wedge resection 65775; KPro 65770; keratoplasty codes 65750‑65757
Include ICD‑10 codes for underlying diagnosis (e.g., H18.601‑H18.629 for keratoconus, H17.x for corneal scars)

Documentation Required

Documentation required when requesting CXL

For CXL requests, include diagnosis codes for keratoconus or corneal ectasia and document procedural parameters: corneal thickness, UVA irradiance and duration, riboflavin protocol used, and whether epithelium was removed. These details support medical necessity and appropriate billing.

Document corneal thickness (minimum 400 μm for conventional Dresden protocol)
Record irradiation parameters (e.g., 3 mW/cm2 for 30 minutes = 5.4 J/cm2) and whether an accelerated protocol was used

Documentation Required

Phakic IOL documentation requirements

For phakic intraocular lens (IOL) procedures, prior authorization requests should document stability of refraction and biometric criteria per device labeling (e.g., anterior chamber depth, refractive range, and stability over required interval).

Document stability of refraction (e.g., ≤0.5 D change over required timeframe)
Include anterior chamber depth and device‑specific eligibility details

Documentation Required

Required clinical documentation for complex corneal procedures

Required clinical documentation for high‑risk procedures (e.g., keratoprosthesis, repeat grafts, complex corneal surgery) includes prior graft failure history, number/timing of prior grafts, and ocular comorbidities (glaucoma, optic neuropathy) that affect prognosis and management.

Provide dates and type of prior grafts and reasons for failure
List comorbid ocular conditions and prior glaucoma interventions

Documentation Required

CXL procedural parameters to document

When reporting conventional (Dresden) CXL, document procedural parameters: corneal thickness at time of treatment, riboflavin formulation and concentration, UVA wavelength and irradiance, exposure time, and cumulative energy delivered. These details are necessary for clinical review and coding.

Minimum corneal thickness typically ≥400 μm for epithelium‑off Dresden protocol
Record UVA irradiance (e.g., 3 mW/cm2 × 30 min = 5.4 J/cm2) and any deviations from standard protocol

Note

Providers responsible for medical advice and clinical decisions

Providers remain responsible for medical advice and treatment decisions. This Clinical Policy Bulletin is a summary to assist benefit administration and does not replace clinical judgment. Ensure that patient care decisions are based on current clinical evidence and individualized assessment.

BP: Bulletin does not constitute a contract or guarantee of coverage
Provide full clinical documentation to support requests

Note

Reference: review history and definitions

Refer to the policy header for review history and policy definition references. Prior authorization requirements and policy interpretations may be updated; check the document's review history and effective/next review dates when preparing submissions.

Effective date: 1995‑08‑03; Next review: 2024‑01‑11 (as listed)
Use Review History and Definitions links in the policy for further administrative guidance

Documentation Required

Sequence of surgical options and documentation prior to KPro

Before pursuing keratoprosthesis, consider sequence of surgical options: attempt autogenous or donor graft and, where clinically appropriate, repeat keratoplasty prior to keratoprosthesis. Document prior graft attempts, timing, and reasons for graft failure to justify prosthetic cornea use.

Document prior graft type(s), number, and intervals between grafts
Explain why repeat donor graft is unlikely to succeed when proposing KPro

Background

Background: Corneal remodeling comprises a range of surgical and laser techniques intended to treat corneal disease, correct surgically induced refractive error, or stabilize progressive ectatic disorders. Covered therapeutic procedures include corneal relaxing incisions for post‑surgical astigmatism when specific thresholds are met (for example, astigmatism ≥ 3.00 diopters and defined time windows after prior surgery), phototherapeutic keratectomy (PTK) for specified surface diseases, endothelial and lamellar keratoplasty for appropriate indications, and conventional epithelium‑off collagen cross‑linking (CXL) with riboflavin and UVA for progressive keratoconus/keratectasia when selection criteria are satisfied. Conversely, elective refractive procedures intended solely to correct refractive errors are generally not covered, and less established techniques (e.g., transepithelial CXL, combined CXL‑plus procedures, novel pharmacologic cross‑linkers) are considered investigational pending stronger evidence.

Definitions

inv-81: PTK vs PRK — definition/key distinction for PTK

PTK vs PRK distinctionPTK uses the excimer laser to treat corneal surface disease; PRK is used to correct refractive errors

Clinical implicationAlthough technically similar, indication differentiates PTK (disease) from PRK (refractive correction)

FDA approvalsPTK is FDA-approved for specific corneal dystrophies and superficial corneal disease

inv-82: Collagen cross-linking (CXL) — definition of epithelium-off riboflavin/UVA procedure

CXL definitionEpithelium-off riboflavin plus UVA photochemical procedure to halt progression of keratoconus/keratectasia (e.g., Photrexa)

Technique noteEpithelium is removed to allow riboflavin penetration prior to UVA irradiation

Evidence noteNICE (2013) concluded adequate evidence for epithelium-off CXL but inadequate evidence for epithelium-on techniques

inv-83: Radial Keratotomy (RK) — definition and typical myopia range

Radial Keratotomy (RK) definitionRadial corneal incisions to correct mild-to-moderate myopia

Typical myopia rangeTypically -2.00 to -8.00 diopters

LimitationsNot proven effective for myopia > -8.00 D or other refractive errors

inv-84: LASIK — definition and approved refractive ranges

LASIK definitionLaser corneal surgery that reshapes cornea with excimer laser to correct refractive errors

FDA-approved rangesMyopia -1.0 to -15.0 D; Hyperopia up to +6.0 D; Astigmatism up to 5.0 D

Efficacy limitsNot proven effective beyond FDA ranges (myopia > -15.0 D, hyperopia > +6.0 D, astigmatism > 5.0 D)

inv-85: Collagen crosslinking (CXL) — concise definition corresponding to coverage stance

CXL concise definitionPhotochemical riboflavin+UVA treatment to strengthen corneal collagen and halt keratoconus progression (epithelium-off standard)

Coverage stance noteEpithelium-off CXL considered medically necessary for keratoconus/keratectasia; epithelium-on and CXL-plus are experimental

CPT linkageConventional epithelium-off CXL corresponds to CPT 0402T in coding listings

inv-86: Penetrating Keratoplasty (PK) — definition of full-thickness corneal transplant

Penetrating Keratoplasty (PK)Full-thickness corneal transplant replacing the full thickness of the cornea with donor tissue

IndicationsUsed for opaque cornea, keratitis unresponsive to therapy, structural restoration, and various corneal dystrophies

LimitationsNot proven effective for routine refractive error correction

inv-87: PTK — definition similar to PRK but for surface disease

PTK definition (procedural)Excimer laser procedure similar to PRK but used to treat corneal surface disease

IndicationsApproved for specific dystrophies, scars, recurrent erosions after conservative measures fail

DistinctionPTK treats surface disease; PRK corrects refractive errors

inv-88: INTACS — intrastromal corneal ring segments definition

INTACS definitionIntrastromal corneal ring segments implanted beneath corneal surface to flatten the cornea

Intended usesFDA-approved for mild myopia and for certain keratoconus patients under HDE

Patient selectionUsed when contact lenses/spectacles no longer provide adequate vision and corneal transplant may be postponed

inv-89: Keratoprosthesis (artificial cornea) — definition and examples

Keratoprosthesis definitionA prosthetic cornea (e.g., Boston KPro, OOKP, AlphaCor) implanted when donor corneal transplantation is likely to fail or has failed

ExamplesBoston KPro, OOKP, AlphaCor

Clinical contextConsidered for multiple failed grafts or high-risk ocular surface disease; practice varies by center

inv-90: DSAEK / DSEK / DMEK — endothelial keratoplasty definitions

DSAEK / DSEK / DMEK definitionEndothelial keratoplasty procedures replacing diseased Descemet's membrane and endothelium with donor tissue

Clinical advantageSmaller incisions and faster visual recovery versus penetrating keratoplasty

Potential complicationsGraft dislocation and endothelial cell loss

inv-91: Corneal collagen crosslinking (CXL) — definition and note on epithelium-off standard

Corneal collagen crosslinking (CXL)Photochemical riboflavin + UVA treatment to strengthen corneal collagen and halt keratoconus progression; epithelium-off is the established standard

Epithelium-off standardEpithelial removal to permit riboflavin saturation prior to UVA irradiation

Evidence noteNICE (2013) supports epithelium-off safety/efficacy; epithelium-on evidence inadequate

inv-92: Conventional (Dresden) CXL — protocol parameters (370 nm, 3 mW/cm2, 30 min)

Conventional (Dresden) CXL parametersUVA 370 nm, irradiance 3 mW/cm2 for 30 minutes (cumulative 5.4 J/cm2)

Minimum corneal thickness>= 400 μm

PurposeProtocol intended to increase corneal stiffness and stabilize keratoconus

inv-93: Femtosecond laser-assisted stromal keratophakia — definition of tissue-additive keratoplasty

Femtosecond-assisted stromal keratophakiaTissue-additive keratoplasty using femtosecond lasers to implant lenticules to expand stromal volume and regularize corneal curvature

Clinical evidenceSystematic reviews identified studies suggesting improved UCVA/BCVA and topography, but technique standardization needed

IndicationInvestigational/novel approach for keratoconus in specialized centers

inv-94: Clinical Policy Bulletin — definition/administrative note describing purpose of bulletin

Clinical Policy Bulletin purposeDeveloped to assist in administering plan benefits and does not constitute offers of coverage or medical advice

Administrative noteDoes not guarantee coverage; providers remain responsible for treatment decisions

Policy identifiersPolicy Number: 0023; Last Review: 06/07/2023; Effective: 08/03/1995