Corneal surgery (formerly corneal transplant, endothelial keratoplasty and keratoprostheses)
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Medical necessity and coverage guidance for corneal transplantation procedures, endothelial keratoplasty techniques, and select keratoprostheses for members of Capital BlueCross products to which this policy applies.
Policy now includes criteria for other corneal surgery previously on policy 1.044 and corresponding codes added (65760, 65765, 65771, 65400, 65767, 65782, S0810).
Removed outdated ICD-10 codes H18.51–H18.55, H18.59, T86.840, T86.841, T86.842, T86.848 and T86.849.
References updated (multiple literature citations and guidelines updated).
Coverage Criteria for Corneal Surgery and Keratoprosthesis
Corneal transplantation — covered indications
Covered when ANY of the following diagnoses are present:
Corneal transplantation for indications other than those listed (e.g., purely refractive indications such as astigmatism correction) is considered investigational.
Endothelial keratoplasty — covered indications
Covered when ALL criteria correspond to treatment of endothelial dysfunction (examples include):
Endothelial keratoplasty is indicated when endothelial dysfunction is the primary cause of corneal decompensation; EK is not appropriate when anterior corneal disease is the dominant pathology.
Boston Keratoprosthesis (Boston KPro) — covered criteria
Covered when ALL of the following are met:
Keratoprosthesis is high-risk with numerous complications; patient selection and documentation (including prior graft failures and visual acuity measurements) are required. Permanent keratoprostheses other than Boston KPro are considered investigational.
Coverage determinations by procedure
Coverage stance summarized from evidence sections:
DETECT RCT reported better acuity for DMEK vs ultra-thin DSAEK.
Multicenter RCT and systematic review show mixed results.
High complication rate; careful selection and specialized centers recommended.
Cleared via 510(k) but outcome data limited.
Complex procedure with extrusion, retinal and vitreoretinal risks.
Covered Indications for Corneal Transplant/Endothelial Keratoplasty
Covered when ALL of the following are met (as implied by enumerated lists in the document):
Exact matching of procedure and diagnosis codes is required per member benefit rules; see coding section for the specific ICD-10 and CPT/HCPCS codes.
Scope expansion / criteria migration
Policy scope expanded to include other corneal surgeries previously on policy 1.044.
See the full policy for detailed medical necessity criteria and coding for each migrated procedure; prior authorization is required for these added procedure codes per the policy.
Corneal transplantation performed for indications that are not enumerated in this policy (for example, procedures undertaken solely for refractive correction such as treatment of astigmatism or routine correction of refractive errors) is considered investigational and may be denied. The policy additionally specifies that implantation of permanent keratoprostheses other than the Boston Keratoprosthesis (Boston KPro) is investigational because there is insufficient evidence to support a general conclusion about net health benefit. Providers should obtain prior authorization and document that the proposed procedure meets one of the listed medically necessary indications before proceeding.
Available evidence for AlphaCor and for osteo-odonto-keratoprosthesis is limited to case series and systematic reviews that do not robustly demonstrate improved net health outcomes. Reported complications with AlphaCor include anterior corneal thinning/melting and corneal necrosis; osteo-odonto procedures, often reported from outside the U.S., show high anatomic survival in some series but poorly described visual outcomes and substantial risks including extrusion and retinal/vitreoretinal complications. Given these limitations and complication profiles, the evidence is judged insufficient to establish a net health benefit for these devices.
The policy explicitly lists certain CPT procedure codes as investigational and not covered. The codes identified in the document as investigational are 65760, 65765, and 65771; claims submitted with these codes may be denied on that basis.
Policy history notes an administrative update that removed several outdated ICD‑10 codes from the policy. The removed codes include H18.51–H18.55, H18.59, T86.840, T86.841, T86.842, T86.848, and T86.849; these legacy codes should not be used per the policy history.
Endothelial keratoplasty is considered investigational when endothelial dysfunction is not the primary cause of the decreased corneal clarity. In such cases the evidence is insufficient to conclude that endothelial keratoplasty improves net health outcomes versus alternative treatments.
Evidence regarding femtosecond laser-assisted endothelial keratoplasty (FLEK/FELEK) is conflicting. Randomized trials and a systematic review report inconsistent findings: some comparisons found worse mean best-corrected visual acuity and higher endothelial cell loss after femtosecond-assisted procedures versus penetrating keratoplasty or manually prepared techniques. Because of these mixed outcomes, the evidence is considered insufficient to establish superior net health benefit for femtosecond-assisted EK.
The excerpts provided for this review do not include explicit, standalone 'not medically necessary' statements for every scenario. Clinicians and billing staff should consult the full policy text and applicable member benefit terms for any additional not medically necessary determinations and for complete procedural guidance before submission or authorization requests.
Coding — Procedure and Diagnosis Codes
| No codes listed |
| FDA product code: HQM | Product code for Boston KPro as listed by FDA |
| 65400 | Procedure code listed as covered when medically necessary |
| 65767 | Procedure code listed as covered when medically necessary |
| 65772 | Procedure code listed as covered when medically necessary |
| 65775 | Procedure code listed as covered when medically necessary |
| 65781 | Procedure code listed as covered when medically necessary |
| 65782 | Procedure code listed as covered when medically necessary |
| S0810 | Procedure code listed as covered when medically necessary |
| 65710 | Procedure code referenced under 'Covered when Medically_Necessary for Corneal Transplant' |
| 65730 | Procedure code referenced under 'Covered when Medically_Necessary for Corneal Transplant' |
| 65750 | Procedure code referenced under 'Covered when Medically_Necessary for Corneal Transplant' |
| 65755 | Procedure code referenced under 'Covered when Medically_Necessary for Corneal Transplant' |
| 65756 | Procedure code value present in document (paired with 65757 elsewhere) |
| 65757 | Procedure code value present in document (paired with 65756 elsewhere) |
| 65770 | Procedure code referenced for endothelial keratoplasty section |
| C1818 | Procedure/HCPCS-like code referenced in endothelial keratoplasty section |
| L8609 | Procedure/HCPCS-like code value present in endothelial keratoplasty section |
| A18.52 | Tuberculous keratitis |
| A18.59 | Other tuberculosis of eye |
| A54.33 | Gonococcal keratitis |
| B00.52 | Herpesviral keratitis |
| B02.33 | Zoster keratitis |
| B05.81 | Measles keratitis and keratoconjunctivitis |
| B30.0 | Keratoconjunctivitis due to adenovirus |
| B60.13 | Keratoconjunctivitis due to Acanthamoeba |
| H16.011 | Central corneal ulcer, right eye |
| H16.012 | Central corneal ulcer, left eye |
| T86.8422 | Corneal transplant infection, Left Eye |
| T86.8423 | Corneal transplant infection, Bilateral |
| T86.8429 | Corneal transplant infection, Unspecified Eye |
| T86.848 | Other complications Of corneal transplant |
| T86.8481 | Other Complications of Corneal Transplant, Right Eye |
| T86.8482 | Other Complications of Corneal Transplant, Left Eye |
| T86.8483 | Other Complications of Corneal Transplant, Bilateral |
| T86.8489 | Other Complications of Corneal Transplant, Unspecified Eye |
| T86.849 | Unspecified complication of corneal transplant |
| T86.8491 | Unspecified Complication of Corneal Transplant, Right Eye |
| C1818 | Procedure code listing (document shows associated entries including 65770) |
| 65770 | Penetrating keratoplasty (as listed in document) |
| 65760 | Added corneal procedure code (policy history) |
| 65765 | Added corneal procedure code (policy history) |
| 65771 | Added corneal procedure code (policy history) |
| 65400 | Added corneal procedure code (policy history) |
| 65767 | Added corneal procedure code (policy history) |
| 65782 | Added corneal procedure code (policy history) |
| S0810 | Added HCPCS code (policy history) |
Provider Actions, Prior Authorization, and Documentation Requirements
Prior Authorization Required
Prior authorization is required for corneal surgery procedures covered under this policy, including Boston Keratoprosthesis (Boston KPro) implantation and corneal transplant procedures, to document indication, prior treatments, and that medical necessity criteria are met. Obtain authorization per the member's benefit plan rules before scheduling or performing services.
- Prior authorization is expected when requesting keratoprosthesis implantation (e.g., Boston KPro) and other corneal surgeries.
- Authorization must be obtained in accordance with the member's benefit program and eligibility rules; coverage is determined by the member's contract and medical necessity review.
- Recent policy expansion migrated additional corneal procedure codes into this policy—prior authorization is required for those added codes.
- Providers should contact Capital Blue Cross Provider Services for specific prior authorization submission requirements and timelines.
Documentation Requirements
Documentation submitted with prior authorization requests must clearly support the clinical indication for the requested procedure, prior treatments attempted, and any prior graft failures when applicable. For Boston KPro requests, document the specific indication(s), history of one or more corneal graft failures (when present), best-corrected visual acuity measurements in both eyes, and why standard penetrating keratoplasty is unlikely to succeed.
- Include best-corrected visual acuity in the affected eye and the contralateral eye (e.g., affected eye <20/400 and contralateral eye <20/40 when applicable).
- Document prior standard treatments (e.g., penetrating keratoplasty attempts, contact lens management for keratoconus) and reasons they failed or are unlikely to succeed.
- For keratoprosthesis candidates, document ability and commitment to postoperative care and follow-up.
Surgical Choice Guidance: Endothelial Keratoplasty
Endothelial keratoplasty should not be substituted for penetrating keratoplasty when significant anterior corneal disease is present. Document the surgical rationale if endothelial keratoplasty is chosen in cases with concurrent anterior corneal pathology.
- Do not replace penetrating keratoplasty when anterior corneal dystrophies, anterior scars, or ectasia affecting the anterior cornea are present unless clinical documentation explains why endothelial disease is the primary cause of vision loss.
- Surgeons performing endothelial keratoplasty should be adequately trained and document technique and device expertise.
High-Risk Procedure — Risk and Site Requirements
Keratoprosthesis procedures are high-risk and associated with numerous potential complications and likely need for additional surgeries. Coverage decisions should weigh the likelihood of visual benefit, the condition of the contralateral eye, and availability of experienced surgical centers.
- Highlight the high complication rate (e.g., retroprosthetic membrane formation, infection, corneal melting) when submitting requests.
- Restrict treatment to centers experienced in keratoprosthesis care and staffed by appropriately trained surgeons.
- Consider the patient's overall prognosis and expected visual benefit prior to approval.
Investigational Procedures and Exclusions
Certain procedures and devices remain investigational and are not covered. Documentation that cites investigational devices or techniques will not alone establish coverage.
- Permanent keratoprostheses other than the Boston KPro (e.g., FLEK/FELEK or other investigational devices) are considered investigational and not covered.
- AlphaCor device outcomes are insufficient to establish net health benefit in all settings; coverage is limited per clinical evidence and may be reviewed case-by-case.
- If a requested device or procedure is investigational, do not assume coverage even if codes exist for billing.
Coding, Coverage, and Claims Processing
Coding and coverage are determined by member benefit terms. The code list in the policy is not exhaustive and may change. Use current codes and ensure submitted documentation aligns with the policy criteria to avoid denials.
- The presence of a code in this policy does not guarantee coverage; verify the member's benefit plan.
- This policy was expanded to include additional codes (e.g., 65760, 65765, 65771, 65400, 65767, 65782, S0810); prior authorization is required for these migrated codes.
- Providers must use current CPT/HCPCS/ICD-10 codes and update claim submissions per payer guidance; failure to do so may result in denial or processing delays.
Coverage Contingent on Member Benefits and Medical Necessity
Final coverage determination is contingent on the member's benefit program, eligibility on the date of service, and a medical necessity review. These policies do not guarantee payment.
- Payment is subject to verification of eligibility, benefit limitations, and exclusions in the member's contract.
- If there are questions regarding coverage or prior authorization requirements, contact Capital Blue Cross Provider Services or Member Services.
Operational Note: Documentation and Coding
Providers should include up-to-date operative and clinical documentation and select appropriate codes consistent with the current policy when submitting prior authorization requests and claims.
- Document the indication consistent with policy criteria, prior graft failures, prior treatments, and anticipated postoperative care needs.
- Use the most current procedure and diagnosis codes; the policy history shows code removals and additions—verify codes before submission.
- Failure to provide required documentation or to use current codes may affect coverage and reimbursement.
Definitions and Background
The cornea is the transparent, dome-shaped anterior structure that provides the majority of the eye’s refractive power. Its layered anatomy includes the epithelium, Bowman's layer, a thick central stroma (approximately 90% of corneal thickness), Descemet membrane and the innermost endothelial cell layer. Endothelial dysfunction (for example, Fuchs dystrophy, bullous keratopathy, or graft failure) impairs the endothelium’s pumping function, leading to stromal edema, loss of corneal clarity and decreased vision. Management options range from full‑thickness penetrating keratoplasty to posterior lamellar techniques such as endothelial keratoplasty (DSEK/DSAEK, DMEK) depending on the location and extent of disease.
Policy Revision History and Updates
Administrative update: Benefit Variations section removed and Disclaimer updated.
Policy scope expanded to include criteria for corneal surgeries migrated from policy 1.044 and corresponding procedure codes added (65760, 65765, 65771, 65400, 65767, 65782, S0810).
References updated and outdated ICD-10 codes removed (H18.51–H18.55, H18.59, T86.840, T86.841, T86.842, T86.848, T86.849).
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