Currentblue cross blue shield - kansasPolicy N/A

Keratoprosthesis

This policy governs coverage of keratoprosthesis (artificial cornea) procedures for patients with corneal blindness who have failed or are not candidates for corneal transplantation; it affects providers performing these surgical procedures and BCBSKS members seeking coverage.

Policy Summary

Payerblue cross blue shield - kansas

PolicyKeratoprosthesis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateOct 25, 2019

Next Review DateN/A

Key ActionSubmit a predetermination (prior authorization) request or contact BCBSKS customer service to verify member benefits and coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

88%Mean device retention rate

54%-84%Visual acuity ≥20/200 (range)

2,176 eyesSystematic review sample

30%Retroprosthetic membrane

PMA 1992Boston KPro regulatory

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Medical necessity criteria — Boston KPro

Covered when ALL of the following are met:

Core coverage criteria: 1) The procedure is the Boston (Dohlman-Doane) Keratoprosthesis (Boston KPro). 2) The eye has severe corneal opacification and cadaveric corneal transplants have failed or have a very low likelihood of success. 3) Conditions indicating a very low likelihood of success for corneal transplant include ALL of the following: severely opaque and vascularized cornea; best-corrected vision 20/400 or less in the affected eye and 20/40 or less in the contralateral eye; no end-stage glaucoma or retinal detachment; and one of the specified high-risk 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; or an ocular condition unlikely to respond favorably to primary corneal transplant such as limbal stem cell compromise or postherpetic anesthesia).see text

Patients must be able and expected to comply with postoperative care; treatment should be restricted to centers experienced in implantation and long-term follow-up.

Not medically necessary / Experimental devices

Noncovered devices: All other types of permanent keratoprostheses (non‑Boston KPro devices) are considered experimental/investigational and are not medically necessary.

See member contract for benefit determinations.

Evidence-based coverage considerations

Evidence summaries and likely coverage considerations from available studies:

Boston KPro evidence: Systematic reviews and multiple case series report improved visual acuity in a substantial proportion of patients after Boston type I KPro implantation; pooled device retention rates vary (reported range 65%–100%, mean ~88%) and retroprosthetic membrane formation is a common complication (reported mean ~30%).

See systematic review (22 series, 2,176 eyes) and large-series retention probabilities for details.

KPro after failed penetrating keratoplasty: Meta-analysis comparing repeat penetrating keratoplasty with KPro after prior graft failure found higher probability of achieving/maintaining ≥20/200 vision at 2 years with KPro (~80%) versus repeat penetrating keratoplasty (~42%), supporting KPro for selected patients with prior graft failure despite substantial complication rates (eg, elevated IOP, glaucoma surgeries).

Complication rates at 2 years include elevated intraocular pressure (~29%) and glaucoma surgery (~8% in some series).

AlphaCor evidence: Only a few case series evaluate the AlphaCor device; reports note device retention issues and complications including anterior corneal thinning/melting and corneal necrosis, with insufficient evidence to demonstrate consistent vision improvement.

Boston Keratoprosthesis (covered with criteria)

Coverage stance summarized from evidence and specialty input

Boston KPro: Boston Keratoprosthesis (Boston KPro) has sufficient evidence from case series and systematic reviews to demonstrate improvement in net health outcome for selected patients with corneal blindness who have failed or are not candidates for corneal transplantation; careful patient selection is required because the procedure is high‑risk with frequent complications; use should be reserved for patients with no reasonable alternative treatment options.

Supported by 2015 systematic review and specialty input that recommend reserved use when alternatives are unavailable.

Osteo-odonto-keratoprosthesis (insufficient evidence)

Summary for osteo-odonto-keratoprosthesis

Osteo-odonto-keratoprosthesis: Evidence for osteo-odonto-keratoprosthesis consists of case series and systematic reviews conducted outside the U.S.; pooled anatomic survival rates are high (eg, ~88% at 5 years, ~81% at 20 years) but visual outcomes are incompletely reported and the procedure is complex with significant complications, so evidence is insufficient to conclude an improvement in net health outcome.

Procedure requires multidisciplinary staged care over months and has risks including extrusion and vitreoretinal complications.

AlphaCor (insufficient evidence)

Summary for AlphaCor device

AlphaCor: Only limited case series evaluate the AlphaCor synthetic keratoprosthesis; reports document device retention concerns and complications such as corneal thinning/melting and necrosis, and there are insufficient data to determine consistent visual benefit or improvement in net health outcome.

AlphaCor is associated with higher risk of anterior corneal melting, particularly in patients with ocular herpes (contraindicated).

Boston KPro Medical Necessity (document history)

Policy statements in revision history describing medical necessity for the Boston KPro

Boston KPro medical necessity (historical statements): Historical policy language states the Boston (Dohlman-Doane) Keratoprosthesis may be considered medically necessary for severe corneal opacification when cadaveric corneal transplants have failed or are very unlikely to succeed; detailed failed/low‑likelihood indications were moved into the Policy Guidelines in later revisions.

See Policy Guidelines for the current list of failed/low-likelihood indications and documentation expectations.

All permanent keratoprostheses other than the Boston (Dohlman-Doane) Keratoprosthesis are considered experimental/investigational and excluded from coverage.

The AlphaCor device is contraindicated in patients with a history of ocular herpes because published case series report a higher prevalence of anterior corneal thinning or 'melting' and corneal necrosis in these patients.

Keratoprostheses are generally not considered ideal as primary treatment in pediatric patients. Patients with severe dry eye and those with autoimmune ocular surface diseases remain challenging to manage and have higher rates of epithelial defects, necrosis, extrusion, and endophthalmitis; such cases require careful consideration and often surface reconstruction prior to KPro placement.

Earlier policy language and revision history designated temporary keratoprostheses and non‑Boston permanent keratoprostheses as experimental/investigational; subsequent updates removed some prior prescriptive requirements but retained the position that non‑Boston permanent devices are not standard covered treatments.

Use of permanent keratoprostheses other than the Boston (Dohlman‑Doane) Keratoprosthesis is considered not medically necessary (classified as experimental/investigational) and therefore not covered.

Evidence for the AlphaCor device is limited to a small number of case series with variable retention and visual outcomes; reported complications—including anterior corneal thinning/melting and corneal necrosis—raise concerns and the data are insufficient to demonstrate consistent improvement in vision.

Osteo‑odonto‑keratoprosthesis (OOKP) case series and a systematic review report high anatomic survival at 5 and 20 years but provide limited description of visual outcomes. Given the complexity of the staged procedure and the incomplete evidence on functional vision benefit, the current literature is insufficient to determine an overall improvement in net health outcome.

Historical policy text required multiple prior failed corneal transplants and treated temporary keratoprosthesis case‑by‑case; revisions simplified and relocated detailed device‑specific criteria but preserved the experimental/investigational designation for non‑Boston permanent keratoprostheses.

Regulatory listing for keratoprosthesis devices includes the FDA product code HQM.

Predetermination, Documentation, and Selection Guidance

Prior Authorization

Predetermination recommended

Predetermination (prior authorization) is recommended. Contact Blue Cross and Blue Shield of Kansas customer service or submit a predetermination request to confirm coverage and reduce risk of claim denial.

Predetermination helps confirm member contract benefits and whether the procedure will be covered for the individual member.
Lack of predetermination may increase the risk of denial even if criteria appear met.

Prior Authorization

Prior authorization/selection documentation

Prior authorization or selection documentation must demonstrate that the Boston Keratoprosthesis is being considered only after appropriate evaluation and that the patient meets selection criteria.

Document failure of prior penetrating keratoplasty(s) or a clear justification for primary keratoprosthesis when transplant has a very low likelihood of success.
Include rationale comparing expected outcomes of repeat penetrating keratoplasty versus Boston KPro for the individual patient.

Denial Risk

Coverage limitation

Coverage is limited: the Boston (Dohlman-Doane) Keratoprosthesis may be considered medically necessary only in select high-risk cases; all other permanent keratoprostheses are considered experimental/investigational and will be denied.

Inclusion of procedure or device codes in the policy is informational and does not guarantee coverage — refer to the member's contract benefits.
Non‑Boston permanent keratoprostheses are considered experimental/investigational.

Denial Risk

High complication rates and need for careful patient selection

Keratoprosthesis implantation is a high‑risk procedure with frequent and potentially serious complications; careful patient selection and documentation of risk/benefit are required.

High complication rates include retroprosthetic membrane formation, device loss/extrusion, endophthalmitis, glaucoma requiring surgery, retinal detachment, and corneal melts.
Because of these risks, clinicians should document that expected benefit justifies the risks and that postoperative care and follow-up can be provided.

Documentation Required

Clinical documentation required

Clinical documentation must demonstrate prior treatments and justify selection of the Boston KPro over repeat corneal transplantation when applicable.

Show prior graft history, number and outcomes of previous penetrating keratoplasties, and reasons for failure.
Document preoperative visual acuity in the affected and contralateral eyes, presence or absence of end‑stage glaucoma or retinal detachment, and patient ability to comply with postoperative care.

Documentation Required

Clinical documentation should include prior graft history, indication, preop visual acuity, and risk factors

Clinical documentation should include prior graft history, indication, preoperative visual acuity, and risk factors that predict poor outcome with repeat transplant.

Specify indications such as Stevens‑Johnson syndrome, ocular cicatricial pemphigoid, autoimmune ocular surface disease, chemical burns, limbal stem cell deficiency, or other conditions unlikely to respond to primary transplant.
Include risk factors (eg, ocular surface exposure, autoimmune disease) that increase risk of keratoprosthesis loss.

Documentation Required

Consideration of repeat penetrating keratoplasty vs keratoprosthesis

When applicable, clinicians should discuss and document consideration of outcomes from repeat penetrating keratoplasty versus Boston KPro and provide rationale for choosing keratoprosthesis implantation.

Published data suggest higher probabilities of maintaining ≥20/200 vision at 2 years with KPro versus repeat penetrating keratoplasty in patients with prior graft failures; document patient‑specific expected outcomes.
Document why repeat penetrating keratoplasty is unlikely to succeed for this patient (eg, severe vascularization, limbal stem cell failure, multiple prior graft failures).

Documentation Required

Selection preference before keratoprosthesis

Selection preference: Boston KPro should generally be reserved for patients with failed corneal transplants or those with a very low likelihood of success with standard penetrating keratoplasty; use as a primary procedure is controversial and should be justified.

Treatments should be performed at centers experienced with KPro and by surgeons trained in device implantation and postoperative management.
Some reviewers support primary KPro without first attempting transplant in very high‑risk eyes, but this is controversial—document the rationale when done.

Note

Historical prior‑treatment considerations

Historical prior‑treatment considerations: policy guidance has emphasized prior failed corneal transplants (often multiple) or specific high‑risk indications as prerequisites for KPro candidacy; exceptions require clear justification.

Past iterations of the criteria required multiple failed grafts; current guidance allows KPro after one or more failed penetrating keratoplasties or when primary transplant has very low likelihood of success.
Document prior treatment timeline, prior reconstructive procedures (eg, limbal allograft), and prior attempts to optimize the ocular surface.

Device and Outcome Definitions

inv-37: Boston KPro — device description and Type 1/Type 2 distinction

Device descriptionBoston (Dohlman-Doane) Keratoprosthesis: a keratoprosthesis using a donor cornea between a central stem and a back plate; central optic held in a cylindrical frame to replace removed cornea

Type 1 vs Type 2Type 1: for eyes with intact lids and tear film; Type 2: modification with an anterior extension for implantation through surgically closed eyelids

Typical materials / constructionConstructed using a central optic and back plate with a donor cornea sandwiched between components and anchored by surrounding tissue

Indication summaryIntended to restore vision in patients with severe bilateral corneal disease for whom corneal transplant is not an option

inv-38: AlphaCor — PMMA device description and FDA clearance

Device compositionAlphaCor consists of polymethylmethacrylate (PMMA) central optic fused to a surrounding sponge skirt

Surgical approachInserted in a 2-stage surgical procedure typically performed by an ophthalmologist in an outpatient or surgery center setting

Regulatory statusCleared by FDA (510[k]) for adults when penetrating keratoplasty is unsuitable (device previously known as Chirila KPro)

inv-39: Osteo-odonto-keratoprosthesis — autologous tooth/bone-supported device

DefinitionOsteo-odonto-keratoprosthesis (OOKP): an autologous keratoprosthesis using a PMMA optical cylinder supported by a tooth root and attached alveolar bone (osteodental lamina)

Biologic supportImplant unit uses extracted tooth root and surrounding alveolar bone as biologic support for the PMMA optic

PurposeIntended as an option for patients not candidates for corneal transplantation to restore vision using autologous tissue support

inv-40: OOKP procedural staging and multidisciplinary requirements

Staged procedure timelineProcedure is staged over 6–12 months, with initial buccal mucosa grafting and temporary subcutaneous implantation of the tooth-bone unit before final insertion

Multidisciplinary teamRequires collaboration among dentists, ophthalmologists, and radiologists for planning and execution

Follow-up requirementLong-term follow-up (at least 5 years preferable) is desirable to assess outcomes and complications

inv-41: AlphaCor keratoprosthesis — synthetic implant and associated risks

Implant type and risksAlphaCor is a synthetic PMMA keratoprosthesis with a central optic and sponge skirt; associated risks include anterior corneal thinning (melting), necrosis, and device retention issues

Evidence limitationsOnly a few published case series exist; insufficient data to demonstrate consistent vision improvement

Contraindications/concernsHigher risk of corneal thinning/melting noted, with specific contraindication concerns in ocular herpes cases

inv-42: Anatomic survival — definition

Anatomic survival — definitionRetention of the keratoprosthesis lamina (implant remains in place)

Measurement contextUsed in OOKP studies and pooled analyses to report device retention at intervals (eg, 5 and 20 years)

Clinical relevanceReflects structural success distinct from visual (functional) outcomes

inv-43: Functional survival — definition used in referenced study

Functional survival — study definitionDefined in the referenced study as best-corrected visual acuity of 0.05 or more on the decimal scale (approximately 20/400 or better)

Use in outcomes reportingFunctional survival used to report long-term visual success of OOKP (eg, 38% at 10 years in one series)

Distinction from anatomic survivalIndicates vision preservation/improvement rather than mere implant retention

inv-44: Boston KPro — restated device definition and indication summary

Device summaryThe Boston (Dohlman-Doane) Keratoprosthesis (Boston KPro) is a permanent keratoprosthesis using a donor cornea between a central stem and back plate to replace the removed cornea

Intended populationFor patients with severe corneal opacification who have failed or are unlikely to benefit from cadaveric corneal transplantation

Clinical considerationsHigh-risk procedure with numerous complications; device retention and visual outcomes reported in multiple series and systematic reviews

inv-45: Osteo-odonto-keratoprosthesis — definition and literature reference

Definition and techniqueOsteo-odonto-keratoprosthesis is a technique using a PMMA optical cylinder supported by autologous tooth root and alveolar bone; implant assembled and housed subcutaneously before final ocular implantation

Literature referenceSystematic review and case series (eg, Tan et al 2012; Falcinelli et al 2005; Michael et al 2008) describe anatomic survival and complications

Outcomes notePooled analyses report high anatomic survival (eg, 5- and 20-year rates) but vision outcomes are variably reported and procedure has significant complications

65770	Keratoprosthesis (CPT)
C1818	Integrated keratoprosthesis (HCPCS)
L8609	Artificial cornea (HCPCS)

H17.11	Central corneal opacity, right eye
H17.12	Central corneal opacity, left eye
H17.13	Central corneal opacity, bilateral
H54.0	Blindness, both eyes
H54.1	Blindness, right eye
H54.2	Blindness, left eye
H54.3	Unspecified visual loss
L51.1	Stevens-Johnson syndrome
T26.61xA	Corrosion of cornea and conjunctival sac, right eye, initial encounter
T26.61xD	Corrosion of cornea and conjunctival sac, right eye, subsequent encounter

T26.62xA	Corrosion of cornea and conjunctival sac, left eye, initial encounter
T26.62xD	Corrosion of cornea and conjunctival sac, left eye, subsequent encounter
T26.62xS	Corrosion of cornea and conjunctival sac, left eye, sequela
T85.318A	Breakdown (mechanical) of other ocular prosthetic devices, implants and grafts, initial encounter
T85.318D	Breakdown (mechanical) of other ocular prosthetic devices, implants and grafts, subsequent encounter
T85.318S	Breakdown (mechanical) of other ocular prosthetic devices, implants and grafts, sequela
T85.328A	Displacement of other ocular prosthetic devices, implants and grafts, initial encounter
T85.328D	Displacement of other ocular prosthetic devices, implants and grafts, subsequent encounter
T85.328S	Displacement of other ocular prosthetic devices, implants and grafts, sequela
T85.398A	Other mechanical complication of other ocular prosthetic devices, implants and grafts, initial encounter

OpenPayer

Keratoprosthesis

Coverage Criteria and Evidence Summary

Procedure, Device, and Diagnosis Codes

Predetermination, Documentation, and Selection Guidance

Background and Policy Scope

Device and Outcome Definitions

Policy Document History