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Clinical Policy Title: Corneal transplantation

Clinical Policy Number: CCP.1138

Effective Date: April 1, 2015

Initial Review Date: November 19, 2014

Most Recent Review Date: November 6, 2018

Next Review Date: November 2019

Related policies:

CCP.1257 Corneal implants

CCP.1077 Therapeutic contact lenses ABOUT THIS POLICY: AmeriHealth Caritas has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas’ clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by AmeriHealth Caritas when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas’ clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas’ clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas will update its clinical policies as necessary. AmeriHealth Caritas’ clinical policies are not guarantees of payment.

Coverage policy

AmeriHealth Caritas considers corneal transplants to be clinically proven and, therefore, medically

necessary for the treatment of corneal opacification or corneal edema if significant tissue thickness is

involved, or a compromised corneal endothelium that is unresponsive to conservative measures.

Common indications include, but are not limited to (InterQual®, 2018; American Academy of

Ophthalmology, 2017):

Bullous keratopathy.

Hereditary conditions (e.g., Fuchs’ endothelial corneal dystrophy).

Corneal thinning or descemetocele and potential for perforation.

Keratoconus.

Graft rejection following a previous corneal transplant.

Corneal failure due to cataract surgery complications.

Policy contains:

Corneal transplant.

Penetrating keratoplasty.

Lamellar (partial thickness)

keratoplasty.

Endothelial keratoplasty.

Keratoprosthesis.

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AmeriHealth Caritas considers the following corneal transplant procedures to be clinically proven and,

therefore, medically necessary (American Academy of Ophthalmology, 2017):

Penetrating keratoplasty for congenital or acquired causes of corneal opacities when

functional vision with eyeglasses or contact lenses can no longer be achieved, or when

persistent corneal edema occurs following hydrops.

Lamellar keratoplasty (e.g., deep anterior lamellar keratoplasty) for disease processes

involving the stroma without significant scarring or hydrops in the presence of healthy

endothelium.

Endothelial keratoplasty using Descemet’s stripping endothelial keratoplasty, Descemet’s

stripping automated endothelial keratoplasty, or Descemet’s membrane endothelial

keratoplasty for treatment of endothelial dysfunction in the absence of corneal scarring, for

example for (American Academy of Ophthalmology, 2017):

- Bullous keratopathy.

- Corneal edema.

- Posterior corneal dystrophies.

- Rupture in Descemet’s membrane.

- Endothelial corneal dystrophy and other posterior corneal dystrophies.

- Mechanical complications due to corneal graft or ocular lens prostheses.

- Iridocorneal endothelial syndrome.

Boston Keratoprosthesis (Boston KPro, Massachusetts Eye and Ear Infirmary, North

Attleboro, Massachusetts) for the treatment of severe corneal opacification when all of the

following criteria are met (Massachusetts Eye and Ear Infirmary, 2017; Lee, 2015):

- Member is at least 18 years of age.

- Failed cadaveric corneal graft with poor prognosis for further grafting.

- Vision less than 20/200 in the affected eye and compromised vision in the opposite

eye.

- No end-stage glaucoma or retinal detachment.

AmeriHealth Caritas considers tissue procurement, preservation, storage, and transportation associated

with medically necessary corneal transplantation to be medically necessary.

Limitations:

The following corneal transplant procedures are not medically necessary (American Academy of

Ophthalmology, 2017):

Descemet’s membrane endothelial keratoplasty, Descemet’s stripping endothelial

keratoplasty, or Descemet’s stripping automated endothelial keratoplasty to treat

conditions of the corneal stroma or conditions with concurrent endothelial disease and

anterior corneal dystrophies (e.g., keratoconus or corneal ulcers caused by infection and

traumatic corneal injuries).

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Penetrating keratoplasty when performed solely to correct astigmatism or other refractive

errors.

Deep anterior lamellar keratoplasty in the presence of unhealthy endothelium or Descemet

membrane.

Descemet’s stripping endothelial keratoplasty for correcting ectatic disorder.

Corneal transplants are considered outpatient procedures and do not require an inpatient stay

(InterQual, 2018).

Potentially recurrent disease is not a contraindication to keratoplasty, but the risks of corneal

perforation from the disease and recurrent infection of donor tissue must be carefully considered prior

to surgery.

For Medicare members only:

Keratoplasty procedures primarily for refractive correction and radial keratotomy are not covered by

Medicare (CMS Manual System, Pub. 100-03, Medicare National Coverage Determinations Manual,

Section 80.7, Refractive Keratoplasty). The CPT manual (at 65710) gives an instruction to use other

codes for refractive keratoplasty, such as CPT codes 65760, 65765, and 65767.

Alternative covered services:

Conservative treatment designed to reduce the fluid accumulation in corneal degeneration, or

treatment ordered by the treating specialist for a specific disorder.

Phototherapeutic keratectomy (American Academy of Ophthalmology, 2017).

Background

Corneal eye disease is the fourth most common cause of blindness (after cataracts, glaucoma, and age-

related macular degeneration) and affects more than 10 million people worldwide (Wachler, 2017).

Common causes of corneal disease include: corneal dystrophies (e.g., keratoconus, Fuchs’ endothelial

corneal dystrophy, lattice dystrophy, and map-dot-fingerprint dystrophy); corneal scar with opacity;

keratitis; corneal transplant rejection; corneal edema; and herpes simplex keratitis (National Eye

Institute, 2016).

An eye bank provides the donor tissue for corneal transplant surgery in the United States. Since 1961,

more than 1.8 million people have had restored vision through corneal transplants (Eye Bank

Association of America, 2017). More than 95 percent of all corneal transplant operations successfully

restore the corneal recipient’s vision. The success of corneal transplantation may be attributed in part to

the normal cornea lacking blood vessels, which may prevent the body from recognizing the “foreign”

donor cornea.

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Corneal transplant procedures:

Corneal transplants are performed on an outpatient basis under local anesthesia (National Eye Institute,

2016). The surgery involves using a cookie-cutter-like knife called a trephine to remove a circular piece

from the recipient’s scarred cornea and donor cornea, which is sewn into place with very fine sutures

smaller in diameter than a human hair. Modifications to the procedure depend on which corneal layers

are affected—the epithelium, Bowman’s layer, stroma, Descemet’s membrane, and the endothelium

(National Eye Institute, 2016).

Penetrating keratoplasty involves the full-thickness resection of the cornea and is the standard surgical

procedure for treating corneal opacities (National Eye Institute, 2016; Donaghy, 2015). Penetrating

keratoplasty is performed to improve poor visual acuity caused by an opaque cornea. Surgically-induced

astigmatism is a potential complication of penetrating keratoplasty that may require refractive surgery.

Component (partial-thickness) lamellar keratoplasty replaces only the affected layer(s) of corneal tissue

(Donaghy, 2015). Further advances have enabled surgeons to perform anterior lamellar, deep lamellar,

and endothelial lamellar procedures. Deep anterior lamellar keratoplasty is the most common and

involves selective transplantation of the corneal stroma that leaves the native Descemet membrane and

healthy endothelium in place. Disease processes that involve the stroma include corneal ectasia, corneal

scars that are not full-thickness, and corneal stromal dystrophies.

Endothelial keratoplasty procedures are performed for treatment of corneal edema in the setting of

endothelial dysfunction. Descemet’s stripping automated endothelial keratoplasty and Descemet’s

membrane endothelial keratoplasty involve selective removal of the Descemet membrane and

endothelium. Descemet’s stripping automated endothelial keratoplasty involves replacing the recipient

Descemet membrane, endothelium, and posterior stroma. Descemet’s membrane endothelial

keratoplasty replaces the Descemet membrane and endothelium and involves less transplanted tissue

and, consequently, minimal optical interface effects (Donaghy, 2015).

Keratoprosthesis involves full-thickness removal of the cornea and replacement by an artificial cornea.

The device can be used in situations in which other types of keratoplasty are not an option, but

infection, device extrusion, and post-operative glaucoma are important complications (Massachusetts

Eye and Ear Infirmary, 2017; Donaghy, 2015).

Regulation:

The U.S. Food and Drug Administration does not regulate surgical procedures, but aspects of the

procedure are subject to regulation. The Center for Devices and Radiological Health (2018) regulates the

instruments used during ophthalmic surgeries, including corneoscleral punches, trephines, forceps,

hooks, retrobulbar needles, and others. The Center for Biologics Evaluation and Research (2018)

regulates human cells or tissue intended for implantation, transplantation, infusion, or transfer into a

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human recipient including cells or tissue from the cornea. Keratoprostheses are regulated as Class II

devices with special controls to provide a transparent optical pathway through an opacified cornea in an

eye that is not a reasonable candidate for any form of corneal transplant, including penetrating

keratoplasty (21CFR886.3400). Three keratoprostheses are approved for commercial use, and the

Boston Type I KPro is the most commonly used in the United States (U.S. Food and Drug Administration,

2018; Donaghy, 2015).

Searches

AmeriHealth Caritas searched PubMed and the databases of:

UK National Health Services Centre for Reviews and Dissemination.

Agency for Healthcare Research and Quality’s National Guideline Clearinghouse and other

evidence-based practice centers.

The Centers for Medicare & Medicaid Services.

We conducted searches on September 18, 2018. Search terms were: “Corneal Transplantation”(MeSH),

“Descemet Stripping Endothelial Keratoplasty”(MeSH), “Keratoplasty, Penetrating”(MeSH), and free text

terms “corneal transplants,” “descemet stripping,” “endothelial keratoplasty,” and “endothelial

dysfunctions.”

We included:

Systematic reviews, which pool results from multiple studies to achieve larger sample sizes

and greater precision of effect estimation than in smaller primary studies. Systematic

reviews use predetermined transparent methods to minimize bias, effectively treating the

review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies.

Guidelines based on systematic reviews.

Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple

cost studies), reporting both costs and outcomes — sometimes referred to as efficiency

studies — which also rank near the top of evidence hierarchies.

Findings

Fuchs’ endothelial corneal dystrophy and keratoconus are the primary indications for corneal

transplantation among the elderly and adolescents, respectively (Duman, 2013; Lowe, 2011).

Keratoplasty for Fuchs’ endothelial corneal dystrophy is typically reserved until a patient experienced a

significant, persistent decrease in vision throughout the day, not simply in the morning, when the

cornea is most swollen.

Keratoplasty for keratoconus in adolescents show excellent survival (Lowe, 2011). Seventy-five percent

of patients achieved 20/40 vision or better (some needed eyeglasses, contact lenses, or vision-correcting

surgery), and 90 percent still had viable corneas at their 10-year follow-up. However, less than 40

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percent of infants (< age 5 years) had functional corneas at 16 years post-surgery, compared with 70

percent in the 5–12 year age group, at 22 years post-surgery. Corneal graft survival and visual outcomes

varied more by indication for graft than recipient age, but presence of serious developmental disorders

may have affected results.

Limited evidence from low-quality randomized controlled trials suggests endothelial keratoplasty results

in more rapid healing, lower rates of surgically-induced astigmatism, and lower rejection rates

compared with penetrating keratoplasty (Nanavaty, 2014). Endothelial keratoplasty is associated with

fewer higher order aberrations but greater endothelial cell loss. Additional randomized controlled trials

are needed to compare the final visual outcomes and long-term graft survival rates between these

techniques.

The most suitable surgical candidates for endothelial keratoplasty are patients with Fuchs’ endothelial

corneal dystrophy or pseudophakic bullous keratopathy (Price, 2010). Some patients with a failed

penetrating keratoplasty may benefit, particularly those without significant stromal scarring,

opacification, or vascularization of the anterior layers (Terry, 2006). Endothelial keratoplasty can be

combined with corneal transplantation and cataract removal. For Descemet’s stripping endothelial

keratoplasty, the entire recipient cornea is left intact; thus, subsequent laser assisted in situ

keratomileusis or other procedures may still be applied. In areas where donor grafts are scarce, the

benefit of multiple recipients for one donated eye is also important. The main disadvantages to

endothelial keratoplasty include the need for specific instrumentation, a steeper learning curve, and the

need for excellent surgical technique.

There is insufficient evidence to determine whether automating the procedure, using precut versus

fresh, surgeon-cut corneal grafts, or the presence of endothelial cell density of the donor cornea

influences outcomes. Variation in surgical technique and expertise between the studies further

complicates data interpretation.

Policy updates:

In 2017, we added two evidence-based guidelines (American Academy of Ophthalmology, 2017 and

2013) and three systematic reviews and meta-analyses (Deng, 2017, updated to 2018; Ahmad, 2016;

Lee, 2015) to the policy. Penetrating keratoplasty, lamellar keratoplasty, and endothelial keratoplasty

procedures are effective for treating corneal opacities and edema. The preferred technique continues to

evolve, and choice will depend on: the presence and extent of subepithelial or stromal scarring; the

potential impact of ocular surface disease on epithelial healing and stability; and the extent of any

reconstructive intraocular surgery that might be necessary at the time of surgery (American Academy of

Ophthalmology, 2017 and 2013).

New information supports the safety and efficacy of the Boston KPro as a treatment alternative for adult

patients with donor corneal graft failure and poor prognosis for further grafting, as it confers a greater

likelihood of maintaining visual improvement without a higher risk of postoperative glaucoma; the

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evidence is insufficient to support its use in persons younger than age 18 years (Ahmad, 2016; Lee,

2015). The developers of the Boston KPro list vision less than 20/200 in the affected eye and

compromised vision in the opposite eye and no end-stage glaucoma or retinal detachment as additional

criteria for use (Massachusetts Eye and Ear Infirmary, 2017). The Boston KPro was added to the list of

corneal transplant procedures.

In 2018, we added four new systematic reviews and meta-analyses to the policy (Stuart, 2018; Henein,

2017; Li, 2017; Wang, 2017). The American Academy of Ophthalmology Corneal Edema and

Opacification Preferred Practice Pattern (2013) has been combined with their Preferred Practice Pattern

on Cornea/External Disease (2017). The new information from systematic reviews provides comparative

safety and efficacy data for different epithelial keratoplasty procedures (Stuart, 2018; Li, 2017),

endothelial keratoplasty versus penetrating keratoplasty after failed primary penetrating keratoplasty

(Henein, 2017; Wang, 2017), and deep anterior lamellar keratoplasty versus penetrating keratoplasty for

keratoconus (Henein, 2017). These results do not change previous findings, and no policy changes are

warranted.

Policy ID changed from CP# 10.03.04 to CCP.1138.

Summary of clinical evidence:

Citation Content, Methods, Recommendations

Stuart (2018) Cochrane review Descemet's membrane endothelial keratoplasty versus Descemet's stripping automated endothelial keratoplasty for corneal endothelial failure

Key points:

Systematic review of four non-randomized studies of 72 total adults (144 eyes)

with corneal endothelial failure due to Fuch's endothelial dystrophy. No studies of pseudophakic bullous keratopathy were included.

Overall quality: low certainty with high risk of bias due to potential unknown confounding factors since Descemet's stripping automated endothelial keratoplasty preceded Descemet's membrane endothelial keratoplasty in all participants.

Endothelial cell count data were inconclusive (four studies, 134 eyes). No primary graft failure and one graft rejection in 144 eyes; most common

complication was graft dislocation. Both procedures can be considered; Descemet's membrane endothelial

keratoplasty offers better best corrected visual acuity, at the cost of more graft dislocations needing re-bubbling (risk ratio 5.40, 95% CI 1.51 to 19.3; four studies, 144 eyes).

American Academy of Ophthalmology (2017) Guideline: cornea/external disease summary benchmarks - 2017

Key points:

Consider lamellar keratoplasty using deep anterior lamellar keratoplasty

techniques for progressive keratoconus without significant scarring or hydrops (High-quality systematic reviews of case-control or cohort studies or high-quality case-control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal [II++], moderate-quality evidence [MQ], discretionary recommendation [DR]).

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Citation Content, Methods, Recommendations

Consider crescentic lamellar keratoplasty when maximal thinning is in the cornea’s periphery. (Nonanalytic studies [III], insufficient quality [IQ], DR).

Recommend standard decentered lamellar keratoplasty for tectonic support followed by a central penetrating keratoplasty later for peripheral thinning and ectasia (III, IQ, DR).

Recommend penetrating keratoplasty when a patient can no longer achieve functional vision with eyeglasses or contact lenses, or persistent corneal edema occurs following hydrops (III, IQ, DR).

Recommend against Descemet’s stripping endothelial keratoplasty to correct ectatic disorder. (III, IQ, DR).

Prefer penetrating keratoplasty over deep anterior lamellar keratoplasty in cases of deep stromal scarring. (III, IQ, DR).

Consider corneal edema and persistent discomfort, but limited or no visual potential, as better candidates for the following procedures:

- Phototherapeutic keratectomy (III, IQ, DR) - Conjunctival flap of Gunderson (III, IQ, DR) - Corneal transplantation. - Endothelial keratoplasty. - Penetrating keratoplasty (III, good-quality [GQ], SR).

Recommend superficial keratectomy, lamellar keratoplasty, penetrating keratoplasty, and keratoprosthesis for anterior corneal lesions extending beyond Bowman’s layer into the anterior and midstroma for more extensive treatment (III, GQ, SR).

American Academy of Ophthalmology (2017) Guideline: cornea/external disease Preferred Practice Pattern

Key points:

Indications for keratoplasty: 1) managing corneal opacification or edema if significant tissue thickness is involved; 2) when the endothelium is compromised and unresponsive to conservative measures.

Endothelial keratoplasty has supplanted penetrating keratoplasty as the procedure of choice in cases of endothelial failure in the absence of corneal scarring because patients achieve more rapid visual astigmatism, significantly reduced risk of postkeratoplasty astigmatism, suture-related infections, and traumatic wound rupture.

Patients with corneal edema and persistent discomfort, but limited or no visual potential, are generally better candidates for corneal transplantation, endothelial keratoplasty, and penetrating keratoplasty (III, GQ, SR).

Anterior corneal lesions, extending beyond Bowman’s layer into the anterior and midstroma, require more extensive treatment, such as superficial keratectomy, lamellar or penetrating keratoplasty, and keratoprosthesis (III, GQ, SR).

The preferred technique continues to evolve and depend on several factors: - Presence and extent of subepithelial or stromal scarring. - Potential impact of ocular surface disease on epithelial healing and

stability. - Extent of any reconstructive intraocular surgery that might be

necessary at the time of surgery. - For endothelial keratoplasty, prior posterior vitrectomy, aphakia,

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Citation Content, Methods, Recommendations

filtering or shunt surgery for glaucoma, extensive posterior synechiae, and a shallow anterior chamber can impact effectiveness.

Deng (2017) for the American Academy of Ophthalmology Descemet’s membrane endothelial keratoplasty: safety and outcomes

Key points:

Systematic review of two randomized controlled trials, 15 case-control and cohort studies or randomized controlled trials with substantial methodologic deficits, 15 low-quality observational studies.

Evidence suggests Descemet’s membrane endothelial keratoplasty is superior to Descemet’s stripping endothelial keratoplasty in achieving a faster visual recovery, a better visual outcome, and a lower immune rejection rate; Descemet’s membrane endothelial keratoplasty induces less refractive error than Descemet’s stripping endothelial keratoplasty.

Descemet’s membrane endothelial keratoplasty and Descemet’s stripping endothelial keratoplasty offer comparable rates of endothelial cell loss, primary and secondary graft failure rate, and perioperative complications, but insufficient comparative evidence of long-term graft survival beyond five years.

Descemet’s membrane endothelial keratoplasty is more technically challenging and could involve a higher rate of air injection than in Descemet’s stripping endothelial keratoplasty during the early part of the learning curve.

Descemet’s stripping endothelial keratoplasty is preferred for treating endothelial dysfunction with abnormal anatomy, such as those with an anterior chamber intraocular lens, large iris defect, or absence of lens support.

Henein (2017) Systematic review comparing penetrating keratoplasty and deep anterior lamellar keratoplasty for management of keratoconus

Key points:

Systematic review of two randomized control trials and 16 comparative studies:

n = 965 eyes underwent deep anterior lamellar keratoplasty; n = 2,402 eyes underwent penetrating keratoplasty.

Penetrating keratoplasty was associated better visual outcomes (best corrected visual acuity), but deep anterior lamellar keratoplasty was associated with reduced refractive astigmatism and rejection. Both procedures had comparable spherical equivalent and keratometric astigmatism outcomes and no difference in endothelial cell density between the two techniques.

Internationally agreed data sets and follow-up protocol are warranted. Li (2017) Efficacy and safety of Descemet's membrane endothelial keratoplasty versus Descemet's stripping endothelial keratoplasty

Key points:

Systematic review and meta-analysis of 19 comparative randomized and non-

randomized trials articles were eligible, and 1,124 eyes underwent Descemet's membrane endothelial keratoplasty and 1,254 eyes underwent Descemet's stripping endothelial keratoplasty mostly for Fuchs' dystrophy followed by pseudophakic bullous keratopathy, iridocorneal endothelial syndrome, and regrafting.

Overall pooled estimates showed a significantly better postoperative best corrected visual acuity (P < .001), a comparable endothelial cell density (P = .882), and an increased graft detachment rate (P < .001) with Descemet's membrane endothelial keratoplasty versus Descemet's stripping endothelial keratoplasty.

Learning curve did not have a marked effect on outcomes.

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Citation Content, Methods, Recommendations

Wang (2017) Endothelial keratoplasty versus repeat penetrating keratoplasty after failed penetrating keratoplasty

Key points:

Systematic review and meta-analysis of four comparative cohort studies (n =

649 eyes). Overall quality: high based on the Newcastle-Ottawa Scale, but significant

selection bias. Endothelial keratoplasty was associated with significantly lower risk of graft

rejection than repeat penetrating keratoplasty (odds ratio 0.43, 95% CI 0.23 to 0.80, P = .007), especially for graft failure due to endothelial edema or endothelial rejection.

No significant differences in graft survival and visual acuity (P ranged from 0.81 to 0.97).

Ahmad (2016) Boston Type 1 KPro v. repeat penetrating keratoplasty for corneal graft failure

Key points:

Systematic review and meta-analysis of 21 case series and 5 cohort studies, along with a comparison of results to a retrospective review of consecutive, nonrandomized, longitudinal case series of KPro implantations performed at five U.S. tertiary care centers.

Probability of maintaining 20/200 or better at two years: repeat penetrating keratoplasty = 42% (95% confidence interval [CI] 30% to 56%) v. KPro = 80% (95% CI 68% to 88%).

Probability of maintaining a clear graft at five years: repeat penetrating keratoplasty 47% (95% CI 40% to 54%) v. KPro = 75% (95% CI 64% to 84%).

Rate of progression of glaucoma at three years: repeat penetrating keratoplasty = 25% (95% CI 10% to 44%) v. KPro = 30%.

Lee (2015) for the American Academy of Ophthalmology Boston KPro: outcomes and complications

Key points:

Systematic review of nine well-designed case-control and cohort studies, and randomized controlled trials with substantial methodologic deficits, that included at least 25 eyes.

Overall quality: moderate with moderate risk of bias. Follow-up time: 8.5 to 21 months in six of nine studies, longest follow-up was 47

months in one study. Outcomes and complications worsened with increased follow-up time.

A best-corrected Snellen visual acuity of 20/200 or better occurred in 45% to 89% of eyes.

Retention rates ranged from 65% to 100%. Most common post-surgical complications were retroprosthetic membrane

formation and glaucoma, followed by corneal melts and infectious keratitis. Posterior segment complications were less common than anterior segment

complications. Higher rates of severe, devastating complications in patients with autoimmune

conditions and conditions associated with neurotrophic corneas and chronicepithelial.

Insufficient data in children.

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References

Professional society guidelines/others:

American Academy of Ophthalmology Cornea/External Disease Summary Benchmarks Preferred Practice

Pattern® Guidelines - 2017. November 2017. American Academy of Ophthalmology website.

https://www.aao.org/summary-benchmark-detail/cornea-external-disease-summary-benchmarks-2017.

Accessed September 18, 2018.

InterQual® Procedures Criteria: Keratoplasty. 2018.1. Change Healthcare, LLC.

National Institute for Health and Care Excellence Interventional Procedures Programme. Interventional

procedure overview of corneal implants for keratoconus. 2007. National Institute for Health and Care

Excellence website. https://www.nice.org.uk/guidance/ipg227/evidence/overview-438707629.

Accessed September 18, 2018.

National Institute for Health and Care Excellence Guidance. Corneal implants for keratoconus.

Interventional procedure guidance 227. Published: 25 July 2007. Updated 14 January 2012. NICE

website. https://www.nice.org.uk/guidance/ipg227/resources/corneal-implants-for-keratoconus-

1899865280552389. Accessed October 23, 2017.

Peer-reviewed references:

21CFR886.3400.

Ahmad S, Mathews PM, Lindsley K, et al. Boston type 1 keratoprosthesis versus repeat donor

keratoplasty for corneal graft failure: a systematic review and meta-analysis. Ophthalmology. 2016;

123(1): 165 177. DOI: 10.1016/j.ophtha.2015.09.028.

Center for Biologics Evaluation and Research. Tissue and tissue products. Updated September 18, 2018.

U.S. Food and Drug Administration website.

http://www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/default.htm. Assessed September

18, 2018.

Center for Devices and Radiological Health. Medical devices. Updated August 22, 2018. U.S. Food and

Drug Administration website. http://www.fda.gov/MedicalDevices/default.htm. Accessed September

18, 2018.

Deng SX, Lee WB, Hammersmith KM, et al. Descemet membrane endothelial keratoplasty: safety and

outcomes: a report by the American Academy of Ophthalmology. Ophthalmology. 2018; 125(2): 295

310. DOI: 10.1016/j.ophtha.2017.08.015.

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Donaghy CL, Vislisel JM, Greiner MA. An Introduction to corneal transplantation. May 21, 2015.

University of Iowa Health Care website. https://eyerounds.org/tutorials/cornea-transplant-intro/.

Accessed September 18, 2018.

Duman F, Kosker M, Suri K, et al. Indications and outcomes of corneal transplantation in geriatric

patients. Am J Ophthal. 2013; 156(3): 600 607. DOI: 10.1016/j.ajo.2013.04.034.

Eye Bank Association of America Statistical Report. 2017. Eye Bank Association of America website.

http://restoresight.org/what-we-do/publications/statistical-report/. Accessed September 18, 2018.

FDA 510(k) Premarket Notification database search using product code HQM. U.S. Food and Drug

Administration website. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm.

Accessed September 18, 2018.

Henein C, Nanavaty MA. Systematic review comparing penetrating keratoplasty and deep anterior

lamellar keratoplasty for management of keratoconus. Cont Lens Anterior Eye. 2017; 40(1): 3 14. DOI:

10.1016/j.clae.2016.10.001.

Lee WB, Shtein RM, Kaufman SC, Deng SX, Rosenblatt MI. Boston keratoprosthesis: outcomes and

complications. Ophthalmology. 2015; 122(7): 1504 1511. DOI: 10.1016/j.ophtha.2015.03.025.

Li S, Liu L, Wang W, et al. Efficacy and safety of Descemet's membrane endothelial keratoplasty versus

Descemet's stripping endothelial keratoplasty: A systematic review and meta-analysis. PLoS One. 2017;

12(12): e0182275. DOI: 10.1371/journal.pone.0182275.

Lowe MT, Keane MC, Coster DJ, Williams KA. The outcome of corneal transplantation in infants,

children, and adolescents. Ophthalmology. 2011 Mar; 118(3): 492 497. DOI:

10.1016/j.ophtha.2010.07.006.

Nanavaty MA, Wang X, Shortt AJ. Endothelial keratoplasty versus penetrating keratoplasty for Fuchs

endothelial dystrophy. Cochrane Database Syst Rev. 2014; (2): Cd008420. DOI:

10.1002/14651858.CD008420.pub3.

National Eye Institute. Facts about the cornea and corneal disease. Last reviewed May 2016. National

Eye Institute website. https://nei.nih.gov/health/cornealdisease/. Accessed September 18, 2018.

Terry MA, Ousley PJ. Deep lamellar endothelial keratoplasty (DLEK): early complications and their

management. Cornea. 2006; 25: 37 - 43. DOI: 10.1097/01.ico.0000164781.33538.b6.

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Price MO, Gorovoy M, Benetz BA, et al. Descemet's stripping automated endothelial keratoplasty

outcomes compared with penetrating keratoplasty from the Cornea Donor Study. Ophthalmology. 2010;

117(3): 438 444. DOI: 10.1016/j.ophtha.2009.07.036.

Stuart AJ, Romano V, Virgili G, Shortt AJ. Descemet's membrane endothelial keratoplasty (DMEK) versus

Descemet's stripping automated endothelial keratoplasty (DSAEK) for corneal endothelial failure.

Cochrane Database Syst Rev. 2018; 6: Cd012097. DOI: 10.1002/14651858.CD012097.pub2.

Wachler BB. Cornea Transplants: What to Expect. Updated June 2017. Allaboutvision.com website.

http://www.allaboutvision.com/conditions/cornea-transplant.htm. Accessed October 23, 2017.

Wang F, Zhang T, Kang YW, et al. Endothelial keratoplasty versus repeat penetrating keratoplasty after

failed penetrating keratoplasty: A systematic review and meta-analysis. PLoS One. 2017; 12(7):

e0180468. DOI: 10.1371/journal.pone.0180468.

Centers for Medicare & Medicaid Services National Coverage Determinations:

80.7 Refractive Keratoplasty.

A55607 Additional information required for coverage and pricing for CPT® codes.

A55681 Additional information required for coverage and pricing for CPT® codes.

Local Coverage Determinations:

No Local Coverage Determinations identified at the writing of this policy.

Commonly submitted codes

Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is

not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and

bill accordingly.

CPT Code Description Comments

65710 Keratoplasty (corneal transplant); anterior lamellar

65730 Keratoplasty (corneal transplant); penetrating except in aphakia or pseudophakia)

65750 Keratoplasty (corneal transplant); penetrating (in aphakia) 65755 Keratoplasty (corneal transplant); penetrating (in pseudophakia) 65756 Keratoplasty (corneal transplant); endothelial

65757 Backbench preparation of corneal endothelial allograft prior to transplantation (List separately in addition to code for primary procedure)

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ICD-10 Code Description Comments

E50.6 Vitamin A deficiency with xerophthalmic scars of cornea

H17.89 Other corneal scars and opacities

H17.9 Unspecified corneal scar and opacity

H18.001 Unspecified corneal deposit, right eye

H18.002 Unspecified corneal deposit, left eye

H18.003 Unspecified corneal deposit, bilateral

H18.009 Unspecified corneal deposit, unspecified eye

H18.009 Unspecified corneal deposit, unspecified eye

H18.20 Unspecified corneal edema

H18.20 Unspecified corneal edema

H18.221 Idiopathic corneal edema, right eye

H18.221 Idiopathic corneal edema, right eye

H18.222 Idiopathic corneal edema, left eye

H18.223 Idiopathic corneal edema, bilateral

H18.229 Idiopathic corneal edema, unspecified eye

H18.231 Secondary corneal edema, right eye

H18.232 Secondary corneal edema, left eye

H18.233 Secondary corneal edema, bilateral

H18.239 Secondary corneal edema, unspecified eye

H18.50 Unspecified hereditary corneal dystrophies

H18.51 Endothelial corneal dystrophy

H18.52 Epithelial (juvenile) corneal dystrophy

H18.53 Granular corneal dystrophy

H18.54 Lattice corneal dystrophy

H18.55 Macular corneal dystrophy

H18.59 Other hereditary corneal dystrophies

H18.601 Keratoconus, unspecified, right eye

H18.602 Keratoconus, unspecified, left eye

H18.603 Keratoconus, unspecified, bilateral

H18.609 Keratoconus, unspecified, unspecified eye

H18.621 Keratoconus, unstable, right eye

H18.622 Keratoconus, unstable, left eye

H18.623 Keratoconus, unstable, bilateral

H18.629 Keratoconus, unstable, unspecified eye

H18.811 Anesthesia and hypoesthesia of cornea, right eye

H18.812 Anesthesia and hypoesthesia of cornea, left eye

H18.813 Anesthesia and hypoesthesia of cornea, bilateral

H18.819 Anesthesia and hypoesthesia of cornea, unspecified eye

L76.81 Other intraoperative complications of skin and subcutaneous tissue

L76.82 Other postprocedural complications of skin and subcutaneous tissue

T26.11XA Burn of cornea and conjunctival sac, right eye, initial encounter

T26.12XA Burn of cornea and conjunctival sac, left eye, initial encounter

T26.60XA Corrosion of cornea and conjunctival sac, unspecified eye, initial encounter

T26.61XA Corrosion of cornea and conjunctival sac, right eye, initial encounter

T26.62XA Corrosion of cornea and conjunctival sac, left eye, initial encounter

T85.318A Breakdown (mechanical) of other ocular prosthetic devices, implants and grafts, initial encounter

T85.328A Displacement of other ocular prosthetic devices, implants and grafts, initial encounter

T85.398A Other mechanical complication of other ocular prosthetic devices, implants and grafts, initial encounter

15

T86.840 Corneal transplant rejection

T86.841 Corneal transplant failure

HCPCS Level II Code

Description Comments

L8609 Artificial cornea C1818 Integrated keratoprosthesis