Clinical Policy Title: Corneal transplants (keratoplasty) Clinical Policy Number: 10.03.04 Effective Date: April 1, 2015 Initial Review Date: November 19, 2014 Most Recent Review Date: November 16, 2016 Next Review Date: November 2017 Related policies: CP# 10.03.06 Corneal implants ABOUT THIS POLICY: AmeriHealth Caritas Pennsylvania has developed clinical policies to assist with making coverage determinations.

AmeriHealth Caritas Pennsylvania’s 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 Pennsylvania 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 Pennsylvania’s 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 Pennsylvania’s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas Pennsylvania will update its clinical policies as necessary. AmeriHealth Caritas Pennsylvania’s clinical policies are not guarantees of payment.

Coverage policy AmeriHealth Caritas Pennsylvania considers corneal transplants (keratoplasty) to be clinically proven

and, therefore, medically necessary when the following criteria are met:

Vision cannot be corrected by eyeglasses, therapeutic contact lenses, or medical therapies.

There is documentation of corneal diseases that cause functional impediment of job

performance or ability to carry out activities of daily living, such as:

­ Scarring from infections (e.g., eye herpes or fungal keratitis).

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

­ Eye diseases (e.g., advanced keratoconus, which is a common corneal disorder

where the central or paracentral cornea undergoes progressive thinning and

steepening, causing irregular astigmatism).

­ Thinning of the cornea and irregular corneal shape (e.g., with keratoconus).

­ Chemical burns of the cornea or damage from an eye injury.

­ Excessive edema (swelling) of the cornea.

­ Graft rejection following a previous corneal transplant.

­ Corneal failure due to cataract surgery complications.

Policy contains:

Corneal transplant.

Penetrating keratoplasty (PK).

Lamellar (partial thickness) keratoplasty (LK).

Endothelial keratoplasty (EK).

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The following procedures are medically necessary for the following indications (including

but not limited to):

Procedures Indications and treatment of corneal diseases that obstruct

visual acuity, such as:

Penetrating (full thickness) keratoplasty (PK): removal and replacement of the entire thickness of the cornea with full thickness donor corneal tissue (corneal transplant).

Opaque cornea.

Persistent severe bacterial, fungal, or amebic inflammation (keratitis) if failure of antibiotic therapy.

Failure or rejection of a previous corneal transplant.

Bullous keratopathy (BK), keratoconus.

Full-thickness (penetrating) corneal transplant in a phakic patient.

Aphakic patient (with no native lens).

Pseudophakic patient (with an artificial lens).

FECD.

Herpes simplex keratitis.

Lamellar (partial thickness) keratoplasty (LK): replacement of the outer two-thirds of the cornea with donor cornea (nonpenetrating keratoplasty).

Scarring.

Corneal edema.

Keratoconus.

Corneal dystrophies, degenerations.

Thinning, distortion.

*Endothelial keratoplasty (EK) using the following techniques:

Posterior lamellar keratoplasty (PLK)/deep lamellar endothelial keratoplasty (DLEK).

Descemet’s stripping endothelial keratoplasty (DSEK).

Descemet’s stripping (automated) endothelial keratoplasty (DSAEK).

Descemet‘s membrane (automated) endothelial keratoplasty (DMAEK).

Descemet’s membrane endothelial keratoplasty (DMEK).

BK.

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 (ICE) syndrome.

*Note: EK should not be used in place of PK for conditions with concurrent endothelial disease and

anterior corneal dystrophies. These situations include anterior corneal scars from trauma or prior

infection, and ectasia after previous laser vision correction surgery (American Academy of

Ophthalmology [AAO] recommendation).

Limitations:

The following corneal transplant (keratoplasty) procedures are not medically necessary:

­ Collagen cross-linking, not approved by the U.S. Food and Drug Administration

(FDA).

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­ The use of DMEK, DSEK, DSAEK, and DMAEK to treat disease or injury of the corneal

stroma (for example, keratoconus, corneal ulcers caused by infection and traumatic

corneal injuries).

­ PK when performed solely to correct astigmatism or other refractive errors.

­ Corneal transplants are considered outpatient procedures and do not require an

inpatient stay (InterQual Clinical Guidelines, 2014).

Note: 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.

Background

The cornea forms the transparent anterior part of the eye. It protects the contents of the eye and serves

as the major refractive element in it. The principal layers of the cornea are the epithelium, Bowman

layer, stroma, Descemet’s membrane, and the endothelium.

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, 2015).

Corneal transplantation removes the scarred, damaged, or diseased cornea and replaces it with a

human donor cornea. Corneal transplant surgery is also called PK, or corneal grafting.

An eye bank provides the donor tissue for corneal transplant surgery. In 2015, 79,304 corneas were

available for transplantation in the U.S (Eye Bank Association of America [EBAA], 2016). Since 1961,

more than 1.5 million people have had restored vision through corneal transplants. 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 (EBAA, 2016).

Efforts are aimed at maintaining the current eye bank system and enhancing its effectiveness, while

simultaneously supporting the efforts to improve vital organ procurement and transplantation (AAO,

1996). Recent advances in techniques for storing donor corneas in fluid for several days have improved

the chances of successful surgery. This also allows for better planning and timing of surgery.

Corneal transplant procedures:

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Corneal transplants are performed on an outpatient basis under local anesthesia. The surgeon performs

the surgery while looking at the eye through a microscope. A cookie-cutter-like knife called a trephine is

used to cut and remove a circular piece from the recipient’s scarred cornea. A similar knife is used to cut

and remove a piece from the donor cornea, which is sewn into place with very fine sutures that are

smaller in diameter than a human hair.

PK is the standard procedure for treating cornea disease. Most PKs are performed to improve poor

visual acuity caused by an opaque cornea. PK is used to remove active corneal disease, such as

persistent severe bacterial, fungal, or amebic inflammation of the cornea (keratitis), after appropriate

antibiotic therapy. The most common indications for PK are: BK, keratoconus, corneal scar with opacity,

keratitis, corneal transplant rejection, FECD, corneal degeneration, other corneal dystrophies, corneal

edema, and herpes simplex keratitis. PK is not used solely to correct astigmatism or other refractive

errors. Surgically-induced astigmatism is a potential complication of PK that may require refractive

surgery.

Recent advances in corneal surgery have enabled component surgery of the cornea to be performed,

replacing only the necessary tissue instead of the entire cornea. Modifications in surgical technique and

instrumentation also contributed to improved visual quality with LK surgery, making the procedures

more accessible and easier to perform, particularly posterior lamellar graft for endothelial dysfunction

— EK. These procedures include (Azur, 2001; Culbertson, 2003; Ehlers, 2000;Fernandez, 2010; Gorovoy,

2006; Ko, 1993; Sandup, 2001; Tappin, 2007):

Deep anterior lamellar keratoplasty (DALK).

DLEK.

Deep lamellar keratoplasty (DLKP).

DMAEK.

DMEK.

DSAEK.

Descemet's stripping automated keratoplasty (DSAK).

Ongoing research in compatibility testing between donor and recipient may lead to ways of increasing

the chance of a successful outcome in high-risk patients. Race, sex, blood type, eye color, and near- and

farsightedness are not considered in selecting the donor, because they do not affect the outcome of the

corneal transplant surgery.

Regulation:

Surgical procedures are not subject to FDA regulation, but the FDA Center for Devices and Radiological

Health (CDRH) does regulate instruments used during ophthalmic surgeries, including corneoscleral

punches, trephines, forceps, hooks, retrobulbar needles, and others (CDRH, 2016). There is a large

number of FDA-approved microkeratomes primarily for corneal dissection during (laser assisted in situ

keratomileusis (LASIK) eye surgery, but the EK procedures are not specifically referenced in the approval

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documents. The FDA classifies these devices with the Product Code HNO. The FDA Center for Biologics

Evaluation and Research (CBER) regulates human cells or tissue intended for implantation,

transplantation, infusion, or transfer into a human recipient including cells or tissue from the cornea

(CBER, 2016).

Searches

AmeriHealth Caritas Pennsylvania 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 (CMS).

We conducted searches on November 9, 2016. Search terms were: “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

FECD and keratoconus are the primary indications for corneal transplantation among the elderly and

adolescents, respectively (Duman, 2013; Lowe, 2011). Keratoplasty for FECD 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 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.

The most suitable surgical candidates for EK would be patients with FECD or pseudophakic bullous

keratopathy (PBK). EK may also be valuable for some patients with a failed PK, particularly those without

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significant stromal scarring, opacification, or vascularization of the anterior layers. Pseudophakic

patients with deep anterior chambers and posterior chamber intraocular lenses are the best candidates

for the novice surgeon, as there is adequate space to unfold the donor button without risk of trauma to

the lens. Similarly, for patients requiring both corneal transplantation and cataract removal, it is

advantageous to perform a triple procedure with removal of the cataract just before the EK portion of

the surgery. This allows the creation of a deeper anterior chamber and avoids the risk of damaging the

donor graft.

No RCTs were found that directly compared DSEK or DSAEK with the reference standard of care, PK, or

with other EK techniques. Hayes (2011) reviewed seven studies, including three comparative trials that

evaluated the efficacy and safety of DSAEK and DSEK. DSAEK and DSEK improve visual acuity in the short

term with little effect on refractive astigmatism, although they are associated with mild hyperopic shifts.

Improvements in best-corrected visual acuity were achieved more quickly following DSAEK and DSEK

compared with PK, although the results of the two surgery types appear similar after one year.

Complication rates of dislocation following Descemet stripping procedures ranged from 2.6 percent to

23.0 percent, and graft failure rates ranged from 0 to 18 percent. Variation in surgical technique and

expertise complicated data interpretation. While promising, the long-term efficacy and safety of

Descemet stripping procedures compared with PK have not been established.

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

fresh, surgeon-cut corneal grafts, or the presence of ECD of the donor cornea influences outcomes.

Variation in surgical technique and expertise between the studies further complicates data

interpretation. Definitive answers await the performance of RCTs with blinded assessment of health

outcomes (Hayes, 2011).

The main benefits of EK include a stronger wound (absence of a full thickness incision), more rapid

healing, and little or no change in refraction. Since the anterior layers remain undisturbed, there is no

need for the use of surface corneal sutures, as for traditional PK. The corneal curvature also remains

more stable over time and the large shifts in refraction that sometimes occur with corneal grafts do not

occur. Late suture-related complications, such as infection or vascularization, are prevented and the

absence of a full-thickness vertical interface in the cornea increases the safety of the procedure, both

during and after the operation.

The absence of penetrating corneal sutures and incisions results in reduced postoperative astigmatism,

normal corneal topography, faster wound healing, earlier visual rehabilitation, and a more stable globe.

In addition, rejection appears to be less frequent during the first two years after EK, and may be less

severe after EK than after PK.

Should rejection occur, aggressive treatment may be considered, as for conventional PK. The minimal

alteration in the contour of the cornea after surgery means that the predictability of intraocular lens

power calculations is enhanced. For DSEK, the entire recipient cornea is left intact; thus, subsequent

LASIK 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 EK include the

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need for specific instrumentation, a steeper learning curve, and the need for excellent surgical

technique. EK requires a different skill set than that required for standard full thickness PK, so

experienced PK surgeons may initially find the EK maneuvers awkward and unfamiliar. It is strongly

recommended that EK should be extensively practiced in the laboratory before embarking on clinical

treatment of patients.

Policy updates: None. Summary of clinical evidence:

Citation Content, Methods, Recommendations

Duman (2013) To identify the most common corneal transplant procedures, indications, coexisting ocular diseases, and outcomes in elderly patients, and to compare younger geriatric patients with super-geriatric patients

Key points:

Retrospective case series of all patients 65 years old and older who underwent corneal transplantation at Wills Eye Institute from April 2007 to January 2013, and were followed up for at least one year. 271 eyes of 253 patients were divided into two groups according to the age of the patient: Group I (65–79 years old) included 181 eyes and Group II (80 years and older) included 90 eyes.

Most common indication was FECD, with 78 eyes (43%) in Group I and 34 eyes (38%) in Group II. Keratoconus was far less common.

In Group I, 93 DSEK (51%), 84 PK (46%), and four keratoprosthesis procedures (2%) were performed; in Group II, 37 DSEK (41%), 51 PK (57%), and two keratoprosthesis procedures (2%) were performed.

Graft survival rate at last visit was 90% for Group I and 88% for Group II. Rejection occurred in 18 Group I eyes (10%) and seven Group II eyes (8%) (P = 0.562).

An increased prevalence of both glaucoma and retinal diseases can affect the visual outcomes after corneal transplantation.

Hayes (2011) DSEK or DSAEK

Key points:

Systematic review of seven studies including three comparative trials of DSAEK and DSEK (n=40 to 629 eyes).

DSAEK and DSEK improve visual acuity in the short term with little effect on refractive astigmatism although they are associated with mild hyperopic shifts.

Improvements in best-corrected visual acuity were achieved more quickly following DSAEK and DSEK vs. PK, although similar results noted after one year.

Complication rates ranged from 2.6% to 23.0%, and graft failure rates ranged from 0 to 18%. Variation in surgical technique and expertise.

RCTs with blinded assessment of outcomes are needed.

Insufficient evidence to establish the long-term efficacy and safety of Descemet stripping procedures compared with penetrating keratoplasty.

Lowe (2011) Corneal graft survival and visual outcomes in patients aged < 20 years

Key points:

Prospective cohort study using Australian Corneal Graft Registry data of 765 grafts in 640 patients enrolled from May 1985 to June 2009.

Infants (< five years) exhibited poorer graft survival than children aged five to 12 years, especially those undergoing transplantation for Peters' anomaly; adolescents (13-19 years) exhibited the best corneal graft survival.

Pediatric graft failure 14%, of which 65% failed within two years post-graft; 44% of failures were due to unknown causes (18) or irreversible rejection (30).

Most (86%) grafts in adolescents were for keratoconus.

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Factors significantly affecting corneal graft survival were indication for graft, graft inflammation, history of intraocular surgery, vascularization, rejection episodes, post-graft operative procedures, and refractive surgery.

Price (2010) The Cornea Donor Study: DSEK vs. PK

Key points:

Two surgeons performed DSEK on 173 patients at three-year follow up: clear grafts (64%) ; clear grafts on last examination but lost to follow up (25%); death (6.4%); graft failure (4%).

Cumulative probability of a DSEK graft survival at three years (94%): DSEK and PKP eyes with FECD (96%); DSEK eyes (86%); PKP eyes with other preoperative diagnoses (84%).

Immunological graft rejection: DSEK group (6.4%) vs. the PKP group (20%) at three years (P = 0.0005).

Median endothelial cell loss (ECL) at three years for DSEK vs. PKP groups (48% vs. 53%, respectively, P = 0.17): ECL with FECD < other preoperative diagnoses, but similar among DSEK and PKP eyes. Of note, more ECL with DSEK eyes than PKP eyes at one year, but less over the subsequent two years.

The two sites used different incision lengths: 3.2 mm and 5.0 mm. The significantly greater ECL observed in the 3.2-mm-incision eyes compared with the 5.0-mm-incision eyes at one year persisted at three years (60% vs. 33%, P = 0.0007). The 5.0-mm incision showed significantly less ECL in the DSEK eyes than in the PKP eyes at three years (33% vs. 53%, P = 0.0017). Compared with PK, DSAEK resulted in lower ECL with comparable cumulative graft survival rates for up to three years in patients with FECD and BK.

Basak (2008) Indications, operative problems, and postoperative complications of DSEK

Key points:

Prospective, nonrandomized, noncomparative, consecutive case series of 75 eyes of 75 patients with endothelial dysfunctions of different etiology, scheduled for DSEK. Healthy donor cornea with a cell count of > 2,000 cells/sq mm was considered. Best corrected visual acuity (BCVA), refractive and keratometric astigmatism, central corneal thickness (CCT), and ECD were analyzed for each patient after a minimum follow-up of three months.

Main indication was pseudophakic corneal edema and BK in 53 (70.7%) eyes. Seventeen (22.7%) cases had moderate to severe FECD with various grades of cataract, and DSEK was combined with manual small-incision cataract surgery (MSICS) with posterior chamber intraocular lens (PCIOL) in those cases.

After three months, best corrected visual acuity was 20/60 or better in 62 (82.7%) cases. Mean refractive and keratometric astigmatism were 1.10 ± 0.55 diopter cylinder (DCyl) and 1.24 ± 0.92 DCyl. The central corneal thickness and ECD were 670.8 ± 0.32 µm and 1485.6 ± 168.6/sq mm, respectively. The mean ECL after three months was 26.8 ± 4.24% (range: 13.3%–38.4%). Dislocation of donor lenticule occurred in six (8.0%) eyes. Graft failure occurred in one case.

DSAEK is a safe and effective procedure in patients with endothelial dysfunctions with encouraging surgical and visual outcomes. It can be safely combined with MSICS with PCIOL in patients with moderate to severe FECD with cataract.

References

Professional society guidelines/others:

American Academy of Ophthalmology. Automated lamellar keratoplasty. Ophthalmology. 1996; 103(5):

852 - 861.

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American Academy of Ophthalmology. Corneal opacification. Preferred Practice Pattern No. 15. San

Francisco, CA: AAO; September 16, 1995. American Academy of Ophthalmology website.

http://www.aao.org/. Accessed November 22, 2016.

Center for Devices and Radiological Health (CDRH). 510k approvals. M3 microkeratome. K032836. June

18, 2004. FDA website. http://www.fda.gov/MedicalDevices/default.htm. Accessed November 22, 2016.

Center for Biologics Evaluation and Research. Tissues. Updated September 19, 2008. FDA website.

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

22, 2016.

InterQual Procedures Clinical Guidelines. 2014 McKesson Corporation.

National Institute for Health and Clinical Excellence (NICE). Corneal endothelial transplantation.

Interventional Procedures Consultation. London, UK: NICE; December 2008.

National Institute for Health and Clinical Excellence (NICE). Corneal implants for keratoconus.

Interventional Procedures Guidance 227. London, UK: NICE; July 2007.

National Keratoconus Foundation. National Eye Institute website. https://nei.nih.gov/content/national-

keratoconus-foundation. Accessed November 22, 2016.

Peer-reviewed references:

Allan BD, Terry MA, Price FW Jr, Price MO, Griffin NB, Claesson M. Corneal transplant rejection rate and

severity after endothelial keratoplasty. Cornea. 2007; 26: 1039 - 1042.

Azar DT, Jain S, Sambursky R, Strauss L. Microkeratome assisted posterior keratoplasty. J Cataract

Refract Surg. 2001; 27: 353 - 356.

Basak SK. Descemet stripping and endothelial keratoplasty in endothelial dysfunctions: Three-month

results in 75 eyes. Indian J Ophthalmol. 2008; 56(4): 291 - 296.

Culbertson WW. Endothelial replacement: flap approach. Ophthalmol Clin North Am. 2003; 16: 113 -

118.

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.

Ehlers N, Ehlers H, Hjortdal J, Moller-Pedersen T. Grafting of the posterior cornea: description of a new

technique with 12-month clinical results. Acta Ophthalmol Scand. 2000; 78: 543 - 546.

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Fernandez M., Afshari N. Endothelial Keratoplasty: From DLEK to DMEK. Middle East Afir J Ophthalmol.

2010, 17(1): 5 - 8.

Gorovoy MS. Descemet-stripping automated endothelial keratoplasty. Cornea. 2006; 25: 886 - 889.

Hayes Inc. Hayes Medical Technology Report. Descemet stripping with Manual or Automated Endothelial

Keratoplasty for Corneal Endothelial Degeneration. Hayes, Inc.; Lansdale, Pa. March 2011.

Kaufman HE, Barron, BA, McDonald, MB, eds. The Cornea, 2d ed. 1996. External Disease and Cornea,

Section 8. Basic and Clinical Science Course, AAO, 2006.

Ko W, Freuh B, Shield C, Costello M, Feldman S. Experimental posterior lamellar transplantation at the

rabbit cornea (abstract). Invest Ophthalmol Vis Sci. 1993; 34: 1102.

Kunimoto DY, Kanitkar KD, Makar M, eds. The Wills Eye Manual, 4th ed. Lippincott, 2004.

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.

Price FW Jr, Price MO. Descemet’s stripping with endothelial keratoplasty in 200 eyes. J Cataract Refract

Surg. 2006; 32: 411 - 418.

Price FW, Price MO. Descemet’s stripping with endothelialkeratoplsty in 50 eyes: a refractive neutral

corneal transplant. J Refract Surg. 2005; 21: 339 - 345.

Price MO, Price FW Jr, Kruse FE, Bachmann BO, Tourtas T. Randomized comparison of topical

prednisolone acetate 1% versus fluorometholone 0.1% in the first year after descemet membrane

endothelial keratoplasty. Cornea. 2014; 33(8): 880 - 886.

Sandeep J, Azar DT. New lamellar keratoplasty techniques: posterior keratoplasty and deep lamellar

keratoplasty. Curr Opin Ophthalmol. 2001; 12: 262 - 268.

Tappin M. A method for true endothelial cell (Tencell) transplantation using a custom-made cannula for

the treatment of endothelial cell failure. Eye. 2007; 21: 775 - 779.

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

management. Cornea. 2006; 25: 37 - 43.

Trousdale ER, Hodge DO, Baratz KH, et al. Vision-related quality of life before and after keratoplasty for

Fuchs’ endothelial dystrophy. Ophthalmology. 2014; 121(11): 2147 - 2152.

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Vajpayee RB, Sharma N, Jhanji V, et al. One donor cornea for 3 recipients: a new concept for corneal

transplantation surgery. Arch Ophthalmol. 2007; 125: 552 - 554.

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

http://www.allaboutvision.com/conditions/cornea-transplant.htm. Accessed November 22, 2016.

Young AL, Rao SK, Cheng LL, Lam, PTH. Endothelial keratoplasty, HK. J Ophthalmol. 2013; 12(1): 25 - 32.

CMS National Coverage Determinations (NCDs):

NCD for Refractive KERATOPLASTY (80.7). Effective date of this version: May 1, 1997. CMS website.

https://www.cms.gov/medicare-coverage-database/details/ncd-

details.aspx?NCDId=72&ncdver=1&SearchType=Advanced&CoverageSelection=Both&NCSelection=NCA

%7cCAL%7cNCD%7cMEDCAC%7cTA%7cMCD&ArticleType=SAD%7cEd&PolicyType=Both&s=All&KeyWor

d=keratoplasty&KeyWordLookUp=Doc&KeyWordSearchType=Exact&kq=true&bc=IAAAACAAAAAAAA%3

d%3d&. Accessed December 20, 2016.

Local Coverage Determinations (LCDs):

No LCDs 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

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

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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

T86.840 Corneal transplant rejection

T86.841 Corneal transplant failure