THIS IS NO LONGER AN ACTIVE POLICY. POLICY WAS ARCHIVED ON 05/15/2025.

DISCLAIMER

Highmark Health Options medical policy is intended to serve only as a general reference resource regarding coverage for the services described. This policy does not constitute medical advice and is not intended to govern or otherwise influence medical decisions.

POLICY STATEMENT

Highmark Health Options may provide coverage under medical surgical benefits of the Company’s Medicaid products for medically necessary. Refer to the Noncovered Services policy for more information.

This policy is designed to address medical necessity guidelines that are appropriate for the majority of individuals with a particular disease, illness or condition. Each person’s unique clinical circumstances warrant individual consideration, based upon review of applicable medical records.

The qualifications of the policy will meet the standards of the National Committee for Quality Assurance (NCQA) and the West Virginia Department of Health and Human Resources (DHHR) and all applicable state and federal regulations.

Purpose 

This medical policy outlines Highmark Health Options services for Corneal Transplantation

Definitions

Endothelial Keratoplasty (EK, DSEK, DSAEK, DMEK, Posterior Lamellar Keratoplasty) – The diseased inner layer of the cornea, the endothelium, is removed and replaced with healthy donor tissue while keeping the anterior corneal surface intact

Highmark Health Options (HHO)- Managed care organization serving vulnerable populations that have complex needs and qualify for Medicaid. Highmark Health Options members include individuals and families with low income, expecting mothers, children, and people with disabilities. Members pay nothing to very little for their health coverage. Highmark Health Options currently services WV Mountain Health Trust (MHT) and West Virginia Health Bridge (WVHB) including an expansion plan (WVHB ABP Alternative Benefit Plan) and WVCHIP members.

Lamellar Keratoplasty (LK) – A partial thickness or penetrating keratoplasty (PK), full thickness cornea is removed and replaced with a donor cornea

Prior Authorization

Prior authorization is required.

Procedures

Corneal transplant may be considered medically necessary for ANY of the following indications:

• Aphakic corneal edema; or
• Chemical injuries; or
• Congenital opacities; or
• Corneal degenerations; or
• Ectasias/thinnings; or
• Microbial/post-microbial keratitis; or
• Noninfectious ulcerative keratitis or
• Perforation; or
• Primary corneal endotheliopathies; or
• Pseudophakic corneal edema; or
• Regraft related to allograft rejection; or
• Regraft unrelated to allograft rejection; or
• Steven-Johnson Syndrome; or
• Stromal corneal dystrophies; or
• Trauma or injuries that cause corneal scarring; or
• Viral/post-viral keratitis; 
• Corneal transplants not meeting the criteria as indicated in this policy is considered not medically necessary.

ARTIFICIAL CORNEA

Keratoprosthesis using a United States Food and Drug Administration (U.S. FDA) approved device may be considered medically necessary when ALL the following criteria are met:

• Cadaveric corneal transplants have failed or there is a very low likelihood of success; and
• The cornea is severely opaque and vascularized.

The use of an artificial cornea device not meeting the criteria as indicated in this policy is considered not medically necessary.

ENDOTHELIAL KERATOPLASTY (DSEK, DSAEK, DMEK, DMAEK)

Endothelial keratoplasty (Descemet stripping endothelial keratoplasty [DSEK]), Descemet stripping automated endothelial keratoplasty (DSAEK), Descemet membrane endothelial keratoplasty (DMEK), or Descemet membrane automated endothelial keratoplasty (DMAEK) may be considered medically necessary for the treatment of endothelial dysfunction, including but not limited to ANY of the following indications:

• Ruptures in Descemet membrane; or
• Endothelial dystrophy; or
• Aphakic, and pseudophakic bullous keratopathy; or
• Iridocorneal endothelial (ICE) syndrome; or
• Corneal edema attributed to endothelial failure; and
• Failure or rejection of a previous corneal transplant. 

Endothelial keratoplasty for any indication other than listed above is considered experimental/investigational and, therefore, noncovered because the safety and/or effectiveness of this services cannot be established by the available peer-reviewed literature.

FEMTOSECOND LASER-ASSISTED CORNEAL ENDOTHELIAL KERATOPLASTY (FLEK)

FLEK or femtosecond and excimer laser assisted endothelial keratoplasty (FELEK) are considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this services cannot be established by the available peer-reviewed literature.

POST-PAYMENT AUDIT STATEMENT

The medical record must include documentation that reflects the medical necessity criteria and is

subject to audit by Highmark Health Options at any time pursuant to the terms of your provider

agreement.

PLACE OF SERVICE: INPATIENT/OUTPATIENT

Experimental/investigational (E/I) services are not covered regardless of place of service.
Corneal Transplantation is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

SUMMARY OF LITERATURE

American Academy of Ophthalmology - 2018

The 2018 Preferred Practice Parameter on ocular edema and opacification by the American Academy of Ophthalmology did not provide specific recommendations on the keratoprosthesis, but discussed the technology and its current use:

“Significant improvements in the design and postoperative management of the Boston type 1 keratoprosthesis has resulted in a steady rise in the number of these procedures performed both in the United States and abroad. Reduced incidence of postoperative stromal necrosis and bacterial endophthalmitis due to the chronic use of protective soft contact lenses and topical antibiotics has resulted in improved retention and visual outcomes and has had a positive impact on surgeons’ perceptions of when to recommend keratoprosthesis. Once considered a procedure of last resort in patients with severe bilateral visual impairment, it is now being used for a variety of unilateral and bilateral indications, such as ocular trauma, herpetic keratitis, aniridia, and Stevens-Johnson syndrome. More recently, as corneal surgeons have gained a greater appreciation of the failure rate of repeat corneal transplantation, a role for a keratoprosthetic in cases of multiple graft failure has become clearer. Despite earlier suggestions, keratoprosthetics are not considered ideal for pediatric cases, particularly as primary treatment.…

“Patients with severe dry eye and autoimmune ocular surface diseases...remain a difficult management group despite the other successes of the Boston type 1 keratoprosthetic. Primary placement of the Boston keratoprosthesis in this group of patients results in a higher rate of epithelial defects, scleral and corneal necrosis, extrusion, and endophthalmitis. Some surgeons advocate ocular surface reconstruction with combined keratolimbal allografts or living related allografts prior to placement of the keratoprosthesis. This can potentially lead to improved outcomes in this group. The Boston type 2 keratoprosthetic designed to be used through the eyelid and the osteo-odonto-keratoprosthesis have been implanted with some success in this group of patients.”

American Academy of Ophthalmology-2009

In 2009, the American Academy of Ophthalmology (AAO) published a position paper on endothelial keratoplasty, stating that the optical advantages, speed of visual rehabilitation, and lower risk of catastrophic wound failure have driven the adoption of endothelial keratoplasty as the standard of care for patients with endothelial failure and otherwise healthy corneas. The 2009 AAO position paper was based on an AAO comprehensive review of the literature on Descemet stripping automated endothelial keratoplasty. AAO concluded that “the evidence reviewed suggests Descemet stripping automated endothelial keratoplasty appears safe and efficacious for the treatment of endothelial diseases of the cornea. Evidence from retrospective and prospective Descemet stripping automated endothelial keratoplasty reports described a variety of complications from the procedure, but these complications do not appear to be permanently sight threatening or detrimental to the ultimate vision recovery in the majority of cases. Long-term data on endothelial cell survival and the risk of late endothelial rejection cannot be determined with this review.” “Descemet stripping automated endothelial keratoplasty should not be used in lieu of penetrating keratoplasty for conditions with concurrent endothelial disease and anterior corneal disease. These situations would include concurrent anterior corneal dystrophies, anterior corneal scars from trauma or prior infection, and ectasia after previous laser vision correction surgery.”