Coverage Policy Manual
Policy #: 2009024
Category: Surgery
Initiated: August 2009
Last Review: April 2024
  Endothelial Keratoplasty
Description:
Endothelial keratoplasty (EK), also referred to as posterior lamellar keratoplasty, is a form of corneal transplantation in which the diseased inner layer of the cornea, the endothelium, is replaced with healthy donor tissue. Specific techniques include Descemet’s stripping endothelial keratoplasty, Descemet’s stripping automated endothelial keratoplasty, Descemet’s membrane endothelial keratoplasty, and Descemet membrane automated endothelial keratoplasty. Endothelial keratoplasty, and particularly the specific techniques mentioned, are becoming standard procedures. Femtosecond laser-assisted endothelial keratoplasty and femtosecond and excimer laser-assisted endothelial keratoplasty have also been reported as alternatives to prepare the donor endothelium.
 
The cornea, a clear, dome-shaped membrane that covers the front of the eye, is a key refractive element of the eye. Layers of the cornea consist of the epithelium (outermost layer); Bowman’s layer; the stroma, which comprises approximately 90% of the cornea; Descemet’s membrane; and the endothelium. The endothelium removes fluid from and limits fluid into the stroma, thereby maintaining the ordered arrangement of collagen and preserving the cornea’s transparency. Diseases that affect the endothelial layer include Fuchs’ endothelial dystrophy, aphakic and pseudophakic bullous keratopathy (corneal edema following cataract extraction), and failure or rejection of a previous corneal transplant.
 
The established surgical treatment for corneal disease is penetrating keratoplasty (PK), which involves the creation of a large central opening through the cornea and then filling the opening with full-thickness donor cornea that is sutured in place. Visual recovery after PK may take a year or more due to slow wound healing of the avascular full-thickness incision, and the procedure frequently results in irregular astigmatism due to the sutures and the full-thickness vertical corneal wound. PK is associated with an increased risk of wound dehiscence, endophthalmitis, and total visual loss after relatively minor trauma for years after the index procedure. There is also risk of severe, sight-threatening complications such as expulsive suprachoroidal hemorrhage, in which the ocular contents are expelled during the operative procedure, as well as postoperative catastrophic wound failure.
 
A number of related techniques have been, or are being, developed to selectively replace the diseased endothelial layer. One of the first endothelial keratoplasty (EK) techniques was termed deep lamellar endothelial keratoplasty (DLEK), which used a smaller incision than PK, allowed more rapid visual rehabilitation, and reduced postoperative irregular astigmatism and suture complications. Modified EK techniques include endothelial lamellar keratoplasty, endokeratoplasty, posterior corneal grafting, and microkeratome-assisted posterior keratoplasty. Most frequently used at this time are Descemet’s stripping endothelial keratoplasty (DSEK), which uses hand-dissected donor tissue, and Descemet’s stripping automated endothelial keratoplasty (DSAEK), which uses an automated microkeratome to assist in donor tissue dissection. A laser may also be utilized for stripping in a procedure called femtosecond laser-assisted corneal endothelial keratoplasty (FLEK) or femtosecond and excimer lasers-assisted endothelial keratoplasty (FELEK). These techniques include some donor stroma along with the endothelium and Descemet’s membrane, which results in a thickened stromal layer after transplantation. If the donor tissue comprises Descemet’s membrane and endothelium alone, the technique is known as Descemet’s membrane endothelial keratoplasty (DMEK). By eliminating the stroma on the donor tissue and possibly reducing stromal interface haze, DMEK is considered to be a potential improvement over DSEK/DSAEK. A variation of DMEK is Descemet’s membrane automated EK (DMAEK). DMAEK contains a stromal rim of tissue at the periphery of the DMEK graft to improve adherence and increase ease of handling of the donor tissue. A laser may also be used for stripping in a procedure called femtosecond laser-assisted endothelial keratoplasty and femtosecond and excimer laser-assisted endothelial keratoplasty.
 
EK involves removal of the diseased host endothelium and Descemet’s membrane with special instruments through a small peripheral incision. A donor tissue button is prepared from corneoscleral tissue after removing the anterior donor corneal stroma by hand (e.g., DSEK) or with the assistance of an automated microkeratome (e.g., DSAEK) or laser (FLEK or FELEK). Several microkeratomes have received clearance for marketing through the U.S. Food and Drug Administration (FDA) 510(k) process. Donor tissue preparation may be performed by the surgeon in the operating room, or by the eye bank and then transported to the operating room for final punch out of the donor tissue button. To minimize endothelial damage, the donor tissue must be carefully positioned in the anterior chamber. An air bubble is frequently used to center the donor tissue and facilitate adhesion between the stromal side of the donor lenticule and the host posterior corneal stroma. Repositioning of the donor tissue with application of another air bubble may be required in the first week if the donor tissue dislocates. The small corneal incision is closed with one or more sutures, and steroids or immunosuppressants may be provided either topically or orally to reduce the potential for graft rejection. Visual recovery following EK is typically 4-8 weeks.
 
Eye Bank Association of America (EBAA) statistics have shown the number of EK cases in the United States increased from 30,710 in 2015 to 35,555 in 2019 (EBAA, 2019). The EBAA report estimated that, as of 2016, nearly 40% of corneal transplants performed in the U.S. were endothelial grafts. As with any new surgical technique, questions have been posed about long-term efficacy and the risk of complications. EK-specific complications include graft dislocations, endothelial cell loss, and rate of failed grafts. Long-term complications include increased intraocular pressure, graft rejection, and late endothelial failure.
Policy/
Coverage:
EFFECTIVE SEPTEMEBER 2013
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Endothelial keratoplasty (Descemet’s stripping endothelial keratoplasty [DSEK], Descemet’s stripping automated endothelial keratoplasty [DSAEK], Descemet’s membrane endothelial keratoplasty [DMEK], or Descemet’s membrane automated endothelial keratoplasty [DMAEK])  meets primary coverage criteria that there be scientific evidence of effectiveness for the treatment of endothelial dysfunction, including but not limited to:
 
    • Ruptures in Descemet’s membrane,
    • Endothelial dystrophy,
    • Aphakic and pseudophakic bullous keratopathy,
    • Iridocorneal endothelial (ICE) syndrome,
    • Corneal edema attributed to endothelial failure, AND
    • Failure or rejection of a previous corneal transplant.
 
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Endothelial keratoplasty does not meet member benefit Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes for conditions with concurrent endothelial disease and anterior corneal disease.  This includes, but is not limited to: concurrent anterior corneal dystrophies, anterior corneal scars from trauma or prior infection and ectasia after previous laser vision correction surgery.
 
For contracts without Primary Coverage Criteria, endothelial keratoplasty for conditions with concurrent endothelial disease and anterior corneal disease, including but not limited to concurrent anterior corneal dystrophies, anterior corneal scars from trauma or prior infection and ectasia after previous laser vision correction surgery is considered investigational.  Investigational services are exclusions in the member benefit certificate of coverage.  
 
Femtosecond laser-assisted corneal endothelial keratoplasty (FLEK) or femtosecond and excimer lasers-assisted endothelial keratoplasty (FELEK) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
Femtosecond laser-assisted corneal endothelial keratoplasty (FLEK) or femtosecond and excimer lasers-assisted endothelial keratoplasty (FELEK) are considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
EFFECTIVE PRIOR TO SEPTEMEBER 2013
Endothelial keratoplasty (Descemet’s stripping endothelial keratoplasty or Descemet’s stripping automated endothelial keratoplasty) meets primary coverage criteria that there be scientific evidence of effectiveness for the treatment of endothelial dysfunction, including but not limited to Fuchs’ endothelial dystrophy, aphakic and pseudophakic bullous keratopathy, and failure or rejection of a previous corneal transplant.
 
Endothelial keratoplasty does not meet member benefit Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes for conditions with concurrent endothelial disease and anterior corneal disease.  This includes, but is not limited to: concurrent anterior corneal dystrophies, anterior corneal scars from trauma or prior infection and ectasia after previous laser vision correction surgery.
 
For contracts without Primary Coverage Criteria, endothelial keratoplasty for conditions with concurrent endothelial disease and anterior corneal disease, including but not limited to concurrent anterior corneal dystrophies, anterior corneal scars from trauma or prior infection and ectasia after previous laser vision correction surgery is considered investigational.  Investigational services are exclusions in the member benefit certificate of coverage.  
Rationale: ################
CPT/HCPCS:
65756Keratoplasty (corneal transplant); endothelial
65757Backbench preparation of corneal endothelial allograft prior to transplantation (List separately in addition to code for primary procedure)
References: American Academy of Ophthalmology Ophthalmic Technology Assessment Committee Cornea and Anterior Segment Disorders Panel.(2009) Safety and efficacy of Descemet’s stripping automated endothelial keratoplasty (DSAEK). Ophthalmology, 2009, in press.

Anshu A, Price MO, Price FW, Jr.(2012) Risk of corneal transplant rejection significantly reduced with Descemet's membrane endothelial keratoplasty. Ophthalmology 2012; 119(3):536-40.

Chamberlain W, Lin CC, Austin A, et al.(2019) Descemet Endothelial Thickness Comparison Trial: A Randomized Trial Comparing Ultrathin Descemet Stripping Automated Endothelial Keratoplasty with Descemet Membrane Endothelial Keratoplasty. Ophthalmology. 2019 Jan;126(1). PMID 29945801

Chen ES, Terry MA, Shamie N et al.(2008) Descemet-stripping automated endothelial keratoplasty: six month results in a prospective study of 100 eyes. Cornea 2008; 27(5):514-20.

Chen ES, Terry MA, Shamie N et al.(2009) Endothelial keratoplasty: vision, endothelial survival, and complications in a comparative case series of fellows vs attending surgeons. Am J Ophthalmol 2009;148(1):26-31.e2.

Cheng YY, Schouten JS, Tahzib NG et al.(2009) Efficacy and safety of femtosecond laser-assisted corneal endothelial keratoplasty: a randomized multicenter clinical trial. Transplantation 2009; 88(11):1294-302.

Dapena I, Ham L, Melles GR.(2009) Endothelial keratoplasty: DSEK/DSAEK or DMEK--the thinner the better? Curr Opin Ophthalmol 2009; 20(4):299-307.

Duggan MJ, Rose-Nussbaumer J, Lin CC et al.(2019) Corneal Higher-Order Aberrations in Descemet Membrane Endothelial Keratoplasty versus Ultrathin DSAEK in the Descemet Endothelial Thickness Comparison Trial: A Randomized Clinical Trial. Ophthalmology. 2019 Jul;126(7). PMID 30776384

Dunker SL, Dickman MM, Wisse RPL, et al.(2020) Descemet Membrane Endothelial Keratoplasty versus Ultrathin Descemet Stripping Automated Endothelial Keratoplasty: A Multicenter Randomized Controlled Clinical Trial. Ophthalmology. Sep 2020; 127(9): 1152-1159. PMID 32386811

Eye Bank Association of America.(2007) Eye banking statistical report. Available at: http://www.restoresight.org/.

Eye Bank Association of America.(2019) 2019 Eye Banking Statistical Report. https://restoresight.org/wp-content/uploads/2020/04/2019-EBAA-Stat-Report-FINAL.pdf. Accessed February 1, 2022.

Guerra FP, Anshu A, Price MO et al.(2011) Descemet's membrane endothelial keratoplasty: prospective study of 1-year visual outcomes, graft survival, and endothelial cell loss. Ophthalmology 2011; 118(12):2368-73.

Ham L, Dapena I, van Luijk C et al.(2009) Descemet membrane endothelial keratoplasty (DMEK) for Fuchs endothelial dystrophy: review of the first 50 consecutive cases. Eye. 2009 Jan 30. [Epub ahead of print]

Heinzelmann S, Bohringer D, Eberwein P, et al.(2016) Outcomes of Descemet membrane endothelial keratoplasty, Descemet stripping automated endothelial keratoplasty and penetrating keratoplasty from a single centre study. Graefes Arch Clin Exp Ophthalmol. Jan 7 2016. PMID 26743748

Hirabayashi KE, Chamberlain W, Rose-Nussbaumer J, et al.(2020) Corneal Light Scatter After Ultrathin Descemet Stripping Automated Endothelial Keratoplasty Versus Descemet Membrane Endothelial Keratoplasty in Descemet Endothelial Thickness Comparison Trial: A Randomized Controlled Trial. Cornea. 2020 Jan. PMID 31939923

Hosny MH, Marrie A, Karim Sidky M, et al.(2017) Results of femtosecond laser-assisted Descemet stripping automated endothelial keratoplasty. J Ophthalmol. Jun 11 2017;2017:8984367. PMID 28695004

Ivarsen A, Hjortdal J.(2018) Clinical outcome of Descemet's stripping endothelial keratoplasty with femtosecond laser-prepared grafts. Acta Ophthalmol. 2018 Aug;96(5). PMID 29372934

Li JY, Terry MA, Goshe J et al.(2012) Three-year visual acuity outcomes after Descemet's stripping automated endothelial keratoplasty. Ophthalmology 2012; 119(6):1126-9.

Liu Y, Li X, Li W, et al.(2021) Systematic review and meta-analysis of femtosecond laser-enabled keratoplasty versus conventional penetrating keratoplasty. Eur J Ophthalmol. May 2021; 31(3): 976-987. PMID 32223431

Marques RE, Guerra PS, Sousa DC, et al.(2019) DMEK versus DSAEK for Fuchs' endothelial dystrophy: A meta-analysis. Eur J Ophthalmol. 2019 Jan;29(1). PMID 29661044

Rose L, Kelliher C, Jun AS.(2009) Endothelial keratoplasty: historical perspectives, current techniques, future directions. Can J Ophthalmol 2009; 44(4):401-5.

Singhal D, Maharana PK.(2019) Three-Year Outcome Comparison Between Femtosecond Laser-Assisted and Manual Descemet Membrane Endothelial Keratoplasty. Cornea. 2019 Nov;38(11). PMID 31414998

Sorkin N, Mednick Z, Einan-Lifshitz A, et al.(2019) Three-Year Outcome Comparison Between Femtosecond Laser-Assisted and Manual Descemet Membrane Endothelial Keratoplasty. Cornea. 2019 Jul;38(7). PMID 30973405

Stuart AJ, Romano V, Virgili G, et al.(2018) Descemet's membrane endothelial keratoplasty (DMEK) versus Descemet's stripping automated endothelial keratoplasty (DSAEK) for corneal endothelial failure. Cochrane Database Syst Rev. 2018 Jun;6:CD012097. PMID 29940078

Tourtas T, Laaser K, Bachmann BO et al.(2012) Descemet membrane endothelial keratoplasty versus descemet stripping automated endothelial keratoplasty. Am J Ophthalmol 2012; 153(6):1082-90 e2.

van Dijk K, Ham L, Tse WH et al.(2013) Near complete visual recovery and refractive stability in modern corneal transplantation: Descemet membrane endothelial keratoplasty (DMEK). Cont Lens Anterior Eye 2013; 36(1):13-21.

Vetter JM, Butsch C, Faust M et al.(2013) Irregularity of the posterior corneal surface after curved interface femtosecond laser-assisted versus microkeratome-assisted descemet stripping automated endothelial keratoplasty. Cornea 2013; 32(2):118-24.

Wacker K, Baratz KH, Maguire LJ, et al.(2016) Descemet stripping endothelial keratoplasty for fuchs' endothelial corneal dystrophy: five-year results of a prospective study Ophthalmology. Jan 2016;123(1):154-160. PMID 26481820

Woo JH, Ang M, Htoon HM, et al.(2019) Descemet Membrane Endothelial Keratoplasty Versus Descemet Stripping Automated Endothelial Keratoplasty and Penetrating Keratoplasty. Am. J. Ophthalmol. 2019 Nov;207:288-303. PMID 31228467

Wu J, Wu T, Li J, et al.(2021) DSAEK or DMEK for failed penetrating keratoplasty: a systematic review and single-arm meta-analysis. Int Ophthalmol. Jul 2021; 41(7): 2315-2328. PMID 34117964
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association.