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DESCRIPTIONEndothelial 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 stripping endothelial keratoplasty (DSEK), Descemet stripping automated endothelial keratoplasty (DSAEK), Descemet membrane endothelial keratoplasty (DMEK), and Descemet membrane automated endothelial keratoplasty (DMAEK). EK, and particularly DSEK, DSAEK, DMEK, and DMAEK, are becoming standard procedures. Femtosecond laser-assisted endothelial keratoplasty (FLEK) and femtosecond and excimer lasers-assisted endothelial keratoplasty (FELEK) 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 for vision. Layers of the cornea consist of the epithelium (outermost layer); Bowman layer; the stroma, which comprises approximately 90% of the cornea; Descemet membrane; and the endothelium. The endothelium removes fluid from the stroma and limits entry of fluid as well, 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 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, 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 stripping endothelial keratoplasty (DSEK), which uses hand-dissected donor tissue, and Descemet stripping automated endothelial keratoplasty (DSAEK), which uses an automated microkeratome to assist in donor tissue dissection. These techniques include some donor stroma along with the endothelium and Descemet membrane, which results in a thickened stromal layer after transplantation. If the donor tissue comprises Descemet membrane and endothelium alone, the technique is known as Descemet 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 membrane automated EK (DMAEK). DMAEK contains a stromal rim of tissue at the periphery of the DMEK graft to improve adherence and increase handling of the donor tissue. A laser may also be used for stripping in a procedure called femtosecond laser-assisted endothelial keratoplasty (FLEK) and femtosecond and excimer lasers-assisted endothelial keratoplasty (FELEK).
EK involves removal of the diseased host endothelium and Descemet 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). 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 show the number of EK cases in the United States increased from 1,429 in 2005 to 23,409 in 2012. EBAA estimated that, as of 2012, approximately one-half of corneal transplants performed in the United States 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.
EK is a surgical procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration (FDA). Several microkeratomes have been cleared for marketing by FDA through the 510(k) process.
Indications for Keratoprosthesis are discussed in a separate policy.
POLICYEndothelial 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:
Femtosecond laser-assisted endothelial keratoplasty (FLEK) or femtosecond and excimer lasers-assisted endothelial keratoplasty (FELEK) are considered investigational.
Endothelial keratoplasty is not medically necessary when endothelial dysfunction is not the primary cause of decreased corneal clarity.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
Endothelial keratoplasty should not be used in place of PK 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. Clinical input suggested that there may be cases where anterior corneal disease should not be an exclusion, particularly if endothelial disease is the primary cause of the decrease in vision. EK should be performed by surgeons who are adequately trained and experienced in the specific techniques and devices used.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member’s specific benefit plan language.
POLICY HISTORY10/13/2009: Policy added
11/19/2009: Approved by MPAC
09/09/2010: Policy reviewed; policy statement unchanged. FEP verbiage added to the Policy Exceptions section.
09/28/2011: Policy reviewed; no changes.
09/27/2012: Policy reviewed; no changes.
03/01/2014: Added the following as medically necessary indications for endothelial keratoplasty: ruptures in Descemet’s membrane, iridocorneal endothelial (ICE) syndrome, and corneal edema attributed to endothelial failure. Policy statement added to state that femtosecond laser-assisted corneal endothelial keratoplasty (FLEK) or femtosecond and excimer lasers-assisted endothelial keratoplasty (FELEK) are considered investigational. Endothelial keratoplasty is not medically necessary when endothelial dysfunction is not the primary cause of decreased corneal clarity. Added ICD-9 codes 364.51, 371.22, and 371.33 to the Code Reference section.
10/15/2014: Policy reviewed; description updated. Policy statement unchanged. Policy guidelines updated regarding the use of endothelial keratoplasty.
08/28/2015: Medical policy revised to add ICD-10 codes.
11/02/2015: Policy description updated. Policy statements unchanged. Policy guidelines updated to add medically necessary and investigative definitions.
04/25/2016: Policy description updated. Investigational statement updated to change "Femtosecond laser-assisted corneal endothelial keratoplasty" to Femtosecond laser-assisted endothelial keratoplasty."
SOURCESBlue Cross Blue Shield Association Policy # 9.03.22
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.