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DESCRIPTIONA keratoprosthesis, consisting of a central optic held in a cylindrical frame, is an artificial cornea that is intended to restore vision to patients with severe bilateral corneal disease for which a corneal transplant is not an option. The keratoprosthesis replaces the cornea that has been removed and is held in place by the surrounding tissue. Various biologic materials are being investigated to improve integration of the prosthetic into the eye.
The cornea, a clear, dome-shaped membrane that covers the front of the eye, is a key refractive element of sight. Layers of the cornea consist of the epithelium (outermost layer); Bowman layer; the stroma, which comprises approximately 90% of the cornea; Descemet’s membrane; and the endothelium. The established surgical treatment for corneal disease is penetrating keratoplasty (PK), which involves making a large central opening through the cornea and then filling the opening with full-thickness donor cornea. In certain conditions, such as Stevens-Johnson syndrome, cicatricial pemphigoid, chemical injury, or prior failed corneal transplant, survival of transplanted cornea is poor. The keratoprosthesis was developed to restore vision in patients for whom a corneal transplant is not an option.
Keratoprosthetic devices consist of a central optic held in a cylindrical frame. The keratoprosthesis replaces the section of cornea that has been removed, and, along with being held in place by the surrounding tissue, may be covered by a membrane to further anchor the prosthesis. A variety of biologic materials are being investigated to improve the integration of prosthetic corneal implants into the stroma and other corneal layers.
The Dohlman-Doane keratoprosthesis, most commonly referred to as the Boston Keratoprosthesis (KPro), is manufactured under the auspices of the Harvard Medical School‒affiliated Massachusetts Eye and Ear Infirmary. The Boston type I KPro uses a donor cornea between a central stem and a back plate. The Boston type 2 prosthesis is a modification of the type 1 prosthesis and is designed with an anterior extension to allow implantation through surgically closed eyelids. The AlphaCor, previously known as the Chirila keratoprosthesis (Chirila KPro) consists of a polymethylmethacrylate (PMMA) device with a central optic region fused with a surrounding sponge skirt; the device is inserted in a 2-stage surgical procedure.
Autologous keratoprostheses use a central polymethylmethacrylate (PMMA) optic supported by a skirt of either tibia bone or the root of a tooth with its surrounding alveolar bone. The most common is the osteo-odonto keratoprosthesis (OOKP), which uses osteodental lamina derived from an extracted tooth root and attached alveolar bone that has been removed from the patient’s jaw. Insertion of the OOKP device requires a complex staged procedure, in which the cornea is first covered with buccal mucosa. The prosthesis itself consists of a PMMA optical cylinder, which replaces the cornea, and is held in place by a biological support made from a canine tooth extracted from the recipient. A hole is drilled through the dental root and alveolar bone, and the PMMA prosthesis is placed within. This entire unit is placed into a subcutaneous ocular pocket, and then retrieved 6 to 12 months later for final insertion.
Hydroxyapatite, with a similar mineral composition to both bone and teeth (phosphate and calcium), may also be used as a bone substitute and as a bioactive prosthesis with the orbit. Collagen coating and scaffolds have also been investigated to improve growth and biocompatibility with the cornea epithelial cells, which form the protective layer of the eye. Many of these materials and devices are currently being tested in vitro or in animal models.
A keratoprosthesis is a Class II device by the U.S. Food and Drug Administration (FDA) and is intended to provide a transparent optical pathway through an opacified cornea, in an eye that is not a reasonable candidate for a corneal transplant. Two permanent keratoprostheses have received 510(k) marketing clearance by the FDA, the Boston KPro (Dohlman-Doane Keratoprosthesis) and the AlphaCor® (Chirila keratoprosthesis). Both devices are indicated as permanent implantable keratoprostheses for eyes that are not corneal transplant candidates and are made of materials that have been proven to be biocompatible. FDA determined that the AlphaCor keratoprosthesis was substantially equivalent to the Dohlman-Doane type 1 keratoprosthesis.
POLICYThe Boston (Dohlman-Doane) Keratoprosthesis (Boston KPro) may be considered medically necessary for the surgical treatment of severe corneal opacification in situations where cadaveric corneal transplants have failed or have a very low likelihood of success. Conditions under which cadaveric corneal transplants have a likelihood of failure include but are not limited to the following:
Patients should be able and expected to comply with postoperative care.
All other types of permanent keratoprostheses are considered investigational.
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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Implantation of a keratoprosthesis is considered a high-risk procedure associated with numerous complications and probable need for additional surgery. Therefore, the likelihood of regaining vision and the patient’s visual acuity in the contralateral eye should be taken into account when considering the appropriateness of this procedure. Treatment should be restricted to centers experienced in treating this condition and staffed by surgeons adequately trained in techniques addressing implantation of this device.
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.
POLICY HISTORY7/15/2004: Approved by Medical Policy Advisory Committee (MPAC)
10/1/2004: Code Reference section completed
5/24/2006: Policy reviewed, no changes
9/25/2007: Policy reviewed, permanent keratoprostheses changed to investigational. Removed "Permanent keratoprostheses may be considered medically necessary in adult patients with corneal opacity not suitable for standard penetrating keratoplasty with donor tissues, or where donor tissue has been declined, or where adjunctive measures required to prevent graft rejection are medically contraindicated."
06/22/2010: Policy description updated regarding treatment approaches and FDA approval of devices. Policy statement revised to indicate that the Boston keratoprosthesis (Boston KPro) may be considered medically necessary for the treatment of corneal blindness when specific criteria are met, and to state that a permanent keratoprosthesis for all other conditions and all other types of permanent keratoprostheses are considered investigational. FEP verbiage added to the Policy Exceptions section. Deleted outdated references in the Sources section. All codes moved from non-covered to covered, and added HCPCS code L8609.
04/20/2011: Policy reviewed; no changes.
03/27/2012: Policy reviewed; no changes.
04/17/2013: Policy reviewed; no changes.
03/18/2014: Policy reviewed; no changes.
07/08/2015: Policy description updated regarding devices. Medically necessary policy statement updated to add the following conditions: 1) Best-corrected vision is ≤20/400 in the affected eye and ≤20/40 in the opposite eye; AND 2) No end-stage glaucoma or retinal detachment is present; AND 3) The patient has one of the following indications: Multiple corneal transplant graft failures; Stevens-Johnson syndrome; Ocular cicatricial pemphigoid; Autoimmune conditions with rare ocular involvement; Ocular chemical burns; An ocular condition unlikely to respond favorably to primary corneal transplant surgery (eg, limbal stem cell compromise or postherpetic anesthesia).
08/27/2015: Code Reference section updated for ICD-10.
05/27/2016: Policy number added. Policy Guidelines updated to add medically necessary and investigative definitions.
07/12/2016: Policy description updated. Policy statement revised to state that the Boston (Dohlman-Doane) Keratoprosthesis (Boston KPro) may be considered medically necessary for the surgical treatment of severe corneal opacification in situations where cadaveric corneal transplants have failed or have a very low likelihood of success. Medically necessary criteria updated to change "vision" to "visual acuity" and "Multiple graft failures" to "History of 1 or more." Removed the following policy statement: A permanent keratoprosthesis for all other conditions is considered investigational. Reworded statement regarding postoperative care.
SOURCE(S)Blue Cross Blue Shield Association policy # 9.03.01
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.