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DESCRIPTIONGas permeable scleral contact lenses, which are also known as ocular surface prostheses, are formed with an elevated chamber over the cornea and a haptic base over the sclera. Scleral contact lenses are being evaluated in patients with corneal disease, including keratoconus, Stevens-Johnson syndrome, chronic ocular graft-versus-host disease, and in patients with reduced visual acuity after penetrating keratoplasty or other types of eye surgery.
Scleral contact lenses create an elevated chamber over the cornea that can be filled with artificial tears. The base or haptic is fit over the less sensitive sclera. A scleral contact lens has been proposed to provide optical correction, mechanical protection, relief of symptoms, and facilitation of healing for a variety of corneal conditions. Specifically, the scleral contact lens may neutralize corneal surface irregularities and, by covering the corneal surface in a reservoir of oxygenated artificial tears, function as a liquid bandage for corneal surface disease. This may be called prosthetic replacement of the ocular surface ecosystem (PROSE).
The development of materials with high gas permeability and technologic innovations in design and manufacturing has stimulated the use of scleral lenses. The Boston Ocular Surface Prosthesis (Boston Foundation for Sight) is a scleral contact lens that is custom fit using computer-aided design and manufacturing (i.e., computerized lathe). Another design is the Jupiter mini-scleral gas permeable contact lens (Medlens Innovations and Essilor Contact Lens). The Jupiter scleral lens is fit using a diagnostic lens series. The Procornea (Eerbeek) scleral lens was developed in Europe. There are 4 variations of the Procornea: spherical, front-surface toric, back-surface toric, and bitoric. Lenses are cut with submicron lathing from a blank.
The Boston Ocular Surface Prosthesis, which is the prosthetic device used in PROSE, was approved by the U.S. Food and Drug Administration (FDA) in 1994.
Related medical policies are Corneal Topography/Computer-Assisted Corneal Topography/Photokeratoscopy and Implantation of Intrastromal Corneal Ring Segments.
POLICYRigid gas permeable scleral lens may be considered medically necessary for patients who have not responded to topical medications or standard spectacle or contact lens fitting, for the following conditions:
Use of a rigid gas permeable scleral lens for any other condition is considered not medically necessary.
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.
State Health Plan (State and School Employees): Refer to the Member's Plan for benefits, limitations, and/or exclusions for this procedure.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY11/17/2011: Approved by Medical Policy Advisory Committee.
12/03/2012: Policy reviewed; no changes.
11/15/2013: Policy reviewed; no changes.
09/26/2014: Policy reviewed; added policy statement that the use of a rigid gas permeable scleral lens for any other condition is considered not medically necessary.
SOURCE(S)Blue Cross Blue Shield Association policy # 9.03.25
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.