Medical Policy: 07.01.72
Original Effective Date: September 2016
Reviewed: September 2017
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Corneal cross-linking (CXL) is an in-office eye procedure that is said to strengthen or stabilize the cornea if it's been weakened by keratoconus, other corneal disease, or a complication of LASIK surgery. During the procedure, riboflavin is applied to the epithelized or de-epithelialized cornea followed by exposure to UV light. Using riboflavin as a photosensitizer and ultraviolet-A (UVA) to increase the formation of intra and interfibrillar covalent bonds by photosensitized oxidation thus, resulting in a measureable stiffening of corneal tissue. This treatment has also been used to treat infectious corneal ulcers and in combination with other treatments, such as intracorneal ring segment implantation.
Alternative and brand names for the procedure include corneal crosslinking, corneal collagen crosslinking, C3-R, CCL and KXL.
The two basic types of corneal cross-linking are:
The main health outcome for corneal CXL treatment is improvement, or stabilization, of visual acuity.
The IPG stratifies their recommendations for corneal CXL as follows: “Most of the published evidence on photochemical corneal collagen cross-linkage (CXL) using riboflavin and ultraviolet A (UVA) for keratoconus and keratectasia relates to the technique known as 'epithelium-off' CXL'. 'Epithelium-on (transepithelial) CXL' is a more recent technique and less evidence is available on its safety and efficacy. Either procedure (epithelium-off or epithelium-on CXL) can be combined with other interventions, and the evidence base for these combination procedures (known as 'CXL-plus') is also limited. Therefore, different recommendations apply to the variants of this procedure, as follows:
In 2016, the FDA approved Avedro’s cross-linking system for progressive keratoconus. The approval was unique, as it is a combination drug and device approval. The approval includes Avedro's Photrexa Viscous and Photrexa, which are riboflavin solutions used with the KXL System during the procedure.
Corneal collagen cross-linking is considered investigational for all indications.
Collagen cross-linking treatment is not a cure for keratoconus, rather, it aims to slow or even halt the progression of the condition. The main aim of this treatment is to arrest progression of keratoconus, and thereby prevent further deterioration in vision and the need for corneal transplantation. In regards to completed studies the overall quality of the evidence was judged to be very low primarily due to downgrading the evidence due to risk of bias in the included studies, imprecision, indirectness and publication bias. The short term outcomes appear promising but more evidence is needed to determine if long term outcomes are achieved and the need for corneal transplantation is actually halted.
To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes and / or diagnosis codes.
Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.
*CPT® is a registered trademark of the American Medical Association.