Q What is corneal collagen cross-linking?

A Corneal collagen cross-linking is a procedure that stiffens the cornea through a combination of exposure to ultraviolet light and eye drops containing riboflavin (vitamin B2). The procedure, as approved, begins with debridement of the epithelium followed by the application of riboflavin eye drops at frequent intervals for about half an hour to saturate the corneal stroma. Some surgeons, however, advocate cross-linking without epithelial debridement, called the “epi-on” technique. This epi-on technique avoids issues with epithelial healing and patient discomfort as short-term concerns.  

After applying riboflavin, the cornea is exposed to UV light, causing the collagen fibrils to interconnect, thus increasing corneal rigidity. CXL has shown promise in clinical trials in several conditions. The idea is to intervene early to stiffen the corneal collagen matrix without affecting the corneal refractive index.

Q What are the clinical indications for this treatment?  

A CXL is used to treat corneal ectasia from progressive conditions such as keratoconus, other corneal degeneration or a complication following keratorefractive surgery. UV light is effective at treating infections, so CXL has also been advocated for some types of corneal infection.

The American Academy of Ophthalmology Preferred Practice Pattern on corneal ectasia notes:

• Young [age]… or postkeratorefractive surgery patients who … have unstable refractions should be evaluated for corneal ectasia.

• Signs of … ectasia include inferior steepening, superior flattening...[and others].

• It is impossible preoperatively to identify all patients at risk …

Collagen cross-linking has the potential to reduce the risk … of ectasia (… in early stages) and stabilize the corneal contour.

Q What are the CXL approval parameters in the United States?

A In April, 2016, Avedro Inc., received approval from the U.S. Food and Drug Administration for Photrexa Viscous, Photrexa and the KXL System. Photrexa Viscous (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) 0.146% and Photrexa (riboflavin 5’-phosphate ophthalmic solution) 0.146% are photoenhancers indicated for use with the KXL System in corneal collagen cross-linking for the treatment of progressive keratoconus.

Q Is there a CPT code for the CXL procedure?

A Yes. Use Category III CPT code 0402T (Collagen cross-linking of cornea including removal of the corneal epithelium and intraoperative pachymetry when performed) to report this procedure. AMA released this code on July 1, 2015, and it was effective January 1, 2016.  

Q Are there any procedures that may not be reported in conjunction with 0402T?

A Yes. 0402T may not be reported in combination with CPT codes 65435, 69990 or 76514.

Q Will third-party payers consider CXL a covered procedure and reimburse for it?  

A As with all Category III codes, payment is at the discretion of the payer and typically handled on a case-by-case basis. Payers may consider this experimental and investigational and therefore, non-covered.  

Q Are there any published payment policies addressing CXL coverage?

A Not many. Aetna has a published policy titled Corneal Remodeling. This policy was slated for review in January, 2017. It includes the following information regarding the medical necessity of CXL:
“Collagen Cross-Linking for Keratoconus: Aetna considers epithelium-off photochemical collagen cross-linkage using riboflavin and ultraviolet A medically necessary for keratoconus and keratectasia. Photochemical collagen cross-linkage is considered experimental and investigational for all other indications because its effectiveness for other indications has not been established. Epithelium-on (transepithelial) collagen cross-linkage is considered experimental and investigational for keratoconus, keratectasia, and all other indications. Performance of photochemical collagen cross-linkage in combination with other procedures (CXL-plus) (e.g., intrastromal corneal ring segments, PRK or phakic intraocular lens implantation) is considered experimental and investigational.”1

Q Are payment rates for CXL published?

A Commercial payers determine their own unique reimbursement rates; rarely do they publish them. The Medicare Physician Fee Schedule doesn’t publish reimbursement rates for Category III codes. Medicare does publish facility rates for ambulatory surgery centers and for hospital outpatient departments for Category III codes. In 2017, the national ASC reimbursement rate for 0402T is $418; for the HOPD it is $774. This includes all equipment and supplies used during the procedure.  

Q May patients be charged for the procedure if insurance coverage is unlikely?

A Yes, patients may be asked to pay for the procedure as long as the patient is informed before the procedure. Explain to the patient why CXL is necessary, and that Medicare or other third-party payers will likely deny the claim. Ask the patient to assume financial responsibility for the charge. A financial waiver can take several forms, depending on insurance:

• An Advance Beneficiary Notice of Noncoverage is required for services where Part B Medicare coverage is ambiguous or doubtful, and may be useful where a service is never covered. You may collect your fee from the patient at the time of service or wait for a Medicare denial. If both the patient and Medicare pay, promptly refund the patient or show why Medicare paid in error.

• For Part C Medicare (Medicare Advantage), determination of benefits is required to identify beneficiary financial responsibility prior to performing non-covered services; MA Plans may have their own waiver processes.

• For commercial insurance beneficiaries, a Notice of Exclusion from Health Plan Benefits is an alternative to an ABN. The patient may be asked to pay in full for the procedure and should the payer provide coverage, the patient receives a refund.

Q If insurance provides reimbursement but the rate is extremely low, what recourse exists?

A Unfortunately, if you are a contracted provider with the payer, you are required to accept the allowed amount as payment in full. You may submit an appeal to the payer providing cost details and request additional funds.   REVIEW

Ms. McCune is vice pres­ident of the Cor­coran Con­sult­ing Group. Con­tact her at DMcCune@corcoranccg.com.

1. http://www.aetna.com/cpb/medical/data/1_99/0023.html accessed 20 March 2017.