Coding & Reimbursement

CXL wins FDA approval, so prepare to code

By Suzanne L. Corcoran

Corneal collagen cross-linking is a fairly new procedure to treat certain corneal diseases. As is often the case, there are lots of questions about coverage from third-party payers at this point.

Q. What is corneal collagen cross-linking?

A. Corneal collagen cross-linking (CXL) is a procedure to stiffen the cornea through a combination of exposure to ultraviolet (UV) light and eye drops containing riboflavin (vitamin B2). To start, the riboflavin eye drops are applied at frequent intervals for about half an hour to saturate the corneal stroma. Some surgeons advocate removing the corneal epithelium to facilitate riboflavin uptake, although this adds 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; the idea is to intervene early to stiffen the corneal collagen matrix while not affecting the corneal refractive index.

Q. What conditions are treated with CXL?

A. CXL is used to treat corneal ectasia from progressive conditions such as keratoconus,¹ other corneal degenerations, or as a complication following keratorefractive surgery.^2-4 UV light is effective at treating infections, so clinicians have also advocated CXL for some types of corneal infections.^5,6

The American Academy of Ophthalmology Preferred Practice Patterns 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 …

• Though not currently approved [by FDA] … collagen crosslinking has the potential to reduce the risk… of ectasia (… in early stages) and stabilize the corneal contour.

Q. Has CXL been approved by the FDA?

A. In April 2016, the FDA approved Avedro, Inc.’s Photrexa Viscous, Photrexa and the KXL System for the treatment of progressive keratoconus. Other products and systems for similar therapy have not yet received FDA approval.

Q. What CPT code describes CXL?

A. 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, effective Jan. 1, 2016.

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

Q. Is CXL covered by Medicare or health insurance?

A. Maybe. Some payers cover it for some conditions; others do not because it is considered experimental and investigational.

The Medicare Physician Fee Schedule does not include payment rates for any Category III codes, although there are fee schedules for hospital outpatient department (HOPD) and ambulatory surgery center facility fees. The 2016 Medicare allowed amounts for 0402T are $697 and $390, respectively. Other third-party payers set their own payment rates.

Q. If coverage of CXL is unlikely or uncertain, how should we proceed?

A. An Advance Beneficiary Notice of Noncoverage (ABN) is required for services when Part B Medicare coverage is ambiguous or doubtful. 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. Part C Medicare (Medicare Advantage) does not use the Medicare ABN form, but must issue a determination of benefits to identify beneficiary financial responsibility prior to performing noncovered services; MA Plans may have their own waiver forms.

For commercial insurance beneficiaries, a Notice of Exclusion from Health Plan Benefits is an alternative to an ABN. OM

REFERENCES

Suzanne L. Corcoran is vice president of Corcoran Consulting Group. She can be reached at (800) 399-6565 or www.corcoranccg.com.