Corneal collagen cross-linking provides a treatment that can stop the progression of keratoconus and ectasia after refractive surgery. But the only FDA-approved method for performing the procedure uses a high-cost medication. Here’s how to manage the financial risk of using this treatment.

Background

Prior to the introduction of cross-linking, corneal specialists could only monitor progression and treat symptoms with contact lenses or corneal transplant surgery.

Cornea specialists around the world have been performing cross-linking for over 10 years, while U.S. ophthalmologists performed the procedure on an experimental basis under investigational new drug and institutional review board control while waiting for federal approval.

In April 2016, the U.S. Food and Drug Administration granted approval for Avedro’s Photrexa formulations and the UVA-based KXL System. This did not, however, lead to easy adoption for practices. The Avedro system uses a high-cost medication. It is imperative that you understand the reimbursement landscape to ensure you can treat these patients while protecting your practice’s bottom line. 

What CPT does and doesn’t say

The Category III Code for cross-linking is 0402T Collagen cross-linking (including removal of the corneal epithelium and intraoperative pachymetry when performed). CPT Assistant Feb 16:12 notes “Do not report 0402T in conjunction with 65435, 69990, 76514.” [i] CPT does not address the medication used with the procedure.

Similar to other ophthalmology services, it is appropriate to report and bill the drug in addition to the procedure: HCPCS code J3490 Unclassified drug[ii], with a notation in Box 19 indicating the medication name.

As with all medications, you should also ensure that you submit the NDC drug code on the claim. You must submit a copy of the medication invoice with the claim.

Commercial carrier coverage

The existence of a CPT code does not ensure coverage under Medicare or commercial payers. However, we have seen rapid adoption of positive cross-linking coverage polices throughout the country. As of this writing, over 30 carriers nationwide cover the procedure, including many of the Blue Shield plans, Aetna and Kaiser Permanente [PDF].

• Positive coverage policy: If your patient’s insurance has a positive coverage policy and you participate with the plan, you should not bill the patient, even if you suspect the insurance payment may not cover the cost of both the procedure and drug. This would most likely violate your contract.
• Negative coverage policy: You may collect payment from the patient.
• No published policy: Contact the carrier and don’t assume non-coverage. If you collect from a patient and they submit the claim themselves and obtain coverage, the carrier may require you to refund the fees collected. The insurance reimbursement may be lower than expected and appeals after the claim has been underpaid require a great deal of work. Be sure to contact the carrier before performing the procedure.

Commercial carrier coding

While a growing number of commercial carriers cover the cross-linking procedure, many policies remain silent on use of separate coding for the medication required. We suggest that you contact your local carriers and ask them if they prefer to see the invoice cost of the medication submitted separately from the cross-linking procedure.

The best way to do this is to submit a predetermination for both 0402T Collagen cross-linking (including removal of the corneal epithelium and intraoperative pachymetry when performed) and J3490 Unclassified drug. Doing this in advance will help clarify the carrier’s preferred method of claim submission.

It is critical to note that a predetermination does not entail a prior authorization. Though both involve pre-surgery review, they have important differences.

• Prior authorization: Requirement that the plan approve the procedure before you perform it.
  • If they require this step and you don’t get approval, the plan won’t cover the procedure.
  • Many plans have a list of procedures that require a prior authorization.
  • If you are billing the service to a payer for the first time and their list does not include the CPT code, you should do a pre-determination to be sure. .
• Predetermination: Request to review a unique situation before performing the case. While it does not ensure coverage, it is very helpful in getting claims through the first time.

You can use predeterminations for both carriers with a published positive or negative coverage policy and those with no published policy at all.

• Plans with a published positive policy: Predetermination can clarify if they want the drug as a separate line item.
• Plans with a negative published policy: Predetermination may allow you to get an exception for your patient.
• Plans with no policy: Predeterminations are imperative to determining whether you should collect your fees up front.

Additionally, for your most common carriers, consider going directly to them for an opinion if you have a strong relationship with your insurance representative or the local medical director. If the predetermination denies coverage, you can collect your fee from the patient. If they approve the 0402T and deny the J3490, you must bill with the single line item 0402T. If they give you a written opinion, you will hopefully no longer need to submit predeterminations.

So, what should you do to protect your practice? The good news is that patients can benefit from this procedure and many commercial insurance plans cover it. The bad news is that we have more work to do to educate carriers on fair reimbursement for this procedure.

Protect your practice by doing your homework before performing these procedures so you do not lose money or potentially violate your insurance contract terms. 

[i] American Medical Association, Current Procedural Terminology Professional, 2017, AMA.
[ii] 2017 HCPCS LEVEL II, Professional Edition, 2017 Elsevier.