Coding & Reimbursement

Alternative ophthalmic drug-delivery systems

Future treatments aid adherence.

By Suzanne L. Corcoran

For most conditions, ophthalmic medications are administered by the patient, be they drop or ointment, and require proper times and intervals for successful results. Unfortunately, some patients have a hard time following instructions, even with the best of intentions, and are not compliant. Then treatment and outcomes are doomed to be suboptimal. So, alternative drug delivery systems that do not require patient activity are attractive alternatives. Here’s a look at them, as well as a primer for coding those currently under investigation.

Q. What are some alternative drug delivery systems?

A. Drug-eluting implants in ophthalmology are not new. Ozurdex (dexamethasone, Allergan)¹, Iluvien (fluocinolone acetonide, Alimera Sciences)², and Retisert (fluocinolone acetonide, Bausch + Lomb)³ are all such intravitreal therapies. Other sustained-release drug-delivery systems are in development.^4-7 Ocular Therapeutix is developing drug-eluting intracanalicular hydrogel plugs for the treatment of postoperative pain and inflammation, glaucoma, allergic conjunctivitis, and some ocular infections.⁸

Ocular Therapeutix’s intracanalicular plugs have a proprietary absorbable polyethylene glycol hydrogel technology designed to release drugs in a sustained fashion over a specific period of time depending on the drug and its corresponding therapeutic need. Some of the relevant drugs with which Ocular Therapeutix has begun clinical trials are:

• Dexamethasone corticosteroid anti-inflammatory agent

• Travoprost (Travatan, Alcon Laboratories) prostaglandin analogue to treat glaucoma

• Moxifloxacin quinolone antibiotic.

At the end of the treatment period, the plug is absorbed and any residual exits the nasolacrimal system without need for the clinician to remove it. The plug contains a visualizing agent for retention monitoring throughout the treatment. At the present time, none of Ocular Therapeutix’s agents has been approved by the FDA; they are investigational.

Q. How would this procedure (including implant) be coded?

A. The American Medical Association’s CPT Panel released a new Category III CPT code, 0356T (Insertion of drug-eluting implant including punctal dilation and implant removal when performed into lacrimal canaliculus, each), on January 1, 2014; it took effect July 1, 2014. The 2015 CPT manual includes the 0356T code.

Category III CPT emerging technology codes allow data collection on emerging technologies, new services and procedures that would otherwise be treated as unlisted or miscellaneous. Significantly, a Category III code does not mean that the service or procedure is endorsed, approved, considered safe or has applicability to clinical practice. Initially, the new code will be used in clinical trials to provide a mechanism for reimbursement for insertion of these intracanalicular drug-eluting plugs where approved by the Medicare Administrative Contractor (MAC).

Q. Outside of clinical trials, what is the reimbursement for Category III codes?

A. Reimbursement for Category III codes is at the discretion of the payer. Within the Part B Medicare program, the default position of the MACs is noncoverage of all Category III CPT codes; exceptions are rare. Other third-party payers usually follow a similar policy. According to Aetna, 0356T is “experimental and investigational” and not covered “…because its effectiveness has not been established.”⁹ The utility of a new procedure only becomes known with experience, time and careful study.

The Medicare Physician Fee Schedule assigns no value to any Category III CPT code. Payment will vary even when the code is covered. Interestingly, when a MAC does cover 0356T, a payment rate is established within the Outpatient Prospective Payment System for the facility, either HOPD or ASC. OM

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