Do we really need a better approach to glaucoma surgery? You betcha. In my editorial last month, I mentioned that there is no shortage of ideas or capital to push the field of glaucoma forward. The other essential component is creating the CPT coding and reimbursement schedules to justify the cost of development and marketing.
The entire process sounds simple: develop a product, validate its safety and efficacy, obtain FDA approval, compare the product to the standard of care, request a CPT code, and commence sales and marketing. Unfortunately, fitting a new procedure into an existing code or creating a new CPT code is a hurdle. The AMA is the sole arbiter of the codes for all medical procedures practiced in the United States. The designated CPT code is defined by the preoperative decision making, the complexity of the procedure, the risks to the patient, and the postoperative care. Trabeculectomy, for example, was reclassified with two codes a few years ago. At that time, clinical studies confirmed that filtering surgery in patients with prior anterior segment surgery required more intra- and postoperative care.
One might expect that obtaining a code from the AMA's CPT panel would be a matter of presenting strong data from well-designed, randomized, prospective, multicenter clinical trials. Certainly, a "simple" treatment that reduced IOP by 30% to 40% from baseline without producing any side effects would be awarded a code. The problems are that simple treatments for glaucoma are currently missing and that glaucoma is a multifaceted disease that is poorly defined and diagnosed. "Lumping" the various types of open-angle glaucoma together (ie, primary, pseudoexfoliation, pigmentary dispersion syndrome)—as most published clinical studies do—does not lend itself to a "simple" cure.
Because not a single member of the AMA's CPT panel is an ophthalmologist, the committee depends on the advice and support of the specialty's organizations, specifically the AAO, ASCRS, and AGS. Strong clinical data are important to a product's developers, but the backing of these organizations is critical. The interaction between device manufacturers and clinical associations (specifically the AGS but to some extent the AAO) has been ineffective. This situation changed in December 2008, when the AGS developed guidelines to assist in the CPT coding process.
With the rules for how to get through the CPT process defined, a final element is missing—the glaucoma specialist. Watching from the sidelines as others attempt to develop products and make them available in the United States only lengthens the process. We all need to get involved with novel technologies and the companies trying to bring new concepts to market. We should participate in their studies and critique their results. If clinicians do not become more involved with emerging technology, innovators and venture capitalists will look to other fields for opportunities. We will then be stuck performing trabeculectomies for the rest of our careers. Let's hope that's not the case!
