Another Reason Adoption of Presbyopia Correcting IOLs is Slower than Expected

Implications: The Center for Medicare and Medicaid Services (CMS) has ruled that beneficiaries may pay out of pocket for additional non-covered services related to presbyopia and astigmatism correcting intraocular lenses (IOLs) that are provided by surgeons and facilities (such as Ambulatory Surgery Centers and Hospital Out Patient Departments). The reasoning behind this ruling includes the logic that these IOLs serve the same function as eyeglasses but are not eyeglasses and therefore are not a covered service.

Surgeons may worry about the specific inclusion and exclusion criteria of these "non-covered services." One clear part of the service is the cost of the IOL itself. The crystalens, ReZoom and ReStor IOLs are priced around $850, well above the $150 generally allowed by CMS. The AcrySof Toric IOL is priced around $600. However, there is also testing and monitoring related specifically to the refractive aspects of these devices, and determining the value of these services is up to the provider. As Alan Reider notes, it is easy to imagine a case of misunderstanding between patient and surgeon ending up in litigation.

Analysis: Penetration of presbyopia IOLs in the US market has generally been less than expected. There are several important reasons for this slow adoption. The first is the change in practice management necessary to allow the additional time and counseling necessary to explain both the technology and the rules surrounding its use to each prospective cataract patient. This requires a commitment to patient education on the part of the surgeon and staff.

The second important reason is the investment in diagnostic technology necessary to produce the outcome that patients expect, i.e., freedom from bifocals. The correction must eliminate nearsightedness, farsightedness, astigmatism and presbyopia. The IOL power selection and the correction of astigmatism require state-of-the-art measurement devices (IOL Master, Immersion Ultrasound, Corneal Topography) and flawless surgical technique (cataract extraction, IOL insertion, limbal relaxing incisions).

Third, the surgeon and facility must have a plan for enhancement procedures (e.g., LASIK) to correct residual refractive errors after surgery. Even the best centers boast about a 5% enhancement rate; some surgeons describe enhancement procedures in 20% of patients. For surgeons who are only so far doing cataract surgery and who do not have access to an excimer laser, the enhancement procedure becomes problematic.

The added legal burden that Alan Reider describes can only add to surgeons' natural conservatism when it comes to trying something new. Nevertheless, in the 5 - 10 year outlook, presbyopia correction remains the cornerstone of any successful business plan for cataract and refractive lens surgery. As CMS reimbursement continues to decline surgeons will be forced to either retire/change professions, accept a significantly reduced life style in comparison to what they feel they deserve based on years of training, expertise and the intrinsic value of the services they provide, or begin accepting fee for service from grateful client/patients who no longer rely on glasses to drive, use a laptop or read the newspaper. What would you choose?