And now for something completely different. Monty Python On May 3, 2005, the Centers for Medicare & Medicaid Services (CMS) announced that Medicare beneficiaries can now pay the additional cost of a presbyopia-correcting intraocular lens (IOL) that is over and above the cost of a standard IOL included in cataract surgery. Beneficiaries may also be charged for “accompanying services” related to cataract surgery. Specifically, the ruling stated Beneficiaries may request presbyopia-correcting IOLs in place of conventional IOLs following cataract surgery. Presbyopia-correcting IOL devices and associated services for fitting the IOL are considered partially covered by Medicare in these cases. Beneficiaries are responsible for paying charges associated with the presbyopia-correcting IOLs that exceed normal charges for inserting conventional IOLs following cataract surgery. This is a momentous ruling that allows Medicare beneficiaries who have cataract surgery access to the latest IOLs for the correction of near and distance visual acuity. Before the ruling, it was unlawful to charge patients additional money for a presbyopia-correcting IOL after standard cataract surgery. Patients who had refractive lens exchange (RLE) were able to choose whatever IOL they and their surgeon thought appropriate since they were paying for the procedure and Medicare was not involved in the transaction. The rapid approval of new multifocal IOLs as well as the development of various types of accommodating IOLs attest to the timeliness of this announcement. The U.S. Food and Drug Administration (FDA) recently approved 2 types of multifocal IOLs for use in cataract patients. Advanced Medical Optic's (AMO) Rezoom multifocal refractive IOL is a 3-piece, hydrophobic acrylic IOL that distributes light over 5 optical zones to enhance visual function at distance, intermediate, and near levels. The Rezoom IOL was developed to reengineer the optics of AMO's previously approved Array IOL; the size of some zones was changed to reduce the amount of glare and halos associated with the IOL. Advanced Medical Optics also has a 3-piece silicone IOL that uses the Tecnis aspheric design in a multifocal IOL currently undergoing trials. The FDA has also approved Alcon's AcrySof ReStor hydrophobic acrylic multifocal IOL, which uses diffractive technology to give patients a relatively full range of near, intermediate, and distance vision. The CMS ruling covers accommodating as well as multifocal IOLs. Eyeonics' Crystalens is the only accommodating IOL approved for use in the U.S. at this time. Before the CMS ruling, use of the Crystalens was limited to RLE (off label) or cataract surgery in non-Medicare patients. Research and development of accommodating IOLs, including hinge- and dual-optic-types, is progressing rapidly. Worldwide, various accommodating IOLs are in development; these will eventually enter clinical studies for potential use in the U.S. The CMS ruling is critically important in allowing research on these IOLs to progress without the financial constraints imposed by not allowing Medicare patients to pay the added cost. The new policy should encourage rather than discourage technological advances. Many questions must be answered now that the ruling is in place. The regulatory language on how the additional services can be billed has not been clarified; ie, how can the services be billed by the Medicare carriers and how should surgeons code for the use of a presbyopia-correcting IOL above the payment for the standard IOL used in cataract surgery. While the CMS announcement covers presbyopia-correcting IOLs, it is unclear whether similar approvals will allow other “value-added” IOLs. This includes the possibility of an expansile-type IOL that may be developed to correct the lack of accommodation in post-cataract-surgery patients. It is also not clear how this ruling will apply to completely different IOL technologies such as the light adjustable lens, which may allow correction of refractive errors following cataract surgery on the IOL itself. Another area of “special IOL” development is the artificial iris–lens diaphragm developed for implantation in patients with anatomically or traumatically induced iris deficiencies. Adequate reimbursement for these “orphan IOLs” may stimulate further development in this area. The decision by CMS to allow additional payments for presbyopia-correcting IOLs is an important departure from previous policies; this is the first time Medicare patients have been allowed to pay the additional cost of a new type of IOL technology over the cost of a standard IOL, which is presently included in cataract surgery. We hope the ruling represents an evolution in Medicare policies that will allow patients to make their own choices, in consultation with their surgeons, regarding value-added services such as new IOL technologies. Rulings such as this should stimulate technological advancement in IOL design and function that will benefit cataract surgery patients in the long term.
No takes yet. Share an insight, caveat, or question.
Nick Mamalis (2005) studied this question.