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A change in Medicare reimbursements will probably make it somewhat easier for ambulatory surgery centers to buy multifocal and toric intraocular lenses. But the overall impact of the payment change is likely to be slight, experts say.
Right now, Medicare reimburses ASCs $150 for each IOL as a part of the facility fee. This amount more than covers the cost of standard silicone IOLs; if purchased in volume, these lenses can be had for well under $100. However, $150 does not cover the cost of many new IOLs, including Allergan's multifocal Array intraocular lens and Staar?? ?s Toric IOL. Both cost between $200 and $300 per lens, depending on volume.
The bundling of the IOL reimbursement with the facility fee has also served to keep other lenses out of ASCs. Even though the Alcon Acrysof is popular among surgeons and can be had for about $150, some ASCs do not carry it, because they can make more profit on standard three-piece or plate haptic silicone lenses.
To help make the more expensive IOLs available to more patients, and to encourage manufacturers to continue their research and development efforts, the FDA created a new subset of lenses called "new technology" IOLs. In a notice published in the Federal Register on June 16, it defined these lenses as having "specific clinical advantages over other IOLs, including a reduced risk of intraoperative or postoperative complication or trauma, accelerated postoperative recovery, reduced induced astigmatism, improved postoperative visual acuity, more stable postoperative vision, or any other comparable clinical advantages."
When ASCs use lenses that qualify for the new technology designation, they will receive an extra $50 in addition to the standard $150 reimbursement.
It's hard to say just what the impact of the new ruling will be. Much depends on which lenses the FDA designates as "new technology." If the agency approves only the Allergan Array multifocal lens and the Staar Toric lens, as some expect, the effect likely will be minimal. Since, each lens costs between $200 and $300 apiece, ASCs will show no profit on lenses in the best-case scenario and lose up to $100 in the worst-case scenario. "It may offset the price a bit, but no one is going to make money off of it," says Robert Kershner, MD, an ophthalmologist and director of the Orange Grove Center for Corrective Eye Surgery in Tucson, Ariz.
For that reason, the change is unlikely to drive sales of either lens. Indianapolis surgeon Kevin Waltz, MD, who implants a number of Array lenses in his surgery center, says the $50 will be a significant help. But he adds that only 10 to 20 percent of U.S. surgeons now implant these lenses regularly, and he doubts whether the reimbursement change will cause more surgeons to use the lenses. In addition to the profitability issue, they take extra time and preparation to implant.
The change could help some ASCs if they can "make it up on volume." Dr. Kershner implants the two lenses in about a fourth of his patients, but he stresses that even with increased reimbursement, the cases will be less profitable than standard cases. However, he says, the use of the lenses may help increase surgical volume. "If we make our patients happy, they'll tell their friends and relatives about us, which helps us build a strong patient population."
If, on the other hand, the FDA approves some of the more popular monofocal lenses submitted for the new technology designation, particularly the Alcon Acrysof and the Allergan Medical Optics SI40NB and SI55NB, the ruling could be considerably more significant for ASCs, since some already use these lenses extensively. However, some industry observers believe Medicare is unlikely to approve these lenses for the new designation. All three have been on the market for quite some time, and if Medicare did decide to grant an extra $50 reimbursement, the cost could be up to $50 million more annually.
Five manufacturers submitted six lenses for the new technology designation in response to the June 16 ruling; the list was published in the Dec. 20 Federal Register. After a 30-day comment period, HCFA and the FDA have 90 days to decide which lenses make the final cut. Expect the extra $50 to kick in around May.
Here, in alphabetical order, are the IOLs that are being considered for the new technology designation:
Alcon Acrysof
This IOL, which accounts for more than one third of all lenses sold today, is composed of an acrylic/methacrylic foldable material of the PMMA family. The lenses are said to be better tolerated than standard PMMA lenses, and may help prevent posterior capsular opacification. A clinical study on this IOL indicated that it had the lowest rate of posterior capsular opacification among the foldable materials, with a rate of about 5 percent after two years, compared to an opacification rate of 7.9 to 10.7 percent for PMMA IOLs.1: A 1998 study found that the acrylic IOL adheres to the posterior capsule better than the other lens materials, 2: which could explain the lower PCO rate. The Acrysof IOL may cause less inflammation after surgery, which may make it a good choice for patients with a history of inflammatory diseases.
Allergan AMO Array Multifocal IOL
The Array Multifocal IOL provides the patient with a range of vision, from near to far. It uses concentric rings of varying optical power with several zones to create a multifocal effect. Most surgeons recommend that this lens be implanted bilaterally; patients who have a monofocal lens in the other eye may find the vision difference very confusing. In a study published in Ophthalmology in 1997, almost 97 percent of the patients had best-corrected distance visual acuity of 20/30. Forty-one percent of the patients reported that they never needed glasses after the surgery, and 57 percent said they needed glasses only occasionally.
Allergan AMO SI40NB and SI55NB
Like the Array, these lenses are all composed of a second-generation silicone material called AMO PhacoFlex II. The company believes the material may help reduce incidences of posterior capsule opacification and Nd:YAG capsulotomy. According to the maker, this material also boasts the highest refractive index of all silicone IOLs. It also features a near-constant center thickness design for consistent handling characteristics regardless of diopter.
Ciba Memory Lens
This pre-folded lens, composed of a hybrid of hydrogel and acrylic material, offers a couple of benefits. It may help reduce posterior capsular opacification - in a four year retrospective study, posterior capsular opacification was shown to be less frequent in the Memory Lens compared to PMMA IOLs - 22.2 percent vs. 38.9 percent. Also, it unfolds very slowly, possibly reducing the risk of capsular rupture, which is one of the most common and significant cataract complications.
Pharmacia & Upjohn CeeOn IOL
In patients with uveitis or diabetes, implantation of an IOL can trigger a foreign body reaction, which can lead to significant inflammation. According to the maker, CeeOn lenses have a special biocompatible surface - termed "heparin surface modification" - that works in three ways to prevent foreign body reaction:
-- a constant molecular surface motion prevents proteins, bacteria, and white blood cells from adhering to the lens surface;
-- a negative charge of the heparin surface repels bacteria and white blood cells; and
-- a hydrophilic surface, which resembles the body's tissues, helps minimize cell adhesion. Staar Toric IOL
Staar Surgical's Toric IOL is designed to replace the opacified lens and correct astigmatism, which affects about 20 percent of all cataract patients. The lens incorporates a specialized optic, the same kind that is used to correct astigmatism in glasses and contact lenses, into a standard IOL. The company says that in clinical studies of more than 300 cataract patients with pre-existing astigmatism, 47 percent had visual acuity of 20/30 or better following implantation with the Staar Toric, allowing them to function most of the time without visual correction.
1. Olson RJ, Crandall AS. Silicone vs. Polymethylmethacrylate intraocular lenses with regard to capsular opacification. Ophthalmic Surg Lasers 1998:29;55.
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