The Future is Now for Multifocals
CMS decision expands their market into Medicare procedures.
BY JERRY HELZNER, SENIOR EDITOR

In late March, two next-generation multifocal intraocular lenses (IOLs) were approved for use in the United States — the AcrySof ReSTOR apodized diffractive IOL (Alcon, Fort Worth, Texas) and the ReZoom (Advanced Medical Optics, AMO, Santa Ana, Calif.). Both of these lenses are designed to provide near, intermediate and distance vision following cataract removal or in a refractive lens exchange (RLE) procedure.

Both the ReSTOR and the ReZoom cost just under $900 per lens, meaning that at the time of their approval it was not financially feasible to use them in Medicare patients. If the approximately 80% of cataract patients covered by Medicare were to have access to these new presbyopia-correcting lenses, a rule prohibiting patients to share in the cost of the procedure would have to be set aside.

As April and early May passed, the winds of change were already blowing.

The ophthalmology community, spearheaded by the IOL manufacturers and supported by surgeons and the major ophthalmology-related organizations — the American Academy of Ophthalmology (AAO), the American Society of Cataract and Refractive Surgery (ASCRS), and the Outpatient Ophthalmic Surgery Society (OOSS) — was pressing its case for a change in the Medicare reimbursement rule.

IOL developer eyeonics had won approval in late 2003 for its crystalens, the first accommodative IOL to enter the US marketplace. Having received approval for the first of the next-generation, presbyopia-correcting IOLs, eyeonics sought a way to make the crystalens available as an option for Medicare patients. The company took the initiative in asking the Centers for Medicare and Medicaid Services (CMS) to adopt so-called "patient-share" billing. Patient-share billing would permit Medicare patients undergoing cataract surgery to have the option of paying out of pocket the difference between a Medicare-covered cataract procedure (CPT 66984) and the total cost of having presbyopia-correcting lenses implanted. By the time the ReSTOR and ReZoom were approved, the ophthalmology community had fallen solidly in line behind eyeonics on the issue of patient-share billing.

As the months passed, the ophthalmology community waited for a decision from CMS. On May 10, they received their answer.

In a groundbreaking ruling, the CMS approved patient-share billing for any Medicare patient who chooses to have presbyopia-correcting IOLs implanted. Initially, the ruling encompasses the crystalens, ReSTOR and ReZoom.

For patients who choose one of these lenses, Medicare will reimburse for standard cataract surgery with monofocal lens insertion, and the patient will pay all of the additional charges. These out-of-pocket charges — covering the extra time spent in discussions with the patient, additional measurements and evaluations, and the more thorough preoperative and postoperative examinations necessary for delivering on the promise of presbyopia-correcting lenses — could be in the range of $2,000 to $3,000 an eye depending on the facility, the practice and the type of lens the patient chooses.

This article will discuss the impact of the reimbursement ruling, the evolution of the presbyopia-correcting lens category, and the performance of the next-generation of multifocal lenses.

Ruling has Immediate Impact

The ophthalmology community warmly welcomed the CMS ruling. Some of the most enthusiastic reaction came from representatives of the three IOL manufacturers whose products are now approved for use in Medicare procedures.

For these manufacturers, the future of the presbyopia-correcting IOL is now.

"This is just about the best possible ruling we could have hoped for," said Mike Judy, vice president of marketing for eyeonics. "Now, the cataract patient covered under Medicare has a choice that he or she didn't have prior to this ruling." In recently released clinical data, crystalens patients have maintained significant improvement in near, intermediate and distance vision 3 years after implantation.

"We applaud CMS for its decision to allow Medicare patients access to new technologies which provide a high level of spectacle freedom," said Cary Rayment, chairman, president and CEO of Alcon. "Physicians and patients now have the freedom to select technology to treat cataracts consistent with the patient's lifestyle needs. In trials, 80% of AcrySof ReSTOR patients reported never wearing reading glasses or bifocals following bilateral cataract surgery."

"This provides an important new opportunity for Medicare cataract patients to enjoy a full range of distance, intermediate and near vision after surgery," said Jim Mazzo, president and CEO of AMO. In a European clinical trial, more than 90% of ReZoom patients said they never or only occasionally wear eyeglasses.

The IOL manufacturers have ample reason to feel good about the CMS ruling. The availability of the next-generation IOLs under Medicare will not only benefit patients and surgeons, it will help the companies on the bottom line.

Theodore Huber, an equity analyst who follows eyecare stocks for Wachovia Securities, says that the CMS ruling opens a previously untapped segment of the marketplace. He projects that the ruling expands the domestic market for presbyopia-correcting IOLs from about $150 million annually to $400 to $500 million a year. Huber believes this could ultimately translate to 20 to 40 cents a share in additional profits for AMO and 15 to 25 cents a share in incremental earnings for Alcon, which has many more shares outstanding. Huber makes no projections for eyeonics because it is a privately held company.

Validating Innovation

For ophthalmology-related organizations such as the AAO, ASCRS and OOSS, the CMS ruling of May 10 sends a positive message that innovations in eyecare technology will continue to be encouraged by government regulators.

"Among the great advances in ophthalmology has been the ability of industry over the years to develop better and better IOLs," says William L. Rich III, M.D., director of Health Policy for the AAO. "We never want to see the stifling of incentives that drive technology. We want all patients to have access to improved and advanced lenses."

The decision to permit patient-share billing for presbyopia-correcting IOLs was, by all accounts, not an easy one for CMS. According to industry sources, it was made at the highest level after months of discussion and negotiation with IOL manufacturers, and with the strong support of Rep. Christopher Cox (R-Calif.).

A Groundbreaking Decision

Prior to May 10, CMS rules already permitted Medicare recipients to have more expensive eyeglasses and hearing aids, better wheelchairs and private hospital rooms if the patient was willing to pay the difference between what Medicare allows and the cost of the additional noncovered benefit. However, CMS broke new ground in its May 10 ruling by permitting patients to pay the difference in charges associated with an advanced, optional medical device (a presbyopia-correcting IOL) implanted during surgery.

Andy Stapars, director of government operations for AMO, has been involved in both AMO's private negotiations with CMS and with an industry-wide lobbying effort called the Industry Coalition for the Advancement of Restorative Eyecare (ICARE).

"Medicare will probably not be able to adequately pay for every advance in medical technology, especially with the shift in demographics indicating significantly increased demand from the baby boom generation coming soon," says Stapars. "Patient-share billing is a concept that will allow Medicare patients to have the option of advanced lenses without adding anything to the costs incurred by CMS. In its decision, CMS is saying that it's willing to see the free market at work here."

More generally, Stapars notes that, through the years, advances in cataract surgery and IOLs have been able to benefit patients, and society as a whole, by allowing millions of people to be more productive and independent. He says the industry can only continue to produce technological innovation if there's a sufficient market for the new and better products.

"For many people, access to improved eyecare technology can translate to a more active lifestyle and a better quality of life," says Stapars.

The New Multifocals

Two of the three presbyopia-correcting IOls that will be permitted to be used for Medicare patients under patient-share billing are the newly approved next-generation multifocals — the ReSTOR and ReZoom. These lenses are the first additions to the U.S multifocal category in 8 years. Given the long gap between multifocal approvals, the evolution of the category merits further examination.

The Array multifocal lens, approved by the Food and Drug Administration (FDA) in 1997, was until recently the only multifocal that could be implanted in the United States. A versatile lens, the Array has been used to correct a wide range of refractive error as an implant in both cataract removal and RLE procedures. AMO has indicated that, with the approval of the ReZoom, the Array will soon be phased out and withdrawn from the market.

R. Bruce Wallace III, M.D., medical director of Wallace Eye Surgery in Alexandria, La., clinical professor of ophthalmology at LSU New Orleans, and associate clinical professor of ophthalmology at Tulane University, has extensive experience in implanting multifocal lenses.

"With the Array, patients do see halos around lights," says Dr. Wallace. "But almost all Array patients learn to adjust and their satisfaction level is very high. We've never explanted an Array lens because of halos."

To fairly judge the Array, it must be viewed as a first-generation multifocal, providing patients with many advantages in terms of vision quality, depth of field and reduced dependence on eyeglasses. Because of the halos, however, the Array never achieved widespread acceptance.

The Next-Generation: ReZoom

Certain that they could improve on the Array design, both AMO and Alcon have spent years working on the next generation of multifocal lenses. In addition to the ReZoom and ReSTOR, AMO's Tecnis Multifocal, which has a modified prolate surface that has demonstrated to improve functional vision for night driving, is in use in Europe and currently in U.S. clinical trials. It could be approved sometime late next year. Other multifocal and accommodative lenses are currently being developed by several companies.

Though some industry observers have characterized the ReZoom as a "new and improved" version of the Array, Ron Bache, vice president of worldwide marketing, AMO refractive group, differs strongly with that description.

"The ReZoom is an optimized optic placed under an acrylic surface," says Bache. "The lens is a next-generation refractive multifocal that improves distance, intermediate and near vision with significantly reduced halos and glare."

Bache says that the ReZoom is a result of examining "the good points and bad points" of the Array.

"The Array is a silicone lens. The ReZoom is an acrylic lens," says Bache. "In dealing with the halos, we knew that they were primarily being caused by the near ad of the lens. We took the fourth near zone, which was causing most of the halos, and made it 57% smaller. We also made the third zone, for distance, 70% larger. The result is that, with the ReZoom, more light is going to distance, reducing halos and glare at night."

The ReZoom also has AMO's Opti-Edge design, which Bache says is another element in reducing glare. The foldable lens can be inserted through a 2.8 mm incision using the Emerald T Unfolder insertion device.

"The ReZoom was tested in Europe and then submitted to the FDA for approval," says Bache. "It is a much better lens than the Array, which we will be phasing out."

Agreeing with that assessment is Mark Tomalla, M.D., who practices in Duisburg, Germany. He has implanted the ReZoom in more than 50 eyes this year and says the lens provides excellent vision, particularly at intermediate distances.

"I am using the ReZoom in hyperopes, high myopes and presbyopes, and particularly for individuals who work primarily at intermediate distances, such as those who spend a great deal of time on computers," says Dr. Tomalla.

Ana Martinez-Palmer, M.D. of Barcelona, Spain, has implanted the ReZoom in 70 eyes.

"What I most like about the ReZoom is that in terms of visual acuity and contrast sensitivity it behaves more like a monofocal," says Dr. Martinez-Palmer. She says the ReZoom compares favorably to the Array in terms of glare, halos and other unwanted images, with significantly fewer ReZoom patients experiencing pseudophakic dysphotopsia.

The Next Generation: ReSTOR

One of the most eagerly awaited products to come out of the Alcon pipeline is the AcrySof ReSTOR lens, an acrylic, foldable multifocal IOL which uses apodized diffractive technology to provide patients with a full range of near, intermediate and distance vision (with studies showing the best visual acuity at near and distance). The FDA clinical studies indicate that 80% of the individuals in the trial did not need to wear eyeglasses at all after they received the ReSTOR lens.

Unlike accommodative IOLs such as the crystalens, the ReSTOR does not depend on contraction of the ciliary muscle to move the lens to create a range of vision. Instead, it combines the complementary technologies of apodization, diffraction and refraction in an optical design that allows appropriate amounts of light to focus on the retina for images at various distances without mechanical movement of the lens.

Apodization gradually blends the diffractive step heights, managing the light energy delivered to the retina. Alcon says this technology distributes the appropriate amount of light to near and distant focal points, regardless of the lighting situation. The apodized diffractive optics of the ReSTOR are designed to improve image quality while minimizing visual disturbances.

More simply stated, when the pupil is constricted, incoming light is equally divided between near and distance vision. When the pupil is enlarged, as in low lighting conditions, the light distribution becomes distance-dominant.

Clinical studies of the ReSTOR show that only 5% of ReSTOR recipients experience significant glare and/or halo. Alcon attributes the ReSTOR's ability to reduce glare and halo to apodization technology. However, as the possibility for severe halos and glare exists, all potential ReSTOR patients must be cautioned about this possible complication. There is no way to pre-determine which patients will experience severe glare and/or halo.

"You can implant the ResTOR through the normal-size phaco incision you would use for the AcrySof SA-60 lens (Alcon)," says Richard Mackool, M.D., a clinical investigator for the ReSTOR and senior attending surgeon at the New York Eye and Ear Infirmary. "I use the Monarch injector B cartridge to insert the lens."

Dr. Mackool says the now-proven ability of the ReSTOR lens to totally eliminate the need for eyeglasses in most patients should greatly enhance the popularity of RLE as an elective procedure of choice for individuals more than 45 years of age who do not have cataracts.

"I think the potential marketplace for RLE with the ReSTOR is enormous," asserts Dr. Mackool.

A Sigh of Relief

The ability of the ReSTOR, the ReZoom and the crystalens to greatly expand the market for RLE will be determined in the coming years. Meanwhile, the CMS decision of May 10 supporting and validating the advanced technology of the presbyopia-correcting lenses has IOL manufacturers and the entire ophthalmology community breathing a sigh of relief.

Michael Romansky, an OOSS attorney who had been involved in the negotiations with CMS, says that in recent months he became more hopeful of a positive decision.

"A couple of months ago, I wouldn't have given patient-share billing any chance to be accepted," he says. "As negotiations continued and we were able to make our case, I came to believe it could happen."