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CMS adds lens to New Technology IOL category

The AcrySof IQ joins the AMO Tecnis models in the IOL category that receives extra reimbursement for reducing spherical aberration.

Issue: June 15, 2006

ByErin L. Boyle

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Alcon’s AcrySof IQ recently joined the Advanced Medical Optics Tecnis IOL models in the “reduced spherical aberration” category of New Technology IOLs.

Lenses with the NTIOL designation, which is conferred by the Centers for Medicare and Medicaid Services, receive an additional $50 when implanted in an ambulatory surgery center.

AMO’s three Tecnis models — two silicone and one acrylic — were the first to receive the NTIOL designation, in January. Alcon’s acrylic AcrySof IQ lens received the designation in May.

Both companies’ lenses are in a class of IOLs newly created this year, called the Reduced Spherical Aberration category. Both are aspheric IOLs designed to improve pseudophakic patients’ vision by compensating for spherical aberration.

How it happens

The CMS annually reviews companies’ requests for IOLs to be considered for NTIOL status. If that status is granted to an IOL, an additional $50 payment is made when a Medicare beneficiary is implanted with that lens in an ambulatory surgery center.

The status is valid for 5 years, beginning when the CMS recognizes a particular class of IOL that shows “specific clinical advantages and superiority over existing IOLs,” according to information on the CMS Web site.

The NTIOL process was begun in 1999 with the creation of two “classes” — multifocal corrective IOLs and toric IOLs for astigmatism correction. Those classes were created in 2000 and expired in 2005. The additional payments for those categories stopped in May 2005.

In that same year, the CMS received a request for NTIOL status from AMO for the Tecnis models Z9000, Z9001 and ZA9003. According to the CMS, AMO provided data demonstrating that “there is clear evidence of improved functional vision and contrast acuity” with the Tecnis IOL.

The CMS approved that request, creating the new class of NTIOLs, Reduced Spherical Aberration, which began in January. This class will expire in February 2011.

In May, the AcrySof IQ IOL also received the NTIOL status, after Alcon provided data showing that its lens had the “same or greater clinical benefit as the lens that established the NTIOL subset,” according to an Alcon press release.

AcrySof IQ

Richard Braunstein, MD, who uses the AcrySof IQ, said in a telephone interview with Ocular Surgery News that the NTIOL status shows several factors that are important in the lens’ effectiveness.

“From the standpoint of the CMS, it’s recognition that the lens is different from a conventional lens implant, so that we are employing a higher level of technology and possibly an additional level of care to the patients,” he said. “It’s justified based on the fact that the lens is doing more than simply correcting the refractive power.”

The AcrySof IQ is an aspheric IOL designed to reduce spherical aberration after cataract surgery and as a result to improve patients’ vision and their night driving abilities, Dr. Braunstein said. The lens incorporates the blue-light filtering properties of the AcrySof Natural IOL, he said.

Dr. Braunstein said he has implanted about 400 of the lenses in the last year. He said the aspheric design should provide patients with better contrast sensitivity and improved visual function postoperatively. He said he has not had to remove any lenses because of abnormal visual phenomena.

Research data support his clinical experience, Dr. Braunstein said, showing a reduction in higher-order aberrations in patients implanted with the lens.

“I use the lens because it offers advantages in quality of vision for patients undergoing cataract surgery,” he said.

Dr. Braunstein said he performed a study comparing wavefront measurement in the AcrySof IQ and the AcrySof Natural. He said the study found a significant difference in higher-order aberrations between the two lens models. The average total higher-order aberrations in eyes implanted with the AcrySof Natural was 0.75 µm, and in the AcrySof IQ 0.32 µm, he said.

“I think we are offering patients an improved benefit with this lens with cataract surgery, compared to any traditional lenses,” Dr. Braunstein said. “I would compare that advantage to doing wavefront-modified laser vision correction vs. conventional laser correction. It’s an incremental improvement in the quality of vision that we’re trying to deliver to our patients.”

Tecnis IOL

K. Ray Shrum, MD, who implants AMO’s Tecnis IOL, said in a telephone interview with Ocular Surgery News that the NTIOL designation confirms the effectiveness of lenses that receive it.

“The NTIOL status indicates an IOL that is significantly better than older lenses in improving the vision of pseudophakic patients,” Dr. Shrum said. “Because it significantly improves patient’s vision, Medicare is willing to reimburse the surgery centers more money to pay for the lenses.”

The Tecnis Z9000 and Z9001 are silicone-optic lenses with clear haptics and a double-square-edge design. The Tecnis Acrylic ZA9003 has an acrylic optic with blue PMMA haptics and AMO’s patented OptiEdge design — the rounded anterior edge, sloping side and squared posterior edge. It is designed to provide 360· barrier protection from posterior capsular opacification while minimizing the edge glare that can be experienced with a double-square-edge lens.

According to Dr. Shrum, the lens provides good visual acuity at distance and near and improved contrast sensitivity during both night and day. He said he has implanted the lens in more than 400 patients over the course of more than a year.

Dr. Shrum said he has used both the silicone and acrylic Tecnis lens models, but he now uses the acrylic exclusively. He said that, while both lenses are excellent choices, the acrylic may be the better choice in a patient at risk for retinal problems. If a patient has to undergo retinal surgery, retinal surgeons typically prefer the acrylic lens, he said.

For more information:

• Richard Braunstein, MD, is the Miranda Wong Tang associate professor of clinical ophthalmology and chief of the division of anterior segment at Columbia University Medical Center. He can be reached at 635 West 165th St., New York, NY 10032; 212-305-3339; e-mail: reb10@columbia.edu. Dr. Braunstein is a member of the Alcon Speakers Bureau.
• K. Ray Shrum, MD, can be reached at 901 East Houston St. #B, Cleveland, TX 77327; e-mail: rlzs4@yahoo.com. Dr. Shrum has no financial interest in the products mentioned in this article, nor is he a paid consultant for any companies mentioned.

• Advanced Medical Optics, maker of the Tecnis IOLs, can be reached at 1700 E. St. Andrew Place, Santa Ana, CA 92799; 714-247-8200; fax: 866-872-5635; Web site: www.amo-inc.com. Alcon, maker of the AcrySof IQ lens, can be reached at 6201 South Freeway, Fort Worth, TX 76134; 817-293-0450; fax: 817-568-6142; Web site: www.alconlabs.com.

• Erin L. Boyle is an OSN Staff Writer who covers all aspects of ophthalmology.