At Press Time

NTIOL $50 Payment Adjustments Ending

No new lens class approved for 2011.

By Samantha Stahl, Assistant Editor

■ Bonus payments for ASCs using New Technology IOLs (NTIOLs) are about to end — at least for a while.

As of Feb. 26, 2011, the current $50 extra payment under CPT code Q1003, awarded to ASCs for using a spherical aberration-reducing NTIOL, will expire. This class of NTIOLs has been active since Feb. 27, 2006, when AMO obtained approval for its Tecnis foldable IOL.

A new class now cannot be implemented until 2012. This is after Alcon was denied NTIOL status earlier this year when it presented the company's Acrysof Natural IOL for blue-light filtering to reduce glare. CMS concluded that the lens did not “demonstrate substantial clinical benefit in comparison with currently available IOLs.” The deadline for submitting applications for a new class of NTIOLs for 2012 implementation is March 5, 2011.

What does the expiration of the NTIOL bonus mean for IOL manufacturers? Giulia Newton, head of global cataract marketing for AMO, remains positive about future NTIOL opportunities for the industry.

“The NTIOL reduced spherical aberration category has done exactly what the program intended,” she says. “It was put in place to encourage industry to develop superior technology that provides patients with superior outcomes. In that regard, the NTIOL program continues to be a positive initiative for patients, surgeons and industry.”

Lenstec vice president Jim Simms says “the IOL industry is starting to feel the impending ‘doom’ of losing another NTIOL category.” He predicts that while the cut will reduce opportunities for some companies, it will create new ones for the prepared.

Satish Modi, MD, of Poughkeepsie, NY, says he hopes that the elimination of the payment adjustment will encourage manufacturers to create an accommodative implant that “allows patients to function more naturally” without requiring a larger incision.

While Dr. Modi also hopes that the elimination of the payment adjustment will motivate lens companies to be more flexible in their pricing, cost won't stop him from using top-of-the-line IOLs. “Patient safety and outcomes are the reason why we do this. Aspheric lenses are infinitely superior, so it's inconceivable to me that I wouldn't use them merely because of their cost.”

The complete list of NTIOL lenses affected is available on the CMS Web site at www.cms.gov/ASCPayment/08_NTIOLs.asp.

Ophthalmologists Break Even in Elections

Two win and two lose; Dr. Rand Paul claims Senate seat.

By René Luthe, Senior Associate Editor

■ Four ophthalmologists ran for national office in the much-ballyhooed 2010 mid-term elections, with two winning their races. While they all shared the goal of repealing “Obamacare,” the pitch apparently did not resonate with all voters. Here's the score card:

► Rand Paul, MD. Probably the best-known ophthalmologist running for office, Tea Party candidate Dr. Paul scored an early win election night for a Kentucky U.S. senate seat. The eye doctor from Bowling Green claimed victory shortly after 8 pm, telling his supporters: “Tonight, there's a Tea Party tidal wave and we're sending a message to lawmakers in Washington. It's a message on fiscal sanity, it's a message on limited constitutional government and balanced budgets.” Dr. Paul also advocates repealing the healthcare reform law shepherded through Congress by the Obama administration earlier this year.

The Senate race was a decisive victory for Dr. Paul, who won 56% of the vote to Democratic rival Jack Conway's 44%.

► Nan Hayworth, MD. Another favorite of the Tea Party movement, Nan Hayworth, MD, won a seat in the US House of Representatives in New York's 19th district (north of New York City, in the lower Hudson Valley). The retired ophthalmologist defeated former rock musician John Hall, receiving about 53% of the vote.

According to her campaign's Web site, “Nan Hayworth spent most of her career restoring vision. Now she'd like to do the same in Congress as the Representative for New York's 19th Congressional District.” Like Dr. Paul, Dr. Hayworth ran on a platform of repealing the new healthcare reform law, as well as reducing both the size of government and federal spending.

► Mariannette Miller-Meeks, MD. One of the two ophthalmologists who did not win her race for the House, Dr. Miller-Meeks ran in Iowa's 2nd district. Her platform was one of reforming the healthcare reform law, claiming that consumer choice is the most significant factor in driving down costs, and simplifying the federal tax code. It was the second time she had faced off against Democratic incumbent Dave Loebsack and lost. Dr. Miller-Meeks had served in the US army and is in private practice in Ottumwa.

► Donna Campbell, MD. Characterizing herself as “an emergency-room physician, a mom with four adopted daughters, and the wife of a small-business owner,” Dr. Campbell ran in Texas' 25th Congressional district. The first-time candidate managed to win 45% of the vote to Democratic incumbent Lloyd Doggett's 53%. Her platform of federal deficit reduction, extension of the Bush tax cuts and repealing the health care reform legislation won her every county in the district but the one with the largest population — Travis County, which includes strongly Democratic Austin.

Getting Back in the Groove

Dr. Holladay in new role after life-changing surgery.

By René Luthe, Senior Associate Editor

■ After experiencing an aortic aneurysm eight months ago, being frozen for the necessary surgery and suffering a stroke during the procedure, Jack T. Holladay MD, MSEE, has lately been re-emerging in the ophthalmic community where he has played such a large part in for the last 35 years.

How large? As an FYI for new ophthalmologists, the Texas cataract and refractive surgeon invented the Brightness Acuity Tester, an instrument that is used all over the world for testing the effects of glare on patients' vision. He also developed the “Holladay IOL Consultant” and “Refractive Surgery Consultant” software programs, to help surgeons optimize patients' vision following cataract and refractive surgery.

He is a prolific author and award winner. His honors include the 1992 Binkhorst medal in ophthalmology and the Ridley Award from the European Society of Cataract and Refractive Surgery; in 2006, he received the Lifetime Achievement and Barraquer Medal from the International Society of Refractive Surgery and in 2007 received the Lifetime Achievement Award from the American Academy of Ophthalmology. He is also a clinical professor at Houston's Baylor College of Medicine.

He tells Ophthalmology Management that his role won't be quite the same as it was, following his surgery last February. Impairments Dr. Holladay experienced as a result of the procedure, in which his blood and body temperature were lowered to approximately two degrees C and no blood flowed to his brain for 17.5 minutes, required that he retire from surgery. However, Dr. Holladay knows that he is very lucky to be alive.

He lost hearing in his right ear. “When somebody yells to me, it always sounds like they're yelling from the left, so I always look to my left, and there's nobody there,” he laughs. What he notices most is that his sense of balance is now impaired, as well as his decreased stamina.

While these losses are part of the reason Dr. Holladay has had to retire from surgery, he says the main reason is the need to keep his blood pressure from spiking. “We have to be careful not to let my blood pressure go over 140 or so, ever, because if it ruptures that outer wall of the aorta, well, then it's ‘Adios, amigo.’”

He is easing back into the ophthalmic world, but has been advised to move slowly.

“My doctor said that it usually takes people about a year before they say that they feel they are back to normal. The operation took place on February 18, so I've got another four or five months. I think you just forget what 100% was by that time!”

In the meantime, Dr. Holladay has found ways to keep his hand in ophthalmology. He has resumed working with manufacturers on devices such as lasers and diagnostic equipment. Ophthalmology meetings are back on his agenda, although he says he has to be selective. Attendance at an Australian ophthalmic meeting was vetoed by his doctor because it would have involved 18 hours on a jet.

The first major meeting that Dr. Holladay was able to attend this year was ESCRS, in September. There, on a professional level at least, he was back in his old routine. “I gave presentations, went to board meetings,” he says. “I tired pretty easily, but it was a very productive meeting.”

The support he received there from colleagues was a big morale booster. “People were very supportive and glad to see me. I was equally glad to see them!”

Research Digest

New & Noteworthy Journal Articles

Compiled by Andrew E. Mathis, PhD, Medical Editor

► Vitamins don't prevent cataract. The lead-off article in the November 2010 issue of Archives of Ophthalmology contains bad news for people looking to prevent age-related cataract by taking vitamin supplements. The authors of the study report on results from over 11,500 male physician-patients at eight-year follow-up. The participants in the study were enrolled in the Physicians' Health Study II, a clinical trial being carried out at Harvard University primarily for the purpose of studying vitamin supplementation of cardiovascular disease and cancer.

The participants, none of whom had a diagnosis of cataract at baseline, were randomized into four groups: 400 IU vitamin E and 500 mg vitamin C; vitamin E plus placebo; vitamin C plus placebo; or double placebo.

After eight years, 579 patients actually receiving vitamin E developed cataracts, as did 593 patients in the active vitamin C group. The placebo group for vitamin C had 581 cases of cataract vs. 595 cases in the vitamin E placebo group. Nuclear cataract was the most common type of cataract in all study arms, followed by cortical cataract and posterior subcapsular cataracts.

The authors conclude that there is no evidence that long-term use of either vitamin had a beneficial effect on the development of cataract. This goes counter to previous reports, which indicated that the combination had some positive effect. As these are the longest-term data yet available, this study may change common thinking about the ocular effects of vitamins on the lens.

► Conjunctival changes. A team of Chinese ophthalmologists seek to determine how the conjunctiva changes at the cellular level in the November 2010 issue of the British Journal of Ophthalmology. Dividing 80 healthy subjects into four age-based groups, the authors conducted in vivo laser scanning confocal microscopy on bulbar conjunctivas, analyzing the number and morphology of goblet cells and dendritic cells and measuring the positive rate of conjunctival microcysts and the diameter of subepithelial fibers.

While no age-related differences were observed in epithelial cells or goblet cells, there was a clearly age-dependent, increasing trend in rate of conjunctival microcysts, with the percentage in the highest age group (over 60 years old) measured at 75%. Conversely, density of dendritic cells decreased relative to age, as did the diameter of subepithelial fibers. The findings on subepithelial fibers were particularly important since, given the lack of statistically significant changes in goblet cells, the findings on the fibers indicated an age-related decline in goblet-cell function.

The study adds to earlier findings on age-related changes in the cornea and limbus as measured by laser scanning confocal microscope. With time, better prediction of ocular surface disease should emerge.

► Comparing glaucoma surgeries. A pair of eye doctors in Singapore have undertaken a meta-analysis of clinical trials of glaucoma treatments to compare the safety and efficacy of trabeculectomy and viscocanaloplasty in uncontrolled glaucoma. Reporting their findings in the October/November 2010 issue of the Journal of Glaucoma, the authors found trabeculectomy was more effective in lowering IOP, but viscocanalostomy had a lower adverse event profile.

The authors analyzed 10 clinical trials that had examined a total of 458 eyes in 397 patients. There was no statistically significant difference in mean preoperative IOP between patients who had undergone viscocanaloplasty vs. patients had undergone trabeculectomy. However, at six and 12 months, mean IOP was lower among trabeculectomy patients, and the differences had a very high level of statistical significance (P<.00001).

Also, while viscocanaloplasty had a significantly higher rate of intraoperative perforation of Descemet's membrane, in all other adverse events measured, including hypotony, hyphema, shallow anterior chamber and cataract, viscocanaloplasty had a lower rate of incidence than trabeculectomy. Finally, trabeculectomy required, on average, fewer postop IOP-lowering medications.

The results led the authors to recommend that surgeons choose a procedure based on individual patient profiles. Both are effective at lowering IOP, so in patients particularly at risk for adverse events, viscocanaloplasty may be a better choice.

► Cataract issue. The Royal Australian and New Zealand College of Ophthalmologists has dedicated the November 2010 issue of Clinical and Experimental Ophthalmology to cataract treatments and surgeries. There are a total of 20 papers on cataract in the issue, and article topics include: spheric vs. toric IOLs in treating corneal astigmatism; a comparison of aspheric, aberration-free and spheric IOLs; and several demographic studies. There is also an editorial on gonioscopy in the issue, as well as the regular array of other ophthalmic topics.

► A dog's life. An article published online October 15 by Molecular Vision has established a link between advanced glaucoma and changes in over 500 genes in the retina — of dogs. However, the study does contribute to a growing body of evidence that glaucoma inflicts a neuroinflammatory response in the retina, and that goes for human beings as well. The upshot is that, down the road, genetic treatments for glaucoma may be developed that can lower IOP without invasive procedures or side effect-laden medications. OM