NEWS REVIEW

VSP and Cole Are the Latest Among Vision Plan/Laser Center Partnerships
NCQA Delays O.D. Credentials
Two Groups Raise the Standards For Refractive Surgery Procedures
In The News: FDA Reviews Drugs
Two Studies Say Whites at Higher Risk for AMD
AOA Names O.D., Young O.D. of the Year
How O.D.s Put Computers to Work in Their Practices -- Alison B. Lazarus, Associate Editor
Study of Extended-Wear Risks: Something New or Déja Vu?
Does the DMV Need a Check-up When it Comes to Driving Standards?
FDA Panel Gives Summit and Visx the Nod for LASIK, Nixes Sunrise's LTK

Medicare Q&A: Billing Rules Aren't Clear on Scarred Cornea

VSP and Cole Are the Latest Among Vision Plan/Laser Center Partnerships
Laser vision correction is perhaps the fastest growing segment of the eye-care market today, and vision plans and HMOs are starting to move into turf that was once the domain of private-pay patients.

It started this spring when TLC The Laser Center and Kaiser Permanente, the nation's largest HMO, formed a joint venture to set up laser facilities in California. Now, Vision Service Plan and Cole National Corporation are going one step further in their partnerships with laser centers. Together, VSP and Cole Managed Vision claim more than 78 covered lives in the United States.

Cole has already signed a deal to have LCA-Vision Inc. set up a nationwide network of LASIK providers, including LCA's 22 U.S. centers. Cole Managed Vision will market discounts on LASIK to its subscribers, who may pick up the coverage as an option. The discounts will begin January 1, 2000. Cole says its plan has some 50 million people enrolled.

LCA Chairman and CEO Stephen N. Joffe explains what's in it for his company: "The discount offered is more than compensated for by the costs we currently incur in marketing and advertising."

All optometrists in all 2,800 Cole outlets—they include Pearl Vision, Sears Optical, Target Optical and B.J.'s Optical—may comanage refractive surgery patients at the level they choose. "This relationship is going to incorporate all O.D.s in all Cole stores to be actively involved and encouraged to participate in the comanagement of these patients," Mr. Joffe says. LCA will educate and credential panel O.D.s, and provide outcomes analysis.

VSP and TLC, meanwhile, are still in the discussion phase. The two companies signed a letter of intent to form what they're calling a "partnership." They'll develop an exclusive, national education program designed to educate VSP's 28 million members on laser vision correction. The program will include materials such as publications and videos, as well as seminars and marketing to employee benefits coordinators.

VSP has 18,000 optometrists and ophthalmologists participating in its plans. Cole Managed Vision counts 2,200 ophthalmologists and optometrists. TLC has 50 laser centers and 17 secondary care centers in North America.

For a complete listing of LCA and TLC centers, see Laser Vision Centers in North America .

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NCQA Delays O.D. Credentials
Are you waiting to be recognized by health plans? Well, hang in there another year, says the National Committee for Quality Assurance (NCQA). The Committee, which accredits managed care organizations, has decided not to require credentialing of optometrists in the accreditation standards for managed care plans for the year 2000.

"It's not a value judgement" against O.D.s, says Brian Schilling, NCQA spokesman. Other non-physician practitioners (save behavioral health providers) were also not included in the final draft. The draft submitted for public review, however, raised hopes because it did include language that mentioned optometrists.

"We had been thinking about requiring credentialing of optometrists, and may still do so in the future. But given some of the other changes to the program, we decided it was too much to ask of the MCOs all at once," Mr. Schilling explains.

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Two Groups Raise the Standards
For Refractive Surgery Procedures
With the mushrooming growth of refractive surgery procedures, two recent groups have organized to raise the standards. One is establishing credentials, the other is a watchdog and support group.

The nonprofit Council for Refractive Surgery Quality Assurance (CRSQA) aims to measure the success of U.S. refractive surgeons and educate the public. Qualified surgeons will be certified by CRSQA. The group will base certification largely on patient outcomes, such as:

     • 90 percent of patients must achieve 20/40 or better uncorrected visual acuity.
     • 50 percent must achieve 20/20 or better.
     • Less than than 3 percent may experience debilitating complications.
     • Less than than 1 percent may experience vision-threatening post-op complications.

CRSQA members include ophthalmologists, optometrists, members of industry, allied health-care professionals, refractive surgery patients and consumer advocates. For more information, visit www. usaeyes.org.

Also Surgical Eyes, a nonprofit, grassroots group was formed and run by patients who've had bad refractive surgery outcomes.

Its main forum is a web site, www.surgicaleyes.com , that provides a platform to share testimonials and information. The web site aims to inform about the misrepresentation of the degree of risk in refractive surgery.

Although some of the testimonials are gruesome and heartbreaking, the organization maintains that it is not against refractive surgery.

It is however "opposed to refractive surgery not done with patients' best interests in mind—before, during and after the procedure."

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In The News: FDA Reviews Drugs
CIBA Vision received FDA approval for its new anti-allergy eye drop. The drug, ketotifen fumarate 0.025 percent (Zaditor), is indicated every 8-12 hours "for the temporary prevention of itching due to allergic conjunctivitis," a company press release says.

In other pharmaceutical news, the FDA's Ophthalmic Drugs Advisory Committee  voted against recommending approval for Allergan's new drug Restasis, the much anticipated cyclosporin treatment for chronic dry eye disease. "There was discomfort in the fact that the sponsor's three studies were not reproducible and they did not show the same findings. They were not able to show an adequate level of efficacy," says Wiley Chambers, M.D., deputy director of the FDA's division of anti-inflammatory analgesic ophthalmic drug products. The FDA can accept or reject the committee's decision, although it generally follows such recommendations.

"We will work very closely with the FDA to address the issues raised during [the] advisory committee meeting," Les Kaplan, vice president of research and development at the Irvine, Calif.-based company, says in a statement.

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Two Studies Say Whites at Higher Risk for AMD
Two separate studies have added to earlier findings that age-related macular degeneration (AMD) is more prevalent in whites.

The first study, part of the Baltimore Eye Survey, examined 5,308 black and white subjects over age 40. The presence of drusen, sometimes an early sign of AMD, was similar in both blacks and whites. But larger drusen and pigmentary anomalies were more common among older whites. The prevalence of AMD was 2.1 percent among whites over 70; no cases of AMD were detected among black subjects.

To explain the racial differences, the authors conclude, "whites are genetically predisposed to more severe maculopathy than blacks." (Ophthalmology 1999;106:1049-1055)

The second study, from a sample of the National Health and Nutrition Examination Survey, investigated the risk factors for age-related maculopathy (ARM) among 8,270 whites, blacks and Hispanics over age 40.

ARM was defined largely by the presence of soft drusen. The frequencies of soft drusen appeared similar among the racial/ethnic groups. However, pigmentary abnormalities and signs of late ARM were more prevalent in whites than in blacks and Hispanics.

The authors note that few personal, medical and environmental factors studied were consistently associated with ARM in the three groups. (Ophthalmology 1999;106: 1056-1065)

In other AMD research, researchers at the University of Texas Southwestern Medical Center have identified a chemical whose accumulation is a key feature of macular-degenerative diseases. The researchers bred mice that lacked the gene for rim protein, and found that these mice had delayed dark adaptation and excess deposition of lipofuscin in retinal pigment epithelium. "Retinal degeneration may result from 'poisoning' of the RPE due to [lipofuscin] accumulation, with secondary photoreceptor degeneration due to loss of the RPE support role," the authors write.
In the short term, patients could at least slow the disease by minimizing exposure to light, such as by wearing sunglasses or spending less time in light, the lead author explained to Reuters Health.

In the long term, further research can look for therapeutic intervention to limit lipofuscin deposition to treat the existing disease. (Cell 1999;98: 13-23)

Meanwhile, the National Eye Institute is sponsoring a study that is now recruiting subjects. The Complications of Age-related Macular Degeneration Prevention Trial (CAPT) will determine if low intensity laser treatment prevents disease progression in people at risk for severe AMD.

For more information, go to www.med.upenn.edu/ophth/research/CAPT.html.

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AOA Names O.D., Young O.D. of the Year
During ceremonies at the AOA Congress in San Antonio, Richard L. Windsor, O.D., of Hartford City, Ind., was named 1999 Optometrist of the Year. The AOA cited Dr. Windsor's service to the profession and to the visual welfare of the public. The association also named Amy R. Lay, O.D., of Westerville, Ohio, as the 1999 Young Optometrist of the Year.

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How O.D.s Put Computers to Work in Their Practices
by Alison B. Lazarus, Associate Editor

Computers have worked their way into homes and businesses with force, and optometric practices are no exception. According our latest National Panel, Doctors of Optometry survey, computers are an integral part of running a practice. Some 23 percent of our 1,000 panelists responded to this month's survey.

Nearly nine out of 10 respondents (88 percent) say they have a computer in their office, and give 3.4 years as the average age of the machine. This high number of computer-owners will probably change little in the future, as it has only increased 1 percent over the past three years. An overwhelming majority of doctors, 91 percent, favor PC-based systems, while only 6 percent own Macintosh computers. And of those with PCs, most (80 percent) have a Windows operating system, while 31 percent have PCs that use DOS.

Like other consumers, optometrists are swept up in the Internet. Seventy-seven percent report they have Internet access—almost every panelist with a computer. They use the Internet for practice building, communications and business transactions.

More than half of our panelists (55 percent) say they use the Internet for filing insurance claims, and 32 percent use it to place lab orders. This number may grow in coming years as many optical labs implement programs and systems with incentives to place orders online. Forty-seven percent of the doctors use it to access personal web sites, but only 13 percent have their own practice web page. They also use the Internet to order supplies and materials (21 percent) and continuing education (20 percent).

Eighty percent of O.D.s use their computers for recall, down from 87 percent in 1996. Billing (79 percent), accounting (75 percent), reports (68 percent), internal marketing (52 percent) and scheduling (42 percent) are other functions for which O.D.s put their computers to work. Among those with two or more computers, 60 percent have them linked in a local area network. (For more on computer networks, see "How to Get Your PCs to Talk to Each Other." )

Computers also aid in communication, both with staff and with patients. One optometrist in Billings, Mont., e-mailed a patient in Africa to stay informed of his LASIK follow-up. He arranged appointments with this patient through e-mail as well on her next trip back.

Though they're keeping apace technology in some areas, in large part optometrists have yet to link their diagnostic capabilities. Very few doctors have systems that integrate diagnostic devices into the local area network. Only 6 percent have an automated perimeter connected, and fewer—4 percent—have an integrated topographer.

Only 11 percent of panelists have computers in their exam rooms. The same percentage store diagnostic images in the computer. An O.D. in Oceanside, Calif., says he has a computer in the exam room to show visual fields to the patient.

Since so few doctors have computers in the exam lanes, as a group optometrists are not incorporating computers into a diagnostic role. They are hooked on e-mail and play around with e-commerce, but 10 percent don't know if their computers are Y2K compliant. Better figure that out soon.

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Study of Extended-Wear Risks: Something New or Déja Vu?
While contact lens manufacturers promote their new generation of extended-wear materials, another study warns against this modality.

In the July 17 issue of The Lancet (354:181-85), a group of Dutch researchers report that wearing soft contact lenses for more than 24 hours significantly increases a patient's chances of developing microbial keratitis.

Dr. Kam Cheng and colleagues conducted telephone surveys from 1994 to 1997 to find out how many people in the Netherlands wore both rigid and soft contact lenses, and for how long. They also surveyed all ophthalmologists in the Netherlands to find out how many cases of microbial keratitis they diagnosed between April and June 1996.

The researchers estimated the annual incidence of microbial keratitis to be 1.1 per 10,000 among daily-wear RGP wearers and 3.5 per 10,000 daily-wear soft lens wearers. The incidence rises dramatically—to 20.0 per 10,000—among people who wear soft contact lenses for more than 24 hours at a time.

While newer silicone-hydrogel materials improve oxygen transmissibility, these and other researchers say that a variety of other factors may also contribute to the development of microbial keratitis. In a commentary in the same issue of The Lancet (174-5), Dr. John Dart, of London, warns that the lifting of restrictions on the use of extended-wear contact lenses (now approved for 30 days in Europe) because of improvements in materials may be premature.

These findings are similar to those a decade earlier in the United States. In 1989  researchers reported in the New England Journal of Medicine (321(12):779-83) that the incidence of ulcerative keratitis jumped from 4.1 per 10,000 daily-wear soft contact lens wearers to 20.9 per 10,000 extended-wear soft contact lens wearers. In response to that study, extended-wear lens manufacturers voluntarily reduced the extended wear times from 30 days to seven days, and included information about the risks in the product labeling.

Contact lens manufacturers, the American Academy of Optometry and other O.D.s point out that the Dutch study does not include newer extended-wear materials such as those used in Bausch & Lomb's PureVision and Ciba Vision's Focus Night & Day lenses.

PureVision, which is approved for up to six days of continuous wear in the United States and 30 days in Europe, Bausch & Lomb says combines silicone and hydrogel for improved oxygen transmissibility, and the lens is designed to provide for optimal fluid transport, water retention and lens movement on the eye. It also says its Performa surface process transforms hydrophobic silicone on the lens into a hydrophilic surface for consistent wettability.

Ciba Vision's Focus Night & Day lenses are available in 11 countries and are in FDA clinical trials in the United States. The lotrafilcon-A lenses, Ciba says, have a high oxygen transmissibility level—175 Dk/t—and patients can wear them for up to 30 nights extended wear.

Phoenix, Md., optometrist Barry Weiner, immediate past chair of the AOA's Cornea and Contact Lens Section, points out some additional problems with the study: It didn't ask about care regimens or compliance, materials, and whether patients wore daily wear materials on an extended-wear basis. Also, researchers asked about cases of microbial keratitis that occurred when seasonal allergies may have been a contributing factor.

In its own statement, the American Academy Optometry says, "Although infection can be severe and be sight threatening, such complications occur in only a small percentage of cases. Proper lens care and routine professional care probably decrease the risk of infection or complication. In the event of infection, it has been shown that prompt and appropriate treatment is effective in decreasing the risk of long-term complication such as loss of visual acuity in the vast majority of cases."

St. Cloud, Minn., optometrist Burt Dubow agrees. None of his patients have asked him about the study The Lancet. "Those of us in serious contact lens practices who recommend and prescribe extended wear know that serious complications are very rare when patients are properly selected, monitored, educated, etc.," he adds. "We are also prepared to treat any related eye disease before it become serious."

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Does the DMV Need a Check-up
When it Comes to Driving Standards?
Visual acuity might not be all that it's cracked up to be when it comes to determining who should be licensed to drive.

A recent study at the University of Alabama at Birmingham School of Medicine concludes that visual acuity is less related to driving safety than are other vision-related areas of study.

States use visual acuity screening to judge the capability of drivers and, subsequently, license them. This study suggests, however, that there is not enough evidence to prove a strong correlation between visual acuity and on-the-road safety. These tests do not identify crash-prone drivers.

Bottom Line: So much emphasis is put on visual acuity to get a license that other visual factors are overlooked. Says Cynthia Owsley, Ph.D., UAB professor of ophthalmology and one of the study coordinators: "Detail vision is not as crucial as peripheral vision, visual attention, contrast sensitivity, etc."

Many times eye doctors do not have the necessary tools to determine whether a driver, especially an older one, has the visual skills to drive a car safely. To be sure, doctors can now refer these patients to a Driving Assessment Clinic like the one Dr. Owsley runs at UAB. The clinic was founded because of a great need in the area. "Clinics of this nature are popping up all over in health-care settings," Dr. Owsley says.

The clinics use two steps to assess a patient visual ability to drive a car. Step one is a battery that includes visual screening, visual attention testing, contrast sensitivity tests, a history of medications and the driver's individual needs.

In step two, a certified driving rehab specialist accompanies the patient for a 45-minute on-the-road test in varying driving conditions and traffic situations. From these tests, the patient and/or family, and referring physician receive a written evaluation and risk assessment.

The state department of motor vehicles still determines who is licensed to drive. The clinics only make recommendations. More research needs to be done on the connection between safety and visual conditions, but the DMV may soon need to give its driving test a check-up.

Owsley C and McGwin G. Vision Impairment and Driving. Survey of Ophthalmology 1999; 43(6):535-48.

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FDA Panel Gives Summit and Visx
Nod for LASIK, Nixes Sunrise's LTK
The FDA's Ophthalmic Devices Panel endorsed Summit Technology's SVS Apex Plus excimer laser workstation and Visx's Model C Star excimer laser last month. Final approval looks good since the FDA generally follows the panel's recommendations.

The panel recommended approval of the Summit laser for treatment of myopia to 14.00D sphere, up to 5.00D of astigmatism. The Visx laser was given approval for myopia from -1.00D to -12.00D sphere, with up to 4.00D of cylinder.

The panel did attach certain conditions to its recommendations for both lasers regarding the safety of LASIK for myopia. The primary one: that doctors warn patients about less predictable outcomes in the higher approved ranges of sphere and cylinders.

The panel gave its endorsement based on results from the CRS LASIK study conducted by CRS Clinical Research Inc. The CRS LASIK study is an independent national surgeon-funded venture designed to validate the procedure and to develop and refine LASIK software.

Sunrise Technologies' Holmium laser LTK system drew a unanimous rejection from the panel because they wanted to see more comprehensive data on stability—initial results suggested regression within 2 years. The procedure involves eight tracer holmium beams directed at the 6 mm diameter of the cornea and another eight at 7 mm. Sunrise plans to eventually re-submit for approval with more detailed and greater follow-up data.

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Medicare Q&A: Billing Rules Aren't Clear on Scarred Cornea
by Jeffrey S. Eisenberg

Question:  One of my patients has a scarred left cornea with irregular astigmatism. The eye is only correctable to 20/200 with glasses, but is correctable to 20/50 with a rigid contact lens. How do I bill Medicare for the fitting, follow-up visits, contact lens materials and corneal topography?—Michael Silverman, O.D., Coral Springs, Fla.

Answer:  Medicare only pays for lenses when medically necessary for patients who have either had the eye's natural lens surgically removed, or a congenital absence of the lens. Covered diagnoses are limited to pseudophakia (V43.1), aphakia (379.31) and congenital aphakia (743.35).

Otherwise, these are non-covered services for which you may bill the patient. Have the patient sign a Medicare waiver of liability acknowledging that Medicare may not cover these services, and that he or she will then be responsible for payment.

Allentown, Pa., optometrist Joe Gackenbach, liaison to his state's Medicare carrier, suggests you also submit a claim to your Durable Medical Equipment Regional Carrier (DMERC). Once the DMERC rejects the claim as non-covered, then bill the patient.

With this patient, however, the contact lens is a non-covered routine service. "Since the routine charges are always non-covered services, a claim would not have to be filed to DMERC," says Heather Loveland, consultant to the Tennessee Optometric Association. "If the patient has a secondary policy that may cover the charge, or if the patient insists you file a claim, then send a claim to DMERC. Make sure you use the appropriate modifier on the charge to indicate you have the patient waiver of liability on file."

Since you're seeing this patient for a medical eye problem, you may bill Medicare for the office visit(s). Use either a 92000 exam code or 99000 evaluation and management code, and a diagnosis of corneal scarring (refer to your ICD-9-CM book for the most specific diagnosis within the 371.xx series). The procedure code you choose depends on your level of documentation. Check your carrier's specific documentation guidelines.

You may bill corneal topography as a separate procedure if the patient's condition is on your carrier's list of acceptable diagnoses. Use code 92499 (unlisted ophthalmologic service or procedure) and specify that you performed corneal topography.

Send questions to Review of Optometry, 201 King of Prussia Road, Radnor, PA 19089; or e-mail them to reviewofoptometry@jobson.com.

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