at press time
CK Is Effective in Presbyopia Study
Refractec Reports 12-Month Results.

Ophthalmic device manufacturer Refractec, Inc. has completed patient enrollment for its Phase III clinical trial of conductive keratoplasty (CK) for treating presbyopia. The company has also released encouraging 12-month results from that study, showing that 96% of the 130 patients reported being "satisfied" or "very satisfied" with their outcome.

ILLUSTRATION: JOEL & SHARON HARRIS ILLUSTRATIONONLINE.COM

In addition, 97% of the study patients could see 20/20 in the distance and read newspaper-size print. And 75% of the patients could see 20/20 and read J2 on an eye chart.

The minimally invasive CK procedure has been approved for the treatment of hyperopia since April of last year. More than 7,000 CK procedures have been performed in the United States since the procedure was initially approved.

CK is performed using a probe as thin as a human hair, which releases radiofrequency energy, shrinking the tissue to reshape the cornea. The 3-minute procedure is usually performed in-office with topical anesthesia.

In reporting the 12-month results, Refractec said all 130 patients had one eye treated for near vision, while 30 of those individuals also had their fellow eye treated for distance vision. The majority of the patients had no correction for distance vision.

According to the company, the restoration of near vision using CK is accomplished by creating a "blended vision" effect. Unlike monovision, in which one eye is treated for near vision and the other for distance vision, the goal of blended vision is to improve near vision without sacrificing distance vision.

"Because CK is minimally invasive and doesn't cut or remove tissue, it's perfect for those patients who seek relief from presbyopia and the feeling of being chained to their reading glasses," said Marguerite B. McDonald, M.D., the principal investigator for the presbyopia trial and clinical professor of ophthalmology at Tulane University in New Orleans.

IN THE NEWS

Medicare fee fix. The 1.6% across-the-board increase in Medicare physician payments for 2003 will actually translate to an overall 1% rise in payments to ophthalmologists. That's because of a 0.6% adjustment for the implementation of the 5-Year Review of Work Values. The Review's purpose is to evaluate work values for specific codes to determine if they're accurate.

House passes malpractice cap. The U.S. House of Representatives has approved legislation that places a $250,000 cap on the noneconomic portion of malpractice awards while also limiting attorneys' contingency fees. The bill, strongly backed by President Bush, passed by a vote of 229-196. The House has previously passed similar legislation, only to see it stall in the Senate, where most Democrats oppose the $250,000 cap.

MedPAC again targets ASCs. In its March report to Congress, the Medicare Payment Advisory Commission (MedPAC) found that ASC reimbursement was currently "more than adequate" and recommended no increases in ASC fees in 2004. MedPAC also reiterated its belief that a new formula to determine fees for procedures performed in ASCs should be implemented. MedPAC said any new formula should be based on the actual costs of operating an ASC, and should also recognize that ASC fees for specific procedures shouldn't exceed hospital outpatient fees for comparable services. Currently, some ASC fees, such as payment for YAG laser capsulotomy, do exceed hospital reimbursement.

Retisert filing delay. Bausch & Lomb said it will delay filing a New Drug Application (NDA) for its Retisert drug delivery implant for the treatment of posterior uveitis. Instead of filing its NDA this summer, as previously planned, the company now expects to file in mid-2004, with commercialization anticipated in 2005. No FDA-approved treatment specifically for posterior uveitis currently exists.

Appointed. Dennis G. Podlesak has been named head of Novartis Ophthalmics, North America. He succeeds C. Daniel Myers, who is leaving the company to pursue other opportunities. Podlesak joins Novartis from Allergan, Inc., where he was vice president/general manager of the Consumer Eye Care business.

Increased reimbursement. The Centers for Medicare & Medicaid Services has raised the national reimbursement for optical biometry to $113.80 when both eyes are tested, an increase of 23%. The change allows providers to bill optical biometry under CPT Code 92136. A leading cataract surgeon, I. Howard Fine, M.D., welcomed the increase, noting that he considers optical biometry more accurate than applanation ultrasound biometry.

SLT study. Wills Eye Hospital and Tulane Medical Center have begun a multicenter study designed to investigate selective laser trabeculoplasty (SLT) as a potential initial treatment for open-angle glaucoma. The 17-site, 340-patient study will compare the effectiveness of SLT with the effectiveness of topical medical therapy.

Jay Katz, M.D., co-director of the glaucoma service at Wills Eye, says that if SLT proves equal or better than medication in lowering eye pressure, the results could be significant in terms of fewer drug-related side effects, reduced treatment costs, eliminating patient noncompliance issues, and providing patients with a better quality of life.

The study is being sponsored and funded by Lumenis, Inc., which manufactures lasers used in performing SLT.

Appointed. Inspire Pharmaceuticals, Inc., which has a partnership with Allergan to develop and market treatments for dry eye, has named Joseph K. Schachle vice president, marketing and sales. Schachle, who most recently served as director of marketing for infectious disease products at Medimmune, was previously employed by Inspire in the area of new product planning and market research.

Reduce Your Appointment Backlog
Take These Steps and See More Patients.

If your appointment schedule is filled for weeks, or even months, in advance, you might feel secure in the fact that your services are in demand. However, your sense of security may be short-lived when existing patients start abandoning you for doctors who'll give them earlier appointment dates and potential new patients choose to go elsewhere.

While eliminating an entire 2-month backlog could be a nearly impossible task that would be highly stressful for everyone in the practice, making a substantial dent in the backlog is a realistic goal. Here are some ideas you should consider to reduce patients' wait for appointments, particularly if you have a solo or relatively small practice:

Make a supply/demand assessment. If you're seeing an average of 20 patients a day and booking an average of 25 new appointments daily, your backlog is going to continue to grow unless you take action. You may need to add to your staff, or even bring in another ophthalmologist. If you're not ready to add employees, identify and correct the conditions that prevent you from seeing more patients each day.

Eliminate bottlenecks. Study your patient flow to determine where time is being lost. Do you have to wait to use a certain piece of equipment? Is it taking too long to retrieve patients' records? Once you determine where the bottlenecks are, you can take steps to eliminate them.

Upgrade your scheduling software. Even for a smaller practice, it may be worth the money to invest in sophisticated scheduling software. This software will help you optimize your time by "red flagging" patients who chronically cancel appointments or those who are often "no shows." The software can also help you maintain momentum throughout the day through consecutive scheduling of similar procedures. You can then schedule the most difficult or time-consuming cases either early or late in the day.

Improve your own techniques. You'll be able to see more patients if you perfect efficient, repeatable techniques, particularly for such high-volume procedures as cataract surgery. Having a consistent, repeatable technique makes it easier for your staff to give you the help that you need with each patient.

Plan ahead. Know who's going to have the day off or be on vacation so that you can allocate staff responsibilities accordingly.

Schedule staff vacations during periods of low patient demand. Use past practice history to govern your staffing for specific days of the week and times of the year.

Remember, being able to offer patients an early appointment date is an excellent way to keep your existing patients loyal while also attracting new patients to your practice.

Two practices have won this year's American Society of Ophthalmic Administrators' William E. Rose Jr. Pinnacle Award for excellence in Medicare billing.

The annual award honors practices that have developed comprehensive internal audit programs to minimize billing mistakes and reduce the chances of fraudulent or abusive Medicare billing. Practices were chosen based on their exemplary billing practices, compliance with government regulations, continuous training of billing staff, and development of open lines of communication, so that any billing errors can be identified and immediately corrected.

The winners are:

• Two-to-four physicians: Ohio Eye Associates Eye Surgery and Laser Center, Mansfield, Ohio. Thomas F. Marquardt, practice administrator.
• Five or more physicians: The DeHaven Eye Clinic, Tyler, Texas. Ava Ashby, practice administrator.

No winner was named this year in the solo physician category.

The Pinnacle Award is named after William E. Rose Jr., the founder of Rose and Associates of Duncanville, Texas, which pioneered in the field of ophthalmic billing and coding consulting. Rose often gave presentations emphasizing accuracy and honesty in billing.

California Cracks Down on Internet Docs
Out-of-State M.D.s Fined for Prescribing.

In what amounts to a stern warning against out-of-state physicians prescribing drugs over the Internet, the Medical Board of California has fined six doctors a total of $48 million. The board said the physicians violated a California law that prohibits doctors from prescribing over the Internet without conducting a physical examination.

The fines are considered the most severe ever levied for improper online prescribing. It's expected that other state boards will now follow California's lead and toughen their stance against out-of-state doctors prescribing online.

California doesn't have the authority to discipline or suspend the licenses of the physicians who are charged with the violations. In fact, some state regulators believe it will be difficult for California to enforce the fines. For the fines to be collected, the California board would have to prove that its authority reaches across state lines.

"The money is secondary to our mission of consumer protection," says Candis Cohen, spokesperson for the Medical Board of California. "We hope this sends a message to the physician community and to the public that this is a dangerous business practice."

(For a thorough discussion of the guidelines you must follow if you plan to prescribe over the Internet, see our October 2002 Risk Manager column, "Beware of Internet Pharmacies".)

Scope of Practice Battle Rages in N.J.
Bill to Benefit O.D.s Raises Questions.

The New Jersey State Assembly is considering a bill that would enable optometrists to receive additional training, which would allow them to perform all types of laser eye procedures, including vision correction, that don't involve a blade. The bill, A-3364, would also allow optometrists to prescribe a wide range of drugs, including narcotics.

Opponents of the proposed legislation, including the New Jersey Academy of Ophthalmology, have pointed to the fact that Assembly Democratic leader Joseph Roberts is part owner of U.S. Vision, a company that operates about 600 retail optical departments (primarily in J.C. Penney and Sears stores) staffed by optometrists.

Roberts was the original sponsor of an earlier version of the bill. He later withdrew the proposed legislation, saying he wanted to avoid charges that his sponsorship would constitute a conflict of interest. However, Assemblyman Jeff Van Drew, another Democrat, then introduced A-3364, whose wording is almost identical to the bill introduced by Roberts.

After a 3-hour hearing on Feb. 10, the Assembly Consumer Affairs Committee approved A-3364 by a 5-1 vote. The bill now goes to the full Assembly, where a vote is expected in May or June. If the legislation passes the Assembly, it will go the New Jersey State Senate, where observers say it would likely face stiff opposition.

Donald Cinotti, M.D., a Jersey City ophthalmologist who serves as legislative chairman for the New Jersey Academy of Ophthalmology, says passage of the bill would literally open the door for optometrists to perform a wide variety of ophthalmic procedures, including LASIK.

"With new technology, you don't need a blade to perform LASIK," says Dr. Cinotti. "You can cut the flap with a laser or a water jet. This bill would leave it entirely up to the New Jersey State Board of Optometrists to decide which procedures O.D.s could perform and what training they'll need to be certified to do them. It's clear that the optometrists have a plan to put themselves on equal footing with ophthalmologists. It's time for some adults to step in and stop this."

REFRACTIVE SURGERY UPDATE

Technolas approval. The FDA has approved the Bausch & Lomb Technolas 217A excimer laser system for correcting hyperopia. The new approval expands the treatment range of the Technolas from myopia up to -12D with or without astigmatism, to hyperopia up to +4D, with or without astigmatism.

CIBA Vision purchases PRL. CIBA Vision has agreed to purchase the PRL posterior chamber phakic IOL from Medennium, Inc. The move signifies an increased CIBA Vision commitment to the PRL.

In 2000, CIBA Vision had signed a worldwide licensing and distribution agreement for the Medennium lens, which is the only phakic IOL designed to be independent of any intraocular support for fixation. The PRL has the CE Mark and is currently in U.S. clinical trials for myopia and hyperopia. CIBA Vision will now assume responsibility for continuing the clinical trials.

Intacs approval. Addition Technology, Inc., the maker of Intacs prescription inserts for surgical vision correction, has won approval to market a wider product line in Europe. The company can now provide six additional inserts in smaller increments of correction within the currently approved range of -1 to -5D.

TLC has wavefront. TLC Vision, a leading operator of laser vision correction centers, says it has completed the installation of wavefront analyzers in all of its approximately 50 U.S. locations. A company spokesperson says TLC Vision is currently offering custom ablation in only the approximately 15 U.S. centers that are equipped with both the Alcon LADARWave analyzer and Alcon LADARVision laser.

China venture. LaserSight Inc., a supplier of laser vision correction equipment, says it has signed a nonbinding letter of intent that could result in the company acquiring 15 refractive surgery centers currently operating in China.