Practice Watch
Tips and News You Can Use

OSHA Targets Sharps-Related Injuries
New Safety Regulations Will Affect Ophthalmologists.

Last year, about 800,000 U.S. healthcare professionals suffered injuries caused by needles or surgical blades. This equates to one sharps-related injury for every 10 healthcare workers.

New OSHA regulations that go into effect this month are aimed at drastically reducing those numbers. The new rules will require physicians and hospitals to document how and why these injuries are occurring and to also take steps to reduce the risk from sharps.

For ophthalmologists, this will mean keeping a special log to record any sharps-related injuries, including the circumstances of the incident and the brand of the device involved. In addition, you'll be required to regularly consult with your nonmanagerial staff on safety-related issues -- and annually document the actions you've taken to adopt safety-engineered sharps.

	Shielded diamond knives and shielded metal blades protect against injuries.

Because surgical blades cause about 6% of sharps-related injuries, companies that make knives for cataract procedures and other intraocular surgeries expect increased demand for shielded blades.

"We recently introduced the first shielded metal blade," says Ron Dykes, president of Diamatrix. "It's simple to operate and provides total protection."

Dykes expects demand for the reusable blade to build as eye surgeons become more aware that OSHA is mandating safer cutting products.

Brian Chandler, president of Accutome, believes the new rules will drive sales of his company's shielded diamond knives, which are designed for cataract procedures.

"A diamond knife can last indefinitely if handled properly," says Chandler. "On a cost-per-procedure basis, our diamond knives are very competitive when compared to the cost of shielded metal blades."

With OSHA now mandating safety-engineered sharps, expect to see more shielded cutting products introduced in the near future.

Complex Cataracts Now on ASC List
HCFA Heeds Requests.

A months-long campaign by the American Academy of Ophthalmology, the American Society of Cataract and Refractive Surgery and other ophthalmic organizations ended in success when the Health Care Financing Administration (HCFA) recently approved the new complex cataract surgery code, 66982, for use in ambulatory surgery centers (ASCs).

HCFA began reimbursing physicians and hospitals for complex cataract surgeries in January, but didn't add 66982 to the approved list for ASCs until recently. ASCs can now submit facility fee claims for all complex cataract surgeries performed in these centers since Jan. 1 of this year. The 66982 code will be included in ASC payment group 8, with a national average reimbursement of $942.

The complex cataract code can only be used in situations in which the eye has been subjected to previous trauma, or has concurrent disease states or congenital abnormalities for which cataract removal requires specialized instruments and techniques. You must decide to use code 66982 before the surgery begins and may not use it for complications that arise during surgery.

"It's important that ophthalmologists request a reopening of previously denied claims because Medicare carriers aren't obligated to reopen claims that have been denied," says Michael Romansky, counsel for the Outpatient Ophthalmic Surgery Society.

Sir Harold Ridley Dies at 94
Recognition Came Slowly for the IOL Inventor.

Sir Harold Ridley, M.D., who designed and implanted the first intraocular lens (IOL) more than 50 years ago, has died in Salisbury, 

England, at age 94. Dr. Ridley was knighted last year as ophthalmologists around the world marked the 50th year of IOL implantation. He was also named one of the 10 most influential ophthalmologists of the twentieth century by the American Society of Cataract and Refractive Surgery.

Sir Harold Ridley, M.D.

Dr. Ridley invented the IOL after his experience as a military surgeon in World War II showed him that pilots were able to tolerate shards of plastic from airplane canopies that lodged in their eyes. He contended that removal of a cloudy lens amounted to what he called "half a cure." He said the operation couldn't be considered complete "until the lost portion is replaced."

Dr. Ridley introduced the IOL to ophthalmology as part of a two-step procedure performed at St. Thomas Hospital in London, England. In late 1949, he performed the extracapsular removal of a cataract on a male patient. Two months later, when Dr. Ridley had determined that the eye was quiet and suitable for implantation, he inserted a plastic IOL manufactured by Rayner Ltd.

In addition to advancing the practice of ophthalmology through his invention of the IOL, Dr. Ridley was an expert in tropical eye diseases. He was also the first eye surgeon to televise an operation, and he developed an electronic system to examine the inner eye.

Recognition came slowly for Dr. Ridley. His initial work with IOLs was treated with skepticism, with some detractors going so far as to label the IOL a ticking time bomb. Finally, in the mid- 1980s, Dr. Ridley began to receive the academic honors that his colleagues believed to be long overdue. He was elected a Fellow of the Royal Society of London in 1986.

Dr. Ridley, who was born in Leicestershire, England, was a graduate of Cambridge University. He received his medical training at St. Thomas Hospital and Moorfields Eye Hospital, both in London.

HCFA Eases Supervision Requirements
New Rules Affect Diagnostic Tests.

Responding to requests from the American Academy of Ophthalmology (AAO), the Health Care Financing Administration (HCFA) has relaxed its rules on physician supervision of several diagnostic tests.

Probably the key win is the change in the supervision requirement for visual fields from "direct" to "general." The action will free ophthalmologists from being present in the office suite while this test is being performed.

HCFA will also permit less restrictive oversight for fluorescein angiography, A-scan biometry and tests in which indocyanine green dye is administered, all of which previously required "personal" supervision (the physician's presence in the room). The new regulations require only that the ophthalmologist be present in the office suite while these tests are being performed.

The AAO, however, continues to lobby for additional relaxation of supervision requirements. The Academy contends that contact B-scan and diagnostic A-scan tests are now primarily performed by trained ophthalmic ultrasonographers, who don't need to be personally supervised. The AAO also believes that HCFA's present rules requiring direct supervision for external photography and personal supervision for special anterior segment photos should both be changed to general supervision.

IN THE NEWS

• Lawsuit settled. Admitting no guilt, Johnson & Johnson's Vistakon unit became the final defendant to settle a 1994 antitrust lawsuit, which charged that several contact lens makers conspired with optometrists and the American Optometric Association to limit the distribution of their contact lenses. The settlement could amount to as much as $60 million in cash and consumer discounts. The company also agreed to broaden its distribution network for replacement lenses.
• Allergan partnership. Allergan and Oculex Pharmaceuticals, Inc. announced they will work together to develop drugs for treatment of conditions affecting the retina and the back of the eye. The effort will be based on using Oculex's proprietary, site-specific, controlled-release drug delivery technologies.
• AMD drug. Pharmacia Corporation will purchase Miravant Medical Technologies' SnET2 PhotoPoint drug for the treatment of wet AMD. The drug is currently in Phase III clinical trials, which are expected to be completed in December. Pharmacia has been helping Miravant fund the SnET2 development program for several years.
• Allergan chairman. David Pyott, president and chief executive officer of Allergan, Inc., will now also serve as chairman of the board of the eyecare and specialty pharmaceutical company.
• Visudyne sales. Sales of Visudyne photodynamic therapy for the treatment of age-related macular degeneration rose to $48 million in the first quarter of 2001, an increase of 26% from the fourth quarter of last year. It's estimated that retinal specialists in more than 35 countries have to date performed more than 120,000 treatments using Visudyne.
• Akorn loss. Akorn Inc., which markets and distributes ophthalmic surgical supplies, announced a $12.9 million first quarter loss and said it was negotiating with its senior lenders to restructure its debt. Akorn said much of the loss was caused by charges related to rebates, returned goods and uncollectible debts. In addition, Akorn named Antonio R. Pera as president and COO of the company.
• Asclepion analyzer. Asclepion-Meditec AG has received FDA premarket approval for its high-end diagnosis system, the WASCA analyzer. The system, which is based on the wavefront aberrometry process, can be used to diagnose the causes of defects in the eye's optical system.
• KeraVision assets. Addition Technology, Inc. of California will purchase the remaining assets of now-bankrupt KeraVision for about $1 million. KeraVision filed for bankruptcy after its Intacs prescription implants for myopia failed to attract wide interest.

Bascom Palmer Eye Institute Has New Leader
Puliafito Appointed to Two Miami Posts.

	Carmen A. Puliafito, M.D.

Carmen A. Puliafito, M.D., M.B.A., has been appointed chairman of the Department of Ophthalmology at the University of Miami School of Medicine and director of its prestigious Bascom Palmer Eye Institute.

Named one of the country's top 10 retinal specialists in a recent survey, Dr. Puliafito is an ophthalmic surgeon specializing in diseases of the retina and vitreous. He's also a recognized authority on ophthalmic lasers and co-inventor of the optical coherence tomography technique. Dr. Puliafito has written six books and more than 120 peer-reviewed articles.

"Ophthalmology's ability to help patients has accelerated rapidly, thanks to recent advances in technology and pharmacology, with more breakthroughs on the horizon," said Dr. Puliafito. "I'm honored to lead this distinguished institution at this exciting time."

Dr. Puliafito joins the University of Miami after serving as director of the New England Eye Center, and as professor and chair of the Department of Ophthalmology at Tufts University School of Medicine in Boston. 

REFRACTIVE SURGERY UPDATE

Patent settlement. LaserSight Inc. and VISX Inc. have reached an agreement that will enable LaserSight to license VISX patents relating to refractive excimer laser technology. LaserSight will pay a royalty to VISX for each procedure performed in the United States using LaserSight's refractive laser. In return, VISX is dropping its patent infringement lawsuit against LaserSight.

Trading suspended. The Canadian Venture Exchange suspended trading in the shares of Icon Laser Eye Centers, Inc., a provider of low-priced laser vision correction services, pending a review of the company's compliance with exchange regulations. In a related matter, the British Columbia Director of Employment Standards has ruled that Icon is responsible for $753,000 (Canadian) in wages and severance pay to former LasikVision employees. Icon acquired LasikVision earlier this year.

LASIK growth. Refractive surgery procedures performed in the United States increased almost 17% in the first quarter of 2001 vs. the final 3 months of last year, says Refractive Market Perspectives.

Sunrise LTK. Clarity Vision, which administers vision coverage programs for more than 2 million Pennsylvanians, has contracted with TruVision to offer Clarity Vision members the Sunrise LTK procedure for hyperopia at a discounted fee of $945 per eye with lifetime enhancements.

Canada approves. Health Canada has approved the Nidek EC-5000 excimer laser system for treatment of hyperopia with and without astigmatism using the LASIK procedure. The EC-5000 is now approved by Health Canada to treat both myopia and hyperopia.