Practice Watch
Tips and News You Can Use

New Web Site Lists Sanctioned Physicians
Detailed Information Is Available on Disciplinary Actions.

The Public Citizen Health Research Group (PCHRG) is now offering on the Internet detailed reports on disciplinary actions taken against thousands of individual physicians. The sanctions, imposed by federal agencies and state medical boards over the past decade, are currently available on a state-by-state basis on a new Web site, www.questionabledoctors.org

Though listings from only 27 states were posted on the site in early October, a spokesperson for PCHRG said information covering physician sanctions in all 50 states will be available by the end of this year. Sanctions listed cover a range of violations including Medicare fraud, malpractice, misuse of controlled substances and nonpayment of student loans.

Visitors to the Web site may obtain a brief summary of a specific physician's offenses for free. However, a detailed report on a physician's infractions and resulting penalties costs $10.

The site's primary intent is to provide information to consumers who want to know if disciplinary action has been taken against a particular physician, but medical practices can also find the site very useful.

For example, if your practice is seeking to hire a new physician, you can use the site to conduct a background check. Similarly, you can check out physicians you refer to, or are thinking of referring to, to help determine if they merit your trust and the trust of your patients.

One important caveat in using the Web site comes from Anne Hamilton, employment law attorney at Arent Fox, a Washington, D.C., law firm that represents many ophthalmology practices.

"Employers or prospective employers who seek to utilize this site should be aware that accessing such information for employment purposes triggers obligations under the federal Fair Credit Reporting Act (FCRA)," says Hamilton. "The information you collect from this site is classified as a consumer report. Thus, you must notify employees or prospective employees that you want to obtain a consumer report on them and receive their written consent to do so. If you intend to take negative employment action based on information from the site, you must give the employee or prospective employee advance notice of that fact and take other steps as required by the FCRA."

Hamilton says the FCRA doesn't apply if you want to check out a physician to determine if he merits your referrals.

PCHRG advises that if you find disciplinary action has been taken against a particular physician, you should check with that state's medical board to learn the physician's current standing. The PCHRG notes that some disciplinary actions are later overturned on appeal. Also, make sure you have the right physician. In many states, different doctors have the same name.

Most Practices Not Ready for HIPAA Rules
Many Request Extensions.

About two-thirds of eyecare practices have spent little or no time preparing to comply with new Health Insurance Portability and Accountability Act (HIPAA) regulations, according to a recent e-mail survey of 321 practitioners conducted by CIBA Vision.

This lack of preparation is underscored by the fact that 73% of survey respondents say they've requested a 1-year extension to comply with the new HIPAA Electronic Transactions standards, which went into effect Oct. 16.

With HIPAA Privacy Regulations due to go into effect in April, and with no extensions being granted, 55% of eyecare practices surveyed have yet to designate a HIPAA compliance officer. When asked to characterize the amount of time the practice has spent on HIPAA issues in the past year, 17% of survey respondents said "none" and 48% responded "minimal." Only 5% of the respondents said they've devoted a large amount of time to HIPAA issues.

The survey shows wide variation in how much practitioners expect to spend over the next year on HIPAA compliance. About 11% of the survey respondents said they expect to spend nothing, while 43% believe that their total expenses will be less than $1,000. Only 13% expect that HIPAA compliance will cost their practices more than $5,000.

In terms of how HIPAA regulations will impact their practices, almost half of the survey respondents said the biggest impact will be in developing systems to protect the privacy of patient records.

If You're Thinking of Offering Botox . . .
Read This Before Administering Your First Injection.

With Botox making headlines as the "hottest" new cosmetic enhancement, many ophthalmologists have begun to administer the wrinkle-removing injections and others are thinking of offering the procedure to patients. However, the Ophthalmic Mutual Insurance Company (OMIC), which provides malpractice insurance to ophthalmologists, cautions that physicians who offer Botox must take into account the potential liability risks associated with performing this procedure. Here are some of the actions OMIC recommends you can take to manage those risks:

Take an approved Botox training course. Allergan, the manufacturer of Botox, offers training in the cosmetic application of Botox. Some of these courses are co-sponsored by the American Academy of Ophthalmology (AAO) and the American Society of Ophthalmic Plastic and Reconstructive Surgery. Contact Allergan or the AAO for information on when and where Botox training will be offered.

Be able to identify patients who shouldn't receive Botox injections. Many individuals have physical and anatomical characteristics that should eliminate them as candidates for Botox treatment. Such characteristics include excessive atrophy or weakness in the target muscle, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, marked facial asymmetry and inflammation at the planned injection site.

Take a basic medical history of each Botox patient. You must also generate and maintain a medical chart on anyone you treat with Botox.

Consider being proctored. For your first few cases, have a physician who's experienced in injecting Botox observe how you perform the procedure.

Inject Botox only in a clinical setting. Health spas, hotel rooms and private homes aren't appropriate settings for performing medical procedures because they don't have the personnel and equipment to safely observe patients, deal with complications and allow proper disposal of medical waste.

Be careful in advertising Botox treatment. All states and the Federal Trade Commission ban ads containing false, fraudulent and misleading material, including guarantees of success. Some states prohibit patient testimonials. The AAO Code of Ethics provides ethical guidelines regarding advertising.

Bausch & Lomb Is Back on a Growth Track
Company Reports Strong Third Quarter; Sees 20% Earnings Gains in 2003.

With earnings driven by double-digit sales gains in contact lenses, lens care products and pharmaceuticals, eyecare giant Bausch & Lomb posted a 48 cent per share profit in the third quarter, beating analysts' estimates of 42 cents.

The company said it's comfortable with analysts' estimates of $1.68 a share for all of 2002, and now predicts that profits will grow by about 20% to the $2.00 to $2.05 range in 2003.

The third-quarter profit was before nonrecurring charges amounting to $16.7 million (31 cents a share) after taxes, including a $3.7 million charge associated with moving the production of PureVision 30-day and night continuous wear contact lenses from the United States to Ireland.

The move was necessitated after a U.S. District Court upheld a patent infringement complaint brought by CIBA Vision concerning the silicone hydrogel material used in PureVision lenses. Bausch & Lomb has appealed that decision, which prohibits the company from manufacturing or selling PureVision lenses in the United States until at least 2005.

Overall, Bausch & Lomb's worldwide sales totaled $466.7 million in the third quarter, an 11% increase over the comparable period last year.

In addition to the strong gains in contact lenses, lens care products and pharmaceuticals, cataract surgery product sales were up 5% from 2001, while refractive surgery product revenues were flat vs. a year ago.

"Our third quarter results show continued solid progress toward improving operational performance," said B & L CEO Ronald L. Zarrella.

Bradley Retires as CIBA Vision CEO
Joseph Mallof Takes Reins.

After leading CIBA Vision for the past 13 years, Dr. Glen Bradley, Ph.D., has retired as chief executive officer of the company, effective Nov. 1. Bradley will formally leave CIBA Vision early next year.

Bradley's successor is Joseph Mallof, who most recently was president, Asia-Pacific, for S.C. Johnson and Son, a global consumer products manufacturer. Mallof brings more than 25 years of international consumer goods experience to CIBA Vision, including a 20-year stint at Procter & Gamble, where he rose from a marketing position to general manager for Japan and the Philippines. Mallof holds an MBA degree from the University of Chicago.

Bradley is completing more than 30 years of service with affiliated Novartis Corporation companies. He first joined Geigy Chemical Corporation in 1969, which later merged with Ciba to form Ciba-Geigy. After a series of increasingly responsible positions with that company, he moved to CIBA Vision in 1986, becoming CEO in 1990.

Under Bradley's leadership, CIBA Vision's sales have grown more than 14 fold. Products launched during his tenure include the Focus Dailies line of daily disposable contact lenses, Focus Night & Day 30-day and night continuous wear contact lenses, and Visudyne, the first treatment approved by the FDA for the wet form of age-related macular degeneration. Bradley also managed the company's successful integration of a number of acquisitions.

Genentech Tests an AMD Treatment
rhuFab V2 Shows Promise.

In what is proving to be a highly competitive race to develop more effective treatments for the wet form of AMD, biotech giant Genentech recently released positive results from a Phase II trial of its rhuFab V2 drug and announced that the company is moving forward with a Phase III study.

Genentech thus joins Alcon and Eyetech Pharmaceuticals in conducting late-stage trials of new treatments for wet AMD. Currently, the only drug approved by the FDA for treating wet AMD is verteporfin for injection (Visudyne), which was co-developed by Novartis Ophthalmics and QLT Inc.

The Genentech drug is a therapeutic antibody fragment designed to bind and inhibit vascular endothelial growth factor (VEGF), a protein that plays a critical role in the formation of new blood vessels. It's believed that blocking the formation of new blood vessels beneath the retina can be effective in halting the leakage of blood and fluid that creates blind spots in central vision.

In the Phase II study of rhuFab V2, 53 patients received intravitreal injections of the drug, while 11 individuals were treated with the standard of care.

Patients who received rhuFab V2 were treated in one eye every 4 weeks for 4 months. Of the 53 patients treated with rhuFab V2, 50 had stable or improved vision at day 98. On average, patients treated with rhuFab V2 gained 9.0 letters at 98 days, compared with patients treated with standard of care, who lost 4.9 letters in that time period.

IN THE NEWS

Ophthalmologists to be busy. The aging of the population will affect ophthalmology and cardiovascular surgery more than any other medical specialties, according to a recent study conducted by a group of Canadian economists. The aggregate dollar volume of ophthalmology services worldwide is expected to grow at almost twice the rate of overall medical services over the next 20 years as tens of millions of baby boomers develop eye conditions associated with aging.

Glaucoma committee. Seventeen of the nation's leading glaucoma specialists have formed a committee to develop practical treatment guidelines for the medical management of glaucoma. The National Committee on Glaucoma Management (NCGM) was created in response to a need among general ophthalmologists for specific, easy-to-follow guidelines on managing glaucoma patients, according to NCGM co-chair Ronald Gross, M.D. The committee has already reached consensus on a number of recommendations but wants to document the information before sharing it with the general ophthalmology community.

Anti-reflective lenses. The AR Council announced that its annual sales survey found that 23% of the lenses sold in the United States last year were anti-reflective. This represents a 4% increase over 2000 sales results. The AR Council represents companies involved in the production and sale of anti-reflective lenses.

Conjunctivitis treatment. InSite Vision Inc. said a Phase II study of its ISV-401 antibiotic for treating both gram-positive and gram-negative strains of bacterial conjunctivitis demonstrated that six drops of ISV-401 administered over 5 consecutive days produced comparable clinical results to 35 drops of currently marketed drugs. ISV-401 contains azithromycin in formulation with InSite Vision's DuraSite drug-delivery vehicle.

Dispute resolved. Alcon, Inc. and Pharmacia Corporation have reached an agreement ending patent and trademark disputes involving the companies' glaucoma drugs, Alcon's Travatan and Pharmacia's Xalatan. The agreement gives Alcon the unrestricted right to continue worldwide sales of Travatan. In return, Alcon will pay Pharmacia royalties for a specified time period based on past and future sales of Travatan. Columbia University, which licenses some of the involved patents to Pharmacia, joined in the settlement.

AMD treatment. Twelve-month data from an ongoing study of anecortave acetate, Alcon Inc.'s investigational new drug for treating wet AMD, showed that 79% of treated patients lost fewer than three lines of vision compared to 53% in the placebo group. In a subgroup of patients with more severe, predominantly classic lesions, 84% of patients maintained vision within three lines compared to 50% of the placebo group. A phase III study of anecortave acetate involving 500 patients at 40 sites is now under way. The new study will compare the efficacy of anecortave acetate vs. verteporfin for injection (Visudyne) in treating classic wet AMD.

Appointed. Bausch & Lomb has named Gary M. Phillips, M.D., as corporate vice president for Global Pharmaceutical and Vitreoretinal products. Dr. Phillips was previously executive director, strategic planning, for Novartis Pharmaceuticals.

Settlement. CIBA Vision has withdrawn its patent infringement lawsuit against CooperVision. In a settlement, CIBA Vision agreed to license several of its color contact lens patents to CooperVision in return for royalties and a cross-license of some of CooperVision's intellectual property rights. CIBA Vision had originally charged that CooperVision's Frequency Colors line of color contact lenses infringed on a basic patent protecting its color contact lens technology.

REFRACTIVE SURGERY UPDATE

Patents infringed. A federal court has ruled that the Nidek excimer laser infringes on two key patents originally held by Summit Technology, Inc. Summit, which filed suit against Nidek in 1998, was acquired by Alcon, Inc. in 2000. The court ruled that Summit/Alcon is entitled to lost profits of $14.8 million, past royalties of $2.4 million and future royalties of 5% of Nidek excimer laser sales. A Nidek spokesperson said the company is disappointed by the decision and doesn't believe it infringed on the Summit patents.

VISX agreement. VISX Inc., a developer of excimer laser technology for vision correction, has licensed its patents relating to refractive excimer lasers to Wavelight Laser Technologie AG, a German company. Under terms of the license, Wavelight will pay a royalty to VISX for each procedure performed in the United States using a Wavelight refractive laser. Wavelight will also pay a royalty to VISX for international equipment sales. The agreement ends a patent infringement action filed by VISX against Wavelight in March.

Nidek seeks approval. Nidek, Inc. has submitted a pre-market application to the FDA for its hyperopia clinical module for treating hyperopia, hyperopic astigmatism and mixed astigmatism with the Nidek EC-5000 Excimer Laser System. The EC-5000 has already been approved for treatment of myopia and moderate myopia with astigmatism.

Antitrust settlement. LCA-Vision, a provider of laser vision correction services, said it has received a $2.28 million settlement in an antitrust class action suit against laser manufacturers. The suit charged that Pillar Point Partners, a joint entity formed by VISX Inc. and Summit Technology in 1995, had engaged in anticompetitive practices. Pillar Point partners was dissolved in 1998. OM after the Federal Trade Commission challenged its existence. In related news, LCA-Vision recently opened its 32nd laser vision correction center in Louisville, Kentucky.