Hallway Controversies highlight the good, the bad and the new at ASCRS

This year’s hot topics included comanagement, Intacs vs. LASIK and discount vs. premium priced refractive surgery.

BOSTON — Get 16 medical field professionals in a room and let them debate two on two on several highly charged subjects and you’re bound to get a lot of talking and a lot to talk about afterward. Such was the scene for this year’s American Society of Cataract and Refractive Surgeons (ASCRS) meeting.

The Hallway Controversies session, which focused on the business of refractive surgery, placed some of the bigger names and newer ideas in the refractive world against each other. It featured such topics as Intacs vs. laser in situ keratomileusis (LASIK), comanagement’s pros and cons and discount refractive surgery vs. traditionally higher priced surgery.

Comanagement

Comanagement has been the hot topic in the eye care world since the American Academy of Ophthalmology (AAO) and ASCRS published a joint paper on the subject. The Hallway Controversies Symposium was the perfect place to get a lot of the discussion out and in the open about exactly what comanagement is and what it all means to the industry.

On the pro side, John D. Hunkeler, MD, said that based on his experiences as a cataract surgeon, he agrees with most of what is in the joint position paper. He related to a group practice comanagement paradigm, which generally is not questioned. But he said he realized that comanagement between independent physicians is held to a different standard.

It was Dr. Hunkeler’s contention that the academic and continuing education of optometrists has led to a larger scope of practice in all states and that the federal government has emphasized the need for competition between ODs and MDs.

George O. Waring III, MD, said the word “comanagement” is one that connotes negativity. “Why not get rid of the word comanagement? Let’s use shared-care.”

He explained that there was no problem when he referred retina cases to a retina specialist. “If I want to have a LASIK practice and one of my MD docs wants to send me a patient for LASIK, there’s no problem.” He felt that it should be the same for an OD who refers a patient.

“Our motive should be to please the patient, help the patient with what they want to do. This is a paradigm shift from Hippocrates, where the doctor was like a god. Now we must treat our patients as partners,” Dr. Waring said.

Dr. Waring said he believes that if a patient wanted to stay with him it would be fine. If a patient wants to go back to his eye care practitioner that should be fine as well. It is a matter of patient preference. But he also said it was a matter of doctor preference as well. He said it might not be necessary for the surgeon to continue follow-up or perhaps if the physician is unable to do follow-up, then it should be his or her decision to send back the patient as well.

He also pointed out that he makes sure his comanaging practitioners are familiar with refractive surgery care.

Dr. Waring warned that the true problem with comanagement is greed. He felt this is where the ASCRS and AAO statement is right on. “Not listening to the patient is where it’s off.”

Fighting the con side of the issue, I. Howard Fine, MD, differed with Dr. Waring’s contention that the patient is a partner. “There is no doubt in my mind that the surgeon knows best when it comes to surgery,” Dr. Fine said.

He went on to explain that the non-surgical doctor is not as credentialed for follow-up care. A surgeon is more cognizant of new materials and theories, he said.

Dr. Fine also said he believed this increases potential for “postop mischief.” He said it was hard to document the qualifications of what non-surgical comanagers have. “Patients don’t understand the difference in what ODs and MDs are qualified [to do].”

In addition, Dr. Fine pointed out that postop care helps physicians to see if the quality of their works needs to be improved. “Also having the surgeon following the patient helps the surgeon to become a better physician.”

J. Trevor Woodhams, MD, scolded Dr. Fine for being too easy on comanagement. Instead, he chose to call it fee-splitting. “Comanagement is a euphemism for what it really is, fee-splitting. This is a truly disguised referral fee.”

Dr. Waring retorted later that it was wrong to refer to all comanagement as fee-splitting. Even the AAO and ASCRS said it was okay to comanagement under the right circumstances.

Dr. Woodhams pointed out that the American College of Eye Surgeons states that fee-splitting creates artificial division of the patient’s care. Dr. Woodhams said he also believed that comanagement creates a break in quality control. A surgeon is in no position to understand the quality of a comanager’s assessment of a situation, he explained. “It’s benign abandonment, in my cases,” Dr. Woodhams said.

He also pointed out that comanagement can be seen as a Trojan horse. “It allows further inroads for optometry into ophthalmology.”

It was also his contention that splitting of fees does not accurately reflect the services rendered for follow-up. Optometrists are getting fees grossly in excess of the service provided. Dr. Woodhams said he believed the fees should reflect a simple eye exam, done perhaps three times over the course of a year, totaling no more than $280. It was his impression that the fees charged now reflect a 20/80 split that would allow an optometrist an $800 follow-up fee on a $4,000 bilateral procedure.

An electronic audience poll conducted after the comanagement session found that 66% thought that comanagement equaled fee-splitting, while 34% disagreed.

Intacs vs. Lasik

The discussion of Intacs vs. LASIK was not effectiveness, but rather, are they complimentary or cooperative? The answer both sides wanted to give was 50/50, but generally the discussion degenerated into a dialogue of marketing campaigns.

Thomas Loarie, CEO of Keravision, the manufacturer of Intacs, and surgeon Daniel S. Durrie, MD, pointed out that the corneal ring segment technology speaks to a large portion of the refractive eye surgery market. Keravision market studies showed that refractive patients want to leave their glasses and contacts off, but either don’t trust LASIK or prefer the removability of Intacs.

The Keravision studies also point out that 72% of the refractive market falls under the Intacs approved range of 1 to 3 diopters, whereas the largest section of LASIK patients tends to be people who suffer 5 D or more of vision interference.

It was Keravision’s contention that Intacs were really a complimentary part of the refractive market since they seemed to be going after a different market share than LASIK. “It’s definitely complimentary, and it’s added to the growth of our practice,” Dr. Durrie said.

Shareef Mahdavi of Visx, and Marguerite McDonald, MD, pointed out that the marketing campaign of Intacs was specifically marketed to point out the “flaws” of LASIK. According to Mr. Mahdavi, the marketing campaign of Intacs specifically points to the fact that Intacs is removable and that it is a non-laser device. It was his belief that the Intacs marketing program was specifically trying to point out not that it is a different option, but that it is a non-laser surgical option, playing on the fears of those people who are afraid of laser surgery.

Discount LASIK

Like all new technologies and services, LASIK is now finding itself in the middle of a battlefield of price wars, with new discount laser shops popping up across the nation, battling the more expensive “high-end” LASIK surgeons and surgery centers.

This particular debate placed pro-discounters Michael Henderson of Lasik Vision Canada and Dan Z. Reinstein, MD, against con-discounters Elias Vamvakas of TLC the Laser Center and Richard L. Lindstrom, MD.

Mr. Henderson stated there was absolutely no connection between quality of care and the price of refractive surgery. “The quality of care resides solely in the hands of the medical providers, the doctors.”

His explanation for the decrease in prices has a lot to do with the opening of the market and the competition, he said. He explained that this was a typical market change from when new products and technologies are introduced and as production costs decrease and competition increases prices go down.

Dr. Reinstein pointed out that there are not supposed to be any superstar surgeons. “Patients expect the highest standard of care from all doctors not based on price.” He didn’t think any doctor would lower his standard of care as he lowered his price for a particular procedure.

Receiving a round of applause, Dr. Lindstrom explained that “LASIK is not a product, like pork bellies. In their group the businessman speaks first and in our group the doctor speaks first.

“I believe the practice of medicine is grounded in the physician-patient relationship. That’s missing in the discount refractive surgery business,” Dr. Lindstrom said. One of the things he said he thought hurt discount laser centers was the lack of preop care and postop care. He explained that as one of Lasik Vision’s comanagers he see patients coming back from Canada looking like “a deer in headlights,” not knowing where to go when complications arise.

He said that the MD must take responsibility for the care of the patients in all facets, “something that does not occur in refractive discounters.”

Mr. Vamvakas emphasized that it is important to make sure companies retain some level of profit, but that if the revenue of surgery decreases, companies must increase surgeries and/or reduce other surgical factors.

The factors that Mr. Vamvakas referred to were shortening of pre-testing and less time discussing possible complications, the reuse of blades and limiting of sterilization. In addition he pointed out that some companies will do less pre-testing of equipment and not provide long-term follow-up.

“Given the logistics, low prices force compromise,” said Mr. Vamvakas.

Opening session

The opening session of the meeting was introduced by ASCRS program committee chairman Manus C. Kraff, MD, who announced that the 1,200 on-site registrations made for a record-breaking attendance of more than 7,000 physicians, allied health care professionals and administrators. Records also were set with more than 300 exhibitors and more than 1,000 papers being presented.

Dr. Kraff cited the ASCRS “NSAID alert” on adverse drug reactions, the society’s work on Medicare reimbursement policy as part of the Practice Expense Coalition and the creation of the Ophthalmology Hall of Fame as highlights of the past year.

Outgoing president Robert M. Sinskey, MD, added that “we issued a comanagement policy that not everyone was happy about,” but said it was a necessary response to issues raised by ASCRS members.

Rise of refractive surgery

Dr. Sinskey noted that half the papers being presented at the meeting were on refractive surgery. That represents a significant change, he said, from the controversy and mass resignations that the society suffered when it broadened its focus and changed its name from the American Intra-Ocular Implant Society.

Perhaps another reflection of the changing nature of refractive surgery and ASCRS itself, according to Dr. Kraff, is the installation of Douglas D. Koch, MD, the first full-time academic ophthalmologist to head the society.

Dr. Koch began his president’s address by listing the many roles, including clinician and small business owner, that ophthalmologists must learn to play today.

“The political area is the easiest to neglect,” Dr. Koch warned. He urged the meeting attendees to work for passage of the Campbell bill, which would authorize collective bargaining for physicians. He directed them to a booth in the exhibit hall where they could call their congressional representatives and encourage votes in support of the bill. From time to time throughout the rest of the meeting, a reminder to visit that booth would resound from the public address system of the Hynes Convention Center.

High note from keynote

Although he is an ophthalmologist, keynote speaker Geoffrey C. Tabin, MD, took the audience far away from the field of eye care all the way to the Himalayas. He told stories and showed photographs illustrating his lifelong pursuit of mountain climbing. Dr. Tabin interrupted his medical training three times to join expeditions to Mount Everest.

It was not until his third expedition, however, that he finally reached the summit. After achieving this feat, he joined a group of surgeons working at an eye surgery camp. That experience showed him the great need for eye care around the world and the great benefits that cataract surgery in particular could provide to patients. He then decided to go into ophthalmology.

Surveys say …

The role of ASCRS as a coordinating agency for survey data seems to be expanding.

In addition to the long-standing annual member survey conducted by David V. Leaming, MD, two other surveys were reported.

Richard J. Duffey, MD, presented the results from the third annual survey of members of both ASCRS and the International Society of Refractive Surgery (ISRS). Among the results was the finding that 89% of respondents reported they are willing to do bilateral same-day LASIK. Forty-six percent said they will do bilateral photorefractive keratectomy (PRK) as a same-day procedure.

Refractive surgery is a second-hand experience for most surgeons today. Only 1% of those surveyed had had PRK. The numbers were higher for radial keratotomy (RK; 4%) and LASIK (5%), with the subgroup of ISRS members reporting the highest rate of surgery: 12% have had LASIK.

IOL explants

The results of a survey on IOLs requiring explantation or secondary intervention were presented by Nick Mamalis, MD.

Power calculation error continues to be the number one cause of explantation, according to Dr. Mamalis, with complaints of visual disturbances or dislocation/decentration responsible for many others. The number of cases in which there was damage to the lens optic has risen sharply, he added, which is to be expected as the use of foldable IOLs increases.

The opening session concluded with Dr. Leaming’s presentation on the practice styles and preferences of ASCRS members.

Cataract volume up

After dipping from approximately 1,935,000 procedures in 1997 to 1,818,000 in 1998, the annualized volume of cataract surgery by ASCRS members rose to 1,864,000 in 1999. The trend may continue, as 53% of those surveyed said they plan to increase their cataract surgery volume in the face of declining reimbursement.

While the number of cases of RK and PRK have dropped each year since 1997, the estimated annual volume of LASIK rose from 170,345 to 440,275 in 1998 and 701,433 in 1999. Sixty-six percent of the surgeons surveyed said they plan to increase their refractive surgery volume.

All the attention being given to comanagement of surgical patients seems well-spent, as 42% and 43% of respondents said they comanage their refractive and cataract surgery patients, respectively.

Innovator’s Session

One of the most well attended portions of the ASCRS meeting was the Innovator’s Session, featuring presentations by the past years’ recipients and the innovator of the year.

This year’s series of speakers included an update on the pneumatic trabeculoplasty treatment (PNT) of glaucoma by Leo D. Bores, M.D. He explained that he was seeing positive results in the clinical trials of the PNT system that uses a pneumatic device to lower the intraocular pressure (IOP) of patients suffering from open-angle and pigmentary glaucoma.

Dr. Bores explained that many of his results have shown that the device reduces IOP non-invasively by using a suction device applied to the eye.

Herbert E. Kaufman, MD showed some of his results using the Intacs technology and how the intracorneal ring segments had proven to be safe and removable, allowing patients to return to their pre-surgery vision.

Peter Choyce, MD showed a videotape documenting the life, struggle and recent knighting of Sir Harold Ridley, MD, the father of modern cataract surgery.

The innovator of the year was named at the session, bestowing the honor to Stephen D. Klyce, PhD, for his work in corneal topography. Dr. Klyce is the first non-MD to receive the honor of Innovator of the Year.

New viscoelastic

In other news, Healon 5 postoperative IOP trials ended May 5, reported Steve A. Arshinoff, MD, FRCSC.

Healon 5 is cohesive at low flow rates and dispersive at higher flow rates. The material was designed to fracture at a flow rate of about 25 cc/min.

“By being fracturable, it sort of behaves as a dispersive at very high flow rates,” he said. “It has this sort of dimorphic personality and you can adjust your flow rate to make it different.”

The phase 3 trials included 359 eyes, 187 that received Healon 5 and 172 that received Healon. Complication rates were comparable, as two capsules ruptured with Healon 5 and one with Healon.

There was no significant difference in the postop IOP spikes reaching higher than 30 mm Hg. At 3, 6, 8, 12 and 24 hours postoperatively, pressure spikes were similar between the two materials. Postoperative pressure spikes probably resulted from surgery when using these materials, he said.

Kerry D. Solomon, MD, used Healon 5 in a small series of patients for the trial.

“Most of us are moving or transitioning to higher flow phacoemulsification techniques using higher and higher flow and higher vacuum and less ultrasound,” he said. “In years past we used to be concerned about corneal endothelial trauma from the delivery of ultrasound to the cornea. Nowadays, since our ultrasound use is so minimal I think we’re more concerned about turbulence and flow, and so having a viscoelastic or a viscoadaptive that stays in the eye is going to become more important.”

Volunteer for clinical trials

One way to add value to a refractive practice is to volunteer for clinical trials, said Marguerite B. McDonald, MD, at a session hosted by the Outpatient Ophthalmic Surgical Society.

Dr. McDonald left academia 6 years ago to start her a single-physician practice with its own laser center.

“You want your facility to be positioned on the cutting edge of technology,” she said. “You have to have the latest technology.”

To accomplish these goals, she maintains a 3-person clinical research staff. She hired credentialed staff with previous experience with clinical trials. The staff is self-supporting and profitable, and it adds a marketing edge to her practice. She now wants to add two more people.

Next, she said, physicians need not be the best known or most experienced clinicians in their area. She told physicians to shake hands at exhibit booths and tell exhibitors of the desire to perform clinical research.

“Use your reps,” she said. “They are exceedingly powerful. Tell them you’re one of their big accounts. Say you are dying to be in clinical trials. And faster than the speed of light, the head of regulatory will call you.”

One company recently showed its new investigator list to Dr. McDonald, and told her it was based on the names of people without as much previous clinical experience as she had expected to see. Instead, the list was comprised of people who had showed enthusiasm about the product.

Eye Alliance formed

Four companies have come together to form an Eye Alliance, in what they believe will create formidable competition for the major ophthalmic manufacturers.

The companies involved in this Eye Alliance include Salt Lake-City based Paradigm Medical, a manufacturer of surgical equipment of cataract surgery, and its acquisition of Vismed (formerly Dicon, of San Diego), a manufacturer of glaucoma and refractive diagnostic products. Paradigm teamed up nearly 2 years ago with Pharmacia Corp. (Peapack, N.J.), manufacturer of Healon viscoelastic, CeeOn IOLs and glaucoma medication Xalatan (latanoprost). Maxxim Medical (Clearwater, Fla.), manufacturer of custom surgical packs for the OR, also has joined this Eye Alliance, the companies announced at an ASCRS press conference.

According to Mark Miehle, Dicon’s former president, who is now president and COO of Paradigm, “What we call cross-merchandising through this Eye Alliance will give us a better opportunity to compete against companies like Alcon, Allergan and Bausch & Lomb.”

Thomas F. Motter, Paradigm CEO, said, “The Dicon acquisition creates an additional market for Paradigm, consisting of 80,000 optometrists worldwide. With the addition of Dicon’s autoperimeter and corneal topographer, this creates substantial leverage in clinical ophthalmology markets in glaucoma when combined with Paradigm’s ultrasound biomicroscope and ocular blood flow analyzer. Doctors will now see the added value of our company,” Mr. Motter said.

He continued, “The LASIK market is very hot right now, and with the addition of the Dicon topographer, Paradigm can offer a very attractive program, combining its LASIK pachymeter for corneal thickness measurements.”

Mr. Miehle said this merger “will offer three P’s. Paradigm and Dicon will offer a broader base of products, which will help us to bring in people to use these products. We have a core of capabilities from taking two smaller companies and combining into one larger company. This will lead to profit.”

Paradigm will continue to operate Dicon’s 30,000-square-foot facility in San Diego.

Paradigm currently awaits final approval from the Food and Drug Administration for its Photon laser cataract removal system, for which it recently received a European CE mark.

Mr. Motter said that sales of Paradigm’s phacoemulsifier, which it purchased from the Mentor Corp. late last year, have been “good.” Many machines have been sold to overseas markets, such as China. “The only system I know of that provides efficient surgical outcomes at a low cost is that product,” Mr. Motter said.

Optos used as screening tool

A new screening tool can detect retinal pathology through a non-mydriatic pupil as effectively as a dilated fundus exam, researchers concluded.

According to Carmen A. Puliafito, MD, of the New England Eye Center, the Optos Panoramic200 implements the scanning laser ophthalmoscopy tool as a screening device.

	Optos Panoramic200 implements the scanning laser ophthalmoscopy tool as a screening device. It can detect retinal pathology through a non-mydriatic pupil as effectively as a dilated fundus exam, researchers concluded.

The camera takes a digital image of 200° of the retina through an undilated pupil. The image is taken in 0.25 seconds.

“This is a screening tool,” he said. “It is the year 2000 version of Helmholtz’s ophthalmoscope. It gives you high quality images. All these images can be readily transmitted by Internet technology.”

Clinical data from a double-blind comparative trial conducted at the New England Eye Center concluded that sensitivity and specificity were comparable to standard fundus photography. Dr. Puliafito and Caroline Baumal, MD, tested 86 eyes and compared them with dilated fundus photographs and a clinical exam.

Dr. Baumal said the Panoramic200 had a sensitivity of 95.8% and a specificity of 100% and missed two cases of pathology. Fundus photography had a sensitivity of 91.6% and a specificity of 100% and missed four cases of pathology.

Another study conducted by Andrew Eller, MD, at the University of Pittsburgh Eye and Ear Institute, concluded that retinal disease could be effectively screened.

His data compared the non-mydriatic imaging with a dilated fundus exam. The Panoramic200 had a sensitivity of 87% and a specificity of 92%. He found that three investigators had a high correlation of detection. He uses the device to screen for retinal pathology for more than 4,000 diabetic patients included in his HMO plan.