The day after PRK approval: Are you ready?

Issue: September 1995

--- Louis J. Catania, OD
More than 20 years ago, Louis J. Catania, OD, helped form one of the first optometry HMOs in the country. A well-known educator and lecturer, Catania has spent recent years preparing for Food and Drug Administration (FDA) approval of photorefractive keratectomy (PRK), expected in late 1995 or early 1996. Catania is vice president of professional services and optometric director for Global Vision Inc. Global Vision is one of several U.S. laser center companies, including LaserVision Centers Inc. and NewVision Technology Inc., that have begun treating corneal disease with phototherapeutic keratectomy, the excimer laser's first FDA-approved application. A charter member of the Primary Care Optometry News Editorial Advisory Board, Catania describes the various networking and corporate systems that are forming to deliver PRK to an eager public. Catania himself has undergone PRK.

Primary Care Optometry News: How many Americans will get PRK after it is approved?

Louis J. Catania, OD: About 25% of the population of the U.S. will be eligible for the procedure. Of those who are eligible, how many will actually have it done? Nobody knows for sure. Will it be 1%, 2%, 5%?

However, I can tell you one thing, that if 0.3% of that potential population chooses to have this procedure, it will keep every instrument busy the first year and manufacturers will reach the limit of how fast they can get them into the market. So I think it is not going to take a lot to drive this business.

PCON: A lot of companies have sprung up to deliver this care, and most work with optometrists in some way, shape or form. What types of arrangements are being made with optometrists?

Catania: There are different models. Some require a commitment on the part of the optometrist in the form of signing an exclusive agreement to refer. Some have nonexclusive agreements; optometrists could then sign with others. Some have investment opportunities where the optometrist is investing in a particular delivery model.

PCON: How many optometrists at this point have formally entered one or more of these arrangements?

Catania: I don't know that anyone has those figures. I can only speak from our experience at Global Vision. We have investigated 26 different markets and are quite extensive in our exposure in those markets. Of the 26, we will close only 18 deals because we know that we will have 18 instruments. A laser center company that can't guarantee that it will have a laser the day after PRK approval isn't doing the optometrist any favors. Patients are going to find a system that is available.

PCON: What does closing a deal entail?

Catania: A commitment to establishing a center when we have the minimum amount of investors needed in that area. Our investors are ODs and MDs, because we form a community-based OD-MD partnership.

At this point, if there are 100 optometrists in market X, for example, we tend to get about 25% to 50% of those optometrists at our first meeting. The first meeting is basically informational, presenting our model and business plan. We usually wind up getting about 15% to 25% of optometrists in the community to sign on. That's an average, and we've had greater and lower percentages in some markets.

So it seems that about 20% to 25% of optometrists in a given market are responding to our particular presentation. Of course, these people are being hit with any number of presentations, so it is hard to judge if every management company has experienced the same thing.

Let's assume that another one or two systems come into the area as well. If you consider all the systems and all the "privates" within a community—for example, ophthalmologists who buy the instrument and try to get optometrists to refer to them—I think by the time you are finished, about 50% of optometrists in any given market are going to be involved in some form of PRK delivery system.

PCON: So the other half won't be involved? Why not?

Catania: I think probably half of those who won't get involved question the legitimacy of the technology for their patients. The remainder are people who don't participate in any kind of a system. They are not saying that this technology is not going to be a valuable entity in vision care, but they are just not joiners.

PCON: What should an optometrist look for when investigating which systems or networks to join?

Catania: In general, optometrists should look for an entity that can provide facilities and an instrument, which is key. The system has to be able to provide and manage a facility, and should have experience doing so. That is important.

The system has to have capital behind it. PRK may be approved later this year or early next year. Or it may take even longer. No one is making a dime until approval, and a system has to have enough capital to keep going. Some of these systems may not make day one.

The system should have integrity. There should be real honesty in what they are doing with the profession. They should be good, sound business people. They should have proven their abilities over the years whether in dealing with MDs or ODs.

I think the system should have a good educational mechanism. They have to be prepared to credential people properly—not just, "We'll send you a videotape" kind of thing and you are on board.

PCON: Is it possible to categorize these systems to get a better idea of how they work?

Catania: I think one can categorize them on the professional side and also on the business side. On the professional side, there are systems in which the optometrist is a participant at the full clinical level in terms of pre- and post-procedural care. I believe most of the systems have reached that point. Optometrists should have an active clinical role in the quality assurance mechanisms and the credentialing and the outcome assessments, etc.

On the business side, I think there are several aspects of any system that can help categorize them. One is access: Does the system have open access for all optometrists and ophthalmologists? The second is parity in payment to optometrists and ophthalmologists. The third is investment opportunity. The fourth is whether the system is a privately or publicly owned company. These are all business aspects worth looking at.

PCON: You mentioned that Global Vision is a mix of ophthalmologist-optometrist investors. Since most of the patients will be coming from optometrists, shouldn't optometrists maintain control of the system?

Catania: Between 70% and 80% of refractive surgery patients are likely to come from optometry. Those patients are going to drive this business. If it hits like most analysts feel it is going to hit, PRK is going to generate windfall profits, multibillion-dollar profits.

Optometrists can look at this business and say, well, I just want to refer my patients to a good center and make sure they are taken care of, then I will take a professional fee and I will be happy. Or they can say, if my patients are going to drive this business, why shouldn't I have some vested interest in it? Indeed, we want to give optometry that opportunity. We want to give ophthalmology the opportunity too, because we really believe that this should be a balanced approach.

The systems that are out there saying we are all optometry and we are run by optometry are making a mistake. It has to be optometry-ophthalmology-based care. Secondly, when you play that game and say, we are optometry, we are controlled and run only by optometry, you are effectively spawning your own competitors. You are forcing ophthalmology to compete with you and do their own thing.

PCON: Can you address the malpractice risk that an optometrist might have if referring someone for this procedure, even after Food and Drug Administration (FDA) approval?

Catania: I have served as an expert witness in cases of this type. The optometrist is not free of liability in this arrangement. As such, they should be very careful in who they deal with. The type of delivery system is important, because if that delivery system doesn't have excruciatingly careful credentialing, education, quality assurance and outcome assessment mechanisms, their liability position is weakened should they ever be named in a suit. They should be sure they are referring to competent ophthalmologists who have gone through an appropriate credentialing process.

This brings up the whole Canadian issue. If you are referring a patient internationally and an untoward event occurs with that patient, you are vulnerable legally, but they can't chase the international entity. All of the liability falls on your shoulder at that point.

PCON: That will be a moot point soon, after FDA approval.

Catania: Not really. Some of those systems intend to continue their international operation even after U.S. approval. There will be a place for that, probably to some degree, for patients who fall outside of the FDA-approved ranges. To refer a PRK patient who falls within FDA ranges to a Canadian center after U.S. approval, however, may increase one's exposure.

PCON: Would you like to say anything about the FDA at this point?

Catania: Clearly we all are excited and want to see approval happen. But at the same time, the FDA has a process that really tries to protect. There has been criticism by some who say the Summit laser isn't the best instrument. Well, it may not be the best instrument among all the technologies worldwide, but you can be sure that the FDA will approve only a technology that is safe in the ranges it recommends. When we do get approval for this technology, we can be fairly certain that we can tell our patients it is a safe and effective technology, and has been tested excruciatingly.

Conversely, of course, the stagnant and slow process is putting the U.S. behind the curve in the development of this technology.

PCON: How have optometrists in other countries adjusted to PRK?

Catania: In the international markets, optometrists so far have not been able to play a significant role. They feel very threatened by PRK. In the U.K. and European countries, and even Canada to some degree, optometrists were left out of the loop. They were left out professionally and educationally and had no opportunity to invest in the technology. Indeed, legislation and even education in some countries don't allow optometrists to participate in this care.

Because these optometrists feel threatened, it's more difficult to give an honest, objective answer to the patient who sits in the chair and asks about PRK. It's easy to say no, this is bad, don't do this. In the U.S., I think optometrists, based on their education, their legislative authority and their recognition that this technology is legitimate, will give an honest, objective appraisal to their patients. If the patient makes the decision to be involved in this kind of care, then optometrists need the chance to participate in a model that allows them to be able to maintain the control and care of that patient and also to be able to participate and share in the potential benefits on the business side.

PCON: What advice can you give to the optometrist who hasn't done anything about getting involved with PRK?

Catania: They should begin to look at options available for them. If they want to be involved properly, they have to be involved with the right kind of model, the right kind of delivery system. There are many systems out there right now and not all of them are right for any number of reasons. Some of them are broke; some of them are really not representing optometry in the proper manner; some of them are not going to be able to deliver what they promise.

PCON: Are there any places where the optometrist who hasn't moved is already too late?

Catania: I don't think so, but the window is getting very, very narrow. I think that if they want to position themselves, they really have to be ready and have to be doing something now. They will not be optimally positioned if they don't move quickly.