Physicians face new challenges with presbyopia correction

During the OSN IOL Economic Summit, William F. Maloney, MD, discussed the ethical challenges of presbyopia correction and the relationship between covered and non-covered services.

Issue: September 15, 2006

ByCara Dickinson

William F. Maloney

As presbyopia becomes the new normal for refractive cataract surgery, physicians face a number of new opportunities, as well as new challenges. During the recent IOL Economic Summit, Cataract Surgery Section Editor William F. Maloney, MD, addressed these challenges.

“We face new surgical challenges and, frankly, I do not see a problem there in terms of our ability to absorb them,” Dr. Maloney said. “In that regard, this new innovation is just business as usual – the next chapter in a story that has been unfolding since Ridley gave us the IOL more than 50 years ago.”

But this is not business as usual when it comes to the ethical challenges, according to Dr. Maloney. “I cannot think of a moment in history where doing the right thing is more important for our long-term success as a profession than right now,” he said.

Splitting of services

Dr. Maloney credited Richard L. Lindstrom, MD, with first coining the term “refractive cataract surgery,” stating that since that time, cataract and refractive surgery have been converging. “Now they have been split apart in terms of reimbursement, and that is a major opportunity,” he said.

“It is split into covered and non-covered services, refractive and cataract; but, and this is crucial, they are not completely autonomous,” Dr. Maloney added. “There is a relationship that remains there that is central to doing this correctly. Non-covered services can be looked at in two ways: the device and the surgeon’s services.”

The device aspect is fairly straightforward, according to Dr. Maloney. The CMS ruling determined that if a physician were to use one of three specified presbyopia-correcting IOLs, there is a non-covered charge for the additional fee for that lens. Dr. Maloney stated that the ruling also reinforced the fact that additional surgeon services may be required to do that properly, and those surgeon services are also non-covered.

“Because of that, it left the misunderstanding that the only time a surgeon can charge for services in relation to presbyopia correction is if one of these lenses is used, and that is not the case,” Dr. Maloney said.

The surgeon’s services segment of this equation was treated separately from the CMS ruling, Dr. Maloney said. This aspect actually predated the CMS ruling, stemming from the fact that presbyopia correction has been determined to be refractive surgery, which is non-covered.

Dr. Maloney stated that non-covered surgeon’s services need to be necessary to the presbyopia correction outcome and completely separate from the cataract surgery component of this hybrid procedure. He said that if there is any overlap between the two, the doctor should not charge. It was stated that all non-covered charges also need to be reasonable.

“‘Well,’ I asked the attorneys, ‘what is reasonable?’” Dr. Maloney said. “We finally got to the point where we were able to determine that reasonable is not as if this was a completely autonomous procedure like LASIK or conductive keratoplasty, but is instead as judged by guess who? Medicare.”

He added that this was why the connection that Medicare still has to these charges is critical; if the charges are seen as excessive by Medicare, they could be viewed as a subsidy and, therefore, possibly as balance billing, which is prohibited. “So let us go slowly, carefully and conservatively on these surgeon charges. More clarity will come in time,” Dr. Maloney said.

Defining cataract/presbyopia

The next challenge physicians face is defining what is a cataract. He stated that the definition of cataract has changed over the past 20 years as a result of refractive innovations, and that eyecare professionals need to be careful to define cataract as Medicare defines it. “If we use glare testing, we need to get those symptoms in the patient’s own writing or as part of a questionnaire,” Dr. Maloney said. “The patient needs to, in writing, describe their glare symptoms in the chart or in matter of a questionnaire.” He added that the cataract definition needs to hold for both eyes since presbyopia correction requires surgery in both eyes.

This brings one to the consideration of a third point: defining presbyopia correction, the foundation of the surgeon’s services involved, Dr. Maloney stated. Presbyopia correction falls under the category of refractive surgery and is non-covered. “What is presbyopia correction? It is defined, for our purposes, as any necessary additional work,” Dr. Maloney said. “Is insertion of a multifocal or other premium presbyopia IOL, without any additional tests or astigmatism correction, presbyopia correction? No.”

He further explained that lens implantation is considered to be a part of cataract surgery and is covered. “If I use a conventional implant and target an arbitrary amount of anisometropia to achieve an indiscriminate, monovision result, is that presbyopia correction? No; again, there is no additional work,” he stated. “Biometry is part of cataract surgery, and simply changing one of the refractive targets to myopia does not constitute additional work. Therefore, there are no legitimate additional charges here.”

When to charge

Dr. Maloney stated that physicians can charge for astigmatic keratotomy and for the techniques used in AK. They can charge for ocular dominance and suppression capacity tests, pupillography and the other tests and assessments designed to create an optimum presbyopia outcome, he added.

“When it comes to these non-covered surgeon services, a good general principle to follow is if there is no additional work, there are no non-covered charges, regardless of the IOL employed and the reading results you might achieve,” Dr. Maloney said.

He suggested that each alternative should be presented to all candidates in terms of its capabilities and compromises in an objective way. The patient should then specify the results that they most want from their presbyopia correction because it is not always the same. “Some people want social reading, while others want fine print reading, and those specified reading goals should be what determine the IOL selected,” he said.

Avoiding ethical failures

“Finally, our medical professional oath comes into play. This is almost a cliché now, and that is most unfortunate,” Dr. Maloney said. “The oath says that we need to do state-of-the-art surgery prior to adding presbyopia correction to our portfolio, and that we do what is necessary to upgrade and re-calibrate our biometry to achieve the accuracies necessary.”

However, the oath also tells physicians how they might advance in this new challenge, according to Dr. Maloney. In some endeavors, using a trial-and-error approach, taking two steps forward and one step back is acceptable; however, doing so in the medical profession is not an option for physicians.

“First, ‘do no harm’ tells us that we need to go about this differently. That is why LASIK is such a worrisome prescedent,” Dr. Maloney said.

According to Dr. Maloney, in 1995, radial keratotomy could correct about 6 D or 7 D of myopia. “Instead of taking that into consideration with LASIK and saying, ‘Let us see how well we do if we go to 8 D, then 9 D and so on,’ we took a collective leap to 20 D and then we spent a decade back peddling from unexpected complications, only to arrive now at 7 D or 8 D,” he said. “That was an ethical failure that we must be sure is not repeated with pseudophakic presbyopia correction.”

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William F. Maloney, MD, is head of Eye Surgery Associates of Vista, Calif., and a well-known teacher of cataract and lens-based refractive surgery techniques. He can be reached at 2023 West Vista Way, Suite A, Vista, CA 92083; e-mail: maloneyeye@yahoo.com. In the interest of objectivity, Dr. Maloney has no financial interest in any ophthalmic product and has no financial relationship with any ophthalmic company.