Presbyopia correction at the time of cataract surgery poses ethical challenge

At a special session held during the OSN New York Symposium, one surgeon cautioned not to overcharge for refractive services associated with presbyopia-correcting IOLs.

NEW YORK — The use of presbyopia-correcting IOLs in conjunction with cataract surgery presents tremendous promise but at the same time one of the “greatest ethical challenges” ophthalmologists have faced in recent years, according to William F. Maloney, MD.

William F. Maloney

Because of the leeway allowed by a somewhat ambiguous ruling set forth by the Centers for Medicare and Medicaid Services, ophthalmologists may be tempted to overcharge for the refractive services associated with presbyopia-correcting IOL implantation, in order to compensate for perceived underpayment by Medicare for cataract surgery, Dr. Maloney noted. But surgeons must resist that urge, both because it is ethically right and because overcharging may come under scrutiny from federal regulators, he said.

Dr. Maloney spoke on the topic in a session called “Incorporating Presbyopic IOLs into your Practice” during the OSN New York Symposium.

“The historic separation of the covered and noncovered fees is a dramatic departure from everything we have come to know and expect from CMS, at least in my lifetime,” Dr. Maloney said. “It is the basis for a significant financial turnaround. The irony is that this financial turnaround, or at least its potential, is also the thing that presents for us one of the greatest ethical challenges we have had to confront in a generation or more.”

Dr. Maloney began his presentation by explaining that he initially declined when asked to speak about the ethics of presbyopia correction.

“I am no evangelist, and I also do not claim any ethical high ground on these issues, but when I started to think about this, I realized how important these ethical issues are from a standpoint of our own long-term interests, and that is the perspective from which I am speaking,” Dr. Maloney said. “This is the real deal. This has huge long-term potential. We ought not to squander it.”

Balanced billing scrutiny

The CMS ruling in May 2005 divided the implantation of a presbyopia-correcting IOL into covered and noncovered portions. When appropriate noncovered services are provided in relation to the implantation of the IOL, the physician and facility may bill the patient for those noncovered services. CMS covers only those charges and materials involved in the implantation of a standard IOL.

The language of the ruling states that “additional physician work and resources for inserting, fitting, and visual acuity testing of presbyopia-correcting IOLs” may be billed to the patient. However, the ruling provides little guidance other than stating that the charges must “reasonably reflect” the value of the additional services provided, Dr. Maloney pointed out.

“This ruling represents such a dramatic departure that, at the very least, we need to understand that it will be closely scrutinized, and I can tell you it is being closely scrutinized,” he said.

The basic issue is that surgeons must not inflate their billing for the noncovered services charges to compensate for decreases in compensation for covered services that have taken place over the past decade and more, he said.

“At the same time, however, we know CMS has said, ‘We maintain no oversight on these non-covered charges.’ In fact, recently they have become more explicit to say they will not set those charges,” he said.

This does not give surgeons freedom to charge for services arbitrarily, he emphasized.

“Whether it is explicit or not, and whether CMS realizes it yet or not, the reality is that these fees will always be reviewable by CMS, and they must always be viewed as reasonable, de facto,” Dr. Maloney said. “This is a situation that calls for tactical restraint on our part, collectively. That is what is in our own best interest right now because those questions will be answered soon enough.”

Redefining cataract surgery

When a single procedure includes both covered and noncovered services, there is a “new calculus” that goes along with the diagnosis of cataract, Dr. Maloney said.

“Suddenly, that diagnosis becomes a candidate for presbyopia correction. As a result, our justification for cataract surgery needs to be unassailable, more than ever,” he said. “That happens at the very same time that the criteria we use are changing dramatically.”

Snellen acuity and glare are being de-emphasized by some surgeons as justification of the need for cataract surgery, and functional status of the patient is being used more often, he said.

“In many cases, it has been left to simply the symptoms of the patient to justify a visually significant cataract,” Dr. Maloney said. “That means we need to change our approach to documentation.”

Permanent medical records for cataract patients should include a questionnaire or some written record of patient symptoms or documentation of lifestyle disability, and the request for surgery from the patient should be in writing, Dr. Maloney said.

Informed consent

“Informed consent is an issue that is rapidly changing,” he added. “We need to fully evaluate every alternative for these patients, not just the one lens we may be most comfortable with.”

Patients view their physicians as their “professional Consumer Reports,” Dr. Maloney said.

“They expect us to assess their needs and present to them the alternative that is best for them,” he said. “They expect to be advised according to their needs, not ours.”

Patients must be told that this presbyopia-correcting procedure is “not medically necessary” and that their cataract procedure will have the same quality outcome regardless of whether they elect to have the presbyopia correction component performed, he said.

Do no harm

Lastly, Dr. Maloney cautioned surgeons not to become “overeager” with presbyopia correction, as some members of the profession did with LASIK in the 1990s.

“When LASIK came along, we should have moved to 8 D of correction and then 9 D and so on. Instead, we took a collective leap to over 20 D of correction and spent the next decade back-pedaling from unanticipated complications, only to arrive back at 8 D, where we sit today,” Dr. Maloney said. “LASIK was unquestionably an important step forward qualitatively, but in taking that step, we lost our way in terms of our professional ethics, and I think we need to face that fact unflinchingly.”

Trial and error is not an option this time, he said.

“‘First do no harm’ does not calculate some ratio of success to failure. It focuses sharply on the unnecessary element of this unfortunate incident,” Dr. Maloney said. “Two steps forward and one step back may be okay when you are learning to change a fuel pump. For us, it is unethical, and that is why the LASIK precedent is worrisome in my view.”

LASIK unfolded against a financial background similar to today, Dr. Maloney said, with many practitioners looking for a way to achieve more practice income that is not dependent on Medicare.

“LASIK was considered one of those financial quick fixes, and thus we were overeager. We need to be sure we do not make the same mistake with presbyopia correction,” he said.

For more information:

• William F. Maloney, MD, is head of Maloney Eye Center 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.

• Daniele Cruz is an OSN Staff Writer who covers all aspects of ophthalmology, focusing on optics, refraction and contact lenses.