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September 2007

 
Feature
High Road Ethics for a High-Tech Era
By Miriam Karmel, Contributing Writer
 
 

Any physician in practice today can be confronted with a challenging ethical question. But the new technologies of cataract and refractive surgery may present an especially complicated—and potentially rewarding—situation.

The dissatisfied patient is nothing new. But last April, following a recent uptick in complaints from angry and disappointed patients, the Academy’s Ethics Committee issued an alert urging doctors to be more mindful of their ethical obligations.

The alert, which is posted here, addressed complaints from patients claiming they hadn’t been adequately informed of the potential visual side effects associated with multifocal or accommodating intraocular lenses. “There’s a perception that experienced cataract surgeons are not increasing their attention to assessment of patient need, and to the learning curve,” said Charles M. Zacks, MD. “That’s resulting in more unhappy refractive patients than ever.” Dr. Zacks, who chairs the Ethics Committee and practices cornea medicine in Portland, Maine, called this “a very big problem. Particularly if patients feel they weren’t adequately informed.”

The prospect for ethical challenges may be especially relevant for the new, high-tech IOLs, but the principles they invoke—informed consent, primacy of the patient’s interest and respect for the learning curve—apply whenever a physician tries incorporating new procedures or technology into clinical practice.

“There’s a lot of new technology in most of the subspecialty fields in ophthalmology,” said Richard L. Abbott, MD, professor of ophthalmology at the University of California, San Francisco. “The challenge, ethically, is which technology to embrace? Where do you draw the line between offering the newest technology over a long-standing proven device or procedure? The bottom line should always be what is in the best interest of your patient.”

More Options Mean More Chair Time

When monofocal IOLs were the only choice, the nature of pseudophakic vision was relatively easy to explain. Now patients have multiple options, which require more discussion and tougher decisions. It’s the surgeon’s responsibility, said Dr. Zacks, to give the patient a realistic impression of what these lenses will and won’t do. Will distance or near vision be important to the patient? How will the patient feel about wearing reading glasses? “Everything’s a trade-off in optics. These lenses can compromise contrast sensitivity and other optical qualities in exchange for multifocality. The patient needs to know the advantages and disadvantages of the lens they’re going to get, in unvarnished terms. Fitting the available technology to the patient is really the goal.”

“If doctors aren’t willing to put time in both before surgery, in terms of education and evaluation, and after, in terms of management to optimize the final result, they shouldn’t be using these lenses.”

Preop hopes meet postop reality. Patients whose expectations aren’t met can be extremely unhappy, said William W. Culbertson, MD, professor of ophthalmology at Bascom Palmer Eye Institute and a member of the Ethics Committee. Take the case of the myopic engineer, a woman in her 50s, who’d been accustomed to taking off her glasses to read the fine print on drawings. Following surgery, her reading varied under different lighting conditions, she could no longer read closely without glasses, and halos put an end to her night driving, said Dr. Culbertson, who saw her by referral. The woman claimed she didn’t know she had multifocal lenses until an optometrist examined her eyes. Perhaps her ophthalmologist had told her, but postoperatively she didn’t recall being told anything about multifocal lenses or their potential optical side effects, Dr. Culbertson said. The point is, she hadn’t been adequately informed of the drawbacks.

“I’m not putting down these lenses,” added Dr. Culbertson, who uses them. “They’re very helpful. But the patient needs to clearly know what’s going on, which takes more chair time,” he said. “You can partially off-load it to brochures and videos and patient counselors. In the end, it comes down to the doctor helping the patient make the best choice and answering all the patient’s questions. If doctors aren’t willing to put time in both before surgery, in terms of education and evaluation, and after, in terms of management to optimize the final result, they shouldn’t be using these lenses.”

New Isn’t Always “Best”

And yet some doctors do regard every patient as a candidate for the new lenses, said Marian S. Macsai, MD, professor and vice chairwoman of ophthalmology, Northwestern University, and chief of ophthalmology, Evanston Northwestern Health Care. She senses “an urgency in the air” to put multifocal lenses into as many patients as possible, as well as an attitude that the cataract surgeon who isn’t using these lenses is behind the times.

Recently, Dr. Macsai heard a doctor say that his goal is “100 percent conversion.” In other words, he would like every one of his patients who comes in with a cataract to walk out with a premium lens upgrade. But these lenses are not for everybody, Dr. Macsai said. There’s no reason, for example, for a doctor to urge multifocal IOLs in a person who doesn’t mind wearing glasses, or for a person whose livelihood depends on driving at night. Similarly, she said, the lenses aren’t suitable for patients who are impaired by other disease, such as age-related macular degneration or diabetic retinopathy, since they lack the visual potential to benefit from multifocals.

When there’s not even a cataract. Then there’s the matter of clear lens exchange. “I’m not sure we should be whipping out lenses of normal people because the technology exists and we want to make money. That’s just not a good enough reason,” Dr. Macsai said. Having said that, she acknowledged a place for them in the armamentarium. “For some patients they’re fabulous. It’s just, ‘Slow down everybody! Make sure we’re doing what’s best for our patients and not our pocketbooks.’”

Physician comfort with the technology. The new technology or device should also be what’s best for the physician in terms of philosophy and comfort level with adopting new procedures. Some physicians adopt new practices more readily than others. “There’s a tension between trying new things, pushing the envelope and what’s safe for the patient,” said Ruth D. Williams, MD, a glaucoma specialist in private practice in Wheaton, Ill. Dr. Williams added that glaucoma specialists, for example, are always trying to think of new ways to do filtering surgery. “When you have a patient in front of you, the question is, ‘We have a gold standard in trabeculectomy, and a gold standard in putting in valves. What are the parameters that make it reasonable to try something else that’s not as proven?’”

In part, the answer rests with personality as well as with responsibility. “Some [physicians] always want to try new things, others want the tried, true and proven. People are different. We need both. Our community needs both,” said Dr. Williams.

Dr. Abbott agrees that some ophthalmologists are greater risk takers than others. “Does that mean they’re doing a better job for their patients? I don’t know. Everybody needs to look within and determine what is his or her own personal comfort level,” he said. “In all cases, however, the bottom line is patient-centered.”

ETHICAL PROBLEM, OR LEGAL?

Dr. Abbott draws a distinction between the ethical concerns that may arise when incorporating new surgical techniques into clinical practice, and the legal.

On the ethical side are the learning curve, patient selection, informed consent and disclosure of experience. Yet any of these may spill over into the risk management, or legal, side and its concerns: failure to document in the medical record; failure to demonstrate proof of learning; failure to demonstrate a graded, cautious approach; and ineffective management of an unanticipated outcome.

“You can mislead a patient as far as your experience. They may ask a question and you may dodge it. That would be an ethical problem,” explained OMIC’s Mr. Weber. It’s a legal problem, he said, when the doctor uses a laser without adequate training, and harms the patient.

Though ethical issues are infrequently the basis of claims against OMIC’s insured, Mr. Weber said that they can exacerbate a claim. A plaintiff’s attorney might exploit an ethical breach to show that the doctor wasn’t honest and forthcoming, making the case more difficult to defend, he said. In other words, when something goes wrong, the ethical lapse could compound a defendant’s problems.

Driving on the Learning Curve

Despite a physician’s personal preference about whether and when to adopt new procedures, marketplace influences and patient demand can put pressure on the physician. “There’s a lot of hype around new devices and new techniques,” said Dr. Abbott, who teaches ethics to ophthalmology residents. The hype, he says, may force a physician to move too quickly through the learning curve, particularly if he or she practices in an area where others have adopted the new procedure, and/or where patients are clamoring for it. “The challenge is deciding which technology or technique to embrace,” Dr. Abbott said. “You make that decision when you feel the new technology offers better outcomes for your patients.” The decision isn’t always easy, he added, particularly if the current technique yields good results, and the new technique threatens to increase the complication rate. “It’s a slow process. It’s a difficult process.”

“There’s a learning curve element. If you’re offering to do a procedure, you need to be practiced at it and competent.”

Dr. Zacks agrees. “We have the potential to really help patients with new technology, but we have to make sure that we offer it to patients who we believe will benefit, and that we do it competently,” he said. “Whenever we introduce a new technique, if substantively different from before, there’s a learning curve element. If you’re offering to do a procedure, you need to be practiced at it and competent.”

Up-to-date competence. Guidelines for meeting that competency challenge are outlined in an Academy advisory, Learning New Techniques After Residency.1 The step-by-step approach to advancing along the learning curve includes: attending oral presentations, studying the scientific literature, using interactive videos, taking courses that offer hands-on laboratory practice, and observing and assisting an experienced surgeon.

Ideally, the first few procedures are performed in the presence of a proctor, on patients for whom no difficulties are anticipated. Patient selection is a huge issue since a new technology isn’t necessarily applicable to each and every patient, Dr. Abbott said. “The physician has to look at his or her own abilities, has to look at the patients that he or she is considering doing this procedure on, has to look at pluses and minuses of the procedure, and then has to decide what the right time is to do that procedure and on which patients to do it.”

Truly, Deeply, Informed Consent

There is an obligation on the part of the physician to disclose to patients his or her experience level with a new technique or device. “If it’s the first procedure you’re doing on a patient, you look at it from the patient’s perspective. The patient would want to know,” said Paul Weber, JD, vice president of the risk management legal department at the Ophthalmic Mutual Insurance Company (OMIC). “Most people would say the reasonable patient would want to know that it’s your first procedure. When you get further out to the 10th procedure, there’s no bright line. It becomes a judgment call depending upon the patient and the procedure.”

The patient also needs to know if the technology is new. “There should be a statement about it in the informed consent material,” Mr. Weber said, adding, “The patient will generally go along with what the doctor suggests.”

Honesty breeds loyalty. Dr. Williams agrees. Before performing her first trabeculectomy in private practice, her patient asked how many she’d done. “‘You’re my first,’” she recalled telling him, and he accepted that. By that point, Dr. Williams had completed a fellowship and was thoroughly trained in the procedure. “The point of the story,” she said, “is that patients need for you to be totally honest with them.” This particular patient stayed with her for 12 years, until his death. “He was proud of being my first.”

She added that a lot of patients are willing to go first because they want to be on the cutting edge. “They want a doctor who is doing new things because it makes them think they have an important doctor,” Dr. Williams said. “But you have to tell them this is a new procedure.”

Elective surgery needs extra caution. Detailed disclosure may be even more imperative when the procedure is elective. For example, an 80-year-old with 20/60 vision may be delighted with a conventional lens that restores him to 20/25, thus enabling him to read and drive again, Dr. Zacks said. But the young executive who wants to tweak his vision with one of the heavily marketed new lenses is a candidate for disappointment, in part because “the public has come to expect remarkable outcomes,” he said. “The more elective the surgery, the more detailed that informed consent has to be, emphasizing the potential downside.”

OMIC’s Mr. Weber said inadequate informed consent is often the source of a patient’s discontent. “When you get into some of the elective procedures with new devices and drugs being utilized, for example LASIK or oculoplastics, the patient may claim that if they were informed this was the technology being used, and that [the technology] was new, then they would not have chosen to have the procedure,” he said.

Put the Money on the Table

Discussion of costs is imperative. Dr. Culbertson tells the story of a patient who complained that she hadn’t been adequately informed about the extra charge for implantation of a multifocal IOL. She understood that she was to pay extra for the lenses, but didn’t realize there would be additional noncovered services associated with the surgery. She felt she’d been deceived and overcharged.

In this case, said Dr. Culbertson, “The ethical problem is disclosure. The patient should know in advance what the extra charge is for and what it covers. Are there additional add-ons for making the limbal relaxing incisions? If the patient needs extra services, like LASIK or other fine-tuning procedures, is that covered or not? You have to explain the medical aspects of it and the financial aspects as well.”

ETHICAL OPHTHALMOLOGY IN THE BIG EASY

The Annual Meeting will offer at least nine hours of programming on ethics, including four Instruction Courses and five Breakfasts with Experts. The titles range from “The Five Most Effective Risk Prevention Strategies” to “Ethical Expert Witness Testimony: A Case-Based Approach.”

To review the entirety of ethics programming, including fees, times and room numbers, go to the meetings page of the Academy’s Web site (www.aao.org/meetings/annual_meeting) and click “Scientific Program,” then “Online Program,” then, under Topic, choose “Ethics” and click “Search.”

When the monofocal lens was the only choice, there wasn’t a need to explain extra costs. The fee was set, with all costs bundled into what a doctor could charge and collect. “The patient would get their surgery and get prescribed glasses afterward, maybe bifocals, to correct residual refractive care. There were no alternatives,” Dr. Culbertson said.

Win-win or lose-lose? “Now the genie’s out of the bottle,” he said, referring to the May 2005 CMS ruling, which relaxed the cataract reimbursement schedule. For the first time, Medicare patients willing to pay out-of-pocket could choose from an array of more costly lenses, and physicians could pass along additional costs to the patient. “So there is an economic incentive to quote ‘sell these lenses and convert patients,’” Dr. Culbertson said. One way to avoid misunderstanding is to have the patient sign a Notice of Exclusion From Medicare Benefits. The form, recommended by CMS and posted on its Web site (www.cms.hhs.gov/BNI/Downloads/CMS20007English.pdf), explains the patient’s financial liability. “It’s not mandatory,” Dr. Culbertson said, “but any documentation you can get that serves to clarify the costs and coverage to the patient is beneficial to everyone.”

Dr. Culbertson acknowledged that when things go right, “It’s potentially a win-win for everybody. The patient should get more value and the doctor gets more compensation.” But it’s potentially an ethical quagmire, too. “Every doctor has a conflict of interest when they recommend any surgery, even routine cataract surgery. So this is not new, except that the potential reimbursement is greater. Any time you recommend a service or operation to a patient that has some alternative, you’re potentially conflicted.”

“The hook,” as Dr. Zacks sees it, is the built-in financial incentive to sell these lenses. “Multifocals cost a lot and the patient pays out of pocket for the premium lens. [About $1,000 compared with $150 for monofocal lenses paid for by Medicare.] The doctor can profit mightily by selling premium lenses, particularly in an environment of diminished reimbursement.” Dr. Zacks’ advice: Be sure the lenses are in the patient’s best interest. “When you suggest a particular surgery or procedure, be sure that it’s for the patient’s benefit, not yours. The physician must always think of the patient and not what’s going on in the marketplace.”
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1 www.aao.org/about/ethics/upload/Learning_New_Techniques_5-4-07.pdf

MEET THE EXPERTS

Richard L. Abbott, MD
Professor of ophthalmology, University of California, San Francisco; chairman Underwriting Committee, OMIC; and secretary for Quality of Care and Knowledge Base Development at the Academy.

William W. Culbertson, MD
Professor of ophthalmology, Bascom Palmer Eye Institute, Miami, Fla.; and member of the Academy’s Ethics Committee.

Marian S. Macsai, MD
Professor and vice chairwoman of ophthalmology, Northwestern University; and chief of ophthalmology, Evanston Northwestern Health Care.

Paul Weber, JD
Vice president of the risk management legal department, Ophthalmic Mutual Insurance Company.

Ruth D. Williams, MD
Glaucoma specialist in private practice, Wheaton Eye Clinic, Wheaton, Ill.; and Academy secretary for Member Services.

Charles M. Zacks, MD
Cornea specialist in private practice, Maine Eye Center, Portland; and chairman of the Academy’s Ethics Committee.