Comanaging Refractive Surgery Patients (Part 2)

By Paul Weber, JD
OMIC Risk Manager

[Digest, Winter, 2000]

Bilateral simultaneous LASIK surgery is being offered in Canada for as low as U.S. $999, and American citizens are traveling across the border to take advantage of these alleged “savings.” Various scenarios are now arising in which ophthalmologists in the United States are being asked to provide preoperative and/or postoperative care to these patients. This column addresses some of the risks arising from this new form of comanagement.

Q What are the risks of providing preop and postop care to patients who have surgery in Canada?
A Anytime you enter into an arrangement with a LASIK patient to provide preop and postop care, you are exposing yourself to a possible claim for care you provide that may “cause” or “contribute to” a poor outcome or result. Sometimes it is unclear exactly what caused an “injury” or contributed to a poor result in a LASIK patient. The U.S. ophthalmologist may not know details of the actual surgery (flap thickness, residual bed, etc.). Was it poor surgical technique by the Canadian surgeon? Was it an improper work-up and poor patient selection by the U.S. ophthalmologist? In most states in the U.S., a physician who causes or contributes to an injury can be held liable for negligence. Under the theory of negligent referral, an ophthalmologist in the U.S. can be held liable for the surgical error of a Canadian physician or laser center if the U.S. ophthalmologist actively referred patients to the Canadian physician or center.

Q Can a Canadian physician be sued in a United States court for medical malpractice?
A As a practical matter, it is not likely that a Canadian physician will be sued in the United States for medical malpractice. American courts usually have no jurisdiction over foreign citizens residing outside the U.S., and plaintiff lawyers, who sue physicians on a contingency fee basis, are simply not going to spend a great deal of time chasing a foreign defendant if there is a more readily accessible defendant. If a patient has a poor result after LASIK surgery performed in Canada, the U.S. ophthalmologist who provided the preop or postop care is the most likely target defendant.

Q What can I do to minimize my risk of a claim if I see patients pre and postoperatively who are having LASIK surgery in Canada?
A The most important issue to address with these patients is the scope of care that you agree to provide as well as that which you specifically do not agree to provide. To avoid any misunderstandings, there must be a very carefully drafted informed consent document stating that you are only providing pre and postoperative care and delineating what that care entails. Include a disclaimer statement that you take no responsibility for the outcome of the surgery or surgical services provided in Canada and inform the patient that regulatory oversight and safety guidelines differ in Canada. It is important to realize that even though you are not performing the surgery, you are deciding during the preop evaluation whether the patient is a good candidate for LASIK. Therefore, an informed consent discussion should take place in your office and the patient should sign a document informing of the risks, benefits, and alternatives to the procedure. Otherwise, the patient can claim that it was below the standard of care not to warn of these risks since you knew the preop evaluation was specifically for the purpose of LASIK surgery.

Q Am I required to provide postoperative care to a LASIK surgery patient who simply makes an appointment with my office?
A Even if you already have an established relationship with a patient, there is no “duty” to take on the postop care of another surgeon whether surgery was performed in Canada or the U.S. you do decide to see the patient, all the risks discussed above apply and you will need a carefully written informed consent document defining what postoperative care will and will not be provided.

Q Should I treat a patient who has had a complication or poor result from surgery in Canada?
A This situation is more problematic than the patient who simply shows up for routine postoperative care. First advise the patient of the option of returning to the surgeon for treatment of the complication or enhancement. This may not be possible if the patient presents with an emergent problem requiring immediate treatment; however, once the problem is stabilized, the patient should be advised of this option. If the patient prefers to have you provide further surgery, you must have a comprehensive informed consent discussion to evaluate whether the patient has reasonable expectations and is likely to be a cooperative participant in his or her follow-up care.

Comanaging Refractive Surgery Patients (Part 3)

By Paul Weber, JD
OMIC Risk Manager

[Digest, Spring, 2000]

Some managed care patients who have LASIK at high volume/low cost surgery centers, particularly those outside the United States, attempt to return to their regular ophthalmologist for postoperative care. This is an emerging concern for many ophthalmologists, some of whom believe that by providing postop care, they are rewarding the patient for finding the cheapest surgical deal. Others are afraid that the patient may be unhappy with the surgical outcome and in a litigious state of mind. Although it may seem objectionable to treat these patients, it is necessary to analyze each situation before refusing treatment to avoid exposure to claims of breach of contract or malpractice.

Q Am I obligated to provide postop care to patients who had an elective procedure outside their managed care health plan?
A First analyze the “included and excluded services” in the managed care contract. If it is a capitated contract, there may be exclusions for complications or care following a non-covered service (LASIK, PRK, etc.) delivered outside the plan. Under a capitated contract, it is possible you would have to see the patient and not be compensated beyond the capitated fee you would ordinarily receive under the contract. Unfortunately, postop care can sometimes take up quite a bit of an ophthalmologist’s time, especially if the patient has a complication. If this is not a capitated contract but a reduced fee for service, the contract still controls whether or not you are required to see the patient; however, you would be able to charge your customary reduced fee for services provided.

Q If a patient is referred to me by a primary care physician (PCP), can I ask the PCP to refer the patient to another ophthalmologist in the network?
A This may seem to be an appropriate option, but it needs to be considered carefully since there is a chance of straining the referral relationship. “It is crucial that the ophthalmologist personally speak with the PCP and explain the problem. He can’t just send the patient back, and he can’t have one of the staff call the PCP’s office to talk to a staffer in that practice. It must be physician to physician.” (Gil Weber, April 25, 2000.) Also, there is a risk in simply assuming that the patient’s complaint or reason for referral is solely related to refractive surgery. It may be prudent to see the patient to avoid running the risk of missing a problem unrelated to the refractive surgery.

Q What are my risks if I refuse to see a managed care patient for LASIK postoperative care?
A If you refuse to see a managed care patient, you may be in breach of the managed care contract and risk exposure to contractual damages as set forth in the agreement and/or regulatory action. If you refuse to see a patient who has a specific clinical problem, there is risk of exposure to a medical malpractice lawsuit for delaying or failing to provide treatment.

Q Do I have to provide enhancements to managed care patients who had refractive surgery outside the plan?
A If the patient needs an enhancement to an elective surgery not covered by the health plan, you probably are not obligated to provide such care.

Q Can I encourage managed care patients to go back to the surgeon who performed the procedure?
A You may encourage a patient to go back to the surgeon who performed the original procedure; however, as a practical matter, the surgeon may be in Canada or otherwise not be accessible. In any case, it is prudent to document that the patient was given the choice of returning to the original surgeon but elected not to. OMIC’s model form, Assumption of LASIK Post-Op Care, was created for situations involving American patients who have refractive surgery in Canada but can be adapted for use with any managed care patient by amending the last paragraph concerning fees.

The recent publication of the joint position paper on ophthalmic postoperative care by the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgery again draws attention to the importance of documenting that patients were properly informed and consented to post-operative care being provided by someone other than the operative surgeon. OMIC addressed this issue in the Fall 1999 Digest, and OMIC’s model form, Confirmation of Postoperative Comanagement Selection by the Ophthalmologist, can be used to document the patient’s understanding of comanagement of postoperative care. Please contact the Risk Management Department at (800) 562-4652 or riskmanagement@omic.com to request this form or Assumption of LASIK Post-Op Care form.

Paul Weber acknowledges and greatly appreciates the comprehensive analysis of this issue by Gil Weber, MBA, a managed care consultant who can be reached at www.gilweber.com for more information regarding comanagement and other managed care issues.

Informed Consent and Elective Procedures

By Paul Weber, JD, OMIC Risk Manager [Digest, Fall 2001]

The majority of ophthalmologists at a recent OMIC risk management seminar (73%) agreed that elective surgery patients are more likely to sue their surgeon than other patients. Of the more than 300 ophthalmologists in attendance, 64% agreed that physicians have legal duty to determine if an elective surgery patient has “realistic expectations” of what surgery can accomplish. Why do patients who undergo elective surgery seem to present a greater liability risk than other patients? What steps can be taken during the informed consent process to better understand these patients’ expectations?

Q  What characteristics of elective surgery patients impact the informed consent process?

A  Elective surgery patients rarely have a vision threatening condition or compelling clinical reason to undergo the procedure. If things go wrong, it is not unusual for them to claim that the ophthalmologist persuaded or cajoled them into having surgery. Ask elective surgery patients to write on the informed consent document or in the chart itself their own personal reasons for having surgery. This helps them acknowledge their primary role in the decision-making process and makes it difficult for them to later claim that the only reason they went forward with the surgery was because of the “undue influence” of the ophthalmologist and staff. Another factor that distinguishes elective surgery patients is that most elective procedures are not covered by health insurance so patients pay out of pocket. This can become problematic if the patient needs an enhancement or revision after the initial surgery. The informed consent process document should specifically state the possibility of future procedures (enhancements/revisions) to get the desired result or to deal with the complications. The fact that there will be additional costs associated with further treatment should be addressed and documented before embarking upon any elective surgery.

Q What impact does advertising have on informed consent?

A Your own advertising and marketing materials will be brought into court if a lawsuit arises. If a statement in your ad conflicts with your informed consent document, that conflict will be raised as evidence that the patient was not properly informed. OMIC considers refractive surgery advertising such a potentially problematic issue that as part of being underwritten for refractive procedures, insureds must submit their advertising and marketing materials to OMIC for review prior to publication. Insureds who have questions about the appropriateness of their advertising should contact the Risk Management Department at (800) 562-6642, ext. 652.

Q How can I determine if a patient has unrealistic expectations?

A There is no substitute for spending time with a patient to find out what he or she expects from surgery. One busy refractive surgeon makes it a point to ask each patient, “What is the most important thing about your vision?” This helps him to determine if he can deliver what the patient wants. During one pre-LASIK interview of a seemingly perfect candidate, a 58-year old -6.00 D, he discovered that the patient’s favorite hobby was tying flies and that he had won championships in it. To tie them, he had to take off his glasses and work about eight inches in front of his face. When asked what he considered especially important about his vision, the patient replied, “I really like how good my vision is right here.” Had they not had this discussion, this important fact would not have been revealed and the surgeon could have been exposed to a claim of failure to provide informed consent if the patient lost his vision after LASIK.

Q Is there a duty to inform the patient about how postoperative care will be handled?

A Postoperative co-management issues often arise in the context of refractive surgery. If it is known in advance that some portion of the postoperative care will be handled by another provider, this should be communicated to the patient. Many times, a patient chooses to have an elective procedure performed by a particular surgeon and has the reasonable expectation that the surgeon will handle the postoperative care. When this is not the case, the patient may be disappointed and upset, especially if there is a complication or concern about the result. Prior to surgery, the patient should understand and consent to the handling of postoperative care by health care providers other than the surgeon.

Q How should informed consent be handled for off-label procedures?

A It is not uncommon for refractive and cosmetic surgeons to use a drug or device in a manner that has not been approved by the FDA. In such cases, the patient should be informed of the nature of the technique, its scientific basis, its benefits, and any possible drawbacks or criticisms from other practitioners. Other options should be discussed, and the patient should be encouraged to seek a second opinion before proceeding.

Charting the Perils of LASIK Comanagement

By Richard F. Callaway, Jr., Esq.

Mr. Callaway is a medical malpractice defense attorney and partner in the Houston law firm of Callaway & Brennig. He represents physicians and other health care providers in professional liability claims. The case study presented is not an OMIC case.

[Digest, Fall, 2002]

Beth, a middle aged woman, had worn glasses since she was six years old. She had tried every brand of contact lens on the market from RGP to extended wear without success. LASIK surgery seemed to be the answer to Beth’s problems. For ten years, she had seen an optometrist for her eye care. She genuinely liked the optometrist, so much so that she sought his care even after she sued him. Over the years, the optometrist had diligently compiled a significant patient history, including annual topographies of Beth’s corneas taken since 1995. Although he was not well trained in their interpretation, he used them to fit Beth’s contact lenses. His inability to interpret topographies was no uncommon given the widespread use of non-standardized topographies. Beth’s topographies were stored electronically on the optometrist’s office computer where they were available in sagittal, tangential, and numeric form, but they were not part of Beth’s chart.

Beth’s optometrist thought she was a good candidate for LASIK. No ocular surface diseases, such as keratoconus, had been detected in any of the optometrist’s regular slit lamp examinations. In 1998, he referred Beth to a highly regarded refractive surgeon for preoperative evaluation. Shortly before the appointment, the optometrist transmitted a brief patient history to the surgeon for the six months preceding the referral using a comanagement form provided by the LASIK center where the surgeon operated. He included Beth’s current refraction, information regarding past visual stability, and topographical maps in numeric form taken two weeks before the referral. The maps, one for each eye, were faxed to the surgeon’s office.

The refractive surgeon performed his own preoperative workup. He checked refraction, measure central corneal thickness, and obtained a history of ocular surface and systemic diseases. All tests were within normal range. Topographies were made using a refractive map and revealed a normal cornea. There was no clinical sign of ocular disease on slit lamp examination. Bilateral simultaneous LASIK surgery performed shortly after the preoperative evaluation. Postoperatively, the patient developed iatrogenic keratectasia. Although Beth’s vision was correctable to 20/25 with RGP, she was contact lens intolerant and eventually had to have bilateral corneal transplants. She soon found a lawyer.

Although Beth had orally consented to comanagement, she had not signed an informed consent acknowledging comanagement. Obviously unhappy with the results of LASIK, Beth sued the optometrist and refractive surgeon alleging, in part, negligent screening and failure to explain the plan to “comanage.” In her suit, Beth maintained she had never consented to and had never fully understood comanagement. There was no written informed consent to contradict Beth.

Worse, after suit was filed, the optometrist produced for the first time his complete patient chart containing more than 125 pages of Beth’s history and four years of successive annual color-coded topographical maps in both tangential and sagittal form. The refractive surgeon was shocked to learn this information existed. He was doubly shocked to see successive annual color-coded topographies in tangential and saggital form that were suggestive of an abnormal cornea. In fact, Beth had subclinical pellucid marginal degeneration that could not be detected in the surgeon’s preop workup. Now that suit had been filed, Beth’s entire history came into play.

Comanagement’s Impact on Litigation

In any LASIK lawsuit, comanagement is the simplest issue for lawyers to understand and master. So much has been written about the comanagement question by the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgeons (ASCRS) that lawyers now have a formidable armamentarium of issues and conflicts to exploit. While technical violation of the ethical suggestions and standards contained in the AAO/ASCRS Joint Position Paper may not equate to a violation of the standard of care, the danger is that the issue will get before the jury were the impact can be devastating.

Discovery regarding a patient’s allegations of comanagement leads, inevitably, to a veritable host of litigation horrors, including requests to produce information from patient files concerning fee allocations for the services rendered; inquiries into corresponding increases in comanagement fee and patient load; investigation of the practice protocols of the comanaging optometrist and refractive surgeon; depositions of principals and office personnel; evaluation of the quality and quantity of information in patient charts; and comparison of the surgeon’s comanagement fees with those of other surgeons in the are. The danger in any suit is that the refractive surgeon and the optometrist may be thought of as each other’s agent, as a single entity, or as joint venturers. Liability may attach to the refractive surgeon who has met the standard of care for no reason other than that the comanager is not knowledgeable about recognizing and treating post-LASIK complications or in interpreting preoperative topographies.

Comanagement Chart Audit

To determine the quality and quantity of information in comanagement files, Callaway & Brennig conducted an audit of 179 files from 48 optometrists who referred patients to refractive surgeons throughout 1998. Files were reviewed for information concerning 1) patient histories, 2) corneal topographies, 3) current and past refraction, and 4) preoperative examination. Many of the optometrist practiced in groups, but the groups appear to have had no standard procedures regarding the transmittal of information. Most comanaging optometrists had attended meetings, either individually or in groups, with the refractive surgeons with whom they comanaged. The surgeon’s desire to acquire “all relevant information” was emphasized at all times. Similar requests to furnish “relevant information” were made to office personnel. There was frequent mention of the need for records and conversations between the respective offices of the refractive surgeons and the comanaging optometrists.

Patient Histories

Only 17 of the 170 files contained any historical information about the patient. It has been estimated that the decision to undergo LASIK surgery is an eight-month process from initial consideration to the date of surgery, suggesting there is more patient history in the optometrists’ records than is being sent to the surgeons. The refractive surgeon cannot know whether records exist in a comanagement arrangement; all the surgeon can do is request records.

Corneal Topographies

Of 179 files, 71 (40%) contained topographical maps, 60 of which were of little additional diagnostic value to the surgeon because they were taken less than a month before LASIK surgery. Only 11 charts had corneal topographies more than a month old. More important, the vast majority of topographies (60) were faxed to the referring surgeon, rendering their color-coded features impossible to interpret when they emerged in black and white from the refractive surgeon’s fax machine. Only 10 charts contained color maps; from a historical perspective, these maps were not useful for comparison and detection of abnormality since they were taken within a month of surgery. Only one chart contained a color topographical map that had been made more than a month prior to surgery. Further complicating the problem, review of the files revealed that relatively few comanaging optometrists used topographical maps and scales that were consistent with those used for preoperative evaluation by the refractive surgeon.

One good preoperative topographical map, made by a well-trained person using a good machine, is almost always adequate to detect pathology. For that reason, a long series of topographical maps is not needed to detect most pathologies. The refractive surgeon should do a topographical map as part of the preop evaluation. Where the optometrist has also made topographical maps, those topographies should be transmitted to the surgeon before the preop exam in a form that is legible and with real diagnostic value.

Current and Past Refraction

While 163 files contained information on current, refraction, only 12 supplied information on past refraction. This is a serious omission because stable refraction is a fundamental requirement for LASIK. In the absence of historical information regarding past stable refraction, the refractive surgeon must depend solely on the patient’s word that his or her spectacle prescription has not changed within the last two years.

Preop Exam and Information Sharing

Half of the 179 charts contained information regarding a preoperative examination. It is probable that most optometrists performed slit lamp examinations, but they failed to document those examinations in information sent to the refractive surgeon. Compounding this lack of information sharing was the fact that bilateral simultaneous LASIK generally occurred within a week of the preoperative evaluation by the optometrist, which often was not enough time for the surgeon to receive the patient’s file form the optometrist.

No one can anticipate all the contingencies that might arise in a comanagement arrangement, but standardized procedures designed to ensure the transmittal of relevant patient information would improve comanagement, benefit that patient, and in the event of litigation, assist the comanager and counsel in defending claims of negligent comanagement.

Beth’s case was settled, so we will never knowing if the jury would have penalized the refractive surgeon for not know that a voluminous ten-year chart, including topographical maps stored on computer, existed in the optometrist’s office.

* * *

Protocol for Comanagement of Refractive Patients

The following SLEDOG Protocol for comanaging optometrists and refractive surgeons was developed by Callaway & Brennig

Simple mandatory procedures should be followed and shared with the comanaging optometrist. Each comanager should sign off on the following: refraction, central corneal thickness, pupil size (and how it is measured), ocular surface/systemic diseases, and topography. The refractive surgeon must see the patient for the first postop visit and be clear about the subsequent postop care to be provided by the optometrist.

Letters to comanaging optometrists should be written at the time of referral to request all relevant patient information. Such letters document that a system is in place to retrieve patient information.

Emphasize these simple mandatory procedures at meetings with comanaging optometrists.

Document your file. OMIC provides an informed consent form specifically for comanagement situations. The form simply requires the patient to acknowledge the comanagement arrangement.

Office personnel continuity should be maintained at all costs. Not only can a disgruntled former employee significantly strengthen a plaintiff’s case, but an office in turmoil is one that makes mistakes.

Give specific persons in your office responsibility for obtaining information about patients who have been referred by comanaging optometrists. While everyone should be generally aware of your simple mandatory procedures, designate one or two employees with specific responsibility for obtaining records. If a lawsuit is ever filed, their testimony will play better before the jury than the testimony of several employees, none of whom is completely familiar with your procedures and process.

Take the Risk Out of Contact Lenses

By Oksana Mensheha, MD

Argus, August, 1991

 It is estimated that approximately 25 million people in the United States wear contact lenses. Historically, ophthalmologists were cautious in prescribing this modality to correct refractive errors; they feared that hard lenses might cause possible damage to the eye. We now know that severe side effects rarely occur. But when they do, they may be quite serious and could theoretically lead to liability actions.

With so many people wearing contacts, familiarity sometimes leads to carelessness. This is particularly true of younger patients. As myopes under the age of 14 move into contact lens wear, there is a greater possibility for complications. Liability for contact lens fitting in children also is greater since children maintain a longer time period during which they can bring a suit against a physician. Parental consent should always be obtained before fitting patients under 18.

One of the primary risk management issues in contact lens fittings relates to the physician’s duty to disclose potential risks and alternatives. Side effects of contact lens wear differ for rigid and soft lenses. Problems with rigid lenses may include intolerance, corneal edema with ulceration, blurred vision due to poor wetting, keratoconus from lens warpage, irritation from chipped or broken lenses, corneal flattening, and an inability to see well with glasses. Problems with soft lenses may include irritation from solutions or protein build-up, giant papillary conjunctivitis and, rarely, severe and potentially blinding corneal infections such as those caused by Endamoeba histolytica.

One way to reduce potential liability exposure is through increased patient education activities. Infections complicating contact lens wear usually occur from a breakdown in hygiene. Hand washing must be carefully taught, and the use of sterile solutions to disinfect or clean lenses is a must. Enzyme tablets, for example, are to be dissolved only in sterile solutions, preferably in aerosol form, not in unsterile tap water nor in bottled distilled water.

To aid your patient and to protect yourself, be sure to provide each new contact lens wearer with written information on the risks and care of contact lenses. Personally instruct each patient about the hygiene of contact lens care and, before the lenses are purchased, explain the cost of fitting. Stress the need for routine follow-up care on a regular basis. It is of critical importance that you document in the patient’s record that such information was given. Some ophthalmologists have even developed an informed consent sheet that their contact lens patients must sign. Documentation-related problems continue to be the single most significant risk management concern in ophthalmic malpractice claims.

Infections from contact lenses have been shown to be a greater problem with all soft lenses, but particularly with extended wear lenses. Disposable lenses have not decreased this risk. Again, the risk here is greater for children who are more active, tend to play in a more contaminated environment, and are less likely to practice good hygiene with their lenses.

Patient anger and poor physician-patient communications contributed to one OMIC malpractice claim involving contact lens fitting. Although the patient was unable to wear her contact lenses, she was aggressively pursued for collection of the final portion of her bill. Communication between the ophthalmologist and patient broke down, and the patient felt her only recourse to get her doctor’s attention was to sue. A few patients do not tolerate contact lenses well even when they are fitted properly. Such cases are disappointing to both the doctor and the patient. The resolution of charges for unsuccessful results should be approached with kindness and compassion.

As a general rule, contact lens wear is popular and appreciated by many patients. Ophthalmologists should nonetheless be sensitive to those areas of potential liability relating to prescribing and fitting contact lenses. Communication with patients, disclosure of risks and alternatives, emphasis on proper hygiene and follow-up care, plus a compassionate approach to the problems of contact lens wear help lower physician liability and contribute to improving long-term patient-physician rapport.