Courts, community standards dictate use of technology

Issue: December 1996

To coincide with the special focus of this month's issue - "New Technology" - Primary Care Optometry News gathered a group of experts to discuss the impact of technology on the standard of care.

How is "standard of care" defined? Are you required to perform corneal topography on refractive surgery patients? Can a third-party payer dictate the use of technology of exonerate you from its use? Read on to find the answers.

Primary Care Optometry News: Has the standard of care become regionalized?

Michael G. Harris, OD, JD: It's important to point out that standard of care is a legal term having to do with whether an individual has practiced at a level commensurate with what the profession demands. Standard of care is not whether to use a particular instrument, it has more to do with what is appropriate practice, because the law does not require you to use a particular test. It does require you to do a reasonable and prudent examination with the appropriate testing procedures.

Jerome Sherman, OD: As far as regionalization, it seems we do have a national standard; mostly everything practiced in one state is practiced in another. Of course, certain individuals in large cities may have access to sophisticated gadgetry. I don't know if we can hold somebody in a small town, where that gadgetry is not available, responsible to that same standard.

Harris: The standard of care is indeed national. However, the law looks at what is known as the "community standard" in determining whether an individual has fulfilled his or her duty to the patient. You are compared to what prudent practitioners in your community would do under similar circumstances.

However, the community is no longer just the small town where you practice. It's the global community of eye care practitioners, both optometrists and ophthalmologists. If you don't have access to certain technology then you can't be expected to use it, but that doesn't excuse you from having to know what tests are appropriate and referring individuals to a place where that technology is available.

Pamela J. Miller, OD, JD: The standard of care is dependent on a variety of situations — not only what the community is doing, but what is being taught and what a certain judge may decide — so that it is one of those nebulous terms we all use, but there is no concrete standard, particularly with new technology.

J. James Thimons, OD: I believe there are significant differences in the nature and level of clinical practice in optometry nationwide because of marked differences in scope of practice and the legislative enactments that have been brought into place over the last 15 years or so. This has brought significantly greater experience and breadth of practice to optometrists in those states. For this reason, it is extremely difficult to define any type of standard of care on a national level.

PCON: Is it necessary when comanaging refractive surgery patients that they have preoperative corneal topography?

Sherman: I feel it is necessary. The clinician who does not have access to topography could refer to a facility that does.

Miller: It's advisable, but I would be hesitant to say it is mandatory. When you start saying something is mandatory, you start controlling how the law changes and now you have escalated the standard of care and the cost.

Thimons: I think it is extremely important that corneal topography be used when assessing the refractive surgery patient prior to the procedure. A reasonable number of patients may be identified as having asymptomatic abnormalities of corneal shapes such as keratoconus or other diseases. Also, there is a reasonable body of literature that supports its use for this purpose. Therefore, a general guideline concerning its use has been created and could be used against a practitioner in a malpractice setting if the test was not performed and the patient's results were less than desirable.

Harris: There are very few absolutes when you look at either standard of care or what the law requires. I think it could be cogently argued in a court of law that if a patient has an adverse result after refractive surgery that could have been avoided by doing presurgical mapping, then that practitioner will probably be liable because he or she failed to meet the standard of care.

PCON: How do practicing clinicians know when to seriously consider integrating new technologies into practice?

Thimons: Optometry, like all other health professions, relies, to a reasonably significant degree, on its educational institutions and its leading clinicians to serve as the initial assessors of new technology and its clinical applications. The transition time between the first announcement of technologies of this type and their subsequent implementation is extremely variable. It is based on several factors, including issues such as percentage of patients to which the technology can be applied, the clinical data the technology generates relative to existing diagnostic entities and, finally, the ability of the practitioner to be reasonably reimbursed for its use and, thus, compensated for its purchase.

Harris: The critical ingredient is when a reasonable and prudent practitioner would have done that test under a particular circumstance. When the literature is rampant with research and clinical evaluations of a procedure, then more people adopt it. If there is a court case that indicates a particular procedure should have been done under a particular circumstance, that adds weight, but there is no magic point in time where you can say "this is the standard of care." There are exceptions: when either courts have indicated or state laws have been changed to indicate practitioners are responsible for certain procedures.

Sherman: Short wavelength automated perimetry (SWAP) is a good example. The advertisements for SWAP seem to suggest you can make a diagnosis of glaucoma 4 or 5 years earlier using SWAP relative to standard perimetry. However, there is little clinical research to back that up. Some researchers feel SWAP is the way to go, but I think many clinicians see these ads and ask: Is this the standard of care? Do I have to go out and update my perimeter to do SWAP? It's easy to get misled. In reality very few clinicians are actually doing it and there is doubt whether it will ever work clinically.

Harris: First of all, someone must show that a procedure is effective for doing what it claims to do. If it is effective and it becomes adopted by practitioners as a routine and reasonable procedure, then it becomes the responsibility of a practitioner to do the procedure when appropriate or refer a patient to someone who can. That's going many steps beyond where we are with SWAP.

PCON: Do optometrists embrace electrodiagnostic (ED) testing as extensively as they should?

Sherman: I clearly see a role for such testing. I have seen lots of cases where the diagnosis cannot be arrived upon any other way and such procedures really help us in making the appropriate decisions. However, I would estimate that less than 1% of all eye care clinicians use ED procedures and perhaps only 2% to 4% actually refer for such procedures. I don't think ED procedures have become the standard of care.

PCON: How do you decide at what point a patient who has symptoms of age-related macular degeneration (AMD) should get fluorescein angiography to rule out wet AMD? How do you present the risks to patients?

Harris: That question is a classic example of what's involved with informed consent. Patients need to have a certain amount of information to make an intelligent decision about a procedure. They need to know the diagnosis; why you are recommending a procedure; the likelihood that the procedure will work; the alternatives; and, maybe most importantly, the risks and consequences. Only after the patient has all of this information can the patient make an intelligence choice as to whether to proceed with a test or therapy.

Sherman: I agree. With fluorescein angiography most ODs or MDs who are not retinal specialists refer the patient to a retinal specialist, who usually makes the decision.

PCON: Can a managed care company exonerate a clinician who does not perform certain tests? If an HMO does not compensate for a procedure at the primary care level, should clinicians allow that to influence their decision-making?

Harris: No. A practitioner's responsibility to the patient is not dependent — from a legal standpoint — on who is paying. Once the doctor-patient relationship is established the practitioner has a responsibility to do what is reasonable and prudent in caring for that patient.

Sherman: In a recent malpractice case, an optometrist sees a 17-year-old male and finds the acuity in one eye has dropped from 20/20 to 20/30 without any other symptoms. The doctor does a comprehensive examination, including confrontation fields, and does not know why the patient has a reduction of acuity from the previous year. He knows the patient's HMO pays for only one examination per year, and that he cannot get any specialized tests such as fluorescein, threshold visual field or magnetic resonance imaging, so he decides the patient should return in 1 year. The patient returns a year later and the acuity in that eye had dropped to no light perception. This optometrist later stated that he was was influenced by the limitations of the patient's HMO.

Harris: He was influenced by the wrong thing. He should have been influenced by what is in his patient's best interest. He compounds the problem by saying, "I think the tests should be done, but I don't think that third party is going to pay." If you are in doubt, have the patient come back in several weeks.

Sherman: This doctor was not thinking in terms of the patient's welfare. He decided to wait a year, and he made a gross error.

Miller: At the very least he had an obligation to inform the patient. Then the patient could say, "We'll fight it out with the health care system." The doctor had a legal obligation and I think he also had a moral and ethical obligation.

PCON: How do you get patients the test you think they need if their HMO will not cover it?

Miller: That's a difficult question, and I'm not sure there is a right answer. That issue is being addressed under the gag rule in different states. I think a doctor's primary obligation is to the patient and not the health care system. Whether I'm right will depend on the courts.

Harris: Each patient is an individual who has the right to assume the practitioner is rendering a thorough and comprehensive exam, although it is difficult to say what that is for a particular circumstance.

Thimons: I believe this represents one of the more pressing dilemmas that faces primary care clinicians in this current health care climate. Obviously, doctors all want to provide the very best care for their patients, but in many instances, because of reimbursement restrictions, patients are forced to pay out of pocket for expenses related to testing not covered by their health insurer. I feel it is imperative that the doctor educate the patient as to the appropriateness of the test being recommended. If the patient chooses either not to follow through with the test or wishes to delay consideration of the test, then document that in the patient's record.

Sherman: It turned out that the patient I mentioned earlier had a brain tumor. The optometrist told him to "come back in a year or sooner if you notice any change." The patient lost his vision but either didn't notice or disregarded any change. We're not talking about somebody with Alzheimer's disease at age 80. We are talking about a college freshman who should have some responsibility for his own health care.

Drug companies now advertise directly to the public and most Americans are aware of various diseases. It seems we're attempting to transfer some of the responsibility to patients and let them participate in their care. Everyone is trying to control the cost of health care and we want patients to be aware of potential problems, but then we have an optometrist who tells his patient, "If it gets worse I want to see you immediately," and the patient goes home and comes back in 12 months completely blind in one eye.

Harris: The patient does have some responsibility, but I think it's important for the OD to make sure the patient understands what the obligation is. That practitioner should have had some words of wisdom for the patient or insisted that the patient return to the optometrist to monitor the changes in vision.

Miller: Discussing the patient's obligation does not relieve the doctor of all liability. That still is the informed consent, the duty to warn. If you have a patient who is suffering a decrease in vision you want to say: "We need to see you in such and such a time if there is a problem, because there is a possibility it may be a tumor." If it's sufficiently put before the patients, then they understand the seriousness and their obligation.

Sherman: And we all agree that it should be well documented in the patient's chart.