December 01, 2005
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Technology affects, but does not define, standard of care

In December 1996, an article appeared in Primary Care Optometry News addressing the impact of emerging technology on the standard of care in a question-and-answer discussion.

“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,” said Michael G. Harris, OD, JD, FAAO, a practitioner involved in the original discussion. “Standard of care is not whether you 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 instrument.”

In the final installment of our 10-year anniversary Retrospective Series, Primary Care Optometry News revisits this topic with the original Q&A participants.

What is standard of care?

According to Pamela J. Miller, OD, FAAO, JD, a private practitioner and legal and practice management consultant in Highland, Calif., standard of care is based on a variety of factors.

PCON cover
December 1996: The article on standard of care was part of the “Focus on New Technology” in this issue. PCON also reported on Pennsylvania becoming one of the last few states to gain therapeutic prescribing privileges.

“It’s based on the laws in your state and what your colleagues are doing. It’s not the lowest common denominator, but the higher denominator,” Dr. Miller said in a recent interview. “Standard of care may also be influenced by litigation and judges’ decisions.”

Instances in which standard of care is driven by litigation would be termed landmark cases, Dr. Miller said. “This would be regardless of the literature, your colleagues and your level of licensure,” she said. “A landmark case is legal resolution.”

She cited the Helling v. Carey decision, which changed the standard of care for the measurement of intraocular pressure. Originally, it was not standard of care to test the intraocular pressure of patients younger than 40. “Now, the standard of care has changed,” she said. “It’s a floating standard. It almost never goes down; it only goes up.”

Dr. Harris defined standard of care as what a reasonable and prudent practitioner would do under the same or similar circumstances. He said while instrumentation may influence standard of care, it does not define it.

“The instrumentation is a tool, but the key is to get the information,” he said in a recent interview. “If you are not using appropriate instrumentation, you are not going to be able to evaluate the health status of eye. It doesn’t mean you need to use a piece of specific equipment.”

Primary Care Optometry News Editorial Board member Jerome Sherman, OD, FAAO, said the law might require the use of certain instruments, but not specific brands.

“For instance, you are supposed to do visual field testing on everyone, but the type of visual field testing is not defined by the American Optometric Association guidelines,” he told PCON. “I think imaging devices for glaucoma are emerging as standard of care. This means using some objective imaging device of the nerve fiber layer, but not any specific product.”

Dr. Sherman said he has heard judges explain standard of care to juries in terms of percentages. “The judge will tell the jury that if there is not a specific standard in writing, such as AOA guidelines, you would ask yourself what a like practitioner would do under a like circumstance,” he said. “The percentage that I have heard for that is 51%.”

Corneal topography: essential care?

In the December 1996 article, the discussion participants did not consider corneal topography prior to refractive surgery as an absolute standard of care. Today, Dr. Harris, believes it is. “That instrument is now available for evaluating patients for refractive surgery. For that purpose, it has been embraced by all reasonable and prudent practitioners,” he said. “It is standard of care because topography has become necessary in determining the status of the cornea prior to refractive surgery. Older equipment, such as keratometry, measures just a small area of the cornea.”

Dr. Sherman said, for an optometrist, corneal topography is highly recommended, but not essential. “Any corneal surgeon to whom you refer is going to do topography,” he said. “Based on the fact that this test will be done at the surgery center, it is not essential for the OD to do it. When an OD refers, he or she is essentially transferring the care.”

Dr. Harris said the standard of care for refractive surgery requires that the practitioner know certain information about the status of the eye. “Regarding the cornea, you need to know its shape, you need to know its thickness, you need to use a topographer and you need to use some type of pachymetry,” he said. “That type of instrumentation is vital in determining whether the patient is an appropriate candidate for refractive surgery. It is also vital in setting the laser to do an appropriate job.”

Integrating new technology

Dr. Miller said deciding when to integrate a new technology into one’s practice is often tricky. “It sometimes centers on the cost factor,” she said. “Then you have to ask yourself what the courts say. There are some basic instruments that you need to have in your office, particularly if you are involved with a third-party payer. You can see how the tail starts to wag the dog, because if the insurance company does not pay unless you have this test capability, you’re going to want to have it.”

Dr. Harris said a new technology becomes standard of care when it is the reasonable and prudent way to determine the status of the visual system. He emphasized that convenience and speed do not necessarily fall into this category.

“Faster does not make it the standard of easier care,” he said. “Certainly, it might be for the practitioner and the office from a practice management standpoint, but speed and efficiency do not define the standard of care.”

Dr. Sherman said a practitioner can often prevent litigation by going beyond the standard of care in terms of instrumentation. “The OD is faced with meeting existing standard of care,” he said, “but one of the better ways to prevent litigation and practice at the highest level is to go beyond the standard.”

He cited an instance where a doctor who provided eye care to a patient from 1966 to 1999 failed to diagnose glaucoma during that time and was sued when it was diagnosed later by another practitioner. “He met the existing standard of care during that time,” Dr. Sherman said. “But if he had gone beyond the standard of care, he might have been able to avoid litigation.”

HMOs and procedures

It is never an easy situation when a test or procedure that is warranted is not covered by a patient’s HMO. “There are a few ways to handle this,” Dr. Miller said. “You could do the test and not charge the patient, or you can make sure the patient understands the importance of the test and explain that insurance will not cover it. The patient always has the right to refuse the test.”

Dr. Harris said the practitioner is obligated to fully explain to his or her patients exactly how important the test is. “The issue for practitioners is not what is covered, but what they need to do to ensure that their patients are healthy,” he said. “It is hoped that you have established rapport with your patients so they trust your judgment.”

Dr. Sherman concurred that explaining the risks and benefits of the test is essential. He said, in some cases, the HMO may allow the practitioner to bill the patient directly; in others, it will not.

“Interestingly enough, we have that problem with a new procedure, the Preview PHP [Preferential Hyperacuity Perimeter, Carl Zeiss Meditec, Dublin, Calif.],” he said. “It is thought that PHP should probably be performed four times a year to detect conversion of dry to wet macular degeneration, but where it is approved for payment, it is understood that Medicare will only pay for it twice a year.”

Dr. Sherman said he believes it is possible to bill the patient directly for the remaining two procedures. “My understanding is that you can tell the patient that it is recommended four times a year and allow the patient to pay for the other two times,” he said.

If a patient decides to forego a recommended treatment or test that is not covered, Dr. Sherman recommends the patient sign a form to this effect in the presence of a witness.

Dr. Sherman contemplated cases in which a procedure or test is not covered, but falls within the standard of care. “This is a trick question,” he said. “Is the practitioner required to do the test anyway?”

He mentioned an upcoming case going to trial within the next few months. In this case, a practitioner did not perform visual field tests on a patient over the course of four exams. The patient eventually died of a brain tumor that could possibly have been detected through visual field testing.

“These are the kinds of cases that actually could change the standard of care,” he said.

For Your Information:
  • Michael G. Harris, OD, JD, FAAO, is associate dean emeritus, clinical professor and past chief of the contact lens clinic at the University of California-Berkeley. He can be reached at the School of Optometry, Berkeley, CA 94720-2020; (510) 642-2020; e-mail: mharris@berkeley.edu.
  • Pamela J. Miller, OD, FAAO, JD, is a private practitioner and legal and practice management consultant. She can be reached at 6836 Palm Ave., Highland, CA 92346-2513; (909) 862-4053; e-mail: Drpam@omnivision.com. Drs. Harris and Miller have no direct financial interest in the products mentioned in this article, nor are they paid consultants for any companies mentioned.
  • Jerome Sherman, OD, FAAO, is a Primary Care Optometry News Editorial Board member and in private practice at the Eye Institute and Laser Center. He can be reached at SUNY College of Optometry, 33 W. 42nd St., New York, NY 10306; (212) 938-5862; e-mail: jsherman@sunyopt.edu. Dr. Sherman has lectured for Carl Zeiss Meditec.