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Appropriate Examination and Treatment Procedures

Advisory Opinion of the Code of Ethics

Subject:

Appropriate Examination and Treatment Procedures

Issues Raised:

How is it determined which examination and treatment procedures are considered appropriate and necessary?

Applicable Rules:

Rule 2. Informed Consent
Rule 6. Pretreatment Assessment
Rule 8. Postoperative Care
Rule 9. Medical and Surgical Procedures
Rule 10. Procedures and Materials

Background

In the vast majority of cases, there is substantial room for differing judgments as to which procedures are appropriate and which are inappropriate. This Advisory Opinion is intended to provide only general guidance on this ethical issue and offer examples of the types of care that deviate so obviously from the range of appropriate professional judgments that they clearly present unethical conduct. It is hoped that the reader can then extrapolate to more ambiguous situations that may arise in practice. This Advisory Opinion is not intended to require or proscribe specific medical practice, to define a "standard of care," or to endorse specific practice patterns. It is specifically recognized that the examinations and treatment procedures that may be appropriate will vary depending on many factors, including the patient's condition and history, the skill, experience, and judgment of the physician, other available sources of care, patient choice, and other considerations.

First Inquiry

Facts — Mr. S is a 70-year-old man whose hometown ophthalmologist stated that his decreasing vision was due to age-related macular degeneration. When Mr. S consulted a second local ophthalmologist, this conclusion was confirmed, and the physician added that there appeared to be subtle evidence of very early nuclear sclerosis. Both ophthalmologists advised Mr. S that the cataracts were not of sufficient density to account for the decline in vision he suffered.

A month later, Mr. S visited his sister in a distant city. Through newspaper and television ads, Mr. S learned of Dr. A, an American Academy of Ophthalmology Fellow, and went to see him.

After examining Mr. S, Dr. A told him that there was an excellent chance that cataract surgery with an intraocular lens implant would restore his vision, and did not mention Mr. S's macular degeneration. Surgery was scheduled; Dr. A operated on one of Mr. S's eyes one day and on the second eye the next day. Despite the lack of a preoperative arrangement, a few days later, Mr. S returned home and received follow?up care from his local ophthalmologists. Examination revealed no visual improvement at 1 month and 3 months postoperatively attributable to the presence of macular degeneration. Mr. S is angry, and he has inquired whether Dr. A acted ethically.

Resolution— It is highly improbable that Mr. S's cataracts advanced significantly in the brief period between the time he was seen by his hometown ophthalmologist and the time he visited Dr. A (although it is theoretically possible). Therefore, in the absence of unique circumstances, it appears that Dr. A performed unnecessary surgery; it did not present any reasonable prospect of benefit to the patient particularly in light of the usual costs and risks of surgery.

It is clear that Dr. A violated Rule 6 of the Code of Ethics, which provides that "surgery shall be recommended only after a careful consideration of the patient's physical, social, emotional and occupational needs." Obviously, Dr. A did not do an adequate workup, since he did not detect or discuss with the patient the macular degeneration problem. There is not even any indication that he elicited from Mr. S the results of the prior evaluation of macular degeneration or that he spoke to Mr. S's home-town ophthalmologists to obtain their evaluations.

Dr. A did not perform surgery with an adequate informed consent, in violation of Rule 2 of the Code of Ethics. The issue of suspected macular degeneration should have been dealt with in the history, evaluation of previous examinations, and personal examination and testing, and by obtaining an informed consent from the patient prior to surgery.

Finally, it appears that Dr. A may not have provided adequate postoperative care, in violation of Rule 8 of the Code of Ethics. It was particularly irresponsible to perform surgery on both of Mr. S's eyes without waiting for a postoperative assessment on the first eye. Additionally, Dr. A did not contact either of the local ophthalmologists before surgery to ensure that one of them would be able to provide postoperative care for the patient.

Second Inquiry

Facts — Dr. B, a member of the American Academy of Ophthalmology, has a large office staff that assists him in performing various diagnostic procedures. His office instruments include Argon and YAG lasers, a specular microscope, A and B scan, ultrasonographic units, a fundus camera, automated visual field, and numerous other instruments.

Dr. B usually sees patients every 6 months, and orders fundus photos of his adult patients at all routine eye examinations of his adult patients. He explains that he wants to document a baseline in order to compare the discs and optic cups with later photos. All adult patients also receive automated visual field evaluations. Chronic open-angle glaucoma patients are examined monthly despite perceived risk, and are checked for intraocular pressure by a technician, but are not always see at that time by Dr. B. Dr. B orders corneal endothelial cell counts for all patients with cataracts at any stage of development, despite absence of relevant clinical findings or history.

Mrs. J, a 35-year-old patient of Dr. B for many years, has received a bill for her semiannual examination, which included fundus photos, visual fields, specular microscopy, and "A" scans, and she is surprised by the cost. She has asked the Academy if Dr. B is performing "unnecessary tests."

Resolution— It is extremely difficult to generalize about what procedures are necessary and what procedures are unnecessary. There may be many patients whose needs are such that even the generalizations would be irresponsible. Therefore, we cannot say that any given conventional diagnostic procedure is "generally" not useful; one must look at the circumstances of the individual patient and obtain the information that is reasonably necessary to serve the interests of that patient. In addition, it is difficult to distinguish between thorough medical practice and defensive medicine, or between "aggressive" management and needless service. It also must be recognized that not all practitioners practice with equal skill, intuition, confidence, and judgment: Some may require more diagnostic tests or treatment techniques than others in order to be comfortable that they are acting in the best interests of their patients.

Despite these difficulties, it is still possible to identify certain egregious practices as excessive or unnecessary. If diagnostic procedures are performed that are not of substantial value in diagnosing disease or predicting the future course of disease processes, the best interest of the patient usually is not served. Most diagnostic procedures have some risk and some cost that must be borne by the patient, provider, or third-party payor. In the absence of any reasonably anticipated benefit, the service is unnecessary and unethical. Charging fees for services for which there is not some substantial benefit exploits patients and payors. Both of these features make such practices unethical for ophthalmologists.

In this case, Dr. B has clearly acted unethically because he has established a uniform schedule of diagnostic tests without regard to the needs of particular patients, or the likelihood that they will benefit from the procedures. Fundus photos are not generally necessary or useful at every examination. The same is true of visual field examinations during routine visits in the absence of any actual or suspected pathology. The evaluation of corneal endothelial cell counts is not generally regarded as necessary to the clinical evaluation of every cataract patient. The failure of Dr. B to provide some individualized medical evaluation is an indication that his motives are likely pecuniary and the patient thus is not receiving proper and efficient medical care. Although each of these procedures may be quite justifiable and even necessary in individual cases, it appears to be unethical for Dr. B to apply them in every case regardless of specific need, whether he does so for pecuniary gain, a "thorough approach," or for reasons relating to "defensive medicine."

Third Inquiry

Facts — Dr. D, a Fellow of the American Academy of Ophthalmology, is a high volume cataract surgeon. She performs posterior capsulotomies with the YAG laser within the first year after cataract surgery on almost every patient with a posterior chamber intraocular lens implant. She uses five to 10 laser bursts in each eye at each session, and has the patient return for a repeat session every 2 to 3 months. Dr. D has a busy practice all day Saturday, performing this procedure on patients at 15-minute intervals. Dr. D charges patients for these services on a per-session basis.

Resolution— Although the service (laser treatment of the capsule) that Dr. D is providing may be necessary in some cases, she appears to be providing it in a manner that is calculated to be inefficient, more costly, and less convenient for the patient. Generally, laser capsulotomy can be completed in a single session making multiple sessions unnecessary and intentionally wasteful. In addition to the inefficiency of multiple sessions, the fact that Dr. D performs YAG laser treatments on almost all of her postoperative cataract patients suggests inappropriately liberal indications or excessive use of the procedure. Since this practice is not medically justifiable, exploits payors and does not serve the patient's interests, it violates Principle 5 and Rules 9 and 10 of the Academy's Code of Ethics.

Fourth Inquiry

Facts — Mrs. T, a 78-year-old woman, comes to the office of Dr. G, saying that she wonders if her eyes are healthy. She asks specifically if she has glaucoma. Dr. G, a Member of the American Academy of Ophthalmology, finds her visual acuity to be 20/40 in each eye, which he believes is due to the presence of early cataracts. Intraocular pressures are 20 mm Hg, and the optic discs appear to be entirely healthy, with virtually no cupping. Dr. G obtains more history and finds that his new patient believes that her eyes are just fine, that she has been taking chemotherapy for a refractory leukemia for the past 6 months, and that she is quite discouraged because she is feeling chronically ill.

Dr. G informs Mrs. T that her intraocular pressure is higher than normal and that it is fortunate that she came to see him. He orders photographs of her optic discs, performs automated visual fields, optical coherence tomography, and prescribes timolol 0.5% in each eye twice daily, and advises her to return to his office in 1 week so that he can evaluate the effect of the timolol. The patient returns 1 week later, at which time Dr. G finds that the intraocular pressure is 18 mm Hg in each eye.

He repeats the visual field examination, which again shows mild generalized depression. Mrs. T tells him that for the past week she has been feeling worse than usual and has been having a sense of unsteadiness when she stands up. Dr. G tells her that the fact that her intraocular pressure fell in response to the timolol proves that she has glaucoma, that she is now in "much better condition" than before, and should continue the timolol. He instructs her to return in 3 months for a repeat visual field examination, retinal tomography and photographs.

Resolution— Dr. G has behaved unethically toward Mrs. T: he has ordered unnecessary diagnostic tests and therapy that clearly do not put the patient's best interests first. Testing the visual field in a patient whose pressure is 20, who has no visual symptoms and no suggestion of glaucomatous optic nerve damage, may arguably may be of some benefit to a patient whose problem is fear of glaucoma, but to repeat the testing 1 week later is wholly unjustifiable. Photographs of the optic discs are expensive and time consuming, and cannot credibly serve a purpose. Timolol and other similar agents have the potential for producing dangerous side effects. The potential risks would therefore appear to far outweigh the potential benefits to this patient. In addition, when the patient returned and specifically complained of symptoms characteristic of those caused by beta?blockers, the potential risk was no longer merely a potential one. A frank discussion with the patient concerning her fears, her prognosis for life, the minimal risk to her vision even if she had glaucoma, and the side effect of glaucoma medications would have served the patient’s needs better. Above all, in addition to violating Mrs. T's autonomy, Dr. G lied to her about being in "better condition." This inquiry presents a clear case in which Dr. G has clearly acted unethically by employing patently unnecessary and inappropriate procedures.

Applicable Rules

"Principle 5. Fees for Ophthalmological Services. Fees for ophthalmological services must not exploit patients or others who pay for the services."

"Rule 2. Informed Consent. The performance of medical or surgical procedures shall be preceded by appropriate informed consent."

"Rule 6. Pretreatment Assessment. Treatment shall be recommended only after a careful consideration of the patient's physical, social, emotional and occupational needs. The ophthalmologist must evaluate the patient and assure that the evaluation accurately documents the ophthalmic findings and the indications for treatment. Recommendation of unnecessary treatment or withholding of necessary treatment is unethical."

"Rule 8. Postoperative Care. The providing of postoperative eye care until the patient has recovered is integral to patient management. The operating ophthalmologist should provide those aspects of postoperative eye care within the unique competence of the ophthalmologist (which do not include those permitted by law to be performed by auxiliaries). Otherwise, the operating ophthalmologist must make arrangements before surgery for referral of the patient to another ophthalmologist, with the patient's approval and that of the other ophthalmologist. The operating ophthalmologist may make different arrangements for the provision of those aspects of postoperative eye care within the unique competence of the ophthalmologist in special circumstances, such as emergencies or when no ophthalmologist is available, so long as the patient's welfare and rights are the primary considerations. Fees should reflect postoperative eye care arrangements with advance disclosure to the patient.

"Rule 9. Medical and Surgical Procedures. An ophthalmologist must not misrepresent the service that is performed or the charges made for that service."

"Rule 10. Procedures and Materials. Ophthalmologists should order only those laboratory procedures, optical devices or pharmacological agents that are in the best interest of the patient. Ordering unnecessary procedures or materials for pecuniary gain is unethical."

Other References "Principle 1. Ethics in Ophthalmology. Ethics address conduct, and relate to what behavior is appropriate or inappropriate, as reasonably determined by the entity setting the ethical standards. An issue of ethics in ophthalmology is resolved by the determination that the best interests of patients are served."


"Principle 2. Providing Ophthalmological Services. Ophthalmological services must be provided with compassion, respect for human dignity, honesty and integrity."

42 U.S.C. §1396y(1)(B); 42 C.F.R. §420.101(a)(2); AMA Opinions of the Judicial Council, §8.06 ("Drugs and Devices: Prescribing"), §8.08 ("Laboratory Services"); American College of Surgeons, Principles of Qualifications for Fellowship, §G. ("Unnecessary Surgery is Condemned"); American Academy of Ophthalmology Ethics Advisory Opinion "Unnecessary Surgery and Related Procedures."

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