of Ethics Online Collection: None
Guidelines for Ethical Behavior Relating to Clinical Practice Issues in Electrodiagnostic Medicine
Glenn A. Mackin, MD, Steven H. Horowitz, MD, James A. Leonard, Jr, MD, David W. Musick, PhD
Acknowledgements: This document was originally drafted by the association’s 1994 Ethics and Peer Review Committee Chair: Robert G. Miller, MD; Members: Neil A. Busis, MD; William W. Campbell, MD, MSHA; Andrew A. Eisen, MD; Donna L. Frankel, MD; Mark Hallett, MD; Janice M. Massey, MD; and Lois M. Nora, MD, JD. The association would like to also acknowledge the contributions of:: J. Russell Burck, PhD; Yasoma B. Challenor, MD; Lawrence R. Robinson, MD; and Jay V. Subbarao, MD.
Approved by the AANEM Board of Directors: October 2004
Introduction
Guidelines for ethical behavior relating to clinical practice issues in electrodiagnostic medicine (EDX) have been developed to formalize the standards of professional behavior for physicians who practice electrodiagnostic medicine—EDX consultants. These guidelines outline professional standards that EDX consultants should observe in their clinical and scientific activities. The guidelines were originally modeled after the Code of Professional Conduct of the American Academy of Neurology and are consistent with the guidelines of the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) and Principles of Medical Ethics as adopted by the American Medical Association. Violation of these guidelines may provide grounds for disciplinary action as outlined in Article 10.0 of the AANEM Bylaws and the AANEM’s Disciplinary Policies and Procedures.
1. The Electrodiagnostic Medicine Patient-Consultant Relationship
1.1 The Patient-Consultant Relationship
The foundation for EDX consultation is the relationship between the patient and the EDX consultant (hereafter “consultant”). The consultant has a fiduciary duty to safeguard the interests of the patient first. The consultant must practice competently, respect patient autonomy and confidentiality, maintain patient safety and protect the patient’s best interest.
1.2 Beginning and Ending the Relationship
The consultant is free to decide whether to perform an EDX consultation on a particular person. The consultant should not decline the consultation on the basis of the patient’s race, religious creed, national origin, gender, sexual orientation, or other personal characteristics. The consultant also should not decline a consultation on the basis of the patient’s known or suspected medical diagnosis. The consultant should decline the performance of the EDX consultation if he/she believes it to be unnecessary or not beneficial to the patient.
If possible, it is best for the consultant and the referring physician to concur on who should inform the patient (or designated surrogate) of the results of the EDX consultation. The consultant should discuss the reason for the consultation and the methods to be employed with the patient. The consultant should advise the patient as to who will be providing the patient with the results of the test. If the patient has a diagnosis that does not require EDX testing, the consultant should so inform the patient and cancel the study or give the patient the right to cancel the study (see Section 5.1).
Once the consultation has begun, the consultant should complete the consultation process unless the patient ends the relationship before the consultation can be completed, or medical contraindications to completing the consultation become apparent during the consultation. After completion, the consultant should return the patient to the care of the referring physician. If the patient does not have a referring physician, the consultant should take responsibility for urgent care of the patient until appropriate referral can be made.<
1.3 Informed Consent in Clinical Consultation
The consultant must obtain valid verbal or written consent as appropriate from the patient or, when the patient is not competent to give such consent, from the patient’s appropriate surrogate decision-maker. The consultant must disclose information that the average person would need to know to make an appropriate medical decision. This information must include the benefits and risks of the proposed tests and should include costs of the proposed tests, if the patient desires this information. If the patient is referred for evaluation of a painful symptom, the consultant should explain before testing that the EDX studies are directed toward certain measurable peripheral nerve abnormalities, not whether pain is present or absent. Consent must be given voluntarily by the patient. If reasonable explanation fails to elicit a patient’s consent to carry out the EDX consultation, the consultant should not undertake the evaluation. The patient may negate a prior consent; if this occurs at any point during testing, the consultant should not continue with the examination. Consultants must comply with applicable state and federal law governing informed consent requirements.
Federal Food and Drug Administration (FDA) and Institutional Review Board (IRB) rules should be followed when conducting experimental or investigational studies of procedures, pharmaceuticals, or medical devices that involve human subjects (see Section 7).
On occasion, EDX testing must be performed on patients who cannot give consent. If a legal guardian is present, or if the patient has designated a surrogate decision-maker through a current and valid durable health care power of attorney, that person should be consulted. If the patient lacks decisional capacity, the guardian or surrogate decision maker is unavailable, and the situation is an emergency, the consultant may proceed without consent.
1.4 Patient Communication, Comfort, and Preparation
The consultant has a duty to communicate with the patient. The consultant should convey relevant information in terms the patient can understand and allow adequate opportunity for the patient to raise questions and discuss matters related to the EDX evaluation. Consultants should make every effort to ensure that patients are adequately prepared for the planned EDX procedures and that they are made as comfortable as possible during the examination. Consultants should be attentive to signs of patient discomfort and safety concerns, and resolve them before proceeding. Consultants may decide whether to admit family members or significant others into the examination room during testing to provide support. Informing the patient of the findings of the examination should be coordinated with the referring physician (see Section 1.2). Moreover, suggestions for changes in clinical management should generally be made to the referring physician unless the referring physician has requested that the consultant participate in clinical management.
1.5 Medical Risk to the Physician
The AANEM recognizes that consultants have needs and concerns that are relevant for ethical decision-making in the context of consultation. At the same time, a consultant should provide appropriate, compassionate care to all patients, including patients with human immunodeficiency virus (HIV) infection and other communicable diseases. A consultant should not deny care to a patient solely because of real or perceived medical risk to the consultant. Consultants must utilize appropriate precautions during the examination of any patient to minimize their own medical risk.
2. General Principles of Electrodiagnostic Medicine Consultation
2.1 Professional Competence
The consultant should perform evaluations only within the scope of his
or her training, experience, and competence. The consultant should provide
care that represents the prevailing standards of EDX practice.
Consultants should use only standard, well-accepted, and published techniques
and methods of interpretation. Evidence-based techniques are preferable.
To this end, consultants should participate in, and maintain documentation
of, a regular program of continuing education. Consultants should maintain
their technical skills, and ensure they have adequate experience before
introducing new techniques into practice. On occasion, such as when dealing
with an unusual clinical problem or a research study, other techniques
may be necessary. If all or part of the consultation is considered research,
it must conform to the guidelines in Section 7.
2.2 Confidentiality
The consultant must maintain patient privacy and confidentiality, both
in performing EDX studies and the configuration of the examination
areas in which they are performed, in accordance with all state and
federal laws and regulations addressing patient privacy. The patient’s
name or other demographic information, as well as details of the patient’s
life or illness that would identify the patient must not be publicized
or published without written permission.
2.3 Patient Records
Consultants should keep and manage medical records that are complete, accurate, and in compliance with Health Insurance Portability and Accountability Act (HIPAA) . The consultant’s records should include a statement of the problem and the indications for the study, description of the findings, statement of normality or abnormality of these findings, and clinical correlation and diagnostic conclusions. Storing recordings of actual waveforms from nerve conduction studies (NCSs) and needle electromyography (EMG) is not required. Information within the medical records should be available only to appropriate individuals including referring physicians, patients and others with a valid release of information signed by the patient. Urgent information should be communicated directly and promptly to the referring physician, and appropriately documented in the consultant’s record.
2.4 Professional Fees
The consultant is entitled to reasonable compensation for EDX services commensurate with specified billing procedures, the difficulty of the study, time involved, and the number of procedures performed.
The fee structure must be made available upon request to patients, referring physicians, or third-party payers. The consultant should bill for and receive compensation for only those services actually rendered or supervised. The consultant must not receive a fee for making a referral or give a fee for receiving a referral (“fee-splitting”). The consultant should not receive a commission from anyone for an item or service ordered for a patient (“kickback”).
2.5 Appropriate Electrodiagnostic Services
The EDX consultation should address the issues involved for a reasonable differential diagnosis. The consultant must be involved in the pretest evaluation of the patient and the plan of the study and should perform only those tests that are medically indicated. Tests selected and procedures used should conform with published guidelines, when available. The consultant has the ultimate responsibility for NCS examinations, even if they are performed by a technologist or another physician under the consultant’s supervision. The consultant must be readily available and must promptly review and evaluate the results of the NCSs. The patient should remain in the examination room until the supervising EDX consultant has reviewed the NCS results. Whenever possible, the NCSs and EMG examination on the same patient should be performed on the same day, by the same EDX consultant, for continuity and consistency.
All needle EMG examinations should be performed by or, in the case of residents or fellows, under the direction of a consultant.
3. Personal Conduct
3.1 Respect for the Patient
The consultant must treat patients with respect and honesty with particular sensitivity to language barriers, socio-cultural diversity concerning personal modesty (appropriate use of chaperones), physical pain and disability. The consultant must not abuse or exploit the patient psychologically, sexually, physically, or financially.
3.2 Respect for Agencies and the Law
The consultant should observe applicable laws. The consultant should cooperate and comply with reasonable requests from insurance, compensation, reimbursement, and government agencies within the constraints of patient privacy and confidentiality.
3.3 Maintenance of the Consultant’s Personal Health
The consultant should strive to maintain physical and emotional health
and should refrain from practices that may impair his or her ability
to provide adequate patient care.
4. Conflicts of Interest
4.1 The Patient’s Interest is Paramount
Whenever a conflict of interest arises, the consultant must attempt to resolve it in the best interest of the patient. Conflicts of interest that cannot be eliminated should be disclosed to the patient. If, after discussing the conflict, the patient does not want to proceed, the consultant should not perform the consultation on the patient.
4.2 Avoidance and Disclosure of Potential Conflicts
The consultant must avoid practices and financial arrangements that would, solely because of personal gain, influence decisions on the types of consultations performed on patients. Financial interests of the consultant that might conflict with appropriate medical care should be disclosed to the patient.
4.3 Healthcare Institutional Conflicts
The consultant should advocate for his or her patient’s medical interests when they are jeopardized by policies of a healthcare institution or agency. The consultant should inform the patient when referral restrictions on testing would limit validity of results.
5. Relationships With Other Professionals
5.1 Cooperation and Communication With Healthcare Professionals
Consultants should cooperate and communicate with other healthcare professionals,
including other physicians, nurses, and therapists in order to provide
the best care possible to patients. Written and oral communication with
other healthcare professionals should be carried out in a timely and
courteous manner. The terms used in the communication should be useful
to the referring physician and be as responsive to the referral question
as possible.
The consultant may teach fellows and residents how to perform the EDX
consultation. Effective teaching requires close supervision of trainees
during the actual testing and careful review of the report of the findings
before it is sent to the referring healthcare professional.
On occasion, the consultant, while evaluating a patient referred for EDX testing, will determine, based on available clinical information, that the patient most likely has a medical problem that is not localized within the peripheral neuromuscular system. The consultant should attempt to communicate this opinion to the referring healthcare professional with the goal of optimizing further care for this patient. Options include not proceeding with the planned EDX testing and redirecting the diagnostic evaluation.
5.2 Referrals From Other Physicians
For the most part, referrals to consultants come from other physicians. Referrals may come from other healthcare professionals and lay persons, however, and patients may refer themselves. If the referral did not come from another physician, every attempt should be made to identify the patient’s primary physician so that the report of the results of the EDX consultation may be sent to that physician if the patient consents. If the patient has no primary care physician the consultant should refer a patient to a primary physician or specialist if one is needed.
If the primary care physician agrees, the consultant may actively participate in further evaluation and treatment of the patient’s neuromuscular problems and may even become the principal provider of the care for these problems.
5.3 Studies Performed on One’s Own Patients – Self Referral
Most consultants see and follow patients for clinical diagnostic and therapeutic reasons. In the course of providing such evaluation and management, a consultant may find it necessary for these patients to have EDX studies to clarify a diagnosis or assist with treatment. Ordering an EDX study on one’s own patient and performing the study oneself can be considered part of the physician-patient relationship, and not an inappropriate “self-referral.” In fact, it may be in the best interest of the patient for the consultant, who knows the patient, to perform the studies. When considering performing EDX studies on one’s own patient, the consultant must keep in mind that there must be a proper indication for the study which is consistent with relevant guidelines. The need for and the scope of the study should be properly documented in the patient’s medical record. Some EDX physicians may prefer to refer their patients to other physicians for EDX testing, to avoid even the appearance of a conflict of interest. Patients also always retain the right to request EDX testing by an independent physician without compromising their ongoing clinical care.
5.4 Peer Review, Utilization Review, and Quality Assurance
The consultant should participate in peer review, utilization review, and quality assurance activities in order to promote optimal patient care.
5.5 Competence of Colleagues and Impaired Physicians
Consultants should not knowingly ignore a colleague’s incompetence
or professional misconduct, thus jeopardizing the safety of the colleague’s
present and future patients. The consultant should strive to protect
the public from an impaired physician and to assist in the identification
and rehabilitation of impaired colleagues. Consultants should cooperate
with peer review processes.
5.6 Expert Witness Testimony
Consultants, as a matter of acting in the public interest, are encouraged
to serve as impartial expert witnesses in clinical and technical matters
regarding electrodiagnostic medicine. Consultants providing expert
medical testimony should be adequately versed in the medical and scientific
issues involved in the matter and, before giving testimony, should
carefully review the relevant records and facts of the case and the
standards of practice prevailing at the time of the occurrence that
gave rise to the claim. It is unethical for expert witnesses to provide
services under a contingent fee arrangement. Compensation should be
reasonable and commensurate with actual services rendered. Consultants
should avoid adopting an advocacy position Consultants should restrict
their concern to the medical, not the legal issues.
5.7 Healthcare Organizations
The consultant may enter into contractual agreements with managed healthcare organizations, prepaid practice plans, or hospitals. The consultant should retain control of medical decisions without undue interference. The patient’s welfare must remain paramount.
6. Relationships With the Public and Community
6.1 Public Representation
Consultants should not represent themselves to the public in an untruthful, misleading, or deceptive manner regarding qualifications, credentials, and expertise through statements, testimonials, photographs, graphics, or other means. A patient’s medical condition must not be discussed publicly without his or her consent (see section 2.2).
6.2 Duties to Community and Society
Consultants should work toward improving the health of all members of society. This may include participation in educational programs, research, public health activities, and the provision of care to patients who are unable to pay for medical services. The consultant should be aware of the limitation of society’s healthcare resources and should not squander those finite resources by performing unnecessary tests. The needs of an individual patient should be given priority.
6.3 Existing Laws
The consultant shall be obligated to obey the laws of the land and refrain from unlawful activities, but is strongly encouraged to help produce change in laws that are not in the best interest of patients and society. Consultants should cooperate with legal authorities and processes. They should honor reasonable requests from insurers and government agencies, consistent with ethical and legal privacy protections required by law.
7. Clinical Research
7.1 Informed Consent
Research is an activity designed to develop and increase knowledge. All research must be approved and in compliance with current IRB rules. Informed consent must be obtained for all research on human subjects. A full disclosure of risks, as well as benefits, must be specified. In all circumstances pertaining to research, informed consent must include a written document signed by the subject. The consultant is responsible for obtaining informed consent from the research subject. If the subject is in a dependent relationship to the consultant and there is a question that the consent may be obtained under duress, the informed consent should be obtained by an investigator completely independent of that relationship. Special care should be taken with vulnerable populations, including children, pregnant women, cognitively impaired individuals, prisoners and others. The refusal of the patient to participate should not interfere with the patient-doctor relationship.
7.2 Institutional Review
The research project should conform to generally accepted scientific principles. The consultant who participates in clinical research must ascertain that the research has been approved by an IRB or other comparable body, and must adhere to the requirements of the approved protocol.
7.3 Financial Charges to Research Subjects
While it is acceptable to mix clinical practice and clinical research procedures in the same setting, the research procedures should be clearly identified in the IRB approved research protocol. Compensation for clinical research should follow applicable study guidelines. Consultants should not bill the patient or the insurer for services already compensated by the study sponsor.
7.4 Disclosure of Potential Conflicts
The consultant who is paid for testing patients in a clinical research project should inform the patient of any compensation he or she receives for the patient’s participation. The compensation for patient testing should be reasonable in amount. The consultant should not bill the patient or the insurer for services compensated by the study sponsor.
7.5 Reporting Research Results
The consultant shall publish research results truthfully, completely, and without distortion. In reporting research results to the news media, the consultant should make statements that are clear, understandable, and supportable by the facts. Consultants shall not publicize results of research until after the data have been subjected to appropriate peer review.
American Medical Association Principles of Medical Ethics1
Preamble
The medical profession has long subscribed to a body of ethical statements developed primarily for the benefit of the patient. As a member of this profession, a physician must recognize responsibility to patients first and foremost, as well as to society, to other health professionals, and to self. The following Principles adopted by the American Medical Association are not laws, but standards of conduct which define the essentials of honorable behavior for the physician.
Principles of Medical Ethics
1. A physician shall be dedicated to providing competent medical care,
with compassion and respect for human dignity and rights.
2. A physician shall uphold the standards of professionalism, be honest in
all professional interactions, and strive to report physicians deficient in
character or competence, or engaging in fraud or deception, to appropriate
entities.
3. A physician shall respect the law and also recognize a responsibility to
seek changes in those requirements which are contrary to the best interests
of the patient.
4. A physician shall respect the rights of patients, colleagues, and other
health professionals, and shall safeguard patient confidences and privacy within
the constraints of the law.
5. A physician shall continue to study, apply, and advance scientific knowledge,
maintain a commitment to medical education, make relevant information available
to patients, colleagues, and the public, obtain consultation, and use the talents
of other health professionals when indicated.
6. A physician shall, in the provision of appropriate patient care, except
in emergencies, be free to choose whom to serve, with whom to associate, and
the environment in which to provide medical care.
7. A physician shall recognize a responsibility to participate in activities
contributing to the improvement of the community and the betterment of public
health.
8. A physician shall, while caring for a patient, regard responsibility to
the patient as paramount.
9. A physician shall support access to medical care for all people.
1Reprinted with permission. Code of Medical Ethics Current ©2001 American Medical Association
