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Standard of Care vs. Innovative Techniques

Wednesday, August 8, 2018   (0 Comments)
Posted by: Adrienne J. Hersh, J.D., ICS Legal Counsel
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Standard of Care vs. Innovative Techniques: How Far Can You Push The Envelope? 


Because chiropractic medicine is designed to assist patients without the use of drugs and surgery, it lends itself uniquely to innovative diagnostic and therapeutic procedures. Chiropractic physicians and their patients also tend to be more open-minded about considering them.

Even so, one of the thorniest issues a physician may face is deciding when it is acceptable to diagnose or treat a patient with a new technique. If the technique is considered experimental or investigational, health payers will not reimburse for it.  Moreover, if the patient has a bad outcome, he or she may file a claim against you and your professional liability carrier.  Finally, you could be called the IDFPR to answer charges of dishonorable, unethical or unprofessional conduct. On the other hand, if no practitioner ever were willing to use a new technique on a patient, bloodletting still might be our only option for health care today. Fortunately, the law recognizes that for the science of health care to progress, some innovation must occur. Pioneering techniques may be used, but certain guidelines should be followed.

How, then, can D.C.s use these techniques? And what special steps should a physician take when using an emerging diagnostic or therapeutic procedure that is not the norm for a particular condition?


Standard of Care – A Moving Target?

Answering these questions first requires examination of the idea of standard of care. In legal terms, the "standard of care" is how similarly qualified practitioners in the same community would manage the patient's care under the same or similar circumstances. And, by definition, the standard of care for a particular condition may vary from case to case. What might be expected in a large, urban area with many health care resources is different than what would be expected in an economically disadvantaged or medically underserved rural setting. Also, although as a D.C. you are supposed to be judged under the standard of what a fellow chiropractic physician would do, in reality (and partly due to your physician status in Illinois), regulatory authorities probably expect that your standards will overlap with those of traditional medical or osteopathic doctors.

Some sources refer to the statistical norm for a particular case as the "primary" standard of care. Although there might be more than one accepted technique for a certain condition, generally one is used most frequently by conventional medicine. Situations might arise, however, where you want to use a technique that is not the primary standard of care or is not "how similarly qualified practitioners in the same community would manage the patient's care under the same or similar circumstances."


Gather Your Evidence

Merely because a statistical or primary standard of care exists for a certain condition does not necessarily mean that the use of any other technique is unprofessional, but the physician should always consider whether a particular technique would be considered the primary standard of care before using it. If it is not, the physician will bear the burden of justifying that the innovative procedure was indicated. Remember that these questions usually arise after the fact in the context of a civil malpractice claim or a licensing complaint. At that point, the facts cannot be changed, and they could be difficult to defend if the doctor hasn't done his or her homework at the time of treatment.

The doctor should always be sure that reliable, recognized empirical evidence exists to support the procedure. No matter how valuable the physician deems the test or treatment, it will be deemed unprofessional if little or no objective corroborating evidence exists when reviewed in a subsequent proceeding. If you are called to defend a procedure in a court case or license hearing, you may need to provide copies of supportive journal articles to prove your case before the Illinois Department of Financial and Professional Regulation, so make sure you have them before you employ a new technique.


Informed Consent – A Critical Step

The ICS has consistently advocated using written Informed Consent forms, but it is critically important when using an innovative procedure. The Informed Consent form documents that the doctor provided the patient with information to make an informed decision. Details regarding the risks and benefits of both the innovative and more conventional treatments should be provided, and signed copy of the form should be maintained in the patient record.

The written form should include the following: the doctor has explained that the procedure is not considered the primary standard of care for the condition in question; the doctor has explained which procedure is considered the primary standard of care; the doctor has explained the risks and benefits of undergoing this procedure, as well as the risks and benefits of other procedures that may be used under the conventional standard of care for the condition; the doctor may recommend additional testing or treatment; and the doctor may advise the patient to consult with other health care professionals where appropriate.

The form should also provide specific details about the use and indications for the procedures used in the particular case. If applicable, the form should include a statement that the patient has requested the specific procedure. The form should state that the doctor has answered any questions the patient has had, and that the patient has chosen to undergo the procedure of his or her own volition with full understanding of the risks and benefits. 

Of course, if no empirical evidence exists to demonstrate the efficacy of a new procedure, or if evidence shows that the procedure is harmful, the physician should not use it, regardless of consent.  To do so would violate professional standards, and a patient’s consent would probably be unenforceable.


Documentation, Documentation, Documentation

As always, documentation is critical. The physician should record reasons for deciding that the innovative procedure was indicated in a particular case, because if it is ever questioned, the doctor's decision will be reviewed in light of the applicable standard of care for the condition. The record should include whether other methods were considered or attempted, why or why not, and the results. This is probably more detail than would be needed when using conventional techniques, but recording this information could make the difference between a finding of unprofessional conduct and a finding that the physician acted within professional boundaries when using a new procedure.


Conclusion: Innovation and Professionalism Can Co-Exist

We are fortunate to live in an era in which we enjoy the benefits of modern health care innovation. While doctors must recognize that limits exist, they can expand the boundaries of health care in an ethical manner. By observing the guidelines of evidence-based health care, informed consent and documentation, it is possible to be at the vanguard of pioneering health care while maintaining required professional standards.


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