For more on this topic, go to www.dentaleconomics.com and search using the following key words: CBCT, informed refusal, informed consent, Dr. Eric Ploumis, Dr. David Gane.
Dr. Eric Ploumis is an orthodontist and an attorney. He is also an associate clinical professor in the Department
Dr. Eric Ploumis
Dr. Gane: 3-D cone beam computed tomography (CBCT) provides practitioners with answers to difficult questions with respect to diagnosis and treatment planning, but it also raises questions related to managing risk. I recently had the opportunity to meet with Dr. Ploumis, who proved to be a wealth of information on this topic.
Dr. Gane: CBCT is a relatively new technology. From your perspective, what type of risk management challenges accompany owning a CBCT? As you see them, what are the main issues?
Dr. Ploumis: As with any emerging technology, law has not kept pace with science. CBCTs are still in their infancy and some of the risks have yet to emerge. Regrettably, some of us will be the ones that make new laws and illuminate those risks. The current, obvious risks are those of missed diagnosis, violation of federal and state antikickback laws, and increased radiation exposure.
Dr. Gane: Many CBCT adopters inquire about making their system available to practitioners in their community to facilitate return on investment. What advice would you give practitioners who are interested in offering such a service to colleagues?
Dr. Ploumis: Be cognizant of the risk factors we discussed in the previous question. First and foremost, make it clear that you are serving only as a technician when taking the scan. Be sure there is no perception by the patient that you have formed a doctor-patient relationship unless that is your intention. Otherwise, you may be liable for any missed pathology and your malpractice will not indemnify you. Second, make sure there is no perception that you are taking the scan for your colleague with the expectation of a referral or something of value. This could be construed as a kickback or referral fee. You can charge a fair fee for your services but you cannot, for example, waive the fee for the scan under the condition that your colleague refers patients to you. Third, especially in light of some of the national press about acceptable radiation exposure, be sure to explain the ionization burden that the patient will receive when you take the scan. If you plan to take scans for colleagues, you should consider getting a separate errors and omissions policy since you will not be covered under your personal malpractice policy for these scans.
Dr. Gane: With 2-D imaging, dentists rarely obtain informed consent prior to receiving radiographs. But I have heard that obtaining informed consent from the patient when using CBCT is recommended. What type of informed consent is appropriate, and how does CBCT differ from traditional 2-D radiographic imaging in this regard?
Dr. Ploumis: Again, because CBCT is so new, we do not yet have the law to guide us on the appropriate informed consent standards. What we do have as a guide is the generally accepted legal standard for informed consent: Would a reasonably prudent person in the patient's condition have undergone a CBCT scan if he or she had been fully informed of the risks, benefits, and costs? Using this definition, your informed consent should consist of a discussion of the diagnostic, treatment, and radiation risks and benefits related to the taking of a scan. Until the law becomes more settled in this area, I would suggest a written informed consent.
Dr. Gane: What is informed refusal, and how does it differ from informed consent?
Dr. Ploumis: Informed consent is the process by which a health professional explains the risks and benefits of a procedure or treatment so that the patient may make a knowledgeable decision whether to proceed with the recommended treatment. Informed refusal is the process by which the patient, after receiving all of the facts, chooses not to undergo a particular treatment or procedure. It is not enough to suggest certain treatment options to a patient; you must also tell the patient what might happen if he or she does not follow your advice. It is just as important to document informed refusal as it is to document informed consent. For example, once presented with all of the risks and benefits, a patient may consent or refuse to undergo a cone beam image. If you, as the treating doctor, think that such an image is essential to the proper diagnosis and treatment of the patient, you may refuse to treat the patient.
Dr. Gane: Is there any type of a disclaimer that can be obtained from the patient to limit one's liability?
Dr. Ploumis: The courts have not recognized disclaimers as an effective shield from allegations of professional negligence. Having a patient sign a disclaimer does not give you the right to treat below the standard of care. One definition of the standard of care is how a similarly qualified practitioner would have managed the patient's care under the same or similar circumstances. If a reasonably prudent practitioner would have taken a cone beam image in a given situation, you cannot obviate that fact by having the patient sign a disclaimer. If you think an image or procedure is necessary, your options are to insist that the patient comply or choose not to treat the patient.
Dr. Gane: Once the CBCT data is acquired, what is the clinician's professional responsibility with respect to interpretation and reporting? Can the clinician do this or does he or she have to recruit the services of an oral maxillofacial radiologist (OMFR)?
Dr. Ploumis: If the clinician feels competent that he or she can interpret the image to the standard of care, it is acceptable to do so. The standard of care requires that the image be read thoroughly and competently, arguably at least as thoroughly as the average OMFR. Just as some general dentists can competently do ortho to the level of the average orthodontist, so too can some orthodontists read their images to the level of an OMFR. My advice, however, is to have every image read by an OMFR and eliminate that risk. The American Academy of Oral and Maxillofacial Radiologists issued a position paper that stated "Dentists using CBCT should be held to the same standards as board certified radiologists." I would not want to have to be judged by those standards in a malpractice trial for a missed diagnosis on a CBCT.
Dr. Gane: If the services of a radiologist are obtained, does the radiologist need to be licensed in the same jurisdiction that the CBCT was acquired, or can an out-of-jurisdiction radiologist be used as a second opinion "over read"?
Dr. Ploumis: This is still a very gray area and each state has its rules and regulations on this issue. But several states have clearly ruled that if you give medical advice, you must be licensed within the state where the advice is to be relied upon. Other states have been a little more lenient with unlicensed doctors giving advice in a foreign jurisdiction. The safest answer, from a risk management perspective, is to make sure the radiologist reading your scans is licensed within your state, provides you with proof of malpractice insurance, and gives you a written agreement to indemnify you in the event of a missed diagnosis.
Dr. Gane: What about a suspicious finding on the image in a region outside of the jaws? Can dentists be expected to make a radiographic diagnosis outside the scope of their license?
Dr. Ploumis: We are not expected to practice outside the scope of dentistry and diagnose pathology unrelated to our training and expertise. We are, however, expected to be able to identify unusual findings and know when to refer and follow up. I concur with the AAO's position: "CBCT scans can show information beyond that which we, as orthodontists, are trained to interpret." However, legally you may be presumed to know all that is shown. Therefore, involving a radiologist relative to the reading of CBCT scans is advisable.
Dr. Gane: Is taking a CBCT the standard of care for some dental treatments? When will CBCT become the standard of care?
Dr. Ploumis: Many of our prosthodontic and oral surgery colleagues think that some of the procedures they perform require CBCTs to comport with the standard of care. Arguably, there are orthodontic procedures, such as impacted canines, that would suggest a CBCT is necessary. Just as a panorex was once cutting-edge technology and is now a routine diagnostic tool, so too will the CBCT scan one day be considered a routine part of our diagnostic armamentarium. We discussed one definition of the standard of care earlier. Another definition would be "the level at which the average, prudent provider in a given community would practice." CBCT will become the standard of care when many of our colleagues rely on the information provided in a CBCT to render a competent diagnosis. I do not think we are at that point yet, but it is coming.
Dr. Gane: Are there any cases pending related to CBCT use that you are aware of and can share? Is there any emerging case law related to the use of CBCT that can help guide us in managing risk?
Dr. Ploumis: Presently, there are no cases reported in official legal compendiums related to cone beam liability issues. There have been several cases in the lower courts related to the failure to diagnose that have not been officially reported. These have been settled in confidential agreements. As I previously noted, some of us will be the ones that make new laws and become enshrined in those official case reports.
Dr. Gane: What is the single most important thing a CBCT owner can do to minimize risk when it comes to obtaining or ordering a CBCT data set?
Dr. Ploumis: Have the data read by a qualified radiologist.
Dr. Eric Ploumis is an attorney, orthodontist, and associate clinical professor at New York University. He limits his legal practice to business and transactional issues related to dentistry, including practice transitions, employment issues, office leases, and defense of allegations of professional misconduct. Reach him at www.DentalPracticeLawyers.com.
Dr. David Gane has a passion for dental imaging and has published and lectured nationally and internationally on the topic. Dr. Gane serves as vice president of Dental Imaging for Carestream Dental LLC, the exclusive maker of Kodak Dental Systems. Reach him at [email protected].
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