Introduction

The question of whether or not to perform a particular diagnostic or treatment procedure on a specific patient is a complex one involving clinical findings, patient preferences—which may include family, social, and cultural considerations, religious beliefs, and ability to pay, among others—and the standard of care. While cone beam computed tomography (CBCT) has been in clinical use since the early 2000s (Sukovic, 2003), for most practitioners it is still in a relatively nascent stage with respect to its use in orthodontics and cannot be said to constitute the standard of care at the present time. Opinions run the gamut from advocating the use of CBCT on every patient to the view that it has a limited role to play in the average orthodontic patient. “To scan or not to scan” thus is a question currently facing all orthodontists. Although evidence-based selection criteria are being developed (see Chapters 1 and 6) and will continue to evolve, the answer to this question is much in flux and is in large part unanswerable currently. However, two points can be made with near certainty. First, it is not appropriate to scan every orthodontic patient; to argue otherwise is to demonstrate a fundamental misunderstanding of the difference between a diagnostic test and a screening procedure (Grimes & Schulz, 2002). Second, it is equally wrong to assert that no patient should be scanned, for some surely will benefit from the information provided. The challenge for the orthodontic profession is to establish selection criteria between these two extremes in such a manner that it is useful clinically.

For the individual orthodontist, when deciding whether or not to take a CBCT scan on a patient, the issue comes down to the standard of care. This chapter is not a discussion of any individ­ual’s opinion of whether and when a CBCT scan is indicated for the orthodontic patient. Neither is it an in-depth discussion on how the specialty of orthodontics should decide that question, although that will be mentioned briefly. Rather this chapter explores: (1) how the standard of care is determined and to which sources practitioners may turn for guidance during the nascent stage of a new technology, and (2) what the “average qualified” or “reasonably prudent” practitioner should do when there is no clearly defined standard based on common usage or as defined by the courts. The chapter concludes by examining some associated ethical and regulatory issues regarding the clinical use of CBCT, thus providing insights on how an individual orthodontist might determine whether a CBCT scan is or has become the standard of care and, if so, when he or she ought to order a scan for a particular patient. The information provided in this chapter is supplemented elsewhere in this book (Chapters 1 and 6) by the emerging evidence-based and case-based selection criteria that emphasize the need to determine the benefit-to-risk ratio prior to CBCT scanning of any given patient.

This chapter addresses only one of the medico-legal aspects related to clinical uses of CBCT, namely, whether or not to scan a patient. There is a multitude of other medico-legal and legal issues related to the CBCT. These include matters related to the purchasing and ownership of a CBCT machine (e.g., what are the legal issues if you choose to buy one in conjunction with a physician?) and the responsibility for interpreting the images. The latter itself raises a plethora of issues, among them being where the radiologist who is interpreting the images needs to licensed if a clinician opts to send a CBCT scan to be read by an out-of-state radiologist. An additional legal issue arises when dentists including orthodontists seek to limit their liability for reading CBCT scans, especially when they read the images themselves, by asking patients to sign a waiver of liability. Of practical importance too is whether a dentist’s malpractice insurance carrier will cover a dentist who owns a machine and takes CBCT scans and interprets them for other dentists. For these and other medico-legal issues, the reader is referred to an article in which these issues are discussed in depth (Friedland, 2009).

Standard of Care

Why Is the Standard of Care Relevant or Important?

Clinicians typically think most explicitly and consciously about the standard of care when they find themselves at the receiving end of a malpractice suit. Subconsciously, however, they apply the standard of care every time they contemplate whether or not to render treatment or perform a diagnostic test (henceforth referred to collectively as procedure[s]) and, if so, how to undertake it appropriately. Thus, the standard of care’s primary purpose is not medico-legal in nature; rather, it is indispensable to the everyday practice of the profession. It is used on a daily basis in deciding what the appropriate course of action is for a particular patient and what to include in the informed consent discussion. Without a standard of care, it would be difficult at best for an individual clinician to know what the appropriate diagnostic and treatment choices are. At a minimum, it serves as a starting point for considering which procedures are appropriate in a given situation. The standard of care has implications beyond the primary aforementioned medical purpose. For example, it may determine whether insurers will cover the cost of care, something that obviously is of concern to both the patient and the clinician.

How Does a Procedure Become the Standard of Care?

Practitioners often perceive incorrectly that the standard of care is a legally mandated standard set by the court or somehow mandated by their medical malpractice carrier. With this mind, we shall examine some issues related to the standard of care. Who and what determine the standard of care? How would an orthodontist know if and when a procedure, in this case CBCT, is the standard of care?

Unlike drugs, which are introduced into the market upon acceptance by the Food and Drug Administration (FDA), there is no overarching governmental organization that approves or provides for an orderly process for the introduction of new procedures. There also is no private group or organization, no matter how well respected in the profession, that is recognized as having the legal authority to establish the standard of care or to mandate a formal mechanism by which a new procedure becomes the standard of care. At one time, it had been suggested that a government agency, the National Center for Health Care Technology (NCHCT), could assume the role of the FDA vis-à-vis medical procedures. Whether this would have proved practical or had any effect is a moot point as the NCHCT was relatively short-lived, having been in existence from only 1979 to 1982 (http://healthaffairs.org/blog/2009/01/22/the-national-center-for-health-care-technology-lessons-learned/, accessed January 5, 2013).

Only rarely is the standard of care established in an instant. In the overwhelming majority of cases it is a slow, imperceptible process, and the time at which a procedure or test became the standard of care often may be recognized only in hindsight. There are a number of ways in which something may become or get recognized as the standard of care. Necheles (1982) explored a few different procedures and how each one came to be accepted as the standard of care. He described how renal transplantation came to be accepted as the standard of care in an unusual manner, namely, through the political process, before it became accepted as such by the medical profession. This resulted from a decision by Congress to enact 42 U.S.C. §426-1, the end-stage renal disease program, an act that still remains in effect (Eggers, 2000). As explained by Necheles (1982), although the decision by Congress was supportable on scientific grounds, it was Congress’s decision that led to the acceptance of kidney transplants as a routine medical procedure.

During and after an investigational phase, a procedure may hover at the margin of clinical acceptance before becoming the standard of care or falling into abeyance. It may make the jump to clinical practice based on one or more respected institution’s decisions to offer the procedure as routine medical care or as a result of the procedure’s endorsement by practitioners who are regarded highly by their peers. Alternatively, a procedure may evolve from an experimental stage to a clinically accepted standard of care when third-party payers decide to cover the cost of such care. This is especially true of Medicare and Medicaid’s decisions to cover the cost of procedures. Private payer’s decisions as to whether to cover a procedure often follow a decision by Medicare and Medicaid to cover that procedure (http://www.prgweb.com/resources/key_elements_of_reimbursement.php, accessed Jan­­uary 5, 2013; http://www.emersonconsultants.com/_assets/document/Fundamentals_of_Reimbursement_Chapter.pdf, accessed January 5, 2013). In its early days, Medicare and Medicaid’s decisions often were based on flimsy evidence. Fink (1981) describes how, as a just graduated second-year medical student in the early days of Medicare, he made coverage decisions for Medicare based on talking to physicians who had done the new procedure, as well as to experts in the field. In those days, that was the sum total of the evidence used to make a decision, at least by Medicare and Medicaid.

Decisions by payers, whether governmental or private, are not dispositive of whether a procedure constitutes the standard of care. However, a decision to pay would be some indication of a procedure’s acceptance by the insurance community and, thus, more meaningful than a decision not to cover a procedure, since the latter may be motivated primarily as a cost-containment measure. In dentistry, in particular, where the use of the word “insurance” really is a misnomer (Weiss et al., 2003), a decision not to cover a procedure frequently involves primarily or exclusively financial considerations for insurers. Thus, the decision to cover a procedure in dentistry is far more meaningful than a decision not to cover it.

In one of the rare instances in which a test or procedure became the standard of care overnight, the Washington state supreme court held that an ophthalmologist was liable for a patient who developed glaucoma at a much younger age than what is typical. The patient had seen the ophthalmologist for several years, beginning in her thirties. The experts for both the plaintiff and defendant testified that the standard of ophthalmologic care did not require routine pressure tests for glaucoma on patients younger than 40 years of age, since the condition is so rare prior to that age. Despite this expert testimony, the court held the ophthalmologist liable, thereby making testing for glaucoma in even young patients the standard of care overnight. The court based its finding on the fact that the test is simple, relatively inexpensive, objective, and definitive in diagnosing the condition and that development of the condition is devastating (Helling v. Carey, 1974). It is rare indeed for a court to hold that an entire profession was practicing negligently, but the case illustrates one way in which a procedure may become a standard of care. Interestingly, despite the court’s decision, ophthalmologists did not begin administering the test to everyone under age 40 automatically. Subsequent to the court’s decision, the Washington legislature passed a statute in an attempt to have the standard of care revert to what it had been previously, a standard which will be examined below. Although not relevant to this discussion here, there are interesting subsequent Washington state cases discussing whether the language in the statute accomplished the legislature’s intent.

In the overwhelmingly majority of cases—indeed, almost universally so—the standard of care is determined by what clinicians actually do in practice. For example, Massachusetts holds that the standard of care is determined by the degree of care and skill of the average qualified practitioner (Brune v. Belinkoff, 1968), while Washington state pronounced that a professional’s conduct is to be measured against that of a reasonably prudent practitioner (Harris v. Groth, 1983). While the precise wording of courts may differ, the intent and effect is the same, namely, it is the professionals “in the field” who set the standard of care. The Brune court refers to the care and skill of the average qualified practitioner. Clearly, the court could not have meant this statement literally as, by definition, a good many practitioners fall below the standard of the average qualified practitioner. Keeton and associates (1984) explained the court’s intent by stating, “It is not the middle but the minimum common skill.” The Brune court added to its enunciated standard the phrase, “Taking into account the advances in the profession.” The latter is an affirmation that one cannot keep doing things only the way one was taught—one must keep up with the times, which is highly relevant to the utilization of CBCT in orthodontics. Continuing education and updating curriculum in teaching programs is, of course, the key to staying current.

In the setting of a trial, a jury typically hears from the plaintiff’s and the defendant’s experts as to what is the standard of care. These experts may base their opinions on experience, knowledge of clinical practice, and texts, treatises, articles, and professional guidelines that the judge, in his or her discretion, may admit into evidence. All of these may be introduced only through an expert witness who must validate or establish the publication as authoritative before it will be allowed into evidence. It then is up to the jury to decide what and whom to believe. It is critical to understand that an expert witness cannot testify to what he or she thinks the standard of care should be, only to what it is, or at least what he or she thinks it is. And what it is depends on what the average qualified practitioner does. To reiterate, the standard of care is set by the profession itself through its practitioners and not by one or more trial experts or by a judge or jury.

New Procedures

A Difficult Dilemma for the Practicing Clinician Regarding the Standard of Care

The issue of whether something constitutes the standard of care is vexing particularly with regard to a new procedure. Clearly, the majority of “average qualified practitioners” do not adopt a new procedure at the same time. Some will be early adopters; the majority will follow later; a few will follow much later; and some perhaps not at all. In determining the standard of care, courts look to the numbers of practitioners who use the procedure. Thus, practitioners who are or who consider themselves to be at the cutting edge theoretically may place themselves at risk of being accused of substandard care when they are early adopters. However, courts also look to the credentials of those who use a procedure, affording the procedure greater status if the adopters, even though a minority, are respected within the profession. Some jurisdictions explicitly follow the “respectable minority” rule (Cramm et al., 2002), which states, “A physician does not incur liability merely by electing to pursue one of several recognized courses of treatment” (Downer v. Veilleux, 1974). Thus, courts accept />