As the nation moves further down the road toward “Accountable Care,” there has been an increasing emphasis on stricter compliance with national guidelines. Theoretically, adherence to clinical guidelines by providers would reduce care variation, decrease unnecessary costs, and improve quality (value). Physicians rightly worry about their own exposure (both legally and financially) if they elect to deviate from published guidelines. In this month’s column, three experts on this topic discuss safe harbor and legal risk for providers with respect to practice guidelines. We appreciate Dr. Adams’ willingness to write from the viewpoint of both a physician (faculty at the University of Michigan) and an attorney.
John I. Allen, M.D., MBA, AGAF, Special Section Editor
The Institute of Medicine defines clinical practice guidelines (CPGs) as “statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.”1 The origin of CPGs can be traced to the desire of physicians and the public to give and receive the best care possible, especially given increasing medical costs, newly developed expensive technologies, evolving modalities of health care delivery, and variation in the quality of care. CPGs are used by diverse stakeholders including patients, legislators and policy makers, insurance companies, litigators, health systems, and physicians, not only to make medical care efficient, but also to hold practitioners accountable across different practice and geographic settings.
Dr. Veeral M. Oza
Although CPGs may be beneficial to overall population health, they may not be the right approach for an individual patient.2 However, there is a real concern among physicians that going against a CPG recommendation could potentially lead to litigation, especially in the setting of a negative outcome. So when, if ever, is it acceptable to go against CPG recommendations? In this article, we present a hypothetical case in which following guideline recommendations would potentially expose the patient to greater risks than intentionally choosing to deviate from guidelines. We then discuss the legal implications of this choice, and the challenges of using CPGs to establish the legal standard of care.
Case
A 24-year-old man, incarcerated, with no past medical history, presents to the emergency department with complaints of dysphagia and an inability to tolerate his oral secretions. The patient reports that he was attempting to swallow a packet of heroin of unknown quantity to hide evidence. A diagnosis of heroin packet impaction in the esophagus is made, and the gastroenterology service is consulted for urgent endoscopy.
Given current CPG recommendations advocating no role for endoscopy in removal of impacted cocaine and heroin,3 the astute gastroenterologist then discusses the case with the surgical service and presents options to the patient: either surgical removal of the impacted object via thoracotomy, or with upper endoscopy with the knowledge that the latter option would be against guidelines and present significant procedural risks, including possible death if the packet ruptures. The dilemma occurs when the patient insists against the surgical approach, makes an informed decision, and consents only to endoscopic removal. How should the gastroenterologist proceed? Will there be medicolegal ramifications of performing a procedure against CPG recommendations, especially if there are complications?
Discussion
With the emergence of health services research in the 1970s and 1980s, practitioners and policy makers began to recognize the existence of widespread practice variation in the provision of health care services. CPGs grew from this body of work in an attempt to encourage more standardized, quality care processes and control ballooning health care costs. Through the Omnibus Budget Reconciliation Act of 1989 (103 Stat. 2159), Congress created the precursor to today’s Agency for Healthcare Research and Quality to enhance the quality, appropriateness, and effectiveness of health care services through various means, including the development of CPGs. A quick search of today’s Agency for Healthcare Research and Quality National Guideline Clearinghouse reveals the existence of 260 gastroenterology-related guidelines from local and national professional societies, hospitals and health care centers, and governmental organizations. Whether and to what extent these guidelines should be used to establish the legal standard of care is a hotly debated topic among both legal and medical circles.
Dr. Megan A. Adams
A medical professional liability claim is a civil claim of negligence. Negligence, in the legal sense, is defined as a breach of the “standard of conduct to which [one] must conform...[and] is that of a reasonable man under like circumstances.”4 To prove negligence on the part of a physician in a medical professional liability case, the plaintiff/patient must prove the required elements of the claim, as follows: 1) the existence of a duty of care, 2) breach of that duty, 3) actual and proximate causation, and 4) damages/harm.
