Medical Malpractice Standard-Setting: Developing Malpractice 'Safe Harbors' as a New Role for Qios?

Recent tort and medical malpractice reform has largely been directed at damages for noneconomic loss, a remedy-centric approach. This article addresses the issue of cost not from a remedy-centric perspective but from the perspective of the impact of the liability-determination process and standards on levels of utilization and therefore cost - the defensive medicine perspective. Establishing medical liability relies on the professional customary practice standard and is premised on the assumption that science determines a standard of care that controls medical decision-making in individual circumstances. Evidence of unexplained practice variation (clinical uncertainty) calls this scientific premise into question in a large number of situations, making compliance with a standard of care difficult, even mythical, in many clinical circumstances. Because the medical profession sets the standard, consideration of cost-benefit issues in individual cases is not part of the liability-determination process in medical malpractice cases. Further, the professional standard of care is established after-the-fact (structural uncertainty) by expert testimony ostensibly based on scientifically validated customary practices. Such ex post standard-setting is understandable in a medical-practice world characterized by scientific evidence, but the evidence on clinical uncertainty undermines that claim. This creates structural uncertainty, which makes compliance with the after-the-fact "standards of care" difficult - pursuit of a moving target. The result of clinical and structural uncertainty is an incentive for risk-averse medical decisionmaking - doing more than might be medically optimal to avoid liability. Such defensive medicine is facilitated by the prevalence of third-party payment, which funds this type of risk-averse clinical decisionmaking and reduces the reliability that custom might otherwise reflect in balancing cost and benefit in a less subsidized market. This article proposes the use of ex ante standard-setting to reduce uncertainty faced by medical providers and to allow for the appropriate balancing of costs and benefits in formulating such protocols. Such standards should be symmetrical - the controlling legal standard that serves both as both a liability sword and shield. From a quality-assurance perspective, this sword-and-shield dimension creates a powerful incentive for compliance. To make ex ante standard-setting work, the standard must be the controlling standard. The federal QIO legislation allows QIOs to establish practice standards that become the standards of care. Such QIO-developed standards trump state-created standards by conferring immunity for conduct in compliance with the QIO standards. To be effective as a defense against defensive medicine, such QIO-developed standards must be modest in conception, narrow in design, and targeted in their implementation. They must be targeted at narrow and specific circumstances, providing specific guidance to practitioners in carefully circumscribed situations. They should be conceived of as "safe harbors," not broad parameters of practice. These safe harbors should be aimed at defensive practices that are sub-optimal - areas in which quality can be maintained while reducing cost. That substantial savings are attainable, consistent with the maintenance of quality, is strongly suggested by research that concludes that, at least regarding some types of services, the most important problem is overuse that exposes patients to the risks of unnecessary treatment.