Potential liability and risk management implications
Many physicians may find it controversial enough that the results of comparative clinical effectiveness research (especially when the relative costs of different interventions are taken into account) may impact their future reimbursement. This controversy could intensify if the results of these studies could be taken into account in liability actions.
What potential legal weight might the results of these studies have in liability actions? What would these studies need to have taken into account in arriving at their conclusions for a physician to be able to use adherence to them as a shield? What would need to be taken into account to permit the other side to use them as a sword against physicians for not following them (or even for following them resulting in a bad outcome)?
A close cousin to comparative clinical effectiveness research (controlled clinical trials) has carried varying degrees of weight in medical liability actions in the past. As the standard of care has slowly evolved from local determinations of “what would a reasonable physician have done under similar circumstances” to what is the recognized best evidence based practice(s) to employ, the results of these studies have acquired more heft in liability actions.
Comparative clinical effectiveness research will likely be somewhat similar in its evolution and probable applications in medical liability actions. What may well turn out to be different about it are at least two things:
· Reimbursement (in whole or in part) may turn in the future upon proof of following the recommendations deriving from this research
· To get their results into the mainstream more quickly and cost effectively than the very expensive and time-consuming controlled clinical trials, comparative clinical effectiveness research may be conducted through the analysis of large electronic databases to link certain practice patterns with superior value (high quality, safely and efficiently produced) clinical outcomes
Especially regarding results of studies that are produced by the analysis of large clinical databases (often derived from the use of electronic medical records), there would need to be certain safeguards built in to ensure fairness and accuracy in using the fact of adherence or non-adherence with best practices as a basis for liability or exoneration. Some of the factors that would need to be taken into account during these studies when applied to demonstrate potential negligence (or lack thereof) for not following their recommendations would be:
· Pre-treatment Severity of Illness: Did the plaintiff in a particular action exhibit a comparable clinical condition and severity of illness to those in the study whose results are being introduced either as a sword by the plaintiff or a shield by the defense?
· Statistically Significant Conclusions: Were there enough patients in the samples comparing interventions to be able to conclude with an acceptable level of statistical significance that the variations in clinical outcomes were due to the differences in the interventions and not due to chance alone?
· Impact of Other Clinical and Non-Clinical Factors: Were there other countervailing factors occurring during the comparative effectiveness studies other than the interventions being evaluated (e.g. preventive measures, lifestyle changes, environmental influences, etc.) which were not sufficiently “teased out” of the analysis of the results so as to open to question the conclusions for recommending one specific intervention over another?
Summary
Of all of the initiatives in the ARRA of 2009, the fresh $1.1 billion appropriated for comparative clinical effectiveness research has probably generated the most controversy. The most immediate reason is the fear expressed by physicians (and some lawmakers) that the results of this research may start us on the slippery slope to cookbook medicine, rationed care and central government-driven medicine.
Other, more nuanced criticisms have questioned whether enough of the unique clinical attributes of individual patients can be taken into account to provide truly useful guidelines to physicians and their patients to promote better decisions resulting in higher quality, safer and more efficient care. Either way, there are still a lot of unanswered questions about the extent to which the results of this research may inform future reimbursement, much less the medical liability of physicians. Nevertheless, physicians need to be aware that this research is coming and be in a position to influence the course and results of the policy debates ahead.