Preference-sensitive treatment decisions involve making value trade-offs between benefits and harms that should depend on informed patient choice. There is strong evidence that patient decision aids not only improve decision quality but also prevent the overuse of options that informed patients do not value. This paper discusses progress in implementing decision aids and the policy prospects for reaching a "tipping point" in the adoption of "informed patient choice" as a standard of practice.

In law, with rare exception such as legislative action, change is evolutionary and methodical. Unlike biomedical science where a breakthrough can quickly lead to dramatic changes in medical practice, legal precedent is more adherent and must evolve either through the legislative process or on a court by court basis in case law. Nevertheless, compelling evidence will pave the road to change within the law. Health care research conducted over the last three decades has produced a body of empirical evidence that suggests an overhaul of our current legal standards of informed consent is overdue.This article uses health services research to examine the fundamental assumptions of our current informed consent laws and propose legal reform. Much has been written on how to bring the law to bear on medical practice in order to improve patient rights and protect physicians, but far less has been done to bring the practice of medicine to inform our legal standards. Prior legal scholarship on informed consent has made arguments regarding reform from both ethical and legal perspectives; however, only a small few have incorporated clinical and health services research as well as ethical and legal principles to analyze informed consent.

Clinical evidence suggests that many patients undergo surgery that they would decline if fully informed. Failure to communicate the relevant risks, benefits, and alternatives of a procedure violates medical ethics and wastes medical resources. Integrating shared decision-making, a method of communication between provider and patient, into medical decisions can satisfy physicians' ethical obligations and reduce unwanted procedures. This article proposes a three-step process for implementing a nationwide practice of shared decision-making: (1) create model integration programs; (2) provide legal incentives to ease the transition; and (3) incorporate shared decision-making into medical necessity determinations.

The recognition that informed patients often choose more conservative and hence less expensive medical options has made shared decision making a focus of valuebased care. 1 In 2007, Washington State passed legislation incentivizing shared decision making as an alternative to traditional informed consent procedures and forms for preference-based treatment decisions that include an elective procedure, such as joint replacement for hip or knee osteoarthritis. 2 To qualify as this alternative to traditional informed consent, clinicians are required to use a certified decision aid to facilitate discussion about the different treatment options and patients need to sign an attestation that they reviewed the decision aid with the clinician, discussed the alternatives, risks, and benefits, and decided on a specific course of action. Clinicians who practice shared decision making will be presumed to have engaged patients in an informed consent process regarding the elective procedure and will be provided with increased protection against potential ensuing litigation based on failure to inform. Specifically, the use of the tools and the process associated with this use would shift the burden in litigation to patients to demonstrate clear and convincing evidence that they were not informed. 2 In 2016, Washington State certified the first decision aids in maternal-fetal care related to decisions for birth options after cesarean delivery, for amniocentesis, and for genetic screening.Washington State's unprecedented legislation coincides with national activity. The National Quality Forum recently developed national certification standards for patient decision aids based on those used in Washington State. 3 The Centers for Medicare & Medicaid Services (CMS) announced shared decision making as a precondition for payment for low-dose computed tomography scans for lung cancer screening and for left atrial appendage closure, and recently announced 2 shared decision making models for beneficiary engagement that focus on 6 preference-sensitive conditions: stable ischemic heart disease; hip osteoarthritis; knee osteoarthritis; herniated disk and spinal stenosis; clinically localized prostate cancer; and benign prostatic hyperplasia. 4 Additionally, the recent Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) included shared decision making in 1 of 4 performance categories used to determine clinician reimbursement under the Merit-Based Incentive Payment System. Even as shared decision making expands, 5 most clinicians and health centers outside the research setting have limited experience with decision aids, which may undermine the potential for shared decision making to engage patients in an open, transparent manner about health care choices.Clinicians who will be incentivized to use shared decision making may have misconceptions about what it is and skepticism of its value. Well-defined standards are needed to help translate new policies into clinical prac-VIEWPOINT