Medicare Mandates for Shared Decision Making with Patient Decision Aids: Linking Payment to Preference

Since 2015, the Centers for Medicare and Medicaid Services (CMS) has increasingly required shared decision making with evidence-based patient decision aids as an essential Medicare condition for payment. CMS is doing this because it recognizes that most healthcare is preference sensitive and value laden. So, whether treatment is “right” or “beneficial” for a patient is not only a matter of clinical expertise. It equally depends on the patient’s values, preferences, and goals. So, CMS wants to ensure that patients understand the risks, benefits, and alternatives to the healthcare that they receive and for which CMS pays. In short, under its new shared decision-making mandates, CMS determines coverage eligibility not only by labs and exams but also by truly informed consent. CMS has included this new payment rule four times. And this trend is likely to continue. CMS has already considered including SDM requirements in NCDs for both transcatheter aortic valve replacement and left ventricular assist devices. And CMS announced plans to continue expanding and extending SDM requirements for more Medicare covered services and procedures. These are consequential moves. Requiring SDM with an evidence-based patient decision aid is a fundamental shift in the healthcare payment landscape. Basically, CMS is refusing to pay providers without better assurance that the patient truly wants and values the very healthcare that she is receiving (and for which CMS is paying). In other words, CMS is requiring not only that the service be “clinically indicated” but also that it be “preference indicated.” CMS’ new SDM mandates promise to protect and promote patient autonomy and self-determination. Patient decision aids (PDAs) are a key component of SDM. These evidence-based educational tools empower patients to make decisions with significantly more knowledge and less decisional conflict than traditional clinician-patient discussions alone. Substantial evidence shows that PDAs help bridge the gap between the theory and practice of informed consent. And since private payers typically follow Medicare reimbursement models, many commentators expect these shared decision-making requirements to spread more widely. Unfortunately, nearly a decade of outcomes from the CMS shared decision-making payment models have failed to make the case for further expansion. This is not because the evidence shows that SDM has failed to impact patient decisions. Instead, the absence of demonstrated effectiveness is due to a catastrophic lack of compliance. Despite the mandate, most providers (providing LDCT, LAAC, ICD, or CAS) have not used a decision aid or otherwise engaged in required elements of shared decision making. In short, early evidence shows neither effectiveness nor ineffectiveness. Too few clinicians have complied with the mandate to know one way or the other. This Article argues that CMS should enforce its SDM/PDA mandates. The mandates are an innovative payment model that promotes patient autonomy and self-determination by assuring value-congruent care. Moreover, the mandate could reduce waste and low value care. Once patients are better informed of risks, benefits, and alternatives, they often choose to forgo expensive therapies. But these potential promises of shared decision making will remain unrealized without testing. We cannot know whether or how to expand the mandate to other services and procedures without first understanding whether or how the mandate protects patients or saves money

Preparing Students for the Artificial Intelligence Era: The Crucial Role of Critical Thinking Skills

As artificial intelligence transforms the legal profession, the role of critical thinking skills among legal professionals becomes increasingly vital. This Essay argues that while AI will automate many routine le-gal tasks, successful legal practice in the AI era will require lawyers to possess robust critical thinking abilities to effectively evaluate AI out-puts, develop strategic solutions, and handle complex analytical work that AI cannot replicate. However, at this crucial juncture, evidence suggests a significant deficit in critical thinking skills among incoming law students. This deficit poses particular challenges as the legal profes-sion increasingly integrates generative AI tools that can handle routine legal tasks but require human oversight and evaluation. This Essay examines the intersection of AI technology, critical thinking skills, and legal education. It begins by analyzing the current state of AI in legal practice, with particular attention to generative AI’s capabilities and limitations. The Essay then explores the nature of criti-cal thinking, including both its cognitive skills and dispositional com-ponents, and explains why these skills are essential for legal practice in the AI era. Finally, the Essay addresses the current critical thinking deficit among law students and proposes that law schools must take a more focused approach to developing these crucial skills. This includes reconsidering traditional assessment methods that may allow students to use AI tools in ways that circumvent the development of essential critical thinking abilities. The Essay concludes that law schools must adapt their curricula and teaching methods to ensure graduates possess the critical thinking skills necessary to practice law effectively in an AI-augmented legal landscape

Deep and Continuous Palliative Sedation Without Artificial Nutrition and Hydration: An International Review

Deep and continuous palliative sedation combined with withholding or withdrawal of artificial nutrition and hydration (collectively termed “PSs̄ANH”) is a medical process regularly used in end-of-life care as a means of alleviating suffering. But PSs̄ANH is often not governed by a clear legal framework. To shed light on different approaches to regulating PSs̄ANH, this Article conducts a comparative analysis of the PSs̄ANH legality across twelve jurisdictions. To facilitate understanding of this broad issue, we subdivided PSs̄ANH into three categories: (1) PSs̄ANH will not hasten death (“Type 1 PSs̄ANH”),(2) PSs̄ANH might, but is not certain to, hasten death (“Type 2 PSs̄ANH”), and(3) PSs̄ANH is certain to hasten death (“Type 3 PSs̄ANH”). This division maximizes the clarity and precision of comparative analysis. But not all twelve of our target jurisdictions recognize this tripartite distinction. This research fills a gap in the current literature on the legality of end-of-life options. Other end-of-life options have been more extensively analyzed. For example, the legality of medical assistance in dying (“MAID”) has received significant academic attention, particularly with the introduction of euthanasia legislation in several countries in recent decades. Voluntary stopping of eating and drinking (“VSED”) has also been the subject of increased commentary. PSs̄ANH, by contrast, has gone largely unexamined. There is a particularly notable absence of international and comparative analyses of PSs̄ANH. Available international analyses cover palliative care generally rather than PSs̄ANH specifically. In two respects, this Article goes beyond the rules on palliative sedation laid down in health care guidelines. First, studies analyzing guidelines in various jurisdictions demonstrate that guidelines often do not discuss Type 3 PSs̄ANH (or any type of PSs̄ANH). Instead, they discuss only palliative sedation and the withholding or withdrawal of artificial nutrition and hydration separately). Second, guidelines may provide an incomplete picture of the legality of PSs̄ANH. Practitioners often rely on guidelines without any further analysis of the actual legal position of PSs̄ANH and related practices. Because the standard of care is often set or influenced by these guidelines, practitioners can often raise the guidelines as a defense to a claim that they acted in breach of their duty of care. However, guidelines may not provide a complete defense in all situations where medical practitioners administer PSs̄ANH

Role-Playing for Learning: Enhancing Skills in Doctrinal Courses

This book addresses the need that educators have to make theoretical concepts tangible. Teachers across various subjects and educational settings grapple with the challenge of communicating abstract ideas to diverse audiences while aiming to ignite curiosity and sustain engagement. The authors offer their insight into the method of role-playing in various law courses in a highly diverse class. The book contains thirteen simulations with teaching notes, along with the theoretical background for this method of teaching. This is the first in a series of skills books published as part of Mitchell Hamline School of Law’s Laboratory for Advancing Dispute Resolution Skills Teaching (DRI Skills Lab).https://open.mitchellhamline.edu/dri_press/1012/thumbnail.jp