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Abstract

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 decisionmaking 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. First, CMS began, in 2015, with a national coverage determination (NCD) on low dose CT scanning for long-time smokers. CMS even created a billing code and payment for the shared decision-making (SDM) visit separate from the billing code and payment for the CT scan itself. Second, in 2016, CMS included even stronger SDM requirements in its NCD for left-atrial appendage closure therapy. Third, in 2018, CMS included SDM requirements for a third time, for implanted cardioverter defibrillators. Fourth, in 2023, CMS included SDM requirements for carotid artery stenting.

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.

Not only does enforcement of SDM/PDA mandates protect patient autonomy and safety but it also prevents healthcare fraud. The SDM/PDA requirement prevents overtreatment. Few would dispute that billing Medicare for giving chemotherapy to patients without cancer is fraud. Few would dispute that billing Medicare for implanting stents in patients without blockages is fraud. The SDM/PDA mandates are similar. It is fraud to bill Medicare for LDCT, LAAC, ICD, or CAS without satisfying the eligibility requirement of shared decision making with an evidence-based decision aid. In short, CMS and other regulators should enforce the mandates to incentivize compliance. Or they could at least guide and support providers to facilitate their compliance.

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