Shared Decision-Making Mandates Under Medicare

Patients often lack understanding of their own health care. Shared-decision making—that is, collaborative deliberation between clinician and patient about medical options that align with the patient’s interests—addresses this problem, argues medical law expert, Thaddeus Mason Pope. Over the last 10 years, the Center for Medicare & Medicaid Services (CMS), the agency that administers federally funded health insurance, has required health care providers to engage in shared-decision making when treating Medicare-insured patients with lung cancer screenings and significant cardiac interventions. But few clinicians have complied.

In a recent article, Pope describes this failure to comply as “catastrophic.” He argues that CMS, along with other regulators, should do more to enforce its shared decision-making mandates and provide guidance on implementing shared decision-making in clinical settings.

CMS imposes conditions for what kinds of medical care are covered under Medicare. These conditions limit how, to whom, and when covered care is administered. Pope explains that CMS established shared decision-making as an eligibility condition for lung cancer screenings and certain cardiac interventions to receive Medicare coverage.

In 2015, CMS issued its first shared decision-making mandate. This mandate applies to annual lung cancer screenings with low dose computed tomography, an x-ray procedure that administers a small amount of radiation. For Medicare to cover such screenings, patients must receive counseling about the procedure and have a shared decision-making visit. Pope explains that this shared decision-making includes the use of at least one patient decision aid.

Patient decision aids serve as “educational tools” that “provide relevant information on healthcare options.” Patients use decision aids to learn about benefits and harms of their care, identify preferences related to their care, and determine what kind of care is best for them. Patient decision aids exist in diverse formats including online videos and written texts with images. Pope asserts that patient decision aids “meaningfully empower patients” and “significantly enhance patients’ knowledge of treatment options.”

In 2016, CMS issued a shared decision-making and patient decision aid mandate for left atrial appendage closure devices. The devices close the left atrial appendage to prevent clots that cause strokes. To receive Medicare coverage for these devices, a patient must have a shared decision-making interaction, involving a patient decision aid, with a physician that does not perform left atrial appendage closure device procedures. CMS insists that physician document the shared decision-making encounter in the patients’ medical records.

Pope emphasizes that the 2016 mandate clarified shared decision-making as a patient-centered, “structured, evidence based and importantly interactive with bilateral exchange of information” between clinician and patient.

In 2018, CMS mandated shared decision-making with patient decision aids for implantable cardioverter defibrillators. The defibrillators comprise an “implanted device that helps prevent sudden cardiac death in people who have a high risk of a life-threatening arrhythmia.” Pope explains that CMS payment for this cardiac treatment requires a qualified practitioner to engage in shared decision-making involving a patient decision aid with the patient.

CMS issued a shared decision-making mandate for carotid artery stenting in 2023. Carotid artery stenting uses a catheter to reverse narrowing of the carotid arteries and lessened blood flow to the brain. CMS’ mandate for the procedure did not include patient decision aids but did provide detailed instructions for the obligatory shared decision-making. These instructions state “discussion of all treatment options … explanation of risks and benefits for each option specific to the beneficiary’s clinical situation, integration of clinical guidelines” and consideration of the beneficiary’s “personal preferences and priorities in choosing a treatment plan.” The 2023 mandate emphasizes the practitioner’s responsibility in conducting shared decision-making, asserts Pope.

He describes current compliance with CMS’s shared decision-making and patient decision aids as “abysmally low.” Pope claims CMS, along with other regulators, should enforce its mandates and issue guidance to implement shared decision-making in clinical settings.

Billing Medicare for a procedure that fails to meet any CMS requirement for that procedure constitutes fraud, according to Pope. He applies this understanding of fraud to shared decision-making mandates, claiming that providers commit fraud when they neglect shared decision-making for procedures that require it and bill Medicare for those procedures. He recommends that the U.S. Department of Justice prosecute noncompliance with CMS’s mandates as health care fraud violations. Pope asserts that the threat of fraud prosecution encourages compliance.

Additional CMS guidance would facilitate the integration of shared decision-making into the clinical setting, argues Pope. He proposes that CMS generate “model workflows,” detailing how shared decision-making operates in the “clinical pathway from referral to follow up.” Pope explains that health care providers hinder the adoption of shared decision-making when they do not include shared decision-making in their routine patient interactions. He argues that model workflows would assist the implementation of shared decision-making into regular patient encounters. He states that the model workflows would also respond to ambiguities in CMS mandates. For example, the mandate for annual lung cancer screenings does not specify if primary care physicians or imaging facilities are obligated to perform shared decision-making.

CMS has announced additional mandates for shared decision-making. Although Pope recognizes that shared decision making can help patients make more informed choices, he argues that clinicians should comply with current mandates before CMS promotes new ones.