Mandates for Shared Decisions: Means to which Ends?

• Published in: The Journal of law, medicine & ethics Vol. 49; no. 4; pp. 630 - 632
• Main Author: Kramer, Daniel B
• Format: Journal Article
• Language: English
• Published: England Cambridge University Press 01.01.2021
• Subjects: Clinical decision making; Clinical trials; Decision Making; Empowerment; Health services; Heart failure; Hospitals; Humans; Informed Consent; Medicaid; Medicaid fraud; Medical treatment; Medicare; Patient-centered care; Patients; Prevention; Quality of life; Reimbursement; United States > US; Informed Consent; Cardiology; Health Policy; Implantable Cardioverter-Defibrillators; Shared Decision-Making
• ISSN: 1073-1105; 1748-720X
• DOI: 10.1017/jme.2021.86

Carefully aligning invasive cardiovascular therapies to patients’ health care goals appeals to every stakeholder involved in treatment decisions.1 Patients should only pursue procedures intended to promote outcomes they value balanced against risks they consider acceptable. Physicians performing procedures and payers providing reimbursement similarly ought to favor matching expensive devices with patients most likely to benefit according to patient-centered preferences for extended survival, improved quality of life, or both. Cardiac electrophysiology therapies including implantable cardioverter-defibrillator (ICD) insertion highlight these shared goals in stark terms: Treatment is designed only to extend survival, without improving quality of life; includes small but important risks for implantation and long-term therapy; and only provides clinically significant benefits to a subset of device recipients.2 ICD implantation would thus seem an ideal environment for formally implementing shared decision-making (SDM) to ensure that patients are well-informed not just on acute procedural considerations, but the overall place of ICD implantation within their health care.3In this issue of JLME, Rao and colleagues explore implications of the controversial 2018 Centers for Medicare and Medicaid Services (CMS) final memo updating national coverage determination conditions for ICD implantation.4 CMS issued its first national coverage determination for ICDs in 1986 and has updated it periodically as new evidence and technology emerged, most recently in 2005 with expansion of primary prevention implantation to include most patients with systolic heart failure. The 2018 updated memo (which CMS curiously called “relatively minimal”) included a controversial requirement for a SDM encounter using an “evidence-based decision aid” prior to primary prevention ICD implantation for heart failure patients.5 As Rao et al observe, formally mandating SDM in a legally-binding, nationwide requirement adding logistical and practical complexity to a common, costly procedure demands a clear understanding of what CMS hoped to accomplish in doing so. It is critical to note that CMS coverage determinations have real teeth: In 2015, nearly 500 hospitals paid >$250 million over False Claims Act allegations brought by the Department of Justice related to ICD implantation outside of coverage requirements.6