Hostname: page-component-78c5997874-dh8gc Total loading time: 0 Render date: 2024-11-10T17:47:03.861Z Has data issue: false hasContentIssue false
  • English
  • Français

Mandates for Shared Decisions: Means to which Ends?

Published online by Cambridge University Press:  10 January 2022

Daniel B. Kramer
Get access Rights & Permissions [Opens in a new window]

Abstract

An abstract is not available for this content so a preview has been provided. Please use the Get access link above for information on how to access this content.
Image of the first page of this content. For PDF version, please use the ‘Save PDF’ preceeding this image.'

Keywords

Implantable Cardioverter-DefibrillatorsShared Decision-MakingInformed ConsentCardiologyHealth Policy
Type
Independent Articles: Commentary
Information
Journal of Law, Medicine & Ethics , Volume 49 , Issue 4: First Amendment Values in Health Care , Winter 2021 , pp. 630 - 632
Copyright
© 2021 The Author(s)

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Lewis, K. B., Carroll, S. L., and Birnie, D. et al., “Incorporating Patients’ Preference Diagnosis in Implantable Cardioverter Defibrillator Decision-Making: A Review of Recent Literature,” Current Opinion in Cardiology 33, no. 1 (2018): 42–49.CrossRefGoogle ScholarPubMed
Knoepke, C. E., Allen, L. A., and Kramer, D. B., et al., “Medicare Mandates for Shared Decision Making in Cardiovascular Device Placement,” Circulation: Cardiovascular Quality and Outcomes 12, no. 7 (2019): e004899.Google ScholarPubMed
Wallace, B. C., Allen, L. A., and Knoepke, C. E., et al., “A Multicenter Trial of a Shared Decision Support Intervention for Patients Offered Implantable Cardioverter-Defibrillators: DECIDE-ICD Rationale, Design, Medicare Changes, and Pilot Data,” American Heart Journal 226 (2020): 161–173.CrossRefGoogle ScholarPubMed
Rao, B. R., Merchant, F. M., and Howard, D. H., et al., “Shared Decision-Making for Implantable Cardioverter-Defibrillators: Policy Goals, Metrics, and Challenges,” Journal of Law, Medicine, and Ethics 49, no. 4 (2021): 622–629.10.1017/jme.2021.85CrossRefGoogle ScholarPubMed
Center for Medicare and Medicaid Services (CMS), “Decision Memo for Implantable Cardioverters-Defibrillators,” (CAG-00157R4), available at <https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=288> (last visited October 13, 2021).+(last+visited+October+13,+2021).>Google Scholar
US Department of Justice, Office of Public Affairs, “Nearly 500 Hospitals Pay United States More Than $250 Million to Resolve False Claims Act Allegations Related to Implantation of Cardiac Devices,” available at <https://www.justice.gov/opa/pr/nearly-500-hospitals-pay-united-states-more-250-million-resolve-false-claims-act-allegations> October 30, 2015, (last visited October 13, 2021).+October+30,+2015,+(last+visited+October+13,+2021).>Google Scholar
CMS, supra note 5.Google Scholar
Rickard, J., Michtalik, H., and Sharma, R., et al., “Use of Cardiac Resynchronization Therapy in the Medicare Population,” (2015), available at <https://pubmed.ncbi.nlm.nih.gov/26247085/> (last visited october 13, 2021); D. B. Kramer, and D. A. Steinhaus, “Cardiac Resynchronization Therapy in Older Patients: Age Is Just a Number, and Yet,” Journal of Cardiac Failure 22, no. 12 (2016): 978-980; D. B. Kramer and M. E. Josephson, “Expanding the Use of Cardiac Resynchronization Therapy: Words of Caution,” Cardiac Electrophysiology Clinics 3, no. 4 (2011): 529-537; D. B. Kramer, S. T. Normand, and R. Volya et al., “Facility-Level Variation and Clinical Outcomes in Use of Cardiac Resynchronization Therapy With and Without an Implantable Cardioverter-Defibrillator,” Circulation: Cardiovascular Quality and Outcomes 11, no. 12 (2018): e004763; D. B. Kramer, M. R. Reynolds, and S. L. Mitchell. “Resynchronization: Considering Device-Based Cardiac Therapy in Older Adults,” Journal of the American Geriatrics Society 61, no. 4 (2013): 615-621.+(last+visited+october+13,+2021);+D.+B.+Kramer,+and+D.+A.+Steinhaus,+“Cardiac+Resynchronization+Therapy+in+Older+Patients:+Age+Is+Just+a+Number,+and+Yet,”+Journal+of+Cardiac+Failure+22,+no.+12+(2016):+978-980;+D.+B.+Kramer+and+M.+E.+Josephson,+“Expanding+the+Use+of+Cardiac+Resynchronization+Therapy:+Words+of+Caution,”+Cardiac+Electrophysiology+Clinics+3,+no.+4+(2011):+529-537;+D.+B.+Kramer,+S.+T.+Normand,+and+R.+Volya+et+al.,+“Facility-Level+Variation+and+Clinical+Outcomes+in+Use+of+Cardiac+Resynchronization+Therapy+With+and+Without+an+Implantable+Cardioverter-Defibrillator,”+Circulation:+Cardiovascular+Quality+and+Outcomes+11,+no.+12+(2018):+e004763;+D.+B.+Kramer,+M.+R.+Reynolds,+and+S.+L.+Mitchell.+“Resynchronization:+Considering+Device-Based+Cardiac+Therapy+in+Older+Adults,”+Journal+of+the+American+Geriatrics+Society+61,+no.+4+(2013):+615-621.>Google Scholar
Kramer, D. B. and Josephson, M. E., “Three Questions for Evidence-Based Cardiac Electrophysiology,” Circulation: Cardiovascular Quality and Outcomes 3, no. 6 (2010): 704–709; L. Kober, J. J. Thune and J. C. Nielsen et al., “Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure,” New England Journal of Medicine 375, no. 13 (2016): 1221-1230.Google ScholarPubMed
Merchant, F. M., Quest, T., and Leon, A. R., et al., “Implantable Cardioverter-Defibrillators at End of Battery Life: Opportunities for Risk (Re)-Stratification in ICD Recipients,” Journal of the American College of Cardiology 67, no. 4 (2016): 435–444; F. M. Merchant, P. Jones, and S. Wehrenberg et al., “Incidence of Defibrillator Shocks after Elective Generator Exchange Following Uneventful First Battery Life,” Journal of the American Heart Association 3, no. 6 (2014): e001289; K. J. McCarthy, A. H. Locke, and M. Coletti, “Outcomes Following Implantable Cardioverter-Defibrillator Generator Replacement in Adults: A Systematic Review,” Heart Rhythm:Tthe Official Journal of the Heart Rhythm Society 17, no. 6 (2020): doi: 10.1016.CrossRefGoogle ScholarPubMed
Merchant, F. M., Levy, W. C., and Kramer, D. B., “Time to Shock the System: Moving Beyond the Current Paradigm for Primary Prevention Implantable Cardioverter-Defibrillator Use,” Journal of the American Heart Association 9, no. 5 (2020): e015139.CrossRefGoogle ScholarPubMed
CMS, supra note 5.Google Scholar
Chambers, J. D., Chenoweth, M., and Cangelosi, M. J., et al., “Medicare is Scrutinizing Evidence More Tightly for National Coverage Determinations,” Health Affairs (Millwood) 34, no. 2 (2015): 253–260; P. J. Neumann and J. D. Chambers, “Medicare’s Enduring Struggle to Define ‘Reasonable and Necessary’ care,” New England Journal of Medicine 367, no. 19 (2012): 1775-1777; P. J. Neumann and J. Chambers, “Medicare’s Reset on ‘Coverage with Evidence Determination’,” Health Affairs Blog, 2013, available at <http://healthaffairs.org/blog/2013/04/01/medicares-reset-on-coverage-with-evidence-development/> (last visited October 15, 2021).10.1377/hlthaff.2014.1123CrossRefGoogle ScholarPubMed
Bardy, G. H., Lee, K. L., and Mark, D. B., et al., “Amiodarone or an Implantable Cardioverter-Defibrillator for Congestive Heart Failure,” New England Journal of Medicine 352, no. 3 (2005): 225–237; A. J. Moss, W. Zareba, and W. J. Hall, et al., “Prophylactic Implantation of a Defibrillator in Patients with Myocardial Infarction and Reduced Ejection Fraction,” New England Journal of Medicine 346, no. 12 (2002): 877-883.CrossRefGoogle ScholarPubMed
Kramer, D. B. and Kesselheim, A. S., “Coverage of Magnetic Resonance Imaging for Patients With Cardiac Devices: Improving the Coverage With Evidence Development Program,” JAMA Cardiology 2, no. 7 (2017): 711–712.CrossRefGoogle ScholarPubMed
Kramer, D. B. and Parasidis, E., “Informed Consent and Compulsory Medical Device Registries: Ethics and Opportunities,” Journal of Medical Ethics Online (2021), available at <https://jme.bmj.com/content/early/2021/02/19/medethics-2020-107031> (last visited October 15, 2021).Google ScholarPubMed
Holtzman, J. N. and Kramer, D. B., “Harmonizing Standards and Incentives in Medical Device Regulation: Lessons Learned from the Parallel Review Pathway,” Journal of Law, Medicine & Ethics 46, no. 4 (2018): 1034–1039.CrossRefGoogle ScholarPubMed
Leipzig Heart Science, The PROFID Study, available at <https://profid-project.eu/trials/#profidtrials> (last visited October 15, 2021).+(last+visited+October+15,+2021).>Google Scholar