The problematic lag between FDA approval of medical devices and CMS coverage

Affiliations

¹ Division of Cardiology, Department of Medicine, Northwestern University, Chicago, Illinois, USA.
² Division of Cardiology, Piedmont Heart Institute, Atlanta, Georgia, USA.
³ Division of Cardiology, Department of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.
⁴ Division of Cardiology, Department of Medicine, Valley Health, New York, New York, USA.
⁵ Division of Cardiology, Department of Medicine, Harvard University, Boston, Massachusetts, USA.

Bradley P Knight et al. J Cardiovasc Electrophysiol. 2021 Jul.

. 2021 Jul;32(7):1801-1802.

doi: 10.1111/jce.15112. Epub 2021 May 30.

¹ Division of Cardiology, Department of Medicine, Northwestern University, Chicago, Illinois, USA.
² Division of Cardiology, Piedmont Heart Institute, Atlanta, Georgia, USA.
³ Division of Cardiology, Department of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.
⁴ Division of Cardiology, Department of Medicine, Valley Health, New York, New York, USA.
⁵ Division of Cardiology, Department of Medicine, Harvard University, Boston, Massachusetts, USA.

No abstract available

Keywords: FDA; Medicare; medical devices.

References

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1. https://www.regulations.gov/document/CMS-2020-0098-0347. Accessed April 5, 2021.
1. Bach PB . After 4 years of Trump, Medicare and Medicaid badly need attention. New York Times; 2021. https://www.nytimes.com/2020/12/01/opinion/trump-medicare-medicaid.html
1. Rathi VK , Johnston JL , Ross JS , Dhruba SS . Medicare's new device-coverage pathway breakthrough or breakdown? N Engl J Med. 2021;384:e43.