Question:
Does Medicare cover leadless pacemakers?
Answer:
Effective January 18, 2017, the Centers for Medicare & Medicaid Services (CMS) cover leadless pacemakers through their Coverage with Evidence Development (CED) policy. This coverage applies when procedures are performed in Food and Drug Administration (FDA) approved studies and in prospective longitudinal studies used in accordance with the FDA-approved label for devices. For more details on this newly announced policy, go to https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R201NCD.pdf.