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AUGUST 2017 COVERAGE, CODING & PAYMENT …

AUGUST 2017 . coverage , CODING &. PAYMENT bulletin Micra . Transcatheter Pacing system CMS Approval of the Medtronic Micra Transcatheter Pacing system Post-Approval Study (PAS) & Prospective Longitudinal Study, the Micra CED. Brief Background Micra Transcatheter Pacing system is the world's smallest pacemaker, delivered percutaneously via a minimally invasive approach, directly into the right ventricle without the use of leads. Leadless pacemakers, also known as intracardiac or transcatheter pacemakers, are the first and only pacemakers in which the components are combined into a single device implanted directly within the heart, without any subcutaneous pocket or tunneling. This is in contrast to traditional transvenous pacemakers that require a subcutaneous generator plus transvenous/epicardial lead(s). On July 28, 2017 , the Centers for Medicare & Medicaid Services (CMS) released the National coverage Determination for the Leadless Effective Jan. 18, 2017 , the CMS will cover leadless pacemakers that are used according to the FDA-labeled indications for the device through coverage with Evidence Development (CED) as outlined below.

Page 1 of 6 | August 2017 AUGUST 2017 COVERAGE, CODING & PAYMENT BULLETIN Brief Background Micra Transcatheter Pacing System is the world’s smallest pacemaker, delivered percutaneously via a minimally invasive

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