Medtronic's Micra Pacing System Receives CMS Coverage
March 10, 2017—Medtronic announced that the US Centers for Medicare & Medicaid Services (CMS) have approved coverage for the company's Micra transcatheter pacing system (TPS). This decision, effective immediately, comes after the approval of two studies required to enable reimbursement through Medicare's policy of Coverage with Evidence Development (CED).
Medtronic noted that in January 2017, CMS issued a final National Coverage Determination (NCD) that covered leadless pacemakers under CED when used in accordance with US Food and Drug Administration (FDA)-approved labeling in FDA-approved studies that have been approved by CMS, or under prospective, longitudinal studies approved by CMS.
According to Medtronic, the two Micra studies approved by CMS are the Micra Post-Approval Study (PAS), which was required by the FDA as a condition of FDA approval of the device in April 2016, and a new Micra CED study, the "Longitudinal Coverage with Evidence Development Study on Micra Leadless Pacemakers," which was developed by Medtronic to address research questions identified by CMS in the NCD.
Micra PAS will enroll a subset of Medicare Micra patients through a traditional clinical research design, while the Micra CED Study will encompass all Medicare beneficiaries who receive Micra under an innovative new approach to CED, linking information from Medtronic's device registration system to Medicare health insurance claims and enrollment data, advised Medtronic.