James Johnston

Nov 15, 2024 | jamanetwork.com | Osman Moneer |James Johnston |Vinay K. Rathi |Joseph Ross

Key PointsQuestion  What evidence do the Centers for Medicare & Medicaid Services (CMS) consider when approving or denying transitional pass-through payments (TPTPs) for new outpatient medical devices? Findings  This cross-sectional study of 43 TPTP applications from 2017 to 2023 found that CMS approved 17 (40%), including all 8 (100%) applications for US Food and Drug Administration (FDA)-designated breakthrough devices.

Oct 25, 2023 | jamanetwork.com | Osman Moneer |Vinay K. Rathi |James Johnston

Aligning US Agency Policies for Cardiovascular Devices Through the Breakthrough Devices Program Abstract Importance  The US Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) have different statutory authorities; FDA evaluates safety and effectiveness for market authorization of medical devices while CMS determines whether coverage is “reasonable and necessary” for its beneficiaries.