Medical Devices Applying for Outpatient Medicare Supplemental Payments.

ABSTRACT:

Importance

Medicare transitional pass-through payments (TPTPs) provide supplemental reimbursement that is intended to facilitate adoption of new devices in the outpatient setting. The US Centers for Medicare & Medicaid Services (CMS) have historically evaluated manufacturer applications for TPTPs based on newness, cost, and evidence of substantial clinical improvement, ie, the traditional pathway. In 2020, CMS introduced an alternative pathway to allow US Food and Drug Administration (FDA)-designated breakthrough devices to qualify for supplemental reimbursement without demonstrating substantial clinical improvement.

Objective

To characterize CMS TPTP approval rates and the premarket evidence used by FDA to support authorization of new outpatient medical devices considered f

SUBMITTER: Moneer O 

PROVIDER: S-EPMC11568453 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature