Medicare Payment for Calcium Modification Technologies Among Patients Undergoing Percutaneous Coronary Intervention, 2021-2022.

Background: The Centers for Medicare and Medicaid Services (CMS) New Technology Add-on Payment (NTAP) program supports adoption of new, costly medical technologies demonstrating substantial clinical improvement. In 2021, CMS waived the "substantial clinical improvement" criterion for devices designated under the FDA Breakthrough Devices Program (BDP). This study characterized risk-standardized payments associated with hospitalizations in which Medicare beneficiaries received calcium modification during PCI for acute myocardial infarction (AMI) following the adoption of the Shockwave C Coronary Intravascular Lithotripsy (IVL) Catheter (Shockwave Medical) with BDP designation.

Services and payments associated with the medicare new technology add-on payment program.

In 2001, the Centers for Medicare and Medicaid Services established the New Technology Add-On Payment (NTAP) program to incentivize access to costly new technologies for Medicare beneficiaries. These technologies, authorized by the Food and Drug Administration (FDA), must demonstrate "substantial clinical improvement" when compared to existing technologies. However, in FY2021, the FDA introduced two expedited authorization pathways, allowing technologies with either designation to bypass the "substantial clinical improvement" criterion.

Assessing Medicare's Coverage With Evidence Development Program.

The Centers for Medicare and Medicaid Services (CMS) coverage with evidence development (CED) program provides coverage for items and services not meeting Medicare's "reasonable and necessary" standard while requiring participation in clinical studies. As additional evidence is available, CMS may reconsider CED decisions. Of twenty-six items and services in the CED program since its 2005 inception, CMS has reconsidered coverage for ten (38 percent).