Publications by authors named "J Schlacter"

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.

View Article and Find Full Text PDF

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.

View Article and Find Full Text PDF

Objective: We estimated the potential outcomes, costs, and cost-effectiveness of the Vortex shunt, a novel fetal vesicoamniotic shunt (VAS), compared to standard shunts for treating fetal lower urinary tract obstruction (LUTO).

Method: We designed a decision-analytic model comparing the Vortex shunt to current shunts using a theoretical cohort of 1000 pregnancies equivalent to the annual U.S.

View Article and Find Full Text PDF

Ensuring reliability of Large Language Models (LLMs) in clinical tasks is crucial. Our study assesses two state-of-the-art LLMs (ChatGPT and LlaMA-2) for extracting clinical information, focusing on cognitive tests like MMSE and CDR. Our data consisted of 135,307 clinical notes (Jan 12th, 2010 to May 24th, 2023) mentioning MMSE, CDR, or MoCA.

View Article and Find Full Text PDF