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Article Abstract
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.
Methods: We analyzed Medicare beneficiaries hospitalized for AMI who underwent PCI between January 2021 and December 2022, stratifying them into four groups: no calcium modification, rotational atherectomy (RA), orbital atherectomy (OA), and coronary IVL. Risk-standardized Medicare payments at 30 days, including index facility, physician, and post-acute care costs, were assessed using non-parametric median and chi-square tests.
Results: Among 87,238 patients, 76,462 (87.6%) received no calcium modification, 8,316 (9.5%) underwent RA, 793 (0.9%) underwent OA, and 1,668 (1.9%) underwent IVL. IVL use increased from 1.6% in October 2021 to 4.4% in December 2022. Median total risk-standardized Medicare payments were significantly higher for patients receiving calcium modification technologies ($27,579 for IVL, $27,353 for OA, $23,240 for RA) compared to those without ($19,115; p<0.001). Payment differences were largest for index facility payments.
Conclusion: Coronary IVL during PCI for Medicare patients hospitalized for AMI was associated with significantly increased Medicare payments. Further studies must determine whether IVL, and calcium modification technologies in general, improve outcomes for patients hospitalized for AMI undergoing PCI and thus warrant higher payments via NTAP.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11759239 | PMC |
| http://dx.doi.org/10.1101/2025.01.12.25320423 | DOI Listing |
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