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 C2 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.

Dr. Dhruva currently receives research funding from the Department of Veterans Affairs and Arnold Ventures; formerly received research support from the Medical Device Innovation Consortium under the National Evaluation System for Health Technology Coordinating Center; and reports serving on the Medicare Evidence Development and Coverage Advisory Committee and Institute for Clinical and Economic Review California Technology Assessment Forum. Dr. Ross currently receives research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from the Food and Drug Administration for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), from the Agency for Healthcare Research and Quality (R01HS022882), and from Arnold Ventures; formerly received research support from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NEST) and from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HS025164, R01HL144644); and in addition, Dr. Ross was an expert witness at the request of Relator's attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc. that was settled September 2022.

This work is supported through a grant (R01HS022882) from Agency for Healthcare Research and Quality (AHRQ). No funding source had any role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the article for publication. The content is solely the responsibility of the authors and does not necessarily represent the official views of the AHRQ.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study was approved by the Yale School of Medicine institutional review board.

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FUNDING AND CONFLICT OF INTERESTS: This work is supported through a grant (R01HS022882) from Agency for Healthcare Research and Quality (AHRQ). No funding source had any role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the article for publication. The content is solely the responsibility of the authors and does not necessarily represent the official views of the AHRQ. Dr. Dhruva currently receives research funding from the Department of Veterans Affairs and Arnold Ventures; formerly received research support from the Medical Device Innovation Consortium under the National Evaluation System for Health Technology Coordinating Center; and reports serving on the Medicare Evidence Development and Coverage Advisory Committee and Institute for Clinical and Economic Review California Technology Assessment Forum.

Dr. Ross currently receives research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from the Food and Drug Administration for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), from the Agency for Healthcare Research and Quality (R01HS022882), and from Arnold Ventures; formerly received research support from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NEST) and from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HS025164, R01HL144644); and in addition, Dr. Ross was an expert witness at the request of Relator’s attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc. that was settled September 2022.

All data used in this study can be requested from the Centers for Medicare and Medicaid Services.