20 new technologies are vying for the bonus payment. Excerpted from Pathways’ Picks April 12: EPA on EtO, CMS on New Tech and Medicare Advantage.
Twenty new devices are vying for New Technology Add-On Payments (NTAPs) to boost Medicare reimbursement in the hospital inpatient setting starting in October, but as of the April 10 release of CMS’ FY 2024 inpatient payment proposed rule, only four technologies are a shoo-in for the bonus payment. Most of the remaining 16 devices are waiting on just one thing—FDA authorization, which must come by July 1 to meet the FY 2024 deadline. And several among the candidates still have some questions to answer to CMS related to clinical improvement or cost calculations for the device. Seventeen of the 20 device candidates are Breakthrough Devices (or pending Breakthrough Devices) trying to leverage CMS’ streamlined NTAP Breakthrough pathway that doesn’t require proof of substantial clinical improvement. These include the four definite new FY 2024 NTAP qualifiers so far, which are:
- Zimmer Biomet’s Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP): A software-containing tibial extension implant used with the Zimmer Persona Personalized Knee System to collect kinematic data. (Maximum NTAP payment beyond standard reimbursement: $850.85 per knee).
- Ultromics’ EchoGo Heart Failure 1.0: An automatic machine-learning enabled decision support diagnostic aid for patients undergoing echocardiography ($1,023.75).
- Phagenesis’ Phagenyx System: Neurostimulation device for treating neurogenic dysphagia($3,250).
- Magnus Medical’s SAINT Neuromodulation System: A noninvasive repetitive transcranial magnetic stimulation (rTMS) system for major depressive disorder ($12,675).
The fate of the remainder of the candidates will be disclosed in the final inpatient rule that will be issued over the summer.
Also in the inpatient proposal, CMS proposed tweaks to its NTAP criteria, particularly around the FDA authorization status of applicants. For an NTAP application to be accepted starting next year, a company must have a complete marketing authorization submission to FDA and the device must be authorized by May 1 of the application year—two months earlier than the current July 1 deadline. The change responds to what is a relatively frequent occurrence: a product goes all the way through the application, CMS analysis, and public commenting process only to miss eligibility in the end because it doesn’t get FDA authorization in time. “CMS believes these policy changes would improve the completeness of submitted NTAP applications, allow for a fuller analysis, and improved ability for CMS to identify eligibility concerns for the proposed rule,” the agency says.
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