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IceCure's ProSense® Achieves Significant Milestone in Medicare Coverage of Breast Cancer Procedures
Receives assignment to a Medicare Payment Group for hospital outpatient paymentMarks CMS's first payment assignment for cryoablation of breast cancer Code and
About this update from Icecure Medical Ltd.
[{"type":"text","content":"Receives assignment to a Medicare Payment Group for hospital outpatient paymentMarks CMS's first payment assignment for cryoablation of breast cancer Code and preliminary payment amount for facility fee will be effective January 1, 2023, which together may lead to a coverage policy subject to receipt of FDA marketing authorization Filed De Novo Classification with FDA for breast cancer marketing authorization in October 2022 CAESAREA, Israel, Nov. 8, 2022 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) (\"IceCure\" or the \"Company\"), developer of minimally-invasive cryoablation technology, the ProSense® System that destroys tumors by freezing, today announced the Centers for Medicare & Medicaid Services (\"CMS\") assigned its ProSense breast cancer cryoablation procedures with CPT Category III code 0581T to ambulatory payment classification 5091, Level 1 Breast/Lymphatic Surgery and Related Procedures. This payment assignment for the procedure will go into effect on January 1, 2023, opening the potential for facilities to be paid, on a case-by-case basis, for these procedures subject to the Company's receipt of U.S. Food and Drug Administration (\"FDA\") marketing authorization of ProSense for breast cancer. A De Novo Classification Request for breast cancer marketing authorization was filed with the FDA for the initial breakthrough indication of early-stage low-risk breast cancer patients at high risk to surgery in October 2022.\n\n \n \n \n \n \n \n\n \nBacked by its ICE3 clinical trial interim analysis data of ProSense, IceCure's application is the first and only Medicare coverage approval of cryoablation procedure for breast cancer.\nBacked by its ICE3 clinical trial interim analysis data of ProSense IceCure's application to the CMS, is the first and only payment group assignment for cryoablation of breast cancer\nAs a minimally invasive procedure that destroys early-stage breast cancer tumors, ProSense significantly reduces the cost burden of treatment as compared to current standard of care lumpectomy procedures. Under the temporary CPT Category III code, IceCure's procedure is priced for coverage by the CMS at approximately $3,400 for the facility fee alone. Additional coverage, including payment for the physician, is expected upon establishment of the permanent CPT Category I code, which is conditioned...