IceCure Medical ( NASDAQ: ICCM ) stock rose ~44% on Tuesday after the company said its ProSense system for breast cancer cryoablation procedures was assigned to a Medicare payment group for hospital outpatient payment.
The Centers for Medicare & Medicaid Services (CMS) assigned ProSense breast cancer cryoablation procedures with CPT Category 3 code 0581T to ambulatory payment classification 5091, Level 1 Breast/Lymphatic Surgery and Related Procedures, the company added.
IceCure noted that this payment assignment for the procedure will go into effect on Jan. 1, 2023, subject to getting U.S. Food and Drug Administration (FDA) marketing authorization for ProSense for breast cancer.
In October, the company filed a De Novo classification request seeking FDA clearance for the system.
ProSense System is designed to destroy tumors through cryoablation (freezing).
IceCure noted that its application is the first and only Medicare coverage approval of cryoablation procedure for breast cancer. The application to the CMS, is the first and only payment group assignment for cryoablation of breast cancer, the company added.
Under the temporary CPT Category 3 code, IceCure's procedure is priced for coverage by the CMS at ~$3.4K for the facility fee alone, according to the company.
"We believe IceCure is the only company that has the clinical data needed to move cryoablation forward on both the regulatory and reimbursement front and to provide women facing breast cancer what they deserve—a state-of-the-art optimized, minimally invasive technology that destroys tumors, so they can simply walk out of the procedure room and return to a cancer-free life," said IceCure CEO Eyal Shamir.
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IceCure soars 44% as ProSense system for breast cancer gets Medicare payment group