Neovasc Reducer assigned outpatient reimbursement code from CMS

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Neovasc has announced that the Centers for Medicare and Medicaid Services (CMS) has assigned the Neovasc Reducer implant procedure a new outpatient reimbursement code payment status indicator, enabling US hospitals to be reimbursed for the device and implant procedure.

Effective from January 2023, the implantation of the Reducer in an outpatient setting is assigned to Healthcare Common Procedure Coding System (HCPCS) code 0645T and payable under the Ambulatory Payment Classifications (APC) code 5194, level 4 endovascular repair.

The new classification enables the device and procedure to be reimbursed in the current COSIRA-II clinical trial single arm registry and upon potential commercial approval in the USA. The randomised arm of the COSIRA-II clinical trial previously received reimbursement approval in the USA under a dedicated HCPCS code (C9783).

“Today’s news is another important step in securing coding, coverage, and payment for the Reducer in the USA. We now have adequate reimbursement for the Reducer, in the CMS population, for both inpatient and outpatient procedures, both during the COSIRA-II clinical trial, and upon potential commercialisation in the USA,” stated Neovasc president and chief executive officer Fred Colen. “Our reimbursement journey has been remarkably successful around the world. We are beginning to see broader adoption in markets where we have successfully obtained reimbursement and look forward to continued rapid growth and commercial expansion.”

Neovasc began a comprehensive reimbursement program in 2019 to establish all the necessary components for diagnosis and treatment of refractory angina in the USA. The Company has worked tirelessly with its physician advisors, consultants, CMS, the American Medical Association, and multiple cardiology societies to secure all the necessary approvals and codes for the diagnosis of refractory angina and the implantation of the Reducer in both inpatient and outpatient settings.

The Reducer is CE-marked in the European Union for the treatment of refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularisation or cardiac drug therapies.

While the Reducer is not approved for commercial use in the USA, the US Food and Drug Administration (FDA) granted breakthrough device designation to the Reducer in October 2018, and it is being studied in the COSIRA-II clinical trial.


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