Neovasc Reducer Obtains Outpatient Reimbursement From CMS

November 8, 2022—Neovasc, Inc. announced that the Centers for Medicare & Medicaid Services (CMS) have assigned the Neovasc Reducer implant procedure a new outpatient reimbursement code payment status indicator, enabling hospitals in the United States to be reimbursed for the device and implant procedure. The Neovasc Reducer device is designed to reduce angina symptoms in patients with refractory angina.

Effective January 1, 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 Code 5194, Level 4 Endovascular Repair.

According to the company, 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 United States. The randomized arm of the COSIRA-II clinical trial previously received reimbursement approval in the United States under a dedicated HCPCS code (C9783).

In January 2022, Neovasc announced enrollment of the first patient in the pivotal COSIRA-II trial of the coronary sinus Reducer device for the treatment of refractory angina. The results of this study will complement existing international safety and effectiveness data and support a premarket approval application to the FDA for approval of the Reducer device in the United States.

The Reducer has received CE Mark approval in the European Union for the treatment of refractory angina.

Neovasc President and Chief Executive Officer Fred Colen stated in the company's press release, “Today’s news is another important step in securing coding, coverage, and payment for the Reducer in the United States. 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 commercialization in the United States. 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.”