VANCOUVER and MINNEAPOLIS, November 8, 2022 — Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN) today announced that the Centers for Medicare and Medicaid Services (“CMS”) has assigned the Neovasc Reducer™ (“Reducer”) implant procedure a new outpatient reimbursement code payment status indicator, enabling U.S. hospitals to be reimbursed for the device and implant procedure.
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 (“APC”) Code 5194, Level 4 Endovascular Repair. APCs are the U.S. government’s method of paying for outpatient services for the Medicare and Medicaid programs. 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).
“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,” 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 United States. 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 revascularization or cardiac drug therapies. It affects millions of patients worldwide, who typically lead severely restricted lives as a result of their disabling symptoms, and its incidence is growing. The Reducer provides relief of angina symptoms by altering blood flow within the myocardium of the heart and increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle. Placement of the Reducer is performed using a minimally invasive transvenous procedure.
While the Reducer is not approved for commercial use in the United States, the FDA granted Breakthrough Device designation to the Reducer in October 2018, and it is being studied in the COSIRA-II Clinical Trial. Breakthrough designation is granted by the FDA in order to expedite the development and review of a device that demonstrates compelling potential to provide a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. In addition, there must be no FDA approved treatments presently available, or the technology must offer significant advantages over existing approved alternatives.
Refractory angina, resulting in continued symptoms despite maximal medical therapy and without revascularization options, is estimated to affect 600,000 to 1.8 million Americans, with 50,000 to 100,000 new cases per year.
About Neovasc Inc.
Neovasc is a specialty medical device company that develops, manufactures, and markets products for the rapidly growing cardiovascular marketplace. Its products include Reducer, for the treatment of refractory angina, which is under clinical investigation in the United States and has been commercially available in Europe since 2015, and Tiara™, a product under clinical investigation for the transcatheter treatment of mitral valve disease. The company remains committed to the ongoing follow-up of patients in Tiara clinical trials and has paused all other Tiara activities. For more information visit: www.neovasc.com.
Read original article here: https://neovasc.com/newsreleases/neovasc-reducer-obtains-u-s-outpatient-reimbursement/