Business
BioCardia Announces New Center for Medicare and Medicaid Services Reimbursement Code Applicable to the CardiAMP Cell Therapy Procedure
New Procedure Reimbursement Code Expected to Enhance Study Performance for Clinical Centers Participating in the CardiAMP Cell Therapy Heart Failure Trial and
About this update from Biocardia, Inc.
[{"type":"text","content":"New Procedure Reimbursement Code Expected to Enhance Study Performance for Clinical Centers Participating in the CardiAMP Cell Therapy Heart Failure Trial and the CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial\nSUNNYVALE, Calif., March 22, 2022 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, announces the designation of a new reimbursement code for the CardiAMP® Cell Therapy procedure to transplant autologous bone marrow cells to treat heart failure from the U.S. Center for Medicare and Medicaid Services (CMS). This new CMS code to be submitted by hospitals performing the CardiAMP cell therapy procedure is available April 1, 2022. The code provides clear reimbursement for the study procedure performed for both the treatment and control arms for the ongoing cell therapy pivotal trials in two cardiovascular indications: the CardiAMP Cell Therapy Heart Failure Trial (NCT02438306) and the CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial (NCT03455725). “This most recent action by CMS further represents its commitment to improving the way ischemic heart failure is treated and is supportive of BioCardia’s therapeutic investigational product candidates furnished by a comprehensive approach to bone marrow cell harvest, processing, and delivery in a single procedure,” commented Peter Altman, Ph.D., BioCardia’s CEO. “Further, it provides additional clarity of CMS financial support for institutions conducting the CardiAMP Cell Therapy Heart Failure Trial and CardiAMP Chronic Myocardial Ischemia Trials. We are grateful for our ongoing collaboration with both CMS and the FDA as we continue to demonstrate the promise of our technology.” The new reimbursement code (designated C9782) is for a blinded procedure for New York Heart Association (NYHA) class ii or iii heart failure, or Canadian Cardiovascular Society (CCS) class iii or iv chronic refractory angina; transcatheter intramyocardial transplantation of autologous bone marrow cells or placebo control, autologous bone marrow harvesting and preparation for transplantation, left heart catheterization including ventriculography, all laboratory service and all imaging with or without guidance, performed in approved investigational device exemption (IDE) study. Pat...