BioCardia’s CardiAMP Cell Therapy Procedure Receives CMS Code for Use in Clinical Trials

March 22, 2022—BioCardia, Inc. announced that the Centers for Medicare & Medicaid Services (CMS) has designated a new reimbursement code for the CardiAMP cell therapy procedure to transplant autologous bone marrow cells to treat heart failure. The new CMS code is available April 1, 2022. CardiAMP cell therapy is limited by United States law to investigational use, advised the company.

According to BioCardia, the code (C9782), which is to be submitted by hospitals performing the CardiAMP cell therapy procedure, provides 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).

BioCardia stated that the new CMS reimbursement code 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 study.

On February 3, BioCardia announced that the FDA granted Breakthrough Device designation for the CardiAMP cell therapy system for the treatment of heart failure.

Peter Altman, PhD, BioCardia’s CEO, commented in the company’s press release, “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. 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.”