The SynCardia temporary Total Artificial Heart (TAH-t) is the only device that provides immediate, safe blood flow of up to 9.5 L/min through each ventricle. This helps speed recovery of vital organs and expedite patients getting listed on transplant waiting lists.
In 1986, the Centers for Medicare and Medicaid Services (CMS) issued a national non-coverage policy for artificial hearts. In 2008, CMS reversed this decision and approved reimbursement for the Total Artificial Heart through the same Diagnostic Related Group codes as ventricular assist devices (VADs) and heart transplants.
Faster Bridge to Transplant
Patients Bridged to Transplant at 6 Months - INTERMACS
74% (1089/1476) of all INTERMACS patients were in the two sickest categories.
*90% (46/51) of all Total Artificial Heart patients were in the two sickest categories.
*73% (1043/1425) of LVAD/BiVAD patients were in the two sickest categories. Source: INTERMACS quarterly statistical report released June 2, 2009
According to INTERMACS, the national registry for patients with FDA-approved mechanical circulatory support devices, at six months, 69% of Total Artificial Heart patients have been bridged to transplant. This is double the bridge-to-transplant rate of other approved mechanical circulatory support devices (see above graph).
The Total Artificial Heart is reimbursed by CMS through the same Diagnostic Related Group codes as ventricular assist devices (VADs) and heart transplants.
While plans’ coverages will vary, the SynCardia TAH-t is reimbursed by most medical insurance plans. In some cases, U.S. hospitals may be allowed to be reimbursed for two procedures:
- Total Artificial Heart implant: When a clinically stable patient is discharged to wait for a matching donor heart outside the hospital, SynCardia anticipates that the hospital will be reimbursed for the Total Artificial Heart implant by most plans that follow CMS reimbursement policies.
- Donor heart transplant: When a matching donor heart becomes available, the patient is readmitted to the hospital and transplanted. When the patient is discharged to go home, SynCardia anticipates that the hospital will be reimbursed for the donor heart transplant.
If no hospital discharge occurs between the implant and transplant procedures, U.S. hospitals are likely to be reimbursed for one procedure and some other related expenses.
"Simply stated, there is not another device or combination thereof that replaces right and left ventricular function as safely and effectively (as the SynCardia Total Artificial Heart).”
Dr. Walter Pae, Jr. Cardiothoracic Surgeon Penn State Hershey Medical Center, PA, U.S.