Better Patient Outcomes = Better U.S. Hospital Reimbursement
The SynCardia temporary Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles. This speeds the recovery of the patient’s vital organs and helps them get listed and transplanted faster.
Top of the Transplant List
Once stable, Total Artificial Heart patients in the hospital are listed UNOS Status 1A and moved to the top of the transplant list.
In contrast, most ventricular assist device (VAD) patients are listed Status 1A for 30 days and then Status 1B thereafter*.
*Source: UNOS Policy 3.7 - Allocation of Thoracic Organs, pages 1-3 http://www.unos.org/PoliciesandBylaws2/policies/pdfs/policy_9.pdf ›› download
According to INTERMACS, the national registry for patients with FDA-approved mechanical circulatory support devices, at 6 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 chart).
The Total Artificial Heart is reimbursed through the same Diagnostic Related Group codes as ventricular assist devices (VADs) and heart transplants.
Currently, the only FDA-approved driver for powering the Total Artificial Heart in the U.S. is the 418-lb hospital driver nicknamed "Big Blue". Stable Total Artificial Heart patients in the U.S. supported by this driver are confined to the hospital while they wait for a matching donor heart. Without discharge, hospitals are only reimbursed for one procedure, the subsequent heart transplant.
SynCardia is conducting an FDA-approved Investigational Device Exemption (IDE) clinical study of the new, lightweight Freedom® driver system. The IDE clinical study is designed to demonstrate that the Freedom driver is a suitable pneumatic driver for stable Total Artificial Heart patients and can be used safely at home.
Through the IDE clinical study, SynCardia anticipates that discharging stable patients with the Freedom driver may allow U.S. hospitals to be reimbursed for both procedures:
- Total Artificial Heart implant: When a stable patient is discharged to wait for their matching donor heart outside the hospital, SynCardia anticipates that the hospital will be reimbursed for the Total Artificial Heart implant.
- 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.
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.
Dr. Walter Pae, Jr.
Penn State Hershey
Medical Center, PA, U.S.
Medicaid Services (CMS)
– July 31, 2008
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