Reimbursement:
Better Patient Outcomes = Better U.S. Hospital Reimbursement

Rapid Recovery

The SynCardia temporary CardioWest™ 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 are listed UNOS Status 1A and moved to the top of the transplant list until a matching donor heart becomes available. In contrast, most ventricular assist device (VAD) patients are listed Status 1A for 30 days and then moved down to 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

Faster Bridge-to-Transplant

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).  

Anticipated Benefits of Discharge

Currently, U.S. Total Artificial Heart patients 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 has submitted an application to the FDA to conduct an IDE clinical study of the new, lightweight Freedom™ driver system. Once approved, the clinical study is designed to demonstrate that stable Total Artificial Heart patients can leave the hospital to wait for a matching donor heart at home.

When the Freedom driver becomes available through an IDE clinical study, SynCardia anticipates that discharging stable patients will allow U.S. hospitals to be reimbursed for both procedures:

1. 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.
2. 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.

Medicare

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. In addition, CMS also approved the Total Artificial Heart for new technology add-on payments through FY 2010.