Harvard Pilgrim HealthCareMedical Policy

Temporary Total Artificial Heart System Bridge-to-Transplant

Subject: Temporary Total Artificial Heart System Bridge-to-Transplant

Background: The SynCardia FREEDOM® driver is for stable Members who meet discharge criteria and can wait for their donor heart at home with the wearable Freedom portable driver which powers the temporary SynCardia Artificial Heart. The Freedom Driver was U.S. FDA Approved June 26, 2014.

The Temporary Total Artificial Heart (TAH-t) functions in place of ventricles and valves by pumping blood to both the pulmonary and systemic circulations. TAH-t is distinguished from prior devices by its portable driver (Freedom driver), a system that powers the device, and is intended for allowing stable Members to recover at home, rather than remain hospitalized while awaiting a Solid Organ Heart Transplant.

Note: Solid organ heart transplantation is a surgical procedure to remove a damaged or diseased heart and replace it with a healthy donor heart. To initiate the prior authorization process for Solid Organ Heart Transplant, refer to the Solid Organ Transplant: Heart Medical Necessity Guidelines.

Policy and Coverage Criteria:

Policy and Coverage Criteria: The Plan may authorize coverage of The SynCardia™ Temporary Total Artificial Heart (TAH-t) System with the Freedom Portable Driver as a bridge-to-transplant for Members who meet ALL of the following criteria:

• Eligible and approved for a solid organ heart transplant AND currently on a heart transplant list
• At risk for imminent death from biventricular failure
• Able to receive adequate anti-coagulation while on the total artificial heart.
• Member and caregiver(s) have completed the SynCardia Discharge Manual and competencies.

Exclusions:

The Plan will not cover the use of the SynCardia TAH-t as destination therapy in patients who are not transplant candidates.