CardiacAssist's TandemHeart Approved for Expanded CMS Reimbursement in New England

July 12, 2011—CardiacAssist, Inc. (Pittsburgh, PA) announced that the company's TandemHeart circulatory support system has been granted expanded reimbursement coverage by NHIC, Corp. (Hingham, MA), a Medicare Administrative Contractor that serves more than 1.3 million beneficiaries and more than 53,000 health care providers in the Northeast region of the United States.


NHIC's Local Coverage Determination for Percutaneous Ventricular Assist Devices (L31518) became effective July 8, 2011, and provides coverage for TandemHeart as a primary treatment option for a wide range of indications. It applies to Medicare beneficiaries throughout NHIC's jurisdiction, including those located in Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont.

According to the company, the TandemHeart system provides a high degree of circulatory support for percutaneous procedures, achieving flow rates up to 5 L/min. The device is composed of a small centrifugal pump, a series of cannulae that connect the pump to the patient, and an electromechanical controller. From a small incision in the leg, cannulae are inserted into the blood vessels and up to the heart. The pump is then activated, allowing damaged heart muscle to rest while augmenting the flow of blood to the patient's vital organs and the rest of the body. The system has been granted clearance by the US Food and Drug Administration and CE Mark approval, the company advised.