CMS Approves Coverage for AbioCor with Evidence Development Decision


May 2, 2008

May 2, 2008 - The Centers for Medicare and Medicaid Services (CMS) has given Abiomed a positive National Coverage Determination (NCD) that allows coverage of the AbioCor Total Replacement Heart, marking the first positive coverage position CMS has taken since a non-coverage determination was issued for artificial hearts in 1986.

CMS Acting Administrator Kerry Weems stated, "Our decision revises a long-standing non-coverage policy and allows beneficiary access to this advanced technology."

AbioCor technology is used for chronic patients who cannot recover their native heart and are not eligible for a transplant and have no other treatment options. The AbioCor Implantable Replacement Heart is able to pump blood through the body, simulating the rhythm of a heartbeat. The complete AbioCor system consists internally of a thoracic unit, a rechargeable battery, a miniaturized electronics package, a power receiver coil, and externally, a power transmitter coil, power and battery pack, handheld alarm monitor and sophisticated computer console.

In addition to covering the AbioCor, CMS previously recommended re-aligning the payment under msDRG 1 or 2 in a draft policy document. MSDRG 1 is the highest paying diagnostic related group (DRG) in Medicare, and the final decision is expected in August 2008.

With this decision, CMS will now reimburse hospitals for the cost of the AbioCor replacement heart and the cost of implanting the device as part of Coverage with Evidence Development (CED). CED approval will cover artificial heart devices for Medicare beneficiaries enrolled in FDA approved studies that meet certain guidelines established by CMS.

Abiomed to date has announced that it has selected four sites as AbioCor Centers for implantation including: The Johns Hopkins University Hospital in Baltimore, MD; Robert Wood Johnson University Hospital in New Brunswick, NJ; Texas Heart Institute at St Luke's Episcopal Hospital in Houston, TX; and St. Vincent in Indianapolis, IN.

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