Friday, May 2, 2008

Abiomed wins Medicare coverage for AbioCor artificial heart

Cardiac device maker Abiomed Inc. says that it has received approval from the Centers for Medicare & Medicaid Services (CMS) for coverage of the company's artificial heart, the AbioCor.

Following this decision, hospitals can now get reimbursement for the cost of the AbioCor replacement heart and the cost of implanting the device for Medicare beneficiaries enrolled in U.S. Food and Drug Administration approved studies that meet certain guidelines set by CMS.

According to officials at Danvers-based Abiomed (Nasdaq: ABMD), private insurance companies Cigna and Humana currently have existing coverage policies for the AbioCor.

CMS acting administrator Kerry Weems said that the new coverage decision reverses a long-standing policy of non-coverage that dates back to the organization's first determination concerning artificial hearts in 1986.

Abiomed says that it has selected four sites as AbioCor centers for implantation, including: The Johns Hopkins University Hospital in Baltimore; Robert Wood Johnson University Hospital in New Brunswick, N.J.; Texas Heart Institute at St Luke's Episcopal Hospital in Houston; and St. Vincent in Indianapolis.

After receiving approval to begin trials of the AbioCor in human patients in Jan. 2001, Abiomed conducted 14 well-publicized trials over the next three years, with most patients living well beyond the 60-day life extension the trials were initially aiming for.

Abiomed, which employs about 300 workers, reported a loss of $27.8 million on revenue of $50.6 million for 2007. The company has an FDA-approved heart-assist device called the Impella, used during cardiac surgeries.