A Medical Device Daily

Abiomed (Danvers, Massachusetts) this week reported a positive recommendation by the Medicare Evidence Development & Coverage Advisory Committee (MedCAC) to include Humanitarian Device Exemption- (HDE) approved technologies as covered “items or services” in the Medicare clinical trial policy.

CMS generally follows the recommendations of its committee and incorporates such recommendations into coverage policy, Abiomed said.

CMS plans to issue a draft of its clinical trial policy in April 2007, and a final decision is slated for July. Abiomed said that the recommendation could allow future coverage of its AbioCor Implantable Replacement Heart, FDA-approved in September under an HDE (Medical Device Daily, Sept. 6, 2006).

“We look forward to working with the Centers for Medicare & Medicaid Services as they assess their coverage for new, life-saving treatments like the AbioCor,” said Michael Minogue, president/CEO and chasirman of Abiomed. “As we progress with the post-market study of the AbioCor, we hope to be able to partner with CMS and private insurers so that patients in bi-ventricular heart failure, who are not candidates for transplant, can have access to the technology.”

The AbioCor implantable artificial heart requires no tethering to an outside power source and features remote diagnostics allowing patients to return home where they can resume normal activities, including bathing.