CMS Agrees to Reimburse for AbioCor Total Replacement Heart
The Centers for Medicare and Medicaid Services (CMS) has delivered a positive National Coverage Determination to Abiomed for the company’s AbioCor Total Replacement Heart. This device is intended to treat patients with heart failure, as described in a press release issued by Abiomed about the determination decision from CMS.
The terms of the decision calls for CMS to provide reimbursement for both the device as well as the costs associated with implantation. Only those patients who participate in clinical trials under the Coverage with Evidence Development (CED) programs will be eligible. Implantation will occur at one of four different facilities. Two private insurers, Humana and Cigna, already provide reimbursement for the device.
The company previously received an expanded indication from the Food and Drug Administration, described on HospitalBuyer. It is now approved to treat patients with severe heart damage who are not eligible to undergo heart transplant. The device is utilized to extend a patient’s life and improve their overall life quality.
Device implantation provides patients the means to be mobile, as well as continuing normal activities of daily living. Wires from the AbioCor Total Replacement Heart do not pierce the patient’s skin, which reduces the likelihood that an infection will occur.
This is the first positive determination for an artificial heart device since the initial non-coverage ruling by CMS in 1986.
May 8, 2008 Related topics: Legal & legislative, Product Approval & Certification, Trends, Cardiology