CardioWest(TM) Artificial Heart Approved For Highest Reimbursement in CMS History.Plus Up To $53,000 New Technology Add-on Payments TUCSON, Ariz. -- On July 31, the Centers for Medicare and Medicaid Services The Centers for Medicare and Medicaid Services (CMS), previously known as the Health Care Financing Administration (HCFA), is a federal agency within the United States Department of Health and Human Services (DHHS) that administers the Medicare program and (CMS (1) See content management system and color management system. (2) (Conversational Monitor System) Software that provides interactive communications for IBM's VM operating system. ) issued its final decision to reimburse the CardioWest temporary Total Artificial Heart (TAH-t) through the highest paying Diagnostic Related Group codes, MS-DRG 001 and 002. In addition, CMS also approved the CardioWest artificial heart for new technology add-on payments for FY 2009, which starts Oct. 1, 2008. On May 1, 2008, CMS reversed its 1986 non-coverage policy for artificial hearts and approved Medicare reimbursement for the CardioWest artificial heart when implanted as part of an FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. study that meets CMS specifications. For more than two decades prior to this decision, Medicare denied reimbursement for the CardioWest artificial heart. In the July 31 decision, CMS agreed that, "the TAH-t fulfills a role that no other mechanical circulatory circulatory /cir·cu·la·to·ry/ (ser´ku-lah-tor?e) 1. pertaining to circulation, particularly that of the blood. 2. containing blood. cir·cu·la·to·ry n. 1. support device can for patients in irreversible biventricular failure." The thresholds for new technology add-on payments for MS-DRGs 001 and 002 are $345,031 and $178,142 respectively and are retroactive to May 1, 2008. CMS also finalized a new technology add-on payment for the CardioWest artificial heart of up to $53,000, starting Oct. 1, 2008. "We continue to believe that the TAH-t meets the newness criterion despite having received FDA approval more than three years ago because it was not covered not covered Health care adjective Referring to a procedure, test or other health service to which a policy holder or insurance beneficiary is not entitled under the terms of the policy or payment system–eg, Medicare. Cf Covered. by Medicare until May 1, 2008," the CMS decision stated. "This decision helps ensure that our hospitals receive adequate reimbursement for the life-saving artificial heart technology they provide," said Rodger Ford, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. and president of SynCardia Systems, Inc., manufacturer of the CardioWest artificial heart. "In the past, hospitals and their patients have experienced great success with our device, but hospitals risked taking substantial economic losses in order to bridge these patients to transplant. Now, our certified centers can afford to save thousands of end stage heart failure patients." Originally designed as a permanent replacement heart, the CardioWest artificial heart is currently approved as a bridge to human heart transplant heart transplant Procedure to remove a diseased heart and replace it with a healthy one from a legally dead donor. The first was performed in 1967 by Christiaan Barnard. for patients dying from end stage biventricular failure. These patients are often days, if not hours from death. Their survival is dependent upon receiving a matching donor heart, or a CardioWest artificial heart as a bridge-to-transplant. The CardioWest artificial heart is the first and only FDA, Health Canada Health Canada (French: Santé Canada) is the department of the government of Canada with responsibility for national public health. Health Canada's goal is to improve Canadian life by improving Canadian longevity, lifestyle and use of public healthcare. and CE Mark approved temporary Total Artificial Heart in the world. There have been more than 740 implants of the CardioWest, accounting for more than 135 patient years of life on the artificial heart. In the 10-year pivotal clinical study of the CardioWest artificial heart (New England Journal of Medicine The New England Journal of Medicine (New Engl J Med or NEJM) is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It is one of the most popular and widely-read peer-reviewed general medical journals in the world. 2004; 351: 859-867), 79 percent of patients receiving the CardioWest survived to transplant. This is the highest bridge-to-transplant rate for any heart device in the world. |
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