The Centers for Medicare & Medicaid Services (CMS) has issued a final National Coverage Determination (NCD) expanding Medicare coverage of artificial hearts when they are implanted as part of a study that is approved by the Food and Drug Administration (FDA) and that meets CMS' Coverage with Evidence Development (CED) clinical research criteria.

"Our decision revises a long-standing non-coverage policy and allows beneficiary access to this advanced technology," said CMS Acting Administrator Kerry Weems. "Our decision also encourages the completion of FDA post-approval studies."

Artificial hearts are used in patients with severe heart failure who are extremely sick and at imminent risk of death. Heart failure affects more than 5 million patients in the United States. Over 500,000 new cases are diagnosed annually, and more than 50,000 heart failure patients die from the disease every year.

Artificial hearts can be used so that a patient will live until a donor heart becomes available for transplant or, for patients who cannot receive transplants, to extend their lives. Since the device requires that a portion of the patient's heart be removed, an artificial heart patient must be supported by the device through the end of life or until heart transplantation.

The use of artificial heart technology has not been available to Medicare beneficiaries due to a 1986 non-coverage policy. Since the 1986 policy, two artificial heart device manufacturers have conducted clinical trials studying the safety and health outcomes of using their devices in these very sick patients. CMS believes there is now sufficient scientific evidence on the use of artificial hearts to allow coverage of these devices for beneficiaries in the carefully controlled clinical environment of an FDA-approved study.

This controlled clinical environment is one of the protections afforded beneficiaries under the Coverage with Evidence Development (CED) framework. CED allows CMS to determine that a technology can be covered when it is provided within a research setting where there are added safety, patient protections, monitoring, and clinical expertise available to the beneficiary.

Ultimately, this additional data will develop into new clinical evidence that can assists in the Medicare coverage process. An even more important outcome of this CED framework, however, is the production of evidence that will influence clinical practice and help Medicare beneficiaries and providers make the most appropriate diagnostic and therapeutic decisions.

The final coverage decision specifies the questions that studies must address and the standards those studies must meet for Medicare coverage. In developing this policy, CMS consulted with the Agency for Healthcare Research and Quality, and both agencies believe the questions and standards meet the requirements of the Medicare statute. CMS will accept submissions from the research community about trials that may answer CMS' questions about artificial hearts. Clinical studies that are determined to meet CMS' requirements will be listed on the CMS website.

"Our policy will allow beneficiaries to access artificial heart technology while also stimulating the research community to develop further evidence about the impact of this technology on improving patient outcomes," Weems said.

The final coverage policy issued today follows a proposed decision issued in February 2008. Public comments received in response to the proposed decision were generally supportive of this decision. The final decision memorandum is available on the CMS Web site at http://www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=211.