Medicare to Cover Artificial Hearts When Used in FDA
Approved Clinical Research
Decision revises a long-standing non-coverage policy
May 2, 2008 - Medicare should soon start paying for
artificial hearts, at least 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.
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.
The Centers for Medicare & Medicaid Services (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. The agency yesterday issued a final National Coverage
Determination (NCD) expanding Medicare coverage of artificial hearts.
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 patients heart be removed, an
artificial heart patient must be supported by the device through the end
of life or until heart transplantation.
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 Thursday follows a
proposed decision issued in February 2008. Public comments received in
response to the proposed decision were generally supportive of this
decision.
