CMS May Cover Artificial Heart
CMS has proposed covering artificial heart devices in Medicare beneficiaries enrolled in Food and Drug Administration-approved studies, reversing a 20-year-old policy. The use of artificial heart technology has not been available to Medicare beneficiaries because of a 1986 noncoverage policy. But since then, two artificial heart makers have run clinical trials studying the safety and health outcomes of using their devices, CMS said. The agency said it now believes there is 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.” A final coverage determination is expected in May.