Artificial hearts may receive CMS coverage. Source: SynCardia Systems.

The Centers for Medicare & Medicaid Services (CMS) has proposed coverage with evidence development of artificial heart devices for Medicare beneficiaries who are enrolled in FDA-approved studies.

“Our proposal relaxes a long-standing non-coverage policy, gives access to our beneficiaries and promotes evidence development through FDA-approved studies of this advanced technology,” said CMS Acting Administrator Kerry Weems.

Patients who receive an artificial heart are extremely sick and at imminent risk of death, and the device can be used to enable a patient to live until a donor heart becomes available for transplant or, for a non-transplant patient, to extend his or her life, according to CMS. “This device may be able to help patients that otherwise have no treatment options available to them,” Weems said.

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

Abiomed and SynCardia Systems are the two manufacturers referenced by CMS.

Abiomed's AbioCor Total Replacement Heart is covered by three health insurance companies, including Cigna and Humana, according to the Danvers, Mass.-based company.

SynCardia’s CardioWest (Jarvik) artificial heart is currently covered by about half of insurers, including Aetna and BlueCross BlueShield, the Tucson, Ariz.-based company said.

The CMS proposal does not guarantee Medicare coverage, but does open a public comment period for 30 days followed by CMS deliberations for a final decision no later than May 1.