The Centers for Medicare & Medicaid Services said yesterday it might reimburse the use of artificial heart devices for Medicare beneficiaries enrolled in FDA-approved studies. The CMS proposal to reimburse for implantation of an artificial heart would reverse the agency’s 22-year policy to not cover this technology.

“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,” Kerry Weems, CMS acting administrator, said in a statement.

Artificial hearts are mechanical replacement devices used in patients with severe, bi-ventricular heart failure. Because these patients are extremely sick and at imminent risk of death, 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.

Because the device requires a portion of the patient’s own heart be removed, an artificial heart patient must be supported by his or her device through the end of life or until heart transplantation, CMS said, apparently the basis of the agency’s non-coverage policy to date.

The policy to not reimburse for the implantation of an artificial heart was put in place in 1986. Since then, two artificial heart device manufacturers have run clinical trials studying the safety and health outcomes of using their devices in these patients.

CMS said it believes there is now sufficient scientific evidence on the use of artificial hearts to allow coverage of these devices for beneficiaries in the controlled clinical environment of an FDA-approved study. Greater evidence development allows CMS to provide faster and more effective coverage with more informed clinical decision-making, it said.

“This device may be able to help patients that otherwise have no treatment options available to them,” Weems said.

CMS said it plans to issue a final national coverage determination in May, following a 30-day public comment period.

The coverage, if approved, would include Abiomed’s (Danvers, Massachusetts) flagship product, AbioCor, as well as the CardioWest artificial heart from SynCardia Systems (Tucson, Arizona).

Richard Smith, a co-founder of SynCardia and technical director of the artificial heart program at University Medical Center (Tucson), told Medical Device Daily that the proposed coverage was anticipated because the company has been working with CMS “for awhile now” to get coverage of the CardioWest, which received FDA approval in 2004 (Medical Device Daily, Oct. 19, 2004).

At the University Medical Center, Smith says he deals with reimbursement for the artificial heart on a day-to-day basis, noting that many small, private insurers use CMS reimbursement as a benchmark for coverage.

“The bigger impact [of the policy change, if approved] is the fact that I can say CMS approves it,” Smith said.

Smith said the company is hoping that when the policy is approved, it will fall into the same category as ventricular assist devices, which have the highest designation of reimbursement as a bridge-to-transplant device.

The CardioWest is covered by about half of insurers, including Aetna and BlueCross BlueShield, according to SynCardia. With final CMS approval, most insurers then are more likely to cover the device, the company said.

The CardioWest, a device which is not fully implanted in the body, costs around $100,000.

Originally designed as a permanent replacement heart, the CardioWest is approved as a bridge-to-transplant for patients dying from end-stage biventricular failure.

SynCardio said CMS posted a notice to its website in August that it would review its non-coverage policy for artificial hearts, after the company submitted a formal request for coverage of the CardioWest when used in accordance with its FDA-approved labeling as a bridge to human heart transplant.

In a 10-year study of the CardioWest, 79% of patients receiving the device survived to transplant, according to SynCardio. This is the highest bridge-to-transplant rate for any heart device in the world, the company says.

The proposed decision also is clearly a positive development for Abiomed and its AbioCor artificial heart which is fully implantable, according to Michael Minogue, president/CEO and chairman.

“This decision by CMS provides momentum towards making the technology available for chronic patients who require bi-ventricular support and have no other treatment options,” Minogue said.

Three insurance companies have existing coverage policies for the AbioCor, including Cigna and Humana, Abiomed noted. The device costs about $250,000.

Under an FDA Humanitarian Device Exemption approval, AbioCor has been made available to a limited patient population with no more than 4,000 patients receiving the technology in the U.S. each year, according to the company. However, since closing its clinical trial, which enrolled 14 patients of a proposed 15, the company has reported no more implants.

Abiomed recently said it has selected four sites as AbioCor Centers: The Johns Hopkins Hospital (Baltimore); Robert Wood Johnson University Hospital (New Brunswick, New Jersey); Texas Heart Institute at St Luke’s Episcopal Hospital (Houston); and St. Vincent’s Hospital (Indianapolis).