Artificial Heart Implantation. Source: National Geographic

The Centers for Medicare & Medicaid Services (CMS) has determined that artificial hearts will be covered by Medicare under Coverage with Evidence Development when beneficiaries are enrolled in a clinical study.

The decision suspends the agency’s 22-year national non-coverage policy for artificial heart devices.

The clinical studies must address at least one of the following questions, according to CMS:

•   Were there unique circumstances, such as expertise, available in a particular facility or an unusual combination of conditions in particular patients that affected their outcomes?
•   What will be the average time to device failure when the device is made available to larger numbers of patients?
•   Do results adequately give a reasonable indication of the full range of outcomes (both positive and negative) that might be expected from more widespread use?

CMS also said that the clinical trials must adhere to the following criteria:

•   The study must be reviewed and approved by the FDA.
•   The principal purpose of the research study is to test whether a particular intervention potentially improves the participants’ health outcomes.
•   The research study is well supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.
•   The research study does not unjustifiably duplicate existing studies.
•   The research study design is appropriate to answer the research question being asked in the study.
•   The research study is sponsored by an organization or individual capable of executing the proposed study successfully.

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

Since the 1986 non-coverage policy, two artificial heart device manufacturers have run clinical trials studying the safety outcomes of using their devices, and CMS said that 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.

Currently, two artificial heart manufacturers have FDA approval, Abiomed and SynCardia Systems, and are referenced by CMS. 

SynCardia makes the CardioWest (Jarvik), and is indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure. The CardioWest TAH-t System is intended for use inside the hospital, according to CMS.

Rodger Ford, CEO and president of SynCardia told Cardiovascular Business News that the company is “gratified” that CMS now believes that the agency has received enough clinical data over the past several years to change their coverage policy. He noted that private payors have been covering it for quite some time.

The CardioWest artificial heart is currently covered by about half of insurers, including Aetna and BlueCross BlueShield, the Tucson, Ariz.-based company said.

“I think more private payors will follow the lead of CMS,” Ford said.

The other company that this coverage considers is Abiomed, which manufactures the AbioCor Total Replacement Heart. The Abiocor is currently covered by three health insurance companies, including Cigna and Humana, according to the Danvers, Mass.-based company.

Michael R. Minogue, Abiomed’s chairman, CEO and president, told Cardiovascular Business News, “We have been working with CMS for a while, and are pleased that the agency has now provided an incentive for the hospitals to provide this life-saving solution.”
   
The CMS determination followed a 30-day public comment period, which closed with 25 comments received.