CMS Proposes Medicare Coverage For Artificial Hearts
Artificialheart manufacturers Abiomed and SynCardiaSystems on Mondayannounced that CMS has proposed to extend Medicare coverage tothe devices for beneficiaries who participate in clinical trials approved by FDA, the AP/Boston Herald reports. The proposal opens a30-day public comment period, with CMS expected to issue a final Medicarecoverage decision by May 1.
The proposal would reverse a policy established in 1986 that denied Medicarecoverage for artificial hearts, which only the sickest patients receive. FDAofficials on Friday said that "there is now sufficient scientific evidenceon the use of artificial hearts to allow coverage" for Medicarebeneficiaries enrolled in trials approved by the agency.
Three private health insurers recently announced they would cover AbioCor, anartificial heart manufactured by Abiomed. FDA in September 2006 allowed Abiomedto market AbioCor, which cost about $250,000, to about 4,000 of the sickestpatients. No patients to date have received AbioCor. According to Abiomedofficials, Medicare coverage for AbioCor might not lead to increased use of thedevice but might address some related cost concerns. Abiomed Chair, Presidentand CEO Michael Minogue said, "We now have a validation from the FDA thatthis technology works, and we have some proposed validation" from CMS.
FDA in October 2004 approved the CardioWest temporary Total Artificial Heart,manufactured by SynCardia. More than 700 terminally ill heart failure patientsto date have received CardioWest as they waited for transplants.
Gregory Simpson, an analyst with Stifel Nicolaus who tracks Abiomed, on Monday in aresearch note said that most investors would consider Medicare coverage forAbioCor a "nonevent" (AP/Boston Herald, 2/4).
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