Tucson-based SynCardia awaits boost from Medicare approval
Company's artificial heart expected to get Medicare reimbursement OK
STAFF AND WIRE REPORTS
Did you know …
SynCardia Systems' CardioWest temporary Total Artificial Heart is a revised version of the first artificial heart ever used, in December 1982. The Jarvik-7 heart kept Barney Clark of Seattle alive at the University of Utah for 112 days.
Dr. Robert Jarvik began collaborating with Dr. Jack Copeland, head of University Medical Center's artificial-heart and heart-and-lung transplant programs, in 1985. That year, Copeland became the first surgeon to use an artificial heart as a bridge to transplant.
Copeland and UMC took over what was then called the Symbion Heart in 1991. UMC kept the device available to patients on a research basis prior to SynCardia's start in 2001.
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BOSTON — In a ruling expected to benefit a Tucson company, the federal government is expected to begin providing Medicare reimbursement to a small number of patients receiving fully implantable artificial hearts.
Tucson-based SynCardia Systems Inc. said the Centers for Medicare and Medicaid Services has proposed to extend coverage for Medicare patients age 65 or older who are enrolled in Food and Drug Administration-approved studies of the technology.
Artificial-heart technology is burdened in part by the $250,000 cost of each potentially lifesaving device.
Syncardia said its CardioWest temporary Total Artificial Heart is currently covered by about half of insurers, including Aetna and BlueCross BlueShield. With final CMS approval, most insurers are likely to cover the CardioWest artificial heart, the company said.
"This decision is a historic step toward making the artificial heart available to most Americans," Rodger Ford, SynCardia President and CEO, said in a prepared statement. "Many smaller insurers use (Centers for Medicare and Medicaid Services) reimbursement decisions as their benchmark for coverage."
The federal agency's proposal opens a 30-day public comment period, followed by a final coverage decision by the Medicare agency expected by May 1.
The agency has proposed changing a policy adopted in 1986 that denied coverage to patients receiving artificial replacement hearts, an extremely rare procedure reserved for those who are gravely ill.
But with two artificial-heart makers having run clinical trials, CMS said in a statement Friday, that it "believes there is now sufficient scientific evidence on the use of artificial hearts to allow coverage" in the controlled setting of an FDA-approved study.
The CardioWest artificial heart received FDA approval in 2004 and was subsequently approved for use in Europe and Canada. It has been implanted in more than 700 patients, accounting for more than 120 patient-years of life on the device, the company said.
Although it was originally designed as a permanent replacement heart, the Cardio-West is currently approved as a bridge to transplant for patients dying from certain types of heart failure.
Another artificial-heart maker could potentially benefit from the proposed policy change.
The Medicare development follows recent decisions by three private insurers to offer coverage for patients receiving the AbioCor heart, developed by Danvers, Mass.-based Abiomed Inc.
The FDA in September 2006 allowed Abiomed to sell its $250,000 device to as many as 4,000 of the sickest heart patients each year. However, no AbioCors have been implanted since that approval because the company has focused on developing a next-generation version of its current device, which is considered largely experimental.
Did you know …
SynCardia Systems' CardioWest temporary Total Artificial Heart is a revised version of the first artificial heart ever used, in December 1982. The Jarvik-7 heart kept Barney Clark of Seattle alive at the University of Utah for 112 days.
Dr. Robert Jarvik began collaborating with Dr. Jack Copeland, head of University Medical Center's artificial-heart and heart-and-lung transplant programs, in 1985. That year, Copeland became the first surgeon to use an artificial heart as a bridge to transplant.
Copeland and UMC took over what was then called the Symbion Heart in 1991. UMC kept the device available to patients on a research basis prior to SynCardia's start in 2001.
● Includes information from The Associated Press.
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