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Medicare to pay for LVAD in heart patients not eligible for a transplant.

Medicare patients who are suffering from chronic end-stage heart failure but are not candidates for a heart transplant will soon be eligible to receive part of the cost of a left ventricular assist device (LVAD).

The Department of Health and Human Services (HHS) Centers for Medicare and Medicaid (CMS) announced on October 1 it intends expand coverage for Medicare patients who have chronic end-stage heart failure, and meet inclusion criteria outlined in the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure trial (REMATCH). The effective date was not announced but is expected to be in the next 30 days.

"This decision is based on the best available scientific evidence following a clinical trial that showed VADs can extend and improve the quality of life in patients with heart failure," said CMS Administrator Tom Scully.

Thoratec, Inc., the maker of the HeartMate XVE LVAS, the only such device currently approved for destination therapy by the FDA, applauded the CMS decision for the "diligent, responsive and cooperative manner in which they conducted their deliberations."

"The conditions outlined by CMS as part of this coverage analysis are very much in line with what we had envisioned as the market opportunity for this indication," said D. Keith Grossman, Thoratec president and CEO.

In a "decision memo" CMA says it has "determined that the evidence is adequate to conclude that implantation of a LVAD approved by the Food and Drug Administration (FDA) for destination therapy is reasonable and necessary as permanent mechanical cardiac support for Medicare beneficiaries who have chronic end-stage heart failure i.e. New York Heart Association Class IV end-stage left ventricular failure for at least 90 days with a life expectance of less than 2 years.

CMS added that LVAD implementation will only be considered "reasonable and necessary" if the procedure is performed in a Medicare-approved heart transplant facility that, between January 1, 2002 and September 30, 2003, implanted at lest 15 LVADs as a bridge to transplant or as destination therapy. The LVADs must have been approved by the FDA for destination therapy or as a bridge to transplant or have been implanted as part of an FDA investigational device exemption (IDE) trial that meet certain conditions.

About 60 US centers meet that criteria and perform approximately 80% of all the LVAD procedures done, according to the Associated Press.

However, price could determine how many of the estimated 100,000 patients who could benefit from the device will ultimately receive one. CMS said it will pay $75,000 - up from the $55,000 it originally agreed to pay, but far short of the total cost of the device and the operation which physicians say will cost between $150,000 and $200,000.

In a press release, Thoratec said it estimates that in many cases the actual payments to hospitals under the revised DRG will be higher-in some cases as much as double the base payment-based on geographical location and other factors. Hospitals can also qualify for additional payments under outlier payment policies, depending on the hospital's actual charges.

CMS noted it plans to develop accreditation standards for facilities that implant LVADs and, when implemented, LVAD implantation will be considered reasonable and necessary only at accredited facilities.
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Title Annotation:Left ventricular assist device
Comment:Medicare to pay for LVAD in heart patients not eligible for a transplant.(Left ventricular assist device)
Publication:Transplant News
Geographic Code:1USA
Date:Oct 31, 2003
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