Healthcare Industry News: RT Technology
News Release - May 2, 2008
Abiomed Receives Approval for National Reimbursement Coverage from CMS for AbioCor(R) Total Replacement HeartCMS Approves Coverage with Evidence Development (CED) Decision
DANVERS, Mass.--(HSMN NewsFeed)--Abiomed Inc. (NASDAQ: ABMD ) announced today it has received a positive National Coverage Determination (NCD) from the Centers for Medicare & Medicaid Services (CMS) that allows coverage of the AbioCor® Total Replacement Heart. The decision is the first positive coverage position CMS has taken since a non-coverage determination was issued for artificial hearts in 1986. In addition to covering the AbioCor, CMS previously recommended re-aligning the payment under msDRG 1 or 2 in a draft policy document. MSDRG 1 is the highest paying diagnostic related group (DRG) in Medicare, and the final decision is expected in August 2008.
"We are pleased with the CMS decision for the advancement of our AbioCor replacement heaRT Technology in the United States," said Michael R. Minogue, Chairman, President and CEO of Abiomed. "This decision supports the utilization of our AbioCor technology for chronic patients who cannot recover their native heart and are not eligible for a transplant and have no other treatment options.”
With this decision, CMS will now reimburse hospitals for the cost of the AbioCor replacement heart and the cost of implanting the device as part of Coverage with Evidence Development (CED). CED approval will cover artificial heart devices for Medicare beneficiaries enrolled in Food and Drug Administration (FDA) approved studies that meet certain guidelines established by CMS. The approval decision was issued today following a 30 day public comment period that resulted in strong support for the recommendation. Currently, private insurance companies Cigna and Humana have existing coverage policies for the AbioCor, and HealthNet, has a positive coverage decision for devices approved by FDA under a Humanitarian Device Exemption (HDE).
In a recent CMS press release, CMS Acting Administrator Kerry Weems stated “Our decision revises a long-standing non-coverage policy and allows beneficiary access to this advanced technology.”
Abiomed to date has announced that it has selected four sites as AbioCor Centers for implantation including: The Johns Hopkins University Hospital in Baltimore, MD; Robert Wood Johnson University Hospital in New Brunswick, NJ; Texas Heart Institute at St Luke's Episcopal Hospital in Houston, TX; and St. Vincent in Indianapolis, IN.
The AbioCor Implantable Replacement Heart is one of the most sophisticated medical devices ever developed and is designed to extend the lives of patients who would otherwise die of heart failure. The AbioCor can potentially offer an improved quality of life so that a patient can be mobile and continue a productive lifestyle. The AbioCor is the only artificial heart without wires piercing through the skin, reducing the chance of infection. Its remote diagnostics allow patients to return home where they can resume normal activities including bathing. The AbioCor is able to pump blood through the body, simulating the rhythm of a heartbeat. The complete AbioCor system consists internally of a thoracic unit, a rechargeable battery, a miniaturized electronics package, a power receiver coil, and externally, a power transmitter coil, power and battery pack, handheld alarm monitor and sophisticated computer console.
Based in Danvers, Massachusetts, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support to acute heart failure patients across the continuum of care in heart recovery. Our products are designed to enable the heart to rest, heal and recover by improving blood flow and/or performing the pumping of the heart. For additional information please visit: www.abiomed.com.
This Release contains forward-looking statements, including statements regarding development of Abiomed's existing and new products, the Company's progress toward commercial growth, and future opportunities. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, anticipated future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the Company's filings with the Securities and Exchange Commission, including the Annual Report filed on Form 10-K and recently filed Form 10-Q. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this Release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this Release or to reflect the occurrence of unanticipated events.
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