STS and ACC Support National Coverage Determination for Transcatheter Aortic Valve Replacement

Cardiothoracic surgeons and cardiologists support coverage of new heart therapy for US patients

PRESS RELEASE - Washington, DC, May 1, 2012 - Today, The Society of Thoracic Surgeons and the American College of Cardiology (ACC) released the following statement in support of the Centers for Medicare and Medicaid Service’s (CMS) release of the official National Coverage Determination (NCD) for transcatheter aortic valve replacement therapy (TAVR). TAVR is a new minimally invasive catheter-based option now available to older patients with aortic stenosis who are too high risk for conventional surgical therapy.

The NCD states that coverage for TAVR be approved under Coverage with Evidence Development (CED) and that TAVR would be covered for the treatment of severe symptomatic aortic stenosis for FDA-approved indications. The FDA has approved TAVR for inoperable patients.

“The Society of Thoracic Surgeons is pleased CMS has released a comprehensive and collaborative approach to TAVR coverage that optimizes patient safety, while allowing Medicare beneficiaries across the country access to the latest in medical technology. The Society commends CMS for providing a clear pathway for both cardiothoracic surgeons and cardiologists, working together as a heart team, to safely bring this life-saving procedure to Medicare patients, who have been demonstrated by the evidence to benefit from TAVR,” said STS President Jeffrey B. Rich, MD. “The physician community and professional societies, in particular STS and ACC, have the responsibility to play an active role in the rational dispersion of this new technology and therefore support this CED policy, which can help bring the right devices to the right patients at the right time. In a field of medicine that is rapidly changing, this TAVR NCD achieves the goal of putting patient safety first, while still promoting medical device innovation.”

“The American College of Cardiology commends CMS on its decision and its comprehensive approach to the introduction of TAVR. This means that this transformative technology will be available to Medicare patients who do not have other options for treating severe, debilitating aortic stenosis,” said ACC President William A. Zoghbi, MD, FACC. “We agree with CMS’s decision to structure the NCD in a manner that supports access to TAVR while ensuring that services are performed by the best qualified team of physicians and hospitals. The ACC hopes this NCD proves to be a successful model for providing rapid access to promising new technologies for Medicare beneficiaries while focusing on patient safety, quality care and outcome.”

Please see the final NCD for additional details on Medicare coverage of TAVR.

NCDs are policies issued by CMS under Section 1869(f) of the Social Security Act to determine whether or not a particular item or service should be covered nationally by Medicare. The NCD grants, limits, or excludes Medicare coverage. NCDs are binding on all Medicare carriers, fiscal intermediaries, quality improvement organizations, health maintenance organizations, competitive medical plans, and health care prepayment plans.

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Note to Editors: For more information about TAVR or to arrange for an interview with Dr. Rich, contact Rachel Estrada (STS) restrada [at] sts [dot] org or (202) 531-5788. To arrange for an interview with Dr. Zoghbi, contact Stephanie Abraham (ACC) sabraham [at] acc [dot] org or (202) 375-6296.

Founded in 1964, The Society of Thoracic Surgeons is a not-for-profit organization representing more than 6,400 surgeons, researchers, and allied health care professionals worldwide who are dedicated to ensuring the best possible outcomes for surgeries of the heart, lung, and esophagus, as well as other surgical procedures within the chest. The mission of the Society is to enhance the ability of cardiothoracic surgeons to provide the highest quality patient care through education, research, and advocacy. Learn more at www.sts.org.

The American College of Cardiology is transforming cardiovascular care and improving heart health through continuous quality improvement, patient-centered care, payment innovation and professionalism. The College is a 40,000-member nonprofit medical society comprised of physicians, surgeons, nurses, physician assistants, pharmacists and practice managers, and bestows credentials upon cardiovascular specialists who meet its stringent qualifications. The College is a leader in the formulation of health policy, standards and guidelines, and is a staunch supporter of cardiovascular research. The ACC provides professional education and operates national registries for the measurement and improvement of quality care. More information about the association is available online at www.cardiosource.org/ACC.

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