Feature | May 01, 2012

CMS to Cover TAVR for Medicare Patients

Medicare patients will be covered for transcatheter aortic valve replacements

May 1, 2012 – The Centers for Medicare and Medicaid Services (CMS) announced today it will now cover transcatheter aortic valve replacement (TAVR) for Medicare patients under certain conditions. The coverage decision announced by CMS Acting Administrator Marilyn Tavenner offers important new technology to some of Medicare’s sickest patients.

Aortic valve replacements are used in patients whose aortic heart valves are damaged, causing the valve to narrow – a condition known as aortic stenosis. Once patients experience symptoms of aortic stenosis, treatment is critical to improve their chances of survival. Until recently, aortic stenosis has been treatable only through invasive surgery. In contrast, TAVR allows doctors to replace a patient’s aortic valve through a small percutaneous opening in the leg. This less invasive procedure gives patients who cannot undergo open-heart surgery a new way to repair their damaged heart valve.

“We are pleased with this decision and the increased access to treatment options it will provide,” said Tavenner. “This decision is particularly important as it highlights cooperative efforts among CMS, the U.S. Food and Drug Administration (FDA), the Agency for Healthcare Research and Quality, medical specialty societies and the medical device industry.”

This final national coverage decision is one of the first coverage decisions completed under a mutual memorandum of understanding between CMS and the FDA, a joint effort aimed at getting sometimes-lifesaving, new technology to patients sooner.

Because this technology is still relatively new, it is important that these procedures are performed by highly trained professionals in optimally equipped facilities. Therefore, this decision uses “coverage with evidence development,” which, as a condition of coverage, will require certain provider, facility and data collection criteria to be met. Such requirements are important to ensure beneficiaries receive the safest and most appropriate care.

The decision includes the Edwards Lifesciences' Sapien valve, which is the only FDA-cleared transcatheter aortic valve. Medtronic’s CoreValve is currently being reviewed in a U.S. pivotal trial that will be used to seek final FDA review.

Edwards commended CMS for issuing a flexible National Coverage Determination (NCD) that authorizes coverage for current and future indications approved by the FDA. Edwards also noted that, under the NCD, coverage would extend to qualified noninferiority or equivalence clinical studies. Additionally, important but small patient populations can be covered under a qualified study. The company continues to support the collection of TAVR outcomes data in a qualified national prospective registry.

"We endorse the NCD's emphasis on the use of multi-disciplinary heart teams in the treatment of TAVR patients," said Michael A. Mussallem, Edwards' chairman and CEO. "While we are still analyzing the policy and its lengthy supporting decision memorandum, we believe that this policy can provide appropriate and prompt access to treatment for these very sick patients."

The decision can be found at: www.cms.gov/medicare-coverage-database/details/nca-details.aspx?NCAId=257&ver=4&NcaName=Transcatheter+Aortic+Valve+Replacement+(TAVR)&bc=ACAAAAAAAAAA&

Related Content

ultrasound-activated microbubbles, heart attack, pig model, NIBIB, human clinical trials

An ultrasound-stimulated microbubble burrows through a fibrin clot (green) allowing penetration of the surrounding fluid into the clot (yellow). Image courtesy of Christopher Acconci and David Goertz, University of Toronto.

News | Ultrasound Imaging| February 11, 2016
Researchers funded by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) used ultrasound-activated...
Fred Hoiberg, Chicago Bulls coach, On-X aortic heart valve, education campaign

Fred Hoiberg, head coach of the NBA Chicago Bulls, is launching a new campaign to help people with heart valve problems on www.heartvalvesurgery.com. Coach Hoiberg, pictured here with his family, wanted a single, life-long solution to his aortic heart valve problem, and received an On-X aortic mechanical valve from On-X Life Technologies Inc. in April 2015.

News | Heart Valve Repair| February 10, 2016
February 10, 2016 — Fred Hoiberg, head coach of the National Basketball Assocation’s (NBA) Chicago Bulls, is launchin

Image courtesy of Boston Scientific

Feature | Business| February 10, 2016 | Dave Fornell
After five years of almost constant lobbying efforts and numerous attempts by the U.S.
CeloNova, COBRA REDUCE trial, first patient enrolled, Cobra PzF coronary stent
News | Stents| February 10, 2016
CeloNova BioSciences Inc. announced this week that the first patient has been enrolled in its COBRA REDUCE trial. The...
HeartWare, terminated acquisition, Valtech Cardio
News | Structural Heart| February 10, 2016
February 10, 2016 — HeartWare International Inc. and Valtech Cardio Ltd.
Valtech Cardioband, reimbursement, Germany, mitral regurgitation in heart failure
News | Heart Valve Repair| February 09, 2016
Valtech Cardio Ltd. announced that it has received German Neue Untersuchungs und Behandlungsmethoden (NUB) Status 1...
ACC late breakers
News | ACC| February 09, 2016
February 9, 2016 — The late-breaking clinical trial presentations have been announced for the 2016 American College o
transcatheter repair of a mitral valve paravalvular leak

Transcatheter repair of a surgical mitral replacement paravalvular leak with an Amplatzer Vascular Plug II.

Feature | Heart Valve Repair| February 08, 2016 | Dave Fornell
Off-label use of the St.
Stereotaxis, Philips, collaboration, Niobe ES remote magnetic navigation system, Allura Xper FD10 cardiovascular X-ray

Niobe ES image courtesy of Stereotaxis Inc.

Technology | Cath Lab| February 04, 2016
February 4, 2016 — Stereotaxis and Philips have signed an addendum pursuant to their existing Development and Coopera
medtronic corevalve, tavr
News | February 03, 2016 | Dave Fornell
Medtronic announced Feb. 3 that the U.S.
Overlay Init