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

Edwards Intuity aortic valve, surgical aortic valve replacement, PinnacleHealth, first U.S. implants
News | Heart Valve Technology| August 26, 2016
This week, PinnacleHealth, Harrisburg, Pa., became the first hospital in the country to implant the Edwards Intuity...
Intact Vascular, TOBA clinical study, one-year results, Tack Endovascular System, Journal of Vascular Surgery
News | Peripheral Arterial Disease (PAD)| August 24, 2016
Intact Vascular Inc. announced that the one-year results from its Tack Optimized Balloon Angioplasty (TOBA) clinical...
Technavio report, renal denervation devices, 2015
News | Renal Denervation| August 23, 2016
August 23, 2016 — Technavio analysts forecast the global...
Jason Burdick, injectable hydrogels, heart failure, heart attack, American Chemical Society

Compared to other types of hydrogels being developed (left), a new hydrogel (right) can form crosslinks after injection into the heart, making the material stiffer and longer-lasting. Image courtesy of American Chemical Society.

News | Heart Failure| August 23, 2016
August 23, 2016 — During a heart attack, clots or narrowed arteries block blood flow, harming or killing cells within
News | Peripheral Arterial Disease (PAD)| August 22, 2016
Avinger Inc. recently announced the closing of its previously announced public offering of 9,857,800 shares of Avinger’...
DMC Heart Hospital, Detroit Medical Center, complex percutaneous intervention education course, PCI, cath lab training
News | Cath Lab| August 22, 2016
The Detroit Medical Center (DMC) Heart Hospital recently completed a Complex Percutaneous Intervention education course...
TAILOR-PCI study, antiplatelet medication, genotype, NHLBI grant
News | Antiplatelet and Anticoagulation Therapies| August 18, 2016
Researchers at the Peter Munk Cardiac Centre, Toronto, and at Mayo Clinic are leading the Tailored Antiplatelet Therapy...
Covidien, Medtronic, TurboHawk, Atherectomy system

The Medtronic TurboHawk atherectomy system. 

Feature | Atherectomy Devices| August 18, 2016 | Dave Fornell
Due to poor outcomes from percutaneous transluminal angioplasty (PTA) ballooning of vessels alone, or of stenting in
Sapien III, Sapien 3, PARTNER III, FDA approval, expanded indication, intermediate risk patients

The Sapien 3 valve has a skirt of fabric at its base that has significantly reduced issues of paravalvular leak, which was an issue with the first generation Sapien device. 

Feature | Heart Valve Technology| August 18, 2016 | Dave Fornell
August 18, 2016 — The U.S.
Corindus Corpath, Acist Medical RXi and CVi, Fairview Southdale Hospital, Minnesota, cath lab
News | Cath Lab| August 17, 2016
Corindus Vascular Robotics Inc. and Acist Medical Systems Inc. are providing Fairview Southdale Hospital, Edina, Minn...
Overlay Init