Better Coordination Leading to Swifter Medicare Coverage and Access

Marilyn Tavenner, Acting Administrator, Centers for Medicare and Medicaid Services 

Today, CMS is proposing that Medicare patients across the country have access to a new procedure, known as “transcatheter aortic valve replacement.” 

The result of an unprecedented level of collaboration between CMS, the Food and Drug Administration (FDA), the Agency for Healthcare Research and Quality (AHRQ), the American College of Cardiology, the Society of Thoracic Surgeons and Edwards Lifesciences, this proposed National Coverage Determination continues CMS’ commitment to cross-agency collaboration and ensuring patients have access to the latest and best medical technology.

Aortic valve replacements are used in patients whose aortic heart valves are damaged and cause 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 surgical aortic valve replacement.  And as our population ages, the number of Americans with aortic stenosis progressively increases. 

Transcatheter aortic valve replacement allows doctors to replace a patient’s aortic valve through a small 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.    

The first transcatheter aortic valve replacement system was approved by the FDA on November 2, 2011.  Since then, we have worked closely with the FDA, AHRQ, the American College of Cardiology, the Society of Thoracic Surgeons, and the device manufacturer, Edwards Lifesciences, to bring this new procedure to Medicare enrollees across the country.

Because this technology is still relatively new, it is important that these procedures are performed by highly trained professionals in optimally equipped facilities.  This decision proposes “coverage with evidence development” which, as a condition of coverage, would 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.

We are hopeful that this proposed decision will lead to increased access to less invasive treatment options for Medicare beneficiaries and save lives.

Today’s proposed decision will be open for 30 days of public comment before CMS issues a final decision later this year.  To read the proposal, visit the CMS website at: http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=257

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