National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430N)

National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430N)

CMS to cover new technology for Medicare patients with heart valve damage

The Centers for Medicare & Medicaid Services (CMS) will now cover transcatheter aortic valve replacement (TAVR) for Medicare patients under certain conditions. The coverage decision announced today 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 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 Acting Administrator Tavenner. “This decision is particularly important as it highlights cooperative efforts among CMS, the 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 can be found at: http://www.cms.gov/medicare-coverage-database/details/nca-details.aspx?NCAId=257&ver=4&NcaName=Transcatheter+Aortic+Valve+Replacement+(TAVR)&bc=ACAAAAAAAAAA&.