Medicare now will cover aortic valve replacements for patients whose aortic heart valves are damaged, if certain treatment conditions are met, the CMS announced Tuesday.
Through a mutual memorandum of understanding, the CMS and the Food and Drug Administration made a joint decision that will permit the CMS to cover transcatheter aortic valve replacement, or TAVR. That technology is used to treat a condition called aortic stenosis, which causes the heart valve to narrow. According to the CMS, until recently, this condition could be treated only through invasive surgery. TAVR will allow physicians to replace a patient's aortic valve through a small opening in the leg.
But Medicare will cover this procedure only if certain requirements are fulfilled
. These include making sure the procedure uses an aortic valve and implantation system that has received pre-market approval from the FDA; that two cardiac surgeons independently have examined the patient face-to-face; and the patient—both before and after the operation—is under the care of a heart team.
“This decision is particularly important as it highlights cooperative efforts among CMS, the Food and Drug Administration, the Agency for Healthcare Research and Quality, medical specialty societies, and the medical device industry,” Marilyn Tavenner, acting administrator for the CMS, said in a news release