Healthcare News & Insights

CMS now covers transcatheter aortic valve replacement

Good news. The Centers for Medicare & Medicaid Services (CMS) now covers new technology for Medicare patients with aortic heart valve damage … under certain conditions.

Transcatheter aortic valve replacement (TAVR), which allows doctors to replace a patient’s aortic valve through a small opening in the leg, is less invasive and gives patients who normally can’t undergo open heart surgery a fighting chance at survival.

The announcement of the coverage decision on May 1, is one of the first under a mutual memorandum between CMS and the FDA to get new, lifesaving technology to patients sooner.

To offer this procedure to patients, certain provider, facility and data collection criteria have to be met. Reason: It’s still a fairly new technology, and CMS and the FDA want to make sure these procedures are done by highly trained professionals in facilities that are well equipped so patients receive the safest and best care possible.

That’s why the decision states the procedure is covered under “Coverage with Evidence Development.”

The procedure will be covered for the treatment of symptomatic aortic-valve stenosis when the following five conditions — each of which has its own criteria — are met:

  • The procedure is performed with a complete aortic valve and implantation system that has received FDA pre-market approval for that system’s FDA approved indication.
  • Two cardiac surgeons have independently examined the patient’s suitability for open aortic valve-replacement surgery.
  • The patient is under the care of a heart team: a cohesive, multidisciplinary team of medical professionals.
  • The heart team’s interventional cardiologists and cardiac surgeons must jointly participate in the intraoperative technical aspects of TAVR, and
  • The treating team and hospital must participate in a national registry that enrolls TAVR patients and tracks the following outcomes: stroke; all-cause mortality; transient ischemic attack; major vascular events; acute kidney injury; repeat aortic valve procedures; and quality of life.

TAVR is covered for uses that aren’t listed as an FDA-approved indication, but only when done within a clinical study that meets required conditions.

For the complete list of all the conditions, click here.

 

 

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