For heart patients with severe aortic stenosis, Medicare will now pay for a device called transcatheter aortic valve implantation (TAVI). The Centers for Medicare and Medicaid Services issued a draft of a memo on this issue back in February, and on Tuesday, May 1st the agency confirmed that the decision to reimburse clinicians for TAVI has been reached.
The February memo outlined 5 conditions that must be met for TAVI reimbursement:
The procedure must use a device approved by the FDA such as the Sapien valve.
Two cardiac surgeons must have reviewed the patient's suitability for surgery.
The patient must be under the care of a multidisciplinary heart team, and the facility must have the appropriate infrastructure to perform TAVI.
Interventional cardiologists and cardiac surgeons must jointly participate in the intra-operative technical aspects of the procedure.
The hospital in which it is performed must participate in a prospective, national, audited registry that follows the patient for at least 1 year but tracks outcomes for 5 years.
According to MedPage Today, in December, the American College of Cardiology and the Society of Thoracic Surgeons launched the a registry that will be linked to the Social Security Death Master File and CMS databases in order to track long-term outcomes of the following conditions:
Stroke
All-cause mortality
Transient ischemic attacks
Major vascular events
Acute kidney injury
Repeat aortic valve procedures
Quality of life
Even if all the above requirements are not met, CMS will reimburse for the procedure if it is performed within a clinical study and follows certain guidelines.
