Criteria required for Medicare reimbursement of transcatheter aortic valve replacement (TAVR) would be eased but not eliminated under a proposed National Coverage Determination Tuesday.
The Centers for Medicare & Medicaid (CMS) appeared to yield to the advice of a group of professional heart societies, whereas its advisory panel that met in July 2018 was split over continuing to use procedural volume to start and maintain coverage in a TAVR program.
Changes from the current criteria proposed included requiring the patient to meet with one cardiac surgeon for evaluation for surgery versus transcatheter treatment, rather than two surgeons as was previously required.
Volume requirements to start a TAVR program were at least 50 open heart surgeries in prior year and 20 aortic valve-related procedures in the prior 2 years, as well as 300 percutaneous coronary interventions (PCIs) per year.
for the year prior to initiation was at least 50 total aortic valve procedures (including ≥10 high-risk patients) and 1,000 catheterizations with ≥400 PCIs.
To maintain a TAVR program, the center would have to perform at least 50 aortic valve replacement procedures (TAVR or surgical) per year (including at least 20 TAVR procedures) or 100 procedures of either type every 2 years (including at least 40 TAVRs). It would also need at least 300 PCIs annually.
For both maintenance and initiation of a TAVR program, the center would also need two physicians with cardiac surgery privileges, and one physician with interventional cardiology privileges, at a minimum.
CMS Administrator Seema Verma said in a that the changes would "broaden access to care while safeguarding quality and safety for Medicare beneficiaries."
The proposal kept the heart team requirement along with participation in a prospective, national, audited TAVR registry.
Reimbursement would be limited to FDA-approved indications (or participation in a clinical trial), which would exclude use in low surgical risk patients for now.
Public comment is being solicited for 30 days, with a final decision expected no later than June 24.