CMS Coverage Proposal for TAVR Preserves Procedure-Volume Focus

March 28, 2019

Seven years after its first national coverage determination (NCD) for the procedure, the US Centers for Medicare and Medicaid Services (CMS) has released a proposed update to its transcatheter aortic valve replacement (TAVR) reimbursement criteria.

The NCD proposal, a preliminary version of what will guide practice pending any changes based on public feedback, has preserved a central role for procedure-volume minimums to be met by heart teams and their hospitals.

In so doing, the proposal takes a position amidst a longstanding controversy about the role such volumes, as opposed to more direct quality metrics, should play in gauging the worthiness of a TAVR program. It presents different volume standards for centers and teams with previous TAVR experience compared with those starting new programs.

The first NCD issued by the agency in 2012 for the nascent procedure of TAVR restricted it to highly experienced interventional centers that would participate in a registry.

The proposed NCD would require TAVR centers to also have both surgical aortic valve replacement (SAVR) and PCI programs and meet one of two sets of volume requirements for the TAVR team and for the hospitals themselves.

Programs at hospitals without previous TAVR experience, the document proposes, would have to have performed at least 50 "open heart" surgeries in the year prior to the TAVR program initiation and at least 20 aortic-valve-related procedures in the previous 2 years.

Heart teams at such hospitals would have to include a cardiovascular surgeon with at least 100 career open heart surgeries, at least 25 aortic-valve related; and an interventional cardiologist with at least 100 career structural heart disease procedures or at least 30 left-sided structural procedures per year, along with the manufacturer-required training for specific devices.

Programs at hospitals with TAVR experience would have to have performed at least 50 TAVRs or SAVRs per year, including at least 20 TAVR procedures in the previous year, or at least 100 TAVRs or SAVRs every 2 years, including at least 40 TAVR procedures in the previous 2 years

The programs, regardless of previous TAVR experience, would also be required to have:

  • at least two physicians with cardiac surgery privileges

  • at least one physician with interventional cardiology privileges

  • at least 300 PCI procedures per year

The proposed new document arrives when the TAVR field is more mature and woven into the fabric of interventional cardiology, and even so is set for a shake up after the recent presentations of the PARTNER 3 and Evolut studies.

The two randomized trials saw clinical outcomes that were at least as good with TAVR as with SAVR in patients deemed at low surgical risk, as reported last week at the American College of Cardiology 68th Annual Scientific Session 2019 (ACC.19).

Such patients make up most of the population that undergo aortic valve replacement, and represent a vast expansion over the high-surgical-risk and later the medium-surgical-risk patients for whom TAVR has been indicated since it entered practice.

Centers for Medicare and Medicaid Services. Proposed National Coverage Determination for Transcatheter Aortic Valve Replacement (TAVR). March 26, 2019

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