CMS has proposed an update to its national coverage policy for transcatheter aortic valve replacement (TAVR), which would require hospitals to perform 50 aortic valve replacements each year to maintain a TAVR program—including at least 20 TAVRs.
The proposal is more flexible than recommendations from four professional cardiology societies, which published a consensus document in August 2018 suggesting the thresholds be raised to 50 TAVRs and 30 surgical AVRs (SAVRs) per year. Those authors cited evidence of better outcomes at higher-volume centers, but other experts have suggested the learning curve with TAVR has shrunk in the past few years due to device improvements and group learning.
Balancing patients’ access to TAVR with achieving quality outcomes was at the center of a debate at TCT.18, and was also a key question CMS attempted to address in its new proposal.
“CMS must continually refine our policies and requirements in light of emerging evidence,” CMS Administrator Seema Verma said in a statement. “Today’s decision updates the requirements for hospitals and physicians to perform TAVR to ensure these requirements are in line with the latest research on patient outcomes, in order to broaden access to care while safeguarding quality and safety for Medicare beneficiaries.”
The proposed decision outlines specific hospital infrastructure requirements, such as needing onsite heart valve surgery and interventional cardiology programs, along with a post-procedural intensive care unit experienced in managing patients following open-heart valve procedures.
In terms of volume requirements, the proposal requires the following for hospitals to begin a program and receive reimbursement for the procedures:
- At least 50 open-heart surgeries in the year prior to starting a TAVR program.
- At least 20 aortic valve-related procedures in the two years before program initiation.
- At least 300 percutaneous coronary interventions (PCIs) per year.
- At least two cardiac surgeons, including one with at least 100 career open-heart surgeries and 25 aortic valve surgeries.
- An interventional cardiologist with at least 100 career structural heart procedures or at least 30 left-sided structural procedures annually, along with device-specific training from valve manufacturers.
In order to maintain reimbursement for a TAVR program, the proposal requires centers to have:
- At least 50 AVRs (TAVR or SAVR) annually or 100 every two years, including 20 or 40 TAVRs over those respective timeframes.
- 300 or more PCIs per year.
- At least one interventional cardiologist and two cardiovascular surgeons.
Another proposed change from the current national coverage determination (NCD), implemented in 2012, is that CMS would require just one surgeon to sign off on the multidisciplinary evaluation for TAVR, SAVR or palliative care. The current NCD requires a two-surgeon signoff.
CMS also plans to require participation in a prospective national registry that tracks patients, operators and facilities for the following outcomes: stroke, all-cause mortality, transient ischemic attacks, major vascular events, acute kidney injury, repeat aortic valve procedures, new permanent pacemaker implantation and quality of life. The registry must also have an actionable plan to answer questions related to device durability, long-term outcomes and adverse events, patient and procedure-related contributors to outcomes and how real-world results compare to those from pivotal clinical studies.
In its statement, CMS said it was looking to gather more information about metrics other than volume that could reliably assess quality and safety.
The 30-day public comment period on the proposal is now open. Comments can be submitted here, and CMS plans to make a final decision on the NCD within 60 days of the comment period ending.