CMS Releases Final Decision Memo on Rules for TAVR Program Reimbursement

W   rapping up a yearlong process, the Centers for Medicare & Medicaid Services (CMS) has at last released its “decision memo” finalizing plans for the national coverage determination (NCD) for TAVR reimbursement. And while its proposed coverage plans prompted a chorus of responses from physicians, industry, and other parties, the final document closely reflects the agency’s stated intent, released in late March.

The new NCD goes into effect immediately.

As previously reported by TCTMD, the proposed update to the original NCD for TAVR has solicited expert opinions and public comments. Many responses have centered on the need for hospitals and practitioners to maintain certain volumes of procedures, while others have stressed the need for TAVR access to be expanded to make sure eligible patients are more likely to get these procedures.

As per its earlier proposal, CMS will now require hospitals with existing TAVR programs to maintain certain procedure volumes if they want to be reimbursed. These are:

• ≥ 50 AVRs (TAVR or SAVR) per year, including ≥ 20 TAVR procedures in the year prior, or;
• ≥ 100 AVRs (TAVR or SAVR) every 2 years, including ≥ 40 TAVR procedures in the 2 years prior, and;
• ≥ two physicians with cardiac surgery privileges, and;
• ≥ one physician with interventional cardiology privileges, and;
• ≥ 300 PCIs annually

For hospitals hoping to begin providing TAVR services, the CMS criteria are marginally more forgiving:

• ≥ 50 open-heart surgeries in the year prior to starting the TAVR program, and;
• ≥ 20 aortic valve-related procedures in the 2 years prior to starting the TAVR program, and;
• ≥ two physicians with cardiac surgery privileges, and;
• ≥ one more physician with interventional cardiology privileges, and;
• ≥ 300 PCIs annually

The cardiothoracic surgeon on the heart team is required to have completed 100 or more open-heart surgeries, of which 25 or more are related to the aortic valve, while the interventional cardiologist must have done 100 or more structural heart disease procedures (or 30 left-sided structural procedures per year), as well as device-specific training by the valve manufacturers.

Requirements for the heart team’s composition and for independent evaluation by both a surgeon and an interventional cardiologist for either a surgical or transcatheter procedure, outlined previously, are both in the final document. The need for two-surgeon sign-off—required in the 2012 NCD—has been removed. Also specified is that the heart team’s interventional cardiologist(s) and cardiac surgeon(s) “must jointly participate in the intraoperative technical aspects of TAVR.”

Hospitals providing TAVR must have on-site valve surgery capability and interventional cardiology services.

The final document also states that both the heart team and the hospital offering TAVR participate in a prospective registry, the aim of which will be to follow a host of endpoints that can be analyzed according to patient, practitioner, and facility variables. This requirement, presumably, may prove useful down the road should CMS decide to break with physician and hospital volumes as the metric for gauging program quality—something critics of the volume requirements have called for in the past and which CMS is open to considering.

“CMS agrees that validated outcome measures may be an appropriate alternative to procedural volume requirements when establishing quality standards for TAVR programs,” the new NCD states. “We will continue to follow the STS/ACC TVT Registry’s progress in developing TAVR-specific outcome measures. As we state in this document, CMS may reconsider this NCD to review replacing procedural volume criteria with an outcome metric; however, it is too premature to predict any timing around a future reconsideration.”