New TAVR NCD a ‘Missed Opportunity’ to Align SAVR, TAVR Quality

The ink is not yet dry on the Centers for Medicare & Medicaid Services (CMS) updated national coverage determination (NCD) for TAVR, but already a group of interventionalists and surgeons is calling for a rethink of how reimbursement rules and quality metrics are applied in the setting of aortic stenosis (AS).

Writing in a JAMA viewpoint just days after the NCD was posted, Satya Shreenivas, MD (The Christ Hospital, Cincinnati, OH), Michael Reardon, MD (Houston Methodist Hospital, TX), and Dean Kereiakes, MD (The Christ Hospital), allege that the updated NCD and also a new American College of Cardiology certification program for TAVR “perpetuate what are now arbitrary distinctions between TAVR and SAVR and subject TAVR to greater regulatory oversight.”

It’s important to take a step back and see the larger picture, Shreenivas explained to TCTMD. “We’ve been thinking of the treatment of aortic stenosis, and looking at TAVR metrics or SAVR metrics for quality and reimbursement, but why aren’t we asking what’s best for the patient with aortic stenosis? By framing this as what’s best or what’s needed, not for providers or for hospitals but what’s best for patients, you might come up with a different answer.”

The underlying argument here is that the heart team is important and if that is the case, then why aren’t we providing that to all patients? Satya Shreenivas

In their paper, published online June 26, 2019, Shreenivas and colleagues point out that CMS rules have been directed solely at TAVR, with no attempt to revamp reimbursement or quality metrics for SAVR. There are approximately 1,200 hospitals that provide aortic valve surgery in the US, Shreenivas noted to TCTMD, but only 500 to 600 that offer both SAVR and TAVR. That means that the need for a heart team—which is a requirement for centers wanting to offer TAVR—isn’t mandated for hospitals that only offer SAVR.

“So at half of those hospitals, patients would go to those programs and not have access to a heart team, or to TAVR,” he observed. “The underlying argument here is that the heart team is important, and if that is the case then why aren’t we providing that to all patients?

“And what are the volume requirements for SAVR reimbursement?” Shreenivas continued. “There are none.”

That’s a point echoed in an editor’s note accompanying the viewpoint. Here, Patrick O’Gara, MD (Brigham and Women’s Hospital, Boston, MA), and colleagues agree that the authors have identified an “important flaw in the conceptualization of best practices for managing patients with aortic stenosis.”

SAVR is the only treatment being offered by hundreds of US centers, write O’Gara et al, yet the focus to date has been on setting volume and quality benchmarks for TAVR programs. “It is equally important to query whether the outstanding surgical outcomes achieved in randomized clinical trials that have evaluated the comparative effectiveness of these two strategies can be extrapolated to surgical programs in the United States, including those that do and those that do not provide an option for TAVR.”

Signing Off on Surgery

This is not the first time Shreenivas, Reardon, and Kereiakes have set out to stir the pot over NCD requirements. In 2018, as reported by TCTMD, they co-authored an opinion piece published just as CMS was convening its Medicare Evidence Development & Coverage Advisory Committee to update the 2012 NCD for TAVR. Last year, they had two-surgeon TAVR sign-off in their crosshairs, a requirement that was subsequently dropped in the updated NCD.

In their current viewpoint, Shreenivas and colleagues zero in on the fact that the new NCD requires a surgeon to independently evaluate a patient prior to TAVR, yet a cardiologist is not required to sign-off on a patient prior to SAVR.

“This is curious in the context of recent data showing either equipoise or superiority of TAVR over SAVR in both patients at intermediate surgical risk and those at low surgical risk,” the authors write. “How does the NCD propose to assure that a patient at low surgical risk who might be better served by TAVR will indeed be offered that therapy when evaluated solely by a cardiac surgeon in a facility that offers SAVR but not TAVR?”

Commenting for TCTMD, Gilbert Tang, MD (Icahn School of Medicine at Mount Sinai, New York, NY), a cardiothoracic surgeon who also performs transcatheter valve procedures and was consulted on the JAMA viewpoint, offered the reminder that TAVR is still not approved for all-comers. That’s the key reason why the traditional referral pattern, wherein the surgeon is the gatekeeper for the decision-making, remains in place.

“Right now the issue is that there are a lot of surgeons out there who are quite resistant to this therapy and of course there is already an imbalance between interventional cardiologists and surgeons, because typically interventional cardiologists refer to surgery and not the other way around,” Tang said. “It’s a sensitive issue, because if the interventional cardiologists try to question the surgeon’s decision-making, I think it’s going to potentially create more tension within the local heart teams or local institutions.”

At the end of the day, you want to be delivering patient-centered care, not therapy-centered care, so I think we need that elevated perspective. Gilbert Tang

That’s a good argument for having a more universal mandate that an interventional cardiologist and a surgeon manage AS collaboratively, keeping in mind that the options are not only surgery and TAVR but also medical therapy, Tang continued.

A key part of collaboration would be making sure that patients, regardless of where they are treated, undergo the same diagnostic studies, Tang noted. Currently, only patients being considered for TAVR, at TAVR-capable centers, typically undergo cardiac CT, while patients being assessed at centers that only offer surgery will head straight to the operating room.

“My perspective is that all patients with aortic stenosis should have a CT scan to determine which therapy is the most suitable, considering the patient-related factors and also the anatomical factors, then use both to determine which is the most appropriate for the patient,” Tang said. “At the end of the day, you want to be delivering patient-centered care, not therapy-centered care, so I think we need that elevated perspective.”

‘Tip of the Iceberg’

Both Shreenivas and Kereiakes acknowledge that this time around, their concerns come too late to be considered in the NCD, but their hope is that by raising the topic it will be considered in future iterations—also, that it won’t be another 7 years before CMS takes a second look.

This was an opportunity missed. Dean Kereiakes

This is particularly important given that TAVR is “the tip of the iceberg” for all of the other transcatheter valve therapies that will ultimately come under review by CMS, and by professional societies looking to establish volume requirements and other quality metrics, Shreenivas argued to TCTMD.

To this end, he and colleagues would like to see subsequent NCDs and professional guidance focus on the care of AS patients rather than on TAVR specifically. “Hopefully a joint document about the care of AS patients will come out of this,” Shreenivas said. “But even if not, at least we are talking about it and thinking about it, and hopefully this would affect the approach to therapies that are coming down the pike.”

For now, however, Kereiakes believes the 2019 NCD was a golden opportunity to insist that all patients presenting with symptomatic severe AS get a comprehensive evaluation and be informed about all of the treatment options, regardless of where in the United States they are seen. That didn’t happen.

“I think this was an opportunity missed,” Kereiakes told TCTMD. “The holistic approach is what we’ve been advocating since the adoption of the heart-team concept, but we need to walk the walk, not talk the talk. And walking the walk here means assuring that every patient with symptomatic severe aortic stenosis has the same opportunities for care, regardless of geographic distribution and socioeconomic factors.”