Before the Overhaul: How Medicare Built the Rules for TAVR (2012–2019)

To understand why CMS’s 2026 proposal feels so consequential, it helps to see what it is unwinding. For more than a decade, Medicare’s coverage of transcatheter aortic valve replacement (TAVR) rested on a single idea — pay for the procedure, but only inside a structure designed to keep proving it works. That structure was built in 2012 and recalibrated once, in 2019.

2012: Coverage with a Catch

The 2012 rules also required two cardiac surgeons to independently examine each candidate, a heart team to share the procedure, and hospitals to clear specific volume thresholds (for inexperienced centers, at least 50 surgical aortic-valve replacements a year and at least 1,000 catheterizations including 400 PCIs). Volume stood in as a proxy for quality at a time when experience was scarce, and the benchmarks drew heavily on the PARTNER pivotal trial and a multisociety consensus statement. Some stakeholders viewed those standards as appropriate aspirational benchmarks but potentially restrictive as a minimum coverage threshold.

2019: The First Loosening

By the late 2010s, TAVR had changed dramatically — newer and safer devices, conscious sedation in place of general anesthesia, and expansion into intermediate-risk patients. The numbers tell the story: roughly 4,627 procedures at 198 sites in 2012 grew to more than 50,000 at 582 sites by 2017. After a MEDCAC advisory panel in July 2018, CMS proposed changes in March 2019 and finalized an updated NCD on June 21, 2019.

The two-surgeon evaluation was cut to one cardiac surgeon plus one interventional cardiologist. The bar for opening a new program dropped — the PCI floor fell from 400 to 300 procedures a year — while maintenance requirements for established centers actually tightened, to at least 50 aortic-valve replacements a year including 20 TAVRs. Crucially, CED and registry participation stayed in place for symptomatic patients, now paired with TAVR-specific quality measures, and CMS underscored the heart team.

How Clinical Roles Evolved

It is worth pausing on a quieter story inside this history: how the roles of cardiac surgeons and interventional cardiologists evolved as TAVR moved from a therapy for a narrow patient group to a mainstream treatment option.

When TAVR emerged in the 2000s, it was initially positioned as an option for patients who could not undergo surgery, while surgical aortic valve replacement remained the established standard for most others. As the evidence base expanded, the clinical community adapted to a therapy whose role was changing more quickly than many initially expected.

The shift also reflected differences in training and practice settings. TAVR depends heavily on catheter and guidewire technique in the cath lab, an area in which interventional cardiologists generally had more established experience. Many cardiac surgeons brought complementary expertise in anatomy, operative risk, and alternative treatment options, while adapting to the skills and workflows required for a transcatheter procedure.

As the evidence moved from inoperable to high-risk, then intermediate- and low-risk patients, interventional teams accumulated procedure volume and referral experience. Surgical participation evolved alongside that growth, with different programs adopting different models of collaboration based on local expertise, resources, and patient needs.

That is why the heart-team requirement became an important part of the coverage framework. The 2012 two-surgeon rule and joint-participation mandate formalized multidisciplinary review during a period of rapid change. For more than a decade, the policy helped ensure that patients were considered from both surgical and transcatheter perspectives. The 2026 proposal raises a new question: how should that collaborative model evolve as TAVR experience becomes more widely distributed?

The Throughline

Across both decisions, the architecture was consistent: cover the procedure, but keep the guardrails — registry surveillance, a heart team, and volume thresholds — in place while the evidence matured. The 2019 update rebalanced access and quality without abandoning either; it eased entry for new centers while holding established programs to a higher standard, and it never touched the core requirement to keep collecting data. That is precisely the throughline the 2026 proposal would break, by ending CED for symptomatic patients for the first time. Seen against this history, 2026 is not another recalibration — it is a change in kind.

That history also offers reason for optimism. The framework did what it was designed to do: it gave a breakthrough therapy room to grow while keeping patients, evidence, and multidisciplinary decision-making at the center. As CMS considers the next chapter, the opportunity is not simply to remove old requirements, but to carry forward the best of what they built including broader access, continued learning, and strong collaboration around the right treatment for each patient. If that balance holds, TAVR’s next era can be both more flexible and more patient-centered.

Sources

American College of Cardiology — policy analyses of the 2012 and 2019 NCDs, and ACC President Richard Kovacs’ statement on the 2019 update.

SCAI — statements on the 2019 reconsideration (CAG-00430R).

CMS — NCD §20.32 and tracking sheets: CAG-00430N (2012) and CAG-00430R (2019).

Circulation / AHA Journals — operator and institutional requirements for TAVR and the 2012/2019 volume rationale.

Cardiovascular Business and TCTMD — reporting on the 2019 NCD update and procedure-volume trends.

By Steven D. Harrington, MD, MBA, FACS, ABTS, FACC, FACCP