When The Gates Open: A Strategy Memo for Low- and Moderate-Volume Structural Heart Programs

For more than a decade, the volume and open-heart-surgery requirements in Medicare’s TAVR coverage did smaller programs a quiet favor: they made the build-or-refer decision for you. The 2026 proposal changes that. By removing the institutional open-heart prerequisites, loosening volume thresholds, ending coverage with evidence development (CED), and expanding the eligible population, CMS is lowering the barrier to entry — and handing low- and moderate-volume centers a strategic decision they have been able to avoid. Here is what it means and how to get ahead of it.

What Actually Changes For You

Three shifts matter most. First, the entry barrier drops: the prior requirement to demonstrate established open-heart-surgery experience would be removed, replaced by an operator-level threshold of roughly 20 transcatheter valve procedures a year, at least 15 of them TAVI. Second, the administrative load lightens: ending CED removes mandatory registry enrollment and follow-up reporting. Third, the addressable market grows: covering asymptomatic severe aortic stenosis — roughly a third of cases — plus younger, lower-risk patients enlarges your local catchment and lengthens the patient relationship. On paper, this is an opening for a smaller center to start or scale a structural heart program.

The Opening — and The Trap

The trap is symmetry: the same rules that let you expand let everyone expand — including the high-volume center down the road that already owns the referral gravity and the surgical bench. And when CED ends, the registry that once certified everyone’s quality goes quiet, which makes outcomes transparency a competitive variable rather than a compliance checkbox. In a deregulated market, “we meet the minimum” stops being a story. The programs that win will be the ones that treat the lifted requirements as a prompt for deliberate strategy, not as permission to coast.

Five Moves to Re-strategize the CV service Line

1. Run the real build-vs-refer-vs-partner math. Lower barriers do not make a program profitable. Model the full cost — imaging, cath lab time, operator recruitment, valve-clinic staffing, device inventory — against realistic local volume and the lifetime value of longitudinal valve patients. For some centers the right answer is a hub-and-spoke affiliation, not an independent program.
2. Solve the operator equation. The new threshold is operator-based, not institutional. You need operators clearing at least 15 TAVI a year. Decide whether to recruit, retain, or share — co-employed or visiting operators and a formal affiliation with a high-volume hub can get a moderate center to threshold without overbuilding.
3. Make quality your moat — voluntarily. Once the mandate disappears, voluntary transparency becomes a differentiator with referrers, payers, and patients — and a hedge against the payer quality policies that will fill the vacuum CMS leaves.
4. Decide your heart-team posture on purpose. Surgical involvement is no longer the gate it was, but a surgical partner remains your safety net for complications and your pathway for the marginal and non-TAVR candidates you should be referring anyway. Choose deliberately — a genuine surgical partnership, a formal referral compact with a tertiary center, or a lean interventional-led model — and resource the choice. Drifting into “surgeon optional” by default is how a program gets caught flat in a complication.
5. Build the valve clinic, not the procedure. The economics are shifting from one-time procedures to longitudinal relationships: screening-echo pathways, asymptomatic surveillance, a structural heart clinic, and eventual valve-in-valve reintervention. Own the front door (referral and screening) and the back end (follow-up and reintervention), and the procedure volume follows.

The Bottom Line

The 2026 proposal is less a threat to low- and moderate-volume centers than a forcing function. The regulatory scaffolding that defined — and limited — your structural heart strategy is being pulled away, which is an opportunity for the centers that move deliberately and a quiet risk for those that mistake deregulation for a tailwind. The window to choose your position opens with the final decision. Decide before the market decides for you. If your organization is evaluating whether to build, partner, scale, or reposition its TAVR program, Corazon can help you strategize how to move forward with confidence. Contact Corazon to start the conversation, and download our accompanying white paper for a deeper look at the policy changes, market implications, and strategic considerations covered throughout this blog series and more.

Sources

• CMS, Proposed Decision Memo for TAVR (CAG-00430R2), June 15, 2026 — operator-volume definition, removal of open-heart-experience prerequisites, and end of CED.
• American College of Cardiology — Transcatheter Valve Certification and STS/ACC TVT Registry program resources.
• Cardiovascular Business — analysis of the proposed operator and volume changes and society reactions.
• TCTMD — operator-threshold detail and heart-team evaluation logistics under the proposal.

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