TL;DR: The Centers for Medicare & Medicaid Services modified NCD 355 governing TAVR coverage, effective January 9, 2026. Here's what billing teams need to do.
CMS TAVR coverage policy under NCD 355 in the CMS Medicare system remains Coverage with Evidence Development (CED), but this update clarifies the facility and heart team qualification thresholds that determine whether a TAVR procedure is billable at all. This policy does not list specific CPT or HCPCS codes — your TAVR billing will route through standard cardiac procedure codes, but coverage turns entirely on whether your facility and heart team meet the structural requirements below. If they don't, you're looking at a claim denial before clinical necessity even enters the picture.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | CMS |
| Policy | Transcatheter Aortic Valve Replacement (TAVR) — NCD 355 |
| Policy Code | NCD 355 |
| Change Type | Modified |
| Effective Date | January 9, 2026 |
| Impact Level | High |
| Specialties Affected | Interventional Cardiology, Cardiac Surgery, Inpatient Hospital Billing, Structural Heart Disease Programs |
| Key Action | Verify your facility and heart team meet NCD 355 volume and qualification thresholds before billing any TAVR claim after January 9, 2026 |
CMS TAVR Coverage Criteria and Medical Necessity Requirements 2026
The Centers for Medicare & Medicaid Services covers TAVR under Coverage with Evidence Development. That means coverage is conditional — not automatic — and the conditions run deep.
To meet medical necessity under NCD 355, the procedure must treat symptomatic aortic valve stenosis. It must also follow an FDA-approved indication and use a complete aortic valve and implantation system with FDA premarket approval (PMA) for that specific indication.
That's the baseline. The real complexity lives in the structural requirements below.
Heart Team Requirements
CMS requires that every TAVR patient be under the care of a heart team — both before and after the procedure. This isn't a checkbox. The policy defines it precisely.
The heart team must include a cardiac surgeon and an interventional cardiologist. Both must have experience treating aortic stenosis. Both must independently examine the patient face-to-face. Both must evaluate the patient's suitability for SAVR, TAVR, or medical and palliative therapy. Both must document their clinical rationale and share it with the full team.
That documentation requirement matters for your billing team. If the chart doesn't reflect independent face-to-face evaluations by both the surgeon and the cardiologist, you have a medical necessity gap that will surface on audit.
The heart team also requires both the interventional cardiologist and the cardiac surgeon to jointly participate in the intra-operative technical aspects of TAVR. Joint participation — not just co-signature. The operative note needs to reflect that.
Facility Requirements
The hospital must have on-site heart valve surgery and an interventional cardiology program. It must have a post-procedure intensive care facility with staff experienced in managing open-heart valve patients.
Then there are the volume thresholds. CMS splits these into two tracks.
CMS TAVR Facility and Heart Team Qualification Thresholds 2026
This is where NCD 355 gets granular — and where most billing problems start.
Track One: New TAVR Programs (No Prior TAVR Experience)
Hospital program requirements:
- ≥ 50 open heart surgeries in the year before TAVR program initiation
- ≥ 20 aortic valve-related procedures in the two years before initiation
- ≥ 2 physicians with cardiac surgery privileges
- ≥ 1 physician with interventional cardiology privileges
- ≥ 300 percutaneous coronary interventions (PCIs) per year
Heart team requirements for new programs:
The cardiovascular surgeon must have ≥ 100 career open heart surgeries, of which ≥ 25 are aortic valve-related.
The interventional cardiologist must have ≥ 100 career structural heart disease procedures, or ≥ 30 left-sided structural procedures per year. They must also have completed device-specific training as required by the manufacturer.
Track Two: Established TAVR Programs (With Prior TAVR Experience)
Established programs must maintain one of the following:
- ≥ 50 AVRs (TAVR or SAVR combined) per year, including ≥ 20 TAVR procedures in the prior year, or
- ≥ 100 AVRs (TAVR or SAVR combined) every two years
The real issue here is the "or" in that second option. A program that had a slow year can satisfy the threshold over a two-year window. But your billing team needs to know which threshold the program is currently using — and have documentation to back it up if a MAC requests it.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| Symptomatic aortic valve stenosis — FDA-approved indication, all structural requirements met | Covered (CED) | Policy does not specify CPT/HCPCS | Requires FDA PMA device, heart team, facility qualification, and CED registry participation |
| TAVR performed outside FDA-approved indication | Not Covered | — | No Medicare reimbursement regardless of clinical rationale |
| TAVR at facility not meeting volume/infrastructure thresholds | Not Covered | — | Claim denial likely; facility must document qualification track |
| TAVR without joint intra-operative participation of surgeon and cardiologist | Not Covered | — | Operative documentation must reflect joint participation |
| TAVR without independent face-to-face evaluation by both surgeon and cardiologist | Not Covered | — | Missing documentation = medical necessity failure |
CMS TAVR Exclusions and Non-Covered Indications
CMS does not cover TAVR performed outside of an FDA-approved indication. Full stop. The CED framework gives CMS a structured way to limit coverage to evidence-supported use — and anything outside the FDA label falls outside the coverage policy.
TAVR performed at a facility that doesn't meet the volume and infrastructure requirements is also non-covered. This isn't a soft guideline. If your hospital doesn't hit the thresholds on the applicable track, the procedure isn't covered for Medicare patients — period.
The same applies to cases where the heart team doesn't meet the individual qualification criteria. If the interventional cardiologist doesn't have ≥ 100 career structural heart disease procedures (or the equivalent volume), and the program is launching without prior TAVR experience, coverage doesn't apply.
One nuance worth flagging: the policy's CED condition means patients must be enrolled in a qualifying registry or clinical study. If your program participates in TAVR but isn't enrolled in an approved CED registry, that's a coverage problem — not just a documentation problem. Talk to your compliance officer if you're unsure whether your current registry participation satisfies the CED requirement under the January 9, 2026 effective date.
CMS TAVR Billing Guidelines and Action Items 2026
The TAVR billing guidelines under NCD 355 require more pre-claim legwork than most cardiac procedures. Here's what to do before you bill a single TAVR claim under the updated policy.
| # | Action Item |
|---|---|
| 1 | Confirm your facility's qualification track. Determine whether your hospital program is operating under the new-program track or the established-program track. Pull the volume numbers — AVRs, TAVRs, open heart surgeries, PCIs — and document them now, before January 9, 2026 questions come up on audit. |
| 2 | Audit your heart team credentialing files. The interventional cardiologist and cardiac surgeon must each meet specific career volume thresholds. Get those credentials documented in your medical staff files and accessible to your billing team. If there's a gap, surface it to your medical director and compliance officer before you submit claims. |
| 3 | Tighten your operative note standards. The operative note must reflect joint intra-operative participation by both the cardiologist and the surgeon. If your current templates don't capture this explicitly, update them now. A claim denial on this basis is completely avoidable with a template change. |
| 4 | Verify face-to-face evaluation documentation for both physicians. Every TAVR claim needs evidence that the cardiac surgeon and the interventional cardiologist independently examined the patient and documented their clinical rationale. Build a pre-bill checklist that flags this as a hard stop before claim submission. |
| 5 | Confirm CED registry enrollment. Coverage under NCD 355 is conditioned on CED participation. Confirm your program is enrolled in an approved registry. If there's any ambiguity about whether your registry satisfies the current CED requirement, get your compliance officer involved before you bill. |
| 6 | Check FDA PMA status for the device used. The implanted system must have FDA PMA for the specific indication being treated. If your team uses multiple TAVR systems, verify that each device's PMA aligns with the indication documented in the record. |
| 7 | Review your prior authorization process for TAVR. CMS doesn't require prior authorization for most inpatient procedures under traditional Medicare, but if your patients are in Medicare Advantage plans, prior auth requirements vary by plan. Don't assume traditional Medicare CED rules apply to your MA population without checking each plan's coverage policy separately. |
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
CPT, HCPCS, and ICD-10 Codes for TAVR Under NCD 355
This policy does not list specific CPT or HCPCS codes. CMS's NCD 355 sets the coverage conditions and medical necessity framework — it doesn't enumerate billable codes directly.
Your TAVR billing will use standard cardiac surgery and interventional cardiology procedure codes. The coverage determination under NCD 355 applies to those claims based on whether the facility, heart team, and clinical conditions meet the criteria above — not based on a specific code list within the NCD itself.
What this means for your charge capture: Work with your coding team to confirm which CPT codes your facility uses for TAVR procedures and map them against the NCD 355 criteria. Your Medicare Administrative Contractor (MAC) may have local coverage guidance or billing instructions that supplement NCD 355. Check with your MAC directly — some have issued companion billing guidance for TAVR that includes code-level specifics.
If you're unsure how this applies to your code mix, loop in your billing consultant or compliance officer before the effective date. A coverage policy this structured — with facility qualification, heart team credentials, CED enrollment, and FDA device requirements all as conditions of payment — leaves a lot of surface area for claim denial.
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