CMS Updates TAVR Coverage Policy: What Cardiac Billing Teams Need to Know (NCD 355)
CMS has modified its national coverage determination for Transcatheter Aortic Valve Replacement under NCD 355, with an effective date of March 12, 2026. This update refines the conditions under which Medicare covers TAVR—also referred to as TAVI or transcatheter aortic valve implantation—and maintains Coverage with Evidence Development (CED) status for the procedure. Billing teams and RCM directors at cardiac surgery and interventional cardiology programs need to review the updated hospital qualification thresholds and heart team requirements before claims start moving through under the new policy.
| Field | Detail |
|---|---|
| Payer | Centers for Medicare & Medicaid Services (CMS) |
| Policy | Transcatheter Aortic Valve Replacement (TAVR) |
| Policy Code | NCD 355 |
| Change Type | Modified |
| Effective Date | 2026-03-12 |
| Impact Level | High |
| Specialties Affected | Cardiac Surgery, Interventional Cardiology, Structural Heart, Inpatient Facility Billing |
| Key Action | Verify your hospital program and heart team meet the updated volume and qualification requirements before submitting TAVR claims under the revised NCD. |
What CMS Covers Under NCD 355: TAVR Coverage with Evidence Development
The Centers for Medicare & Medicaid Services covers TAVR under a Coverage with Evidence Development (CED) framework. CED coverage means Medicare pays for the procedure, but only when specific structural and clinical conditions are met—and typically when the procedure is tied to a CMS-approved registry or clinical study. For billing teams, this matters because a claim that doesn't satisfy every condition in the NCD can be denied on medical necessity grounds even when the clinical care was appropriate.
Coverage is extended to TAVR for the treatment of symptomatic aortic valve stenosis, consistent with an FDA-approved indication. The device used must have received FDA premarket approval (PMA) specifically for the system and indication being billed. Submitting a claim for a device configuration or patient population outside that FDA approval is a direct path to denial under this NCD.
CMS TAVR Medical Necessity Criteria: Heart Team Requirements
One of the most operationally significant requirements in NCD 355 is the heart team mandate. CMS requires that the patient be under the care of a formal, multidisciplinary heart team both preoperatively and postoperatively. This isn't a documentation checkbox—it's a substantive coverage condition.
The heart team must include:
| # | Covered Indication |
|---|---|
| 1 | A cardiac surgeon and an interventional cardiologist, both experienced in treating aortic stenosis, who have each independently examined the patient face-to-face |
| 2 | Both physicians must have individually evaluated the patient's suitability for SAVR (surgical aortic valve replacement), TAVR, or medical/palliative therapy |
| 3 | Each must document their clinical rationale and make it available to the rest of the heart team |
| 4 | Both the interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of the TAVR procedure |
The heart team also includes providers from other physician groups, advanced practice practitioners, nurses, research personnel, and administrators. But for billing purposes, the two-physician independent evaluation and intraoperative joint participation requirements are the ones most likely to create documentation gaps that trigger denials.
Hospital Infrastructure Requirements Under NCD 355
CMS sets explicit infrastructure conditions for facilities that perform TAVR. The hospital must have:
- An on-site heart valve surgery program and an interventional cardiology program
- A post-procedure intensive care facility staffed with personnel experienced in managing open-heart valve patients
Volume thresholds vary based on whether the hospital is establishing a new TAVR program or operating an existing one—and this is where the updated NCD requires careful attention.
Hospitals Without Prior TAVR Experience
To initiate a TAVR program, a hospital must meet all five of the following in the period prior to program initiation:
| Requirement | Threshold |
|---|---|
| Open heart surgeries (prior year) | ≥ 50 |
| Aortic valve-related procedures (prior 2 years) | ≥ 20 |
| Physicians with cardiac surgery privileges | ≥ 2 |
| Physicians with interventional cardiology privileges | ≥ 1 |
| Percutaneous coronary interventions (PCIs) per year | ≥ 300 |
Heart teams without TAVR experience must also meet individual physician thresholds. The cardiac surgeon must have ≥ 100 career open heart surgeries, of which at least 25 are aortic valve-related. The interventional cardiologist must have either ≥ 100 career structural heart disease procedures or ≥ 30 left-sided structural procedures per year, plus device-specific training required by the manufacturer.
Hospitals With Existing TAVR Experience
Established programs must maintain volume by meeting one of the following on an ongoing basis:
| Option | Threshold |
|---|---|
| AVRs (TAVR or SAVR) per year, including ≥ 20 TAVR | ≥ 50 |
| AVRs (TAVR or SAVR) every 2 years | ≥ 100 |
Programs that fall below these thresholds risk non-coverage on any TAVR claims submitted during a period of insufficient volume. Revenue cycle teams should build volume tracking into their quality and compliance workflows—not just leave it to clinical leadership.
| 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 |
Affected Codes
The updated NCD 355 policy document does not list specific CPT or HCPCS codes. Billing teams should reference their MAC's local guidance and the FDA-approved device documentation to confirm appropriate procedure code assignment for TAVR claims. No ICD-10-CM codes are enumerated in the policy data for this update.
Note: The absence of specific codes in the NCD does not mean any code is acceptable. TAVR procedures are billed under Inpatient Hospital Services and Physicians' Services benefit categories. Consult your MAC's billing guidance and the applicable IPPS/OPPS payment rules for current procedure code requirements.
What Your Billing Team Should Do
| # | Action Item |
|---|---|
| 1 | Audit your hospital's current volume data now—before March 12, 2026. Pull AVR counts (both TAVR and SAVR) for the prior year and prior two years. If you're at or near the volume thresholds, flag this immediately for clinical and administrative leadership. Claims submitted from a program that doesn't meet volume requirements are exposed to post-payment audit and recoupment. |
| 2 | Review your heart team documentation protocols. Confirm that your workflow produces discrete, dated, face-to-face evaluation notes from both the cardiac surgeon and the interventional cardiologist for every TAVR patient. Each note must document independent assessment of the patient's candidacy for SAVR, TAVR, or medical/palliative therapy. Generic shared notes won't satisfy this requirement. |
| 3 | Verify intraoperative participation documentation. The NCD requires joint intraoperative participation from both the cardiologist and the cardiac surgeon. Make sure your operative reports explicitly reflect this, and that your co-surgeon billing is consistent with that documentation. Missing or vague intraoperative notes are among the most common audit triggers for TAVR claims. |
| 4 | Confirm FDA PMA alignment for the device used. Before billing, verify that the specific valve and implantation system used carries FDA PMA for the exact indication documented in the patient's record. Device-indication mismatches create both coverage and compliance exposure. |
| 5 | Check your CED registry participation status. Because coverage is granted under Coverage with Evidence Development, confirm that your program is enrolled in and actively submitting data to a CMS-approved registry or study. CED requirements are a condition of payment, not just a clinical recommendation. |
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