NCD 20.32: Transcatheter Aortic Valve Replacement (TAVR)

A. General

Transcatheter aortic valve replacement (TAVR - also known as TAVI or transcatheter aortic valve implantation) is used in the treatment of aortic stenosis. A bioprosthetic valve is inserted percutaneously using a catheter and implanted in the orifice of the aortic valve.

B. Nationally Covered Indications

The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) under Coverage with Evidence Development (CED) with the following conditions:

A. TAVR is covered for the treatment of symptomatic aortic valve stenosis when furnished according to a Food and Drug Administration (FDA)-approved indication and when all of the following conditions are met:

• The procedure is furnished with a complete aortic valve and implantation system that has received FDA premarket approval (PMA) for that system's FDA approved indication.

• The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multi-disciplinary, team of medical professionals. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care. The heart team includes the following:

• Cardiac surgeon and an interventional cardiologist experienced in the care and treatment of aortic stenosis who have:

• independently examined the patient face-to-face, evaluated the patient’s suitability for surgical aortic valve replacement (SAVR), TAVR or medical or palliative therapy;

• documented and made available to the other heart team members the rationale for their clinical judgment.

• Providers from other physician groups as well as advanced patient practitioners, nurses, research personnel and administrators.

• The heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR.

• TAVR must be furnished in a hospital with the appropriate infrastructure that includes but is not limited to:

• On-site heart valve surgery and interventional cardiology programs,

• Post-procedure intensive care facility with personnel experienced in managing patients who have undergone open-heart valve procedures,

• Appropriate volume requirements per the applicable qualifications below:

There are two sets of qualifications; the first set outlined below is for hospital programs and heart teams without previous TAVR experience and the second set is for those with TAVR experience.

Qualifications to begin a TAVR program for hospitals without TAVR experience:

The hospital program must have the following:

• ≥ 50 open heart surgeries in the previous year prior to TAVR program initiation, and;

• ≥ 20 aortic valve related procedures in the 2 years prior to TAVR program initiation, and;

• ≥ 2 physicians with cardiac surgery privileges, and;

• ≥ 1 physician with interventional cardiology privileges, and;

• ≥ 300 percutaneous coronary interventions (PCIs) per year.

Qualifications to begin a TAVR program for heart teams without TAVR experience:

The heart team must include:

• Cardiovascular surgeon with:

• ≥ 100 career open heart surgeries of which ≥ 25 are aortic valve related; and,

• Interventional cardiologist with:

• Professional experience of ≥ 100 career structural heart disease procedures; or, ≥ 30 left-sided structural procedures per year; and,

• Device-specific training as required by the manufacturer.

Qualifications for hospital programs with TAVR experience:

The hospital program must maintain the following:

• ≥ 50 AVRs (TAVR or SAVR) per year including ≥ 20 TAVR procedures in the prior year ; or,

• ≥ 100 AVRs (TAVR or SAVR) every 2 years, including ≥ 40 TAVR procedures in the prior 2 years; and,

• ≥ 2 physicians with cardiac surgery privileges; and,

• ≥ 1 physician with interventional cardiology privileges, and

• ≥ 300 percutaneous coronary interventions (PCIs) per year; and,

• The heart team and hospital are participating in a prospective, national, audited registry that: 1) consecutively enrolls TAVR patients; 2) accepts all manufactured devices; 3) follows the patient for at least one year; and, 4) complies with relevant regulations relating to protecting human research subjects, including 45 CFR Part 46 and 21 CFR Parts 50 & 56.

The following outcomes must be tracked by the registry; and the registry must be designed to permit identification and analysis of patient, practitioner and facility level variables that predict each of these outcomes:

• Stroke;

• All-cause mortality;

• Transient Ischemic Attacks (TIAs);

• Major vascular events;

• Acute kidney injury;

• Repeat aortic valve procedures;

• New permanent pacemaker implantation;

• Quality of Life (QoL).

• The registry shall collect all data necessary and have a written executable analysis plan in place to address the following questions (to appropriately address some questions, Medicare claims or other outside data may be necessary). Specifically, for the CED question iv, this must be addressed through a composite metric. For the below CED questions (i-iv), the results must be reported publicly as described in CED criterion k.

• When performed outside a controlled clinical study, how do outcomes and adverse events compare to the pivotal clinical studies?

• What is the long term durability of the device?

• What are the long term outcomes and adverse events?

• What morbidity and procedure-related factors contribute to TAVR patients outcomes?

Consistent with section 1142 of the Act, the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS determines meet the above-listed standards and address the above-listed research questions.

B. TAVR is covered for uses that are not expressly listed as an FDA-approved indication when performed within a clinical study that fulfills all of the following:

• The heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR.

• As a fully-described, written part of its protocol, the clinical research study must critically evaluate not only each patient's quality of life pre- and post-TAVR (minimum of 1 year), but must also address at least one of the following questions:

• What is the incidence of stroke?

• What is the rate of all-cause mortality?

• What is the incidence of new permanent pacemaker implantation?

• What is the incidence of transient ischemic attacks (TIAs)?

• What is the incidence of major vascular events?

10/2022 - Transmittal 11546, dated August 4, 2022, is being rescinded and replaced by Transmittal 11636,

dated, October 5, 2022, to remove ICD-10 dx codes added in error to NCD 150.3, business requirement 12842.4, and restore ICD-10 dx C91.92 removed in error to NCD 110.23, business requirement 12842.3. All other information remains the same. ( TN 11636 ) (CR12842)

08/2022 - The purpose of this Change Request (CR) is to provide a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. ( TN 11546 ) (CR12842)

06/2020 - Transmittals 217 dated March 13, 2020, are being rescinded and replaced by Transmittals 10179 dated, June 10, 2020 to update numbering in the NCD manual to align with the final decision memorandum. All other information remains the same. ( TN 10179 ) (CR11660)

03/2020 - The purpose of this change request (CR) is to inform MACs that effective June 21, 2019, CMS will continue to cover TAVR under Coverage with Evidence Development (CED) when the procedure is furnished for the treatment of symptomatic aortic stenosis and according to an FDA approved indication for use with an approved device, in addition to the coverage criteria outlined in the NCD Manual. Effective date: 06/21/2019 Implementation date: 06/12/2020 TN 217 (CR11660)

9/2012 - Transmittal 145, dated August 3, 2012, is being rescinded and replaced by Transmittal 147, dated September 24, 2012, to include revisions to language in the “Summary of Changes” and clarification to the “Policy Section” of the business requirements for the Pub 100-03 and Pub 100-04 documents. All other information remains the same.