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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules say that 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. 
 
The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) 
under Coverage with Evidence Development (CED) with the following conditions: 
 
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 patients 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. 
 
You can find these rules in the National Coverage Determination (NCD) Transcatheter Aortic Valve 
Replacement (TAVR) 20.32. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.