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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 state that: 
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: 
1. 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. 
 
2. 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: 
a. Cardiac surgeon and an interventional cardiologist experienced in the care and treatment of 
aortic stenosis who have: 
i. independently examined the patient face-to-face, evaluated the patients suitability for 
surgical aortic valve replacement (SAVR), TAVR or medical or palliative therapy; 
ii. documented and made available to the other heart team members the rationale for their 
clinical judgment. 
b. Providers from other physician groups as well as advanced patient practitioners, nurses, research 
personnel and administrators. 
 
3. The heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the 
intra-operative technical aspects of TAVR. 
4. TAVR must be furnished in a hospital with the appropriate infrastructure that includes but is not limited 
to: 
a. On-site heart valve surgery and interventional cardiology programs, b. Post-procedure intensive care facility with personnel experienced in managing patients who 
have undergone open-heart valve procedures, 
c. 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: 
a.  50 open heart surgeries in the previous year prior to TAVR program initiation, and; 
b.  20 aortic valve related procedures in the 2 years prior to TAVR program initiation, and; 
c.  2 physicians with cardiac surgery privileges, and; 
d.  1 physician with interventional cardiology privileges, and; 
e.  300 percutaneous coronary interventions (PCIs) per year. 
Qualifications to begin a TAVR program for heart teams without TAVR experience: 
The heart team must include: 
a. Cardiovascular surgeon with: 
i.  100 career open heart surgeries of which  25 are aortic valve related; and, 
b. Interventional cardiologist with: 
i. Professional experience of  100 career structural heart disease procedures; or,  30 left-
sided structural procedures per year; and, 
ii. Device-specific training as required by the manufacturer. 
Qualifications for hospital programs with TAVR experience: 
The hospital program must maintain the following: 
a.  50 AVRs (TAVR or SAVR) per year including  20 TAVR procedures in the prior year ; or, 
b.  100 AVRs (TAVR or SAVR) every 2 years, including  40 TAVR procedures in the prior 2 
years; and, 
c.  2 physicians with cardiac surgery privileges; and, 
d.  1 physician with interventional cardiology privileges, and 
e.  300 percutaneous coronary interventions (PCIs) per year; and, 
5. 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: 
i. Stroke; 
ii. All-cause mortality; 
iii. Transient Ischemic Attacks (TIAs); 
iv. Major vascular events; v. Acute kidney injury; 
vi. Repeat aortic valve procedures; 
vii. New permanent pacemaker implantation; 
viii. Quality of Life (QoL). 
6. 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. 
i. When performed outside a controlled clinical study, how do outcomes and adverse events 
compare to the pivotal clinical studies? 
ii. What is the long-term durability of the device? 
iii. What are the long-term outcomes and adverse events? 
iv. 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: 
1. The heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the 
intra-operative technical aspects of TAVR. 
2.  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: 
o What is the incidence of stroke? 
o What is the rate of all-cause mortality? 
o What is the incidence of new permanent pacemaker implantation? 
o What is the incidence of transient ischemic attacks (TIAs)? 
o What is the incidence of major vascular events? 
o What is the incidence of acute kidney injury? 
o What is the incidence of repeat aortic valve procedures? 
 
You can find this rule at the Medicare National Coverage Determination (NCD) 20.32: Transcatheter Aortic 
Valve Replacement (TAVR). 
 
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.