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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 an inpatient admission is generally appropriate when the admitting physician expects the 
patient to need hospital care that crosses at least two midnights. The expectation should be based on such 
complex medical factors as medical history, the severity of signs and symptoms, current medical needs, and 
medical risk. The factors must be documented in the medical record.  
 
If an unforeseen event, such as a patient's death or transfer, results in a shorter stay, the patient may be 
considered to be treated as an inpatient. An inpatient admission for a surgical procedure listed by Medicare as 
inpatient only is generally appropriate, regardless of the length of stay. An inpatient admission may be 
appropriate if the admitting physician expects a patient to require hospital care for only a limited period of 
time. The decision to admit as an inpatient must be based on the clinical judgment of the physician and must be 
supported by the medical record. You can find this rule at 42 CFR Section 412.3. 
 
The rules say 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: 
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? 
 
3. The clinical study must adhere to the following standards of scientific integrity and relevance to the 
Medicare population:  
o The principal purpose of the study is to test whether the item or service meaningfully improves 
health  outcomes of affected beneficiaries who are represented by the enrolled subjects. 
o The rationale for the study is well supported by available scientific and medical evidence. 
o The study results are not anticipated to unjustifiably duplicate existing knowledge. 
o The study design is methodologically appropriate and the anticipated number of enrolled 
subjects is s sufficient to answer the research question(s) being asked in the National 
Coverage Determination. 
o The study is sponsored by an organization or individual capable of completing it successfully. o The research study is in compliance with all applicable Federal regulations concerning the 
protection of  human subjects found in the Code of Federal Regulations (CFR) at 45 CFR Part 
46. If a study is  regulated by the FDA, it is also in compliance with 21 CFR Parts 50 and 
56. In addition, to further  enhance the protection of human subjects in studies conducted 
under CED, the study must provide and  obtain meaningful informed consent from patients 
regarding the risks associated with the study items  and /or services, and the use and eventual 
disposition of the collected data. 
o All aspects of the research study are conducted according to appropriate standards of scientific 
integrity. 
o The study has a written protocol that clearly demonstrates adherence to the standards listed here 
as  Medicare requirements. 
o The study is not designed to exclusively test toxicity or disease pathophysiology in healthy 
individuals.  Such studies may meet this requirement only if the disease or condition being 
studied is life threatening  as defined in 21 CFR 312.81(a) and the patient has no other 
viable treatment options. 
o The clinical research studies and registries are registered on the www.ClinicalTrials.gov website 
by the  principal sponsor/investigator prior to the enrollment of the first study subject. Registries 
are also  registered in the Agency for Healthcare Quality (AHRQ) Registry of Patient 
Registries (RoPR). 
o The research study protocol specifies the method and timing of public release of all prespecified 
 outcomes to be measured including release of outcomes if outcomes are negative or 
study is terminated  early. The results must be made public within 12 months of the studys 
primary completion date, which  is the date the final subject had final data collection for the 
primary endpoint, even if the trial does not  achieve its primary aim. The results must include 
number started/completed, summary results for  primary and secondary outcome measures, 
statistical analyses, and adverse events. Final results must be  reported in a publicly 
accessibly manner; either in a peer-reviewed scientific journal (in print or on- line), in an 
on-line publicly accessible registry dedicated to the dissemination of clinical trial  information 
such as ClinicalTrials.gov, or in journals willing to publish in abbreviated format (e.g., for 
 studies with negative or incomplete results). 
o The study protocol must explicitly discuss beneficiary subpopulations affected by the item or 
service  under investigation, particularly traditionally underrepresented groups in clinical 
studies, how the  inclusion and exclusion criteria effect enrollment of these populations, 
and a plan for the retention and  reporting of said populations on the trial. If the inclusion 
and exclusion criteria are expected to have a  negative effect on the recruitment or retention of 
underrepresented populations, the protocol must  discuss why these criteria are necessary. 
o The study protocol explicitly discusses how the results are or are not expected to be 
generalizable to  affected beneficiary subpopulations. Separate discussions in the protocol 
may be necessary for  populations eligible for Medicare due to age, disability or Medicaid 
eligibility. 
 Consistent with section 1142 of the Act, the Agency for Healthcare Research and Quality (AHRQ) 
 supports clinical research studies that meet the above-listed standards and address the above-listed 
 research questions. 
 
TAVR is not covered for patients in whom existing co-morbidities would preclude the expected benefit from 
correction of the aortic stenosis. 
 
You can find this information in the Centers for Medicare and Medicaid Services, Internet-Only Manual, 
Publication 100-03, National Coverage Determination (NCD) for 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.