CMS Pub. 100-03, ch. 1, § 20.32

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:

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 patient’s

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:

 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?

 What is the incidence of acute kidney injury?

 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:

a. 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.

b. The rationale for the study is well supported by available scientific and

medical evidence.

c. The study results are not anticipated to unjustifiably duplicate existing

knowledge.

d. The study design is methodologically appropriate and the anticipated

number of enrolled subjects is sufficient to answer the research question(s)

being asked in the National Coverage Determination.

e. The study is sponsored by an organization or individual capable of

completing it successfully.

f. 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 Food

and Drug Administration (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.

g. All aspects of the research study are conducted according to appropriate

standards of scientific integrity.

h. The study has a written protocol that clearly demonstrates adherence to the

standards listed here as Medicare requirements.

i. 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.

j. 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).

k. 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 study’s 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).

l. 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.

m. 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.

The principal investigator must submit the complete study protocol, identify the relevant

CMS research question(s) that will be addressed, and cite the location of the detailed

analysis plan for those questions in the protocol, plus provide a statement addressing how

the study satisfies each of the standards of scientific integrity (a. through m. listed above),

as well as the investigator's contact information, to the address below. The information

will be reviewed, and approved studies will be identified on the CMS Website.

Director, Coverage and Analysis Group

Re: TAVR CED

Centers for Medicare & Medicaid Services (CMS)

7500 Security Blvd., Mail Stop S3-02-01

Baltimore, MD 21244-1850

Email address for protocol submissions: clinicalstudynotification@cms.hhs.gov

Email subject line: “CED [NCD topic (i.e. TAVR)] [name of sponsor/primary

investigator]”

C. Nationally Non-Covered Indications

TAVR is not covered for patients in whom existing co-morbidities would preclude the

expected benefit from correction of the aortic stenosis.

D. Other

NA

(This NCD last reviewed June 2019)