CMS Pub. 100-03, ch. 1, § 20.34

A. General

Patients with atrial fibrillation (AF), an irregular heartbeat, are at an increased risk of

stroke. The left atrial appendage (LAA) is a tubular structure that opens into the left

atrium and has been shown to be one potential source for blood clots that can cause

strokes. While thinning the blood with anticoagulant medications has been proven to

prevent strokes, percutaneous LAA closure (LAAC) has been studied as a non-pharmacologic alternative for patients with AF.

B. Nationally Covered Indications

The Centers for Medicare & Medicaid Services (CMS) covers percutaneous LAAC for

non-valvular atrial fibrillation (NVAF) through Coverage with Evidence Development

(CED) with the following conditions:

a. LAAC devices are covered when the device has received Food and Drug

Administration (FDA) Premarket Approval (PMA) for that device’s FDA-approved indication and meet all of the conditions specified below:

The patient must have:

o A CHADS2 score ≥ 2 (Congestive heart failure, Hypertension, Age >75,

Diabetes, Stroke/transient ischemia attack/thromboembolism) or CHA2DS2-

VASc score ≥ 3 (Congestive heart failure, Hypertension, Age ≥ 65, Diabetes,

Stroke/transient ischemia attack/thromboembolism, Vascular disease, Sex

category)

o A formal shared decision making interaction with an independent non-interventional physician using an evidence-based decision tool on oral

anticoagulation in patients with NVAF prior to LAAC. Additionally, the shared

decision making interaction must be documented in the medical record.

o A suitability for short-term warfarin but deemed unable to take long-term oral

anticoagulation following the conclusion of shared decision making, as LAAC is

only covered as a second line therapy to oral anticoagulants. The patient

(preoperatively and postoperatively) is under the care of a cohesive,

multidisciplinary team (MDT) of medical professionals. The procedure must be

furnished in a hospital with an established structural heart disease (SHD) and/or

electrophysiology (EP) program.

The procedure must be performed by an interventional cardiologist(s),

electrophysiologist(s), or cardiovascular surgeon (s) that meet the following criteria:

• Has received training prescribed by the manufacturer on the safe and effective use

of the device prior to performing LAAC; and,

• Has performed ≥ 25 interventional cardiac procedures that involve transeptal

puncture through an intact septum; and,

• Continues to perform ≥ 25 interventional cardiac procedures that involve

transeptal puncture through an intact septum, of which at least 12 are LAAC, over

a 2-year period.

The patient is enrolled in, and the MDT and hospital must participate in, a prospective,

national, audited registry that: 1) consecutively enrolls LAAC patients, and, 2) tracks the

following annual outcomes for each patient for a period of at least 4 years from the time

of the LAAC:

• Operator-specific complications

• Device-specific complications including device thrombosis

• Stroke, adjudicated, by type

• Transient Ischemic Attack (TIA)

• Systemic embolism

• Death

• Major bleeding, by site and severity

The registry must be designed to permit identification and analysis of patient,

practitioner, and facility level factors that predict patient risk for these outcomes. The

registry must collect all data necessary to conduct analyses adjusted for relevant

confounders, and have a written executable analysis plan in place to address the

following questions:

• How do the outcomes listed above compare to outcomes in the pivotal clinical

trials in the short term (≤12 months) and in the long term (≥ 4 years)?

• What is the long term (≥ 4 year) durability of the device?

• What are the short term (≤12 months) and the long term (≥4 years) device-specific complications including device thromboses?

To appropriately address some of these questions, Medicare claims or other outside data

may be necessary.

Registries must be reviewed and approved by CMS. Potential registry sponsors must

submit all registry documentation to CMS for approval, including the written executable

analysis plan and auditing plan. CMS will review the qualifications of candidate

registries to ensure that the approved registry follows standard data collection practices,

and collects data necessary to evaluate the patient outcomes specified above. The

registry’s national clinical trial number must be recorded on the claim.

Consistent with section 1142 of the Social Security Act (the Act), the Agency for

Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS

determines address the above-listed research questions and the a-m criteria listed in

Section c. of this decision.

All approved registries will be posted on the CED website located at:

https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/index.html.

b. LAAC is covered for NVAF patients not included in Section a. of this decision

when performed within an FDA-approved randomized controlled trial (RCT) if

such trials meet the criteria established below:

As a fully-described written part of its protocol, the RCT must critically answer, in

comparison to optimal medical therapy, the following questions:

• As a primary endpoint, what is the true incidence of ischemic stroke and systemic

embolism?

• As a secondary endpoint, what is cardiovascular mortality and all-cause

mortality?

FDA-approved RCTs must be reviewed and approved by CMS. Consistent with section

1142 of the Act, AHRQ supports clinical research studies that CMS determines address

the above-listed research questions and the a-m criteria listed in Section c. of this

decision.

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 in

section c. of this decision, as well as the investigator’s contact information, to the address

below.

Director, Coverage and Analysis Group

Re: LAAC CED

Centers for Medicare & Medicaid Services

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

Baltimore, MD 21244-1850

c. All clinical studies, RCTs and registries submitted for review 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 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 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

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 in 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.

C. Nationally Non-Covered Indications

LAAC is non-covered for the treatment of NVAF when not furnished under CED

according to the above-noted criteria.

(This NCD last reviewed February 2016.)