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Decision: unknown

 
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: 
 
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 devices FDA-approved indication and meet all of the conditions 
specified below: 
The patient must have: 
 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) 
 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.  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 registrys 
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 investigators 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 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). 
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. 
You can find this rule at the Medicare National Coverage Determination (NCD) 20.34: Percutaneous Left 
Atrial Appendage Closure (LAAC). 
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.