MEDICAL POLICY – 2.02.32

Leadless Cardiac Pacemakers

BCBSA Ref. Policy: 2.02.32

Effective Date: Jan. 3, 2020

Last Revised: Sept. 10, 2019

Replaces: N/A

RELATED MEDICAL POLICIES:

None

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POLICY CRITERIA | DOCUMENTATION REQUIREMENTS | CODING

RELATED INFORMATION | EVIDENCE REVIEW | REFERENCES | HISTORY

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Introduction

A pacemaker is a small device that corrects an abnormal heart rhythm (arrhythmia). It is placed

in the chest, just under the skin near the collarbone. A conventional pacemaker has a battery

(pulse generator) with wires (leads) that connect from the shoulder vein to the heart. When the

heart is beating too slow, too fast, or at an irregular rate, the pacemaker sends electrical pulses

to keep the heart beating properly. The most common problems with this kind of pacemaker

come from the leads and from the surgical site. Another pacemaker option is a leadless

pacemaker. It is a self-contained device that does not have wires and is smaller than a

conventional pacemaker. It is inserted through a long, thin tube (catheter) from the leg vein into

the heart. This policy describes when a leadless cardiac pacemaker may be considered medically

necessary.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The

rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for

providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can

be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a

service may be covered.

Policy Coverage Criteria

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Device Medical Necessity Micra™ transcatheter

pacing system

The Micra™ transcatheter pacing system may be considered

medically necessary when BOTH of the following conditions

are met:

• The patient has ONE of the following conditions:

o Symptomatic paroxysmal arteriovenous block

o Permanent high-grade arteriovenous block

o Symptomatic bradycardia-tachycardia syndrome

o Sinus node dysfunction (sinus bradycardia or sinus pauses).

AND

• The patient has a significant contraindication precluding

placement of conventional single-chamber ventricular

pacemaker leads such as ANY of the following:

o History of an endovascular or cardiovascular implantable

electronic device (CIED) infection or who are at high risk for

infection

o Limited access for transvenous pacing given venous

anomaly, occlusion of axillary veins or planned use of such

veins for a semi-permanent catheter or current or planned

use of an AV fistula for hemodialysis

o Presence of a bioprosthetic tricuspid valve

The Micra™ transcatheter pacing system is considered

investigational in all other situations in which the above

criteria are not met.

Contraindications As per the FDA label, the Micra™ Model MC1VR01 pacemaker is contraindicated for patients

who have the following types of devices implanted:

• An implanted device that would interfere with the implant of the Micra device in the judgment

of the implanting physician

• An implanted inferior vena cava filter

• A mechanical tricuspid valve

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Contraindications • An implanted cardiac device providing active cardiac therapy which may interfere with the

sensing performance of the Micra™ device

As per the FDA label, the Micra™ Model MC1VR01 pacemaker is also contraindicated for

patients who have the following conditions:

• Femoral venous anatomy unable to accommodate a 7.8 mm (23 French) introducer sheath or

implant on the right side of the heart (for example, due to obstructions or severe tortuosity)

• Morbid obesity that prevents the implanted device to obtain telemetry communication within

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Coding

Code Description

CPT 33274 Transcatheter insertion or replacement of permanent leadless pacemaker, right

ventricular, including imaging guidance (eg, fluoroscopy, venous ultrasound,

ventriculography, femoral venography) and device evaluation (eg, interrogation or

programming), when performed

Note: CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS

codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).

Related Information

N/A

Evidence Review

Description

Pacemakers are intended to be used as a substitute for the heart’s intrinsic pacing system to

correct cardiac rhythm disorders. Conventional pacemakers consist of two components: a pulse

generator and electrodes (or leads). Pacemakers are considered life-sustaining, life-supporting

class III devices for patients with a variety of bradyarrhythmias. Even though the efficacy and

safety profile of conventional pacemakers are excellent, in a small proportion of patients, they

may result in lead complications and the requirement for a surgical pocket. Further, some

patients are medically ineligible for conventional pacemakers due to lack of venous access and

recurrent infection. Leadless pacemakers are single-unit devices that are implanted in the heart

via femoral access, thereby eliminating the potential for complications as a result of leads and

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surgical pocket. The Micra™ transcatheter pacing system is the only commercially available

leadless pacemaker in the U. S. approved by the Food and Drug Administration.

Background

Conventional Pacemakers

Pacemakers are intended to be used as a substitute for the heart’s intrinsic pacing system to

correct cardiac rhythm disorders. By providing an appropriate heart rate and heart rate

response, cardiac pacemakers can reestablish effective circulation and more normal

hemodynamics that are compromised by a slow heart rate. Pacemakers vary in system

complexity and can have multiple functions as a result of the ability to sense and/or stimulate

both the atria and the ventricles.

Transvenous pacemakers or pacemakers with leads (hereinafter referred to as conventional

pacemakers) consist of two components: a pulse generator (ie, battery component) and

electrodes (ie, leads). The pulse generator consists of a power supply and electronics that can

provide periodic electrical pulses to stimulate the heart. The generator is commonly implanted

in the infraclavicular region of the anterior chest wall and placed in a pre-pectoral position; in

some cases, a subpectoral position is advantageous. The unit generates an electrical impulse,

which is transmitted to the myocardium via the electrodes affixed to the myocardium to sense

and pace the heart as needed.

Conventional pacemakers are also referred to as single-chamber or dual-chamber systems. In

single-chamber systems, only one lead is placed, typically in the right ventricle. In dual-chamber

pacemakers, two leads are placed-one in the right atrium and the other in the right ventricle.

Single-chamber ventricular pacemakers are more common.

Annually, approximately 200,000 pacemakers are implanted in the U. S. and 1 million

worldwide.1 Implantable pacemakers are considered life-sustaining, life-supporting class III

devices for patients with a variety of bradyarrhythmias. Pacemaker systems have matured over

the years with well-established, acceptable performance standards. As per the Food and Drug

Administration (FDA), the early performance of conventional pacemaker systems from

implantation through 60 to 90 days have usually demonstrated acceptable pacing capture

thresholds and sensing. Intermediate performance (90 days through more than 5 years) has

usually demonstrated the reliability of the pulse generator and lead technology. Chronic

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performance (5-10 years) includes a predictable decline in battery life and mechanical reliability

but a vast majority of patients receive excellent pacing and sensing free of operative or

mechanical reliability failures.

Even though the safety profile of conventional pacemakers is excellent, they are associated with

complications particularly related to leads. Most safety data on the use of conventional

pacemakers come from registries from Europe, particularly from Denmark where all pacemaker

implants are recorded in a national registry. These data are summarized in Table 1. It is

important to recognize that valid comparison of complication rates is limited by differences in

definitions of complications, which results in a wide variance of outcomes, as well as by the large

variance in follow-up times, use of single-chamber or dual-chamber systems, and data reported

over more than two decades.2 As such, the following data are contemporary and limited to

single-chamber systems when reported separately.

In many cases when a conventional pectoral approach is not possible, alternative approaches

such as epicardial pacemaker implantation and trans-iliac approaches have been used.3 Cohen

et al (2001) reported outcomes from a retrospective analysis of 123 patients who underwent 207

epicardial lead implantations.4 Congenital heart disease was present in 103 (84%) of the patients.

Epicardial leads were followed for 29 months (range 1 to 207 months). Lead failure was defined

as the need for replacement or abandonment due to pacing or sensing problems, lead fracture,

or phrenic/muscle stimulation. The 1-, 2-, and 5-year lead survival was 96%, 90%, and 74%,

respectively. Epicardial lead survival in those placed by a subxiphoid approach was 100% at 1

year and at 10 years, by the sternotomy approach (93.9% at 1 year and 75.9% at 10 years) and

lateral thoracotomy approach (94.1% at 1 year and 62.4% at 10 years).

Doll et al (2008) reported results of a randomized controlled trial comparing epicardial

implantation vs conventional pacemaker implantation.in 80 patients with indications for cardiac

resynchronization therapy5 The authors reported that the conventional pacemaker group had a

significantly shorter intensive care unit stay, less blood loss, and shorter ventilation times while

the epicardial group had less exposure to radiation and less use of contrast medium. The left

ventricular pacing threshold was similar in the two groups at discharge but longer in the

epicardial group during follow-up. Adverse events were also similar in the two groups. The

following events were experienced by one (3%) patient each in the epicardial group: pleural

puncture, pneumothorax, wound infection, Acute Respiratory Distress Syndrome, and hospital

mortality.

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As a less invasive alternative to the epicardial approach, the trans-iliac approach has also been

utilized. Data using trans-iliac approach is limited. Multiple other studies with smaller sample

size report a wide range of lead longevity.

Harakeet al (2018) reported a retrospective analysis of 5 patients who underwent a transvenous

iliac approach (median age 26.9 years).6 Pacing indications included AV block in three patients

and sinus node dysfunction in two. After a median follow-up of 4.1 years (range 1.0-16.7 years),

outcomes were reported for 4 patients. One patient underwent device revision for lead position-

related groin discomfort; a second patient developed atrial lead failure following a Maze

operation and underwent lead replacement by the iliac approach. One patient underwent heart

transplantation six months after implant with only partial resolution of pacing-induced

cardiomyopathy. Tsutsumi et al (2010) reported a case series of 4 patients from Japan in whom

conventional pectoral approach was precluded due to recurrent lead infections (n=1), superior

vena cava obstruction following cardiac surgery (n=2) and a postoperative dermal scar (n=1).

The mean follow-up was 24 months and the authors concluded the iliac vein approach was

satisfactory and less invasive alternative to epicardial lead implantation. However, the authors

reported that the incidence of atrial lead dislodgement using this approach in the literature

ranged from 7 to 21%. Experts who provided clinical input reported that trans-iliac or surgical

epicardial approach requires special expertise and long-term performance is suboptimal.7

Table 1. Reported Complication Rates with Conventional Pacemakers

Complications Rates,

%8,9,10,a

Traumatic complications

RV perforation 0.2-0.8

RV perforation with tamponade 0.07-0.4

Pneumo(hemo)thorax 0.7-2.2

Pocket complications

Including all hematomas, difficult to control bleeding, infection, discomfort, skin erosion 4.75

Including only those requiring invasive correction or reoperation 0.66-1.0

Lead-related complications

https://www.evidencepositioningsystem.com/BCBSA/html/_w_05f48e9da60521ea138ae62f3d1e95193feef56b1177147d/#reference-3https://www.evidencepositioningsystem.com/BCBSA/html/_w_05f48e9da60521ea138ae62f3d1e95193feef56b1177147d/#reference-4https://www.evidencepositioningsystem.com/BCBSA/html/_w_05f48e9da60521ea138ae62f3d1e95193feef56b1177147d/#reference-5

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Complications Rates,

%8,9,10,a

Including lead fracture, dislodgement, insulation problem, infection, stimulation threshold

problem, diaphragm or pocket stimulation, other

1.6-3.8

All system-related infections requiring reoperation or extraction 0.5-0.7

Adapted from Food and Drug Administration executive summary memorandum (2016).11

a Rates are for new implants only and ventricular single-chamber devices when data were available. Some rates listed

in this column are for single- and dual-chamber devices when data were not separated in the publication. Note that

Micra transcatheter pacing system is a single-chamber device.

The potential advantages of leadless pacemakers fall into three categories: avoidance of risks

associated with intravascular leads in conventional pacemakers, avoidance of risks associated

with pocket creation for placement of conventional pacemakers, and an additional option for

patients who require a single-chamber pacer.12

Lead complications include lead failure, lead fracture, insulation defect, pneumothorax,

infections requiring lead extractions and replacements that can result in a torn subclavian vein

or the tricuspid valve. In addition, there are risks of venous thrombosis and occlusion of the

subclavian system from the leads. Use of a leadless system eliminates such risks with the added

advantage that a patient has vascular access preserved for other medical conditions (eg, dialysis,

chemotherapy).

Pocket complications include infections, erosions, and pain that can be eliminated with leadless

pacemakers. Further, a leadless cardiac pacemaker may be more comfortable and appealing

because unlike conventional pacemakers, patients are unable to see or feel the device or have

an implant scar on the chest wall.

Leadless pacemakers may also be a better option than surgical endocardial pacemakers for

patients with no vascular access due to renal failure or congenital heart disease.

Leadless pacemakers are self-contained in a hermetically sealed capsule. The capsule houses a

battery and electronics to operate the system. Similar to most pacing leads, the tip of the

capsule includes a fixation mechanism and a monolithic controlled-release device. The

controlled-release device elutes glucocorticosteroid to reduce acute inflammation at the

implantation site. Leadless pacemakers have rate-responsive functionality, and current device

https://www.evidencepositioningsystem.com/BCBSA/html/_w_05f48e9da60521ea138ae62f3d1e95193feef56b1177147d/#reference-3https://www.evidencepositioningsystem.com/BCBSA/html/_w_05f48e9da60521ea138ae62f3d1e95193feef56b1177147d/#reference-4https://www.evidencepositioningsystem.com/BCBSA/html/_w_05f48e9da60521ea138ae62f3d1e95193feef56b1177147d/#reference-5

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longevity estimates are based on bench data. Estimates have suggested that these devices may

last over ten years, depending on the programmed parameters.11

Three systems are currently being evaluated in clinical trials: (1) the Micra Transcatheter Pacing

System (Medtronic), (2) the Nanostim leadless pacemaker (St. Jude Medical); and (3) the WiCS

Wireless Cardiac Stimulation System (EBR Systems). The first two devices are free-standing

capsule-sized devices that are delivered via femoral venous access using a steerable delivery

sheath. However, the fixing mechanism differs between the two devices. In the Micra

Transcatheter Pacing System, the fixation system consists of four self-expanding nitinol tines,

which anchor into the myocardium; for the Nanostim device, there is a screw-in helix that

penetrates about 1 mm into the myocardium, with nylon tines that provide secondary fixation.

In both devices, the cathode is steroid eluting and delivers pacing current; the anode is located

in a titanium case. The third device, WiCS system differs from the other devices; this system

requires implanting a pulse generator subcutaneously near the heart, which then wirelessly

transmits ultrasound energy to a receiver electrode implanted in the left ventricle. The receiver

electrode converts the ultrasound energy and delivers electrical stimulation to the heart

sufficient to pace the left ventricle synchronously with the right.11

Of these three, only the Micra transcatheter pacing system is approved by the FDA and

commercially available in the U. S. Multiple clinical studies of Nanostim have been

published1,13,14,15,16,17,18 but trials have been halted due to the migration of the docking button in

the device. Evidence on Nanostim is not reviewed further because the device is not yet FDA

approved.

The Micra™ is about 26 mm in length and introduced using a 23 French catheter via the femoral

vein to the right ventricle. It weighs about 2 grams and has an accelerometer-based rate

response.

Nanostim is about 40 mm in length and introduced using an 18 French catheter to the right

ventricle. It also weighs about 2 grams and uses a temperature-based rate response sensor.19

Summary of Evidence

For individuals with a guidelines-based indication for a ventricular pacing system who are

medically eligible for a conventional pacing system who receive a Micra™ transcatheter pacing

system, the evidence includes a pivotal prospective cohort study and a postapproval prospective

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cohort study. The relevant outcomes are overall survival, disease-specific survival, and

treatment-related mortality and morbidity. Results at 6 months and 1 year for the pivotal study

reported high procedural success (>99%) and device effectiveness (pacing capture threshold

met in 98% patients). Most of the system- or procedural-related complications occurred within

30 days. At one year, the incidence of major complication did not increase substantially from six

months (3.5% at six months vs 4% at one year). Results of the postapproval study were

consistent with a pivotal study and showed a lower incidence of major complications up to 30

days postimplantation as well as 1 year (1.5% and 2.7%, respectively). In both studies, the point

estimates of major complications were lower than the pooled estimates from six studies of

conventional pacemakers used as a historical comparator. While Micra device eliminates lead-

and surgical pocket-related complications, its use can result in potentially more serious

complications related to implantation and release of the device (traumatic cardiac injury) and

less serious complications related to the femoral access site (groin hematomas, access site

bleeding). Considerable uncertainties and unknowns remain in terms of the durability of device

and device end-of-life issues. Early and limited experience has suggested that retrieval of these

devices is unlikely because in due course, the devices will be encapsulated. There are limited

data on device-device interactions (both electrical and mechanical), which may occur when there

is a deactivated Micra device alongside another leadless pacemaker or when a leadless

pacemaker and transvenous device are both present. While the current evidence is encouraging,

overall benefit with the broad use of Micra transcatheter pacing system compared with

conventional pacemakers has not been shown. Clinical input suggests that some individuals who

are eligible for conventional pacing but are concerned about the long-term risk of lead-related

issues may prefer initial use of a leadless pacemaker after considering the balance of benefits

and harms using shared decision making. The evidence is insufficient to determine the effects of

technology on health outcomes.

For individuals with a guidelines-based indication for a ventricular pacing system who are

medically ineligible for a conventional pacing system who receive a Micra™ transcatheter pacing

system, the evidence includes subgroup analysis of a pivotal prospective cohort study and a

postapproval prospective cohort study. The relevant outcomes are overall survival, disease-

specific survival, and treatment-related mortality and morbidity. Information on the outcomes in

the subgroup of patients from the postapproval study showed that the Micra™ device was

successfully implanted in 98% of cases and safety outcomes were similar to the original cohort.

Even though the evidence is limited, and long-term effectiveness and safety are unknown, the

short-term benefits outweigh the risks because the complex trade-off of adverse events for

these devices needs to be assessed in the context of the life-saving potential of pacing systems

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for patients, ineligible for conventional pacing systems. Clinical input supplements and informs

the interpretation of the published evidence. Clinical input supports the use of leadless

pacemakers in individuals who are ineligible for conventional pacing. The evidence is sufficient

to determine that the technology results in a meaningful improvement in the net health

outcome.

Ongoing and Unpublished Clinical Trials

Some currently ongoing and unpublished trials that might influence this review are listed in

Table 2.

Table 2. Summary of Key Trials

NCT No. Trial Name Planned

Enrollment

Completion

Date

Ongoing

NCT03039712 Longitudinal Coverage With Evidence Development

Study on Micra Leadless Pacemakers (Micra CED)

37,000 Jun 2021

NCT02610673a WiCS-LV Post Market Surveillance Registry 100 Nov 2021

NCT02051972a Nanostim Study for a Leadless Cardiac Pacemaker

System

1000 Mar 2024

NCT02536118a Micra Transcatheter Pacing System Post-Approval

Registry

3100 Aug 2026

NCT: national clinical trial.

a Denotes industry-sponsored or cosponsored trial.

https://www.clinicaltrials.gov/ct2/show/NCT03039712?term=NCT03039712&rank=1https://www.clinicaltrials.gov/ct2/show/NCT02610673?term=NCT02610673&rank=1https://www.clinicaltrials.gov/ct2/show/NCT02051972?term=NCT02051972&rank=1https://www.clinicaltrials.gov/ct2/show/NCT02536118?term=NCT02536118&rank=1

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Clinical Input Received from Physician Specialty Societies and Academic

Medical Centers

2019

In response to requests, while this policy was under review in 2018/2019, clinical input on the

use of leadless cardiac pacemakers was received from two respondents, including one specialty

society-level response and one physician-level response identified through specialty societies

including physicians with academic medical center affiliations.

Practice Guidelines and Position Statements

American College of Cardiology Foundation et al

The American College of Cardiology Foundation, American Heart Association, and Heart Rhythm

Society’s (2012) focused update on device-based therapy of cardiac rhythm abnormalities

incorporated into their joint 2008 guidelines for device-based therapy of cardiac rhythm

abnormalities does not include recommendations on leadless cardiac pacemakers.34

The Heart Rhythm Society and American College of Cardiology Foundation (2012) expert

consensus statement on pacemaker device and mode selection did not include

recommendations on leadless cardiac pacemakers.35

Medicare National Coverage

The Centers for Medicare & Medicaid (CMS) cover leadless pacemakers under coverage with

evidence development criteria when procedures are performed in “prospective longitudinal

studies” approved by the Food and Drug Administration (FDA) using “leadless pacemakers … in

accordance with the FDA approved label for devices that have either:

• An associated ongoing FDA approved postapproval study; or

• Completed an FDA post-approval study.

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• Each study must be approved by CMS and as a fully-described, written part of its protocol,

must address the following research questions:

• What are the peri-procedural and post-procedural complications of leadless pacemakers?

• What are the long term outcomes of leadless pacemakers?

• What are the effects of patient characteristics (age, gender, comorbidities) on the use and

health effects of leadless pacemakers?”36

The following two studies are currently approved by CMS:

• The Micra™ CED Study (NCT03039712); CMS approval date: 03/09/17

• Micra™ Transcatheter Pacing System Post-Approval Registry (NCT02536118); CMS approval

date: 02/09/17 (see Table 2 for details).

Regulatory Status

In April 2016, the Micra™ transcatheter pacing system (Medtronic) was approved by the FDA

through the premarket approval process for use in patients who have experienced one or more

of the following conditions:

• symptomatic paroxysmal or permanent high-grade arteriovenous block in the presence of

atrial fibrillation

• paroxysmal or permanent high-grade arteriovenous block in the absence of atrial fibrillation,

as an alternative to dual-chamber pacing, when atrial lead placement is considered difficult,

high-risk, or not deemed necessary for effective therapy

• symptomatic bradycardia-tachycardia syndrome or sinus node dysfunction (sinus

bradycardia or sinus pauses), as an alternative to atrial or dual-chamber pacing, when atrial

lead placement is considered difficult, high-risk, or not deemed necessary for effective

therapy

References

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2016;

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dvisoryCommittee/CirculatorySystemDevicesPanel/UCM485093.pdf Accessed September 2019.

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18. Sperzel, JJ, Defaye, PP, Delnoy, PP, Garcia Guerrero, JJ, Knops, RR, Tondo, CC, Deharo, JJ, Wong, TT, Neuzil, PP. Primary safety

results from the LEADLESS Observational Study. Europace, 2018 Jan 25;20(9). PMID 29365073.

19. Zuckerman B, Shein M, Paulsen J, et al. Circulatory System Devices Panel Meeting: Leadless Pacemakers. FDA Presentation.

2016;

https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesA

dvisoryCommittee/CirculatorySystemDevicesPanel/UCM486733.pdf Accessed September 2019.

20. Ritter P, Duray GZ, Zhang S, et al. The rationale and design of the Micra Transcatheter Pacing Study: safety and efficacy of a

novel miniaturized pacemaker. Europace. May 2015;17(5):807-813. PMID 25855677.

21. Ritter P, Duray GZ, Steinwender C, et al. Early performance of a miniaturized leadless cardiac pacemaker: the Micra

Transcatheter Pacing Study. Eur Heart J. Oct 1 2015;36(37):2510-2519. PMID 26045305.

22. Tjong, FF, Beurskens, NN, de Groot, JJ, Waweru, CC, Liu, SS, Ritter, PP, Reynolds, DD, Wilde, AA, Knops, RR. Health-related

quality of life impact of a transcatheter pacing system. J. Cardiovasc. Electrophysiol., 2018 Sep 1;29(12). PMID 30168233.

23. Reynolds D, Duray GZ, Omar R, et al. A leadless intracardiac transcatheter pacing system. N Engl J Med. Feb 11 2016;374(6):533-

541. PMID 26551877.

24. Lloyd M, Reynolds D, Sheldon T, et al. Rate adaptive pacing in an intracardiac pacemaker. Heart Rhythm. Feb 2017;14(2):200-

205. PMID 27871854.

25. Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED): Micra Transcatheter Pacing System (PMS

P150033). 2016; https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150033B.pdf Accessed September 2019.

26. Transcript of the United States of America Department of Health and Human Services Food and Drug Administration Center for

Devices and Radiological Health Medical Devices Advisory Committee: Circulatory System Devices Panel Meeting. February 18,

2016.

https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesA

dvisoryCommittee/CirculatorySystemDevicesPanel/UCM489547.pdf Accessed September 2019.

27. Medtronic. Meet Micra (brochure). n.d.; http://www.medtronic.com/content/dam/medtronic-

com/01_crhf/brady/pdfs/medtronic-micra-transcatheter-pacing-system-hcp-brochure.pdf Accessed September 2019.

28. Grubman, EE, Ritter, PP, Ellis, CC, Giocondo, MM, Augostini, RR, Neuzil, PP, Ravindran, BB, Patel, AA, Omdahl, PP, Pieper, KK,

Stromberg, KK, Hudnall, JJ, Reynolds, DD. To retrieve, or not to retrieve: System revisions with the Micra transcatheter

pacemaker. Heart Rhythm, 2017 Jul 18;14(12). PMID 28713024.

29. Roberts PR, Clementy N, Al Samadi F, et al. A leadless pacemaker in the real-world setting: The Micra Transcatheter Pacing

System Post-Approval Registry. Heart Rhythm. Sep 2017;14(9):1375-1379. PMID 28502871.

30. El-Chami MF, Brock Johansen J, Zaidi A, et al. Leadless Pacemaker Implant in Patients with Pre-Existing Infections: Results from

the Micra Post-Approval Registry. Paper presented at: Heart Rhythm Scientific Sessions. 2018 May 10; Boston, MA.

31. El-Chami, MM, Al-Samadi, FF, Clementy, NN, Garweg, CC, Martinez-Sande, JJ, Piccini, JJ, Iacopino, SS, Lloyd, MM, Viñolas Prat,

XX, Jacobsen, MM, Ritter, PP, Johansen, JJ, Tondo, CC, Liu, FF, Fagan, DD, Eakley, AA, Roberts, PP. Updated performance of the

Micra transcatheter pacemaker in the real-world setting: A comparison to the investigational study and a transvenous historical

control. Heart Rhythm, 2018 Aug 14;15(12). PMID 30103071.

32. Duray GZ, Ritter P, El-Chami M, et al. Long-term performance of a transcatheter pacing system: 12-Month results from the

Micra Transcatheter Pacing Study. Heart Rhythm. May 2017;14(5):702-709. PMID 28192207.

https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM486733.pdfhttps://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM486733.pdfhttps://www.accessdata.fda.gov/cdrh_docs/pdf15/P150033B.pdfhttps://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM489547.pdfhttps://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM489547.pdfhttp://www.medtronic.com/content/dam/medtronic-com/01_crhf/brady/pdfs/medtronic-micra-transcatheter-pacing-system-hcp-brochure.pdfhttp://www.medtronic.com/content/dam/medtronic-com/01_crhf/brady/pdfs/medtronic-micra-transcatheter-pacing-system-hcp-brochure.pdf

Page | 16 of 16 ∞

33. El-Chami, MM, Johansen, JJ, Zaidi, AA, Faerestrand, SS, Reynolds, DD, Garcia-Seara, JJ, Mansourati, JJ, Pasquie, JJ, McElderry, HH,

Roberts, PP, Soejima, KK, Stromberg, KK, Piccini, JJ. Leadless pacemaker implant in patients with pre-existing infections: Results

from the Micra postapproval registry. J. Cardiovasc. Electrophysiol., 2019 Jan 21;30(4). PMID 30661279.

34. Epstein AE, DiMarco JP, Ellenbogen KA, et al. 2012 ACCF/AHA/HRS focused update incorporated into the ACCF/AHA/HRS 2008

guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology

Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. Jan

22 2013;61(3):e6-75. PMID 23265327.

35. Gillis AM, Russo AM, Ellenbogen KA, et al. HRS/ACCF expert consensus statement on pacemaker device and mode selection. J

Am Coll Cardiol. Aug 14 2012;60(7):682-703. PMID 22854177.

36. Centers for Medicare & Medicaid Services. Decision Memo for Leadless Pacemakers (CAG-00448N). 2017;

https://www.cms.gov/medicare-coverage-database/details/nca-decision-

memo.aspx?NCAId=285&bc=ACAAAAAAQAAA& Accessed September 2019.

History

Date Comments 10/01/19 New policy, approved September 10, 2019, effective January 3, 2020. Policy created

with literature review through May 2019. The Micra™ transcatheter pacing system may

be considered medically necessary in patients who are not eligible for conventional

pacemakers when all of the specified conditions are met.

Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The

Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and

local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review

and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit

booklet or contact a member service representative to determine coverage for a specific medical service or supply.

CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). ©2019 Premera

All Rights Reserved.

Scope: Medical policies are systematically developed guidelines that serve as a resource for Company staff when

determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to

the limits and conditions of the member benefit plan. Members and their providers should consult the member

benefit booklet or contact a customer service representative to determine whether there are any benefit limitations

applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=285&bc=ACAAAAAAQAAA&https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=285&bc=ACAAAAAAQAAA&

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មានយ៉ា ំ ់ ត ងសខាន។ េសចក ំណឹងេនះរបែហល

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ងេសចកត ី នដណងេនះ។ អករបែហលជារតវការបេញញសមតភាព ដល់ ណត់ ំ ឹ ន ូ ច ថ កំ ជូ កន ុ determinadas fechas para mantener su cobertura médica o ayuda con los អន ៃថងជាកចបាសនានា េដ ី ឹ ុ ៉ ប់ ុខភាពរបស់ ក ឬរបាក់ costos. Usted tiene derecho a recibir esta información y ayuda en su idioma ់ ់ ើមបនងរកសាទកការធានារា រងស

ក sin costo alguno. Llame al 800-592-6804 (TTY: 800-842-5357). ជ ំ យេចញៃថ កមានសិ េដាយមិ ុ ើ ូ ូ នអសលយេឡយ។ សមទ

ទធ នួ ល។ អន នួ ិ ួលព័ ៌ ិងជំ ន ុងភាសារបស ទទ តមានេនះ ន យេនៅក អន ់

800-592-6804 (TTY: 800-842-5357)។

រស័

ਅੰ

ਜਾਬੀ (Punjabi): paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon ਇਸ ਨੋ ਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹੈ. ਇਸ ਨੋ ਿਟਸ ਿਵਚ LifeWise Health Plan of tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng LifeWise

Health Plan of Washington. Maaaring may mga mahalagang petsa dito sa Washington ਵਲ ਤੁ ਜ ਅਤੇ ਅਰਜੀ ਬਾਰੇ ਮਹਤਵਪੂ ੋ ਸਕਦੀ ਹਾਡੀ ਕਵਰੇ ੱ ਰਨ ਜਾਣਕਾਰੀ ਹ

ពទ

paunawa. Maaring mangailangan ka na magsagawa ng hakbang sa ilang ਹੈ ੋ ਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹੋ ਂ ਹਨ. ਜੇ ੁ ੇ ੱ ਖਣੀ ਹੋ ੇ mga itinakdang panahon upang mapanatili ang iyong pagsakop sa . ਇਸ ਨ ਸਕਦੀਆ ਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰ ਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵੱਚ ਮਦਦ ਦੇ ੱ ੁ ੋ ਤਾਂ ਤੁ ੰ ੂ ਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾਂ ਕੁ kalusugan o tulong na walang gastos. May karapatan ka na makakuha ng ਇਛਕ ਹ ਹਾਨ ੱ ਝ ਖਾਸ

ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag ਕਦਮ ਚੁਕਣ ਦੀ ਲੜ ਹੋ ਸਕਦੀ ਹ ੈ,ਤੁ ੰ ੂ ਮੁ ੱ ਚ ਤੇ ੱ ਚ ਜਾਣਕਾਰੀ ਅਤੇ ੱ ੋ ਹਾਨ ਫ਼ਤ ਿਵ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵ ਮਦਦ sa 800-592-6804 (TTY: 800-842-5357). ਪ੍ਰ ੈਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ,ਕਾਲ 800-592-6804 (TTY: 800-842-5357).

ਪੰ

Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang

ไทย (Thai): ประกาศน ้ีมีข้อมลูสําคญั ประกาศน ้ีอาจมีข้อมลูที่สําคญัเกี่ยวกบัการการสมคัรหรือขอบเขตประกนั

(Farsi): فارسی فرم بارهدر ھمم اطالعات حاوی است ممکن يهمالعا اين . ميباشد ھمم اطالعات یوحا يهمالعا اين

สขุภาพของคณุผ่าน LifeWise Health Plan of Washington และอาจมีกําหนดการในประกาศ طريق از ماش ای مهبي وششپ يا و تقاضا LifeWise Health Plan of Washington به .باشدี น جهتو يهمالعا اين در ھمم ھای خيتار يا تان بيمه وششپ حقظ برای است کنمم ماش . يدماين کمک คณุอาจจะต้องดําเนินการภายในกําหนดระยะเวลาที่แน่นอนเพื่อจะรักษาการประกนัสขุภาพของคณุ

اجتياح صیاخ کارھای امانج برای صیمشخ ھای خيتار به تان، انیمدر ھای زينهھ پرداخت درหรือการช่วยเหลือที่มีค่าใช้จ่าย คณุมีสิทธิที่จะได้รับข้อมลูและความช่วยเหลือน ้ีในภาษาของคณุโดยไม่ม ีباشيد داشته . رايگان ورط به ودخ انزب به را مکک و اطالعات اين که داريد را اين حق ماش

(ค่าใช้จ่าย โทร 800-592-6804 (TTY: 800-842-5357 مارهش با اطالعات سبک برای . نماييد دريافت 800-592-6804 . اييد نم برقرار استم ) 5357-842-800 مارهباش اس تم TTY کاربران(

Polskie (Polish): To ogłoszenie może zawierać ważne informacje. To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez LifeWise Health Plan of Washington. Prosimy zwrócic uwagę na kluczowe daty, które mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminów w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami. Macie Państwo prawo do bezpłatnej informacji we własnym języku. Zadzwońcie pod 800-592-6804 (TTY: 800-842-5357).

Português (Portuguese): Este aviso contém informações importantes. Este aviso poderá conter informações importantes a respeito de sua aplicação ou cobertura por meio do LifeWise Health Plan of Washington. Poderão existir datas importantes neste aviso. Talvez seja necessário que você tome providências dentro de determinados prazos para manter sua cobertura de saúde ou ajuda de custos. Você tem o direito de obter esta informação e ajuda em seu idioma e sem custos. Ligue para 800-592-6804 (TTY: 800-842-5357).

Український (Ukrainian): Це повідомлення містить важливу інформацію. Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через LifeWise Health Plan of Washington. Зверніть увагу на ключові дати, які можуть бути вказані у цьому повідомленні. Існує імовірність того, що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того, щоб зберегти Ваше медичне страхування або отримати фінансову допомогу. У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові. Дзвоніть за номером телефону 800-592-6804 (TTY: 800-842-5357).

Tiếng Việt (Vietnamese): Thông báo này cung cấp thông tin quan trọng. Thông báo này có thông tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quý vị qua chương trình LifeWise Health Plan of Washington. Xin xem ngày quan trọng trong thông báo này. Quý vị có thể phải thực hiện theo thông báo đúng trong thời hạn để duy trì bảo hiểm sức khỏe hoặc được trợ giúp thêm về chi phí. Quý vị có quyền được biết thông tin này và được trợ giúp bằng ngôn ngữ của mình miễn phí. Xin gọi số 800-592-6804 (TTY: 800-842-5357).