Leadless Cardiac Pacemakers

Policy ID: S-267-003

Section: Surgery

Effective Date: July 05, 2021

Last Reviewed: May 23, 2023

Applies To: Commercial and Medicaid Expansion

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 individuals with a variety of brady-arrhythmias. Even though the efficacy and safety profile of conventional pacemakers are excellent, in a small proportion of individuals, they may result in lead complications and the requirement for a surgical pocket. Further, some individuals 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 surgical pocket. The Micra transcatheter pacing system is the only commercially available leadless pacemaker in the United States (U. S.) approved by the Food and Drug Administration (FDA).

Criteria

The Micra transcatheter pacing system may be considered medically necessary in individuals when BOTH conditions below are met:

The individual has symptomatic paroxysmal or permanent high-grade arteriovenous block or symptomatic bradycardia-tachycardia syndrome or sinus node dysfunction (sinus bradycardia or sinus pauses); and
The individual has a significant contraindication precluding placement of conventional single-chamber ventricular pacemaker leads such as ANY of the following:
- History of an endovascular or cardiovascular implantable electronic device (CIED) infection or who are at high risk for infection; or
- 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; or
- Presence of a bio-prosthetic tricuspid valve.

The Micra transcatheter pacing system not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

33274

33275

Contraindications

As per the U.S. FDA label, the Micra transcatheter pacing system is contraindicated for individuals 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; or
An implanted inferior vena cava filter; or
A mechanical tricuspid valve; or
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 transcatheter pacing system is also contraindicated for individuals 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); or
Morbid obesity that prevents the implanted device to obtain telemetry communication within <12.5 cm (4.9 in); or
Known intolerance to titanium, titanium nitride, parylene C, primer for parylene C, polyether ether ketone, siloxane, nitinol, platinum, iridium, liquid silicone rubber, silicone medical adhesive, and heparin or sensitivity to contrast medical which cannot be adequately pre-medicated

As per the FDA label, the Micra transcatheter pacing system should not be used in individuals for whom a single dose of 1.0 mg dexamethasone acetate cannot be tolerated because the device contains a molded and cured mixture of dexamethasone acetate with the target dosage of 272 μg dexamethasone acetate. It is intended to deliver the steroid to reduce inflammation and fibrosis.

Diagnosis Codes

Covered Diagnosis Codes for 33274 and 33275

G90.01

I44.1

I44.2

I45.2

I45.3

I45.5

I47.2

R00.1

I48.0

I48.11

I48.19

I48.20

I48.21

I48.3

I48.4

I48.91

I48.92

I49.3

I49.5

ND Committee Review

Internal Medical Policy Committee 9-26-2019 New Policy for ND

Internal Medical Policy Committee 5-20-2021 Adopted policy to replace S-5032 of the same name.

Internal Medical Policy Committee 5-24-2022 Annual Review-no changes in criteria

Internal Medical Policy Committee 5-23-2023 Annual Review-no changes in criteria

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: S-267-002