Medicare Advantage Policy Manual

IMPORTANT REMINDER

The Medicare Advantage Medical Policy manual is not intended to override the member Evidence of Coverage (EOC), which defines the insured's benefits, nor is it intended to dictate how providers are to practice medicine. Physicians and other health care providers are expected to exercise their medical judgment in providing the most appropriate care for the individual member.

The Medicare Advantage Medical Policies are designed to provide guidance regarding the decision-making process for the coverage or non-coverage of services or procedures in accordance with the member EOC and the Centers of Medicare and Medicaid Services (CMS) policies, when available. In the event of a conflict, applicable CMS policy or EOC language will take precedence over the Medicare Advantage Medical Policy. In the absence of CMS guidance for a requested service or procedure, the health plan may apply their Medical Policy Manual or MCG™ criteria, both of which are developed with an objective, evidence-based process using scientific evidence, current generally accepted standards of medical practice, and authoritative clinical practice guidelines.

Medicare and EOCs exclude from coverage, among other things, services or procedures considered to be investigational, cosmetic, or not medically necessary, and in some cases, providers may bill members for these non-covered services or procedures. Providers are encouraged to inform members in advance when they may be financially responsible for the cost of non-covered or excluded services.

DESCRIPTION

Dual chamber leadless pacemakers are self-contained devices that are implanted directly in the right atrium and right ventricle via femoral access. Leadless pacemakers are used in patients who are ineligible for conventional pacemakers due to complications such as lack of venous access or recurrent infection.

MEDICARE ADVANTAGE POLICY CRITERIA

Note: See Regulatory Status below for leadless pacemaker system contraindications.

CMS covers leadless pacemakers when procedures are performed in approved studies. CMS will review studies to determine if they meet the criteria listed in the NCD. If CMS determines that the study meets the criteria, the study will be posted on CMS' leadless pacemaker Coverage with Evidence Development web page. According to NCD 20.8.4, leadless pacemakers are non-covered when furnished outside of a CMS approved CED study.

POLICY GUIDELINES

REQUIRED DOCUMENTATION

The information below must be submitted for review to determine whether policy criteria are met. If any of these items are not submitted, it could impact our review and decision outcome:

• History and Physical/Chart Notes
• Documentation of symptoms, associated diagnoses and treatments
• Name of Food and Drug Administration (FDA)-approved leadless device
• Documentation that supports contraindication of placement of conventional single-chamber ventricular pacemaker leads
• Documentation of the coverage with evidence development (CED) study. This is a CMS requirement per the NCD 20.8.4.

REGULATORY STATUS

Aveir™ DR Leadless Pacemaker system (Abbott)

In June 2023, the Aveir™ DR Leadless Pacemaker system was approved by the FDA through the premarket approval process. The device is indicated for management of one or more of the following permanent conditions:

• syncope
• pre-syncope
• fatigue
• disorientation.

The device has multiple pacing functions including rate-modulated pacing, atrial pacing, ventricular pacing and dual chamber pacing. Each function has specific indications:

Rate-Modulated Pacing

Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity.

Atrial Pacing

Atrial Pacing is indicated for patients with:

• Sinus node dysfunction and normal AV and intraventricular conduction systems

Ventricular Pacing

Ventricular Pacing is indicated for patients with:

• Significant bradycardia and normal sinus rhythm with only rare episodes of AV block or sinus arrest
• Chronic atrial fibrillation
• Severe physical disability

Dual-Chamber Pacing

Dual-Chamber Pacing is indicated for patients exhibiting:

• Sick sinus syndrome
• Chronic, symptomatic second- and third-degree AV block
• Recurrent Adams-Stokes syndrome
• Symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out.

MR Conditional

MR Conditional: The Aveir Leadless Pacemaker is conditionally safe for use in the MRI environment and according to the instructions in the MRI-Ready Leadless System Manual.

Aveir™ DR Leadless System Contraindications

As per the FDA label, the Aveir™ Leadless Pacemaker System is contraindicated in the following situations:

• Use of any pacemaker is contraindicated in patients with a co-implanted ICD because high-voltage shocks damage the pacemaker, and the pacemaker could reduce shock effectiveness.
• Single-chamber ventricular demand pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or suffer a drop in arterial blood pressure with the onset of ventricular pacing.
• Programming of rate-responsive pacing is contraindicated in patients with intolerance of high sensor-driven rates.
• Use is contraindicated in patients with an implanted vena cava filter or mechanical tricuspid valve because of interference between these devices and the delivery system during implantation.
• Persons with known history of allergies to any of the components of this device may suffer an allergic reaction to this device. Prior to use on the patient, the patient should be counseled on the materials (listed in IFU Product Materials) contained in the device and a thorough history of allergies must be discussed.
• For the MRI contraindications for patients implanted with Aveir Leadless Pacemaker, refer to the MRI Procedure Manual.
• There are no contraindications for use of the Aveir Link Module.

CROSS REFERENCES

Coverage with Evidence Development (CED) Studies and Registries, Medicine, Policy No. M-156

Intracardiac Ischemia Monitoring, Surgery, Policy No. M-208

REFERENCES

1. MLN Matters® Number MM10117, Updated July 28, 2017
2. Medicare Claims Processing Manual, Chapter 32 - Billing Requirements for Special Services, §380 - Leadless Pacemakers (and all related subsections)

CODING

*IMPORTANT NOTE: Medicare Advantage medical policies use the most current Medicare references available at the time the policy was developed. Links to Medicare references will take viewers to external websites outside of the health plan's web control as these sites are not maintained by the health plan.