Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Leadless Pacemakers
Policy #:MA05.067b

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

LEADLESS PACEMAKERS

EXPERIMENTAL/INVESTIGATIONAL
In accordance with Medicare, leadless pacemakers are considered experimental/investigational and, therefore, not covered, with the exception of Coverage with Evidence Development (CED).

COVERAGE WITH EVIDENCE DEVELOPMENT (CED)
Leadless pacemakers will be covered under Medicare's Coverage with Evidence Development (CED) when individuals are enrolled in a clinical study that fulfills ALL of the requirements as stated in Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) for Leadless Pacemakers (20.8.4).

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

BILLING REQUIREMENTS

Claims for leadless pacemakers for individuals enrolled in a CED clinical study should be submitted to the Medicare Advantage plan.

Providers must report Modifier Q0 with procedure codes 0387T, 0389T, 0390T, 0391T to represent investigational clinical service provided in a Centers for Medicare & Medicaid Services (CMS) approved clinical research study.
Policy Guidelines

This policy is consistent with Medicare’s coverage determination. The Company’s payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, leadless pacemakers are covered under the applicable medical benefits of the Company's Medicare Advantage products when the requirements for Coverage with Evidence Development (CED) listed in this medical policy are met.

COVERAGE WITH EVIDENCE DEVELOPMENT (CED)

A list of approved CED studies for leadless pacemakers are listed and maintained on the CMS website at:
https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Medtronic Micra Transcatheter Pacemaker System was approved by the FDA on April 6, 2016 and is indicated for use in individuals who have experienced one or more of the following conditions:
  • Symptomatic parxoysmal or permanent high-grade AV block in the presence of atrial fibrillation (AF).
  • Symptomatic parxoysmal or permanent high-grade AV block in the absence of atrial fibrillation (AF) 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.

Description

Leadless pacemakers are intended to treat bradycardia in individuals that require single-chamber ventricular pacing. The leadless pacemaker eliminates the need for a device pocket and insertion of a pacing lead which are integral elements of traditional pacing systems. The removal of these elements eliminate an important source of complications associated with traditional pacing systems while providing similar benefits. Leadless pacemakers are delivered via catheter to the heart, and function similarly to other transvenous single-chamber ventricular pacemakers.
References

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Leadless Pacemakers (20.8.4). 01/18/2017. [CMS website]. Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=370&ncdver=1&bc=AAAAgAAAAAAAAA%3d%3d&. Accessed August 23, 2017.

Centers for Medicare & Medicaid Services (CMS). MLN Matters.National Coverage Determination (NCD): Leadless Pacemakers. MM10117. [CMS website]. 01/18/2017. Available at: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10117.pdf. Accessed August 23, 2017.

Reynolds D, Duray GZ, Omar R, et al. A leadless intracardiac transcatheter pacing system. N Engl J Med. 2016;374(6):533-41.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Premarket approval letter. Medtronic Micra™ Transcatheter Pacemaker System (Pacemaker Model MC1VR01 and Programmer Application Software Model SW022 version 1.1). [FDA Web site]. 04/06/16. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150033a.pdf. Accessed August 23, 2017.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

33274, 33275


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

Z00.6 Encounter for examination for normal comparison and control in clinical research program


HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A


Misc Code

Modifiers:

THE FOLLOWING MODIFIER MUST BE APPENDED TO 33274 IN ORDER TO BE CONSIDERED FOR REIMBURSEMENT:

Q0 Investigational clinical service provided in a clinical research study that is in an approved clinical research study.




Coding and Billing Requirements






Policy History

MA05.067b
01/01/2020This policy has been identified for the annual HCPCS code update effective 01/01/2020.

The following CPT code narrative has been revised in this policy

33275

MA05.067a
02/13/2019This policy has been reissued in accordance with the Company's annual review process.
01/01/2019This policy has been identified for the CPT code update effective 01/01/2019.

The following CPT codes have been termed from this policy: 0387T, 0388T, 0389T, 0390T, 0391T.

The following CPT codes have been added to this policy: 33274, 33275.

MA05.067
08/15/2018This policy has been reissued in accordance with the Company's annual review process.
11/03/2017This version of the policy will become effective 11/03/2017.

The following new policy has been developed to communicate the Company’s coverage criteria for leadless pacemakers.





Version Effective Date: 01/01/2020
Version Issued Date: 12/30/2019
Version Reissued Date: N/A