AVEIR™ AR Right Atrial Leadless Pacemaker System

Introduction

The AVEIR™ AR Right Atrial Leadless Pacemaker (LP) System is a right atrial pacing system implanted in a patient's right atrial chamber of the heart. As a leadless pacemaker system, the AVEIR™ AR Right Atrial LPs do not need a connector, pacing lead, or pulse generator pocket. The LP is delivered percutaneously via the femoral vein through an AVEIR™ Introducer and Delivery Catheter.

Reimbursement Hotline: Abbott offers a reimbursement hotline, which provides live coding and reimbursement information from dedicated reimbursement specialists. Coding and reimbursement support is available from 8 a.m. to 5 p.m. Central Time, Monday through Friday at 855-569-6430 or HCE@abbott.com. Coding and reimbursement assistance is provided subject to the disclaimers set forth in this content.

Disclaimer

This material and the information contained herein is for general information purposes only and is not intended, and does not constitute, legal, reimbursement, business, clinical, or other advice. Furthermore, it is not intended to and does not constitute a representation or guarantee of reimbursement, payment, or charge, or that reimbursement or other payment will be received. It is not intended to increase or maximize payment by any payer. Abbott makes no express or implied warranty or guarantee that the list of codes and narratives in this document is complete or error-free. Similarly, nothing in this document should be viewed as instructions for selecting any particular code, and Abbott does not advocate or warrant the appropriateness of the use of any particular code. The ultimate responsibility for coding and obtaining payment/reimbursement remains with the customer. This includes the responsibility for accuracy and veracity of all coding and claims submitted to third-party payers. In addition, the customer should note that laws, regulations, and coverage policies are complex and are updated frequently, and, therefore, the customer should check with its local carriers or intermediaries often and should consult with legal counsel or a financial, coding, or reimbursement specialist for any questions related to coding, billing, reimbursement, or any related issues. This material reproduces information for reference purposes only. It is not provided or authorized for marketing use.

Medicare Coverage

Leadless Pacemaker Therapy

The leadless pacemaker procedure using AVEIR™ AR Right Atrial Leadless Pacemaker System is approved by CMS under a claims analysis study that will passively collect and analyze real world data to demonstrate the role of the therapy in patients that need a pacemaker. View NCD: Leadless Pacemakers (20.8.4) for more information: https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=370. Leadless Pacemaker must be used in accordance with FDA approved label for the device. It is the responsibility of the physician to determine whether the procedure meets the criteria for coverage and for confirming use in accordance with approved labeling. It is the responsibility of the physician to diagnose and treat the patient and to confirm coverage, coding and claim submission guidance with the patient's health insurance plan to ensure claims are accurate, complete and supported by documentation in the patient's medical record.

Medicare Claim Form Instructions

Physician is responsible for determining whether the procedure meets the criteria for coverage and confirming use in accordance with approved labeling. It is the responsibility of the physician to diagnose and treat the patient and to confirm coverage, coding and claim submission guidance with the patient's health insurance plan to ensure claims are accurate, complete, and supported by documentation in the patient's medical record.

Claims Identifying Information to Signify Patient is Participating in a Study

Coverage with Evidence Development Frequently Asked Questions (FAQs)

These FAQs are intended for general informational purposes only to help provide information that may assist in understanding of Medicare's Coverage with Evidence Development (CED) Study policy relating to the AVEIR™ AR Right Atrial Leadless Pacemaker System when used in accordance with its FDA approved labeling. Physician is responsible for determining whether the procedure meets the criteria for coverage and confirming use in accordance with approved labeling. It is the responsibility of the physician to diagnose and treat the patient and to confirm coverage, coding and claim submission guidance with the patient's health insurance plan to ensure claims are accurate, complete and supported by documentation in the patient's medical record.

FAQ

Is AVEIR™ AR Right Atrial LP covered by CMS?

The Centers for Medicare and Medicaid has a National Coverage Determination for leadless pacemakers, Policy 20.8.4. This is a CED policy that is applicable to all leadless pacemaker procedures for all Medicare beneficiaries, including Medicare fee-for-service and Medicare Advantage. As part of the coverage criteria, CMS requires all patients to be included in a CMS approved study. Abbott has a real-world study for AVEIR™ AR Right Atrial LP, AVEIR™ AR Right Atrial LP CED study to meet these coverage requirements and has obtained approval. The AVEIR™ AR Right Atrial LP CED study has a clinical trial number to be utilized only for patients indicated for AVEIR™ AR Right Atrial LP.

FAQ

How do I report that the AVEIR™ AR Right Atrial LP patient is part of a CMS approved study?

Under the CMS CED policy, CMS requires that you report a National Clinical Trial number on the applicable claim. The NCT number for the AVEIR™ AR Right Atrial LP CED study is NCT06100770.

FAQ

Is the AVEIR™ AR Right Atrial LP CED study the same as AVEIR™ AR's Leadless Pacemaker FDA post-approval study (PAS)?

No. They are two separate studies with two different NCT numbers. The AVEIR™ AR Right Atrial LP CED study study is a CMS approved CED Study that is required for CMS coverage. The PAS is a predetermined group of sites participating in a registry that was established to meet post approval FDA requirements, independent from the CED study.

WHAT DOES THIS MEAN FOR MY HOSPITAL?

Medicare coverage is now available for AVEIR™ AR Leadless Pacemaker implant procedures for any Medicare beneficiaries indicated for a leadless pacemaker and included in the AVEIR™ AR Right Atrial LP CED study.

The inclusion of the AVEIR™ AR Right Atrial LP CED study NCT number (NCT 06100770) is required for CMS coverage purposes.

The NCT number (NCT 06100770) assigned to the AVEIR™ AR Right Atrial LP CED study is unique to the AVEIR™ AR Leadless Pacemaker. The inclusion of the unique AVEIR™ AR Right Atrial LP CED study NCT number (NCT 006100770) is a requirement for CMS coverage for AVEIR™ AR LP procedures.

FAQ

Does my hospital's Institutional Review Board (IRB) need to approve the AVEIR™ AR Right Atrial LP CED study?

The AVEIR™ AR Right Atrial LP CED study involves CMS claims or clinical data that are collected in the context of healthcare delivery, and the data collection involves no direct patient contact and will not influence the care a patient receives during routine interactions with the healthcare system. Therefore, IRB approvals are unlikely to be required by the hospital. Abbott, being the main entity in the AVEIR™ AR Right Atrial LP CED study study, has requested and been granted a waiver of informed consent and a HIPAA waiver from Western IRB. The Council for International Organizations of Medical Sciences (CIOMS), in a publication issued jointly with the World Health Organization (WHO), has stated that a waiver of the informed consent requirement may be granted by an IRB, "when the research design involves no more than minimal risk and a requirement of individual informed consent would make the conduct of the research impracticable (for example, where the research involves only excerpting data from subjects' records)". (Data on file at Abbott)

FAQ

Is the AVEIR™ AR Right Atrial LP CED study NCT number (NCT 06100770) required to be reported on private payer or Medicaid patient claims for coverage?

The NCT number (NCT 06100770) does not apply to private payers or Medicaid. The AVEIR™ AR Right Atrial LP CED study NCT number (NCT 06100770) is required for Medicare beneficiaries' coverage only, including Fee-For-Service and Medicare Advantage.

FAQ

Who can I contact if I have more questions?

Contact the Health Economics team at Abbott: LeadlessReimbursement@abbott.com or you can contact the reimbursement hotline, which provides live coding and reimbursement information from dedicated reimbursement specialists. Coding and reimbursement support is available from 8 a.m. to 5 p.m. Central Time, Monday through Friday at (855) 569-6430.

WHAT DOES THIS MEAN FOR MY HOSPITAL?

It is unlikely an IRB approval would be required by the hospital. We recommend that you review the hospital's policies and procedures along with this information.

AVEIR™ AR Right Atrial LP CED study NCT number (NCT 06100770) is only required in connection with claims for coverage for Medicare beneficiaries.

Please contact the Abbott team using these channels when needed.

Physician Crosswalk

FDA approved June 29, 2023, the AVEIR™ AR Right Atrial Leadless Pacemaker (LP) is capable of pacing and sensing in the right atrium. Atrial pacing indications include sinus mode dysfunction and normal AV and intraventricular conduction systems.

The American Medical Association (AMA) has approved a series of Category III CPT‡ codes to report right atrial single chamber leadless pacemaker procedures. The Category III CPT‡ codes became effective on January 1, 2024. Category III CPT‡ codes are a set of temporary codes to report emerging technology, services, and procedures. These codes are intended to be used to track the usage of these services, and the data collected may be used to substantiate widespread usage by the AMA.

However, Category III codes are not valued and assigned a federal physician fee schedule by CMS. This document provides reference material related to general considerations for physician crosswalk payment for right atrial single chamber leadless pacemaker system procedures when performed consistent with the product's labeling.

Physician Services Considerations for Right Atrial Single Chamber Leadless Pacemaker Procedures

Category III CPT‡ codes do not have an assigned payment rate (established Relative Value Unit (RVU)) in Medicare's physician fee schedule, and therefore private insurers do not have assignment of RVUs to use as a basis for setting physician payment. Since Category III CPT‡ codes do not have established RVUs, prior authorization requests (please note that traditional Medicare does not require prior authorization) and claims must generally be submitted with supporting documentation and may be subject to review. Comparable Category I CPT‡ codes that are similar to the Category III code may be identified to provide accurate information to payers for consideration when they are processing claims. By providing a comparable Category I CPT‡ code along with additional documentation, payers can better understand what took place during the procedure, and value it accordingly.

Payers will review each claim with a Category III CPT‡ code for right atrial single chamber leadless pacemaker procedures individually, and payment determinations will be made on a case-by-case basis. Therefore, it is strongly recommended that the provider contact payers to ensure the new Category III CPT‡ codes are included in contracts and to inquire about any guidelines for submission and documentation of these claims.

Recommended Supporting Documentation for Claim Submission (List is not comprehensive; check with your applicable payer)

1. A cover letter describing the services rendered and why the service was needed
2. Copy of operative report that details the procedure including provider's time and effort during procedure
   • Time, effort and equipment necessary to perform procedure
   • Include the relevant crosswalk Category I CPT‡ code for a comparable procedure while also noting any and all differences with the services provided for the right atrial single chamber leadless pacemaker procedure with an increase or decreased percentage of the work/time associated with the referenced comparable procedure
3. Customized Letter of Medical Necessity for the patient receiving the procedure
4. Copy of FDA Approval Letter
5. Copy of published clinical data

Considerations when choosing a comparable procedure to reference in supporting documentation

Physicians are encouraged to identify comparable crosswalk Category I CPT‡ codes to reference in supporting documentation provided with the claim submission when billing for leadless pacemaker procedures. Physicians will need to document in detail the work involved with specificity of time, the complexity of the procedure, and practice expense relative to comparable procedures with established RVUs and payment amounts.

Considerations when reporting a coding crosswalk on a claim

Physicians should report the appropriate Category III CPT‡ code for the procedure and bill an amount comparable to the crosswalk code. If a comparable crosswalk includes multiple units, then the explanation line should include all activity combined into one explanation (do not enter multiple lines of crosswalk codes). An example of a crosswalk comparison is below.

AVEIR™ AR Right Atrial LP System Category III CPT‡ Codes

Category III Coding Crosswalk Examples

When considering comparable procedures, the following procedures may require similar effort, expertise, time and resource utilization. It is strongly encouraged that physicians include operative notes detailing the effort and time of the procedure to support adequate reimbursement. (Coding options/examples presented below have been reviewed with independent consultants and certified coders).

Coding Crosswalk Options: AVEIR™ AR Right Atrial Leadless Pacemaker - Insertion

Potential CPT‡ code crosswalks for 0823T

Coding Crosswalk Options: AVEIR™ AR Right Atrial Leadless Pacemaker - Removal

Potential CPT‡ code crosswalks for 0824T

Coding Crosswalk Options: AVEIR™ AR Right Atrial LP System Removal & Replacement

Potential CPT‡ Code Crosswalks for 0825T

Coding Crosswalk Options: AVEIR AR Right Atrial Leadless Pacemaker - Programming

Potential CPT‡ Code Crosswalks for 0826T

Note: The Category I CPT‡ code represented in the above tables are provided for convenience for illustrative purposes only and are not meant to be all-inclusive. Physicians are responsible for providing all information payers may require in support of a claim including selecting the appropriate Category I CPT‡ code comparator and for explaining how the work involved, including the time and complexity of the procedure and the practice expense, is similar to the procedure taking place.

Please note that where a Category III CPT‡ code is available it MUST be reported. Any comparator CPT‡ code identified should be included only in the supporting documentation submitted with the claim.

Sample Forms

Illustrative examples of claim forms are provided for reference.

Sample CMS 1500 Form

AVEIR™ AR Right Atrial LP FOR ILLUSTRATIVE PURPOSES ONLY

Sample CMS UB-04 Form

AVEIR™ AR Right Atrial LP FOR ILLUSTRATIVE PURPOSES ONLY

AVEIR™ AR Right Atrial Leadless Pacemaker (LP) System - Hospital Inpatient

Effective Dates: October 1, 2023 - September 30, 2024

AVEIR™ AR Right Atrial Leadless Pacemaker System - Hospital Outpatient

Effective Dates: January 1, 2024 - December 31, 2024

HCPCS Device Category C-Codes and ICD-10-CM Diagnosis Codes

HCPCS Device Category C-Codes

• C1786: Pacemaker, single-chamber rate responsive (implantable)
• C1894: Introducer/sheath, other than guiding, other than intracardiac electrophysiological, nonlaser
• *C1889: Implantable/insertable device, not otherwise classified (*A new C-code assignment with the TPT assignment for AVEIR™ DR & AR upgrades.)

ICD-10-CM (International Classification of Diseases, Tenth Revision, Clinical Modification) Diagnosis Codes

Diagnosis codes are used by both hospitals and physicians to document the indication for the procedure. For Cardiac Pacemaker, Implantable Cardioverter Defibrillator (ICD) and Implantable/Insertable Cardiac Monitors (ICM) patients, there are many possible diagnosis code scenarios and a wide variety of possible combinations. The possible scenarios and combinations are too numerous to capture in this document. The customer should check with their local carriers or intermediaries and should consult with legal counsel or a financial, coding or reimbursement specialist for coding, reimbursement or billing questions related to ICD-10-CM diagnosis codes. Diagnosis is the sole responsibility of the physician and reimbursement support provided is not intended to affect the physician's independent clinical judgment.

Commercial (Private) Payers

Coverage for leadless pacemakers varies by payer policy. We encourage providers to contact non-Medicare payers to confirm coverage prior to performing the procedure.

Important Safety Information

Brief Summary: Prior to using these devices, please review the Instructions for Use, inside the product carton (when available) or at vascular.eifu.abbott or at medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. This material is intended for use with healthcare professionals only.

Indications: The AVEIR™ Leadless Pacemaker system is indicated for management of one or more of the following permanent conditions: Syncope, Pre-syncope, Fatigue, Disorientation. Rate-modulated pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. 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. Atrial pacing is indicated for patients with: Sinus node dysfunction and normal AV and intraventricular conduction systems. 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. 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.

Intended Use: The AVEIR™ Leadless Pacemaker (LP) is designed to provide bradycardia pacing as a pulse generator with built-in battery and electrodes for implantation in the right ventricle and/or right atrium. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy within the implanted chamber for the target treatment group. The LP is also intended to operate optionally with another co-implanted LP to provide dual-chamber pacing therapy. The AVEIR™ Delivery Catheter is intended to be used in the peripheral vasculature and the cardiovascular system to deliver and manipulate an LP. Delivery and manipulation includes implanting an LP within the target chamber of the heart.

Contraindications: Use of the AVEIR™ Leadless Pacemaker is contraindicated in these cases:

• Use of any pacemaker is contraindicated in patients with a co-implanted ICD because high-voltage shocks could 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 the Product Materials section of the IFU) contained in the device and a thorough history of allergies must be discussed.

Adverse Events: Potential complications associated with the use of the AVEIR™ Leadless Pacemaker system are the same as with the use of single or dual chamber pacemakers with active fixation pacing leads including, but not limited to: Cardiac perforation, Cardiac tamponade, Pericardial effusion, Pericarditis, Valve damage and/or regurgitation, Heart failure, Pneumothorax/hemothorax, Cardiac arrhythmias, Diaphragmatic/phrenic nerve stimulation / extra-cardiac stimulation, Palpitations, Hypotension, Syncope, Cerebrovascular accident, Infection, Hypersensitivity reaction to device materials, contrast media, medications, or direct toxic effect of contrast media on kidney function, Pacemaker syndrome, Inability to interrogate or program the LP due to programmer or LP malfunction, Intermittent or complete loss of pacing and/or sensing due to dislodgement or mechanical malfunction of the LP (non-battery related), Loss of capture or sensing due to embolization or fibrotic tissue response at the electrode, Increased capture threshold, Inappropriate sensor response, Interruption of desired LP function due to electrical interference, either electromyogenic or electromagnetic, Battery malfunction/ premature battery depletion, Device-related complications (Premature deployment, Device dislodgement/embolization of foreign material, Helix distortion), Death. As with any percutaneous catheterization procedure, potential complications include, but are not limited to: Vascular access complications; such as perforation, dissection, puncture, groin pain, Bleeding or hematoma, Thrombus formation, Thromboembolism, Air embolism, Local and systemic infection, Peripheral nerve damage. General surgery risks and complications from comorbidities; such as hypotension, dyspnea, respiratory failure, syncope, pneumonia, hypertension, cardiac failure, reaction to sedation, renal failure, anemia, and death.

References

1. FY2024 IPPS Final Rule Home Page. U.S. Centers for Medicare and Medicaid Services. [cited: August 2023]. https://www.cms.gov/medicare/acute-inpatient-pps/fy-2024-ipps-final-rule-home-page
2. CY2024 MPFS Final Rule Home Page. U.S. Centers for Medicare and Medicaid Services. [cited: November 2023]. https://www.cms.gov/medicare/medicare-fee-service-payment/physicianfeesched/pfs-federal-regulation-notices/cms-1784-f
3. CY2024 OPPS Final Rule Home Page. U.S. Centers for Medicare and Medicaid Services. [cited: November 2023]. https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/regulations-notices/cms-1786-fc
4. CMS 2024 ICD-10-CM [cited: August 2023]. https://www.cms.gov/medicare/coding-billing/icd-10-codes/2024-icd-10-cm
5. Leadless Pacemakers [cited: June 2022]. https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/Leadless-Pacemakers
6. Claim Submission [cited: June 2022]. https://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00232303
7. AMA CPT‡ Category III Codes, First Ten Years [cited: January 2024] https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwjU6N3r65GDAxXW4TgGHbl-D2MQFnoECBMQAQ&url=https%3A%2F%2Fwww.ama-assn.org%2Fmedia%2F9291%2Fdownload&usg=AOvVaw0ZTX992B4EB2S5k76J8slK&opi=89978449
8. AMA CPT‡ Category III codes long [cited: January 2024] https://www.ama-assn.org/system/files/cpt-category3-codes-long-descriptors.pdf
9. National Coverage Determination Leadless Pacemakers 20.8.4 [cited: January 2024] https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=370
10. Medicare Claims Processing Manual, Chapter 32, Section 380 - Leadless Pacemakers [cited: January 2024] https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/clm104c32.pdf
11. Aveir AR Coverage With Evidence Development Post-Approval Study (CED) [cited: April 2024] https://clinicaltrials.gov/study/NCT06100770?lead=Abbott%20Medical%20Devices&rank=5
12. CMS 1500 Claim Form [cited: April 2024] https://www.cms.gov/medicare/cms-forms/cms-forms/downloads/cms1500.pdf
13. CMS UB-04 Claim Form [cited: April 2024] https://www.cms.gov/regulations-and-guidance/legislation/paperworkreductionactof1995/downloads/cms-1450.zip

Contact Information

CAUTION: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or at vascular.eifu.abbott or at medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. This material is intended for use with healthcare professionals only.

Information contained herein for DISTRIBUTION in the US ONLY.

Data on File at Abbott

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