Abbott AVEIR DR Dual Chamber Leadless Pacemaker System User Guide
- June 1, 2024
- Abbott
Table of Contents
- Abbott AVEIR DR Dual Chamber Leadless Pacemaker System
- Product Information
- Product Usage Instructions
- TERMS AND CONDITIONS
- NATIONAL AVEIRTM LEADLESS PACEMAKERS MEDICARE REIMBURSEMENT GUIDE
- MEDICARE COVERAGE
- COVERAGE WITH EVIDENCE DEVELOPMENT FREQUENTLY ASKED QUESTIONS (FAQs)
- MEDICARE COVERAGE
- AVEIR™ VENTRICULAR (VR) LEADLESS PACEMAKER (LP) SYSTEM
- IMPORTANT SAFETY INFORMATION
- AVEIR™ DR Dual Chamber LP System Physician Coding
- Category III Coding Crosswalk Examples
- Category III Coding Crosswalk Examples
- AVEIR™ DR DUAL CHAMBER LEADLESS PACEMAKER (LP) SYSTEM
- AVEIR™ DR DUAL CHAMBER LEADLESS PACEMAKER (LP) SYSTEM
- IMPORTANT SAFETY INFORMATION
- MEDICARE ADDITIONAL PAYMENT
- Hospital Inpatient – New Technology Add-On Payment (NTAP)
- AVEIR™ VR Ventricular LP FOR ILLUSTRATIVE PURPOSES ONLY
- References
- Read User Manual Online (PDF format)
- Download This Manual (PDF format)
Abbott AVEIR DR Dual Chamber Leadless Pacemaker System
Product Information
Specifications
- Product Name: AVEIRTM Leadless Pacemakers (LP)
- Effective Date: January 1st, 2024
- Manufacturer: Abbott
Product Usage Instructions
-
Introduction
The AVEIRTM Leadless Pacemakers are advanced medical devices designed for cardiac rhythm management. These pacemakers offer innovative technology to support patients in need of pacing therapy. -
Medicare Reimbursement Guide
For healthcare professionals seeking reimbursement information related to Medicare coverage, Abbott provides a comprehensive guide that outlines the reimbursement process and requirements. Please refer to the Medicare Reimbursement Guide for detailed instructions. -
Reimbursement Hotline
If you require immediate assistance with coding and reimbursement queries, you can contact Abbott’s reimbursement hotline at 855-569-6430 or email at HCE@abbott.com. The hotline operates from 8 a.m. to 5 p.m. Central Time, Monday through Friday.
Frequently Asked Questions (FAQ)
-
Q: How can I determine if the procedure is covered by Medicare?
A: Physicians are responsible for assessing if the procedure meets coverage criteria and aligns with approved labeling. They should verify coverage with the patient’s health insurance plan. -
Q: Are there specific codes or forms required for Medicare reimbursement?
A: Yes, healthcare providers need to use appropriate codes and forms when submitting claims for Medicare reimbursement. Refer to the billing forms section for more details.
Cardiac Rhythm Management
- AVEIR™ LEADLESS PACEMAKERS (LP)
- Medicare Reimbursement Guide
- Effective January 1st, 2024
Information contained herein for DISTRIBUTION in the US ONLY. ©2024 Abbott. All rights reserved. MAT-2201720 v9.0
TERMS AND CONDITIONS
- All content herein may be based upon several sources, included but not limited to primary sources, scientific literature, commercially available data sets, customer supplied information, and external sources.
- Estimates shown are for illustrative purposes only. This content is not intended for any other purpose.
- It should be noted that there are usually differences between economic modelling actual results. Abbott does not take responsibility for any such discrepancies. There is no guarantee of any potential economic outcome, including payment, cost savings, or procedure volume. Economic outcomes are dependent on many factors and will vary.
- Certain Maryland hospitals paid under Maryland Waiver provisions using All Patient Refined Diagnosis Related Group (APR-DRG) are excluded from payment under the Medicare Inpatient Prospective Payment System (IPPS).
- Reimbursement Calculators should not be provided at no charge to actively licensed Healthcare Professionals (HCPs) who regularly practice in Vermont.
- This information is not to be distributed to third parties.
INTRODUCTION
NATIONAL AVEIRTM LEADLESS PACEMAKERS MEDICARE REIMBURSEMENT GUIDE
-
AVEIR™ VR Ventricular Leadless Pacemaker
System Introduction -
The AVEIR™ VR Ventricular Leadless Pacemaker (LP) System is a single-chamber pacing system implanted in a patient’s right ventricular chamber of the heart. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy for patients indicated for the therapy. As a leadless pacemaker, the AVEIR™ VR LP does 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.
-
AVEIR™ DR Dual Chamber Leadless
-
Pacemaker System Introduction
-
The AVEIR™ DR Dual Chamber Leadless Pacemaker (LP) System is a dual-chamber pacing system implanted in a patient’s right ventricular and right atrial chambers of the heart. The LP system is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy in both chambers for patients indicated for the therapy. As a leadless pacemaker system, the AVEIR™ DR
-
Dual Chamber LPs do not need a connector, pacing lead, or pulse generator pocket. Each 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™ VR Ventricular 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 the NCD: Leadless Pacemakers
(20.8.4). 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.
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™ VR Ventricular 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.
MEDICARE COVERAGE
-
LEADLESS PACEMAKER THERAPY
The leadless pacemaker procedure using AVEIR™ DR Dual Chamber LP 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 the NCD: Leadless Pacemakers (20.8.4). 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.
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™ DR Dual Chamber LP 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.
AVEIR™ VENTRICULAR (VR) LEADLESS PACEMAKER (LP) SYSTEM
- Facility rates shown with an * reflect payment when modifier 26 is used (i.e. payment only for the professional component).
- NA : Medicare has not established a payment amount for this code. Check with your local Medicare Administrative Contractor (MAC) to verify the payment amount.
- It is incumbent upon the physician to determine which, if any, modifiers should be used first.
J1: Hospital Part B services paid through a comprehensive APC
N: I tems and Services Packaged into APC Rates
Q1 : STV-Packaged Codes
NA: Medicare has not established a payment amount for this code. Check
with your local Medicare Administrative Contractor (MAC) to verify the payment
amount.
Effective Dates: October 1, 2023 – September 30, 2024
HCPCS Device Category C-Codes
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
- Rx Only
- Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Indications: The Aveir™ Leadless Pacemaker system is indicated for patients with significant bradycardia and:
- Normal sinus rhythm with rare episodes of A-V block or sinus arrest Chronic atrial fibrillation
- Severe physical disability
- Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity.
- 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. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy to the target patient population.
- The Aveir™ Delivery Catheter system 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 Product Materials section in 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 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, 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).
AVEIR™ DR DUAL CHAMBER LEADLESS PACEMAKER (LP) SYSTEM
- FDA approved June 29, 2023, the AVEIR™ DR Leadless Pacemaker (LP) System is capable of pacing and sensing in both chambers of the heart through the combination of an atrial leadless pacemaker and a ventricular leadless pacemaker. Dual chamber, leadless synchronous pacing between the atrium and the ventricle is made possible with implant-to-implant communication technology, capable of providing pacing for continuous, atrioventricular synchrony. On July 1, 2023, the American Medical Association (AMA) approved a series of Category III CPT‡ Codes to report dual chamber leadless pacemaker procedures. 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 dual chamber leadless pacemaker system procedures when performed consistent with the product’s labeling.
- Reporting a Category III CPT code for Physician services require special considerations, in that Category III CPT codes for Dual Chamber Leadless Pacemaker Procedures do not have an assigned payment rate (established RVU (Relative Value Unit)) in Medicare’s physician fee schedule, and private insurers do not have assignment of RVUs to use as a basis for setting physician payment. Since
- Category III 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 CPT‡ code for dual 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 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)
- A cover letter describing the services rendered and why the service was needed
- 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 dual chamber leadless pacemaker procedure with an increase or decreased percentage of the work/time associated with the referenced comparable procedure
- Customized Letter of Medical Necessity for the patient receiving the procedure
- Copy of FDA Approval Letter
- Copy of published clinical data
AVEIR™ DR DUAL CHAMBER LEADLESS PACEMAKER (LP) SYSTEM
Physicians are encouraged to identify comparable crosswalk Category I CPT‡
codes to reference in supporting documentation provided with the claim
submission when billing for Dual Chamber Leadless Pacemaker procedures. Since
the Category III CPT‡ code does not have established RVUs, payers do not have
a pre-defined reference for establishing payment. 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.
Physicians should enter 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). Applicable Category III codes for dual chamber leadless
pacemaker procedures and an example of Crosswalk comparisons are included on
the following pages in this section.
AVEIR™ DR Dual Chamber LP System Physician Coding
Category III Codes
AVEIR™ DR Dual Chamber LP System Physician Coding
PROGRAMMING DEVICE EVALUATION
Category I Code
INTERROGATION
Category III Coding Crosswalk Examples
When considering comparable procedures, the following procedures may require
similar effort, expertise, time and resource utilization.(Coding
options/examples presented below have been reviewed with independent
consultants and certified coders)
Coding Crosswalk Options: AVEIR™ DR Dual Chamber LP System Insertion
INSERTION
- If inserting 2 devices, provider can report 2 units; second unit will be discounted to 50%; reimbursement will adjust to 1.5 units.
- ^33340 is an additional option when inserting 2 units.
- Coding Crosswalk Options: AVEIR™ DR Dual Chamber LP System Upgrade
UPGRADE
Category III Coding Crosswalk Examples
Coding Crosswalk Options: AVEIR™ DR Dual Chamber LP System Removal
Removal
- If removing both devices, provider can report 2 units; second unit will be discounted to 50%; reimbursement will adjust to 1.5 units.
- ^33236 is an additional option when removing both units.
Coding Crosswalk Options: AVEIR™ DR Dual Chamber LP System Removal & Replacement
REMOVAL & REPLACEMENT
- If removing/replacing both devices, provider can report 2 units; second unit will be discounted 50%, reimbursement to 1.5 units
- It is strongly encouraged that physicians include op notes detailing the effort and time of the removal portion of the procedure to support adequate reimbursement.
Category III Coding Crosswalk Examples
Coding Crosswalk Options: AVEIR™ DR Dual Chamber LP System Programming
PROGRAMMING
- Provider can report 2 units; second unit will be discounted to 50%; reimbursement will adjust to 1.5 units
- Can only be reported in conjunction with CPT 95983
- Note: The Category I CPT‡ codes 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 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 CMS 1500 FORM
AVEIR™ DR Dual Chamber LP FOR ILLUSTRATIVE PURPOSES ONLY
AVEIR™ DR DUAL CHAMBER LEADLESS PACEMAKER (LP) SYSTEM
- Effective Dates: January 1, 2024 – December 31, 2024
- J1: Hospital Part B services paid through a comprehensive APC
AVEIR™ DR DUAL CHAMBER LEADLESS PACEMAKER (LP) SYSTEM
- Effective Dates : January 1, 2024 – December 31, 2024
- Q1: STV-Packaged Codes
AVEIR™ DR DUAL CHAMBER LEADLESS PACEMAKER (LP) SYSTEM
HCPCS Device Category C-Codes
- Applies to de novo AVEIR DR procedures, as well as AR upgrades when the patient has an existing VR device.
- 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.
AVEIR™ DR DUAL CHAMBER LEADLESS PACEMAKER (LP) SYSTEM
IMPORTANT SAFETY INFORMATION
Rx Only
Brief Summary: Prior to using these devices, please review the
Instructions for Use for a complete listing of indications, contraindications,
warnings, precautions, potential adverse events and directions for use.
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.
MEDICARE ADDITIONAL PAYMENT
- Medicare provides a pathway for additional device reimbursement when certain new medical technologies are used for eligible cases on Medicare beneficiaries in the hospital inpatient and outpatient settings*. The payment pathway in the hospital inpatient setting is the new technology add-on payment (NTAP) pathway. The purpose of NTAP is to ensure Medicare beneficiaries’ access to technologies that are too new to be well represented in the data CMS uses to set rates under Medicare’s Inpatient Prospective Payment System (IPPS). In other words, NTAP payments are intended to minimize cost and payment barriers that would otherwise inhibit the adoption of new, outcome-improving technologies for Medicare beneficiaries. A criterion for NTAP applications is that the new medical technology represents a substantial clinical improvement over current therapy options. CMS determined the AVEIR™ DR Dual Chamber Leadless Pacemaker (LP) met this criterion.
- NTAP payments will be available when the AVEIR™ DR Dual Chamber LP is used on traditional Medicare beneficiaries for eligible cases in the hospital inpatient setting. In addition, CMS announced that the AVEIR™ DR Dual Chamber LP maps to Medicare Severity Diagnosis Related Group (MS-DRGs) 228 and 229 for inpatient hospital services**.
Hospital Inpatient – New Technology Add-On Payment (NTAP)
The NTAP reimburses procedures performed in the hospital inpatient setting for costs related to their use of eligible new technologies in addition to the prospective diagnosis related group (MS-DRG) payment. The NTAP amount is the lesser of 65 percent of the cost of the new medical technology or 65 percent of the amount by which the costs of the case exceed the standard MS-DRG payment.
NTAP Payment Example (does not represent any known hospital)
SAMPLE CMS 1500 FORM
AVEIR™ VR Ventricular LP FOR ILLUSTRATIVE PURPOSES ONLY
SAMPLE CMS UB-04 FORM
AVEIR™ VR Ventricular LP FOR ILLUSTRATIVE PURPOSES ONLY
SAMPLE CMS 1500 FORM
AVEIR™ DR Dual Chamber LP FOR ILLUSTRATIVE PURPOSES ONLY
SAMPLE CMS UB-04 FORM
AVEIR™ DR Dual Chamber LP FOR ILLUSTRATIVE PURPOSES ONLY
-
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 -
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 -
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 -
CMS 2024 ICD-10-CM [cited: August 2023].
https://www.cms.gov/medicare/coding-billing/icd-10-codes/2024-icd-10-cm -
Leadless Pacemakers [cited: June 2022].
https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development /Leadless-Pacemakers -
Claim Submission [cited: June 2022].
https://www.novitas- solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00232303 -
Aveir VR Coverage With Evidence Development Post-Approval Study (CED) [cited: June 2022] https://clinicaltrials.gov/ct2/show/NCT05336877?term=NCT05336877&draw=2&rank=1
-
Aveir DR Coverage With Evidence Development Post-Approval Study (CED) [cited: November 2023] https://clinicaltrials.gov/study/NCT05932602
-
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%2F
www.ama- assn.org%2Fmedia%2F9291%2Fdownload&usg=AOvVaw0ZTX992B4EB2S5k76J8slK&opi=89978449 -
AMA CPT‡ Category III codes long [cited: January 2024] https://www.ama-assn.org/system/files/cpt-category3-codes-long-descriptors.pdf
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National Coverage Determination Leadless Pacemakers 20.8.4 [cited: January 2024] https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=370
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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
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Pass-Through Payment Status and New Technology Ambulatory Payment Classification (APC) [cited: January 2024] https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/pass-through-payment-status-new-technology-ambulatory-payment-classification-apc
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
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Information contained herein for DISTRIBUTION in the US ONLY.
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Data on file at Abbott
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Abbott
One St. Jude Medical Dr., St. Paul, MN 55117, USA, Tel: 1 651 756 2000 -
™ indicates a trademark of the Abbott Group of Companies
‡ Indicates a third party trademark, which is property of its respective owner. -
www.cardiovascular.abbott
©2024 Abbott. All rights reserved. MAT-2201720 v9.0 | Item approved for U.S. use only.
References
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