Abbott AVEIRTM VR Aveir Leadless Pacemaker System Instruction Manual

Instruction Manual for Abbott models including: AVEIRTM VR, AVEIRTM AR, AVEIRTM DR, AVEIRTM VR Aveir Leadless Pacemaker System, AVEIRTM VR, Aveir Leadless Pacemaker System, Leadless Pacemaker System, Pacemaker System

[PDF] AVEIRâ¢ LEADLESS PACEMAKER SYSTEM - Abbott Cardiovascular www.cardiovascular.abbott âº reimbursement âº crm âº coding-coverage

AVEIR Medicare Coverage Coding Guide

Cardiac Rhythm Management Coding and Coverage Resources | Abbott

File Info : application/pdf, 20 Pages, 1.06MB

AVEIR Medicare Coverage Coding Guide

Cardiac Rhythm Management
AVEIRTM LEADLESS PACEMAKER SYSTEM
MEDICARE COVERAGE GUIDE
Effective January 1st, 2025
Information contained herein for DISTRIBUTION in the US ONLY. ©2024 Abbott. All rights reserved. MAT-2201720 v13.0
1

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.

MEDICARE COVERAGE GUIDE

Information contained herein for DISTRIBUTION in the US ONLY. ©2024 Abbott. All rights reserved. MAT-2201720 v13.0
2

AVEIRTM VR DE NOVO AVEIRTM AR DE NOVO AVEIRTM DR DE NOVO & UPGRADES IMPORTANT SAFETY INFORMATION REFERENCES CLOSING
AVEIRTM VR de novo

AVEIRTM VR Ventricular Leadless Pacemaker System Introduction
The AVEIRTM 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 AVEIRTM VR LP does not need a connector, pacing lead, or pulse generator pocket. The LP is delivered percutaneously via the femoral vein through an AVEIRTM 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 855569-6430 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 errorfree. 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.

AMVEEDIRICTMARVERCLOeaVdElReAssGPEaGceUmIDaEker Reimbursement Guide

Information contained herein for DISTRIBUTION in the US ONLY. ©2024 Abbott. All rights reserved. MAT-2201720 v13.0
3

AVEIRTM VR DE NOVO AVEIRTM AR DE NOVO AVEIRTM DR DE NOVO & UPGRADES IMPORTANT SAFETY INFORMATION REFERENCES CLOSING
AVEIRTM VR de novo

MEDICARE COVERAGE
LEADLESS PACEMAKER THERAPY
The leadless pacemaker procedure using AVEIRTM 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 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 National Clinical Trial (NCT) Number Condition Code 30 Secondary Diagnosis Code
Q0 Modifier
Value codes

PROFESSIONAL CLAIM FORM (CMS 1500-837P)

INSTITUTIONAL CLAIM FORM (UB-04-837i)

05336877 (For paper claims, Report: CT05336877)

05336877

Not reported on Physician Claim

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

Q0 (Investigational clinical service provided in a clinical Q0 (Investigational clinical service provided in a

research study that is an approval clinical research

clinical research study that is an approved clinical

study)

research study)

Not applicable

D4 ("code") and NCT number ("amount")

AMVEEDIRICTMARVERCLOeaVdElReAssGPEaGceUmIDaEker Reimbursement Guide

Information contained herein for DISTRIBUTION in the US ONLY. ©2024 Abbott. All rights reserved. MAT-2201720 v13.0
4

AVEIRTM VR DE NOVO AVEIRTM AR DE NOVO AVEIRTM DR DE NOVO & UPGRADES IMPORTANT SAFETY INFORMATION REFERENCES CLOSING

AVEIRTM VR de novo

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 AVEIRTM 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.

FAQ
Is AVEIRTM VR Ventricular 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-forservice 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 AVEIRTM VR Ventricular LP, AVEIRTM VR Ventricular LP CED study to meet these coverage requirements and has obtained approval. The AVEIRTM VR Ventricular LP CED study has a clinical trial number to be utilized only for patients indicated for AVEIRTM VR Ventricular LP. How do I report that the AVEIRTM VR Ventricular 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 AVEIRTM VR Ventricular LP CED study is NCT05336877. Is the AVEIRTM VR Ventricular LP CED study study the same as AVEIRTM VR's Leadless Pacemaker FDA post-approval study (PAS)? No. They are two separate studies with two different NCT numbers. The AVEIRTM VR Ventricular 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 AVEIRTM VR Leadless Pacemaker implant procedures for any Medicare beneficiaries indicated for a leadless pacemaker and included in the AVEIRTM VR Ventricular LP CED study.
The inclusion of the AVEIRTM VR Ventricular LP CED study NCT number (NCT 05336877) is required for CMS coverage purposes.
The NCT number (NCT 05336877) assigned to the AVEIRTM VR Ventricular LP CED study is unique to the AVEIRTM VR Leadless Pacemaker. The inclusion of the unique AVEIRTM VR Ventricular LP CED study NCT number (NCT 05336877) is a requirement for CMS coverage for AVEIRTM VR LP procedures.

AMVEEDIRICTMARVERCLOeaVdElReAssGPEaGceUmIDaEker Reimbursement Guide

Information contained herein for DISTRIBUTION in the US ONLY. ©2024 Abbott. All rights reserved. MAT-2201720 v13.0
5

AVEIRTM VR DE NOVO AVEIRTM AR DE NOVO AVEIRTM DR DE NOVO & UPGRADES IMPORTANT SAFETY INFORMATION REFERENCES CLOSING
AVEIRTM VR de novo
COVERAGE WITH EVIDENCE DEVELOPMENT FAQs (continued)

FAQ
Does my hospital's Institutional Review Board (IRB) need to approve the AVEIRTM VR Ventricular LP CED study? The AVEIRTM VR Ventricular 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 AVEIRTM VR Ventricular 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) Is the AVEIRTM VR Ventricular LP CED study NCT number (NCT 05336877) required to be reported on private payer or Medicaid patient claims for coverage? The NCT number (NCT 05336877) does not apply to private payers or Medicaid. The AVEIRTM VR Ventricular LP CED study NCT number (NCT 05336877) is required for Medicare beneficiaries' coverage only, including Fee-For-Service and Medicare Advantage. 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.
AVEIRTM VR Ventricular LP CED study NCT number (NCT 05336877) is only required in connection with claims for coverage for Medicare beneficiaries.
AVEIRTM VR Ventricular LP CED study NCT number (NCT 05336877) is only required in connection with claims for coverage for Medicare beneficiaries.

AMVEEDIRICTMARVERCLOeaVdElReAssGPEaGceUmIDaEker Reimbursement Guide

Information contained herein for DISTRIBUTION in the US ONLY. ©2024 Abbott. All rights reserved. MAT-2201720 v13.0
6

AVEIRTM VR DE NOVO AVEIRTM AR DE NOVO AVEIRTM DR DE NOVO & UPGRADES IMPORTANT SAFETY INFORMATION REFERENCES CLOSING
AVEIRTM AR de novo

AVEIRTM AR Atrial Leadless Pacemaker System Introduction
The AVEIRTM AR 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 AVEIRTM AR Atrial LPs do not need a connector, pacing lead, or pulse generator pocket. The LP is delivered percutaneously via the femoral vein through an AVEIRTM 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 855569-6430 or HCE@abbott.com. Coding and reimbursement assistance is provided subject to the disclaimers set forth in this content.

MEDICARE COVERAGE GUIDE

Information contained herein for DISTRIBUTION in the US ONLY. ©2024 Abbott. All rights reserved. MAT-2201720 v13.0
7

AVEIRTM VR DE NOVO AVEIRTM AR DE NOVO AVEIRTM DR DE NOVO & UPGRADES IMPORTANT SAFETY INFORMATION REFERENCES CLOSING
AVEIRTM AR de novo

MEDICARE COVERAGE
LEADLESS PACEMAKER THERAPY
The leadless pacemaker procedure using AVEIRTM AR 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 National Clinical Trial (NCT) Number Condition Code 30 Secondary Diagnosis Code
Q0 Modifier
Value codes

PROFESSIONAL CLAIM FORM (CMS 1500-837P)

INSTITUTIONAL CLAIM FORM (UB-04-837i)

06100770 (For paper claims, Report: CT06100770)

06100770

Not reported on Physician Claim

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

Q0 (Investigational clinical service provided in a clinical Q0 (Investigational clinical service provided in a

research study that is an approval clinical research

clinical research study that is an approved clinical

study)

research study)

Not applicable

D4 ("code") and NCT number ("amount")

MEDICARE COVERAGE GUIDE

Information contained herein for DISTRIBUTION in the US ONLY. ©2024 Abbott. All rights reserved. MAT-2201720 v13.0
8

AVEIRTM VR DE NOVO AVEIRTM AR DE NOVO AVEIRTM DR DE NOVO & UPGRADES IMPORTANT SAFETY INFORMATION REFERENCES CLOSING

AVEIRTM AR de novo

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 AVEIRTM AR 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 AVEIRTMAR 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 AVEIRTM AR Atrial LP, AVEIRTM AR Atrial LP CED study to meet these coverage requirements and has obtained approval. The AVEIRTM AR Atrial LP CED study has a clinical trial number to be utilized only for patients indicated for AVEIRTM AR Atrial LP. How do I report that the AVEIRTM AR 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 AVEIRTM AR Atrial LP CED study is NCT06100770. Is the AVEIRTM AR Atrial LP CED study the same as AVEIRTM AR's Leadless Pacemaker FDA post-approval study (PAS)? No. They are two separate studies with two different NCT numbers. The AVEIRTM AR 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 AVEIRTM AR Leadless Pacemaker implant procedures for any Medicare beneficiaries indicated for a leadless pacemaker and included in the AVEIRTM AR Atrial LP CED study.
The inclusion of the AVEIRTM AR Atrial LP CED study NCT number (NCT 06100770) is required for CMS coverage purposes.
The NCT number (NCT 06100770) assigned to the AVEIRTM AR Atrial LP CED study is unique to the AVEIRTM AR Leadless Pacemaker. The inclusion of the unique AVEIRTM AR Atrial LP CED study NCT number (NCT 006100770) is a requirement for CMS coverage for AVEIRTM AR LP procedures.

MEDICARE COVERAGE GUIDE

Information contained herein for DISTRIBUTION in the US ONLY. ©2024 Abbott. All rights reserved. MAT-2201720 v13.0
9

AVEIRTM VR DE NOVO AVEIRTM AR DE NOVO AVEIRTM DR DE NOVO & UPGRADES IMPORTANT SAFETY INFORMATION REFERENCES CLOSING
AVEIRTM AR de novo

COVERAGE WITH EVIDENCE DEVELOPMENT FAQs (continued)

FAQ
Does my hospital's Institutional Review Board (IRB) need to approve the AVEIRTM AR Atrial LP CED study? The AVEIRTM AR 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 AVEIRTM AR 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) Is the AVEIRTM AR 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 AVEIRTM AR Atrial LP CED study NCT number (NCT 06100770) is required for Medicare beneficiaries' coverage only, including Fee-For-Service and Medicare Advantage. 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.
AVEIRTM AR 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.

MEDICARE COVERAGE GUIDE

Information contained herein for DISTRIBUTION in the US ONLY. ©2024 Abbott. All rights reserved. MAT-2201720 v13.0
10

AVEIRTM VR DE NOVO AVEIRTM AR DE NOVO AVEIRTM DR DE NOVO & UPGRADES IMPORTANT SAFETY INFORMATION REFERENCES CLOSING
AVEIRTM DR de novo & Upgrades

AVEIRTM DR Dual Chamber Leadless Pacemaker System Introduction
The AVEIRTM 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 AVEIRTM 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 AVEIRTM 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 855569-6430 or HCE@abbott.com. Coding and reimbursement assistance is provided subject to the disclaimers set forth in this content.

MEDICARE COVERAGE GUIDE

Information contained herein for DISTRIBUTION in the US ONLY. ©2024 Abbott. All rights reserved. MAT-2201720 v13.0
11

AVEIRTM VR DE NOVO AVEIRTM AR DE NOVO AVEIRTM DR DE NOVO & UPGRADES IMPORTANT SAFETY INFORMATION REFERENCES CLOSING
AVEIRTM DR de novo & Upgrades

MEDICARE COVERAGE
LEADLESS PACEMAKER THERAPY
The leadless pacemaker procedure using AVEIRTM 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 NCD: Leadless Pacemakers (20.8.4) for more information https://www.cms.gov/medicarecoverage-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 National Clinical Trial (NCT) Number Condition Code 30 Secondary Diagnosis Code
Q0 Modifier
Value codes

PROFESSIONAL CLAIM FORM (CMS 1500-837P)

INSTITUTIONAL CLAIM FORM (UB-04-837i)

05932602 (For paper claims, Report: CT05932602)

05932602

Not reported on Physician Claim

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

Q0 (Investigational clinical service provided in a clinical Q0 (Investigational clinical service provided in a

research study that is an approval clinical research

clinical research study that is an approved clinical

study)

research study)

Not applicable

D4 ("code") and NCT number ("amount")

MEDICARE COVERAGE GUIDE

AVEIRTM VR DE NOVO AVEIRTM AR DE NOVO AVEIRTM DR DE NOVO & UPGRADES IMPORTANT SAFETY INFORMATION REFERENCES CLOSING

AVEIRTM DR de novo & Upgrades

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 AVEIRTM 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.

FAQ
Is AVEIRTM DR Dual Chamber 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 AVEIRTM DR Dual Chamber LP, AVEIRTM DR Dual Chamber LP CED study to meet these coverage requirements and has obtained approval. The AVEIRTM DR Dual Chamber LP CED study study has a clinical trial number to be utilized only for patients indicated for AVEIRTM DR Dual Chamber LP. How do I report that the AVEIRTM DR Dual Chamber 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 AVEIRTM DR Dual Chamber LP CED study is NCT05932602.
Is the AVEIRTM DR Dual Chamber LP CED study the same as AVEIRTM DR Dual Chamber Leadless Pacemaker's FDA post-approval study (PAS)? No. They are two separate studies with two different NCT numbers. The AVEIRTM DR Dual Chamber LP CED 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 AVEIRTM DR Dual Chamber Leadless Pacemaker Leadless Pacemaker implant procedures for any Medicare beneficiaries indicated for a leadless pacemaker and included in the AVEIRTM DR Dual Chamber LP CED study.
The inclusion of the AVEIRTM DR Dual Chamber LP CED study NCT number (NCT 05932602) is required for CMS coverage purposes.
The NCT number (NCT 05932602) assigned to the AVEIRTM DR Dual Chamber LP CED study is unique to the AVEIRTM DR Dual Chamber LP. The inclusion of the unique ACED study NCT number (NCT 05932602) is a requirement for CMS coverage for AVEIRTM DR Dual Chamber LP procedures.

MEDICARE COVERAGE GUIDE

AVEIRTM VR DE NOVO AVEIRTM AR DE NOVO AVEIRTM DR DE NOVO & UPGRADES IMPORTANT SAFETY INFORMATION REFERENCES CLOSING
AVEIRTM DR de novo & Upgrades

COVERAGE WITH EVIDENCE DEVELOPMENT FAQs (continued)

FAQ
Does my hospital's Institutional Review Board (IRB) need to approve the AVEIRTM DR Dual Chamber LP CED study? The AVEIRTM DR Dual Chamber 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 AVEIRTM DR Dual Chamber LP CED 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) Is the AVEIRTM DR Dual Chamber LP CED NCT number (NCT 05932602) required to be reported on private payer or Medicaid patient claims for coverage? The NCT number (NCT 05932602) does not apply to private payers or Medicaid. The AVEIRTM DR Dual Chamber LP CED NCT number (NCT 05932602) is required for Medicare beneficiaries' coverage only, including Fee-For-Service and Medicare Advantage. 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.
AVEIRTM DR Dual Chamber LP CED study NCT number (NCT 05932602) is only required in connection with claims for coverage for Medicare beneficiaries. Please contact the Abbott team using these channels when needed.

MEDICARE COVERAGE GUIDE

AVEIRTM VR DE NOVO AVEIRTM AR DE NOVO AVEIRTM DR DE NOVO & UPGRADES IMPORTANT SAFETY INFORMATION REFERENCES CLOSING
AVEIRTM DR de novo & Upgrades

COVERAGE WITH EVIDENCE DEVELOPMENT FAQs (continued)

FAQ
If a patient with an existing AVEIRTM VR ventricular leadless pacemaker is being upgraded to a dual chamber leadless pacemaker with an AVEIRTM AR atrial component, what NCT number would apply? NCT 05932602 for the AVEIRTM DR Dual Chamber LP CED Study, as these patients are now receiving dual chamber leadless pacing therapy post procedure.
If a patient with an existing AVEIRTM AR atrial leadless pacemaker is being upgraded to a dual chamber leadless pacemaker with an AVEIRTM VR ventricular component, what NCT number would apply? NCT 05932602 for the AVEIRTM DR Dual Chamber LP CED Study, as these patients are now receiving dual chamber leadless pacing therapy post procedure.

WHAT DOES THIS MEAN FOR MY HOSPITAL?
AVEIRTM DR Dual Chamber LP CED study NCT number (NCT 05932602) is applicable to patients receiving AVEIRTM Dual Chamber leadless pacing capabilities.
AVEIRTM DR Dual Chamber LP CED study NCT number (NCT 05932602) is applicable to patients receiving AVEIRTM Dual Chamber leadless pacing capabilities.

MEDICARE COVERAGE GUIDE

AVEIRTM VR DE NOVO AVEIRTM AR DE NOVO AVEIRTM DR DE NOVO & UPGRADES IMPORTANT SAFETY INFORMATION REFERENCES CLOSING
AVEIRTM VR Ventricular 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 AveirTM 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 AveirTM 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 AveirTM 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 AveirTM 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 AveirTM 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).

MEDICARE COVERAGE GUIDE

AVEIRTM VR DE NOVO AVEIRTM AR DE NOVO AVEIRTM DR DE NOVO & UPGRADES IMPORTANT SAFETY INFORMATION REFERENCES CLOSING
AVEIRTM AR Atrial 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 AVEIRTM 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 AVEIRTM 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, Endocarditis, Valve damage 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 capture, pacing or sensing (non-battery related), Oversensing, Increased capture threshold, Inappropriate sensor response, Corrupted, intermittent, or loss of i2i communications, 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, Inability to release/re-dock of the LP from the catheter, Helix distortion), Additional surgery or intervention, 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 dyspnea, respiratory failure, pneumonia, hypertension, cardiac failure, reaction to sedation, renal failure, anemia, and death.

MEDICARE COVERAGE GUIDE

AVEIRTM VR DE NOVO AVEIRTM AR DE NOVO AVEIRTM DR DE NOVO & UPGRADES IMPORTANT SAFETY INFORMATION REFERENCES CLOSING
AVEIRTM 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 AVEIRTM 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 AVEIRTM 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, Endocarditis, Valve damage 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 capture, pacing or sensing (non-battery related), Oversensing, Increased capture threshold, Inappropriate sensor response, Corrupted, intermittent, or loss of i2i communications, 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, Inability to release/re-dock of the LP from the catheter, Helix distortion), Additional surgery or intervention, 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 dyspnea, respiratory failure, pneumonia, hypertension, cardiac failure, reaction to sedation, renal failure, anemia, and death.

MEDICARE COVERAGE GUIDE

AVEIRTM VR DE NOVO AVEIRTM AR DE NOVO AVEIRTM DR DE NOVO & UPGRADES IMPORTANT SAFETY INFORMATION REFERENCES CLOSING
1. FY2025 IPPS Interim Final Comment Rule Home Page. U.S. Centers for Medicare and Medicaid Services. [cited: November 2024]. https://www.cms.gov/medicare/payment/prospective-payment-systems/acute-inpatient-pps/fy-2025-ipps-final-rule-home-page
2. CY2025 MPFS Final Rule Home Page. U.S. Centers for Medicare and Medicaid Services. [cited: November 2024]. https://www.cms.gov/medicare/payment/fee-schedules/physician/federal-regulation-notices/cms-1807-f
3. CY2025 OPPS Final Rule Home Page. U.S. Centers for Medicare and Medicaid Services. [cited: November 2024]. https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/regulations-notices/cms-1809-fc
4. CMS 2025 ICD-10-CM [cited: November 2024]. https://www.cms.gov/medicare/coding-billing/icd-10-codes#CodeFiles
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. 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
8. Aveir DR Coverage With Evidence Development Post-Approval Study (CED) [cited: November 2023] https://clinicaltrials.gov/study/NCT05932602
9. Aveir AR Coverage With Evidence Development Post-Approval Study (CED) [cited: April 2024] https://clinicaltrials.gov/study/NCT06100770?lead=Abbott%20Medical%20Devices&rank=5
10. 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=AOvVaw0ZTX9 92B4EB2S5k76J8slK&opi=89978449
11. AMA CPT Category III codes long [cited: January 2024] https://www.ama-assn.org/system/files/cpt-category3-codes-long-descriptors.pdf
12. National Coverage Determination Leadless Pacemakers 20.8.4 [cited: January 2024] https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=370
13. 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
14. CMS New Technology Add-on Payment [cited: April 2024] https://www.cms.gov/medicare/payment/prospective-payment-systems/acute-inpatient-pps/new-medical-services-and-new-technologies
15. CMS 1500 Claim Form [cited: April 2024] https://www.cms.gov/medicare/cms-forms/cms-forms/downloads/cms1500.pdf
16. CMS UB-04 Claim Form [cited: April 2024] https://www.cms.gov/regulations-and-guidance/legislation/paperworkreductionactof1995/downloads/cms-1450.zip
17. Pass-Through Payment Status and New Technology Ambulatory Payment Classification (APC) [cited: May 2024] https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/pass-through-payment-status-new-technology-ambulatory-payment-classification-apc
18. Device Offset Code Pairs [cited: September 2024] https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient-pps/device-offset-code-pairs

MEDICARE COVERAGE GUIDE

AVEIRTM VR DE NOVO AVEIRTM AR DE NOVO AVEIRTM DR DE NOVO & UPGRADES IMPORTANT SAFETY INFORMATION REFERENCES CLOSING
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 Abbott One St. Jude Medical Dr., St. Paul, MN 55117, USA, Tel: 1 651 756 2000 TM 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 v13.0 | Item approved for U.S. use only.
20

References

pdftk-java 3.0.9 itext-paulo-155 (itextpdf.sf.net-lowagie.com)

[PDF] AVEIRâ¢ LEADLESS PACEMAKER SYSTEM - Abbott Cardiovascular www.cardiovascular.abbott âº reimbursement âº crm âº coding-coverage

AVEIR Medicare Coverage Coding Guide

References

[PDF] AVEIRâ¢ LEADLESS PACEMAKER SYSTEM - Abbott Cardiovascular www.cardiovascular.abbott âº reimbursement âº crm âº coding-coverage