ABBOTT CODING GUIDE STRUCTURAL HEART AND VALVES CONGENITAL DEFECTS SURGICAL HEART VALVES AMPLATZER PFO OCCLUDER. Effective January 1, 2019

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EFFECTIVE JANUARY 2019

SUPPLEMENTAL MATERIAL

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ABBOTT CODING GUIDE STRUCTURAL HEART AND VALVES Effective January 1, 2019

STRUCTURAL HEART AND VALVES Effective Janaury 1, 2019 Introduction The Structural Heart and Valves Coding Guide is intended to provide reference material related to the reimbursement of Abbott products when used consistently with their labeling. Reimbursement Hotline In addition, 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. This guide and all supporting documents are available at https:// www.cardiovascular.abbott/us/en/hcp/reimbursement/structural-heart.html. Coding and reimbursement assistance is provided subject to the disclaimers set forth in this guide. Disclaimer This document and the information contained herein is for general information purposes only and is not intended and does not constitute legal, reimbursement, coding, business or other advice. Furthermore, it is not intended to increase or maximize payment by any payer. Nothing in this document should be construed as a guarantee by Abbott regarding levels of reimbursement, payment or charge, or that reimbursement or other payment will be received. Similarly, nothing in this document should be viewed as instructions for selecting 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. Also note that the information presented herein represents only one of many potential scenarios, based on the assumptions, variables and data presented. In addition, the customer should note that laws, regulations, coverage and coding policies are complex and updated frequently. Therefore, the customer should check with their local carriers or intermediaries often and should consult with legal counsel or a financial, coding or reimbursement specialist for any coding, reimbursement or billing questions or related issues. This information is for reference purposes only. It is not provided or authorized for marketing use.

PHYSICIAN CODING HOSPITAL OUTPATIENT HOSPITAL INPATIENT ADDITIONAL CODES ABBOTT CODING GUIDE Effective January 1, 2019

PHYSICIAN CODING HOSPITAL OUTPATIENT HOSPITAL INPATIENT ADDITIONAL CODES CODING AND REIMBURSEMENT FOR Physician 1 CPT CODE ATRIAL SEPTAL DEFECT/PATENT FORAMEN OVALE 93580 Percutaneous transcatheter closure of congenital interatrial communication (i.e., fontan fenestration, atrial septal defect) with implant PATENT DUCTUS ARTERISUS WORK RVU NATIONAL MEDICARE RATE FACILITY NON FACILITY 17.97 $1,025 NA 93582 Percutaneous transcatheter closure of patent ductus arteriosus 12.31 $700 NA VENTRICULAR SEPTAL DEFECT 93581 Percutaneous transcatheter closure of congenital ventricular septal defect with implant 24.39 $1,397 NA It is incumbent upon the physician to determine which, if any modifiers should be used first. Effective Dates: January 1, 2019 - December 31, 2019

PHYSICIAN CODING HOSPITAL OUTPATIENT HOSPITAL INPATIENT ADDITIONAL CODES CODING AND REIMBURSEMENT FOR Hospital Outpatient 2 CPT CODE STATUS INDICATOR APC NATIONAL MEDICARE RATE ATRIAL SEPTAL DEFECT 93580 Percutaneous transcatheter closure of congenital interatrial communication (i.e., fontan fenestration, atrial septal defect) with implant PATENT DUCTUS ARTERIOSUS J1 5194 $15,355 93582 Percutaneous transcatheter closure of patent ductus arteriosus J1 5194 $15,355 VENTRICULAR SEPTAL DEFECT 93581 Percutaneous transcatheter closure of congenital ventricular septal defect with implant J1 5194 $15,355 J1 = Hospital Part B services paid through a comprehensive APC Effective Dates: January 1, 2019 - December 31, 2019

PHYSICIAN CODING HOSPITAL OUTPATIENT HOSPITAL INPATIENT ADDITIONAL CODES PAGE 1 PAGE 2 CODING AND REIMBURSEMENT FOR Hospital Inpatient 3 ICD-10 PCS CODE TYPICAL MS-DRG ASSIGNMENT NATIONAL MEDICARE RATE PATENT DUCTUS ARTERIOSUS 270 with MCC $30,924 02LR3DT Occlusion of ductus ateriosis with intraluminal device, percutaneous 271 with CC $21,345 272 without CC/MCC $15,995 *For vascular plug ICD-10 PCS position four code, please click on Additonal Codes, and then Vessel Location Effective Dates: October 1, 2018 - September 30, 2019

PHYSICIAN CODING HOSPITAL OUTPATIENT HOSPITAL INPATIENT ADDITIONAL CODES PAGE 1 PAGE 2 CODING AND REIMBURSEMENT FOR Hospital Inpatient 3 ICD-10 PCS CODE TYPICAL MS-DRG ASSIGNMENT NATIONAL MEDICARE RATE ATRIAL SEPTAL DEFECT 02U53JZ Supplement atrial septum with synthetic substitute, percutaneous approach 273 with MCC $22,314 274 without MCC $18,196 VENTRICULAR SEPTAL DEFECT 02UM3JZ Supplement ventriclar septum with synthetic substitute, percutaneous approach 228 with MCC $40,176 229 without MCC $28,399 Effective Dates: October 1, 2018 - September 30, 2019

PHYSICIAN CODING HOSPITAL OUTPATIENT HOSPITAL INPATIENT ADDITIONAL CODES C-CODES DIAGNOSIS CODING AND REIMBURSEMENT FOR HCPCS Device Category C-Codes 5 C-CODE C1817 C1769 C1766 Septal defect implant system, intracardiac Guide wire Introducer/sheath, guiding, intracardiac electrophysiological, steerable, other than peel-away Effective Dates: January 1, 2019 - December 31, 2019

PHYSICIAN CODING HOSPITAL OUTPATIENT HOSPITAL INPATIENT ADDITIONAL CODES C-CODES DIAGNOSIS CODING AND REIMBURSEMENT FOR ICD-10-CM Diagnosis Codes 4 Diagnosis codes are used by both hospitals and physicians to document the indication for the procedure. For Structural Heart and Valve 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. Effective Dates: January 1, 2019 - December 31, 2019

PHYSICIAN CODING HOSPITAL INPATIENT ADDITONAL CODES ABBOTT CODING GUIDE Effective January 1, 2019

PHYSICIAN CODING HOSPITAL INPATIENT ADDITONAL CODES CODING AND REIMBURSEMENT FOR Physician 1 CPT CODE AND ANNULOPLASTY RINGS 33405 Replacement, aortic valve, open, with cardiopulmonary bypass; with prosthetic valve other than homograft or stentless valve WORK RVU NATIONAL MEDICARE RATE FACILITY NON FACILITY 41.32 $2,367 NA 33411 Replacement, aortic valve; with aortic annulus enlargement, noncoronary sinus 62.07 $3,508 NA 33412 Replacement, aortic valve, with transventricular aortic annulus enlargement (Konno procedure) 59.00 $3,282 NA 33425 Valvuloplasty, mitral valve, with cardiopulmonary bypass 49.96 $2,849 NA 33426 Valvuloplasty, mitral valve, with cardiopulmonary bypass; with prosthetic ring 43.28 $2,486 NA 33427 Valvuloplasty, mitral valve, with cardiopulmonary bypass; radical reconstruction, with or without ring 44.83 $2,552 NA 33430 Replacement, mitral valve, with cardiopulmonary bypass 50.93 $2,921 NA 33464 Valvuloplasty, tricuspid valve, with ring insertion 44.62 $2,548 NA It is incumbent upon the physician to determine which, if any modifiers should be used first. Effective Dates: January 1, 2019 - December 31, 2019

PHYSICIAN CODING HOSPITAL INPATIENT ADDITONAL CODES CODING AND REIMBURSEMENT FOR Hospital Inpatient 3 ICD-10 PCS CODE TYPICAL MS-DRG ASSIGNMENT NATIONAL MEDICARE RATE AND ANNULOPLASTY RINGS 02QF0ZZ Repair aortic valve, open approach 216 with MCC $59,999 02QG0ZZ Repair mitral valve, open approach 217 with CC $38,872 02QJ0ZZ Repair tricuspid valve, open approach 218 without CC/MCC $36,077 02RF0JZ 02RF08Z 02RG0JZ 02RG08Z Replacement of aortic valve with synthetic substitute, open approach Replacement of aortic valve with zooplastic tissue, open approach Replacement of mitral valve with synthetic substitute, open approach Replacement of mitral valve with zooplastic tissue, open approach 219 with MCC 220 with CC 221 without CC/MCC $46,990 $31,801 $28,148 Notes: Surgical heart valve procedures are not allowed in Outpatient or Non-Facility settings. Level II HCPCS codes, including C-codes, are not applicable to surgical valve procedures. C-codes are used in conjucntion with the Medicare prospective payment system for outpatient procedures only. Effective Dates: October 1, 2018 - September 30, 2019

PHYSICIAN CODING HOSPITAL INPATIENT ADDITONAL CODES CODING AND REIMBURSEMENT FOR ICD-10-CM Diagnosis Codes 4 Diagnosis codes are used by both hospitals and physicians to document the indication for the procedure. For Surgical Heart and Valve patients, there are many possible diagnosis code scenarios and a wide variety of possible combinations. The possible scenarios ICD-10-CM 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.

PHYSICIAN - HOSPITAL OUTPATIENT - INPATIENT CODING ADDITIONAL CODES ABBOTT CODING GUIDE Effective January 1, 2019

PHYSICIAN - HOSPITAL OUTPATIENT - INPATIENT CODING ADDITIONAL CODES CODING AND REIMBURSEMENT FOR Physician 1 CPT CODE 93580 Percutaneous transcatheter closure of congenital interatrial communication (i.e., Fontan fenestration, atrial septal defect) with implant WORK RVU NATIONAL MEDICARE RATE FACILITY NON FACILITY 17.97 $1,025 NA Effective Dates: January 1, 2019 - December 31, 2019 Hospital Outpatient 2 CPT CODE 93580 Percutaneous transcatheter closure of congenital interatrial communication (i.e., Fontan fenestration, atrial septal defect) with implant STATUS INDICATOR APC NATIONAL MEDICARE RATE J1 5194 $15,355 J1 = Hospital Part B services paid through a comprehensive APC Effective Dates: January 1, 2019 - December 31, 2019 Hospital Inpatient 3 ICD-10 PCS CODE TYPICAL MS-DRG ASSIGNMENT NATIONAL MEDICARE RATE 02U53JZ Supplement atrial septum with synthetic substitute, percutaneous approach 273 $22,314 274 $18,196 Effective Dates: October 1, 2018 - September 30, 2019 It is incumbent upon the physician to determine which, if any modifiers should be used first.

PHYSICIAN - HOSPITAL OUTPATIENT - INPATIENT CODING ADDITIONAL CODES C-CODES DIAGNOSIS CODING AND REIMBURSEMENT FOR HCPCS Device Category C-Codes 5 C-CODE C1817 C1769 C1766 Septal defect implant system, intracardiac Guidewire Introducer/sheath, guiding, intracardiac electrophysiological, steerable, other than peel-away closure device, vasular (implantable/ insertable) Effective Dates: January 1, 2019 - December 31, 2019

PHYSICIAN - HOSPITAL OUTPATIENT - INPATIENT CODING ADDITIONAL CODES C-CODES DIAGNOSIS CODING AND REIMBURSEMENT FOR ICD-10-CM Diagnosis Codes 4 ICD-10-CM Q21.1 Atrial septal defect While there are no ICD-10-CM diagnosis codes to specifically describe cryptongenic stroke (CS) as a secondary condition, there is only one generic ICD-10-CM diagnosis code for ischemic stroke with no specification as to the type of the cerbrovascular condition which could be used for reporting of the CS: 163.9, Cerebral infarction, unspecified Claims submission to a majority of U.S. private insurance companies is often driven by the existance of specific coding to explain the services requested. Payers will often require additional information on the claim form, or in addition to the claim form, in order to adjudicate the claims. Documentation requirements may vary by payer, however, at minimum, the following documentation should be provided. Description of test results performed to confirm PFO Description of test results confirming CS and likelihood of PFO involvement (other causes of stroke should be ruled out).

References 1. Physician Prospective Payment-Final rule with Comment Period and Final CY2019 Payment Rates. CMS-1693-F: https://www.cms.gov/medicare/medicare-fee-for-service-payment/physicianfeesched/pfs- Federal-Regulation-Notices-Items/CMS-1693-F.html 2. Hospital Outpatient Prospective Payment-Final Rule with Comment Period and Final CY2019 Payment Rates. CMS-1695-FC: https://www.cms.gov/medicare/medicare-fee-for-service-payment/ HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices-Items/CMS-1695-FC.html 3. Hospital Inpatient Prospective Payment-Final Rule with Comment Period and Final FY2019 Payment Rates. CMS-1694-F: https://www.cms.gov/medicare/medicare-fee-for-service-payment/ AcuteInpatientPPS/FY2019-IPPS-Final-Rule-Home-Page-Items/FY2019-IPPS-Final-Rule-Regulations.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=ascending 4. American Medical Association 2019 ICD-10-CM: The Complete Official Codebook. Edition 1; 2019. 5. CMS, 2019 Alpha-Numeric Index HCPS code set: https://www.cms.gov/medicare/coding/hcpcsreleasecodesets/alpha-numeric-hcpcs-items/2019-alpha-numeric-hcpcs-file. html?dlpage=1&dlentries=10&dlsort=0&dlsortdir=descending 6. CMS 2019 ICD-10-PCS Procedure Coding System and Index: https://www.cms.gov/medicare/coding/icd10/2019-icd-10-pcs.html CAUTION: Products in this guide are 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 medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. Abbott 3200 Lakeside Dr., Santa Clara, CA 95054 USA Tel: 1.800.227.9902 cardiovascular.abbott Indicates a trademark of the Abbott group of companies. Indicates a third party trademark, which is property of its respective owner. 2019 Abbott. All Rights Reserved. SJM-HER-0917-0101(4) Item approved for U.S. use only.