TRANSCATHETER AORTIC VALVE REPLACEMENT …

1 Physician Coding And ReimbursementBilling requirements for physician claims Append modifiers 62 and Q0 (zero) to the CPT 1 procedure code 33361-33365 Diagnosis code - Encounter for examination for normal comparison and control in clinical research program Place of Service 21 Inpatient hospital Enter the 8 digit registry number preceded by CT in field 19 of the CMS 1500 paper claim form CPT Code 1 CPT Description12018 Work RVUs22018 Total Facility RVUs22018 Medicare National Average2 Modifier -62 Payment for EACH Provider. Payment is of Total Payment*33361 TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR/TAVI) with prosthetic VALVE ; percutaneous femoral artery $1,421$88833362 TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR/TAVI) with prosthetic VALVE ; open femoral artery $1,551$96933363 TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR/TAVI) with prosthetic VALVE ; open axillary artery $1,608$1,00533364 TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR/TAVI) with prosthetic VALVE ; open iliac artery $1,694$1,05933365 TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR/TAVI) with prosthetic VALVE ; transaortic approach (eg, median sternotomy, mediastinotomy) $1,863$1,165 Add-on Codes 33367 TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR/TAVI) with prosthetic VALVE .

2 Cardiopulmonary bypass support with percutaneous peripheral arterial and venous cannulation (eg femoral vessels) (List separately in addition to code for primary procedure) $657Do not use 62-modifier33368 TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR/TAVI) with prosthetic VALVE ; cardiopulmonary bypass support with open peripheral arterial and venous cannulation (eg, femoral, iliac, axillary vessels) (List separately in addition to code for primary procedure) $781Do not use 62-modifier33369 TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR/TAVI) with prosthetic VALVE ; cardiopulmonary bypass support with central arterial and venous cannulation (eg, aorta, right atrium, pulmonary artery) (List separately in addition to code for primary procedure) $1,031Do not use 62-modifier Add-on codes 33367-33369 for cardiopulmonary bypass during the TAVR/TAVI procedure, when performed, are billed by the cardiac surgeon only as applicable.

3 These codes do not require appending modifier 62. 1 CPT copyright 2018 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Restrictions Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained CY2018 payment calculated with the Conversion Factor (CF) $ CMS CY 2018 Medicare Physician Fee Schedule Final Rule. Available at: CMS may make adjustments to any or all of the data inputs from time to time without notice.

4 *CMS has indicated for selected procedures the -62 modifier is required for CardioVascular Reimbursement Hotline: 1-866-616-8400 TRANSCATHETER AORTIC VALVE REPLACEMENT 2018 CODING AND REIMBURSEMENTThis information is provided for your consideration. It is the provider s responsibility to determine and submit appropriate codes, modifiers, and charges for the services Billing DetailDifferences in Physician Billing RequirementsAll TAVR Claims: FDA-Approved Indications and IDE Clinicals TrialsITEM AND CODE INSTRUCTIOND iagnosis - Encounter for examination for normal comparison and control in clinical research programPlace of Service21 Inpatient hospitalCPT Procedure Codes33361-33365 for TAVR procedureModifiers62 Two surgeons/ co-surgeonsQ0 (zero) Participation in a qualifying registry or qualified clinical study Differences in Submitting Claims for FDA-Approved Indications vs.

5 IDE Clinical TrialsITEM AND CODE INSTRUCTIONForm TypeItemFDA-Approved IndicationsIDE Clinical Trials (Information is for illustration only)Paper FormCMS-1500 Item 19(Addl Claim Information)CT 01737528(CT + Registry #)CT 99999999 (CT + NCT #)Item 23(PAN used for IDE #)N/AG999999 (IDE #)Electronic Form837pLoop 2300 REF02 (REF01=P4)(Addl Claim Information)01737528(Registry #)99999999(NCT #)Segment 2300, REF02(REF01=LX)(PAN used for IDE #)N/AG999999(IDE #)FL: Form Locator NCT: National Clinical Trial Number IDE: Investigational Device ExemptionSources: TAVR Claims Processing Instructions: CHANGE REQUEST 8401: DisclaimerReimbursement information provided by medtronic is for illustrative purposes only and does not constitute legal advice. Information provided is gathered from third party sources and is subject to change without notice due to frequently changing laws, rules and regulations.

6 medtronic makes no guarantee that the use of this information will prevent differences of opinion or disputes with Medicare or other third party payers as to the correct form of billing or the amount that will be paid to providers of service. The provider of service has the responsibility to determine medical necessity and to submit appropriate codes and charges for care provided. Please contact your local payers, reimbursement specialists and/or legal counsel for interpretation of coding, coverage, and payment policies. medtronic does not promote the use of its products outside FDA-approved // CardioVascular Reimbursement Hotline: 1-866-616-8400 INDICATIONS The medtronic CoreValve and CoreValve Evolut R systems are indicated for use in patients with symptomatic heart disease due to either severe native calcific AORTIC stenosis or failure (stenosed, insufficient, or combined) of a surgical bioprosthetic AORTIC VALVE who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (ie, Society of Thoracic Surgeons predicted risk of operative mortality score 8% or at a 15% risk of mortality at 30 days).

7 CONTRAINDICATIONS The CoreValve and CoreValve Evolut R systems are contraindicated for patients presenting with any of the following conditions: known hypersensitivity or contraindication to aspirin, heparin (HIT/HITTS) and bivalirudin, ticlopidine, clopidogrel, Nitinol (Titanium or Nickel), or sensitivity to contrast media, which cannot be adequately premedicated; ongoing sepsis, including active endocarditis; preexisting mechanical heart VALVE in AORTIC General Implantation of the CoreValve and CoreValve Evolut R systems should be performed only by physicians who have received medtronic CoreValve training. This procedure should only be performed where emergency AORTIC VALVE surgery can be performed promptly.

8 Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. TRANSCATHETER AORTIC VALVE (Bioprosthesis) Accelerated deterioration of the bioprosthesis may occur in patients presenting with an altered calcium General The safety and effectiveness of the CoreValve and CoreValve Evolut R systems have not been evaluated in the pediatric population. The safety and effectiveness of the bioprosthesis for AORTIC VALVE REPLACEMENT have not been evaluated in the following patient populations: patients who do not meet the criteria for symptomatic sever native AORTIC stenosis as defined: (1) symptomatic severe high gradient AORTIC stenosis AORTIC VALVE area or AORTIC VALVE area index cm2/m2, a mean AORTIC VALVE gradient 40 mmHg; or a peak AORTIC -jet velocity m/s, (2) symptomatic severe low-flow/low-gradient AORTIC stenosis AORTIC VALVE area or AORTIC VALVE area index cm2/m2, a mean AORTIC VALVE gradient <40 mmHg; and a peak AORTIC -jet velocity < m/s ; who are at moderate or low surgical risk (predicted perioperative mortality risk of <15%).

9 With untreated, clinically significant coronary artery disease requiring revascularization; with a preexisting prosthetic heart VALVE with a rigid support structure in either the mitral or pulmonic position if either the preexisting prosthetic heart VALVE could affect the implantation or function of the bioprosthesis or the implantation of the bioprosthesis could affect the function of the preexisting prosthetic heart VALVE ; with cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support. The safety and effectiveness of a CoreValve or CoreValve Evolut R bioprosthesis implanted within a failed preexisting TRANSCATHETER bioprosthesis has not been demonstrated. Implanting a CoreValve or CoreValve Evolut R bioprosthesis in a degenerated surgical bioprosthesis [ TRANSCATHETER AORTIC VALVE in surgical AORTIC VALVE (TAV in SAV)] should be avoided in the following conditions.

10 The degenerated surgical bioprosthesis presents with a: significant concomitant perivalvular leak (between the prosthesis and the native annulus), is not securely fixed in the native annulus, or is not structurally intact (eg, wireform frame fracture); partially detached leaflet that in the AORTIC position may obstruct a coronary ostium; stent frame with a manufacturer s labeled inner diameter <17 mm. The safety and effectiveness of the bioprosthesis for AORTIC VALVE REPLACEMENT have not been evaluated in patient populations presenting with the following: blood dyscrasias as defined: leukopenia (WBC <1000 cells/mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states; congenital bicuspid or unicuspid VALVE ; mixed AORTIC VALVE disease ( AORTIC stenosis and AORTIC regurgitation with predominant AORTIC regurgitation [3-4+]); moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation; hypertrophic obstructive cardiomyopathy; new or untreated echocardiographic evidence of intracardiac mass, thrombus, or vegetation.