Cardiac CryoAblation Catheter) GUIDE - …

1 EN Medtronic 2015. Minneapolis, MN. All Rights Reserved. Printed in USA. 10/2015 Medtronic710 Medtronic Parkway Minneapolis, MN 55432-5604 USA Tel: (763) 514-4000 Fax: (763) 514-4879 Toll-free: 1 (800) 328-2518(24-hour technical support for physicians and medical professionals) Updated October 1, 2015 CATHETER ABLATION REIMBURSEMENT GUIDER eferences1 International Classification of Diseases, Ninth Revision of Clinical Modification. 2 International Classification of Diseases, Tenth Revision, Procedure Coding System. 3 International Classification of Diseases, Tenth Revision, Clinical Modification. Social Security Act Section 1862 42 1395y(a)(1)(A), is available at Current Procedural Terminology (CPT) is copyright 2014 American Medical Association.

2 All Rights Reserved. No fee schedules, basic units, relative causes or related listings are included in CPT. The AMA assumes no liability for the data contained herein. 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 the data contained or not contained Statement (for Arctic Front Advance Cardiac CryoAblation Catheter, CryoConsole and Freezor MAX Cardiac CryoAblation Catheter) IndicationsMedtronic CryoCath CryoAblation system is comprised of CryoAblation catheters and a CryoConsole.

3 The Arctic Front Advance ST Cardiac CryoAblation Catheter system is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The Freezor MAX Cardiac CryoAblation Catheter is used as an adjunctive device in the endocardial treatment of paroxysmal atrial f ibrillation in conjunction with the Arctic Front Advance Cryoballoon. Please read the specif ic product labeling indications for use before using the CryoAblation of Arctic Front Advance ST Cryoballoon is contraindicated as follows: n in the ventricle because of the danger of catheter entrapment in the chordae tendinaen in patients with active systemic infectionsn in conditions where the manipulation of the catheter within the heart would be unsafe ( ,intracardiac mural thrombus)n in patients with cryoglobulinemian in patients with one or more pulmonary vein stentsUse of Freezor MAX cryocatheter is contraindicated in patients with the following conditions.

4 N active systemic infectionsn cryoglobulinemian other conditions where the manipulation of the catheter would be unsafe ( , intracardiac mural thrombus)Warnings and PrecautionsDo not resterilize the CryoAblation catheters for purpose of reuse. Use only the appropriate size of the FlexCath Steerable Sheath family with the Arctic Front Advance CryoAblation catheters because using another sheath may damage the catheter or balloon segment. Do not inf late the balloon inside the sheath. Always verify with f luoroscopy or by using the proximal shaft visual marker that the balloon is fully outside the sheath before inf lation to avoid catheter damage. Do not position the balloon within the tubular portion of the pulmonary vein to minimize phrenic nerve injury and pulmonary vein stenosis.

5 Do not connect the CryoAblation catheter to a radiofrequency (RF) generator or use it to deliver RF energy because this may cause catheter malfunction or patient harm. The catheter contains pressurized refrigerant during operation; release of this gas into the circulatory system due to equipment failure or misuse could result in gas embolism, which can occlude vessels and lead to tissue infarction with serious consequences. Always advance and withdraw components slowly to minimize the vacuum created and therefore minimize the risk of air embolism. Do not pull on the catheter, sheath, umbilical cables, or console while the catheter is frozen to the tissue, as this may lead to tissue injury. Do not advance the balloon beyond the GUIDE wire to reduce risk of tissue damage.

6 Do not pass the catheter through a prosthetic heart valve (mechanical or tissue) to avoid damage to the valve, valvular insuff iciency, or premature failure of the prosthetic valve. Always inf late the balloon in the atrium then position it at the pulmonary vein ostium to avoid vascular injury. Do not ablate in the tubular portion of the pulmonary vein. Monitor the status of the phrenic nerve continuously during right-sided pulmonary vein applications using an appropriate monitoring technique. Stop ablation immediately if phrenic nerve impairment is observed. Consider appropriate medical strategies to minimize the risk of damage to the lung or tracheobronchial tree and the risk of esophogeal injury. Use appropriate levels of contrast media in patients with comorbidities.

7 Follow contrast labeling and institutional procedures regarding the appropriate medical strategies to minimize risk when using contrast media. The CryoAblation (Arctic Front Advance and Freezor MAX) family of catheters were not studied for safety of changes in anticoagulation therapy in patients with atrial fibrillation. This equipment should be used only by or under the supervision of physicians trained in left-atrial CryoAblation procedures . CryoAblation procedures should be performed only in a fully equipped ComplicationsPotential complications/adverse events that may be associated with Cardiac catheterization and ablation listed alphabetically below include but are not limited to: anemia; anxiety; atrial f lutter; back pain; bleeding from puncture sites; blurred vision; bradycardia; bronchial constriction, bronchitis; bruising; Cardiac tamponade; cardiopulmonary arrest; cerebral vascular accident; chest discomfort/pain/pressure; cold feeling; cough; death; diarrhea; dizziness; esophageal damage (including esophageal fistula); fatigue; fever; gastroparesis; headache; hemoptysis; hypotension/hypertension; lightheadedness; myocardial infarction; nausea/vomiting; nerve injury.

8 Pericardial effusion; pulmonary vein stenosis; shivering; shortness of breath; sore throat; tachycardia; transient ischemic attack; urinary infection; vasovagal reaction; visual to the device technical manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1 (800) 328-2518 and/or consult Medtronic s website at : Federal law (USA) restricts this device to sale by or on the order of a 2015 October 20152 of 73 of 7 TABLE OF CONTENTSA blation Catheters ..3 CryoAblation Catheters n Arctic Front Cardiac CryoAblation Catheter, Arctic Front Advance Cardiac CryoAblation Catheter, Arctic Front Advance ST Cardiac CryoAblation Catheter, Freezor Cardiac CryoAblation Catheter, Freezor MAX Cardiac CryoAblation CatheterConventional Radiofrequency (RF) Ablation Catheters n Marinr Conventional Radiofrequency (RF) Ablation Catheter, RF Conductr MC Conventional Radiofrequency (RF) Ablation Catheter, and RF Contactr Conventional Radiofrequency (RF) Ablation Catheter, Enhancr Conventional Radiofrequency (RF) Ablation CatheterCoverage for Catheter Ablation procedures .

9 4 MedicareOther PayersPhysician Services Coding ..4 Catheter AblationDiagnostic Electrophysiologic Study (EPS)Inpatient Hospital Coding ..6 ICD-9-CM1 crosswalk to ICD-10-PCS2 Procedure CodesMedicare Severity Diagnosis Related Group (MS-DRG) AssignmentsOutpatient Hospital Coding ..6 Comprehensive Ambulatory Payment Classification (C-APCs):Medicare Hospital Outpatient Catheter Ablation C-Code ListingDiagnosis Coding ..7 ICD-9-CM crosswalk to ICD-10-CM3 Diagnosis CodesFor questions or for more information, please contact Medtronic at 1 (866) coding suggestions and coding guidelines in this GUIDE do not replace seeking coding advice from the payer and/or your own coding staff. The ultimate responsibility for correct coding lies with the provider of services.

10 Please contact your local payer for interpretation of the appropriate codes to use for specific procedures . 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 reimbursement is requested for the use of a product that may be inconsistent or not expressly specified in the FDA cleared or approved labeling ( , instructions for use, operator s manual, or package insert), consult with your billing advisors or payers for advice on handling such billing issues. Some payers may have policies that make it inappropriate to submit claims for such items or related CATHETERSA rctic Front , Arctic Front Advance , and Arctic Front Advance ST Cardiac CryoAblation CathetersCatheterIndicationArctic Front , Arctic Front Advance , and Arctic Front Advance ST Cardiac CryoAblation CathetersTreatment of drug refractory recurrent symptomatic Paroxysmal Atrial Fibrillation (PAF)The Arctic Front , Arctic Front Advance , and Arctic Front Advance ST Cardiac CryoAblation catheters deliver refrigerant (via the CryoConsole) through an inflatable balloon to remove heat from tissue, freezing and disabling unwanted electrical circuits in the pulmonary veins that may contribute to PAF.