PIPELINE FLEX EMBOLIZATION DEVICE CODING AND REIMBURSEMENT GUIDE

PIPELINE FLEX EMBOLIZATION DEVICE CODING AND REIMBURSEMENT GUIDE

Pipeline Flex Embolization Device The Pipeline Flex embolization device is a braided, multi-alloy cylindrical mesh indicated for the endovascular treatment of adults (age 22 and above) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments. The Pipeline Flex device is intended to treat intracranial aneurysms by two mechanisms of action: FLOW DISRUPTION Placement of a Pipeline Flex device in the parent artery disrupts the pulsatile flow of blood from the parent artery into the intracranial aneurysm fundus. Stasis of blood in the intracranial aneurysm fundus leads to increased blood viscosity, which favors thrombosis. Formation of a blood clot relieves the aneurysm fundus walls from systematic blood pressure, minimizing the risk of spontaneous rupture. RE-ENDOTHELIALIZATION The Pipeline Flex device forms a scaffold upon which endothelial cells can grow. Full coverage of the implant, including over the neck of the intracranial aneurysm, seals the intracranial aneurysm fundus from the parent artery, minimizing the risk of spontaneous rupture as well as recanalization of the aneurysm. The device mesh forms a distinct but smooth border between parent artery and aneurysm fundus. For Medicare patients, the procedure with the Pipeline Flex device is required to be performed in the hospital inpatient setting. 1

DIAGNOSIS CODING HOSPITAL INPATIENT PROCEDURE CODING AND DRG PAYMENT Medtronic provides this information for your convenience only. It does not constitute legal advice or a recommendation regarding clinical practice. Information provided is gathered from third-party sources and is subject to change without notice due to frequently changing laws, rules and regulations. Medtronic makes no guarantee that the use of this information will prevent differences of opinion or disputes with Medicare or other payers as to the correct form of billing or the amount that will be paid to providers of service. Please contact your Medicare contractor, other payers, reimbursement specialists and/or legal counsel for interpretation of coding, coverage and payment policies. This document provides assistance for FDA approved or cleared indications. Where reimbursement is sought for use of a product that may be inconsistent with, or not expressly specified in, the FDA cleared or approved labeling (eg, instructions for use, operator s manual or package insert), consult with your billing advisors or payers on handling such billing issues. Some payers may have policies that make it inappropriate to submit claims for such items or related service. The following information is calculated per the footnotes included and does not take into effect Medicare payment reductions resulting from sequestration associated with the Budget Control Act of 2011. Sequestration reductions went into effect on April 1, 2013. For questions please contact us at neuro.us.reimbursement@medtronic.com ICD-10-CM DIAGNOSIS CODES 1 effective October 1, 2017 ICD-10-CM diagnosis codes are used by both physicians and hospitals to report the indication for the procedure. CODE 2 NON-RUPTURED CEREBRAL ANEURYSM 3 I67.1 Q28.3 Cerebral aneurysm, nonruptured NON-RUPTURED CONGENITAL CEREBRAL ANEURYSM Other malformations of cerebral vessels 4 ICD-10-PCS PROCEDURE CODES 5 effective October 1, 2017 ICD-10-PCS procedure codes are used by hospitals to report surgeries and procedures performed in the inpatient setting. CODE PIPELINE FLEX EMBOLIZATION DEVICE PROCEDURE 6,7 03VG3DZ Restriction of intracranial artery with intraluminal device, percutaneous approach CEREBRAL ARTERIOGRAPHY B31R1ZZ Fluoroscopy of intracranial arteries using low osmolar contrast B31RYZZ Fluoroscopy of intracranial arteries using other contrast 8 DRG ASSIGNMENT FY2018 effective October 1, 2017 Under Medicare s MS-DRG methodology for hospital inpatient payment, each inpatient stay is assigned to one of about 750 diagnosis-related groups, based on the ICD-10 codes assigned to the diagnoses and procedures. Each MS-DRG has a relative weight that is then converted to a flat payment amount. Implanted devices are typically included in the flat payment and are not paid separately. Only one MS-DRG is assigned for each inpatient stay, regardless of the number of procedures performed. MS-DRGs shown are those typically assigned to the following scenarios. MS-DRG 9 MS-DRG TITLE 9,10 RELATIVE GEOMETRIC SUBJECT MEDICARE WEIGHT MEAN LENGTH TO PACT NATIONAL OF STAY 9 9,11 AVERAGE 12 NON-RUPTURED INTRACRANIAL ANEURYSM 025 Craniotomy and Endovascular Intracranial Procedures W MCC 4.3064 7.0 $25,952 026 Craniotomy and Endovascular Intracranial Procedures W CC 2.9971 4.2 $18,062 027 Craniotomy and Endovascular Intracranial Procedures WO CC/MCC 2.3665 2.2 $14,262 HCPCS DEVICE CODES 13 HCPCS device codes are assigned by the entity that purchased and supplied the device to the patient. In the case of Pipeline Flex, that is the hospital. However, hospitals assign HCPCS device codes only when the device is provided in the hospital outpatient setting. HCPCS device codes cannot be assigned or billed for procedures performed in the inpatient setting. If a hospital requires a HCPCS device code for an inpatient case for internal purposes only, such as for tracking, please refer to the HCPCS addendum for references. 2 3

PHYSICIAN PROCEDURE CODING AND PAYMENT REFERENCES PHYSICIAN PROCEDURE CODING AND RBRVS PAYMENT Physicians use CPT codes for all services. Under Medicare s Resource-Based Relative Value Scale (RBRVS) methodology for physician payment, each CPT code is assigned a point value, the relative value unit (RVU), which is then converted to a flat payment amount. CPT CODES 14 effective January 1, 2018 CY 2018 RBRVS FACTORS 16 effective January 1, 2018 CPT CODE 15 PIPELINE FLEX EMBOLIZATION PROCEDURE 20,21 61624 75894-26 Transcatheter permanent occlusion or embolization (eg, for tumor destruction, to achieve hemostasis, to occlude a vascular malformation), percutaneous, any method, central nervous system (intracranial, spinal cord) Transcatheter therapy, embolization, any method, radiological supervision and interpretation CEREBRAL ANGIOGRAPHY 22,23 36224 36226 +36228 Selective catheter placement, internal carotid artery, unilateral, with angiography of the ipsilateral intracranial carotid circulation and all associated radiological supervision and interpretation, includes angiography of the extracranial carotid and cervicocerebral arch, when performed Selective catheter placement, vertebral artery, unilateral, with angiography of the ipsilateral vertebral circulation and all associated radiological supervision and interpretation, includes angiography of the cervicocerebral arch, when performed Selective catheter placement, each intracranial branch of the internal carotid or vertebral arteries, unilateral, with angiography of the selected vessel circulation and all associated radiological supervision and interpretation (eg, middle cerebral artery, posterior inferior cerebellar artery) CATHETERIZATION 24,25 36216 36217 Selective catheter placement, arterial system, initial second order or more selective thoracic or brachiocephalic branch, within a vascular family Selective catheter placement, arterial system, initial third order or more selective thoracic or brachiocephalic branch, within a vascular family COMPLETION ANGIOGRAPHY 26 MULTIPLE PROCEDURE DISCOUNTING 17 CY2018 MEDICARE RVUS (FACILITY SETTING) 18 33.58 2.05 10.37 10.28 6.99 CY2018 MEDICARE NATIONAL AVERAGE (FACILITY SETTING) 18,19 Angiography through existing catheter for follow-up study 75898-26 for transcatheter therapy, embolization, or infusion other 2.56 $92 than thrombolysis 7.95 9.49 $1,209 $74 $373 $370 $252 $286 $342 1. ICD-10-CM: Department of Health and Human Services, Centers for Disease Control and Prevention. International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM). http://www.cdc.gov/nchs/icd/icd10cm.htm 2. For code I67.1, note that the first digit is the letter I and the last digit is the number 1. 3. According to the Index and Tabular instructional notes, code I67.1 includes the intracranial portion of the internal carotid artery. Aneurysm of the extracranial portion of the internal carotid artery is coded elsewhere. 4. Code Q28.3 includes non-ruptured congenital cerebral aneurysm, among other congenital malformations. 5. ICD-10-PCS: Department of Health and Human Services, Centers for Medicare & Medicaid Services. International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS). https://www.cms.gov/medicare/coding/icd10/2018-icd-10-cm-and-gems.html 6. In code 03VG3DZ, the fourth character represents the body part: G-Intracranial Artery. There are other body part values for internal carotid artery, but these are not shown. From the petrous to the superior hypophyseal segment, the internal carotid artery lies within the cranial vault and is intracranial by definition. (See also Coding Clinic, 1st Q 2016, p.19.) 7. Root Operation V-Restriction is defined as partially closing an orifice or the lumen of a tubular body part. When an aneurysm is repaired by placing a device into the lumen of an artery, allowing blood to flow through the rest of the artery while excluding the aneurysmal portion, the procedure is coded to this root operation. Coding Clinic, 1st Q 2014, p.9. 8. Fifth character Y-Other Contrast can be used for iso-osmolar contrast, eg, Visipaque,(Coding Clinic 3rd Q 2016, p.36). 9. Centers for Medicare & Medicaid Services. Medicare Program: Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Changes and FY2018 Rates Final Rule, 81 Fed. Reg. 37990-38589. https://www.gpo.gov/fdsys/pkg/fr-2017-08-14/pdf/2017-16434.pdf. Published August 14, 2017. Centers for Medicare & Medicaid Services. Medicare Program: Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Changes and FY2018 Rates Final Rule; Correction, 82 Fed. Reg. 46138-46163. https://www.gpo.gov/fdsys/pkg/fr-2017-10-04/pdf/2017-21325.pdf. Published October 4, 2017. 10. W MCC in MS-DRG titles refers to secondary diagnosis codes that are designated as major complications or comorbidities. MS-DRGs W MCC have at least one major secondary complication or comorbidity. Similarly, W CC in MS-DRG titles refers to secondary diagnosis codes designated as other (non-major) complications or comorbidities, and MS-DRGs W CC have at least one other (non-major) secondary complication or comorbidity. MS-DRGs WO CC/MCCs have no secondary diagnoses that are designated as complications or comorbidities, major or otherwise. te that some secondary diagnoses are only designated as CCs or MCCs when the conditions were present on admission, and do not count as CCs or MCCs when the conditions are acquired in the hospital during the stay. 11. Post-Acute Care Transfer (PACT) status refers to selected DRGs in which payment to the hospital may be reduced when the patient is discharged by being transferred out. The DRGs impacted are those marked and the patient must be transferred out before the geometric mean length of stay to certain post-acute care providers, including rehabilitation hospitals, long term care hospitals, skilled nursing facilities, or to home under the care of a home health agency. When these conditions are met, the DRG payment is converted to a per diem and payment is made as double the per diem rate for the first day plus the per diem rate for each remaining day up to the full DRG payment. 12. Payment is based on the average standardized operating amount ($5,574.11) plus the capital standard amount ($453.97). Centers for Medicare & Medicaid Services. Medicare Program: Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Changes and FY2018 Rates; 81 Fed. Reg. 38548. Tables 1A-1D. https://www.gpo.gov/fdsys/pkg/fr-2017-08-14/pdf/2017-16434.pdf. Published August 14, 2017. The payment rate shown is the standardized amounts for facilities with a wage index greater than one. The average standard amounts shown also assume facilities receive the full quality update. The payment will also be adjusted by the Wage Index for specific geographic locality. Therefore, payment for a specific hospital will vary from the stated Medicare national average payment levels shown. Also note that any applicable coinsurance, deductible, and other amounts that are patient obligations are included in the national average payment amount shown. 13. HCPCS Level II codes are maintained by the Centers for Medicare and Medicaid Services. (Centers for Medicare and Medicaid Services. Healthcare Common Procedure Coding System. http://www. cms.gov/medicare/coding/hcpcsreleasecodesets/alpha-numeric-hcpcs.html. HCPCS II codes are updated once per quarter. Updates are available at https://www.cms.gov/medicare/coding/ HCPCSReleaseCodeSets/HCPCS-Quarterly-Update.html 14. CPT copyright 2017 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. fee schedules, basic units, relative values, 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. 15. Modifier -26 is appended to certain imaging codes to show that the physician is reporting only the professional interpretation, because the hospital is providing the imaging equipment and technicians. 16. Centers for Medicare & Medicaid Services. Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2018 Final Rule; 82 Fed. Reg. 52976-53371. https://www.gpo.gov/fdsys/pkg/fr-2017-11-15/pdf/2017-23953.pdf. Published vember 15, 2017. 17. For codes marked, multiple procedure discounting indicates that when a procedure code is reported on the same day as another higher-weighted procedure code, the highest-weighted code is paid at 100% of the fee schedule amount and additional codes are paid at 50% of the fee schedule amount. Procedure codes marked are always paid at 100% of the fee schedule amount regardless of whether they are submitted with other procedure codes. January 2018 release of the PFS Relative Value File RVU18A at http://www.cms.gov/medicare/medicare-fee-for-service-payment/ PhysicianFeeSched/PFS-Relative-Value-Files.html. 18. The total RVU as shown here is the sum of three components: physician work RVU, practice expense RVU, and malpractice RVU. RVUs and the Medicare National Average are shown for the facility setting only because the Pipeline Flex embolization procedure is always performed in the hospital, rather than the non-facility (physician office) setting. 19. Medicare national average payment is determined by multiplying the sum of the three RVUs by the conversion factor. Effective January 1, 2017, the conversion factor for CY2018 is $35.9996 per CY 2018 Final Rule; 82 Fed. Reg. 80543. https://www.gpo.gov/fdsys/pkg/fr-2017-11-15/pdf/2017-23953.pdf. Published vember 15, 2017. See also the January 2018 release of the PFS Relative Value File RVU18A at http://www.cms.gov/medicare/medicare-fee-for-service-payment/physicianfeesched/pfs-relative-value-files.html. Final payment to the physician is adjusted by the Geographic Practice Cost Indices (GPCI). Also note that any applicable coinsurance, deductible, and other amounts that are patient obligations are included in the payment amount shown. 20. Some payers recognize either code 61624 or code 61635 for placement of embolization devices that have stent-like features. However, code 61635 is not displayed here because it is conventionally assigned for placement of a dilation stent to open vessel stenosis. This is the opposite effect of the Pipeline Flex device, which excludes the aneurysm by partially closing a vessel. 21. Component coding conventions apply to code 61624, so radiological supervision and interpretation is coded separately. Code 75894 represents the radiologic service linked to code 61624. 22. Codes 61624 and 75894 for the Pipeline Flex embolization procedure include intraprocedural road-mapping and fluoroscopic guidance necessary to perform the intervention. However, cerebral angiography may be coded separately with 61624 when it is truly diagnostic. According to CPT manual instructions (Radiology section, Vascular Procedures heading), a truly diagnostic study means that no prior angiography is available and the decision to intervene is based on the current angiography or, if angiography was previously performed, the patient s condition has changed since the prior angiography, there is inadequate visualization of the anatomy or pathology on prior angiography, or there is a clinical change during the procedure requiring new evaluation. See also CPT manual instructions (Surgery section, Cardiovascular System chapter, Diagnostic Studies of Cervicocerebral Arteries heading) and NCCI Policy Manual, 01/01/2017, Chapter V, D12. 23. A 4-view cervical and cerebral angiography, from catheter placement in the internal carotid arteries and vertebral arteries bilaterally, is coded 36224-50 and 36226-50. Add-on code +36228 would also be assigned if additional angiography was performed from catheter placement in, for example, the superior hypophyseal artery. 24. Catheter placement may be coded separately with 61624. Code 36216 would typically represent catheterization of the left internal carotid artery. Code 36217 would typically represent catheterization of the right internal carotid artery or higher level, eg, the superior hypophyseal artery on either side. 25. If diagnostic cerebral angiography is also performed during the same operative encounter, catheterization is not coded at all. According to CPT manual instructions (Surgery section, Cardiovascular System chapter, Diagnostic Studies of Cervicocerebral Arteries heading), catheterization is already included in the diagnostic cerebral angiography codes. Likewise, catheterization is not coded if a balloon occlusion test is performed during the same operative encounter, because catheterization is already included in code 61623. Catheterization for the intervention 61624 would be subsumed into the codes for the angiography. See also 2011 Interventional Radiology Coding Update, SIR and ACR, p.22 FAQ-4. 26. Code 75898 can be assigned multiple times, once for each completion or follow-up angiogram performed during the embolization. However, physicians are advised to assign 75898 judiciously and to maintain clear documentation on the medical necessity for each angiography. 4 5

ESSENTIAL PRESCRIBING INFORMATION (EPI) STATEMENT: The Pipeline Flex embolization device should be used only by physicians trained in percutaneous, intravascular techniques and procedures at medical facilities with the appropriate fluoroscopy equipment. Indications for Use: The Pipeline Flex embolization device is indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments. CAUTION: Federal (USA) law restricts this device to sale, distribution and use byor on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device. Warnings: 1) Resheathing of the Pipeline Flex embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid. 2) Persons with known allergy to platinum or cobalt/chromium alloy (including the major elements platinum, cobalt, chromium, nickel, molybdenum or tungsten) may suffer an allergic reaction to the Pipeline Flex embolization device implant. 3) Person with known allergy to tin, silver, stainless steel or silicone elastomer may suffer an allergic reaction to the Pipeline Flex embolization device delivery system. 4) Do not reprocess or resterilize. Reprocessing and resterilization increase the risk of patient infection and compromised device performance. 5) Delayed rupture may occur with large and giant aneurysms. 6) Placement of multiple Pipeline Flex embolization devices may increase the risk of ischemic complications. Precautions: 1) Do not use product if the sterile package is damaged. 2) Do not use the Pipeline Flex embolization device in patients in whom angiography demonstrates inappropriate anatomy, such as severe pre or post-aneurysmal narrowing. 3) The Pipeline Flex embolization device should be used only by physicians trained in percutaneous, intravascular techniques and procedures at medical facilities with the appropriate fluoroscopic equipment. 4) Physicians should undergo appropriate training prior to using the Pipeline Flex embolization device in patients. 5) The Pipeline Flex embolization device is provided sterile for single use only. Store in a cool, dry place. 6) Carefully inspect the sterile package and device components prior to use to verify that they have not been damaged during shipping. Do not use kinked or damaged components. 7) Use the Pipeline Flex embolization device system prior to the Use By date printed on the package. 8) The appropriate anti-platelet and anti-coagulation therapy should be administered in accordance with standard medical practice. 9) A thrombosing aneurysm may aggravate pre-existing, or cause new, symptoms of mass effect and may require medical therapy. 10) Do not attempt to reposition after deployment. 11) Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis. 12) Use of implants with labeled diameter larger than the parent vessel diameter may result in decreased effectiveness and additional safety risk due to incomplete foreshortening resulting in an implant longer than anticipated. Potential Complications: Potential complications, some of which could be fatal, include, but are not limited to the following: Adverse reaction to anti-platelet/anticoagulation agents or contrast media, Blindness, Coma, Device fracture, Device migration or misplacement, Dissection of the parent artery, Embolism, Groin injury, Headache, Hemorrhage, Hydrocephalus, Infection, Intracerebral bleeding, Ischemia, Mass effect, Neurological deficits, Parent Artery Stenosis, Perforation, Perforator occlusion, Postprocedure bleeding, Ruptured or perforated aneurysm, Seizure, Stroke, Thromboembolism, Transient Ischemic Attack (TIA), Vasospasm, Vessel occlusion, Vessel perforation, Vision impairment. Contraindications: The use of the Pipeline Flex embolization device is contraindicated for patients with any of the following conditions: 1) Patients with active bacterial infection. 2) Patients in whom dual antiplatelet therapy (aspirin and clopidogrel) is contraindicated. 3) Patients who have not received dual antiplatelet agents prior to the procedure. 4) Patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location. 9775 Toledo Way Irvine, CA 92618 USA Tel 877.526.7890 Fax 763.526.7888 medtronic.com 2018 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. CPT is a registered trademark of the American Medical Association. All other brands are trademarks of a Medtronic company. DC00035442 Rev D JAN/2018