Reimbursement Guide Zenith Fenestrated AAA Endovascular Graft

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MEDICAL Reimbursement Guide Zenith Fenestrated AAA Endovascular Graft Disclaimer: The information provided herein reflects Cook s understanding of the procedure(s) and/or device(s) from sources that may include, but are not limited to, the CPT coding system; Medicare payment systems; commercially available coding guides; professional societies; and research conducted by independent coding and reimbursement consultants. This information should not be construed as authoritative. The entity billing Medicare and/or third party payers is solely responsible for the accuracy of the codes assigned to the services and items in the medical record. Cook does not, and should not, have access to medical records, and therefore cannot recommend codes for specific cases. When you are making coding decisions, we encourage you to seek input from the AMA, relevant medical societies, CMS, your local Medicare Administrative Contractor and other health plans to which you submit claims. Cook does not promote the off-label use of its devices.

The FDA approval of the Zenith Fenestrated AAA Endovascular Graft enables physicians to use a FDA-approved endovascular procedure for treating abdominal aortic aneurysms in patients with shorter infrarenal aortic necks unsuitable for standard endovascular graft repair. However, as with many new procedures in medicine, reimbursement may present certain challenges, and the Zenith Fenestrated AAA Endovascular Graft is no exception. COVERAGE Medicare carriers may issue Local Coverage Decisions listing criteria that must be met prior to coverage. Physicians are urged to review these policies (http://www.cms.gov/mcd/search.asp?) and contact their carrier s medical director (http://www.cms.gov/apps/contacts) or commercial insurers to determine if a procedure is covered. Also, you may contact the Cook Medical Reimbursement department with questions concerning coverage and your local Medicare carrier. PHYSICIAN CODING AND REIMBURSEMENT AAA Fenestrated Endovascular Planning and Sizing Effective January 1, 2015, physician planning and sizing for a patient-specific fenestrated visceral aortic endograft should be reported with the following Category I CPT code below (34839). The planning includes review of high-resolution crosssectional images (eg, CT, CTA, MRI) and utilization of 3D software for iterative modeling of the aorta and device in multiplanar views and center line of flow analysis. Code 34839 may only be reported when the physician spends a minimum of 90 total minutes performing patient-specific fenestrated endograft planning. Physician planning time does not need to be contiuous and should be clearly documented in the patient record. Code 34839 is reported on the date that planning work is complete and may not include time spent on the day before or the day of the fenestrated endovascular repair procedure (34845-34848) nor be reported on the day before or the day of the fenestrated endovascular repair 1 procedure. 34839 Physician planning of a patient-specific fenestrated visceral aortic endograft requiring a minimum of 90 minutes of physician time AAA Fenestrated Endovascular Procedures Repair performed using a Zenith Fenestrated AAA graft is reported with one of the following Category I CPT codes below (34845-34848). These codes are considered inclusive or bundled codes, so the following are NOT separately reportable when performed in conjunction with a fenestrated repair: a) introduction of guide wires and catheters in the aorta and visceral and/or renal arteries; b) balloon angioplasty within the target treatment zone, before or after endograft deployment; and c) fluoroscopic guidance and radiological S&I (includes angiographic diagnostic imaging of the aorta and branches prior to deployment of the endovascular device; fluoroscopic guidance in the delivery of the fenestrated components; and intraprocedural arterial angiography [eg, confirm position, detect endoleak, evaluate runoff]). 1 Note: The number of branch vessels receiving covered stents is a major factor in determining the correct CPT code. Adjunctive procedure codes and physician reimbursement rates are provided in Table C. 34845 34846 34847 34848 performed; including one visceral artery endoprosthesis (superior mesenteric, celiac or renal artery) performed; including two visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s]) performed; including three visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s]) performed; including four or more visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s]) *Do not report 34845-34848 in conjunction with 34800-34805, 34841-34844, 35081, 35102, 35452, 35472, 75952) *Do not report 34845-34848 in conjunction with 37236, 37637 for bare metal or covered stents placed into the visceral branches within the endoprosthesis target zone) *For placement of distal extension prosthesis[es] terminating in the internal iliac, external iliac, or common femoral artery[s], see 34825-34826, 75953, 0254T, 0255T *Use 34845-34848 in conjunction with 37220-37223, only when 37220-37223 are performed outside the target treatment zone of the endoprosthesis 1. American Medical Association. Fenestrated Endovascular Repair of the Visceral and Infrarenal Aorta. In: CPT 2016 Professional Edition. Chicago, IL: American Medical Association; 2015:221-222 Disclaimer: The information provided herein reflects Cook s understanding of the procedure(s) and/or device(s) from sources that may include, but are not limited to, the CPT coding system; Medicare payment systems; commercially available coding guides; professional societies; and research conducted by independent coding and reimbursement

Establishing a Value for CPT codes 34845-34848 Even though Category I CPT codes were created, there are currently no relative value units (RVUs) associated with these codes. Since RVUs were not created, Medicare payment rates have not been pre-established so physicians will have to work with their local insurance carriers, including Medicare, to establish payment rates. NOTE: The creation of these Category I CPT codes will not necessarily result in coverage of fenestrated procedures. In Table A Below is a recommendation for Carrier pricing fenestrated endograft repair from the Society of Vascular Surgeons (SVS). SVS used a building block methodology to capture all of the steps included in these complex procedures. In addition, a surrogate value for the fenestrated main body stent was created by a blend of the codes for distal TEVAR extension and a proximal EVAR extension as this stent occupies the anatomy that lies between the two extensions. Table B is a recommendation from SVS for valuing the newly created planning and sizing code. SVS believes the physician work is comparable between CPT code 77301 and 34839. Table A Reference Service CPT Codes for Fenestrated Procedures (34845-34848) for CY 2016 CPT Long Descriptor 2014 Work RVU2 Multiple Procedure 2. 2014 Medicare physician fee schedule out-of-office, ie, facility global RVU. Federal Register. 2014;79(219):Addendum B. 2014 Total Facility RVUs2 Multiple Procedure 34846 Endovascular repair of visceral aorta and infrarenal abdominal aorta (eg, anuerysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) by deployment of a fenestrated visceral aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including two visceral artery endoprosthesis ( superior mesenteric, celiac or renal artery) Endovascular repair of infrarenal abdominal aortic 34803 aneurysm or dissection; using modular bifurcated 24.82 24.82 37.96 37.96 prosthesis (2 docking limbs) Blend Visceral segment (34825 & 33886) 15.45 7.73 24.61 12.31 36245 First order selective catheter placement, arterial system; each first order abdominal, pelvic, or lower 4.90 2.45 7.44 3.72 extremity artery branch, within a vascular family 36245 First order selective catheter placement, arterial system; each first order abdominal, pelvic, or lower 4.90 2.45 7.44 3.72 extremity artery branch, within a vascular family 37236 Transcatheter placement of an intravascular stent (s) (except lower extremity, cervical carotid, extracranial vertebral or intrathorcic carotid, intracranial or coronary), open or percutaneous, 9.00 4.50 13.46 6.73 including radiological supervision and interpretation and including all angioplasty within the same vessel, when performed; initial artery 37237 Transcatheter placement of an intravascular stent (s) (except lower extremity, cervical carotid, extracranial vertebral or intrathorcic carotid, intracranial or coronary), open or percutaneous, including radiological supervision and 9.00 4.50 13.46 6.73 interpretation and including all angioplasty within the same vessel, when performed; each additional artery 75952 Endovascular repair of intrarenal abdominal aortic aneursym or dissection, radiological supervision 4.49 4.49 6.51 6.51 and interpretation Blend Visceral segment S&I (75953 & 75959) 2.43 2.43 3.58 3.58 TOTAL 53.12 80.81 Table B Reference Service CPT Code for Planning and Sizing (34839) for CY 2016 Multiple Procedure 2014 Work 2014 Total CPT Long Descriptor RVU2 Facility RVUs2 Multiple Procedure 34839 Physician planning of a patient-specific fenestrated visceral aortic endograft requiring a minimum of 90 minutes of physician time Intensity modulated radiotherapy plan, including 77301 dose-volume histograms for target and critical structure partial tolerance specifications 7.99 7.99 11.58 11.58

Table C 2016 Physician Medicare Reimbursement for Procedures Adjunctive to a Zenith Fenestrated AAA Endovascular Graft Procedure CPT Code Description Physician Fees (National Medicare Avg 3 ) +34808 Endovascular placement of iliac artery occlusion device (List separately in addition to code for primary procedure) $218.91 34812 Open femoral artery exposure for delivery of endovascular prosthesis, by groin incision, unilateral $357.20 +34813 34820 34825 +34826 75953-26 34830 34831 34832 34833 34834 Placement of femoral-femoral prosthetic graft during endovascular aortic aneurysm repair (List separately in addition to code for primary procedure) (Use 34813 in conjunction with 34812) Open iliac artery exposure for delivery of endovascular prosthesis or iliac occlusion during endovascular therapy, by abdominal or retroperitoneal incision, unilateral Placement of proximal or distal extension prosthesis for endovascular repair of infrarenal abdominal aortic or iliac aneurysm, false aneurysm, or dissection; initial vessel Placement of proximal or distal extension prosthesis for endovascular repair of infrarenal abdominal aortic or iliac aneurysm, false aneurysm, or dissection; each additional vessel (List separately in addition to code for primary procedure) (Use 34826 in conjunction with 34825) (For radiological supervision and interpretation, use 75953) Placement of proximal or distal extension prosthesis for endovascular repair of infrarenal aortic or iliac artery aneurysm, pseudoaneurysm, or dissection, radiological supervision and interpretation following unsuccessful endovascular repair; tube prosthesis following unsuccessful endovascular repair; aorto-bi-iliac prosthesis following unsuccessful endovascular repair; aorto-bifemoral prosthesis Open iliac artery exposure with creation of conduit for delivery of aortic or iliac endovascular prosthesis, by abdominal or retroperitoneal incision, unilateral (Do not report 34833 in addition to 34820) (For bilateral procedure, use modifier -50) Open brachial artery exposure to assist in the deployment of aortic or iliac endovascular prosthesis by arm incision, unilateral (For bilateral procedure, use modifier -50) $250.08 $520.94 $733.76 $216.04 $69.51 $1,869.14 $2,014.24 $1,998.48 $644.54 $289.13 Transcatheter placement of an intravascular stent(s) (except lower extremity artey(s) for occlusive disease, 37236 cervical carotid, extracranial vertebral or intrathoracic carotid, intracranial, or coronary), open or percutaneous, including radiological supervision and interpretation and including all angioplasty within $476.51 the same vessel, when performed; initial artery Transcatheter placement of an intravascular stent(s) (except lower extremity artey(s) for occlusive disease, cervical carotid, extracranial vertebral or intrathoracic carotid, intracranial, or coronary), open or +37237 percutaneous, including radiological supervision and interpretation and including all angioplasty within $224.64 the same vessel, when performed; each additional artery (List separately in addition to code for primary procedure) 3. 2016 Medicare Physician Fee Schedule. 2016 physician fees for your local area can be found at the following CMS links: http://www.cms.hhs.gov/pfslookup/02_pfssearch.asp#topofpage or http://www.cms.hhs.gov/physicianfeesched/pfsnpaf/list.asp#topofpage Disclaimer: The information provided herein reflects Cook s understanding of the procedure(s) and/or device(s) from sources that may include, but are not limited to, the CPT coding system; Medicare payment systems; commercially available coding guides; professional societies; and research conducted by independent coding and reimbursement

Contesting Non-Coverage If the procedure is denied by Medicare or another payer after your initial submission of the claim, you may need to further educate the payer regarding medical necessity, FDA approval and/or the efficacy of the procedure. If reimbursement is denied, the reason should be listed under the explanation of benefits (EOB), and we encourage the operating physician to contact the local health plan s medical directors to discuss the clinical merits of this procedure. Influencing Payer Decision Making If Medicare is a dominant payer and you plan to do the procedure on a regular basis, we advise you to check your local Medicare carrier's local coverage determination (LCD) to verify coverage of the procedure. Private-payer coverage determinations are usually made by the payer s technology or medical device group. As with Medicare, we encourage you to contact your other local commercial health plans to discuss coverage of this procedure, whether for a specific case or for overall approval of the Zenith Fenestrated AAA Endovascular Graft. Commercial Insurance Unlike Medicare, commercial insurers have not established a consistent national payment methodology, so arrangements between insurers and hospitals vary considerably. Because of this, it s not possible for Cook Medical to offer guidance to hospitals regarding any individual plan. We encourage you to work closely with your local hospital management and insurance plans to understand the contracted payment arrangements between them. A coordinated effort between the physician and the hospital can be quite effective in obtaining reimbursement. If you have any questions, please contact our reimbursement team at: 800.468.1379 or by e-mail at: reimbursement@cookmedical.com Disclaimer: The information provided herein reflects Cook s understanding of the procedure(s) and/or device(s) from sources that may include, but are not limited to, the CPT coding system; Medicare payment systems; commercially available coding guides; professional societies; and research conducted by independent coding and reimbursement COOK 2016 RG_AI_ZFENCORG_RE_201601