Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Endovascular Grafts for Abdominal Aortic Aneurysms (AAA), Aortic-Iliac Aneurysms, and Infrarenal Aortic Aneurysms

Policy #:11.02.10m

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

MEDICALLY NECESSARY

Endovascular graft repair of nonruptured abdominal aortic aneurysms (AAA), aortic-iliac aneurysms, and infrarenal aortic aneurysms is considered medically necessary and, therefore, covered when using Food and Drug Administration (FDA)--approved devices, based on approved specifications.

Emergency endovascular repair (eEVAR) of a ruptured abdominal aortic aneurysm with an endoprosthesis is considered medically necessary and, therefore, covered when all of the following criteria are met:
  • A US Food and Drug Administration (FDA)--approved device is used for the surgical procedure.
  • The individual must be sufficiently stable to undergo detailed CT examination for anatomic measurements.
  • The aneurysm should be anatomically appropriate for endovascular repair.

EXPERIMENTAL/INVESTIGATIONAL

Implanted wireless intra-aneurysm pressure sensors that are placed in the aneurysmal sac to detect endoleaks intraoperatively and/or postoperatively following endovascular aneurysm repair are considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

All other uses for endovascular graft repair of abdominal aortic aneurysms (AAA), aortic-iliac aneurysms, and infrarenal aortic aneurysms are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, the endovascular graft repair of abdominal aortic aneurysms (AAA), aortic-iliac aneurysms, and infrarenal aortic aneurysms is covered under the medical benefits of the Company's products when the medical necessity criteria listed in this medical policy are met. However, services that are identified in this policy as experimental/investigational are not eligible for coverage or reimbursement by the Company.

Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous devices approved by the FDA for the endovascular graft repair of AAAs, aortic-iliac aneurysms, and infrarenal aortic aneurysms.

Description

An aneurysm is the abnormal bulging of a vessel, usually due to a congenital or acquired weakness or thinning of the vessel wall. A true aneurysm is a degenerative atherosclerotic process that involves all three layers of the aorta: the endothelium, the media, and the adventitia. Aneurysms are classified by shape, how they are formed, and their location along the aorta. Symptoms may or may not be present and differ with location. The majority of aneurysms are coincidentally found during clinical examination or radiographic investigations for other diseases. The incidence of aneurysms is known to increase with age, to be more common in men than in women, and to be strongly associated with cigarette smoking.

The most common type of aneurysm is an abdominal aortic aneurysm (AAA), which is an abnormal dilatation of the lower part of the aorta. Elective procedures for AAA repair and rupture prevention are usually considered when the diameter of the aneurysm is 1.5 times the diameter of the normal segment. Generally, this measurement is 5.0 cm in diameter in men and 4.5 cm in diameter in women.

Aortic-iliac aneurysm repair and infrarenal aneurysm endovascular repair are assessed according to the location, size, and configuration of the anatomic site. There must be an adequate normal aorta wall above and below the aneurysm to anchor the device and to ensure that the aneurysm is likely to be excluded from circulation. This assessment is usually made on the basis of diagnostic imaging (mainly CT scanning) and, occasionally, angiography.

The method of intervention for an aneurysm usually depends on the size, symptoms, rate of growth noted with successive diagnostic imaging tools, and whether the individual is considered healthy enough to undergo the repair procedure. One method of intervention for aneurysm repair is the use of endovascular grafts.

Endovascular grafts were developed and used as a minimally invasive, catheter-based alternative to open surgical repair because they have lower mortality and morbidity rates. An endovascular graft is applied by inserting a catheter into the femoral artery and utilizing radiologic guidance to advance and position a guidewire for placement at the aneurysm site. The components of the endograft device are then deployed to exclude the aneurysm from the circulation and to establish normal blood flow.

Emergency endovascular repair (eEVAR) of ruptured AAAs is being studied as an alternative to decrease the high mortality rate associated with open surgical repair. Additional considerations, such as the possibility of aneurysm enlargement, graft migration, endoleaks, the need for possible reintervention, and paraplegia due to spinal cord ischemia during the endovascular procedure illustrate the need for further research.

Several endovascular grafts and their delivery systems have been approved by the US Food and Drug Administration (FDA) for use in the abdominal aorta, aortic-iliac bifurcation, and infrarenal aorta. Fenestrated grafts are designed with openings in the wall that are placed across the renal or celiac arteries while maintaining vessel patency. Additionally, extensions can be placed from inside the endograft into the visceral arteries to create a hemostatic seal.

Wireless sensors implanted in an aortic aneurysm sac after endovascular repair are being investigated to measure postprocedural pressure. It is thought that low pressures may correlate with positive prognoses, and high pressures may indicate the need for revision. An example is the CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System (CardioMEMS, Inc.; Atlanta, GA). During the endovascular repair, an endosensor is placed in the portion of the aneurysmal sac that was excluded by the stent graft. An antenna-like device is held over the individual's abdomen to obtain measurements from the endosensor regarding the pressure inside the aneurysmal sac; these pressure readings are then recorded. The CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System received 510(k) approval by the FDA on October 28, 2005, with an updated approval on March 15, 2007. There is no current published literature to indicate that an endosensor is a recommended part of the endovascular repair of AAA.

Current published studies are lacking support for the use of wireless pressure sensors to indicate endoleaks in aneurysm repairs. Further long-term studies are needed to assess for any long-term complications. The evidence to date consists mainly of small case series, which is insufficient to permit conclusions concerning the effect of this device on health outcomes.
References


Anderson PL, Arons RR, Moskowitz AJ, et al. A statewide experience with endovascular abdominal aortic aneurysm repair: rapid diffusion with excellent early study results. J Vasc Surg. 2004:39(1):10-19.

Badger S, Bedenis R, Blair PH, et al. Endovascular treatment for ruptured abdominal aortic aneurysm. Cochrane Database Syst Rev. 2014;7:CD005261.

Becquemin JP, Pillet JC, Lescalie F, et al. A randomized controlled trial of endovascular aneurysm repair versus open surgery for abdominal aortic aneurysms in low- to moderate-risk patients. J Vasc Surg. 2011;53(5):1167-1173 e1161.

Biancari F, Catania A, D'Andrea V. Elective endovascular vs. open repair for abdominal aortic aneurysm in patients aged 80 years and older: systematic review and meta-analysis. Eur J Vasc Endovasc Surg. 2011;42(5):571-576.

Blankensteijn JD, de Jong SE, Prinssen M, et al. Two-year outcomes after conventional or endovascular repair of abdominal aneurysms. N Engl J Med. 2005;352(23):2398-2405.

Blum U, Voshage G, Lammer J, et al. Endoluminal stent-grafts for infrarenal abdominal aortic aneurysms. N Engl J Med. 1997;336(1):13-20.

Brown LC, Thompson SG, Greenhalgh RM, et al. Incidence of cardiovascular events and death after open or endovascular repair of abdominal aortic aneurysm in the randomized EVAR trial 1. Br J Surg. 2011;98(7):935-942.

Bryce Y, Rogoff P, Romanelli D, et al. Endovascular repair of abdominal aortic aneurysms: vascular anatomy, device selection, procedure, and procedure-specific complications. Radiographics. 2015;35(2):593-615.

Cao P, De Rango P, Verzini F, et al. Comparison of surveillance versus aortic endografting for small aneurysm repair (CAESAR): results from a randomised trial. Eur J Vasc Endovasc Surg. 2011;41(1):13-25.

CardioMEMS, Inc. EndoSure™ Wireless AAA Pressure Measurement System. Available at: http://www.cardiomems.com/content.asp?display=medical+mb&expand=ess. [The link to this reference is no longer active on the CardioMEMS Web site]. Accessed November 11, 2015.

Chaikof EL, Brewster DC, Dalman RL, et al. SVS practice guidelines for the care of patients with an abdominal aortic aneurysm: executive summary. J Vasc Surg. 2009;50(4):880-896.

Cronenwett JL. Endovascular aneurysm repair: important midterm results. Lancet. 2005;365(9478):2156-2158.

De Bruin JL, Baas AF, Buth J, et al. Long-term outcome of open or endovascular repair of abdominal aortic aneurysm. N Engl J Med. 2010;362(20):1881-1889.

De Rango P, Verzini F, Parlani G, et al. Quality of life in patients with small abdominal aortic aneurysm: the effect of early endovascular repair versus surveillance in the CAESAR trial. Eur J Vasc Endovasc Surg. 2011;41(3):324-331.

Desgranges P, Kobeiter H, Katsahian S, et al. ECAR (Endovasculaire ou Chirurgie dans les Anevrysmes aortoiliaques Rompus): A French randomized controlled trial of endovascular versus open surgical repair of ruptured aorto-iliac aneurysms. Eur J Vasc Endovasc Surg. 2015;50(3):303-310.

Dias NV, Ivancev K, Malina M, et al. Intra-aneurysm sac pressure measurements after endovascular aneurysm repair: differences between shrinking, unchanged, and expanding aneurysms with and without endoleaks. J Vasc Surg. 2004;39(6):1229-1235.

Dillon M, Cardwell C, Blair PH, et al. Endovascular treatment for ruptured abdominal aortic aneurysm. Cochrane Database Syst Rev. 2007;1:CD005261.

Edwards ST, Schermerhorn ML, O'Malley AJ, et al. Comparative effectiveness of endovascular versus open repair of ruptured abdominal aortic aneurysm in the Medicare population. J Vasc Surg. 2014;59(3):575-582.

Egorova N, Giacovelli J, Greco G, et al. National outcomes for the treatment of ruptured abdominal aortic aneurysm: comparison of open versus endovascular repairs. J Vasc Surg. 2008;48(5):1092-100.

Ellozy SH, Carroccio A, Lookstein RA, et al. Abdominal aortic aneurysm sac shrinkage after endovascular aneurysm repair: correlation with chronic sac pressure measurement. J Vasc Surg. 2006;43(1):2-7.

Ellozy SH, Carroccio A, Lookstein RA, et al. First experience in human beings with a permanently implantable intrasac pressure transducer for monitoring endovascular repair of abdominal aortic aneurysms. J Vasc Surg. 2004;40(3):405-412.

Erbel R, Aboyans V, Boileau C, et al. 2014 ESC Guidelines on the diagnosis and treatment of aortic diseases: Document covering acute and chronic aortic diseases of the thoracic and abdominal aorta of the adult. The Task Force for the Diagnosis and Treatment of Aortic Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2014;35(41):2873-2926.

Ernst CB. Current therapy for infrarenal aortic aneurysms. N Engl J Med. 1997;336(1):59-60.

EVAR Trial Participants. Endovascular aneurysm repair and outcome in patients unfit for open repair of abdominal aortic aneurysm (EVAR trial 2): randomised controlled trial. Lancet. 2005;365(9478):2187-2192.

EVAR Trial Participants. Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysm (EVAR trial 1): randomised controlled trial. Lancet. 2005;365(9478):2179-2186.

Filardo G, Powell JT, Martinez MA, et al. Surgery for small asymptomatic abdominal aortic aneurysms. Cochrane Database Syst Rev. 2012;3:CD001835.

Golzarian J, Valenti D. Endoleakage after endovascular treatment of abdominal aortic aneurysms: diagnosis, significance and treatment. Eur Radiol. 2006;16(12):2849-2857.

Greenberg RK, Haulon S, Lyden SP, et al. Endovascular management of juxtarenal aneurysms with fenestrated endovascular grafting. J Vasc Surg. 2004;39(2):279-287.

Greenlagh R, Brown IC, Epstein D, et al. Endovascular aneurysm repair and outcome in patients unfit for open repair of abdominal aortic aneurysm (EVAR trial 2): randomised controlled trial. Lancet. 2005;365(9478):2187-2192.

Greenlagh R, Brown IC, Epstein D, et al. Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysm (EVAR trial 1): randomised controlled trial. Lancet. 2005;365(9478):2179-2186.

Greenhalgh RM, Brown LC, Powell JT, et al. Endovascular versus open repair of abdominal aortic aneurysm. N Engl J Med. 2010;362(20):1863-1871.

Greenhalgh RM, Brown LC, Powell JT, et al. Endovascular repair of aortic aneurysm in patients physically ineligible for open repair. N Engl J Med. 010;362(20):1872-1880.

Greenhalgh RM, Brown LC, Kwong GP, et al. Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR 1 trial), 30-day operative mortality results: randomised controlled trial. Lancet. 2004;364(9437):843-848.

Hirsch AT, Haskal ZJ, Hertzer NR, et al. ACC/AHA 2005 guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): executive summary a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease) endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. J Am Coll Cardiol. 2006;47(6):1239-1312.

Hoppe H, Segall JA, Liem TK, et al. Aortic aneurysm sac pressure measurements after endovascular repair using an implantable remote sensor: initial experience and short-term follow-up. Eur Radiol. 2008;18(5):957-65.

Hua HT, Cambria RP, Chuang SK, et al. Early outcomes of endovascular versus open abdominal aortic aneurysms repair in the National Surgical Quality Improvement Program--Private Sector (NSQIP-PS). J Vasc Surg. 2005; 41(3):382-9.

Improve Trial Investigators, Powell JT, Sweeting MJ, et al. Endovascular or open repair strategy for ruptured abdominal aortic aneurysm: 30 day outcomes from IMPROVE randomised trial. BMJ. 2014;348:f7661.

Improve Trial Investigators. Endovascular strategy or open repair for ruptured abdominal aortic aneurysm: oneyear outcomes from the IMPROVE randomized trial. Eur Heart J. 2015;36(31):2061-2069.

Krenzien F, Matia I, Wiltberger G, et al. Outcome after open surgery repair in endovascular-suitable patients with ruptured abdominal aortic aneurysms. Vasa. 2013;42(6):442-448.

Lederle FA. Endovascular repair of abdominal aortic aneurysm--round two. N Engl J Med. 2005;352(23):2443-2445.

Lederle FA, Freischlag JA, Kyriakides TC, et al. Long-term comparison of endovascular and open repair of abdominal aortic aneurysm. N Engl J Med. 2012;367(21):1988-1997.

Lee WA, Carter JW, Upchurch G, et al. Perioperative outcomes after open and endovascular repair of intact abdominal aortic aneurysms in the United States during 2001. J Vasc Surg. 2004;39(3): 491-6.

Lim S, Halandras PM, Park T, et al. Outcomes of endovascular abdominal aortic aneurysm repair in high-risk patients. J Vasc Surg. 2015;61(4):862-868.

Medtronic, Inc. FDA approves Medtronic's Talent® Abdominal Stent Graft for repairing aortic aneurysms. [Medtronic Web site]. 04/16/08. Available at: http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1208365439159&lang=nl_NL. Accessed November 6, 2017.

McPhee J, Eslami MH, Arous EJ, et al. Endovascular treatment of ruptured abdominal aortic aneurysms in the United States (2001-2006): a significant survival benefit over open repair is independently associated with increased institutional volume. J Vasc Surg. 2009;49(4):817-26.

Milner R, Ruurda JP, Blankensteijn JD. Durability and validity of a remote, miniaturized pressure sensor in an animal model of abdominal aortic aneurysm. J Endovasc Ther. 2004;11(4):372-377.

National Heart, Lung, and Blood Institute. US Department of Health and Human Services. National Institute of Health (NIH). Diseases and Conditions Index. April 2011. What is an aneurysm? Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/arm/arm_what.html. Accessed November 6, 2017.

National Institute for Health and Clinical Excellence (NICE). Endovascular stent-grafts for the treatment of abdominal aortic aneurysms. [NICE Web site]. February 2009. Available at: http://www.nice.org.uk/. Accessed November 6, 2017.

National Institute of Health (NIH), Medlineplus. Aortic aneurysm repair – endovascular. [NIH Website]. 10/03/2017. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/007391.htm. Accessed November 6, 2017.

Novitas Inc., Local Article Coverage for Endovascular Repair of Aortic and/or Iliac Aneurysms. A53124. 01/01/2018. Available at: https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=53124. Accessed January 29, 2018.

Ohki T, Ouriel K, Silveira PG, et al. Initial results of wireless pressure sensing for endovascular aneurysm repair: the APEX Trial, Acute Pressure Measurement to Confirm Aneurysm Sac Exclusion. J Vasc Surg. 2007;45(2):236-242.

Ouriel K, Clair DG, Kent KC, et al. Endovascular repair compared with surveillance for patients with small abdominal aortic aneurysms. J Vasc Surg. 2010;51(5):1081-1087.

Paravastu SC, Jayarajasingam R, Cottam R, et al. Endovascular repair of abdominal aortic aneurysm. Cochrane Database Syst Rev. 2014;1:CD004178.

Parsa CJ, Daneshmand MA, Lima B, et al. Utility of remote wireless pressure sensing for endovascular leak detection after endovascular thoracic aneurysm repair. Ann Thorac Surg. 2010;89(2):446-452.

Powell JT, Sweeting MJ, Ulug P, et al. Meta-analysis of individual-patient data from EVAR-1, DREAM, OVER and ACE trials comparing outcomes of endovascular or open repair for abdominal aortic aneurysm over 5 years. Br J Surg. 2017;104(3):166-178.

Prinssen M, Verhoeven EL, Buth J, et al. A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms. N Engl J Med. 2004;351(16):1606-1618.

Reimerink JJ, Hoornweg LL, Vahl AC, et al. Endovascular repair versus open repair of ruptured abdominal aortic aneurysms: a multicenter randomized controlled trial. Ann Surg. 2013;258(2):248-256.

Rooke TW, Hirsch AT, Misra S, et al. 2011 ACCF/AHA focused update of the guideline for the management of patients with peripheral artery disease (updating the 2005 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2011;58(19):2020-2045.

Sajid MS, Desai M, Haider Z, et al. Endovascular aortic aneurysm repair (EVAR) has significantly lower perioperative mortality in comparison to open repair: a systematic review. Asian J Surg. 2008;31(3):119-23.

Schermerhorn ML, Buck DB, O'Malley AJ, et al. Long-term outcomes of abdominal aortic aneurysm in the Medicare population. N Engl J Med. 2015;373(4):328-338.

Silveira PG, Miller CW, Mendes RF, et al. Correlation between intrasac pressure measurements of a pressure sensor and an angiographic catheter during endovascular repair of abdominal aortic aneurysm. Clinics. 2008;63(1):59-66.

Society of Thoracic Surgeons (STS). Aortic aneurysms. Available at: http://www.sts.org/sections/patientinformation/aneurysmsurgery/aorticaneurysms/index.html. [The link to this reference is no longer active on the STS Web site]. Accessed November 11, 2015.

Sonesson B, Dias N, Malina M, et al. Intra-aneurysm pressure measurements in successfully excluded abdominal aortic aneurysm after endovascular repair. J Vasc Surg. 2003;37(4):733-738.

Sweeting MJ, Balm R, Desgranges P, et al. Individual-patient meta-analysis of three randomized trials comparing endovascular versus open repair for ruptured abdominal aortic aneurysm. Br J Surg. 2015;102(10):12291239.

Upchurch GR Jr, Schaub TA. Abdominal aortic aneurysm. Am Fam Physician. 2006;73(7):1198-1204.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. CardioMEMS EndoSure™ S2 Wireless AAA Pressure Measurement System. 510(k) summary. [FDA Web site]. 08/19/08. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf8/K082191.pdf. Accessed November 6, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System. 510(k) summary. [FDA Web site]. 03/15/07. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf7/K070448.pdf. Accessed November 6, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Endologix® Powerlink System. Premarket Approval Letter. [FDA Web site]. 10/29/04. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf4/P040002A.pdf. Accessed November 6, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Gore Excluder® AAA Endoprosthesis. Premarket Approval (PMA) Database [FDA Web site]. 12/20/02. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P020004. Accessed November 6, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Medtronic Vascular Talent® Abdominal Stent Graft System. Premarket Approval (PMA) Database. [FDA Web site]. Original 04/15/08. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P070027. Accessed November 6, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. ZenithTM AAA Endovascular Graft and H&L-B One-ShotTM Introduction System. Premarket approval letter.. [FDA Web site]. 05/23/03. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf2/P020018A.pdf. Accessed November 6, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. CardioMEMS EndoSure Wireless. 510(k) summary. [FDA Web site]. 02/15/06. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf6/K061046.pdf. Accessed November 6, 2017.

US Food and Drug Administration (FDA). Department of Health and Human Services. Federal register. Medical devices; cardiovascular devices; classification of implantable intra-aneurysm pressure measurement system. [FDA Web site]. 02/15/06. Available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/06-1417.htm. November 6, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Zenith® Fenestrated AAA Endovascular Graft (with the adjunctive Zenith Alignment Stent). Approval letter. [FDA Web site]. 04/11/2012. Available at:
https://www.accessdata.fda.gov/cdrh_docs/pdf2/P020018S040A.pdf. Accessed November 6, 2017.

van Beek SC, Reimerink JJ, Vahl AC, et al. Outcomes after open repair for ruptured abdominal aortic aneurysms in patients with friendly versus hostile aortoiliac anatomy. Eur J Vasc Endovasc Surg. 2014;47(4):380-387.

Walker TG, Kalva SP, Yeddula K, et al. Clinical practice guidelines for endovascular abdominal aortic aneurysm repair: written by the Standards of Practice Committee for the Society of Interventional Radiology and endorsed by the Cardiovascular and Interventional Radiological Society of Europe and the Canadian Interventional Radiology Association. J Vasc Interv Radiol. 2010;21(11):1632-1655.

White RA, Donayre CE, Walot I, et al. Modular bifurcation endoprosthesis for treatment of abdominal aortic aneurysms. Ann Surg. 1997;226(3):381-391.

Wilt TJ, Lederle FA, Macdonald R, et al. Comparison of endovascular and open surgical repairs for abdominal aortic aneurysm. Evid Rep Technol Assess (Full Rep). 2006(144):1-113.

Zarins CK, White RA, Schwarten D, et al. AneuRx stent graft versus open surgical repair of abdominal aortic aneurysms: multicenter prospective clinical trial. J Vasc Surg. 1999;29(2):292-308.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

34701, 34702, 34703, 34704, 34705, 34706, 34707, 34708, 34709, 34710, 34711, 34712, 34713, 34714, 34715, 34716, 34808, 34812, 34813, 34820, 34833, 34834, 34841, 34842, 34843, 34844, 34845, 34846, 34847, 34848, 36140, 36200, 36245, 36246, 36247, 36248

THE FOLLOWING CODES ARE USED TO REPRESENT AN UNSUCCESSFUL ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM (AAA) THAT REQUIRED TREATMENT WITH AN URGENT OR EMERGENT OPEN PROCEDURE:

34830, 34831, 34832


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

A52.01 Syphilitic aneurysm of aorta

I71.3 Abdominal aortic aneurysm, ruptured

I71.4 Abdominal aortic aneurysm, without rupture

I72.3 Aneurysm of iliac artery

Q25.43 Congenital aneurysm of aorta

S35.09xA Other injury of abdominal aorta, initial encounter

S35.09xD Other injury of abdominal aorta, subsequent encounter

S35.09xS Other injury of abdominal aorta, sequela



HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

Revision from 11.02.10m
03/26/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on Endovascular Grafts for Abdominal Aortic Aneurysms (AAA), Aortic-Iliac Aneurysms, and Infrarenal Aortic Aneurysms.

The following ICD-10 CM codes have been removed from this policy:
  • I71.02 Dissection of abdominal aorta
  • I77.811 Abdominal aortic ectasia
  • Q25.49 Other congenital malformations of aorta

The following ICD-10 CM code has been added to this policy:

  • Q25.43 Congenital aneurysm of aorta

Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date: 03/26/2018
Version Issued Date: 03/26/2018
Version Reissued Date: N/A

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