Latest Review Date:   May 2024

Category:  Surgery                                                                

POLICY:

Endovascular stent grafts approved by the U.S. Food and Drug Administration (FDA) and used according to device indications, may be considered medically necessary for the treatment of abdominal aortic aneurysms (AAA).

DESCRIPTION OF PROCEDURE OR SERVICE:

Endovascular stent grafts can be used as minimally invasive alternatives to open surgical repair for treatment of abdominal aortic aneurysms (AAAs). Open surgical repair of AAAs has high morbidity and mortality, and endovascular grafts have the potential to reduce the operative risk associated with AAA repair.

Management of a clinically significant AAA consists of surgical excision with placement of a sutured woven graft or endovascular grafting. Surgical excision is associated with a perioperative mortality rate between 1% and 5%. Perioperative morbidity and mortality are highest in older female patients with cardiac, pulmonary, or kidney disease; the most common cause of death is multisystem organ failure.

Due to the high mortality rate, endovascular prostheses were developed as a less risky and minimally invasive, catheter-based alternative to open surgical excision of AAAs. These devices are deployed across the aneurysm such that the aneurysm is effectively “excluded” from the circulation, with subsequent restoration of normal blood flow.

The main potential advantage of endovascular grafts for an AAA is that they offer a less invasive and less risky approach to the repair of abdominal aneurysms. While the use of an endovascular approach has the potential to reduce the relatively high perioperative morbidity and mortality associated with open AAA repair, use of endovascular grafts also has potential disadvantages. In particular, there are concerns about the durability of the anchoring system, aneurysm expansion, and other late complications related to the prosthetic graft. Aneurysm expansion may result from perivascular leaks, also known as endoleaks, which are a unique complication of endoprostheses. Perivascular leaks may result from an incompetent seal at one of the graft attachment sites, blood flow in aneurysm tributaries (these tributaries are ligated during open surgery), or perforation of graft fabric.

Several types of grafts are currently in use: straight grafts, in which both ends are anchored to the infrarenal aorta, and bifurcated grafts, in which the proximal end is anchored to the infrarenal aorta, and the distal ends are anchored to the iliac arteries. Fenestrated grafts have also been investigated. These grafts are designed with openings in the wall that can be placed across the renal or celiac arteries while still protecting vessel patency through these critical arteries. In addition, extensions can be placed from inside the main endograft body into the visceral arteries to create a hemostatic seal.

KEY POINTS:

The most recent literature update covers the period through March 14, 2024.

Summary of Evidence

For individuals who have AAAs eligible for open repair who receive endovascular stent grafts, the evidence includes randomized controlled trials (RCTs), systematic reviews of RCTs, and cohort studies. Relevant outcomes are overall survival, morbid events, and treatment-related mortality and morbidity. Evidence from a patient-level meta-analysis of 4 RCTs comparing endovascular aneurysm repair (EVAR) with open repair for elective treatment of AAAs has indicated that neither approach is clearly superior to the other. While EVAR is associated with an early reduction in mortality, outcomes at 5 years or longer have shown a greater reintervention rates and endovascular mortality and comparable overall survival rates for EVAR and open repair. Thus, the early advantage of EVAR is offset by a higher rate of late complications over the long term. Based on these data, EVAR may be considered as an alternative to open surgery in patients who are candidates for both procedures. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have ruptured AAAs who receive endovascular stent grafts, the evidence includes RCTs, systematic reviews of RCTs and nonrandomized comparative studies. Relevant outcomes are overall survival, morbid events, and treatment-related mortality and morbidity. For patients with ruptured AAAs, evidence from 3 RCTs and 2 meta-analyses have indicated that short- and intermediate-term survival (up to 1 year) following EVAR is comparable with open repair, while perioperative complications are reduced with EVAR. Evidence from a large nonrandomized matched comparison demonstrated that EVAR is associated with a perioperative mortality benefit up to 4 years post surgery, at the cost of the increased likelihood of the need for reintervention. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Practice Guidelines and Position Statements

American College of Cardiology Foundation and American Heart Association

In 2022, the American College of Cardiology and the American Heart Association (ACC/AHA) published a guideline for the management of aortic disease, including AAA. Recommendations from the guideline regarding AAA repair are listed below.

Guideline on Management of Patients with Aortic Disease: Abdominal Aortic Aneurysm Repair

Recommendation	COR	LOE
In patients with nonruptured AAA with low to moderate operative risk and suitable anatomy, a shared decision-making process weighing the risks and benefits of endovascular versus open repair is recommended.	I	A
In patients with nonruptured AAA with high operative risk, endovascular repair is reasonable to reduce risk of 30-daymorbidity, mortality, or both.	IIa	B-NR
In patients with nonruptured AAA with moderate to high operative risk and suitable anatomy for an FDA-approved fenestrated endovascular device, endovascular repair is reasonable over open repair to reduce risk of perioperative complications.	IIa	B-NR
In patients with ruptured AAA with suitable anatomy, endovascular repair is recommended over open repair to reduce risk of morbidity and morality.	I	B-R

AAA: abdominal aortic aneurysm; COR: class of recommendation; FDA: Food and Drug Administration; LOE: level of evidence; NR: nonrandomized; R: randomized.

 

In 2011, the ACC/AHA released an update to their 2005 guidelines on the management of AAAs that focused on the management of patients with peripheral artery disease. These guidelines made the following recommendations:

Guidelines on Management of Patients with Peripheral Artery Disease

Recommendation	COR	LOE
Open or endovascular repair of infrarenal AAAs and/or common iliac aneurysms is indicated in patients who are good surgical candidates	I	A
Periodic long-term surveillance imaging should be performed to monitor for endoleak, confirm graft position, document shrinkage or stability of the excluded aneurysm sac, and determine the need for further intervention in patients who have undergone endovascular repair of infrarenal aortic and/or iliac aneurysms	I	A
Open aneurysm repair is reasonable to perform in patients who are good surgical candidates but who cannot comply with the periodic long-term surveillance required after endovascular repair	IIa	C
Endovascular repair of infrarenal aortic aneurysms in patients who are at high surgical or anesthetic risk as determined by the presence of coexisting severe cardiac, pulmonary, and/or renal disease is of uncertain effectiveness	IIb	C

AAA: abdominal aortic aneurysm; COR: class of recommendation; LOE: level of evidence.

In 2006, the ACC/AHA suggested in their professional guidelines, based on both randomized and nonrandomized trials, that endovascular repair of infrarenal aortic and/or common iliac aneurysms is reasonable in patients at high risk of complication from open surgeries.

Society of Interventional Radiology et al

Guidelines on the use of EVAR were developed jointly by the Society of Interventional Radiology, the Cardiovascular and Interventional Radiological Society of Europe, and the Canadian Interventional Radiology Association in 2010. These guidelines indicated that:

“Indications for EVAR are currently the same as open repair….”

“Patient preference for EVAR versus open repair should be considered when appropriate….”

“Endovascular abdominal aortic aneurysm repair should be considered as having an intermediate to high cardiac risk that ranges from 3% to 7%.”

There has been increasing use of EVAR for ruptured aneurysms. “Achieving optimal EVAR results for ruptured AAA requires establishment of a treatment protocol involving the emergency department, the endovascular team, anesthesiology, and the operating room personnel.”

“Lifelong imaging surveillance of patients after EVAR is critical for

1. the detection and, if possible, the characterization of endoleaks;
2. evidence of expansion or shrinkage of the residual AAA sac through measurement of aneurysm size, volume calculation, and identification of substantial changes in aneurysm dimensions;
3. detection of mechanical changes in the stent-graft, such as migration, kinking, or fracture;
4. evaluation of the long-term performance of the endoprosthesis.”

Society for Vascular Surgery

The Society for Vascular Surgery published guidelines for the treatment of AAAs in 2018. As in previous publications, these guidelines indicated that open surgery and EVAR are options for patients with aneurysms that meet the current treatment threshold. These guidelines also contained the following statements and recommendations.

Guidelines on Management of Patients with Aneurysms

Recommendation	QOE	LOR
EVAR is progressively replacing open surgery as the treatment of choice, and accounts for more than half of all elective AAA repairs in the United States
Emergent EVAR should be considered for treatment of a ruptured AAA, if anatomically feasible	Moderate	Strong
EVAR may be considered for high-risk patients unfit for surgical repair	Low	Weak
For patients with ruptured aneurysm, immediate repair is recommended.	High	Strong

AAA: abdominal aortic aneurysm; EVAR: endovascular aneurysm repair; LOR: level of recommendation; QOE: quality of evidence.

National Institute for Health and Care Excellence

Recommendations for the diagnosis and management of AAAs were published by the National Institute for Health and Care Excellence (NICE) in March 2020.

Recommendations for repairing unruptured aneurysms include:

• "1.5.1: Consider aneurysm repair for people with an unruptured AAA, if it is:
  • symptomatic
  • asymptomatic, larger than 4.0 cm, and has grown by more than 1 cm in 1 year (measured inner-to-inner maximum anterior-posterior aortic diameter on ultrasound)
  • asymptomatic and 5.5 cm or larger (measured inner-to-inner maximum anterior-posterior aortic diameter on ultrasound)."
• "1.5.4: Consider endovascular aneurysm repair (EVAR) for people with unruptured AAAs who meet the criteria in recommendation 1.5.1 and who have abdominal copathology, such as a hostile abdomen, horseshoe kidney or a stoma, or other considerations, specific to and discussed with the person, that may make EVAR the preferred option"

 

• "1.5.5: Consider EVAR or conservative management for people with unruptured AAAs meeting the criteria in recommendation 1.5.1 who have anaesthetic risks and/or medical comorbidities that would contraindicate open surgical repair."

Recommendations for repairing ruptured aneurysms include:

• "1.6.1: Consider endovascular aneurysm repair (EVAR) or open surgical repair for people with a ruptured infrarenal AAA. Be aware that:
  • EVAR provides more benefit than open surgical repair for most people, especially men over 70 and women of any age
  • Open surgical repair is likely to provide a better balance of benefits and harms in men under 70."
• "1.6.2: Consider open surgical repair for people with a ruptured AAA if standard EVAR is unsuitable."

U.S. Preventive Services Task Force Recommendations

Recommendations from the U.S. Preventive Services Task Force (USPSTF) on AAA screening were updated on December 10, 2019. The USPSTF notes the following in their section on "Current Practice" as it relates to this topic:

"The standard of care for elective repair is that patients with an AAA of 5.5 cm or larger in diameter should be referred for surgical intervention with either open repair or EVAR. This recommendation is based on RCTs conducted in men. The AAA size needed for surgical intervention in women may differ. As a result, guidelines from the Society for Vascular Surgery recommend repairing AAAs between 5.0 and 5.4 cm in diameter in women. However, concerns about poorer surgical outcomes in women, who have more complex anatomy and smaller blood vessels, have led some to caution against lowering the threshold for surgical intervention in women."

KEY WORDS:

EVAR, AAA, abdominal aortic aneurysm, endovascular repair, AneuRx® Prosthesis System, Gore® Excluder®, Zenith® AAA Endovascular Graft, Endologix Powerlink®, Talent® Abdominal Stent Graft System, Endurant® II, Ovation™, Aorfix™, abdominal aneurysm, TREO

APPROVED BY GOVERNING BODIES:

A large number of endovascular grafts have been approved by the U.S. Food and Drug Administration (FDA) through the premarket approval (PMA) process for treatment of abdominal aortic aneurysms (see Table below). The original PMA dates are shown. Most stents have undergone device modification, name changes, and have approved supplements to the original PMA.

Abdominal Aortic Stent Grafts Approved by FDA

Stent Name	PMA Applicant	Approval Date	PMA No.
AneuRx® Prosthesis System (AneuRx AAAdvantage Stent Graft)	Medtronic Vascular	1999	P990020
Ancure® Aortoiliac System	Guidant Endovascular Technologies	2002	P990017
Gore® Excluder®	W.L. Gore & Associates	2002	P020004
Zenith® AAA Endovascular Graft	Cook	2003	P020018
Talent® Abdominal Stent Graft System	Medtronic	2008	P070027
Endologix Powerlink® (Afx Endovascular AAA system)	Endologix	2004	P040002
Endurant® II AAA Stent Graft System	Medtronic	2010	P100021
Ovation™ Abdominal Stent Graft System	TriVascular	2012	P120006
Aorfix™ AAA Flexible Stent Graft System	Lombard Medical	2013	P110032
Incraft® AAA Stent Graft System	Cordis	2018	P150002
TREO®	Bolten Medical	2020	P190015
Alto® Abdominal Stent Graft System	Endologix, LLC	2023	P120006

 

PMA: premarket approval.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING: 

CPT Codes:    

The overall procedure involves 4 steps: establishing vascular access, introducing catheters and guide wires into the arterial system, deploying the endoprosthesis, and radiologic supervision. Below are the codes for the procedure.

 

34701	Endovascular repair of infrarenal aorta by deployment of an aorto-aortic tube endograft including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, all endograft extension(s) placed in the aorta from the level of the renal arteries to the aortic bifurcation, and all angioplasty/stenting performed from the level of the renal arteries to the aortic bifurcation; for other than rupture (eg, for aneurysm, pseudoaneurysm, dissection, penetrating ulcer)
34702	Endovascular repair of infrarenal aorta by deployment of an aorto-aortic tube endograft including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, all endograft extension(s) placed in the aorta from the level of the renal arteries to the aortic bifurcation, and all angioplasty/stenting performed from the level of the renal arteries to the aortic bifurcation; for rupture including temporary aortic and/or iliac balloon occlusion, when performed (eg, for aneurysm, pseudoaneurysm, dissection, penetrating ulcer, traumatic disruption)
34703	Endovascular repair of infrarenal aorta and/or iliac artery(ies) by deployment of an aorto-uni-iliac endograft including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, all endograft extension(s) placed in the aorta from the level of the renal arteries to the iliac bifurcation, and all angioplasty/stenting performed from the level of the renal arteries to the iliac bifurcation; for other than rupture (eg, for aneurysm, pseudoaneurysm, dissection, penetrating ulcer)
34704	Endovascular repair of infrarenal aorta and/or iliac artery(ies) by deployment of an aorto-uni-iliac endograft including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, all endograft extension(s) placed in the aorta from the level of the renal arteries to the iliac bifurcation, and all angioplasty/stenting performed from the level of the renal arteries to the iliac bifurcation; for rupture including temporary aortic and/or iliac balloon occlusion, when performed (eg, for aneurysm, pseudoaneurysm, dissection, penetrating ulcer, traumatic disruption)
34705	Endovascular repair of infrarenal aorta and/or iliac artery(ies) by deployment of an aorto-bi-iliac endograft including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, all endograft extension(s) placed in the aorta from the level of the renal arteries to the iliac bifurcation, and all angioplasty/stenting performed from the level of the renal arteries to the iliac bifurcation; for other than rupture (eg, for aneurysm, pseudoaneurysm, dissection, penetrating ulcer)
34706	Endovascular repair of infrarenal aorta and/or iliac artery(ies) by deployment of an aorto-bi-iliac endograft including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, all endograft extension(s) placed in the aorta from the level of the renal arteries to the iliac bifurcation, and all angioplasty/stenting performed from the level of the renal arteries to the iliac bifurcation; for rupture including temporary aortic and/or iliac balloon occlusion, when performed (eg, for aneurysm, pseudoaneurysm, dissection, penetrating ulcer, traumatic disruption)
34707	Endovascular repair of iliac artery by deployment of an ilio-iliac tube endograft including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, and all endograft extension(s) proximally to the aortic bifurcation and distally to the iliac bifurcation, and treatment zone angioplasty/stenting, when performed, unilateral; for other than rupture (eg, for aneurysm, pseudoaneurysm, dissection, arteriovenous malformation)
34708	Endovascular repair of iliac artery by deployment of an ilio-iliac tube endograft including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, and all endograft extension(s) proximally to the aortic bifurcation and distally to the iliac bifurcation, and treatment zone angioplasty/stenting, when performed, unilateral; for rupture including temporary aortic and/or iliac balloon occlusion, when performed (eg, for aneurysm, pseudoaneurysm, dissection, arteriovenous malformation, traumatic disruption)
34709	Placement of extension prosthesis(es) distal to the common iliac artery(ies) or proximal to the renal artery(ies) for endovascular repair of infrarenal abdominal aortic or iliac aneurysm, false aneurysm, dissection, penetrating ulcer, including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, and treatment zone angioplasty/stenting, when performed, per vessel treated (List separately in addition to code for primary procedure)
34710	Delayed placement of distal or proximal extension prosthesis for endovascular repair of infrarenal abdominal aortic or iliac aneurysm, false aneurysm, dissection, endoleak, or endograft migration, including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, and treatment zone angioplasty/stenting, when performed; initial vessel treated
34711	Delayed placement of distal or proximal extension prosthesis for endovascular repair of infrarenal abdominal aortic or iliac aneurysm, false aneurysm, dissection, endoleak, or endograft migration, including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, and treatment zone angioplasty/stenting, when performed; each additional vessel treated (List separately in addition to code for primary procedure)
34712	Transcatheter delivery of enhanced fixation device(s) to the endograft (eg, anchor, screw, tack) and all associated radiological supervision and interpretation
34713	Percutaneous access and closure of femoral artery for delivery of endograft through a large sheath (12 French or larger), including ultrasound guidance, when performed, unilateral (List separately in addition to code for primary procedure)
34714	Open femoral artery exposure with creation of conduit for delivery of endovascular prosthesis or for establishment of cardiopulmonary bypass, by groin incision, unilateral (List separately in addition to code for primary procedure)
34715	Open axillary/subclavian artery exposure for delivery of endovascular prosthesis by infraclavicular or supraclavicular incision, unilateral (List separately in addition to code for primary procedure)
34716	Open axillary/subclavian artery exposure with creation of conduit for delivery of endovascular prosthesis or for establishment of cardiopulmonary bypass, by infraclavicular or supraclavicular incision, unilateral (List separately in addition to code for primary procedure)
34812	Open femoral artery exposure for delivery of endovascular prosthesis, by groin incision, unilateral (List separately in addition to code for primary procedure)
34820	Open iliac artery exposure for delivery of endovascular prosthesis or iliac occlusion during endovascular therapy, by abdominal or retroperitoneal incision, unilateral (List separately in addition to code for primary procedure)
34839	Physician planning of a patient-specific fenestrated visceral aortic endograft requiring a minimum of 90 minutes of physician time.
34841	Endovascular repair of visceral aorta (e.g., aneurysm, 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 one visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s])
34842	;including two visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s])
34843	;including three visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s])
34844	;including three visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s])
34845	Endovascular repair of visceral aorta and infrarenal abdominal aorta (e.g., aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) with a fenestrated visceral aortic endograft and concomitant unibody or modular infrarenal aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including one visceral artery endoprosthesis (superior mesenteric, celiac or renal artery)
34846	;including two visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s])
34847	;including two visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s])
34848	;including two visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s])
36200	Induction of catheter, aorta

 

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43. Powell JT, Sweeting MJ, Thompson MM, et al. Endovascular or open repair strategy for ruptured abdominal aortic aneurysm:30 day outcomes from IMPROVE randomised trial. BMJ. Jan 13 2014; 348: f7661.
44. 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. Feb 2017; 104(3):166-178.
45. Prinssen M, Verhoeven EL, Buth J, et al. A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms. N Engl J Med. Oct 14 2004; 351(16): 1607-18.
46. 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. Aug 2013; 258(2):248-256.
47. 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. Nov 1 2011; 58(19):2020-2045.
48. Schermerhorn ML, Buck DB, O'Malley AJ, et al. Long-term outcomes of abdominal aortic aneurysm in the Medicare population. N Engl J Med. Jul 23 2015; 373(4):328-338.
49. Shahin Y, Dixon S, Kerr K, et al. Endovascular aneurysm repair offers a survival advantage and is cost-effective compared with conservative management in patients physiologically unfit for open repair. J Vasc Surg. Feb 2023; 77(2): 386-395.e3.
50. 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. Sep 2015; 102(10):1229-1239.
51. Sweeting MJ, Patel R, Powell JT, et al. Endovascular repair of abdominal aortic aneurysm in patients physically ineligible for open repair: very long-term follow-up in the EVAR-2 randomized controlled trial. Ann Surg. Nov 2017;266(5):713-719.
52. Ulug P, Powell JT, Martinez MA, et al. Surgery for small asymptomatic abdominal aortic aneurysms. Cochrane Database SystRev. Jul 01 2020; 7: CD001835.
53. Ulug P, Sweeting MJ, von Allmen RS, et al. Morphological suitability for endovascular repair, non-intervention rates, and operative mortality in women and men assessed for intact abdominal aortic aneurysm repair: systematic reviews with meta-analysis. Lancet. Jun 24 2017;389(10088):2482-2491.
54. 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. Apr 2014; 47(4):380-387.
55. 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. Nov 2010; 21(11):1632-1655.
56. Yokoyama Y, Kuno T, Takagi H. Meta-analysis of phase-specific survival after elective endovascular versus surgical repair of abdominal aortic aneurysm from randomized controlled trials and propensity score-matched studies. J Vasc Surg. Oct 2020;72(4): 1464-1472.e6.

POLICY HISTORY:

Medical Policy Panel, May 2017

Medical Policy Group, June 2017 (4): Adopted new policy.

Medical Policy Administration Committee, July 2017

Available for comment June 31 through August 13, 2017

Medical Policy Group, December 2017: Annual Coding Update 2018.  Added new codes 34701 – 34716 effective 01/01/18.  Created Previous Coding section and moved deleted codes 34800 – 34805, 34825, 75952 and 75953 to this section. Updated verbiage for revised CPT codes 34812 and 34820.

Medical Policy Panel, May 2018

Medical Policy Group, June 2018 (4): Updates to Description, Key Points, Key Words, and References.  Added Key Word abdominal aneurysm. No change to policy statement.

Medical Policy Panel, May 2019

Medical Policy Group, June 2019 (4): Updates to Key Points.  No change to policy statement.

Medical Policy Panel, May 2020

Medical Policy Group, June 2020 (4): Updates to Key Points, Approved by Governing Bodies, and References.  No change to policy statement.

Medical Policy Panel, May 2021

Medical Policy Group, June 2021 (4): Updates to Key Points and References.  Policy statement updated to remove “not medically necessary,” no change to policy intent. The following references were removed: 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; 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). Aug 2006(144):1-113.

Medical  Policy Panel, May 2022

Medical Policy Group, May 2022 (4): Updates to Key Points and References.  No change to policy statements. Removed Previous Coding section with codes 34800 – 34805, 34825, 75952, and 75953 that were deleted 12/31/17.

Medical Policy Panel, May 2023

Medical Policy Group, May 2023 (4): Updates to Key Points, Practice Guidelines, Governing Bodies, Key Words (TREO) Benefit Application,  and References.

Medical Policy Panel, May 2024

Medical Policy Group, May 2024 (4): Updates to Description, Key Points, Approved by Governing Bodies, and References

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.