Endovascular Stent Grafts for Abdominal Aortic Aneurysms

POLICY NUMBER

A.7.01.67

DESCRIPTION

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 abdominal aortic aneurysm (AAA) consists of surgical excision with the 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 abdominal aortic aneurysms. 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. Also, extensions can be placed from inside the main endograft body into the visceral arteries to create a hemostatic seal.

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 the treatment of abdominal aortic aneurysms (see the 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 the FDA

Note: This policy addresses abdominal aortic aneurysms only. For discussion of endoprostheses for the treatment of thoracic aortic aneurysms, please see  Endovascular Stent Grafts for Disorders of the Thoracic Aorta policy.

POLICY

The use of endoprostheses approved by the FDA as a treatment of abdominal aortic aneurysms may be considered medically necessary in any of the following clinical situations:

• an aneurysmal diameter greater than 5.0 cm

• an aneurysmal diameter of 4 to 5.0 cm that has increased in size by 0.5 cm in the last 6 months

• an aneurysmal diameter that measures twice the size of the normal infrarenal aorta

• a ruptured abdominal aortic aneurysm (See Policy Guidelines).

The use of endoprostheses approved by the FDA as a treatment of abdominal aortic aneurysms is considered investigational when the above criteria are not met, including but not limited to the following clinical situations:

POLICY EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member’s specific benefit plan language.

For treatment of ruptured abdominal aortic aneurysms with endoprostheses, several factors must be considered including the following:

• The individual must be sufficiently stable to undergo detailed computed tomography examination for anatomic measurements,

• The aneurysm should be anatomically appropriate for endovascular repair, and

• Specialized personnel should be available.

To monitor for leaking of the graft after implantation, individuals will typically undergo routine imaging with computed tomography or ultrasonography every 6 to 12 months, or more frequently if perivascular leaks or aneurysm enlargement are detected.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

1/20/2009: Policy added.

6/04/2010: Description section revised to add more common name for abdominal graft systems such as AneuRX® AAAdvantage; Zenith Flex® AAA Endovascular and Medtronic Talent™ System. Policy statement revised to include a ruptured abdominal aortic aneurysm as a clinical situation that the use of FDA-approved endoprostheses may be considered medically necessary. Policy statement regarding the use of endoprostheses as a treatment of ruptured abdominal aortic aneurysm is investigational was removed. Policy Guidelines section was revised to include factors to be considered when treating ruptured abdominal aortic aneurysms with endoprostheses and the use of monitoring for leaking of the graft after implantation. ICD-9 diagnosis codes 441.3 and 441.4 were added to Covered Codes Table.

06/21/2011: Policy reviewed; no changes.

05/09/2012: Added the following policy statement: The use of endoprostheses approved by the FDA as a treatment of abdominal aortic aneurysms is considered investigational for the following clinical situations: treatment of smaller aneurysms that do not meet the current recommended threshold for surgery or treatment of aneurysms that do meet the recommended threshold for surgery in patients who are ineligible for open repair due to physical limitations or other factors.

08/07/2013: Policy reviewed; no changes.

07/16/2014: Policy reviewed; description updated regarding available devices. Second policy statement revised to add "when the above criteria are not met, including but not limited to" for clarity purposes.

12/31/2014: Added the following new 2015 CPT code to the Code Reference section: 34839.

08/25/2015: Code Reference section updated to add ICD-10 codes. Added ICD-9 procedure code 39.71. Updated the code description for 34825, 34826, and 75953.

09/14/2015: Policy reviewed; no change in policy statements. Policy Guidelines section updated to add medically necessary and investigative definitions.

05/31/2016: Policy number A.7.01.67 added.

08/17/2016: Policy title changed from "Endovascular Grafts for Abdominal Aortic Aneurysms" to "Endovascular Stent Grafts for Abdominal Aortic Aneurysms." Policy description updated regarding endovascular grafts. Policy statements unchanged.

09/30/2016: Code Reference section updated to add the following new ICD-10 procedure codes: 04V03D6, 04V03E6, 04V03EZ, 04V03F6, 04V03FZ, 04V03Z6, 04V04E6, 04V04EZ, 04V04F6, and 04V04FZ.

06/22/2017: Policy description updated regarding perioperative mortality rate and stent grafts. Policy statements unchanged.

12/20/2017: Code Reference section updated to add new 2018 CPT codes 34701, 34702, 34703, 34704, 34705, 34706, 34707, 34708, 34709, 34710, 34711, 34712, and 34714. Revised code descriptions for CPT codes 34812 and 34820 effective 01/01/2018.

06/18/2018: Policy description updated regarding advantages and disadvantages of endovascular grafts. Policy statements unchanged.

06/10/2019: Policy description updated regarding FDA approved stents. Policy statements unchanged. Code Reference section updated to remove deleted CPT codes 34800, 34802, 34803, 34804, 34805, 34825, 34826, 75952, and 75953.

09/30/2019: Code Reference section updated regarding deleted ICD-10 procedure codes.

07/07/2020: Policy description updated regarding FDA-approved abdominal aortic stent grafts. Policy statements unchanged.

08/10/2021: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Code Reference section updated to remove deleted ICD-10 procedure codes 04V03D6, 04V03E6, 04V03F6, 04V03Z6, 04V04E6, and 04V04F6.

06/21/2022: Policy reviewed; no changes.

09/27/2022: Code Reference section updated to add new ICD-10 diagnosis codes I71.30, I71.31, I71.32, I71.33, I71.40, I71.41, I71.42, and I71.43, effective 10/01/2022.

07/17/2023: Policy description updated regarding abdominal aortic stent grafts. Policy statements unchanged.

06/14/2024: Policy description updated regarding abdominal aortic stent grafts approved by the FDA. Investigational policy statement and Policy Guidelines updated to change "patients" to "individuals." Code Reference section updated to remove deleted ICD-10 diagnosis codes I71.3 and I71.4.

08/14/2025: Policy reviewed; no changes.

10/01/2025: Code Reference section updated to add new ICD-10 procedure code 04U03LZ.

SOURCE(S)

Blue Cross Blue Shield Association Policy # 7.01.67

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.