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In March 2005, the GORE-TAG Thoracic Endoprosthesis was approved by the U.S. Food and Drug Administration (FDA) for endovascular repair of aneurysms of the descending thoracic aorta. Use of this device requires patients have adequate iliac/femoral access; aortic inner diameter in the range of 23-37 mm; and 2 cm non-aneurysmal aorta proximal and distal to the aneurysm.

In May 2008, the Zenith TX2® TAA Endovascular Graft” (Cook Incorporated, Bloomington, IN) was approved by the FDA through the PMA process for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta. Indicated aortic inner diameter is in the range of 24-38 mm.

In June 2008, the Talent™ Thoracic Stent Graft System (Medtronic Vascular, Santa Rosa, CA) was approved by the FDA through the PMA process for the endovascular repair of fusiform and saccular aneurysms/penetrating ulcers of the descending thoracic aorta. Indicated aortic inner diameter is in the range of 18 - 42mm.

• Treatment of descending thoracic aortic aneurysms without dissection (see Policy Guidelines);
• Treatment of acute, complicated (organ or limb ischemia or rupture) Type B thoracic aortic dissection.

Endovascular stent grafts are considered investigational for the treatment of thoracic aortic arch aneurysms.

None

• The GORE TAG® endoprosthesis is approved by the U.S. Food and Drug Administration (FDA) for “>2 cm non-aneurysmal aorta proximal and distal to the aneurysm and an “aortic inner diameter of 23–37 mm.”
• The Talent™ Thoracic Stent Graft System is approved by the FDA for “non-aneurysmal aortic proximal and distal neck lengths >20mm” and “non-aneurysmal aortic diameter in the range of 18–42 mm.”
• The Zenith 2X2® device is approved by the FDA for non-aneurysmal aortic segments “of at least 25 mm in length” and “diameter measured outer wall to outer wall of no greater than 38 mm and no less than 24 mm.”

Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.

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

4/20/2005: Hyperlink to Endovascular Grafts for Abdominal Aortic Aneurysms deleted

3/23/2006: Coding updated. CPT4 2006 revisions added to policy

5/18/2006: Policy revised. Revisions approved by Medical Policy Advisory Committee (MPAC)

6/22/2006: Code reference section updated, all CPT codes moved from non-covered table to covered table. CPT code 33891 added to covered table. ICD-9 procedure code 39.73 added to covered table.

8/19/2009: Policy reviewed, no changes

05/09/2011: Policy description revised to add additional FDA-approved devices: Zenith 2X2® device and Talent™ Thoracic Stent Graft System.  The first policy statement was revised to indicate that endovascular stent grafts may be considered medically necessary for the treatment of descending thoracic aortic aneurysms using devices approved by the U.S. Food and Drug Administration for their approved specifications.  The approved specifications for each device were added to the Policy Guidelines section.

09/23/2011:  Policy statement revised to indicate that thoracic endovascular aneurysm repair may be considered medically necessary for complicated Type B dissections.  

09/25/2012: Policy reviewed; no changes.

Blue Cross Blue Shield Association policy # 7.01.86

Hayes Medical Technology Directory

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

Covered Codes

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