Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Endovascular Stent-Graft Repair of Thoracic Aortic Aneurysms and Nonaneurysmal Lesions
Policy #:MA11.062

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


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. 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. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

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 Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

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

Endovascular stent grafts are considered medically necessary and, therefore, covered for the treatment of descending thoracic aortic aneurysm, when using Food and Drug Administration (FDA)--approved devices, based on approved specifications.

Endovascular stent grafts are medically necessary and, therefore, covered for the treatment of diagnosed nonaneurysmal lesions of the descending thoracic aorta, when using Food and Drug Administration (FDA)--approved devices, based on approved specifications.

Endovascular stent grafts are medically necessary and, therefore, covered for the treatment of rupture of the descending thoracic aorta.

All other indications for the use of endovascular stent grafts 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.
Policy Guidelines

In March 2005, the GORE TAG® Thoracic Endoprosthesis (W.L. Gore and Associates, Inc. Flagstaff, AZ) was approved by the U.S. Food and Drug Administration (FDA) for the endovascular repair of aneurysms of the descending thoracic aorta with2 cm non-aneurysmal aorta proximal and distal to the aneurysm and an aortic inner diameter of 23-37 mm. In January 2012, the device was approved for endovascular repair of isolated lesions (not including dissections) of the descending thoracic aorta with aortic inner diameter in the range of 16-42 mm, and ≥20 mm non-aneurysmal aorta proximal and distal to the lesion. In September 2013, the device was approved for endovascular repair of all lesions of the descending thoracic aorta, including Type B dissections with ≥ 20 mm landing zone proximal to the primary entry tear and the diameter at the proximal extent of proximal landing zone in the range of 16-42 mm.

In May 2008, the Zenith TX2® Thoracic TAA Endovascular Graft (Cook Incorporated, Bloomington, IN) was approved by the FDA for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta non-aneurysmal aortic segments proximal and distal to the aneurysm or ulcer with a length of at least 25 mm and a diameter-measured outer wall--to--outer wall of no greater than 38 mm and no less than 24 mm.

In June 2008, the Talent™ Thoracic Stent Graft System (Medtronic Vascular, Santa Rosa, CA) was approved by the FDA for endovascular repair of fusiform aneurysms and saccular aneurysms/penetrating ulcers of the descending thoracic aorta with non-aneurysmal aortic proximal and distal neck lengths 20 mm and non-aneurysmal aortic diameter in the range of 18-42 mm.

In April 2011, the Valiant® Thoracic Stent Graft (Medtronic Vascular, Santa Rosa, CA) was approved by the FDA for endovascular repair of fusiform aneurysms and saccular aneurysms/penetrating ulcers of the descending thoracic aorta with non-aneurysmal aortic diameter in the range of 18-42 mm and non-aneurysmal aortic proximal and distal neck lengths ≥20 mm. In October 2012, the device was approved for the endovascular repair of isolated lesions (excluding dissections) of the descending thoracic aorta with non-aneurysmal aortic diameter in the range of 18-42 mm (fusiform and saccular aneurysms/penetrating ulcers) or 18-44 mm (blunt traumatic aortic injuries) and non-aneurysmal aortic proximal and distal neck lengths ≥ 20 mm. In January 2014, this device was approved for all lesions of the descending thoracic aorta (DTA), including nonaneurysmal aortic diameter in the range of 18 mm to 42 mm (fusiform and saccular aneurysms/penetrating ulcers), or 18 mm to 44 mm (blunt traumatic aortic injuries), or 20 mm to 44 mm (dissections); and nonaneurysmal aortic proximal and distal neck lengths ≥20 mm (fusiform and saccular aneurysms/penetrating ulcers); landing zone ≥20 mm proximal to the primary entry tear (blunt traumatic aortic injuries, dissections).

In September 2012, the Relay® Thoracic Stent Graft (Bolton Medical, Sunrise, Florida) was approved by the FDA for the endovascular repair of fusiform aneurysms and saccular aneurysms/penetrating atherosclerotic ulcers in the descending thoracic aorta with non-aneurysmal aortic neck diameter in the range of 19-42 mm and non-aneurysmal proximal aortic neck lengths between 15 and 25 mm and distal aortic neck lengths between 25 and 30 mm, depending on the diameter stent-graft required.

There is no Medicare coverage criteria addressing this service; therefore, the Company policy is applicable.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, endovascular stent-graft repair of thoracic aortic aneurysms and nonaneurysmal lesions are covered under the medical benefits of the Company's Medicare Advantage products when the medical necessity criteria in this policy are met.

Subject to the terms and conditions of the applicable Evidence of Coverage, endovascular stent-graft repair for rupture of the descending thoracic aorta is covered under the medical benefits of the Company's Medicare Advantage products when the medical necessity criteria in this policy are met.

However, services that are identified in this policy as experimental/investigational are not eligible for coverage or reimbursement by the Company.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous devices approved by the FDA for the treatment of descending thoracic aortic
aneurysms.

Description

THORACIC ANEURYSM

An aortic aneurysm is an abnormal swelling, or dilation, in the wall of the aorta, the body's largest artery. A thoracic aortic aneurysm occurs in an area of the aorta that passes through the chest. A thoracic aortic aneurysm can occur anywhere along the aorta above the diaphragm, including the ascending aorta, the aortic arch, and the descending thoracic aorta. Left untreated, an aortic aneurysm can enlarge over time, increasing the risk of dissection. The most common cause of a thoracic aortic aneurysm is hardening of the arteries. Thoracic aneurysms are also associated with individuals who have high cholesterol and long-term high blood pressure, as well as individuals who have congenital connective tissue disorders (i.e., Marfan syndrome).

The traditional standard of treatment for a thoracic aortic aneurysm is open surgical repair, which involves resection of the aneurysm and graft implantation of the diseased segment. This surgical procedure entails a long operative duration that includes lateral thoracotomy and cardiopulmonary bypass. Complications may include spinal cord ischemia, myocardial infarction, pulmonary dysfunction, renal failure, and bowel ischemia or infarction. Abdominal aortic aneurysms have been successfully treated with endovascular stent grafts, which generated an interest in applying endovascular stent graphs to thoracic aortic aneurysms.

Thoracic endovascular aneurysm repair (TEVAR) has been investigated as an alternative to the open surgical procedure for repairing a thoracic aortic aneurysm, and can also be used as prophylactic treatment of an aneurysm at significant risk of future rupture or dissection. TEVAR involves the percutaneous (through the skin) placement of a stent graft in the descending thoracic or thoracoabdominal aorta to reduce mortality from aneurysm rupture. Indications for elective surgical repair of aortic aneurysm are based on the estimated prognosis of the untreated aneurysm weighed against the morbidity and mortality of the intervention. The prognosis of thoracic aortic aneurysms is based on the risk of rupture according to the size and location of the aneurysm (i.e., the ascending or descending or thoracoabdominal aorta).

Several grafts have been approved by the FDA for the treatment of descending thoracic aortic aneurysms, including: the GORE TAG® Thoracic Endoprosthesis (W.L. Gore and Associates, Inc. Flagstaff, AZ), the Zenith TX2® Thoracic TAA Endovascular Graft (Cook Incorporated, Bloomington, IN), the Talent Thoracic Stent Graft System (Medtronic Vascular, Santa Rosa, CA), the Valiant® Thoracic Stent Graft (Medtronic Vascular, Santa Rosa, CA), and the Relay® Thoracic Stent Graft (Bolton Medical, Sunrise, FL).

According to the Society of Thoracic Surgeons, TEVAR is performed as follows: During endovascular surgery, a synthetic graft (stent-graft consisting of a polyester tube inside a metal cylinder) is attached to the end of a thin tube (catheter), which is inserted into the bloodstream, usually through the femoral artery in the groin. The surgeon threads the stent-graft to the part of the aorta where the aneurysm is located by watching the progression of the catheter on an X-ray monitor. Once the graft is in place over the aneurysm, the graft is expanded. The stent-graft reinforces the weakened section of the aorta to prevent the aneurysm from rupturing. The metal cylinder framing the stent-graft is expanded to hold tightly against the wall of the aorta, thus diminishing the blood supply to the aneurysm. Ultimately, the blood flows through the stent-graft, bypassing the aneurysm. Over time, the aneurysm should shrink.

THORACIC DISSECTION

A thoracic dissection involves an intimal tear that permits blood to enter the potential space between the intima and the muscular wall of the thoracic aorta. This leakage of blood between the layers of the vessel wall can result in rupture of the aorta. Rupture of the aorta can lead to serious consequences, including death.

Aortic dissections can be subdivided into two categories: Type A and Type B. Type A involves the aortic arch or the ascending part of the aorta and is usually treated surgically. Type B is confined to the descending aorta and can be treated medically when there are no serious complications (i.e., shock or visceral ischemia), which would require surgical intervention. Type B dissection can be further categorized as complicated and uncomplicated dissection. For uncomplicated descending (type B) aortic dissection, the evidence does not support TEVAR for treatment. Medical therapy is still superior for this condition. A complicated acute type B aortic dissection can have either of the following clinical presentations: 1) a rupture of the descending aorta into the free pleural space, or 2) malperfusion, which results from the dissection compromising the blood flow, creating a false lumen pressurization and obliteration of the true lumen, so that branch artery flow is threatened, which can cause ischemic complications.

Zeeshan et al conducted a study of patients with acute type B aortic dissection, using TEVAR in 45 patients, open surgical repair in 20 patients, and medical management in 12 patients. The results were as follows: 2 TEVAR patients died within 30 days of hospitalization (4%); 8 patients died in open surgery (40%); and 4 patients died during medical management (33%) (P=0.006). One-year survival for the TEVAR group was 82%. Thus, although this study was not controlled for TEVAR, TEVAR does appear to be a treatment option for patients with catastrophic acute type B aortic dissection.

Additionally, Steuer et al published a retrospective, single-centre, consecutive case series from Europe. In this study, during the period 1999-2009, TEVAR was performed in 50 patients with non-traumatic, acute, complicated type B dissection, and in 10 patients with acute complications such as rupture, end-organ ischemia, and acute dilatation during primary hospitalization but more than 14 days after onset of symptoms. In total, 60 patients were included. Within 30 days, 2 (3%) deaths, 1 (2%) paraplegia, and 3 (5%) strokes were observed. Five-year survival was 87%, and freedom from re-intervention at 5 years was 65%. The authors concluded that, in patients with acute complicated type B aortic dissection, TEVAR can be performed with excellent early and long-term survival.

THORACIC AORTIC RUPTURE

Rupture of the thoracic aorta is a life-threatening emergency that is nearly always fatal if untreated. Thoracic artery rupture can result from a number of factors. Aneurysms can rupture due to progressive dilatation and pressure of the aortic wall. Rupture can also occur as a result of traumatic injury to the aorta, such as occurs with blunt chest trauma. Penetrating injuries that involve the aorta can also lead to rupture. Penetrating ulcers can occur in the setting of widespread atherosclerotic disease and lead to aortic rupture.

Emergent repair of thoracic artery rupture is indicated in many cases in which there is free bleeding into the mediastinum and/or complete transection of the aortic wall. In some cases of aortic rupture, where the aortic media and adventitia are intact, watchful waiting with delayed surgical intervention can be performed. With the advent of TEVAR, the decision making for intervention may be altered, as there may be a greater tendency to intervene on borderline cases due to the potential for less adverse events with TEVAR.

For traumatic thoracic aortic injury and aortic rupture, nonrandomized comparative data suggests a benefit for TEVAR in reducing peri-procedural morbidity and mortality. The FDA granted approval for endovascular treatment of thoracic aortic ruptures in 2012, and specialty society recommendations include endovascular stent grafts as a treatment option for acute thoracic aortic rupture. In addition, it is expected that random controlled trials will be difficult to perform for this indication due to the emergent nature.

SUMMARY

Multiple studies suggest that, compared to open surgery, elective repair of descending thoracic aortic aneurysms with endovascular stent-grafts, for the treatment of a thoracic aortic aneurysm, is associated with lower short-term mortality and lower complication rates.

The more recent published studies of complicated acute type B dissections suggest increased survival for patients treated with TEVAR, especially those who are not candidates for open surgical repair.

The available, albeit limited, evidence suggests that early mortality and complications are less with endovascular stent graft treatment of thoracic artery ruptures compared with open surgery.
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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)

33880, 33881, 33883, 33884, 33889, 33891


THE FOLLOWING CODES ARE RADIOLOGICAL GUIDANCE CODES FOR THE PROCEDURE:
75956, 75957, 75958



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

I71.00 Dissection of unspecified site of aorta

I71.01 Dissection of thoracic aorta

I71.03 Dissection of thoracoabdominal aorta

I71.1 Thoracic aortic aneurysm, ruptured

I71.2 Thoracic aortic aneurysm, without rupture

I71.8 Aortic aneurysm of unspecified site, ruptured

I71.5 Thoracoabdominal aortic aneurysm, ruptured

I71.6 Thoracoabdominal aortic aneurysm, without rupture

I71.9 Aortic aneurysm of unspecified site, without rupture

I79.0 Aneurysm of aorta in diseases classified elsewhere

S25.02xA Major laceration of thoracic aorta, initial encounter

S25.02xD Major laceration of thoracic aorta, subsequent encounter

S25.02xS Major laceration of thoracic aorta, sequel



HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements






Policy History

MA11.062
12/18/2019This policy has been reissued in accordance with the Company's annual review process.
05/11/2016The policy has been reviewed and reissued to communicate the Company’s continuing position on Endovascular Stent-Graft Repair of Thoracic Aortic Aneurysms and Nonaneurysmal Lesions. The references have been updated accordingly.
08/19/2015The policy has been reviewed and reissued to communicate the Company’s continuing position on Endovascular Stent-Graft Repair of Thoracic Aortic Aneurysms and Nonaneurysmal Lesions.
01/01/2015This is a new policy.






Version Effective Date: 01/01/2015
Version Issued Date: 01/01/2015
Version Reissued Date: 12/19/2019