Clinical & Quality Management

MEDICAL POLICY

Magnetic Resonance Angiography (MRA) and Magnetic Resonance Venography (MRV) Policy Number: 2015M0093A

Effective Date: November 01, 2015

Table of Contents:

Page:

POLICY DESCRIPTION COVERAGE RATIONALE/CLINICAL CONSIDERATIONS BACKGROUND REGULATORY STATUS CLINICAL EVIDENCE APPLICABLE CODES REFERENCES POLICY HISTORY/REVISION INFORMATION

2 2 4 6 9 11 13 16

Cross Reference Policy: Positron Emission Tomography, 2015M0086A Proton Beam Radiation Therapy, 2013M0022A Transcatheter Heart Valve Replacement, 2012M0020A

INSTRUCTIONS: “Medical Policy assists in administering UCare benefits when making coverage determinations for members under our health benefit plans. When deciding coverage, all reviewers must first identify enrollee eligibility, federal and state legislation or regulatory guidance regarding benefit mandates, and the member specific Evidence of Coverage (EOC) document must be referenced prior to using the medical policies. In the event of a conflict, the enrollee's specific benefit document and federal and state legislation and regulatory guidance supersede this Medical Policy. In the absence of benefit mandates or regulatory guidance that govern the service, procedure or treatment, or when the member’s EOC document is silent or not specific, medical policies help to clarify which healthcare services may or may not be covered. This Medical Policy is provided for informational purposes and does not constitute medical advice. In addition to medical policies, UCare also uses tools developed by third parties, such as the InterQual Guidelines®, to assist us in administering health benefits. The InterQual Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice. Other Policies and Coverage Determination Guidelines may also apply. UCare reserves the right, in its sole discretion, to modify its Policies and Guidelines as necessary and to provide benefits otherwise excluded by medical policies when necessitated by operational considerations.”

Copyright 2015, Proprietary Information of UCare Page. 1 of 16

Clinical & Quality Management

MEDICAL POLICY

POLICY DESCRIPTION: Magnetic resonance angiography (MRA) is an application of magnetic resonance imaging (MRI) that provides visualization of blood flow, as well as images of normal and diseased blood vessels. This policy describes the principles for using magnetic resonance angiography (MRA) and magnetic resonance venography (MRV) for the diagnosis, treatment planning and evaluation of various medical conditions in the pediatric and adult patient.

COVERAGE RATIONALE / CLINICAL CONSIDERATIONS: Magnetic resonance angiography (MRA) of the head and neck may be considered MEDICALLY NECESSARY for diagnosis, treatment planning and evaluation of the following conditions: • Stenotic/occlusive disease (e.g, atherosclerotic occlusive disease and thromboembolic phenomena) • Intracranial and spinal hemorrhage (leaking/ruptured intracranial aneurysm (ICA) or arteriovenous malformation (AVM)) • Vascular anatomy, such as aneurysm and arteriovenous malformation • Vertebrobasilar insufficiency • Injury to the carotid artery • Arterial dissection • Vascular supply to tumors • Dural sinus thrombosis and intracranial venous occlusive disease Magnetic resonance angiography (MRA) of the thoracic, abdominal, and pelvic may be considered MEDICALLY NECESSARY for diagnosis, treatment planning and evaluation of the following conditions: • Aneurysm • Stenosis • Vascular malformation • Venous disease, including occlusion, thrombosis and tumor invasion • Venous anatomy, including congenital abnormalities, extrinsic compression, or causes of intrinsic stenosis or obstruction (e.g., suspected Budd-Chiari syndrome) • Dissection of the aorta • Vascular mapping • Vascular anastomoses Magnetic resonance angiography (MRA) of the lower extremities may be considered MEDICALLY NECESSARY as an initial test for diagnosis and surgical planning in the treatment of peripheral arterial disease of the lower extremity. A subsequent angiography study is only required if the inflow vessel is not identified on the MRA. If conventional catheter angiography is performed first, doing a subsequent MRA may be indicated if a distal run-off vessel is not identified. Both tests should not be routinely performed. Magnetic resonance angiography (MRA) of the spinal canal may be considered MEDICALLY NECESSARY in individuals with known cases of spinal cord arteriovenous fistula (AVF) or arteriovenous malformation (AVM). Copyright 2015, Proprietary Information of UCare Page. 2 of 16

Clinical & Quality Management

MEDICAL POLICY

The use of MRA is considered MEDICALLY NECESSARY in members with documented allergy to iodinated contrast material, and in members who have accelerating hypertension and/or accelerating renal insufficiency. CHILDREN (age less than 18 years) Magnetic resonance angiography (MRA) is particularly applicable in children due to the risk related to catheter-based angiographic procedures, including the small potential risk of exposure to ionizing radiation. MRA may be considered MEDICALLY NECESSARY for diagnosis, treatment planning and evaluation of the following conditions: • Congenital anomalies of the aorta, coronary arteries, pulmonary vasculature and branch vessels • Congenital venous anomalies • Aortic, pulmonary arterial and branch vessel vasculopathy • Vasculitis • Arterial dissection • Aneurysm • Renovascular hypertension • Mesenteric ischemia • Vascular abnormalities associated with sickle cell anemia • Peripheral vascular malformations of the extremities in congenital anomalies • Venous occlusive disease • Thrombosis • Vascular neoplasms • Vascular anastomoses and complication of organ transplant • Surgically created dialysis fistulas and grafts Magnetic resonance angiography (MRA) of the cervicocerebral region of the body in children may be considered MEDICALLY NECESSARY for diagnosis, treatment planning and evaluation of the following conditions: • Arterial dissection or occlusive disease • Dural sinus thrombosis and intracranial venous occlusive disease • Cerebral arteriovenous malformations • Aneurysm • Vascular abnormalities, such as sickle cell anemia, large vessel vasculitis, moyamoya disease • Vascular neoplasms • Intracranial and spinal hemorrhage • Traumatic injury to cervicocerebral vessels • Congenital or acquired vascular abnormality • Evaluation of aortic arch and subclavian arteries Magnetic resonance venography (MRV) is considered PROVEN AND MEDICALLY NECESSARY for the following indications: • Evaluation of thrombus or compression by tumor of the cerebral venous sinus • Evaluation of venous thrombosis or occlusion in the large systemic veins Copyright 2015, Proprietary Information of UCare Page. 3 of 16

Clinical & Quality Management •

MEDICAL POLICY

Evaluation of venous thrombosis or occlusion in the portal and/or hepatic venous system, such as Budd-Chiari syndrome

MRA is considered EXPERIMENTAL and/or INVESTIGATIONAL for all other indications because its effectiveness has not been established, including, but not limited to, the following: • • • • • • • • •

Cardiac MRI for velocity flow mapping Evaluating accessory renal arteries in prospective renal donors, including potential living kidney donors Evaluating members with symptoms suggestive of dural, sagittal or cavernous sinus thrombosis/occlusion Evaluating microvascular compression associated with trigeminal neuralgia Ruling out intracranial aneurysm (ICA) in members who have vague central nervous system symptoms (e.g., dizziness, headache, non-specific sensory loss, or vertigo) Evaluating premature ventricular contraction Evaluating recurrent cystic hygroma of the axilla Screening for renovascular hypertension Screening of the general population for ICAs

MRV is considered EXPERIMENTAL and/or INVESTIGATIONAL for diagnosis of deep vein thrombosis in the arms or legs because the peer-reviewed medical literature has not established MRV to be superior to Duplex ultrasonography for this purpose. MRV is considered EXPERIMENTAL and/or INVESTIGATIONAL for all other indications (e.g., diagnosis of chronic cerebrospinal venous insufficiency) because its effectiveness for indications other than the ones listed above has not been established.

Clinical Considerations: MRA is contraindicated in patients with metallic surgical clips, cardiac pacemakers, defibrillators, or other electromechanical implants (including neurostimulators, bone-growth stimulators, and cochlear implants); in patients who are on life support; in patients with allergies to contrast materials; and in pregnant women. Also, MRA may be difficult in patients with severe claustrophobia or who are unable to cooperate.

BACKGROUND: Magnetic resonance angiography (MRA) is a noninvasive technique of imaging based on magnetic resonance imaging (MRI) technology. The application of an external magnetic field creates a contrast between flowing blood and surrounding stationary tissues to depict blood vessel morphology and blood flow (rate and direction). MRA may be helpful to diagnose and plan treatment for vascular diseases of the abdomen, thorax, heart, pelvis and extremities, and head and neck. MRA depicts blood flow and blood vessel morphology without the use of potentially toxic contrast agents, and does not involve radiation exposure. The reference standards for diagnosis of vascular abnormalities include conventional contrast angiography (CCA), Doppler ultrasound (US), standard MRI, computed tomography (CT), radionuclide

Copyright 2015, Proprietary Information of UCare Page. 4 of 16

Clinical & Quality Management

MEDICAL POLICY

scanning, and surgery. Advantages of MRA compared with CCA are that it is noninvasive and does not involve exposure to potentially toxic contrast agents or ionizing radiation. Clinical applications of peripheral MRA include the diagnosis of PVD, specifically, arteriosclerotic stenoses and occlusions, and detection of runoff vessels prior to medical or surgical treatment. A determination of the length and location of the diseased segment(s), whether they are stenotic or occlusive, and potential sites for a graft origin and target outflow vessels suitable for grafting, aids in deciding whether medical therapy, percutaneous transluminal angioplasty (PTA), or surgical bypass grafting is appropriate. Deep-vein thrombosis (DVT) of the pelvic and lower extremities, is a major cause of morbidity and mortality in the Unites States with as many as 5 million episodes occurring annually. From 75% to 95% of pulmonary emboli originate in the veins of the lower extremity and pelvis. DVT is treated with anticoagulants, such as heparin, in an effort to decrease the risk of embolism. The clinical diagnosis of DVT can be difficult since it displays variable symptoms depending on whether its presentation is acute or chronic. The reference standard of diagnosis for DVT is contrast venography (CV); however, this technique is limited by its invasiveness, exposure to potentially allergenic or nephrotoxic contrast agents, problems with venous cannulation, development of local or systemic thrombosis, and incomplete filling of the pelvic venous structures. The interpretation of CV images is subject to reader variability. A noninvasive alternative, duplex Doppler US, is limited by problems with operator dependence and inadequate sensitivity for the pelvic veins. Impedance plethysmography is another alternative, but is susceptible to false-negative results in cases of partial thrombosis of collateral vessels and problems in imaging of chronic thrombosis and veins of the lower extremities. Thus, the diagnostic accuracy of another noninvasive alternative imaging method, MRA, has been evaluated in clinical studies. The major clinical applications of abdominal MRA include imaging of the renal vasculature, aorta, portal venous system, mesenteric arteries, and other abdominal blood vessels. MRA is used to determine whether renal artery stenosis (RAS) is causing hypertension; renovascular hypertension accounts for 1% to 5% of cases of secondary hypertension. RAS is amenable to treatment by surgical revascularization or bypass surgery, percutaneous transluminal angioplasty, or endovascular stent placement. Abdominal MRA is also used for the diagnosis and preoperative evaluation of abdominal aortic aneurysms (AAA), aortic stenoses (≥ 50%), aortic occlusions and dissections, and chronic mesenteric ischemia. Clinical applications for MRA of the thoracic vasculature include diagnosis and pre- and postoperative evaluation of abnormalities of the thoracic aorta (dissection, coarctation, aneurysm), aortic arch vessel disease, anomalies of the aortic arch and pulmonary venous connections, congenital heart valve anomalies, deep venous occlusion or thrombosis, and pulmonary embolism. While conventional MRI has been widely used to diagnose aortic dissections and aneurysms, its accuracy is limited by respiratory motion and blood flow artifacts, as well as an inability to adequately depict three-dimensional (3D) images. A complete MRI examination of the thoracic aorta for dissections encompasses the aortic root to the iliac vessels to define the presence and location of an intimal flap, to assess aortic diameter and branch vessel patency, and to determine the presence of hematomas. 3D MRA with gadolinium enhancement depicts the entire aorta in a very short time, supplementing the findings of conventional MRI. MRA demonstrates the relationship between the intimal flap and the branch vessels, thrombi, arteriosclerotic ulcers, postoperative pseudoaneurysms, progressive dilation of the false lumen, secondary aneurysm formation, and extension of dissection, conditions that may require surgical intervention and grafting but cannot readily differentiate true from false lumen. The most well researched applications of MRA have been of the blood flow in the carotid arteries, the circle Copyright 2015, Proprietary Information of UCare Page. 5 of 16

Clinical & Quality Management

MEDICAL POLICY

of Willis, the anterior, middle or posterior cerebral arteries, the vertebral or basilar arteries and the venous sinuses. Children demonstrate a different spectrum of disease than do adults, and the routine protocols used for evaluating the adult patient may not be optimal or even appropriate in evaluating children. As the brain and the cervicocerebral vascular region develop during infancy and childhood, cervicocerebral MRA can provide valuable information regarding flow conditions and pathologic processes within the brain and spine. However, technical and safety issues are more complex in pediatric patients. The smaller size of the pediatric patient increases the demand for higher resolution and special attention must be paid to the appropriate dose of contrast media, the unique considerations for assessing renal insufficiency, the use of gadolinium-based contrast agents, and the methods of administering contrast and fluid. In addition, sedation is frequently required to successfully complete the examination.

REGULATORY STATUS: 1. U.S. FOOD AND DRUG ADMINISTRATION (FDA): On December 24, 2008, the U.S. FDA approved Vasovist injection (gadofosveset trisodium, marketed as Ablavar) the first contrast imaging agent for use in patients undergoing MRA. 2. CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS): The Centers for Medicare and Medicaid Services (CMS) issued a 2010 National Coverage Decision (NCD) that merged the Magnetic Resonance Angiography (MRA) and the Magnetic Resonance Imaging (MRI) NCDs. Currently, coverage is limited to MRI units that have received Food and Drug Administration (FDA) premarket approval, and such units must be operated within the parameters specified by the approval. Other uses of MRI for which CMS has not specifically indicated national coverage or national non-coverage are at the discretion of Medicare’s local contractors. On February 8, 2011, the FDA granted approval of the first pacemaker designed for use in the MR environment for certain MRI exams. On February 24, 2011, CMS issued a NCD that provided coverage of MRI for beneficiaries with implanted pacemakers (PMs) or implantable cardiac defibrillators through Coverage with Evidence Development (CED)/Coverage with Study Participation (CSP) in approved clinical studies of MRI. The NCD was updated in July 2011 to remove the contraindication for Medicare coverage of MRI in beneficiaries with implanted PMs when the PMs are used according to the FDAapproved labeling for use in an MRI environment. Other contraindications that may be present in any given beneficiary continue to apply in patients with PMs. National Coverage Determination (NCD) for magnetic resonance angiograpy (220.3): MRA is a specific application of MRI. CMS believes that the continued existence of separate NCDs is unnecessary, and that the provisions of the MRA NCD at section 220.3, should be merged under the NCD for MRI at section 220.2. Thus, section 220.3, MRA, will no longer appear as a separate NCD. The effect of this change will maintain existing national coverage for both MRI and MRA, and will eliminate the noncoverage language that currently exists for MRA at section 220.3, thereby permitting local Medicare contractors to cover (or not cover) all indications of MRA (and MRI) that are not specifically nationally covered or nationally non-covered.

Copyright 2015, Proprietary Information of UCare Page. 6 of 16

Clinical & Quality Management

MEDICAL POLICY

Local Coverage Determination (LCD): Magnetic Resonance Angiography (MRA) (L25367). This local coverage determination is a restatement of the National Coverage Determination for MRI and MRA documented in CMS Publication 100-03, Medicare National Coverage Determinations Manual, Part 4: 220.2.A.2 Magnetic Resonance Imaging (MRI). MRA (MRI for Blood flow) Currently covered indications include using MRA for specific conditions to evaluate flow in internal carotid vessels of the head and neck, peripheral arteries of lower extremities, abdomen and pelvis, and the chest. Coverage is limited to MRA units that have received FDA premarket approval, and such units must be operated within the parameters specified by the approval. In addition, the services must be reasonable and necessary for the diagnosis or treatment of the specific patient involved. (CMS Publication 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Section 220.2.B.2). Head and Neck Effective April 15, 2003, studies have proven that MRA is effective for evaluating flow in internal carotid vessels of the head and neck. However, not all potential applications of MRA have been shown to be reasonable and necessary. All of the following criteria must apply in order for Medicare to provide coverage for MRA of the head and neck: • MRA is used to evaluate the carotid arteries, the circle of Willis, the anterior, middle or posterior cerebral arteries, the vertebral or basilar arteries or the venous sinuses; • MRA is performed on patients with conditions of the head and neck for which surgery is anticipated and may be found to be appropriate based on the MRA. These conditions include, but are not limited to, tumor, aneurysms, vascular malformations, vascular occlusion or thrombosis. Within this broad category of disorders, medical necessity is the underlying determinant of the need for an MRA in specific diseases. The medical records should clearly justify and demonstrate the existence of medical necessity; and, •

MRA and CA are not expected to be performed on the same patient for diagnostic purposes prior to the application of anticipated therapy. Only one of these tests will be covered routinely unless the physician can demonstrate the medical need to perform both tests. (CMS Publication 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Section 220.2.B.2a).

MRA is appropriately used to verify the presence of a condition, suspected because of findings from another test (usually an imaging study). For example, a patient who presents with a transient ischemic attack (TIA) should not undergo MRA simply because he might have a lesion which is amenable to surgery. However, if that patient has a carotid bruit and is found by doppler study to have carotid stenosis, an MRA may be appropriate to evaluate the stenotic section of artery for surgical intervention. Please note that the anticipated surgery may be a percutaneous procedure such as carotid angioplasty with stent insertion. Another patient may present with a headache; it is not appropriate to proceed directly to MRA to rule out the possibility of an intracranial aneurysm. However, if that patient was found to have a clinically significant amount of blood in the cerebrospinal fluid, or the patient demonstrated signs and symptoms strongly suggesting an unruptured intracranial aneurysm, an MRA (or cerebral angiogram) may be

Copyright 2015, Proprietary Information of UCare Page. 7 of 16

Clinical & Quality Management

MEDICAL POLICY

appropriate. An MRA is not considered medically necessary for screening asymptomatic patients for intracranial aneurysms. Please note that the anticipated surgery may be a percutaneous procedure such as carotid angioplasty with stent insertion. Peripheral Arteries of Lower Extremities Effective April 15, 2003, studies have proven that MRA of peripheral arteries is useful in determining the presence and extent of peripheral vascular disease in lower extremities. This procedure is noninvasive and has been shown to find occult vessels in some patients for which those vessels were not apparent when CA was performed. Medicare will cover either MRA or CA to evaluate peripheral arteries of the lower extremities. However, both MRA and CA may be useful in some cases, such as: • A patient has had CA and this test was unable to identify a viable run-off vessel for bypass. When exploratory surgery is not believed to be a reasonable medical course of action for this patient, MRA may be performed to identify the viable runoff vessel; or, • A patient has had MRA, but the results are inconclusive.(CMS Publication 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Section 220.2.B.2.b). Abdomen and Pelvis i. Pre-operative Evaluation of Patients Undergoing Elective Abdominal Aortic Aneurysm (AAA) Repair Effective July 1, 1999, MRA is covered for pre-operative evaluation of patients undergoing elective AAA repair if the scientific evidence reveals MRA is considered comparable to CA in determining the extent of AAA, as well as in evaluating aortoiliac occlusion disease and renal artery pathology that may be necessary in the surgical planning of AAA repair. These studies also reveal that MRA could provide a net benefit to the patient. If preoperative CA is avoided, then patients are not exposed to the risks associated with invasive procedures, contrast media, end-organ damage, or arterial injury. ii. Imaging the Renal Arteries and the Aortoiliac Arteries in the Absence of AAA or Aortic Dissection Effective July 1, 2003, MRA coverage is expanded to include imaging the renal arteries and the aortoiliac arteries in the absence of AAA or aortic dissection. MRA should be obtained in those circumstances in which using MRA is expected to avoid obtaining CA, when physician history, physical examination, and standard assessment tools provide insufficient information for patient management, and obtaining an MRA has a high probability of positively affecting patient management. However, CA may be ordered after obtaining the results of an MRA in those rare instances where medical necessity is demonstrated. (CMS Publication 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Section 220.2.B.2.c). An MRA of the abdomen for evaluation of possible renal artery stenosis would not be considered medically necessary without some evidence consistent with renovascular hypertension. Such evidence might include: • a history of early or late onset of hypertension, hypertension refractory to medication, or worsening renal function; • the presence of a renal artery bruit; • laboratory tests (elevated serum renins, increasing creatinine); or • other radiologic tests (ultrasound, captopril scintigraphy, or other imaging showing small kidney or Copyright 2015, Proprietary Information of UCare Page. 8 of 16

Clinical & Quality Management

MEDICAL POLICY

unequal kidney sizes). Chest i. Diagnosis of Pulmonary Embolism Current scientific data has shown that diagnostic pulmonary MRAs are improving due to recent developments such as faster imaging capabilities and gadolinium-enhancement. However, these advances in MRA are not significant enough to warrant replacement of pulmonary angiography in the diagnosis of pulmonary embolism for patients who have no contraindication to receiving intravenous iodinated contrast material. Patients who are allergic to iodinated contrast material face a high risk of developing complications if they undergo pulmonary angiography or computed tomography angiography. Therefore, Medicare will cover MRA of the chest for diagnosing a suspected pulmonary embolism when it is contraindicated for the patient to receive intravascular iodinated contrast material. ii. Evaluation of Thoracic Aortic Dissection and Aneurysm Studies have shown that MRA of the chest has a high level of diagnostic accuracy for pre-operative and post-operative evaluation of aortic dissection of aneurysm. Depending on the clinical presentation, MRA may be used as an alternative to other non-invasive imaging technologies, such as transesophageal echocardiography and CT. Generally, Medicare will provide coverage only for MRA or for CA when used as a diagnostic test. However, if both MRA and CA of the chest are used, the physician must demonstrate the medical need for performing these tests. While the intent of this policy is to provide reimbursement for either MRA or CA, CMS is also allowing flexibility for physicians to make appropriate decisions concerning the use of these tests based on the needs of individual patients. CMS anticipates, however, low utilization of the combined use of MRA and CA. As a result, CMS encourages contractors to monitor the use of these tests and, where indicated, requires evidence of the need to perform both MRA and CA. (CMS Publication 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Section 220.2.B.2.d). All other uses of MRA are nationally non-covered unless coverage is specifically indicated.

3. MINNESOTA DEPARTMENT OF HUMAN SERVICES (DHS): Minnesota DHS does not have a policy

statement regarding magnetic resonance angiography in its Provider Manual or other specific provider references.

CLINICAL EVIDENCE: The diagnostic accuracy of MRA is compared to reference standards for conventional contrast angiography (CCA), digital subtraction angiography (DSA), Doppler ultrasound (US), standard MRI, computed tomography (CT), and histopathological examination of surgical specimens. One advantage of MRA is that it does not require the use of potentially toxic contrast agents, which are often poorly tolerated by liver and renal disease patients.

Copyright 2015, Proprietary Information of UCare Page. 9 of 16

Clinical & Quality Management

MEDICAL POLICY

SUMMARY:

The diagnostic accuracy of MRA compared with reference standards of diagnosis for vascular diseases has been investigated in prospective blinded case series or retrospective, unblinded studies; no long-term, randomized, controlled clinical trials were identified in a search of the medical literature. MRA was shown to be a promising, noninvasive alternative to conventional methods of diagnosing and planning treatment for PVD related to arteriosclerosis of the lower extremities, and for diagnosing DVT of the pelvis and lower extremities. MRA demonstrated adequate sensitivity, specificity, positive and negative predictive values, and accuracy for the diagnosis of diseases of the peripheral vasculature. The major technical limitation of MRA of the peripheral arteries, i.e., its tendency to overestimate stenosis severity, is mainly due to signal loss caused by complex vessel anatomy and turbulent blood flow. Underestimation of lesion severity also occurs, particularly at sites where arteries and veins overlap. False-positive diagnoses of DVT were primarily related to intraluminal filling defects or technical problems from vessel compression. Both false-positive and false-negative diagnoses can lead to inappropriate therapeutic decisions. A falsepositive diagnosis might lead to unnecessary surgery in PVD patients, while a false-negative diagnosis might result in potentially beneficial treatment being withheld, or to blind surgical exploration with its attendant risks. MRA does appear to have some impact on treatment decision-making in PVD patients with arterial stenoses or occlusions, although none of the studies provided data on long-term outcomes on vessel patency, limb salvage, or restenosis rates following thrombolysis, thrombectomy, bypass surgery or PTA. None of the studies on DVT examined the effects of MRA on treatment or prognosis. For RAS associated with secondary hypertension, aortic aneurysms, aorto-iliac occlusive disease, and chronic mesenteric ischemia, and the diagnosis of portal venous abnormalities in liver transplant candidates, and in patients with portal hypertension or Budd-Chiari syndrome, MRA was shown to be a promising, noninvasive alternative or adjunct to conventional methods of diagnosis; however, none of the case series determined the impact of MRA on long-term outcomes. Further, promising findings in studies of diagnostic sensitivity and specificity do not necessarily translate into improved patient prognoses or costeffective treatments. Due to the very small number of patients who were evaluated prior to TIPS and the descriptive nature of the data, no conclusions regarding the efficacy of MRA for this specific indication can be rendered at this time. MRA may be an alternative for liver or renal patients who cannot tolerate contrast agents employed in conventional imaging. Magnetic resonance angiography is an effective non-invasive technique for establishing a diagnosis and evaluating the extent and severity of nearly all diseases of the thoracic aorta. Studies have shown that MRA of the chest has a high level of diagnostic accuracy for pre-operative and post-operative evaluation of aortic dissection of aneurysm. Depending on the clinical presentation, MRA may be used as an alternative to other non-invasive imaging technologies (e.g., trans-esophageal echocardiography and CT). The majority of the case series investigating the efficacy and safety of MRA for the diagnosis of head and neck vascular disease are limited to assessments of its diagnostic sensitivity, specificity, and accuracy compared with that of the reference standards of diagnosis. Although relatively inaccurate for the diagnosis of carotid artery ulcerations, MRA accurately diagnoses carotid artery stenosis and is efficacious for screening patients prior to CCA and surgery; diagnostic accuracy is highest when MRA and US are combined. MRA may have a role in screening patients with a clinical suspicion of stroke prior to CCA, or who might

Copyright 2015, Proprietary Information of UCare Page. 10 of 16

Clinical & Quality Management

MEDICAL POLICY

benefit from thrombolytic therapy if performed while therapy would still be efficacious. MRA may be less risky than CCA for patients with extracranial or intracranial vascular disease who are at high risk for stroke. However, false-positive diagnoses by MRA may result in confirmation by CCA with its attendant risks. Conversely, patients with false-negative diagnoses by MRA may develop stroke or other serious neurological sequelae if treatment is not given. Although its accuracy is lower for small aneurysms, MRA provided additional data in patients with unruptured aneurysms or ruptured aneurysms and subarachnoid hemorrhage and may be a useful adjunct to other diagnostic modalities; however, it cannot completely replace CCA prior to surgery or other treatment. A patient with a false-negative diagnosis of unruptured aneurysm faces a high risk of morbidity and mortality if a potentially treatable lesion ruptures. The optimal clinical role for MRA in patients with subarachnoid hemorrhage is unclear, as they are often critically ill and unable to cooperate during imaging. While MRA has high diagnostic sensitivity and specificity for arteriovenous malformations compared with DSA and is equivalent to the reference standard CT for detecting dural sinus thromboses, there is a need to confirm these findings in larger samples. While it is a good noninvasive alternative, CT is superior for the visualization of small cerebral vessels and sinuses; CT can be used in cases in which MRA results are inconclusive. Data are lacking on the sensitivity and specificity of MRA for this indication. Head and neck MRA has technical limitations: the acquisition time makes it susceptible to motion artifacts and MRA of the cerebral vasculature is limited by slow flow or long in-plane flow and signal dropouts due to flow turbulence. False-positive diagnoses of occlusive disease may occur in the presence of signal loss or at vessel bifurcations. MRA has lower spatial resolution compared with CCA. Comparisons between the results of the various studies and data interpretation are hampered by interstudy differences in methodology, MRA techniques performed, patient inclusion and exclusion criteria, and outcome measures. There is a need for additional research to validate MRA techniques and to better standardize imaging protocols. Case series are inherently limited due to the possibility of patient selection bias, and the lack of a comparison group. Although MRA appeared to be a useful adjunct to the reference standards of diagnosis, there were no rigorous analyses of the effects of MRA on treatment decisionmaking, surgical planning, and patient prognosis. MRA is efficacious for several head and neck vascular indications, but its optimal clinical uses will remain uncertain until additional, well-designed, long-term, randomized, controlled, blinded studies, comparing MRA with conventional diagnostic methods and surgical results are performed. Magnetic Resonance Venography (MRV) is considered effective for the evaluation of diseases of larger veins.

APPLICABLE CODES: The Current Procedural Terminology (CPT®) codes and HCPCS codes listed in this policy are for reference purposes only. Listing of a service or device code in this policy does not imply that the service described by this code is a covered or non-covered health service. The inclusion of a code does not imply any right to reimbursement or guarantee claims payment. Other medical policies and coverage determination guidelines may apply.

HCPCS Codes A9583

Description

Injection, Gadofosveset Trisodium, 1 ml [Ablavar, Vasovist]

Copyright 2015, Proprietary Information of UCare Page. 11 of 16

Clinical & Quality Management C8909 C8910 C8911 C8912 C8913 C8914 ICD-9 Codes 155.0 238.9 277.3 362.30 405.91 424.1 440.1 441.02 441.4 444.0 456.1 593.81

ICD-10 Codes A52.05 C71.0-C71.9 C76.0 D33.0-D33.2 D43.0-D43.9 G08 G44.1 G45.0-G45.9 H34.00-H34.03 I60.00-I60.9 I67.0-I67.9 I71.02 - I71.03 I71.3 - I71.4 I71.5 - I71.6 177.71 177.74 M43.6 Q28.2 R13.10 - R13.19 R51 R55 R83.9 S15.001+ - S15.099+ Z82.3

MEDICAL POLICY

Magnetic resonance angiography with contrast, chest (excluding myocardium) Magnetic resonance angiography without contrast, chest (excluding myocardium) Magnetic resonance angiography without contrast followed by with contrast, chest (excluding myocardium) Magnetic resonance angiography with contrast, lower extremity Magnetic resonance angiography without contrast, lower extremity Magnetic resonance angiography without contrast, followed by with contrast, lower extremity Description Hepatocellular carcinoma Carcinoid tumor Amyloidosis Portal vein occlusion Renovascular hypertension Abdominal aortic stenosis Renal artery atherosclerosis Abdominal aortic dissection Abdominal aortic aneurysm Leriche's syndrome Esophageal varices Renal artery occlusion

Description Other cerebrovascular syphilis [intracranial aneurysm] Malignant neoplasm of brain Malignant neoplasm of head, face and neck Benign neoplasm of brain Neoplasm of uncertain behavior of brain and central nervous system Intracranial and intraspinal phlebitis and thrombophlebitis [intracranial aneurysm] Vascular headache, not elsewhere classified [sudden explosive headache, unilateral headache] Transient cerebral ischemic attacks and related syndromes Transient retinal artery occlusion Nontraumatic subarachnoid hemorrhage Other cerebrovascular diseases Dissection of abdominal or thoracoabdominal aorta Abdominal aortic aneurysm, ruptured or without rupture Thoracoabdominal aneurysm, ruptured or without mention of rupture Dissection of carotid artery Dissection of vertebral artery Torticollis Arteriovenous malformation of cerebral vessels Dysphagia Headache [sudden explosive headache, unilateral headache] Syncope and collapse Unspecified abnormal findings in cerebrospinal fluid [blood in CSF] Injury of carotid artery of neck Family history of stroke

Copyright 2015, Proprietary Information of UCare Page. 12 of 16

Clinical & Quality Management CPT® Codes 70544 70545 70546 70547 70548 70549

MEDICAL POLICY Description

Magnetic resonance angiography, head; without contrast material(s) with contrast material(s) without contrast material(s), followed by contrast material(s) and further sequences Magnetic resonance angiography, neck; without contrast material(s) with contrast material(s) without contrast material(s), followed by contrast material(s) and further sequences

CPT® is a registered trademark of the American Medical Association.

REFERENCES: 1. 2.

3.

4.

5.

6. 7. 8.

9.

10. 11.

12.

13.

Aetna. Magnetic Resonance Angiography (MRA). Last Review 3/20/2015. Available at: http://www.aetna.com/cpb/medical/data/1_99/0094.html. Accessed Sep 1, 2015. American College of Radiology (ACR), American Society of Neuroradiology (ASNR), Society of NeuroInterventional Surgery (SNIS), Society for Pediatric Radiology (SPR). ACR-ASNR-SNIS-SPR practice guideline for the performance of pediatric and adult cervicocerebral magnetic resonance angiography (MRA). Oct 13, 2011. Available at: http://www.guideline.gov/content.aspx?id=32519#Section420. Accessed Sep 4, 2015. American College of Radiology (ACR), North American Society for Cardiovascular Imaging (NASCI), Society for Pediatric Radiology (SPR). ACR-NASCI-SPR practice guideline for the performance of pediatric and adult body magnetic resonance angiography (MRA). Nov 4, 2011. Available at: http://www.guideline.gov/popups/printView.aspx?id=32520. Accessed Sep 4, 2015. Atlas SW, Sheppard L, Goldberg HI, et al. Intracranial aneurysms: detection and characterization with MR angiography with use of an advanced postprocessing technique in a blinded-reader study. Radiology. 1997;203:807-814. Bates SM, Jaeschke R, Stevens SM, et al; American College of Chest Physicians. Diagnosis of DVT: Antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012;141(2 Suppl):e351S-e418S. Baum RA, Rutter CM, Sunshine JH, et al. Multicenter trial to evaluate vascular magnetic resonance angiography of the lower extremity. JAMA. 1995;274:875-880. Bergin CJ, Hauschildt J, Rios G, et al. Accuracy of MR angiography compared with radionuclide scanning in identifying the cause of pulmonary arterial hypertension. AJR Am J Roentgenol. 1997;168:1549-1555. Bosch E, Kreitner KF, Peirano MF, et al. Safety and efficacy of gadofosveset-enhanced MR angiography for evaluation of pedal arterial disease: Multicenter comparative phase 3 study. AJR Am J Roentgenol. 2008;190(1):179-186. Carpenter JP, Holland GA, Baum RA, et al. Magnetic resonance venography for the detection of deep venous thrombosis: comparison with contrast venography and duplex Doppler ultrasonography. J Vasc Surg. 1993;18:734-741. Catalano C, Pavone P, Laghi A, et al. Role of MR venography in the evaluation of deep venous thrombosis. Acta Radiol. 1997;38:907-912. Centers for Medicare & Medicaid Services (CMS). Magnetic Resonance Angiography. Pub 100-03 Medicare National Coverage Determinations. July 9, 2010. Available at: http://www.cms.gov/transmittals/downloads/R123NCD.pdf. Accessed Sep 8, 2015. Centers for Medicare & Medicaid Services (CMS). Magnetic Resonance Angiography and Magnetic Resonance Imaging. Available at: https://www.cms.gov/Medicare/Coverage/Coverage-with-EvidenceDevelopment/MRA_MRI.html. Accessed Sep 1, 2015. De Cobelli F, Vanzulli A, Sironi S, et al. Renal artery stenosis: evaluation with breath-hold, three-dimensional,

Copyright 2015, Proprietary Information of UCare Page. 13 of 16

Clinical & Quality Management

14.

15. 16. 17. 18. 19. 20.

21.

22. 23.

24.

25.

26.

27.

28. 29. 30.

MEDICAL POLICY

dynamic, gadolinium-enhanced versus three-dimensional, phase-contrast MR angiography. Radiology. 1997;205:689-695. De Marco JK, Nesbit GM, Wesbey GE, Richardson D. Prospective evaluation of extracranial carotid stenosis: MR angiography with maximum-intensity projections and multiplanar reformation compared with conventional angiography. AJR Am J Roentgenol. 1994;163:1205-1212. Ecklund K, Hartnell GG, Hughes LA, et al. MR angiography as the sole method in evaluating abdominal aortic aneurysms: correlation with conventional techniques and surgery. Radiology. 1994;192:345-350. Essig M, Engenhart R, Knopp MV, et al. Cerebral arteriovenous malformations: improved nidus demarcation by means of dynamic tagging MR-angiography. Magn Reson Imaging. 1996;14:227-233. Farb RI, Kim JK, Willinsky RA, et al. Spinal dural arteriovenous fistula localization with a technique of first-pass gadolinium-enhanced MR angiography: Initial experience. Radiology. 2002;222(3):843-850. Gillard JH, Oliverio PJ, Barker PB, et al. MR angiography in acute cerebral ischemia of the anterior circulation: a preliminary report. Am J Neuroradiol. 1997;18:343-350. Glickerman DJ, Obregon RG, Schmiedl UP, et al. Cardiac-gated MR angiography of the entire lower extremity: a prospective comparison with conventional angiography. AJR Am J Roentgenol. 1996;167:445-451. Hany TF, Debatin JF, Leung DA, Pfammatter T. Evaluation of the aortoiliac and renal arteries: comparison of breath-hold, contrast-enhanced, three-dimensional MR angiography with conventional catheter angiography. Radiology. 1997;204:357-362. Harrison MJ, Johnson BA, Gardner GM, Welling BG. Preliminary results on the management of unruptured intracranial aneurysms with magnetic resonance angiography and computed tomographic angiography. Neurosurgery. 1997;40:947-957. Hartnell GG, Hughes LA, Finn JP, Longmaid HE III. Magnetic resonance angiography of the central chest veins. A new gold standard? Chest. 1995;107:1053-1057. Hayes, Winifred S. Magnetic Resonance Angiography, Abdominal Applications. Medical Technology Directory. Annual Review: March 16, 2005. Available at: https://www.hayesinc.com/subscribers/articleList.do?query=mra&keyword_type=all&status=all&tf_from_date= &tf_to_date=. Accessed Sep 3, 2015. Hayes, Winifred S. Magnetic Resonance Angiography, Head and Neck Applications. Medical Technology Directory. Annual Review: September 24, 2005. Available at: https://www.hayesinc.com/subscribers/articleList.do?query=mra&keyword_type=all&status=all&tf_from_date= &tf_to_date=. Accessed Sep 3, 2015. Hayes, Winifred S. Magnetic Resonance Angiography, Peripheral Applications. Medical Technology Directory. Annual Review: April 25, 2005. Available at: https://www.hayesinc.com/subscribers/articleList.do?query=mra&keyword_type=all&status=all&tf_from_date= &tf_to_date=. Accessed Sep 3, 2015. Hayes, Winifred S. Magnetic Resonance Angiography, Thoracic Applications. Medical Technology Directory. Annual Review: September 12, 2005. Available at: https://www.hayesinc.com/subscribers/articleList.do?query=mra&keyword_type=all&status=all&tf_from_date= &tf_to_date=. Accessed Sep 3, 2015. Holland GA, Dougherty L, Carpenter JP, et al. Breath-hold ultrafast three-dimensional gadolinium-enhanced MR angiography of the aorta and the renal and other visceral abdominal arteries. AJR Am J Roentgenol. 1996;166:971-981. Holmes DR Jr, Monahan KH, Packer D. Pulmonary vein stenosis complicating ablation for atrial fibrillation: Clinical spectrum and interventional considerations. JACC Cardiovasc Interv. 2009;2(4):267-276. Hughes LA, Hartnell GG, Finn JP, et al. Time-of-flight MR angiography of the portal venous system: value compared with other imaging procedures. AJR Am J Roentgenol. 1996;166:375-378. Ida M, Kurisu Y, Yamashita M. MR angiography of ruptured aneurysms in acute subarachnoid hemorrhage. Am J

Copyright 2015, Proprietary Information of UCare Page. 14 of 16

Clinical & Quality Management

MEDICAL POLICY

Neuroradiol. 1997;18:1025-1032. 31. Johnson DB, Lerner CA, Prince MR, et al. Gadolinium-enhanced magnetic resonance angiography of renal transplants. Magn. Reson Imaging. 1997;15:13-20. 32. Kane R, Eustace S. Diagnosis of Budd-Chiari syndrome: comparison between sonography and MR angiography. Radiology. 1995;195:117-121. 33. Kasner SE, Hankins LL, Bratina P, Morgenstern LB. Magnetic resonance angiography demonstrates vascular healing of carotid and vertebral artery dissections. Stroke. 1997;28:1993-1997. 34. King, BF. MR angiography of the renal arteries. Semin Ultrasound CT MR. 1996;17:398-403. 35. Korogi Y, Takahashi M, Mabuchi N, et al. Intracranial aneurysms: diagnostic accuracy of MR angiography with evaluation of maximum intensity projection and source images. Radiology. 1996;199:199-207. 36. Krinsky GA, Rofsky NM, DeCorato DR, et al. Thoracic aorta: comparison of gadolinium-enhanced threedimensional MR angiography with conventional MR imaging. Radiology. 1997;202:183-193. 37. Laissy JP, Soyer P, Tebboune D, et al. Abdominal aortic aneurysms: assessment with gadolinium-enhanced timeof-flight coronal MR angiography (MRA). Eur Radiol. 1995;20:1-8. 38. Loubeyre P, Revel D, Douek P, et al. Dynamic contrast-enhanced MR angiography of pulmonary embolism: comparison with pulmonary angiography. AJR Am J Roentgenol. 1994;162:1035-1039. 39. Luetmer PH, Lane JI, Gilbertson JR, et al. Preangiographic evaluation of spinal dural arteriovenous fistulas with elliptic centric contrast-enhanced MR angiography and effect on radiation dose and volume of iodinated contrast material. AJNR Am J Neuroradiol. 2005;26(4):711-718. 40. McDermott VG, Meakem TJ, Carpenter JP, et al. Magnetic resonance angiography of the distal lower extremity. Clin Radiol. 1995;50:741-746. 41. McGregor R, Vymazal J, Martinez-Lopez M, et al. A multi-center, comparative, phase 3 study to determine the efficacy of gadofosveset-enhanced magnetic resonance angiography for evaluation of renal artery disease. Eur J Radiol. 2008;65(2):316-325. 42. Meaney JFM, Weg JG, Chenvert TL, et al. Diagnosis of pulmonary embolism with magnetic resonance angiography. N Engl J Med. 1997;336:1422-1427. 43. Meckel S, Maier M, Ruiz DS, et al. MR angiography of dural arteriovenous fistulas: Diagnosis and follow-up after treatment using a time-resolved 3D contrast-enhanced technique. AJNR Am J Neuroradiol. 2007;28(5):877-884. 44. Mull M, Nijenhuis RJ, Backes WH, et al. Value and limitations of contrast-enhanced MR angiography in spinal arteriovenous malformations and dural arteriovenous fistulas. AJNR Am J Neuroradiol. 2007;28(7):1249-1258. 45. Müller MF, Edelman RR. Magnetic resonance angiography of the abdomen. Gastroenterol Clin North Am. 1995;24:435-456. 46. Murakami T, Igarashi H, Matsushita HOM, et al. Time-of-flight MR angiography of portal system and collaterals in portal hypertension using a 2-DFT fast spoiled gradient recalled steady-state precession technique. Acta Radiol. 1994;35:581-585. 47. Ozsvath RR, Casey SO, Lustrin ES, et al. Cerebral venography: comparison of CT and MR projection venography. AJR Am J Roentgenol. 1997;169:1696-1699. 48. Patel MR, Kuntz KM, Klufas RA, et al. Preoperative assessment of the carotid bifurcation. Can magnetic resonance angiography and duplex ultrasonography replace contrast arteriography? Stroke. 1995;26:1753-1758. 49. Prince MR, Narasimham DL, Jacoby WT, et al. Three-dimensional gadolinium-enhanced MR angiography of the thoracic aorta. AJR Am J Roentgenol. 1996;166:1387-1397. 50. Rose SC, Gomes AS, Yoon HC. MR angiography for mapping potential central venous access sites in patients with advanced venous occlusive disease. AJR Am J Roentgenol. 1996;166:1181-1187. 51. Saremi F, Tafti M. The role of computed tomography and magnetic resonance imaging in ablation procedures for treatment of atrial fibrillation. Semin Ultrasound CT MR. 2009;30(2):125-156. 52. Sharma AK, Westesson PL. Preoperative evaluation of spinal vascular malformation by MR angiography: How

Copyright 2015, Proprietary Information of UCare Page. 15 of 16

Clinical & Quality Management

MEDICAL POLICY

reliable is the technique: Case report and review of literature. Clin Neurol Neurosurg. 2008;110(5):521-524. 53. Shrier DA, Tanaka H, Numaguchi Y, et al. CT angiography in the evaluation of acute stroke. Am J Neuroradiol. 1997;18:1011-1020. 54. Silverman JM, Friedman ML, Van Allan RJ. Detection of main renal artery stenosis using phase-contrast cine MR angiography. AJR Am J Roentgenol. 1996;166:1131-1137. 55. Silverman JM, Julien PJ, Herfkens RJ, Pelc NJ. Magnetic resonance imaging evaluation of pulmonary vascular malformations. Chest. 1994;106:1333-1338. 56. Silverman JM, Podesta L, Villamil F, et al. Portal vein patency in candidates for liver transplantation: MR angiographic analysis. Radiology. 1995;197:147-152. 57. Steffens JC, Link J, Müller-Hülsbeck S, et al. Cardiac-gated two-dimensional phase-contrast MR angiography of lower extremity occlusive disease. AJR Am J Roentgenol. 1997;169:749-754. 58. Stock KW, Radue EW, Jacob AL, et al. Intracranial arteries: prospective blinded comparative study of MR angiography and DSA in 50 patients. Radiology. 1995;195:451-456. 59. U.S. Food and Drug Administration (FDA). Drugs@FDA. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm. Accessed Sep 8, 2015. 60. Wasser MN, Geelkerken RH, Kouwenhoven M, et al. Systolically gated 3D phase contrast MRA of mesenteric arteries in suspected mesenteric ischemia. J Comput Assist Tomogr. 1996;20:262-268. 61. White JE, Russell WL, Greer MS, Whittle MT. Efficacy of screening MR angiography and Doppler ultrasonography in the evaluation of carotid artery stenosis. Am Surg. 1994;60:340-348. 62. Wilcock D, Jaspan T, Holland I, et al. Comparison of magnetic resonance angiography with conventional angiography in the detection of intracranial aneurysms in patients presenting with subarachnoid haemorrhage. Clin Radiol. 1996;51:330-334. 63. Yoshizako T, Sugimura K, Kawamitsu H, Yoshikawa K. Two-dimensional time-of-flight MR venography: assessment with detection of chronic deep venous thrombosis in combination with magnetization transfer contrast. J Comput Assist Tomogr. 1996;20:957-964.

POLICY HISTORY: DATE

ACTION/DESCRIPTION

09/14/2015

New policy 2015M0093A approved by the Medical Policy Committee.

09/24/2015

Reviewed and approved by the Quality Improvement Advisory and Credentialing Committee (QIACC).

10/01/2015

Published to UCare.org.

Copyright 2015, Proprietary Information of UCare Page. 16 of 16