Effective for dates of service on or after April 1, 2013, refer to:

Transcription

1 Effective for dates of service on or after April 1, 2013, refer to: Name of Policy: Magnetic Resonance Angiography of Vessels of the Head, Neck, Abdomen, Pelvis, Spinal Canal, and Upper and Lower Extremity Policy #: 290 Latest Review Date: February 2013 Category: Radiology Policy Grade: A Background: As a general rule, benefits are payable under Blue Cross and Blue Shield of Alabama 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. Page 1 of 9

2 Description of Procedure or Service: Magnetic resonance angiography (MRA) is a technique for imaging vascular anatomy and pathology that does not use ionizing radiation. MRA is performed using magnetic resonance imaging (MRI) machines, and vascular images may be generated either with or without intravenous contrast agents, depending on the clinical application. However, the contrast agents used for MRA are associated with less risk of allergic reaction or nephrotoxicity than those used for conventional angiography. MRA is the general term used to describe MR imaging of vascular structures, but when MR is used to image a vein instead of an artery, the term magnetic resonance venography (MRV) may be used. The technical capabilities of current MRA make it most suitable for evaluation of medium-to-large size vessels. In the head, this includes the Circle of Willis and major posterior circulation vessels, while in the body this includes the aorta and its major arterial branches such as carotid, renal, hepatic and mesenteric arteries. MRA is less suitable for providing detailed information about the small, peripheral vasculature. Policy: Effective for dates of service on or after April 1, 2013, refer to: Effective for dates of service on or after September 1, 2007 through March 31, 2013: MRA of the head meets Blue Cross and Blue Shield of Alabama s medical criteria for coverage for the following conditions: Patients suspected of having stenotic-occlusive disease of the mid or large size intracranial arteries; Patients suspected of having cerebral aneurysm or with known subarachnoid hemorrhage; Patients suspected of having intracranial vascular malformation, MRI not diagnostic; Patients suspected of having cerebral venous sinus compression or thrombosis; Patients with pulsatile tinnitus; Vasculitis Suspicion of trigeminal neuralgia MRA of the neck meets Blue Cross and Blue Shield of Alabama s medical criteria for coverage for the following conditions: Patients suspected of having carotid stenosis or occlusion; Patients suspected of having cervicocranial arterial dissection; Patients suspected of having vertebrobasilar insufficiency; Patients with recent stroke; Patients with suspected traumatic or spontaneous carotid dissection; Patients with carotid body tumor; Preoperative evaluation of head and neck tumor for vascular invasion; Patients with TIA by history. MRA of the spinal canal meets Blue Cross and Blue Shield of Alabama s medical criteria for coverage for the following conditions: Page 2 of 9

3 Dural arteriovenous fistula (DAVF) suspected on MRI; Spinal arteriovenous malformation (AVM). MRA of the upper extremity meets Blue Cross and Blue Shield of Alabama s medical criteria for coverage for the following conditions: Suspected occlusion or stenosis; Suspected arteriovenous malformation (AVM); Venous aneurysm MRA of the abdomen/pelvis meets Blue Cross and Blue Shield of Alabama s medical criteria for coverage for patients with the following conditions: Patients suspected of having atherosclerotic renal artery stenosis; Patients with suspected chronic mesenteric Ischemia; Patients with abdominal aortic aneurysm who are to undergo elective repair of the aneurysm; Patients requiring evaluation of the portal and/or hepatic venous system; Patients requiring evaluation of the systemic venous system Acute mesenteric ischemia Evaluation and follow up of organ transplantation; Aneurysm of iliac arteries; Suspected AV malformation; Pelvic trauma with suspected vascular injury; Malignant neoplasm of kidney when allergic to iodine contrast. MRA of the abdomen meets Blue Cross and Blue Shield of Alabama s medical criteria for coverage for the following conditions Evaluation of renal transplant donor; Arterial occlusive disease of the lower extremities. MRA of the pelvis/lower extremities meets Blue Cross and Blue Shield of Alabama s medical criteria for coverage for the following conditions: Patients with suspected atherosclerotic disease of the lower extremity; Patients with known atherosclerotic disease of the lower extremity who are being evaluated for bypass surgery and in whom angiography fails to identify runoff vessels suitable for bypass. MRA of the lower extremities meets Blue Cross and Blue Shield of Alabama s medical criteria for coverage for patients for the following conditions: Suspected occlusion stenosis; Femoral or popiteal artery aneurysm; Popiteal trauma; Fibular transfer graft; Venous aneurysm. Page 3 of 9

4 Blue Cross and Blue Shield of Alabama 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. Blue Cross and Blue Shield of Alabama administers benefits based on the members' 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. Key Points: Head Invasive cerebral angiography has been traditionally considered the reference standard to which the performance of noninvasive diagnostic tests is compared. Both magnetic resonance angiography (MRA) and transcranial Doppler ultrasonography (TCD) have been shown to be effective noninvasive diagnostic tests for evaluating patients suspected of having intracranial arterial steno-occlusive disease and may be used by some physicians as a replacement for invasive cerebral angiography. In some circumstances, either MRA or TCD alone may provide adequate information to guide appropriate management; however, there are other circumstances whereby it may be necessary to obtain both noninvasive tests before management decisions can be made. For example, the initial noninvasive study may be technically limited by patient motion (particularly a problem for MRA) or by the patient having an inadequate acoustic window (a problem unique to TCD). When this is the case, diagnostic information may be sought using the alternative noninvasive imaging tool. Furthermore, the results of the initial noninvasive evaluation may be borderline or equivocal. Since CDUS and MRA use different physical and technical principles for evaluating the cerebral vasculature, the information obtained from each test can be complementary rather than duplicative in some circumstances. Neck Invasive angiography of the cervical carotid arteries has been used traditionally as the definitive preoperative diagnostic evaluation in patients with carotid artery bifurcation stenosis who are being considered for carotid endarterectomy (CEA). However, as recent improvements have been made in noninvasive diagnostic tests to evaluate the carotid bifurcation region, some physicians have favored a preoperative diagnostic approach using noninvasive imaging tests such as carotid duplex ultrasonography (CDUS) and/or MRA to guide management decisions. CDUS is most commonly used as the initial noninvasive evaluation of the carotid bifurcation as it is less expensive than MRA and generally more readily available than MRA. When the clinical suspicion for steno-occlusive disease is considered along with the results of the initial test (usually CDUS), the physician can decide whether there is sufficient information to determine subsequent management for the patient or whether additional imaging is necessary. One of the imaging strategies that has emerged and that is supported in the available evidence uses both CDUS and MRA to evaluate patients prior to CEA. When both noninvasive tests agree as to the necessity of CEA, the surgical management decision is made based on noninvasive imaging alone. However, if there is discordance in the results of MRA and CDUS Page 4 of 9

5 (e.g., 1 test suggests a severe carotid stenosis but the other test suggests only a mild-tomoderate degree of stenosis), then invasive angiography is performed to determine the management decision. Using this combination strategy, the utilization of invasive angiography for preoperative evaluation for CEA has been reported to decrease substantially. Abdomen A variety of abdominal vascular conditions have been proposed for evaluation with contrastenhanced MRA. Patients who are suspected of having renal artery stenosis may benefit when MRA is used to rule out significant stenosis, thus sparing the patient from invasive angiography. Patients with positive results on MRA may require confirmatory angiography before receiving surgical or intravascular stent treatment for renal artery stenosis. However, confirmation may often be performed during the catheterization for the therapeutic procedure. Similarly, patients with suspected chronic mesenteric ischemia or suspected hepatic arterial disease may benefit from the use of MRA. Potential living renal donors may benefit by using contrast-enhanced MRA for preoperative evaluation of renal anatomy as an alternative to invasive digital subtraction angiography and or computed tomographic angiography (CTA), both of which require ionizing radiation and potentially nephrotoxic iodinated intravenous contrast agents. Patients who are to undergo elective repair of an abdominal aortic aneurysm undergo preoperative angiographic evaluation to delineate the size and location of the aneurysm as well as its relationship with renal and other branch arteries. MRA has been proposed as a replacement for invasive angiography in this situation. Similarly, patients who are to undergo abdominal organ transplantation may require presurgical angiography and may benefit from the use of MRA. CTA is also proposed as a noninvasive alternative, though CT uses iodinated contrast agents that pose a higher risk for allergic and nephrotoxic reactions. Patients with suspected abdominal or pelvic venous thrombo-occlusive disease may benefit by using MRA to obviate the need for invasive venography. Pelvis Pelvic arteriography or venography may be useful in several situations to avoid the need for invasive angiography. Patients with suspected aorto-iliac atherosclerotic disease may benefit by the use of MRA to avoid the need for invasive angiography, and this evaluation often includes arterial evaluation of the lower extremities as well in patients with suspected peripheral vascular disease (e.g., claudication). Other uses of pelvic MRA would include evaluation of renal arteries with ectopic pelvic location of the kidney and evaluation of pelvic veins for thromboocclusive disease. Upper and Lower Extremity MRA may be useful for evaluating the arterial and venous structures of the lower extremity. In patients with suspected peripheral vascular disease, MRA may be able to evaluate the extent of disease and guide therapeutic decision making without the need for invasive angiography. Furthermore, MRA may be more sensitive than conventional angiography in identifying distal runoff vessels in potential candidates for peripheral bypass surgery. Page 5 of 9

6 Spinal Canal Dural arteriovenous fistulas (DAVF) are the most common spinal cord vascular malformation and often present with symmetric or asymmetric sensory loss, lower limb weakness, and sometimes pain in the low back and lower limbs that can worsen with standing, walking and Valsalva s maneuver. DAVF affect middle-aged and older men more often than women, and it is believed that high-pressure arterial flow from a radicular artery causes venous hypertension, engorgement, and secondary spinal cord ischemia. The large Majority of DAVF involve the thoracolumbar sinal cord. Spinal magnetic resonance angiography is used to confirm the presence of a DAVF and guide the performance of conventional catheter spinal angiography, which can define the abnormal vascular anatomy and help plan surgical intervention. Patients with spinal arteriovenous malformation (AVM) have progressive or fluctuating neurological dysfunction because of hemorrhage, venous hypertension, vascular steal phenomenon, or mass effect from venous varicosity. Conventional diagnostic methods include magnetic resonance imaging (MRI), supine myelogram, and angiogram. MRI can localize the vascular nidus in the cord, but it may sometimes be normal. Spinal angiogram is the definitive diagnostic modality. Key Words: Magnetic resonance angiography, MRA Approved by Governing Bodies: FDA approved In 2006, the Food and Drug Administration (FDA) issued a Public Health Advisory to healthcare professionals regarding Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD) which may occur in patients with moderate to end-stage kidney disease after they have a MRI or Magnetic resonance angiography (MRA) with a gadolinium-based contrast agent. First identified in 1997, NSF/NFD is almost exclusively found in patients with renal failure and acidosis. Patients with this condition develop fibrosis of the skin and connective tissues throughout the body. The skin thickening may inhibit flexion and extension of joints, resulting in contractures. In addition, patients may develop widespread fibrosis in other organs. A skin biopsy is necessary to make a definitive diagnosis. The disease is progressive and may be fatal. Its cause is unknown. Patients who receive gadolinium-containing contrast agents should be aware of the following possible signs and symptoms of NSF/NFD and advised to seek medical attention if these occur: swelling and tightening of the skin; difficulty extending the joints of arms, hands, legs, and feet; weakness, reddened or darkened areas on the skin; burning or itching of the skin; and deep bone pain in the hips and ribs. Physicians should be cautious regarding the use of gadolinium-containing contrast imaging agents, especially at high doses, in patients with moderate to end-stage renal failure. Page 6 of 9

7 Benefit Application: Coverage is subject to member s specific benefits. Group specific policy will supersede this policy when applicable. ITS: Home Policy provisions apply BellSouth/AT&T contracts: No special consideration FEP contracts: Special benefit consideration may apply. Refer to member s benefit plan. Wal-Mart: Special benefit consideration may apply. Refer to member s benefit plan. Pre-certification requirements: Effective for dates of service on or after November 1, 2007, required when ordered by a provider in a Blue Cross and Blue Shield of Alabama s Preferred or Participating Network for a patient covered by Blue Cross and Blue Shield of Alabama who will receive outpatient imaging services(s) from a Preferred Medical Doctor (PMD) or Preferred Radiology Participating (PRP) provider. Exceptions to the Alabama PMD and PRP pre-certification requirement: NASCO, Wal- Mart, Blue Advantage, Flowers Foods, Inc., FEP. In addition to the above Blue Cross and Blue Shield of Alabama PMD/PRP Network requirement, some self-insured national account groups may require pre-certification for all MRIs effective for dates of service on or after January 1, Please confirm during your benefit verification process if a pre-certification is required. Reviews to verify accuracy of pre-certification information will be conducted. Pre-determination requirements: Not required. Codes: CPT codes: Magnetic Resonance angiography, head; without contrast material(s) Magnetic resonance angiography, head; with contrast material(s) Magnetic resonance angiography, head; without contrast material(s), followed by contrast material(s) and further sequences Magnetic resonance angiography, neck; without contrast material(s) Magnetic resonance angiography, neck; with contrast material(s) Magnetic resonance angiography, neck; without contrast material(s), followed by contrast material(s) and further sequences Magnetic resonance angiography spinal conal and contents, with or without contrast material(s) Magnetic resonance angiography, upper extremity, with or without contrast Magnetic resonance angiography, lower extremity, with or without contrast material(s) Page 7 of 9

8 References: 1. American College of Radiology Appropriateness Criteria Andreoni KA, Weeks SM, Gerber DA et al. Incidence of donor renal fibromuscular dysplasia: does it justify routine angiography? Transplantation 2002; 73(7): Atkinson JLD, Miller GM, Krauss WE, et al. Clinical and radiographic features of dural arteriovenous fistula, a treatable cause of myelopathy. Mayo Clin Proc 2001;(76): Bagheri SC, Farhidvac F, Perciaccante VJ. Diagnosis and treatment of patients with trigeminal neuralgia. JADA 2004:135: Baum RA, Rutter CM, Sunshine JH et al. Multicenter trial to evaluate vascular magnetic resonance angiography of the lower extremity. JAMA 1995;274(11): Carpenter JP, Golden MA, Barker CF et al. The fate of bypass grafts to angiographically occult runoff vessels detected by magnetic resonance angiography. J Vasc Surg 1996; 23(3): FDA Information for Healthcare Professionals. Gadolinium-Based Contrast Agents for Magnetic Resonance Imaging Scans. Accessed January Fink C, Hallscheidt PJ, Hosch WP et al. Preoperative evaluation of living renal donors: value of contrast-enhanced 3D magnetic resonance angiography and comparison of three rendering algorithms. Eur Radiol 2003; 13(4): Giessing M, Kroencke TJ, Taupitz M et al. Gadolinium-enhanced three-dimensional magnetic resonance angiography versus conventional digital subtraction angiography: which modality is superior in evaluating living kidney donors? Transplantation 2003; 76(6): Goldman: Cecil Textbook of Medicine, 22 nd ed., Imaging techniques W.B. Saunders Company Goyen M, Ruehm SG, Debatin JF. MR angiography for assessment of peripheral vascular disease. Radiol Clin North Am 2002; 40(4): Halpern EJ, Mitchell DG, Wechsler RJ et al. Preoperative evaluation of living renal donors: comparison of CT angiography and MR angiography. Radiology 2000; 216(2): Ho VB, Corse WR. MR angiography of the abdominal aorta and peripheral vessels. Radiol Clin North Am 2003; 41(1): Hussain SM, Kock MC, IJzermans JN et al. MR imaging: a one-stop shop modality for preoperative evaluation of potential living kidney donors. Radiographics 2003; 23(2): Israel GM, Lee VS, Edye M et al. Comprehensive MR imaging in the preoperative evaluation of living donor candidates for laparoscopic nephrectomy: initial experience. Radiology 2002; 225(2): Jha RC, Korangy SJ, Ascher SM et al. MR angiography and preoperative evaluation for laparoscopic donor nephrectomy. AJR Am J Roentgenol 2002; 178(6): Koelemay MJ, Lijmer JG, Stoker J, eta al. Magnetic resonance angiography for the evaluation of lower extremity arterial disease: a meta-analysis. JAMA 2001;285(10): Pui MH. Gadolinium-enhanced MR angiography of spinal arteriovenous malformation. Clin Imaging 2004;28(1): Page 8 of 9

9 18. Rajagopalan S, Prince M. Magnetic resonance angiographic techniques for the diagnosis of arterial disease. Cardiol Clin 2002; 20(4): Rowe VL, Tucker SW. Advances in vascular imaging. Surg Cli N Am 2004;(84): Schievink WI. Spontaneous dissection of the carotid and vertebral arteries. N Engl J Med 2001;344(12): Sontheimer JL. Peripheral vascular disease: diagnosis and treatment. Am Fam Physician 2006;73: TEC Assessments 1997: Tab TEC Assessments 1996: Tab TEC Assessments 1996: Tab Yucel EK, Anderson CM, Edelman RR et al. AHA Scientific Statement. Magnetic resonance angiography: update of applications for extracranial arteries. Circulation 1999; 100(22): Policy History: Medical Policy Group, August 2006 (2) Medical Policy Administration Committee, August 2006 Available for comment August 15-September 1, 2006 Medical Policy Group, September 2006 (2) Medical Policy Administration Committee, September 2006 Available for policy September 2-October 16, 2006 Medical Policy Group, December 2006 (2) Medical Policy Administration Committee, January 2007 Available for comment January 12-February 25, 2007 Medical Policy Group, September 2007 (2) Medical Policy Administration Committee, October 2007 Available for comment October 23-December 6, 2007 Medical Policy Group, December 2008 (2) Medical Policy Group, July 2009 (2) Medical Policy Group, February 2013 (2): Updated policy with link to CareCore National medical policies effective April 1, 2013 Medical Policy Administration Committee, March 2013 Available for comment February 15 through March 31, 2013 Medical Policy Group, November 2013 (2): Updated policy with link to CareCore National This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a caseby-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. Page 9 of 9