LCD L34424

Coverage Guidance

Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Title XVIII of the Social Security Act, §1862(a)(1)(E) excludes expenses for items or services which are not reasonable and necessary to carry out research conducted pursuant to §1142 of the Act.

Title XVIII of the Social Security Act, §1862(a)(7) states Medicare will not cover any services or procedures associated with routine physical checkups.

42 CFR §410.32 indicates that diagnostic tests may only be ordered by the treating physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements).

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 16, §20 Services Not Reasonable and Necessary

CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 4, §220.2 Magnetic Resonance Imaging (MRI).

Indications and Limitations of Coverage

Magnetic resonance angiography (MRA) is a modern diagnostic technique based on the effect of nuclear magnetic resonance and is like magnetic resonance imaging (MRI). During the procedure, the device reads electromagnetic waves received during the oscillation of the nuclei of hydrogen atoms, after which the computer converts the information received into a three-dimensional image of the zone under study. MRA is utilized to carry out studies of arteries, veins and lymphatic vessels of any location, to carry out a detailed assessment of the state of vascular networks, to identify pathological changes in the early stages, and to determine the cause of the pathology.1

The coverage criteria and definition of MRA are found in the CMS Internet-only Manual, Pub. 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 4, §220.2. MRA with or without contrast is considered appropriate when it can replace a more invasive test (e.g., contrast angiography) and reduce risk for beneficiaries. MRA is a covered indication for various diseases and abnormalities involving the arterial, venous and lymphatic systems. In addition, the services must be reasonable and necessary for the diagnosis or treatment of the specific patient involved.

The use of MRA would have the same contraindications as MRI and should not be used in patients with implanted ferromagnetic structures and electronic devices.

Summary of Evidence

MRA encompasses several imaging techniques based on MRI developed for studying the arterial and venous systems. The benefits of an MRA in comparison to traditional angiography is that it is noninvasive, it lacks ionizing radiation exposure, it has the potential for a non-contrast examination, and it can produce high-resolution volumetric images. The MRA gadolinium contrast material is less likely to cause an allergic reaction than the iodine-based contrast materials used for computed tomography scanning.

An MRA is often indicated to evaluate the following abnormalities and conditions and is used for screening1 and monitoring purposes1: arterial aneurysm(s)1, arteriovenous malformations2-4, aortic coarctation1, aortic dissection5,6, cerebral stroke1, carotid artery disease7,8, peripheral atherosclerosis of the extremities1, congenital heart disease1, coronary artery disease and, if indicated, graft patency9-12, mesentery artery ischemia13,14, renal artery stenosis15, pulmonary embolism16,17, trigeminal neuralgia18-20, moyamoya disease21,22 and intracranial aneurysms.23,24

MRA has the same contraindications as MRI, including patients with implanted ferromagnetic structures and electronic devices. Such devices might include, but are not limited to the following: a cardiac implantable electronic device, mechanical metallic heart valves, metallic foreign bodies, implantable neurostimulation system, cochlear implants/ear implant, non-removable drug infusion pumps, catheters with metallic components, cerebral artery aneurysm clips which are non-MRI compatible, and tissue expanders with magnetic infusion ports.25 Other contraindications for use of the contrast medium include a previous allergic or anaphylactic reaction to gadolinium.26

Analysis of Evidence

MRA of cerebral vessels is useful to create detailed three-dimensional images of vascular networks and surrounding brain tissues, identify hematomas, hemorrhages, aneurysms, arteriovenous shunts and areas of circulatory disorders. MRI angiography is indicated for suspected post-traumatic intracranial hematoma, stroke, chronic cerebral ischemia with vertebrobasilar insufficiency, encephalopathy, post-traumatic or post-stroke changes, as well as with vegetative-vascular dystonia, pituitary adenoma, Parkinson’s disease and some other pathological conditions. The study can be both with and without contrast.

MRA of the vessels of the extremities is utilized to determine the structure of vascular networks, the condition, localization and interposition of the arteries and veins of the extremities, as well as hemodynamic parameters in unchanged areas and areas of pathological changes. MRA is used for atherosclerosis, vasculitis, thrombosis, chronic venous insufficiency, angiopathies of various genesis, traumatic injuries of arteries and veins, compression or germination of vessels by neoplasms, aneurysms, malformations and vascular dysplasia of the extremities. In some cases, contrast-free MRA is performed. When indicated, gadolinium contrast is used.

MRA of mesenteric vessels is performed to recreate a complete picture of the localization and structure of the abdominal aorta and the vessels departing from it and to identify various pathological changes (structural abnormalities, stenosis, occlusion, traumatic injury, etc.). MRA is prescribed for circulatory disorders in the abdominal aorta basin, with suspicion of abdominal aorta coarctation, atherosclerotic lesion of abdominal vessels, aneurysm aorta, malformations and vascular ruptures of traumatic origin. Vascular contrast can be used to increase the informative value of MRA.

MRA of the lymphatic system makes it possible to assess the condition of the entire lymphatic system and its individual areas. During the procedure, lymph nodes and large collectors are examined. A determination of the level of fluid content in tissues can be made and conclusions about the degree of disruption of lymphatic drainage function can be ascertained. MRA is used for lymphedema caused by inflammatory processes, oncological lesions and fibrous changes that have arisen as a result of previously treated and untreated diseases.27

In addition, when utilized to make a diagnosis, MRA of the spinal vessels, MRA of the heart and coronary vessels, MRA of the thoracic aorta and several other studies may also be indicated.

Based upon the evidence reviewed, there may be other indications for MRA due to its utility to detect abnormalities involving the blood vessels and lymphatic system. Therefore, MRA is considered reasonable and necessary with and without contrast agent to assess any of the above indications and can be used for other vascular abnormalities when clinical indications are reasonable and necessary.

Associated Information

Utilization Guidelines

Medicare will allow coverage of MRIs for patients with implanted permanent pacemakers when used according to the Food and Drug Administration's (FDA) approved labeling for use in an MRI environment.

Bibliography

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• Arai N, Akiyama T, Fujiwara K, et al. Silent MRA: Arterial spin labeling magnetic resonant angiography with ultra-short time echo assessing cerebral arteriovenous malformation. Neuroradiology. 2020;62(4):455-461.

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• Gamaleldin OA, Donia MM, Elsebaie NA, Abdelrazek AA, Rayan T, Khalifa MH. Role of fused three-dimensional time-of-flight magnetic resonance angiography and 3-dimensional T2-weighted imaging sequences in neurovascular compression. World Neurosurg. 2020;133:e180-e186.

• Docampo J, Gonzalez N, Muñoz A, Bravo F, Sarroca D, Morales C. Neurovascular study of the trigeminal nerve at 3 t MRI. Neuroradiol J. 2015;28(1):28-35.

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• Pamarthi V, Pabon-Ramos WM, Marnell V, Hurwitz LM. MRI of the central lymphatic system: Indications, imaging technique, and pre-procedural planning. Top Magn Reson Imaging. 2017;26(4):175-180.