LCD L34865

Coverage Guidance

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for magnetic resonance angiography (MRA). Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for MRA and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site.

IOM Citations:

• CMS IOM Publication 100-02, Medicare Benefit Policy Manual,

• Chapter 6, Section 20.4: Outpatient Diagnostic Services.

• Chapter 15, Section 80: Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests.

• Chapter 16, Section 20: Services Not Reasonable and Necessary.

• CMS IOM Publication 100-03: Medicare National Coverage Determinations (NCD) Manual,

• Chapter 1, Part 4, Section 220.2: Magnetic Resonance Imaging (MRI).

• CMS IOM Publication 100-04: Medicare Claims Processing Manual,

• Chapter 13, Section 40.1: Magnetic Resonance Angiography (MRA), Section 40.1.1: Magnetic Resonance Angiography (MRA) Coverage Summary.

• CMS IOM Publication 100-08: Medicare Program Integrity Manual,

• Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD.

Social Security Act (Title XVIII) Standard References:

• Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

• Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

• Title XVIII of the Social Security Act, Section 1865 states effects of accreditation.

Code of Federal Regulations (CFR) References:

• CFR, Title 42, Volume 2, Chapter IV, Part 410.32(d)(3) Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.

Indications and Limitations of Coverage

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

Magnetic resonance angiography (MRA) is a non-invasive diagnostic test that is an application of magnetic resonance imaging (MRI). By analyzing the amount of energy released from tissues exposed to a strong magnetic field, MRA provides images of normal and diseased blood vessels as well as visualization and quantification of blood flow through these vessels.

Please refer to the National Coverage Determination for MRI and MRA documented in CMS Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 4, Section 220.2 Magnetic Resonance Imaging (MRI) for coverage details.

COVERED INDICATIONS

I. HEAD AND NECK

Please refer to CMS Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 4, Section 220.2.A.2 and 220.2.B.2 for coverage details and guidelines on the use of MRA of the head and neck.

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 appropriate.

An MRA is not considered medically reasonable and necessary for screening asymptomatic patients for intracranial aneurysms.

II. PERIPHERAL ARTERIES OF LOWER EXTREMITIES

Please refer to CMS Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 4, Section 220.2.B.2.b for coverage details and guidelines on the use of MRA in the peripheral arteries of the lower extremities.

III. ABDOMEN AND PELVIS

Please refer to CMS Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 4, Section 220.2.B.2.c for coverage details and guidelines on the use of MRA in the pre-operative evaluation of patients undergoing elective abdominal aortic aneurysm (AAA) repair and imaging of the renal arteries and aortoiliac arteries in the absence of AAA or aortic dissection.

An MRA of the abdomen for evaluation of possible renal artery stenosis would not be considered medically reasonable and 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 unequal kidney sizes).

IV. CHEST

Diagnosis of Pulmonary Embolism

Please refer to CMS Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 4, Section 220.2.B.2.d.i for coverage details and guidelines on the use of MRA in the diagnosis of pulmonary embolism.

Evaluation of Thoracic Aortic Dissection and Aneurysm

Please refer to CMS Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 4, Section 220.2.B.2.d.ii for coverage details and guidelines on the evaluation of thoracic aortic dissection and aneurysm.

NOTE: This LCD does not address cardiac magnetic resonance imaging.

Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.

The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this LCD.

Summary of Evidence

N/A

Analysis of Evidence

N/A

Associated Information

Please refer to the Local Coverage Article: Billing and Coding: Magnetic Resonance Angiography (MRA), A56805, for all coding information.

Documentation Requirements

• All documentation must be maintained in the patient’s medical record and made available to the contractor upon request.

• Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.

• The medical record documentation must support the medical necessity of the services as stated in this policy.

• Documentation to support the medical necessity of the combined use of MRA and CA must be maintained in the patient's medical record.

• Hospital, office or mobile unit records should clearly document the service was performed by or under direct physician supervision, reason for the exam and its frequency. In addition, mobile units must maintain a record of the attending physician's order for a scan performed in their facility.

• In instances where multiple diagnostic services are medically necessary, documentation supporting this need must be available upon request.

Utilization Guidelines

In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.

Bibliography

• Sanchez T, Santoro P, Torres de Medeiros I, et al. Magnetic resonance angiography in pulsatile tinnitus: The role of anatomical cariations. Int Tinnitus J. 1998;4(2):122-126.

• Kent, DL, Haynor, DR, Longstreth, WT, Larson, EB. The clinical efficacy of magnetic resonance imaging in neuroimaging. Annals Int Med. 1994;120(10); 856-871.