LCD L34372

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 Magnetic Resonance Angiography (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.

Internet Only Manual (IOM) Citations:

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

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

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

• Chapter 1, Section 220.2 Magnetic Resonance Imaging (MRI)

• 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 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

Federal Register References:

• Code of Federal Regulations (CFR), Title 42, Volume 2, Chapter IV, Part 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions and Part 410.33 Independent diagnostic testing facility.

Indications and Limitations of Coverage

History/Background and/or General Information

Magnetic Resonance Angiography (MRA) is an application of magnetic resonance (MR) imaging that provides visualization of blood flow, as well as images of normal and diseased blood vessels. Since MRA contrast agents are not nephrotoxic and are rarely associated with allergic type reactions, MRA without or with gadolinium-based contrast enhancement is an imaging alternative for patients who cannot tolerate iodine-based contrast media.

Although MRA appears to be a rapidly developing technology, the clinical safety and effectiveness of this procedure for all anatomical regions has not been proven. As a result coverage will be provided on a limited basis. Below are the indications for coverage allowed for MRA. All other uses of MRA will not be covered.

Covered Indications

Please refer to CMS IOM Publication 100-03, Medicare National Coverage Determination (NCD) Manual, Chapter 1, Section 220.2 Magnetic Resonance Imaging for covered MRA Indications for Head and Neck, Peripheral Arteries of Lower Extremities, Abdomen and Pelvis, and Chest.

MRA and contrast angiography (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. The medical record must clearly document the medical necessity of performing both tests.

Examples of indications that support medical necessity of contrast angiography (CA) performed as an adjunct to MRA:

• Clarify conditions where test results or clinical information are contradictory (e.g., MRA and duplex Doppler ultrasound are discordant with the clinical differential diagnosis and conventional angiography, with its ability to directly measure pressure gradients across stenosis of questionable hemodynamic significance, can provide more definitive information).

• Verify the site of clinically important vascular stenosis and help map out the surgical/endovascular approach (e.g., to determine which lesions should have an angioplasty and/or stent vs. which lesions require surgical bypass graft or no treatment at all).

• Identify situations where MRA is nonconclusive or degraded by metallic artifact.

Abdomen and Pelvis

Studies show that diagnostic evaluation of several upper abdominal malignancies may require an evaluation for vascular invasion by the tumor in deciding if the patient is a candidate for surgical resection of the tumor. One example is with pancreatic carcinoma. Pancreatic head carcinomas can grow in close proximity to the superior mesenteric vein.

Evidence suggests that MRA provides reliable, noninvasive evaluation of the portal and hepatic veins. MRA can provide focused evaluation of particular areas of interest as well as a broad overview anatomic display that is helpful to surgeons and interventionalists planning procedures.

As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.

Summary of Evidence

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Analysis of Evidence

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Associated Information

Documentation Requirements

Please refer to the Local Coverage Article: Billing and Coding: Magnetic Resonance Angiography (MRA) (A57779) for documentation requirements that apply to the reasonable and necessary provisions outlined in this LCD.

Utilization Guidelines

Please refer to the Local Coverage Article: Billing and Coding: Magnetic Resonance Angiography (MRA) (A57779) for utilization guidelines that apply to the reasonable and necessary provisions outlined in this LCD.

Bibliography

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