LCD L33585

Coverage Guidance

Language quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section 1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

Title XVIII of the Social Security Act (SSA):

Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Code of Federal Regulations:

42 CFR Section 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) who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary's specific medical problem. Tests not ordered by the physician (or other qualified non-physician provider) who is treating the beneficiary are not reasonable and necessary (see Sec. 411.15(k)(1) of this chapter).

42 CFR Section 410.34 specifies the conditions for and limitation on coverage.

42 CFR, Section 486 specifies the conditions for coverage of portable x-ray services.

CMS Publications:

CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 15:

80.4.3 Scope of Portable X-Ray Benefit

CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 15:

80.4.4 Exclusions From Coverage as Portable X-Ray Services

CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 15:

80.6 Requirements for Ordering and Following Orders for Diagnostic Tests

CMS Publication 100-03, Medicare National Coverage Determinations Manual, Chapter 1:

220.5 Ultrasound Diagnostic Procedures

CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 13:

90 Services of Portable X-Ray Suppliers

Indications and Limitations of Coverage

Abstract:

This LCD describes magnetic resonance imaging of the breast, ultrasonic evaluation of the breast, and ductography.

Breast sonography is the ultrasonic evaluation of an abnormal breast lesion.

Breast MRI is the application of magnetic resonance principles to breast imaging.

Ductography (galactography) is a contrast-enhanced visualization of the breast ducts.

Indications:

Breast Sonography

Breast sonography may be indicated for conditions such as:

• Guidance for breast interventional procedures

• Assessment of implant related problems

• Radiation treatment planning

• Initial evaluation of palpable masses in women under 30

• In lactating and pregnant women

• Assessment of palpable abnormalities on physical exam

• Assessment to distinguish simple mastitis from abscess formation

• Assessment of any mass to determine whether it is suitable for percutaneous intervention (core biopsy, for instance)

• Assess stability of a sonographically visible mass that is mammographically invisible

• Non-palpable masses, detected by mammography, to differentiate cysts from solid lesions

• Palpable masses, if needle aspiration is not performed

• Symptomatic, possible ruptured silicone breast prosthesis when an MRI is not possible

• Calcifications to determine if an invasive component exists that would be amenable to core biopsy when supported by additional clinical indications.

Breast ultrasonography should not be routinely used along with diagnostic mammography. Ultrasonography may be indicated in addition to diagnostic mammography for the evaluation of some ambiguous mammographic or palpable masses or focal asymmetric densities that may represent or mask a mass.

Breast ultrasonography may be performed, in some cases, without having a diagnostic mammography first. However, an order from the treating physician for the ultrasonography is required. For example: a 22-year-old female presents with a painful breast lump. An ultrasound is performed and documents a large simple cyst, which subsequently is aspirated and resolved without the need for a prior diagnostic mammography.

A treating provider's (physician or qualified non-physician practitioner) order is required for breast ultrasound. This requirement is not applicable to hospital based radiologists for inpatient or outpatient breast ultrasound.

Breast sonography should be performed under the general supervision of a physician qualified in breast ultrasonography.

Breast MRI

Breast MRI studies are to be used very selectively. The modality should be restricted to:

• cases where diagnosis is inconclusive, even after standard work-up;

• evaluation of the post-operative patient when scar tissue cannot be differentiated from tumors;

• patients with positive axillary nodes but no known primary;

• patients with rupture of a breast implant; or

• determination of the extent of disease in patients with known malignancy, prior to treatment (to assure confinement to one segment of the breast).

Breast MRI should be performed under the general supervision of a physician qualified in magnetic resonance imaging.

A treating provider's (physician or qualified non-physician practitioner) order is required for breast MRI. This requirement is not applicable to hospital based radiologists for inpatient or outpatient breast MRI.

Ductogram (Galactogram)

Ductography is useful as an aid in diagnosing the cause of an abnormal nipple discharge and is valuable in diagnosing intraductal papillomas.

Ductography should be performed under the personal supervision of a physician qualified in ductography.

A treating provider's (physician or qualified non-physician practitioner) referral is required for ductography. This requirement is not applicable to hospital based radiologists for an inpatient or outpatient ductogram (galactogram).

Limitations:

• There is no separate transportation cost allowed for other breast imaging procedures. To receive transportation payments, the approved portable x-ray supplier must also meet the certification requirements of Section 354 of the Public Health Service Act.

Summary of Evidence

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Analysis of Evidence

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Bibliography

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