Breast Imaging Mammography/Breast Echography (Sonography)/Breast MRI/Ductography

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:

21 CFR Section 900.11 specifies FDA certification requirements for suppliers of mammography services.

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 100-03, Medicare National Coverage Decisions Manual, Chapter 1:

220.4 Mammograms

CMS Publication 100-03, Medicare National Coverage Decisions 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

CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 18:

20 Mammography Services (Screening and Diagnostic)

Abstract:

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

Screening mammography is a radiological procedure furnished to a woman without signs or symptoms of breast disease, for the purpose of early detection of breast cancer and includes a physician’s interpretation of the results. It is inherently bilateral. The minimum requirements of a screening mammogram are cranio-caudal (CC) and medio-lateral oblique (MLO) views.

A diagnostic mammography subsequent to a suspicious screening mammography may include extra views without repeating the cranio-caudal (CC) and medio-lateral oblique (MLO) views, when the two tests are performed within a reasonable proximity of time of each other.

Diagnostic mammography is the specific evaluation of a patient with signs or symptoms of a breast disorder, or with screening-detected abnormalities. The goal of this radiographic evaluation is to arrive at precise management decisions, such as sonography, magnetic resonance imaging (MRI), biopsy, etc. Diagnostic mammography is to be distinguished from screening mammography in that the latter is done on patients who are asymptomatic. The minimum requirements for a diagnostic mammogram are cranio-caudal (CC) and medio-lateral oblique (MLO) views. Additional views may be required, but are considered part of the complete diagnostic examination.

The components of a screening mammogram include the radiographic test (the mammogram itself), interpretation and report, and the communication of the results to the patient.

The components of a diagnostic mammogram include a brief history (reason for the exam), palpation of the breasts (when indicated), the radiographic test (the mammogram itself), interpretation and report, and the communication of the results to the patient.

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:

Screening Mammography

Medicare covers annual screening mammography for all women age 40 and over, and one baseline screening mammography for women between the ages of 35-39. A screening mammography is not subject to the Part B deductible and coinsurancedoes not apply. Diagnostic mammograms are still subject to the deductible and coinsurance.

Medicare Part B covers screening mammography services if they are furnished by a supplier that meets the certification requirements in 21 CFR Section 900.11. The Mammography Quality Standards Act requires that all mammography centers that bill Medicare be certified by the Food and Drug Administration (FDA). Medicare will only reimburse FDA-certified mammography centers.


A physician's referral is not required for a screening mammography.

When a screening mammography detects a radiographic abnormality prompting the interpreting radiologist to order additional views on the same day, the interpreting radiologist may do so without an additional order from the treating physician and may bill for both the screening mammography and the diagnostic mammography.

Radiologists who order additional views (diagnostic mammogram) may do so without an additional order from the treating physician, but must refer to the treating physician or qualified non-physician practitioner for his/her NPI and report the condition of the patient back to the treating physician. If there is no treating/referring physician, the radiologist must report the exam results directly to the patient. The cost for additional views is included in the fee for the diagnostic mammography service.

A screening mammography is covered when provided by a hospital, physician (in office or clinic) or independent diagnostic testing facility (IDTF) but cannot be performed by a portable x-ray supplier.

Diagnostic Mammography

Diagnostic mammography is indicated when:

• there are signs or symptoms suggestive of malignancy (e.g., mass, some types of spontaneous nipple discharge, skin changes, unilateral breast pain, or unilateral axillary lymph nodes);
• there are radiographic abnormalities detected on screening mammography;
• performed in a patient with metastatic disease of undetermined etiology, in whom the source is suspected to be breast;
• performed on a patient with axillary lymphadenopathy of undetermined etiology; or
• there is short interval follow-up (at six month intervals, for 2 years) necessary for unresolved clinical/radiographic concerns;
• A personal history of breast malignancy exists.
• Benign, biopsy-proven breast disease.
• Medicare Part B covers diagnostic mammography services if they are furnished by a facility that meets the certification requirements of 21 CFR Section 900.11. The Mammography Quality Standards Act requires that all mammography centers that bill Medicare be certified by the Food and Drug Administration (FDA). Medicare will only reimburse FDA-certified mammography centers.

A treating provider's (physician or qualified non-physician practitioner) referral is required for a diagnostic mammography (except when performed at the discretion of the radiologist when prompted to do so by findings on the same day of the screening mammography). The referral should specify the diagnosis prompting the request for a diagnostic mammogram. When a screening mammogram is converted to a diagnostic mammogram, a note in the radiologist's report will fulfill this provision. This requirement is not applicable to hospital based radiologists for inpatient or outpatient diagnostic mammography.

Diagnostic mammography must be performed under the direct supervision of an interpreting physician qualified in mammography. The physician must be present and immediately available to furnish assistance and direction throughout the performance of the procedure. In the case of digital mammography, direct supervision may also be accomplished via telemammography. The radiologist need not be present as long as the interpreting physician is immediately available.

Diagnostic mammography may require that the performing radiologist review the history with the patient, review the prior mammograms, and perform an examination as part of the mammography. Also, the findings of the examination are typically discussed with the patient at the completion of the mammogram. Therefore, if telemammography is being used with digital diagnostic mammography, the radiologist need not be present for the mammography, however, he/she must be available to discuss the history with the patient, examine the patient and to discuss results of the findings of the examination with the patient within an acceptable period of time.

A diagnostic mammography is covered when provided by a hospital, physician (in office or clinic), independent diagnostic testing facility (IDTF) or portable x-ray supplier.

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 planned
• 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.

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.

Limitations:

The following limitations apply to screening mammography:

• The service must be, at a minimum, a two-view exposure (cranio-caudal and a medial-lateral oblique view) of each breast.
• Payment may not be made for screening mammography performed on a woman under age 35.
• Payment may only be made for a screening mammography when performed after at least 11 months have passed following the month in which the last screening mammography service was rendered.
• Mammography facilities that perform screening mammography services may not release screening mammography x-rays for interpretation to physicians who are not approved under the facilities certification number unless:
  • the patient has requested a transfer of the films from one facility to another for a second opinion, or
  • the patient has moved to another part of the country where the next screening mammography will be performed.
  • Only one type of screening mammography will be allowed in a calendar year. Either a screening mammography –film OR a screening mammography – digital will be paid.
  • A screening mammography is not payable for a male beneficiary.
  • The following limitations apply to diagnostic mammography
• Only one type of diagnostic mammography will be allowed on the same claim. Either a diagnostic mammography –film OR diagnostic mammography – digital will be paid.
• A diagnostic mammogram, a breast sonogram, or a breast MRI for a diagnosis of neoplasm of unspecified nature of bone, soft tissue and skin (D49.2) is acceptable only when related to the breast (i.e., metastasis).
• An evaluation and management (E&M) service (e.g., CPT codes 99201-99275) should not be coded in addition to the mammogram on the same date or on a subsequent date, by a provider whose sole responsibility is the performance of the mammogram (e.g., a radiologist).
• A physician such as an obstetrician, gynecologist, or breast surgeon may perform an E&M service in addition to the mammogram if there are separately identifiable services rendered other than the components of the mammogram.
• The interpretation of a mammogram [Codes 77065, 77066, 77067with the 26 modifier] may not be billed by a provider reviewing the test as part of another service (e.g., E&M service) if the interpretation has already been billed by the mammographer.
• Transportation costs are associated with mobile units for diagnostic mammography tests only. There is no separate transportation cost allowed for screening mammography, or 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.

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This bibliography presents those sources that were obtained during the development of this policy. CGS is not responsible for the continuing viability of Web site addresses listed below.

ACR Practice Guideline for the Performance of Screening and Diagnostic Mammography. 2008;525-534.

Adams JS, Song CF, Kantorovich V. Breast symptoms among women enrolled in a Health Maintenance Organization. Annals of Internal Medicine. 1999;130.

Berry DA. Benefits and risks of screening mammography for women in their forties: a statistical appraisal, Journal of the National Cancer Institute, 1998;90:19:1431-1439.

Ductogram (galactogram): imaging the breast ducts. Breast Health. http://www.imaginis.com/breasthealth/ductography.asp. Accessed March 26, 2009.

Expanded role of ultrasound in breast masses. Radiology. 1995;196.

High Definition Imaging: The role of ultrasound in the diagnosis of breast cancer (Summary of an international multicenter clinical study). ATL Ultrasound Reference Library.

Lehman C, Gatsonis C, Kuhl C, et al. MRI evaluation of the contralateral breast in women with recently diagnosed breast cancer. N Engl J Med. 2007;356(13):1295-1303.

McGraw-Hill's, Access Medicine- Harrison's Internal Medicine, Chapter 86, Breast cancer (17th edition), screening.

McGraw-Hill's, Access Medicine- Harrison's Internal Medicine, Chapter 86, Breast Cancer (17th edition), Evaluation of breast masses in men and women.

National Guideline Clearinghouse. Recommended Breast Cancer Surveillance Guidelines. 1999.

Saslow D, Boetes C, Burke W, et al. American Cancer Society guidelines for breast screening with MRI as an adjunct to mammography. CA Cancer J Clin. 2007;57(2):75-89.

Screening vs. diagnostic mammography. CPT Assistant, Volume 6, Issue 7, July 1996.

Standards, American College of Radiology, Reston, VA, 1997.

U.S. Preventive Services Task Force. Screening for breast cancer: recommendations and rationale. Ann Intern Med. 2002 ;137(5 Part 1):344-346.

What is Breast MRI? Department of Radiology, Magnetic Resonance Science Center at UC San Francisco.

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