Local Coverage Determination (LCD)

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

L33585

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L33585
Original ICD-9 LCD ID
Not Applicable
LCD Title
Breast Imaging: Breast Echography (Sonography)/Breast MRI/Ductography
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 10/24/2019
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

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Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

Issue

Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

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

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

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

N/A

Analysis of Evidence (Rationale for Determination)

N/A

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information
N/A
Sources of Information

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

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

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.

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.

Bibliography

N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
10/24/2019 R9

Consistent with Change Request 10901, all coding information, National coverage provisions, and Associated Information (Documentation Requirements, Utilization Guidelines) have been removed from the LCD and placed in the related Billing and Coding Article, A52849. There has been no change in coverage with this LCD revision.

  • Revisions Due To Code Removal
10/01/2019 R8

LCD revised due to the annual ICD-10-CM update, N63.15 and N63.25 were added to the ICD-10 Codes that Support Medical Necessity section in Group 1.

  • Revisions Due To ICD-10-CM Code Changes
01/01/2019 R7

Due to the annual CPT/HCPCS Code update the following codes have been deleted from Group 1 in the "CPT/HCPCS Codes" section: 77058, 77059, C8904, C8907 and the following new codes were added: 77046, 77047, 77048, 77049.

DATE (01/01/2019): At this time, the 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Revisions Due To CPT/HCPCS Code Changes
10/01/2017 R6

Due to the annual ICD-10-CM code update, ICD-10-CM code N63 was deleted from Group 1 of the "ICD-10-CM Codes that Support Medical Necessity" section of the LCD. ICD-10-CM codes N63.11, N63.12, N63.13, N63.14, N63.21, N63.22, N63.23, N63.24, N63.31, N63.32, N63.41 and N63.42 were added as the replacement codes.

Removed the obsolete references to CPT code 76645 in the “CPT/HCPCS Codes” and “ICD-10-CM Codes that Support Medical Necessity” sections.

DATE (10/01/2017): At this time, the 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

 

 

 

 

  • Revisions Due To ICD-10-CM Code Changes
10/01/2016 R5 Due to the annual ICD-10-CM code update for 2017, ICD-10-CM code N61 was deleted from Group 1 of the "ICD-10-CM Codes that Support Medical Necessity" section of the LCD. ICD-10-CM codes N61.0 and N61.1 were added as the replacement codes.

Removed Revenue Codes 0401 and 0403 for diagnostic and screening mammography services.
  • Revisions Due To ICD-10-CM Code Changes
10/01/2015 R4 Based on a provider request, ICD-10-CM codes C50.911 and C50.912 were added to Group 1 in the “ICD-10-CM Codes that Support Medical Necessity” section.
  • Request for Coverage by a Provider (Part A)
10/01/2015 R3 Minor template language change.
  • Other
10/01/2015 R2 Based on the National Coverage Determination (NCD) 220.4, all references to a diagnostic mammography were removed from the LCD.

Due to the annual HCPCS update for 2015, CPT code 76645 was deleted and removed from the “CPT/HCPCS Codes” section. An explanatory note regarding the code deletion was added to this section. CPT codes 76641 and 76642 were added as replacement codes. HCPCS code G0279 was added to the “CPT/HCPCS Codes” section. The descriptors were changed for HCPCS codes G0204 and G0206. HCPCS code G0279 was added to Group 1 and CPT codes 76641 and 76642 to Group 2 in the “ICD-10-CM Codes that Support Medical Necessity” section. Based on the National Coverage Determination (NCD) 220.4, all references to a screening mammography were removed from the LCD.

ICD-10-CM codes were added for the 7th character for D=subsequent encounter and S=sequela, where the 7th character, A=initial encounter, was already included.
  • Revisions Due To CPT/HCPCS Code Changes
  • Revisions Due To ICD-10-CM Code Changes
10/01/2015 R1 ICD-10-CM code N63 was inadvertently omitted from Groups 2 and 3 in the "ICD-10-CM Codes that Support Medical Necessity" section.
  • Revisions Due To ICD-10-CM Code Changes
N/A

Associated Documents

Attachments
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Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
10/18/2019 10/24/2019 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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