Humana Breast Imaging Form

Description

Breast cancer screening is performed on a regular basis when there are no symptoms present and timing is often based on age, family history and/or other contributing factors. Diagnostic breast imaging occurs when there are signs or symptoms suggestive of breast cancer (eg, palpable lump, nipple discharge, skin changes) or a history of breast cancer. A variety of breast imaging techniques have been developed for these purposes.

For information regarding genetic testing for breast cancer susceptibility, please refer to Genetic Testing for Breast, Ovarian and Pancreatic Cancer Susceptibility Medical Coverage Policy.

Mammography (or mammogram)

is the most widely used imaging modality for the detection of breast cancer. This specialized test uses a low dose X-ray which is transmitted through the breast tissue, as well as the surrounding tissue, and is performed by compressing the breast firmly between two plates. The two dimensional (2D) radiographic images are analyzed for abnormal findings. Conventional mammography was recorded onto screen-film cassettes. Today, images are more often recorded via digital detectors, known as full field digital mammography (FFDM). FFDM enables radiologists to manipulate the mammographic data (eg, brightness, contrast, magnification) to improve the ability of distinguishing between normal and malignant tissue.

Digital breast tomosynthesis (DBT)

is a three-dimensional (3D) breast imaging technique based on 2D FFDM mammography. DBT is similar to a computed tomography (CT) scan that only images the breasts. An X-ray source repeatedly sweeps over the breast at regularly spaced intervals to obtain cross-sectional images of adjacent segments of tissue.

Magnetic resonance imaging (MRI) of the breast

is another tool for the detection of breast cancer in select circumstances, as well as for the assessment of silicone implant integrity. MRI creates images of the breast by measuring changes in the movement of protons in fat and water with the application of changing magnetic fields. An image is acquired by processing signal changes that occur following application of pulses of energy.

Computer-aided detection (CAD) software systems

(CADe [detection], CADx [diagnosis]) assess images for patterns that may represent microcalcifications or masses indicative of breast cancer. CAD is not intended to be used in place of a radiologist, but rather as a second examination of the images. CAD has been incorporated into many mammography systems over the past several years, including their billing and coding. However, its use in DBT, MRI or ultrasound has not become as routine. (Refer to Coverage Limitations section)

Positron emission tomography (PET)

generates 3D images of tissue metabolism by using a radioactive tracer. The tracer is thought to accumulate in rapidly dividing and metabolizing tissue, such as tumors. PET scanning is not indicated for surveillance or monitoring. (Refer to Coverage Limitations section) However, it may be performed to obtain additional information on suspicious or equivocal findings and for locally advanced disease.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

For information regarding oncologic PET/CT of the breast, please refer to Fusion Imaging for Cancer Indications Medical Coverage Policy.

Other techniques to evaluate breasts include, but may not be limited to, the following:

• 3D computed tomography (CT) – Breast imaging system intended to provide 3D images to possibly aid in diagnosis of individuals with signs/symptoms of breast cancer or who may have had abnormal findings on other imaging. CT breast imaging is not intended to screen an asymptomatic individual for breast cancer. An example of this technology is the Koning Vera Breast CT. (Refer to Coverage Limitations section)
• Artificial intelligence (AI) software – Software purported to automatically detect and characterize suspicious soft tissue lesions and calcifications in mammography and DBT images to assess the likelihood of malignance. Genius AI Detection, MammoScreen, ProFound AI, QmTRIAGE and Saige-Density are examples of this type of technology. (Refer to Coverage Limitations section)
• Automated Whole Breast Ultrasound (AWBU) – A noninvasive imaging technology which utilizes high frequency sound waves to create detailed images of the breast tissue. It scans the entire breast, providing a 3D volumetric image that can potentially detect small or earlier stage tumors. It is not intended to be used as a replacement for mammography. Examples of systems which perform this type of ultrasound include, but may not be limited to, the Invenia ABUS 2.0, SoftVue Automated Whole Breast Ultrasound System and SonoCine. There are also automated 3D whole breast ultrasound systems such as the ATUSA Automated 3D Breast Ultrasound System, which is AI driven. (Refer to Coverage Limitations section)
• Contrast enhanced mammography (CEM) or contrast enhanced spectral mammography (CESM) – Specialized vascular-based breast imaging technique that uses iodinated contrast to reveal areas of increased blood supply within the breast which purportedly depicts tumor vascularity. CEM is suggested for use when additional information is needed, such as during clinical studies. (Refer to Coverage Limitations section)

Breast Imaging Effective Date: 10/01/2023
Revision Date: 10/01/2023
Review Date: 08/24/2023
Policy Number: HUM-0374-025
Page: 4 of 32

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Electrical impedance scanning (EIS) – Involves the transmission of continuous electricity into the body via an electrical patch on the arm or a handheld device. As the current travels through the breast, it is measured by a probe on the surface of the skin. Cancerous and normal tissue theoretically conduct electricity differently, therefore cancerous images may appear as bright white areas. (Refer to Coverage Limitations section)
• Handheld ultrasound – Using high frequency sound waves to create an image, this test is often completed to assist with biopsy. Investigators are studying the use of this technology as an adjunct to screening mammography in an individual with dense breasts and of average risk for developing breast cancer. (Refer to Coverage Limitations section)
• Noninvasive test which is conducted by shining high intensity infrared light through the breast or reflecting such light off of the breast. The amount of light that returns is measured and is purportedly useful in visualizing lesions or the blood vessels that supply them. An example of optical imaging is Computed Tomography Laser Mammography (CTLM). (Refer to Coverage Limitations section)
• Laser optics and sound (conventional ultrasound), in real time, to produce high-resolution images. This supposedly identifies tumors as small as 3mm and the ability to see submillimeter vascular structures. (Refer to Coverage Limitations section)

• The Imagio Breast Imaging System is an example of this technology, and it includes an AI based software to assist in assessing the BI-RADS classification. (Refer to Coverage Limitations section)
• Positron emission mammography (PEM) – High resolution nuclear medicine imaging modality that is suggested to detect or characterizes breast cancer. It is not recommended for routine use due to a higher radiation dose compared to other imaging. (Refer to Coverage Limitations section)
• Quantitative transmission ultrasound – Without compression, radiation or injections this ultrasound calculates fibroglandular volume (FGV) of the breast and the ratio of FGV to total breast volume. This calculation purportedly helps assess the risk for breast cancer and changes to the ratio could potentially be used to measure the efficacy of the prevention or treatment of breast cancer. This device is known as the QTscan and is not intended to be used as a replacement for mammography screenings. (Refer to Coverage Limitations)
• Scintimammography (or molecular breast imaging [MBI]) – Noninvasive imaging test that uses radiopharmaceuticals to detect abnormalities of breast tissue. The system visually illuminates enhanced metabolic activity in the breast allegedly associated with the occurrence of a tumor. One example of this technology is the LumaGem Molecular Breast Imaging System. (Refer to Coverage Limitations section)

Breast Imaging Effective Date: 10/01/2023
Revision Date: 10/01/2023
Review Date: 08/24/2023
Policy Number: HUM-0374-025
Page: 5 of 32

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• A device (eg, Bexa) which employs shear-wave elastography to produce a map of abnormal breast tissues and masses. Its sensor array samples breast tissue elasticity measurements thousands of times a second to define tissue detail. The proprietary algorithms then analyze these signals to create the map which purportedly records the presence (or absence), size, shape, hardness and location of breast lesions. (Refer to Coverage Limitations section)
• A technique in which an infrared camera is used to measure temperature variations on the surface of the body, producing images that may reveal sites of abnormal tissue growth. The theory behind this technology is that tumors may exhibit higher metabolic activity and will demonstrate an increase in body temperature while new blood vessels formed in cancerous tissue should fail to constrict in response to cold because they lack a layer of muscle. A newer thermography device, the SMILE-100 Breast Thermography System, has also been developed which includes a computer aided diagnostic engine that is powered by AI (Thermalytix). (Refer to Coverage Limitations section)

Coverage Determination

Any state mandates for breast imaging take precedence over this medical coverage policy.

Screening Mammography (with or without CAD) and DBT

Breast Imaging Effective Date: 10/01/2023
Revision Date: 10/01/2023
Review Date: 08/24/2023
Policy Number: HUM-0374-025
Page: 6 of 32

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Humana members may be eligible under the Plan for screening mammography* with or without the use of CAD (77067) or DBT (77063) for the following indications:

• Annual breast cancer screening as indicated by one or more of the following:
  • Female or transmasculine (female-to-male) individual 40 years of age or older; OR
  • Female or transmasculine (female-to-male) individual 39 years of age or younger at a higher risk for breast cancer as evidenced by:
    • Carrier of pathogenic or likely pathogenic variant high-risk breast cancer gene (eg, BRCA1, BRCA2, CDH1, PALB2, PTEN, TP53); OR
    • Individual has a diagnosis of, or has a first-degree relative with, one or more of the following:
      • Bannayan-Riley-Ruvalcaba syndrome; OR
      • Cowden syndrome; OR
      • Hereditary diffuse gastric cancer with pathogenic or likely pathogenic variant of CDH1 gene; OR
      • Li-Fraumeni syndrome; OR
      • Peutz-Jeghers syndrome; OR
      • Lifetime risk estimated at greater than or equal to 20% based on a familial risk stratification tool (eg, BRCAPRO, Tyrer-Cuzick); OR
      • Other high-risk family history as indicated by one or more of the following:
        • At least one first-, second- or third-degree relative with male breast cancer; OR
    • Individual has a first-degree relative who is a carrier of pathogenic or likely pathogenic variant high-risk breast cancer gene BRCA1 or BRCA2; OR
    • Previous radiation to the chest between 10 – 30 years of age; OR
  • Male 50 years of age or older (or 10 years before the earliest known male breast cancer in the family) who is a carrier of pathogenic or likely pathogenic variant high-risk breast cancer gene BRCA1 or BCRA2 44; OR
  • Male with unilateral breast enlargement where there is uncertainty whether the palpable tissue represents gynecomastia or another lesion90; OR
  • Transfeminine (male-to-female) individual 25 years of age or older (with past or current hormone use of 5 years or greater) at a higher risk for breast cancer as indicated by one or more of the following:
    • Carrier of pathogenic or likely pathogenic variant high-risk breast cancer gene (eg, BRCA1, BRCA2, CDH1, PALB2, PTEN, TP53); OR
    • Individual has a diagnosis of, or has a first-degree relative with, one or more of the following:
      • Bannayan-Riley-Ruvalcaba syndrome; OR
      • Cowden syndrome; OR
      • Hereditary diffuse gastric cancer with pathogenic or likely pathogenic variant of CDH1 gene; OR
      • Li-Fraumeni syndrome; OR
      • Peutz-Jeghers syndrome; OR
      • Lifetime risk estimated at greater than or equal to 20% based on a familial risk stratification tool (eg, BRCAPRO, Tyrer-Cuzick); OR

Breast Imaging Effective Date: 10/01/2023
Revision Date: 10/01/2023
Review Date: 08/24/2023
Policy Number: HUM-0374-025
Page: 7 of 32

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Breast Imaging Effective Date: 10/01/2023
Revision Date: 10/01/2023
Review Date: 08/24/2023
Policy Number: HUM-0374-025
Page: 8 of 32

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Other high-risk family history as indicated by one or more of the following:

• At least one first-, second- or third-degree relative with male breast cancer; OR
• Individual has a first-degree relative who is a carrier of pathogenic or likely pathogenic variant high-risk breast cancer gene BRCA1 or BRCA2; OR
• Previous radiation to the chest between 10 – 30 years of age

Diagnostic Mammography (with or without CAD) and DBT

Humana members may be eligible under the Plan for diagnostic mammography* with or without the use of CAD (77065, 77066) or DBT (77061, 77062, G0279) for the following indications:

• Breast abnormality as indicated by one or more of the following:
  • Abnormal findings identified on ultrasound; OR
  • Abnormal nipple or areolar symptoms (eg, bleeding, dimpling, discharge, edema, persistent pain, ulceration); OR
  • Breast abnormality on clinical exam (eg, induration, palpable breast mass); OR
  • Breast implant rupture, known or suspected; OR
  • Localized axillary mass; OR
  • Short interval (6 month) follow-up after a screening mammogram with a BI-RADS Category 3; OR
  • Suspected inflammatory breast cancer (IBC) (eg, individual presents with rapidly progressive inflammation of the breast with no improvement after a course of antibiotics); OR
• Known breast cancer and one or more of the following:
  • Assessment of tumor response to preoperative chemotherapy to determine appropriateness of breast-conserving surgery; OR
  • Following initial breast cancer treatment; OR
  • Post-excision to determine adequacy of the excision; OR
  • Post-radiation therapy;
• Occult breast cancer suspected as indicated by BOTH of the following:
  • Diagnosis of adenocarcinoma or carcinoma not otherwise specified; AND
  • No palpable breast mass suitable for biopsy; OR
• Repeat evaluation required as indicated by one or more of the following:
  • Change in clinical status (eg, new associated symptoms, worsening symptoms); OR
  • Following a core needle biopsy of a nonmalignant breast mass; OR
  • Re-imaging prior to or following an invasive procedure

FFDM is an acceptable alternative to screen-film mammography

Breast MRI

Humana members may be eligible under the Plan for breast MRI (77021, 77046-77049, C8903, C8905, C8906, C8908) without CAD for the following indications:

• Breast abnormality evaluation needed, as indicated by one or more of the following:
  • Anatomic guidance during biopsy of breast lesion (77021); OR
  • Breast implant complication suspected (eg, leak, rupture);

Breast Imaging Effective Date: 10/01/2023
Revision Date: 10/01/2023
Review Date: 08/24/2023
Policy Number: HUM-0374-025
Page: 10 of 32

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Nipple discharge present and etiology was indeterminate on mammography or ultrasound; OR
• Suspected Paget disease of the breast (eg, nipple/areola bleeding, itching, ulceration) and negative mammogram; OR
• Equivocal mammogram results and ALL of the following:
  • Individual is a candidate for MRI-directed needle biopsy (77021); AND
  • Nonpalpable breast lesion not visible on ultrasound and not amenable to fine needle biopsy; AND
  • Ultrasound findings are indeterminate; OR
• Breast cancer screening (no prior breast or ovarian cancer) and one or more of the following:
  • Carrier of pathogenic or likely pathogenic variant high-risk breast cancer gene (eg, BRCA1, BRCA2, CDH1, PALB2, PTEN, TP53); OR
  • Individual has a diagnosis of, or has a first-degree relative with, one or more of the following:
    • Bannayan-Riley-Ruvalcaba syndrome; OR
    • Cowden syndrome; OR
    • Hereditary diffuse gastric cancer with pathogenic or likely pathogenic variant of CDH1 gene; OR
    • Li-Fraumeni syndrome; OR
    • Peutz-Jeghers syndrome; OR
  • Lifetime risk estimated at greater than or equal to 20% based on a familial risk stratification tool (eg, BRCAPRO, Tyrer-Cuzick); OR
• Other high-risk family history as indicated by one or more of the following:
  • At least one first-, second- or third-degree relative with male breast cancer; OR
  • Individual has a first-degree relative who is a carrier of pathogenic or likely pathogenic variant high-risk breast cancer gene BRCA1 or BRCA2; OR
  • Previous radiation to the chest between 10 – 30 years of age; OR

Breast Imaging Effective Date: 10/01/2023
Revision Date: 10/01/2023
Review Date: 08/24/2023
Policy Number: HUM-0374-025
Page: 11 of 32

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Known breast cancer and one or more of the following:
  • Assessment of tumor response to preoperative chemotherapy to determine appropriateness of breast-conserving surgery; OR
  • Confirmed diagnosis of Paget disease to define extent or identify additional disease; OR
  • Evaluation for suspected cancer recurrence; OR
  • Evaluation in a newly diagnosed individual with a negative or indeterminate mammogram result for contralateral breast involvement; OR
  • Further evaluation of invasive breast cancer; OR
  • Locoregional staging when there is a high risk or suspicion of occult disease (eg, triple-negative breast cancer, BRCA1 positive, BRCA2 positive); OR
  • Postsurgical follow-up as indicated by one or more of the following:
    • Assessment for residual disease with close or positive margins following a lumpectomy; OR
    • Surveillance in contralateral breast in an individual at higher risk (eg, BRCA1 positive, BRCA2 positive); OR

Breast Imaging Effective Date: 10/01/2023
Revision Date: 10/01/2023
Review Date: 08/24/2023
Policy Number: HUM-0374-025
Page: 12 of 32

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Suspected tumor recurrence at lumpectomy site with negative or equivocal mammogram

• Occult breast cancer suspected as indicated by ALL of the following:
  • Diagnosis of adenocarcinoma or carcinoma not otherwise specified; AND
  • Mammogram and breast ultrasound show no evidence of cancer; AND
  • No palpable breast mass suitable for biopsy; OR

• Repeat evaluation required as indicated by one or more of the following:
  • Change in clinical status (eg, new associated symptoms, worsening symptoms); OR
  • Following a core needle biopsy of a nonmalignant breast mass; OR
  • Re-imaging prior to or following an invasive procedure

PET Imaging of the Breast

Humana members may be eligible under the Plan for PET of the breast (78811) for the following indications:

• Additional imaging information is required for one or more of the following:
  • Equivocal or suspicious findings on MRI; OR
  • Locally advanced breast cancer; OR
  • Planned invasive diagnostic or therapeutic procedure for breast cancer where assessment is needed for identifying appropriateness or anatomic location; OR
  • Subsequent staging/re-staging is needed for diagnosed breast cancer or for monitoring treatment response

Breast Imaging Effective Date: 10/01/2023
Revision Date: 10/01/2023
Review Date: 08/24/2023
Policy Number: HUM-0374-025
Page: 13 of 32

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Note: The criteria for mammography are not consistent with the Medicare National Coverage Policy, and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Note: The criteria for PET scans are not consistent with the Medicare National Coverage Policy, and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Coverage Limitations

Breast MRI, DBT, Mammography and PET

Humana members may NOT be eligible under the Plan for breast MRI, DBT, mammography or PET for any indications other than those listed above including, but not limited to, the following:

• Adjunctive screening for breast cancer using DBT or MRI in women identified as having dense breasts on an otherwise negative mammogram108; OR
• MRI as a primary screening tool in an asymptomatic, average risk individual; OR
• PET for surveillance or monitoring; OR
• Routine screening of males108

These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for CAD (eg, CADe, CADx) for breast MRI, DBT or ultrasonography for screening or diagnostic indications. These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Other Breast Imaging Techniques

Humana members may NOT be eligible under the Plan for any other breast imaging for diagnosis or screening including, but not limited to:

Breast Imaging Effective Date: 10/01/2023
Revision Date: 10/01/2023
Review Date: 08/24/2023
Policy Number: HUM-0374-025
Page: 14 of 32

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• 3D CT (eg, Koning Vera Breast CT) (0633T-0638T); OR
• Adjunctive screening for breast cancer using ultrasonography (including handheld devices) in women identified as having dense breasts on an otherwise negative mammogram¹⁰⁶ (76641, 76642); OR
• Automated whole breast ultrasound (ABUS/ABWU) (eg, Invenia ABUS 2.0, SoftVue Automated Whole Breast Ultrasound System, SonoCine) (76641, 76642); OR
• Contrast enhanced mammography (CEM) (77065, 77067); OR
• Electrical impedance scanning (EIS) (76499); OR
• Optical imaging (76499); OR
• Opto-acoustic ultrasound (eg, Imagio Breast Imaging System) (0857T); OR
• PEM (G0252); OR
• Quantitative transmission ultrasound (eg, QTscan) (76499); OR
• Scintimammography (eg, LumaGem Molecular Breast Imaging System) (S8080); OR
• Tactile breast imaging with computer-aided sensors (eg, Bexa) (0422T); OR
• Thermography (eg, BreastAlert Differential Temperature Sensor, SMILE-100 Breast Thermography System) (76499)

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Breast Imaging Effective Date: 10/01/2023
Revision Date: 10/01/2023
Review Date: 08/24/2023
Policy Number: HUM-0374-025
Page: 15 of 32

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Humana members may NOT be eligible under the Plan for AI software intended to detect breast lesions during mammography or DBT (eg, Genius AI Detection, MammoScreen, ProFound AI, QmTRIAGE, Saige-Density). This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Note: The criteria for thermography are consistent with the Medicare National Coverage Policy, and therefore apply to Medicare members. Refer to the CMS website for additional information.

Additional information about breast disease may be found from the following websites:

• Background
  • American Cancer Society
  • National Library of Medicine
• Medical Alternatives
  • Physician consultation is advised to make an informed decision based on an individual's health needs.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.

Provider Claims Codes

Breast Imaging Effective Date: 10/01/2023
Revision Date: 10/01/2023
Review Date: 08/24/2023
Policy Number: HUM-0374-025
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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

77066 Diagnostic mammography, including computer-aided detection (CAD) when performed; bilateral Not Covered if used to report any imaging outlined in Coverage Limitations section

Breast Imaging Effective Date: 10/01/2023
Revision Date: 10/01/2023
Review Date: 08/24/2023
Policy Number: HUM-0374-025
Page: 17 of 32

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Breast Imaging Effective Date: 10/01/2023 Revision Date: 10/01/2023 Review Date: 08/24/2023 Policy Number: HUM-0374-025 Page: 18 of 32

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

References

• American Cancer Society (ACS).

• American Cancer Society guidelines for breast cancer screening with MRI as an adjunct to mammography. https://www.cancer.org. Published March/April 2007. Accessed August 3, 2023.
• American Cancer Society (ACS). Breast cancer screening for women at average risk: 2015 guideline update from the American Cancer Society. https://www.cancer.org. Published October 20, 2015. Accessed August 3, 2023.
• American College of Obstetricians and Gynecologists (ACOG). Committee Opinion. Health care for transgender and gender diverse individuals. https://www.acog.org. Published March 2021. Accessed July 28, 2023.
• Breast Imaging Effective Date: 10/01/2023 Revision Date: 10/01/2023 Review Date: 08/24/2023 Policy Number: HUM-0374-025 Page: 19 of 32Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.
• American College of Obstetricians and Gynecologists (ACOG). Committee Opinion. Hereditary cancer syndromes and risk assessment. https://www.acog.org. Published December 2019. Updated 2020. Accessed July 28, 2023.
• American College of Obstetricians and Gynecologists (ACOG). Committee Opinion. Management of women with dense breasts diagnosed by mammography. https://www.acog.org. Published March 2015. Updated 2020. Accessed July 28, 2023.
• American College of Obstetricians and Gynecologists (ACOG). Practice Advisory. The U.S. Food and Drug Administration requires notification of breast density in mammography reports. https://www.acog.org. Published April 2023. Accessed July 28, 2023.
• American College of Obstetricians and Gynecologists (ACOG). Practice Bulletin. Breast cancer risk assessment and screening in average-risk women. https://www.acog.org. Published July 2017. Updated 2021. Accessed July 28, 2023.
• American College of Obstetricians and Gynecologists (ACOG). Practice Bulletin. Diagnosis and management of benign breast disorders. https://www.acog.org. Published June 2016. Updated 2023. Accessed July 28, 2023.
• American College of Obstetricians and Gynecologists (ACOG). Practice Bulletin. Hereditary breast and ovarian cancer syndrome. https://www.acog.org. Published September 2017. Updated 2021. Accessed August 1, 2023.
• American College of Obstetricians and Gynecologists (ACOG). Technology Assessment. Digital breast tomosynthesis. https://www.acog.org. Published June 2013. Updated 2020. Accessed July 28, 2023.
• American College of Physicians (ACP). Screening for breast cancer in average- risk women: a guidance statement from the American College of Physicians. https://www.acponline.org. Published April 16, 2019. Accessed August 1, 2023.
• Breast Imaging Effective Date: 10/01/2023 Revision Date: 10/01/2023 Review Date: 08/24/2023 Policy Number: HUM-0374-025 Page: 20 of 32Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.
• American College of Radiology (ACR). ACR Appropriateness Criteria. Breast cancer screening. https://www.acr.org. Updated 2017. Accessed August 3, 2023.
• American College of Radiology (ACR). ACR Appropriateness Criteria. Breast imaging of pregnant and lactating women. https://www.acr.org. Published 2018. Accessed August 3, 2023.
• American College of Radiology (ACR). ACR Appropriateness Criteria. Breast implant evaluation. https://www.acr.org. Updated 2023. Accessed August 3, 2023.
• American College of Radiology (ACR). ACR Appropriateness Criteria. Breast pain. https://www.acor.org. Updated 2018. Accessed August 3, 2023.
• American College of Radiology (ACR). ACR Appropriateness Criteria. Evaluation of nipple discharge. https://www.acr.org. Updated 2022.

• American College of Radiology (ACR). ACR Appropriateness Criteria. Evaluation of the symptomatic male breast. https://www.acr.org. Updated 2018. Accessed August 3, 2023.
• American College of Radiology (ACR). ACR Appropriateness Criteria. Imaging after breast surgery. https://www.acr.org. Published 2022. Accessed August 3, 2023.
• American College of Radiology (ACR). ACR Appropriateness Criteria. Imaging after mastectomy and breast reconstruction. https://www.acr.org. Published 2020. Accessed August 3, 2023.
• American College of Radiology (ACR). ACR Appropriateness Criteria. Monitoring response to neoadjuvant systemic therapy for breast cancer. https://www.acr.org. Updated 2022. Accessed August 3, 2023.

Breast Imaging Effective Date: 10/01/2023
Revision Date: 10/01/2023
Review Date: 08/24/2023
Policy Number: HUM-0374-025
Page: 21 of 32

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• American College of Radiology (ACR). ACR Appropriateness Criteria. Palpable breast masses. https://www.acr.org. Updated 2022. Accessed August 3, 2023.
• American College of Radiology (ACR). ACR Appropriateness Criteria. Stage I breast cancer: initial workup and surveillance for local recurrence and distant metastases in asymptomatic women. https://www.acr.org. Updated 2019. Accessed August 3, 2023.
• American College of Radiology (ACR). ACR Appropriateness Criteria. Supplemental breast cancer screening based on breast density. https://www.acr.org. Published 2021. Accessed August 3, 2023.
• American College of Radiology (ACR). ACR Appropriateness Criteria. Transgender breast cancer screening. https://www.acr.org. Published 2021. Accessed August 4, 2023.
• American College of Radiology (ACR). ACR BI-RADS Atlas – Breast MRI 2013. https://www.acr.org. Published 2013. Accessed August 3, 2023.
• American College of Radiology (ACR). ACR BI-RADS Atlas – Mammography 2013. https://www.acr.org. Published 2013. Accessed August 3, 2023.
• American College of Radiology (ACR). ACR practice parameter for the performance of a diagnostic breast ultrasound examination. https://www.acr.org. Published 1994. Updated 2021. Accessed August 3, 2023.
• American College of Radiology (ACR). ACR practice parameter for the performance of contrast-enhanced magnetic resonance imaging (MRI) of the breast. https://www.acr.org. Published 2004. Updated 2018. Accessed August 3, 2023.
• American College of Radiology (ACR). ACR practice parameter for the performance of digital breast tomosynthesis (DBT). https://www.acr.org. Published 2018. Accessed August 3, 2023.

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• American College of Radiology (ACR). ACR practice parameter for the performance of molecular breast imaging (MBI) using a dedicated gamma camera. https://www.acr.org. Published 2017. Updated 2022. Accessed August 3, 2023.
• American College of Radiology (ACR). ACR practice parameter for the performance of screening and diagnostic mammography. https://www.acr.org. Published 2008. Updated 2018. Accessed August 3, 2023.
• American College of Radiology (ACR). ACR practice parameter for the performance of whole-breast ultrasound for screening and staging. https://www.acr.org. Published 2019. Accessed August 3, 2023.

• Contrast enhanced mammography (CEM), a supplement to ACR BI-RADS Atlas (Mammography) 2013. https://www.acr.org. Published 2022. Accessed August 3, 2023.
• American Society of Breast Surgeons (ASBS). Consensus guideline on diagnostic and screening magnetic resonance imaging of the breast. https://www.breastsurgeons.org. Published June 22, 2017. Accessed August 1, 2023.
• American Society of Breast Surgeons (ASBS). Position statement on screening mammography. https://www.breastsurgeons.org. Published May 3, 2019. Accessed August 1, 2023.
• American Society of Clinical Oncology (ASCO). American Cancer Society/ American Society of Clinical Oncology breast cancer survivorship care guideline. https://www.asco.org. Published December 7, 2015. Accessed August 1, 2023.
• American Society of Clinical Oncology (ASCO). Breast cancer follow-up and management after primary treatment: American Society of Clinical Oncology clinical practice guideline update. https://www.asco.org. Published March 1, 2012. Accessed August 1, 2023.
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• American Society of Clinical Oncology (ASCO). Management of hereditary breast cancer: American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology guideline. https://www.asco.org. Published April 4, 2020. Updated August 3, 2021. Accessed August 1, 2023.
• American Society of Clinical Oncology (ASCO). Management of male breast cancer: ASCO guideline. https://www.asco.org. Published February 14, 2020. Accessed August 1, 2023.
• Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD). Mammograms (220.4). https://www.cms.gov. Published May 15, 1978. Accessed July 28, 2023.
• Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD). Positron emission tomography (FDG) for oncologic conditions (220.6.17). https://www.cms.gov. Published June 11, 2013. Accessed July 28, 2023.
• Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD). Thermography (220.11). https://www.cms.gov. Published December 21, 1992. Accessed July 28, 2023.
• ClinicalKey. Clinical Overview. Breast cancer in females. https://www.clinicalkey.com. Updated April 13, 2023. Accessed July 26, 2023.
• ClinicalKey. Clinical Overview. Breast cancer in males. https://www.clinicalkey.com. Updated July 7, 2023. Accessed July 26, 2023.
• ClinicalKey. LePetross H, Stafford RJ, Bedrosian I, Garvey PB, Woodward WA, Moulder-Thompson SL. Breast cancer. In: Silverman PM. Oncologic Imaging: A Multidisciplinary Approach. 2nd ed. Elsevier; 2023:476-502. https://www.clinicalkey.com. Accessed July 26, 2023.
• ECRI Institute. Clinical Evidence Assessment. Automated breast ultrasound systems for diagnosing breast cancer. https://www.ecri.org. Published July 1, 2019. Updated July 9, 2021. Accessed June 19, 2023.
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• ECRI Institute. Clinical Evidence Assessment. Breast computed tomography for diagnosing breast cancer and ductal carcinoma in situ. https://www.ecri.org. Published November 30, 2020. Accessed June 19, 2023.
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64. HAYES, Inc. Health Technology Brief (ARCHIVED). Magnetic resonance imaging (MRI) for surveillance for breast cancer recurrence following mastectomy and breast reconstruction. https://evidence.hayesinc.com. Published August 21, 2014. Updated July 12, 2016. Accessed June 20, 2023.
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66. HAYES, Inc. Medical Technology Directory (ARCHIVED). Computer-aided detection (CADe) and computer-aided diagnosis (CADx) for mammography. https://evidence.hayesinc.com. Published April 27, 2011. Updated April 10, 2015. Accessed June 20, 2023.
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71. HAYES, Inc. Medical Technology Directory (ARCHIVED). Positron emission tomography (PET) for breast cancer. https://evidence.hayesinc.com. Published August 19, 2003. Updated January 10, 2008. Accessed June 20, 2023.
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76. Merck Manual: Professional Version. Breast cancer screening and prevention. https://www.merckmanuals.com. Updated July 2023. Accessed July 27, 2023.
77. National Cancer Institute (NCI). Breast cancer screening (PDQ) – health professional version. https://www.cancer.gov. Updated June 7, 2023. Accessed August 1, 2023.
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81. UpToDate, Inc. Breast cancer in men. https://www.uptodate.com. Updated July 2023. Accessed August 8, 2023.
82. UpToDate, Inc. Breast cysts: clinical manifestations, diagnosis, and management. https://www.uptodate.com. Updated July 2023. Accessed August 8, 2023.
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91. UpToDate, Inc. Clinical features, diagnosis and staging of newly diagnosed breast cancer. https://www.uptodate.com. Updated July 2023. Accessed August 8, 2023.
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102. UpToDate, Inc. Peutz-Jeghers syndrome: clinical manifestations, diagnosis, and management. Updated July 2023. Accessed August 8, 2023.
103. UpToDate, Inc. Phyllodes tumors of the breast. Updated July 2023. Accessed August 8, 2023.
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Appendix A Family Relationships

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Appendix B Breast Imaging Reporting & Data System (BI-RADS)²⁶