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Horizon BCBSNJ
Uniform Medical Policy ManualSection:Radiology
Policy Number:177
Effective Date: 03/10/2020
Original Policy Date:04/10/2018
Last Review Date:02/11/2020
Date Published to Web: 05/17/2018
Subject:
Adult Breast Imaging

Description:
_______________________________________________________________________________________

IMPORTANT NOTE:

The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.

Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.

__________________________________________________________________________________________________________________________

Table of Contents

Abbreviations for Breast Guidelines 3
BI-RADS™ Categories Chart 5
BR-1: Breast Ultrasound 7
BR-2: MRI Breast 9
BR-3: Breast Reconstruction 11
BR-4: MRI Breast is NOT Indicated 12
BR-5: MRI Breast Indications 13
BR-6: Nipple Discharge/Galactorrhea 16
BR-7: Breast Pain (Mastodynia) 17
BR-8: Alternative Breast Imaging Approaches 18
BR-9: Suspected Breast Cancer in Males 20

Abbreviations for Breast Policies

AAA
abdominal aortic aneurysm
ACE
angiotensin-converting enzyme
AVM
arteriovenous malformation
BI-RADS
Breast Imaging Reporting and Database System
BP
blood pressure
BRCA
tumor suppressor gene
CAD
computer-aided detection
CBC
Complete blood count
COPD
chronic obstructive pulmonary disease
CT
computed tomography
CTA
computed tomography angiography
CTV
computed tomography venography
DCIS
ductal carcinoma in situ
DVT
deep venous thrombosis
ECG
electrocardiogram
EM
electromagnetic
EMG
electromyogram
FDA
Food and Drug Administration
FDG
fluorodeoxyglucose
FNA
fine needle aspiration
GERD
gastroesophageal reflux disease
GI
gastrointestinal
HRCT
high resolution computed tomography
IPF
idiopathic pulmonary fibrosis
LCIS
lobular carcinoma in situ
LFTP
localized fibrous tumor of the pleura
MRA
magnetic resonance angiography
MRI
magnetic resonance imaging
MRV
magnetic resonance venography
NCV
nerve conduction velocity
PE
pulmonary embolus
PEM
positron-emission mammography
PET
positron emission tomography
PFT
pulmonary function tests
PPD
purified protein derivative of tuberculin
RODEO
Rotating Delivery of Excitation Off-resonance MRI
SPN
solitary pulmonary nodule
SVC
superior vena cava


Bi-RadsTM Categories Chart
Category 0: Incomplete
Need additional imaging evaluation or prior mammograms for comparison.

Category 1: Negative
There is nothing to comment on. The breasts are symmetrical and no masses, architectural disturbances, or suspicious calcifications are present.

Category 2: Benign Finding
This is also a negative mammogram, but the interpreter may wish to describe a finding. Involuting, calcified fibroadenomas, multiple secretory calcifications, fat containing lesions (such as oil cysts, lipomas, galactoceles, and mixed density hamartomas) all have characteristic appearances, and may be labeled with confidence. The interpreter might wish to describe intramammary lymph nodes, implants, etc. while still concluding that there is no mammographic evidence of malignancy.

Category 3: Probably Benign Finding – Short Interval Follow-up Suggested
A finding placed in this category should have a very high probability of being benign. It is not expected to change over the follow-up interval, but the radiologist would prefer to establish its stability. Data is becoming available that sheds light on the efficacy of short interval follow-up. At the present time, most approaches are intuitive. These will likely undergo future modification as more data accrue as to the validity of an approach, the interval required, and the type of findings that should be followed.

Category 4: Suspicious Abnormality – Biopsy Should Be Considered
There are lesions that do not have the characteristic morphologies of breast cancer but have a definite probability of being malignant. The radiologist has sufficient concern to urge a biopsy. If possible, the relevant possibilities should be cited so that the patient and her physician can make the decision on the ultimate course of action.

Category 5: Highly Suggestive of Malignancy-Appropriate Action Should Be Taken
These lesions have a high probability of being cancer and should be biopsied or treated surgically

Category 6: Known Biopsy-Proven Malignancy – Appropriate Action Should Be Taken
These lesions have been biopsied and are known to be malignant.

BI-RADS™ Breast Density Categories
Category A: Almost entire fatty

Category B: Scattered fibroglandular densites

Category C: Heterogeneously dense

Category D: Extremely dense


Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)

BR-1: Breast Ultrasound

BR-1: Breast Ultrasound
This General Policy section provides an overview of the basic criteria for which breast imaging may be medically necessary. Details regarding specific conditions or clinical presentations and the associated criteria for which imaging is medically necessary are described in subsequent sections.

For this condition imaging is medically necessary based on the following criteria:

Routine performance of breast ultrasound as stand-alone screening or with screening mammography is inappropriate.1,2,3

    ® Ultrasound screening for women whose only indication is dense breast tissue is not indicated.1,2,3
    ® Equivocal or Occult Findings:
      ¡ Radiologist Report recommendation for Breast ultrasound (CPT® 76641 or CPT® 76642) and inconclusive or conflicting findings on mammography or MRI Breast
Breast ultrasound (CPT® 76641: unilateral, complete OR CPT® 76642: unilateral, limited) can be used to further evaluate abnormalities found on mammogram, especially in differentiating cysts from solid lesions.1
    ® A clinical office visit is not necessary prior to breast ultrasound when an abnormality has been identified on recent (within the last 60 days) mammogram.

BI-RADS™ Cat 3 ultrasound follow up imaging for stable findings at 6 months
    ® If repeat imaging remains BI-RADS™ 3, repeat at 12 months, 18 months, and 24 months from the date of the initial imaging. After 2 years of stability, the finding should be assessed as benign (Cat 2).16
    ® If repeat imaging is BI-RADS™ 1 or 2, then imaging reverts to routine per individuals risk profile.

Palpable breast masses or other clinical abnormalities (such as skin change, pain, nipple inversion) should be evaluated with mammography and breast ultrasound, in any order, regardless of age. Ultrasound can enhance biopsy.3

Axilla ultrasound (CPT® 76882)

    ® For women with clinically suspicious lymph nodes, preoperative axillary ultrasound with a FNA or biopsy can help identify members who have positive nodes.3
      ¡ See Adult Chest Imaging Policy (Policy #150 in the Radiology Section); CH-2.2: Axillary Lymphadenopathy
    ® Bilateral should be coded CPT® 76882 x 2

US guided breast biopsy (CPT® 19083) includes the imaging component.
    ® Additional lesions should be billed using CPT® 19084.

Ultrasound Breast can be repeated at least 6 months after an US directed breast biopsy to document successful lesion sampling if histology is benign and nonspecific, equivocal or uncertain.

State Specific Density Reporting and Imaging Mandate Laws

    ® Breast density notification laws have been put into effect by many states. Breast density notification laws vary, but some also contain mandates for additional imaging, which may include MRI and/or ultrasound. For applicable requests involving members in these states, their legislative mandates should be followed. The pertinent language in these mandates is provided via the link below.
For members or covered persons in benefit plans that are subject to the New Jersey breast cancer screening mandate (P.L.2017, c.305)and for ASO/ASC/self-funded groups which opted to adopt the New Jersey breast cancer screening mandate, coverage includes ultrasound evaluation, a magnetic resonance imaging scan, a three-dimensional mammography, or other additional testing of an entire breast or breasts, after a baseline mammogram examination, if the mammogram demonstrates extremely dense breast tissue, if the mammogram is abnormal within any degree of breast density including not dense, moderately dense, heterogeneously dense, or extremely dense breast tissue, or if the member has additional risk factors for breast cancer including but not limited to family history of breast cancer, prior personal history of breast cancer, positive genetic testing, extremely dense breast tissue based on the Breast Imaging Reporting and Data System established by the American College of Radiology, or other indications as determined by the member's health care provider.


BR-2: Breast MRI

BR-2: Breast MRI
For this condition imaging is medically necessary based on the following criteria:

The use of gadolinium contrast is required for the evaluation of breast parenchyma.

The use of gadolinium contrast is not necessary for the evaluation of implant integrity in asymptomatic, average-risk members.

Computer-aided detection (CAD) is included with the MRI Breast CPT® 77049 and CPT® 77048 procedures. The use of HCPCS code C8937 (CAD including computer algorithm analysis of MRI Breast data for lesion detection/characterization, pharmacokinetic analysis, with further physician review for interpretation) is unnecessary with these procedures.

    ® The use of CAD has little influence on the sensitivity and specificity of MRI Breast interpretation.9
    ® The use of HCPCS code C8937 (CAD including computer algorithm analysis of MRI Breast data for lesion detection/characterization, pharmacokinetic analysis, with further physician review for interpretation) is currently considered investigational.
    ® Since the CAD software automatically performs 3D imaging, CPT® 76376 or CPT® 76377 should not be used in conjunction with CPT® 77049, CPT® 77048 or HCPCS code C8937

Magnetic resonance imaging, breast, without and with contrast material(s), including computer-aided detection (CAD real-time lesion detection, characterization and pharmacokinetic analysis), when performed; bilateral (CPT® 77049) is preferred in most individuals for the evaluation of breast parenchyma.

Magnetic resonance imaging, breast, without and with contrast material(s), including computer-aided detection (CAD real-time lesion detection, characterization and pharmacokinetic analysis), when performed; unilateral (CPT® 77048) may be preferred in some individuals after mastectomy, per physician request.

Magnetic resonance imaging, breast, without contrast material; bilateral (CPT® 77047) or Magnetic resonance imaging, breast, without contrast material; unilateral (CPT® 77046) may be performed if there are clinical reasons or concerns regarding the use of gadolinium contrast.

MRI guided breast biopsy (CPT® 19085) includes the imaging component.

    ® Additional lesions should be billed using CPT® 19086.

MRI Breast can be repeated at least 6 months after an MRI directed breast biopsy to document successful lesion sampling if histology is benign and nonspecific, equivocal or uncertain.5

MRI Breast – Practice Notes

Although MRI Breast has superior sensitivity in identifying new unknown malignancies, it carries a significant false positive risk when compared to mammogram and ultrasound. Incidental lesions are seen on 15% of MRI Breast and increase with younger age. The percentage of incidental lesions that turn out to be malignant varies from 3% to 20% depending on the member population. Cancer is identified by MRI Breast in only 0.7% of those with “inconclusive mammographic lesions”.6,7


BR-3: Breast Reconstruction

BR-3: Breast Reconstruction

For this condition imaging is medically necessary based on the following criteria:

CTA or MRA of the body part from which the free tissue transfer flap is being taken, can be performed for breast reconstruction preoperative planning.2,3

    ® For example, CTA Abdomen and/or Pelvis (CPT® 74175 or CPT® 72191 or CPT® 74174) or MRA Abdomen and/or Pelvis (CPT® 74185 and/or CPT®.72198) for Deep Inferior Epigastric Perforators (DIEP) flap.8

There is currently insufficient evidence-based data to support the need for routine advanced imaging for TRAM flaps or other flaps performed on a vascular pedicle.8


BR-4: Breast MRI is NOT Indicated

BR-4: Breast MRI is NOT Indicated

For this condition imaging is medically necessary based on the following criteria:

MRI Breast should not be used to determine biopsy recommendations for suspicious or indeterminate lesion(s) that can be readily biopsied, either using imaging guidance or physical exam, such as palpable masses and microcalcifications.3,6

Members with dense breasts as determined by mammogram

    ® To date, evidence does not suggest improved outcomes for women whose only risk factor is breast density [See heading “Equivocal or Occult Findings” (Radiologist Report) in BR-5: MRI Breast Indications].13,14,15

Low risk, probably benign (BI-RADS™ 3) lesions
    ® Repeat the original type study (mammogram, US, or MRI) in 6 months
      ¡ If repeat imaging remains BI-RADS™ 3, repeat original study at 12 months, 18 months, and 24 months from the date of the initial imaging. After 2 years of stability, the finding should be assessed as benign (Cat 2).16
      ¡ If repeat imaging is BI-RADS™ 1 or 2, then imaging reverts to routine per individuals risk profile.
Suspicious (BI-RADS™ 4 or 5) lesion on mammogram and/or ultrasound.
    ® A lesion categorized as have BI-RADS™ 4 or 5 should be biopsied.16

Surveillance MRI for silent/asymptomatic rupture of silicone implants is considered investigational, as there is no evidence basis that surveillance reduces morbidity and/or mortality.
    ® Certain payers do not include breast implants in their coverage policies if the breast implants were placed as part of purely cosmetic surgery. Thus, surveillance MRI in these members would also not be included in the coverage policy. Their coverage policies will take precedence over Horizon BCBSNJ’ guidelines.

Routine surveillance MRI Breast following mastectomy is not indicated45


BR-5: Breast MRI Indications

BR-5: Breast MRI Indications
For this condition imaging is medically necessary based on the following criteria:

MRI Breast is indicated for breast augmentation, breast implants (saline or silicone), breast reconstruction, free injection, and capsular contracture to:

    ® Evaluate or confirm breast implant rupture when mammography or ultrasound is uninterpretable.1

Phyllodes Tumor (Cystosarcoma Phyllodes)
    ® MRI Breast is indicated preoperatively to establish extent of disease where a diagnosis of malignant phyllodes tumor has previously been established by tissue diagnosis.18,19,20 (See Practice Note)

Equivocal or Occult Findings
    ® Radiologist Report Recommendation for MRI Breast and inconclusive or conflicting findings on mammography or ultrasound of a finding that is not a discrete palpable mass.
    ® A probably benign lesion on MRI (MRI BI-RADSTM 3) should undergo repeat MRI in 6 months
      ¡ If repeat imaging remains BI-RADS™ 3, repeat at 12 months, 18 months, and 24 months from the date of the initial imaging. After 2 years of stability, the finding should be assessed as benign (Cat 2).16
      ¡ If repeat imaging is BI-RADS™ 1 or 2, then imaging reverts to routine per individuals risk profile.
MRI Breast can be repeated at least 6 months after an MRI directed breast biopsy to document successful lesion sampling if histology is benign and nonspecific, equivocal or uncertain.5

Newly Diagnosed Breast Cancer4 (including DCIS).1,6,24,25,26

Newly Diagnosed Paget’s Disease5 (thereafter treat as DCIS according to these guidelines).26,28

Residual or Recurrent Malignancy

    ® Assessment of residual tumor in members who have undergone lumpectomy and have close or positive margins, when the findings may indicate a significant change in surgical management.29
    ® Evaluate clinical suspicion of recurrence, following evaluations with mammography and/or ultrasound, if those evaluations are inconclusive or conflict with physical examination or other clinical indicators. This applies to intact breasts, reconstructed breasts, and possible chest wall recurrences following mastectomy.29

Indications for annual MRI Breast screening See table below:
High Risk Indications
MRI screening to begin at age 20:
1.
Li-Fraumeni Syndrome (TP53 mutation) should start annual breast screening MRI starting at age 20 or at the age of the earliest diagnosed breast cancer in the family, whichever comes first.
MRI screening to begin at diagnosis but not prior to age 25:
2.
Members with a history of :
      ® Atypical ductal hyperplasia (ADH)
      ® Atypical lobular hyperplasia (ALH)
      ® Lobular carcinoma in situ (LCIS) 21
MRI screening to begin at age determined by gene mutation:
3.
BRCA 1 or BRCA 2, Peutz-Jehgers Syndrome (STK11, LKB1 gene variations) begin age 25
4.
PTEN Mutation (Cowden Syndrome), CDH1, NF1, PALB2 begin age 30
5.
ATM, CHEK2, NBN begin age 40
6.
The following have unknown or insufficient evidence of breast cancer risk and additional MRI screening is not indicated at this time:
      ® BARD1, MSH2, MLH1, MSH6, PMS2, EPCAM, RAD51C, Genetic variants of unknown significance, genetic variants favoring polymorphism, genetic variants of intermediate penetrance.41
MRI screening begins at age 40, or 10 years before the age of relative when first diagnosed with breast cancer, but not prior to the age of 25:4,12,22,30,42,43
7.
First-degree relative (parent, sibling, child) with BRCA 1 or BRCA 2, if member has not been tested for BRCA mutation. (If member has been tested and negative for mutation then annual screening is not indicated.)
8.
Two or more first-degree relatives with breast or ovarian cancer.
9.
One first-degree relative with breast cancer or ovarian cancer that was diagnosed ≤age 50.
10.
One first-degree relative with bilateral breast cancer, or both breast and ovarian cancer.
11.
A first or second-degree male relative (father, brother, uncle, grandfather) diagnosed with breast cancer.
12.
Clinical lifetime risk estimated at greater than or equal to 20% using genetic risk or clinical risk estimator such as Gail, Claus, Tyrer-Cuzick or BRCAPRO models.
Additional Risks:
13.
Women with history of radiation to the chest between ages 10 and 30; breast screening should start 8 to 10 years post-therapy, or at age 25, whichever comes first.4,12,30
Personal History of Breast Cancer
14.
MRI Breast surveillance (annual) is indicated for members with a personal history of breast cancer (not treated with bilateral mastectomy) who had a clinical lifetime risk estimated at greater than or equal to 20% using genetic risk or clinical risk estimator such as the Gail, Claus, Tyrer-Cuzick or BRCAPRO models prior to initial diagnosis of breast cancer.11,12
15.
MRI Breast surveillance (annual) is indicated for members with a personal history of breast cancer and extremely dense breast tissue (Category D) on mammography.39
16.
MRI Breast surveillance (annual) is indicated for members with a personal history of breast cancer diagnosed before age 50.39
MRI Breast Indications - Practice Notes
MRI should not be used in lieu of mammographically, clinically, and/or sonographically suspicious findings (ACR Practice Guidelines).

State Specific Density Reporting and Imaging Mandate Laws

    For members or covered persons in benefit plans that are subject to the New Jersey breast cancer screening mandate (P.L.2017, c.305)and for ASO/ASC/self-funded groups which opted to adopt the New Jersey breast cancer screening mandate, coverage includes ultrasound evaluation, a magnetic resonance imaging scan, a three-dimensional mammography, or other additional testing of an entire breast or breasts, after a baseline mammogram examination, if the mammogram demonstrates extremely dense breast tissue, if the mammogram is abnormal within any degree of breast density including not dense, moderately dense, heterogeneously dense, or extremely dense breast tissue, or if the member has additional risk factors for breast cancer including but not limited to family history of breast cancer, prior personal history of breast cancer, positive genetic testing, extremely dense breast tissue based on the Breast Imaging Reporting and Data System established by the American College of Radiology, or other indications as determined by the member's health care provider.

Phyllodes Tumor (Cystosarcoma Phyllodes)
    ® Phyllodes tumor is usually benign and has clinical characteristics of fibroadenoma, although they may exhibit rapid growth. Breast MRI has not been shown to be of value in distinguishing fibroadenoma from phyllodes tumor.
    ® Diagnosis is made by tissue diagnosis (percutaneous core biopsy or excisional biopsy). FNA biopsy is inaccurate in phyllodes tumor diagnosis and is not recommended.
    ® Treatment is wide local excision. Axillary lymph node dissection is not necessary. It has a predilection for local recurrence following local excision.
    ® If biopsy establishes a diagnosis of malignant phyllodes (cystosarcoma phyllodes), it should be treated as a soft tissue sarcoma (See Adult Oncology Imaging Policy (Policy #155 in the Radiology Section); ONC-12: Sarcomas – Bone, Soft Tissue and GIST).18,19,20


BR-6: Nipple Discharge/Galactorrhea

BR-6: Nipple Discharge/Galactorrhea

    For this condition imaging is medically necessary based on the following criteria:


Pathologic nipple discharge is defined as unilateral, bloody or serous, arising from a single duct, persistent, and spontaneous.
    ® If the nipple discharge is pathologic, ductography should be attempted.
    ® If mammogram and ultrasound are negative, and ductography is unavailable or technically limited, MRI Breast can be performed.31,32,33,34

Physiologic nipple discharge is predominantly bilateral, but may be unilateral. It is commonly multi-duct. It is predominantly milky, but may be white or a variety of colors including serous, yellow, green, brown, or gray. Evaluation for hyperprolactinemia can be considered (See Practice Note).31,32 33,34

Mammogram and ultrasound (CPT® 76641: unilateral, complete or CPT® 76642: unilateral, limited) should be obtained as initial imaging, with clinical pathway determined by results.31,32,33,34

If nipple discharge is physiologic, there are no suspicious findings on clinical exam, and mammogram and ultrasound are negative, no additional imaging is necessary, and the member can be reassured.31,32,33,34

Nipple Discharge/Galactorrhea - Practice Notes

For milky discharge, prolactin and TSH levels are recommended to diagnose prolactinoma; pituitary imaging is not needed if normal serum Prolactin..


BR-7: Breast Pain (Mastodynia)

BR-7: Breast Pain (Mastodynia)
For this condition imaging is medically necessary based on the following criteria:

Mammogram and ultrasound are the initial imaging for breast pain.39

Advanced imaging is NOT routinely indicated in members with breast pain and negative evaluation (evaluation includes member history and physical exam, pregnancy test, mammogram and ultrasound (CPT® 76641: unilateral, complete or CPT® 76642: unilateral, limited).39

    ® If evaluation is not negative, See BR-5: MRI Breast Indications

Breast Pain – Practice Notes
The risk of malignancy following a negative clinical examination (clinical breast exam, mammogram, ultrasound) has been estimated to be only 0.5%.39


BR-8: Alternative Breast Imaging Approaches

BR-8: Alternative Breast Imaging Approaches
For this condition imaging is medically necessary based on the following criteria:

New and/or alternative breast imaging techniques include:

    ® Nuclear breast imaging, including:
      ¡ Scintimammography
      ¡ Molecular breast imaging (MBI)
      ¡ Breast specific gamma imaging (BSGI)
    ® PET Mammography (PEM)
    ® Thermography
    ® Impedance Mammography
    ® Other techniques to detect oxygen consumption, light absorption, microwave transmission, nitrous oxide production
    ® CT Breast
    ® Coned Beam CT Breast

While alternative breast imaging techniques may have FDA approval, they remain investigational with respect to both screening and diagnosis of breast cancer.

Alternative Breast Imaging Approaches - Practice Notes

Positron Emission Mammography

    ® There is currently insufficient data available to generate appropriateness criteria for this modality, and this procedure should be considered investigational at this time
      ¡ High-resolution positron-emission mammography (PEM) by Naviscan™ PET Systems, also referred to as Naviscan™ or PET mammography, performs high- resolution metabolic imaging for breast cancer using an FDG tracer. The PEM detectors are integrated into a conventional mammography system, allowing acquisition of the emission images immediately after the mammogram.
      ¡ Requesting providers often ask for PEM as CPT® 78811 or “PET scan of the breast”.
      ¡ The spatial resolution of this technique is at the individual duct level (1.5 mm) and allows visualization of intraductal as well as invasive breast cancers. This technique is especially adept at detecting ductal carcinoma in situ.
      ¡ Early clinical trials have shown high clinical accuracy in characterizing lesions identified as suspicious on conventional imaging or physical examination, as well as in detecting incidental breast cancers not seen on other imaging modalities
      ¡ A prospective multi-center clinical trial for women with newly diagnosed breast cancer anticipating breast-conservation surgery was performed. These women underwent both high-resolution PEM imaging and breast MRI. Results showed that PEM and MRI had comparable breast-level sensitivity, although MRI had greater lesion-level sensitivity and more accurately depicted the need for mastectomy. PEM had greater specificity at the breast and lesion levels. Of these, 3.6% of the women had tumors seen only with PEM.
      ¡ The radiation exposure from a PEM study is 23 times higher than for digital mammography.

BR-9: Suspected Breast Cancer in Males

BR-9: Suspected Breast Cancer in Males

For this condition imaging is medically necessary based on the following criteria:

Breast cancer in men presents as a mass, skin/nipple change, or pathologic nipple discharge.

For men <25 years of age with an indeterminate palpable mass, ultrasound is recommended as initial imaging followed by mammography if ultrasound is inconclusive or suspicious.

For men ≥25 years of age with an indeterminate palpable mass or with a concerning physical examination, mammography is recommended initially followed by ultrasound if mammography is inconclusive or suspicious.

There is limited evidence on the use of MRI in the evaluation of male breast disease.

Further diagnostic pathway for suspicious clinical or imaging findings usually requires tissue diagnosis.


Medicaid Coverage:

For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.

FIDE SNP:

For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

___________________________________________________________________________________________________________________________

Index:
Adult Breast Imaging
Breast Cancer
Breast Ultrasound
Breast MRI
Mammography

References:

References
1. Final Recommendation Statement: Breast Cancer: Screening. U.S. Preventive Services Task Force. November 2016. https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/breast-cancer-screening.
2. Mainiero MB, Lourenco A, Mahoney MC, et al. ACR Appropriateness Criteria® Breast cancer screening. Journal of the American College of Radiology. 2013; 10(1):11-14.
3. Sprague BL, Stout NK, Schechter C, et al. Benefits, harms, and cost-effectiveness of supplemental ultrasonography screening for women with dense breasts. Ann Intern Med. 2015; 162(3):157-166.
4. Mendelson EB, Böhm-Vélez M, Berg WA, et al. ACR BI-RADS® Ultrasound. In: ACR BI-RADS® Atlas, Breast imaging reporting and data system. Reston, VA, American College of Radiology. 2013.
5. National Comprehensive Cancer Network (NCCN) Guidelines Version 2.2017 – May 17, 2017. Thyroid Carcinoma. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) for Breast Cancer Screening and Diagnosis 2.2017. ©2017 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines™ and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org.
6. Peters NHG, Borel Rinkes IHM, Zuithoff NPA, et al. Meta-analysis of MR imaging in the diagnosis of breast lesions. Radiology 2008; 246(1).
7. Moy L, Elias K, Patel V, et al. Is Breast MRI helpful in the evaluation of inconclusive mammographic findings? American Journal of Roentgenology. 2009; 193(4):986-993.
8. Pinel-Giroux FM, El Khoury MM, Trop I, et al. Continuing medical education: breast reconstruction: review of surgical methods and spectrum of imaging findings. Radiographics. 2013; 33(2):435-453.
9. Dorrius MD, Van der Weide MCJ, van Ooijen PMA, et al. Computer-Aided Detection in Breast MRI: A systematic review and meta-analysis. Eur Radiol. August 2011; 21(8):1600–1608..
10. Lehman CD, Blume JD, DeMartini WB, et al. Accuracy and interpretation time of computer-aided detection among novice and experienced breast MRI readers. American Journal of Roentgenology 2013; 200(6):W683–W689.
11. NCCN Guidelines Version 2.2017. Invasive Breast Cancer: Principles of Dedicated Breast MRI Testing. National Comprehensive Cancer Network (NCCN) Guidelines Version 2.2017: Breast Cancer. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) for Breast Cancer 2.2017 ©2014 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines™ and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org.
12. 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.
13. Emaus MJ, Bakker MF, Peeters PHM, et al. MR Imaging as an additional screening modality for the detection of breast cancer in women aged 50-75 years with extremely dense breasts: The DENSE trial study design. Radiology. 2015; 277(2).
14. American College of Obstetricians and Gynecologists. Management of women with dense breasts diagnosed by mammography. Committee Opinion No. 625 American College of Obstetricians and Gynecologists. Obstet Gynecol. 2015; 125. https://www.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-Gynecologic-Practice/Management-of-Women-With-Dense-Breasts-Diagnosed-by-Mammography#here.
15. Siu AL. Screening for breast cancer: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2016; 164(4):279-296.
16. Sickles EA and D’Orsi CJ. ACR BI-RADS® Follow-up and Outcome Monitoring. In: ACR BI-RADS® atlas, breast imaging reporting and data system. American College of Radiology. 2013.
17. McCarthy CM, Pusic A, and Kerrigan CL. Silicone breast implants and magnetic resonance imaging screening for rupture: do U.S. food and drug administration recommendations reflect an evidence-based practice approach to patient care? Plastic & Reconstructive Surgery: April 2008; 121(4):1127-1134.
18. Holmich LR, Vejborg I, Conrad C, et al. Untreated Silicone Breast Implant Rupture, Plastic & Reconstructive Surgery: July 2004; 114(1):204-214.
19. Grau AM, Bapsi C, Chugh R, et al. Phyllodes tumors of the breast. UpToDate, 6/2017.
20. Tan H, Zhang S, Liu H, et al, Imaging findings in phyllodes tumors of the breast. Eur J Radiol. Jan 2012; 81(1):e62-69..
21. NCCN Guidelines Version 2.2017: Phyllodes Tumor National Comprehensive Cancer Network (NCCN) Guidelines Version 2.2017: Breast Cancer. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) for Breast Cancer 2.2017 ©2014 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines™ and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org.
22. NCCN Guidelines Version 1.1017: Breast Cancer Risk Reduction National Comprehensive Cancer Network (NCCN) Guidelines Version 2.2017: Breast Cancer. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) for Breast Cancer 2.2017 ©2014 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines™ and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org.
23. Morris EA, Comstock CE, Lee CH, et al. ACR BI-RADS® Magnetic Resonance Imaging. In: ACR BI-RADS® Atlas, Breast Imaging Reporting and Data System. Reston, VA, American College of Radiology. 2013.
24. Institute for Clinical Systems Improvement (ICSI). Diagnosis of breast disease. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2012 Jan. 45 p.
25. NCCN Guidelines Version 2.2017: Ductal Carcinoma in Situ. National Comprehensive Cancer Network (NCCN) Guidelines Version 2.2017: Breast Cancer. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) for Breast Cancer 2.2017 ©2014 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines™ and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org.
26. NCCN Guidelines Version 2.2017: Invasive Breast Cancer National Comprehensive Cancer Network (NCCN) Guidelines Version 2.2017: Breast Cancer. Breast Cancer. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) for Breast Cancer 2.2017 ©2014 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines™ and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org.
27. Lehman CD, Gatsonis C, Kuhl CK, et al. MRI evaluation of the contralateral breast in women with recently diagnosed breast cancer. N Engl J Med. 2007 March; 356(13):1295-1303.
28. NCCN Guidelines Version 2.2017: Paget’s Disease. National Comprehensive Cancer Network (NCCN) Guidelines Version 2.2017: Breast Cancer. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) for Breast Cancer 2.2017 ©2014 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines™ and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org.
29. Lim HS et al. Paget Disease of the breast: mammographic, US, and MR imaging findings with pathologic correlation. Radiographics. 2011; 31(7); 1973-1987.
30. Moy L, Newell MS, Mahoney MC, et al. ACR Appropriateness criteria stage I breast cancer: initial workup and surveillance for local recurrence and distant metastases in asymptomatic women. Journal of the American College of Radiology. 2016; 13(11):43-52.
31. NCCN Guidelines Version 3.2019. Genetic/Familial High-Risk Assessment: Breast and Ovarian. National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2019: Breast Cancer. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) for Breast Cancer 3.2019 ©2019 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines™ and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org.
32. Lee SJ, Trikha S, Moy L, et al. ACR Appropriateness Criteria® Evaluation of Nipple Discharge. Journal of the American College of Radiology. 2017; 14(5):138-153.
33. Berger N, Luparia A, Di G, et al. Diagnostic Performance of MRI versus galactography in women with pathologic nipple discharge: a systematic review and meta-analysis. AJR. American Journal of Roentgenology. August 2017; 209(2):465-471.
34. Bahl M, Gadd MA, Lehman CD. Diagnostic utility of MRI after negative or inconclusive mammography for the evaluation of pathologic nipple discharge. American Journal of Roentgenology. 2017; 209(6):1404-1410.
35. Morrogh M, Morris EA, Liberman L, et al. The predictive value of ductography and magnetic resonance imaging in the management of nipple discharge. Ann Surg Oncol. 2007; 14; 3369.
36. Expert Im, Mainiero MB, Moy L, et al. ACR Appropriateness Criteria® Breast Cancer Screening. American College of Radiology. 14(11s):s383-s390.
37. Berg WA. Current status of dedicated nuclear breast imaging. Society of breast imaging white paper. Journal of Nuclear Medicine.2016 Feb; 57(Supplement 1):46S-52S..
38. Lee CH, Dershaw DD, Kopans D, et al. Breast cancer screening with imaging: recommendations from the Society of Breast Imaging and the ACR on the use of mammography, breast MRI, breast ultrasound, and other technologies for the detection of clinically occult breast cancer. J Am Coll Radiol. 2010; 7(1):18-27.
39. Expert Im, Jokich PM, Bailey L, et al. ACR Appropriateness Criteria® Breast Pain. American College of Radiology. 2014(5S).
40. Monticciolo DL, Newell MS, Moy L, Niell B, Monsees B, Sickles EA. Breast Cancer Screening in Women at Higher-Than-Average Risk: Recommendations From the ACR. Journal of the American College of Radiology. 2018;15(3):408-414.
41. Centers for Disease Control and Prevention (CDC). https://www.cdc.gov/genomics/gtesting/file/print/fbr/BCAnaVal.pdf.
42. NCCN Guidelines Version 3.2018, Breast Cancer Screening and Diagnosis. National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2018: Breast Cancer. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) for Breast Cancer 3.2018 ©2018 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines™ and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org.
43. NCCN Guidelines Version 3.2019, Genetic/Familial High Risk Assessment: Breast and Ovarian. National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2019: Breast Cancer. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) for Breast Cancer 3.2019 ©2019 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines™ and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org.
44. Koning Breast CT. Koning Corporation. http://koninghealth.com/en/kbct/. Accessed March 18, 2019.
45. Golan O, Amitai Y, Barnea Y, Menes TS. Yield of surveillance magnetic resonance imaging after bilateral mastectomy and reconstruction: a retrospective cohort study. Breast Cancer Research and Treatment. 2018;174(2):463-468. doi:10.1007/s10549-018-05077-9.

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*
76641
76642
76882
77058
77059
19085
19086
74175
72191
74185
72198
76376
76377

    HCPCS

    * CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

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    Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.

    The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy

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