MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
Original Issue Date (Created):
July 1, 2002
Most Recent Review Date (Revised):
July 22, 2014
Effective Date:
December 1, 2014
POLICY
RATIONALE
DISCLAIMER
POLICY HISTORY
PRODUCT VARIATIONS
DEFINITIONS
CODING INFORMATION
DESCRIPTION/BACKGROUND
BENEFIT VARIATIONS
REFERENCES
I. POLICY
Note: Refer to Capital Blue Cross’s Health Maintenance Guidelines for recommendations
concerning the use of mammography for screening indications for adult Members covered
under commercial products.
For Sr. Blue products please see below for the designated Health Maintenance Guidelines.
Sr. Blue HMO - https://seniorbluehmo.capbluecross.com/PreventiveHealthCare/
Sr. Blue PPO - https://seniorblueppo.capbluecross.com/PreventiveHealthCare/
A mammogram may be considered medically necessary, regardless of age if the patient has the
following:

A personal history of breast cancer; or

Exhibits distinct symptoms for which a mammogram is indicated such as (but not
limited to) the following:
o Breast mass or nodes;
o Tender or painful breasts;
o Nipple discharge; or
o Change in the color, surface size and/or shape of the breast, skin, or nipple.
A mammogram may be considered medically necessary and appropriate regardless of age for
patients with:

A history or presence of endometrial cancer; or

Metastases or nodes in areas of the body other than the breast; or

A history of previous suspicious lesions or masses of the breast; or
Page 1
MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008

In cases where palpation is impaired due to large, fatty breasts, implanted or
augmented breasts.
A mammogram may be considered medically necessary for a patient with fibrocystic disease
that is experiencing any of the aforementioned symptoms or conditions.
Direct full-field digital mammography may be considered medically necessary, both as a
screening or diagnostic technique.
Computer-Aided Detection Mammography
Computer-assisted detection devices used as an adjunct to single-reader interpretation of
digitized film screening mammograms, or used as an adjunct to single-reader interpretation of
direct, full field digital mammography may be considered medically necessary.
Digital Breast Tomosynthesis
Digital breast tomosynthesis is considered investigational in the screening or diagnosis of
breast cancer. There is insufficient evidence to support a conclusion concerning the health
outcomes or benefits associated with this procedure.
Positron Emission Mammography (PEM)
The use of positron emission mammography (PEM) is considered investigational. There is
insufficient evidence to support a conclusion concerning the health outcomes or benefits
associated with this procedure.
Cross References:
MP-5.021 Scintimammography /Breast Specific Gamma Imaging/Molecular Breast Imaging
MP-5.002 MRI of the Breast With or Without Computer-Aided Detection of Malignancy
(Cancer and Breast Implant Indications)
II. PRODUCT VARIATIONS
Top
[N] = No product variation, policy applies as stated
[Y] = Standard product coverage varies from application of this policy, see below
[N] Capital Cares 4 Kids
[N] Indemnity
[N] PPO
[N] SpecialCare
[Y] HMO*
[N] POS
[N] SeniorBlue HMO
[Y] FEP PPO**
[N] SeniorBlue PPO
Page 2
MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
* All members may self-refer to a participating provider for their screening mammograms,
including a baseline mammogram between ages 35-39.
**Refer to FEP Medical Policy Manual MP-6.01.53 Digital Breast Tomosynthesis and MP6.01.52 Positive Emission Mammography (PEM). The FEP Medical Policy manual can
be found at: www.fepblue.org
III. DESCRIPTION/BACKGROUND
Top
A mammogram is an x-ray image of the breast. A screening mammogram is used to detect
early breast cancer in asymptomatic women. Diagnostic mammography is used to tailor the
mammographic examination to evaluate patients with breast symptoms. Symptoms can include
breast pain, nipple discharge, or palpable masses. Diagnostic mammograms are also used to
clarify potential abnormalities detected on screening studies and for evaluating patients with
past history of breast cancer.
Film screen mammography refers to the use of radiosensitive phosphors and film emulsion
systems to capture an x-ray image on film. Full screen digital mammography refers to the use
of radiosensitive digital detectors to capture and store the x-ray image for display on highresolution CRT monitors without the use of film. As of 2005, both have been shown to be
equivalent for the detection of breast cancer.
The Mammography Act (Act 148 of 1992) is a Pennsylvania state mandate, which requires
insurers to provide for one annual mammogram for women age forty (40) and over and for any
other mammogram recommended by a physician for women under age forty (40).
Early detection of breast cancer reduces morbidity and mortality.
Computer-Aided Detection Mammography
Screening mammograms have a wide variability in interpretation and accuracy among
radiologists. Some of the reasons for this include the complex radiographic structure of the
breast. Computer-assisted diagnosis (CAD) has been suggested as an adjunct to screening
mammograms to decrease errors in perception (i.e. failure to see an abnormality). Studies have
shown that CAD increases the number of cancers detected during screening mammography.
Early detection of cancer allows for early treatment interventions, which may lead to a higher
cure rate.
Page 3
MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
The use of CAD systems requires a digitized image, either generated by digitization of a
screening film mammogram, or generated directly. Commercially available CAD systems then
use computerized algorithms for identifying suspicious regions of interest on the digital image.
The locations of the abnormalities are marked such that the reader can then reference the same
areas in the original mammogram for further review. The intent of CAD is to aid in detection of
potential abnormalities for the radiologist to re-review. CAD systems are not designed to
replace original mammograms or to replace the radiologist’s reading. The radiologist, not
CAD, makes the diagnosis if a clinically significant abnormality exists and determines whether
future diagnostic evaluation is warranted.
The distinction between digitized screen-film mammograms (SFM) and direct full-field digital
mammograms (FFDM) is important. Since these two images are generated in different ways,
the associated diagnostic performance of adjunctive CAD must be considered separately.
Conceptually, the CAD systems used with digital mammography are very similar to those used
with film mammography. The computer analyzes the digital images collected directly by the
FFDM system, applies a set of algorithms that capture characteristics known to be associated
potentially with malignancies, and produces an image with markings that show the site of
suspicious findings. Sometimes, different marks are used for suspected masses and suspected
microcalcifications. The major difference between CAD for FFDM and CAD for SFM is the
extensive data set provided by the former and its interaction with the CAD algorithms.
Digital Breast Tomosynthesis
Digital breast tomosynthesis uses modified digital mammography equipment to obtain
additional radiographic data that are used to reconstruct cross-sectional “slices” of breast
tissue. Tomosynthesis may improve the accuracy of digital mammography by reducing
problems caused by overlapping tissue. Tomosynthesis typically involves additional imaging
time and radiation exposure, although a recently improved modification may change this.
Conventional mammography produces 2-dimensional (2D) images of the breast. Overlapping tissue on a
2D image can mask suspicious lesions or make benign tissue appear suspicious, particularly in women
with dense breast tissue. As a result, women may be recalled for additional mammographic spot views.
Inaccurate results may lead to unnecessary biopsies and emotional stress, or to a potential delay in
diagnosis. Spot views often are used to evaluate microcalcifications, opacities, or architectural
distortions; to distinguish masses from overlapping tissue; and to view possible findings close to the
chest wall or in the retro-areolar area behind the nipple.(1) The National Cancer Institute (NCI) reports
that approximately 20% of cancers are missed at mammography screening.(2) Average recall rates are
approximately 10%, with an average cancer detection rate of 4.7 per 1000 screening mammography
examinations.(3) The Mammography Quality Standards Act audit guidelines anticipate 2-10 cancers
detected per 1000 screening mammograms.(4) Interval cancers, which are detected between
screenings, tend to have poorer prognoses.(5) Digital breast tomosynthesis was developed to improve
the accuracy of mammography by capturing 3-dimensional (3D) images of the breast, further clarifying
areas of overlapping tissue. Developers proposed that its use would result in increased sensitivity and
Page 4
MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
specificity, as well as fewer recalls due to inconclusive results.(6) Digital breast tomosynthesis produces
a 3D image by taking multiple low-dose images per view along an arc over the breast. During breast
tomosynthesis, the compressed breast remains stationary while the x-ray tube moves approximately 1
degree for each image in a 15-50 degree arc, acquiring 11-49 images.(7) These images are projected as
cross-sectional “slices” of the breast, with each slice typically 1-mm thick. Adding breast tomosynthesis
takes about 10 seconds per view. In one study in a research setting, mean (SD) time for interpretation of
results was 1.22 (1.15) minutes for digital mammography and 2.39 (1.65) minutes for combined digital
mammography and breast tomosynthesis. (8) With conventional 2D mammography, breast compression
helps decrease tissue overlap and improve visibility. By reducing problems with overlapping tissue,
compression with breast tomosynthesis may be reduced by up to 50%. This change could result in
improved patient satisfaction. (7)A machine equipped with breast tomosynthesis can perform 2D digital
mammography, 3D digital mammography, or a combination of both 2D and 3D mammography during a
single compression. Radiation exposure from tomosynthesis is roughly equivalent to mammography.
Therefore, adding tomosynthesis to mammography doubles the radiation dose, although it still is below
the maximum allowable dose established in the U.S. Mammography Quality Standards Act.
Studies typically compare 1-view (i.e., mediolateral oblique view [MLO]), or more commonly, 2-view
(MLO plus cranio-caudal view [CC]) breast tomosynthesis alone or combined with standard 2D
mammography to standard 2D mammography alone. A 2014 TEC Assessment focused on 2-view
tomosynthesis.(9) The FDA Radiological Devices Panel, which reviewed this new modality in 2011,
recommended that 2- view breast tomosynthesis is preferable to 1-view tomosynthesis (both used in
combination with full-field digital mammography).(10) In May 2013, FDA approved new tomosynthesis
software that permits creation of 2D images (called C view) from images obtained during tomosynthesis.
(11) As a result, 2D mammography may become unnecessary, thereby lowering radiation dose. In other
words, only the tomosynthesis procedure will be needed, and both 2D and 3D images will be created. It
is too early to gauge how traditional mammography plus tomosynthesis compares with C view plus
tomosynthesis
FDA Status
The Selenia® Dimensions® 3D System manufactured by Hologic, Inc. (Bedford, MA), received U.S.
Food and Drug Administration (FDA) approval on February 11, 2011 through the premarket application
(PMA) approval process (PMA# P080003). Currently it is the only commercially-available tomosynthesis
system with FDA-approval. This system is a software and hardware upgrade of the Selenia®
Dimensions 2D full-field digital mammography system, which FDA approved in 2008. Facilities using a
digital breast tomosynthesis system must apply to FDA for a certificate extension covering use of the
breast tomosynthesis portion of the unit. The Mammography Quality Standards Act requires interpreting
physicians, radiologic technologists, and medical physicists to complete 8 hours of digital breast
tomosynthesis training, and mandates a detailed mammography equipment evaluation before use. In
May 2013, FDA also approved Hologic's C-View 2D imaging software. This software is used to create
2D images from the tomosynthesis results, rather than perform a separate mammogram.
Several other manufacturers are working toward FDA approval of their digital breast tomosynthesis systems. GE
Healthcare is seeking FDA-approval for breast tomosynthesis, specifically as an add-on option for the
Senographe™ Essential mammography device. FDA has agreed to a modular PMA submission, which means that
GE Healthcare will submit the request in different sections. The first of 4 sections was submitted in November
2011. Three completed trials sponsored by GE are listed at online site, ClinicalTrials.gov. They focus on the use of
breast tomosynthesis in routine screening (NCT00535678), in diagnostic mammography (NCT00535327), and for
breast biopsy (NCT00535184). Results do not appear to have been published to date.
Page 5
MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
Positron Emission Mammography (PEM)
Positron emission mammography (PEM) is a form of positron emission tomography (PET) that
uses a high-resolution, mini-camera detection technology for imaging the breast. As with PET,
PEM provides functional rather than anatomic information about the breast. PEM has been
studied primarily for use in presurgical planning and staging; it also has been used to monitor
therapy response and breast cancer recurrence Positron emission mammography (PEM) is a
form of positron emission tomography (PET) that uses a high-resolution, mini-camera detection
technology for imaging the breast. As with PET, a radiotracer, usually 18F-fluorodeoxyglucose
(FDG), is administered and the camera is used to provide a higher resolution image of a limited
section of the body than would be achievable with FDG-PET. Gentle compression is used, and
the detector(s) are mounted directly on the compression paddle(s). (1-3) PEM was developed to
overcome the limitations of PET for detecting breast cancer tumors. Patients usually are supine
for PET procedures, and the breast tissue may spread above the chest wall, making it potentially
difficult to differentiate breast lesions from other organs that take up the radiopharmaceutical.
PET’s resolution is generally limited to about 5 mm, which may not detect early breast cancer
tumors. (4) PEM allows for the detection of lesions smaller than 2 cm and creates images that
are more easily compared to mammography, since they are acquired in the same position.
Three-dimensional reconstruction of the PEM images is also possible. As with PET, PEM
provides functional rather than anatomic information on the breast. (1-3) In studies of PEM,
exclusion criteria included some patients with diabetes (e.g., references (5, 6)). PET may be
used for other indications for breast cancer patients, namely, detecting loco-regional or distant
recurrence or metastasis (except axillary lymph nodes) when suspicion of disease is high and
other imaging is inconclusive.
Regulatory Status
In August 2003, the PEM 2400 PET Scanner (PEM Technologies, Inc.) was cleared for
marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The
FDA determined that this device was substantially equivalent to existing devices for use in
“medical purposes to image and measure the distribution of injected positron emitting
radiopharmaceuticals in human beings for the purpose of determining various metabolic and
physiologic functions within the human body.” In March 2009, the Naviscan PEM Flex Solo II
High Resolution PET Scanner (Naviscan, Inc.) was cleared for marketing by the FDA through
the 510(k) process for the same indication. The PEM 2400 PET Scanner was the predicate
device. The newer device is described by the manufacturer as “a high spatial resolution, small
field-of-view PET imaging system specifically developed for close-range, spot, i.e., limited
field, imaging.”
On September 11, 2008, there was a class 2 recall of the Naviscan PET Systems Inc. PEM
Flex™ Solo II PET Scanner due to “a report from a user indicating that the motorized
compression exceeded 25 pounds of compression force during the pre-scan positioning of the
patient.” Software for the PEM Flex™ Solo I and PEM Flex™ Solo II PET scanners was
Page 6
MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
recalled in August 2007. One report indicated that the Mexican medical company, Compañía
Mexicana de Radiología SA de CV (CMR), acquired Naviscan in December 2013 and plans to
file a new marketing approval application with FDA to sell the PEM Flex™ Solo II PET
Scanner in the U.S. (9) However, no applications from CMR were found on FDA websites
IV. RATIONALE
Top
Digital Breast Tomosynthesis
Literature Review
Primary outcomes to be examined include the number of cancers detected and the number of
unnecessary recalls and biopsies. Improvement in sensitivity and specificity of testing is an
intermediate outcome that will impact ultimate health outcomes, but is not by itself sufficient to
establish that outcomes are improved. If the sensitivity of breast cancer detection is improved
by tomosynthesis, then the number of cases detected will increase. If the specificity of cancer
detection is improved, then the number of recalls and biopsies for patients without cancer will
decrease. If tomosynthesis is performed during screening, the number of unnecessary recalls
may decline, along with attendant anxiety and inconvenience for the patient. If tomosynthesis is
performed as part of the diagnostic workup, after a woman is recalled for questionable findings
during screening, then a lower false-positive rate could prevent unnecessary biopsies.
Screening
The 2014 TEC Assessment identified 4 studies that addressed the use of mammography with
or without digital breast tomosynthesis for screening. These studies are summarized below.
The strongest evidence for using mammography and breast tomosynthesis for screening women
for breast cancer comes from interim results of a large 2013 trial in Norway.(12, 13) The sample
comprised 12,621 women with 121 cancers detected on routine screening. Cancer detection rate
was 6.1 per 1000 screenings for mammography alone and 8.0 per 1000 screenings for
mammography plus digital breast tomosynthesis. Cancers missed by digital breast
tomosynthesis were missed due to reading errors, either detection or interpretation.(14) After
adjusting for reader differences, the ratio of cancer detection rates for mammography plus breast
tomosynthesis versus mammography alone was 1.27 (98.5% confidence interval [CI], 1.06 to
1.53; p=0.001). The authors did not ascertain any improvement in detecting ductal carcinoma in
situ (DCIS) by adding breast tomosynthesis; i.e., additional cancers detected were mostly
invasive. The false-positive rate was 61.1 per 1000 screenings for mammography alone and
53.1 per 1000 screenings for mammography plus breast tomosynthesis. A reduction in the falsepositive rate would decrease the number of women recalled after screening for additional
imaging or biopsy. In Norway, as in much of Europe, women are screened every other year, and
2 readers independently interpret the images, which differs from usual practice in the U.S. After
adjusting for differences across readers, the ratio of false-positive rates for mammography plus
Page 7
MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
breast tomosynthesis versus mammography alone was 0.85 (98.5% CI, 0.76 to 0.96; p<0.001).
For this interim analysis, only limited data were available about interval cancers so
“conventional absolute sensitivity and specificity” could not be estimated. Additional
information will be available when the trial (NCT01248546) is completed (estimated study
completion date, September 2015).
The second study (STORM) examined comparative cancer detection for traditional
mammography with or without breast tomosynthesis in a general Italian, asymptomatic
screening population of 7292 women. (15) The reference standard was pathology for women
undergoing biopsies; women with negative results on both mammography and breast
tomosynthesis were not followed up, so neither sensitivity nor specificity could be calculated.
Mammography plus breast tomosynthesis revealed all 59 cancers; 20 (34%) were missed by
traditional mammography (p<0.001). Incremental cancer detection by using both modalities was
2.7 cancers per 1000 screens (95% CI, 1.7 to 4.2). There were 395 false-positive results: 181
were false positive using either mammography or both imaging modalities together; an
additional 141 occurred using mammography only; and 73 occurred using mammography and
breast tomosynthesis combined (p<0.001). In preplanned analyses, combined results of
mammography and digital breast tomosynthesis yielded more cancers in both age groups (<60
vs ≥60 years) and breast density categories (1 [least dense] and 2 vs 3 and 4 [most dense]).
Another study compared results of mammography alone versus breast tomosynthesis plus
mammography among 997 patients with mixed indications: 780 women were undergoing
routine screening, and 217 were scheduled for biopsy. (16) Two retrospective reader studies
were conducted. Some of these results were included in the submission to the U.S. Food and
Drug Administration (FDA) for premarketing application approval of Hologic, Inc.’s Selenia®
Dimensions tomosynthesis system. Readers were trained in interpreting tomosynthesis images,
and training was augmented between the first and second reader studies to emphasize how to
read certain lesions that were often misinterpreted in the first reader study. In both reader
studies, the area under the receiver operating characteristic curve (ROC) for mammography plus
breast tomosynthesis was greater than for mammography alone; the difference for the second
study was 6.8% (95% CI, 4.1% to 9.5%; p<0.001). For noncancer cases, adding breast
tomosynthesis to mammography changed the mean recall rate across readers for study 2 from
48.8% (95% CI, 28.2% to 69.1%; SD=12.3%) to 30.1% (95% CI, 19.8% to 41.3%; SD=7.6%)
for the combined modalities. Almost all of the improvement among readers was attributable to
noncalcification cases, including masses, asymmetries, and architectural distortions.
All of these studies had a medium risk of bias using the Quality Assessment of Diagnostic
Accuracy Studies (QUADAS)-2 tool (available online at: www.quadas.org), except for the
fourth screening study, which had a high risk of bias.(8, 17, 18) One of 3 related articles on this
study reported that the recall rate among noncancer cases was 0.42 (95% CI, 0.38 to 0.45) for
Page 8
MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
digital mammography alone and 0.28 (95% CI, 0.25 to 0.31) for digital mammography plus
breast tomosynthesis (p<0.001). Analogous rates for cancer cases were 0.88 (95% CI, 0.84 to
0.91) for digital mammography alone and 0.93 (95% CI, 0.90 to 0.96) for digital mammography
plus breast tomosynthesis. Sensitivity of digital mammography alone was 60% and increased to
72% when breast tomosynthesis was added (p=0.034, but the authors note the small number of
positive findings). These articles did not describe the sample, the time between digital
mammography and breast tomosynthesis, or how the reference standard was verified.
Several studies assessing digital breast tomosynthesis for breast cancer screening have been
published subsequent to the TEC Assessment. These studies are summarized in Table 1.
Studies by Friedewald et al (19) and Rose et al (20) were retrospective; all others were
prospective. Studies consistently showed improved breast cancer detection rates (sensitivity)
with addition of tomosynthesis to digital mammography. Improvements were not always
statistically significant or statistical significance was not reported. Reduction in noncancer
recall rate was observed in 2 studies, but reduction in noncancer biopsy rate was observed in
only 1 of 2 studies. The smallest study (21) reported the largest improvements in performance
with the addition of tomosynthesis. Performance of breast tomosynthesis did not vary by breast
density or age group in 4 studies that examined these variables.(15, 20, 22, 23) Table 1
includes a study by Skaane et al (2014) of 2D images reconstructed from digital tomosynthesis
(C view or synthesized 2D mammography).(24) In another study of C view tomosynthesis
(N=236), Zuley et al (2014) compared diagnostic accuracy of synthesized 2D mammography
and digital mammography, both alone and in combination with 3D breast tomosynthesis.(25)
Area under the receiver operating characteristic curve was 0.894 and 0.889 for synthesized and
digital mammography, respectively; with the addition of 3D tomosynthesis, values increased
to 0.916 and 0.939, respectively. In the second half of the Skaane et al (2014) study (after
improvements to 2D image processing were made), there was no statistical difference in
cancer detection rates, positive predictive values, and false positive rates (noncancer recall
rates) between synthesized and digital mammography (both in combination with
tomosynthesis). Mean glandular radiation dose for a single mammographic view was 45% less
in the synthesized mammography group compared with the digital mammography group
(mean, 1.58 mGy vs 3.53 mGy, respectively.
Table 1. Studies of Digital Breast Tomosynthesis for Breast Cancer Screening
Noncancer
Recall Rate
Noncancer
Biopsy Rate
CDR/1000
Digital Mammography vs Digital Mammography + Tomosynthesis
Bernardi 2014(15, 26-28) (STORM), N=7292
DM
2.8%
NR
5.3
PPV
NR
Page 9
MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
DM + DBT
2.2%
NR
8.1
NR
Destounis 2014(21), N=1048
DM
6.9%
1.9%
3.8
16.7%
DM + DBT
0.6%
5.7
50.0%
Friedewald 2014(19), N= 454,850
DM
10.1%
1.4%
4.2
4.3%
DM + DBT
1.3%
5.4
Greenberg 2014(22), N=59,617
DM
NR
1.75
49
DM + DBT
2.0%
1.0%
8.4%
NR
a
6.3
a
6.4%
23.8%
a
22.8%
Haas 2013(23), N=13,158
DM
NR
NR
5.2
NR
DM + DBT
NR
5.7
NR
Rose 2013(20), N=23,355
DM
8.3%
4.9%
4.0
4.7%
DM + DBT
0.8%
5.4
NR
7.8
32.1%
NR
7.7
34.9%
NR
1.1%
a
10.1%
Digital Mammography + Tomosynthesis vs 2D Tomosynthesis +3D Tomosynthesis
Skaane 2014(24), N=12,270
DM + DBT
4.6%
C view + DBT
4.5%
b
DBT, digital breast tomosynthesis (2-view unless noted otherwise); DM, digital mammography
(2-view unless noted otherwise); NR, not reported
a
b
Statistically significant difference from DM
Second of 2 sequential cohorts reported here.
Section summary. These studies provided some evidence that adding breast tomosynthesis to
mammography may increase accuracy (and possibly sensitivity) of screening while reducing
the number of women who are recalled unnecessarily. However, the available studies have
methodological limitations. Several studies did not have adequate follow-up of women with
negative screening results; 1 larger study provided interim results. Other studies were
retrospective case reviews; patients had mixed or unclear indications for screening. More
Page 10
MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
recently, prospective and large retrospective studies have reported cancer detection rates with
reduced false recall rates. This evidence is from nonrandomized designs with a lack of longterm follow-up to assess false negative results. Therefore, performance of digital breast
tomosynthesis in the screening setting cannot be determined with certainty. Two studies of
synthesized 2D mammography showed comparable diagnostic performance with digital
mammography and lower radiation exposure. Replication of these findings is warranted.
Diagnosis
Lei et al (2014) conducted a systematic review with meta-analysis of 7 studies (total number of
patients, 2014; total number of lesions, 2666) that compared digital breast tomosynthesis with
digital mammography in patients with Breast Imaging-Reporting and Data System (BI-RADS)
2 or higher breast lesions.(29) All studies were rated high quality using the QUADAS tool. As
shown in Table 2, compared with histological diagnosis, performance of both imaging
modalities was approximately similar; positive predictive values were low (57% for breast
tomosynthesis and 50% for digital mammography), and negative predictive values were high.
2
Statistical heterogeneity in these analyses was considerable (I30) approximately 90%). Studies
used both 1-view (n=4) and 2-view (n=3) breast tomosynthesis. Pooled sensitivity and
specificity for only 1-view breast tomosynthesis studies were 81% and 77%, respectively; for 2view studies, pooled sensitivity and specificity were 97% and 79% respectively.(
Table 2. Side-by-Side Comparison of Digital Breast Tomosynthesis and Digital
Mammography Diagnostic Performance Compared with Histological Diagnosis: Pooled
Results (29)
Digital Breast Tomosynthesis,
pooled estimate (95% CI)
Digital Mammography,
pooled estimate (95% CI)
Sensitivity
90% (87 to 92)
89% (86 to 91)
Specificity
79% (77 to 81)
72% (70 to 74)
a
57% (53 to 61)
50% (46 to 53)
96% (95 to 97)
95% (94 to 97)
26.04 (8.70 to 77.95
3.50 (2.31 to 5.30)
0.15 (0.06 to 0.36)
0.867
16.24 (5.61 to 47.04)
2.83 (1.77 to 4.52)
0.18 (0.09 to 0.38)
0.856
PPV
a
NPV
DOR
LR+
LR–
AUC
AUC, area under the summary receiver operating characteristic curve; DOR, diagnostic odds ratio (ratio of the odds
of positivity in cases to the odds of positivity in controls = [LR+] ÷ [LR–]); LR+, positive likelihood ratio (ratio of the
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POLICY NUMBER
MP-5.008
probability of positivity in cases to the probability of positivity in controls = sensitivity ÷ [1-specificity]); LR–, negative
likelihood ratio (ratio of the probability of a negative result in cases to the probability of a negative result in controls =
[1-sensitivity] ÷ specificity); NPV, negative predictive value; PPV, positive predictive value
a
Calculated by author
The 2014 TEC Assessment identified 6 studies that addressed the use of breast tomosynthesis in
the diagnostic setting, i.e., when there are suspicious findings on screening mammography or
when the woman is symptomatic. Studies vary considerably in types of suspicious
mammographic findings (e.g., calcifications vs noncalcifications); patient sample; and
comparators to breast tomosynthesis (e.g., 2-view mammography, mammographic spot views,
or ultrasound). One study had a medium risk of bias; the remainder, a high risk of bias using the
QUADAS-2 tool. These studies are summarized below.
In a study of 158 women consecutively recalled after screening mammography, breast
tomosynthesis was evaluated as a possible triage tool to reduce the number of false-positive
results.(31) Results of diagnostic assessment (including ultrasound and needle biopsy when
performed) were used as the reference standard. Breast tomosynthesis eliminated 102 (65%) of
158 recalls, all of which were unnecessary (i.e., false-positive results on mammography). No
cancers were missed on breast tomosynthesis. Performance of breast tomosynthesis did not vary
by breast density or age group, but reduction in recalls was greater for asymmetric densities and
distortions, and nodular opacities with regular margins. As noted by the authors, the observed
decline in recall rates after breast tomosynthesis exceeded that observed in blinded comparisons
of digital mammography and breast tomosynthesis.
Another study compared the performance of mammographic spot views versus tomosynthesis
among 52 consecutive recalled women with a BI-RADS rating on initial screening of 0 (which
means “Need Additional Imaging Evaluation and/or Prior Mammograms for Comparison”).(1)
Women with calcifications were excluded. The study was designed as a noninferiority analysis
of area under the ROC curve, sensitivity, and specificity, with a noninferiority margin of
delta=0.05, so that if breast tomosynthesis were noninferior to mammographic spot views,
breast tomosynthesis could be performed right after screening mammography to avoid a recall.
Sensitivity and specificity were extremely high for both modalities, and there was no
statistically significant difference between them.
A third study compared diagnostic mammography to breast tomosynthesis among women with
abnormalities on screening mammography with no calcifications in a “simulated clinical
setting.”(4) Breast tomosynthesis rating was based on both readers’ ratings and their confidence
that no additional studies were needed, as well as ultrasound results in some cases. The
reference standard was either results of the entire clinical workup, including biopsy if
performed, or follow-up for women not undergoing biopsy (86% of the entire sample).There
was no statistically significant difference between diagnostic mammography and breast
tomosynthesis in sensitivity or specificity.
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Two of the these 3studies found no difference in sensitivity and specificity between breast
tomosynthesis and a clinical workup comprising diagnostic mammographic images or a more
comprehensive diagnostic work-up. The third study examined the use of breast tomosynthesis to
triage women recalled after screening and substantially reduced the recall rate.
Another study evaluated 738 women with 759 lesions recalled after screening with film
mammography. This unblinded study assessed the incremental value of breast tomosynthesis
added to film and digital mammography.(32) The reference standard comprised pathology
results or follow-up for 18 to 36 months. The addition of breast tomosynthesis to film and
digital mammography increased the area under the ROC curve from 0.895 (95% CI, 0.871 to
0.919) to 0.967 (95% CI, 0.957 to 0.977) (p=0.001). Complete sensitivity (i.e., counting ratings
of 3-5 as positive) increased from 39.7% for digital mammography to 58.3% when breast
tomosynthesis was added; confidence intervals or p-values were not reported. Specificity
increased from 51% to 74.2% when breast tomosynthesis was added to digital mammography.
The difference in areas under the ROC curve after the addition of breast tomosynthesis was
statistically significant for soft-tissue lesions, but not for microcalcifications.
One study compared diagnostic mammography images to dual-view breast tomosynthesis in
217 lesions (72 [33%] malignant) among 182 women. (33) This retrospective study included
women who had undergone diagnostic mammography and breast tomosynthesis. The sample
included women with clinical symptoms such as a palpable lump, or findings on
mammography, ultrasound, or magnetic resonance imaging (MRI). Women with only
calcifications were excluded. Area under the ROC curve was 0.83 (95% CI, 0.77 to 0.83; range
across readers = 0.74-0.87) for diagnostic mammography, and 0.87 (95% CI: 0.82 to 0.92;
range across readers = 0.80-0.92) for tomosynthesis (p<0.001).
Authors of the Norse screening trial wrote about their initial experience with digital breast
tomosynthesis in a clinical setting. (34)
Several studies assessing diagnostic digital breast tomosynthesis have been published
subsequently to the TEC Assessment. These studies are summarized in Table 3. These studies
reported that addition of tomosynthesis to digital mammography increased diagnostic accuracy
overall, with improvements in true-positive rates (sensitivity) exceeding improvements in truenegative rates (specificity). However, positive predictive value remained low (approximately
50%). Differences in test performance between studies (i.e., between Rafferty 2014(35) and
Thibault 2013(36)) are likely due to the difference in technologies studied (2-view digital
mammography plus 1-view tomosynthesis vs 1-view digital mammography plus 1-view
tomosynthesis, respectively), but also to differences in sample size (310 vs 130, respectively),
setting (U.S. vs Europe, respectively), number of readers (15 vs 7, respectively), training (150
cases vs 20 cases, respectively).
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Table 3. Studies of Diagnostic Digital Breast Tomosynthesis
AUC
Sens
Spec
PPV
NPV
DM
0.828
63%
86%
47%
92%
DM + 1-view DBT
0.864
a
71%
86%
50%
94%
DM + 2-view DBT
0.895
a
79%
85%
50%
95%
Rafferty 2014(35)
N=310
Gennaro 2013(37)
N=463
DM
NR
76%
NR
NR
NR
1-view ( CC) DM + 1-view DBT
NR
79%
NR
NR
NR
DM
0.756
73%
53%
53%
74%
1-view ( CC) DM + 1-view DBT
0.780
68%
64%
58%
74%
DM + 1-view DBT + US
0.763
81%
52%
55%
79%
Thibault 2013(36)
N=130
AUC, area under the receiver operating characteristic curve; CC, cranio-caudal; DBT, digital breast tomosynthesis;
DM, digital mammography (2-view unless noted otherwise); MLO, mediolateral-oblique; NR, not reported; US,
ultrasound
Note: 1-view DBT is MLO unless noted otherwise.
a
b
Statistically significant difference from DM
Statistically significant difference from 1-view DBT
Section summary. This mixed set of articles provides evidence of either a similar diagnostic
performance between breast tomosynthesis and other approaches or an advantage for breast
tomosynthesis. Mixed patient populations, differences in references standard, use of different
imaging tests to compare with breast tomosynthesis, and variations in follow-up make it
difficult to draw conclusions from these studies.
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POSITRON EMISSION MAMMOGRAPHY)
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Summary
Screening
The Norse and Italian screening studies published in 2013 provide the strongest evidence
available to date on the use of mammography plus digital breast tomosynthesis versus
mammography alone for screening women for breast cancer. This evidence suggests that use
of mammography plus breast tomosynthesis may modestly increase the number of cancers
detected, with a large decrease in the number of women who undergo unnecessary recalls or
biopsies. For example, in interim analysis of the Norse screening trial, the ratio of cancer
detection rates per 1000 screens for mammography plus breast tomosynthesis versus
mammography alone was 1.27 (98.5% CI, 1.06 to 1.53; p=0.001). The ratio of false-positive
rates for mammography plus breast tomosynthesis versus mammography alone was 0.85
(98.5% CI, 0.76 to 0.96; p<0.001). Even if adding breast tomosynthesis simply maintained the
same sensitivity as mammography, a decline in the false-positive rate would reduce the
substantial number of unnecessary diagnostic work-ups in the U.S. and spare women the
psychological stress these engender
Additional studies generally have supported these findings, with no observed differences in
test performance across subgroups defined by age or breast density. However, all studies were
nonrandomized. Lack of long-term follow-up prevents assessment of false negative results and
full assessment of test performance. Further, overall impacts on health outcomes are unknown.
Long-term effects of additional radiation exposure also are unknown. For these reasons, digital
breast tomosynthesis is considered investigational. A trial that randomizes women to digital
mammography with or without tomosynthesis, or performs both screening methods in the
same woman, is required to demonstrate that improvements in screening are due to
tomosynthesis and not to confounding variables, e.g., patient characteristics or radiologist
experience in tomosynthesis interpretation
The configuration of mammography and breast tomosynthesis used in these studies roughly
doubled the radiation dose of mammography alone, but exposure was still lower than the
guideline established in the Mammography Standards and Quality Act. On May 20, 2013, the
U.S. Food and Drug Administration approved new tomosynthesis software from Hologic, Inc.
that creates a 2D image from tomosynthesis images (C view), obviating the need for a separate
mammogram. This approach reduces the radiation dose of the combination. Two studies
reported comparable performance with digital mammography plus breast tomosynthesis, which
reduces radiation exposure. Results warrant replication.
Diagnosis
The potential of digital breast tomosynthesis, as an addition to diagnostic mammography (such
as spot views), is primarily to reduce the number of women who are biopsied by screening out
some fraction of women who have false-positive results. The body of evidence on breast
tomosynthesis to evaluate women who are recalled for a diagnostic work-up after a suspicious
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finding on screening mammography is weaker than that on adding breast tomosynthesis to
mammography for screening. Confounding this analysis is the fact that diagnostic
mammography is not the only imaging modality used during the diagnostic work-up.
Ultrasound is also commonly used and less often, MRI. As a result, study designs are more
complicated in terms of how they incorporate ultrasound into the comparison between
diagnostic mammography and breast tomosynthesis. A different research design is needed to
assess the incremental value of tomosynthesis compared with currently-used diagnostic tests.
Additionally, some studies focused on 1 type of finding, eg, masses versus calcification. These
studies do not provide data on the accuracy of breast tomosynthesis for the full range of
findings.
Ongoing Research
Digital breast tomosynthesis continues to be an active field of investigation. A search of online
site, ClinicalTrials.gov, identified 17 active studies of digital breast tomosynthesis. All but 2
studies had sample sizes larger than 100, and 6 studies were larger than 1000 (eg, 15,000
[NCT01091545] and 25,000 [NCT01248546, the study whose interim analysis was reported
by Skaane et al (2013) (12)]).
A large study with target enrollment of 12,000 was suspended due to funding unavailability
(NCT01593384).
Several studies have assessed different breast tomosynthesis equipment, including a study of the
Siemens Inspiration Digital Breast Tomosynthesis system (NCT01373671) and 3 completed
studies sponsored by GE Healthcare that have not yet been published (NCT NCT00535184,
NCT NCT00535327, NCT00535678).
Practice Guidelines and Position Statements
American College of Radiology (ACR)
ACR does not include digital breast tomosynthesis in its Appropriateness Criteria for screening
(38) or diagnostic (39) breast imaging. However, in a joint news release with the Society of
Breast Imaging after release of the Norse study interim analysis by Skaane et al (2013)(12), the
organizations stated, “While the study results are promising, they do not provide adequate
information to define the role of tomosynthesis in clinical practice.” (40) They also noted that
while cancer detection was greater with tomosynthesis, it is unknown whether incremental
health benefits would be the same during a second round of screening.
Furthermore, they noted “how the technology will affect screening accuracy among women of
different ages, risk profiles and parenchymal density is uncertain. In addition, how this
technology would affect reader performance among U.S. radiologists with varying practice
patterns and expertise is also uncertain. Other questions include whether computer aided
detection will provide any further benefit, and if reconstructed images (presumably 2D) can be
used, in lieu of standard full field digital images, to reduce radiation dose.”
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POLICY NUMBER
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American College of Obstetricians and Gynecologists (ACOG)
In its 2011 practice bulletin on breast cancer screening, ACOG noted that digital breast
tomosynthesis is 1 of several screening techniques that were considered but not recommended
for routine screening. (41)
National Comprehensive Cancer Network (NCCN)
According to the National Comprehensive Cancer Network, “Early studies show promise for
tomosynthesis mammography. Two large trials showing a combined use of digital
mammography and tomosynthesis resulted in improved cancer detection and decreased call
back rates; of note, this is double the dose of radiation and is a factor in recommending this
modality. Definitive studies are still pending.” (42)
U.S. Preventive Services Task Force (USPSTF)
In 2009, USPSTF updated its recommendations for breast cancer screening using film
mammography and using methods other than film mammography. (43) USPSTF recommends
mammography and digital mammography but does not include digital tomosynthesis.
However, the Department of Health and Human Services, in implementing the Affordable
Care Act, utilizes USPSTF 2002 recommendations on breast cancer screening.(44) These
recommendations do not include digital breast tomosynthesis. USPSTF is in the process of
updating its recommendations for breast cancer screening. (45)
Positron Emission Mammography
PEM for Use in Women With Newly Diagnosed Breast Cancer as Part of Presurgical Planning
The published literature, comprising 2 prospective, nonrandomized comparative studies, 1
prospective, single-arm study, and a meta-analysis that included these studies, is summarized.
Nonrandomized Comparative Studies
Schilling et al (2011) conducted a single-site, prospective study comparing PEM and magnetic
resonance imaging (MRI) (1.5 T) for presurgical planning. (10) Performance of PEM, MRI, and
whole body positron emission tomography (WBPET) were compared with final surgical
histopathology in women with newly diagnosed, biopsy-proven breast cancer. For PEM and
WBPET (performed consecutively), median 18F-fluorodeoxyglucose (FDG) dose was 432.9
MBq (equivalent to 11.7 mCi); 4-to-6 hour fasting glucose less than 7.8 mmol/L was required
for study entry. One of 6 readers evaluated PEM, radiographic mammography, and MRI images
with access to conventional imaging (mammography or ultrasound) results “but without
influence of the alternative (PEM or MRI) imaging modality”; WBPET images were interpreted
by a nuclear medicine physician. For evaluating PEM images, readers used a proposed PEM
lexicon based on MRI BI-RADS (Breast Imaging Reporting and Data System). Patients
underwent surgery approximately 3 weeks after PEM and WBPET imaging. Of 250 patients
approached to participate in this study, 31 were disqualified, and 26 were ineligible because
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they underwent PEM or MRI before study entry; the analysis therefore included 182 patients.
Almost half (46%) of lesions were clinically palpable. On pathology, 78% of patients had
invasive disease; 21% ductal carcinoma in situ (DCIS); and 2% Paget disease. For index
lesions, both PEM and MRI had a sensitivity of 93% (95% confidence interval [CI], 88 to 96;
p=not significant), which was greater than the sensitivity of WBPET (68% [95% CI, 60 to 70];
p<0.001). Specificity was not reported because only malignant index lesions were analyzed.
Sensitivity of PEM and MRI was not affected by breast density, menopausal status, or use of
hormone replacement therapy. PEM tended to overestimate the size of the largest lesion,
compared with surgical pathology and MRI (120 mm for PEM vs 95 mm for pathology and
MRI); however, correlation between tumor size on histopathology versus size on either PEM or
MRI was the same (r=0.61). Twelve lesions were missed on both PEM and MRI; 3 of them
were not in the PEM field of view due to patient positioning. For 67 additional ipsilateral
lesions detected (40 malignancies), sensitivity of PEM and MRI was 85% (95% CI, 70 to 94)
and 98% (95% CI, 89 to 100; p=0.074), respectively; and specificity of PEM and MRI were
74% (95% CI, 54 to 89) and 48% (95% CI, 29 to 68; p=0.096), respectively. Further
investigation is needed to determine whether these are 2 points along the same operating curve
(i.e., whether PEM is being read to emphasize specificity compared with MRI). Additional
larger studies also are warranted.
Berg et al (2011) compared PEM with MRI (6) and initially reported results at the 2010 Annual
Meeting of the Radiological Society of North American. The study was funded in part by
Naviscan, which manufactures the U.S. Food and Drug Administration (FDA)-cleared PEM
device, and by the National Institutes of Health. The first author was a consultant to Naviscan;
other authors included a former employee and a current employee.
The study was conducted at 6 sites and enrolled 388 women who had newly diagnosed breast cancer
detected at core-needle or vacuum-assisted biopsy and were eligible for breast-conserving
surgery. Median age was 58 years. Of 472 women originally enrolled, 18 were ineligible and 66
were excluded. The latter 66 patients were statistically significantly more likely than the women
included in the analysis to have larger invasive tumor components, less likely to have 1
ipsilateral malignancy at study entry, and more likely to have known axillary node metastases
(and more missing data). Study participants had tumor size 4 cm or less, or for women with
large breasts, 5 cm or less. PEM and MRI were performed in random order without regard to
timing in the menstrual cycle. Mean FDG dose with PEM was 10.9 mCi, and mean blood
glucose level was 91 g/dL. PEM and MRI were read by different investigators; some but not all
readers were blinded to results of the other test. PEM results with a BIRADS score of 4a or
higher or a score of 3 with a recommendation for biopsy were considered positive. Negative
cases included those with negative pathology or follow-up of at least 6 months with no
suspicious change.
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Before surgery, 404 malignancies were detected in 388 breasts. After surgery, 386 lesion sites
in 370 breasts were confirmed. This difference presumably was due to biopsies that removed all
malignant tissue. Among 386 surgically-confirmed lesion sites, there was no statistically
significant difference in sensitivity of PEM (93%) and MRI (89%) when only tumor sites were
included (p=0.79). When tumors and biopsy sites were visualized, MRI had higher sensitivity
than PEM (98% vs 95%, respectively; p=0.004). There were no visible tumor or biopsy site
changes in 7 breasts on MRI and in 19 cases on PEM; however, there was residual tumor on
surgery in all of these breasts.
Of 388 enrolled women, 82 (21%) had additional tumor foci after study entry. Sensitivity for
identifying breasts with these lesions was 60% (95% CI, 48 to 70) for MRI and 51% for PEM
(95% CI, 40 to 62; p=0.24). Of 82 additional lesions, 21 (26%) were detected only with MRI,
14 (17%) only with PEM (p=0.31), and 7 (8.5%) only with conventional imaging. Adding PEM
to MRI increased sensitivity from 60% to 72% (p<0.01). Twelve women who had additional
foci in the breast with the primary tumor were not identified by any of the imaging techniques.
Among women with an index tumor and no additional lesions in the ipsilateral breast, PEM was
more specific than MRI (91% vs 86%, respectively; p=0.032). Difference between PEM and
MRI area under the receiver operating characteristic (ROC) curve was not statistically
significantly different. Again, the question arises whether differences in sensitivity and
specificity between the 2 tests are due to selecting different operating points along the ROC
curve.
Of 116 malignant lesions unknown at study entry, 53% were reported as suspicious on MRI
versus 41% on PEM (p=0.04). There was no difference between PEM and MRI in detecting
DCIS in this study (41% vs 39%; p=0.83). Adding PEM to MRI would increase the sensitivity
for detecting DCIS from 39% with MRI alone to 57% combined (p=0.001); another 7 DCIS foci
were seen only on conventional imaging. MRI was more sensitive than PEM in detecting
invasive cancer (64% vs 41%; p=0.004), but the 2 combined would have a higher sensitivity
than MRI alone (73% vs 64%; p=0.025). MRI was more sensitive than PEM in dense breasts
(57% vs 37%; p=0.031).
In a second article based on the same study, (7) the performance of PEM and MRI for detecting
lesions in the contralateral breast were compared. In this case, readers were blinded to results of
the other test but knew results of conventional imaging and pathology from prestudy biopsies.
After recording results for a single modality, readers then assessed results across all modalities.
Readers had 1 to 15 years of experience in interpreting contrast-enhanced breast MRI and
underwent training for interpreting PEM; 5 of 30 readers had prior experience in interpreting
PEM. The final patient sample size was 367; 9 patients were excluded because the highest
scored lesion was a BIRADS 3 (probably benign) based on all imaging, and no follow-up or
histopathology was performed. The contralateral breast could not be assessed in 12 women, eg,
due to prior mastectomy or lumpectomy and radiotherapy.
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Fifteen (4%) of the 367 participants had contralateral cancer. PEM detected cancer in 3 of these
women and MRI in 14. Sensitivity of PEM and MRI was 20% (95% CI, 5 to 46) and 93% (95%
CI, 66 to 94), respectively (p<0.001), and specificity was 95% (95% CI, 92 to 97) and 90%
(95% CI, 86 to 92), respectively (p=0.002). Area under the ROC curve was 68% (95% CI, 54 to
82) for PEM and 96% (95% CI, 94 to 99) for MRI (p<0.001). Among women undergoing
biopsies, positive predictive value (PPV) did not differ statistically between modalities (21% for
PEM vs 28% for MRI; p=0.58). There were more benign biopsies based on MRI results (39
biopsies in 34 of 367 women) than for PEM results (11 biopsies in 11 of 367 women)
(p<0.001). The authors discussed possible improvements in interpreting PEM, based in part on
results of having the lead investigators reread the PEM images. They determined that 7 of 12
false-negative PEM results were due to investigator error. This could only be confirmed through
further study. They also noted that a substantial proportion of contralateral lesions may be
effectively treated by chemotherapy and that PEM cannot optimally evaluate the extreme
posterior breast. For additional articles on the same study that focus on identifying malignant
characteristics on PEM and on training and evaluating readers of PEM, see references (11, 12).
Three of 6 sites included in the Berg et al (2011) study participated in a substudy that compared
the diagnostic performance of PEM with that of WBPET and PET/CT in 2 small cohorts of
women with newly diagnosed breast cancer who were eligible for breast conserving surgery.
(13) Fasting blood glucose less than 148 mg/dL was required for study entry. Of 388 women in
the original study, 178 (46%) participated in the substudy. Use of WBPET or PET/CT was
determined by protocols at each participating site. Most patients (113 [63%]) underwent PEM
followed by WBPET or PET/CT on the same day with the same radiotracer dose; the remaining
65 patients (37%) had PET/CT a median of 3 days before PEM (range, 20 days before to 7 days
after) with a whole body-specific dose of FDG. Sensitivity, specificity, and PPV for cancer
detection were similar for PET/CT performed on the same day as PEM (mean FDG dose 411
MBq) or on a different day (mean FDG dose 566 MBq). These subgroups were therefore
combined for analysis. Readers interpreting PEM images were blinded to WBPET and PET/CT
results but had access to radiographic mammography, ultrasound, and prestudy biopsy results.
For any identified lesion, a true positive was defined as diagnosis of malignancy within 1 year;
true negative was defined as diagnosis of benign or high-risk pathology as the most severe
finding, a probably benign lesion that decreased in size or resolved at any follow-up, or
maximum BIRADS score of 2 after all imaging (PEM, MRI, radiographic mammography,
ultrasound). No statistical adjustment for multiple comparisons was made.
In the WBPET cohort (n=69), PEM detected 61 (92%) of 66 index tumors, and WBPET
detected 37 (56%; McNemar test, p<0.001). In the PET/CT cohort (n=109), PEM detected 104
(95%) of 109 index tumors, and PET/CT detected 95 (87%, McNemar test, p=0.029). As shown
in Table 1, PEM was statistically more sensitive than WBPET (McNemar test, p=0.014) and
PET/CT (McNemar test, p=0.003) for detecting additional ipsilateral malignant tumors, but no
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statistically significant differences in specificity, PPV, or negative predictive value (NPV)
between PEM and WBPET or PET/CT were found. Table 1 also shows sensitivities of imaging
modalities by index tumor size. Trends for decreasing sensitivity with decreasing tumor size
were statistically significant for both WBPET (Cochran-Armitage test, p<0.001) and PET/CT
(Cochran-Armitage test, p=0.004) but not for PEM (Cochran-Armitage test, p=0.15). Samples
were small for most of these comparisons. Other test performance characteristics (i.e.,
specificity, PPV, NPV) were not reported by tumor size.
The greatest weakness of this substudy was the choice of comparators. Current clinical practice
guidelines do not include PET imaging in the diagnostic workup of newly diagnosed breast
lesions (14) nor for postoperative surveillance. (15) Conventional imaging (radiographic
mammography, ultrasound, and/or MRI) would have been a more informative comparator.
Table 1. Performance of PEM, WBPET, and PET/CT for Ipsilateral Malignant Tumors in Kalinyak et
al (2014) (13)
PEM
WBPET
n=69
PEM
PET/CT
n=109
Sensitivity
0.47a
Specificity
0.91
PPV
0.58
NPV
0.86
Sensitivity by size of index tumor c
0.07
0.96
0.33
0.79
0.57b
0.91
0.62
0.89
0.13
0.95
0.43
0.80
>2 to ≤5 cm
>1 to ≤2 cm
0.5 to ≤1 cm
0.1 to ≤0.5
cm
0.92 (11/12)
0.61 (17/28)
0.39 (9/23)
0 (0/3)
0.96 (25/26)
0.96 (53/55)
0.96 (22/23)
0.80 (4/5)
0.96 (25/26
0.89 (49/55)
0.83 (19/23)
0.40 (2/5)
1.0 (12/12)
0.93 (26/28)a
0.91 (21/23)a
0.67 (2/3)
PPV, positive predictive value; NPV, negative predictive value; WBPET, whole body positron emission tomography
Statistically significant comparisons are noted.
a Statistically significant difference vs WBPET (McNemar test)
b Statistically significant difference vs PET/CT (McNemar test)
c There were no index tumors >5 cm.
Single-Arm Studies
Caldarella et al (2014) conducted a systematic review with meta-analysis of PEM studies in
women with newly discovered breast lesions suspicious for malignancy. (16) Literature was
searched through January 2013. Eight studies (total N=873) of 10 or more patients (range, 16388) that used histological review as criterion standard, including the 3 studies described in
detail next, were included. Pooled sensitivity and specificity were 85% (95% CI, 83 to 88;
Page 21
MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
I2=74%) and 79% (95% CI, 74 to 83; I2=63%), respectively. Pooled PPVs and NPVs were 92%
and 64%, respectively. Comparator arms were not pooled. Other limitations of the study
included substantial statistical heterogeneity in meta-analyses and lack of blinding of both PEM
and histopathology readers in individual studies.
In an early (2005) 4-site clinical study, Tafra et al imaged 94 women who had suspected (n=50)
or proven (n=44) breast cancer with PEM. (17) Median dose of FDG was 13 mCi. Median
patient age was 57 years, and median tumor size was 22 mm on pathology review. Seventyseven percent of primary lesions were nonpalpable. Median time from injection to imaging was
99 minutes; imaging took 10 minutes per image, and median slice thickness was 5.2 mm.
“Unevaluable” cases were excluded (n not reported). Eight readers had access to mammography
and clinical breast examination (CBE) results, as well as clinical information, but no
information on surgical planning or outcomes. At least 2 readers evaluated each case in random
order. The performance of PEM in this study is listed next; results are presented in detail to
illustrate potential uses of PEM:





BIRADS 4b, 4c, or 5 (probably malignant) assigned to 39 of 44 (89%) pathologically
confirmed breast cancers. Five missed lesions ranged in size from 1 to 10 mm, and 4
were low grade.
Extensive DCIS predicted in 3 cases and confirmed to be malignant; they were not
detected by other imaging modalities.
Among 44 patients with proven breast cancer, 5 incidental benign lesions were correctly
classified, and 4 of 5 incidental malignant tumors were detected, 3 of which were not
detected with other imaging modalities (not evident whether MRI was performed on
these specific patients).
Correctly detected multifocality in 64% of 31 patients evaluated for it, and correctly
predicted its absence in 17 patients.
Correctly predicted 6 of 8 patients undergoing partial mastectomy who had positive
margins and 11 of 11 who had negative margins.
Berg et al (2006) published a follow-up study of 77 patients. (18) Patients with type 1 or type 2
diabetes were excluded; because FDG is glucose-based, diabetic patients must have wellcontrolled glucose for the test to work. Median age was 53 years. Of 77 patients, 33 had
suspicious findings on core biopsy before PEM, 38 had abnormalities on radiographic
mammography, and 6 had suspicious findings on CBE. Five women had personal histories of
breast cancer, 1 of whom had had reconstructive surgery. Readers had access to mammographic
and clinical findings, as it was assumed they would in clinical practice. Median dose of FDG
was 12 mCi (range, 8.2-21.5). Forty-two of 77 cases were malignant, and 2 had atypical ductal
hyperplasia. Sensitivity and specificity of PEM was 93% and 85%, respectively, for index
lesions, and 90% and 86%, respectively, for index and incidental lesions. These values were
similar or higher if lesions were clearly benign on conventional imaging. Adding PEM to
Page 22
MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
radiographic mammography and ultrasound (when available) yielded sensitivity and specificity
of 98% and 41%, respectively. (Specificity of PEM combined with conventional imaging was
lower than PEM alone due to the large number of false positive lesions prompted by
conventional imaging.)
Other Indications
No full-length, published studies were identified that addressed other indications for PEM,
including management of breast cancer and evaluation for recurrence of breast cancer.
Radiation Dose Associated With PEM
The label-recommended dose of FDG for PEM is 370 MBq (10 mCi). Hendrick (2010)
calculated mean glandular doses, and from those, lifetime attributable risk of cancer (LAR) for
film mammography, digital mammography, breast-specific gamma imaging (BSGI), and PEM.
(19) The author, who is a consultant to GE Healthcare and a member of the medical advisory
boards of Koning (which is working on dedicated breast computed tomography [CT]) and
Bracco (MR contrast agents), used BEIR VII Group risk estimates (20) to gauge the risks of
radiation-induced cancer incidence and mortality from breast imaging studies. Estimated
lifetime attributable risk of cancer for a patient with average-sized compressed breast during
mammography of 5.3 cm (risks would be higher for larger breasts) for a single breast procedure
at age 40 years is:




5 per 100,000 for digital mammography (breast cancer only);
7 per 100,000 for screen film mammography (breast cancer only);
55 to 82 per 100,000 for BSGI (depending on the dose of technetium Tc 99m sestamibi);
and
75 per 100,000 for PEM.
The corresponding lifetime attributable risk (LAR) of cancer mortality at age 40 years is:




1.3 per 100,000 for digital mammography (breast cancer only);
1.7 per 100,000 for screen film mammography (breast cancer only);
26 to 39 per 100,000 for BSGI; and
31 per 100,000 for PEM.
A major difference in the impact of radiation between mammography, on the one hand, and
BSGI or PEM, on the other, is that for mammography, radiation dose is limited to the breast,
whereas with BSGI and PEM, all organs are irradiated. Furthermore, as one ages, risk of cancer
induction from radiation exposure decreases more rapidly for the breast than for other
Page 23
MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
radiosensitive organs. Organs at highest risk for cancer are the bladder with PEM and the colon
with BSGI; these cancers, along with lung cancer, are also less curable than breast cancer. Thus,
the distribution of radiation throughout the body adds to the risks associated with BSGI and
PEM. Hendrick (19) concluded that “results reported herein indicate that BSGI and PEM are
not good candidate procedures for breast cancer screening because of the associated higher risks
for cancer induction per study compared with the risks associated with existing modalities such
as mammography, breast US [ultrasound], and breast MR imaging. The benefit-to-risk ratio for
BSCI and PEM may be different in women known to have breast cancer, in whom additional
information about the extent of disease may better guide treatment.”
O’Connor et al (2010) estimated the lifetime attributable risk of cancer and cancer mortality
from use of digital mammography, screen film mammography, PEM, and MBI. (21) Only
results for digital mammography and PEM are reported here. The study concluded that in a
group of 100,000 women at age 80 years, a single digital mammogram at age 40 years would
induce 4.7 cancers with 1.0 cancer deaths; 2.2 cancers with 0.5 cancer deaths for a mammogram
at age 50; 0.9 cancers with 0.2 cancer deaths for a mammogram at age 60; and 0.2 cancers with
0.0 cancer deaths for a mammogram at age 70. Comparable numbers for PEM would be 36
cancers and 17 cancer deaths for PEM at age 40; 30 cancers and 15 cancer deaths for PEM at
age 50; 22 cancers and 12 cancer deaths for PEM at age 60; and 9.5 cancers and 5.2 cancer
deaths for PEM at age 70. The authors also analyzed the cumulative effect of annual screening
between ages 40 and 80, as well as between ages 50 and 80. For women at age 80 who were
screened annually from ages 40 to 80, digital mammography would induce 56 cancers with 15
cancer deaths; for PEM, the analogous numbers were 800 cancers and 408 cancer deaths. For
women at age 80 who were screened annually from ages 50 to 80, digital mammography would
induce 21 cancers with 6 cancer deaths; for PEM, the analogous numbers were 442 cancers and
248 cancer deaths. However, background radiation from age 0 to 80 is estimated to induce 2174
cancers and 1011 cancer deaths. These calculations, like all estimated health effects of radiation
exposure, are based on several assumptions. Comparing digital mammography and PEM, two
conclusions are clear: Many more cancers are induced by PEM than by digital mammography;
and for both modalities, adding annual screening from 40 to 49 roughly doubles the number of
induced cancers. In a benefit/risk calculation performed for digital mammography but not for
PEM, O’Connor et al nevertheless reported that the benefit/risk ratio of annual screening is still
approximately 3 to 1 for women in their 40s, although it is much higher for women 50 and
older. Like Hendrick, (19) the authors concluded that “if molecular imaging techniques
[including PEM] are to be of value in screening for breast cancer, then the administered doses
need to be substantially reduced to better match the effective doses of mammography.” (21)
As noted in the section on Practice Guidelines and Position Statements, the American College
of Radiology assigns a relative radiation level (effective dose) of 10 to 30 mSv to PEM. (22, 23)
They also state that because of radiation dose, PEM and breast-specific gamma imaging in their
present form are not indicated for screening.
Page 24
MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
Because the use of BSGI or molecular breast imaging (MBI) has been proposed for women at
high risk of breast cancer, it should be mentioned that there is controversy and speculation over
whether some women, such as those with BRCA mutations, have heightened radiosensitivity.
(24, 25) Of course, if women with BRCA mutations are more radiosensitive than the general
population, the above estimates may underestimate the risks they face from breast imaging with
ionizing radiation (i.e., mammography, BSGI, MBI, PEM, [single-photon emission computed
tomography] SPECT/CT, breast-specific CT, and tomosynthesis; ultrasound and MRI do not
involve the use of radiation). More research will be needed to resolve this issue. Also, risks
associated with radiation exposure will be greater for women at high risk of breast cancer,
whether or not they are more radiosensitive, because they start screening at a younger age when
risks associated with radiation exposure are increased.
Summary
Three principal studies on positron emission mammography (PEM) were reviewed. The first
single-arm study (17, 18) provided preliminary data on sensitivity. Given that there is at least 1
imaging test for each potential use in breast cancer, any new or newly disseminating technology
must be compared with existing modalities. Two nonrandomized studies (4 articles) that
compare the use of PEM and magnetic resonance imaging (MRI) (6, 7, 10) or positron emission
tomography (PET) imaging (13) in presurgical planning are therefore important. However, each
has its limitations, eg, single site, lack of full blinding to results of alternate test, lack of
adjustment for multiple comparisons, choice of comparator. It is also possible that apparent
differences between PEM and MRI, eg, possibly higher sensitivity for MRI and potentially
higher specificity for PEM, are due in part to selection of different operating points on the
receiver operating characteristic (ROC) curve. Furthermore, ignoring the timing of testing in the
2012 Berg et al study (6) may have biased results against MRI.
A 2011 study by Berg et al (6) on the use of PEM in women with newly diagnosed breast
cancer reported that PEM provided additional information (improved sensitivity) for detecting
ductal carcinoma in situ (DCIS), but this finding requires replication in additional studies. This
study also included several subgroup comparisons (eg, women with no sign of multicentric or
multifocal disease); a better study design would compare PEM with MRI in women before
biopsy and follow them through to treatment, and ideally afterward, to gauge patient outcomes.
A companion article (7) reported that MRI was far more sensitive than PEM for detecting
contralateral cancer, although MRI was somewhat less specific.
However, there was no statistical difference in positive predictive value (PPV) among women
undergoing biopsy of the contralateral lesion. A substudy (13) compared PEM with whole body
positron emission tomography (PET) and with PET/computed tomography (CT) in separate
small cohorts. Although PEM was found to be more sensitive than both imaging modalities,
specificity, PPV, and negative predictive value were not statistically different. Further, clinical
Page 25
MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
relevance of the findings is uncertain because PET imaging is not currently used in the
diagnostic workup of newly diagnosed breast lesions. Finally, even if the addition of PEM to
MRI improved accuracy, this finding must be weighed against potential risks from radiation
exposure associated with PEM and lack of a full chain of evidence for some of these findings,
specifically, that improved accuracy for some uses results in better patient outcomes. Thus,
because impacts on net health outcome are uncertain, PEM is considered investigational.
Practice Guidelines and Position Statements
American College of Radiology
ACR includes PEM in 2 sets of appropriateness criteria: 1 on breast screening (22, 23, 26) and
the other on the initial diagnostic workup of breast microcalcifications. In the first, PEM is rated
2 (usually not appropriate) for use in screening women at high or intermediate risk of breast
cancer, and 1 for screening women at average risk of breast cancer. ACR also assigns a relative
radiation level (effective dose) of 10 to 30 mSv to PEM and states, “Radiation dose from BSGI
and PEM are 15-30 times higher than the dose of a digital mammogram, and they are not
indicated for screening in their present form.”(22) In the second set of appropriateness criteria,
PEM was rated 1 (usually not appropriate) for initial work-up of all 18 variants of
microcalcifications. The authors note, “The use of magnetic resonance imaging (MRI), breast
specific gamma imaging (BSGI), positron emission mammography (PEM), and ductal lavage in
evaluating clustered microcalcifications has not been established….In general, they should not
be used to avoid biopsy of mammographically suspicious calcifications.”(26)
National Comprehensive Cancer Network
Current (version 2.2013) NCCN guidelines for breast cancer screening and diagnosis do not
include PEM. (14)
American Society of Clinical Oncology
Current (2013) ASCO guidelines for follow-up and management of breast cancer after primary
treatment do not include PEM. (15)
Ongoing Clinical Trials
A search of online clinical site, ClinicalTrials.gov, using the search term, “positron emission
mammography,” yielded 4 active studies of PEM, 2 of which are comparative:

Nonrandomized trials
o PEM versus standard mammography for screening women with dense breast tissue
or at high risk of breast cancer (NCT00896649), N=260 (ongoing but not recruiting
participants)
Page 26
MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
o Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC) PET
and PEM versus MRI as a staging tool and indicator of therapeutic response in breast
cancer patients (NCT01864083), N=50

Single-arm studies
o Diagnosis of breast carcinoma: characterization of breast lesions with ClearPEMSonic: feasibility study (NCT01569321), N=20. A European collaborative group,
Crystal Clear Collaboration, is developing ClearPEM-Sonic, which uses PEM plus
ultrasound to collect metabolic, morphologic, and structural information about
tissues imaged.(27)
o Presurgery PEM for newly diagnosed breast cancer (testing reduced dose of
radiotracer; NCT01241721), N=130
V. DEFINITIONS
Top
N/A
VI. BENEFIT VARIATIONS
Top
The existence of this medical policy does not mean that this service is a covered benefit under
the member's contract. Benefit determinations should be based in all cases on the applicable
contract language. Medical policies do not constitute a description of benefits. A member’s
individual or group customer benefits govern which services are covered, which are excluded,
and which are subject to benefit limits and which require preauthorization. Members and
providers should consult the member’s benefit information or contact Capital for benefit
information.
VII. DISCLAIMER
Top
Capital’s medical policies are developed to assist in administering a member’s benefits, do not constitute medical
advice and are subject to change. Treating providers are solely responsible for medical advice and treatment of
members. Members should discuss any medical policy related to their coverage or condition with their provider
and consult their benefit information to determine if the service is covered. If there is a discrepancy between this
medical policy and a member’s benefit information, the benefit information will govern. Capital considers the
information contained in this medical policy to be proprietary and it may only be disseminated as permitted by law.
Page 27
MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
VIII. CODING INFORMATION
TOP
Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The
identification of a code in this section does not denote coverage as coverage is determined by the
terms of member benefit information. In addition, not all covered services are eligible for
separate reimbursement.
Covered when medically necessary:
CPT Codes ®
77051
77052
77055
77056
77057
Current Procedural Terminology (CPT) copyrighted by American Medical Association. All Rights Reserved.
HCPCS
Code
G0202
G0204
G0206
Description
SCREENING MAMMOGRAPHY, PRODUCING DIRECT DIGITAL IMAGE, BILATERAL, ALL
VIEWS
DIAGNOSTIC MAMMOGRAPHY, PRODUCING DIRECT DIGITAL IMAGE, BILATERAL, ALL
VIEWS
DIAGNOSTIC MAMMOGRAPHY, PRODUCING DIRECT DIGITAL IMAGE, UNILATERAL,
ALL VIEWS
ICD-9-CM
Diagnosis
Code*
Description
V10.3
PERSONAL HISTORY OF MALIGNANT NEOPLASM OF BREAST
V15.89
V16.3
V76.11
V76.12
OTHER SPECIFIED PERSONAL HISTORY PRESENTING HAZARDS TO HEALTH
FAMILY HISTORY OF MALIGNANT NEOPLASM OF BREAST
SCREENING MAMMOGRAM FOR HIGH-RISK PATIENT
OTHER SCREENING MAMMOGRAM
*If applicable, please see Medicare LCD or NCD for additional covered diagnoses.
The following code is investigational when used for breast tomosynthesis and positron
emission mammography as outlined in the policy section; therefore not covered:
CPT Codes ®
76499
Current Procedural Terminology (CPT) copyrighted by American Medical Association. All Rights Reserved.
Page 28
MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
The following ICD-10 diagnosis codes will be effective October 1, 2015
ICD-10-CM
Diagnosis Code*
Description
C50.011-C50.019
Malignant neoplasm of female breast code range
C50.211-C50.219
Malignant neoplasm of female breast code range
C50.311-C50.319
Malignant neoplasm of female breast code range
C50.411-C50.419
Malignant neoplasm of female breast code range
C50.511-C50.519
Malignant neoplasm of female breast code range
C50.611-C50.619
Malignant neoplasm of female breast code range
C50.811-C50.819
Malignant neoplasm of female breast code range
C50.911-C50.919
Malignant neoplasm of female breast code range
C50.021-C50.029
Malignant neoplasm of male breast code range
C50.121-C50.129
Malignant neoplasm of male breast code range
C50.221-C50.229
Malignant neoplasm of male breast code range
C50.321-C50.329
Malignant neoplasm of male breast code range
C50.421-C50.429
Malignant neoplasm of male breast code range
C50.521-C50.529
Malignant neoplasm of male breast code range
C50.621- C50-629
Malignant neoplasm of male breast code range
C50.821-C50.829
Malignant neoplasm of male breast code range
C50.921-C50.929
Malignant neoplasm of male breast code range
C79.81
Secondary malignant neoplasm of breast
D05.9
Carcinoma in situ of breast
N63
Lump or mass of breast
Z85.3
Personal history of breast cancer
Z80.3
Family history of breast cancer
Page 29
MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
ICD-10-CM
Diagnosis Code*
Description
Z15.01
Genetic susceptibility to malignant neoplasm of breast
*If applicable, please see Medicare LCD or NCD for additional covered diagnoses.
IX.
REFERENCES
Top
Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD)
220.4 Mammograms. Effective 05/15/78. CMS [Website]: http://www.cms.gov/medicarecoverage-database/details/ncddetails.aspx?NCDId=186&ncdver=1&CoverageSelection=Both&ArticleType=All&PolicyT
ype=Final&s=Pennsylvania&KeyWord=mammogram&KeyWordLookUp=Title&KeyWord
SearchType=And&bc=gAAAACAAAAAA&. Accessed June 18, 2014
Fletcher S. Screening for breast cancer. In: UpToDate Online Journal [serial online].
Waltham, MA: UpToDate; updated June 11, 2013. . [Website]: www.uptodate.com .
Accessed June 18, 2014.
MedlinePlus Medical Encyclopedia. Mammography. Updated March 22, 2013. [Website]:
http://www.nlm.nih.gov/medlineplus/ency/article/003380.htm Accessed June 18, 2014.
Pennsylvania State Mandate Act 148 of 1992 (Mammography Act). Effective 2/13/93.
U.S. Preventive Services Task Force. Screening for Breast Cancer. Updated December 2009.
[Website]: http://www.uspreventiveservicestaskforce.org/uspstf/uspsbrca.htm. Accessed
June 18, 2014.
Full-Field Digital Mammography
BCBSA 2002 TEC Assessment: Computer-aided Detection in Mammography.
BCBSA 2006 TEC Assessment: Full-field Digital Mammography.
Pisano ED, Gatsonis E, et al. Diagnostic Performance of Digital versus Film Mammography
for Breast-Cancer Screening. N Engl J Med 2005; 353.
Computer-Aided Detection Mammography
BCBSA 2006 TEC Assessment: Computer-Aided Detection (CAD) with Full-Field Digital
Mammography.
BCBSA 2002 TEC Assessment: Computer-Aided Detection in Mammography.
Brancato B, Houssami N, Francesca D et al. Does computer-aided detection (CAD) contribute
to the performance of digital mammography in a self-referred population? Breast Cancer
Res Treat 2007; Oct 16 (E-pub).
Page 30
MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
Dean JC, Ilvento CC. Improved cancer detection using computer-aided detection with
diagnostic and screening mammography: prospective study of 104 cancers. AJR Am J
Roentgenol 2006; 187(1): 20-8
ECRI Evidence Report. Computer-aided Detection (CAD) Mammography for Breast Cancer
Screening. December 12, 2008.
ECRI Hotline. Cost-effectiveness and Recall Rates of Single Computer-aided Detection (CAD)
Compared to a Double Reading. September 9, 2009.
FDA Radiological Devices Panel Meeting, March 2008, Briefing Package. FDA [Website]:
http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4349b101%20FDA%20Radiological%20Devices%20Panel%20Meeting%20Introd.pdf Accessed
June 19, 2014.
Fenton JJ, Taplin SH, Carney PA et al. Influence of computer-aided detection on performance
of screening mammography. N Engl J Med 2007; 356(14): 1399-409.
Gromet M. Comparison of computer-aided detection to double reading of screening
mammograms: Review of 231,221 mammograms. AJR Am J Roentgenol 2008; 190(4):8549.
Karssemeijer N, Bluekens AM, Beijerinck D et al. Breast cancer screening results 5 years after
introduction of digital mammography in a population-based screening program. Radiology
2009; 253(2): 353-8.
Morton MJ, Whaley DH, Brandt KR et al. Screening mammograms: interpretation with
computer-aided detection- - prospective evaluation. Radiology 2006; 239(2): 375-83.
Noble M, Bruening W, Uhl S et al. Computer-aided detection mammography for breast cancer
screening: systematic review and meta-analysis. Arch Gynectol Obstet 2009; 279(6):88190.
Pisano ED, Gatsonis CA, Yaffe MJ et al. American College of Radiology Imaging Network
Digital Mammographic Imaging Screening Trial: objectives and methodology. Radiology
2005; 404-12.
Pisano ED, Gatsonis C, Hendrick E et al. Diagnostic performance of digital versus film
mammography for breast cancer screening. N Engl J Med 2005; 353 (published online
September 16, 2005).
Skaane P, Kshirsagar A, Stapleton S et al. Effect of computer-aided detection on independent
double reading of paired screen-film and full-field digital screening mammograms. AJR Am
J Roentgenol 2007; 188(2): 377-84.
Taylor P, Potts HW. Computer aids and human second reading as interventions in screening
mammography: Two systematic reviews to compare effects on cancer detection and recall
rate. Eur J Cancer 2008; 44(6):798-807.
Page 31
MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
van den Biggelaar FJ, Kessels AG, van Engelshoven JM et al. Computer-aided detection in fullfield digital mammography in a clinical population: performance of radiologist and
technologists. Breast Cancer Res Treat 2009 May 6 [Epub ahead of print].
Wei J, Hadjiiski LM, Sahiner B et al. Computer-aided detection systems for breast masses:
comparison of performances on full-field digital mammograms and digitized screen-film
mammograms. Acad Radiol 2007; 14(6): 659-69.
Digital Breast Tomosynthesis
1. Tagliafico A, Astengo D, Cavagnetto F et al. One-to-one comparison between digital spot
compression view and digital breast tomosynthesis. Eur Radiol 2012; 22(3):539-44.
2. National Cancer Institute (NCI). Factsheet: Mammograms. 2012. Available online at:
http://www.cancer.gov/cancertopics/factsheet/detection/mammograms Accessed July 2,
2014.
3. Rosenberg RD, Yankaskas BC, Abraham LA et al. Performance benchmarks for screening
mammography. Radiology 2006; 241(1):55-66.
4. Brandt KR, Craig DA, Hoskins TL et al. Can digital breast tomosynthesis replace
conventional diagnostic mammography views for screening recalls without calcifications? A
comparison study in a simulated clinical setting. AJR Am J Roentgenol 2013; 200(2):291-8.
5. Shen Y, Yang Y, Inoue LY et al. Role of detection method in predicting breast cancer
survival: analysis of randomized screening trials. J Natl Cancer Inst 2005; 97(16):1195203.
6. Smith A. Fundamentals of breast tomosynthesis [WP-00007]. Bedford, MA: Hologic, Inc.;
2008:8.
7. Alakhras M, Bourne R, Rickard M et al. Digital tomosynthesis: A new future for breast
imaging? Clin Radiol 2013.
8. Gur D, Abrams GS, Chough DM et al. Digital breast tomosynthesis: observer performance
study. AJR Am J Roentgenol 2009; 193(2):586-91
9. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Use of
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POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
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combined digital mammography and breast tomosynthesis compared with digital
mammography alone: results of a multicenter, multireader trial. Radiology 2013;
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17. Good WF, Abrams GS, Catullo VJ et al. Digital breast tomosynthesis: a pilot observer
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18. Gur D, Bandos AI, Rockette HE et al. Localized detection and classification of
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25. Zuley ML, Guo B, Catullo VJ et al. Comparison of Two-dimensional Synthesized
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MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
27. Caumo F, Bernardi D, Ciatto S et al. Incremental effect from integrating 3D-mammography
(tomosynthesis) with 2D-mammography: Increased breast cancer detection evident for
screening centres in a population-based trial. Breast 2014; 23(1):76-80.
28. Houssami N, Macaskill P, Bernardi D et al. Breast screening using 2D-mammography or
integrating digital breast tomosynthesis (3D-mammography) for single-reading or doublereading - Evidence to guide future screening strategies. Eur J Cancer 2014; 50(10):1799807.
29. Lei J, Yang P, Zhang L et al. Diagnostic accuracy of digital breast tomosynthesis versus
digital mammography for benign and malignant lesions in breasts: a meta-analysis. Eur
Radiol 2014; 24(3):595-602.
30. Lei J, Yang P, Zhang L et al. Reply to Letter to the Editor re: Diagnostic accuracy of digital
breast tomosynthesis versus digital mammography for benign and malignant lesions in
breasts: a meta-analysis. Eur Radiol 2014; 24(4):928-9.
31. Bernardi D, Ciatto S, Pellegrini M et al. Prospective study of breast tomosynthesis as a
triage to assessment in screening. Breast Cancer Res Treat 2012; 133(1):267-71.
32. Michell MJ, Iqbal A, Wasan RK et al. A comparison of the accuracy of film-screen
mammography, full-field digital mammography, and digital breast tomosynthesis. Clin
Radiol 2012.
33. Zuley ML, Bandos AI, Ganott MA et al. Digital breast tomosynthesis versus supplemental
diagnostic mammographic views for evaluation of noncalcified breast lesions. Radiology
2013; 266(1):89-95.
34. Skaane P, Gullien R, Bjorndal H et al. Digital breast tomosynthesis (DBT): initial
experience in a clinical setting. Acta Radiol 2012; 53(5):524-9. 35.
35. Rafferty EA, Park JM, Philpotts LE et al. Diagnostic accuracy and recall rates for digital
mammography and digital mammography combined with one-view and two-view
tomosynthesis: results of an enriched reader study. AJR Am J Roentgenol 2014; 202(2):27381.
36. Thibault F, Dromain C, Breucq C et al. Digital breast tomosynthesis versus mammography
and breast ultrasound: a multireader performance study. Eur Radiol 2013; 23(9):2441-9.
37. Gennaro G, Hendrick RE, Toledano A et al. Combination of one-view digital breast
tomosynthesis with one-view digital mammography versus standard two-view digital
mammography: per lesion analysis. Eur Radiol 2013; 23(8):2087-94.
38. American College of Radiology. ACR Appropriateness Criteria®: breast cancer screening;
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http://www.acr.org/Quality-Safety/Appropriateness-Criteria. Accessed July 2, 2014.
40. American College of Radiology (ACR). ACR, SBI Statement on Skaane et al. -Tomosynthesis Breast Cancer Screening Study. News Releases 2013. Available online at:
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MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
http://www.acr.org/About-Us/Media-Center/Press-Releases/2013-PressReleases/20130110ACR-SBI-Statement-on-Skaane-et-al. Last accessed June 2014.
41. American College of Obstetricians and Gynecologists (ACOG). Breast cancer screening.
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Aug. 11 p. (ACOG practice bulletin; no. 122).
42. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in
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progress). Available online at: http://www.nccn.org/professionals/physician_gls/pdf/breastscreening.pdf. Accessed July 2, 2014.
43. U.S. Preventive Services Task Force. Screening for breast cancer: recommendation
statement, updated December 2009. Available online at:
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July 2, 2014.
44. U.S. Preventive Services Task Force. Screening for breast cancer (2002). Available online
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2, 2014.
45. U.S. Preventive Services Task Force. Screening for Breast Cancer. Available online at:
http://www.uspreventiveservicestaskforce.org/breastcancer.htm. Accessed July 2, 2014.
Positron Emission Mammography (PEM)
1. Birdwell RL, Mountford CE, Iglehart JD. Molecular imaging of the breast. AJR Am J
Roentgenol 2009; 193(2):367-76.
2. Eo JS, Chun IK, Paeng JC et al. Imaging sensitivity of dedicated positron emission
mammography in relation to tumor size. Breast 2012; 21(1):66-71.
3. Tafreshi NK, Kumar V, Morse DL et al. Molecular and functional imaging of breast cancer.
Cancer Control 2010; 17(3):143-55.
4. Prekeges J. Breast imaging devices for nuclear medicine. J Nucl Med Technol 2012;
40(2):71-8.
5. Shkumat NA, Springer A, Walker CM et al. Investigating the limit of detectability of a
positron emission mammography device: a phantom study. Med Phys 2011; 38(9):5176-85.
6. Berg WA, Madsen KS, Schilling K et al. Breast cancer: Comparative effectiveness of positron
emission mammography and MR imaging in presurgical planning for the ipsilateral breast.
Radiology 2011; 258(1):59-72.
7. Berg WA, Madsen KS, Schilling K et al. Comparative effectiveness of positron emission
mammography and MRI in the contralateral bread of women with newly diagnosed breast
cancer. AJR Am J Roentgenol 2012; 198(1):219-32.
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http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K032063.
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Page 35
MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
9. Fikes BJ. Naviscan's assets sold to Mexican company. The San Diego Union-Tribune,
12/11/2013. Available online at: http://www.utsandiego.com/news/2013/Dec/11/naviscansold-mexican-cmr-positron/. Last accessed May 2014.
10. Schilling K, Narayanan D, Kalinyak JE et al. Positron emission mammography in breast
cancer presurgical planning: comparisons with magnetic resonance imaging. Eur J Nucl
Med Mol Imaging 2011; 38(1):23-36.
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mammography and MRI by experienced breast imaging radiologists: performance and
observer reproducibility. AJR Am J Roentgenol 2011; 196(4):971-81.
12. Narayanan D, Madsen KS, Kalinyak JE et al. Interpretation of positron emission
mammography: feature analysis and rates of malignancy. AJR Am J Roentgenol 2011;
196(4):956-70.
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breast PET compared to whole-body PET or PET/CT. Eur J Nucl Med Mol Imaging 2014;
41(2):260-75.
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breast cancer screening and diagnosis, version 2.2013. Available online at:
http://www.nccn.org/professionals/physician_gls/f_guidelines.asp#detection. Accessed June
18, 2014.
15. Khatcheressian JL, Hurley P, Bantug E et al. Breast cancer follow-up and management
after primary treatment: American Society of Clinical Oncology clinical practice guideline
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16. Caldarella C, Treglia G, Giordano A. Diagnostic Performance of Dedicated Positron
Emission Mammography Using Fluorine-18-Fluorodeoxyglucose in Women With Suspicious
Breast Lesions: A Meta-analysis. Clin Breast Cancer 2013.
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190(4):628-32.
18. Berg WA, Weinberg IN, Narayanan D et al. High-resolution fluorodeoxyglucose position
emission tomography with compression (“position emission mammography”) is highly
accurate in depicting primary breast cancer. Breast J 2006; 12(4):309-23.
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2010; 257(1):246-53.
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ionizing radiation: BEIR VII, Phase 2--Committee to Assess Health Risks for Exposure to
Low Levels of Ionizing Radiation. Washington, DC: National Academies Press;2006.
21. O’Connor MK, Li H, Rhodes DJ et al. Comparison of radiation exposure and associated
radiation-induced cancer risks from mammography and molecular imaging of the breast.
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Page 36
MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
22. American College of Radiology (ACR). ACR Appropriateness Criteria® breast cancer
screening. 2012. Available online at:
http://www.acr.org/~/media/ACR/Documents/AppCriteria/Diagnostic/BreastCancerScreenin
g.pdf. Accessed June 18, 2014.
23. Mainiero MB, Lourenco A, Mahoney MC et al. ACR Appropriateness Criteria Breast
Cancer Screening. J Am Coll Radiol 2013; 10(1):11-4.
24. Berrington dGA, Berg CD, Visvanathan K et al. Estimated risk of radiation-induced breast
cancer from mammographic screening for young BRCA mutation carriers. J Natl Cancer
Inst 2009; 101(3):205-9.
25. Ernestos B, Nikolaos P, Koulis G et al. Increased chromosomal radiosensitivity in women
carrying BRCA1/BRCA2 mutations assessed with the G2 assay. Int J Radiat Oncol Biol Phys
2010; 78(4):1199-205.
26. American College of Radiology (ACR). ACR Appropriateness Criteria® breast
microcalcifications — initial diagnostic workup. 2009. Available online at:
http://www.acr.org/~/media/ACR/Documents/AppCriteria/Diagnostic/BreastMicrocalcificati
ons.pdf. Accessed June 18, 2014.
27. Crystal Clear Collaboration. Clear PEM sonic, 2011. Available online at:
http://crystalclear.web.cern.ch/crystalclear/pemsonic.html. Accessed June 18, 2014.
X. POLICY HISTORY
MP 5.008
Top
CAC 6/29/04
CAC 5/31/05
CAC 1/31/06 Combined Full Field Digital Mammography with this policy
CAC 2/27/07
CAC 5/27/08
CAC 5/26/09 Consensus
CAC 5/25/2010 Consensus
CAC 7/26/11 Minor Revision. Information on Digital Breast Tomosynthesis and
Positron Emission Mammography (PEM) added to the policy; both considered
investigational. An FEP variation was added. The statements regarding screening
mammograms for women over 40 and the statement regarding studies for women
under 40 were removed. A link to CBC preventative guidelines was added in their
place.
CAC 9/24/13 Consensus review. References updated but no changes to the
policy statements. Background for Digital Breast Tomosynthesis and
Positron Emission Mammography (PEM) updated. FEP variation revised.
Page 37
MEDICAL POLICY
POLICY TITLE
MAMMOGRAPHY ( INCLUDING COMPUTER AIDED DETECTION
MAMMOGRAPHY, DIGITAL BREAST TOMOSYNTHESIS, AND
POSITRON EMISSION MAMMOGRAPHY)
POLICY NUMBER
MP-5.008
CAC 7/22/14 Consensus. No change to policy statements. References
updated. Rationale section added.
12/1/14 Removed the Medicare variation referencing NCD 220.4. Coding
reviewed.
TOP
Health care benefit programs issued or administered by Capital BlueCross and/or its subsidiaries, Capital Advantage
Insurance Company®, Capital Advantage Assurance Company® and Keystone Health Plan® Central. Independent
licensees of the BlueCross BlueShield Association. Communications issued by Capital BlueCross in its capacity as
administrator of programs and provider relations for all companies.
Page 38

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