Final Regulatory Impact Analysis

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Mammography Quality Standards Act; Amendments
to Part 900 Regulations
Docket No. FDA-2013-N-0134

Final Regulatory Impact Analysis
Final Regulatory Flexibility Analysis
Unfunded Mandates Reform Act Analysis

Economics Staff
Office of Economics and Analysis
Office of Policy, Legislation, and International Affairs
Office of the Commissioner

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I. Introduction and Summary
A. Introduction
B. Summary of Benefits and Costs
C. Comments on the Preliminary Economic Analysis of Impacts and Our Responses
D. Summary of Changes
II. Final Regulatory Impact Analysis
A. Background
B. Market Failure Requiring Federal Regulatory Action
C. Purpose of the Final Rule
D. Baseline Conditions
E. Benefits of the Final Rule
1.

Accuracy of Mammography

2.

Breast Density Notification Requirements
a. Affected Population and Health Gains
b. Reduced Cancer Mortality
c. Reduced Cancer Morbidity
d. Reduced Cancer Treatment Costs

3. Summary of Total Benefits
F. Costs of the Final Rule
1. Mammography Facilities Costs
a. Affected Entities
b. Approach to Estimating Costs
c. Facility Costs
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2. Costs Associated with Supplemental Testing and Biopsies
3. Summary of Total Costs
G. Distributional Effects
H. International Effects
I. Uncertainty and Sensitivity Analysis
J. Analysis of Regulatory Alternatives to the Final Rule
III. Initial Small Entity Analysis
A. Description and Number of Affected Small Entities
B. Description of the Potential Impacts of the Final Rule on Small Entities
C. Aternatives to Minimize the Burden on Small Entities
IV. References

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I. Introduction and Summary
A. Introduction
FDA has examined the impacts of the final rule under Executive Order 12866, Executive
Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates
Reform Act of 1995 (Public Law 104-4). Executive Orders 12866 and 13563 direct us to assess
all costs and benefits of available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including potential economic,
environmental, public health and safety, and other advantages; distributive impacts; and equity).
The Office of Information and Regulatory Affairs has determined that this final rule is a
significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would
minimize any significant impact of a rule on small entities. Because many facilities that will be
affected by this rule are defined as small businesses, we find that the final rule will have a
significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a
written statement, which includes an assessment of anticipated costs and benefits, before
proposing “any rule that includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or
more (adjusted annually for inflation) in any one year.” The current threshold after adjustment
for inflation is $165 million, using the most current (2021) Implicit Price Deflator for the Gross
Domestic Product. This final rule would not result in an expenditure in any year that meets or
exceeds this amount.
B. Summary of Benefits and Costs
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The final rule will modernize mammography regulations by incorporating current science
and mammography best practices to improve the delivery of mammography services. These
updates include requirements on recordkeeping, reporting, and communication of results. This
final rule also addresses procedural requirements in several areas related to quality control and
management of mammography facilities.
The benefits and costs associated with this final rule are summarized in Table 1. The
quantified benefits are derived from reduced mortality and breast cancer treatment costs resulting
from the breast density reporting requirements. We use two methods of measuring the value of
reduced mortality: the value per statistical life (VSL) approach and an approach based on the
value of lost life years (LY). Under the VSL approach, the estimate of annualized benefits over
10 years ranges from $42.00 million to $232.69 million at a 7 percent discount rate. Using a 3
percent discount rate, the annualized benefits range from $48.42 million to $266.09 million.
Under the LY approach, the estimate of annualized benefits over 10 years ranges from $12.99
million to $66.90 million at a 7 percent discount rate. Using a 3 percent discount rate, the
annualized benefits range from $8.50 million to $37.96 million. Because there is uncertainty in
the literature about the most appropriate method for analyzing reduced mortality for the
population affected by this final rule, we do not present a primary value and use estimates from
both methods to create the range of values in Table 1. The high estimate in Table 1 is based on
the VSL approach, which yields the higher-bound estimate of the two methods. The low
estimate is based on the LY approach, which yields the lower-bound estimate of the two
methods. Other benefits that we are not able to quantify include reduced cancer morbidity and
improvements in the accuracy of mammography by improving quality control and strengthening
the medical audit.

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The costs of the final rule include costs to mammography facilities to comply with the
requirements of the regulation and costs associated with supplemental testing and biopsies
resulting from the breast density requirements. The estimate of annualized costs over 10 years
range from $28.87 million to $45.42 million at a 7 percent discount rate with a primary value of
$36.31 million. Using a 3 percent discount rate, the annualized costs range from $27.61 million
to $44.16 million with a primary value of $35.05 million.

Table 1. Summary of Benefits and Costs in millions 2020 Dollars Over a 10 Year Time Horizon
Category

Benefits

Costs

Primary
Estimate

Annualized
Monetized
$/year
Annualized
Quantified
Qualitative

Annualized
Monetized
$/year
Annualized
Quantified

Low
Estimate

High
Estimate

$12.99

$232.69

Units
Year
Dollars
2020

$8.50

$266.09

2020

Discou
nt Rate
7%
3%

Period
Covered
10 years
10 years

Note
s

7%
3%

Improvements in the accuracy of
mammography and better
management of mammography
facilities.
$36.31

$28.87

$45.42

2020

$35.05

$27.61

$44.16

2020

7%
3%

10 years
10 years

7%
3%

Qualitative
Transfer
s

Effects

Federal
7%
Annualized
3%
Monetized
$/year
From/ To
From:
To:
Other
7%
Annualized
3%
Monetized
$/year
From/To
From:
To:
State, Local or Tribal Government:
Small Business: Annual cost per affected small entity estimated as $416-$727, which would
represent a maximum of 1.2 percent of annual receipts

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Wages:
Growth:

C. Comments on the Preliminary Economic Analysis of Impacts and Our Responses
On March 28, 2019, FDA published a proposed rule to amend the mammography
regulations that were issued under the Mammography Quality Standards Act of 1992 (MQSA)
and the Federal Food, Drug, and Cosmetic Act (FD&C Act) (84 Federal Register 11669). We
prepared a preliminary regulatory impact analysis (PRIA) for the proposed rule. In the
paragraphs below, we describe and respond to the comments received on the PRIA. The number
assigned to each comment is purely for organizational purposes and does not signify the
comment’s value, importance, or the order in which it was received.
(Comment 1) Several comments mention there is a lack of benefit of density notification and that
linking high breast density to additional imaging testing is not supported by evidence. These
comments also mention that overdiagnosis and overtreatment should be addressed.
(Response 1) Recent research has shown that 7% to 11% of patients who are informed that they
have dense breasts undergo supplemental ultrasound screening (Weigert and Steenbergen, 2012;
Hooley et al., 2012; Saulsberry et al., 2019). Research studies have also shown that adjunct
ultrasound screening in high-risk women with dense breasts results on average in the detection
between 2.75 to 3.90 additional cancers per 1,000 women (Berg et al., 2008; Scheel et al. 2015;
Houssami and Lee, 2018; Keating and Pace, 2019; Butler and Hooley, 2020). Because survival
rates are higher for cancers detected at an earlier stage, early cancer detection due to
supplemental screening such as ultrasound for women with dense breasts may result in a
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reduction in cancer fatalities. We use this existing evidence to support our analysis related to
quantified benefits of breast density reporting requirements. Additionally, the density
notification requirement does not specify additional clinical management. We believe that a
discussion of overtreatment and overdiagnosis of cancer is outside the scope of this analysis.
(Comment 2) A comment suggests that the analysis be revised to include distributional and
equity effects.
(Response 2) FDA recognizes that distributional and equity considerations may exist as they
relate to mammography practice and density notification. We have revised the distribution
section of the FRIA to include a qualitative discussion of sociodemographic differences in
mammography practice and outcomes.

D. Summary of Changes
We have made edits to the analysis based on changes applied to the final rulemaking and
the comments received outlined above.

We extended the distributional effects section to

discuss disparities across subpopulations and made minor updates for inflation. We have also
updated several estimates with recent literature as well as industry and population data.

II. Final Regulatory Impact Analysis
A. Background
Mammography is an X-ray imaging examination used to identify signs of breast cancer.
For patients to receive the full benefit of mammography, the service must be of high quality,
including performance of the examination by qualified technologists; using equipment which is
tested and properly functioning; interpretation by qualified physicians; and clear and prompt
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communication of results to patients and their referring health care providers. The FDA is
amending the mammography regulations that were issued under the MQSA and the FD&C Act.
The MQSA establishes uniform baseline Federal standards designed to ensure that all patients
nationwide have access to quality mammography services, and its implementing regulations
address standards for accreditation bodies and certifying agencies, qualifications of personnel at
mammography facilities, standards for mammography equipment, quality assurance testing,
recordkeeping, and communication of results. This final rule would update the regulations by
incorporating current science and mammography best practices.
FDA is making a number of changes to the mammography report in the MQSA
regulations that are intended to facilitate communication between mammography facilities,
healthcare providers and patients; facilitate the retrieval of mammography images; and help
ensure that health care providers and patients are obtaining the necessary information from the
mammography facility to enable a woman and her health care provider to make informed
medical decisions, including breast density notification requirements.
Current federal regulations do not require that a notification of breast density be part of
the report provided to the health care provider or of the lay summary be provided to the patient.
However, there is increasing interest in breast density reporting. Thirty-eight States have passed
laws mandating notification of breast density, although the laws impose requirements that vary
from State to State. To ensure all patients receive breast density information from their
mammograms, and that such required information is consistent, FDA is proposing to amend the
mammography reporting requirements to require that the written report of the results of the
mammographic examination which is provided to the health care provider and the lay summary

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of the results that is provided to the patient also include information concerning patient breast
density.

B. Market Failure Requiring Federal Regulatory Action
Information asymmetry implies that information may not be equal on both sides of a
market. The market failure that this final rule seeks to address is the information asymmetry that
exists when patients may not be fully informed of breast density information. The MQSA and
current regulations require a mammography facility to provide a written report on each
mammographic examination to the patient’s health care provider. The mammography facility is
also required to provide a summary of the report in lay language to the patient. However, current
regulations do not require that a notification of breast density be part of the report provided to the
health care provider or the lay summary provided to the patient.
Breast density refers to the proportion of fibroglandular tissue in the breast, as seen on a
mammogram. Mammograms of breasts with higher density are harder to interpret than those of
less dense breasts, because the dense tissue can obscure cancers (American College of
Radiology, 2017). Dense breast tissue is one of the factors that increases the chances that a
woman will develop breast cancer, and accordingly is listed as a risk factor for breast cancer.
(Boyd, et. al., 2007; Centers for Disease Control and Prevention, 2017). As a result, some
patients with dense breasts, in consultation with their healthcare providers, will likely choose to
undergo additional screening. Additional screening of patients with dense breasts can detect
some additional cancers and reduce delays in treatment (Kolb, et al., 2002; Leconte, et al., 2003;
Berg, et al., 2008).
There is increasing public awareness of the benefits of breast density reporting. Between
2009 and December 2021, 38 States plus the District of Columbia have passed laws mandating
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notification of breast density. The legislative action taken at the State level further provides
evidence of a market failure at the federal level, because States have begun to act on their own in
place of federal changes under the MQSA. This has also led to an increase in the salience of
density reporting.
Although several States have passed laws requiring density reporting, federal regulation
is still necessary. There remain 12 States without any density notification requirements.
Furthermore, State laws impose requirements that vary from State to State, such that all patients
in covered States do not receive the same type of information. State reporting requirements
range from information about breast density in general to specific information on a patient’s
breast density level and risk factors. This final rule would enact a standard requirement that
would ensure that all patients and providers receive complete and consistent breast density
information in mammography reports.
Market failure arising from inadequate information can provide an economic rationale for
the government to intervene to ensure that breast density information is provided to all patients.
The variation in State notification requirements makes it unlikely that consistent and detailed
density notification requirements for all patients would arise through market forces. Proposing
nationwide requirements that patients and their providers receive comprehensive information
about breast density after a mammogram addresses the market failure of inadequate information
about breast density and its implications.
C. Purpose of the Final Rule
MQSA was enacted to ensure that all patients have access to quality mammography for
the detection of breast cancer in its early, most treatable stages. Its provisions encompass facility
accreditation, facility certification, and mammography quality standards. FDA’s regulations
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implementing MQSA have not been amended since their inception, and the amendments in this
final rule are designed to, among other things, address subsequent changes in mammography
technology as well as recommendations made in the Institute of Medicine’s (IOM) 2005 report
(IOM, 2005).
Based on technology changes in mammography and our experience with the
administration of the MQSA program, FDA is amending the mammography regulations to better
address the protection of public health. These updates will modernize the regulations by
addressing mammography technologies that were not in use at the time the current regulations
were published; help to ensure the availability of appropriate records for comparison purposes to
enhance the benefit of mammography; require facilities to provide more information, including
breast density information, to patients and their health care providers to allow for more informed
health care decision making; further standardize the communication of mammography results to
patients and providers.

D. Baseline Conditions
The baseline for this analysis is determined by the current standard practice of
mammography facilities and State-level density regulations as they relate to the provisions in the
final rule. We consulted FDA’s Division of Mammography Quality Standards (DMQS) and the
Eastern Research Group (ERG) in determining the degree to which current standard practices
align with provisions of the final rule. New requirements relating to statistics reporting are
included in the final rule, as well as provisions that will require that facilities make plans for
retention and transfer of personnel records, mammograms, and patient reports in the event of
facility closure. Additional assessment categories in mammography reports will also allow for

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more precise categorization of mammography results and reflect the current practice of
mammography. These changes will have incremental effects on mammography facilities as well
as to patients.
Additionally, current MQSA regulations do not require breast density reporting in the
mammography report or lay summary. Although the mammography report often includes this
information, the frequency of inclusion is unknown. As of December 2021, 38 States including
the District of Columbia have passed legislation requiring information about breast density to be
communicated to patients 1. We assume that in the baseline the States currently without density
reporting requirements would remain the same in the absence of this final rule 2.

E. Benefits of the Final Rule
We consider the potential impact of the final rule on the accuracy of mammography as
well as the impact of potential behavioral changes induced by the breast density notification
requirements 3.
1. Accuracy of Mammography
The final rule will modify procedural requirements in several areas 4. Such improvements
in procedures might result in better quality control and management of mammography facilities.

http://densebreast-info.org/legislation.aspx.
We note that there is a tendency toward underestimation due to an assumption that all States covered by density
notification laws communicate density levels to patients. In section B we note that there is variation among States in
the level of density information reported to patients. If more States add density reporting requirements or if density
reporting were to become widespread on a voluntary basis, then we would overstate the impact of this final rule. It
is also possible that women living in States without reporting requirements undergo mammography at facilities in
States with the requirement, and vice versa, which also adds to the uncertainty of baseline density reporting. Breast
density reporting may also be influenced by the recommendations of professional medical organizations.
3
Our discussion of benefits is partially adapted from Section 5 of ERG’s Final Report (2012a) and ERG’s breast
density addendum (2012b).
4
We do not anticipate that this would lead to facility closures or reduction in services.
1
2

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There are, however, no data with which to develop a quantitative estimate of the impact of such
changes on public health.
This final rule could potentially improve the accuracy of mammography by improving
quality control, strengthening the medical audit and ensuring that records are properly
maintained for comparison purposes. Mammography accuracy can be evaluated by sensitivity,
specificity, positive predictive value, and negative predictive value which are in turn defined by
true positives, false positives, true negatives, and false negatives (ERG, 2012b). FDA is
clarifying the minimum required components of the medical outcomes audit, including the
calculation of three clinically significant metrics known as positive predictive value, cancer
detection rate, and recall rate. Calculating and tracking the three audit metrics specified in the
final rule will allow facilities and interpreting physicians to review their performance, evaluate
their accuracy in detecting breast cancer, and enact quality improvement measures as necessary.
Proper records management is also important in maintaining quality in mammography services.
This final rule will ensure that patient and personnel records are made available to patients and
personnel, respectively, after the facility’s closure. The ability to compare previous
mammography examinations is often necessary to make an accurate final assessment. Delays in
the transfer of patient records can also lead to delays in diagnosis or treatment. Additionally,
when personnel cannot obtain copies of their MQSA records to document their MQSA
qualifications, they may not be able to work at additional or new facilities, which can lead to
reduced public access to mammography services.
Improvements in the accuracy of mammography results could lead to a reduction in the
number of false positives and false negatives. Table 2 shows the general relationship between
true and false positives, true and false negatives, sensitivity, and specificity. Results from

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estimating annual values for screening mammography in the U.S. are shown in Table 3 and
described in the following paragraph. Because data on sensitivity are difficult to obtain and
estimates vary, calculations are presented using both a high and low estimate of sensitivity.
Data from the Surveillance, Epidemiology, and End Results (SEER) Program (2021)
yield estimates that there were 281,550 new female breast cancer cases diagnosed in 2021.
Assuming that these diagnoses are accurate, this suggests up to 281,550 true positives each year.
Approximately 10 percent of screening mammograms produce false-positive results (Brewer, et
al., 2007; Nelson et al., 2016). As of July 1, 2022, there were approximately 39,329,133 total
annual mammography procedures reported to FDA by MQSA accrediting bodies, based on
facility-provided information (FDA, 2022). Agency data collected from the accreditation bodies,
provided to them by facilities, indicate that approximately 76 percent 5 of the total procedures
reported were screening mammograms, yielding a total of 29,890,141 exams. This suggests that
there are approximately 2,989,014 (0.10 x 29,890,141) false positives a year in the initial
screening.
The number of false negatives can be deduced from the sensitivity estimates as specified
in Table 2. Using a higher sensitivity estimate of 79 percent as provided in Rosenberg et al.,
(2006) would mean that the number of true positive screening mammograms divided by the total
number of cases of cancer (total number of condition positives) each year is equal to 79 percent.
Thus, the total number of condition positives is 356,392 (281,550 / 0.79). Subtracting the number
of true positives (281,550) from the total condition positive cases (356,392) indicates that there
are 74,842 false negative screening mammograms a year. Using the lowest estimate of
sensitivity of 66 percent (Pisano et al., 2005) and performing the same calculations indicates that
5

This percentage is only an estimate due to the possibility of over or under reporting by facilities.

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there are 426,591 condition positives (281,550/ 0.66) and 145,041 false negative screening
mammograms (426,591 – 281,550). Finally, subtracting the sum of true positive (281,550), false
positive (2,989,014), and false negative (74,842 to 145,041) screening mammograms from the
total number of screening mammograms (29,890,141) suggests between 26,474,536 and
26,544,735 true negative screening mammograms per year.

Table 2. Sensitivity and Specificity Definitions

Test Outcome

Positive
Negative
Sum

Positive
True Positive
False Negative
Total Positive Cases

Sensitivity

Sensitivity =

Specificity

True Condition

∑ 𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇 𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃
∑ 𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶 𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃

Negative
False Positive
True Negative
Total Negative Cases
Specificity =

Source: ERG (2012a)

∑ 𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇 𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁
∑ 𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶 𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁

Table 3. Screening Mammography Sensitivity and Specificity
79 Percent Sensitivity Estimate

Positive
Negative
Sum
Sensitivity
Specificity
66 Percent Sensitivity Estimate
Test Outcome

Test Outcome

Positive
Negative
Sum
Sensitivity
Specificity

True Condition
Positive
Negative
281,550
2,989,014
74,842
26,544,735
356,392
29,533,749
79.0%
88.9%
True Condition
Positive
Negative
281,550
2,989.014
145,041
26,474,536
426,591
29,463,550
66.0%
88.9%

Sum
3,270,564
26,619,577
29,890,141

Sum
3,270,564
26,619,577
29,890,141

Table 3 shows that screening mammography yields nearly 3 million false positives each
year. False positives often lead to additional screening or biopsies. The cost of a breast
16

ultrasound with image documentation is estimated to be $144.14 and the total cost of a needle
core breast biopsy and pathology is estimated to be $271.90 (Vlahiotis et al., 2018 6). Reducing
false positives has the potential to reduce the costs associated with unnecessary interventions as
well as short-term anxiety on the part of affected patients. 7
Reducing false negatives would improve public health by helping to ensure that cancer is
detected and treated as early as possible. In the context of screening mammography, a false
negative result means that routine mammography fails to detect cancer in an asymptomatic
woman when it is present, thus delaying treatment. Reducing false negatives would also mean
increasing mammography’s sensitivity (i.e., increasing the proportion of screened patients with
breast cancer who have abnormal mammographic results).
Patients with false negative screening mammograms would typically face delays in
diagnosis and treatment until they either experience symptoms of breast cancer or have another
mammogram a year or more later. Because five-year survival rates decrease with more
advanced stages at diagnosis and with tumor size (Sarveazad et al., 2018; American Cancer
Society, 2019) and cancer undetected by screening mammography might progress in stage or
increase in size before it is detected, a delay in detection due to false negative screening
mammograms could lead to increased morbidity and mortality.
Table 3 shows that screening mammography produces an estimated 74,842 to 145,041
false negatives each year. It is estimated that 25 percent of cancers in false negative
mammograms are detectable (Yankaskas et al., 2001; Houssami and Hunter, 2017). This means
that between 18,461 (25 percent of 74,842) and 35,777 (25 percent of 145,041) cancers that
could be detected on screening mammograms annually are not. We are unable to estimate to
6
7

Estimates were updated to 2020 dollars.
For further discussion of the short-term anxiety caused by false positive mammograms, see Totson, et al. (2014).

17

what extent this final rule will affect the number of false negatives, but given the large health
consequences of early cancer detection, any reduction could yield substantial public health
benefits. We also note, however, that cancers undetected by screening mammography might be
inherently different from cancers that are detected. Therefore, using data for patients with true
positive screening mammograms may not lead to an accurate estimate of the potential reduction
in morbidity and mortality for patients with false negative screening mammograms.
Eliminating false negatives is a challenge with any screening test. The fact that many are
due to characteristics of the patient or tumor means that the scope for regulation to reduce
morbidity and mortality is limited. False negatives due to human error may be difficult to
eliminate. Insofar as the MQSA regulations improve quality through provisions set forth in this
final rule, they could reduce at least some portion of these preventable false negatives and thus
reduce morbidity and mortality.
Other individual provisions also serve to amplify beneficial elements of the final
mammography regulation, although the impact of these changes could not be quantified.
Specifically, the final regulation requires facilities to retain mammograms for up to ten years and
transfer them upon patient request; under the final rule, such requirements will apply even if a
facility closes. Cady & Michaelson (2001) suggest that the availability of an earlier
mammogram for comparative review can reduce false positives by half. Thus, while we lack any
means to predict how often past mammograms would be lost upon facility closure without this
provision, it appears likely that some patients will benefit from the record retention that
otherwise might not occur. Facility closures in the past have sometimes led to problems in
preserving the exam records. Thus it is possible that in some instances, due to these provisions,
interpreting physicians will be better able to interpret exams.

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2. Breast Density Notification Requirements
The final regulation includes provisions that will require the inclusion of breast density
information in the mammography report and lay summary, and additional text about the effects
of breast density on mammography’s sensitivity in the lay summary. The updated notification
language in the final rule does not recommend supplemental imaging evaluation for patients with
dense breasts, but rather provides a baseline of information for discussion between a patient and
their healthcare provider. However, these provisions will likely result in supplemental screening
for some high-risk women with dense breasts. We discuss the size of the affected population and
estimate the benefits of additional ultrasound screening that may be induced by the final rule.
The benefits that are expected to result from this provision would be potential reductions in
cancer treatment costs due to early cancer detection in high-risk women who decide to undergo
supplemental screening after being fully informed of breast density information, as well as
reductions in breast cancer mortality and morbidity. This final rule would enact a standard
requirement that would ensure that all patients and providers receive complete and consistent
breast density information in mammography reports.
Affected Population and Health Gains

As discussed above, there are 29,890,141 screening mammograms performed each year.
Approximately 87 percent, or 26,004,423 (29,890,141 x 0.87), of screening mammograms show
normal results (ERG, 2012b). Assuming 41 to 47 percent of screening mammograms show
dense breasts (Poplack et al., 2005; Tice et al., 2008; Sprague et al., 2014; Kerlikowske et al.,
2015), we estimate that between 10,661,813 and 12,222,079 normal mammograms show dense
breasts each year. As of December 2021, 38 States have passed legislation requiring information
about breast density to be communicated to patients. Based on U.S. Census population
projections, these States cover approximately 92.4 percent of the U.S. population, while 7.6
19

percent of women reside in States that do not require breast density information to be
communicated to patients. 8 Assuming that mammograms are distributed among States
proportionally according to population, approximately 814,420 (10,661,813 x 0.076) to 933,603
(12,222,079 x 0.076) normal mammograms would show dense breasts annually in States not
already requiring density information to be communicated to patients. This represents the
population affected by the density notification requirements. The density reporting will likely
lead to additional testing. 9 Some providers may recommend additional action for women with
abnormal results regardless of the breast density results. Our analysis does not include additional
testing that is recommended based on factors other than breast density information. If some lay
summaries now include density information where they are not required by law, the number of
new lay summary notifications would be lower than we assume here.
We do not have information on the proportion of women who already receive
comprehensive information about breast density from their physician, but for women who do
not, the notification to be included in the lay summary would enable them to better understand
the meaning of their mammographic result. Regardless of what information women receive from
their physician, this notification would provide them with an indication that will likely cause
increased numbers to follow through with any additional screening. However, not every patient
with dense breasts would be advised to undergo supplemental screening, and not every patient
advised to do so would do so. Several studies have been conducted on the utilization of
ultrasounds for women with dense breasts. It is estimated that between 7 percent and 11 percent
of patients who were advised to undergo supplemental screening ultrasound did undergo that

8

https://data.census.gov/cedsci/table?q=EC1700&n=621512%3A622%3AN0300.62%3AN0600.62

We note that the provision could also result in an increase in additional testing in states with existing density
notification legislation, which may understate our estimates of the affected population.

9

20

exam (Weigert and Steenbergen, 2012; Holley et al., 2012; Saulsberry et al., 2019). 10 By
multiplying the number of women with dense breasts in states without breast density laws by the
percentage of women who undergo additional ultrasound screening, we estimate that between
58,883 (814,420 x 0.07) and 103,163 (933,603 x 0.11) women would undergo supplemental
ultrasound screening annually.
Adjunct ultrasound screening in high-risk women with dense breasts results on average in
the detection between 2.75 to 3.90 additional cancers per 1,000 women (Berg et al., 2008; Scheel
et al. 2015; Houssami and Lee, 2018; Keating and Pace, 2019; Butler and Hooley, 2020).
Applying this rate to the number of women undergoing supplemental ultrasound screening
results in 162 ((58,883/1,000) x 2.75) to 402 ((103,163/1,000) x 3.90) additional cancers detected
annually as a result of the breast density notification provision, with a primary value of 266
((79,885/1,000) x 3.33).
Some of the public health benefit from this final rule would come from a reduction in
breast cancer related fatalities. Because survival rates are higher for cancers detected at an
earlier stage, early cancer detection due to supplemental screening for women with dense breasts
may result in a reduction in cancer fatalities. To estimate the annual number of breast cancer
related fatalities that could be averted, we use estimates reported in an analysis by Sprague et.al
(2015). In this analysis, the authors assess the effects of supplemental screening ultrasonography
for women with dense breasts using three established Cancer Intervention and Surveillance
Modeling Network breast cancer models. The models incorporate evidence from clinical trials
and observational studies to estimate the effect of various screening scenarios on several breast
cancer outcomes, including breast cancer mortality. It is estimated that, compared with biennial
10

A follow up study shows that the percent of patients may be slightly higher, so our estimate is a lower bound.

21

mammography screening alone, supplemental ultrasound screening for women with dense
breasts would avert 0.36 additional breast cancer deaths per 1,000 women. Multiplying this
fatality estimate by the number of women undergoing additional ultrasound screening per year
yields 21 (0.36 x (58,883/1,000)) to 37 (0.36 x (103,163/1,000)) deaths per year that could be
averted as a result of the breast density notification provision, with a primary estimate of
approximately 29 (0.36 x (79,885/1,000)) deaths averted.
We project that the full public health benefits will accumulate over a period of 10 years,
but the timing of the benefits from early cancer detection and avoided deaths accrue over a
lagged period. We assume that the early detection in breast cancer cases would begin 3 years
after the effective date of the final rule, and the reduction in breast cancer deaths would begin 6
years after the effective date. 11 The full effects over a 10 year period correspond to a total of
1,133 to 2,816 early cancers detected with a primary estimate of 1,859. Total averted deaths at
the full benefit level ranges from 85 to 149, with a primary estimate of 115. Tables 4 and 5
shows the stream of early cancers detected and averted deaths over a 10 year period.
Table 4. Total Early Cancers Detected Over a 10 Year Period
Years after Effective Date of
Rule (from 2024 to 2033)
1
2
3
4
5
6
7
8
9

Low

0
0
0
162
162
162
162
162
162

Primary

0
0
0
266
266
266
266
266
266

High

0
0
0
402
402
402
402
402
402

11
Our analysis assumes that supplemental testing will lead to early cancer diagnosis, such that in absence of the
final rule if finalized, cancer would be detected at a later stage and time period. Additionally, the median age at
death from breast cancer is 6 years past the median age at diagnosis. As such, we assume a 3 year latency period for
realization of early cancer detection benefits and a 6 year lag for avoided cancer death. We incorporate these lags in
each section of the benefits analysis below.

22

10
Total

162
1,133

266
1,859

402
2,816

Table 5. Total Deaths Averted Over a 10 Year Period
Years after Effective Date of
Rule (from 2024 to 2033)
1
2
3
4
5
6
7
8
9
10
Total

Low

0
0
0
0
0
0
21
21
21
21
85

Primary

0
0
0
0
0
0
29
29
29
29
115

High

0
0
0
0
0
0
37
37
37
37
149

a. Reduced Cancer Mortality
We value avoided breast cancer deaths using two different methods: the average value of
a statistical life and the value of life-years saved. The value per statistical life (VSL) approach
uses a range of VSL estimates to measure the monetary value of reduced cancer mortality. VSL
estimates do not represent the dollar value of a person’s life, but a statistic that represents the
amount society would be willing to pay to reduce the probability of death. We use VSL estimates
based on the Department of Health and Human Services (HHS) guidelines following the final
rule’s effective date (for the purpose of this analysis, we assume the rule to be effective in 2024)
(HHS 2016). The estimates of VSL in 2020 dollars range from $5.5 million to $17.9 million,
with a mid-point value of $11.8 million. VSL values in future years are adjusted for projected
real income growth. The Congressional Budget Office (CBO) projects real income growth 0.8

23

percent per year through year 2051 12. These VSL estimates are multiplied by the corresponding
estimated number of averted deaths for each year as described above. We apply 3 and 7 percent
discount rates to estimate the present discounted value of the averted deaths in each year, and the
values for each year are summed across the 10 year period to give the present discounted value.
The second method for estimating the value of avoided breast cancer deaths uses the
value of lost life years (LY) 13. We use this supplemental approach for valuing mortality
reductions because the age distribution of breast cancer patients is older than in the general
population used to estimate VSL. The value of LYs approach accounts for these age differences
by estimating the expected future life-years for an age distribution specific to breast cancer
patients. To generate these estimates, we use LY values from Sprague et.al (2015) and assume
that supplemental screening would yield 2.1 additional LYs for each affected patient.
To monetize these estimated gains for premature deaths averted, we use estimates of the
value per LY from the HHS guidelines referenced above. With the assumption that this rule will
become effective in the year 2024, the value per LY in the first year ranges from $235,366 to
$767,741 at a 3 percent discount rate and $398,215 to $1,298,938 at a 7 percent discount rate.
We multiply the estimates for life years gained from an avoided death at the age of 62 by the
value per LY and the overall number of avoided deaths in each year after the final rule takes

12. Congressional Budget Office. "The 2021 Long-Term Budget Outlook." Table A-2. Average Annual Values for Economic
Variables That Underlie CBO’s Extended Baseline Projections: Growth of Real Earnings per Worker, 2021-2051.
https://www.cbo.gov/publication/57038#_idTextAnchor040. Accessed November 2022. (34)

As noted in Circular A-4, the Memorandum to the President’s Management Council on Benefit-Cost Methods and
Lifesaving Rules and the 2015 Report to Congress on the Benefits and Costs of Federal Regulations, OMB
recommends using both VSL and VSLY methods for valuing delayed mortality. VSL has the advantage of a more
extensive empirical literature, whereas VSLY has the advantage of better alignment with the notion that lives are
extended rather than permanently saved. For regulations intended to delay mortality, OMB guidance encourages
discussion of these analytic tradeoffs without emphasizing either VSL or VSLY as a primary technique, except in
cases where the empirical approach underlying one estimate is especially well tailored to the regulatory policy being
analyzed or when a third benefit estimation method provides independent confirmation for one of the first two.
13

24

effect. Finally, we adjust the results with 3 and 7 percent rates of discount and sum across each
year of the 10 year period.
b. Reduced Cancer Morbidity
In addition to lower cancer mortality, the final rule would have effects on health-related
quality of life. Some women with breast cancer would receive the same treatment, and thus
experience the same stream of health effects, with the only rule-induced difference being an
acceleration in the timing. For others, however, the final rule could lead, after the initial effects
of accelerated treatment, to an overall reduction in time spent suffering from cancer and its
effects. These effects include the health costs of breast cancer and any physical or mental
impacts associated with having or surviving cancer. We are unable to quantify and monetize
these avoided costs due to limited information on health-related quality of life effects.
c. Reduced Cancer Treatment Costs
Cancer costs increase with the stage of cancer, such that diagnosis at an earlier stage
would lead to reduced treatment costs. Ultrasound has been shown to find cancers at an early
stage, generally at a comparable or earlier stage than cancers detected by mammography
(Houssami et al., 2009). Most cancers detected by ultrasound tend to be small in size, node
negative, and classified at stage 0 or 1 (Kaplan, 2001; Bae et al., 2011; Scheel et al., 2015). As a
result, women with ultrasound-detected cancer are more likely to have cancers with
characteristics that lead to a better prognosis, such as small size and lack of lymph node
involvement, and earlier cancer diagnosis (ERG, 2012b). We define the cancer treatment cost

25

savings as the difference between the cost of treating cancer at a later stage and treating cancer
an earlier stage 14.
The additional cancer cases detected attributed to the breast density notification
requirement may lead to treatment cost savings due to the detection of cancer at an earlier stage.
We estimate treatment cost savings as the sum of direct medical costs and non-medical costs.
Direct medical costs include hospitalizations, screenings, physician visits, and other health
services. Non-medical costs to patients that include time spent traveling to and from treatments,
in treatment, and waiting on treatment.
We use values from several research analyses on direct medical costs of breast cancer to
derive average estimates of treatment costs by stage at diagnosis 15. The average treatment costs
in 2020 dollars are $40,533 at the local stage, $64,709 at the regional stage, and $79,973 at the
distant stage. Because supplemental screening is more likely to detect cancer at the localized
stage, we estimate the cancer treatment cost savings by subtracting the cost of treating local
cancer from the average treatment costs of regional and distant cancer. Because the later-stage
cancer is assumed to be detected three years further into the future, we also discount the cost
savings. This calculation yields average annual cost savings of $19,533 at 7 percent and $27,075
at 3 percent discount rate.
Non-medical costs are derived from Yabroff et al. (2007), which estimates the additional
time spent by cancer patients on travel, waiting time, consultations, and receiving treatment
associated with the initial and last-year-of-life phases. Patient time estimates associated with

There may be situations in which patients receive additional screening and treatment for cases that do not result in
cancer. We do not capture the costs associated with undergoing unnecessary treatment, such as additional medical
or anxiety costs.
15
Average treatment costs were derived from Blumen et al. (2016), Schousboe et al. (2011), Subramanian et al.
(2011), Trogdon et al. (2017), and Vyas et al. (2017), and updated to 2020 dollar values.
14

26

medical care for breast cancer are 66.2 hours per year in the initial phase and 185.9 hours per
year in the terminal phase. Cancer patients are likely to spend some amount of time on treatment
during the continuing phase, also. However, we would expect the time spend to be substantially
less than during the initial and terminal phases. We estimate an average time cost for cancer
during each year of the continuing phase of treatment to be half of the time cost during the initial
phase, or 33.1 (= 66.2 hours / 2) hours.
To quantify the opportunity cost of changes in time use for unpaid activities, we construct
a range where the upper bound is the fully loaded mean hourly wage and the lower bound is the
hourly value of time based on after-tax wages. Our primary estimate of the value of time is the
average of the upper and lower bounds. The mean hourly wage in 2020 was $27.07 16. We
double this wage to yield a fully loaded wage of $54.14, which is our upper bound estimate of
the value of time. To calculate the lower bound, we start with a measurement of the usual
weekly earnings of wage and salary workers of $998. 17 We divide this weekly rate by 40 hours
to calculate an hourly pre-tax wage rate of $24.95. We adjust this hourly rate downwards by an
estimate of the effective tax rate for median income households of about 17%, resulting in a
post-tax hourly wage rate of $20.71. We estimate the value of time for changes in time use for
unpaid activities ranges from $20.71 and $54.14, with a primary estimate of $37.43.
The estimated annual time costs per patient for each phase of care is $2,478 ($37.43 per
hour x 66.2 hours) during the initial phase, $1,239 ($37.43 per hour x 33.1 hours) during the

16

http://www.bls.gov/oes/current/oes_nat.htm

U.S. Bureau of Labor Statistics. Employed full time: Median usual weekly nominal earnings (second quartile):
Wage and salary workers: 16 years and over [LEU0252881500A], retrieved from FRED, Federal Reserve Bank of
St. Louis; https://fred.stlouisfed.org/series/LEU0252881500A, June 9, 2022. Annual Estimate, 2021.

17

27

continuing phase, and $6,957 ($37.43 per hour x 185.9 hours) during the terminal phase. 18 We
discount the estimates to account for the three year lag. This yields an average annual cost
savings of $2,904 at a 7 percent discount rate and $3,256 at 3 percent.
3. Summary of Total Benefits
Table 6 summarizes the combined mortality and treatment costs savings associated with
the final rule. When the mortality estimates are based on estimates calculated using the VSL,
over a 10 year period, present discounted value of total benefits ranges from $295.01 million to
$1.63 billion at a 7 percent discount rate, and $412.99 million to $2.27 billion at a 3 percent
discount rate. Our primary estimates are $837.39 million at a 7 percent discount rate and $1.17
billion at a 3 percent discount rate. The annualized values of the primary estimates are $119.23
million at a 7 percent discount rate and $136.59 million at a 3 percent discount rate.
In Table 6 we also summarize combined mortality and treatment costs savings with
mortality estimates calculated using the value of LY gained per averted death. Over a 10-year
period, present discounted value of total benefits ranges from $91.26 million to $469.91 million
at a 7 percent discount rate, and $72.50 million to $323.85 million at a 3 percent discount rate.
Our primary estimates are $245.06 million at a 7 percent discount rate and $175.28 million at a 3
percent discount rate. The annualized values of the primary estimates are $34.89 million at a 7
percent discount rate and $20.55 million at a 3 percent discount rate.
Table 6. Total Benefits Over a 10 Year Period (in millions 2020 $)
Scope
Mortality
(VSL
Approach)

Description
Present
Discounted
Value
Annualized
Value

Discount Rate
7%
3%
7%
3%

Low
$279.03
$384.99

Primary
$811.18
$1,119.23

High
$1,594.61
$2,200.19

$39.73
$45.13

$115.49
$131.21

$227.04
$257.93

The initial phase was defined as the first 12 months following diagnosis, and the last-year-of-life phase was
defined as the final 12 months of life (Yabroff et al., 2007)
18

28

Mortality (LY Present
Approach)
Discounted
Value
Annualized
Value
Treatment
Present
Cost Savings Discounted
Value
Annualized
Value
Total Benefits Present
(VSL
Discounted
Approach)
Value
Annualized
Value
Total Benefits Present
(LY
Discounted
Approach)
Value
Annualized
Value

7%
3%

$75.28
$44.49

$218.84
$129.35

$430.20
$254.27

7%
3%
7%
3%

$10.72
$5.22

$15.98
$28.00

$31.16
$15.16

$26.22
$45.93

$61.25
$29.81

$39.71
$69.58

7%
3%
7%
3%

$2.28
$3.28
$295.01
$412.99

$3.73
$5.38
$837.39
$1,165.17

$5.65
$8.16
$1,634.32
$2,269.77

7%
3%
7%
3%

$42.00
$48.42

$119.23
$136.59

$232.69
$266.09

7%
3%

$12.99
$8.50

$34.89
$20.55

$66.90
$37.96

$91.26
$72.50

$245.06
$175.28

$469.91
$323.85

F. Costs of the Final Rule
The estimated costs of this final rule include costs incurred by mammography facilities
and the costs associated with supplemental testing and biopsies incurred by patients 19.
1. Mammography Facilities Costs
a. Affected Entities
As of July 1, 2022, FDA’s data on registered facilities showed that there were 8,781
facilities certified to perform mammography, operating 24,122 mammography units (FDA,
2022). Mammography is performed in private practices, clinics, health maintenance
organizations, and hospitals. For cost estimation, we have classified facilities as small (one unit),

Mammography services have undergone rapid change in recent years. We recognize that continuing changes in
the industry introduce additional uncertainty into the estimated baseline and incremental costs of the final rule.
19

29

medium (two units), or large (three or more units). The distribution of affected entities by size is
presented in Table 7. 20
Table 7. Mammography Facilities by Size
Size
Large
Medium
Small
Total

Number of
Mammography Number of
Units
Establishments
3 or more
996
2 units
2,016
1 unit
5,769
8,781

b. Approach to Estimating Costs
Estimates for facility costs are based on a cost model derived by ERG. To estimate
compliance levels and cost values, ERG visited and spoke with representatives of each type of
affected entity. ERG also received input from the FDA’s Division of Mammography Quality and
Radiation Programs and project consultants. The costs to industry of complying with this final
rule were estimated by identifying the incremental activities that will be required for new
provisions, categorizing the provision according to the type of entity, and estimating how well
current practices satisfy the requirements of each provision in the final regulation (ERG, 2012a).
Representatives of each type of affected entity and FDA’s DMQS was consulted in deriving
current costs. We found that baseline practices in some cases came close to satisfying some of
the new regulatory requirements. Under baseline practices, some facilities’ practices would
satisfy most of the new provisions without any changes, while virtually no facilities’ practices
would satisfy some of the new provisions. No incremental costs will be incurred for provisions
that are currently satisfied by all facilities. Where applicable, the costs for each entity are

We assume the proportion of mammography facilities that are large, medium, and small is the same as estimated
by ERG (2012a).
20

30

estimated on a provision-by-provision basis. Finally, we aggregate these per-entity costs to
capture total costs over a 10-year time horizon.
Some of the changes in this final rule will add to or clarify existing regulatory
requirements but will not generate incremental costs. Additionally, many provisions will
generate negligible incremental costs (or savings), such as minor revisions to administrative
procedures. We are not anticipating that this final rule will lead to facility closures or reduction
in services.
c. Facility Costs
The final rule will affect four types of staff members at mammography facilities:
interpreting physicians, radiologic technologists, medical physicists, and administrative staff.
The costs of complying with the final amendments are determined using input from health
industry consultants and the facilities affected. Some costs will vary with the size of the facility;
for example, larger facilities may require more time to develop procedures than smaller ones 21.
The final rule contains five provisions with nonzero estimated costs or cost savings
affecting mammography facilities. Modifying mammography report forms by adding additional
categories for the final and incomplete assessment and adding breast density information will
make the largest contribution to the estimated one-time costs of this final rule. We note that our
cost estimate assumes that current forms are not in alignment with the final rule and that
modification would require not only a change in the form, but also a change in procedure with
associated costs for training, discussion, and coordination among staff within mammography
facilities.

21

Labor costs from ERG (2012a) were updated to 2020 wages and adjusted for benefits and overhead.

31

Several of the final provisions will lead to incremental annual costs for some
mammography facilities.
Provisions for transfer of records in the event the facility closes – Facilities that close
will incur costs to ensure that patient and personnel records are transferred to a nearby facility or
otherwise made available to patients and personnel after the facility’s closure. We assume that
one percent of facilities will be closing on an annual basis and apply closing costs to those
facilities. Because mammography facilities will generally attempt to transfer records
appropriately to another facility, we estimate that 75 percent of closing facilities will undertake
the transfer without the regulatory requirement. We assume that the notification requirement for
facility closure will apply only to facilities that are closing within a foreseeable timeframe, and
not to all other facilities operating normally.
Miscellaneous procedure rewriting and development – Where procedures for preparation
of lay summaries need to be rewritten or supplemented, we allot time (approximately one-half
the time required for initial development) to annually revisit the procedures to ensure their
continued appropriateness and effectiveness. This time will be used to draft changes and then to
circulate the procedures among the staff.
Provisions to include breast density reporting in lay summary – The final rule includes
provisions requiring that the written report of the results of the mammographic examination
provided to the healthcare provider and the lay summary of the results provided to the patient
also include information concerning patient breast density. The costs associated with these
provisions will result from making modifications to the mammography report and lay summary
text.

32

Provisions for positive predictive value (PPV), cancer detection rate, and recall rate –
Although the facilities contacted were all calculating the various statistics specified in this final
provision, the literature on mammography quality measures suggests that not all mammography
facilities are developing and compiling these statistics. Smaller facilities are somewhat less
likely than larger facilities to be compiling these statistics. We allotted on average 40 hours per
year for facilities to develop these statistics if they are not doing so currently.
Table 8 presents the per-facility costs for mammography facilities. This table takes into
account current standard practice as well as facility size. We judged that small facilities would
incur three-fourths of the costs of average facilities, and large facilities would incur 125 percent
of the costs of average facilities. These scale factors were applied to all individual cost
estimates.

Table 8. Mammography Facility Costs per entity (in millions 2020 $)
Provision

Action

900.12(a)(4)

Make personnel
records available
upon request and
upon facility
closing
Rewrite
mammography
report forms or
insert new fields
in electronic
forms to allow
for new
assessment
categories; add
overall
assessment of
breast density
Include breast
density reporting
in lay summary

900.12(c)(1)(ivvi)

900.12(c)(2)(iiiiv)

One-Time
Large
Mediu
m

Small

Annual
Large

$0

$0

$0

$6,134

$4,897

$1,127

$902

33

Mediu
m

Small

$9

$7

$6

$3,672

$0

$0

$0

$676

$0

$0

$0

900.12(c)(4)(v)

900.12(f)(1)
Total

Provide access to
mammographic
records if
facilities are
closed
Record PPV,
Cancer Detection
Rate, Recall Rate

$0

$0

$0

$9

$7

$6

$168
$7,429

$271
$6,069

$309
$4,658

$398
$416

$637
$651

$716
$727

Table 9. Aggregate Mammography Facility Costs (in millions 2020 $)
Provision

900.12(a)(4)

Action
Make personnel records available upon request
and upon facility closing

One-Time

Annual

$0

$55,682

Rewrite mammography report forms or insert
new fields in electronic forms to allow for new
assessment categories; add overall assessment
of breast density

$37,166,396

$0

900.12(c)(2)(iii-iv)

Include breast density reporting in lay summary

$6,844,077

$0

900.12(c)(4)(v)

Provide access to mammographic records if
facilities are closed

$0

$55,682

900.12(f)(1)

Record PPV, Cancer Detection Rate, Recall
Rate

$2,496,452
$46,506,925

$5,807,650
$5,919,015

900.12(c)(1)(iv-vi)

Total

Individuals from affected entities will need to devote time to reading and understanding
this final rule. We assume an average of one health services manager at each facility will read
the rule. At an adult average reading speed of 200-250 words per minute, we estimate that each
reader will spend about 3.5 hours. We value the opportunity cost of one hour using the mean
hourly wage of a medical and health services manager, which is doubled to account for benefits
and other indirect costs. We estimate the time spent learning about the rule at a cost of $119.04
per facility (BLS 2020). Multiplying this estimate by the total number of mammography
facilities yields a total one-time cost for reading the rule of $3,658,516.
2. Costs Associated with Supplemental Testing and Biopsies

34

The costs in this analysis also include costs associated with supplemental testing and
biopsies resulting from the breast density notification requirement. This final rule requires,
among other things, that women with dense breasts be informed of their breast density in the lay
summary report of the screening mammography, which will likely lead to supplemental
ultrasound or other supplemental screening for some women with dense breasts. Although
supplemental screening may lead to additional cancer detection for women with dense breasts, it
may also lead to an increase in the number of biopsies for women without cancer. 22 The costs
related to this rule include the cost of supplemental ultrasound screening for women with dense
breasts and the cost of unnecessary biopsies. 23
The cost of testing includes not only the cost of ultrasound but also the cost of any
follow-up biopsies. As reported above, the cost of a breast ultrasound with image documentation
is estimated to be $144.14 and the total cost of a needle core breast biopsy and pathology is
estimated to be $271.90. As discussed above, we determine the number of women to receive
ultrasound screening by multiplying the number of women with dense breasts living in states
uncovered by density reporting requirements by the percentage of patients estimated to undergo
screening. Using the range of 58,883 to 103,163 women with dense breasts receiving
ultrasounds, we estimate the total annual cost of ultrasound screening of women with dense
breasts is estimated to range from $8,487,187 to $14,869,685. Sprague et.al (2015) estimate that
supplemental ultrasonography screening for women with heterogeneously or extremely dense
breasts resulted in 354 biopsy recommendations per 1,000 women after a false-positive
ultrasonography result. Multiplying this estimate by the number of women to undergo additional

Supplemental screening may also result in an increase in the number of false-positives (Melnikow, 2016).
However, we do not have sufficient data to estimate the quantitative impacts.
23
See Berg (2015) for additional discussion on additional costs that may arise as a result of supplemental screening,
including the cost for screening MRI.
22

35

screening annually yields a total of 20,844 (354 x (58,883/1,000)) to 36,520 (354 x
(103,163/1,000)) biopsies received. Multiplying this range by the average price of a biopsy
yields the total cost of a biopsy ranging from $5,667,512 to $9,929,570. Adding the total cost of
biopsies to the total costs of ultrasounds yields an annual cost ranging from $14,154,700 to
$24,799,255, with a primary estimate of $19,203,367.
We also estimate patients’ time costs associated with additional biopsies and ultrasounds.
We assume that an average time required for a needle core breast biopsy and ultrasound is
approximately one hour for each procedure 24. We construct a range where the upper bound is
the fully loaded mean hourly wage and the lower bound is the national mean wage of $20.71.
The mean hourly wage in 2020 was $27.07 25. Doubling this wage results in a fully loaded wage
of $54.14, our upper bound estimate of the value of time. Our primary estimate of the value of
time is the average of the upper and lower bounds ($37.43). Multiplying the range of time by the
number of ultrasounds and biopsies yields the total time costs associated with each procedure.
The time cost associate with additional ultrasounds is estimated to range from $1,219,458
(58,883 x $20.71) to $5,585,253 (103,163 x $54.14). The time cost associate with additional
biopsies is estimated to range from $431,688 (20,844 x $20.71) to $1,977,180 (36,520 x $54.14).
The total annual time costs to patients range from $1,651,146 to $7,562,433, with a primary
estimate of $4,048,031.

3. Summary of Total Costs

Sources: https://www.insideradiology.com.au/breast-core-biopsy/
https://www.insideradiology.com.au/breast-ultrasound/
25
http://www.bls.gov/oes/current/oes_nat.htm.
24

36

Table 10 shows total undiscounted costs. Present value and annualized costs are
presented in Table 11. Present value costs over a 10 year period range from $202.75 million to
$319.03 million at a 7 percent discount rate, and $235.48 million and $376.71 million at a 3
percent discount rate. Our primary estimates are $255.05 million at a 7 percent discount rate and
$298.99 million at a 3 percent discount rate. The annualized cost values of the primary estimates
are $36.31 million at a 7 percent discount rate and $35.05 million at a 3 percent discount rate.
Table 10. Total Undiscounted Costs (in millions 2020 $)
Type

One-time

Industry Cost-Mammography Facilities
Public Cost-Density Notification

Total

Annual
Low

Primary

High

$50.17

$5.92

$5.92

$5.92

$0.00

$15.81

$23.25

$32.36

$50.17

$21.72

$29.17

$38.28

Table 11. Present Value and Annualized Costs Over a 10 Year Period (in millions 2020 $)
Discount Rate
7%
3%
7%
3%

Low
$202.75
$235.48
$28.87
$27.61

Primary
$255.05
$298.99
$36.31
$35.05

High
$319.03
$376.71
$45.42
$44.16

G. Distributional Effects
We recognize that socioeconomic factors including race/ethnicity, income, education,
and rurality exist in mammographic practice and breast cancer outcomes. These disparities are
also present as it relates to breast density notification. Patients who are low income, lack health
insurance coverage, or in certain racial or ethnic minority groups have been less likely to obtain
screening mammograms (GAO 2006). Studies have also shown that minority patients are

37

diagnosed with breast cancer at more advanced stages (Smith-Bindman et al. 2006, Smigal et al.
2006, Shoemaker et al., 2018). Additionally, patients’ understanding of mammography and
preference for early detection of breast cancer have been shown to be influenced by differences
in ethnic backgrounds (Jafri 2008). These studies suggest that there may be notable differences
in how density notification may have been communicated to patients. This final rule would enact
a standard requirement that would ensure that all patients and providers receive complete and
consistent breast density information in mammography reports. In 2019, the latest year for
which incidence data are available, in the United States, 20,450 new cases of breast cancer were
reported among Black, Non-Hispanic women, and 6,600 Black, Non-Hispanic women died of
this cancer. For every 100,000 Black, Non-Hispanic women, 128 new breast cancer cases were
reported and 28 Black, Non-Hispanic women died of this cancer. 26 Health disparity and equity
considerations may exist as they relate to mammography practice and density notification, and
we acknowledge sociodemographic differences in mammography practice and outcomes. The
final rule provides standard requirements that help to ensure that all patients and providers
receive complete and consistent breast density information in mammography reports.

H. International Effects
This final rule is based on mammography services performed domestically. We therefore
do not expect effects outside of the United States or on international trade.

I. Uncertainty and Sensitivity Analysis

26

https://www.cdc.gov/cancer/breast/statistics/

38

Our analysis is sensitive to the number of States we assume would not have breast
density reporting requirements in the absence of the final rule. There has been increasing interest
in breast density at the State level over time. Since 2009, 38 States including the District of
Columbia have adopted density notification laws and this appears to be an upward trend. In
absence of the rule, we expect that there may be gradual adoption by more States over time. If
all States independently adopt breast density reporting laws by the time of publication of the
final rule, the potential effects may be reduced.
J. Analysis of Regulatory Alternatives to the Final Rule
In our analysis of alternatives, we compare the total cost of the final rule with one option
that would be less stringent and one option that would be more stringent. The first two
alternatives would eliminate provisions in the final rule resulting in lower total costs, and the
third alternative would slightly increase costs. The first regulatory alternative excludes the
provisions related to the breast density notification requirements. The second regulatory
alternative only includes breast density reporting and excludes the other costly provisions. The
third regulatory alternative includes additional requirements for facilities that are not included in
this final rule relating to administrative procedures and personnel matters, such as establishing
written cleaning procedures and documenting personnel information. 27 This alternative gives an
example of the implications of including supplementary requirements that are not directly related
to mammography practice.
Table 12 presents the undiscounted one-time and annual costs for each alternative and for
the final rule. Table 13 shows the present value and annualized costs at 7 percent and 3 percent
discount rates.
27

These costs were also estimated by ERG.

39

Table 12. Total Costs of Alternatives (in millions 2020 $)
Scope
Alternative 1
Alternative 2
Alternative 3
Final Rule

One-time
$6.15
$47.67
$52.02
$50.17

Annual
$21.72
$15.81
$21.97
$21.72

Table 13. Present Value and Annualized Costs of Alternatives Over a 10 Year Period (in millions
2020 $)
Scope
Alternative 1
Alternative 2

Alternative 3

Discount
Rate
7%
3%
7%
3%
7%
3%
7%
3%

Present
Discounted
Value
$158.74
$191.47
$158.68
$180.10
$206.32
$239.42
$202.75
$235.48

Annualized
Value
$22.60
$22.45
$22.59
$21.11
$29.38
$28.07
$28.87
$27.61

The first regulatory alternative, which excludes the density reporting requirements, would
reduce the undiscounted one-time cost by $44.01 million. This option would substantially
reduce the costs associated with the final regulation. However, this would eliminate any
potentials benefits resulting from the breast density notification provision.
The second alternative only includes the provisions related to the breast density
notification requirements. This option would reduce undiscounted one-time costs by $2.50
million and reduce annual costs by $5.92 million. Although this alternative would slightly
reduce total costs, the full benefits of the final regulation would not be fully realized if the other
provisions were excluded from the final rule. This would include unquantified benefits related to
the accuracy of mammography that include improvements in quality control and records
management.

40

The third alternative includes additional requirements not in the final rule that are
administrative in nature. This option increases the one-time costs by $1.86 million, and
increases the annual costs by $0.24 million. The requirements in this alternative would not
directly influence mammography practices, and would not result in any additional benefits that
could be quantified. As such, this alternative would increase the cost of implementing the final
regulation without corresponding medical benefits.

III. Final Small Entity Analysis
The Regulatory Flexibility Act requires Agencies to analyze regulatory options that
would minimize any significant impact of a rule on small entities. Because most facilities that
will be affected by this rule are defined as small businesses, we find that the final rule will have a
significant economic impact on a substantial number of small entities. This analysis, as well as
other sections in this document, serves as the Final Regulatory Flexibility Analysis, as required
under the Regulatory Flexibility Act 28.
A. Description and Number of Affected Small Entities
Mammography facilities fall within multiple North American Industry Classification
System (NAICS) codes. This analysis considers two NAICS codes that capture mammography
facilities: 621512 (Diagnostic Imaging Centers) and 622 (Hospitals). We assume that all
mammography providers are represented in either of these two NAICS codes. Using the FDA’s
registration data, we estimate that there were 4,550 non-hospital facilities (all non-hospital
entries), and 4,074 hospitals that performed mammography in 2011 (ERG, 2012a). Assuming

28

This discussion is partly derived from ERG (2012a).

41

that hospitals account for the same proportion of mammography facilities in 2021, we estimate
that there are 4,633 non-hospital facilities and 4,148 hospitals that perform mammography.
Data from the 2017 Economic Census provide a breakdown of facilities in these NAICS
codes, by revenue size (U.S. Census Bureau, 2017). However, not all facilities in these NAICS
codes provide mammography services. Using the counts of diagnostic imaging centers and
hospitals above and distributing them proportionally across the revenue distribution from the
Economic Census yields an estimated breakdown of mammography facilities by revenue size, as
shown in Tables 14 and 15.
Table 14. Distribution of Revenues for Diagnostic Imaging Centers

All Establishments
Establishments Operated for Entire Year
< $100,000 receipts
$100,000 - $249,999 receipts
$250,000 - $499,999 receipts
$500,000 - $999,999 receipts
$1,000,000 - $2,499,999 receipts
$2,500,000 - $4,999,999 receipts
$5,000,000 - $9,999,999 receipts
$10,000,000+ receipts
Establishments Not Operated Entire Year

Number of
Establishments
6,318
5,479
381
620
660
782
1,245
842
598
351
839

Mammography
Facilities
4,633
4,018
279
455
484
573
913
617
438
257
615

Sources: 2017 Economic Census and ERG estimates.

The Small Business Administration (SBA) size standard for small diagnostic imaging
centers is annual receipts under $16.5 million. 29 Of the 4,018 mammography facilities projected
to operate for the entire year, all but some of the 257 in the largest size category would be small

29

Small Business Association. Table of Size Standards. Aug 19, 2019. Available from:

https://www.sba.gov/document/support--table-size-standards

42

according to the 2019 size standard. Thus, a minimum of 3,760 of the mammography facilities
in operation for the entire year, or 94 percent of the total, would be small.
Table 15. Distribution of Revenues for Hospitals
Number of
Establishments
5,109
5,048
D
56
243
4,731
61

All Establishments
Establishments Operated for Entire Year
< $2,500,000 receipts
$2,500,000 - $4,999,999 receipts
$5,000,000 - $9,999,999 receipts
$10,000,000+ receipts
Establishments Not Operated Entire Year

Mammography
Facilities
4,148
4,099
D
45
197
3,841
50

Sources: 2017 Economic Census and ERG estimates.
Note: D - Withheld to avoid disclosing data for individual companies; data are included in higher level totals.

The SBA size standard for small hospitals is annual receipts under $41.5 million.30 Of
the 4,099 hospitals with mammography in operation for the entire year, all but some of those in
the largest revenue category would be small according to the 2019 size standard. Therefore, a
minimum of 243 (the sum of all hospitals with less than $10 million in annual receipts), or 6
percent of the total, are small. In addition, an unknown number of the 3,841 hospitals with
receipts of $10 million or more would be small.
B. Description of the Potential Impacts of the Final Rule on Small Entities
We compiled the costs associated with the final rule and compared it to the estimated
annual receipts of mammography facilities. Tables 16 and 17 present the calculations for
diagnostic imaging centers and hospitals. The estimated one-time cost is $4,777 to $7,548 per
facility, depending on its size classification. The estimated annual cost is $416 to $727 per
facility.
30

Small Business Association. Table of Size Standards. Aug 19, 2019. Available from:

https://www.sba.gov/document/support--table-size-standards

43

Table 16: Small Business Costs as a Percentage of Receipts at Diagnostic Imaging Centers

Receipts Size
< $100,000
$100,000 - $249,999
$250,000 - $499,999
$500,000 - $999,999
$1,000,000 - $2,499,999
$2,500,000 - $4,999,999
$5,000,000 - $9,999,999
$10,000,000+ receipts

Number of
Mammography
Facilities

Average
Receipts

279
$60,081
455
$167,917
484
$368,719
573
$722,147
913 $1,649,853
617 $3,540,593
438 $6,901,246
257 $22,280,622

Establishments Not
615
Operated Entire Year
Source: 2017 Economic Census and ERG estimates.

$497,382

One-time
Cost

$4,777
$4,777
$4,777
$4,777
$5,483
$6,188
$6,868
$7,548

One-time
Cost as a %
of Receipts

8.0%
2.8%
1.3%
0.7%
0.3%
0.2%
0.1%
0.0%

$4,777

1.0%

Annual
Cost

$727
$727
$727
$727
$689
$651
$534
$416
$727

Annual
Cost as
a % of
Receipts

1.2%
0.4%
0.2%
0.1%
0.0%
0.0%
0.0%
0.0%
0.1%

Table 17: Small Business Costs as a Percentage of Receipts at Hospitals
Number of
Mammography
Facilities
D
45
197
3,841

Receipts Size
Avg Receipts
< $2,500,000
D
$2,500,000 - $4,999,999
$3,984,431
$5,000,000 - $9,999,999
$7,797,791
$10,000,000+
$210,607,801
Establishments Not
Operated Entire Year
50
$71,473,481
Source: 2017 Economic Census and ERG estimates.

One-time
Cost
$4,777
$4,777
$4,777
$6,171

One-time
Cost as a %
of Receipts
D
0.12%
0.06%
0.00%

Annual
Cost
$727
$727
$727
$598

Annual
Cost as a
% of
Receipts
D
0.02%
0.01%
0.00%

Note: D - Withheld to avoid disclosing data for individual companies; data are included in higher level totals.

As shown in Table 16, one-time costs are 8 percent of receipts and annual costs are 1.2
percent of receipts for the smallest diagnostic imaging centers (those with annual receipts of less
than $100,000). The final regulation will have smaller effects on hospitals because they provide
more diversified services and tend to be larger. As shown in Table 17, in the smallest hospital
size category for which we have receipts information, the one-time cost would be 0.12 percent of
receipts and the annual cost would be 0.02 percent of receipts.

44

C. Alternatives to Minimize the Burden on Small Entities
Regulatory alternatives 1 and 2, described in Section J, would reduce costs for all
mammography facilities. Therefore, these alternatives offer potential regulatory relief for small
entities. Below we show how the reduction in cost under these alternatives would reduce the
cost of this final rule on diagnostic imaging centers.
As shown in Table 18, under the first regulatory alternative, the one-time costs per
mammography facility would be $287 to $428. This is a relatively large reduction of between
$4,349 and $7,261 compared with the final rule. The annual costs per facility would be between
$416 and $727, which is no change from the final rule. Firms in the small size class experience
the smallest reduction in one-time costs compared with the final rule. For the smallest diagnostic
imaging centers, one-time costs would be 0.07 percent of receipts and annual costs would be 1.2
percent of receipts.
Table 18: Small Business Costs as a Percentage of Receipts at Diagnostic Imaging Centers under
Regulatory Alternative 1

Receipts Size
< $100,000
$100,000 - $249,999
$250,000 - $499,999
$500,000 - $999,999
$1,000,000 - $2,499,999
$2,500,000 - $4,999,999
$5,000,000 - $9,999,999
$10,000,000+ receipts

Number of
Mammography
Facilities
279
455
484
573
913
617
438

257
Establishments Not
Operated Entire Year
615
Source: 2017 Economic Census and ERG estimates.

Average
Receipts

One-time
Cost

One-time
Cost as a
% of
Receipts

Annual
Cost as a
% of
Receipts
1.2%
0.4%
0.2%
0.1%
0.0%
0.0%
0.0%

$60,081
$167,917
$368,719
$722,147
$1,649,853
$3,540,593
$6,901,246
$22,280,62
2

$428
$428
$428
$428
$409
$390
$338

0.7%
0.3%
0.1%
0.1%
0.0%
0.0%
0.0%

Annual
Cost
$727
$727
$727
$727
$689
$651
$534

$287

0.0%

$416

0.0%

$497,382

$428

0.1%

$727

0.1%

Table 19 shows that under the second regulatory alternative, the one-time costs per
mammography facility would be $4,468 to $7,380. This is a modest reduction of between $168
45

and $309 compared with the final rule. This alternative does not include annual costs per
facility. Firms in the small size class experience the smallest reduction in one-time costs
compared with the final rule. For the smallest diagnostic imaging centers, one-time costs would
be 7.4 percent of receipts.
Table 19: Small Business Costs as a Percentage of Receipts at Diagnostic Imaging Centers under
Regulatory Alternative 2
Number of
Mammography Average
Facilities
Receipts

Receipts Size
< $100,000
279
$100,000 - $249,999
455
$250,000 - $499,999
484
$500,000 - $999,999
573
$1,000,000 - $2,499,999
913
$2,500,000 - $4,999,999
617
$5,000,000 - $9,999,999
438
$10,000,000+ receipts
257
Establishments Not
Operated Entire Year
615
Source: 2017 Economic Census and ERG estimates.

$60,081
$167,917
$368,719
$722,147
$1,649,853
$3,540,593
$6,901,246
$22,280,622
$497,382

46

One-time
Cost

$4,468
$4,468
$4,468
$4,468
$5,193
$5,918
$6,649
$7,380
$4,468

One-time
Cost as a
% of
Receipts

7.4%
2.7%
1.2%
0.6%
0.3%
0.2%
0.1%
0.0%

Annual
Cost
$0
$0
$0
$0
$0
$0
$0
$0

Annual
Cost as
a % of
Receipts
0%
0%
0%
0%
0%
0%
0%
0%

0.9%

$0

0%

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