patients to speak with their healthcare providers. In 2011, there was
some disagreement among the members of the Committee on particular
issues such as the definition of a dense breast, the degree of cancer
risk conferred by dense breast tissue, and recommendations for further
evaluation of patients with dense breasts. FDA notes that since 2011
there is now greater consensus in the scientific and medical practice
community on the categorization of breast density and the degree of
risk it confers, and also greater availability of imaging modalities
for supplemental screening (Ref. 31). This final rule only recommends
that patients speak with their providers, and does not make any
specific recommendations for further imaging or other evaluation, which
is more appropriately reserved for the unique clinical decision-making
process that takes place between a patient and their provider.
    (Comment 60) A comment recommends that there be four different
patient notification statements in the lay summary rather than two. A
comment recommends adding detailed explanatory information regarding
breasts as ``dense'' or ``not dense,'' or adding a four-category
patient density notification.
    (Response 60) FDA concludes that the two patient notification
statements (i.e., informing patients that they have ``dense'' breast
tissue or ``not dense'' breast tissue) provide a clear message to
patients regarding their breast density, and that generating four
different categories, each with unique language in the lay summary,
would potentially add confusion for some patients, as well as an
increased burden on facilities. FDA concludes that the language in this
final rule for the lay summaries (Sec.  900.12(c)(2)(iii) and (iv))
provides an adequate baseline for breast density notification to
patients given that the purpose of the letter is not to serve as a
complete resource for breast density information and, further, that the
inclusion of more detailed information might detract from the actual
notification, including by dissuading patients from reading the notice
at all, given its length.
    (Comment 61) A comment asserts that there is variability and
limited reproducibility in the determination of dense versus non-dense
breasts, and that if this variation is expressed as changing
assessments, women may lose confidence in the screening mammography
process.
    (Response 61) FDA acknowledges that for some patients there may be
some degree of variability in the determination of breast density due
to interobserver and intra-observer variability. FDA notes that there
have been advancements in technology (e.g., density classification
software devices) that may help mitigate such variability in
assessment. In addition, we conclude that potential variability in
density assessment does not outweigh the importance of communicating
breast density to patients and their healthcare providers. FDA
disagrees with the comment that patients will lose confidence in
mammography if their breast density assessment changes. If a patient
has any concerns regarding any aspect of the mammogram, including the
breast density assessment, the patient may contact the referring
provider or the mammography facility. This final rule contains
requirements for facilities regarding providing mammogram studies and
reports to patients upon request (Sec.  900.12(c)(4)).
    (Comment 62) A comment recommends that the final rule not contain
the statement that some patients with high breast density may need
other imaging tests in addition to mammography, as this is not
supported by evidence, and may lead to false positives, overtreatment,
and overdiagnosis.
    (Response 62) The language in the final rule is not intended to
require additional imaging evaluation for patients with dense breasts,
but rather to provide a baseline of information for discussion between
a patient and their healthcare provider. Accordingly, we are revising
this sentence of the notification to reflect that other imaging tests
in addition to a mammogram may help find cancers, as opposed to stating
that some patients with dense tissue ``may need'' additional imaging.
The notification in this final rule states, in part, that ``In some
people with dense tissue, other imaging tests in addition to a
mammogram may help find cancers.'' (see Sec.  900.12(c)(2)(iv) in this
final rule). The density notification requirement does not specify
additional clinical management, but the Agency believes that the
communication of breast density information is important for a patient
to better understand their own situation and to facilitate joint
decision-making by the patient and the healthcare provider.
    (Comment 63) A comment recommends that FDA withdraw the requirement
for breast density notification to patients from the final rule until
better evidence is available, asserting that breast density
notification will cause undue worry for women without specific actions
they can take.
    (Response 63) FDA disagrees with the recommendation to withdraw the
requirement for breast density notification to patients. We conclude
that there is already adequate support for informing patients of their
breast density, and while we do not believe that it is appropriate for
this final rule to contain requirements regarding specific followup
imaging tests, this rule does contain the recommendation for a patient
to discuss their breast density and individual situation with their
healthcare provider.
    (Comment 64) A comment recommends that FDA allow variation in the
wording of the breast density notification in the lay summary and
states that the commenter's State already requires density reporting
with the use of four density categories.

Another comment states that FDA already has density wording.
    (Response 64) FDA disagrees with the recommendation to allow
variations in the wording of the density notification. The required
breast density notification language in this final rule is intended to
provide a uniform density notification; however, the final rule does
not prohibit facilities from providing patients with additional
information regarding breast density. FDA disagrees with the assertion
that there was already density notification wording provided by FDA
prior to the publication of this rule.
    (Comment 65) A comment recommends that increased risk of breast
cancer be included in the lay summary for patients with dense breasts,
and that qualifying words such as ``may'' be eliminated.
    (Response 65) FDA agrees with the recommendation to include a
statement in the lay summary about the increased risk of breast cancer
associated with dense tissue (see Response 75). We are revising the
notification language in this final rule, including the sentence
``Dense tissue makes it harder to find breast cancer on a mammogram and
also raises the risk of developing breast cancer'' (see Sec.
900.12(c)(2)(iii) and (iv) in this final rule). The word ``may'' is
used in the revised statement that ``In some people with dense tissue,
other imaging tests in addition to a mammogram may help find cancers''
(see Sec.  900.12(c)(2)(iv) in this final rule). FDA believes that this
language in the lay summary is appropriate for communicating breast
density information and recommendations without causing undue alarm to
patients.
    (Comment 66) A comment recommends adding BI-RADS density categories
to the MQSA regulations.
    (Response 66) We note that the breast density assessment statements
in the report to the healthcare provider, as written in Sec.
900.12(c)(1)(vi)(A) through (D) in this final rule, correspond to the
wording of the density categories in the BI-RADS 5th edition (Ref. 34)
(see also Response 35).
    (Comment 67) A comment recommends that facilities be required to
have different lay summaries, for those given to patients at ``time of
service'' and for those that are mailed.
    (Response 67) FDA does not agree that it is necessary to require
facilities to have different versions of the lay summary based on when
the letter is delivered to the patient. This final rule does not
prohibit a facility from adopting such a practice, but the required
language in Sec.  900.12(c)(2) must be included in any version of the
lay summary.
    (Comment 68) A comment specifically recommends that the lay summary
make it clear to a patient whether their breast density is high or low.
    (Response 68) As addressed in Responses 76 and 79, we are revising
this final rule and replacing the wording of high density and low
density with ``dense'' and ``not dense,'' respectively (see Sec.
900.12(c)(2)(iii) and (iv) in this final rule). We conclude that these
revised terms will be clearer to patients. FDA believes that the
language in the final rule for the lay summaries is adequate and
accomplishes its intent of communicating breast density information and
recommendations to patients.
    (Comment 69) A comment recommends that before finalizing the rule,
FDA should document the benefits of breast density notification and
ensure that unintended harms are avoided.
    (Response 69) FDA notes that communicating breast density to
patients is an important component of empowering them to make decisions
regarding their healthcare, and is the primary benefit of the breast
density notifications set forth in this rulemaking. As most States
already have breast density notification requirements, which vary
across the country (Ref. 8), FDA concludes that it is important to have
a consistent baseline for the content of these notifications. Some
patients with dense breast tissue and other risk factors may be advised
by their providers (based on their individual risk factors) to undergo
supplemental screening, such as with ultrasound, which has been shown
to increase cancer detection, particularly of small and node-negative
cancers (Ref. 32); this early detection may decrease morbidity from the
cancers and their treatment.
    (Comment 70) A comment recommends that FDA should support
development of an evidence base and guidelines for care for women with
dense breasts, which can then be used to develop and provide
educational materials to clinical providers in providing evidence-based
supplemental screening recommendations.
    (Response 70) FDA disagrees with the comment. There are many
existing resources, including recommendations from professional
societies and a large base of literature, that already provide
recommendations on care for patients with dense breasts (including, but
not limited to Refs. 10, 12 to 14, 28, 31, and 33 to 37). The MQSA
implementing regulations (including this final rule) are designed to
ensure that patients in the United States have access to quality
mammography services.
    (Comment 71) Some comments recommend that breast density
notification should not be required in the lay summary sent to women in
the non-dense categories, and that if FDA requires breast density
notification to women in these categories, that verbiage describing the
implications of having dense tissue be minimized.
    (Response 71) FDA disagrees with the comment. The Agency believes
that it is important to communicate information regarding breast
density to patients in all density categories. FDA concludes that the
language in this final rule for the lay summary for patients who have
non-dense breasts (see Sec.  900.12(c)(2)(iii)) is of an appropriate
level of detail and provides context for the breast density
notification.
    (Comment 72) A comment asserts that the way that risk is described
by statisticians and epidemiologists, for example by comparing the risk
of breast cancer between women whose breast tissue is at the extremes
of greatest and least density, is misleading to the average lay person.
    (Response 72) FDA notes that the language in this final rule for
breast density notification in the lay summary does not communicate
risk information to patients in the manner in which the commenter
asserts risk information is described by statisticians or
epidemiologists. As addressed in Responses 68, 75, 76, and 79, we have
revised the notification statements to patients with both dense and
non-dense tissue to say, in part, ``Dense tissue . . . raises the risk
of developing breast cancer'' (see Sec.  900.12(c)(2)(iii) and (iv) in
this final rule).
    (Comment 73) Several comments recommend that information on next
steps needs to be included with the dense tissue notification to
patients. Another comment recommends that more specific recommendations
be given beyond discussing breast density with a healthcare provider,
that radiologists should be specific in recommending additional imaging
studies, and that all possible imaging modalities that may be more
effective than mammography should specifically be mentioned in the lay
summary.
    (Response 73) The language in this final rule for the patient lay
summary for patients with dense breasts (see Sec.  900.12(c)(2)(iv))
includes the recommendation to speak with the patient's healthcare
provider regarding breast density, breast cancer risk, and the
patient's individual situation. FDA concludes that it is not
appropriate to indicate any additional steps in a

patient's care prior to this interaction and based only on the
mammogram, as individual situations and risk factors vary. FDA does not
agree that it is appropriate to require the lay summary to include a
discussion of all possible breast imaging modalities that may be more
effective for some patients than mammography, as this would require a
significant amount of information that may be difficult for patients to
interpret. We believe that it is more appropriate for the healthcare
provider to discuss this information with the patient and engage in
shared clinical decision-making based on the patient's individual
circumstances. This rule does not prohibit a facility from providing
further information to patients in addition to the required language in
the final rule if the facility chooses to do so.

J. Breast Density Notification Language

    (Comment 74) Several comments recommend deleting the phrase ``more
glands than fat in the breasts'' from Sec.  900.12(c)(2)(iii),
asserting that it is inaccurate because: (1) the ratio of fat to
glandular tissue is not always related to density on mammography due to
regional variation of fat and glandular tissue as well as a fibrous
tissue component; (2) fibrous tissue is distinct from glandular tissue
and often accounts for the majority of the density seen on mammograms;
and (3) dense breasts have more fat than dense tissue when quantified.
Another comment asserts that the breast density depends upon other
factors, such as the glandular tissue and stroma projecting together,
the compliance of the breast under pressure of the compression paddle
and the amount of fat in the macroscopic component of stroma.
    (Response 74) FDA acknowledges the presence of fibrous stroma in
the composition of the breast, and agrees with the comments regarding
the many anatomic, technical, and other factors that contribute to
mammographic breast density. We also agree with the recommended
deletion. Accordingly, we have deleted the phrase ``more glands than
fat in the breasts'' from the density notifications in Sec.
900.12(c)(2)(iii) and (iv) of this final rule. Additionally, this final
rule does not use the term ``glandular tissue'' in either the
assessment of breast tissue density in the report to the healthcare
provider (see Sec.  900.12(c)(1)(vi)(A) through (D)) or the
notification of density in the lay summary to the patient (see Sec.
900.12(c)(2)(iii) and (iv)).
    (Comment 75) Several comments recommend modifying the language in
the patient lay summary in proposed Sec.  900.12(c)(2)(iv) to include a
statement that higher breast density raises a patient's risk of
developing breast cancer.
    (Response 75) FDA agrees with the comments, and notes that studies
show that women with dense breast tissue do have an elevated risk of
developing breast cancer (Refs. 12 to 15). Accordingly, we have added
to the patient notification language in Sec.  900.12(c)(2)(iii) and
(iv) of this final rule, a statement that ``Dense tissue . . . raises
the risk of developing breast cancer.''
    (Comment 76) Several comments recommend that FDA adopt the density
notification language proposed by two commenters. This language
includes: (1) a revision of FDA's proposed introductory sentences
beginning with ``Some patients,'' out of concern that they will cause
alarm to patients with non-dense breasts and confusion to patients with
dense breasts; (2) a recommendation to include an elective option to
use four density categories in States whose notification regulations
require this; (3) a recommendation to substitute the term ``scattered
fibroglandular tissue'' for the term ``scattered areas of
fibroglandular density'' in the mammography report, to avoid patient
confusion of the phrase ``scattered . . . density'' with tissue that is
``dense''; (4) a recommendation that patients with non-dense breasts
should not be advised to speak to their provider; (5) a recommendation
that patients be advised to continue routine screening mammography; and
(6) a recommendation to add a statement that risk factors such as
density can change.
    (Response 76) FDA appreciates these comments. As described in the
following and organized according to the numbered topics identified in
Comment 76, we are revising some of the wording in the final rule for
the lay summary.
    (1) We have modified the introductory language to remove the
reference to ``Some patients,'' but we disagree with the assertion that
providing some basic information about density will cause alarm to
patients with non-dense breast tissue or confusion to patients with
dense breast tissue.
    (2) As addressed in Responses 68 and 79, we have retained the two
categories of density, but changed the wording from the comparative
terms ``high density'' and ``low density'' to ``dense'' and ``not
dense,'' in order to provide a clear message to the patient. We have
also corrected Sec.  900.12(c)(2) to specify that the lay summary shall
include ``an assessment of breast density as described in paragraphs
(c)(2)(iii) and (iv) of this section'' (i.e., the two categories of
``dense'' and ``not dense''). In States where notification using four
density categories is required by State law, facilities may also
provide that information to patients, but this is distinct from the
notification paragraph required by this MQSA final rule.
    (3) As the commenter notes, the phrase ``scattered areas of
fibroglandular density'' is only required in the report intended for
the healthcare provider, where this phrase conforms to current clinical
practice and should not cause confusion to healthcare providers. One of
the goals of the MQSA and its implementing regulations is ensuring
clear communication between the IP and the referring provider;
therefore, the report is written using medical terminology. The phrase
is not required in the lay summary to the patient; therefore, we do not
agree that the phrase will cause patient confusion. For all patients,
whether referred by a provider or self-referred, the lay summary will
only contain a clear statement that the patient's breast tissue is
``dense'' or ``not dense.'' Patients who are self-referred will also
receive the report, but the lay summary should help avoid confusion.
Even a patient who is self-referred for a mammogram may give the report
to their healthcare provider; therefore, the precision of the report
should not be sacrificed in order to tailor the language to the lay
patient, who will also receive a lay summary.
    (4) Regarding the commenter's recommendation that FDA should remove
the advice for patients whose tissue is assessed as ``not dense'' to
discuss breast density with a healthcare provider, FDA disagrees with
this recommendation, as we believe that this conversation is
appropriate for patients in all density categories.
    (5) In response to the recommendation to add a statement
instructing patients to continue routine screening mammograms, we
believe that is part of a larger discussion, including regarding
screening methods and time intervals, that should take place between a
patient and the patient's healthcare provider.
    (6) In response to the recommendation to add a statement that
breast density and other risk factors can change, FDA concludes that
adding this statement in the lay summary may be confusing and may
detract from the information provided regarding the current assessment
of the patient's breast density.
    (Comment 77) Several comments recommend that not all women should
be informed of breast density risks, and that notifying all women is
ineffective

and doing so may cause confusion. Another comment recommends that
breast density language should only be included in lay summaries to
women with dense breast tissue.
    (Response 77) FDA disagrees with the comments. A primary goal of
this provision of the final rule is to provide information to patients
and their healthcare providers to help guide each individual patient's
care. Therefore, as noted in Response 76, FDA believes that it is
appropriate for patients in all density categories to discuss breast
density with their healthcare providers. The intent of this final rule
is to provide breast density information to all patients and their
healthcare providers to help guide each patient's care.
    (Comment 78) A comment recommends that patients should be
encouraged to discuss their mammography findings with their physician
to determine what additional tests may be beneficial in their specific
circumstances.
    (Response 78) FDA agrees with the comment, and concludes that the
current wording in the final rule, Sec.  900.12(c)(2)(iii) and (iv),
accomplishes this.
    (Comment 79) Several comments recommend using the terms ``dense''
and ``not dense'' rather than ``high density'' and ``low density.''
    (Response 79) FDA agrees with this recommendation to improve
clarity and reflect clinical practice. Accordingly, as noted in
Responses 68 and 76, we are revising the final rule to now state, in
Sec.  900.12(c)(2)(iii), ``Your breast tissue is not dense,'' and in
Sec.  900.12(c)(2)(iv), ``Your breast tissue is dense.''
    (Comment 80) A comment recommends clarification on whether FDA will
provide acceptable alternative breast density reporting language, and
requests that FDA consider replacing the breast density notification
language with a list of required key information points proposed by one
commenter.
    (Response 80) FDA disagrees with the comment. One of the intents of
this rulemaking is to ensure that patients receive a consistent
baseline of information regarding their breast density; additionally,
the notification should be subject to straightforward verification
during the MQSA inspection. Therefore, the Agency is not providing
alternative breast density reporting language aside from that which is
included in the final rule, nor changing the notification requirement
from a required paragraph to a list of key points. FDA recognizes that
individual States as well as facilities may choose to provide patients
with additional information, beyond the information required in this
final rule, where it does not conflict with the MQSA and its
implementing regulations.
    (Comment 81) A comment recommends that FDA be cautious in the use
of the word ``normal'' when referring to women with dense breasts,
since dense breasts may be pathologic and should be a subject of
research for disease prevention. Conversely, several comments recommend
that lay summaries should state that dense breasts are not abnormal.
    (Response 81) FDA agrees that it is not necessary to characterize
dense breast tissue as normal or abnormal, but rather to focus on
communicating whether a patient has breast tissue that is dense or not
dense. In this final rule, FDA does not use the words ``normal'' or
``abnormal'' in the breast density notification statements for patients
with either dense or non-dense breast tissue.
    (Comment 82) A comment recommends that the lay summary should
emphasize that dense breasts are common and that most women with dense
breasts do not reach the clinical threshold for having an elevated risk
for breast cancer.
    (Response 82) FDA agrees that dense breast tissue is common;
however, we disagree with the comment regarding elevated risk of
cancer. We note that studies show that women with dense breast tissue
do have an elevated risk of developing breast cancer (Refs. 12 to 15),
and as noted in Response 75, we are revising the patient notification
language (see Sec.  900.12(c)(2)(iii) and (iv) in this final rule) to
include a statement that dense tissue raises the risk of developing
breast cancer.
    (Comment 83) A comment recommends that FDA include recommendations
to use FDA-cleared automated breast density assessment devices, and
that instead of the four categories of breast density proposed for the
report to the healthcare provider, breast density should be reported
along a continuum based on such automated breast density devices.
    (Response 83) FDA acknowledges that there are various methods for
the assessment of breast density, which may include automated processes
such as FDA-cleared density assessment software devices. However, the
categories in Sec.  900.12(c)(1)(vi)(A) and (D) of this final rule are
consistent with the four ACR BI-RADS categories of breast composition,
which are ``defined by the visually estimated content of
fibroglandular-density tissue within the breasts'' (Ref. 34) and do not
require automated assessment. The MQSA and implementing regulations do
not require the purchase or use of specific products as a condition of
facility certification, and ABs may not require the purchase or use of
specific equipment or software as a condition of facility accreditation
(see Sec.  900.4(a)(5)). Furthermore, not all facilities may have or be
able to afford the same equipment or software, and requiring specific
equipment could potentially limit access to mammography services.
Finally, the four density categories in this final rule are in wide use
in current clinical practice, and will be more readily understood by
clinicians than a report of individual results along a continuum.
    (Comment 84) A comment recommends that the lay summary specify how
dense breast tissue impacts the statistical accuracy of mammography.
    (Response 84) FDA disagrees with making this a requirement of the
lay summary. The Agency notes that any information included in the lay
summary must account for patient understandability. FDA concludes that
including a discussion of statistics in the lay summary may detract
from the effectiveness of the breast density notification and
recommendations. Additionally, knowledge of breast conditions and
disease processes is subject to change with ongoing research, and
specific statistical information may become outdated and misleading.
However, as noted in Response 52, we are revising the notifications to
include the statement that ``Dense tissue makes it harder to find
breast cancer on a mammogram. . . .'' (see Sec.  900.12(c)(2)(iii) and
(iv) in this final rule). We believe that this language adequately
conveys the existence of a masking effect of dense tissue on
mammography.
    (Comment 85) Several comments recommend that the lay summary use
four categories for breast density, similar to the report to the
healthcare provider; however, the language used in the lay summary
should be written at an appropriate education level. Another comment
recommends adding the word ``significantly'' in reports for patients
with extremely dense breasts.
    (Response 85) FDA does not consider it necessary to use four
categories of breast density in a lay summary. In clinical practice,
further management decisions are typically based on the distinction
between non-dense and dense, i.e., two categories, as well as on other
patient risk factors. The Agency believes that the two categories for
breast density in the lay summary represent an appropriate balance
between patient understanding and precision of the underlying
information.

We believe that using four categories rather than two in the lay
summary would not be more effective in communicating breast density
information, and that doing so may be confusing to patients and
burdensome to facilities. As noted in Response 60, we are revising
Sec.  900.12(c)(2) to specify that the lay summary shall include ``an
assessment of breast density as described in paragraphs (c)(2)(iii) and
(iv) of this section,'' i.e., the two categories of ``dense'' and ``not
dense,'' and have simplified the language used in these patient
notifications.
    Similarly, we note that adding the word ``significantly'' would
effectively divide the single category of dense breast tissue into two
categories, and detract from the goal of providing a clear message to
patients with dense breast tissue. Also, this may cause undue alarm to
patients, as this term is subjective and will not be consistently
interpreted by all patients. The healthcare provider will receive the
report that assesses the density on a four-category scale, and can
incorporate this information into their clinical recommendations to the
patient.
    (Comment 86) A comment recommends that when a patient views their
online medical chart from their primary care physician, rather than a
report that describes their breast density, the patient's actual
mammogram images should be displayed, and the patient can assess where
their own density is located along a normal distribution.
    (Response 86) FDA agrees that patients should be informed and
empowered in the decision-making related to their healthcare.
Therefore, this final rule includes the requirement for mammography
facilities to directly notify patients of their breast density in the
lay summary (see Sec.  900.12(c)(2)(iii) and (iv)), not through viewing
a primary care provider's medical chart. However, we disagree with
including an image display requirement for several reasons. First, the
primary care physician or other referring healthcare provider may not
have the mammogram images, unless the patient has requested that the
images be sent to that provider (see Sec.  900.12(c)(4)(ii) and (iii)).
Also, requiring primary care physicians to display online medical
charts in a specific manner is not within the scope of the MQSA;
furthermore, not all patients may choose to access online charts even
when these are made available. We also conclude that it is not
reasonable to expect patients to assess their own breast density and
generate plans for followup based on their self-assessment. Finally, we
note that providing patients with the images from their mammogram
studies when requested continues to be a requirement in the final rule
(see Sec.  900.12(c)(4)(ii) and (iii)), so if patients choose to do so,
they can directly obtain their mammogram images from the performing
facility, without any need to use their primary care provider as an
intermediary.
    (Comment 87) A comment recommends that, due to the variety of
recommendations for patients with dense breasts, the lay summary should
include a statement to follow the recommendations in the lay summary
and in the report sent to the patient's healthcare provider.
    (Response 87) The Agency finds that the notification language in
this final rule for patients assessed to have dense breast tissue (see
Sec.  900.12(c)(2)(iv)) is adequate. In the course of the clinical
decision-making, the referring provider will typically read and
interpret the mammography report, including its recommendations, in the
context of other clinical information about the patient. We also note
that all patients will receive the lay summary, but most patients
(except for those who are self-referred) will not receive the report
that is sent to the referring healthcare provider. A referred patient
would therefore not typically have the ability to independently follow
the recommendations in that report. Although the lay summary does not
explicitly state that patients should follow the recommendations in the
report to the patient's healthcare provider, it does state that
patients should speak with their healthcare provider. That interaction
is an opportunity for the patient to receive recommendations from their
healthcare provider.
    (Comment 88) A comment recommends that the lay summary should
encourage patients and referring providers to discuss mammogram results
with the radiologist who interpreted the mammogram. Another comment
recommends that patients should have the opportunity to speak with the
radiologist.
    (Response 88) FDA interprets the word ``radiologist'' to mean the
IP, as the majority of qualified IPs under the MQSA and its
implementing regulations are radiologists. We agree that the IP for a
mammogram is a potential resource for both patients and their
healthcare providers, and this final rule does not prohibit
communication between these parties. However, we conclude that it is
neither necessary nor practical to include a recommendation for
patients and healthcare providers to discuss the results of every
mammogram with the IP. Workflow varies across facilities; many
mammograms are interpreted in batches at times when the imaged patients
are not present, and many mammograms are interpreted at sites other
than the facilities where the images were performed. Therefore, the IP
may not be readily available to speak to all patients. The
recommendations to encourage all patients to discuss their results with
the IP, or to require the facility to provide an opportunity for the
patient to speak with the IP, are likely to cause a significant burden
on IPs and facilities, and could reduce access to mammography services.
Furthermore, the referring healthcare provider is likely to have a more
complete knowledge of each patient's history and risk factors than the
IP, and it is therefore more appropriate for the patient to discuss
their results with their provider. There is also no need for the lay
summary to encourage the referring healthcare provider to discuss the
results with the IP, as the provider does not receive the lay summary
(but does receive the more detailed mammography report). Healthcare
providers who require additional information after reading a
mammography report can typically contact the IP.
    (Comment 89) A comment asserts that DBT is considered supplemental
to conventional mammography, and recommends that this be made clear in
the notification wording, to prevent a large increase in orders for
screening breast ultrasound examinations.
    (Response 89) FDA disagrees with this comment. The choice of
imaging modalities and the various clinical guidelines for breast
cancer screening are more appropriately left to the judgment of the
referring provider and the IP as part of the clinical decision-making
process. However, FDA notes that many facilities that have DBT
equipment use this DBT modality for primary screening of many or all of
their patients, and do not reserve it only for supplemental screening.
Furthermore, as noted in Response 108, with the exception of the
medical outcomes audit (see Sec.  900.12(f)(1) in this final rule), the
MQSA and its implementing regulations do not distinguish between
screening and diagnostic mammograms. Under the MQSA and its
implementing regulations, DBT is a mammographic modality, and is
subject to MQSA quality standards and requirements, including the
reporting requirements. Therefore, under this final rule, the lay
summary for a DBT examination, just like the lay summary for a screen-
film mammogram or a full-field digital

mammogram, must include the breast density notification that is
appropriate to the patient's breast tissue (see Sec.  900.12(c)(2)(iii)
and (iv)). See also Response 2.
    (Comment 90) A comment recommends that, in addition to notifying
patients about their breast density, the lay summary should also inform
patients that ultrasound or MRI may be performed for additional
screening. Another comment recommends that the lay summary should
explicitly state that for women with dense breasts, it may be
appropriate to consider additional imaging tests. Conversely, a comment
notes that the U.S. Preventive Services Task Force (USPSTF) has not
taken a definitive position regarding supplemental MRI or ultrasound.
    (Response 90) In Sec.  900.12(c)(2)(iv) of this final rule, the
notification language for patients with dense breasts is being revised
to include the statement that ``In some people with dense tissue, other
imaging tests in addition to a mammogram may help find cancers.'' FDA
believes that this information, in addition to the recommendation to
discuss breast density with a patient's healthcare provider that is
also included in Sec.  900.12(c)(2)(iv), provides a reasonable basis
for the patient and the healthcare provider to determine an individual
plan that takes into account that patient's breast density. FDA
acknowledges that in current clinical practice, ultrasound and MRI
examinations are frequently used as imaging modalities in breast
evaluation; however, practice can change over time, and therefore we do
not believe that it is necessary to specify these particular modalities
in the lay summary, but rather, the various options may be discussed by
the patient and the healthcare provider. In response to the comment
recommending an explicit statement that it may be appropriate to
consider additional imaging tests for women with dense breasts, FDA
believes that the language in this final rule adequately communicates
that other imaging tests may provide benefit in the evaluation of some
patients with dense breast tissue. Finally, FDA agrees with the comment
about the USPSTF. As noted above in Responses 2, 55, 62, and elsewhere,
we have also not specified the further management of patients with
dense breast tissue.
    (Comment 91) Several comments address the grade level, literacy
level, and readability of the notification wording, in general or for
particular patient populations. A comment expresses concern that the
wording is above the fifth grade level and may cause misunderstanding,
confusion, and fear. Another comment recommends that the breast density
notification should adhere to FDA's best practices requirement to use
plain language and should ensure that the readability is at or below
the eighth grade level, or that FDA should explain why this
notification is not subject to its general policy on risk
communications, and continues that if the reading level exceeds the
eighth grade level, FDA should issue a supplemental rule with modified
breast density notification. Another comment asserts that the reading
level recommended for U.S. women is the fifth to sixth grade level, and
recommends that any prescribed language should undergo assessment with
tools such as Flesch-Kincaid, Dale-Chall, or the Patient Education
Materials Assessment. A similar comment recommends that the Agency
should apply textual analysis tools to its proposed notification and
consider how to address issues raised with understandability and
readability. A comment recommends that if FDA conducted message
testing, the results should be made available, and if it did not, it
should undertake testing to determine whether the notification is
capable of achieving its intended purpose. Another similar comment
recommends that FDA should use accepted readability tools to analyze
its notification language for readability and understandability, and
test the notification among a diverse and representative set of
mammography-eligible women, to ensure that it is clear and
understandable to all women, and adequately explains all ``hard''
terms, particularly ``breast density.'' Another comment recommends that
the Agency should test the notification with an adequate sample of
African-American and Hispanic women.
    (Response 91) FDA acknowledges these comments. The notification
language in this final rule is not intended to be a complete discussion
of breast density, but rather to encourage further discussion between
each individual patient and their healthcare provider. Readability
testing was performed internally by FDA on an earlier draft of the
breast density notifications, and although FDA modified the text of the
breast density notification from the draft the committee reviewed, FDA
incorporated the feedback it received to modify the required breast
density notification statements to a lower grade reading level. Many
factors, including but not limited to scientific accuracy, adequacy,
and readability, were considered in composing the final patient density
notifications in this rule. As noted in several responses, in this
final rule we are revising both the non-dense and dense breast
notifications. The non-dense breast notification (see Sec.
900.12(c)(2)(iii) in this final rule) now states, ``Breast tissue can
be either dense or not dense. Dense tissue makes it harder to find
breast cancer on a mammogram and also raises the risk of developing
breast cancer. Your breast tissue is not dense. Talk to your healthcare
provider about breast density, risks for breast cancer, and your
individual situation.'' The dense breast notification (see Sec.
900.12(c)(2)(iv) in this final rule) now states, ``Breast tissue can be
either dense or not dense. Dense tissue makes it harder to find breast
cancer on a mammogram and also raises the risk of developing breast
cancer. Your breast tissue is dense. In some people with dense tissue,
other imaging tests in addition to a mammogram may help find cancers.
Talk to your healthcare provider about breast density, risks for breast
cancer, and your individual situation.'' Both of these notification
statements are below the eighth grade reading level on the Flesch-
Kincaid readability scale, which is the average reading level among
adults. FDA believes that these notifications and their reading level
appropriately balance readability with scientific accuracy and adequacy
of information. The Agency also notes that the wording of the
notification statements in this final rule is simpler than most of the
State breast density notification statements currently used across the
country, which are written at a higher reading level (see Ref. 8 for
the State notification statements). The simpler language of the Federal
notification statements represents a baseline national standard for
density notification. FDA notes that further information about
appropriate reading levels is also addressed in the response to Comment
92.
    (Comment 92) Several comments discuss the research literature on
public health messaging in general and breast density notification in
particular. A comment recommends that FDA consider the literature on
how public health messages are received. Another comment recommends
that FDA acknowledge the findings of the Boston University study and
other research on the readability and understandability of public
health messaging. A comment encourages the Agency to consult the
researchers funded by the ACS who are studying the communication of
breast density information to women. Another

comment recommends that FDA should assess the State breast density
notification requirements to evaluate their benefits to public health,
including reviewing the existing literature, and performing an
assessment either alone or in partnership with other entities.
    (Response 92) FDA acknowledges these comments. We have reviewed
some of the research on the readability and understandability of breast
density notification, such as References 37 to 40, including the
research of the Boston University group (including Refs. 42 to 44). As
noted in Responses 52 and 91, FDA believes that the revised
notification language in this final rule appropriately balances
readability, accuracy, and adequacy, and is simpler than most of the
State breast density notifications currently in effect across the
country. The revised notification statements in this final rule (see
Sec.  900.12(c)(2)(iii) and (iv)) are consistent with the
recommendations of most of these researchers, including that the
density notification should be written at a lower grade level than most
current State density notifications. The Agency agrees with the Boston
University researchers (see Ref. 43) that the notification in this
final rule should not be the only information a patient receives about
breast density, but rather is intended to establish a consistent
national baseline standard and to encourage further discussion between
each individual patient and their healthcare provider.
    (Comment 93) Several comments address the use of languages other
than English. A comment recommends that FDA identify and require best
practices for disseminating messages about breast density in multiple
languages, to reduce anxiety and confusion. Another comment recommends
that facilities should be urged or even required to translate the
density information into the prevalent or dominant languages of their
patient populations. Another comment asserts that there must be a
Spanish translation, and recommends that translation into Mandarin,
Hindi, or other commonly used languages should also be performed.
    (Response 93) FDA acknowledges that patients of limited English
literacy may need assistance with the interpretation of the lay
summary. However, FDA does not believe that it is necessary to add
additional language requirements for the lay summary. The MQSA and its
implementing regulations establish baseline national standards. Under
the current regulations, the required statements in the mammography
report, such as the final assessment statement, are in English.
Likewise, the required statements on breast density that this final
rule adds to the mammography report (Sec.  900.12(c)(1)(vi)) and the
corresponding required breast density notification statements that this
final rule adds to the lay summary (Sec.  900.12(c)(2)(iii) and (iv))
are in English. Facilities are encouraged to make every effort to
communicate with their patients, and FDA recognizes that facilities may
choose to provide patients with a translation of the breast density
notification statement, but FDA does not believe it is practical for
the Agency to regulate such translation. The English-language
notification statement in this rule must be included in the lay summary
regardless of any additional information or translation that a facility
may elect to provide to the patient.

K. Breast Density Notification and the Role of the Referring Healthcare
Provider

    (Comment 94) Several comments recommend that, in addition to breast
density notification, FDA should require that the report to the
healthcare provider include a recommendation that the healthcare
provider perform a risk assessment.
    (Response 94) The reporting requirements in this final rule are
intended to promote clear communication about the results of the
mammogram, not to prescribe other aspects of patient care. FDA
acknowledges that risk assessments may be an important component of
care for some patients; however, the Agency generally defers to
healthcare providers to determine when a risk assessment is appropriate
for their patients, and so declines to require that such an express
recommendation be included in mammography reports. As noted in several
other responses, the notification statements to patients with dense or
non-dense tissue both say, in part, ``Talk to your healthcare provider
about breast density, risks for breast cancer, and your individual
situation'' (see Sec.  900.12(c)(2)(iii) and (iv) in this final rule).
We believe that the interaction between patients and their healthcare
provider presents an appropriate opportunity for the healthcare
provider to assess the patient's individual risk factors.
    (Comment 95) A comment asserts that most healthcare providers are
not equipped to discuss potential options for further assessment with
patients who are reported as having dense breasts.
    (Response 95) FDA disagrees with this comment. Many resources
related to breast density are available to healthcare providers from
various sources such as professional societies, continuing education
courses, and articles in professional journals (including, but not
limited to Refs. 10, 12 to 14, 28, and 31 to 37), so healthcare
providers should generally be equipped to discuss with patients
potential options for further assessment.
    (Comment 96) A comment asserts that there is little difference
between heterogeneously dense breasts and extremely dense breasts, and
that there is interobserver variability in assessing breast density.
    (Response 96) FDA acknowledges that in some cases there may be
interobserver variability in breast density assessment (i.e., different
IPs may assign different density categories to the same examination).
However, we note that categorizing breast density is part of the IP's
mammogram interpretation, and is not controlled by FDA. After the IP
assigns a category, the final rule requires the category to be included
in the mammography report, using the wording in this final rule (see
Sec.  900.12(c)(1)(vi)(A) and (D)), to promote clarity of communication
between the IP and referring healthcare provider. We also note that the
two categories of breast density cited by the commenter, which appear
in Sec.  900.12(c)(1)(vi)(C) and (D), respectively, as well as the
other two categories in Sec.  900.12(c)(1)(vi)(A) and (B), are already
in wide use and conform to current clinical practice.
    (Comment 97) A comment recommends that additional information and
images regarding breast density be provided to clinicians and patients,
and that FDA should consider providing, for clinicians, a reference to
a specific article on breast density and the risk of interval cancer
(Ref. 45).
    (Response 97) FDA disagrees in part with this comment. Patients are
not trained to interpret mammograms; the patient's referring healthcare
provider is best suited to explain the mammogram results to the patient
and provide additional information as needed. For healthcare providers,
some references are cited in this final rule (including, but not
limited to Refs. 10, 12 to 14, 28, 31 to 37, and 45) and healthcare
providers can also identify additional resources such as medical
journal articles, continuing education courses, or practice guidelines
from professional societies that are most current or most relevant to
the specific situation of the healthcare provider's patient.

L. Format for Image Interpretation, Retention, Transfer of Original
Images, and Release of Copies

    (Comment 98) A comment recommends clarification of the meaning and
intent of the term ``original format'' as it relates to mammographic
studies. Another comment recommends that digital images should not
contain computer-aided detection (CAD) markings. A comment agrees with
the proposed requirement to retain mammograms in the original modality
in which they were obtained and not copied or digitized, and recommends
that facilities be required to adhere to this requirement immediately
upon publication of the rule rather than 18 months after publication of
the rule.
    (Response 98) We note that neither the proposed rule nor this final
rule uses the phrase ``original format.'' The rule states that
mammograms must be presented for interpretation in the ``original
mammographic modality'' in which they were performed (see Sec.
900.12(c)(1)), must be retained in retrievable form in the mammographic
modality in which they were produced (see Sec.  900.12(c)(4)(i)), and
cannot be produced by copying or digitizing hardcopy originals (see
Sec.  900.12(c)(4)(i)). For mammographic images obtained by screen-film
mammography, this means that the original films that were performed and
used for interpretation must be retained, and they cannot be copied,
scanned, or digitized to meet the record retention requirement.
Mammographic images obtained by FFDM or DBT must be retained in digital
format. In the rare situations in which FFDM images, which are produced
in a digital format, are then printed and interpreted on hardcopy film,
the facility may choose to retain this hardcopy print alongside the
digital data, but if this hardcopy in turn is scanned or digitized,
such scan cannot be the sole record of the examination that is
retained. To ensure compliance with the requirement to maintain the
original mammograms in Sec.  900.12(c)(4)(i) and (ii), digital (FFDM or
DBT) images must be retained such that the file format and all other
characteristics of the original digital image files are preserved.
Moreover, to ensure compliance with this requirement any CAD markings
placed by computer software after the mammographic images are obtained,
and which typically overlie and obscure portions of the image, must be
removable and the images must be capable of being displayed without the
CAD marks. A facility may choose to retain a set of the images with
permanent CAD marks, but this set of images alone would not meet the
retention requirement. FDA does not believe that these requirements
should be effective earlier than the other provisions of the rule.
    (Comment 99) Several comments recommend requiring facilities to
store and transfer images in Digital Imaging and Communication in
Medicine (DICOM) format. A comment recommends that DICOM be required so
that proprietary file formats, which receiving facilities may not be
able to view, are not used.
    (Response 99) FDA disagrees with these comments. Although FDA
acknowledges that DICOM is currently the predominant format used for
image files in medical imaging, requiring the use of a specific file
format in the MQSA regulations is overly restrictive and may limit the
future development of alternative formats, including formats that offer
improvements.
    (Comment 100) Comments were received that recommend the use of
lossy compression for digital mammogram images.
    (Response 100) FDA disagrees with these comments. Section
900.12(c)(4)(i) of this final rule states that a facility ``Shall . . .
maintain the mammograms and mammography reports in a permanent medical
record of the patient'' for a specified time period, and Sec.
900.12(c)(4)(ii) states that a facility ``Shall upon request by, or on
behalf of, the patient, permanently or temporarily transfer the
original mammograms and copies of the patient's reports to a medical
institution, a physician or healthcare provider of the patient, or to
the patient directly'' during this time period. Thus, the facility must
retain the original mammogram, and must have it available for transfer
upon request. Because lossless compression permits complete
reconstruction of the image data, images undergoing such compression
would be generally considered to be ``original'' mammograms for the
purposes of Sec.  900.12(c)(4) (this aligns with statements made by FDA
in the PGHS (Refs. 46 to 48) regarding lossless compression of digital
mammographic images). In contrast, images that have undergone lossy
compression, which does not maintain all of the data related to the
mammogram image files, would generally not be considered to be
``original'' mammograms for the purposes of Sec.  900.12(c)(4).
Transferring images that have undergone lossy compression would have
potential consequences regarding the ability to process the digital
mammogram files, and potential implications for the visualization of
both normal tissue and abnormalities that may extend beyond the
subjective image quality. While we acknowledge that data storage and
transfer may pose significant considerations for facilities, we do not
believe there is consensus on what loss of information is acceptable
while maintaining the standards to be able to review and/or transfer
the original mammogram images as required in the regulations.
    (Comment 101) FDA received several comments that requested
clarification on the conditions by which digital mammogram files are
transferred between facilities, including the permissibility of
downloading images from one facility to another, digitization of
comparison images, and uploading of digital mammogram images from a
compact disc (CD) to a receiving facility's picture archiving and
communication system (PACS). A separate comment recommends that FDA
require that mammograms be available for electronic transfer rather
than by using physical media such as a CD. Another comment recommends
that FDA develop a cloud-based or electronic repository of mammogram
images for all MQSA-certified facilities.
    (Response 101) Section 900.12(c)(4)(ii) and (iii) of this final
rule address the transfer of original mammograms and release/provision
of copies of mammograms, respectively. The Agency wishes to clarify its
use of the terms transfer and release/provision of copies. In these
regulations, ``transfer'' means the conveyance of the mammogram such
that the sending facility no longer retains it. Screen-film
examinations often are transferred; transfer of FFDM and DBT
examinations is extremely rare because the original images are
typically retained in the sending facility's PACS even when copies are
released upon request. In the final rule, FDA distinguishes between
``interpretation'' (i.e., initial, repeat, or additional review of a
mammogram), for which an examination must be presented in the original
mammographic modality in which it was performed (see Sec.  900.12(c)(1)
in this final rule), and ``comparison'' (i.e., using a mammogram to aid
in the interpretation of another exam), which is not subject to that
requirement. Under the final rule, if transfer is requested, original
mammograms must be transferred in the mammographic modality in which
they were produced. Also, under the final rule, for interpretation
purposes (including ``second opinion'' or additional interpretation),
digital examinations must be presented to the IP in their

original digital modality. Thus, if a facility requests an FFDM or DBT
examination in order to perform a second or additional interpretation
at the request of the patient or their representative, the exam must be
provided in its original modality (FFDM or DBT, respectively). We note
that this may be accomplished either through transfer of the original
images (which is rare), following the processes described in Sec. Sec.
900.12(c)(4)(ii) and (iv) of this final rule, or through the release of
a digital copy, following the processes described in Sec.
900.12(c)(4)(iii) and (iv) of this final rule. FDA recognizes that many
facilities may request the release of copies of mammograms not for
interpretation of the requested exam, but for comparison purposes
(i.e., in order to aid the interpretation of a subsequent exam); such
release must follow the processes described in Sec.  900.12(c)(4)(iii)
and (iv) (see also Response 102 below).
    Technical methods of either transfer or release are not prescribed
by the final rule, and may include, but are not limited to the
following (assuming such transfers/releases otherwise comply with
applicable law): direct electronic transmission of digital mammogram
files that is arranged between two facilities utilizing Health
Insurance Portability and Accountability Act of 1996 (HIPAA)-compliant
and appropriate practices for privacy and data security; providing the
requesting facility with HIPAA-compliant remote electronic access to
the images in the PACS of the originating facility; the viewing of
digital mammogram images located on a physical storage medium such as a
CD; or the uploading of such images from a digital storage medium to a
receiving facility's PACS. FDA views all of these methods as meeting
the requirement to provide original digital images electronically. FDA
disagrees with the comment recommending that FDA require facilities to
have the capability to electronically transmit original images or
copies, rather than transmit via physical media such as CD-ROM, as FDA
believes such a requirement may be overly burdensome and could impact a
facility's ability to operate, which could reduce patient access to
mammography services. We also disagree with the recommendation that FDA
should develop and maintain a repository of mammogram images performed
at all MQSA-certified facilities. We note that while such a repository
could facilitate image comparison between facilities, there are
significant privacy concerns, and also concern for the expense and
resources required to establish and maintain such a repository. In
addition, it may be excessively burdensome for facilities to
participate in such a repository when facilities are already required
to retain original mammogram images.
    (Comment 102) A comment recommends that FDA develop a form asking
if a facility is able to view hardcopy images, and a similar comment
recommends that ``some consideration be given for facilities that no
longer have equipment suitable for viewing hardcopy images.'' A comment
also recommends that facilities should be required to transfer 2D
images and images from other breast imaging modalities only, but should
not be required to transmit DBT image sets due to their file size
unless specifically requested.
    (Response 102) FDA disagrees with the recommendation to develop a
form regarding hardcopy viewing capability. As discussed in Response
101, this final rule includes different requirements when transferring
original mammograms versus when releasing copies (see Sec.
900.12(c)(4)(ii) and (iii) of this final rule). We reiterate that, in
current practice, it is very rare for any facility to transfer a
digital mammogram, whether FFDM or DBT. For these digital modalities,
if a comparison is sought, typically only copies are provided, while
the original images are retained by the performing facility, i.e., they
are not transferred. The requirements in this final rule are less
stringent for the release of copies than for transfer of the original
examination. Either original images or exact copies of digital exams
may be used for interpretation (such as a second opinion) or comparison
(see Sec.  900.12(c)(1)). Copies of screen-film examinations may be
used for comparison but not for interpretation (see Sec.
900.12(c)(1)). However, FDA does not consider film copies of screen-
film examinations to be in the original mammographic modality for
purposes of Sec.  900.12(c)(1), and thus such copies may be used for
comparison but not for interpretation. As noted in Response 101, a
facility may provide a digitized or scanned copy of a hardcopy
original, such as a scan of a screen-film mammogram, either directly or
via physical storage media. Therefore, a receiving facility that cannot
view a hardcopy image may request a scanned or digitized copy for
comparison purposes; the original film is only required if it is being
submitted for interpretation, such as a second opinion. Note that this
rule does not specify any requirement for the type of images that must
be included when copies are released. Also, images from non-mammography
imaging modalities are outside the scope of this rulemaking.

M. Deadlines for Image Transfer and the Release of Copies

    (Comment 103) Several comments were received regarding ``transfer''
of comparison studies between facilities. A comment states that 15
calendar days is too long for a facility to transfer patient mammograms
if a final report is required within 21 to 30 days. A comment notes
that 15 calendar days is too accelerated a time for facilities to
transfer large image files such as those associated with DBT image
files when original images are requested for transfer. A comment agrees
with requiring transfer of images within 15 days, but it recommends
that FDA encourage facilities to transfer images within 7 days.
    (Response 103) FDA generally disagrees with these comments. As
noted in Responses 101 and 102, this rule distinguishes between
transfer of original examinations and release of copies. For digital
(FFDM and DBT) examinations, it is very rare to transfer the original;
when comparison is sought, typically a copy is released. However, under
this rule, the required timeframe is the same for either the transfer
of originals or the release of copies, and therefore this response
addresses both scenarios.
    FDA believes that requiring the transfer of original mammogram
studies, and the release of copies, within 15 calendar days of a
request provides adequate time for a comparison to be made and a
followup report to be issued (see Sec.  900.12(c)(4)(ii) and (iii)),
because the receiving facility will be aware of the deadline for
issuing the final report, and can prioritize making the necessary
comparison upon receiving the prior examination. FDA also notes that 15
days is the maximum amount of time allowed for a facility either to
transfer original mammogram studies or to release copies, and is
intended to be a baseline requirement, but we anticipate that the
transfer or release will frequently occur in less than 15 days. FDA
disagrees that 15 days is too little time for DBT studies to be
transferred (or copies to be released) between facilities, despite the
size of the image files, as the size of the file does not significantly
affect the time required to provide electronic access to it, transmit
it, or copy it. FDA believes that requiring the transfer of original
examinations or the release of copies within 7 days may not allow
adequate time for a facility to effect this transfer or release.

    (Comment 104) A comment recommends that the 15-day requirement for
the transfer of patient files be reconsidered since some records are
faxed or mailed and would be difficult for a facility to track, and
because there are already specific rules for medical recordkeeping,
making this requirement redundant.
    (Response 104) The 15-day deadline refers to the sending of (or
provision of electronic access to) the requested records by the sending
facility, not to their receipt by the receiving facility. FDA
acknowledges that delivery time may be delayed by factors that are
beyond the control of the sending facility, so the tracking time is not
included in the required timeline. Given the importance of ensuring
timely communication regarding final results of mammograms, FDA
disagrees that a deadline for facsimile transmission or delivery of
physical media is overly burdensome as to warrant the removal of this
requirement from the regulations. Moreover, although there may be other
applicable State and local medical recordkeeping requirements, such
requirements are subject to change/repeal and there may be no
requirements in certain States/localities. FDA believes it is important
that there be consistent Federal regulations that clearly specify a
timeframe in which a facility is required to transfer or release
patient files, as this may have a significant impact on a patient's
care and management.
    (Comment 105) A comment recommends that FDA provide a guidance
document that explains how a facility can demonstrate compliance with
the records transfer and release requirements, including the method of
determining the dates at which relevant actions occur.
    (Response 105) We believe the records transfer and release
requirements in this final rule, including the method of determining
the dates at which relevant actions occur, are sufficiently clear. If
facilities have specific questions about applicability to their
situation, we believe such questions would be best addressed by
directing the questions to FDA's MQSA Facility Hotline or the
facility's AB.

N. Facility Closure and Mammography Record Retention

    (Comment 106) A comment recommends that FDA create standard forms
for use by closing facilities to communicate with patients and
healthcare providers. Another comment recommends that the patients of a
facility that closes or ceases mammography services should be notified,
and a comment recommends defining the term ``reasonable efforts'' to be
made in notifying affected patients.
    (Response 106) Due to the variety of circumstances that may lead to
the closure or cessation of mammography services at a facility, FDA
believes that a standard form would not be feasible. This final rule
requires that a facility that closes or ceases to provide mammography
services notify its AB and certification agency of the arrangements
that the facility has made, including making reasonable efforts to
notify all affected patients (see Sec.  900.12(c)(4)(v)). FDA believes
this process will enable the AB and certification agency to assess the
specific circumstances of the facility to help ensure that reasonable
efforts are made by the facility to notify affected patients.
Reasonable efforts may include, but are not limited to, sending written
notification to patients using a traceable method, speaking directly to
patients by telephone, or asking referring providers to reach those
patients who the facility was unable to contact directly after
attempting the above methods. However, FDA acknowledges the wide range
of circumstances and unique factors that may be related to the
reasonableness of a facility's efforts to notify all affected patients,
and therefore this final rule requires the facility to discuss its
notification efforts with its AB and certifying agency.
    (Comment 107) A comment recommends that FDA include a requirement
that before a facility closes or ceases performing mammography
services, the facility must arrange for the permanent transfer of
records to a facility that will provide access for at least 24 months.
    (Response 107) FDA disagrees with this comment. Section
900.12(c)(4)(v) of the final regulations states that a facility that is
closing or ceasing to perform mammography services must permanently
transfer mammographic records to a patient or the patient's healthcare
provider, or transfer the mammographic records to another facility or
entity that will provide access to those records for the patient or the
patient's healthcare provider for the time periods specified in Sec.
900.12(c)(4)(i), which are longer than 24 months. Because mammography
records can be of continuing value to a patient's care, the Agency
believes that they should remain accessible for the same length of time
whether they were performed at a facility that continues to perform
mammography or whether they were performed at a facility that has
closed or ceased to perform mammography. Therefore, the time periods
for retention specified in Sec.  900.12(c)(4)(i) apply from the date of
performance of the exam at the facility through the time after records
are transferred from facilities that close or cease to perform
mammography to another facility or entity that will provide access to
patients and healthcare providers (see Sec.  900.12(c)(4)(v) of this
final rule).
    FDA also believes that if a mammography facility that is part of a
medical entity such as a radiology practice or hospital ceases to
perform mammography, but the medical entity does not close, the medical
entity may be able to continue to retain and release the mammography
records in a manner consistent with the requirements in Sec.
900.12(c)(4)(i) through (iv). Accordingly, we are revising the proposed
requirement that a facility must make arrangements for access by
patients and healthcare providers to their mammographic records before
the facility closes or ceases to provide mammography services, in Sec.
900.12(c)(4)(v), to add that ``If a facility ceases to perform
mammography but continues to operate as a medical entity, and is able
to satisfy the recordkeeping requirements of Sec.  900.12(c)(4)(i)
through (iv), it may choose to continue to retain the medical records
rather than transfer them to another facility, unless such a transfer
is requested by, or on behalf of, the patient.''

O. Mammography Medical Outcomes Audit

    (Comment 108) Several comments recommend that FDA provide
additional guidance regarding the medical outcomes audit, including
clarification of the definition of a positive study, specifying which
method should be used to calculate the PPV, and differentiating between
screening and diagnostic mammogram studies when calculating PPV.
Related comments recommend the use of a patient's screening interval,
which may or may not be 1 year, as the time period over which to
calculate PPV, and updating the definitions of positive and negative
studies in the MQSA implementing regulations to conform to the
definitions in the ACR BI-RADS 5th edition (Ref. 49).
    (Response 108) In Sec.  900.2(mm), a positive mammogram is defined
as a mammogram that has an overall assessment of findings that are
either ``suspicious'' or ``highly suggestive of malignancy.'' This
definition was used in the discussion of the metrics for the outcomes
audit within Sec.  900.12(f). The MQSA and its implementing regulations

apply to all mammograms, including those performed for either screening
or diagnosis. In this final rule, only for the purposes of calculating
the audit metrics, FDA has acknowledged the distinct clinical roles of
screening mammography and diagnostic mammography. For clarification, in
this final rule we are replacing the phrase ``For the purposes of these
requirements'' in the medical audit outcomes provision with the phrase
``For the purposes of these audit requirements'' (see Sec.
900.12(f)(1) in this final rule).
    We note that the clinical practice community recognizes several
different methods for calculating the PPV, including the PPV1, PPV2sc,
PPV2dx, and PPV3 (Refs. 49 and 50.). Of these variants, the PPV2sc
includes the outcomes of all biopsy recommendations, whether that
recommendation resulted directly from a screening mammogram (a sequence
that is clinically discouraged (Ref. 49) and rarely occurs in practice)
or from a subsequent diagnostic mammogram performed after an abnormal
screening mammogram. As stated in Sec.  900.12(f)(1)(i) in this final
rule, FDA will require facilities to calculate the PPV as the percent
of patients with positive mammograms who are diagnosed with breast
cancer within 1 year of the date of the mammographic examination. This
metric is essentially identical to the PPV2sc used by the clinical
practice community, and uses a 1-year interval like the PPV2sc. The use
of this metric is considered a minimum requirement; facilities are also
permitted to calculate additional PPVs using other methods if they
choose to do so. However, FDA disagrees with the recommendation to
adopt definitions from a particular edition of a particular clinical
practice guideline, to avoid restricting the future development of
mammography practice.
    (Comment 109) Several comments also recommend clarification of the
definition of cancer detection rate (CDR) and recommend separate
calculations for CDR for screening and diagnostic mammogram studies.
    (Response 109) FDA recognizes that the clinical practice community
uses various methods for calculating CDR, including calculating CDR
only for screening mammograms, or separately for screening and
diagnostic mammograms. The CDR calculation required by this final rule
(see Sec.  900.12(f)(1)(ii) in this final rule) is a single calculation
for CDR for screening mammograms. As with Response 108, regarding PPV,
the calculation method for CDR in this final rule is also considered a
minimum requirement. Facilities are permitted to calculate CDR using
additional methods if they choose to do so. However, FDA also notes
that the PPV required by Sec.  900.12(f)(1)(i) of this final rule is
essentially equivalent to the CDR calculation for diagnostic
mammograms, so by meeting the requirements of this final rule,
facilities will be calculating both the CDR for screening mammograms
and a value (i.e., PPV) using a calculation that is essentially
equivalent to the calculation done for the CDR for diagnostic
mammograms.
    (Comment 110) A comment states that in BI-RADS, a screening
mammogram assessed as either category 0, 3, 4, or 5 (i.e., Incomplete,
Probably Benign, Suspicious, or Highly Suggestive of Malignancy,
respectively) is considered positive, and may be suggesting that FDA
adopt this approach.
    (Response 110) This final rule states that recall rate will be
calculated as the percentage of screening mammograms given an
assessment of ``Incomplete: Need additional imaging evaluation'' (see
Sec.  900.12(f)(1)(iii)). We note that assigning any of the other
assessments mentioned by the commenter--Probably Benign, Suspicious, or
Highly Suggestive of Malignancy--to a screening mammogram is clinically
discouraged (Ref. 51) and rarely occurs in practice.
    (Comment 111) Several comments recommend that FDA offer further
guidance on how facilities should interpret medical outcomes data and
derive performance data. A comment recommends linking the medical
outcomes data with cancer registries.
    (Response 111) The medical outcomes audit is intended to allow each
facility to assess and improve its own performance. FDA's finalized
metrics of PPV, CDR, and recall rate for the outcomes audit are minimum
requirements; facilities are not restricted from calculating additional
metrics if they choose to do so. Regarding the recommendation to link
medical outcomes data with cancer registries, this is outside the scope
of this rule, although the regulations do not prohibit facilities from
adopting this practice.
    (Comment 112) Comments recommend that mammograms used for
localization should have no numeric value and should be excluded from
medical outcomes audits.
    (Response 112) FDA agrees that mammograms used for localization
should be excluded from the medical outcomes audit, and the required
calculations in Sec.  900.12(f)(1)(i) through (iii) in this final rule
do not include mammograms that are in this category. As noted in
Responses 38 and 108, only a mammogram that receives an overall
assessment of either ``suspicious'' or ``highly suggestive of
malignancy'' is defined as a positive mammogram (see Sec.  900.2(mm)).
This final rule adds the assessment category ``Post-Procedure Mammogram
for Marker Placement'' (see Sec.  900.12(c)(1)(iv)(G)), which may be
assigned in the clinical scenario described in this comment. If a
mammogram receives the assessment ``Post-Procedure Mammogram for Marker
Placement,'' rather than the positive assessment of ``suspicious'' or
``highly suggestive of malignancy,'' then it is not a positive
mammogram, and should not be counted in any audit calculations that
track the outcomes of positive mammograms.
    FDA also reiterates that all of the assessment statements in the
MQSA regulations are comprised exclusively of words or phrases, as
noted in Response 35, and do not include numeric values or codes (see
Sec.  900.12(c)(1)(iv) and (v) of this final rule); code numbers are
used together with assessments in some clinical practice guidelines,
such as ACR BI-RADS, but are not part of the approved assessment
statements.
    (Comment 113) A comment recommends maintaining the current medical
outcomes audit requirements, as the comments states that additional
requirements in the proposed regulations will result in inspection
failures at facilities with limited resources.
    (Response 113) FDA disagrees with the comment. The Agency believes
that it is appropriate to provide the additional requirements for the
medical outcomes audit that are included in this final rule (see Sec.
900.12(f)(1)). The three additional metrics in this final rule are
widely acknowledged in the clinical practice community and are already
in wide use in mammography practices. Because all certified facilities
already perform a medical outcomes audit, which for many facilities
already includes these specific metrics, we believe that adding these
metrics to the requirements will not be unduly burdensome. Also, we
note that although MQSA inspectors will check whether each facility is
performing these calculations, those inspectors generally will not
document the specific values obtained by the audit.
    (Comment 114) Several comments recommend additional clarification
regarding the medical outcomes audit, including how it relates to
annual facility inspection, how long it should be retained, and who has
access to the audit.

    (Response 114) During a facility's annual inspection, the inspector
generally will verify that a facility has completed its medical
outcomes audit during the time period for which the annual inspection
is evaluating the facility, or (in the event the inspection occurs
during the first 2 years of the facility's operation) will verify that
the facility has established the required audit procedures and
designated an audit IP (Ref. 18). This final rule requires that
facilities, at a minimum, calculate the PPV, CDR, and recall rate (see
Sec.  900.12(f)(1) in this final rule), and the inspector generally
will check whether these three metrics, at a minimum, have been
calculated, or that the procedures for calculating them are in place,
as applicable. However, FDA does not anticipate that the inspector will
document the specific values obtained by the medical outcomes audit.
The inspector will generally verify that the audit IP has notified each
IP at the facility of their respective individual audit results and the
facility's aggregate results, or, in the event the inspection occurs
during the first 2 years of the facility's operation, generally will
verify that the facility has established a procedure for such
notification. The inspector generally will also verify that the audit
IP has documented any followup actions taken, or that the facility has
established a system for such documentation. Because the audit
information is subject to inspection, at a minimum, the data must be
retained by the facility until the MQSA inspection that covers that
medical outcomes audit (see Sec.  900.12(f)(4)). After the MQSA
inspection that covers that medical outcomes audit, the facility and
the audit IP may determine any ongoing utility of the medical outcomes
audit data, and may elect a longer retention time if this is deemed
beneficial to the facility. As noted, Sec.  900.12(f)(3) requires that
each IP be notified of that IP's respective individual audit results
and the facility's aggregate results; beyond this requirement, the
facility and the audit IP can determine who else, if anyone, may have
access to the data.

P. Patient and Referring Provider Notification

    (Comment 115) A comment recommends that FDA and the State
certification agency be required to directly notify patients and
providers, and that they may use mass media only if all other options
for direct notification have been exhausted, for PPNs, when a facility
is not able or willing to perform the PPN.
    (Response 115) FDA disagrees with the comment. The Agency notes
that some facilities that have been required to perform a PPN have
reported that they were unable or unwilling to do so, but the
circumstances of each facility differed. This provision of the rule
(see Sec.  900.12(j)(2) of this final rule) expressly states that FDA
or a State certification agency may notify the affected population if a
facility is unable or unwilling to perform such notification. The
requirement recommended in the comment could cause significant delays
in notification of affected patients and their providers, related to
both the attempt to identify all possible options and the practical
considerations of performing individual notification. If a facility is
unable or unwilling to perform a required PPN, FDA intends that State
certification agencies and FDA will act in the manner that best serves
the interests of public health and will consider the specific
circumstances when selecting the method(s) for notification of patients
and healthcare providers.
    (Comment 116) A comment recommends that the description of non-
physician healthcare providers in Sec.  900.12(j)(2) (i.e., ``other
healthcare providers''), in the context of PPNs, be included earlier in
the final regulations.
    (Response 116) FDA agrees with the comment. The reference to non-
physician healthcare providers in Sec.  900.12(j)(2) in this final rule
revises this specific provision in the 1997 MQSA final rule (62 FR
55852), which previously listed only patients and their referring
physicians as parties who must be notified in the event of a PPN. This
revision is intended to address notification of non-physician referring
providers when their patients are among the affected PPN population.
However, we agree that some earlier references in the regulations to
referring physicians should also be revised to use or incorporate the
term ``healthcare provider.'' In this final rule, FDA is either
replacing the word ``physician'' with the term ``provider'' or
``healthcare provider,'' or adding one of these terms in addition to
``physician,'' in Sec. Sec.  900.2(c)(2), 900.2(k), 900.2(ii),
900.4(f)(1)(ii)(B), and 900.12(j). Some other sections of the
regulations already use the term ``provider,'' and FDA believes that
this term in those instances remains accurate (see Sec. Sec.
900.12(c)(1)(vi), 900.12(c)(2)(i) and (ii), 900.12(c)(3),
900.12(c)(3)(i) and (ii), 900.12(c)(4)(ii)).

Q. Revocation of Certification

    (Comment 117) A comment recommends using boldface text to state
that a State agency that is an FDA-approved State certification agency
(SCA) under the States-as-certifiers provision may suspend or revoke a
certificate.
    (Response 117) FDA understands the concern for readability of the
regulations; however, FDA is unable to change the typeface and font
used for display and printing of regulations in the CFR, as such
stylistic issues are determined by the U.S. Government Publishing
Office for the entire Federal government. For clarification, part 900,
subpart C (``States as Certifiers'') establishes the procedures for a
State to apply to become an FDA-approved SCA, and the requirements and
standards for the SCA to use to ensure that all mammography facilities
are adequately and consistently evaluated for compliance with quality
standards at least as stringent as those established by FDA. SCAs are
required to have appropriate criteria and processes for suspension and
revocation of certificates and to have a process for appeals of
inspection findings, enforcement actions, and adverse certification
decisions (Sec.  900.22(d) and (e)). SCAs cannot suspend or revoke
certificates under the authority in Sec.  900.14, but instead are
required to have their own process for taking such actions.
    (Comment 118) A comment recommends that FDA define an operator of a
facility.
    (Response 118) FDA disagrees with this recommendation. The exact
role, responsibilities, and title of an operator varies depending on
the specific circumstances of the individual facility and operator.
Operators may include the lead IP, other IPs, QC technologist, other
radiologic technologists, medical physicists, or other staff, depending
on the circumstances. Operators may have varied responsibilities,
including but not limited to ensuring that a facility's quality
assurance program meets the requirements set forth in this final rule,
interpreting mammograms, evaluating the performance of mammography
equipment, positioning patients for radiographic examinations, or
performing other staff responsibilities at a facility.
    (Comment 119) A comment recommends that a facility that has had its
certificate revoked should not return to practice without probationary
oversight.
    (Response 119) FDA disagrees with this recommendation. Before a
facility whose certificate was revoked can return to the practice of
mammography, it will have to comply with all corrective actions
required by its AB. Additionally, under the MQSA, when a facility's
certificate is revoked, the owners and operators of the facility at

the time of the revocation may not own or operate a mammography
facility for 2 years (42 U.S.C. 263b(i)(3)). At the end of those 2
years, those operators will have failed to maintain their
qualifications under the MQSA and implementing regulations, and will be
required to reestablish qualification, each according to the
requirements for their profession (either Sec.  900.12(a)(1)(iv) for
IPs; Sec. Sec.  900.12(a)(2)(iii)(D) and 900.12(a)(2)(iv)(B) for
radiologic technologists; or Sec.  900.12(a)(3)(iv) for medical
physicists) before they may resume practice at a certified facility.
FDA thinks that the facility and its operators will have received
sufficient training and completed sufficient corrective action before
they are permitted to return to practice. Furthermore, upon returning
to practice, the facility and personnel again become subject to all
accreditation and certification requirements of the AB and FDA (or
SCA).

R. Interpreting Physician Qualifications, Including Continuing
Experience

    (Comment 120) Several comments were submitted regarding the
continuing experience and continuing education requirements for IPs.
Comments recommend: (1) increasing the number of mammographic
examinations that an IP must interpret to satisfy the continuing
experience requirement; (2) adding a requirement for a minimum number
of diagnostic mammograms that must be read; (3) requiring continuous
feedback to IPs on individual cases rather than only at the time of the
annual medical outcomes audit; (4) requiring that IPs ``work up'' their
own recalled cases; and (5) requiring that IPs at facilities with lower
volumes and in low-income areas be exposed to more mammography
examinations.
    (Response 120) (1) Regarding the number of mammographic
examinations an IP must interpret to satisfy the continuing experience
requirement, although FDA acknowledges that there may be certain
benefits to increasing the continuing experience requirement, this must
be weighed against a potential loss in access to mammography services
if IPs are unable to satisfy these increased requirements. FDA believes
that the current continuing experience requirements, as described in
Sec.  900.12(a)(1)(ii), represent a reasonable balance between the
goals of maintaining an IP's ongoing ability to interpret mammograms
and preserving access to mammography services at facilities across the
country.
    (2) Regarding an additional requirement for a minimum number of
diagnostic mammograms versus screening mammograms, FDA again believes
that while there may be certain benefits with such a requirement,
establishing such a requirement may adversely impact the ability of IPs
who work in varied settings to meet these requirements and to continue
interpreting mammogram studies, again potentially impacting access to
mammography services. Furthermore, as noted in Response 108, with the
exception of the outcomes audit requirements (see Sec.  900.12(f) in
this final rule), the MQSA regulations do not distinguish between
mammograms performed for screening or diagnosis.
    (3) Regarding the recommendation for requiring continuous feedback
on individual cases to IPs, FDA notes that there is a requirement in
Sec.  900.12(i) that ``[c]linical images produced by any certified
facility must continue to comply with the standards for clinical image
quality established by that facility's accreditation body.'' To ensure
compliance with such standards, facilities conduct regular periodic
reviews of the image quality of samples of the images performed by each
RT and the images accepted for interpretation by each IP (see Ref. 52).
This is a mechanism for providing periodic image quality feedback to
IPs. The Agency believes that this requirement, together with the
requirement to provide IPs with outcomes feedback from the annual
medical outcomes audit and the requirements for continuing education
and continuing experience are reasonable and appropriate to ensure an
IP's ongoing ability to interpret mammographic examinations.
    (4) Regarding the recommendation that IPs be required to work up
their own recalled cases, FDA notes that workflow as well as personnel
schedules vary across facilities; also, some facilities perform only
screening and not diagnostic mammograms. Therefore, we believe that
such a requirement would be significantly burdensome for facilities to
implement, and may be both impractical and restrictive for scheduling,
both for the IP and for the patient, which could lead to decreased
access to mammography services.
    (5) Regarding IPs at lower volume facilities or in areas with a
low-income population, such IPs are required to meet the continuing
experience requirements (see Sec.  900.12(a)(2)(ii)). FDA believes that
placing additional requirements on IPs at these facilities would be
detrimental to these facilities' ongoing ability to operate and provide
services to their patient populations. As with other MQSA requirements,
the continuing experience requirement is a baseline national standard;
the MQSA regulations do not prohibit IPs from obtaining additional
experience nor facilities from requiring that their employees obtain
additional experience.
    (Comment 121) A comment recommends that continuing education be
specifically required to be obtained through active, case-based
learning, and test sets with feedback.
    (Response 121) FDA disagrees with the comment, and so has not
incorporated this requirement in the final rule. FDA believes that the
continuing education requirements for IPs, as described in Sec.
900.12(a)(1)(ii)(B), are appropriate and adequate to ensure the ongoing
education of IPs in mammography. Adding specific requirements such as
those recommended by the commenter may be overly burdensome, risking a
decrease in personnel and in patient access to mammography services.
FDA also notes that specific requirements for active, case-based
learning and for test sets with user feedback may be confusing to IPs
and facilities determining how to satisfy such requirements.
    (Comment 122) A comment recommends that double-reading be required
for some IPs, such as newly trained IPs, requalifying IPs, or those who
do not meet benchmarks.
    (Response 122) FDA disagrees with the comment, and has not added
this requirement in the final rule. FDA believes that the requirements
for initial qualification of IPs, as described in Sec.
900.12(a)(1)(i), and for requalifying IPs, as described in Sec.
900.12(a)(1)(iv), are adequate, and in both of these situations, there
is already a requirement for interpretation of certain numbers of
mammograms under the direct supervision of a qualified IP. The MQSA and
part 900 do not contain specific benchmarks for the performance of IPs
in the interpretation of mammograms, and while we note that careful
review of the results of the annual medical outcomes audit may be
beneficial for IPs and informative in guiding their selection of
continuing education to address areas where improvement is needed, we
do not agree that it is necessary to introduce a requirement for
additional supervised interpretation for qualified IPs.

S. Cleaning of Mammography Equipment

    (Comment 123) A comment recommends that the MQSA regulations be
more specific regarding when and how mammography equipment should be
cleaned.

    (Response 123) FDA disagrees that more specificity is needed in
these regulations regarding this issue. The regulations already
describe processes that facilities must follow regarding cleaning and
disinfecting mammography equipment (see Sec. Sec.  900.12(e)(11)(ii)
and 900.12(e)(13)). The Agency is not aware of information showing that
the existing requirements have led to contamination of equipment. This
final rule does not provide additional requirements beyond those
already specified because we believe that these requirements are
adequate in their detail regarding the cleaning and disinfecting of
mammography equipment.

T. Availability and Clinical Role of Breast Imaging Modalities,
Screening Mammography Guidelines

    (Comment 124) A comment recommends that facilities should be
required to offer 3D mammography (i.e., DBT) and ultrasonography within
6 months of publication of this final rule; another comment recommends
that facilities should be required to offer DBT within 10 years of
publication of this rule; and a comment recommends that every
mammography facility should be required to have at least one 3D
mammography unit. A different comment suggests that a list of
facilities offering advanced technologies, including 3D mammography,
should be published.
    (Response 124) FDA disagrees with these comments. Various devices
cleared or approved by FDA are respectively capable of performing
examinations using different mammographic modalities, including screen-
film, FFDM, and DBT; the choice of the specific technology used to
image each patient is a decision by the IP and the patient's referring
healthcare provider, if any. FDA does not require facilities to offer
specific equipment or particular imaging modalities. Additionally, as
stated in the proposed rule, Executive Summary section I.A, the MQSA
and implementing regulations are designed to ensure that all patients
nationwide have access to quality mammography services, and FDA is
concerned that instituting a requirement to use only more expensive
technology (e.g., DBT) may place a significant financial burden on
facilities, potentially impacting their ability to operate, which may
then reduce patient access to mammography services. Regarding the
recommendation to publish a list of facilities offering 3D mammography,
FDA does offer a public database of all certified facilities (Ref. 53),
but the Agency thinks that including information on the equipment at
each facility would be impractical, as equipment changes at facilities
may occur at irregular and potentially frequent intervals, including
both the introduction and removal of equipment, which may impact the
accuracy of the information in such a list.
    (Comment 125) Many comments recommend the use of specific medical
imaging technologies, including 3D mammography and other modalities
such as ultrasound and MRI, in varying clinical situations for the
examination of patients with dense breasts. Specifically, several
comments recommend that women with dense breasts should either have
only 3D mammography performed, or have both 3D mammography and
ultrasound performed, with a comment recommending that mammography and
ultrasound should be performed every 3 months, or that imaging
modalities other than mammography should be used. A comment recommends
that information regarding the benefits of 3D mammography be provided
to patients. Conversely, another comment recommends that 3D mammography
be pulled from use until additional safety and efficacy studies have
been performed due to its higher radiation dose compared to 2D imaging.
Another comment recommends that patients be provided with information
on ultrasound and that women should be able to choose to have either a
mammogram or an ultrasound.
    (Response 125) FDA disagrees with incorporating these
recommendations into the regulations. Certain 2D and 3D (i.e., DBT)
mammography equipment has been approved or cleared by FDA following
FDA's review of a premarket approval application or premarket
notification (510(k)) submission. The choice of particular breast
imaging modalities or screening time intervals, whether for patients
with dense breasts or for any other patients, is a decision for
healthcare providers to make in caring for their patients. Likewise, we
defer to healthcare providers on provider-patient discussions regarding
use of ultrasound or other tests when caring for their patients.
    (Comment 126) Several comments recommend that providers be notified
of the possibility that additional imaging modalities may be needed.
    (Response 126) The consideration of the benefits, risks, and uses
of various tests or imaging modalities is most appropriately left to
the licensed healthcare provider. We decline to incorporate this
recommendation.
    (Comment 127) Several comments recommend that patients be informed
of other options for breast imaging such as molecular breast imaging
(MBI), ultrasound, and MRI. A comment also recommends that patients be
informed that their health insurance plan may not cover these tests.
    (Response 127) FDA disagrees with adding a requirement to the
regulations to inform patients of other options for breast imaging,
including because the options for breast imaging may change with
technological advancements. The required density notification language
in the final rule includes a recommendation that all patients discuss
their individual situation with their healthcare provider (see Sec.
900.12(c)(2)(iii) and (iv)), and advises patients with dense breasts
that in some people with dense tissue, other imaging tests in addition
to a mammogram may help find cancers (see Sec.  900.12(c)(2)(iv)).
Insurance coverage and reimbursement are outside the scope of these
regulations; furthermore, FDA is also concerned that including
references to insurance coverage in the lay summary may distract from
the information in the breast density notification.
    (Comment 128) Several comments suggest that MBI should be
recommended to patients, be added to a list of supplemental screening
methods, or have information about it provided to patients.
    (Response 128) FDA believes that decisions about the use of various
imaging modalities, including whether or not to consider them, are more
appropriate for the healthcare provider to make, as they can take into
consideration their understanding of the specific patient and the
patient's needs from their relationship with the patient and medical
history.
    (Comment 129) A comment recommends that FDA approve thermography
and ultrasound used together as an alternative to mammography.
    (Response 129) As we noted in various responses, the MQSA applies
only to mammography activities. Accordingly, breast sonography and
thermography are both outside the scope of this rulemaking and are both
outside the scope of the MQSA. Additionally, FDA has issued a Safety
Communication (Ref. 54) and a Consumer Update (Ref. 55) that warn that
thermography is not an effective alternative to mammography, and that
there is no valid scientific data to demonstrate that thermography
devices, on their own or with another diagnostic test, are an effective
screening tool for any medical condition, including the early detection
of breast cancer. People who choose thermography instead of

mammography may miss the chance to detect breast cancer at its earliest
and most treatable stages.

U. Clinical Decision-Making

    (Comment 130) A comment recommends that healthcare facilities be
required to arrange mammography appointments for patients on the same
day that a clinical breast exam is performed. Another comment
recommends that healthcare providers be required to schedule followup
appointments with patients reported to have dense breasts, and a
comment recommends that physicians use shared decision-making with
their patients. Several comments recommend that IPs be able to assume
the role of healthcare provider for a patient with no referring
provider, and that the IP should be able to order additional imaging
studies such as ultrasound. A comment also recommends that patients be
able to self-refer for supplemental breast imaging.
    (Response 130) FDA agrees that providing timely breast imaging
services to patients is important. However, the scope of the MQSA is
limited to the regulation of mammography facilities and their
activities (see 42 U.S.C. 263b(a)(3)), as opposed to regulation of more
general healthcare provider practices, such as the ordering of imaging
studies or general followup with patients by their primary care
physician or referring provider. Radiologist ordering of additional
imaging studies and patient self-referral for imaging are both largely
dependent on State or local requirements or specific facility policies
and are outside the scope of this rulemaking (see also Responses 70,
89, 90, 125, and 131).
    (Comment 131) A comment recommends that breast imaging centers
should not refuse to perform annual mammography on patients with dense
breasts. A comment recommends that facilities should interpret
mammograms in real time and add ultrasound for patients with dense
breasts. Another comment recommends that radiologists use all available
technologies to determine breast density.
    (Response 131) The MQSA regulations do not take a position on the
frequency or interval for screening mammography, as these vary and FDA
generally defers to healthcare providers on such matters involving
clinical decision-making with their patients. Similarly, other than the
requirement to issue the report and lay summary (following
interpretation of the mammogram) within respectively specified time
periods (see Sec.  900.12(c)(2) and (3) in this final rule), the timing
and workflow for the interpretation itself is generally outside the
scope of this rule. FDA notes that imposing a requirement to interpret
examinations in real time may be overly burdensome to many facilities
and may impact their ability to operate, thus reducing patient access
to mammography services. The recommendation to require facilities to
add ultrasound or other non-mammographic breast imaging modalities is
outside the scope of authority of the MQSA, and is addressed in
responses to other comments (see Responses 2, 4, 6, 41). FDA also
concludes that a requirement for facilities to use all available
technologies, or any particular technology, to determine breast density
is overly burdensome and would unnecessarily restrict facilities both
in terms of the resources and time required to acquire the equipment
and to implement such a requirement. Also, the MQSA regulations do not
require the use of specific devices; similarly, no AB is permitted to
require the use of specific devices or products as a condition of
accreditation (see Sec.  900.4(a)(5)).
    (Comment 132) Comments recommend that mammography patients should
be informed of the limitations and radiation risk of mammography and
asked to provide consent prior to undergoing mammography, and that
patients should be informed of the risk of overdiagnosis and
overtreatment of breast cancer due to screening mammography.
    (Response 132) As noted in Response 131, the clinical indications
used to decide when to perform a mammogram are more appropriate for the
referring healthcare provider to consider. FDA notes that the
healthcare provider who refers a patient for a mammogram can discuss
with that patient the benefits and risks of the examination, including
the implications of the potential results, and the patient and provider
can utilize shared decision-making to determine whether to proceed with
the examination. Additionally, although not addressed in the MQSA or
its implementing regulations, a critical component of FDA premarket
approval or clearance of any mammography equipment is a benefit-risk
analysis that considers the radiation exposure associated with imaging
with the device, among other information, before determining that the
device meets the standard for approval, clearance, or marketing
authorization when used according to its stated indications (Ref. 56).
    (Comment 133) A comment recommends that all mammograms should be
performed as screening mammography.
    (Response 133) The MQSA was passed to improve the quality of
mammography, regardless of the clinical scenario in which a particular
mammogram is recommended or performed. With the exception of the
medical outcomes audit, as discussed in Sec.  900.12(f)(1) in this
final rule, the MQSA and its implementing regulations do not
distinguish between screening and diagnostic mammography. As we noted
in Response 131, the choice of a screening time interval and other
clinical decisions related to mammography are more appropriate for the
healthcare provider in the course of clinical decision-making with the
patient.

V. Insurance Coverage

    (Comment 134) Many of these comments recommend the following: (1)
insurance should cover all breast imaging services, including
mammography, MRI, ultrasound, and breast biopsy procedures; (2)
insurance should be required to reimburse for ``3D breast imaging''
(this term is not specific, but the commenter may be referring to DBT,
which is a mammographic modality subject to MQSA); (3) insurance
coverage should not be impacted by a patient having dense breasts; (4)
insurance coverage should be mandated such that socioeconomic
disparities in treatment and outcomes will not be worsened; (5)
additional reimbursement per examination should be granted to
facilities in rural and underserved areas to cover the cost of new
equipment; and (6) genetic testing and patient education should be
provided at no additional expense to the patient. Another comment
suggests that FDA should limit the interest rate charged by equipment
manufacturers for facilities that finance equipment purchases from
them. Finally, several comments recommend requiring insurers, including
Medicare/Medicaid, to increase reimbursement for screening mammography
and to eliminate patient expense for annual mammograms for patients
aged 40 to 74 years and for high-risk patients aged 25 to 40 years.
    (Response 134) FDA considers the recommendations within these
comments to be outside the scope of its authority to regulate under the
MQSA or other authorities. We recognize that healthcare costs are a
significant concern to the public. FDA recommends that patients check
with their insurance company regarding coverage before

undergoing mammography examinations.

W. Economic Impact of This Rule

    (Comment 135) A comment asserts that the costs associated with MQSA
are high, and recommends that a less expensive way be found to
encourage and mandate that facilities use ``decent'' equipment and
personnel.
    (Response 135) To the extent the comment is about the cost of the
proposed rule, FDA disagrees with the comment. As discussed in the
proposed rule and elsewhere in this final rule, we considered costs and
benefits. We conclude that the current final rule represents an
appropriate balance between costs and benefits, with the goal of
improving mammography quality and the public health.
    (Comment 136) One comment expresses support for the modernization
of the MQSA regulations, but states that the ``breast x-ray examination
fee is relatively high in the proposed rules, which ranges from $600 to
$1,800,'' and recommends that the regulations provide examination
methods that are less expensive than mammography.
    (Response 136) FDA appreciates the commenter's support for the
regulations. We note that the commenter misunderstood the preliminary
economic analysis, which estimated at between $615.44 and $1,819.96 the
present value of the costs to each facility to implement the changes to
the MQSA regulations; these costs do not represent a fee charged to a
patient undergoing a mammogram. Furthermore, as we noted in Response
134, issues of insurance coverage and reimbursement are outside the
scope of FDA's authority.
    (Comment 137) Several comments state that the benefits estimated in
the Preliminary Regulatory Impact Analysis related to fatalities and
cost savings due to density reporting are not supported by existing
evidence, and that the estimates of costs of overtreatment and
overdiagnosis are omitted from the analysis.
    (Response 137) Recent research has shown that 7 percent to 11
percent of patients who are informed that they have dense breasts
undergo supplemental ultrasound screening (Refs. 57-59). 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 (Refs. 11, 32, and 60
to 62). 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
reduction in cancer fatalities. We use this existing evidence to
support our analysis related to quantified benefits of breast density
reporting requirements. These potential outcomes are discussed
qualitatively in the Final Regulatory Impact Analysis (FRIA) (Ref. 63).
Additionally, the density notification requirement does not discuss
additional clinical management beyond imaging. We believe that a
discussion of overtreatment and overdiagnosis of cancer is outside the
scope of this rulemaking, and so have not been addressed by this
analysis.
    (Comment 138) A comment suggests that the analysis be revised to
include distributional and equity effects.
    (Response 138) 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.

X. Federalism and the Relationship Between Federal and State Breast
Density Reporting Requirements

    (Comment 139) Some comments recommend that FDA clarify the
relationship between Federal and State breast density requirements, and
specifically: (1) whether facilities must always use the Federal breast
density notification language and (2) whether the Federal breast
density notification requirements preempt State requirements. If there
is preemption, a comment states that FDA should consider whether it has
adequate evidence to justify such preemption, consistent with Executive
Order 13132 (Ref. 64). Some of the comments submitted regarding
preemption seem to be addressing express preemption, whereas others
seem to be addressing implied preemption.
    (Response 139) With regard to the first question, all facilities
providing mammography services will be required to comply with FDA's
reporting requirements, regardless of whether there are applicable
State requirements. Under Sec.  900.12(c)(1)(vi), (c)(2)(iii), and
(iv), facilities must provide the breast density information specified
in those regulations in mammography reports to healthcare providers and
in lay summaries to patients. The regulations do not include exceptions
for facilities in States with breast density reporting requirements. As
discussed in Response 140, FDA believes these requirements are
critical, among other things, to ensuring that patients and healthcare
providers receive accurate, complete, and understandable breast density
information.
    With regard to the second question, Federal law can expressly
preempt State law when the text of a Federal statute explicitly
manifests Congress's intent to displace state law. Federal law also can
impliedly preempt State law when Congress's preemptive intent is
implicit in the relevant Federal law's text, structure, and purpose.
Courts have identified two subcategories of implied preemption--field
preemption and conflict preemption. Field preemption occurs when a
comprehensive scheme of Federal regulation implicitly precludes
supplementary State regulation. Conflict preemption occurs when
simultaneous compliance with Federal and State law is impossible
(``impossibility preemption'') or when State law poses an obstacle to
the accomplishment of Federal goals (``obstacle preemption'').
    Here, Congress included a preservation provision addressing State
laws, which provides: ``Nothing in this section shall be construed to
limit the authority of any State to enact and enforce laws relating to
the matters covered by this section that are at least as stringent as
this section or the regulations issued under this section.'' (42 U.S.C.
263b(m)). Thus, the statute preserves any State law that is ``at least
as stringent'' as the regulations issued by FDA under the MQSA. See
also 138 Cong. Rec. 33615 (October 7, 1992) (``The bill allows and
encourages states to carry out the certification program requirements
and to implement standards no less stringent than those of the national
program.'').
    Based on the preservation clause of the MQSA, FDA's reporting
requirements do not preempt State reporting requirements that are ``at
least as stringent'' as the Federal requirements. The provisions of the
MQSA, however, do not resolve which State reporting requirements, if
any, that are less stringent than the Federal requirements may be
subject to preemption. That analysis would be informed by the specific
provisions of the State laws in question, and FDA has not undertaken a
50-state analysis of all current State breast density reporting laws.
We note, however, that it is possible for a State breast density
reporting law to be preempted based on these regulations. For example,
if a State law theoretically were to prohibit facilities from providing
a breast density notification to patients with non-dense breasts, we
believe that law could be preempted because it would be impossible for
facilities to comply with

both the Federal law (which requires such breast density reporting) and
the State law (which forbids it). As another example, if a State were
to require a breast density statement that directly contradicts or
undermines a key message in FDA's breast-density reporting requirement
(such as the message that ``dense tissue makes it harder to find breast
cancer on a mammogram,'' or ``dense tissue . . . raises the risk of
developing breast cancer,''), that State law could be preempted on the
basis that it poses an obstacle to the accomplishment of FDA's goals in
communicating clear, consistent, and understandable information about
breast density to patients and healthcare providers.
    For further discussion of this final rule and the federalism
principles expressed in Executive Order 13132, please see other
responses in section X.
    (Comment 140) Several comments express concern with having
potentially two different breast density notifications for patients and
their healthcare providers, one required by Federal law and one
required by State law. The comments note that different notifications
could lead to patient confusion and be overly burdensome for
facilities. For these and related reasons, some comments recommend that
FDA include a clear statement that the Federal breast density reporting
requirements preempt State requirements, while other comments recommend
that FDA not require Federal breast density reporting language and
allow State language to be used instead, at least in certain
circumstances (e.g., so long as certain information is included in the
notification). One comment proposes that FDA develop a ``waiver''
process to allow the State to apply to FDA to use its alternative
notification.
    (Response 140) FDA declines to adopt these recommendations. As
previously explained, all facilities providing mammography will be
required to comply with FDA's reporting requirements, regardless of
whether there are applicable State requirements. As such, all patients
will receive information about their breast anatomy, and this
rulemaking will require consistent baseline information be provided.
But the statute does not authorize FDA to categorically assert
preemption over all State reporting requirements. As discussed in
Response 139, Congress specifically preserved State laws that are at
least as stringent as Federal law. Depending upon the circumstances,
some State laws could be found to be preempted, such as less stringent
State laws that make it impossible to comply with both Federal and
State requirements, or that stand as an obstacle to the accomplishment
of Federal goals. FDA has not performed a State by State analysis to
determine whether any specific, current State law may be subject to
preemption. FDA notes that no comment proffered a State law that was
asserted to be subject to preemption.
    We also disagree with the recommendation that FDA does not require
Federal breast density report language and allow certain State breast
density language to be used alone instead. Although FDA recognizes that
many States have their own breast density reporting requirements, the
Agency believes that consistent national breast density reporting
requirements are critical in order to ensure that: (1) breast density
reporting occurs in all States and (2) patients and healthcare
providers receive accurate, complete, and understandable breast density
information.
    First, the Agency believes it is important to ensure that patients
receive a baseline set of key breast density information. Not all
States currently have a breast density reporting requirement. If FDA
does not require breast density reporting, in those States that also do
not have reporting requirements, patients and their healthcare
providers generally would not receive any breast density information,
which raises significant public health concerns for all of the reasons
set forth in this preamble, and the preamble to the proposed rule.
    Second, even in those States that already have a breast density
reporting requirement, FDA believes there is value in having a single,
consistent set of FDA-required information shared with the public. FDA
breast density notification language is drafted by FDA subject-matter
experts, contains the information FDA believes is critical to
communicate, and is drafted using easily understandable language. FDA
does not have the resources to monitor all State laws, particularly as
they change over time, in order to ensure that the key information is
being communicated consistently and effectively to patients and
providers under State law. Requiring uniform breast density reporting
on a Federal level ensures that patients and providers nationwide
receive the appropriate information and avoids mistakes and gaps in
critical information being communicated to patients and their
healthcare providers.
    Regarding the comment that patients may be confused by receiving
Federal and State notifications and the recommendation that FDA should
take measures to avoid such confusion, we note that in this final rule
we have simplified the notification statements to patients with either
non-dense or dense tissue, using concise and understandable language,
and have concluded both statements with the recommendation, ``Talk to
your healthcare provider about breast density, risks for breast cancer,
and your individual situation'' (see Sec.  900.12(c)(2)(iii) and (iv)
in this final rule). We believe that the clear language and the
recommendation to talk directly to the healthcare provider will
minimize the likelihood of patient confusion.
    Regarding the potential burden on facilities, we believe the breast
density notification requirement established in this final rule is
simple for mammography facilities and Agency personnel to understand
and implement. Ultimately, FDA anticipates that it will be easier for
both facilities and the Agency if FDA requires uniform notification
language, which consists of specific language for the overall
assessment of breast density in the mammography report (see Sec.
900.12(c)(1)(vi)) and four to five lines of text in the lay summary to
patients (see Sec.  900.12(c)(2)(iii) and (iv)), as opposed to
permitting State language to be used alone in certain circumstances.
FDA is concerned that alternative approaches, such as requiring that
specific information rather than specific statements be communicated to
patients, would be complex, inefficient, and difficult to administer,
and would consume unnecessary resources in the long term. Moreover,
including FDA-required text in mammography reports and lay summaries
will not be unduly burdensome for facilities, including because
facilities will not need to expend resources in crafting their own
language. Rather, facilities will have to add the FDA-required text.
    (Comment 141) Several comments note that it may be difficult for
States and facilities to determine if State requirements are ``more
stringent'' than Federal requirements, and request that FDA provide
input to help determine what requirements are ``more stringent'' than
the Federal requirements.
    (Response 141) As explained in Response 140, all facilities
providing mammography services will be required to comply with FDA's
reporting requirements, regardless of whether there are applicable
State requirements. As discussed in Responses 139 and 140, FDA has not
conducted a State-by-State preemption analysis or evaluated whether
current State laws are more or less stringent than FDA breast density

reporting requirements. We note that FDA has defined ``[m]ore
stringent,'' albeit in regard to language used in section 521 of the
FD&C Act (21 U.S.C. 360k), as ``a requirement of greater
restrictiveness or one that is expected to afford those who may be
exposed to a risk of injury from a device a higher degree of protection
than is afforded by a requirement applicable to the device under the
act'' (21 CFR 808.3(c)).

Y. Effective Date of This Rule

    (Comment 142) A comment recommends that all provisions of the rule
except the density notification should become effective 6 months after
publication. Conversely, some comments assert that 18 months is an
inadequate period of time for facilities to implement the new
requirements under the rule. A separate comment recommends that FDA
consult with equipment manufacturers regarding an appropriate
implementation date.
    (Response 142) FDA disagrees with these recommendations. FDA does
not anticipate that facilities would be able to implement all of the
requirements of this rule into facility practice within 6 months
without undue hardship. Based on FDA's experience with the effective
date of the previous MQSA final rule (62 FR 55852), FDA concludes that
18 months is a practical timeframe for this final rule to take effect