Mammography Quality Standards Act, 15126-15171 [2023-04550]
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15126
Federal Register / Vol. 88, No. 47 / Friday, March 10, 2023 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 900
[Docket No. FDA–2013–N–0134]
RIN 0910–AH04
Mammography Quality Standards Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA, Agency, or we) is
issuing a final rule to update the
mammography regulations that were
issued under the Mammography Quality
Standards Act of 1992 (MQSA) and the
Federal Food, Drug, and Cosmetic Act
(FD&C Act). We are issuing updates to
modernize the regulations by
incorporating current science and
mammography best practices. These
updates are intended to improve the
delivery of mammography services by
strengthening the communication of
healthcare information; allowing for
more informed decision making by
patients and providers (by requiring
facilities to provide them with
additional health information); helping
to ensure the availability of qualified
mammography personnel; bolstering the
medical outcomes audit to provide
feedback to improve mammography
interpretations; modernizing
technological aspects of the standards;
and adding additional tools to deal with
noncompliant facilities.
DATES: This rule is effective on
September 10, 2024.
ADDRESSES: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number found in brackets in the
heading of this final rule into the
‘‘Search’’ box and follow the prompts,
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Preetham Sudhaker, Division of
Mammography Quality Standards
(DMQS), Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Silver Spring, MD 20993,
301–796–5911.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
I. Executive Summary
A. Purpose of the Final Rule
B. Legal Authority
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I. Executive Summary
A. Purpose of the Final Rule
Mammography is an x-ray imaging
examination used to identify signs of
breast cancer. For patients to receive the
Table of Contents
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C. Summary of the Major Provisions of the
Final Rule
D. Costs and Benefits of the Final Rule
II. Table of Abbreviations and Acronyms
Commonly Used in This Document
III. Background
A. Need for Amendments to
Mammography Regulations
B. Summary of Comments to the Proposed
Rule
C. General Overview of the Final Rule’s
Changes From the Proposed Rule
IV. Legal Authority
V. Comments to the Proposed Rule and
FDA’s Responses
A. General Comments on the Proposed
Rule
B. Scope of MQSA Regulations
C. Repeated Failure To Achieve
Accreditation
D. Retention and Release of Personnel
Records
E. Digital Accessories
F. Facility Identification Information in
Mammography Report and Lay Summary
G. Final and Incomplete Assessments and
Lay Summaries
H. Deadlines for Mammography Reports
I. Breast Density Notification—General
Support for Density Notification
J. Breast Density Notification Language
K. Breast Density Notification and the Role
of the Referring Healthcare Provider
L. Format for Image Interpretation,
Retention, Transfer of Original Images,
and Release of Copies
M. Deadlines for Image Transfer and the
Release of Copies
N. Facility Closure and Mammography
Record Retention
O. Mammography Medical Outcomes
Audit
P. Patient and Referring Provider
Notification
Q. Revocation of Certification
R. Interpreting Physician Qualifications,
Including Continuing Experience
S. Cleaning of Mammography Equipment
T. Availability and Clinical Role of Breast
Imaging Modalities, Screening
Mammography Guidelines
U. Clinical Decision-Making
V. Insurance Coverage
W. Economic Impact of This Rule
X. Federalism and the Relationship
Between Federal and State Breast
Density Reporting Requirements
Y. Effective Date of This Rule
Z. Miscellaneous Comments
VI. Effective Date and Compliance Date
VII. Economic Analysis of Impacts
A. Introduction
B. Summary and Accounting Statement
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With
Indian Tribal Governments
XII. References
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full benefit of mammography, the
service must be of high quality,
including performance of the
examination by qualified technologists,
using equipment that is tested and
properly functioning; interpretation by
qualified physicians; and clear and
prompt communication of results to
patients and their referring healthcare
providers. The MQSA establishes
uniform baseline Federal standards
designed to ensure, among other things,
that all patients nationwide have access
to quality mammography services. The
MQSA implementing regulations
address, among other things, standards
for accreditation bodies and certifying
agencies and mammography quality
standards for facilities, such as
qualifications of personnel at
mammography facilities, standards for
mammography equipment, the content
and terminology for mammography
reports, the requirement to establish a
quality assurance program, standards
and timing for quality assurance testing,
standards for clinical image quality,
recordkeeping, communication of
results, and clinical image review by the
facility’s accrediting body. Based on
technology changes in mammography
and our experience with the
administration of the MQSA program,
FDA is modernizing and updating the
regulations as well as improving the
information, including breast density
information, provided by
mammography facilities to patients and
their healthcare providers. This final
rule requires that the summary of the
mammography report written in lay
terms (‘‘lay summary’’) that is provided
to patients identifies whether the
patient has dense or non-dense breast
tissue and includes a prescribed
paragraph on the significance of breast
density. The rule also establishes four
categories for reporting breast tissue
density in the mammography report that
is provided to the patient’s referring
healthcare provider.
B. Legal Authority
The MQSA was enacted on October
27, 1992, and is codified, as amended in
1998 and 2004, under section 354 of the
Public Health Service (PHS) Act. Public
Law 102–539, 2, 106 (1992), codified as
amended at 42 U.S.C. 263b. Under the
MQSA, all mammography facilities,
except facilities of the Department of
Veterans Affairs (VA), must be
accredited by an approved accreditation
body (AB) and certified by FDA (or an
approved State certification agency) to
provide mammography services. FDA is
amending the mammography
regulations established under the PHS
Act, and sections of the FD&C Act.
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C. Summary of the Major Provisions of
the Final Rule
FDA is making three categories of
improvements to our mammography
regulations: improvements that address
changes in mammography technology;
improvements that enhance
enforcement of quality standards; and
improvements in the way
mammography results are categorized,
reported, retained, and transferred to
patients and healthcare providers.
Specifically, in this final rule FDA is
making the following amendments:
• New and amended provisions
related to technology that, among other
things, update several equipment and
quality control provisions in the
regulations to address current
technology, including digital
mammography;
• Improvements that enhance
enforcement that, among other things:
Æ Require that mammograms
submitted for interpretation be
presented in the mammographic
modality in which they were originally
produced, and not be copied or
digitized from hardcopy original images,
which could adversely affect the
accuracy of interpretation;
Æ Prohibit accreditation bodies from
accepting an application for
accreditation from a facility that has
failed to become accredited after three
consecutive attempts until 1 year after
the most recent accreditation failure;
Æ Expressly state that a facility’s
certificate may be suspended or revoked
due to a failure to comply with requests
by FDA, the State certification agency,
or the AB for records, including clinical
images for an additional mammography
review (AMR), or with requests by
current or former facility personnel for
records documenting their
qualifications;
Æ Add the State certification agency
as an entity that may initiate an AMR,
which can help detect quality issues,
and also to state expressly that FDA and
the State certification agency can notify
patients and their providers
individually or through the mass media
when a facility is unable or unwilling to
perform a required patient and referring
physician notification (PPN), which
would help to ensure that patients and
providers are informed of serious risks
to human health resulting from
mammography that fails to meet quality
standards;
Æ Require that, before a facility closes
or no longer provides mammography
services, it must make arrangements for
access by patients and healthcare
providers to mammography images and
reports; and
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Æ Require facilities to provide
personnel with copies of their MQSA
qualification records, which are often
needed to work at additional or new
facilities.
• Improvements in the way
mammography results are categorized,
reported, retained, and transferred to
patients and healthcare providers that,
among other things:
Æ Require that the mammographic
examination report include the facility
name and location (at a minimum, the
city, State, ZIP code, and telephone
number of the facility), in order to help
to ensure that healthcare providers can
obtain the necessary information to
enable them to assist patients in making
informed healthcare decisions;
Æ Change the explanatory language in
one final assessment category
(‘‘Benign’’) to promote greater
consistency and accuracy in the use of
the category, and add three new
categories of mammographic assessment
to the existing categories in the
regulations, which will allow
mammography facilities to precisely
classify and communicate findings;
Æ Add a specific, required timeframe
for facilities to send mammography
reports to healthcare providers and the
summary written in lay terms to
patients whose mammograms have
either ‘‘Suspicious’’ or ‘‘Highly
Suggestive of Malignancy’’ final
assessment categories, which could lead
to earlier definitive tissue diagnosis of
malignancy and earlier start of
treatment, and avoid, for the patient, the
anxiety of a protracted waiting period;
Æ Require reporting to patients and
healthcare providers to include an
assessment of breast density, in order to
provide them with additional
information about their mammography
and the potential limitations of their
mammogram results so that patients and
their healthcare providers can make
informed healthcare decisions by;
D Retaining the two categories of
density in the patient lay summary, but
changing the wording from the
comparative terms ‘‘high density’’ and
‘‘low density’’ to ‘‘dense’’ and ‘‘not
dense,’’ in order to align with clinical
practice and improve clarity to the
patient.
D Revising the written lay summary of
the results provided to the patient to
contain one of the following breast
density notification statements. The
non-dense breast notification (see
§ 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
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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 § 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.’’
D Requiring that the written report of
the results of the mammographic
examination provided to the healthcare
provider include information
concerning an overall assessment of
breast density, classified in one of the
following categories: (A) ‘‘The breasts
are almost entirely fatty.’’ (B) ‘‘There are
scattered areas of fibroglandular
density.’’ (C) ‘‘The breasts are
heterogeneously dense, which may
obscure small masses.’’ (D) ‘‘The breasts
are extremely dense, which lowers the
sensitivity of mammography.’’
Æ Require each mammography
facility to implement policies and
procedures to minimize the loss of
mammography images and reports
because the loss of these records can
have a significant, negative impact on
clinical care, and also specify the
timeframe within which facilities must
transfer original mammograms and
copies of reports to patients, healthcare
providers, and others because delays in
the transfer of these records can lead to
delays in diagnosis or treatment; and
Æ Clarify the minimum information
that facilities must collect during the
mammography medical outcomes audit
because calculating and tracking these
values is important to the evaluation of
accuracy in detecting breast cancer,
allowing facilities and interpreting
physicians to review their performance
and enact quality improvement
measures.
D. Costs and Benefits of the Final Rule
The quantified benefits of this rule are
derived from reduced mortality and
breast cancer treatment costs resulting
from the breast density reporting
requirements. The estimate of
annualized benefits over 10 years ranges
from $12.99 million to $232.69 million
at a 7 percent discount rate and $8.50
million to $266.09 million at a 3 percent
discount rate. Other benefits that we are
not able to quantify include reduced
cancer morbidity and improvements in
the accuracy of mammography by
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improving quality control and
strengthening the medical audit. The
costs of the final rule include costs to
mammography facilities to comply with
the requirements and costs associated
with supplemental testing and biopsies
resulting from the breast density
requirements. The estimate of
annualized costs over 10 years ranges
from $28.87 million to $45.42 million at
a 7 percent discount rate with a primary
value of $36.31 million. Using a 3
percent discount rate, the annualized
costs range from $27.61 million to
Abbreviation or acronym
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III. Background
According to the Centers for Disease
Control and Prevention (CDC), in 2018,
the most recent year for which numbers
are available, over 254,000 women were
diagnosed with breast cancer, and more
than 42,000 women died of the disease
(Ref. 1). According to the National
Cancer Institute of the National
Institutes of Health, in 2020, over
276,000 women were projected to be
diagnosed with breast cancer, and over
42,000 women were projected to die of
the disease (Ref. 2). Breast cancer is rare
in men, with approximately 2,300 new
cases and 500 deaths reported in the
United States in 2017, according to the
CDC (Ref. 3). Among women, however,
breast cancer is now the most common
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II. Table of Abbreviations and
Acronyms Commonly Used in This
Document
What it means
AB .......................................................................
ACR ....................................................................
ACS .....................................................................
AMR ....................................................................
BICOE .................................................................
BI–RADS .............................................................
CAD ....................................................................
CD .......................................................................
CDC ....................................................................
CDR ....................................................................
CDRH ..................................................................
CFR .....................................................................
CRCPD ...............................................................
DBT .....................................................................
DICOM ................................................................
DMQS .................................................................
ERG ....................................................................
FDA, Agency, or we ...........................................
FD&C Act ............................................................
FFDM ..................................................................
FRIA ....................................................................
HIPAA .................................................................
IP .........................................................................
MBI ......................................................................
MQSA .................................................................
MQSRA ...............................................................
MRI .....................................................................
NAPBC ................................................................
NMQAAC ............................................................
OMB ....................................................................
PACS ..................................................................
PGHS ..................................................................
PHS Act ..............................................................
PPN .....................................................................
PPV .....................................................................
QC .......................................................................
QI ........................................................................
SCA .....................................................................
U.S.C. .................................................................
USPSTF ..............................................................
VA .......................................................................
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$44.16 million with a primary value of
$35.05 million.
Accreditation Body.
American College of Radiology.
American Cancer Society.
Additional Mammography Review.
Breast Imaging Centers of Excellence.
Breast Imaging—Reporting and Data System.
Computer-Aided Detection.
Compact Discs.
Centers for Disease Control and Prevention.
Cancer Detection Rate.
Center for Devices and Radiological Health.
Code of Federal Regulations.
Conference of Radiation Control Program Directors, Inc..
Digital Breast Tomosynthesis.
Digital Imaging and Communication in Medicine.
Division of Mammography Quality Standards.
Eastern Research Group.
Food and Drug Administration.
Federal Food, Drug, and Cosmetic Act.
Full-Field Digital Mammography.
Final Regulatory Impact Analysis.
Health Insurance Portability and Accountability Act of 1996.
Interpreting Physician.
Molecular Breast Imaging.
Mammography Quality Standards Act of 1992.
Mammography Quality Standards Reauthorization Acts of 1998 and 2004.
Magnetic Resonance Imaging.
National Accreditation Program for Breast Centers.
National Mammography Quality Assurance Advisory Committee.
Office of Management and Budget.
Picture Archiving and Communication System.
Policy Guidance Help System.
Public Health Service Act.
Patient and Referring Physician Notification.
Positive Predictive Value.
Quality Control.
Quality Indicator.
State Certification Agency.
United States Code.
U.S. Preventive Services Task Force.
Department of Veterans Affairs.
non-skin cancer and the second leading
cause of cancer deaths after lung cancer
(Ref. 4). There are also disparities in
both the incidence of breast cancer, and
in mortality from breast cancer, by both
race and ethnicity. In 2019, the latest
year for which incidence data are
available, in the United States, 30,450
new cases of breast cancer were
reported among Black, Non-Hispanic
women, and 6,600 Black, Non-Hispanic
women died of this cancer. For every
100,000 Black, Non-Hispanic women,
128 new breast cancer cases were
reported and 28 Black, Non-Hispanic
women died of this cancer (Ref. 1).
Health disparity and equity
considerations may exist as they relate
to mammography practice and density
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notification, and we have considered
sociodemographic differences in
mammography practice and outcomes.
This final rule provides standard
requirements that help to ensure that all
patients and providers receive complete
and consistent breast density
information in mammography reports.
Early detection of female breast
cancer, typically involving
mammography, is the best means of
preventing deaths that can result if the
diagnosis is delayed until the onset of
more advanced symptoms (Ref. 5).
Mammography is a type of medical
imaging that uses x-rays to create images
(mammograms) of the internal
structures of the breasts. There are three
types of mammography referred to in
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this document: screen-film
mammography, full field digital
mammography, and digital breast
tomosynthesis. In screen-film
mammography, x-rays are transmitted
through the breast and expose a sheet of
x-ray film enclosed in a cassette. In full
field digital mammography, the x-rays
go through to an image receptor that is
a radiation-sensitive electronic device or
plate. Images are displayed on a
computer workstation, and can, for
example, be digitally magnified. Digital
breast tomosynthesis also uses an
electronic image receptor and a
computer workstation, and obtains
multiple images at different angles
around the breast, then uses a computer
to reconstruct a series of parallel images
that resemble slices through the breast.
Mammography can help detect breast
cancer in its earliest, most treatable
stages, when it is too small to be felt or
detected by any other method (Ref. 6).
However, as noted by the Government
Accountability Office (GAO), a
mammogram is among the most difficult
radiographic images to interpret (Ref. 7).
The mammogram must be of high
quality for accurate image
interpretation. If the image quality is
poor, the interpreter may miss a
cancerous lesion. Such a false negative
diagnosis could delay treatment and
result in an avoidable death or increased
morbidity. It is equally true that poor
quality images or inaccurate
interpretations can lead to a false
positive diagnosis when normal tissue is
misinterpreted as abnormal. This could
lead to needless anxiety for the patient,
costly additional testing, and
unnecessary biopsies.
A. Need for Amendments to
Mammography Regulations
Most of the requirements in our
mammography regulations are over 20
years old. As described below and in the
proposed rule (84 FR 11669, March 28,
2019), major developments in
understanding relating to the
importance of certain breast anatomy on
breast cancer risk have occurred, and
FDA believes these developments
should be reflected in our nationwide
standard. In addition, we are updating
our mammography regulations in
response to several gaps that we have
identified as we have implemented the
current regulations. Current regulations
do not require that a notification of
breast density be part of the report
provided to the healthcare provider or
the lay summary provided to the
patient. However, there is increasing
interest in breast density reporting, and
States are taking action. Between 2009
and June 2021, 38 States have passed
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laws mandating notification of breast
density (Ref. 8). These State laws
impose requirements that vary from
State to State. To ensure all patients
receive breast density information from
their mammograms, and that such
required baseline information is
consistent, FDA is amending the
mammography reporting requirements
to require that the written report of the
results of the mammographic
examination provided to the healthcare
provider and the lay summary of the
results provided to the patient also
include information concerning patient
breast density. FDA is also requiring
that both the mammography report and
lay summary include basic
mammography facility identification
information. Technology has also
advanced since the regulations were
issued, so the amended regulations will
make changes to reflect current
mammography best practices and
technologies.
B. Summary of Comments to the
Proposed Rule
In the Federal Register of March 28,
2019, FDA published a rule proposing
amendments to the MQSA regulations.
The comment period for the proposed
rule closed on June 26, 2019. FDA
received many comments on the
proposed rule from several entities
including medical device associations,
industry, medical and healthcare
professional associations, public health
advocacy groups, law firms, and
individuals. While several comments
object to particular sections or
subsections of the proposed rule, almost
all comments voice support for the
objective intent of the proposed rule, to
establish updates to modernize the
MQSA regulations to incorporate
current science and mammography best
practices.
Some comments raise concerns or
request clarification regarding:
• the scope of the MQSA regulations,
• failure of facility accreditation,
• retention of personnel records,
• mammography reports (including
assessment categories) and lay
summaries,
• breast density notification to
patients and referring providers,
• requirements for image retention,
transfer of original images, and release
of copies,
• the mammography medical
outcomes audit,
• patient and provider notification,
• the availability and use of various
imaging modalities, and
• issues related to clinical decisionmaking.
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C. General Overview of the Final Rule’s
Changes From the Proposed Rule
FDA considered all comments
received on the proposed rule and made
changes, primarily for clarity and
accuracy and to improve understanding
of breast density notification language to
healthcare providers and patients. On
its own initiative, FDA is also making
minor technical changes to make the
withdrawal provisions clearer. The
changes from the proposed rule include
the following significant revisions,
additions, and removals to the codified
section:
• add or substitute the term
‘‘provider’’ or ‘‘healthcare provider’’ in
several paragraphs in place of references
to referring physician (§§ 900.2(c)(2),
900.2(k), 900.2(ii), 900.4(f)(1)(ii)(B), and
900.12(j)),
• revise language to clarify that no AB
shall accept an application for
accreditation from a facility that has had
three consecutive failures
(§ 900.4(a)(6)(ii)),
• include additional language
requiring that facilities must retain
personnel qualification records of
former employees for at least 24 months
(§ 900.12(a)(4)),
• remove the proposed term ‘‘digital
accessory components’’ and clarify the
premarket requirements for devices
used in mammography
(§ 900.12(b)(2)(i)),
• include additional language
clarifying that the required final
assessment statements are only the
words or phrases in quotation marks
(§ 900.12(c)(1)(iv)),
• revise the requirement that clinical
findings or symptoms in a patient
whose mammogram assessment is
negative or benign shall be
‘‘documented and addressed,’’ rather
than ‘‘explained’’ (§ 900.12(c)(1)(iv)(A)
and (B)),
• correct the reference to the two
categories of breast density that shall be
included in the lay summary provided
to the patient (§ 900.12(c)(2)),
• include additional language
clarifying the deadline for sending the
mammography report to a self-referred
patient when the assessment is
‘‘Suspicious’’ or ‘‘Highly Suggestive of
Malignancy’’ (§ 900.12(c)(2)(i)),
• include additional language
clarifying the situations in which a
facility must maintain a system for
referring self-referred patients to a
healthcare provider (§ 900.12(c)(2)(ii)),
• revise the breast density
notification language that must be
included in lay summaries provided to
patients with non-dense and dense
tissue, respectively (§ 900.12(c)(2)(iii)
and (iv)),
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• add language clarifying the length
of time a facility is required to maintain
the original mammograms and
mammography reports in a permanent
medical record of the patient by
clarifying it is for the longer of the
applicable Federal timeframes, or the
mandated State or local timeframes
(§ 900.12(c)(4)(i)),
• add language clarifying that a
facility that ceases to perform
mammography but continues to operate
as a medical entity may retain, rather
than transfer, its mammography records
(§ 900.12(c)(4)(v)),
• add or substitute the term ‘‘patient’’
in place of references to ‘‘women’’ or
‘‘woman’’ (§§ 900.12(c)(4)(v) and (f)(1)),
• add the word ‘‘audit’’ to clarify that
the use of certain terms applies to the
medical outcomes audit (§ 900.12(f)(1)),
and
• include an amendment changing
the name of Healthcare Financing
Administration to Centers for Medicare
& Medicaid Services and updating the
Center for Devices and Radiological
Health (CDRH) office’s name
(§ 900.15(d)(1)).
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IV. Legal Authority
The MQSA (Pub. L. 102–539) was
enacted on October 27, 1992, and is
codified under section 354 of the Public
Health Service (PHS) Act (42 U.S.C.
263b). Under the MQSA, all
mammography facilities, except
facilities of the VA, must be accredited
by an approved AB and certified by
FDA (or an approved State certification
agency) to provide mammography
services (42 U.S.C. 263b(b)(1) and
(d)(1)(iv)). FDA is making these
amendments to the mammography
regulations (set forth in part 900 (21
CFR part 900)) under section 354 of the
PHS Act, and sections of the FD&C Act
(sections 519, 537, and 704(e); 21 U.S.C.
360i, 360nn, and 374(e)).
V. Comments on the Proposed Rule and
FDA’s Responses
We received several sets of comments
on the proposed rule by the close of the
comment period, each containing one or
more comments on one or more issues.
We received comments from medical
device associations, industry, medical
and healthcare professional
associations, public health advocacy
groups, law firms, and individuals. We
describe and respond to comments in
sections A through Z of this document.
We have numbered each comment to
help distinguish between different
comments. We have grouped similar
comments together under the same
number so that FDA’s responses could
be addressed by topic, instead of each
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comment addressed independently,
and, in some cases, we have separated
different issues discussed in the same
comment and designated them as
distinct comments for purposes of our
responses. The number assigned to each
comment or comment topic is purely for
organizational purposes and does not
signify the comment’s value or
importance or the order in which
comments were received or considered.
A. General Comments on the Proposed
Rule
(Comment 1) FDA received many
comments that express support for the
MQSA proposed rule. Some comments
express support for requiring density
notification to patients and for
establishing a national standard for such
notification. Other comments
respectively express support for the
changes to the assessment categories,
equipment quality control (QC), and
requirements related to the provision of
copies of mammograms. Some
comments express support for the
changes to the patient and provider
notification in the event of
compromised mammographic quality,
which may represent a serious risk to
human health, including the
notification of nonphysician referring
healthcare providers. Another comment
compliments FDA on proposing
amendments to the regulations, but
recommends more frequent changes to
respond promptly to new information.
(Response 1) FDA appreciates the
public support for the rule. FDA notes
that the notification requirement
regarding breast tissue density will
enhance communication between
patients, interpreting physicians (IP),
and referring providers about this
important factor in the effectiveness of
mammography, and ensure that
required baseline information is
consistent. FDA also concludes that the
other amendments to the regulations
(part 900), including the changes to the
equipment QC, assessment categories,
provision of copies of mammograms,
and notification to nonphysician
healthcare providers when necessary,
will also contribute to improvement in
the quality of mammography and of
communication about mammography
between patients, IPs, and providers.
Regarding the recommendation for more
frequent changes, FDA notes that it
continues to engage with the National
Mammography Quality Assurance
Advisory Committee (NMQAAC) and
the professional and patient
mammography communities regarding
the need for changes to the regulations,
but the frequency of amendments to the
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regulations is based on public health
need and Agency resources.
(Comment 2) Several comments
express opposition to the proposed rule,
including the following concerns: (1)
that patients will not understand that
dense tissue is a normal variant, and
that the proposed breast density
notification will increase their anxiety;
(2) that breast cancer information to be
given to a patient should be determined
only by the patient’s healthcare
provider, or that the new requirement
places a burden on the healthcare
provider; (3) that all medical tests
should be interpreted by clinicians with
years of training who can identify the
findings that require intervention; (4)
that ultrasound rather than digital breast
tomosynthesis (DBT) is the method to
screen for cancers that are not
mammographically visible; and (5) that
there is no clinical recommendation to
change patient management based on
density or to perform additional
ultrasound and magnetic resonance
imaging (MRI) for screening dense
breasts, and that current evidence
contradicts the suggestion that
supplemental screening based on breast
density reduces breast cancer mortality.
The latter comment also recommends
that FDA’s suggestion that additional
imaging based on density alone may
reduce breast cancer mortality should be
deleted from the cost and benefit
information of the rule.
(Response 2) FDA acknowledges the
comments and responds according to
the numbered topics identified in
Comment 2:
(1–2) We note that breast tissue
density is an important factor in
mammography, both because of the
masking effect of dense tissue, which
limits the sensitivity of mammography
(Refs. 9 to 11), and because density is an
independent risk factor for the
development of breast cancer (Refs. 12
to 15). FDA concludes that patients
benefit from having information about
their breast anatomy, and should be
informed of their density so that the
patient and their healthcare provider
can make informed and shared
decisions about the patient’s healthcare.
This rulemaking provides consistent
language for communicating that
information, as FDA concludes that
there is also a benefit from obtaining
baseline information in a consistent
manner.
The requirement to notify patients
about their density is a baseline
standard and does not constrain a
healthcare provider from further
discussing density with the patient.
FDA has determined that the benefit of
informing patients of their density
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outweighs both the burden on
healthcare providers to provide density
information and the risk of patient
anxiety. FDA also notes that the Agency
received many comments in support of
the proposed rule and the breast density
notification to patients. FDA also notes
that 38 States have passed laws
mandating notification of breast density,
which may mitigate any potential
burden on healthcare providers in those
states (Ref. 8).
(3) The MQSA provides authority to
FDA to ensure quality mammography,
and FDA has determined that the initial
and continuing qualification
requirements for IPs in § 900.12(a)(1) are
sufficient to ensure that mammograms,
including density observations, are
interpreted by personnel with adequate
training to ensure quality
mammography.
(4–5) FDA acknowledges there are
conflicting comments about the utility
of other imaging modalities besides
DBT, such as ultrasound, for
supplemental screening of women with
dense breasts; however, this final rule
does not specify any particular
supplemental imaging modality or other
particular clinical management of
patients with dense breasts. FDA has
not indicated any particular additional
steps in a patient’s care 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,
which would encompass a significant
amount of information that may be
overwhelming and difficult for patients
to interpret (see also Responses 57 and
60). 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. In this final
rule, to allow patients and their
healthcare providers to make shared
decisions appropriate for each patient,
the notification to these patients in
§ 900.12(c)(2)(iv) simply states, in part,
‘‘In some people with dense tissue,
other imaging tests in addition to a
mammogram may help find cancers,’’
and advises the patient to discuss their
individual situation with their provider
(see also Response 62). FDA notes that
there is conflicting evidence about the
effect of supplemental screening on
breast cancer mortality, including Chiu
in 2010 (Ref. 16), which found that
dense tissue was associated with
increased mortality from breast cancer.
Therefore, FDA disagrees with the
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assertion that additional imaging based
on breast density is not relevant, or that
the mortality information should be
deleted from the economic cost and
benefit analysis of the rule.
(Comment 3) A comment opposes
more mammography regulation, and
asserts:* that MQSA duplicates an
American College of Radiology (ACR)
program which ‘‘certifies’’
mammography facilities; that FDA
dictating what IPs should say in their
reports constitutes the practice of
medicine; and that MQSA regulations
are driving physicians out of
mammography and limiting access. This
comment recommends that FDA limit
itself to its ‘‘original mandate’’ to ensure
that mammography units produce
quality images at a reasonable radiation
dose.
(Response 3) FDA disagrees with the
comment. The ACR does not certify
mammography facilities. The MQSA
and its implementing regulations
distinguish between accreditation and
certification (see 42 U.S.C. 263b(e) and
(q); part 900, subparts A and C; see also
Response 145). The ACR is one of
several FDA-approved accreditation
bodies. Accreditation, which mainly
focuses on the quality of clinical images
and phantom images, is one of the
prerequisites for facility certification by
FDA or a State certifying agency. FDA
does not specify which assessment
category an IP should assign to a
mammogram because this is more
appropriately left to the provider’s
interpretation in the course of clinical
decision-making. However, FDA does
provide for the specific phrasing of the
final assessment statements, which is
standardized in accordance with the
MQSA (42 U.S.C. 263b(a)(3)(B)) to
ensure clear consistent communication
between patients, IPs, and referring
healthcare providers. FDA does not
track practice rates of IPs or other
facility personnel, but is not aware of
information showing a decrease in
access to mammography services;
according to MQSA national statistics
(Ref. 17), from November 2003 to
February 2022, there has been a 4
percent decrease in the total number of
certified facilities across the United
States but a 29 percent increase in the
total number of mammograms
performed. Therefore, FDA concludes
that these amendments to the MQSA
regulations are neither duplicative of
the ACR program nor have the existing
MQSA regulations had a negative
impact on access to mammography.
B. Scope of the MQSA Regulations
(Comment 4) Several comments
address the scope of the MQSA
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regulations, including comments that
support the objectives of the proposed
rule and/or provide the following
recommendations: (1) FDA’s proposal
should remove xeromammography from
the examples of mammographic
modalities, which accompany the
definition provided in proposed
§ 900.2(z), and replace it with full-field
digital mammography (FFDM); (2) FDA
should remove screen-film
mammography from these examples of
modalities; (3) comments that FDA
should also add the example of DBT as
a modality; (4) that mammography IPs
should also be qualified in breast
ultrasound; and (5) that FDA should
consider requiring mammography
facilities to meet additional quality
standards, such as the ACR’s Breast
Imaging Centers of Excellence (BICOE)
program or the American Cancer Society
(ACS) National Accreditation Program
for Breast Centers (NAPBC), in addition
to MQSA certification requirements.
(Response 4) The scope of FDA’s
authority over mammography facilities
is established in the MQSA, and, as
described in the following and
organized according to the numbered
topics identified in Comment 4, FDA is
adopting limited changes to this rule:
(1–3) The MQSA and its
implementing regulations apply only to
radiological equipment used in facilities
to perform mammographic modalities,
which do not include breast sonography
or other non-mammographic modalities
(42 U.S.C. 263b(a)(5) and (6), (b)(1) and
(2)). However, FDA agrees that the
modality of DBT has reached wide
clinical use and should be listed as an
example of a mammographic modality
in this rule. Xeromammography is no
longer in clinical use in the United
States, and screen-film mammography is
in limited use. Therefore, in this final
rule, FDA is revising the examples of
mammographic modalities to remove
xeromammography, and to list screenfilm mammography, FFDM, and DBT,
all of which are currently in clinical use
in the United States (see § 900.2(z) in
this final rule). Other modalities are
covered by the requirements of the
FD&C Act, and may be subject to
performance standards prescribed
pursuant to section 534 (Electronic
Product Radiation Control (EPRC)) of
the FD&C Act.
(4) FDA disagrees with the
recommendation to require
mammography IPs to also be qualified
in breast ultrasound. As noted, the
MQSA does not provide for the
establishment of requirements related to
breast sonography for IPs, other
personnel, or facilities.
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(5) FDA notes that the ACR BICOE
program covers other breast imaging
modalities and interventions in addition
to mammography, and the ACS NAPBC
covers additional breast imaging as well
as other aspects of clinical breast care.
Therefore, these programs are not
implemented within the scope of the
MQSA regulations.
(Comment 5) Several comments
recommend removing the exclusion of
invasive interventions for biopsy or
localization in § 900.2(aa)(1) so that they
are included within the scope of the
MQSA regulations. A separate comment
recommends that post-procedure
mammograms for marker placement
should not be regulated under the
MQSA.
(Response 5) FDA disagrees with
these comments. The MQSA was
enacted by Congress in 1992 due to
evidence of poor quality in
mammographic imaging in the United
States at that time. However, since then,
the implementation of the MQSA and
the widespread adoption of digital
imaging technologies and other
technological and QC advances have
contributed to quality improvement not
only in screening and diagnostic
mammography, but also in
interventional mammography. The
majority of personnel performing
interventional mammography also
perform non-interventional
mammography and are therefore subject
to the requirements of the MQSA.
Currently, FDA is not aware of
information showing significant quality
problems with interventional
mammography in the United States. At
this time, FDA concludes that it is not
necessary to introduce regulations
covering interventional mammography.
Unlike the targeted images of a small
portion of the breast that are typically
performed during localization or
intervention, a post-procedure
mammogram typically includes the
entire breast; may be performed using
general mammography equipment
rather than dedicated interventional
equipment; and is often logged,
reported, and charged as an
independent examination, separate from
the interventional procedure that
precedes it. Therefore, FDA concludes
that this post-procedure examination
should continue to meet the quality
standards mandated under the MQSA
regulations. As discussed in Responses
32, 38, and 39, this final rule includes
the assessment statement ‘‘PostProcedure Mammogram for Marker
Placement,’’ which may be appropriate
for such mammograms (see
§ 900.12(c)(1)(iv)(G)).
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(Comment 6) Several comments
suggest that the MQSA regulations
should be expanded to cover other
imaging modalities in addition to
mammography, including ultrasound
and MRI.
(Response 6) The MQSA was passed
by Congress in 1992 in response to
evidence of poor quality in
mammographic imaging in the United
States at that time (42 U.S.C. 263b). As
we noted in Response 4, the MQSA
applies only to mammographic imaging.
As such, the MQSA does not provide for
the establishment of requirements
related to breast sonography or MRI, and
the MQSA regulations have not been
amended to include such modalities.
(Comment 7) A comment
recommends that medical offices be
required to display posters depicting
breast anatomy and to distribute
literature regarding breast physical
examination.
(Response 7) FDA disagrees with the
comment. FDA notes that the shared
clinical decision-making process
generally takes place between the
patient and their referring healthcare
provider or other clinical healthcare
provider, not with the interpreting
physician at the mammography facility,
and therefore does not agree that there
is a need to require posters of breast
anatomy at mammography facilities,
although facilities may choose to
display patient education resources.
Referring healthcare providers who
order mammography studies, and are
not themselves the reviewing physicians
of the clinical images at issue (see 42
U.S.C. 263b(a)(8)), are not generally
subject to the requirements specified in
the MQSA and its implementing
regulations. Clinical healthcare
providers may provide such patient
education resources if they choose to do
so, but this recommendation is outside
the scope of this final rulemaking.
C. Repeated Failure To Achieve
Accreditation
(Comment 8) Several comments
express concerns with the number and
type of accreditation failures after which
an AB may not accept a facility’s
application for accreditation for 1 year.
One comment recommends that this
provision be revised to apply to a
facility that has ‘‘failed to become
accredited after four consecutive
failures’’; another comment
recommends that this be revised to
apply to a facility which has ‘‘failed to
become accredited after four failed
accreditation cycles’’; and another
comment recommends that this be
revised to apply to a facility that has
had ‘‘three consecutive failures of
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accreditation granting cycles.’’ Two of
these comments also express concern
over the effect of this provision on the
timing of the AB’s onsite visit to the
facility to provide oversight and handson training.
(Response 8) FDA disagrees with
these comments. The Agency believes
that a facility that has failed to become
accredited after three consecutive
attempts should not be permitted to
become accredited until it has
implemented all necessary corrective
actions and any other necessary
changes, such as additional training or
personnel changes, specific to the
facility’s individual situation (see
§ 900.4(a)(6)(ii) in this final rule). The
Agency believes that the 1-year waiting
period will allow the facility sufficient
time to make these corrections.
Regarding the terminology used for
these failures, the Agency notes that the
various FDA-approved ABs currently
use different terms, such as
‘‘deficiency’’ and ‘‘failure,’’ for the
initial failure to become accredited.
Therefore, FDA concludes that the
phrasing of the provision, ‘‘If a facility
has failed to become accredited after
three consecutive attempts,’’ is
sufficiently clear and broad to apply to
facilities accredited by any AB.
Regarding the AB onsite visits to
facilities, the various ABs currently
have different policies for the timing of
their onsite visits, each respectively
approved by FDA. FDA notes that, upon
publication of this final rule, the ABs
can review and, if needed, revise their
procedures to accommodate the change
in the regulations, including to account
for any procedures to address tracking
the number of facility applications
submitted to an AB, and submit their
proposed policy changes to FDA for
review and approval.
(Comment 9) Some comments
recommend that facilities not be
allowed to switch ABs in order to avoid
this 1-year exclusion after three
consecutive failed attempts at
accreditation.
(Response 9) FDA agrees with this
recommendation. Accordingly, we are
revising § 900.4(a)(6)(ii) to state ‘‘If a
facility has failed to become accredited
after three consecutive attempts, no AB
shall accept an application for
accreditation from the facility for a
period of 1 year from the date of the
most recent accreditation failure.’’
(Comment 10) Some comments
address the situation of a facility with
more than one mammography unit, of
which one unit fails to receive
accreditation but one or more units
receive accreditation. These comments
recommend either that the facility be
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permitted to continue to perform
mammography with the remaining
accredited unit(s), or that the facility’s
individual situation be evaluated by the
AB to determine the appropriate course
of action.
(Response 10) We appreciate the
comment, but note that the commenter
misunderstood the proposed
amendment. The provision that was
proposed for revision refers to overall
facility accreditation (see
§ 900.4(a)(6)(ii) in both the proposed
and final rule) as opposed to individual
unit accreditation (see §§ 900.4(e) and
900.12(e)). FDA acknowledges that some
reasons for the failure of a facility to
receive accreditation, such as a
mechanical deficiency in a
mammography unit, may be limited to
that particular unit, while other reasons
for failure, such as poor patient
positioning, may extend to the practice
of mammography throughout the entire
facility. The various FDA-approved ABs
have policies to address the
requirements for accreditation of a
facility that has multiple mammography
units. The ABs also have policies
regarding the circumstances, including
poor quality noted on accreditation
images, which may prompt an AMR to
assess the overall quality of
mammography at a facility. FDA
believes that if a facility fails three
consecutive attempts to receive
accreditation, it should be subject to a
1-year waiting period to allow the
facility adequate time to address issues
that have prevented accreditation (see
also Response 8). FDA anticipates that
the ABs may review their policies and
procedures, and if needed, may decide
to submit revised policies and
procedures to FDA (see § 900.4(a)(8)) to
conform to this provision of the final
rule; if the ABs do so, the Agency will
review and consider the ABs’ proposals.
(Comment 11) A comment
recommends that a facility under its
third provisional certificate have all
exams double-read by a qualified IP
from an accredited and certified facility,
until the applying facility either fails or
receives accreditation.
(Response 11) FDA disagrees with
adding this requirement to the
regulations. Such increased oversight of
facilities with provisional certificates is
not appropriate in this circumstance,
considering that there are existing
regulations requiring corrective action.
Depending on the specific
circumstances of the failure, the
applying facility’s AB will either have
required the facility to perform
corrective action after the first two
failures, or will first have performed an
AMR to determine the extent and
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severity of the quality problems at the
facility (see § 900.4(a)(1)(i)), and will
have required corrective action (see
§§ 900.4(a)(1)(ii) and 900.4(b)(3)).
Corrective action is individualized by
the AB for the specific facility, but often
includes requirements for additional
training for the facility personnel.
Therefore, FDA concludes that the IP
and other personnel will be sufficiently
trained to correct the quality problems
at the facility.
(Comment 12) A comment
recommends clearer language about the
facility’s next steps, corrective action,
‘‘necessary information,’’ and the
duration of effectiveness of a
provisional certificate for a facility that
has had a year-long waiting period after
having failed to become accredited after
three consecutive attempts. The same
comment recommends clearer language
about FDA’s action if a facility fails
accreditation for a third time, and also
recommends that a facility be
permanently ineligible to provide
mammography services after a fourth
failure.
(Response 12) Regarding improving
clarity about the process for reapplying
for accreditation, FDA disagrees with
this comment. The process is subject to
the policies and procedures of each AB,
and the Agency notes that the necessary
information as well as the steps to apply
for accreditation are clearly specified by
each AB’s policies and procedures (see,
e.g., § 900.4(e) and (f)). We further note
that the duration of effectiveness of a
provisional certificate is already
discussed in current § 900.11(b) and (c).
Regarding the commenter’s
recommendation that a facility be
ineligible to provide mammography
services after a fourth failure, FDA
concludes that a facility that has
performed all required corrective action
may reapply for accreditation, but notes
that, in accordance with AB policies, an
AB may take into account the facility’s
entire history and practice of
mammography, such as a lack of
improvement after multiple corrective
actions, in considering a decision to
suspend or revoke the facility’s
accreditation, or to revoke its
application for accreditation (see
§ 900.4(a) and (b)). Also, the AB must
notify FDA if it believes that a facility’s
practice of mammography may pose a
serious risk to human health (see
§ 900.4(a)(2)). Likewise, the Agency may
take into account the facility’s entire
history in determining that its practice
poses a serious risk to human health
and in considering the suspension or
revocation of a facility’s certificate (see
§ 900.14). Therefore, FDA concludes
that a facility whose practice warrants
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such a determination will be identified,
and appropriate accreditation and/or
certificate actions will be taken. Finally,
as noted in Responses 8 and 10, if the
ABs review their policies and
procedures in light of this provision of
the final rule and decide to submit
revised policies and procedures to FDA
(see § 900.4(a)(8)), the Agency will
review and consider those policies and
procedures.
D. Retention and Release of Personnel
Records
(Comment 13) Several comments were
submitted that recommend specifying
the amount of time that a facility must
retain personnel records for employees
that are no longer at that facility. Some
comments recommend that facilities
only be required to keep the records for
former employees from the time of one
inspection to the time of the next annual
inspection. Another comment
recommends that facilities only be
required to give employees their records
at the time of the employees’ departure.
Other comments recommend that
facilities be required to keep personnel
records for former employees for 24
months following the departure of that
employee.
(Response 13) FDA agrees that a
minimum length of time should be
included in the amendments to the
regulations for the personnel records
retention requirement. We note that
previous employees may need access to
these personnel records to document
their MQSA qualifications to permit
them to provide mammography services
at other facilities. Accordingly, we
conclude that former employees should
have an opportunity to obtain their
personnel records for a time period
beyond the immediate date of their
departure from a facility. After
considering the comments on this
requirement, we are revising and
finalizing the provision as follows:
‘‘Records of personnel no longer
employed by the facility must be
maintained for no less than 24 months
from the date of the departure of an
employee, and these records must be
available for review at the time of any
annual inspection occurring during
those 24 months’’ (see § 900.12(a)(4) in
this final rule). FDA has made this
change to the codified language to
clarify that the records must be available
during an inspection that can occur at
any point during the 24 months after
which an employee departs, which
better aligns with the records retention
requirement and is distinct from any
FDA determination regarding
compliance with the MQSA and its
implementing regulations that would
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otherwise occur following the next
annual inspection after the employee
departs. FDA is also revising the
provision to distinguish and clarify the
requirements for providing such records
to current and former employees, as
follows: ‘‘The facility shall provide
copies of these personnel records to
current interpreting physicians (IPs),
radiologic technologists, and medical
physicists upon their request. Facilities
must provide personnel records to
former employees if the former
employees communicate their request
within 24 months of the date of their
departure. If it has been greater than 24
months and the facility has maintained
those records, the facility must provide
those records to former employees upon
request.’’
(Comment 14) Rather than providing
records after an employee leaves, a
comment recommends that facilities
should require a qualifications package
for each employee that would only be
retained until after the first inspection
following the hiring of that employee, at
which point the package should be
given to the employee to retain, and any
continuing experience or other
information would be accumulated and
maintained from the time that the
qualifications package is given to the
employee.
(Response 14) FDA disagrees with this
comment. Personnel qualifications
under § 900.12(a) include both initial
and continuing requirements, and both
components are reviewed at the time of
inspection (Ref. 18). The personnel
record keeping requirements apply to
facilities, not individual personnel (see
42 U.S.C. 263b(d)(1)(A)(ii)(III), (B)(ii)(II),
and (g)(1)(C), and § 900.12(a)(4)).
Therefore, each facility is required to
document the qualifications of its
personnel. Also, FDA is concerned that
the comment’s recommended changes
would not be as effective as the current
system in maintaining the necessary
documentation of qualification of a
facility’s personnel.
(Comment 15) A comment
recommends that FDA specify a penalty
for facilities that do not adhere to the
personnel records requirement.
(Response 15) FDA agrees with this
comment. A facility that does not
comply with the personnel records
retention requirement (see § 900.12(a)(4)
in this final rule) may receive a citation
at the time that this failure is identified
at inspection, in a manner similar to
other comparable violations (Ref. 18).
The totality and severity of violations
identified at inspection determine the
consequences for the facility.
(Comment 16) A comment
recommends that facilities should only
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need to provide personnel records to
former employees if the employee
submits the request in written format.
(Response 16) FDA disagrees with this
recommendation. FDA concludes that
requiring requests from former
employees for their personnel records to
be transmitted in writing may be overly
burdensome to both facilities and
former employees because it may delay
how quickly a facility would receive the
request, and may reduce access to
mammography by delaying how quickly
those records could be provided to
facilities evaluating the qualifications of
new personnel. FDA believes that
minimizing barriers to the provision of
qualification records to former
employees will facilitate the hiring of
these personnel at other facilities, thus
preserving patient access to
mammography services.
(Comment 17) A comment
recommends that facilities give
personnel records to personnel when
the facility ceases performing
mammography, and it also asks for
clarification as to whether the phrase
‘‘ceases to perform mammography’’
refers to the facility or to specific
personnel.
(Response 17) The final rule states
that ‘‘Before a facility closes or ceases to
perform mammography services, it must
make arrangements for access by current
and former personnel to their MQSA
records,’’ and that this may be
accomplished by either ‘‘the permanent
transfer of these records to the
personnel or the transfer of the records
to a facility or other entity that will
provide access to these records for no
less than 24 months from the date of
facility closure or cessation of
mammography services’’ (see
§ 900.12(a)(4)). FDA believes that these
two pathways provide adequate access
for personnel to their MQSA records.
The primary reason that personnel may
require access to their qualification
records is that they are continuing to
practice mammography at other
facilities. Therefore, the clause ‘‘Before
a facility closes or ceases to provide
mammography services’’ (see
§ 900.12(a)(4) in this final rule) refers to
the closure or cessation of
mammography services of a facility and
not to the cessation of specific
personnel from practicing
mammography.
(Comment 18) A comment requests
that FDA provide guidance on how to
demonstrate compliance with the
requirement to provide access for
personnel to their MQSA records when
a facility closes or ceases mammography
services.
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(Response 18) The Agency believes
that the current regulations, and the
regulations being revised at
§ 900.12(a)(4) in this final rule, are clear
on the requirements regarding personnel
records for facilities that close or cease
to provide mammography services.
Facilities that close or cease to perform
mammography services should inform
their AB, which will assist them in
complying with record retention
obligations and other applicable MQSA
requirements. (Ref. 19.)
E. Digital Accessories
(Comment 19) Several comments
request that FDA provide additional
clarification of the definition of a digital
accessory component, or ask for clarity
on whether specific equipment, such as
display monitors, are included in this
category.
(Response 19) FDA defines an
‘‘accessory’’ of a device as ‘‘A finished
device that is intended to support,
supplement, and/or augment the
performance of one or more parent
devices’’ (Ref. 20). Because a device
accessory is a ‘‘device,’’ we believe the
broader term ‘‘devices’’ is simpler and
allows for a clearer understanding of the
mammography regulations. In this final
rule, we are revising § 900.12(b)(2)(i) for
clarity, to state that ‘‘All devices used in
mammography must have met the
applicable FDA premarket authorization
requirements for medical devices of that
type and intended use.’’ This applies to
devices used in the acquisition,
processing, or display of digital
mammographic images. For example, a
display device used in the interpretation
of digital mammographic images
generally needs to have 510(k) clearance
prior to being used in a mammographic
facility. Not all equipment needs
clearance or approval; for example,
some devices, such as medical image
storage devices, may be exempted from
premarket notification requirements. (It
is important to consult the appropriate
classification regulation to determine
the premarket authorization
requirements.)
(Comment 20) Several comments
recommend changing the effective date
for the digital accessory component
requirements from 18 months to 24
months.
(Response 20) FDA disagrees with the
recommendation to extend the effective
date to 24 months after publication of
this final rule. FDA considers 18 months
to be a reasonable amount of time for
facilities to achieve compliance with
this requirement, based on both
previous experience with the 18-month
effective date specified in the 1997
MQSA final rule (62 FR 55852, October
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28, 1997) and the need for timely
effectiveness of this rule.
(Comment 21) Other comments
recommend that, for QC testing of
digital accessories, in addition to the
use of QC procedures in the
manufacturer’s manual, the proposed
rule should add an option to use the
ACR QC manual.
(Response 21) Alternative
requirements for § 900.12 quality
standards are addressed in § 900.18. The
current ‘‘ACR Digital Mammography
Quality Control Manual for Full-Field
Digital Mammography Systems and
Supplement for Digital Breast
Tomosynthesis Mammography
Systems’’ has been approved as
applicable to any facility as alternative
standard #24 (Ref. 21; see also
§ 900.18(f)). The use of approved
alternative standards such as the ACR
QC manual as they relate to digital
accessories remains acceptable;
however, since the ACR manual may
undergo future revisions, and a revision
would have to undergo FDA review to
determine whether it is at least as
effective in ensuring quality
mammography as the standard it
proposes to replace, the current ACR
manual is not specified in the codified
section of the final rule.
(Comment 22) A comment expresses
concern that a facility using displays
that are not specific for mammography
or for a use that could include
mammography would be in violation.
Another comment suggests that, if a
manufacturer QC procedure exists, there
is no need for FDA premarket
authorization of displays, and continues
that there is no need for FDA premarket
authorization for equipment since there
are alternative standards for QC from
the ACR. A comment also asserts that
the process by which FDA clears or
approves displays is not transparent.
(Response 22) These comments tend
to confuse two separate processes: (1)
the premarket approval or clearance of
a medical device as described in 21 CFR
807.81 and (2) the MQSA requirements
for mammography facilities under 42
U.S.C. 263b and the implementing
regulations under part 900. Medical
devices are subject to FDA’s medical
device requirements, which may
include premarket authorization.
Mammography equipment must also
meet MQSA regulatory requirements
that govern its use in a mammography
facility.
FDA premarket authorization of a
display intended for use in interpreting
mammography images is a premarket
device requirement; however, after this
final rule becomes effective, any
applicable premarket authorization
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requirements will also be required
under the MQSA quality standards for
use of the display for interpreting
mammography images (see
§ 900.12(b)(2)(i) in this final rule).
Therefore, FDA agrees with the
comment that a facility interpreting
mammograms using a display that has
not met the applicable FDA premarket
authorization requirements for use in
interpreting mammography images
would generally be in violation of the
MQSA quality standards regulations.
The QC tests for a display are another
MQSA quality standard required for use
of that display for mammography
interpretation (see § 900.12(e)(6)), but
the existence of QC tests for a display
is generally not sufficient to satisfy all
FDA premarket regulatory requirements
that may apply to the device. Likewise,
the existence of a QC program for other
mammography equipment does not
generally satisfy all the premarket
regulatory requirements applicable to
that equipment. Regarding the comment
that states there are QC procedures
available from ACR, we also note that
facilities that adopt the ACR QC manual
for the QC of their FFDM or DBT system
may not limit the use of the manual to
a single piece of equipment or
accessory, such as a display, while
following a different QC program (such
as the manufacturer’s QC manual) for
the mammography unit (Refs. 21 and
22), and we reiterate that the existence
of a QC program does not necessarily
reflect that any applicable FDA
premarket authorization requirements
are being met.
Regarding the comment on the clarity
of FDA premarket review process for
mammography displays, the premarket
requirements for displays that are
intended to be used in interpreting
mammography images, among others,
are discussed in 21 CFR 892.2050 and
FDA’s guidance ‘‘Display Devices for
Diagnostic Radiology’’ (Ref. 23).
(Comment 23) A comment states that
the requirement that mammograms
submitted for interpretation be
‘‘presented in the mammographic
modality’’ in which they were originally
produced is unclear, and suggests that
mammograms are being read on a device
not intended for mammography. The
comment also recommends including a
statement to caution facilities that they
should be aware of potential
compatibility issues in their imaging/
reading chain.
(Response 23) The requirement that
mammograms be presented for
interpretation in the mammographic
modality in which they were originally
produced means, for example, that
screen-film mammograms must be
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presented for interpretation as the
original hardcopy films, and not
digitized or scanned. FDA does not
agree that this requirement would
reasonably be interpreted to mean that
mammograms are being read on
equipment not intended for
mammography. FDA notes that all
equipment used for mammography must
be specifically designed for
mammography (see § 900.12(b)(2) in this
final rule) and that all devices used in
mammography (including displays, as
discussed in Responses 19 and 22) must
have met the applicable FDA premarket
authorization requirements for medical
devices of that type and intended use
(see § 900.12(b)(2)(i) in this final rule).
FDA agrees that facilities are
responsible for ensuring that any
equipment they use in the acquisition,
processing, interpretation, retention,
and retrieval of mammographic images
be compatible, in order to facilitate
mammography practice and to allow
compliance with the record retention,
transfer, and release provisions in
§ 900.12(c)(4) of this final rule. The
Agency does not believe it is necessary
to include a cautionary statement in the
final rule, as facilities in the course of
their practice of mammography will
readily be able to determine whether
their equipment is interoperable.
F. Facility Identification Information in
Mammography Report and Lay
Summary
(Comment 24) A comment requests
clarification, in the case of a facility that
is associated with a centralized entity
that sends reports and summaries, as to
whether the centralized entity may be
the only name on the report or
summary, whether an abbreviated name
for the actual facility is acceptable, and
whether an alias (e.g., ‘‘Doing Business
As’’ or DBA) is required to appear on
the report. The commenter also requests
clarification of the required timeframe
for a facility to report a name change.
(Response 24) FDA distinguishes each
mammography facility based on its
physical location (see 42 U.S.C.
263b(a)(3) and § 900.12(c)(1)(ii) in this
final rule). Healthcare networks that
offer mammography services at several
locations are accredited and certified as
several separate facilities. The name
recognized by FDA for a facility is the
name under which the facility is
accredited by its AB (see § 900.11(b)).
Therefore, the facility identification
information in the report to the
healthcare provider (see
§ 900.12(c)(1)(ii) in this final rule) and
the lay summary sent to the patient (see
§ 900.12(c)(2) in this final rule) must be
unique to the actual facility where the
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mammogram was performed, and must
include the name under which the
facility is accredited and certified. A
change to a facility’s name must be
submitted to the facility’s AB, and is
subsequently conveyed to FDA by the
AB (see § 900.11(b)); therefore, the
timeframe for reporting a name change,
as well as the acceptability of an alias
or DBA, are governed by the policies of
the AB.
(Comment 25) A comment
recommends that FDA specify whether
the report identification information is
required for a ‘‘consult report.’’
(Response 25) The commenter’s
reference to a ‘‘consult report’’ is not
clear. Typically, a mammogram will be
interpreted only once, and will have
only a single report and a single lay
summary. In some cases, a mammogram
that has already been interpreted and for
which a report and lay summary have
been issued is subsequently presented
to another IP for a repeat interpretation
or ‘‘second opinion.’’ By referencing
determinations made by an ‘‘outside
consultant,’’ the commenter may either
be referring to a later IP rendering such
an additional opinion on an
examination that has already been
interpreted, or may be referring to an IP
who is a contractor to a facility (rather
than a facility employee) rendering the
initial or sole interpretation. If the
comment refers to the reinterpretation of
a previously interpreted mammogram,
the second (or subsequent) IP must also
meet the existing personnel
requirements of § 900.12(a)(1), and must
separately comply with the reporting
requirements of § 900.12(c) in this final
rule. To help distinguish them from the
original interpretation, we recommend
that a second (or subsequent) report and
lay summary be identified as a second
opinion or similar term. If the comment
refers to a report rendered by an IP who
is a contractor or consultant to the
facility rather than a facility employee,
that IP must also meet all personnel
requirements, and the report and lay
summary must meet all reporting
requirements.
(Comment 26) Several comments
address the required identification
information in the lay summary. A
comment asserts that most facilities
already provide facility identification in
the lay summary. Another comment
recommends that the patient name and
the facility information be required in
the lay summary. A separate comment
recommends that the summary include
separately both the contact information
of the facility or business where a
patient can request images and records,
and the actual physical location where
the mammography services were
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provided. Another comment
recommends that FDA not specify the
information that is required ‘‘at a
minimum,’’ but rather specify all
required information, including the
facility telephone number, email
address, and instructions for clear
communication.
(Response 26) FDA agrees that there
have been situations in which the
facility information in the lay summary
was inadequate. FDA concludes that the
expanded requirements in § 900.12(c)(2)
of the final rule will enhance
communication between the facility, the
patient, and the referring provider, and
lead to improved patient care. Because,
as noted in Response 24, FDA identifies
each facility by its unique location (see
§ 900.12(a)(1), in both the proposed and
final rule), the location of the facility
where the mammogram was performed
must be included in the lay summary.
In response to the comment
recommending that a facility’s parent
company information be included in the
header, FDA does not agree that such
additional information should be
required because FDA identifies each
facility by its unique location and not by
any affiliation with a network or
company. However, a facility may
choose to include additional
information about a healthcare network,
affiliated site, or records storage site. In
addition, FDA agrees with the
recommendation that the facility
telephone number be included with the
lay summary, and notes that
§ 900.12(c)(2) of both the proposed and
final rule include this requirement.
Because in FDA’s experience, some
facilities do not have email addresses,
and some others communicate through
patient portals, FDA disagrees with the
recommendation to require that the lay
summary include an email address or
instructions for clear communication
between the patient and the facility.
FDA notes that facilities may choose to
include this additional contact
information.
(Comment 27) A comment
recommends that the lay summary be
required to include the name of the IP,
so that patients will know who is
involved with their care, and if
dissatisfied, can request a different IP.
(Response 27) FDA does not believe it
is necessary to require the name of the
IP as part of the lay summary. A facility
may choose to include this information,
but it is not required. The Agency notes
that the lay summary is prepared after
the examination has been interpreted, so
adding the name of the IP to the lay
summary will not intervene early
enough for the patient to request a
different IP. A patient who prefers a
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particular IP would have to discuss such
a request with the facility staff before
the mammogram is interpreted. After
interpretation by the IP, FDA notes that
the name of the IP is included in the
report to the referring provider, per
§ 900.12(c)(1)(iii), and the patient can
request the name either from the facility
or from the referring provider.
G. Final and Incomplete Assessments
and Lay Summaries
(Comment 28) A comment
recommends that FDA clarify the limits
of the required assessment language for
each mammographic assessment
category, and recommends that the rule
preserve the concept that the assessment
statement is required, while the
explanatory language is not required to
be included in the mammography
report.
(Response 28) For each assessment
category, the required assessment
statement is only the word or phrase in
quotation marks (see § 900.12(c)(iv) in
this final rule). As in the existing
regulations, each assessment statement,
identified in quotation marks, is
followed by explanatory language,
which is not in quotation marks; this
explanatory language not in quotation
marks is intended to provide an
explanation of the assessment category
in order to promote its consistent use,
but it is not part of the assessment
statement, and is not required to be
included in the report to the referring
healthcare provider nor in the lay
summary to the patient. This format of
an assessment statement in quotation
marks followed by explanatory language
outside the quotation marks was also
used in the existing regulations, and
FDA is not aware of significant
confusion caused by this format. In both
the proposed and final rule,
§ 900.12(c)(1)(iv)(A) through (G), the
explanatory language is distinguished
from the assessment statement by the
closing quotation mark at the end of the
assessment. For added clarity, in this
final rule we are revising
§ 900.12(c)(1)(iv) to add the
parenthetical clarification, ‘‘the
assessment statement is only the word
or phrase within the quotation marks.’’
We are also revising § 900.12(c)(1)(iv) to
replace the colon with a period within
the quotation marks surrounding each
assessment statement, to further clarify
the distinction between the required
statement and its explanatory language.
(Comment 29) A comment asserts that
the negative and benign assessment
categories are functionally equivalent
and recommends combining them.
(Response 29) FDA disagrees with this
comment. Although we acknowledge
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that in most instances there may be no
difference in clinical management
between patients with negative
mammograms and those whose
mammograms show benign findings, the
Agency notes that IPs often distinguish
between these examinations and
identify benign findings if they are
present; therefore, we conclude that the
negative and benign assessment
categories should remain separate.
(Comment 30) A comment stated that
the new ‘‘Benign’’ phrasing would be
confusing to patients if sent to them.
Another comment recommends that the
verbiage explaining the term ‘‘Benign’’
not be required to be in the report.
(Response 30) FDA disagrees with the
comment that the ‘‘Benign’’ phrasing
would be confusing to patients. We note
that the explanatory language following
the word ‘‘Benign’’ in
§ 900.12(c)(1)(iv)(B) in this final rule is
not part of the assessment statement. It
is intended only to explain the category
to IPs and other facility personnel, and
is not required to be included in the
report to the referring provider nor in
the lay summary to the patient;
therefore, patients are unlikely to be
presented with such phrasing. We
further note that even the word
‘‘Benign’’ need not be stated to the
patient; a patient summary in lay terms
of either a negative or a benign report
might say, for example, ‘‘Your
mammogram is normal,’’ ‘‘Your
mammogram shows no sign of cancer,’’
or similar phrasing.
(Comment 31) A comment
recommends that, in the parenthetical
statement ‘‘if the interpreting physician
is aware of clinical findings or
symptoms, despite the benign
assessment, these shall be explained’’
(in proposed § 900.12(c)(1)(iv)(B)), the
word ‘‘explained’’ should be revised to
‘‘documented.’’
(Response 31) FDA agrees in part with
the comment. The parenthetical
statement in the explanation of the
benign assessment category is intended
to mirror the existing parenthetical
statement in the explanation of the
negative assessment category (in
§ 900.12(c)(1)(iv)(A)), ‘‘if the
interpreting physician is aware of
clinical findings or symptoms, despite
the negative assessment, these shall be
explained.’’ However, FDA agrees with
the commenter that the IP may not
always be able to explain the clinical
finding or symptom in a patient with a
negative or benign mammogram.
Furthermore, the IP may have clinical
information from a patient history form
or interview that is not yet known to the
referring healthcare provider, and is
therefore not addressed by the
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subsequent requirement in proposed
§ 900.12(c)(1)(vii) that ‘‘All clinical
questions raised by the referring
healthcare provider shall be addressed
in the report to the extent possible, even
if the assessment is negative or benign.’’
FDA believes that this pertinent clinical
information should be documented and,
if possible, explained or otherwise
addressed. Therefore, the Agency
concludes that these parenthetical
statements should be retained, with
revision as suggested, for the negative
assessment category (see
§ 900.12(c)(1)(iv)(A)) and for the benign
assessment category (see
§ 900.12(c)(1)(iv)(B)). As such, FDA is
revising the parenthetical language in
this final rule for the negative and
benign categories, respectively, to state
that ‘‘if the interpreting physician is
aware of clinical findings or symptoms,
despite the negative assessment, these
shall be documented and addressed,’’
and ‘‘if the interpreting physician is
aware of clinical findings or symptoms,
despite the benign assessment, these
shall be documented and addressed.’’
(Comment 32) A comment requests
confirmation that the new assessment
categories are part of the alternative
standard approved in 2003. Another
comment requests confirmation that the
‘‘FDA-approved’’ equivalent wording for
assessment categories is still permitted,
and asserts that IPs should have the
option to report equivalent language
rather than the assessment statements in
the regulations.
(Response 32) The new assessment
statement ‘‘Post-Procedure Mammogram
for Marker Placement’’
(§ 900.12(c)(1)(iv)(G)) is identical to
alternative standard #12 approved by
FDA in 2003 (Ref. 24). The new
assessment statements ‘‘Incomplete:
Need Additional Imaging Evaluation’’
(§ 900.12(c)(1)(v)(A)) and ‘‘Incomplete:
Need Prior Mammograms for
Comparison’’ (§ 900.12(c)(1)(v)(B)) are
derived from alternative standard #11
approved by FDA in 2003 (Ref. 25). The
statements ‘‘Incomplete: Need
Additional Imaging Evaluation’’ and
‘‘Incomplete: Need Prior Mammograms
for Comparison’’ represent the division
of the single assessment statement in
alternative standard #11 into two new
assessment statements. These
statements reflect FDA’s recognition
that some mammograms require
comparison for interpretation, while
some mammograms require additional
imaging to reach a final interpretation.
The only authorized assessment
statements are those in the quality
standards and the approved alternative
standards (Refs. 22 and 24; see also
§§ 900.12(c)(1)(iv) and 900.18). In
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addition, as described in the MQSA
Policy Guidance Help System (PGHS),
FDA has acknowledged that some
closely worded variations of the
approved assessment statements may
generally be acceptable where the
particular wording does not change the
meaning of the category (Ref. 26).
(Comment 33) A comment expresses
concern that the reporting requirements,
which seemingly would allow for an
automated process of an IP selecting
prepared comments that match the
assessment categories, do not include an
assessment statement or comment for
patients with a history of breast cancer
surgery who are subsequently
undergoing routine screening.
(Response 33) Although FDA places
requirements on the wording of the
assessment statement used to describe
the assessment category selected by the
IP to promote clarity of communication
between the IP and the referring clinical
healthcare provider, we anticipate that
the mammography report may include
additional information about the
findings of the examination, before the
concluding assessment statement. FDA
agrees that, after an IP examines the
images, the IP may select prepared
statements that in the IP’s judgment
accurately describe the findings of the
examination, and likewise may select
the final assessment from a prepared list
of the approved assessment statements.
The Agency anticipates that there will
be some mammograms whose findings
necessitate additional nonstandard
statements within the report, but the
report must conclude with one of the
standard approved assessment
statements listed in § 900.12(c)(1)(iv)(A)
through (G). As applicable to the
commenter’s example, the patient’s
history of cancer and prior surgery, and
any relevant post-surgical findings on
the images, may be described in the
report, but it must conclude with a final
assessment chosen from the approved
statements; for example, ‘‘Benign’’ (see
§ 900.12(c)(1)(iv)(B)) or ‘‘Suspicious’’
(see § 900.12(c)(1)(iv)(D)). The Agency
does not believe it is necessary to add
a unique assessment statement for
patients with the history described by
the commenter, as the statements listed
in § 900.12(c)(1)(iv)(A) through (G) are
adequate to encompass patients who
have previously had breast cancer and
those who have had surgery, whether
for cancer or other reasons.
(Comment 34) A comment mentions
the potential limitations of a
mammogram when a patient either
cannot cooperate with or cannot
understand instructions, and
recommends that FDA add assessment
categories that reflect these limitations,
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including ‘‘Benign with technical
limitation’’ and ‘‘Normal with technical
limitation.’’ Similarly, another comment
mentions the limitation of dense breast
tissue and recommends that FDA add an
assessment category for ‘‘Normal but
dense.’’
(Response 34) FDA agrees that some
mammograms have technical
limitations, but concludes that the
limitations should be documented
elsewhere in the report, not in the
assessment statement. For clarity, the
assessment statement should represent
only the IP’s final conclusion about the
results of the examination. The
limitation of breast density is addressed
elsewhere in this final rule (see
§ 900.12(c)(1)(vi)(A) through (D)). In
particular, the limitations conferred by
dense tissue must be stated elsewhere in
the report, using the language in
§ 900.12(c)(1)(vi)(C) of the final rule,
‘‘The breasts are heterogeneously dense,
which may obscure small masses,’’ or
§ 900.12(c)(1)(vi)(D) of the final rule,
‘‘The breasts are extremely dense, which
lowers the sensitivity of
mammography.’’
(Comment 35) Several comments
address the assessment category
‘‘Suspicious,’’ which the commenters
erroneously refer to as a numerical
category 4. These comments recommend
that the use of alphanumeric
subcategories 4a, 4b, and 4c be allowed,
be encouraged, or be considered a
legitimate option.
(Response 35) FDA disagrees with the
recommendations to permit or
encourage the use of alphanumeric
subcategories instead of the assessment
statement ‘‘Suspicious.’’ All the
required assessment statements under
the MQSA quality standards are words
or phrases, not numbers. Thus, the
assessment statements are not identical
to the numerical codes derived from
ACR’s Breast Imaging—Reporting and
Data System (BI–RADS) (Refs. 26 and
27). BI–RADS is a practice guideline
published by a professional society (the
ACR), and is not associated with the
MQSA quality standard requirements.
While a numeric or alphanumeric BI–
RADS assessment code in addition to
the assessment statement may be used,
one of the overall final assessment of
findings statements as described in
§ 900.12(c)(1)(iv) of this final rule must
appear in the report.
For example, in BI–RADS, category 4
(Suspicious) offers optional
subcategories a through c, and phrases
associated with each letter (4a: ‘‘Low
suspicion for malignancy,’’ 4b:
‘‘Moderate suspicion for malignancy,’’
and 4c: ‘‘High suspicion for
malignancy’’), to further refine the level
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of suspicion (Ref. 28). However, for any
mammogram that would receive an ACR
BI–RADS code of either 4, 4a, 4b, or 4c,
the assessment statement required
under the MQSA quality standards is
not a number or a letter, but the word
‘‘Suspicious.’’ Additionally, the phrase
associated with each ACR BI–RADS
code 4a through 4c is not an approved
alternative standard for use as an
assessment statement; while the final
rule does not prohibit such a statement
from being included in the report, the
overall final assessment statement,
‘‘Suspicious,’’ would be the appropriate
statement to include as the final
assessment category of the mammogram
(Ref. 29).
(Comment 36) A comment
recommends that FDA provide
examples of when referral of a selfreferred patient to a healthcare provider
is mammographically indicated.
(Response 36) The proposed
§ 900.12(c)(2)(ii) stated that ‘‘Each
facility that accepts patients who do not
have a healthcare provider shall
maintain a system for referring such
patients to a healthcare provider when
mammographically or clinically
indicated.’’ FDA believes that such
referral is indicated when the
mammographic findings warrant
followup imaging or intervention sooner
than at a routine screening interval.
Therefore, for patients who do not have
a healthcare provider and whose
mammogram results are either probably
benign, suspicious, or highly suggestive
of malignancy, referral to a provider is
generally mammographically indicated.
For clarity, FDA is revising this
provision to state, ‘‘Each facility that
accepts patients who do not have a
healthcare provider shall maintain a
system for referring such patients to a
healthcare provider when clinically
indicated, which shall include when
such patients’ mammogram assessment
is either probably benign, suspicious, or
highly suggestive of malignancy’’ (see
§ 900.12(c)(2)(ii) in this final rule).
(Comment 37) A comment
recommends that the lay summary
inform the patient if risk factors such as
density, pain, calcifications, discharge,
and other items are identified on the
mammogram.
(Response 37) FDA does not believe it
is necessary to require this information
in the lay summary. The facility is
required to send the patient a summary
of the mammography report written in
lay terms (see § 900.12(c)(2) in this final
rule). This final rule adds breast density
notification language to the lay
summary requirement, but it does not
require that the lay summary mention
patient symptoms or individual
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mammographic findings. FDA does not
believe that it is appropriate to require
specific language for the wide range of
breast symptoms and mammographic
findings that may be identified. For
example, some of the items mentioned
in the comment, such as pain and
discharge, cannot be identified on a
mammogram. The regulations require
that the mammography report to the
provider address findings, clinical
questions raised by the referring
healthcare provider, and
recommendations for additional actions,
if any, (see §§ 900.12(c)(1)(iv)(A) and (B)
and (vii) in this final rule). Some
findings or symptoms may be present
but not clinically significant. The
referring healthcare provider, who
receives the mammography report and
is also familiar with the patient’s history
and physical findings, is best positioned
to discuss the case with the patient.
(Comment 38) Several comments
address the proposed final assessment
category ‘‘Post Procedure Mammograms
for Marker Placement.’’ A comment
asserts that the addition of an
assessment category for a postprocedure mammogram is unnecessary.
Another comment asserts that the postprocedure mammogram is ‘‘bundled
into’’ the interventional procedure and
does not receive an assessment. A
comment requests clarification on
whether a mammogram documenting a
biopsy clip or marker requires
documentation.
(Response 38) The assessment
statement ‘‘Post Procedure
Mammograms for Marker Placement’’
was approved as alternative standard
#12 on September 17, 2003 (Ref. 24),
under the mechanism described in
current § 900.18 for the approval of
alternatives to the MQSA quality
standards in § 900.12. Since its approval
in 2003, it has been available and
acceptable for use as a final assessment
statement. In this final rule,
§ 900.12(c)(1)(iv)(G), FDA is adding the
nearly identical assessment statement
‘‘Post-Procedure Mammogram for
Marker Placement’’ to the implementing
regulations. The situations in which this
assessment should be given to any
particular mammogram are more
appropriate for the IP to determine in
the course of clinical decision-making.
As FDA described in approval of the
alternative standard, if a facility makes
the post-procedure examination part of
the interventional procedure instead of
a separately charged examination, then
the examination is not subject to the
MQSA quality standard requirement
and need not receive an assessment
(Ref. 24). Nor would it require any
report separate from the report of the
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interventional procedure. However,
when the post-procedure mammogram
is logged or charged separately from the
interventional procedure, this
mammogram is a separate examination
and requires a separate report.
This ‘‘Post-Procedure’’ assessment
category is useful to distinguish
examinations that simply document the
localization of a known abnormality or
a known marker without contributing
new diagnostic information, so that
these examinations are not
misconstrued as showing new or
additional abnormalities. The
availability of a post-procedure
assessment category also helps maintain
the accuracy of the medical outcomes
audit required under § 900.12(f). The
audit requires followup for positive
mammograms, defined in existing
§ 900.2(mm) as mammograms receiving
assessments of either ‘‘Suspicious’’ or
‘‘Highly Suggestive of Malignancy,’’ but
a post-procedure mammogram of a
patient with a previously identified
abnormality is not intended to be
counted as a new positive result; this
assessment category helps facilities to
distinguish and exclude post-procedure
mammograms from the audit.
(Comment 39) Two comments object
to FDA’s mention of a ‘‘localization
needle’’ in the explanation of one
potential use for this ‘‘Post-Procedure
Mammogram for Marker Placement’’
final assessment, since spatial
localization may not always be
performed with a needle, and
recommends revising this explanation
to ‘‘localization device’’ or ‘‘localization
marker.’’ Another comment asserts that
a marker may not always deploy and
recommends changing the wording of
the assessment statement to ‘‘Post
procedure mammogram.’’
(Response 39) FDA agrees that some
localization devices are not needles, and
is clarifying our explanation of the
assessment category as follows: this
category is primarily used for a
mammogram performed following a
biopsy to confirm the deployment and
position of a breast tissue marker. The
other use of this final assessment
category is for a mammogram performed
to document the position of a
localization needle or other marker.
During preoperative localization, a
needle or other temporary marker may
be positioned to direct subsequent
surgery for a nonpalpable lesion seen on
earlier mammography. The postprocedure mammogram is performed as
a guide to identify the suspicious site
for the surgeon who will biopsy or
excise the lesion and remove the needle
or marker.
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The post-procedure mammogram is
typically performed in an attempt to
localize a device, such as a needle or
other tissue marker, or to determine
whether the device has deployed. FDA
concludes that this intention is
accurately captured by the phrasing
‘‘Post-Procedure Mammogram for
Marker Placement,’’ even in cases in
which the mammogram reveals that a
marker failed to deploy. FDA notes that
all mammographic views obtained in a
single examination are typically referred
to collectively as a ‘‘mammogram,’’ and
therefore agrees in part with the
comment that recommends changing the
wording of the assessment statement to
the singular ‘‘Post procedure
mammogram.’’ Accordingly, we are
revising the wording of the assessment
statement to the singular ‘‘PostProcedure Mammogram for Marker
Placement’’ (see § 900.12(c)(1)(iv)(G) in
this final rule), in addition to clarifying
the description as noted.
(Comment 40) One comment asserts
that a lay-language summary to the
patient should not be required for a
mammogram performed for marker
placement, because the mammogram is
performed for localization rather than
for diagnosis, and receiving a lay
summary of such an examination may
confuse the patient.
(Response 40) As discussed in
Response 38, we have explained that if
a facility makes the post-procedure
mammogram a separately logged or
charged examination rather than part of
the interventional procedure, the
mammogram is subject to all MQSA
quality standard requirements,
including a report to the referring
healthcare provider and a summary of
the report in lay language to the patient.
The lay summary must be specific to the
examination and report; for example, if
the assessment statement in a report
states that an examination was a postprocedure mammogram for marker
placement, then the lay summary of that
report should likewise mention the
procedure or the marker placement, but
it would not be appropriate to state that
the mammogram results were abnormal,
worrisome, suspicious for cancer, etc.
FDA believes that a lay summary
limited to discussing the fact that the
mammogram was performed for
localization after a procedure will not
confuse a patient who has just
undergone a procedure.
(Comment 41) Several comments
recommend that FDA revise the
assessment statement ‘‘Incomplete:
Need prior mammograms for
comparison’’ (proposed
§ 900.12(c)(1)(v)(B)) to replace
‘‘mammograms’’ with ‘‘breast imaging’’
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or ‘‘breast examinations,’’ to include
other imaging modalities such as breast
ultrasound.
(Response 41) FDA disagrees with this
recommendation. The Agency
concludes that extending the assessment
statement ‘‘Incomplete: Need prior
mammograms for comparison’’ to a
comparison with other breast imaging
modalities, which may have been
performed at multiple different imaging
facilities and centers, could impose
delays in obtaining those prior
examinations and issuing the final
interpretation of the mammogram. As
addressed in Response 4, the MQSA and
FDA’s implementing regulations apply
specifically to mammography facilities,
so facilities where a patient’s prior
mammograms were performed would
have retained those examinations,
pursuant to the MQSA record retention
requirement (see § 900.12(c)(4)(i) in this
final rule), and would presumably
respond to the patient’s request to
transfer them or release copies of their
records, pursuant to the MQSA record
release requirements (see
§ 900.12(c)(4)(ii) and (iii) in this final
rule). In contrast, other imaging centers
not subject to the MQSA quality
standards are not required to release
prior non-mammography imaging
within these regulatory deadlines.
Additionally, other imaging modalities
may not provide the type of information
that is directly comparable to the
mammogram.
(Comment 42) A comment requests
confirmation that an Incomplete
assessment statement, which the
commenter cites as ‘‘Category 0:
Incomplete—need additional imaging
evaluation and/or comparison with
prior examination(s),’’ remains
acceptable. Similarly, another comment
recommends that FDA allow facilities to
choose whether to separate the two
Incomplete assessment categories or to
keep them grouped together.
(Response 42) The first commenter’s
citation of the assessment statement is
incorrect on two points. As we noted in
Response 35, all approved assessment
statements under the MQSA quality
standards are words or phrases, not
numeric or alphanumeric codes, so the
numeral zero is not required as part of
the assessment. Also, the Incomplete
assessment statement approved by FDA
in 2003 as alternative standard #11 does
not refer to ‘‘prior examinations,’’ but to
‘‘prior mammograms.’’ Therefore, the
phrasing cited by the first commenter is
not acceptable. However, we note that
even after the introduction of the two
Incomplete assessment statements in
this final rule, alternative standard #11
remains in effect, such that the
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combined assessment statement
‘‘Incomplete: Need additional imaging
evaluation and/or prior mammograms
for comparison’’ may also be used.
Therefore, FDA agrees with the second
commenter that a facility may choose
either to use one of the separate
Incomplete assessment statements that
appear in this final rule (see
§ 900.12(c)(1)(v)(A) and (B)), or to use
the combined statement as found in
alternative standard #11, which remains
an approved alternative standard.
(Comment 43) A comment
recommends that FDA expand and
clarify its justification of the assessment
category ‘‘Incomplete: Need prior
mammograms for comparison’’ with a
more evidence-based justification
addressing the value of the comparison
of a mammogram with prior
mammograms. The proposed rule
(under section V.E.3 of the
Supplemental Materials) includes the
statement, ‘‘Comparison to previous
examinations is sometimes required to
make a final assessment.’’ However, the
comment recommends that FDA instead
justify the value of comparison
mammograms by using the statement,
‘‘Evidence shows that comparison with
a single prior exam, and more so with
multiple prior examinations, improves
accuracy, including a reduction in the
recall rate and an improvement in
sensitivity and predictive value.’’
(Response 43) The reference cited by
the commenter (Ref. 30) demonstrates
that comparison to two or more prior
exams reduces the recall rate, and
increases the cancer detection rate and
a positive predictive value (PPV) known
as PPV1. Although comparison to
previous examinations is valuable, FDA
does not believe that the recommended
statement is fully supported by the cited
reference. However, FDA agrees with
the commenter’s broader implication
that there are many benefits to
interpreting a mammogram in
comparison to one or more of the
patient’s previous mammograms,
including but not limited to improved
accuracy and reduced recall rate. FDA
believes that the final rule adequately
reflects the value of making
comparisons to previous mammograms
when available.
(Comment 44) Some comments
express concern about the timing of
interpretation of a mammogram
following an assessment of ‘‘Incomplete:
Need prior mammograms for
comparison.’’ A comment asserts that a
patient may not be able to obtain prior
mammograms within 30 days, and
another comment asserts that the rule
would permit a total of 60 days from the
performance of the examination to the
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final interpretation, assuming 30 days to
obtain the prior examination and
another 30 days to make the comparison
and issue a final report, and that during
that time the patient’s insurance or
healthcare provider may change. One of
the commenters recommends that FDA
impose a total limit of 30 days from the
performance of the examination to the
issuance of the final report, and one
recommends that FDA monitor the use
and benefit of the new assessment
category.
(Response 44) A facility is required to
issue a report to the referring healthcare
provider and a summary in lay terms to
the patient no later than 30 days after
the examination (§ 900.12(c)(3)(i)), and
to issue a followup report no later than
30 days after issuing an initial report of
‘‘Incomplete: Need prior mammograms
for comparison,’’ whether or not
comparison views can be obtained
(§ 900.12(c)(1)(v)(B) in this final rule).
However, we note that these 30-day
intervals are maximums, and represent
baseline standards. There is no
requirement that a facility wait a full 30
days for a patient to submit prior
images, and likewise no requirement
that a facility wait a full 30 days after
receiving a prior comparison
examination before issuing a final
report. A facility may establish policies
regarding a shorter interval to wait for
prior examinations and a shorter
interval in which to issue a final report
after receiving comparison
examinations, perhaps with exceptions
for a patient’s individual situation.
Therefore, FDA concludes that the
reporting deadlines stated in the
regulations as proposed and finalized
are adequate. FDA also notes that
although the two ‘‘Incomplete’’
assessment statements are new to the
quality standards regulations, they are
derived from the ‘‘Incomplete’’
assessment statement approved in
alternative standard #11 in 2003 (Ref.
25) and in widespread use since that
time. FDA is not aware of any concerns
raised about the benefit of the use of this
assessment category or concerns about
the timing of the final report. The
Agency further notes that the report is
required to be sent to the healthcare
provider who referred the patient for the
mammogram, unless the patient informs
the facility of a new or additional
provider (§ 900.12(c)(3)).
(Comment 45) A comment expresses
opposition to the new assessment
statement ‘‘Incomplete: Need prior
mammograms for comparison,’’
asserting that this will lead to an
increase in the number of mammograms
that either do not receive a final
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assessment within 30 days, or do not
receive one at all.
(Response 45) FDA disagrees with this
comment. First, as noted in Response
44, this assessment statement is derived
from one that has already been eligible
for use since 2003 under the approved
alternative standard #11 (Ref. 25).
Furthermore, in this final rule, use of
the assessment statement ‘‘Incomplete:
Need prior mammograms for
comparison’’ in § 900.12(c)(v)(B) also
requires that ‘‘a followup report with an
assessment category identified in
paragraphs (c)(1)(iv)(A) through (E) of
this section must be issued within 30
calendar days of the initial report
whether or not comparison views can be
obtained.’’ Thus, the imperative to issue
a final assessment for the examination
within 30 days is directly linked to the
initial use of this incomplete assessment
category. As noted, since the time that
alternative standard #11 was approved
in 2003, FDA has not become aware of
any concerns raised about the timing or
issuance of the final report.
H. Deadlines for Mammography Reports
(Comment 46) A comment
recommends that the report to the
healthcare provider and the lay
summary to the patient should have the
same deadline of 14 days. A separate
comment recommends that screening
mammograms should have a deadline
for reports and lay summaries of 30 days
from the date of the examination.
Another comment recommends that
when prior mammograms are needed for
comparison, the report should have a
deadline of 14 days and the lay
summary a deadline of 21 days,
respectively, from the receipt of the
prior mammogram, not from the date of
the current examination.
(Response 46) FDA disagrees with
these comments. The deadline of 30
days from the date of the examination
(or from the date of the initial
Incomplete report, if applicable) is a
maximum and a baseline standard. As
noted in Response 44, facilities may
choose to establish policies of shorter
deadlines for releasing prior
examinations and for performing
comparisons to prior examinations. FDA
concludes that the deadline stated in
this final rule is adequate. Aside from
the specific audit provisions in
§ 900.12(f), the MQSA and FDA’s
implementing regulations do not
distinguish between mammograms
whose clinical role is screening or
diagnosis. All examinations must meet
the reporting deadlines, and the
commenter’s recommendation of a 30day deadline is generally consistent
with the regulations. FDA concludes
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that the deadline for the report should
be linked to the date of the examination.
This is because the receipt of prior
comparison examinations may be
unpredictable and inconsistent, and
using the date of receipt of prior
examinations as opposed to the date of
the current examination for the
reporting deadline could lead to delays
in reporting.
(Comment 47) Several comments note
an inconsistency between, on the one
hand, the 30-day deadlines for all
mammography reports (§ 900.12(c)(3)(i))
and lay summaries (§ 900.12(c)(2)), and
on the other hand, the new earlier
deadlines for the report of 14 days (in
proposed § 900.12(c)(3)(ii)) and lay
summary of 21 days (in proposed
§ 900.12(c)(2)) when a mammogram is
interpreted as ‘‘Suspicious’’ or ‘‘Highly
Suggestive of Malignancy.’’
(Response 47) FDA agrees with the
comments and acknowledges that these
proposed deadlines were inconsistent
with respect to deadlines calculated
from the date of the mammographic
examination. Accordingly, in this final
rule we are revising § 900.12(c)(2) by
deleting the words ‘‘but in no case later
than 21 calendar days from the date of
the mammographic examination,’’ and
revising § 900.12(c)(3)(ii) by deleting the
words ‘‘but in no case later than 14
calendar days from the date of the
mammographic examination.’’ All
reports and lay summaries, regardless of
the assessment of the mammogram,
must be sent within 30 calendar days of
the examination (see § 900.12(c)(2) and
(3)(ii) in this final rule). However, as
noted in Response 46, this 30-day
deadline is a maximum and a baseline
standard. In many facilities, the
interpretation and communication of
the results is typically performed much
sooner than at 30 days. Accordingly, we
consider the within-30-day timeframe of
the mammographic examination to be
appropriate, except in the following
circumstances: We require that, for
positive mammograms (defined as
mammograms with an assessment
category of either suspicious or highly
suggestive of malignancy (see
§ 900.2(mm)), the facility send both the
report and the lay summary within 7
calendar days of the final interpretation
of the mammogram. For these
situations, the deadline for providing
the lay summary is earlier than the
general 30-day deadline from the date of
the mammographic examination for all
reports and lay summaries (see
§§ 900.12(c)(2) and (c)(3)(ii) in this final
rule). As discussed in the proposed rule
(84 FR 11676), FDA believes such action
by the facility is appropriate for these
two final assessment categories because
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they both indicate findings that warrant
further evaluation.
We have noted an additional
inconsistency, regarding the deadlines
for sending a report to a ‘‘self-referred’’
patient who has not identified a
referring healthcare provider. A selfreferred patient receives both the lay
summary and the mammography report.
As discussed above (in this response),
the timeframe for sending the lay
summary to any patient, including a
self-referred patient, is within 30 days of
the performance of the examination, and
within 7 days of interpretation if the
assessment is ‘‘Suspicious’’ or ‘‘Highly
Suggestive of Malignancy’’ (see
§ 900.12(c)(2) in this final rule). The
timeframe for sending the report to the
self-referred patient is within 30 days of
the examination (see § 900.12(c)(2)(i) in
this final rule), but the proposed rule
did not specify any change in that
deadline when the results are
suspicious or highly suggestive of
malignancy. We are now adding the
statement ‘‘If the assessment of the
mammography report is ‘‘Suspicious’’ or
‘‘Highly Suggestive of Malignancy,’’ the
facility shall send this report to the
patient within 7 calendar days of the
final interpretation of the
mammograms’’ (see § 900.12(c)(2)(i) in
this final rule). This addition makes the
30-day and 7-day deadlines consistent
for sending the mammography report to
either the referring provider (if a patient
identifies a provider) or directly to a
patient who has not identified a
provider.
I. Breast Density Notification—General
Support for Density Notification
(Comment 48) FDA received
comments that support the proposed
requirements to provide information
regarding breast density to both patients
and their healthcare providers, with
comments recommending that FDA
finalize the regulations with the two
categories of breast density in patient
lay summaries and four categories in
reports to healthcare providers as
proposed.
(Response 48) FDA appreciates the
public support for the density
notification requirement. FDA believes
that receiving consistent baseline
information regarding breast density is
important for both patients and their
healthcare providers to make informed
shared decisions, and that the respective
requirements for the report and lay
summary strike an appropriate balance
between providing sufficient
information to healthcare providers
while maintaining a clear message to
patients. Therefore, in this final rule,
FDA is requiring that the breast density
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notification use two categories of breast
density in the lay summary to patients
(see § 900.12(c)(2)(iii) and (iv)) and four
categories in the report to healthcare
providers (see § 900.12(c)(1)(vi)(A)
through (D)).
(Comment 49) A comment states that
the proposed rule creates a standard that
is not backed by medical evidence.
(Response 49) FDA disagrees with this
comment. The commenter is referring to
the requirement for breast density
notification. Both the proposed
amendments and this final rule do not
specify the further management of
patients with dense tissue, only that
these patients and their providers must
be notified of their breast density. As
discussed in Response 62, the Agency is
revising the notification to patients with
dense breast tissue to reflect that ‘‘In
some people with dense tissue, other
imaging tests in addition to a
mammogram may help find cancers.’’
(see § 900.12(c)(2)(iv) in this final rule),
which is supported by many scientific
studies demonstrating increased cancer
detection in dense breasts using
supplemental imaging modalities (Refs.
10, 11, 31, and 32). This increased
detection facilitates earlier treatment of
mammographically occult cancers, and
may reduce morbidity from the tumor
and its treatment.
(Comment 50) Several comments
recommend that the lay summary
should contain simple, clear language,
and several comments recommend that
the density information should be
placed at the top of the letter instead of
following the result or assessment
statement.
(Response 50) FDA agrees with the
recommendation that the lay summary
should contain clear language. In this
final rule, both of the revised
notification statements for the lay
summary are below the eighth grade
reading level on the Flesch-Kincaid
scale. We conclude that the notification
language represents a balance of
understandability and accuracy (see
§ 900.12(c)(2)(iii) and (iv) in this final
rule). However, the Agency does not
agree that it is necessary to require that
the breast density notification statement
be placed in a specific location relative
to other mammogram result information
in the lay summary. We incidentally
note that the lay summary is not
required to include an assessment
category or statement. Furthermore,
given the range of mammogram results
and recommendations that may need to
be communicated by a facility to a
patient, we conclude that it may be
unduly restrictive to make this a
requirement for facilities, and that it
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may potentially be confusing to
patients.
(Comment 51) A comment
recommends that an explanation of
medical terms must be included in all
lay summaries.
(Response 51) FDA disagrees with the
comment. We note that the language for
the lay summary in this final rule
excludes medical terminology that may
not be understandable to a wide
audience. We do not believe that it is
necessary to require that an additional
explanation of medical terms be
included in a lay summary.
(Comment 52) A comment
recommends that the lay summary
include additional information about
mammography and its limitations.
(Response 52) FDA disagrees with
requiring this information in the lay
summary. The language in this final rule
for the lay summary includes the
statement that ‘‘Dense tissue makes it
harder to find breast cancer on a
mammogram,’’ and FDA concludes that
this statement is adequate in addressing
the limitations of mammography as they
relate to breast density. As is also stated
in the breast density notification
language (see § 900.12(c)(2)(iii) and (iv)
in this final rule), FDA recommends that
patients speak to their healthcare
provider after receiving the lay
summary, and this discussion can
include more information on
mammography and its limitations.
(Comment 53) A comment
recommends that FDA work with
individuals to improve the readability
and understandability of any proposed
language and describes existing breast
density notification language as poor in
understandability and causing
confusion and misinformation.
(Response 53) The breast density
notification language in this final rule is
the result of discussion between
clinicians, patients, and FDA. Both the
notification statement to patients with
non-dense breasts (see § 900.12(c)(2)(iii)
in this final rule) and the notification
statement to patients with dense breasts
(see § 900.12(c)(2)(iv) in this final rule)
are below the eighth grade reading level
on the Flesch-Kincaid scale. We believe
that these statements represent an
appropriate balance between patient
understandability and accuracy of the
information conveyed. FDA cannot
comment on the understandability of
various State breast density
notifications; however, FDA
recommends that patients speak to their
healthcare provider about any language
that they do not understand.
(Comment 54) A comment
recommends that visual aids and
medical cartoons for patients with low
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literacy should be included, to decrease
health disparities.
(Response 54) FDA acknowledges that
patients of limited literacy may need
assistance with the interpretation of the
lay summary. However, FDA does not
believe it is necessary to require this
information in the summary. The
requirements for the lay summary
represent baseline standards; FDA
recognizes that facilities may choose to
provide additional information or
explanation they feel is needed by their
patients. The breast density notification
language in this final rule is meant to be
concise and clear, and adding visual
aids and medical cartoons into the lay
summary may potentially distract from
the primary message regarding a
patient’s breast density and resulting
recommendations. FDA notes that the
interaction between a patient and their
healthcare provider presents an
appropriate opportunity to address
questions that a patient may have
regarding the lay summary. The
required language in this final rule
(§ 900.12(c)(2)(iii) and (iv)) includes
such a recommendation to talk to a
healthcare provider.
(Comment 55) Several comments
recommend that in addition to the
breast density notification, FDA add
patient education and a clear plan of
management to the lay summary.
(Response 55) FDA disagrees with the
comment. We conclude that the
language in this final rule provides a
foundation for patients to be informed
regarding their breast density when
using mammography. The intent of the
lay summary being required and
provided to the patient is not to serve
as an exhaustive resource regarding
breast disease and its management. The
lay summary includes the
recommendation for the patient to talk
to their healthcare provider, and we
note that this interaction is an
appropriate opportunity for additional
patient education. Regarding the
recommendation that the lay summary
include a clear plan of management,
FDA notes that the lay summary is
generated by the breast imaging facility,
whereas the plan of clinical
management for each individual patient
will be developed by the patient and
their healthcare provider, and as such,
it is not appropriate for this type of
information to be included in the lay
summary.
(Comment 56) A comment
recommends replacing the phrase, ‘‘The
breasts are almost entirely fatty,’’ in
§ 900.12(c)(1)(vi)(A), with the phrase,
‘‘The breast tissue is of low density,’’
asserting that the former statement has
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‘‘negative connotations’’ to many
patients.
(Response 56) FDA disagrees with the
comment. FDA notes that this category,
and the others in § 900.12(c)(1)(vi)(A)
through (D), are already in widespread
use in breast density reporting. Thus,
FDA believes it would be confusing to
replace the ‘‘almost entirely fatty’’
category with the ‘‘low density’’
sentence recommended by the
commenter, as it would be unclear
whether ‘‘low density’’ referred to the
breast density category in
§ 900.12(c)(1)(vi)(A), ‘‘The breasts are
almost entirely fatty,’’ or the density
category in § 900.12(c)(1)(vi)(B), ‘‘There
are scattered areas of fibroglandular
density.’’ Additionally, the breast
density assessment statement in
§ 900.12(c)(1)(vi)(A) is included only in
the report intended for the healthcare
provider, and not in the lay summary
sent to the patient, so it will not be sent
to patients with a referring provider.
Self-referred patients will receive the
lay summary as well as the report,
which should help mitigate any
unintended negative connotations of the
report.
(Comment 57) A comment questions
the benefit of the density notification
and recommends that FDA should
involve more individuals in the drafting
of density notification language, and
that this language should describe the
limitations of density assessment, the
risks of overdiagnosis and overtreatment
such as gadolinium exposure from MRI
and radiation exposure from additional
mammographic evaluation, and the lack
of benefit of density notification. A
comment recommends adding
additional language educating patients
about breast density, what it means to
a patient, and how patients can take
extra steps to protect themselves.
(Response 57) FDA disagrees with the
assertion of lack of benefit in informing
patients and their healthcare providers
of a patient’s breast density. FDA
considers it to be a benefit to inform
patients about their breast anatomy. In
addition, FDA considers it to be a
benefit to inform patients in a consistent
manner about their breast density. The
language in the final rule is intended as
a baseline for breast density
information, which can be used by
patients and their healthcare providers
to help inform and guide patient care.
FDA notes that the provider-patient
interaction is an appropriate
opportunity for further discussion of
breast density and of the benefits and
risks of possible further evaluation. We
conclude that including too wide a
range of information in the lay
summary, particularly information that
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may not be supported by a wide
consensus in the scientific community
or current information that may be
subject to change with future advances
in knowledge and understanding, may
unnecessarily increase patient
confusion and lead to reduced
effectiveness of the breast density
notification.
(Comment 58) A comment
recommends eliminating the
recommendation in § 900.12(c)(2)(iii) for
patients with non-dense breast tissue to
talk to their healthcare provider.
Another comment recommends that
patients should be directed to additional
information on breast density, not just
to their referring physician.
(Response 58) The Agency believes it
is important for patients to have an
understanding of their breast density to
promote informed and shared decision
making about whether supplemental
screening is appropriate based on each
patient’s individual circumstances, and
speaking with their healthcare provider
is an additional opportunity to
accomplish this. The final rule does not
prohibit facilities or healthcare
providers from providing additional
information on breast density to
patients; however, FDA concludes that
specific additional resources on breast
density should not be codified in the
final rule as a requirement to be
provided as part of the lay summary,
particularly since these sources of
information may change or become
outdated.
(Comment 59) A comment asserts that
there are conflicting reports of the
density discussion at the 2011
NMQAAC meeting.
(Response 59) FDA disagrees with the
comment. A transcript of the 2011
NMQAAC meeting is available (Ref. 33).
The transcript shows there was general
agreement on requiring density
notification and advising 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
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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
(§ 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
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facilities regarding providing
mammogram studies and reports to
patients upon request (§ 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 § 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 decisionmaking 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.
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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 § 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 § 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 § 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 § 900.12(c)(2) must
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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 § 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
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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
§ 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 § 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
§ 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
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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 decisionmaking 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
§ 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
§ 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 § 900.12(c)(1)(vi)(A)
through (D)) or the notification of
density in the lay summary to the
patient (see § 900.12(c)(2)(iii) and (iv)).
(Comment 75) Several comments
recommend modifying the language in
the patient lay summary in proposed
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§ 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
§ 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 § 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
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(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
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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,
§ 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
§ 900.12(c)(2)(iii), ‘‘Your breast tissue is
not dense,’’ and in § 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
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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 § 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 § 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
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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 § 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
§ 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.
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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 § 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 § 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
§ 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 selfassessment. Finally, we note that
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providing patients with the images from
their mammogram studies when
requested continues to be a requirement
in the final rule (see § 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 § 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 selfreferred) 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
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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 decisionmaking 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 § 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
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mammogram, must include the breast
density notification that is appropriate
to the patient’s breast tissue (see
§ 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 § 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 § 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
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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, DaleChall, 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 mammographyeligible 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
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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 nondense breast notification (see
§ 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 § 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 FleschKincaid 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
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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
§ 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
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statements on breast density that this
final rule adds to the mammography
report (§ 900.12(c)(1)(vi)) and the
corresponding required breast density
notification statements that this final
rule adds to the lay summary
(§ 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 Englishlanguage 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
§ 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
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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
§ 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
§ 900.12(c)(1)(vi)(C) and (D),
respectively, as well as the other two
categories in § 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.
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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
§ 900.12(c)(1)), must be retained in
retrievable form in the mammographic
modality in which they were produced
(see § 900.12(c)(4)(i)), and cannot be
produced by copying or digitizing
hardcopy originals (see
§ 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
§ 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
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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
§ 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
§ 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 § 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
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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 § 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
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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 §§ 900.12(c)(4)(ii) and (iv) of this final
rule, or through the release of a digital
copy, following the processes described
in § 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
§ 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
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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 § 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
§ 900.12(c)(1)). Copies of screen-film
examinations may be used for
comparison but not for interpretation
(see § 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 § 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
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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 § 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.
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(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
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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
§ 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
§ 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
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mammography. Therefore, the time
periods for retention specified in
§ 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
§ 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
§ 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
§ 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 § 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 § 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 § 900.12(f). The
MQSA and its implementing regulations
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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 § 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
§ 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
§ 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
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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 § 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 § 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 § 900.12(f)(1)(i) through
(iii) in this final rule do not include
mammograms that are in this category.
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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
§ 900.2(mm)). This final rule adds the
assessment category ‘‘Post-Procedure
Mammogram for Marker Placement’’
(see § 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 § 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 § 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.
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(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 § 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 § 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, § 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
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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
§ 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
§ 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 nonphysician healthcare providers in
§ 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
§§ 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 §§ 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 FDAapproved State certification agency
(SCA) under the States-as-certifiers
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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 (§ 900.22(d) and
(e)). SCAs cannot suspend or revoke
certificates under the authority in
§ 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
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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 § 900.12(a)(1)(iv)
for IPs; §§ 900.12(a)(2)(iii)(D) and
900.12(a)(2)(iv)(B) for radiologic
technologists; or § 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
§ 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
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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 § 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 § 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 § 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
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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 § 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
§ 900.12(a)(1)(i), and for requalifying
IPs, as described in § 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.
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(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
§§ 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
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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
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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
§ 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 § 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
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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
§ 900.12(c)(2) and (3) in this final rule),
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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 nonmammographic 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
§ 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).
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(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
§ 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
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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
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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 § 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
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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
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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
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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
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15159
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
§ 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
§ 900.12(c)(1)(vi)) and four to five lines
of text in the lay summary to patients
(see § 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 FDArequired 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
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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 (see also
Response 20). Regarding the
recommendation to consult with
equipment manufacturers, FDA notes
that, beyond meeting any applicable
FDA premarket authorization
requirements for medical devices, the
provisions of this final rule do not
necessitate the design or manufacture of
any new equipment by manufacturers.
Moreover, all members of the public,
including equipment manufacturers,
had an opportunity to comment on the
proposed rule. As such, recognizing that
FD&C Act requirements have been, and
continue to be, applicable to medical
devices generally, notwithstanding the
provisions in this final rule, FDA does
not believe that specific consultation is
warranted.
(Comment 143) Several comments
recommend that the breast density
notification requirements become
effective earlier than 18 months after
publication of the final rule, including
specific recommendations for
alternative timeframes of 30 days or 12
months. Another comment recommends
allowing flexibility in the effective date
of the breast density notification
requirements due to the cost of making
these changes.
(Response 143) FDA disagrees with
these comments. FDA notes that breast
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density notification is an important
addition to the final regulations;
however, we also note that facilities
should be allowed adequate time to
implement these requirements into their
facility practice before the requirements
become effective. In addition, the breast
density notification requirements
should not be subject to a separate
scheduled effective date than other
requirements in this final rule. Facilities
are not precluded from including the
required breast density notifications
prior to 18 months if they choose to do
so, and considering any applicable State
requirements. Because of the
importance of establishing a consistent
national standard for density reporting
and notification, FDA does not agree
that a longer effective date of this
provision is warranted. Although there
may be financial considerations for a
facility in transitioning to compliance
with the breast density notification
requirements, FDA has concluded that
18 months is an adequate amount of
time to make any necessary changes.
Z. Miscellaneous Comments
(Comment 144) A comment
recommends that FDA and the ACR
focus on increasing the consistency and
quality of MQSA inspections by
inspectors.
(Response 144) The ACR and other
accreditation bodies are only involved
in facility accreditation, not certification
or inspection. Inspection is part of the
process of certification, not
accreditation. FDA trains all MQSA
inspectors, both FDA employees and
those who are State employees that
perform MQSA inspections under State
contracts with the Agency. FDA sends
updated information to all inspectors
whenever necessary. Furthermore, other
FDA staff including Radiological Health
representatives and auditors oversee
and provide inspectional guidance to
inspectors. The Agency concludes that
these existing measures already promote
consistency and quality in the MQSA
inspection process.
(Comment 145) A comment
recommends that FDA become the sole
AB, and hire some of the staff currently
employed by the ACR AB.
(Response 145) FDA disagrees with
this comment. The MQSA and the
implementing regulations distinguish
between the separate responsibilities of
the ABs and the certification agencies,
which include FDA and the SCAs (see
42 U.S.C. 263b(e) and (q); part 900,
subparts A and C). The ACR is one of
several FDA-approved ABs. FDA (or an
SCA) certifies facilities, after they have
satisfied all necessary prerequisites,
including accreditation by an AB.
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(Comment 146) A comment
recommends that FDA analyze how to
improve the quality of care for women
through using technology to improve
the quality of mammograms and the
accuracy of interpretation, and
recommends that random samples of
mammograms from all facilities be sent
to FDA radiologists for review.
(Response 146) FDA disagrees with
this comment. The ABs already initially
and continually assess mammographic
image quality at facilities they accredit,
and are required to inform FDA of
equipment or practices that may pose a
serious risk to human health (see
§ 900.4(a)). At this time, FDA believes
that the regulations afford FDA adequate
opportunities to investigate any such
occurrences and take action as
necessary (see part 900, subpart B). The
AB’s responsibilities include not only
reviews of the initial and renewal
accreditation images, but also random
image reviews of a sample of facilities
accredited by the AB. The interpretation
of a mammogram is a decision made by
IPs, but we note that many of the MQSA
regulatory requirements, including the
initial and continuing qualifications for
IPs and the annual medical outcomes
audit, promote quality mammography
practice by IPs.
(Comment 147) A comment
recommends that an independent
commission review the relationship
between the ACR and FDA for conflict
of interest.
(Response 147) FDA disagrees with
this comment. The relationship between
FDA and each of the ABs, including the
ACR, is regulated by the MQSA and the
implementing regulations and meets all
applicable Federal ethics requirements
(see, e.g., 18 U.S.C. 201, et seq.).
(Comment 148) A comment asserts
that improving mammography
outcomes, such as lower rates of recalls
and biopsies, could justify different
clinical protocols, such as a younger
screening age and shorter screening
interval than are currently supported by
the USPSTF.
(Response 148) This comment is
beyond the scope of this rulemaking.
This final rule requires that each facility
include recall rate and certain other
metrics in the audit of its
mammography medical outcomes (see
§ 900.12(f)(1)(i) through (iii) in this final
rule), but the MQSA quality standards
do not specify benchmark or target
values for these metrics. This rule
requires that facilities compile this
information and review it internally, to
encourage their own quality
improvement. However, decisions on
which clinical practice guidelines, if
any, to follow for such things as the
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recommended age range or time interval
for breast cancer screening with
mammography are more appropriately
for the healthcare provider to make.
(Comment 149) A comment
recommends that FDA propose special
amendments to address ‘‘cystic fibroid
breast disease,’’ because the commenter
states that with this condition, her
mammograms are more painful and are
limited by the associated breast tissue
density.
(Response 149) The commenter is
likely describing fibrocystic change, one
of many conditions that may contribute
to dense breast tissue. FDA disagrees
with the recommendation to propose
unique amendments to address a
specific clinical condition apart from
the requirements at
§§ 900.12(c)(1)(vi)(A) through (D) and
900.12(c)(2)(iii) and (iv) in this final
rule, which, as discussed in other
responses throughout this final rule, are
necessary to address the limitations of
mammography in the presence of dense
breast tissue caused by any etiology.
(Comment 150) One commenter cites
a news article that discusses a research
study showing that breast cancer
screening increases the detection of
early-stage cancers rather than late-stage
cancers.
(Response 150) The intent of the
MQSA is to ensure that the practice of
mammography, across the country and
whenever it is recommended by
clinicians, meets consistent baseline
quality standards. Decisions about
whether to follow any recommendations
or guidelines regarding patient age or
interval for screening mammography are
decisions more appropriate for the
patient’s clinical healthcare provider to
make.
(Comment 151) One comment states
only ‘‘Should be standard of care for all
women.’’
(Response 151) The subject of the
comment is not clear. FDA notes that
the MQSA requirements apply
consistently to all facilities that provide
mammography services. Thus, every
person who undergoes mammography at
a certified facility in the United States
can be assured that baseline national
quality standards apply. However,
decisions on whether to follow clinical
practice guidelines, including
recommendations for screening
mammography at a certain age and/or a
certain time interval, and any other
clinical standards of care, are more
appropriately made in the course of
clinical decision-making by the provider
and the patient.
(Comment 152) A comment
recommends that image quality must be
held to the highest possible standard.
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(Response 152) FDA believes the
amended regulations will continue to
ensure appropriate national standards
for quality mammography services. We
note that provisions of the MQSA and
its implementing regulations, including
many that are not amended in this final
rule, already address image quality.
These include: the role of the ABs in
clinical image review and phantom
image review (§ 900.4), the eight image
quality attributes that must be included
in AB clinical image reviews
(§ 900.4(c)(2)(i) through (viii)),
personnel qualifications (§ 900.12(a)),
equipment requirements (§ 900.12(b)),
quality assurance requirements
(§ 900.12(d) through (f)), and the general
requirement that clinical images must
continue to comply with the image
quality standards of the facility’s AB
(§ 900.12(i)). We further note that some
of these requirements related to the
facility’s responsibility to maintain
clinical image quality were highlighted
by the introduction in 2017 of FDA’s
Enhancing Quality Using the Inspection
Program (EQUIP) initiative (Ref. 52).
(Comment 153) A comment
recommends that FDA should spend
$2.5 million per year for 10 years for
public service announcements,
advertisements, and a website.
(Response 153) FDA disagrees with
the comment. General patient outreach
and education is not within the scope of
this final rulemaking. The MQSA
program certifies mammography
facilities and is funded largely by the
user fees paid by those certified
facilities. However, we note that the
MQSA program maintains a public
website (Ref. 65), and also occasionally
uses email and social media to
disseminate important information
about the MQSA program. FDA also
notes that the HHS Office of Women’s
Health, and the FDA Office of Women’s
Health are each committed to advancing
issues regarding women’s health and to
providing health education materials
through outreach activities and
collaborative partnerships. Among other
things, these offices use resources to
maintain the programs and publish
resources regarding cancer,
mammography, and other relevant
health issues.
(Comment 154) A comment
recommends that FDA should grant
$500,000 per year for 10 years to
DenseBreast-Info for webinars and its
website.
(Response 154) FDA disagrees with
the comment. As noted in Response
153, general patient education and
outreach are not within the scope of this
rulemaking. Similarly, individual grant-
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15161
making activities are also outside the
scope of this rulemaking.
(Comment 155) A comment
recommends that FDA name this rule in
memory of an advocate for breast
density notification.
(Response 155) FDA appreciates the
comment. We acknowledge the
important work done by advocates for
breast density notification in educating
the public about the significance of
breast tissue density. However, we
disagree with the recommendation to
name this rule after any one individual.
The title of the rule is based on the
specific regulations being amended, but
the rule is not ‘‘named.’’
(Comment 156) A comment asserts
that the ‘‘FDA device pathway’’ is very
different from, and much slower than,
the Center for Drug Evaluation and
Research Fast Track program for drug
approval.
(Response 156) FDA acknowledges
the comment, but notes that the
pathways for premarket review of
medical devices as they relate to those
of drugs are outside the scope of this
rulemaking. The MQSA is found under
the Public Health Service Act in Title 42
of the U.S.C., and it is implemented by
DMQS in FDA’s CDRH. The authority
for FDA’s regulation of drugs and
medical devices is found under the
FD&C Act in Title 21 of the CFR.
VI. Effective Date and Compliance Date
This rule is effective 18 months after
the date of publication in the Federal
Register. Mammography facilities will
need to be in compliance with the
amended MQSA regulations in this final
rule by September 10, 2024.
VII. Economic Analysis of Impacts
A. Introduction
We have examined the impacts of the
final rule under Executive Order 12866,
Executive Order 13563, the Regulatory
Flexibility Act (5 U.S.C. 601–612), and
the Unfunded Mandates Reform Act of
1995 (Pub. L. 104–4). Executive Orders
12866 and 13563 direct us to assess all
costs and benefits of available regulatory
alternatives and, when regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety,
and other advantages; distributive
impacts; and equity). The Office of
Information and Regulatory Affairs has
determined that this final rule is a
significant regulatory action as defined
by Executive Order 12866.
The Regulatory Flexibility Act
requires us to analyze regulatory options
that would minimize any significant
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impact of a rule on small entities.
Because many facilities that will be
affected by this rule are defined as small
businesses, we find that the final rule
will have a significant economic impact
on a substantial number of small
entities.
The Unfunded Mandates Reform Act
of 1995 (section 202(a)) requires us to
prepare a written statement, which
includes an assessment of anticipated
costs and benefits, before issuing ‘‘any
rule that includes any Federal mandate
that may result in the expenditure by
State, local, and tribal governments, in
the aggregate, or by the private sector, of
$100,000,000 or more (adjusted
annually for inflation) in any one year.’’
The current threshold after adjustment
for inflation is $165 million, using the
most current (2021) Implicit Price
Deflator for the Gross Domestic Product.
This final rule would not result in an
expenditure in any year that meets or
exceeds this amount.
B. Summary and Accounting Statement
The final rule will modernize
mammography regulations by
incorporating current science and
mammography best practices to improve
the delivery of mammography services.
These updates include requirements on
recordkeeping, reporting, and
communication of results. This final
rule also addresses procedural
requirements in several areas related to
quality control and management of
mammography facilities.
The benefits and costs associated with
this final rule are summarized in table
1. The quantified benefits are derived
from reduced mortality and breast
cancer treatment costs resulting from
the breast density reporting
requirements. We use two methods of
measuring the value of reduced
mortality: the value per statistical life
(VSL) approach and an approach based
on the value of lost life years (LY).
Under the VSL approach, the estimate of
annualized benefits over 10 years ranges
from $42.00 million to $232.69 million
at a 7 percent discount rate. Using a 3
percent discount rate, the annualized
benefits range from $48.42 million to
$266.09 million. Under the LY
approach, the estimate of annualized
benefits over 10 years ranges from
$12.99 million to $66.90 million at a 7
percent discount rate. Using a 3 percent
discount rate, the annualized benefits
range from $8.50 million to $37.96
million. Because there is uncertainty in
the literature about the most appropriate
method for analyzing reduced mortality
for the population affected by this final
rule, we do not present a primary value
and use estimates from both methods to
create the range of values in table 1. The
high estimate in table 1 is based on the
VSL approach, which yields the higherbound estimate of the two methods. The
low estimate is based on the LY
approach, which yields the lower-bound
estimate of the two methods. Other
benefits that we are not able to quantify
include reduced cancer morbidity and
improvements in the accuracy of
mammography by improving quality
control and strengthening the medical
audit.
The costs of the final rule include
costs to mammography facilities to
comply with the requirements of the
regulation and costs associated with
supplemental testing and biopsies
resulting from the breast density
requirements. The estimate of
annualized costs over 10 years range
from $28.87 million to $45.42 million at
a 7 percent discount rate with a primary
value of $36.31 million. Using a 3
percent discount rate, the annualized
costs range from $27.61 million to
$44.16 million with a primary value of
$35.05 million.
TABLE 1—SUMMARY OF BENEFITS AND COSTS IN MILLIONS 2020 DOLLARS OVER A 10-YEAR TIME HORIZON
Units
Primary
estimate
Low
estimate
High
estimate
Year dollars
Benefits:
Annualized Monetized $/year ..............
....................
Annualized Quantified .........................
....................
$12.99
8.50
....................
$232.69
266.09
....................
2020
2020
....................
7
3
7
3
10
10
....................
Qualitative ............................................
Improvements in the accuracy of mammography and better management of
mammography facilities.
....................
....................
....................
36.31
35.05
....................
28.87
27.61
....................
45.42
44.16
....................
2020
2020
....................
10
10
....................
....................
....................
....................
....................
7
3
7
3
....................
....................
....................
....................
....................
7
3
....................
7
3
....................
Category
Costs:
Annualized Monetized $/year ..............
Annualized Quantified .........................
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Qualitative ............................................
Transfers:
Federal Annualized Monetized $/year
From/To ...............................................
From:
Other Annualized Monetized $/year ....
....................
From/To ...............................................
From:
Discount
rate
(percent)
Period
covered
(years)
Notes
....................
To:
....................
....................
....................
To:
Effects:
State, Local or Tribal Government:
Small Business: Annual cost per affected small entity estimated as $416–$727, which would represent a maximum of 1.2 percent of annual
receipts.
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TABLE 1—SUMMARY OF BENEFITS AND COSTS IN MILLIONS 2020 DOLLARS OVER A 10-YEAR TIME HORIZON—Continued
Units
Primary
estimate
Category
Low
estimate
High
estimate
Year dollars
Discount
rate
(percent)
Period
covered
(years)
Notes
Wages:
Growth:
We have developed a comprehensive
Economic Analysis of Impacts that
assesses the impacts of the final rule.
The full analysis of economic impacts is
available in the docket for this final rule
(Ref. 63) and at https://www.fda.gov/
AboutFDA/ReportsManualsForms/
Reports/EconomicAnalyses/default.htm.
VIII. Analysis of Environmental Impact
The Agency has determined under 21
CFR 25.30(h) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
IX. Paperwork Reduction Act of 1995
This final rule contains information
collection provisions that are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3521). The title, description, and
respondent description of the
information collection provisions are
shown in the following paragraphs with
an estimate of the annual third-party
disclosure burden. Included in the
estimate is the time for reviewing
instructions, searching existing data
sources, gathering and maintaining the
data needed, and completing and
reviewing each collection of
information.
Title: Mammography Facilities,
Standards, and Lay Summaries for
Patients; OMB Control Number 0910–
0309.
Description: FDA is amending its
mammography reporting requirements
to require that the mammography report
provided to the healthcare provider and
the lay summary provided to the patient
include basic mammography facility
identification information and
information concerning patient breast
density. This action is intended to
facilitate communication among
mammography facilities, healthcare
providers, and patients; facilitate the
retrieval of mammography images; and
help ensure that healthcare providers
and patients obtain the necessary
information from the mammography
facility to enable a patient and their
healthcare provider to make informed
healthcare decisions. FDA also is
including categories be added to the list
of assessments that facilities are
required to use in the mammography
report. In addition, FDA is amending its
requirements related to the transfer and
provision of mammography records, the
transfer and provision of personnel
records upon request or facility closure,
and FDA notification and
mammographic records access upon
facility closure.
Description of Respondents:
Respondents to this information
collection are facilities that perform
mammographic examinations and State
certification agencies. As of July, 1,
2022, FDA internal data on facilities
showed that there were 8,781 facilities
certified to perform mammography (Ref.
65).
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity; 21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Total capital
costs
Total operating
and maintenance
costs
Mammography
medical
outcomes audit—900.12(f) ...........
8,781
1
8,781
16
140,496
$2,496,452
$5,807,650
Total capital
costs
Total operating
and maintenance
costs
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
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Activity; 21 CFR section
Provision of personnel records
to IPs—900.12(a)(4).
Transfer of personnel records by
closing facilities—900.12(a)(4).
New assessment categories and
breast density reporting in
mammography report (onetime burden)—900.12(c)(1)(iv)
to (vi).
Breast density reporting in lay
summary (one-time burden)—
900.12(c)(2).
Transfer/provision of copies of
mammograms and records
upon patient’s request—
900.12(c)(4)(ii) and (iii).
Facility closure; notification and
records access—
900.12(c)(4)(v).
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Number of
disclosures per
respondent
Number of
respondents
Average
burden per
disclosure
Total annual
disclosures
Total hours
615
1
615
0.08 (5 minutes) ...
49
........................
$55,682
88
1
88
5 ...........................
440
........................
..............................
8,781
1
8,781
23 .........................
201,963
$37,166,396
..............................
8,781
1
8,781
11 .........................
96,591
6,844,077
..............................
8,781
1,135
9,966,435
0.08 (5 minutes) ...
797,315
........................
..............................
88
1
88
32 .........................
2,816
........................
55,682
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TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Patient notification of significant
risk (by State certification
agency)—900.12(j)(2).
Total ....................................
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1 Numbers
Number of
disclosures per
respondent
Number of
respondents
Activity; 21 CFR section
Average
burden per
disclosure
Total annual
disclosures
Total hours
Total capital
costs
Total operating
and maintenance
costs
5
1
5
100 .......................
500
........................
..............................
........................
..............................
........................
...............................
1,099,674
44,010,473
111,364
have been rounded.
Personnel records—§ 900.12(a)(4):
Under § 900.12(a)(4), facilities are
required to maintain records of training
and experience regarding personnel
who work or have worked at the facility
as IPs, radiologic technologists, or
medical physicists. Facilities must
maintain records of personnel no longer
employed by the facility for no less than
24 months from the date of the
departure of an employee, and these
records must be available for review at
the time of any annual inspection
occurring during those 24 months.
Also, under § 900.12(a)(4), facilities
shall provide copies of personnel
records to current or former interpreting
personnel (physician, radiological
technologist and medical physicist)
upon their request. We estimate that
there are, on average, seven interpreting
personnel per facility (approximately
61,467 total). We estimate that 1 percent
of these personnel (615 personnel
annually) will request the records and
that it will take approximately 5
minutes to provide the copies for each
request.
Additionally, under § 900.12(a)(4),
facilities must provide personnel
records to former employees if the
former employees communicate their
request within 24 months of the date of
their departure. If it has been greater
than 24 months and the facility has
maintained those records, the facility
must provide those records to former
employees upon request.
Finally, under § 900.12(a)(4), before a
facility closes or ceases to provide
mammography services, it will have to
make arrangements for personnel to
access their MQSA personnel records.
This access may be provided by the
permanent transfer of these records to
the personnel or the transfer of the
records to a facility or other entity that
will provide access to these records. We
estimate that annually 1 percent of the
total facilities will close or cease to
provide mammography services and
that it will take each of the facilities
approximately 5 hours to transfer the
records.
Medical records and mammography
reports—§ 900.12(c)(1) through (4):
Section 900.12(c)(1), Contents and
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terminology, sets forth the requirement
for facilities to prepare a written report
of the results of each mammographic
examination performed under its
certificate. Section 900.12(c)(1) requires
that the report include patient
identifying information, date of
examination, facility name and location,
the final assessment of findings (or
classification as to why no final
assessment can be made), name of the
IP, and recommendations to the
healthcare provider.
This final rule includes two
additional final assessment categories
and an additional classification in the
mammography report and also requires
an assessment of breast density in the
report (§ 900.12(c)(1)(iv) through (vi)).
We estimate a one-time burden for
facilities to update their existing
mammography reports with these new
categories. Based on the Eastern
Research Group (ERG), Inc.’s report, we
believe this will take 23 hours per
facility (Refs. 66 and 67).
Under the final rule, if the final
assessment is ‘‘Suspicious’’ or ‘‘Highly
Suggestive of Malignancy,’’ the facility
must provide the report to the
healthcare provider, or if the referring
healthcare provider is unavailable, to a
responsible designee (§ 900.12(c)(3)(ii))
within a specified timeframe. The
provision of the report to the healthcare
provider was not included in the
currently approved information
collection burden, OMB control number
0910–0309, because it was considered
usual and customary practice and was
part of the standard of care prior to the
implementation of the regulations (see 5
CFR 1320.3(b)(2)). Provision of the
mammography report to healthcare
providers continues to be part of the
standard of care and remains the usual
and customary business practice.
Under § 900.12(c)(2), Communication
of mammography results to the patients,
within 30 days of the mammographic
examination, each facility shall provide
each patient a summary of the
mammography report written in lay
terms. If the final assessment is
‘‘Suspicious’’ or ‘‘Highly Suggestive of
Malignancy,’’ the facility shall provide
the patient a summary of the
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mammography report within a specified
timeframe (§ 900.12(c)(2)). The summary
shall include the name of the patient
and name, address, and telephone
number of the facility. The requirements
for the lay summary to include this
information do not result in a change to
the currently approved information
collection burden for § 900.12(c)(2).
Section 900.12(c)(2) also requires
facilities to provide an assessment of
breast density (as described in
§ 900.12(c)(2)(iii) to (iv)) in the lay
summary. We estimate a one-time
burden for facilities to update their
existing lay summaries with the breast
density assessments. Based on the ERG
report, we believe this will take 11
hours per facility (Refs. 65 and 66).
Also, under § 900.12(c)(2)(ii), each
facility that accepts patients who do not
have a healthcare provider shall
maintain a system for referring such
patients to a healthcare provider when
clinically indicated.
The requirements in § 900.12(c)(2)(iii)
and (iv) to provide an explanation of the
breast density assessment identified in
§ 900.12(c)(1)(vi) are not considered to
be ‘‘collections of information’’ because
the language is originally supplied by
the Federal government for the purpose
of disclosure to members of the public
(5 CFR 1320.3(c)(2)).
Under § 900.12(c)(4)(i), facilities that
perform mammograms must maintain
mammographic records. The rule
requires that facilities implement
policies and procedures to minimize the
possibility of record loss and requires
that records be maintained in the
modality in which they were produced.
Under § 900.12(c)(4)(ii), facilities
shall, upon request by or on behalf of
the patient, transfer or release the
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. Under § 900.12(c)(4)(ii) and
(iii), facilities must transfer original
mammograms (and copies of associated
reports) or provide copies of
mammograms (and copies of associated
reports) within a specified period of
time. Copies of mammograms must be
in the same modality in which they
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were produced. Moreover, for digital
mammograms or digital breast
tomosynthesis, the facility must be able
to provide the recipient with original
digital images electronically if the
examination is being transferred for
final interpretation. We estimate that
approximately one third of patients will
request transfer or release of the records
and it will take approximately 5
minutes per request. To calculate the
estimated number of requests, we use
the estimated number of screening
mammograms (29,890,141) (Ref. 62)
divided by 3. This results in
approximately 9,963,380 requests, or an
average of 1,135 requests per facility.
Under § 900.12(c)(4)(v), before a
facility closes or ceases to provide
mammography services, it must make
arrangements for access by patients and
healthcare providers to their
mammographic records. Additionally,
the facility must notify its accreditation
body and certification agency in writing
of the arrangements it has made and
must make reasonable efforts to notify
all affected patients. If a facility ceases
to perform mammography but continues
to operate as a medical entity, and is
able to satisfy the recordkeeping
requirements of § 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. We estimate that 1 percent
of facilities per year will close and that
it will take each facility approximately
32 hours to provide notification and
access to the records.
Quality assurance-mammography
medical outcomes audit—§ 900.12(f):
Section 900.12(f)(1) requires each
facility to establish a system to collect
and review outcome data for all
mammographic examinations
performed, including followup on the
disposition of all positive mammograms
and correlation of pathology results
with the IP’s mammography report. The
rule clarifies that positive predictive
value, cancer detection rate, and recall
rate must be collected during this audit.
Additional mammography review and
patient and referring provider
notification—§ 900.12(j): Under
§ 900.12(j)(1), if FDA or the State
certification agency believes that
mammographic quality at a facility has
been compromised and may present a
significant risk to human health, the
facility must provide clinical images
and other relevant information for
review by the accreditation body or the
State certification agency.
Under § 900.12(j)(2), when FDA has
determined that the quality of
mammography performed by the facility
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poses a significant risk to human health,
a facility may be required to notify all
patients who received mammograms at
the facility or those patients who are
determined to be at risk due to the
quality of their mammography, and
their referring physicians or healthcare
providers, of the deficiencies and
resulting potential harm, appropriate
remedial measures, and other relevant
information. Also under the rule, State
certification agencies (along with FDA)
may notify patients and their providers
if a facility is unable or unwilling to do
so.
We received several comments related
to the proposed rule. Descriptions of the
comments and our responses are
provided in section V of this final rule,
Comments to the Proposed Rule and
FDA’s Response. Comments and
responses related to the provisions that
underlie the information collection are
described in the following sections: V.A,
regarding general comments; V.D,
regarding retention and release of
personnel records; V.E, regarding digital
accessories; V.F, regarding facility
identification information in
mammography report and lay summary;
V.G, regarding final and incomplete
assessments and lay summaries; V.H,
regarding deadlines for mammography
reports; V.I, regarding breast density
notification—general support for
density notification; V.J, regarding
breast density notification language;
V.K, regarding breast density
notification and the role of the referring
healthcare provider; V.L, regarding
format for image interpretation,
retention, transfer, and release of copies;
V.M, regarding deadlines for image
transfer and the release of copies; V.N,
regarding facility closure and
mammography record retention; V.O,
regarding mammography medical
outcomes audit; V.P, regarding patient
and referring provider notification; V.Q,
regarding revocation of certification;
V.X, regarding federalism and the
relationship between Federal and State
breast density reporting requirements;
and V.Y, regarding timeframe for
implementation of this rule. We have
not made changes to the estimated
burden as a result of the comments.
The information collection provisions
in this final rule have been submitted to
OMB for review as required by section
3507(d) of the Paperwork Reduction Act
of 1995.
Before the effective date of this final
rule, FDA will publish a notice in the
Federal Register announcing OMB’s
decision to approve, modify, or
disapprove the information collection
provisions in this final rule. An Agency
may not conduct or sponsor, and a
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15165
person is not required to respond to, a
collection of information unless it
displays a currently valid OMB control
number.
X. Federalism
The MQSA established minimum
national quality standards for
mammography. The MQSA replaced a
patchwork of Federal, State, and private
standards with uniform Federal
standards designed to ensure that all
patients nationwide receive adequate
quality mammography services. FDA
has worked very closely with State
officials in developing the national
standards for the MQSA program and
has sought and obtained input from
States at every step of the process.
FDA issued final rules implementing
the MQSA on October 28, 1997
(‘‘Quality Mammography Standards,’’ 62
FR 55852) and February 6, 2002 (‘‘State
Certification of Mammography
Facilities,’’ 67 FR 5446). As required by
Executive Order 13132 (August 4, 1999),
FDA prepared a federalism assessment
in this latter final rule and determined
that the rule was consistent with the
federalism principles expressed in
Executive Order 13132 (Ref. 64).
This final rule amends, among other
things, the requirements in the MQSA
for reporting to healthcare providers and
patients to ensure that patients receive
all necessary information after their
mammograms, including an assessment
of breast density, while not unduly
burdening the mammography facility.
Although certain provisions impact
Federal-State relations, FDA does not
believe that they impose any additional,
significant burden on the States. The
division of responsibilities between
FDA, the States, and State agencies will
not change as the regulations will
continue to provide for necessary
uniformity of minimum national
standards and, at the same time, provide
maximum flexibility to states
administering the States as Certifier
program within their State, and State
agencies serving as accreditation bodies.
On November 4, 2011, FDA convened
a public meeting of the NMQAAC where
possible amendments to the MQSA
regulations, including breast density
reporting, were discussed (Ref. 33). This
meeting was open to the public, and
time was allotted for public statements
on issues of concern in the
mammography field. FDA has also met
and held teleconferences several times a
year with its approved accreditation
bodies and State certification agencies
to discuss issues of mutual concern.
The Agency also has long enjoyed a
good relationship with the Conference
of Radiation Control Program Directors,
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Inc. (CRCPD), which is the professional
organization of the State agencies
concerned with radiation protection.
The CRCPD has established a standing
Mammography Committee, which meets
with FDA mammography staff at least
once a year.
For the reasons discussed previously,
FDA believes that this final rule is
consistent with the federalism
principles expressed in Executive Order
13132.
XI. Consultation and Coordination With
Indian Tribal Governments
We have analyzed this rule in
accordance with the principles set forth
in Executive Order 13175. We have
determined that the rule does not
contain policies that have substantial
direct effects on one or more Indian
Tribes, on the relationship between the
Federal Government and Indian Tribes,
or on the distribution of power and
responsibilities between the Federal
Government and Indian Tribes.
Accordingly, we conclude that the rule
does not contain policies that have
tribal implications as defined in the
Executive Order and, consequently, a
tribal summary impact statement is not
required.
XII. References
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The following references marked with
an asterisk (*) are on display in the
Dockets Management Staff (see
ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; they are also available
electronically at https://
www.regulations.gov. References
without asterisks are not on public
display at https://www.regulations.gov
because they have copyright restriction.
Some may be available at the website
address, if listed. References without
asterisks are available for viewing only
at the Dockets Management Staff. FDA
has verified the website addresses, as of
the date this document publishes in the
Federal Register, but websites are
subject to change over time.
* 1. CDC, ‘‘Breast Cancer Statistics.’’
Available at https://www.cdc.gov/
cancer/breast/statistics.
* 2. National Institutes of Health, National
Cancer Institute, ‘‘Surveillance,
Epidemiology, and End Results
Program.’’ Available at https://
seer.cancer.gov/statfacts/html/
breast.html.
* 3. CDC, ‘‘Male Breast Cancer Incidence and
Mortality, United States—2013–2017,’’
U.S. Cancer Statistics Data Briefs, No. 19,
October 2020. Available at https://
www.cdc.gov/cancer/uscs/about/databriefs/no19-male-breast-cancer-
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incidence-mortality-UnitedStates-20132017.htm.
* 4. CDC, ‘‘United States Cancer Statistics:
Data Visualizations.’’ Available at
https://gis.cdc.gov/Cancer/USCS/
DataViz.html.
5. Michaelson, J.S., M. Silverstein, J. Wyatt,
et al., ‘‘Predicting the Survival of
Patients with Breast Carcinoma Using
Tumor Size,’’ Cancer, 2002; 95(4): 713–
723.
6. ACS, ‘‘Can Breast Cancer Be Found Early?’’
Available at https://www.cancer.org/
cancer/breastcancer/detailedguide/
breast-cancer-detection.
* 7. Government Accountability Office,
‘‘GAO–06–724 Mammography: Current
Nationwide Capacity Is Adequate, but
Access Problems May Exist in Certain
Locations (July 2006).’’ Available at
https://www.gao.gov/new.items/
d06724.pdf.
8. DenseBreast Info website. Legislative
Information. Available at https://
densebreast-info.org/legislation.aspx.
9. Kolb, T.M., J. Lichy, J.H. Newhouse,
‘‘Comparison of the Performance of
Screening Mammography, Physical
Examination, and Breast U.S. and
Evaluation of Factors that Influence
Them: an Analysis of 27,825 Patient
Evaluations,’’ Radiology 2002; 225: 165–
175.
10. Leconte, I., et al., ‘‘Mammography and
Subsequent Whole-Breast Sonography of
Nonpalpable Breast Cancers: The
Importance of Radiologic Breast
Density,’’ American Journal of Radiology
2003; 180: 1675–1679.
11. Berg, W. et al., ‘‘Combined Screening
with Ultrasound and Mammography vs.
Mammography Alone in Women at
Elevated Risk of Breast Cancer,’’ Journal
of the American Medical Association,
2008; 299(18); 2151–2163. Available at
https://jamanetwork.com/journals/jama/
fullarticle/181896.
12. McCormack, V.A. and I. dos Santos Silva,
‘‘Breast Density and Parenchymal
Patterns as Markers of Breast Cancer
Risk: A Meta-Analysis,’’ Cancer
Epidemiol Biomarkers and Prevention.
2006; 15: 1159–1169.
13. Boyd, N.F., H. Guo, L.J. Martin, et al.,
‘‘Mammographic Density and the Risk
and Detection of Breast Cancer,’’ New
England Journal of Medicine. 2007; 356:
227–236.
14. Vachon C., C. van Gils, T. Sellers, et al.,
‘‘Mammographic Density, Breast Cancer
Risk and Risk Prediction,’’ Breast Cancer
Research. 2007; 9: 217.
* 15. Centers for Disease Control and
Prevention, ‘‘What are the Risk Factors
for Breast Cancer? ’’ Available at https://
www.cdc.gov/cancer/breast/basic_info/
risk_factors.htm.
16. Chiu, S.Y., et al., ‘‘Effect of Baseline
Breast Density on Breast Cancer
Incidence, Stage, Mortality, and
Screening Parameters: 25-Year Followup of a Swedish Mammographic
Screening,’’ Cancer Epidemiology,
Biomarkers, and Prevention, 2010: 19(5):
1219–28. Available at https://
www.researchgate.net/publication/
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Sfmt 4700
43226895_Effect_of_Baseline_Breast_
Density_on_Breast_Cancer_Incidence_
Stage_Mortality_and_Screening_
Parameters_25-Year_Follow-up_of_a_
Swedish_Mammographic_Screening.
* 17. MQSA National Statistics, available at
https://www.fda.gov/radiation-emittingproducts/mqsa-insights/mqsa-nationalstatistics.
* 18. MQSA Inspection Procedures, Version
7.0, Revision June 2015, available at
https://www.fda.gov/radiation-emittingproducts/facility-certification-andinspection-mqsa/inspection-procedures.
* 19. MQSA PGHS. Available at Policy
Guidance Help System—Before a facility
permanently stops performing
mammography, what actions should it
take to avoid future MQSA problems and
how should it deal with retention of
mammographic medical records?
* 20. FDA guidance on ‘‘Medical Device
Accessories,’’ issued on December 20,
2017. Available at https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/medical-deviceaccessories-describing-accessories-andclassification-pathways.
* 21. MQSA Alternative Standard #24,
approved on July 13, 2018. Available at
https://www.fda.gov/radiation-emittingproducts/regulations-mqsa/24-approvalalternative-standard-using-qualityassurance-program-recommended-acrdigital-mammography.
* 22. FDA MQSA Alternative Standards
website. Available at https://
www.fda.gov/radiation-emittingproducts/regulations-mqsa/alternativestandards-mqsa.
* 23. FDA guidance ‘‘Display Devices for
Diagnostic Radiology,’’ issued on
October 2, 2017, available at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/displaydevices-diagnostic-radiology.
* 24. MQSA Alternative Standard #12,
approved on September 17, 2003.
Available at https://www.fda.gov/
radiation-emitting-products/regulationsmqsa/mqsa-alternative-standard-12assessment-category-post-proceduremammograms-marker-placement.
* 25. MQSA Alternative Standard #11,
approved on August 29, 2003. Available
at https://www.fda.gov/radiationemitting-products/regulations-mqsa/
mqsa-alternative-standard-11modifications-assessment-categoriesused-medical-reports.
* 26. MQSA PGHS. Available at https://
www.accessdata.fda.gov/cdrh_docs/
presentations/pghs/Is_it_necessary_to_
include_an_assessment_code_(e.g., _0,_
1,_2,_3,_4,_5_or_N,_B,_P,_S,_M,_A),_in_
addition_to_the_assessment_category,_
on_all_mammography_reports__Is_
there....htm.
27. D’Orsi, C.J., et al., ACR BI–RADS Atlas,
Breast Imaging Reporting and Data
System, 5th Edition. Reston, VA:
American College of Radiology, 2013.
28. Sickles, E.A., et al., ‘‘Mammography.’’ In:
ACR BI–RADS Atlas, Breast Imaging
Reporting and Data System. Reston, VA:
American College of Radiology, 2013,
pp. 153–4.
E:\FR\FM\10MRR2.SGM
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* 29. MQSA PGHS. Available at https://
www.accessdata.fda.gov/cdrh_docs/
presentations/pghs/The_American_
College_of_Radiology_Breast_Imaging_
Reporting_and_Data_System_BIRADS_
suggests_that_facilities_subdivide_the_
Suspicious_assessment_category_into_
one_of_three_subca.htm.
30. Hayward, J.H., et al., ‘‘Improving
Screening Mammography Outcomes
Through Comparison With Multiple
Prior Mammograms,’’ American Journal
of Roentgenology, 2016; 207: 918–924.
Available at https://www.ajronline.org/
doi/full/10.2214/AJR.15.15917.
31. Berg, W.A. and J. A. Harvey, ‘‘Breast
Density and Supplemental Screening
(White Paper),’’ Society of Breast
Imaging, issued on May 1, 2017.
Available at https://www.sbi-online.org/
white-papers/breast-density-andsupplemental-screening.
32. Butler, R.S. and Hooley, R.J., 2020.
Screening Breast Ultrasound: Update
After 10 Years of Breast Density
Notification Laws. American Journal of
Roentgenology, 214(6), pp.1424–1435.
* 33. Transcript of 2011 NMQAAC meeting.
Available at https://wayback.archiveit.org/7993/20170404143636/https://
www.fda.gov/downloads/
AdvisoryCommittees/CommitteesMeeting
Materials/Radiation-EmittingProducts/
NationalMammography
QualityAssuranceAdvisoryCommittee/
UCM282944.pdf.
34. Sickles, E.A., et al. ‘‘Mammography.’’ In:
ACR BI–RADS Atlas, Breast Imaging
Reporting and Data System. Reston, VA:
American College of Radiology, 2013,
pp. 123–6.
35. California Breast Density Information
Group, ‘‘Breast Density, Breast Cancer
Risk, and California Breast Density
Notification Law SB 1538: Scenarios for
Clinicians,’’ 2013. Available at: For
Health Care Providers: Density Scenarios
| Department of Radiology (unc.edu).
36. DenseBreast Info website, ‘‘Cancer
Detection by Screening Method.’’
Available at https://densebreast-info.org/
screening-technologies/cancer-detectionby-screening-method/.
37. Berg, W.A., E.A. Rafferty, S.M.
Friedewald, et al., ‘‘Screening
Algorithms in Dense Breasts: AJR Expert
Panel Narrative Review,’’ American
Journal of Roentgenology, 2021; 216:
275–294, and associated video lecture
available at https://www.youtube.com/
watch?v=aGIFTa6xMeY.
38. Saraiya A., G.L. Baird, and A.P. Lourenco,
‘‘Breast Density Notification Letters and
websites: Are They Too ‘Dense? ’,’’
Journal of the American College of
Radiology 16: 717, May 2019.
39. Capello, N.M., D. Richetelli, and C.I. Lee,
‘‘The Impact of Breast Density Reporting
Laws on Women’s Awareness of DensityAssociated Risks and Conversations
Regarding Supplemental Screening With
Providers,’’ Journal of the American
College of Radiology 16(2): 139–146,
February 2019. Available at: https://
doi.org/10.1016/j.jacr.2018.08.009.
40. Nguyen D.L., E.B. Ambinder, M.K. Jones,
L.A. Mullen, and S.C. Harvey,
VerDate Sep<11>2014
18:18 Mar 09, 2023
Jkt 259001
‘‘Improving State-Mandated Breast
Density Notifications,’’ Journal of the
American College of Radiology 173):
384–390, March 2020. Available at:
https://doi.org/10.1016/j.jacr.
2019.08.023.
41. Kyanko, K.A., J. Hoag, S.H. Busch, J.A.
Aminawung, et al., ‘‘Dense Breast
Notification Laws, Education, and
Women’s Awareness and Knowledge of
Breast Density: A Nationally
Representative Survey,’’ Journal of
General Internal Medicine, 2020 July;
35(7):1940–1945. DOI: 10.1007/s11606–
019–05590–7.
42. Kressin, N.R., C.M. Gunn, and T.A.
Battaglia, ‘‘Content, Readability, and
Understandability of Dense Breast
Notifications by State,’’ Journal of the
American Medical Association 315:
1786, April 26, 2016.
43. Kressin, N.R., J.B. Wormwood, T.A.
Battaglia, and C.M. Gunn, ‘‘Differences
in Breast Density Awareness,
Knowledge, and Plans [Letter]’’, Journal
of General Internal Medicine 2020; 35(8):
2473. DOI: 10.1007/s11606–020–05840z.
44. Kressin, N.R., T.A. Battaglia, J.B.
Wormwood, P.J. Slanetz, and C.M. Gunn,
‘‘Dense Breast Notification Laws’
Association With Outcomes in the US
Population: A Cross-Sectional Study,’’
Journal of the American College of
Radiology, 2021 May; 18(5): 685–695.
DOI: 10.1016/j.jacr.2020.11.012.
45. Kerlikowske, K., W. Zhu, A. Tosteson, et
al., ‘‘Identifying Women with Dense
Breasts at High Risk of Interval Cancers,’’
Annals of Internal Medicine, 2015 May
19; 162(10): 673–681. Available at
Identifying Women with Dense Breasts at
High Risk of Interval Cancers—PMC
(nih.gov).
* 46. MQSA PGHS, available at https://
www.accessdata.fda.gov/cdrh_docs/
presentations/pghs/Can_a_facility_use_
lossless_compression_to_store_FFDM_
images_for_retention_purposes_.htm.
* 47. MQSA PGHS, available at https://
www.accessdata.fda.gov/cdrh_docs/
presentations/pghs/Can_a_facility_use_
lossless_compression_to_transmit_
images_to_the_patient_or_other_
medical_institutions_for_final_
interpretation_.htm.
* 48. MQSA PGHS, available at https://
www.accessdata.fda.gov/cdrh_docs/
presentations/pghs/Can_a_facility_use_
lossy_compression_to_store_FFDM_
images_for_retention_purposes_.htm.
49. Sickles, E.A., et al., ‘‘ACR BI–RADS
Follow-Up and Outcome Monitoring.’’
In: ACR BI–RADS Atlas: Breast Imaging
Reporting and Data System, 5th ed.
Reston, VA, American College of
Radiology, 2013, pp. 18–19.
50. D’Orsi, C.J., ‘‘Audit.’’ Lecture presented at
Institute of Medicine Workshop on
Assessing and Improving Imaging
Interpretation in Breast Cancer
Screening, Washington, DC, May 12–13,
2015. Lecture slides available at https://
www.nationalacademies.org/event/0512-2015/assessing-and-improvingimaging-interpretation-in-breast-cancerscreening.
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15167
51. Sickles, E.A. et al., ‘‘Mammography.’’ In:
ACR BI–RADS Atlas, Breast Imaging
Reporting and Data System. Reston, VA:
American College of Radiology, 2013,
pp. 136–7, 150–1.
*52. FDA EQUIP web pages. Available at
https://www.fda.gov/radiation-emittingproducts/facility-certification-andinspection-mqsa/inspection-news.
* 53. FDA database of certified
mammography facilities. Available at
https://www.fda.gov/radiation-emittingproducts/consumer-information-mqsa/
search-certified-facility.
* 54. FDA Safety Communication, issued
February 25, 2019. Available at 2022–
06–16 13:39 | Archive of FDA
(pagefreezer.com).
* 55. FDA Consumer Update, issued October
27, 2017. Available at https://
www.fda.gov/consumers/consumerupdates/breast-cancer-screeningthermogram-no-substitute-mammogram.
* 56. FDA Class II Special Controls Guidance
on Full-Field Digital Mammography
System, issued March 27, 2012.
Available at https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/class-ii-specialcontrols-guidance-document-full-fielddigital-mammography-system-guidanceindustry.
57. Hooley, R.J., K.L. Greenberg, R.M.
Stackhouse, et al., ‘‘Screening US
[ultrasonography] in Patients with
Mammographically Dense Breasts: Initial
Experience with Connecticut Public Act
09–41,’’ Radiology, 2012; 265(1):59–69.
58. Weigert, J. and S. Steenbergen, ‘‘The
Connecticut Experiment: The Role of
Ultrasound in the Screening of Women
with Dense Breasts,’’ Breast Journal,
2012; 18(6):517–22.
59. Saulsberry, L. et al. 2019. ‘‘The Impact of
Breast Density Notification Laws on
Supplemental Breast Imaging and Breast
Biopsy.’’ Journal of General Internal
Medicine, 34(8), pp. 1441–1451.
60. Scheel et al. ‘‘Screening Ultrasound as an
Adjunct to Mammography in Women
with Mammographically Dense Breasts.’’
American Journal of Obstetrics and
Gynecology 212.1 (2015): 9–17.
61. Houssami, N. and Lee, C.I., 2018. ‘‘The
Impact of Legislation Mandating Breast
Density Notification—Review of the
Evidence.’’ The Breast, 42, pp. 102–112.
62. Keating, N.L. and Pace, L.E., 2019. ‘‘New
Federal Requirements to Inform Patients
About Breast Density: Will They Help
Patients?’’ JAMA, 321(23), pp. 2275–
2276.
* 63. FDA, FRIA, available at https://
www.fda.gov/AboutFDA/Reports
ManualsForms/Reports/
EconomicAnalyses/default.htm.
* 64. Executive Order 13132, Federalism,
August 4, 1999, available at https://
www.govinfo.gov/content/pkg/FR-199908-10/pdf/99-20729.pdf.
* 65. FDA MQSA home page. Available at
https://www.fda.gov/radiation-emittingproducts/mammography-qualitystandards-act-and-program.
* 66. ERG, Inc. ‘‘Baseline Quality Measures of
Screening Mammography and the
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Impacts of Proposed Revisions to
Regulations Implementing the
Mammography Quality Standards Act.’’
Final Report, July 19, 2012. [ERG, 2012a]
* 67. ERG, Inc. ‘‘Proposed Density
Notification Addition to Regulations
Implementing the Mammography
Quality Standards Act: Addendum to the
Final Report.’’ July 17, 2012. [ERG,
2012b]
(ii) Patient means any individual who
undergoes a mammography evaluation
in a facility, regardless of whether the
person is referred by a healthcare
provider or is self-referred.
*
*
*
*
*
■ 3. In § 900.4 revise paragraphs (a)(6)
and (f)(1)(ii)(B) to read as follows:
List of Subjects in 21 CFR Part 900
Electronic products, Health facilities,
Medical devices, Radiation protection,
Reporting and recordkeeping
requirements, X-rays.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 900 is
amended as follows:
§ 900.4
PART 900—MAMMOGRAPHY
1. The authority citation for part 900
continues to read as follows:
■
Authority: 21 U.S.C. 360i, 360nn, 374(e);
42 U.S.C. 263b.
2. In § 900.2, revise paragraphs (c)(2),
(k), (z), and (aa)(1) and (2), add
paragraph (aa)(3), and revise paragraph
(ii) to read as follows:
■
§ 900.2
Definitions.
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*
*
*
*
*
(c) * * *
(2) Failure to send mammography
reports within 30 days to the referring
healthcare provider or in a timely
manner to the self-referred patient; and
*
*
*
*
*
(k) Consumer means an individual
who chooses to comment or complain in
reference to a mammography
examination, including the patient or
representative of the patient (e.g., family
member or referring healthcare
provider).
*
*
*
*
*
(z) Mammographic modality means a
technology, within the scope of 42
U.S.C. 263b, for radiography of the
breast. Examples are screen-film
mammography, full field digital
mammography, and digital breast
tomosynthesis.
(aa) * * *
(1) Radiography of the breast
performed during invasive interventions
for localization or biopsy procedures;
(2) Radiography of the breast
performed with an investigational
mammography device as part of a
scientific study conducted in
accordance with FDA’s investigational
device exemption regulations in part
812 of this chapter; or
(3) Computed tomography of the
breast.
*
*
*
*
*
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Standards for accreditation bodies.
(a) * * *
(6)(i) When an accreditation body
denies accreditation to a facility, the
accreditation body shall notify the
facility in writing and explain the bases
for its decision. The notification shall
also describe the appeals process
available from the accreditation body for
the facility to contest the decision.
(ii) If a facility has failed to become
accredited after three consecutive
attempts, no accreditation body shall
accept an application for accreditation
from the facility for a period of 1 year
from the date of the most recent
accreditation failure.
*
*
*
*
*
(f) * * *
(1) * * *
(ii) * * *
(B) Review of facility documentation
to determine if appropriate
mammography reports are sent to
patients and providers as required;
*
*
*
*
*
■ 4. In § 900.11 revise paragraph (c)(4)
to read as follows:
§ 900.11
Requirements for certification.
*
*
*
*
*
(c) * * *
(4) If a facility’s certificate was
revoked on the basis of an act described
in 42 U.S.C. 263b(i)(1), as implemented
by § 900.14(a), no person who owned or
operated that facility at the time the act
occurred may own or operate a
mammography facility within 2 years of
the date of revocation.
■ 5. In § 900.12:
■ a. Revise paragraph (a)(4);
■ b. Add paragraphs (b)(2)(i) and (ii);
■ c. Revise paragraph (b)(11);
■ d. Add paragraph (b)(16);
■ e. Revise paragraphs (c)(1) and (2),
(c)(3)(ii), (c)(4), and (f)(1);
■ f. Add paragraph (f)(4); and
■ g. Revise paragraph (j).
The additions and revisions read as
follows:
§ 900.12
Quality standards.
(a) * * *
(4) Retention of personnel records.
Facilities shall maintain records of
training and experience relevant to their
qualification under MQSA for personnel
who work or have worked at the facility
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as interpreting physicians, radiologic
technologists, or medical physicists.
These records must be available for
review by the MQSA inspectors.
Records of personnel no longer
employed by the facility must be
maintained for no less than 24 months
from the date of the departure of an
employee, and these records must be
available for review at the time of any
annual inspection occurring during
those 24 months. The facility shall
provide copies of these personnel
records to current interpreting
physicians, radiologic technologists,
and medical physicists upon their
request. Facilities must provide
personnel records to former employees
if the former employees communicate
their request within 24 months of the
date of their departure. If it has been
greater than 24 months and the facility
has maintained those records, the
facility must provide those records to
former employees upon request. Before
a facility closes or ceases to provide
mammography services, it must make
arrangements for access by current and
former personnel to their MQSA
personnel records. This access may be
provided by the permanent transfer of
these records to the personnel or the
transfer of the records to a facility or
other entity that will provide access to
these records for no less than 24 months
from the date of facility closure or
cessation of mammography services.
(b) * * *
(2) * * *
(i) All devices used in mammography
must have met the applicable FDA
premarket authorization requirements
for medical devices of that type with
that intended use.
(ii) A mammography unit that is
converted from one mammographic
modality to another is considered a new
unit at the facility under this part and
must, prior to clinical use, undergo a
mammography equipment evaluation
demonstrating compliance with
applicable requirements. The facility
must also follow its accreditation body’s
procedures for applying for
accreditation of that unit.
*
*
*
*
*
(11) Film. For facilities using screenfilm units, the facility shall use x-ray
film for mammography that has been
designated by the film manufacturer as
appropriate for mammography. For
facilities using hardcopy prints of
digital images for transfer, retention, or
final interpretation purposes, the facility
shall use a type of film designated by
the film manufacturer as appropriate for
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these purposes and compatible with the
printer being used.
*
*
*
*
*
(16) Equipment—other modalities.
Systems with image receptor modalities
other than screen-film shall demonstrate
compliance with quality standards by
successful results of quality assurance
testing as specified under paragraph
(e)(6) of this section.
(c) Medical records and
mammography reports—(1) Contents
and terminology. Each facility shall
prepare a written report of the results of
each mammographic examination
performed under its certificate. The
mammographic examination presented
for interpretation must be in the original
mammographic modality in which it
was performed, and must not consist of
digital images produced through
copying or digitizing hardcopy original
images. The mammography report shall
include the following information:
(i) The name of the patient and an
additional patient identifier;
(ii) Date of examination, facility name,
and location. At a minimum, the
location shall include the city, State,
ZIP code, and telephone number of the
facility;
(iii) The name of the interpreting
physician who interpreted the
mammogram;
(iv) Overall final assessment of
findings, classified in one of the
following categories (the assessment
statement is only the word or phrase
within the quotation marks):
(A) ‘‘Negative.’’ Nothing to comment
upon (if the interpreting physician is
aware of clinical findings or symptoms,
despite the negative assessment, these
shall be documented and addressed);
(B) ‘‘Benign.’’ Also a normal result,
with benign findings present, but no
evidence of malignancy (if the
interpreting physician is aware of
clinical findings or symptoms, despite
the benign assessment, these shall be
documented and addressed);
(C) ‘‘Probably Benign.’’ Finding(s) has
a high probability of being benign;
(D) ‘‘Suspicious.’’ Finding(s) without
all the characteristic morphology of
breast cancer but indicating a definite
probability of being malignant;
(E) ‘‘Highly Suggestive of
Malignancy.’’ Finding(s) has a high
probability of being malignant;
(F) ‘‘Known Biopsy-Proven
Malignancy.’’ Reserved for known
malignancies being mammographically
evaluated for definitive therapy; and
(G) ‘‘Post-Procedure Mammogram for
Marker Placement.’’ Reserved for a postprocedure mammogram used to confirm
the deployment and position of a breast
tissue marker.
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(v) In cases where no final assessment
category can be assigned due to
incomplete work-up, one of the
following classification statements shall
be assigned as an assessment and
reasons why no final assessment can be
made shall be stated by the interpreting
physician.
(A) ‘‘Incomplete: Need additional
imaging evaluation.’’ Reserved for
examinations where additional imaging
needs to be performed before an
assessment category identified in
paragraphs (c)(1)(iv)(A) through (G) of
this section can be given; or
(B) ‘‘Incomplete: Need prior
mammograms for comparison.’’
Reserved for examinations where
comparison with prior mammograms
should be performed before an
assessment category identified in
paragraphs (c)(1)(iv)(A) through (G) of
this section can be given. If this
assessment category is used, a followup
report with an assessment category
identified in paragraphs (c)(1)(iv)(A)
through (E) of this section must be
issued within 30 calendar days of the
initial report whether or not comparison
views can be obtained.
(vi) Overall assessment of breast
density, classified in one of the
following categories:
(A) ‘‘The breasts are almost entirely
fatty.’’
(B) ‘‘There are scattered areas of
fibroglandular density.’’
(C) ‘‘The breasts are heterogeneously
dense, which may obscure small
masses.’’
(D) ‘‘The breasts are extremely dense,
which lowers the sensitivity of
mammography.’’
(vii) Recommendations made to the
healthcare provider about what
additional actions, if any, should be
taken. All clinical questions raised by
the referring healthcare provider shall
be addressed in the report to the extent
possible, even if the assessment is
negative or benign.
(2) Communication of mammography
results to the patients. Each facility shall
provide each patient a summary of the
mammography report written in lay
terms within 30 calendar days of the
mammographic examination which
shall, at a minimum, include the name
of the patient; the name, address, and
telephone number of the facility
performing the mammographic
examination; and an assessment of
breast density as described in
paragraphs (c)(2)(iii) and (iv) of this
section. If the assessment of the
mammography report is ‘‘Suspicious’’ or
‘‘Highly Suggestive of Malignancy,’’ the
facility shall provide the patient a
summary of the mammography report
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written in lay language within 7
calendar days of the final interpretation
of the mammograms.
(i) Patients who do not name a
healthcare provider to receive the
mammography report shall be sent the
report described in paragraph (c)(1) of
this section within 30 days, in addition
to the written notification of results in
lay terms. If the assessment of the
mammography report is ‘‘Suspicious’’ or
‘‘Highly Suggestive of Malignancy,’’ the
facility shall send this report to the
patient within 7 calendar days of the
final interpretation of the mammograms.
(ii) Each facility that accepts patients
who do not have a healthcare provider
shall maintain a system for referring
such patients to a healthcare provider
when clinically indicated, which shall
include when such patients’
mammogram assessment is either
probably benign, suspicious, or highly
suggestive of malignancy.
(iii) If the mammography report
identifies the patient’s breast density as
‘‘The breasts are almost entirely fatty’’
or ‘‘There are scattered areas of
fibroglandular density,’’ the lay
summary shall include the statement
‘‘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.’’
(iv) If the mammography report
identifies the breast density as ‘‘The
breasts are heterogeneously dense,
which may obscure small masses’’ or
‘‘The breasts are extremely dense, which
lowers the sensitivity of
mammography,’’ the lay summary shall
include the statement ‘‘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.’’
(3) * * *
(ii) If the assessment is ‘‘Suspicious’’
or ‘‘Highly Suggestive of Malignancy,’’
the facility shall provide a written
report of the mammographic
examination, including the items listed
in paragraph (c)(1) of this section, to the
referring healthcare provider, or if the
referring healthcare provider is
unavailable, to a responsible designee of
the referring healthcare provider within
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7 calendar days of the final
interpretation of the mammograms.
(4) Recordkeeping. Each facility that
performs mammograms:
(i) Shall (except as provided in
paragraph (c)(4)(ii) of this section)
maintain the original mammograms and
mammography reports in a permanent
medical record of the patient for the
longest of the following: a period of not
less than 5 years, a period of not less
than 10 years if no additional
mammograms of the patient are
performed at the facility, or a period, if
any, mandated by State or local law.
Facilities shall implement policies and
procedures to minimize the possibility
of loss of these records. The original
mammograms must be retained in
retrievable form in the mammographic
modality in which they were produced.
They cannot be produced by copying or
digitizing hardcopy originals.
(ii) 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 the time specified in
paragraph (c)(4)(i) of this section.
Transfer of the mammograms and
mammography reports must take place
within 15 calendar days of the facility
receiving such request. The transferred
mammograms must be in the
mammographic modality in which they
were produced, and cannot be produced
by copying or digitizing hardcopy
originals. For digital mammograms or
digital breast tomosynthesis, if the
examination is being transferred for
final interpretation purposes, the facility
must be able to provide the recipient
with original digital images
electronically;
(iii) Shall upon request by, or on
behalf of, the patient, provide copies of
mammograms and copies of
mammogram reports to a medical
institution, a physician or healthcare
provider of the patient, or to the patient
directly during the time specified in
paragraph (c)(4)(i) of this section.
Release of the copies must take place
within 15 calendar days of the facility
receiving such request. For digital
mammograms or digital breast
tomosynthesis, if the copies are being
released for final interpretation
purposes, the facility must be able to
provide the recipient with digital
images electronically;
(iv) Any fee charged to the patients for
providing the services in paragraphs
(c)(4)(ii) or (iii) of this section shall not
exceed the documented costs associated
with this service; and
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(v) Before a facility closes or ceases to
provide mammography services, it must
make arrangements for access by
patients and healthcare providers to
their mammographic records. This
access may be provided by the
permanent transfer of mammographic
records to the patient or the patient’s
healthcare provider or the transfer of the
mammographic records to a facility or
other entity that will provide access to
patients and healthcare providers.
Access to the records must be provided
by such other facility or entity for the
remainder of the time periods specified
in paragraph (c)(4)(i) of this section. If
a facility ceases to perform
mammography but continues to operate
as a medical entity, and is able to satisfy
the recordkeeping requirements of
paragraphs (c)(4)(i) through (iv) of this
section, 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. The facility must
notify its accreditation body and
certification agency in writing of the
arrangements it has made and must
make reasonable efforts to notify all
affected patients.
*
*
*
*
*
(f) * * *
(1) General requirements. For the
purposes of these audit requirements, a
mammographic examination consisting
of routine views of an asymptomatic
patient shall be termed a screening
mammogram, while a mammographic
examination consisting of
individualized views of a patient with
breast symptoms, physical signs of
breast disease, or abnormal findings on
a screening mammogram shall be
termed a diagnostic mammogram. Each
facility shall establish a system to
collect and review outcome data for all
mammographic examinations
performed, including followup on the
disposition of all positive mammograms
and correlation of pathology results
with the interpreting physician’s
mammography report. In addition, for
cases of breast cancer among patients
imaged at the facility that subsequently
become known to the facility, the
facility shall promptly initiate followup
on surgical and/or pathology results and
review of the mammographic
examinations taken prior to the
diagnosis of a malignancy. Analysis of
these outcome data shall be made
individually and collectively for all
interpreting physicians and, at a
minimum, shall consist of a
determination of the following:
(i) Positive predictive value—percent
of patients with positive mammograms
PO 00000
Frm 00046
Fmt 4701
Sfmt 4700
who are diagnosed with breast cancer
within 1 year of the date of the
mammographic examination.
(ii) Cancer detection rate—of the
patients initially examined with
screening mammograms who receive an
assessment of ‘‘Incomplete: Need
additional imaging evaluation,’’
‘‘Suspicious,’’ or ‘‘Highly Suggestive of
Malignancy’’ on the screening
mammogram or on a subsequent
diagnostic mammogram, the number of
patients who are diagnosed with breast
cancer within 1 year of the date of the
initial screening mammogram,
expressed arithmetically as a ratio per
1,000 patients.
(iii) Recall rate—percentage of
screening mammograms given an
assessment of ‘‘Incomplete: Need
additional imaging evaluation.’’
*
*
*
*
*
(4) The records and data required to
demonstrate compliance with the
requirements in paragraphs (f)(1)
through (3) of this section must be
retained until the annual inspection that
follows the facility’s analysis of that
information.
*
*
*
*
*
(j) Additional mammography review
and patient and referring provider
notification. (1) If FDA or the State
certification agency believes that
mammographic quality at a facility has
been compromised and may present a
significant risk to human health, the
facility shall provide clinical images
and other relevant information, as
specified by FDA or the State
certification agency, for review by the
accreditation body or the State
certification agency. This additional
mammography review will help FDA or
the State certification agency determine
whether the facility is in compliance
with this section and whether there is
a need to notify affected patients, their
referring physicians or other healthcare
providers, and/or the public that there
is a significant risk to human health.
(2) Based on the results of the
additional mammography review, the
facility’s failure to comply with the
terms of the additional mammography
review, or other information, FDA or the
State certification agency may
determine that the quality of
mammography performed by a facility,
whether or not certified under § 900.11,
was so inconsistent with the quality
standards established in this part as to
present a significant risk to human
health. FDA or the State certification
agency may require such a facility to
notify all patients who received
mammograms at the facility or those
patients who are determined to be at
E:\FR\FM\10MRR2.SGM
10MRR2
Federal Register / Vol. 88, No. 47 / Friday, March 10, 2023 / Rules and Regulations
risk due to the quality of their
mammography, and their referring
physicians or other healthcare
providers, of the deficiencies and
resulting potential harm, appropriate
remedial measures, and such other
relevant information as FDA or the State
certification agency may require. Such
notification shall occur within a
timeframe and in a manner specified by
FDA or the State certification agency. If
the facility is unable or unwilling to
perform such notification, FDA or the
State certification agency may notify
patients and their referring physicians
or other healthcare providers
individually or through the mass media.
■ 6. In § 900.14 revise paragraphs (a)
introductory text and (a)(3), (5), and (6)
and add paragraph (a)(7) to read as
follows:
§ 900.14 Suspension or revocation of
certificates.
lotter on DSK11XQN23PROD with RULES2
(a) Except as provided in paragraph
(b) of this section, FDA may suspend or
revoke a certificate if FDA finds, after
providing the owner or operator of the
facility with notice and opportunity for
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18:18 Mar 09, 2023
Jkt 259001
a hearing in accordance with part 16 of
this chapter, that the facility, owner,
operator, or any employee of the facility:
*
*
*
*
*
(3) Has failed to comply with
reasonable requests of FDA, the State
certification agency, or the accreditation
body for records, information, reports,
or materials, including clinical images
for an additional mammography review
under § 900.12(j), that FDA or the State
certification agency believes are
necessary to determine the continued
eligibility of the facility for a certificate
or continued compliance with the
standards of § 900.12;
*
*
*
*
*
(5) Has violated or aided and abetted
in the violation of any provision of or
regulation issued pursuant to 42 U.S.C.
263b;
(6) Has failed to comply with prior
sanctions imposed by FDA or the State
certification agency under 42 U.S.C.
263b(h), including a directed plan of
correction or a patient and referring
physician notification; or
(7) Has failed to comply with requests
of current or former facility personnel
PO 00000
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Fmt 4701
Sfmt 9990
15171
for records of their training or
experience relevant to their
qualification under MQSA, in violation
of § 900.12(a)(4).
*
*
*
*
*
7. In § 900.15 revise paragraph (d)(1)
to read as follows:
■
§ 900.15 Appeals of adverse accreditation
or reaccreditation decisions that preclude
certification or recertification.
*
*
*
*
*
(d) * * *
(1) References to the Centers for
Medicare and Medicaid Services in 42
CFR part 498 should be read as the
Division of Mammography Quality
Standards (DMQS), Center for Devices
and Radiological Health, Food and Drug
Administration.
*
*
*
*
*
Dated: February 27, 2023.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2023–04550 Filed 3–9–23; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\10MRR2.SGM
10MRR2
Agencies
[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)]
[Rules and Regulations]
[Pages 15126-15171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04550]
[[Page 15125]]
Vol. 88
Friday,
No. 47
March 10, 2023
Part II
Department of Health and Human Services
-----------------------------------------------------------------------
Food and Drug Administration
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21 CFR Part 900
Mammography Quality Standards Act; Final Rule
Federal Register / Vol. 88, No. 47 / Friday, March 10, 2023 / Rules
and Regulations
[[Page 15126]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 900
[Docket No. FDA-2013-N-0134]
RIN 0910-AH04
Mammography Quality Standards Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
issuing a final rule to update the mammography regulations that were
issued under the Mammography Quality Standards Act of 1992 (MQSA) and
the Federal Food, Drug, and Cosmetic Act (FD&C Act). We are issuing
updates to modernize the regulations by incorporating current science
and mammography best practices. These updates are intended to improve
the delivery of mammography services by strengthening the communication
of healthcare information; allowing for more informed decision making
by patients and providers (by requiring facilities to provide them with
additional health information); helping to ensure the availability of
qualified mammography personnel; bolstering the medical outcomes audit
to provide feedback to improve mammography interpretations; modernizing
technological aspects of the standards; and adding additional tools to
deal with noncompliant facilities.
DATES: This rule is effective on September 10, 2024.
ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this final rule into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
240-402-7500.
FOR FURTHER INFORMATION CONTACT: Preetham Sudhaker, Division of
Mammography Quality Standards (DMQS), Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Silver Spring, MD 20993, 301-796-5911.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of the Final Rule
B. Legal Authority
C. Summary of the Major Provisions of the Final Rule
D. Costs and Benefits of the Final Rule
II. Table of Abbreviations and Acronyms Commonly Used in This
Document
III. Background
A. Need for Amendments to Mammography Regulations
B. Summary of Comments to the Proposed Rule
C. General Overview of the Final Rule's Changes From the
Proposed Rule
IV. Legal Authority
V. Comments to the Proposed Rule and FDA's Responses
A. General Comments on the Proposed Rule
B. Scope of MQSA Regulations
C. Repeated Failure To Achieve Accreditation
D. Retention and Release of Personnel Records
E. Digital Accessories
F. Facility Identification Information in Mammography Report and
Lay Summary
G. Final and Incomplete Assessments and Lay Summaries
H. Deadlines for Mammography Reports
I. Breast Density Notification--General Support for Density
Notification
J. Breast Density Notification Language
K. Breast Density Notification and the Role of the Referring
Healthcare Provider
L. Format for Image Interpretation, Retention, Transfer of
Original Images, and Release of Copies
M. Deadlines for Image Transfer and the Release of Copies
N. Facility Closure and Mammography Record Retention
O. Mammography Medical Outcomes Audit
P. Patient and Referring Provider Notification
Q. Revocation of Certification
R. Interpreting Physician Qualifications, Including Continuing
Experience
S. Cleaning of Mammography Equipment
T. Availability and Clinical Role of Breast Imaging Modalities,
Screening Mammography Guidelines
U. Clinical Decision-Making
V. Insurance Coverage
W. Economic Impact of This Rule
X. Federalism and the Relationship Between Federal and State
Breast Density Reporting Requirements
Y. Effective Date of This Rule
Z. Miscellaneous Comments
VI. Effective Date and Compliance Date
VII. Economic Analysis of Impacts
A. Introduction
B. Summary and Accounting Statement
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. References
I. Executive Summary
A. Purpose of the Final Rule
Mammography is an x-ray imaging examination used to identify signs
of breast cancer. For patients to receive the full benefit of
mammography, the service must be of high quality, including performance
of the examination by qualified technologists, using equipment that is
tested and properly functioning; interpretation by qualified
physicians; and clear and prompt communication of results to patients
and their referring healthcare providers. The MQSA establishes uniform
baseline Federal standards designed to ensure, among other things, that
all patients nationwide have access to quality mammography services.
The MQSA implementing regulations address, among other things,
standards for accreditation bodies and certifying agencies and
mammography quality standards for facilities, such as qualifications of
personnel at mammography facilities, standards for mammography
equipment, the content and terminology for mammography reports, the
requirement to establish a quality assurance program, standards and
timing for quality assurance testing, standards for clinical image
quality, recordkeeping, communication of results, and clinical image
review by the facility's accrediting body. Based on technology changes
in mammography and our experience with the administration of the MQSA
program, FDA is modernizing and updating the regulations as well as
improving the information, including breast density information,
provided by mammography facilities to patients and their healthcare
providers. This final rule requires that the summary of the mammography
report written in lay terms (``lay summary'') that is provided to
patients identifies whether the patient has dense or non-dense breast
tissue and includes a prescribed paragraph on the significance of
breast density. The rule also establishes four categories for reporting
breast tissue density in the mammography report that is provided to the
patient's referring healthcare provider.
B. Legal Authority
The MQSA was enacted on October 27, 1992, and is codified, as
amended in 1998 and 2004, under section 354 of the Public Health
Service (PHS) Act. Public Law 102-539, 2, 106 (1992), codified as
amended at 42 U.S.C. 263b. Under the MQSA, all mammography facilities,
except facilities of the Department of Veterans Affairs (VA), must be
accredited by an approved accreditation body (AB) and certified by FDA
(or an approved State certification agency) to provide mammography
services. FDA is amending the mammography regulations established under
the PHS Act, and sections of the FD&C Act.
[[Page 15127]]
C. Summary of the Major Provisions of the Final Rule
FDA is making three categories of improvements to our mammography
regulations: improvements that address changes in mammography
technology; improvements that enhance enforcement of quality standards;
and improvements in the way mammography results are categorized,
reported, retained, and transferred to patients and healthcare
providers. Specifically, in this final rule FDA is making the following
amendments:
New and amended provisions related to technology that,
among other things, update several equipment and quality control
provisions in the regulations to address current technology, including
digital mammography;
Improvements that enhance enforcement that, among other
things:
[cir] Require that mammograms submitted for interpretation be
presented in the mammographic modality in which they were originally
produced, and not be copied or digitized from hardcopy original images,
which could adversely affect the accuracy of interpretation;
[cir] Prohibit accreditation bodies from accepting an application
for accreditation from a facility that has failed to become accredited
after three consecutive attempts until 1 year after the most recent
accreditation failure;
[cir] Expressly state that a facility's certificate may be
suspended or revoked due to a failure to comply with requests by FDA,
the State certification agency, or the AB for records, including
clinical images for an additional mammography review (AMR), or with
requests by current or former facility personnel for records
documenting their qualifications;
[cir] Add the State certification agency as an entity that may
initiate an AMR, which can help detect quality issues, and also to
state expressly that FDA and the State certification agency can notify
patients and their providers individually or through the mass media
when a facility is unable or unwilling to perform a required patient
and referring physician notification (PPN), which would help to ensure
that patients and providers are informed of serious risks to human
health resulting from mammography that fails to meet quality standards;
[cir] Require that, before a facility closes or no longer provides
mammography services, it must make arrangements for access by patients
and healthcare providers to mammography images and reports; and
[cir] Require facilities to provide personnel with copies of their
MQSA qualification records, which are often needed to work at
additional or new facilities.
Improvements in the way mammography results are
categorized, reported, retained, and transferred to patients and
healthcare providers that, among other things:
[cir] Require that the mammographic examination report include the
facility name and location (at a minimum, the city, State, ZIP code,
and telephone number of the facility), in order to help to ensure that
healthcare providers can obtain the necessary information to enable
them to assist patients in making informed healthcare decisions;
[cir] Change the explanatory language in one final assessment
category (``Benign'') to promote greater consistency and accuracy in
the use of the category, and add three new categories of mammographic
assessment to the existing categories in the regulations, which will
allow mammography facilities to precisely classify and communicate
findings;
[cir] Add a specific, required timeframe for facilities to send
mammography reports to healthcare providers and the summary written in
lay terms to patients whose mammograms have either ``Suspicious'' or
``Highly Suggestive of Malignancy'' final assessment categories, which
could lead to earlier definitive tissue diagnosis of malignancy and
earlier start of treatment, and avoid, for the patient, the anxiety of
a protracted waiting period;
[cir] Require reporting to patients and healthcare providers to
include an assessment of breast density, in order to provide them with
additional information about their mammography and the potential
limitations of their mammogram results so that patients and their
healthcare providers can make informed healthcare decisions by;
[ssquf] Retaining the two categories of density in the patient lay
summary, but changing the wording from the comparative terms ``high
density'' and ``low density'' to ``dense'' and ``not dense,'' in order
to align with clinical practice and improve clarity to the patient.
[ssquf] Revising the written lay summary of the results provided to
the patient to contain one of the following breast density notification
statements. 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.''
[ssquf] Requiring that the written report of the results of the
mammographic examination provided to the healthcare provider include
information concerning an overall assessment of breast density,
classified in one of the following categories: (A) ``The breasts are
almost entirely fatty.'' (B) ``There are scattered areas of
fibroglandular density.'' (C) ``The breasts are heterogeneously dense,
which may obscure small masses.'' (D) ``The breasts are extremely
dense, which lowers the sensitivity of mammography.''
[cir] Require each mammography facility to implement policies and
procedures to minimize the loss of mammography images and reports
because the loss of these records can have a significant, negative
impact on clinical care, and also specify the timeframe within which
facilities must transfer original mammograms and copies of reports to
patients, healthcare providers, and others because delays in the
transfer of these records can lead to delays in diagnosis or treatment;
and
[cir] Clarify the minimum information that facilities must collect
during the mammography medical outcomes audit because calculating and
tracking these values is important to the evaluation of accuracy in
detecting breast cancer, allowing facilities and interpreting
physicians to review their performance and enact quality improvement
measures.
D. Costs and Benefits of the Final Rule
The quantified benefits of this rule are derived from reduced
mortality and breast cancer treatment costs resulting from the breast
density reporting requirements. The estimate of annualized benefits
over 10 years ranges from $12.99 million to $232.69 million at a 7
percent discount rate and $8.50 million to $266.09 million at a 3
percent discount rate. Other benefits that we are not able to quantify
include reduced cancer morbidity and improvements in the accuracy of
mammography by
[[Page 15128]]
improving quality control and strengthening the medical audit. The
costs of the final rule include costs to mammography facilities to
comply with the requirements and costs associated with supplemental
testing and biopsies resulting from the breast density requirements.
The estimate of annualized costs over 10 years ranges from $28.87
million to $45.42 million at a 7 percent discount rate with a primary
value of $36.31 million. Using a 3 percent discount rate, the
annualized costs range from $27.61 million to $44.16 million with a
primary value of $35.05 million.
II. Table of Abbreviations and Acronyms Commonly Used in This Document
------------------------------------------------------------------------
Abbreviation or acronym What it means
------------------------------------------------------------------------
AB........................... Accreditation Body.
ACR.......................... American College of Radiology.
ACS.......................... American Cancer Society.
AMR.......................... Additional Mammography Review.
BICOE........................ Breast Imaging Centers of Excellence.
BI-RADS...................... Breast Imaging--Reporting and Data
System.
CAD.......................... Computer-Aided Detection.
CD........................... Compact Discs.
CDC.......................... Centers for Disease Control and
Prevention.
CDR.......................... Cancer Detection Rate.
CDRH......................... Center for Devices and Radiological
Health.
CFR.......................... Code of Federal Regulations.
CRCPD........................ Conference of Radiation Control Program
Directors, Inc..
DBT.......................... Digital Breast Tomosynthesis.
DICOM........................ Digital Imaging and Communication in
Medicine.
DMQS......................... Division of Mammography Quality
Standards.
ERG.......................... Eastern Research Group.
FDA, Agency, or we........... Food and Drug Administration.
FD&C Act..................... Federal Food, Drug, and Cosmetic Act.
FFDM......................... Full-Field Digital Mammography.
FRIA......................... Final Regulatory Impact Analysis.
HIPAA........................ Health Insurance Portability and
Accountability Act of 1996.
IP........................... Interpreting Physician.
MBI.......................... Molecular Breast Imaging.
MQSA......................... Mammography Quality Standards Act of
1992.
MQSRA........................ Mammography Quality Standards
Reauthorization Acts of 1998 and 2004.
MRI.......................... Magnetic Resonance Imaging.
NAPBC........................ National Accreditation Program for Breast
Centers.
NMQAAC....................... National Mammography Quality Assurance
Advisory Committee.
OMB.......................... Office of Management and Budget.
PACS......................... Picture Archiving and Communication
System.
PGHS......................... Policy Guidance Help System.
PHS Act...................... Public Health Service Act.
PPN.......................... Patient and Referring Physician
Notification.
PPV.......................... Positive Predictive Value.
QC........................... Quality Control.
QI........................... Quality Indicator.
SCA.......................... State Certification Agency.
U.S.C........................ United States Code.
USPSTF....................... U.S. Preventive Services Task Force.
VA........................... Department of Veterans Affairs.
------------------------------------------------------------------------
III. Background
According to the Centers for Disease Control and Prevention (CDC),
in 2018, the most recent year for which numbers are available, over
254,000 women were diagnosed with breast cancer, and more than 42,000
women died of the disease (Ref. 1). According to the National Cancer
Institute of the National Institutes of Health, in 2020, over 276,000
women were projected to be diagnosed with breast cancer, and over
42,000 women were projected to die of the disease (Ref. 2). Breast
cancer is rare in men, with approximately 2,300 new cases and 500
deaths reported in the United States in 2017, according to the CDC
(Ref. 3). Among women, however, breast cancer is now the most common
non-skin cancer and the second leading cause of cancer deaths after
lung cancer (Ref. 4). There are also disparities in both the incidence
of breast cancer, and in mortality from breast cancer, by both race and
ethnicity. In 2019, the latest year for which incidence data are
available, in the United States, 30,450 new cases of breast cancer were
reported among Black, Non-Hispanic women, and 6,600 Black, Non-Hispanic
women died of this cancer. For every 100,000 Black, Non-Hispanic women,
128 new breast cancer cases were reported and 28 Black, Non-Hispanic
women died of this cancer (Ref. 1). Health disparity and equity
considerations may exist as they relate to mammography practice and
density notification, and we have considered sociodemographic
differences in mammography practice and outcomes. This final rule
provides standard requirements that help to ensure that all patients
and providers receive complete and consistent breast density
information in mammography reports.
Early detection of female breast cancer, typically involving
mammography, is the best means of preventing deaths that can result if
the diagnosis is delayed until the onset of more advanced symptoms
(Ref. 5). Mammography is a type of medical imaging that uses x-rays to
create images (mammograms) of the internal structures of the breasts.
There are three types of mammography referred to in
[[Page 15129]]
this document: screen-film mammography, full field digital mammography,
and digital breast tomosynthesis. In screen-film mammography, x-rays
are transmitted through the breast and expose a sheet of x-ray film
enclosed in a cassette. In full field digital mammography, the x-rays
go through to an image receptor that is a radiation-sensitive
electronic device or plate. Images are displayed on a computer
workstation, and can, for example, be digitally magnified. Digital
breast tomosynthesis also uses an electronic image receptor and a
computer workstation, and obtains multiple images at different angles
around the breast, then uses a computer to reconstruct a series of
parallel images that resemble slices through the breast.
Mammography can help detect breast cancer in its earliest, most
treatable stages, when it is too small to be felt or detected by any
other method (Ref. 6).
However, as noted by the Government Accountability Office (GAO), a
mammogram is among the most difficult radiographic images to interpret
(Ref. 7). The mammogram must be of high quality for accurate image
interpretation. If the image quality is poor, the interpreter may miss
a cancerous lesion. Such a false negative diagnosis could delay
treatment and result in an avoidable death or increased morbidity. It
is equally true that poor quality images or inaccurate interpretations
can lead to a false positive diagnosis when normal tissue is
misinterpreted as abnormal. This could lead to needless anxiety for the
patient, costly additional testing, and unnecessary biopsies.
A. Need for Amendments to Mammography Regulations
Most of the requirements in our mammography regulations are over 20
years old. As described below and in the proposed rule (84 FR 11669,
March 28, 2019), major developments in understanding relating to the
importance of certain breast anatomy on breast cancer risk have
occurred, and FDA believes these developments should be reflected in
our nationwide standard. In addition, we are updating our mammography
regulations in response to several gaps that we have identified as we
have implemented the current regulations. Current regulations do not
require that a notification of breast density be part of the report
provided to the healthcare provider or the lay summary provided to the
patient. However, there is increasing interest in breast density
reporting, and States are taking action. Between 2009 and June 2021, 38
States have passed laws mandating notification of breast density (Ref.
8). These State laws impose requirements that vary from State to State.
To ensure all patients receive breast density information from their
mammograms, and that such required baseline information is consistent,
FDA is amending the mammography reporting requirements to require that
the written report of the results of the mammographic examination
provided to the healthcare provider and the lay summary of the results
provided to the patient also include information concerning patient
breast density. FDA is also requiring that both the mammography report
and lay summary include basic mammography facility identification
information. Technology has also advanced since the regulations were
issued, so the amended regulations will make changes to reflect current
mammography best practices and technologies.
B. Summary of Comments to the Proposed Rule
In the Federal Register of March 28, 2019, FDA published a rule
proposing amendments to the MQSA regulations. The comment period for
the proposed rule closed on June 26, 2019. FDA received many comments
on the proposed rule from several entities including medical device
associations, industry, medical and healthcare professional
associations, public health advocacy groups, law firms, and
individuals. While several comments object to particular sections or
subsections of the proposed rule, almost all comments voice support for
the objective intent of the proposed rule, to establish updates to
modernize the MQSA regulations to incorporate current science and
mammography best practices.
Some comments raise concerns or request clarification regarding:
the scope of the MQSA regulations,
failure of facility accreditation,
retention of personnel records,
mammography reports (including assessment categories) and
lay summaries,
breast density notification to patients and referring
providers,
requirements for image retention, transfer of original
images, and release of copies,
the mammography medical outcomes audit,
patient and provider notification,
the availability and use of various imaging modalities,
and
issues related to clinical decision-making.
C. General Overview of the Final Rule's Changes From the Proposed Rule
FDA considered all comments received on the proposed rule and made
changes, primarily for clarity and accuracy and to improve
understanding of breast density notification language to healthcare
providers and patients. On its own initiative, FDA is also making minor
technical changes to make the withdrawal provisions clearer. The
changes from the proposed rule include the following significant
revisions, additions, and removals to the codified section:
add or substitute the term ``provider'' or ``healthcare
provider'' in several paragraphs in place of references to referring
physician (Sec. Sec. 900.2(c)(2), 900.2(k), 900.2(ii),
900.4(f)(1)(ii)(B), and 900.12(j)),
revise language to clarify that no AB shall accept an
application for accreditation from a facility that has had three
consecutive failures (Sec. 900.4(a)(6)(ii)),
include additional language requiring that facilities must
retain personnel qualification records of former employees for at least
24 months (Sec. 900.12(a)(4)),
remove the proposed term ``digital accessory components''
and clarify the premarket requirements for devices used in mammography
(Sec. 900.12(b)(2)(i)),
include additional language clarifying that the required
final assessment statements are only the words or phrases in quotation
marks (Sec. 900.12(c)(1)(iv)),
revise the requirement that clinical findings or symptoms
in a patient whose mammogram assessment is negative or benign shall be
``documented and addressed,'' rather than ``explained'' (Sec.
900.12(c)(1)(iv)(A) and (B)),
correct the reference to the two categories of breast
density that shall be included in the lay summary provided to the
patient (Sec. 900.12(c)(2)),
include additional language clarifying the deadline for
sending the mammography report to a self-referred patient when the
assessment is ``Suspicious'' or ``Highly Suggestive of Malignancy''
(Sec. 900.12(c)(2)(i)),
include additional language clarifying the situations in
which a facility must maintain a system for referring self-referred
patients to a healthcare provider (Sec. 900.12(c)(2)(ii)),
revise the breast density notification language that must
be included in lay summaries provided to patients with non-dense and
dense tissue, respectively (Sec. 900.12(c)(2)(iii) and (iv)),
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add language clarifying the length of time a facility is
required to maintain the original mammograms and mammography reports in
a permanent medical record of the patient by clarifying it is for the
longer of the applicable Federal timeframes, or the mandated State or
local timeframes (Sec. 900.12(c)(4)(i)),
add language clarifying that a facility that ceases to
perform mammography but continues to operate as a medical entity may
retain, rather than transfer, its mammography records (Sec.
900.12(c)(4)(v)),
add or substitute the term ``patient'' in place of
references to ``women'' or ``woman'' (Sec. Sec. 900.12(c)(4)(v) and
(f)(1)),
add the word ``audit'' to clarify that the use of certain
terms applies to the medical outcomes audit (Sec. 900.12(f)(1)), and
include an amendment changing the name of Healthcare
Financing Administration to Centers for Medicare & Medicaid Services
and updating the Center for Devices and Radiological Health (CDRH)
office's name (Sec. 900.15(d)(1)).
IV. Legal Authority
The MQSA (Pub. L. 102-539) was enacted on October 27, 1992, and is
codified under section 354 of the Public Health Service (PHS) Act (42
U.S.C. 263b). Under the MQSA, all mammography facilities, except
facilities of the VA, must be accredited by an approved AB and
certified by FDA (or an approved State certification agency) to provide
mammography services (42 U.S.C. 263b(b)(1) and (d)(1)(iv)). FDA is
making these amendments to the mammography regulations (set forth in
part 900 (21 CFR part 900)) under section 354 of the PHS Act, and
sections of the FD&C Act (sections 519, 537, and 704(e); 21 U.S.C.
360i, 360nn, and 374(e)).
V. Comments on the Proposed Rule and FDA's Responses
We received several sets of comments on the proposed rule by the
close of the comment period, each containing one or more comments on
one or more issues. We received comments from medical device
associations, industry, medical and healthcare professional
associations, public health advocacy groups, law firms, and
individuals. We describe and respond to comments in sections A through
Z of this document. We have numbered each comment to help distinguish
between different comments. We have grouped similar comments together
under the same number so that FDA's responses could be addressed by
topic, instead of each comment addressed independently, and, in some
cases, we have separated different issues discussed in the same comment
and designated them as distinct comments for purposes of our responses.
The number assigned to each comment or comment topic is purely for
organizational purposes and does not signify the comment's value or
importance or the order in which comments were received or considered.
A. General Comments on the Proposed Rule
(Comment 1) FDA received many comments that express support for the
MQSA proposed rule. Some comments express support for requiring density
notification to patients and for establishing a national standard for
such notification. Other comments respectively express support for the
changes to the assessment categories, equipment quality control (QC),
and requirements related to the provision of copies of mammograms. Some
comments express support for the changes to the patient and provider
notification in the event of compromised mammographic quality, which
may represent a serious risk to human health, including the
notification of nonphysician referring healthcare providers. Another
comment compliments FDA on proposing amendments to the regulations, but
recommends more frequent changes to respond promptly to new
information.
(Response 1) FDA appreciates the public support for the rule. FDA
notes that the notification requirement regarding breast tissue density
will enhance communication between patients, interpreting physicians
(IP), and referring providers about this important factor in the
effectiveness of mammography, and ensure that required baseline
information is consistent. FDA also concludes that the other amendments
to the regulations (part 900), including the changes to the equipment
QC, assessment categories, provision of copies of mammograms, and
notification to nonphysician healthcare providers when necessary, will
also contribute to improvement in the quality of mammography and of
communication about mammography between patients, IPs, and providers.
Regarding the recommendation for more frequent changes, FDA notes that
it continues to engage with the National Mammography Quality Assurance
Advisory Committee (NMQAAC) and the professional and patient
mammography communities regarding the need for changes to the
regulations, but the frequency of amendments to the regulations is
based on public health need and Agency resources.
(Comment 2) Several comments express opposition to the proposed
rule, including the following concerns: (1) that patients will not
understand that dense tissue is a normal variant, and that the proposed
breast density notification will increase their anxiety; (2) that
breast cancer information to be given to a patient should be determined
only by the patient's healthcare provider, or that the new requirement
places a burden on the healthcare provider; (3) that all medical tests
should be interpreted by clinicians with years of training who can
identify the findings that require intervention; (4) that ultrasound
rather than digital breast tomosynthesis (DBT) is the method to screen
for cancers that are not mammographically visible; and (5) that there
is no clinical recommendation to change patient management based on
density or to perform additional ultrasound and magnetic resonance
imaging (MRI) for screening dense breasts, and that current evidence
contradicts the suggestion that supplemental screening based on breast
density reduces breast cancer mortality. The latter comment also
recommends that FDA's suggestion that additional imaging based on
density alone may reduce breast cancer mortality should be deleted from
the cost and benefit information of the rule.
(Response 2) FDA acknowledges the comments and responds according
to the numbered topics identified in Comment 2:
(1-2) We note that breast tissue density is an important factor in
mammography, both because of the masking effect of dense tissue, which
limits the sensitivity of mammography (Refs. 9 to 11), and because
density is an independent risk factor for the development of breast
cancer (Refs. 12 to 15). FDA concludes that patients benefit from
having information about their breast anatomy, and should be informed
of their density so that the patient and their healthcare provider can
make informed and shared decisions about the patient's healthcare. This
rulemaking provides consistent language for communicating that
information, as FDA concludes that there is also a benefit from
obtaining baseline information in a consistent manner.
The requirement to notify patients about their density is a
baseline standard and does not constrain a healthcare provider from
further discussing density with the patient. FDA has determined that
the benefit of informing patients of their density
[[Page 15131]]
outweighs both the burden on healthcare providers to provide density
information and the risk of patient anxiety. FDA also notes that the
Agency received many comments in support of the proposed rule and the
breast density notification to patients. FDA also notes that 38 States
have passed laws mandating notification of breast density, which may
mitigate any potential burden on healthcare providers in those states
(Ref. 8).
(3) The MQSA provides authority to FDA to ensure quality
mammography, and FDA has determined that the initial and continuing
qualification requirements for IPs in Sec. 900.12(a)(1) are sufficient
to ensure that mammograms, including density observations, are
interpreted by personnel with adequate training to ensure quality
mammography.
(4-5) FDA acknowledges there are conflicting comments about the
utility of other imaging modalities besides DBT, such as ultrasound,
for supplemental screening of women with dense breasts; however, this
final rule does not specify any particular supplemental imaging
modality or other particular clinical management of patients with dense
breasts. FDA has not indicated any particular additional steps in a
patient's care 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, which would encompass a significant amount of information
that may be overwhelming and difficult for patients to interpret (see
also Responses 57 and 60). 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. In this final rule, to allow patients and
their healthcare providers to make shared decisions appropriate for
each patient, the notification to these patients in Sec.
900.12(c)(2)(iv) simply states, in part, ``In some people with dense
tissue, other imaging tests in addition to a mammogram may help find
cancers,'' and advises the patient to discuss their individual
situation with their provider (see also Response 62). FDA notes that
there is conflicting evidence about the effect of supplemental
screening on breast cancer mortality, including Chiu in 2010 (Ref. 16),
which found that dense tissue was associated with increased mortality
from breast cancer. Therefore, FDA disagrees with the assertion that
additional imaging based on breast density is not relevant, or that the
mortality information should be deleted from the economic cost and
benefit analysis of the rule.
(Comment 3) A comment opposes more mammography regulation, and
asserts:* that MQSA duplicates an American College of Radiology (ACR)
program which ``certifies'' mammography facilities; that FDA dictating
what IPs should say in their reports constitutes the practice of
medicine; and that MQSA regulations are driving physicians out of
mammography and limiting access. This comment recommends that FDA limit
itself to its ``original mandate'' to ensure that mammography units
produce quality images at a reasonable radiation dose.
(Response 3) FDA disagrees with the comment. The ACR does not
certify mammography facilities. The MQSA and its implementing
regulations distinguish between accreditation and certification (see 42
U.S.C. 263b(e) and (q); part 900, subparts A and C; see also Response
145). The ACR is one of several FDA-approved accreditation bodies.
Accreditation, which mainly focuses on the quality of clinical images
and phantom images, is one of the prerequisites for facility
certification by FDA or a State certifying agency. FDA does not specify
which assessment category an IP should assign to a mammogram because
this is more appropriately left to the provider's interpretation in the
course of clinical decision-making. However, FDA does provide for the
specific phrasing of the final assessment statements, which is
standardized in accordance with the MQSA (42 U.S.C. 263b(a)(3)(B)) to
ensure clear consistent communication between patients, IPs, and
referring healthcare providers. FDA does not track practice rates of
IPs or other facility personnel, but is not aware of information
showing a decrease in access to mammography services; according to MQSA
national statistics (Ref. 17), from November 2003 to February 2022,
there has been a 4 percent decrease in the total number of certified
facilities across the United States but a 29 percent increase in the
total number of mammograms performed. Therefore, FDA concludes that
these amendments to the MQSA regulations are neither duplicative of the
ACR program nor have the existing MQSA regulations had a negative
impact on access to mammography.
B. Scope of the MQSA Regulations
(Comment 4) Several comments address the scope of the MQSA
regulations, including comments that support the objectives of the
proposed rule and/or provide the following recommendations: (1) FDA's
proposal should remove xeromammography from the examples of
mammographic modalities, which accompany the definition provided in
proposed Sec. 900.2(z), and replace it with full-field digital
mammography (FFDM); (2) FDA should remove screen-film mammography from
these examples of modalities; (3) comments that FDA should also add the
example of DBT as a modality; (4) that mammography IPs should also be
qualified in breast ultrasound; and (5) that FDA should consider
requiring mammography facilities to meet additional quality standards,
such as the ACR's Breast Imaging Centers of Excellence (BICOE) program
or the American Cancer Society (ACS) National Accreditation Program for
Breast Centers (NAPBC), in addition to MQSA certification requirements.
(Response 4) The scope of FDA's authority over mammography
facilities is established in the MQSA, and, as described in the
following and organized according to the numbered topics identified in
Comment 4, FDA is adopting limited changes to this rule:
(1-3) The MQSA and its implementing regulations apply only to
radiological equipment used in facilities to perform mammographic
modalities, which do not include breast sonography or other non-
mammographic modalities (42 U.S.C. 263b(a)(5) and (6), (b)(1) and (2)).
However, FDA agrees that the modality of DBT has reached wide clinical
use and should be listed as an example of a mammographic modality in
this rule. Xeromammography is no longer in clinical use in the United
States, and screen-film mammography is in limited use. Therefore, in
this final rule, FDA is revising the examples of mammographic
modalities to remove xeromammography, and to list screen-film
mammography, FFDM, and DBT, all of which are currently in clinical use
in the United States (see Sec. 900.2(z) in this final rule). Other
modalities are covered by the requirements of the FD&C Act, and may be
subject to performance standards prescribed pursuant to section 534
(Electronic Product Radiation Control (EPRC)) of the FD&C Act.
(4) FDA disagrees with the recommendation to require mammography
IPs to also be qualified in breast ultrasound. As noted, the MQSA does
not provide for the establishment of requirements related to breast
sonography for IPs, other personnel, or facilities.
[[Page 15132]]
(5) FDA notes that the ACR BICOE program covers other breast
imaging modalities and interventions in addition to mammography, and
the ACS NAPBC covers additional breast imaging as well as other aspects
of clinical breast care. Therefore, these programs are not implemented
within the scope of the MQSA regulations.
(Comment 5) Several comments recommend removing the exclusion of
invasive interventions for biopsy or localization in Sec. 900.2(aa)(1)
so that they are included within the scope of the MQSA regulations. A
separate comment recommends that post-procedure mammograms for marker
placement should not be regulated under the MQSA.
(Response 5) FDA disagrees with these comments. The MQSA was
enacted by Congress in 1992 due to evidence of poor quality in
mammographic imaging in the United States at that time. However, since
then, the implementation of the MQSA and the widespread adoption of
digital imaging technologies and other technological and QC advances
have contributed to quality improvement not only in screening and
diagnostic mammography, but also in interventional mammography. The
majority of personnel performing interventional mammography also
perform non-interventional mammography and are therefore subject to the
requirements of the MQSA. Currently, FDA is not aware of information
showing significant quality problems with interventional mammography in
the United States. At this time, FDA concludes that it is not necessary
to introduce regulations covering interventional mammography.
Unlike the targeted images of a small portion of the breast that
are typically performed during localization or intervention, a post-
procedure mammogram typically includes the entire breast; may be
performed using general mammography equipment rather than dedicated
interventional equipment; and is often logged, reported, and charged as
an independent examination, separate from the interventional procedure
that precedes it. Therefore, FDA concludes that this post-procedure
examination should continue to meet the quality standards mandated
under the MQSA regulations. As discussed in Responses 32, 38, and 39,
this final rule includes the assessment statement ``Post-Procedure
Mammogram for Marker Placement,'' which may be appropriate for such
mammograms (see Sec. 900.12(c)(1)(iv)(G)).
(Comment 6) Several comments suggest that the MQSA regulations
should be expanded to cover other imaging modalities in addition to
mammography, including ultrasound and MRI.
(Response 6) The MQSA was passed by Congress in 1992 in response to
evidence of poor quality in mammographic imaging in the United States
at that time (42 U.S.C. 263b). As we noted in Response 4, the MQSA
applies only to mammographic imaging. As such, the MQSA does not
provide for the establishment of requirements related to breast
sonography or MRI, and the MQSA regulations have not been amended to
include such modalities.
(Comment 7) A comment recommends that medical offices be required
to display posters depicting breast anatomy and to distribute
literature regarding breast physical examination.
(Response 7) FDA disagrees with the comment. FDA notes that the
shared clinical decision-making process generally takes place between
the patient and their referring healthcare provider or other clinical
healthcare provider, not with the interpreting physician at the
mammography facility, and therefore does not agree that there is a need
to require posters of breast anatomy at mammography facilities,
although facilities may choose to display patient education resources.
Referring healthcare providers who order mammography studies, and are
not themselves the reviewing physicians of the clinical images at issue
(see 42 U.S.C. 263b(a)(8)), are not generally subject to the
requirements specified in the MQSA and its implementing regulations.
Clinical healthcare providers may provide such patient education
resources if they choose to do so, but this recommendation is outside
the scope of this final rulemaking.
C. Repeated Failure To Achieve Accreditation
(Comment 8) Several comments express concerns with the number and
type of accreditation failures after which an AB may not accept a
facility's application for accreditation for 1 year. One comment
recommends that this provision be revised to apply to a facility that
has ``failed to become accredited after four consecutive failures'';
another comment recommends that this be revised to apply to a facility
which has ``failed to become accredited after four failed accreditation
cycles''; and another comment recommends that this be revised to apply
to a facility that has had ``three consecutive failures of
accreditation granting cycles.'' Two of these comments also express
concern over the effect of this provision on the timing of the AB's
onsite visit to the facility to provide oversight and hands-on
training.
(Response 8) FDA disagrees with these comments. The Agency believes
that a facility that has failed to become accredited after three
consecutive attempts should not be permitted to become accredited until
it has implemented all necessary corrective actions and any other
necessary changes, such as additional training or personnel changes,
specific to the facility's individual situation (see Sec.
900.4(a)(6)(ii) in this final rule). The Agency believes that the 1-
year waiting period will allow the facility sufficient time to make
these corrections. Regarding the terminology used for these failures,
the Agency notes that the various FDA-approved ABs currently use
different terms, such as ``deficiency'' and ``failure,'' for the
initial failure to become accredited. Therefore, FDA concludes that the
phrasing of the provision, ``If a facility has failed to become
accredited after three consecutive attempts,'' is sufficiently clear
and broad to apply to facilities accredited by any AB. Regarding the AB
onsite visits to facilities, the various ABs currently have different
policies for the timing of their onsite visits, each respectively
approved by FDA. FDA notes that, upon publication of this final rule,
the ABs can review and, if needed, revise their procedures to
accommodate the change in the regulations, including to account for any
procedures to address tracking the number of facility applications
submitted to an AB, and submit their proposed policy changes to FDA for
review and approval.
(Comment 9) Some comments recommend that facilities not be allowed
to switch ABs in order to avoid this 1-year exclusion after three
consecutive failed attempts at accreditation.
(Response 9) FDA agrees with this recommendation. Accordingly, we
are revising Sec. 900.4(a)(6)(ii) to state ``If a facility has failed
to become accredited after three consecutive attempts, no AB shall
accept an application for accreditation from the facility for a period
of 1 year from the date of the most recent accreditation failure.''
(Comment 10) Some comments address the situation of a facility with
more than one mammography unit, of which one unit fails to receive
accreditation but one or more units receive accreditation. These
comments recommend either that the facility be
[[Page 15133]]
permitted to continue to perform mammography with the remaining
accredited unit(s), or that the facility's individual situation be
evaluated by the AB to determine the appropriate course of action.
(Response 10) We appreciate the comment, but note that the
commenter misunderstood the proposed amendment. The provision that was
proposed for revision refers to overall facility accreditation (see
Sec. 900.4(a)(6)(ii) in both the proposed and final rule) as opposed
to individual unit accreditation (see Sec. Sec. 900.4(e) and
900.12(e)). FDA acknowledges that some reasons for the failure of a
facility to receive accreditation, such as a mechanical deficiency in a
mammography unit, may be limited to that particular unit, while other
reasons for failure, such as poor patient positioning, may extend to
the practice of mammography throughout the entire facility. The various
FDA-approved ABs have policies to address the requirements for
accreditation of a facility that has multiple mammography units. The
ABs also have policies regarding the circumstances, including poor
quality noted on accreditation images, which may prompt an AMR to
assess the overall quality of mammography at a facility. FDA believes
that if a facility fails three consecutive attempts to receive
accreditation, it should be subject to a 1-year waiting period to allow
the facility adequate time to address issues that have prevented
accreditation (see also Response 8). FDA anticipates that the ABs may
review their policies and procedures, and if needed, may decide to
submit revised policies and procedures to FDA (see Sec. 900.4(a)(8))
to conform to this provision of the final rule; if the ABs do so, the
Agency will review and consider the ABs' proposals.
(Comment 11) A comment recommends that a facility under its third
provisional certificate have all exams double-read by a qualified IP
from an accredited and certified facility, until the applying facility
either fails or receives accreditation.
(Response 11) FDA disagrees with adding this requirement to the
regulations. Such increased oversight of facilities with provisional
certificates is not appropriate in this circumstance, considering that
there are existing regulations requiring corrective action. Depending
on the specific circumstances of the failure, the applying facility's
AB will either have required the facility to perform corrective action
after the first two failures, or will first have performed an AMR to
determine the extent and severity of the quality problems at the
facility (see Sec. 900.4(a)(1)(i)), and will have required corrective
action (see Sec. Sec. 900.4(a)(1)(ii) and 900.4(b)(3)). Corrective
action is individualized by the AB for the specific facility, but often
includes requirements for additional training for the facility
personnel. Therefore, FDA concludes that the IP and other personnel
will be sufficiently trained to correct the quality problems at the
facility.
(Comment 12) A comment recommends clearer language about the
facility's next steps, corrective action, ``necessary information,''
and the duration of effectiveness of a provisional certificate for a
facility that has had a year-long waiting period after having failed to
become accredited after three consecutive attempts. The same comment
recommends clearer language about FDA's action if a facility fails
accreditation for a third time, and also recommends that a facility be
permanently ineligible to provide mammography services after a fourth
failure.
(Response 12) Regarding improving clarity about the process for
reapplying for accreditation, FDA disagrees with this comment. The
process is subject to the policies and procedures of each AB, and the
Agency notes that the necessary information as well as the steps to
apply for accreditation are clearly specified by each AB's policies and
procedures (see, e.g., Sec. 900.4(e) and (f)). We further note that
the duration of effectiveness of a provisional certificate is already
discussed in current Sec. 900.11(b) and (c). Regarding the commenter's
recommendation that a facility be ineligible to provide mammography
services after a fourth failure, FDA concludes that a facility that has
performed all required corrective action may reapply for accreditation,
but notes that, in accordance with AB policies, an AB may take into
account the facility's entire history and practice of mammography, such
as a lack of improvement after multiple corrective actions, in
considering a decision to suspend or revoke the facility's
accreditation, or to revoke its application for accreditation (see
Sec. 900.4(a) and (b)). Also, the AB must notify FDA if it believes
that a facility's practice of mammography may pose a serious risk to
human health (see Sec. 900.4(a)(2)). Likewise, the Agency may take
into account the facility's entire history in determining that its
practice poses a serious risk to human health and in considering the
suspension or revocation of a facility's certificate (see Sec.
900.14). Therefore, FDA concludes that a facility whose practice
warrants such a determination will be identified, and appropriate
accreditation and/or certificate actions will be taken. Finally, as
noted in Responses 8 and 10, if the ABs review their policies and
procedures in light of this provision of the final rule and decide to
submit revised policies and procedures to FDA (see Sec. 900.4(a)(8)),
the Agency will review and consider those policies and procedures.
D. Retention and Release of Personnel Records
(Comment 13) Several comments were submitted that recommend
specifying the amount of time that a facility must retain personnel
records for employees that are no longer at that facility. Some
comments recommend that facilities only be required to keep the records
for former employees from the time of one inspection to the time of the
next annual inspection. Another comment recommends that facilities only
be required to give employees their records at the time of the
employees' departure. Other comments recommend that facilities be
required to keep personnel records for former employees for 24 months
following the departure of that employee.
(Response 13) FDA agrees that a minimum length of time should be
included in the amendments to the regulations for the personnel records
retention requirement. We note that previous employees may need access
to these personnel records to document their MQSA qualifications to
permit them to provide mammography services at other facilities.
Accordingly, we conclude that former employees should have an
opportunity to obtain their personnel records for a time period beyond
the immediate date of their departure from a facility. After
considering the comments on this requirement, we are revising and
finalizing the provision as follows: ``Records of personnel no longer
employed by the facility must be maintained for no less than 24 months
from the date of the departure of an employee, and these records must
be available for review at the time of any annual inspection occurring
during those 24 months'' (see Sec. 900.12(a)(4) in this final rule).
FDA has made this change to the codified language to clarify that the
records must be available during an inspection that can occur at any
point during the 24 months after which an employee departs, which
better aligns with the records retention requirement and is distinct
from any FDA determination regarding compliance with the MQSA and its
implementing regulations that would
[[Page 15134]]
otherwise occur following the next annual inspection after the employee
departs. FDA is also revising the provision to distinguish and clarify
the requirements for providing such records to current and former
employees, as follows: ``The facility shall provide copies of these
personnel records to current interpreting physicians (IPs), radiologic
technologists, and medical physicists upon their request. Facilities
must provide personnel records to former employees if the former
employees communicate their request within 24 months of the date of
their departure. If it has been greater than 24 months and the facility
has maintained those records, the facility must provide those records
to former employees upon request.''
(Comment 14) Rather than providing records after an employee
leaves, a comment recommends that facilities should require a
qualifications package for each employee that would only be retained
until after the first inspection following the hiring of that employee,
at which point the package should be given to the employee to retain,
and any continuing experience or other information would be accumulated
and maintained from the time that the qualifications package is given
to the employee.
(Response 14) FDA disagrees with this comment. Personnel
qualifications under Sec. 900.12(a) include both initial and
continuing requirements, and both components are reviewed at the time
of inspection (Ref. 18). The personnel record keeping requirements
apply to facilities, not individual personnel (see 42 U.S.C.
263b(d)(1)(A)(ii)(III), (B)(ii)(II), and (g)(1)(C), and Sec.
900.12(a)(4)). Therefore, each facility is required to document the
qualifications of its personnel. Also, FDA is concerned that the
comment's recommended changes would not be as effective as the current
system in maintaining the necessary documentation of qualification of a
facility's personnel.
(Comment 15) A comment recommends that FDA specify a penalty for
facilities that do not adhere to the personnel records requirement.
(Response 15) FDA agrees with this comment. A facility that does
not comply with the personnel records retention requirement (see Sec.
900.12(a)(4) in this final rule) may receive a citation at the time
that this failure is identified at inspection, in a manner similar to
other comparable violations (Ref. 18). The totality and severity of
violations identified at inspection determine the consequences for the
facility.
(Comment 16) A comment recommends that facilities should only need
to provide personnel records to former employees if the employee
submits the request in written format.
(Response 16) FDA disagrees with this recommendation. FDA concludes
that requiring requests from former employees for their personnel
records to be transmitted in writing may be overly burdensome to both
facilities and former employees because it may delay how quickly a
facility would receive the request, and may reduce access to
mammography by delaying how quickly those records could be provided to
facilities evaluating the qualifications of new personnel. FDA believes
that minimizing barriers to the provision of qualification records to
former employees will facilitate the hiring of these personnel at other
facilities, thus preserving patient access to mammography services.
(Comment 17) A comment recommends that facilities give personnel
records to personnel when the facility ceases performing mammography,
and it also asks for clarification as to whether the phrase ``ceases to
perform mammography'' refers to the facility or to specific personnel.
(Response 17) The final rule states that ``Before a facility closes
or ceases to perform mammography services, it must make arrangements
for access by current and former personnel to their MQSA records,'' and
that this may be accomplished by either ``the permanent transfer of
these records to the personnel or the transfer of the records to a
facility or other entity that will provide access to these records for
no less than 24 months from the date of facility closure or cessation
of mammography services'' (see Sec. 900.12(a)(4)). FDA believes that
these two pathways provide adequate access for personnel to their MQSA
records. The primary reason that personnel may require access to their
qualification records is that they are continuing to practice
mammography at other facilities. Therefore, the clause ``Before a
facility closes or ceases to provide mammography services'' (see Sec.
900.12(a)(4) in this final rule) refers to the closure or cessation of
mammography services of a facility and not to the cessation of specific
personnel from practicing mammography.
(Comment 18) A comment requests that FDA provide guidance on how to
demonstrate compliance with the requirement to provide access for
personnel to their MQSA records when a facility closes or ceases
mammography services.
(Response 18) The Agency believes that the current regulations, and
the regulations being revised at Sec. 900.12(a)(4) in this final rule,
are clear on the requirements regarding personnel records for
facilities that close or cease to provide mammography services.
Facilities that close or cease to perform mammography services should
inform their AB, which will assist them in complying with record
retention obligations and other applicable MQSA requirements. (Ref.
19.)
E. Digital Accessories
(Comment 19) Several comments request that FDA provide additional
clarification of the definition of a digital accessory component, or
ask for clarity on whether specific equipment, such as display
monitors, are included in this category.
(Response 19) FDA defines an ``accessory'' of a device as ``A
finished device that is intended to support, supplement, and/or augment
the performance of one or more parent devices'' (Ref. 20). Because a
device accessory is a ``device,'' we believe the broader term
``devices'' is simpler and allows for a clearer understanding of the
mammography regulations. In this final rule, we are revising Sec.
900.12(b)(2)(i) for clarity, to state that ``All devices used in
mammography must have met the applicable FDA premarket authorization
requirements for medical devices of that type and intended use.'' This
applies to devices used in the acquisition, processing, or display of
digital mammographic images. For example, a display device used in the
interpretation of digital mammographic images generally needs to have
510(k) clearance prior to being used in a mammographic facility. Not
all equipment needs clearance or approval; for example, some devices,
such as medical image storage devices, may be exempted from premarket
notification requirements. (It is important to consult the appropriate
classification regulation to determine the premarket authorization
requirements.)
(Comment 20) Several comments recommend changing the effective date
for the digital accessory component requirements from 18 months to 24
months.
(Response 20) FDA disagrees with the recommendation to extend the
effective date to 24 months after publication of this final rule. FDA
considers 18 months to be a reasonable amount of time for facilities to
achieve compliance with this requirement, based on both previous
experience with the 18-month effective date specified in the 1997 MQSA
final rule (62 FR 55852, October
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28, 1997) and the need for timely effectiveness of this rule.
(Comment 21) Other comments recommend that, for QC testing of
digital accessories, in addition to the use of QC procedures in the
manufacturer's manual, the proposed rule should add an option to use
the ACR QC manual.
(Response 21) Alternative requirements for Sec. 900.12 quality
standards are addressed in Sec. 900.18. The current ``ACR Digital
Mammography Quality Control Manual for Full-Field Digital Mammography
Systems and Supplement for Digital Breast Tomosynthesis Mammography
Systems'' has been approved as applicable to any facility as
alternative standard #24 (Ref. 21; see also Sec. 900.18(f)). The use
of approved alternative standards such as the ACR QC manual as they
relate to digital accessories remains acceptable; however, since the
ACR manual may undergo future revisions, and a revision would have to
undergo FDA review to determine whether it is at least as effective in
ensuring quality mammography as the standard it proposes to replace,
the current ACR manual is not specified in the codified section of the
final rule.
(Comment 22) A comment expresses concern that a facility using
displays that are not specific for mammography or for a use that could
include mammography would be in violation. Another comment suggests
that, if a manufacturer QC procedure exists, there is no need for FDA
premarket authorization of displays, and continues that there is no
need for FDA premarket authorization for equipment since there are
alternative standards for QC from the ACR. A comment also asserts that
the process by which FDA clears or approves displays is not
transparent.
(Response 22) These comments tend to confuse two separate
processes: (1) the premarket approval or clearance of a medical device
as described in 21 CFR 807.81 and (2) the MQSA requirements for
mammography facilities under 42 U.S.C. 263b and the implementing
regulations under part 900. Medical devices are subject to FDA's
medical device requirements, which may include premarket authorization.
Mammography equipment must also meet MQSA regulatory requirements that
govern its use in a mammography facility.
FDA premarket authorization of a display intended for use in
interpreting mammography images is a premarket device requirement;
however, after this final rule becomes effective, any applicable
premarket authorization requirements will also be required under the
MQSA quality standards for use of the display for interpreting
mammography images (see Sec. 900.12(b)(2)(i) in this final rule).
Therefore, FDA agrees with the comment that a facility interpreting
mammograms using a display that has not met the applicable FDA
premarket authorization requirements for use in interpreting
mammography images would generally be in violation of the MQSA quality
standards regulations.
The QC tests for a display are another MQSA quality standard
required for use of that display for mammography interpretation (see
Sec. 900.12(e)(6)), but the existence of QC tests for a display is
generally not sufficient to satisfy all FDA premarket regulatory
requirements that may apply to the device. Likewise, the existence of a
QC program for other mammography equipment does not generally satisfy
all the premarket regulatory requirements applicable to that equipment.
Regarding the comment that states there are QC procedures available
from ACR, we also note that facilities that adopt the ACR QC manual for
the QC of their FFDM or DBT system may not limit the use of the manual
to a single piece of equipment or accessory, such as a display, while
following a different QC program (such as the manufacturer's QC manual)
for the mammography unit (Refs. 21 and 22), and we reiterate that the
existence of a QC program does not necessarily reflect that any
applicable FDA premarket authorization requirements are being met.
Regarding the comment on the clarity of FDA premarket review
process for mammography displays, the premarket requirements for
displays that are intended to be used in interpreting mammography
images, among others, are discussed in 21 CFR 892.2050 and FDA's
guidance ``Display Devices for Diagnostic Radiology'' (Ref. 23).
(Comment 23) A comment states that the requirement that mammograms
submitted for interpretation be ``presented in the mammographic
modality'' in which they were originally produced is unclear, and
suggests that mammograms are being read on a device not intended for
mammography. The comment also recommends including a statement to
caution facilities that they should be aware of potential compatibility
issues in their imaging/reading chain.
(Response 23) The requirement that mammograms be presented for
interpretation in the mammographic modality in which they were
originally produced means, for example, that screen-film mammograms
must be presented for interpretation as the original hardcopy films,
and not digitized or scanned. FDA does not agree that this requirement
would reasonably be interpreted to mean that mammograms are being read
on equipment not intended for mammography. FDA notes that all equipment
used for mammography must be specifically designed for mammography (see
Sec. 900.12(b)(2) in this final rule) and that all devices used in
mammography (including displays, as discussed in Responses 19 and 22)
must have met the applicable FDA premarket authorization requirements
for medical devices of that type and intended use (see Sec.
900.12(b)(2)(i) in this final rule). FDA agrees that facilities are
responsible for ensuring that any equipment they use in the
acquisition, processing, interpretation, retention, and retrieval of
mammographic images be compatible, in order to facilitate mammography
practice and to allow compliance with the record retention, transfer,
and release provisions in Sec. 900.12(c)(4) of this final rule. The
Agency does not believe it is necessary to include a cautionary
statement in the final rule, as facilities in the course of their
practice of mammography will readily be able to determine whether their
equipment is interoperable.
F. Facility Identification Information in Mammography Report and Lay
Summary
(Comment 24) A comment requests clarification, in the case of a
facility that is associated with a centralized entity that sends
reports and summaries, as to whether the centralized entity may be the
only name on the report or summary, whether an abbreviated name for the
actual facility is acceptable, and whether an alias (e.g., ``Doing
Business As'' or DBA) is required to appear on the report. The
commenter also requests clarification of the required timeframe for a
facility to report a name change.
(Response 24) FDA distinguishes each mammography facility based on
its physical location (see 42 U.S.C. 263b(a)(3) and Sec.
900.12(c)(1)(ii) in this final rule). Healthcare networks that offer
mammography services at several locations are accredited and certified
as several separate facilities. The name recognized by FDA for a
facility is the name under which the facility is accredited by its AB
(see Sec. 900.11(b)). Therefore, the facility identification
information in the report to the healthcare provider (see Sec.
900.12(c)(1)(ii) in this final rule) and the lay summary sent to the
patient (see Sec. 900.12(c)(2) in this final rule) must be unique to
the actual facility where the
[[Page 15136]]
mammogram was performed, and must include the name under which the
facility is accredited and certified. A change to a facility's name
must be submitted to the facility's AB, and is subsequently conveyed to
FDA by the AB (see Sec. 900.11(b)); therefore, the timeframe for
reporting a name change, as well as the acceptability of an alias or
DBA, are governed by the policies of the AB.
(Comment 25) A comment recommends that FDA specify whether the
report identification information is required for a ``consult report.''
(Response 25) The commenter's reference to a ``consult report'' is
not clear. Typically, a mammogram will be interpreted only once, and
will have only a single report and a single lay summary. In some cases,
a mammogram that has already been interpreted and for which a report
and lay summary have been issued is subsequently presented to another
IP for a repeat interpretation or ``second opinion.'' By referencing
determinations made by an ``outside consultant,'' the commenter may
either be referring to a later IP rendering such an additional opinion
on an examination that has already been interpreted, or may be
referring to an IP who is a contractor to a facility (rather than a
facility employee) rendering the initial or sole interpretation. If the
comment refers to the reinterpretation of a previously interpreted
mammogram, the second (or subsequent) IP must also meet the existing
personnel requirements of Sec. 900.12(a)(1), and must separately
comply with the reporting requirements of Sec. 900.12(c) in this final
rule. To help distinguish them from the original interpretation, we
recommend that a second (or subsequent) report and lay summary be
identified as a second opinion or similar term. If the comment refers
to a report rendered by an IP who is a contractor or consultant to the
facility rather than a facility employee, that IP must also meet all
personnel requirements, and the report and lay summary must meet all
reporting requirements.
(Comment 26) Several comments address the required identification
information in the lay summary. A comment asserts that most facilities
already provide facility identification in the lay summary. Another
comment recommends that the patient name and the facility information
be required in the lay summary. A separate comment recommends that the
summary include separately both the contact information of the facility
or business where a patient can request images and records, and the
actual physical location where the mammography services were provided.
Another comment recommends that FDA not specify the information that is
required ``at a minimum,'' but rather specify all required information,
including the facility telephone number, email address, and
instructions for clear communication.
(Response 26) FDA agrees that there have been situations in which
the facility information in the lay summary was inadequate. FDA
concludes that the expanded requirements in Sec. 900.12(c)(2) of the
final rule will enhance communication between the facility, the
patient, and the referring provider, and lead to improved patient care.
Because, as noted in Response 24, FDA identifies each facility by its
unique location (see Sec. 900.12(a)(1), in both the proposed and final
rule), the location of the facility where the mammogram was performed
must be included in the lay summary. In response to the comment
recommending that a facility's parent company information be included
in the header, FDA does not agree that such additional information
should be required because FDA identifies each facility by its unique
location and not by any affiliation with a network or company. However,
a facility may choose to include additional information about a
healthcare network, affiliated site, or records storage site. In
addition, FDA agrees with the recommendation that the facility
telephone number be included with the lay summary, and notes that Sec.
900.12(c)(2) of both the proposed and final rule include this
requirement. Because in FDA's experience, some facilities do not have
email addresses, and some others communicate through patient portals,
FDA disagrees with the recommendation to require that the lay summary
include an email address or instructions for clear communication
between the patient and the facility. FDA notes that facilities may
choose to include this additional contact information.
(Comment 27) A comment recommends that the lay summary be required
to include the name of the IP, so that patients will know who is
involved with their care, and if dissatisfied, can request a different
IP.
(Response 27) FDA does not believe it is necessary to require the
name of the IP as part of the lay summary. A facility may choose to
include this information, but it is not required. The Agency notes that
the lay summary is prepared after the examination has been interpreted,
so adding the name of the IP to the lay summary will not intervene
early enough for the patient to request a different IP. A patient who
prefers a particular IP would have to discuss such a request with the
facility staff before the mammogram is interpreted. After
interpretation by the IP, FDA notes that the name of the IP is included
in the report to the referring provider, per Sec. 900.12(c)(1)(iii),
and the patient can request the name either from the facility or from
the referring provider.
G. Final and Incomplete Assessments and Lay Summaries
(Comment 28) A comment recommends that FDA clarify the limits of
the required assessment language for each mammographic assessment
category, and recommends that the rule preserve the concept that the
assessment statement is required, while the explanatory language is not
required to be included in the mammography report.
(Response 28) For each assessment category, the required assessment
statement is only the word or phrase in quotation marks (see Sec.
900.12(c)(iv) in this final rule). As in the existing regulations, each
assessment statement, identified in quotation marks, is followed by
explanatory language, which is not in quotation marks; this explanatory
language not in quotation marks is intended to provide an explanation
of the assessment category in order to promote its consistent use, but
it is not part of the assessment statement, and is not required to be
included in the report to the referring healthcare provider nor in the
lay summary to the patient. This format of an assessment statement in
quotation marks followed by explanatory language outside the quotation
marks was also used in the existing regulations, and FDA is not aware
of significant confusion caused by this format. In both the proposed
and final rule, Sec. 900.12(c)(1)(iv)(A) through (G), the explanatory
language is distinguished from the assessment statement by the closing
quotation mark at the end of the assessment. For added clarity, in this
final rule we are revising Sec. 900.12(c)(1)(iv) to add the
parenthetical clarification, ``the assessment statement is only the
word or phrase within the quotation marks.'' We are also revising Sec.
900.12(c)(1)(iv) to replace the colon with a period within the
quotation marks surrounding each assessment statement, to further
clarify the distinction between the required statement and its
explanatory language.
(Comment 29) A comment asserts that the negative and benign
assessment categories are functionally equivalent and recommends
combining them.
(Response 29) FDA disagrees with this comment. Although we
acknowledge
[[Page 15137]]
that in most instances there may be no difference in clinical
management between patients with negative mammograms and those whose
mammograms show benign findings, the Agency notes that IPs often
distinguish between these examinations and identify benign findings if
they are present; therefore, we conclude that the negative and benign
assessment categories should remain separate.
(Comment 30) A comment stated that the new ``Benign'' phrasing
would be confusing to patients if sent to them. Another comment
recommends that the verbiage explaining the term ``Benign'' not be
required to be in the report.
(Response 30) FDA disagrees with the comment that the ``Benign''
phrasing would be confusing to patients. We note that the explanatory
language following the word ``Benign'' in Sec. 900.12(c)(1)(iv)(B) in
this final rule is not part of the assessment statement. It is intended
only to explain the category to IPs and other facility personnel, and
is not required to be included in the report to the referring provider
nor in the lay summary to the patient; therefore, patients are unlikely
to be presented with such phrasing. We further note that even the word
``Benign'' need not be stated to the patient; a patient summary in lay
terms of either a negative or a benign report might say, for example,
``Your mammogram is normal,'' ``Your mammogram shows no sign of
cancer,'' or similar phrasing.
(Comment 31) A comment recommends that, in the parenthetical
statement ``if the interpreting physician is aware of clinical findings
or symptoms, despite the benign assessment, these shall be explained''
(in proposed Sec. 900.12(c)(1)(iv)(B)), the word ``explained'' should
be revised to ``documented.''
(Response 31) FDA agrees in part with the comment. The
parenthetical statement in the explanation of the benign assessment
category is intended to mirror the existing parenthetical statement in
the explanation of the negative assessment category (in Sec.
900.12(c)(1)(iv)(A)), ``if the interpreting physician is aware of
clinical findings or symptoms, despite the negative assessment, these
shall be explained.'' However, FDA agrees with the commenter that the
IP may not always be able to explain the clinical finding or symptom in
a patient with a negative or benign mammogram. Furthermore, the IP may
have clinical information from a patient history form or interview that
is not yet known to the referring healthcare provider, and is therefore
not addressed by the subsequent requirement in proposed Sec.
900.12(c)(1)(vii) that ``All clinical questions raised by the referring
healthcare provider shall be addressed in the report to the extent
possible, even if the assessment is negative or benign.'' FDA believes
that this pertinent clinical information should be documented and, if
possible, explained or otherwise addressed. Therefore, the Agency
concludes that these parenthetical statements should be retained, with
revision as suggested, for the negative assessment category (see Sec.
900.12(c)(1)(iv)(A)) and for the benign assessment category (see Sec.
900.12(c)(1)(iv)(B)). As such, FDA is revising the parenthetical
language in this final rule for the negative and benign categories,
respectively, to state that ``if the interpreting physician is aware of
clinical findings or symptoms, despite the negative assessment, these
shall be documented and addressed,'' and ``if the interpreting
physician is aware of clinical findings or symptoms, despite the benign
assessment, these shall be documented and addressed.''
(Comment 32) A comment requests confirmation that the new
assessment categories are part of the alternative standard approved in
2003. Another comment requests confirmation that the ``FDA-approved''
equivalent wording for assessment categories is still permitted, and
asserts that IPs should have the option to report equivalent language
rather than the assessment statements in the regulations.
(Response 32) The new assessment statement ``Post-Procedure
Mammogram for Marker Placement'' (Sec. 900.12(c)(1)(iv)(G)) is
identical to alternative standard #12 approved by FDA in 2003 (Ref.
24). The new assessment statements ``Incomplete: Need Additional
Imaging Evaluation'' (Sec. 900.12(c)(1)(v)(A)) and ``Incomplete: Need
Prior Mammograms for Comparison'' (Sec. 900.12(c)(1)(v)(B)) are
derived from alternative standard #11 approved by FDA in 2003 (Ref.
25). The statements ``Incomplete: Need Additional Imaging Evaluation''
and ``Incomplete: Need Prior Mammograms for Comparison'' represent the
division of the single assessment statement in alternative standard #11
into two new assessment statements. These statements reflect FDA's
recognition that some mammograms require comparison for interpretation,
while some mammograms require additional imaging to reach a final
interpretation.
The only authorized assessment statements are those in the quality
standards and the approved alternative standards (Refs. 22 and 24; see
also Sec. Sec. 900.12(c)(1)(iv) and 900.18). In addition, as described
in the MQSA Policy Guidance Help System (PGHS), FDA has acknowledged
that some closely worded variations of the approved assessment
statements may generally be acceptable where the particular wording
does not change the meaning of the category (Ref. 26).
(Comment 33) A comment expresses concern that the reporting
requirements, which seemingly would allow for an automated process of
an IP selecting prepared comments that match the assessment categories,
do not include an assessment statement or comment for patients with a
history of breast cancer surgery who are subsequently undergoing
routine screening.
(Response 33) Although FDA places requirements on the wording of
the assessment statement used to describe the assessment category
selected by the IP to promote clarity of communication between the IP
and the referring clinical healthcare provider, we anticipate that the
mammography report may include additional information about the
findings of the examination, before the concluding assessment
statement. FDA agrees that, after an IP examines the images, the IP may
select prepared statements that in the IP's judgment accurately
describe the findings of the examination, and likewise may select the
final assessment from a prepared list of the approved assessment
statements. The Agency anticipates that there will be some mammograms
whose findings necessitate additional nonstandard statements within the
report, but the report must conclude with one of the standard approved
assessment statements listed in Sec. 900.12(c)(1)(iv)(A) through (G).
As applicable to the commenter's example, the patient's history of
cancer and prior surgery, and any relevant post-surgical findings on
the images, may be described in the report, but it must conclude with a
final assessment chosen from the approved statements; for example,
``Benign'' (see Sec. 900.12(c)(1)(iv)(B)) or ``Suspicious'' (see Sec.
900.12(c)(1)(iv)(D)). The Agency does not believe it is necessary to
add a unique assessment statement for patients with the history
described by the commenter, as the statements listed in Sec.
900.12(c)(1)(iv)(A) through (G) are adequate to encompass patients who
have previously had breast cancer and those who have had surgery,
whether for cancer or other reasons.
(Comment 34) A comment mentions the potential limitations of a
mammogram when a patient either cannot cooperate with or cannot
understand instructions, and recommends that FDA add assessment
categories that reflect these limitations,
[[Page 15138]]
including ``Benign with technical limitation'' and ``Normal with
technical limitation.'' Similarly, another comment mentions the
limitation of dense breast tissue and recommends that FDA add an
assessment category for ``Normal but dense.''
(Response 34) FDA agrees that some mammograms have technical
limitations, but concludes that the limitations should be documented
elsewhere in the report, not in the assessment statement. For clarity,
the assessment statement should represent only the IP's final
conclusion about the results of the examination. The limitation of
breast density is addressed elsewhere in this final rule (see Sec.
900.12(c)(1)(vi)(A) through (D)). In particular, the limitations
conferred by dense tissue must be stated elsewhere in the report, using
the language in Sec. 900.12(c)(1)(vi)(C) of the final rule, ``The
breasts are heterogeneously dense, which may obscure small masses,'' or
Sec. 900.12(c)(1)(vi)(D) of the final rule, ``The breasts are
extremely dense, which lowers the sensitivity of mammography.''
(Comment 35) Several comments address the assessment category
``Suspicious,'' which the commenters erroneously refer to as a
numerical category 4. These comments recommend that the use of
alphanumeric subcategories 4a, 4b, and 4c be allowed, be encouraged, or
be considered a legitimate option.
(Response 35) FDA disagrees with the recommendations to permit or
encourage the use of alphanumeric subcategories instead of the
assessment statement ``Suspicious.'' All the required assessment
statements under the MQSA quality standards are words or phrases, not
numbers. Thus, the assessment statements are not identical to the
numerical codes derived from ACR's Breast Imaging--Reporting and Data
System (BI-RADS) (Refs. 26 and 27). BI-RADS is a practice guideline
published by a professional society (the ACR), and is not associated
with the MQSA quality standard requirements. While a numeric or
alphanumeric BI-RADS assessment code in addition to the assessment
statement may be used, one of the overall final assessment of findings
statements as described in Sec. 900.12(c)(1)(iv) of this final rule
must appear in the report.
For example, in BI-RADS, category 4 (Suspicious) offers optional
subcategories a through c, and phrases associated with each letter (4a:
``Low suspicion for malignancy,'' 4b: ``Moderate suspicion for
malignancy,'' and 4c: ``High suspicion for malignancy''), to further
refine the level of suspicion (Ref. 28). However, for any mammogram
that would receive an ACR BI-RADS code of either 4, 4a, 4b, or 4c, the
assessment statement required under the MQSA quality standards is not a
number or a letter, but the word ``Suspicious.'' Additionally, the
phrase associated with each ACR BI-RADS code 4a through 4c is not an
approved alternative standard for use as an assessment statement; while
the final rule does not prohibit such a statement from being included
in the report, the overall final assessment statement, ``Suspicious,''
would be the appropriate statement to include as the final assessment
category of the mammogram (Ref. 29).
(Comment 36) A comment recommends that FDA provide examples of when
referral of a self-referred patient to a healthcare provider is
mammographically indicated.
(Response 36) The proposed Sec. 900.12(c)(2)(ii) stated that
``Each facility that accepts patients who do not have a healthcare
provider shall maintain a system for referring such patients to a
healthcare provider when mammographically or clinically indicated.''
FDA believes that such referral is indicated when the mammographic
findings warrant followup imaging or intervention sooner than at a
routine screening interval. Therefore, for patients who do not have a
healthcare provider and whose mammogram results are either probably
benign, suspicious, or highly suggestive of malignancy, referral to a
provider is generally mammographically indicated. For clarity, FDA is
revising this provision to state, ``Each facility that accepts patients
who do not have a healthcare provider shall maintain a system for
referring such patients to a healthcare provider when clinically
indicated, which shall include when such patients' mammogram assessment
is either probably benign, suspicious, or highly suggestive of
malignancy'' (see Sec. 900.12(c)(2)(ii) in this final rule).
(Comment 37) A comment recommends that the lay summary inform the
patient if risk factors such as density, pain, calcifications,
discharge, and other items are identified on the mammogram.
(Response 37) FDA does not believe it is necessary to require this
information in the lay summary. The facility is required to send the
patient a summary of the mammography report written in lay terms (see
Sec. 900.12(c)(2) in this final rule). This final rule adds breast
density notification language to the lay summary requirement, but it
does not require that the lay summary mention patient symptoms or
individual mammographic findings. FDA does not believe that it is
appropriate to require specific language for the wide range of breast
symptoms and mammographic findings that may be identified. For example,
some of the items mentioned in the comment, such as pain and discharge,
cannot be identified on a mammogram. The regulations require that the
mammography report to the provider address findings, clinical questions
raised by the referring healthcare provider, and recommendations for
additional actions, if any, (see Sec. Sec. 900.12(c)(1)(iv)(A) and (B)
and (vii) in this final rule). Some findings or symptoms may be present
but not clinically significant. The referring healthcare provider, who
receives the mammography report and is also familiar with the patient's
history and physical findings, is best positioned to discuss the case
with the patient.
(Comment 38) Several comments address the proposed final assessment
category ``Post Procedure Mammograms for Marker Placement.'' A comment
asserts that the addition of an assessment category for a post-
procedure mammogram is unnecessary. Another comment asserts that the
post-procedure mammogram is ``bundled into'' the interventional
procedure and does not receive an assessment. A comment requests
clarification on whether a mammogram documenting a biopsy clip or
marker requires documentation.
(Response 38) The assessment statement ``Post Procedure Mammograms
for Marker Placement'' was approved as alternative standard #12 on
September 17, 2003 (Ref. 24), under the mechanism described in current
Sec. 900.18 for the approval of alternatives to the MQSA quality
standards in Sec. 900.12. Since its approval in 2003, it has been
available and acceptable for use as a final assessment statement. In
this final rule, Sec. 900.12(c)(1)(iv)(G), FDA is adding the nearly
identical assessment statement ``Post-Procedure Mammogram for Marker
Placement'' to the implementing regulations. The situations in which
this assessment should be given to any particular mammogram are more
appropriate for the IP to determine in the course of clinical decision-
making. As FDA described in approval of the alternative standard, if a
facility makes the post-procedure examination part of the
interventional procedure instead of a separately charged examination,
then the examination is not subject to the MQSA quality standard
requirement and need not receive an assessment (Ref. 24). Nor would it
require any report separate from the report of the
[[Page 15139]]
interventional procedure. However, when the post-procedure mammogram is
logged or charged separately from the interventional procedure, this
mammogram is a separate examination and requires a separate report.
This ``Post-Procedure'' assessment category is useful to
distinguish examinations that simply document the localization of a
known abnormality or a known marker without contributing new diagnostic
information, so that these examinations are not misconstrued as showing
new or additional abnormalities. The availability of a post-procedure
assessment category also helps maintain the accuracy of the medical
outcomes audit required under Sec. 900.12(f). The audit requires
followup for positive mammograms, defined in existing Sec. 900.2(mm)
as mammograms receiving assessments of either ``Suspicious'' or
``Highly Suggestive of Malignancy,'' but a post-procedure mammogram of
a patient with a previously identified abnormality is not intended to
be counted as a new positive result; this assessment category helps
facilities to distinguish and exclude post-procedure mammograms from
the audit.
(Comment 39) Two comments object to FDA's mention of a
``localization needle'' in the explanation of one potential use for
this ``Post-Procedure Mammogram for Marker Placement'' final
assessment, since spatial localization may not always be performed with
a needle, and recommends revising this explanation to ``localization
device'' or ``localization marker.'' Another comment asserts that a
marker may not always deploy and recommends changing the wording of the
assessment statement to ``Post procedure mammogram.''
(Response 39) FDA agrees that some localization devices are not
needles, and is clarifying our explanation of the assessment category
as follows: this category is primarily used for a mammogram performed
following a biopsy to confirm the deployment and position of a breast
tissue marker. The other use of this final assessment category is for a
mammogram performed to document the position of a localization needle
or other marker. During preoperative localization, a needle or other
temporary marker may be positioned to direct subsequent surgery for a
nonpalpable lesion seen on earlier mammography. The post-procedure
mammogram is performed as a guide to identify the suspicious site for
the surgeon who will biopsy or excise the lesion and remove the needle
or marker.
The post-procedure mammogram is typically performed in an attempt
to localize a device, such as a needle or other tissue marker, or to
determine whether the device has deployed. FDA concludes that this
intention is accurately captured by the phrasing ``Post-Procedure
Mammogram for Marker Placement,'' even in cases in which the mammogram
reveals that a marker failed to deploy. FDA notes that all mammographic
views obtained in a single examination are typically referred to
collectively as a ``mammogram,'' and therefore agrees in part with the
comment that recommends changing the wording of the assessment
statement to the singular ``Post procedure mammogram.'' Accordingly, we
are revising the wording of the assessment statement to the singular
``Post-Procedure Mammogram for Marker Placement'' (see Sec.
900.12(c)(1)(iv)(G) in this final rule), in addition to clarifying the
description as noted.
(Comment 40) One comment asserts that a lay-language summary to the
patient should not be required for a mammogram performed for marker
placement, because the mammogram is performed for localization rather
than for diagnosis, and receiving a lay summary of such an examination
may confuse the patient.
(Response 40) As discussed in Response 38, we have explained that
if a facility makes the post-procedure mammogram a separately logged or
charged examination rather than part of the interventional procedure,
the mammogram is subject to all MQSA quality standard requirements,
including a report to the referring healthcare provider and a summary
of the report in lay language to the patient. The lay summary must be
specific to the examination and report; for example, if the assessment
statement in a report states that an examination was a post-procedure
mammogram for marker placement, then the lay summary of that report
should likewise mention the procedure or the marker placement, but it
would not be appropriate to state that the mammogram results were
abnormal, worrisome, suspicious for cancer, etc. FDA believes that a
lay summary limited to discussing the fact that the mammogram was
performed for localization after a procedure will not confuse a patient
who has just undergone a procedure.
(Comment 41) Several comments recommend that FDA revise the
assessment statement ``Incomplete: Need prior mammograms for
comparison'' (proposed Sec. 900.12(c)(1)(v)(B)) to replace
``mammograms'' with ``breast imaging'' or ``breast examinations,'' to
include other imaging modalities such as breast ultrasound.
(Response 41) FDA disagrees with this recommendation. The Agency
concludes that extending the assessment statement ``Incomplete: Need
prior mammograms for comparison'' to a comparison with other breast
imaging modalities, which may have been performed at multiple different
imaging facilities and centers, could impose delays in obtaining those
prior examinations and issuing the final interpretation of the
mammogram. As addressed in Response 4, the MQSA and FDA's implementing
regulations apply specifically to mammography facilities, so facilities
where a patient's prior mammograms were performed would have retained
those examinations, pursuant to the MQSA record retention requirement
(see Sec. 900.12(c)(4)(i) in this final rule), and would presumably
respond to the patient's request to transfer them or release copies of
their records, pursuant to the MQSA record release requirements (see
Sec. 900.12(c)(4)(ii) and (iii) in this final rule). In contrast,
other imaging centers not subject to the MQSA quality standards are not
required to release prior non-mammography imaging within these
regulatory deadlines. Additionally, other imaging modalities may not
provide the type of information that is directly comparable to the
mammogram.
(Comment 42) A comment requests confirmation that an Incomplete
assessment statement, which the commenter cites as ``Category 0:
Incomplete--need additional imaging evaluation and/or comparison with
prior examination(s),'' remains acceptable. Similarly, another comment
recommends that FDA allow facilities to choose whether to separate the
two Incomplete assessment categories or to keep them grouped together.
(Response 42) The first commenter's citation of the assessment
statement is incorrect on two points. As we noted in Response 35, all
approved assessment statements under the MQSA quality standards are
words or phrases, not numeric or alphanumeric codes, so the numeral
zero is not required as part of the assessment. Also, the Incomplete
assessment statement approved by FDA in 2003 as alternative standard
#11 does not refer to ``prior examinations,'' but to ``prior
mammograms.'' Therefore, the phrasing cited by the first commenter is
not acceptable. However, we note that even after the introduction of
the two Incomplete assessment statements in this final rule,
alternative standard #11 remains in effect, such that the
[[Page 15140]]
combined assessment statement ``Incomplete: Need additional imaging
evaluation and/or prior mammograms for comparison'' may also be used.
Therefore, FDA agrees with the second commenter that a facility may
choose either to use one of the separate Incomplete assessment
statements that appear in this final rule (see Sec. 900.12(c)(1)(v)(A)
and (B)), or to use the combined statement as found in alternative
standard #11, which remains an approved alternative standard.
(Comment 43) A comment recommends that FDA expand and clarify its
justification of the assessment category ``Incomplete: Need prior
mammograms for comparison'' with a more evidence-based justification
addressing the value of the comparison of a mammogram with prior
mammograms. The proposed rule (under section V.E.3 of the Supplemental
Materials) includes the statement, ``Comparison to previous
examinations is sometimes required to make a final assessment.''
However, the comment recommends that FDA instead justify the value of
comparison mammograms by using the statement, ``Evidence shows that
comparison with a single prior exam, and more so with multiple prior
examinations, improves accuracy, including a reduction in the recall
rate and an improvement in sensitivity and predictive value.''
(Response 43) The reference cited by the commenter (Ref. 30)
demonstrates that comparison to two or more prior exams reduces the
recall rate, and increases the cancer detection rate and a positive
predictive value (PPV) known as PPV1. Although comparison to previous
examinations is valuable, FDA does not believe that the recommended
statement is fully supported by the cited reference. However, FDA
agrees with the commenter's broader implication that there are many
benefits to interpreting a mammogram in comparison to one or more of
the patient's previous mammograms, including but not limited to
improved accuracy and reduced recall rate. FDA believes that the final
rule adequately reflects the value of making comparisons to previous
mammograms when available.
(Comment 44) Some comments express concern about the timing of
interpretation of a mammogram following an assessment of ``Incomplete:
Need prior mammograms for comparison.'' A comment asserts that a
patient may not be able to obtain prior mammograms within 30 days, and
another comment asserts that the rule would permit a total of 60 days
from the performance of the examination to the final interpretation,
assuming 30 days to obtain the prior examination and another 30 days to
make the comparison and issue a final report, and that during that time
the patient's insurance or healthcare provider may change. One of the
commenters recommends that FDA impose a total limit of 30 days from the
performance of the examination to the issuance of the final report, and
one recommends that FDA monitor the use and benefit of the new
assessment category.
(Response 44) A facility is required to issue a report to the
referring healthcare provider and a summary in lay terms to the patient
no later than 30 days after the examination (Sec. 900.12(c)(3)(i)),
and to issue a followup report no later than 30 days after issuing an
initial report of ``Incomplete: Need prior mammograms for comparison,''
whether or not comparison views can be obtained (Sec.
900.12(c)(1)(v)(B) in this final rule). However, we note that these 30-
day intervals are maximums, and represent baseline standards. There is
no requirement that a facility wait a full 30 days for a patient to
submit prior images, and likewise no requirement that a facility wait a
full 30 days after receiving a prior comparison examination before
issuing a final report. A facility may establish policies regarding a
shorter interval to wait for prior examinations and a shorter interval
in which to issue a final report after receiving comparison
examinations, perhaps with exceptions for a patient's individual
situation. Therefore, FDA concludes that the reporting deadlines stated
in the regulations as proposed and finalized are adequate. FDA also
notes that although the two ``Incomplete'' assessment statements are
new to the quality standards regulations, they are derived from the
``Incomplete'' assessment statement approved in alternative standard
#11 in 2003 (Ref. 25) and in widespread use since that time. FDA is not
aware of any concerns raised about the benefit of the use of this
assessment category or concerns about the timing of the final report.
The Agency further notes that the report is required to be sent to the
healthcare provider who referred the patient for the mammogram, unless
the patient informs the facility of a new or additional provider (Sec.
900.12(c)(3)).
(Comment 45) A comment expresses opposition to the new assessment
statement ``Incomplete: Need prior mammograms for comparison,''
asserting that this will lead to an increase in the number of
mammograms that either do not receive a final assessment within 30
days, or do not receive one at all.
(Response 45) FDA disagrees with this comment. First, as noted in
Response 44, this assessment statement is derived from one that has
already been eligible for use since 2003 under the approved alternative
standard #11 (Ref. 25). Furthermore, in this final rule, use of the
assessment statement ``Incomplete: Need prior mammograms for
comparison'' in Sec. 900.12(c)(v)(B) also requires that ``a followup
report with an assessment category identified in paragraphs
(c)(1)(iv)(A) through (E) of this section must be issued within 30
calendar days of the initial report whether or not comparison views can
be obtained.'' Thus, the imperative to issue a final assessment for the
examination within 30 days is directly linked to the initial use of
this incomplete assessment category. As noted, since the time that
alternative standard #11 was approved in 2003, FDA has not become aware
of any concerns raised about the timing or issuance of the final
report.
H. Deadlines for Mammography Reports
(Comment 46) A comment recommends that the report to the healthcare
provider and the lay summary to the patient should have the same
deadline of 14 days. A separate comment recommends that screening
mammograms should have a deadline for reports and lay summaries of 30
days from the date of the examination. Another comment recommends that
when prior mammograms are needed for comparison, the report should have
a deadline of 14 days and the lay summary a deadline of 21 days,
respectively, from the receipt of the prior mammogram, not from the
date of the current examination.
(Response 46) FDA disagrees with these comments. The deadline of 30
days from the date of the examination (or from the date of the initial
Incomplete report, if applicable) is a maximum and a baseline standard.
As noted in Response 44, facilities may choose to establish policies of
shorter deadlines for releasing prior examinations and for performing
comparisons to prior examinations. FDA concludes that the deadline
stated in this final rule is adequate. Aside from the specific audit
provisions in Sec. 900.12(f), the MQSA and FDA's implementing
regulations do not distinguish between mammograms whose clinical role
is screening or diagnosis. All examinations must meet the reporting
deadlines, and the commenter's recommendation of a 30-day deadline is
generally consistent with the regulations. FDA concludes
[[Page 15141]]
that the deadline for the report should be linked to the date of the
examination. This is because the receipt of prior comparison
examinations may be unpredictable and inconsistent, and using the date
of receipt of prior examinations as opposed to the date of the current
examination for the reporting deadline could lead to delays in
reporting.
(Comment 47) Several comments note an inconsistency between, on the
one hand, the 30-day deadlines for all mammography reports (Sec.
900.12(c)(3)(i)) and lay summaries (Sec. 900.12(c)(2)), and on the
other hand, the new earlier deadlines for the report of 14 days (in
proposed Sec. 900.12(c)(3)(ii)) and lay summary of 21 days (in
proposed Sec. 900.12(c)(2)) when a mammogram is interpreted as
``Suspicious'' or ``Highly Suggestive of Malignancy.''
(Response 47) FDA agrees with the comments and acknowledges that
these proposed deadlines were inconsistent with respect to deadlines
calculated from the date of the mammographic examination. Accordingly,
in this final rule we are revising Sec. 900.12(c)(2) by deleting the
words ``but in no case later than 21 calendar days from the date of the
mammographic examination,'' and revising Sec. 900.12(c)(3)(ii) by
deleting the words ``but in no case later than 14 calendar days from
the date of the mammographic examination.'' All reports and lay
summaries, regardless of the assessment of the mammogram, must be sent
within 30 calendar days of the examination (see Sec. 900.12(c)(2) and
(3)(ii) in this final rule). However, as noted in Response 46, this 30-
day deadline is a maximum and a baseline standard. In many facilities,
the interpretation and communication of the results is typically
performed much sooner than at 30 days. Accordingly, we consider the
within-30-day timeframe of the mammographic examination to be
appropriate, except in the following circumstances: We require that,
for positive mammograms (defined as mammograms with an assessment
category of either suspicious or highly suggestive of malignancy (see
Sec. 900.2(mm)), the facility send both the report and the lay summary
within 7 calendar days of the final interpretation of the mammogram.
For these situations, the deadline for providing the lay summary is
earlier than the general 30-day deadline from the date of the
mammographic examination for all reports and lay summaries (see
Sec. Sec. 900.12(c)(2) and (c)(3)(ii) in this final rule). As
discussed in the proposed rule (84 FR 11676), FDA believes such action
by the facility is appropriate for these two final assessment
categories because they both indicate findings that warrant further
evaluation.
We have noted an additional inconsistency, regarding the deadlines
for sending a report to a ``self-referred'' patient who has not
identified a referring healthcare provider. A self-referred patient
receives both the lay summary and the mammography report. As discussed
above (in this response), the timeframe for sending the lay summary to
any patient, including a self-referred patient, is within 30 days of
the performance of the examination, and within 7 days of interpretation
if the assessment is ``Suspicious'' or ``Highly Suggestive of
Malignancy'' (see Sec. 900.12(c)(2) in this final rule). The timeframe
for sending the report to the self-referred patient is within 30 days
of the examination (see Sec. 900.12(c)(2)(i) in this final rule), but
the proposed rule did not specify any change in that deadline when the
results are suspicious or highly suggestive of malignancy. We are now
adding the statement ``If the assessment of the mammography report is
``Suspicious'' or ``Highly Suggestive of Malignancy,'' the facility
shall send this report to the patient within 7 calendar days of the
final interpretation of the mammograms'' (see Sec. 900.12(c)(2)(i) in
this final rule). This addition makes the 30-day and 7-day deadlines
consistent for sending the mammography report to either the referring
provider (if a patient identifies a provider) or directly to a patient
who has not identified a provider.
I. Breast Density Notification--General Support for Density
Notification
(Comment 48) FDA received comments that support the proposed
requirements to provide information regarding breast density to both
patients and their healthcare providers, with comments recommending
that FDA finalize the regulations with the two categories of breast
density in patient lay summaries and four categories in reports to
healthcare providers as proposed.
(Response 48) FDA appreciates the public support for the density
notification requirement. FDA believes that receiving consistent
baseline information regarding breast density is important for both
patients and their healthcare providers to make informed shared
decisions, and that the respective requirements for the report and lay
summary strike an appropriate balance between providing sufficient
information to healthcare providers while maintaining a clear message
to patients. Therefore, in this final rule, FDA is requiring that the
breast density notification use two categories of breast density in the
lay summary to patients (see Sec. 900.12(c)(2)(iii) and (iv)) and four
categories in the report to healthcare providers (see Sec.
900.12(c)(1)(vi)(A) through (D)).
(Comment 49) A comment states that the proposed rule creates a
standard that is not backed by medical evidence.
(Response 49) FDA disagrees with this comment. The commenter is
referring to the requirement for breast density notification. Both the
proposed amendments and this final rule do not specify the further
management of patients with dense tissue, only that these patients and
their providers must be notified of their breast density. As discussed
in Response 62, the Agency is revising the notification to patients
with dense breast tissue to reflect 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), which is
supported by many scientific studies demonstrating increased cancer
detection in dense breasts using supplemental imaging modalities (Refs.
10, 11, 31, and 32). This increased detection facilitates earlier
treatment of mammographically occult cancers, and may reduce morbidity
from the tumor and its treatment.
(Comment 50) Several comments recommend that the lay summary should
contain simple, clear language, and several comments recommend that the
density information should be placed at the top of the letter instead
of following the result or assessment statement.
(Response 50) FDA agrees with the recommendation that the lay
summary should contain clear language. In this final rule, both of the
revised notification statements for the lay summary are below the
eighth grade reading level on the Flesch-Kincaid scale. We conclude
that the notification language represents a balance of
understandability and accuracy (see Sec. 900.12(c)(2)(iii) and (iv) in
this final rule). However, the Agency does not agree that it is
necessary to require that the breast density notification statement be
placed in a specific location relative to other mammogram result
information in the lay summary. We incidentally note that the lay
summary is not required to include an assessment category or statement.
Furthermore, given the range of mammogram results and recommendations
that may need to be communicated by a facility to a patient, we
conclude that it may be unduly restrictive to make this a requirement
for facilities, and that it
[[Page 15142]]
may potentially be confusing to patients.
(Comment 51) A comment recommends that an explanation of medical
terms must be included in all lay summaries.
(Response 51) FDA disagrees with the comment. We note that the
language for the lay summary in this final rule excludes medical
terminology that may not be understandable to a wide audience. We do
not believe that it is necessary to require that an additional
explanation of medical terms be included in a lay summary.
(Comment 52) A comment recommends that the lay summary include
additional information about mammography and its limitations.
(Response 52) FDA disagrees with requiring this information in the
lay summary. The language in this final rule for the lay summary
includes the statement that ``Dense tissue makes it harder to find
breast cancer on a mammogram,'' and FDA concludes that this statement
is adequate in addressing the limitations of mammography as they relate
to breast density. As is also stated in the breast density notification
language (see Sec. 900.12(c)(2)(iii) and (iv) in this final rule), FDA
recommends that patients speak to their healthcare provider after
receiving the lay summary, and this discussion can include more
information on mammography and its limitations.
(Comment 53) A comment recommends that FDA work with individuals to
improve the readability and understandability of any proposed language
and describes existing breast density notification language as poor in
understandability and causing confusion and misinformation.
(Response 53) The breast density notification language in this
final rule is the result of discussion between clinicians, patients,
and FDA. Both the notification statement to patients with non-dense
breasts (see Sec. 900.12(c)(2)(iii) in this final rule) and the
notification statement to patients with dense breasts (see Sec.
900.12(c)(2)(iv) in this final rule) are below the eighth grade reading
level on the Flesch-Kincaid scale. We believe that these statements
represent an appropriate balance between patient understandability and
accuracy of the information conveyed. FDA cannot comment on the
understandability of various State breast density notifications;
however, FDA recommends that patients speak to their healthcare
provider about any language that they do not understand.
(Comment 54) A comment recommends that visual aids and medical
cartoons for patients with low literacy should be included, to decrease
health disparities.
(Response 54) FDA acknowledges that patients of limited literacy
may need assistance with the interpretation of the lay summary.
However, FDA does not believe it is necessary to require this
information in the summary. The requirements for the lay summary
represent baseline standards; FDA recognizes that facilities may choose
to provide additional information or explanation they feel is needed by
their patients. The breast density notification language in this final
rule is meant to be concise and clear, and adding visual aids and
medical cartoons into the lay summary may potentially distract from the
primary message regarding a patient's breast density and resulting
recommendations. FDA notes that the interaction between a patient and
their healthcare provider presents an appropriate opportunity to
address questions that a patient may have regarding the lay summary.
The required language in this final rule (Sec. 900.12(c)(2)(iii) and
(iv)) includes such a recommendation to talk to a healthcare provider.
(Comment 55) Several comments recommend that in addition to the
breast density notification, FDA add patient education and a clear plan
of management to the lay summary.
(Response 55) FDA disagrees with the comment. We conclude that the
language in this final rule provides a foundation for patients to be
informed regarding their breast density when using mammography. The
intent of the lay summary being required and provided to the patient is
not to serve as an exhaustive resource regarding breast disease and its
management. The lay summary includes the recommendation for the patient
to talk to their healthcare provider, and we note that this interaction
is an appropriate opportunity for additional patient education.
Regarding the recommendation that the lay summary include a clear plan
of management, FDA notes that the lay summary is generated by the
breast imaging facility, whereas the plan of clinical management for
each individual patient will be developed by the patient and their
healthcare provider, and as such, it is not appropriate for this type
of information to be included in the lay summary.
(Comment 56) A comment recommends replacing the phrase, ``The
breasts are almost entirely fatty,'' in Sec. 900.12(c)(1)(vi)(A), with
the phrase, ``The breast tissue is of low density,'' asserting that the
former statement has ``negative connotations'' to many patients.
(Response 56) FDA disagrees with the comment. FDA notes that this
category, and the others in Sec. 900.12(c)(1)(vi)(A) through (D), are
already in widespread use in breast density reporting. Thus, FDA
believes it would be confusing to replace the ``almost entirely fatty''
category with the ``low density'' sentence recommended by the
commenter, as it would be unclear whether ``low density'' referred to
the breast density category in Sec. 900.12(c)(1)(vi)(A), ``The breasts
are almost entirely fatty,'' or the density category in Sec.
900.12(c)(1)(vi)(B), ``There are scattered areas of fibroglandular
density.'' Additionally, the breast density assessment statement in
Sec. 900.12(c)(1)(vi)(A) is included only in the report intended for
the healthcare provider, and not in the lay summary sent to the
patient, so it will not be sent to patients with a referring provider.
Self-referred patients will receive the lay summary as well as the
report, which should help mitigate any unintended negative connotations
of the report.
(Comment 57) A comment questions the benefit of the density
notification and recommends that FDA should involve more individuals in
the drafting of density notification language, and that this language
should describe the limitations of density assessment, the risks of
overdiagnosis and overtreatment such as gadolinium exposure from MRI
and radiation exposure from additional mammographic evaluation, and the
lack of benefit of density notification. A comment recommends adding
additional language educating patients about breast density, what it
means to a patient, and how patients can take extra steps to protect
themselves.
(Response 57) FDA disagrees with the assertion of lack of benefit
in informing patients and their healthcare providers of a patient's
breast density. FDA considers it to be a benefit to inform patients
about their breast anatomy. In addition, FDA considers it to be a
benefit to inform patients in a consistent manner about their breast
density. The language in the final rule is intended as a baseline for
breast density information, which can be used by patients and their
healthcare providers to help inform and guide patient care. FDA notes
that the provider-patient interaction is an appropriate opportunity for
further discussion of breast density and of the benefits and risks of
possible further evaluation. We conclude that including too wide a
range of information in the lay summary, particularly information that
[[Page 15143]]
may not be supported by a wide consensus in the scientific community or
current information that may be subject to change with future advances
in knowledge and understanding, may unnecessarily increase patient
confusion and lead to reduced effectiveness of the breast density
notification.
(Comment 58) A comment recommends eliminating the recommendation in
Sec. 900.12(c)(2)(iii) for patients with non-dense breast tissue to
talk to their healthcare provider. Another comment recommends that
patients should be directed to additional information on breast
density, not just to their referring physician.
(Response 58) The Agency believes it is important for patients to
have an understanding of their breast density to promote informed and
shared decision making about whether supplemental screening is
appropriate based on each patient's individual circumstances, and
speaking with their healthcare provider is an additional opportunity to
accomplish this. The final rule does not prohibit facilities or
healthcare providers from providing additional information on breast
density to patients; however, FDA concludes that specific additional
resources on breast density should not be codified in the final rule as
a requirement to be provided as part of the lay summary, particularly
since these sources of information may change or become outdated.
(Comment 59) A comment asserts that there are conflicting reports
of the density discussion at the 2011 NMQAAC meeting.
(Response 59) FDA disagrees with the comment. A transcript of the
2011 NMQAAC meeting is available (Ref. 33). The transcript shows there
was general agreement on requiring density notification and advising
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.
[[Page 15144]]
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
[[Page 15145]]
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
[[Page 15146]]
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.
[[Page 15147]]
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
[[Page 15148]]
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
[[Page 15149]]
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.
[[Page 15150]]
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
[[Page 15151]]
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.
[[Page 15152]]
(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
[[Page 15153]]
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.
[[Page 15154]]
(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
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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.
[[Page 15156]]
(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
[[Page 15157]]
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
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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
[[Page 15159]]
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
[[Page 15160]]
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
(see also Response 20). Regarding the recommendation to consult with
equipment manufacturers, FDA notes that, beyond meeting any applicable
FDA premarket authorization requirements for medical devices, the
provisions of this final rule do not necessitate the design or
manufacture of any new equipment by manufacturers. Moreover, all
members of the public, including equipment manufacturers, had an
opportunity to comment on the proposed rule. As such, recognizing that
FD&C Act requirements have been, and continue to be, applicable to
medical devices generally, notwithstanding the provisions in this final
rule, FDA does not believe that specific consultation is warranted.
(Comment 143) Several comments recommend that the breast density
notification requirements become effective earlier than 18 months after
publication of the final rule, including specific recommendations for
alternative timeframes of 30 days or 12 months. Another comment
recommends allowing flexibility in the effective date of the breast
density notification requirements due to the cost of making these
changes.
(Response 143) FDA disagrees with these comments. FDA notes that
breast density notification is an important addition to the final
regulations; however, we also note that facilities should be allowed
adequate time to implement these requirements into their facility
practice before the requirements become effective. In addition, the
breast density notification requirements should not be subject to a
separate scheduled effective date than other requirements in this final
rule. Facilities are not precluded from including the required breast
density notifications prior to 18 months if they choose to do so, and
considering any applicable State requirements. Because of the
importance of establishing a consistent national standard for density
reporting and notification, FDA does not agree that a longer effective
date of this provision is warranted. Although there may be financial
considerations for a facility in transitioning to compliance with the
breast density notification requirements, FDA has concluded that 18
months is an adequate amount of time to make any necessary changes.
Z. Miscellaneous Comments
(Comment 144) A comment recommends that FDA and the ACR focus on
increasing the consistency and quality of MQSA inspections by
inspectors.
(Response 144) The ACR and other accreditation bodies are only
involved in facility accreditation, not certification or inspection.
Inspection is part of the process of certification, not accreditation.
FDA trains all MQSA inspectors, both FDA employees and those who are
State employees that perform MQSA inspections under State contracts
with the Agency. FDA sends updated information to all inspectors
whenever necessary. Furthermore, other FDA staff including Radiological
Health representatives and auditors oversee and provide inspectional
guidance to inspectors. The Agency concludes that these existing
measures already promote consistency and quality in the MQSA inspection
process.
(Comment 145) A comment recommends that FDA become the sole AB, and
hire some of the staff currently employed by the ACR AB.
(Response 145) FDA disagrees with this comment. The MQSA and the
implementing regulations distinguish between the separate
responsibilities of the ABs and the certification agencies, which
include FDA and the SCAs (see 42 U.S.C. 263b(e) and (q); part 900,
subparts A and C). The ACR is one of several FDA-approved ABs. FDA (or
an SCA) certifies facilities, after they have satisfied all necessary
prerequisites, including accreditation by an AB.
(Comment 146) A comment recommends that FDA analyze how to improve
the quality of care for women through using technology to improve the
quality of mammograms and the accuracy of interpretation, and
recommends that random samples of mammograms from all facilities be
sent to FDA radiologists for review.
(Response 146) FDA disagrees with this comment. The ABs already
initially and continually assess mammographic image quality at
facilities they accredit, and are required to inform FDA of equipment
or practices that may pose a serious risk to human health (see Sec.
900.4(a)). At this time, FDA believes that the regulations afford FDA
adequate opportunities to investigate any such occurrences and take
action as necessary (see part 900, subpart B). The AB's
responsibilities include not only reviews of the initial and renewal
accreditation images, but also random image reviews of a sample of
facilities accredited by the AB. The interpretation of a mammogram is a
decision made by IPs, but we note that many of the MQSA regulatory
requirements, including the initial and continuing qualifications for
IPs and the annual medical outcomes audit, promote quality mammography
practice by IPs.
(Comment 147) A comment recommends that an independent commission
review the relationship between the ACR and FDA for conflict of
interest.
(Response 147) FDA disagrees with this comment. The relationship
between FDA and each of the ABs, including the ACR, is regulated by the
MQSA and the implementing regulations and meets all applicable Federal
ethics requirements (see, e.g., 18 U.S.C. 201, et seq.).
(Comment 148) A comment asserts that improving mammography
outcomes, such as lower rates of recalls and biopsies, could justify
different clinical protocols, such as a younger screening age and
shorter screening interval than are currently supported by the USPSTF.
(Response 148) This comment is beyond the scope of this rulemaking.
This final rule requires that each facility include recall rate and
certain other metrics in the audit of its mammography medical outcomes
(see Sec. 900.12(f)(1)(i) through (iii) in this final rule), but the
MQSA quality standards do not specify benchmark or target values for
these metrics. This rule requires that facilities compile this
information and review it internally, to encourage their own quality
improvement. However, decisions on which clinical practice guidelines,
if any, to follow for such things as the
[[Page 15161]]
recommended age range or time interval for breast cancer screening with
mammography are more appropriately for the healthcare provider to make.
(Comment 149) A comment recommends that FDA propose special
amendments to address ``cystic fibroid breast disease,'' because the
commenter states that with this condition, her mammograms are more
painful and are limited by the associated breast tissue density.
(Response 149) The commenter is likely describing fibrocystic
change, one of many conditions that may contribute to dense breast
tissue. FDA disagrees with the recommendation to propose unique
amendments to address a specific clinical condition apart from the
requirements at Sec. Sec. 900.12(c)(1)(vi)(A) through (D) and
900.12(c)(2)(iii) and (iv) in this final rule, which, as discussed in
other responses throughout this final rule, are necessary to address
the limitations of mammography in the presence of dense breast tissue
caused by any etiology.
(Comment 150) One commenter cites a news article that discusses a
research study showing that breast cancer screening increases the
detection of early-stage cancers rather than late-stage cancers.
(Response 150) The intent of the MQSA is to ensure that the
practice of mammography, across the country and whenever it is
recommended by clinicians, meets consistent baseline quality standards.
Decisions about whether to follow any recommendations or guidelines
regarding patient age or interval for screening mammography are
decisions more appropriate for the patient's clinical healthcare
provider to make.
(Comment 151) One comment states only ``Should be standard of care
for all women.''
(Response 151) The subject of the comment is not clear. FDA notes
that the MQSA requirements apply consistently to all facilities that
provide mammography services. Thus, every person who undergoes
mammography at a certified facility in the United States can be assured
that baseline national quality standards apply. However, decisions on
whether to follow clinical practice guidelines, including
recommendations for screening mammography at a certain age and/or a
certain time interval, and any other clinical standards of care, are
more appropriately made in the course of clinical decision-making by
the provider and the patient.
(Comment 152) A comment recommends that image quality must be held
to the highest possible standard.
(Response 152) FDA believes the amended regulations will continue
to ensure appropriate national standards for quality mammography
services. We note that provisions of the MQSA and its implementing
regulations, including many that are not amended in this final rule,
already address image quality. These include: the role of the ABs in
clinical image review and phantom image review (Sec. 900.4), the eight
image quality attributes that must be included in AB clinical image
reviews (Sec. 900.4(c)(2)(i) through (viii)), personnel qualifications
(Sec. 900.12(a)), equipment requirements (Sec. 900.12(b)), quality
assurance requirements (Sec. 900.12(d) through (f)), and the general
requirement that clinical images must continue to comply with the image
quality standards of the facility's AB (Sec. 900.12(i)). We further
note that some of these requirements related to the facility's
responsibility to maintain clinical image quality were highlighted by
the introduction in 2017 of FDA's Enhancing Quality Using the
Inspection Program (EQUIP) initiative (Ref. 52).
(Comment 153) A comment recommends that FDA should spend $2.5
million per year for 10 years for public service announcements,
advertisements, and a website.
(Response 153) FDA disagrees with the comment. General patient
outreach and education is not within the scope of this final
rulemaking. The MQSA program certifies mammography facilities and is
funded largely by the user fees paid by those certified facilities.
However, we note that the MQSA program maintains a public website (Ref.
65), and also occasionally uses email and social media to disseminate
important information about the MQSA program. FDA also notes that the
HHS Office of Women's Health, and the FDA Office of Women's Health are
each committed to advancing issues regarding women's health and to
providing health education materials through outreach activities and
collaborative partnerships. Among other things, these offices use
resources to maintain the programs and publish resources regarding
cancer, mammography, and other relevant health issues.
(Comment 154) A comment recommends that FDA should grant $500,000
per year for 10 years to DenseBreast-Info for webinars and its website.
(Response 154) FDA disagrees with the comment. As noted in Response
153, general patient education and outreach are not within the scope of
this rulemaking. Similarly, individual grant-making activities are also
outside the scope of this rulemaking.
(Comment 155) A comment recommends that FDA name this rule in
memory of an advocate for breast density notification.
(Response 155) FDA appreciates the comment. We acknowledge the
important work done by advocates for breast density notification in
educating the public about the significance of breast tissue density.
However, we disagree with the recommendation to name this rule after
any one individual. The title of the rule is based on the specific
regulations being amended, but the rule is not ``named.''
(Comment 156) A comment asserts that the ``FDA device pathway'' is
very different from, and much slower than, the Center for Drug
Evaluation and Research Fast Track program for drug approval.
(Response 156) FDA acknowledges the comment, but notes that the
pathways for premarket review of medical devices as they relate to
those of drugs are outside the scope of this rulemaking. The MQSA is
found under the Public Health Service Act in Title 42 of the U.S.C.,
and it is implemented by DMQS in FDA's CDRH. The authority for FDA's
regulation of drugs and medical devices is found under the FD&C Act in
Title 21 of the CFR.
VI. Effective Date and Compliance Date
This rule is effective 18 months after the date of publication in
the Federal Register. Mammography facilities will need to be in
compliance with the amended MQSA regulations in this final rule by
September 10, 2024.
VII. Economic Analysis of Impacts
A. Introduction
We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity).
The Office of Information and Regulatory Affairs has determined that
this final rule is a significant regulatory action as defined by
Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant
[[Page 15162]]
impact of a rule on small entities. Because many facilities that will
be affected by this rule are defined as small businesses, we find that
the final rule will have a significant economic impact on a substantial
number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $165
million, using the most current (2021) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in an
expenditure in any year that meets or exceeds this amount.
B. Summary and Accounting Statement
The final rule will modernize mammography regulations by
incorporating current science and mammography best practices to improve
the delivery of mammography services. These updates include
requirements on recordkeeping, reporting, and communication of results.
This final rule also addresses procedural requirements in several areas
related to quality control and management of mammography facilities.
The benefits and costs associated with this final rule are
summarized in table 1. The quantified benefits are derived from reduced
mortality and breast cancer treatment costs resulting from the breast
density reporting requirements. We use two methods of measuring the
value of reduced mortality: the value per statistical life (VSL)
approach and an approach based on the value of lost life years (LY).
Under the VSL approach, the estimate of annualized benefits over 10
years ranges from $42.00 million to $232.69 million at a 7 percent
discount rate. Using a 3 percent discount rate, the annualized benefits
range from $48.42 million to $266.09 million. Under the LY approach,
the estimate of annualized benefits over 10 years ranges from $12.99
million to $66.90 million at a 7 percent discount rate. Using a 3
percent discount rate, the annualized benefits range from $8.50 million
to $37.96 million. Because there is uncertainty in the literature about
the most appropriate method for analyzing reduced mortality for the
population affected by this final rule, we do not present a primary
value and use estimates from both methods to create the range of values
in table 1. The high estimate in table 1 is based on the VSL approach,
which yields the higher-bound estimate of the two methods. The low
estimate is based on the LY approach, which yields the lower-bound
estimate of the two methods. Other benefits that we are not able to
quantify include reduced cancer morbidity and improvements in the
accuracy of mammography by improving quality control and strengthening
the medical audit.
The costs of the final rule include costs to mammography facilities
to comply with the requirements of the regulation and costs associated
with supplemental testing and biopsies resulting from the breast
density requirements. The estimate of annualized costs over 10 years
range from $28.87 million to $45.42 million at a 7 percent discount
rate with a primary value of $36.31 million. Using a 3 percent discount
rate, the annualized costs range from $27.61 million to $44.16 million
with a primary value of $35.05 million.
Table 1--Summary of Benefits and Costs in Millions 2020 Dollars Over a 10-Year Time Horizon
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
---------------------------------------
Category Primary Low High Discount Period Notes
estimate estimate estimate Year rate covered
dollars (percent) (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized $/year............ ........... $12.99 $232.69 2020 7 10 .............................
8.50 266.09 2020 3 10
Annualized Quantified.................. ........... ........... ........... ........... 7 ........... .............................
3
---------------------------------------
Qualitative............................ Improvements in the accuracy of ........... ........... ........... .............................
mammography and better management of
mammography facilities.
---------------------------------------
Costs:
Annualized Monetized $/year............ 36.31 28.87 45.42 2020 7 10 .............................
35.05 27.61 44.16 2020 3 10
Annualized Quantified.................. ........... ........... ........... ........... 7 ........... .............................
3
Qualitative............................ ........... ........... ........... ........... ........... ........... .............................
Transfers:
Federal Annualized Monetized $/year.... ........... ........... ........... ........... 7 ........... .............................
3
------------------------------------------------------------------------------
From/To................................ From:
To: ...........
------------------------------------------------------------------------------
Other Annualized Monetized $/year...... ........... ........... ........... ........... 7 ........... .............................
3
------------------------------------------------------------------------------
From/To................................ From:
To: ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government:..................................................................................................................
Small Business: Annual cost per affected small entity estimated as $416-$727, which would represent a maximum of 1.2 percent of annual receipts.....
[[Page 15163]]
Wages:..............................................................................................................................................
Growth:.............................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. The full analysis of economic
impacts is available in the docket for this final rule (Ref. 63) and at
https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
VIII. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
IX. Paperwork Reduction Act of 1995
This final rule contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The title,
description, and respondent description of the information collection
provisions are shown in the following paragraphs with an estimate of
the annual third-party disclosure burden. Included in the estimate is
the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
Title: Mammography Facilities, Standards, and Lay Summaries for
Patients; OMB Control Number 0910-0309.
Description: FDA is amending its mammography reporting requirements
to require that the mammography report provided to the healthcare
provider and the lay summary provided to the patient include basic
mammography facility identification information and information
concerning patient breast density. This action is intended to
facilitate communication among mammography facilities, healthcare
providers, and patients; facilitate the retrieval of mammography
images; and help ensure that healthcare providers and patients obtain
the necessary information from the mammography facility to enable a
patient and their healthcare provider to make informed healthcare
decisions. FDA also is including categories be added to the list of
assessments that facilities are required to use in the mammography
report. In addition, FDA is amending its requirements related to the
transfer and provision of mammography records, the transfer and
provision of personnel records upon request or facility closure, and
FDA notification and mammographic records access upon facility closure.
Description of Respondents: Respondents to this information
collection are facilities that perform mammographic examinations and
State certification agencies. As of July, 1, 2022, FDA internal data on
facilities showed that there were 8,781 facilities certified to perform
mammography (Ref. 65).
FDA estimates the burden of this collection of information as
follows:
Table 2--Estimated Annual Recordkeeping Burden \1\
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Total operating
Activity; 21 CFR section Number of Number of records Total annual Average burden Total hours Total capital and maintenance
recordkeepers per recordkeeper records per recordkeeping costs costs
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Mammography medical outcomes audit--900.12(f)................... 8,781 1 8,781 16 140,496 $2,496,452 $5,807,650
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Total operating
Activity; 21 CFR section Number of disclosures per Total annual Average burden per Total hours Total capital and maintenance
respondents respondent disclosures disclosure costs costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Provision of personnel 615 1 615 0.08 (5 minutes).... 49 .............. $55,682
records to IPs--
900.12(a)(4).
Transfer of personnel 88 1 88 5................... 440 .............. .................
records by closing
facilities--900.12(a)(4).
New assessment categories 8,781 1 8,781 23.................. 201,963 $37,166,396 .................
and breast density
reporting in mammography
report (one-time burden)--
900.12(c)(1)(iv) to (vi).
Breast density reporting in 8,781 1 8,781 11.................. 96,591 6,844,077 .................
lay summary (one-time
burden)--900.12(c)(2).
Transfer/provision of copies 8,781 1,135 9,966,435 0.08 (5 minutes).... 797,315 .............. .................
of mammograms and records
upon patient's request--
900.12(c)(4)(ii) and (iii).
Facility closure; 88 1 88 32.................. 2,816 .............. 55,682
notification and records
access--900.12(c)(4)(v).
[[Page 15164]]
Patient notification of 5 1 5 100................. 500 .............. .................
significant risk (by State
certification agency)--
900.12(j)(2).
---------------------------------------------------------------------------------------------------------------------------
Total................... .............. ................. .............. .................... 1,099,674 44,010,473 111,364
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Numbers have been rounded.
Personnel records--Sec. 900.12(a)(4): Under Sec. 900.12(a)(4),
facilities are required to maintain records of training and experience
regarding personnel who work or have worked at the facility as IPs,
radiologic technologists, or medical physicists. Facilities must
maintain records of personnel no longer employed by the facility for no
less than 24 months from the date of the departure of an employee, and
these records must be available for review at the time of any annual
inspection occurring during those 24 months.
Also, under Sec. 900.12(a)(4), facilities shall provide copies of
personnel records to current or former interpreting personnel
(physician, radiological technologist and medical physicist) upon their
request. We estimate that there are, on average, seven interpreting
personnel per facility (approximately 61,467 total). We estimate that 1
percent of these personnel (615 personnel annually) will request the
records and that it will take approximately 5 minutes to provide the
copies for each request.
Additionally, under Sec. 900.12(a)(4), facilities must provide
personnel records to former employees if the former employees
communicate their request within 24 months of the date of their
departure. If it has been greater than 24 months and the facility has
maintained those records, the facility must provide those records to
former employees upon request.
Finally, under Sec. 900.12(a)(4), before a facility closes or
ceases to provide mammography services, it will have to make
arrangements for personnel to access their MQSA personnel records. This
access may be provided by the permanent transfer of these records to
the personnel or the transfer of the records to a facility or other
entity that will provide access to these records. We estimate that
annually 1 percent of the total facilities will close or cease to
provide mammography services and that it will take each of the
facilities approximately 5 hours to transfer the records.
Medical records and mammography reports--Sec. 900.12(c)(1) through
(4): Section 900.12(c)(1), Contents and terminology, sets forth the
requirement for facilities to prepare a written report of the results
of each mammographic examination performed under its certificate.
Section 900.12(c)(1) requires that the report include patient
identifying information, date of examination, facility name and
location, the final assessment of findings (or classification as to why
no final assessment can be made), name of the IP, and recommendations
to the healthcare provider.
This final rule includes two additional final assessment categories
and an additional classification in the mammography report and also
requires an assessment of breast density in the report (Sec.
900.12(c)(1)(iv) through (vi)). We estimate a one-time burden for
facilities to update their existing mammography reports with these new
categories. Based on the Eastern Research Group (ERG), Inc.'s report,
we believe this will take 23 hours per facility (Refs. 66 and 67).
Under the final rule, if the final assessment is ``Suspicious'' or
``Highly Suggestive of Malignancy,'' the facility must provide the
report to the healthcare provider, or if the referring healthcare
provider is unavailable, to a responsible designee (Sec.
900.12(c)(3)(ii)) within a specified timeframe. The provision of the
report to the healthcare provider was not included in the currently
approved information collection burden, OMB control number 0910-0309,
because it was considered usual and customary practice and was part of
the standard of care prior to the implementation of the regulations
(see 5 CFR 1320.3(b)(2)). Provision of the mammography report to
healthcare providers continues to be part of the standard of care and
remains the usual and customary business practice.
Under Sec. 900.12(c)(2), Communication of mammography results to
the patients, within 30 days of the mammographic examination, each
facility shall provide each patient a summary of the mammography report
written in lay terms. If the final assessment is ``Suspicious'' or
``Highly Suggestive of Malignancy,'' the facility shall provide the
patient a summary of the mammography report within a specified
timeframe (Sec. 900.12(c)(2)). The summary shall include the name of
the patient and name, address, and telephone number of the facility.
The requirements for the lay summary to include this information do not
result in a change to the currently approved information collection
burden for Sec. 900.12(c)(2).
Section 900.12(c)(2) also requires facilities to provide an
assessment of breast density (as described in Sec. 900.12(c)(2)(iii)
to (iv)) in the lay summary. We estimate a one-time burden for
facilities to update their existing lay summaries with the breast
density assessments. Based on the ERG report, we believe this will take
11 hours per facility (Refs. 65 and 66).
Also, under Sec. 900.12(c)(2)(ii), each facility that accepts
patients who do not have a healthcare provider shall maintain a system
for referring such patients to a healthcare provider when clinically
indicated.
The requirements in Sec. 900.12(c)(2)(iii) and (iv) to provide an
explanation of the breast density assessment identified in Sec.
900.12(c)(1)(vi) are not considered to be ``collections of
information'' because the language is originally supplied by the
Federal government for the purpose of disclosure to members of the
public (5 CFR 1320.3(c)(2)).
Under Sec. 900.12(c)(4)(i), facilities that perform mammograms
must maintain mammographic records. The rule requires that facilities
implement policies and procedures to minimize the possibility of record
loss and requires that records be maintained in the modality in which
they were produced.
Under Sec. 900.12(c)(4)(ii), facilities shall, upon request by or
on behalf of the patient, transfer or release the 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. Under
Sec. 900.12(c)(4)(ii) and (iii), facilities must transfer original
mammograms (and copies of associated reports) or provide copies of
mammograms (and copies of associated reports) within a specified period
of time. Copies of mammograms must be in the same modality in which
they
[[Page 15165]]
were produced. Moreover, for digital mammograms or digital breast
tomosynthesis, the facility must be able to provide the recipient with
original digital images electronically if the examination is being
transferred for final interpretation. We estimate that approximately
one third of patients will request transfer or release of the records
and it will take approximately 5 minutes per request. To calculate the
estimated number of requests, we use the estimated number of screening
mammograms (29,890,141) (Ref. 62) divided by 3. This results in
approximately 9,963,380 requests, or an average of 1,135 requests per
facility.
Under Sec. 900.12(c)(4)(v), before a facility closes or ceases to
provide mammography services, it must make arrangements for access by
patients and healthcare providers to their mammographic records.
Additionally, the facility must notify its accreditation body and
certification agency in writing of the arrangements it has made and
must make reasonable efforts to notify all affected patients. 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. We estimate that 1 percent of facilities per year will close
and that it will take each facility approximately 32 hours to provide
notification and access to the records.
Quality assurance-mammography medical outcomes audit--Sec.
900.12(f): Section 900.12(f)(1) requires each facility to establish a
system to collect and review outcome data for all mammographic
examinations performed, including followup on the disposition of all
positive mammograms and correlation of pathology results with the IP's
mammography report. The rule clarifies that positive predictive value,
cancer detection rate, and recall rate must be collected during this
audit.
Additional mammography review and patient and referring provider
notification--Sec. 900.12(j): Under Sec. 900.12(j)(1), if FDA or the
State certification agency believes that mammographic quality at a
facility has been compromised and may present a significant risk to
human health, the facility must provide clinical images and other
relevant information for review by the accreditation body or the State
certification agency.
Under Sec. 900.12(j)(2), when FDA has determined that the quality
of mammography performed by the facility poses a significant risk to
human health, a facility may be required to notify all patients who
received mammograms at the facility or those patients who are
determined to be at risk due to the quality of their mammography, and
their referring physicians or healthcare providers, of the deficiencies
and resulting potential harm, appropriate remedial measures, and other
relevant information. Also under the rule, State certification agencies
(along with FDA) may notify patients and their providers if a facility
is unable or unwilling to do so.
We received several comments related to the proposed rule.
Descriptions of the comments and our responses are provided in section
V of this final rule, Comments to the Proposed Rule and FDA's Response.
Comments and responses related to the provisions that underlie the
information collection are described in the following sections: V.A,
regarding general comments; V.D, regarding retention and release of
personnel records; V.E, regarding digital accessories; V.F, regarding
facility identification information in mammography report and lay
summary; V.G, regarding final and incomplete assessments and lay
summaries; V.H, regarding deadlines for mammography reports; V.I,
regarding breast density notification--general support for density
notification; V.J, regarding breast density notification language; V.K,
regarding breast density notification and the role of the referring
healthcare provider; V.L, regarding format for image interpretation,
retention, transfer, and release of copies; V.M, regarding deadlines
for image transfer and the release of copies; V.N, regarding facility
closure and mammography record retention; V.O, regarding mammography
medical outcomes audit; V.P, regarding patient and referring provider
notification; V.Q, regarding revocation of certification; V.X,
regarding federalism and the relationship between Federal and State
breast density reporting requirements; and V.Y, regarding timeframe for
implementation of this rule. We have not made changes to the estimated
burden as a result of the comments.
The information collection provisions in this final rule have been
submitted to OMB for review as required by section 3507(d) of the
Paperwork Reduction Act of 1995.
Before the effective date of this final rule, FDA will publish a
notice in the Federal Register announcing OMB's decision to approve,
modify, or disapprove the information collection provisions in this
final rule. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.
X. Federalism
The MQSA established minimum national quality standards for
mammography. The MQSA replaced a patchwork of Federal, State, and
private standards with uniform Federal standards designed to ensure
that all patients nationwide receive adequate quality mammography
services. FDA has worked very closely with State officials in
developing the national standards for the MQSA program and has sought
and obtained input from States at every step of the process.
FDA issued final rules implementing the MQSA on October 28, 1997
(``Quality Mammography Standards,'' 62 FR 55852) and February 6, 2002
(``State Certification of Mammography Facilities,'' 67 FR 5446). As
required by Executive Order 13132 (August 4, 1999), FDA prepared a
federalism assessment in this latter final rule and determined that the
rule was consistent with the federalism principles expressed in
Executive Order 13132 (Ref. 64).
This final rule amends, among other things, the requirements in the
MQSA for reporting to healthcare providers and patients to ensure that
patients receive all necessary information after their mammograms,
including an assessment of breast density, while not unduly burdening
the mammography facility.
Although certain provisions impact Federal-State relations, FDA
does not believe that they impose any additional, significant burden on
the States. The division of responsibilities between FDA, the States,
and State agencies will not change as the regulations will continue to
provide for necessary uniformity of minimum national standards and, at
the same time, provide maximum flexibility to states administering the
States as Certifier program within their State, and State agencies
serving as accreditation bodies.
On November 4, 2011, FDA convened a public meeting of the NMQAAC
where possible amendments to the MQSA regulations, including breast
density reporting, were discussed (Ref. 33). This meeting was open to
the public, and time was allotted for public statements on issues of
concern in the mammography field. FDA has also met and held
teleconferences several times a year with its approved accreditation
bodies and State certification agencies to discuss issues of mutual
concern.
The Agency also has long enjoyed a good relationship with the
Conference of Radiation Control Program Directors,
[[Page 15166]]
Inc. (CRCPD), which is the professional organization of the State
agencies concerned with radiation protection. The CRCPD has established
a standing Mammography Committee, which meets with FDA mammography
staff at least once a year.
For the reasons discussed previously, FDA believes that this final
rule is consistent with the federalism principles expressed in
Executive Order 13132.
XI. Consultation and Coordination With Indian Tribal Governments
We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that have substantial direct effects on one or
more Indian Tribes, on the relationship between the Federal Government
and Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes. Accordingly, we
conclude that the rule does not contain policies that have tribal
implications as defined in the Executive Order and, consequently, a
tribal summary impact statement is not required.
XII. References
The following references marked with an asterisk (*) are on display
in the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they are also available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.
* 1. CDC, ``Breast Cancer Statistics.'' Available at https://www.cdc.gov/cancer/breast/statistics.
* 2. National Institutes of Health, National Cancer Institute,
``Surveillance, Epidemiology, and End Results Program.'' Available
at https://seer.cancer.gov/statfacts/html/breast.html.
* 3. CDC, ``Male Breast Cancer Incidence and Mortality, United
States--2013-2017,'' U.S. Cancer Statistics Data Briefs, No. 19,
October 2020. Available at https://www.cdc.gov/cancer/uscs/about/data-briefs/no19-male-breast-cancer-incidence-mortality-UnitedStates-2013-2017.htm.
* 4. CDC, ``United States Cancer Statistics: Data Visualizations.''
Available at https://gis.cdc.gov/Cancer/USCS/DataViz.html.
5. Michaelson, J.S., M. Silverstein, J. Wyatt, et al., ``Predicting
the Survival of Patients with Breast Carcinoma Using Tumor Size,''
Cancer, 2002; 95(4): 713-723.
6. ACS, ``Can Breast Cancer Be Found Early?'' Available at https://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-detection.
* 7. Government Accountability Office, ``GAO-06-724 Mammography:
Current Nationwide Capacity Is Adequate, but Access Problems May
Exist in Certain Locations (July 2006).'' Available at https://www.gao.gov/new.items/d06724.pdf.
8. DenseBreast Info website. Legislative Information. Available at
https://densebreast-info.org/legislation.aspx.
9. Kolb, T.M., J. Lichy, J.H. Newhouse, ``Comparison of the
Performance of Screening Mammography, Physical Examination, and
Breast U.S. and Evaluation of Factors that Influence Them: an
Analysis of 27,825 Patient Evaluations,'' Radiology 2002; 225: 165-
175.
10. Leconte, I., et al., ``Mammography and Subsequent Whole-Breast
Sonography of Nonpalpable Breast Cancers: The Importance of
Radiologic Breast Density,'' American Journal of Radiology 2003;
180: 1675-1679.
11. Berg, W. et al., ``Combined Screening with Ultrasound and
Mammography vs. Mammography Alone in Women at Elevated Risk of
Breast Cancer,'' Journal of the American Medical Association, 2008;
299(18); 2151-2163. Available at https://jamanetwork.com/journals/jama/fullarticle/181896.
12. McCormack, V.A. and I. dos Santos Silva, ``Breast Density and
Parenchymal Patterns as Markers of Breast Cancer Risk: A Meta-
Analysis,'' Cancer Epidemiol Biomarkers and Prevention. 2006; 15:
1159-1169.
13. Boyd, N.F., H. Guo, L.J. Martin, et al., ``Mammographic Density
and the Risk and Detection of Breast Cancer,'' New England Journal
of Medicine. 2007; 356: 227-236.
14. Vachon C., C. van Gils, T. Sellers, et al., ``Mammographic
Density, Breast Cancer Risk and Risk Prediction,'' Breast Cancer
Research. 2007; 9: 217.
* 15. Centers for Disease Control and Prevention, ``What are the
Risk Factors for Breast Cancer? '' Available at https://www.cdc.gov/cancer/breast/basic_info/risk_factors.htm.
16. Chiu, S.Y., et al., ``Effect of Baseline Breast Density on
Breast Cancer Incidence, Stage, Mortality, and Screening Parameters:
25-Year Follow-up of a Swedish Mammographic Screening,'' Cancer
Epidemiology, Biomarkers, and Prevention, 2010: 19(5): 1219-28.
Available at https://www.researchgate.net/publication/43226895_Effect_of_Baseline_Breast_Density_on_Breast_Cancer_Incidence_Stage_Mortality_and_Screening_Parameters_25-Year_Follow-up_of_a_Swedish_Mammographic_Screening.
* 17. MQSA National Statistics, available at https://www.fda.gov/radiation-emitting-products/mqsa-insights/mqsa-national-statistics.
* 18. MQSA Inspection Procedures, Version 7.0, Revision June 2015,
available at https://www.fda.gov/radiation-emitting-products/facility-certification-and-inspection-mqsa/inspection-procedures.
* 19. MQSA PGHS. Available at Policy Guidance Help System--Before a
facility permanently stops performing mammography, what actions
should it take to avoid future MQSA problems and how should it deal
with retention of mammographic medical records?
* 20. FDA guidance on ``Medical Device Accessories,'' issued on
December 20, 2017. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-accessories-describing-accessories-and-classification-pathways.
* 21. MQSA Alternative Standard #24, approved on July 13, 2018.
Available at https://www.fda.gov/radiation-emitting-products/regulations-mqsa/24-approval-alternative-standard-using-quality-assurance-program-recommended-acr-digital-mammography.
* 22. FDA MQSA Alternative Standards website. Available at https://www.fda.gov/radiation-emitting-products/regulations-mqsa/alternative-standards-mqsa.
* 23. FDA guidance ``Display Devices for Diagnostic Radiology,''
issued on October 2, 2017, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/display-devices-diagnostic-radiology.
* 24. MQSA Alternative Standard #12, approved on September 17, 2003.
Available at https://www.fda.gov/radiation-emitting-products/regulations-mqsa/mqsa-alternative-standard-12-assessment-category-post-procedure-mammograms-marker-placement.
* 25. MQSA Alternative Standard #11, approved on August 29, 2003.
Available at https://www.fda.gov/radiation-emitting-products/regulations-mqsa/mqsa-alternative-standard-11-modifications-assessment-categories-used-medical-reports.
* 26. MQSA PGHS. Available at https://www.accessdata.fda.gov/cdrh_docs/presentations/pghs/Is_it_necessary_to_include_an_assessment_code_(e.g.,
_0,_1,_2,_3,_4,_5_or_N,_B,_P,_S,_M,_A),_in_addition_to_the_assessment
_category,_on_all_mammography_reports__Is_there....htm.
27. D'Orsi, C.J., et al., ACR BI-RADS Atlas, Breast Imaging
Reporting and Data System, 5th Edition. Reston, VA: American College
of Radiology, 2013.
28. Sickles, E.A., et al., ``Mammography.'' In: ACR BI-RADS Atlas,
Breast Imaging Reporting and Data System. Reston, VA: American
College of Radiology, 2013, pp. 153-4.
[[Page 15167]]
* 29. MQSA PGHS. Available at https://www.accessdata.fda.gov/cdrh_docs/presentations/pghs/The_American_College_of_Radiology_Breast_Imaging_Reporting_and_Data_System_BIRADS_suggests_that_facilities_subdivide_the_Suspicious_assessment_category_into_one_of_three_subca.htm.
30. Hayward, J.H., et al., ``Improving Screening Mammography
Outcomes Through Comparison With Multiple Prior Mammograms,''
American Journal of Roentgenology, 2016; 207: 918-924. Available at
https://www.ajronline.org/doi/full/10.2214/AJR.15.15917.
31. Berg, W.A. and J. A. Harvey, ``Breast Density and Supplemental
Screening (White Paper),'' Society of Breast Imaging, issued on May
1, 2017. Available at https://www.sbi-online.org/white-papers/breast-density-and-supplemental-screening.
32. Butler, R.S. and Hooley, R.J., 2020. Screening Breast
Ultrasound: Update After 10 Years of Breast Density Notification
Laws. American Journal of Roentgenology, 214(6), pp.1424-1435.
* 33. Transcript of 2011 NMQAAC meeting. Available at https://wayback.archive-it.org/7993/20170404143636/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Radiation-EmittingProducts/NationalMammographyQualityAssuranceAdvisoryCommittee/UCM282944.pdf.
34. Sickles, E.A., et al. ``Mammography.'' In: ACR BI-RADS Atlas,
Breast Imaging Reporting and Data System. Reston, VA: American
College of Radiology, 2013, pp. 123-6.
35. California Breast Density Information Group, ``Breast Density,
Breast Cancer Risk, and California Breast Density Notification Law
SB 1538: Scenarios for Clinicians,'' 2013. Available at: For Health
Care Providers: Density Scenarios [verbar] Department of Radiology
(unc.edu).
36. DenseBreast Info website, ``Cancer Detection by Screening
Method.'' Available at https://densebreast-info.org/screening-technologies/cancer-detection-by-screening-method/.
37. Berg, W.A., E.A. Rafferty, S.M. Friedewald, et al., ``Screening
Algorithms in Dense Breasts: AJR Expert Panel Narrative Review,''
American Journal of Roentgenology, 2021; 216: 275-294, and
associated video lecture available at https://www.youtube.com/watch?v=aGIFTa6xMeY.
38. Saraiya A., G.L. Baird, and A.P. Lourenco, ``Breast Density
Notification Letters and websites: Are They Too `Dense? ','' Journal
of the American College of Radiology 16: 717, May 2019.
39. Capello, N.M., D. Richetelli, and C.I. Lee, ``The Impact of
Breast Density Reporting Laws on Women's Awareness of Density-
Associated Risks and Conversations Regarding Supplemental Screening
With Providers,'' Journal of the American College of Radiology
16(2): 139-146, February 2019. Available at: https://doi.org/10.1016/j.jacr.2018.08.009.
40. Nguyen D.L., E.B. Ambinder, M.K. Jones, L.A. Mullen, and S.C.
Harvey, ``Improving State-Mandated Breast Density Notifications,''
Journal of the American College of Radiology 173): 384-390, March
2020. Available at: https://doi.org/10.1016/j.jacr.2019.08.023.
41. Kyanko, K.A., J. Hoag, S.H. Busch, J.A. Aminawung, et al.,
``Dense Breast Notification Laws, Education, and Women's Awareness
and Knowledge of Breast Density: A Nationally Representative
Survey,'' Journal of General Internal Medicine, 2020 July;
35(7):1940-1945. DOI: 10.1007/s11606-019-05590-7.
42. Kressin, N.R., C.M. Gunn, and T.A. Battaglia, ``Content,
Readability, and Understandability of Dense Breast Notifications by
State,'' Journal of the American Medical Association 315: 1786,
April 26, 2016.
43. Kressin, N.R., J.B. Wormwood, T.A. Battaglia, and C.M. Gunn,
``Differences in Breast Density Awareness, Knowledge, and Plans
[Letter]'', Journal of General Internal Medicine 2020; 35(8): 2473.
DOI: 10.1007/s11606-020-05840-z.
44. Kressin, N.R., T.A. Battaglia, J.B. Wormwood, P.J. Slanetz, and
C.M. Gunn, ``Dense Breast Notification Laws' Association With
Outcomes in the US Population: A Cross-Sectional Study,'' Journal of
the American College of Radiology, 2021 May; 18(5): 685-695. DOI:
10.1016/j.jacr.2020.11.012.
45. Kerlikowske, K., W. Zhu, A. Tosteson, et al., ``Identifying
Women with Dense Breasts at High Risk of Interval Cancers,'' Annals
of Internal Medicine, 2015 May 19; 162(10): 673-681. Available at
Identifying Women with Dense Breasts at High Risk of Interval
Cancers--PMC (nih.gov).
* 46. MQSA PGHS, available at https://www.accessdata.fda.gov/cdrh_docs/presentations/pghs/Can_a_facility_use_lossless_compression_to_store_FFDM_images_for_retention_purposes_.htm.
* 47. MQSA PGHS, available at https://www.accessdata.fda.gov/cdrh_docs/presentations/pghs/Can_a_facility_use_lossless_compression_to_transmit_images_to_the_patient_or_other_medical_institutions_for_final_interpretation_.htm.
* 48. MQSA PGHS, available at https://www.accessdata.fda.gov/cdrh_docs/presentations/pghs/Can_a_facility_use_lossy_compression_to_store_FFDM_images_for_retention_purposes_.htm.
49. Sickles, E.A., et al., ``ACR BI-RADS Follow-Up and Outcome
Monitoring.'' In: ACR BI-RADS Atlas: Breast Imaging Reporting and
Data System, 5th ed. Reston, VA, American College of Radiology,
2013, pp. 18-19.
50. D'Orsi, C.J., ``Audit.'' Lecture presented at Institute of
Medicine Workshop on Assessing and Improving Imaging Interpretation
in Breast Cancer Screening, Washington, DC, May 12-13, 2015. Lecture
slides available at https://www.nationalacademies.org/event/05-12-2015/assessing-and-improving-imaging-interpretation-in-breast-cancer-screening.
51. Sickles, E.A. et al., ``Mammography.'' In: ACR BI-RADS Atlas,
Breast Imaging Reporting and Data System. Reston, VA: American
College of Radiology, 2013, pp. 136-7, 150-1.
*52. FDA EQUIP web pages. Available at https://www.fda.gov/radiation-emitting-products/facility-certification-and-inspection-mqsa/inspection-news.
* 53. FDA database of certified mammography facilities. Available at
https://www.fda.gov/radiation-emitting-products/consumer-information-mqsa/search-certified-facility.
* 54. FDA Safety Communication, issued February 25, 2019. Available
at 2022-06-16 13:39 [verbar] Archive of FDA (pagefreezer.com).
* 55. FDA Consumer Update, issued October 27, 2017. Available at
https://www.fda.gov/consumers/consumer-updates/breast-cancer-screening-thermogram-no-substitute-mammogram.
* 56. FDA Class II Special Controls Guidance on Full-Field Digital
Mammography System, issued March 27, 2012. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/class-ii-special-controls-guidance-document-full-field-digital-mammography-system-guidance-industry.
57. Hooley, R.J., K.L. Greenberg, R.M. Stackhouse, et al.,
``Screening US [ultrasonography] in Patients with Mammographically
Dense Breasts: Initial Experience with Connecticut Public Act 09-
41,'' Radiology, 2012; 265(1):59-69.
58. Weigert, J. and S. Steenbergen, ``The Connecticut Experiment:
The Role of Ultrasound in the Screening of Women with Dense
Breasts,'' Breast Journal, 2012; 18(6):517-22.
59. Saulsberry, L. et al. 2019. ``The Impact of Breast Density
Notification Laws on Supplemental Breast Imaging and Breast
Biopsy.'' Journal of General Internal Medicine, 34(8), pp. 1441-
1451.
60. Scheel et al. ``Screening Ultrasound as an Adjunct to
Mammography in Women with Mammographically Dense Breasts.'' American
Journal of Obstetrics and Gynecology 212.1 (2015): 9-17.
61. Houssami, N. and Lee, C.I., 2018. ``The Impact of Legislation
Mandating Breast Density Notification--Review of the Evidence.'' The
Breast, 42, pp. 102-112.
62. Keating, N.L. and Pace, L.E., 2019. ``New Federal Requirements
to Inform Patients About Breast Density: Will They Help Patients?''
JAMA, 321(23), pp. 2275-2276.
* 63. FDA, FRIA, available at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
* 64. Executive Order 13132, Federalism, August 4, 1999, available
at https://www.govinfo.gov/content/pkg/FR-1999-08-10/pdf/99-20729.pdf.
* 65. FDA MQSA home page. Available at https://www.fda.gov/radiation-emitting-products/mammography-quality-standards-act-and-program.
* 66. ERG, Inc. ``Baseline Quality Measures of Screening Mammography
and the
[[Page 15168]]
Impacts of Proposed Revisions to Regulations Implementing the
Mammography Quality Standards Act.'' Final Report, July 19, 2012.
[ERG, 2012a]
* 67. ERG, Inc. ``Proposed Density Notification Addition to
Regulations Implementing the Mammography Quality Standards Act:
Addendum to the Final Report.'' July 17, 2012. [ERG, 2012b]
List of Subjects in 21 CFR Part 900
Electronic products, Health facilities, Medical devices, Radiation
protection, Reporting and recordkeeping requirements, X-rays.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
900 is amended as follows:
PART 900--MAMMOGRAPHY
0
1. The authority citation for part 900 continues to read as follows:
Authority: 21 U.S.C. 360i, 360nn, 374(e); 42 U.S.C. 263b.
0
2. In Sec. 900.2, revise paragraphs (c)(2), (k), (z), and (aa)(1) and
(2), add paragraph (aa)(3), and revise paragraph (ii) to read as
follows:
Sec. 900.2 Definitions.
* * * * *
(c) * * *
(2) Failure to send mammography reports within 30 days to the
referring healthcare provider or in a timely manner to the self-
referred patient; and
* * * * *
(k) Consumer means an individual who chooses to comment or complain
in reference to a mammography examination, including the patient or
representative of the patient (e.g., family member or referring
healthcare provider).
* * * * *
(z) Mammographic modality means a technology, within the scope of
42 U.S.C. 263b, for radiography of the breast. Examples are screen-film
mammography, full field digital mammography, and digital breast
tomosynthesis.
(aa) * * *
(1) Radiography of the breast performed during invasive
interventions for localization or biopsy procedures;
(2) Radiography of the breast performed with an investigational
mammography device as part of a scientific study conducted in
accordance with FDA's investigational device exemption regulations in
part 812 of this chapter; or
(3) Computed tomography of the breast.
* * * * *
(ii) Patient means any individual who undergoes a mammography
evaluation in a facility, regardless of whether the person is referred
by a healthcare provider or is self-referred.
* * * * *
0
3. In Sec. 900.4 revise paragraphs (a)(6) and (f)(1)(ii)(B) to read as
follows:
Sec. 900.4 Standards for accreditation bodies.
(a) * * *
(6)(i) When an accreditation body denies accreditation to a
facility, the accreditation body shall notify the facility in writing
and explain the bases for its decision. The notification shall also
describe the appeals process available from the accreditation body for
the facility to contest the decision.
(ii) If a facility has failed to become accredited after three
consecutive attempts, no accreditation body shall accept an application
for accreditation from the facility for a period of 1 year from the
date of the most recent accreditation failure.
* * * * *
(f) * * *
(1) * * *
(ii) * * *
(B) Review of facility documentation to determine if appropriate
mammography reports are sent to patients and providers as required;
* * * * *
0
4. In Sec. 900.11 revise paragraph (c)(4) to read as follows:
Sec. 900.11 Requirements for certification.
* * * * *
(c) * * *
(4) If a facility's certificate was revoked on the basis of an act
described in 42 U.S.C. 263b(i)(1), as implemented by Sec. 900.14(a),
no person who owned or operated that facility at the time the act
occurred may own or operate a mammography facility within 2 years of
the date of revocation.
0
5. In Sec. 900.12:
0
a. Revise paragraph (a)(4);
0
b. Add paragraphs (b)(2)(i) and (ii);
0
c. Revise paragraph (b)(11);
0
d. Add paragraph (b)(16);
0
e. Revise paragraphs (c)(1) and (2), (c)(3)(ii), (c)(4), and (f)(1);
0
f. Add paragraph (f)(4); and
0
g. Revise paragraph (j).
The additions and revisions read as follows:
Sec. 900.12 Quality standards.
(a) * * *
(4) Retention of personnel records. Facilities shall maintain
records of training and experience relevant to their qualification
under MQSA for personnel who work or have worked at the facility as
interpreting physicians, radiologic technologists, or medical
physicists. These records must be available for review by the MQSA
inspectors. Records of personnel no longer employed by the facility
must be maintained for no less than 24 months from the date of the
departure of an employee, and these records must be available for
review at the time of any annual inspection occurring during those 24
months. The facility shall provide copies of these personnel records to
current interpreting physicians, radiologic technologists, and medical
physicists upon their request. Facilities must provide personnel
records to former employees if the former employees communicate their
request within 24 months of the date of their departure. If it has been
greater than 24 months and the facility has maintained those records,
the facility must provide those records to former employees upon
request. Before a facility closes or ceases to provide mammography
services, it must make arrangements for access by current and former
personnel to their MQSA personnel records. This access may be provided
by the permanent transfer of these records to the personnel or the
transfer of the records to a facility or other entity that will provide
access to these records for no less than 24 months from the date of
facility closure or cessation of mammography services.
(b) * * *
(2) * * *
(i) All devices used in mammography must have met the applicable
FDA premarket authorization requirements for medical devices of that
type with that intended use.
(ii) A mammography unit that is converted from one mammographic
modality to another is considered a new unit at the facility under this
part and must, prior to clinical use, undergo a mammography equipment
evaluation demonstrating compliance with applicable requirements. The
facility must also follow its accreditation body's procedures for
applying for accreditation of that unit.
* * * * *
(11) Film. For facilities using screen-film units, the facility
shall use x-ray film for mammography that has been designated by the
film manufacturer as appropriate for mammography. For facilities using
hardcopy prints of digital images for transfer, retention, or final
interpretation purposes, the facility shall use a type of film
designated by the film manufacturer as appropriate for
[[Page 15169]]
these purposes and compatible with the printer being used.
* * * * *
(16) Equipment--other modalities. Systems with image receptor
modalities other than screen-film shall demonstrate compliance with
quality standards by successful results of quality assurance testing as
specified under paragraph (e)(6) of this section.
(c) Medical records and mammography reports--(1) Contents and
terminology. Each facility shall prepare a written report of the
results of each mammographic examination performed under its
certificate. The mammographic examination presented for interpretation
must be in the original mammographic modality in which it was
performed, and must not consist of digital images produced through
copying or digitizing hardcopy original images. The mammography report
shall include the following information:
(i) The name of the patient and an additional patient identifier;
(ii) Date of examination, facility name, and location. At a
minimum, the location shall include the city, State, ZIP code, and
telephone number of the facility;
(iii) The name of the interpreting physician who interpreted the
mammogram;
(iv) Overall final assessment of findings, classified in one of the
following categories (the assessment statement is only the word or
phrase within the quotation marks):
(A) ``Negative.'' Nothing to comment upon (if the interpreting
physician is aware of clinical findings or symptoms, despite the
negative assessment, these shall be documented and addressed);
(B) ``Benign.'' Also a normal result, with benign findings present,
but no evidence of malignancy (if the interpreting physician is aware
of clinical findings or symptoms, despite the benign assessment, these
shall be documented and addressed);
(C) ``Probably Benign.'' Finding(s) has a high probability of being
benign;
(D) ``Suspicious.'' Finding(s) without all the characteristic
morphology of breast cancer but indicating a definite probability of
being malignant;
(E) ``Highly Suggestive of Malignancy.'' Finding(s) has a high
probability of being malignant;
(F) ``Known Biopsy-Proven Malignancy.'' Reserved for known
malignancies being mammographically evaluated for definitive therapy;
and
(G) ``Post-Procedure Mammogram for Marker Placement.'' Reserved for
a post-procedure mammogram used to confirm the deployment and position
of a breast tissue marker.
(v) In cases where no final assessment category can be assigned due
to incomplete work-up, one of the following classification statements
shall be assigned as an assessment and reasons why no final assessment
can be made shall be stated by the interpreting physician.
(A) ``Incomplete: Need additional imaging evaluation.'' Reserved
for examinations where additional imaging needs to be performed before
an assessment category identified in paragraphs (c)(1)(iv)(A) through
(G) of this section can be given; or
(B) ``Incomplete: Need prior mammograms for comparison.'' Reserved
for examinations where comparison with prior mammograms should be
performed before an assessment category identified in paragraphs
(c)(1)(iv)(A) through (G) of this section can be given. If this
assessment category is used, a followup report with an assessment
category identified in paragraphs (c)(1)(iv)(A) through (E) of this
section must be issued within 30 calendar days of the initial report
whether or not comparison views can be obtained.
(vi) Overall assessment of breast density, classified in one of the
following categories:
(A) ``The breasts are almost entirely fatty.''
(B) ``There are scattered areas of fibroglandular density.''
(C) ``The breasts are heterogeneously dense, which may obscure
small masses.''
(D) ``The breasts are extremely dense, which lowers the sensitivity
of mammography.''
(vii) Recommendations made to the healthcare provider about what
additional actions, if any, should be taken. All clinical questions
raised by the referring healthcare provider shall be addressed in the
report to the extent possible, even if the assessment is negative or
benign.
(2) Communication of mammography results to the patients. Each
facility shall provide each patient a summary of the mammography report
written in lay terms within 30 calendar days of the mammographic
examination which shall, at a minimum, include the name of the patient;
the name, address, and telephone number of the facility performing the
mammographic examination; and an assessment of breast density as
described in paragraphs (c)(2)(iii) and (iv) of this section. If the
assessment of the mammography report is ``Suspicious'' or ``Highly
Suggestive of Malignancy,'' the facility shall provide the patient a
summary of the mammography report written in lay language within 7
calendar days of the final interpretation of the mammograms.
(i) Patients who do not name a healthcare provider to receive the
mammography report shall be sent the report described in paragraph
(c)(1) of this section within 30 days, in addition to the written
notification of results in lay terms. If the assessment of the
mammography report is ``Suspicious'' or ``Highly Suggestive of
Malignancy,'' the facility shall send this report to the patient within
7 calendar days of the final interpretation of the mammograms.
(ii) Each facility that accepts patients who do not have a
healthcare provider shall maintain a system for referring such patients
to a healthcare provider when clinically indicated, which shall include
when such patients' mammogram assessment is either probably benign,
suspicious, or highly suggestive of malignancy.
(iii) If the mammography report identifies the patient's breast
density as ``The breasts are almost entirely fatty'' or ``There are
scattered areas of fibroglandular density,'' the lay summary shall
include the statement ``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.''
(iv) If the mammography report identifies the breast density as
``The breasts are heterogeneously dense, which may obscure small
masses'' or ``The breasts are extremely dense, which lowers the
sensitivity of mammography,'' the lay summary shall include the
statement ``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.''
(3) * * *
(ii) If the assessment is ``Suspicious'' or ``Highly Suggestive of
Malignancy,'' the facility shall provide a written report of the
mammographic examination, including the items listed in paragraph
(c)(1) of this section, to the referring healthcare provider, or if the
referring healthcare provider is unavailable, to a responsible designee
of the referring healthcare provider within
[[Page 15170]]
7 calendar days of the final interpretation of the mammograms.
(4) Recordkeeping. Each facility that performs mammograms:
(i) Shall (except as provided in paragraph (c)(4)(ii) of this
section) maintain the original mammograms and mammography reports in a
permanent medical record of the patient for the longest of the
following: a period of not less than 5 years, a period of not less than
10 years if no additional mammograms of the patient are performed at
the facility, or a period, if any, mandated by State or local law.
Facilities shall implement policies and procedures to minimize the
possibility of loss of these records. The original mammograms must be
retained in retrievable form in the mammographic modality in which they
were produced. They cannot be produced by copying or digitizing
hardcopy originals.
(ii) 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
the time specified in paragraph (c)(4)(i) of this section. Transfer of
the mammograms and mammography reports must take place within 15
calendar days of the facility receiving such request. The transferred
mammograms must be in the mammographic modality in which they were
produced, and cannot be produced by copying or digitizing hardcopy
originals. For digital mammograms or digital breast tomosynthesis, if
the examination is being transferred for final interpretation purposes,
the facility must be able to provide the recipient with original
digital images electronically;
(iii) Shall upon request by, or on behalf of, the patient, provide
copies of mammograms and copies of mammogram reports to a medical
institution, a physician or healthcare provider of the patient, or to
the patient directly during the time specified in paragraph (c)(4)(i)
of this section. Release of the copies must take place within 15
calendar days of the facility receiving such request. For digital
mammograms or digital breast tomosynthesis, if the copies are being
released for final interpretation purposes, the facility must be able
to provide the recipient with digital images electronically;
(iv) Any fee charged to the patients for providing the services in
paragraphs (c)(4)(ii) or (iii) of this section shall not exceed the
documented costs associated with this service; and
(v) Before a facility closes or ceases to provide mammography
services, it must make arrangements for access by patients and
healthcare providers to their mammographic records. This access may be
provided by the permanent transfer of mammographic records to the
patient or the patient's healthcare provider or the transfer of the
mammographic records to a facility or other entity that will provide
access to patients and healthcare providers. Access to the records must
be provided by such other facility or entity for the remainder of the
time periods specified in paragraph (c)(4)(i) of this section. If a
facility ceases to perform mammography but continues to operate as a
medical entity, and is able to satisfy the recordkeeping requirements
of paragraphs (c)(4)(i) through (iv) of this section, 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. The facility must notify its accreditation body and
certification agency in writing of the arrangements it has made and
must make reasonable efforts to notify all affected patients.
* * * * *
(f) * * *
(1) General requirements. For the purposes of these audit
requirements, a mammographic examination consisting of routine views of
an asymptomatic patient shall be termed a screening mammogram, while a
mammographic examination consisting of individualized views of a
patient with breast symptoms, physical signs of breast disease, or
abnormal findings on a screening mammogram shall be termed a diagnostic
mammogram. Each facility shall establish a system to collect and review
outcome data for all mammographic examinations performed, including
followup on the disposition of all positive mammograms and correlation
of pathology results with the interpreting physician's mammography
report. In addition, for cases of breast cancer among patients imaged
at the facility that subsequently become known to the facility, the
facility shall promptly initiate followup on surgical and/or pathology
results and review of the mammographic examinations taken prior to the
diagnosis of a malignancy. Analysis of these outcome data shall be made
individually and collectively for all interpreting physicians and, at a
minimum, shall consist of a determination of the following:
(i) Positive predictive value--percent of patients with positive
mammograms who are diagnosed with breast cancer within 1 year of the
date of the mammographic examination.
(ii) Cancer detection rate--of the patients initially examined with
screening mammograms who receive an assessment of ``Incomplete: Need
additional imaging evaluation,'' ``Suspicious,'' or ``Highly Suggestive
of Malignancy'' on the screening mammogram or on a subsequent
diagnostic mammogram, the number of patients who are diagnosed with
breast cancer within 1 year of the date of the initial screening
mammogram, expressed arithmetically as a ratio per 1,000 patients.
(iii) Recall rate--percentage of screening mammograms given an
assessment of ``Incomplete: Need additional imaging evaluation.''
* * * * *
(4) The records and data required to demonstrate compliance with
the requirements in paragraphs (f)(1) through (3) of this section must
be retained until the annual inspection that follows the facility's
analysis of that information.
* * * * *
(j) Additional mammography review and patient and referring
provider notification. (1) If FDA or the State certification agency
believes that mammographic quality at a facility has been compromised
and may present a significant risk to human health, the facility shall
provide clinical images and other relevant information, as specified by
FDA or the State certification agency, for review by the accreditation
body or the State certification agency. This additional mammography
review will help FDA or the State certification agency determine
whether the facility is in compliance with this section and whether
there is a need to notify affected patients, their referring physicians
or other healthcare providers, and/or the public that there is a
significant risk to human health.
(2) Based on the results of the additional mammography review, the
facility's failure to comply with the terms of the additional
mammography review, or other information, FDA or the State
certification agency may determine that the quality of mammography
performed by a facility, whether or not certified under Sec. 900.11,
was so inconsistent with the quality standards established in this part
as to present a significant risk to human health. FDA or the State
certification agency may require such a facility to notify all patients
who received mammograms at the facility or those patients who are
determined to be at
[[Page 15171]]
risk due to the quality of their mammography, and their referring
physicians or other healthcare providers, of the deficiencies and
resulting potential harm, appropriate remedial measures, and such other
relevant information as FDA or the State certification agency may
require. Such notification shall occur within a timeframe and in a
manner specified by FDA or the State certification agency. If the
facility is unable or unwilling to perform such notification, FDA or
the State certification agency may notify patients and their referring
physicians or other healthcare providers individually or through the
mass media.
0
6. In Sec. 900.14 revise paragraphs (a) introductory text and (a)(3),
(5), and (6) and add paragraph (a)(7) to read as follows:
Sec. 900.14 Suspension or revocation of certificates.
(a) Except as provided in paragraph (b) of this section, FDA may
suspend or revoke a certificate if FDA finds, after providing the owner
or operator of the facility with notice and opportunity for a hearing
in accordance with part 16 of this chapter, that the facility, owner,
operator, or any employee of the facility:
* * * * *
(3) Has failed to comply with reasonable requests of FDA, the State
certification agency, or the accreditation body for records,
information, reports, or materials, including clinical images for an
additional mammography review under Sec. 900.12(j), that FDA or the
State certification agency believes are necessary to determine the
continued eligibility of the facility for a certificate or continued
compliance with the standards of Sec. 900.12;
* * * * *
(5) Has violated or aided and abetted in the violation of any
provision of or regulation issued pursuant to 42 U.S.C. 263b;
(6) Has failed to comply with prior sanctions imposed by FDA or the
State certification agency under 42 U.S.C. 263b(h), including a
directed plan of correction or a patient and referring physician
notification; or
(7) Has failed to comply with requests of current or former
facility personnel for records of their training or experience relevant
to their qualification under MQSA, in violation of Sec. 900.12(a)(4).
* * * * *
0
7. In Sec. 900.15 revise paragraph (d)(1) to read as follows:
Sec. 900.15 Appeals of adverse accreditation or reaccreditation
decisions that preclude certification or recertification.
* * * * *
(d) * * *
(1) References to the Centers for Medicare and Medicaid Services in
42 CFR part 498 should be read as the Division of Mammography Quality
Standards (DMQS), Center for Devices and Radiological Health, Food and
Drug Administration.
* * * * *
Dated: February 27, 2023.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2023-04550 Filed 3-9-23; 8:45 am]
BILLING CODE 4164-01-P