Notice of Request for Public Comments on Draft Recommendations for the HRSA-Supported Women's Preventive Services Guidelines Relating to Screening and Counseling for Intimate Partner and Domestic Violence, Breast Cancer Screening for Women at Average Risk, and Patient Navigation for Breast and Cervical Cancer Screening, 84354-84357 [2024-24445]
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Federal Register / Vol. 89, No. 204 / Tuesday, October 22, 2024 / Notices
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ddrumheller on DSK120RN23PROD with NOTICES1
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Drug Interactions Section of Labeling
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Biological Products—Content and
Format.’’ The draft guidance is intended
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DRUG INTERACTIONS section of the
Prescribing Information labeling as
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Prescription drug labeling must
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1 21 CFR 201.56(a) and (d) and 201.57(c)(8). This
guidance applies to drugs, including biological
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primary tool for FDA to communicate
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The draft guidance, when finalized,
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FDA on ‘‘Drug Interaction Information
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Dated: October 16, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024–24442 Filed 10–21–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of Request for Public
Comments on Draft Recommendations
for the HRSA-Supported Women’s
Preventive Services Guidelines
Relating to Screening and Counseling
for Intimate Partner and Domestic
Violence, Breast Cancer Screening for
Women at Average Risk, and Patient
Navigation for Breast and Cervical
Cancer Screening
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
AGENCY:
ACTION:
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Federal Register / Vol. 89, No. 204 / Tuesday, October 22, 2024 / Notices
This notice seeks comment on
draft recommendations for the HRSAsupported Women’s Preventive Services
Guidelines (‘‘Guidelines’’) relating to
Screening and Counseling for Intimate
Partner and Domestic Violence, Breast
Cancer Screening for Women at Average
Risk, and Patient Navigation for Breast
and Cervical Cancer Screening. These
draft recommendations have been
developed by the Women’s Preventive
Services Initiative (WPSI), through
which clinicians, academics, and expert
health professionals develop draft
recommendations for HRSA’s
consideration. Under applicable law,
non-grandfathered group health plans
and health insurance issuers must
include coverage, without cost sharing,
for certain preventive services,
including those provided for in the
HRSA-supported Guidelines. The
Departments of Labor, HHS, and
Treasury have issued regulations and
policy guidance which describe how
group health plans and health insurance
issuers apply the coverage requirements.
DATES: Members of the public are
invited to provide written comments no
later than November 21, 2024. All
comments received on or before this
date will be reviewed and considered by
WPSI and provided for further
consideration by HRSA in determining
the recommended updates that it will
support.
ADDRESSES: Members of the public who
wish to provide comments can do so by
accessing the public comment web page
at https://www.womenspreventive
health.org/.
FOR FURTHER INFORMATION CONTACT:
Kimberly Sherman, HRSA, Maternal
and Child Health Bureau, telephone
(301) 443–8283, email: wellwomancare@
hrsa.gov.
SUPPLEMENTARY INFORMATION: Under
section 1001(5) of the Patient Protection
and Affordable Care Act, Public Law
111–148, which added section 2713 to
the Public Health Service Act, 42 U.S.C.
300gg–13, the preventive care and
screenings set forth in the HRSASupported Women’s Preventive Services
Guidelines are required to be covered
without cost-sharing by certain group
health plans and health insurance
issuers. HRSA established the
Guidelines in 2011 based on expert
recommendations by the Institute of
Medicine, now known as the National
Academy of Medicine.
Since 2016, HRSA has funded
cooperative agreements to support WPSI
to convene clinicians, academics, and
consumer-focused health professional
organizations to conduct a rigorous
review of current scientific evidence,
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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solicit and consider public input, and
make recommendations to HRSA
regarding updates to the Guidelines to
improve women’s health across the
lifespan. HRSA determines whether to
support, in whole or in part, the
recommended updates to the
Guidelines. WPSI consists of an
Advisory Panel and two expert
committees, the Multidisciplinary
Steering Committee and the
Dissemination and Implementation
Steering Committee, which are
comprised of a broad coalition of
organizational representatives who are
experts in disease prevention and
women’s health issues. With oversight
by the Advisory Panel, and with input
from the Multidisciplinary Steering
Committee, WPSI examines the
evidence to develop new (and update
existing) recommendations for women’s
preventive services. WPSI’s
Dissemination and Implementation
Steering Committee takes HRSAapproved recommendations and
disseminates them through the
development of implementation tools
and resources for both patients and
practitioners.
WPSI bases its recommended updates
to the Guidelines on review and
synthesis of existing clinical guidelines
and new scientific evidence, following
the National Academy of Medicine
standards for establishing foundations
for and rating strengths of
recommendations, articulation of
recommendations, and external reviews.
Additionally, HRSA requires that WPSI
incorporate processes to assure
opportunity for public comment,
including participation by patients and
consumers, in the development of its
recommendations to update the
Guidelines. This notice seeks comment
on three Guidelines:
(1) Screening and Counseling for
Intimate Partner and Domestic Violence
WPSI recommends updating the
existing Guideline for Screening and
Counseling for Interpersonal and
Domestic Violence. The current
Guideline for Screening and Counseling
for Interpersonal and Domestic Violence
is: ‘‘WPSI recommends screening
adolescents and women for
interpersonal and domestic violence, at
least annually, and, when needed,
providing, or referring for initial
intervention services. Interpersonal and
domestic violence includes physical
violence, sexual violence, stalking and
psychological aggression (including
coercion), reproductive coercion,
neglect, and the threat of violence,
abuse, or both. Intervention services
include, but are not limited to,
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84355
counseling, education, harm reduction
strategies, and referral to appropriate
supportive services.’’
The proposed updated Guideline for
Screening and Counseling for Intimate
Partner and Domestic Violence is: ‘‘The
Women’s Preventive Services Initiative
recommends screening adolescent and
adult women for intimate partner and
domestic violence, at least annually,
and, when needed, providing or
referring to intervention services.
Intimate partner and domestic violence
includes physical violence, sexual
violence, stalking and psychological
aggression (including coercion),
reproductive coercion, neglect, and the
threat of violence, abuse, or both.
Intervention services include, but are
not limited to, counseling, education,
harm reduction strategies, and
appropriate supportive services.’’
Background
WPSI recommends several updates to
the language of this Guideline. The first
change is a revision to the title of the
Guideline from ‘‘Interpersonal and
Domestic Violence’’ to ‘‘Intimate Partner
and Domestic Violence.’’ This change to
the title was made to be consistent with
language generally used in the clinical
setting and the more commonly used
term of ‘‘intimate partner violence’’ in
the medical field. Corresponding
revisions to change references from
‘‘interpersonal’’ to ‘‘intimate partner’’
have been made throughout the text of
the recommendation. WPSI also
recommends adding the word ‘‘adult’’
prior to ‘‘women’’ in the
recommendation, to clarify that both
adolescent and adult women are
included in the screening and
counseling guidance. The words
‘‘referral to’’ were removed from the last
sentence to assist with clarity on the
meaning of ‘‘intervention services.’’
Comments are sought on these proposed
updates.
(2) Breast Cancer Screening for Women
at Average Risk
WPSI is recommending updating the
existing Guideline for Breast Cancer
Screening for Average-Risk Women. The
current guideline for Breast Cancer
Screening for Average-Risk Women is:
‘‘WPSI recommends that average-risk
women initiate mammography
screening no earlier than age 40 and no
later than age 50. Screening
mammography should occur at least
biennially and as frequently as
annually. Screening should continue
through at least age 74 and age alone
should not be the basis to discontinue
screening.
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Federal Register / Vol. 89, No. 204 / Tuesday, October 22, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
These screening recommendations are
for women at average risk of breast
cancer. Women at increased risk should
also undergo periodic mammography
screening, however, recommendations
for additional services are beyond the
scope of this recommendation.’’
The proposed updated Guideline for
Breast Cancer Screening for Women at
Average Risk is: ‘‘The Women’s
Preventive Services Initiative
recommends that women at average-risk
of breast cancer initiate mammography
screening no earlier than age 40 and no
later than age 50. Screening
mammography should occur at least
biennially and as frequently as
annually. Women may require
additional imaging to complete the
screening process or to address findings
on the initial screening mammography.
If additional imaging (e.g., MRI,
ultrasound, mammography) and
pathology exams are indicated, those
services are also recommended to
complete the screening process for
malignancies. Screening should
continue through at least age 74 and age
alone should not be the basis to
discontinue screening.
‘‘Women at increased risk should also
undergo periodic mammography
screening, however, recommendations
for additional services are beyond the
scope of this recommendation.’’
Background
WPSI recommends several updates to
the language of this Guideline. The first
change is a revision to the title from
‘‘Breast Cancer Screening for AverageRisk Women’’ to ‘‘Breast Cancer
Screening for Women at Average Risk.’’
This change to the title was made to be
consistent with changes recommended
for the first sentence of this Guideline
and to use person-first language that
puts the individual before the diagnosis
or screening modality. WPSI
recommends updates to the first
sentence of this Guideline, replacing the
phrase ‘‘average-risk women’’ with
‘‘women at average-risk for breast
cancer’’ to clarify that the target
population for this recommendation is
specific to breast cancer.
Two new sentences were added to
follow the first sentence: ‘‘Women may
require additional imaging to complete
the screening process or to address
findings on the initial screening
mammography. If additional imaging
(e.g., MRI, ultrasound, mammography)
and pathology exams are indicated,
those services are also recommended to
complete the screening process for
malignancies.’’ These modifications
address the circumstances where initial
mammography screening for women at
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17:10 Oct 21, 2024
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average risk for breast cancer is
incomplete or additional action is
necessary to fully complete breast
cancer screening for the individual.
Specifically, these two sentences were
added to ensure completed screening for
women who were initially screened for
breast cancer and need additional
screening tests. Imaging in addition to
initial screening mammography, such as
special mammography views,
ultrasound, or MRI, may be needed in
individual clinical situations when
clinicians require an enhanced view of
breast tissue to differentiate normal
from abnormal findings. A tissue biopsy
may also need to be performed to
determine whether abnormal findings
are cancer, normal tissue, or other type
of lesion. In an analysis of 405,191
women in the Breast Cancer
Surveillance Consortium breast imaging
registry who underwent digital
mammography, 40,557 (10 percent)
were recommended for additional
imaging, and 6,628 (1.6 percent) were
recommended for biopsy.1
WPSI also has recommended
removing the following sentence from
the existing Guideline, ‘‘These screening
recommendations are for women at
average risk of breast cancer’’ as this
information is now included in the
revised first sentence of the updated
Guideline. Comments are sought on
these proposed updates.
(3) Patient Navigation for Breast and
Cervical Cancer Screening
WPSI is proposing a new Guideline
for Patient Navigation for Breast and
Cervical Cancer Screening, as follows:
‘‘The Women’s Preventive Services
Initiative (WPSI) recommends patient
navigation services for breast and
cervical cancer screening and follow-up,
as relevant, to increase utilization of
screening recommendations based on an
assessment of the patient’s need for
navigation services. Patient navigation
services involve person-to-person (e.g.,
in-person, virtual, hybrid models)
contact with the patient. Components of
patient navigation services should be
individualized.
Services include, but are not limited
to, person-centered assessment and
planning, health care access and health
system navigation, referrals to
appropriate support services (e.g.,
1 Nelson HD, O’Meara ES, Kerlikowske K, Balch
S, Miglioretti D. Factors Associated With Rates of
False-Positive and False-Negative Results From
Digital Mammography Screening: An Analysis of
Registry Data. Ann Intern Med. 2016 Feb
16;164(4):226–35. doi: 10.7326/M15–0971. Epub
2016 Jan 12. PMID: 26756902; PMCID:
PMC5091936.
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language translation, transportation, and
social services), and patient education.’’
Background
WPSI has submitted a new draft
clinical recommendation on Patient
Navigation for Breast and Cervical
Cancer Screening for review, comment,
and consideration. Recent clinical
research has found consistent
effectiveness of patient navigation
services for breast and cervical cancer
screening in reducing barriers to
screening and follow-up care, resulting
in higher screening rates. Breast cancer
screening rates were 14.1% higher for
35,752 patients randomized to patient
navigation services versus usual care or
active controls in a WPSI meta-analysis
of 33 randomized control trials based in
U.S. health care settings. The same
meta-analysis showed rates for cervical
cancer screening and follow-up were
higher with patient navigation by
15.7%, based on 22 randomized control
trials with 12,221 participants.
Research suggests that patient
navigation is effective across a wide
range of health care settings and
provider types. In one study included in
WPSI’s meta-analysis, prevention care
managers working in federally qualified
health centers (FQHCs) who employed
patient navigation services increased
breast cancer screening among patients
without a mammogram in the past 18
months to 68% compared to 57% for
patients in usual care.2 Another study
included in the meta-analysis analyzed
rural Latinas who had not previously
undergone recommended screening.
The study found that enhanced
education efforts increased cervical
cancer screening to 53.4% as compared
to 34% in usual care without these
navigation services.3
Research also shows that reducing
barriers to screening and follow-up care
can result in earlier identification of
breast and cervical cancer, enabling
patients to enter into treatment earlier,
preventing progression of these
conditions, improving health outcomes
and survival rates, and ultimately can
reduce disparities in cancer morbidity
and mortality. In the meta-analysis,
patient navigation services increased
screening and follow-up for breast
cancer by 10.2% in populations
described as low-income. Based on this
2 Beach ML, Flood AB, Robinson CM, et al. Can
language-concordant prevention care managers
improve cancer screening rates? Cancer Epidemiol
Biomarkers Prev. 2007;16(10):2058–64. doi:
10.1158/1055–9965.EPI–07–0373. PMID: 17932353.
3 Thompson B, Carosso EA, Jhingan E, et al.
Results of a randomized controlled trial to increase
cervical cancer screening among rural Latinas.
Cancer. 2017;123(4):666–74. doi: 10.1002/
cncr.30399. PMID: 27787893.
E:\FR\FM\22OCN1.SGM
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Federal Register / Vol. 89, No. 204 / Tuesday, October 22, 2024 / Notices
the ACTPCMD website meeting page at
https://www.hrsa.gov/advisorycommittees/primarycare-dentist/
meetings.
FOR FURTHER INFORMATION CONTACT:
Shane Rogers, Designated Federal
Officer, Division of Medicine and
Dentistry, Bureau of Health Workforce,
HRSA, 5600 Fishers Lane, Room
15N102, Rockville, Maryland 20857;
301–443–5260; or SRogers@hrsa.gov.
SUPPLEMENTARY INFORMATION:
ACTPCMD provides advice and
recommendations to the Secretary of
Health and Human Services on policy,
program development, and other
Carole Johnson,
matters of significance concerning the
Administrator.
activities under Section 747 of Title VII
[FR Doc. 2024–24445 Filed 10–21–24; 8:45 am]
of the Public Health Service (PHS) Act,
BILLING CODE 4165–15–P
as it existed upon the enactment of
Section 749 of the PHS Act in 1998.
ACTPCMD prepares an annual report
DEPARTMENT OF HEALTH AND
describing the activities of the
HUMAN SERVICES
committee, including findings and
recommendations made by the
Health Resources and Services
committee concerning the activities
Administration
under Section 747, as well as training
Meeting of the Advisory Committee on programs in oral health and dentistry.
Training and Primary Care Medicine
The annual report is submitted to the
and Dentistry
Secretary of Health and Human Services
as well as the Chair and ranking
AGENCY: Health Resources and Services
members of the Senate Committee on
Administration (HRSA), Department of
Health, Education, Labor and Pensions
Health and Human Services.
and the House of Representatives
ACTION: Notice.
Committee on Energy and Commerce.
ACTPCMD also develops, publishes,
SUMMARY: In accordance with the
and implements performance measures
Federal Advisory Committee Act, this
and guidelines for longitudinal
notice announces that the Advisory
evaluations of programs authorized
Committee on Training in Primary Care
under Title VII, Part C of the PHS Act,
Medicine and Dentistry (ACTPCMD or
and recommends appropriation levels
Committee) will hold one additional
for programs under this Part.
public meeting in the 2024 calendar
Since priorities dictate meeting times,
year. Information about ACTPCMD,
be advised that start times, end times,
agendas, and materials for these
and agenda items are subject to change.
meetings can be found on the
For the November 15th meeting, agenda
ACTPCMD website at https://
items may include, but are not limited
www.hrsa.gov/advisory-committees/
to, discussion of recommendations for
primarycare-dentist/meetings. This
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about ACTPCMD’s calendar year 2024
committee’s 24th report. Refer to the
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ACTPCMD website listed above for all
notice dated May 15, 2024, Meeting of
current and updated information
the Advisory Committee on Training
concerning the November 15th
and Primary Care Medicine and
ACTPCMD meeting, including the
Dentistry.
agenda and meeting materials that will
DATES: The ACTPCMD meeting will be
be posted 20 calendar days before the
held on:
meeting.
• November 15, 2024, 10:00 a.m.–5:00
Members of the public will have the
p.m. Eastern Time.
opportunity to provide comments.
Public participants may submit written
ADDRESSES: This meeting will be held
statements in advance of the scheduled
by teleconference and/or a video
meeting. Oral comments will be
conference platform. For updates on
honored in the order they are requested
how the meeting will be held, visit the
and may be limited as time allows.
ACTPCMD website 20 days before the
Requests to submit a written statement
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or make oral comments to the
for joining the meeting will be posted.
ACTPCMD should be sent to Shane
For meeting information updates, go to
ddrumheller on DSK120RN23PROD with NOTICES1
clinical evidence that supports the
preventive benefits of patient navigation
services for breast and cervical cancer
screening, WPSI recommends adding
these patient navigation services to the
Guidelines. Comments are sought on
this proposed Guideline.
Members of the public can view the
complete updated and new draft clinical
recommendations, as well as the
implementation considerations and
research recommendations (which are
not part of the Guidelines), by accessing
WPSI’s web page at https://
www.womenspreventivehealth.org/.
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84357
Rogers using the contact information
above at least 5 business days before the
meeting date.
Individuals who need special
assistance or another reasonable
accommodation should notify Shane
Rogers using the contact information
listed above at least 10 business days
before the meeting they wish to attend.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024–24328 Filed 10–21–24; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
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]]>Agencies
[Federal Register Volume 89, Number 204 (Tuesday, October 22, 2024)]
[Notices]
[Pages 84354-84357]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24445]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Notice of Request for Public Comments on Draft Recommendations
for the HRSA-Supported Women's Preventive Services Guidelines Relating
to Screening and Counseling for Intimate Partner and Domestic Violence,
Breast Cancer Screening for Women at Average Risk, and Patient
Navigation for Breast and Cervical Cancer Screening
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: This notice seeks comment on draft recommendations for the
HRSA-supported Women's Preventive Services Guidelines (``Guidelines'')
relating to Screening and Counseling for Intimate Partner and Domestic
Violence, Breast Cancer Screening for Women at Average Risk, and
Patient Navigation for Breast and Cervical Cancer Screening. These
draft recommendations have been developed by the Women's Preventive
Services Initiative (WPSI), through which clinicians, academics, and
expert health professionals develop draft recommendations for HRSA's
consideration. Under applicable law, non-grandfathered group health
plans and health insurance issuers must include coverage, without cost
sharing, for certain preventive services, including those provided for
in the HRSA-supported Guidelines. The Departments of Labor, HHS, and
Treasury have issued regulations and policy guidance which describe how
group health plans and health insurance issuers apply the coverage
requirements.
DATES: Members of the public are invited to provide written comments no
later than November 21, 2024. All comments received on or before this
date will be reviewed and considered by WPSI and provided for further
consideration by HRSA in determining the recommended updates that it
will support.
ADDRESSES: Members of the public who wish to provide comments can do so
by accessing the public comment web page at https://www.womenspreventivehealth.org/.
FOR FURTHER INFORMATION CONTACT: Kimberly Sherman, HRSA, Maternal and
Child Health Bureau, telephone (301) 443-8283, email:
[email protected].
SUPPLEMENTARY INFORMATION: Under section 1001(5) of the Patient
Protection and Affordable Care Act, Public Law 111-148, which added
section 2713 to the Public Health Service Act, 42 U.S.C. 300gg-13, the
preventive care and screenings set forth in the HRSA-Supported Women's
Preventive Services Guidelines are required to be covered without cost-
sharing by certain group health plans and health insurance issuers.
HRSA established the Guidelines in 2011 based on expert recommendations
by the Institute of Medicine, now known as the National Academy of
Medicine.
Since 2016, HRSA has funded cooperative agreements to support WPSI
to convene clinicians, academics, and consumer-focused health
professional organizations to conduct a rigorous review of current
scientific evidence, solicit and consider public input, and make
recommendations to HRSA regarding updates to the Guidelines to improve
women's health across the lifespan. HRSA determines whether to support,
in whole or in part, the recommended updates to the Guidelines. WPSI
consists of an Advisory Panel and two expert committees, the
Multidisciplinary Steering Committee and the Dissemination and
Implementation Steering Committee, which are comprised of a broad
coalition of organizational representatives who are experts in disease
prevention and women's health issues. With oversight by the Advisory
Panel, and with input from the Multidisciplinary Steering Committee,
WPSI examines the evidence to develop new (and update existing)
recommendations for women's preventive services. WPSI's Dissemination
and Implementation Steering Committee takes HRSA-approved
recommendations and disseminates them through the development of
implementation tools and resources for both patients and practitioners.
WPSI bases its recommended updates to the Guidelines on review and
synthesis of existing clinical guidelines and new scientific evidence,
following the National Academy of Medicine standards for establishing
foundations for and rating strengths of recommendations, articulation
of recommendations, and external reviews. Additionally, HRSA requires
that WPSI incorporate processes to assure opportunity for public
comment, including participation by patients and consumers, in the
development of its recommendations to update the Guidelines. This
notice seeks comment on three Guidelines:
(1) Screening and Counseling for Intimate Partner and Domestic Violence
WPSI recommends updating the existing Guideline for Screening and
Counseling for Interpersonal and Domestic Violence. The current
Guideline for Screening and Counseling for Interpersonal and Domestic
Violence is: ``WPSI recommends screening adolescents and women for
interpersonal and domestic violence, at least annually, and, when
needed, providing, or referring for initial intervention services.
Interpersonal and domestic violence includes physical violence, sexual
violence, stalking and psychological aggression (including coercion),
reproductive coercion, neglect, and the threat of violence, abuse, or
both. Intervention services include, but are not limited to,
counseling, education, harm reduction strategies, and referral to
appropriate supportive services.''
The proposed updated Guideline for Screening and Counseling for
Intimate Partner and Domestic Violence is: ``The Women's Preventive
Services Initiative recommends screening adolescent and adult women for
intimate partner and domestic violence, at least annually, and, when
needed, providing or referring to intervention services. Intimate
partner and domestic violence includes physical violence, sexual
violence, stalking and psychological aggression (including coercion),
reproductive coercion, neglect, and the threat of violence, abuse, or
both. Intervention services include, but are not limited to,
counseling, education, harm reduction strategies, and appropriate
supportive services.''
Background
WPSI recommends several updates to the language of this Guideline.
The first change is a revision to the title of the Guideline from
``Interpersonal and Domestic Violence'' to ``Intimate Partner and
Domestic Violence.'' This change to the title was made to be consistent
with language generally used in the clinical setting and the more
commonly used term of ``intimate partner violence'' in the medical
field. Corresponding revisions to change references from
``interpersonal'' to ``intimate partner'' have been made throughout the
text of the recommendation. WPSI also recommends adding the word
``adult'' prior to ``women'' in the recommendation, to clarify that
both adolescent and adult women are included in the screening and
counseling guidance. The words ``referral to'' were removed from the
last sentence to assist with clarity on the meaning of ``intervention
services.'' Comments are sought on these proposed updates.
(2) Breast Cancer Screening for Women at Average Risk
WPSI is recommending updating the existing Guideline for Breast
Cancer Screening for Average-Risk Women. The current guideline for
Breast Cancer Screening for Average-Risk Women is: ``WPSI recommends
that average-risk women initiate mammography screening no earlier than
age 40 and no later than age 50. Screening mammography should occur at
least biennially and as frequently as annually. Screening should
continue through at least age 74 and age alone should not be the basis
to discontinue screening.
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These screening recommendations are for women at average risk of
breast cancer. Women at increased risk should also undergo periodic
mammography screening, however, recommendations for additional services
are beyond the scope of this recommendation.''
The proposed updated Guideline for Breast Cancer Screening for
Women at Average Risk is: ``The Women's Preventive Services Initiative
recommends that women at average-risk of breast cancer initiate
mammography screening no earlier than age 40 and no later than age 50.
Screening mammography should occur at least biennially and as
frequently as annually. Women may require additional imaging to
complete the screening process or to address findings on the initial
screening mammography. If additional imaging (e.g., MRI, ultrasound,
mammography) and pathology exams are indicated, those services are also
recommended to complete the screening process for malignancies.
Screening should continue through at least age 74 and age alone should
not be the basis to discontinue screening.
``Women at increased risk should also undergo periodic mammography
screening, however, recommendations for additional services are beyond
the scope of this recommendation.''
Background
WPSI recommends several updates to the language of this Guideline.
The first change is a revision to the title from ``Breast Cancer
Screening for Average-Risk Women'' to ``Breast Cancer Screening for
Women at Average Risk.'' This change to the title was made to be
consistent with changes recommended for the first sentence of this
Guideline and to use person-first language that puts the individual
before the diagnosis or screening modality. WPSI recommends updates to
the first sentence of this Guideline, replacing the phrase ``average-
risk women'' with ``women at average-risk for breast cancer'' to
clarify that the target population for this recommendation is specific
to breast cancer.
Two new sentences were added to follow the first sentence: ``Women
may require additional imaging to complete the screening process or to
address findings on the initial screening mammography. If additional
imaging (e.g., MRI, ultrasound, mammography) and pathology exams are
indicated, those services are also recommended to complete the
screening process for malignancies.'' These modifications address the
circumstances where initial mammography screening for women at average
risk for breast cancer is incomplete or additional action is necessary
to fully complete breast cancer screening for the individual.
Specifically, these two sentences were added to ensure completed
screening for women who were initially screened for breast cancer and
need additional screening tests. Imaging in addition to initial
screening mammography, such as special mammography views, ultrasound,
or MRI, may be needed in individual clinical situations when clinicians
require an enhanced view of breast tissue to differentiate normal from
abnormal findings. A tissue biopsy may also need to be performed to
determine whether abnormal findings are cancer, normal tissue, or other
type of lesion. In an analysis of 405,191 women in the Breast Cancer
Surveillance Consortium breast imaging registry who underwent digital
mammography, 40,557 (10 percent) were recommended for additional
imaging, and 6,628 (1.6 percent) were recommended for biopsy.\1\
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\1\ Nelson HD, O'Meara ES, Kerlikowske K, Balch S, Miglioretti
D. Factors Associated With Rates of False-Positive and False-
Negative Results From Digital Mammography Screening: An Analysis of
Registry Data. Ann Intern Med. 2016 Feb 16;164(4):226-35. doi:
10.7326/M15-0971. Epub 2016 Jan 12. PMID: 26756902; PMCID:
PMC5091936.
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WPSI also has recommended removing the following sentence from the
existing Guideline, ``These screening recommendations are for women at
average risk of breast cancer'' as this information is now included in
the revised first sentence of the updated Guideline. Comments are
sought on these proposed updates.
(3) Patient Navigation for Breast and Cervical Cancer Screening
WPSI is proposing a new Guideline for Patient Navigation for Breast
and Cervical Cancer Screening, as follows: ``The Women's Preventive
Services Initiative (WPSI) recommends patient navigation services for
breast and cervical cancer screening and follow-up, as relevant, to
increase utilization of screening recommendations based on an
assessment of the patient's need for navigation services. Patient
navigation services involve person-to-person (e.g., in-person, virtual,
hybrid models) contact with the patient. Components of patient
navigation services should be individualized.
Services include, but are not limited to, person-centered
assessment and planning, health care access and health system
navigation, referrals to appropriate support services (e.g., language
translation, transportation, and social services), and patient
education.''
Background
WPSI has submitted a new draft clinical recommendation on Patient
Navigation for Breast and Cervical Cancer Screening for review,
comment, and consideration. Recent clinical research has found
consistent effectiveness of patient navigation services for breast and
cervical cancer screening in reducing barriers to screening and follow-
up care, resulting in higher screening rates. Breast cancer screening
rates were 14.1% higher for 35,752 patients randomized to patient
navigation services versus usual care or active controls in a WPSI
meta-analysis of 33 randomized control trials based in U.S. health care
settings. The same meta-analysis showed rates for cervical cancer
screening and follow-up were higher with patient navigation by 15.7%,
based on 22 randomized control trials with 12,221 participants.
Research suggests that patient navigation is effective across a
wide range of health care settings and provider types. In one study
included in WPSI's meta-analysis, prevention care managers working in
federally qualified health centers (FQHCs) who employed patient
navigation services increased breast cancer screening among patients
without a mammogram in the past 18 months to 68% compared to 57% for
patients in usual care.\2\ Another study included in the meta-analysis
analyzed rural Latinas who had not previously undergone recommended
screening. The study found that enhanced education efforts increased
cervical cancer screening to 53.4% as compared to 34% in usual care
without these navigation services.\3\
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\2\ Beach ML, Flood AB, Robinson CM, et al. Can language-
concordant prevention care managers improve cancer screening rates?
Cancer Epidemiol Biomarkers Prev. 2007;16(10):2058-64. doi: 10.1158/
1055-9965.EPI-07-0373. PMID: 17932353.
\3\ Thompson B, Carosso EA, Jhingan E, et al. Results of a
randomized controlled trial to increase cervical cancer screening
among rural Latinas. Cancer. 2017;123(4):666-74. doi: 10.1002/
cncr.30399. PMID: 27787893.
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Research also shows that reducing barriers to screening and follow-
up care can result in earlier identification of breast and cervical
cancer, enabling patients to enter into treatment earlier, preventing
progression of these conditions, improving health outcomes and survival
rates, and ultimately can reduce disparities in cancer morbidity and
mortality. In the meta-analysis, patient navigation services increased
screening and follow-up for breast cancer by 10.2% in populations
described as low-income. Based on this
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clinical evidence that supports the preventive benefits of patient
navigation services for breast and cervical cancer screening, WPSI
recommends adding these patient navigation services to the Guidelines.
Comments are sought on this proposed Guideline.
Members of the public can view the complete updated and new draft
clinical recommendations, as well as the implementation considerations
and research recommendations (which are not part of the Guidelines), by
accessing WPSI's web page at https://www.womenspreventivehealth.org/.
Carole Johnson,
Administrator.
[FR Doc. 2024-24445 Filed 10-21-24; 8:45 am]
BILLING CODE 4165-15-P
