Notice2024-24445
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
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Published
October 22, 2024
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
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.
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<title>Federal Register, Volume 89 Issue 204 (Tuesday, October 22, 2024)</title>
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[Federal Register Volume 89, Number 204 (Tuesday, October 22, 2024)]
[Notices]
[Pages 84354-84357]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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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[[Page 84355]]
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 <a href="https://www.womenspreventivehealth.org/">https://www.womenspreventivehealth.org/</a>.
FOR FURTHER INFORMATION CONTACT: Kimberly Sherman, HRSA, Maternal and
Child Health Bureau, telephone (301) 443-8283, email:
<a href="/cdn-cgi/l/email-protection#7106141d1d061e1c101f1210031431190302105f161e07"><span class="__cf_email__" data-cfemail="dcabb9b0b0abb3b1bdb2bfbdaeb99cb4aeafbdf2bbb3aa">[email protected]</span></a>.
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.
[[Page 84356]]
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
[[Page 84357]]
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 <a href="https://www.womenspreventivehealth.org/">https://www.womenspreventivehealth.org/</a>.
Carole Johnson,
Administrator.
[FR Doc. 2024-24445 Filed 10-21-24; 8:45 am]
BILLING CODE 4165-15-P
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