[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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[[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 https://www.womenspreventivehealth.org/.

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 https://www.womenspreventivehealth.org/.

Carole Johnson,
Administrator.
[FR Doc. 2024-24445 Filed 10-21-24; 8:45 am]
BILLING CODE 4165-15-P


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