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[Federal Register Volume 89, Number 249 (Monday, December 30, 2024)]
[Notices]
[Pages 106522-106525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31228]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

Update to the Health Resources and Services Administration-
Supported Women's Preventive Services Guidelines

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services.

ACTION: Notice.

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SUMMARY: The Health Resources and Services Administration (HRSA) 
published a Federal Register Notice on October 22, 2024, with proposed 
updates to the HRSA-supported Women's Preventive Services Guidelines 
(Guidelines). The proposed updates specifically relate to 
recommendations for Screening and Counseling for Intimate Partner and 
Domestic Violence, Breast Cancer Screening for Women at Average Risk, 
and Patient Navigation Services for Breast and Cervical Cancer 
Screening. Recommendations to update the Guidelines are developed by 
the Women's Preventive Services Initiative (WPSI) for consideration by 
HRSA. WPSI convenes expert health professionals to conduct rigorous 
reviews of the evidence following the National Academy of Medicine 
standards for establishing foundations for and rating strengths of 
recommendations, articulation of recommendations, and external reviews 
and it develops draft recommendations for HRSA's consideration. After 
consideration of public comment, HRSA has accepted the recommendations 
as revised and detailed in this notice. Under applicable law, non-
grandfathered group health plans and health insurance issuers offering 
non-grandfathered group and individual health insurance coverage must 
include coverage, without cost sharing, for certain preventive 
services, including those provided for in the HRSA-supported 
Guidelines. The Departments of Labor, Health and Human Services, and 
the Treasury have previously issued regulations describing how group 
health plans and health insurance issuers apply the coverage 
requirements. Please see https://www.hrsa.gov/womens-guidelines for 
additional information.

FOR FURTHER INFORMATION CONTACT: Kimberly Sherman, HRSA, Maternal and 
Child Health Bureau, telephone: (301) 443-2170, email: 
[email protected].

[[Page 106523]]

SUPPLEMENTARY INFORMATION: Under the Patient Protection and Affordable 
Care Act, Public Law 111-148, the preventive care and screenings set 
forth in the HRSA-supported Women's Preventive Services Guidelines 
(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, developed 
under a contract with the Department of Health and Human Services. 
Since 2016, HRSA has funded cooperative agreements with the American 
College of Obstetricians and Gynecologists for the Women's Preventive 
Services Initiative (WPSI) to convene a coalition representing 
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 adult women's 
health across the lifespan. HRSA then determines whether to support, in 
whole or in part, the recommended updates to the Guidelines.
    WPSI includes 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 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.
    For clarity, note that the Implementation Considerations of the 
WPSI documents address aspects of clinical and practical application of 
the Clinical Recommendations. Research Recommendations are provided to 
highlight areas where further research and clinical trials are needed 
to inform the development of Clinical Recommendations. The 
Implementation Considerations and Research Recommendations sections are 
not a part of the Clinical Recommendations accepted by the HRSA 
Administrator, and therefore have no impact on health insurance 
coverage without cost-sharing.
    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 the updated Guidelines.

Discussion of Recommended Updated Guidelines

    As is standard practice, HRSA published a Federal Register Notice 
seeking public comment regarding the proposed updates to the Guidelines 
(89 FR 84354).\1\ WPSI considered all public comments as part of its 
deliberative process, provided the comments to HRSA for its 
consideration, and submitted final recommended updates for Screening 
and Counseling for Intimate Partner and Domestic Violence, Breast 
Cancer Screening for Women at Average Risk, and Patient Navigation 
Services for Breast and Cervical Cancer Screening. A total of 28 
comments were received and considered.
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    \1\ See https://www.federalregister.gov/documents/2024/10/22/2024-24445/notice-of-request-for-public-comments-on-draft-recommendations-for-the-hrsa-supported-womens.
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Screening and Counseling for Intimate Partner and Domestic Violence

    WPSI largely recommended retaining the existing Guideline on 
Screening and Counseling for Intimate Partner and Domestic Violence 
with several minor updates. The first proposed change was a revision to 
the title of the Guideline, with corresponding revisions throughout, to 
better reflect current clinical terminology by replacing 
``Interpersonal and Domestic Violence'' with ``Intimate Partner and 
Domestic Violence.'' WPSI also recommended 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 improve clarity.
    WPSI received eight comments on these proposed updates. One 
commenter suggested adding universal education as a mechanism to 
address intimate partner violence in health care settings. Based on 
this comment, WPSI added universal education to the Implementation 
Considerations section for the recommendation. Another comment 
recommended an expansion of research into intimate partner violence, 
which WPSI added to the Research Recommendations. Another commenter 
suggested adding referral and consult to a forensic medical examiner to 
the recommendation, which was not accepted as it was not represented in 
the evidence review for this topic. Several commenters supported WPSI's 
recommendations and one suggested the development of continuous care 
frameworks for follow-up services and the use of telehealth in support 
of those services. These comments were not accepted as they are already 
included in the implementation considerations of the recommendation or 
are beyond the scope of the review, which did not include the 
development of a continuous care frameworks. One comment suggested 
alignment with the U.S. Preventive Services Task Force (USPSTF), which 
describes specific populations, including vulnerable patients, and 
another suggested specifying the inclusion of ``older adult women.'' 
These comments were not accepted, as WPSI's evidence review and 
recommendation supports screening of all women, not just certain 
vulnerable populations or age groups.

Breast Cancer Screening for Women at Average Risk

    WPSI recommended several updates to the existing Guideline on 
Breast Cancer Screening for Women at Average Risk. WPSI recommended 
updates to the first sentence of this Guideline, replacing the phrase 
``average-risk women'' with ``women at average risk for breast cancer'' 
to clarify the target population for this recommendation and to use 
person-first language that puts the individual before the diagnosis or 
screening modality. The title was also changed from ``Breast Cancer 
Screening for Average-Risk Women'' to ``Breast Cancer Screening for 
Women at Average Risk'' for similar reasons. Two new sentences were 
added following 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 two sentences were added to ensure women who need 
additional screening to complete their initial screening receive it. 
Imaging in addition to initial screening

[[Page 106524]]

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. WPSI also 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.
    WPSI received thirteen comments on this proposed update. One 
comment requested a definition for ``women at average risk,'' which is 
provided in the full evidence review and will be restated on WPSI's 
website, as the 2016 evidence review defined ``women at average risk'' 
as those without risk factors indicating high risk (includes 
deleterious BRCA mutations and their untested first-degree relatives; 
other hereditary genetic syndromes; previously diagnosed high-risk 
breast lesions; and history of high dose radiation therapy to the chest 
between the ages of 10 to 30 years). Two commenters requested screening 
for women under age 40. No change was made as WSPI did not document new 
evidence changes in its review. Others requested screening for women of 
increased risk. No change was made in response to these comments as 
this specific guideline relates to women at average risk of breast 
cancer. Another comment requested edits to the recommendation related 
to racial disparities and gender inclusivity WSPI made no changes given 
that the proposed recommendation is intended to address all women at 
average risk. Three commenters requested that the recommendation 
address ``annual screening'' and one commenter opposed ending screening 
at age 74. No changes were made based on these comments as they were 
not supported by evidence that met WPSI's inclusion criteria. One 
commenter suggested that the recommendation would be clearer if the 
phrase ``pathology exams'' was changed to ``pathology tests.'' In 
response to this comment, WPSI updated the recommendation to 
``pathology evaluation'' to improve clarity. Multiple commenters 
requested language to address dense breast tissue, and one recommended 
using digital mammography for women with dense breast tissue. While 
there are currently no randomized controlled trials to support separate 
recommendations for women with dense breasts, the updated clinical 
recommendation supports additional testing to complete initial 
screening, if needed, which may be more common for women with dense 
breasts. No changes were made in response to these comments. One 
comment recommended WPSI align with the U.S. Preventive Services Task 
Force (USPSTF) recommendations on breast cancer screening. No changes 
were made in response to this comment as WPSI's charge differs from 
that of the USPSTF, with WPSI's statutory authority including coverage 
of additional preventive care and screenings not described in evidence-
based items or services that have a rating of ``A'' or ``B'' in the 
current recommendations of the USPSTF.

Patient Navigation Services for Breast and Cervical Cancer Screening

    Based on clinical research, patient navigation services for breast 
and cervical cancer screening have been found to be effective in 
reducing barriers to screening and follow-up care, resulting in higher 
screening rates. WPSI recommended a new Guideline on Patient Navigation 
Services for Breast and Cervical Cancer Screening. 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. 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.
    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.
    WPSI received seven comments on this proposed recommendation. 
Comments were generally supportive and WPSI appreciated the positive 
feedback. Two commenters recommended adding culturally appropriate 
components to patient navigation services and addressing relevant 
social determinants of health. No changes were made based on these 
comments as these considerations are outlined in the Implementation 
Considerations section. Three commenters requested including billing 
and coding guidance to support the implementation of the 
recommendation. One comment suggested it may be premature to release 
the guideline without such information. Under its cooperative agreement 
with HRSA, WPSI develops tools and resources for patients and providers 
that include information on billing and coding, which will be updated 
to address these patient navigation services. Another comment requested 
WPSI expand the Research Recommendations to include comparative 
effectiveness trials of patient navigation services. WPSI updated the 
Research Recommendations to include this suggestion. Two commenters 
questioned the level of evidence available to support the guideline and 
one of them requested the evidence review. The October 22, 2024, 
Federal Register notice provided data from the WPSI evidence review to 
detail the clinical effect of the proposed recommendation and the final 
evidence review includes a comprehensive listing of the clinical 
evidence considered by WSPI. A final comment requested cervical cancer 
screening guidelines be updated. WPSI will begin reviewing the evidence 
for cervical cancer screening in 2025, if funds are available to 
support the review.

Acceptance of Recommendation

    On December 20, 2024, the HRSA Administrator accepted WPSI's 
recommendations, which are revised as described above, and, as such, 
updated the HRSA-supported Women's Preventive Services Guidelines. The 
final Guidelines for these topics read as follows:

(1) Screening and Counseling for Intimate Partner and Domestic Violence

    The final Guideline for Screening and Counseling for Intimate 
Partner and Domestic Violence reads: ``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.

[[Page 106525]]

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.''

(2) Breast Cancer Screening for Women at Average Risk

    The final Guideline for Breast Cancer Screening for Women at 
Average Risk reads: ``The Women's Preventive Services Initiative 
recommends that women at average risk of breast cancer initiate 
mammography screening no earlier than age 40 years and no later than 
age 50 years. 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., magnetic resonance 
imaging (MRI), ultrasound, mammography) and pathology evaluation are 
indicated, these services also are recommended to complete the 
screening process for malignancies. Screening should continue through 
at least age 74 years, and age alone should not be the basis for 
discontinuing screening.
    Women at increased risk also should undergo periodic mammography 
screening, however, recommendations for additional services are beyond 
the scope of this recommendation.''

(3) Patient Navigation Services for Breast and Cervical Cancer 
Screening

    The final Guideline for Patient Navigation Services for Breast and 
Cervical Cancer Screening reads: ``The Women's Preventive Services 
Initiative 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 needs 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.''
    Non-grandfathered group health plans and health insurance issuers 
offering group or individual health insurance coverage must cover 
without cost-sharing the services and screenings listed on the updated 
Women's Preventive Services Guidelines for plan years (in the 
individual market, policy years) that begin 1 year after this date. 
Thus, for most plans, this update will take effect for purposes of the 
Section 2713 coverage requirement in 2026. Additional information 
regarding the Women's Preventive Services Guidelines can be accessed at 
the following link: https://www.hrsa.gov/womens-guidelines.
    Authority: Section 2713(a)(4) of the Public Health Service Act, 42 
U.S.C. 300gg-13(a)(4).

Carole Johnson,
Administrator.
[FR Doc. 2024-31228 Filed 12-27-24; 8:45 am]
BILLING CODE 4165-15-P
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