Notice2024-31228
Update to the Health Resources and Services Administration-Supported Women's Preventive Services Guidelines
Primary source
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Published
December 30, 2024
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 249 (Monday, December 30, 2024)</title>
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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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.hrsa.gov/womens-guidelines">https://www.hrsa.gov/womens-guidelines</a> for
additional information.
FOR FURTHER INFORMATION CONTACT: Kimberly Sherman, HRSA, Maternal and
Child Health Bureau, telephone: (301) 443-2170, email:
<a href="/cdn-cgi/l/email-protection#1760727b7b60787a767974766572577f65647639707861"><span class="__cf_email__" data-cfemail="f582909999829a98949b96948790b59d878694db929a83">[email protected]</span></a>.
[[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 <a href="https://www.federalregister.gov/documents/2024/10/22/2024-24445/notice-of-request-for-public-comments-on-draft-recommendations-for-the-hrsa-supported-womens">https://www.federalregister.gov/documents/2024/10/22/2024-24445/notice-of-request-for-public-comments-on-draft-recommendations-for-the-hrsa-supported-womens</a>.
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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: <a href="https://www.hrsa.gov/womens-guidelines">https://www.hrsa.gov/womens-guidelines</a>.
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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