Update to the Women's Preventive Services Guidelines

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<title>Federal Register, Volume 91 Issue 2 (Monday, January 5, 2026)</title>
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[Federal Register Volume 91, Number 2 (Monday, January 5, 2026)]
[Notices]
[Pages 283-287]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-24235]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

Update to the Women's Preventive Services Guidelines

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

ACTION: Notice.

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SUMMARY: The Health Resources and Services Administration (HRSA)
published a Federal Register Notice on October 1, 2025, with proposed
updates to the HRSA-supported Women's Preventive Services Guidelines
(Guidelines). The proposed updates specifically relate to
recommendations for Screening for Cervical Cancer. Recommendations to
update the Guidelines are developed under a

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HRSA-funded cooperative agreement, the Women's Preventive Services
Initiative (WPSI), for consideration by HRSA. Under this agreement,
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 developed 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, HHS, 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#82f5e7eeeef5edefe3ece1e3f0e7c2eaf0f1e3ace5edf4"><span class="__cf_email__" data-cfemail="addac8c1c1dac2c0ccc3ceccdfc8edc5dfdecc83cac2db">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under the Patient Protection and Affordable
Care Act, Public Law 111-148, the preventive care and screenings set
forth in the 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 HHS. Since 2016, HRSA has
funded cooperative agreements for 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.
For clarity, note that the Implementation Considerations 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. In the description of responses to the public comments below,
the term ``recommendation'' is sometimes used in place of ``Clinical
Recommendation.''
Recommended updates to the Guidelines are based on review and
synthesis of existing clinical guidelines and new scientific evidence,
following robust standards for establishing foundations for and rating
strengths of recommendations, articulation of recommendations, and
external reviews. Additionally, HRSA provides opportunity for public
comment, including participation by patients and consumers, in the
development of the Guidelines.

Discussion of Recommended Updated Guideline

As is standard practice, HRSA published a Federal Register Notice
seeking public comment regarding the proposed updates to the Guidelines
for Screening for Cervical Cancer (90 FR 47313 (Oct. 1, 2025)). All
public comments were reviewed and considered as part of the
deliberative process. A total of 42 responses were received, with each
response containing one or more distinct comments.

Screening for Cervical Cancer

WPSI recommended retaining the existing Guideline on Screening for
Cervical Cancer, with several updates to the language. Language of the
final Clinical Recommendation is set out at the end of this Notice.
<bullet> The first change is the use of the full form of Women's
Preventive Services Initiative, instead of the acronym WPSI, in the
first sentence of the Guideline.
<bullet> The second change occurs in the second sentence of the
Guideline and only restructures the sentence for clarity and does not
provide any changes to the recommendation.
<bullet> Next, the abbreviation ``hrHPV'' was added after the term
``human papillomavirus'' for consistency and increased clarity that the
recommendation is specific to high-risk HPV types. Corresponding
revisions using the abbreviation are provided throughout the remaining
text of the updated recommendation.
<bullet> The word ``co-testing'' was previously unhyphenated in the
recommendation; a hyphen was added in the latest version of the
recommendation.
<bullet> WPSI updated the Guideline regarding cervical cancer
testing for women aged 30-65 and added ``primary hrHPV testing every 5
years (preferred) or cytology and hrHPV testing (co-testing) every 5
years. If hrHPV testing is not available, continue screening with
cytology alone every 3 years.'' This update reflects current evidence-
based practice on testing and interval screening.
<bullet> Next, a new sentence was added (``Patient-collected hrHPV
testing is an appropriate method and should be offered as an option for
cervical cancer screening in women aged 30 to 65 years at average
risk.'') to reflect the new evidence and developments supporting the
expansion of options for cervical cancer screening through patient-
collected hrHPV testing.
<bullet> The last update to the Guideline adds language on
additional testing to complete the cervical cancer screening process
(``Additional testing may be required to complete the screening process
and follow-up findings on the initial screening. If additional testing
(e.g., cytology, biopsy colposcopy, extended genotyping, dual stain)
and pathologic evaluation are indicated, these services also are
recommended to complete the screening process for malignancies.'').
This update ensures the screening process for malignancies is complete
should additional testing services (e.g., cytology, biopsy colposcopy,
extended genotyping, dual stain) and pathologic evaluation be
clinically indicated. Additional testing to complete the screening
process covers all cases of cervical cancer screening, regardless of
whether the test was collected by the patient or clinician.
HRSA received 42 responses on these proposed updates, with each
response containing one or more distinct comments. Public comments were
largely positive about the updated Guideline, with an overwhelming
majority of respondents expressing support for at least one component
of the recommendation. The comments have been reviewed and organized
into categories, with overview summaries of comments and responses
provided below:
<bullet> Adjusting Screening by Risk-Level/Defining Average Risk:
[cir] Comments: Thirteen comments suggested adjustments to
screening by risk, socioeconomic group, or age with

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some requesting screening past 65, before age 20, and others requesting
screening begin at age 25 in alignment with other guidelines. Four of
these comments requested a definition for average risk.
[cir] Response: The evidence review did not determine a need to
change the age for the start or stop of screening. Among the five major
guidelines for average-risk women examined in the evidence review, four
aligned on the same starting age, and all five recommended concluding
screening at age 65. These guidelines are meant for average-risk women,
a definition of which is available in the full evidence review (<a href="https://www.hrsa.gov/sites/default/files/hrsa/about/cervical-cancer-screening-update.pdf">https://www.hrsa.gov/sites/default/files/hrsa/about/cervical-cancer-screening-update.pdf</a>); the Implementation Considerations also provides notes
around how WPSI defines average-risk. Screening approaches for those at
high-risk are outside the scope of these recommendations. At present,
the evidence does not support tailoring screening approaches based on
socioeconomics. Accordingly, these comments were not accepted and no
change was made in response to these comments.
<bullet> Uniform Data System/Healthcare Effectiveness and Data
Information Set Alignment:
[cir] Comments: Ten comments noted that the addition of self-
collection for cervical cancer screening provides the opportunity for
HRSA to collect information through its Uniform Data System (UDS) for
health centers for ``member-collected samples'' for cervical cancer
screening that would align with an existing measure noted in the 2024
Healthcare Effectiveness and Data Information Set (HEDIS) General
Guidelines used by health plans; one of these commentors requested UDS
be revised to adopt the HEDIS measure language.
Another comment recommended that specific language be added to the
recommendation to improve data collection in the UDS by socioeconomic
subgroups as well as metrics regarding issues with screening (such as
``never-screened,'' ``delayed-initiation,'' etc.).
[cir] Response: While these comments go beyond the scope of this
evidence review and recommendation, and thus no changes were made to
the recommendation, HRSA has shared these observations and suggestions
with HRSA staff that administer the Health Center Program, including
UDS.
<bullet> Supporting Implementation, Follow-up Care, and Public
Education:
[cir] Comments: Seven comments were provided that focused on
supporting implementation, follow-up, and public education on the
updated recommendation. Six of these comments requested more support/
systems to address follow-up of positive results for home-based self-
collection, particularly given concerns around loss to follow-up and
access for underserved populations. One of these comments specifically
requested expansion of community-based services and language on patient
navigation for follow-up.
[cir] Response: While these comments go beyond the scope of this
evidence review and recommendation, it should be noted that starting
January 1, 2026, the evidence-based WPSI Patient Navigation Services
for Breast and Cervical Cancer Screening Guideline, 89 FR 106522 (Dec.
30, 2024), takes effect, providing person-to-person navigation services
without patient copay. A reminder of this recommendation has been added
to the Implementation Considerations and additional research on the
impact of patient navigation on follow-up care is already noted in the
Research Recommendations.
[cir] Comments: Two comments requested more language delineating
all necessary follow-up procedures/care or circumstances for additional
testing; one of these requested specific language on an in-person
follow-up visit for positive self-collected test results.
[cir] Response: While specific follow-up procedures and management
of abnormal results are beyond the scope of the evidence review and
recommendation, a note has been added to the Implementation
Considerations stating follow-up for abnormal test results should
follow established clinical guidelines.
[cir] Comments: Three of the seven comments suggested more robust
outreach and education efforts, with one of the three asking for
education to be tailored to highest need.
[cir] Response: While these comments go beyond the scope of this
evidence review and recommendation, additional language has been added
to the Implementation Considerations on the importance of patient-
centered discussion and education, as well as the WPSI Patient
Navigation Services for Breast and Cervical Cancer Screening Guideline,
as noted above.
<bullet> Equal Preference for hrHPV, Cytology, and Co-Testing/
Adjusting Preferences:
[cir] Comments: Seven comments requested equal weight be given to
cytology, hrHPV, and co-testing, removing the preference for primary
hrHPV testing; a number of these comments mentioned a desire to align
with the draft 2024 U.S. Preventive Services Task Force (USPSTF)
guideline. One comment requested cytology be used in conjunction with
hrHPV testing.
[cir] Response: As per the 2025 WPSI evidence review, newer
evidence released since the 2024 USPSTF evidence review informs primary
hrHPV based screening for the 30 to 65 year age group as the preferred
method, with increased detection of precancer compared with cytology-
based screening and lower rates of precancer with subsequent screening
seen with this modality. As such, these comments were not accepted and
no change was made in response to these comments.
<bullet> FDA Intended Use for Self-Collection and Other:
[cir] Comments: Six comments mentioned concerns related to FDA
approvals, and included concern that the FDA intended use for self-
collected samples is only for situations when a clinician-collected
sample cannot be obtained, a desire to note in the recommendation that
FDA approvals are required for use, or other perceived FDA-related/
regulatory limitations.
[cir] Response: In May 2025, the FDA approved the first at-home
cervical cancer screening self-collection kit; this follows their
earlier May 2024 approval of in-clinic self-collection kits for the
same purpose. To provide additional clarity, a note was added to the
Implementation Considerations on FDA approved methods.
<bullet> Self-Collection Screening Frequency Changed to Shorter
Interval:
[cir] Comments: Five comments requested a shorter screening
frequency for self-collected samples.
[cir] Response: No changes were made to the recommendation as self-
collected samples had a similar test accuracy as clinician-collected
samples and WPSI's evidence review did not support changing to an
increased frequency of screening. A Research Recommendation has been
added to address this.
<bullet> Self-Collections as a Secondary Option:
[cir] Comments: Five comments recommended self-collection as a
secondary option or that it be considered only for select populations.
[cir] Response: The WPSI evidence review concluded that self-
collected vaginal hrHPV has similar test accuracy for precancer when
compared to clinician-collected samples, yielding similar proportions
of positive screening results. Self-collection can also increase
screening uptake, which facilitates earlier detection of cervical
disease. Earlier detection is associated with improved treatment
outcomes and, ultimately, the potential to prevent more

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cervical cancer-related deaths. Accordingly, these comments were not
accepted and no change was made in response to these comments.
<bullet> Lack of U.S. Data:
[cir] Comments: Three commentors mentioned a concern over the use
of European studies or the lack of U.S. data around self-collection or
preference for primary hrHPV testing.
[cir] Response: The studies used in the WPSI evidence review were
comparable to the broader U.S. population for the research questions
examined. Most comparative screening studies used in the WPSI Evidence
Review's analysis were conducted in countries with organized screening
programs similar to the U.S., along with one large population cohort
study conducted in a U.S. health setting with an organized screening
program representing a diverse group of patients. Accordingly, these
comments were not accepted and no change was made to the recommendation
in response to these comments.
<bullet> Clarifications on Additional Screening to Complete the
Screening Process:
[cir] Comments: Two comments requested defining ``additional
screening'' and what constitutes the end of screening, particularly for
the purposes of billing and coding, with one of these comments
requesting information on what to do about inconclusive results and two
comments requesting guidance on coding and billing for the additional
tests.
[cir] Response: This change to the recommendation was made in
alignment with similar language in the breast cancer screening
guideline, added in 2024, which also recommended additional testing to
complete the screening process for malignancies. While billing and
coding are not specifically addressed by the Clinical Recommendation,
the Center for Consumer Information and Insurance Oversight and the
tri-department committee, made up of the Department of Labor, the
Department of the Treasury, and HHS, makes determinations regarding
coverage and can be approached for assistance with billing and coding.
As reflected in the recommendation, an inconclusive result would
require additional testing to complete the screening process. As such,
no change to the recommendation was made in response to these comments.
<bullet> For and Against Extended Genotyping During Primary
Screening:
[cir] Comments: One commenter noted that they do not recommend
routine extended genotyping with primary screening and appreciated the
addition of ``hr'' in front of HPV to help indicate this, while another
two comments requested including extended genotyping as part of primary
screening.
[cir] Response: No changes were made to the recommendation as there
was no evidence to support extended genotyping during primary screen
for average risk populations.
<bullet> Additional Technical Details Requested Comments and
Responses:
[cir] Three comments requested additional technical details.
One of these comments requested additional technical details
including a need to test patients/partners for anal and oropharyngeal
HPV, which was outside the scope of this recommendation and thus no
change was made.
One comment requested exit screening protocols, which is already
mentioned in the Implementation Considerations.
An additional comment supported hrHPV as the preferred method of
testing but suggested including language indicating that other forms of
screening, such as co-testing, are also effective. This language is
reflected in the existing recommendation, thus no additional changes
were made.
<bullet> Single Comments and Responses:
[cir] Single comments were received on the following topics:
One commenter requested the evidence review, which can be accessed
by visiting HRSA's Women's Preventive Services Guidelines pages <a href="https://www.hrsa.gov/womens-guidelines">https://www.hrsa.gov/womens-guidelines</a>). No change was made to the
recommendation in response to this comment.
One comment was concerned the recommendation may lead to women
having fewer gynecologic exams and potential increases in associated
cancers. No changes were made as this recommendation does not change
existing WPSI recommendations around the annual well-woman visit or any
existing preventive cancer screenings connected to ongoing well-woman
care.
One comment shared a concern that the recommendation will weaken
reimbursement and institutional support. This comment was beyond the
scope of the evidence review and recommendation, and no change was
made.
One comment stressed the need to ensure scientific integrity for
the development of the recommendation, which is a shared priority for
HHS and HRSA. The evidence-based guideline development process is
described elsewhere in this notice. No change was made to the
recommendation in response to this comment.
One comment requested more inclusive language. No change was made
based on this comment, as the guideline relates to all women at average
risk of cervical cancer.
One comment requested a Research Recommendation to better assess
age for first screening, which was added to the Research
Recommendations.
Another comment requested more research on the best ways for
providers to communicate to underserved groups. No change was made in
response to this comment, as this goes beyond the scope of this
evidence review and recommendation.
One commenter suggested adding a comma between ``biopsy'' and
``colposcopy'' in the final recommendation. The guideline was updated
to include this grammatical edit, which does not change the substance
or intent of the recommendation.

Acceptance of Recommendation

On December 29, 2025, the HRSA Administrator accepted WPSI's
recommendation, which is revised as described above, and, as such,
updated the HRSA-supported Women's Preventive Services Guidelines. The
final Guideline for this topic reads as follows:

Screening for Cervical Cancer

``The Women's Preventive Services Initiative recommends cervical
cancer screening for average-risk women aged 21 to 65 years. For women
aged 21 to 29 years, cervical cancer screening using cervical cytology
(Pap test) every 3 years is recommended. Co-testing with cytology and
human papillomavirus (hrHPV) testing is not recommended for women
younger than 30 years. Women aged 30 to 65 years should be screened
with primary hrHPV testing every 5 years (preferred) or cytology and
hrHPV testing (co-testing) every 5 years. If hrHPV testing is not
available, continue screening with cytology alone every 3 years. Women
who are at average risk should not be screened more than once every 3
years. Patient-collected hrHPV testing is an appropriate method and
should be offered as an option for cervical cancer screening in women
aged 30 to 65 years at average risk. Additional testing may be required
to complete the screening process and follow-up findings on the initial
screening. If additional testing (e.g., cytology, biopsy, colposcopy,
extended genotyping, dual stain) and pathologic evaluation are
indicated, these services

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also are recommended to complete the screening process for
malignancies.''
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 2027. 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).

Thomas J. Engels,
Administrator.
[FR Doc. 2025-24235 Filed 1-2-26; 8:45 am]
BILLING CODE 4165-15-P

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Update to the Women's Preventive Services Guidelines

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