Notice2025-19186
Notice of Request for Comments on Draft Recommendations To Update the HRSA-Supported Women's Preventive Services Guidelines Relating to Screening for Cervical Cancer
Primary source
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Published
October 1, 2025
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 for Cervical Cancer. 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, Health and Human Services, and Treasury have issued regulations and policy guidance which describe how group health plans and health insurance issuers apply the coverage requirements.
Full Text
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<title>Federal Register, Volume 90 Issue 188 (Wednesday, October 1, 2025)</title>
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[Federal Register Volume 90, Number 188 (Wednesday, October 1, 2025)]
[Notices]
[Pages 47313-47314]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-19186]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Notice of Request for Comments on Draft Recommendations To Update
the HRSA-Supported Women's Preventive Services Guidelines Relating to
Screening for Cervical Cancer
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
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SUMMARY: This notice seeks comment on draft recommendations for the
HRSA-supported Women's Preventive Services Guidelines (Guidelines)
relating to Screening for Cervical Cancer. 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, Health and Human Services, 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 October 31, 2025. All comments received on or before this
date will be reviewed and considered by HRSA in determining the
recommended updates that it will support.
ADDRESSES: Public comments must be submitted electronically to HRSA at
<a href="/cdn-cgi/l/email-protection#ddaab8b1b1aab2b0bcb3bebcafb89db5afaebcf3bab2ab"><span class="__cf_email__" data-cfemail="fd8a9891918a92909c939e9c8f98bd958f8e9cd39a928b">[email protected]</span></a>.
FOR FURTHER INFORMATION CONTACT: Kimberly Sherman, HRSA, Maternal and
Child Health Bureau, at (301) 443-8283 or <a href="/cdn-cgi/l/email-protection#1f687a73736870727e717c7e6d7a5f776d6c7e31787069"><span class="__cf_email__" data-cfemail="d0a7b5bcbca7bfbdb1beb3b1a2b590b8a2a3b1feb7bfa6">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under section 1001(5) of the Patient
Protection and Affordable Care Act, Public Law 111-148 (<a href="https://www.govinfo.gov/link/plaw/111/public/148">https://www.govinfo.gov/link/plaw/111/public/148</a>), which added section 2713 to
the Public Health Service Act, 42 U.S.C. 300gg-13 (<a href="https://www.govinfo.gov/link/uscode/42/300gg-13">https://www.govinfo.gov/link/uscode/42/300gg-13</a>), 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
initial Guidelines in 2011.
Since 2016, HRSA has funded cooperative agreements to support the
Women's Preventive Services Initiative (WPSI) to convene clinicians,
academics, and consumer-focused health professional organizations who
are experts in disease prevention and women's health issues to conduct
a rigorous review of current scientific evidence and make
recommendations to HRSA regarding updates to the Guidelines to improve
women's health across the lifespan. After public comment is solicited
and considered, HRSA determines whether to support, in whole or in
part, the recommended updates to the Guidelines.
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 requires incorporation of
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
one draft Guideline:
Screening for Cervical Cancer
The current Guideline for Screening for Cervical Cancer is: ``WPSI
recommends cervical cancer screening for average-risk women aged 21 to
65 years. For women aged 21 to 29 years, the Women's Preventive
Services Initiative recommends cervical cancer screening using cervical
cytology (Pap test) every 3 years. Co-testing with cytology and human
papillomavirus testing is not recommended for women younger than 30
years. Women aged 30 to 65 years should be screened with cytology and
human papillomavirus testing every 5 years or cytology alone every 3
years. Women who are at average risk should not be screened more than
once every 3 years.''
The proposed updated Guideline for Screening for Cervical Cancer
is: ``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 also are recommended to complete the
screening process for malignancies.''
Background
WPSI recommends several updates to the language of this Guideline.
The first change is the use of the full form of WPSI in the first
sentence of the Guideline. 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. Next,
there was a recommendation to add the abbreviation ``hrHPV'' after the
term ``human papillomavirus'' for consistency and increased clarity
that the recommendation is specific to high-risk HPV types.
Corresponding revisions utilizing the abbreviation are provided
throughout the remaining text of the updated recommendation. WPSI also
recommends updates to 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. 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. The last update to
the Guideline adds a sentence on the necessity of additional testing to
complete the cervical cancer screening process (``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
[[Page 47314]]
screening process covers all cases of cervical cancer screening,
regardless if the test was collected by the patient or clinician.
Comments are sought on these proposed updates. Members of the
public can view the complete updated draft clinical recommendation,
evidence review, as well as the implementation considerations and
research recommendations (which are not part of the Guidelines), by
accessing <a href="https://www.hrsa.gov/womens-guidelines">https://www.hrsa.gov/womens-guidelines</a>.
Thomas J. Engels,
Administrator.
[FR Doc. 2025-19186 Filed 9-30-25; 8:45 am]
BILLING CODE 4165-15-P
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