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[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 10763 Introduced in House (IH)]
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119th CONGRESS
2d Session
H. R. 10763
To direct the Secretary of Health and Human Services to submit to
Congress a report on breast cancer risk assessment tools, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
October 6, 2026
Ms. Letlow introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To direct the Secretary of Health and Human Services to submit to
Congress a report on breast cancer risk assessment tools, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Know Your Risk Act''.
SEC. 2. FINDINGS.
Congress finds the following:
(1) In 2026, approximately 382,640 women in the United
States will be diagnosed with breast cancer.
(2) Early detection of breast cancer is associated with
improved survival rates, including a 5-year relative survival
rate of approximately 99 percent for cancers detected at a
localized stage.
(3) In the United States alone, women have a 1-in-8
lifetime risk of being diagnosed with breast cancer.
(4) Approximately 85 percent of individuals diagnosed with
breast cancer have no family history of the disease.
(5) The risk that an individual will develop breast cancer
is influenced by factors including age, race, ethnicity,
genetic mutations, reproductive history, breast density, family
history, and exposures to certain drugs.
(6) Most risk factors for breast cancer do not directly
cause cancer but do increase the chance of DNA damage in cells
that may lead to breast cancer.
(7) Breast cancer risk assessment tools support health care
providers in estimating the risk that a woman will develop
breast cancer and informing appropriate screening, detection,
treatment, and prevention strategies.
(8) Multiple breast cancer risk assessment tools exist,
including the National Cancer Institute's Gail Model and the
Tyrer-Cuzick Risk Assessment Calculator.
(9) Despite the availability of such tools, there is no
single, centralized, or widely recognized breast cancer risk
assessment tool for patients, providers, and health systems.
(10) Strengthening education and awareness of breast cancer
risks and of tools that assess such risks can alleviate
disparities in early detection and treatment across geographic
regions, age groups, and health care settings.
(11) In 2025, the Food and Drug Administration granted De
Novo authorization to the first artificial intelligence-based
mammogram risk assessment tool to predict breast cancer risk,
further expanding the range of available tools but also
increasing the need for improved coordination and evaluation of
methodologies to reach a broader range of women.
(12) Increasing Federal investments in breast cancer
research and strengthening public-private partnerships is
essential to streamline the current patchwork of breast cancer
risk assessment tools to improve consistency and access while
enabling earlier and more accurate detection for women
nationwide.
SEC. 3. REPORT ON BREAST CANCER RISK ASSESSMENT TOOLS.
(a) In General.--Not later than 180 days after the date of
enactment of this Act, the Secretary of Health and Human Services shall
submit to Congress a report that includes--
(1) identification of inaccuracies resulting from the use
of existing breast cancer risk assessment tools;
(2) gaps in use of existing breast cancer risk assessment
tools among different populations; and
(3) factors that contribute to such inaccuracies and gaps
in use.
(b) Development of Comprehensive Breast Cancer Risk Assessment
Tool.--The report under subsection (a) shall include--
(1) an outline of the planning needed to create a single
breast cancer risk assessment tool that is comprehensive and
publicly accessible;
(2) strategies to provide for public awareness of such a
breast cancer risk assessment tool; and
(3) recommendations on how to build consensus on the
development of such a breast cancer risk assessment tool
among--
(A) patients;
(B) medical providers;
(C) institutions of higher education;
(D) for-profit and nonprofit entities;
(E) health care entities (as defined in section
60.3 of title 45, Code of Federal Regulations (or any
successor regulation)); and
(F) other entities, as the Secretary determines
relevant.
SEC. 4. BREAST CANCER RISK ASSESSMENT REQUIREMENT IN GRANT PROGRAMS.
(a) Breast Cancer Risk Assessment Requirement.--
(1) Grant requirements.--Section 1501(a) of the Public
Health Service Act (42 U.S.C. 300k) is amended--
(A) in paragraph (1), by inserting ``conduct
evidence-based breast cancer risk assessments and to''
before ``screen women'';
(B) in paragraph (4), by inserting ``, including
training on and clinical application of validated
breast cancer risk assessment models'' before the
semicolon at the end;
(C) in paragraph (5), by striking ``; and'' and
inserting a semicolon;
(D) by redesignating paragraph (6) as paragraph
(9);
(E) by inserting after paragraph (5) the following:
``(6) to implement standardized, evidence-based breast
cancer risk assessment tools in appropriate clinical settings,
including through integration into electronic health record
systems;
``(7) to develop and disseminate public information and
education programs regarding breast cancer risk factors,
individualized risk assessment, genetic predisposition, and
available risk-reduction strategies;
``(8) to support research, validation, and improvement of
existing breast cancer risk assessment models to improve
accuracy across racial, ethnic, geographic, and age
populations; and''; and
(F) in paragraph (9), as redesignated, by striking
``(5)'' and inserting ``(8)''.
(2) Conforming amendments.--Section 1503 of the Public
Health Service Act (42 U.S.C. 300mm) is amended--
(A) in subsection (a)(4), by striking ``(6)'' and
inserting ``(9)''; and
(B) in subsection (d)(3)(B)(ii), by striking
``(6)'' and inserting ``(9)''.
(b) Risk Assessment Reporting.--Section 1504(i) of the Public
Health Service Act (42 U.S.C. 300n) is amended to read as follows:
``(i) Reports to Secretary.--
``(1) Required reports.--The Secretary may not make a grant
under section 1501 unless the State involved agrees to submit
to the Secretary the report required under paragraph (2) and
such other reports as the Secretary may require with respect to
the grant.
``(2) Risk assessment reporting.--A State receiving a grant
under section 1501 shall submit to the Secretary, at such time
and in such manner as the Secretary may require, information
on--
``(A) the number of individuals receiving breast
cancer risk assessments under the programs of the State
funded through such grant;
``(B) the number and percentage of individuals
receiving breast cancer risk assessments under such
programs identified as being at elevated risk;
``(C) the number of referrals made for enhanced
screening, genetic counseling, preventive therapy, or
other breast cancer risk-reduction services through
such programs; and
``(D) disparities in access to breast cancer risk
assessments and follow-up services among geographic
regions, medically underserved populations, and other
populations, as determined relevant by the
Secretary.''.
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