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[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [H.R. 10763 Introduced in House (IH)] <DOC> 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.''. <all>
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