II 118th CONGRESS 2d Session S. 4246 IN THE SENATE OF THE UNITED STATES May 2, 2024 Mrs. Murray (for herself, Ms. Murkowski , Ms. Baldwin , Ms. Collins , Ms. Klobuchar , Mrs. Capito , Ms. Cantwell , Ms. Cortez Masto , Ms. Duckworth , Mrs. Gillibrand , Ms. Hassan , Ms. Hirono , Ms. Rosen , Mrs. Shaheen , Ms. Sinema , Ms. Smith , and Ms. Stabenow ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To improve menopause care and mid-life women's health, and for other purposes.

1. Short title; table of contents (a) Short title This Act may be cited as the Advancing Menopause Care and Mid-Life Women’s Health Act . (b) Table of contents The table of contents for this Act is as follows: Sec. 1. Short title; table of contents. Sec. 2. Research with respect to menopause and mid-life women’s health. Sec. 3. Public health promotion and prevention. Sec. 4. Public health awareness, education, and outreach program on menopause and mid-life women’s health. Sec. 5. Training programs to improve care and treatment of menopausal symptoms. Sec. 6. Centers of excellence in menopause cause and mid-life women's health. Sec. 7. Reporting requirement. Sec. 8. Coordination. 2. Research with respect to menopause and mid-life women’s health (a) NIH research Part A of title IV of the Public Health Service Act ( 42 U.S.C. 281 et seq. ) is amended by adding at the end the following: 404P. Research with respect to menopause and mid-life women’s health (a) Research and innovation (1) In general The Director of NIH, acting through the Director of the Office of Research on Women's Health, shall coordinate and expand research activities conducted by all institutes, centers, and offices of the National Institutes of Health to develop and implement Federal research programs with respect to— (A) the impact of the symptoms and trajectories of changes across the menopausal transition and the postmenopausal period on women’s physical, mental, behavioral, and cognitive health; and (B) the prevention of related adverse health outcomes among women during the menopausal transition and the postmenopausal period. (2) Grants In carrying out paragraph (1), the Director of NIH shall award grants to eligible entities to support— (A) biomedical and public health research and innovation in the development of new treatments and diagnostic testing services for perimenopause and acute and chronic menopausal symptoms; and (B) researchers and clinicians engaged in clinical and translational research on menopause and mid-life women’s health. (3) Eligible entities To be eligible to receive a grant under subsection (b), an entity shall meet such criteria as the Director of NIH may establish, and shall be— (A) an accredited entity that offers education to students in various health professions, such as― (i) a teaching hospital; (ii) an accredited school of medicine, osteopathic medicine, nursing, or pharmacy, or a physician assistant training program, including a historically Black college or university (as defined by the term part B institution in section 322 of the Higher Education Act of 1965 or described in section 326(e)(1) of the Higher Education Act of 1965) or other minority-serving institutions (as described in section 371(a) of the Higher Education Act of 1965)); (iii) a certified behavioral health clinic with an accredited medical or nursing residency program; (iv) an accredited public or nonprofit private hospital with an accredited medical or nursing residency program; (v) an accredited nurse practitioner residency program that includes and accredited nursing residency program; or (vi) a related accredited program engaged in the care, treatment, or management of menopausal symptoms; (B) an academic research institution or other nonprofit research institution; (C) a small business; or (D) such other entity as the Director of NIH may determine appropriate. (b) Research, condition, and disease categorization The Director of NIH shall designate, in the Research, Condition, and Disease Categorization, new categories for chronic or debilitating conditions among women, to analyze and coordinate current and future research on menopause, menopausal symptoms, and short-term and long-term effects of such symptoms on mid-life women’s health. (c) Coordination The Director of the NIH shall coordinate and expand Federal research programs and activities to study acute and chronic menopausal symptoms, including— (1) vasomotor symptoms; (2) osteoporosis; (3) sarcopenia; (4) temporomandibular disorders; (5) joint and nerve pain; (6) trauma, anxiety, depression, mood disorders, and related mental and behavioral health conditions; (7) short-term memory loss; (8) genitourinary conditions; (9) alopecia; (10) vision or hearing impairments; (11) digestive and metabolic disorders; (12) chronic sleep deficiency, insomnia, and related sleep disorders; and (13) other menopausal symptoms and related conditions, as the Director of NIH determines appropriate. (d) Translational research The Secretary shall expand translational research activities to accelerate translation of Federal research on perimenopause and menopausal symptoms and facilitate equitable delivery of perimenopause and menopause care and related mid-life women’s health services. (e) Outreach and engagement The Secretary shall expand outreach and engagement activities with accredited schools of medicine, institutions of higher education, and research institutions to support Federal research activities with respect to menopausal symptoms. . (b) Public health research and data reporting activities Part A of title III of the Public Health Service Act ( 42 U.S.C. 241 et seq. ) is amended by adding at the end the following: 310C. Research relating to mid-life women's health (a) Public health research The Secretary shall expand research activities with respect to the severity and duration of menopausal symptoms and related chronic conditions affecting mid-life health outcomes among women, including mental and behavioral health outcomes. In carrying out activities under this section, the Secretary shall coordinate with existing programs and activities of the Department of Health and Human Services. (b) Health care quality research The Secretary shall expand research, program evaluation, and quality improvement activities to improve health care delivery for the care, treatment, or management of perimenopause and menopausal symptoms and related chronic conditions, including data collection with respect to preventive services that support mid-life health outcomes among women and barriers to care. (c) Dashboard The Secretary shall establish and maintain a dashboard for the reporting of data on menopausal symptoms and mid-life health outcomes among women gathered through public health surveillance activities with respect to screening, testing, treatment, and prevention services, and the impact of this section and section 404P on such efforts. (d) Occupational health research The Secretary shall conduct research activities and expand data collection with respect to workplace stressors related to severe acute or chronic menopausal symptoms, physical injury, or other adverse health outcomes among women, including traumatic stress, anxiety, depression, and related mental and behavioral health conditions. The Secretary shall review existing evidence, identify gaps in services, and develop evidence-informed recommendations for related public health interventions and support services. (e) Interagency coordination The Secretary shall develop and implement new interagency research initiatives or programs to address menopausal symptoms. . (c) Authorization of appropriations For the purpose of carrying out sections 404P and 310C of the Public Health Service Act, as added by subsections (a) and (b), respectively, there are authorized to be appropriated $25,000,000 for each of fiscal years 2025 through 2029. 3. Public health promotion and prevention Title III of the Public Health Service Act ( 42 U.S.C. 241 et seq. ) is amended by adding at the end the following: W Activities to promote mid-life women's health 399OO. Public health promotion activities (a) Chronic conditions and public health promotion The Secretary shall expand public health promotion and prevention activities with respect to mid-life women’s health and chronic conditions, including diabetes, hypertension, heart disease, iron-deficiency anemia, inflammation, fibroids, endometriosis, and other related conditions and adverse health outcomes, at the discretion of the Secretary. (b) Early detection, diagnosis, and treatment (1) In general The Secretary shall award grants to eligible entities to improve the early detection, diagnosis, and treatment of perimenopause and menopausal symptoms and support public health activities to expand access to quality care services and improve mid-life health outcomes among women. (2) Eligible entities To be eligible to receive a grant under paragraph (1), an entity shall― (A) be— (i) a State, local, Tribal, or territorial public health department; (ii) an accredited entity that offers education to students in various health professions; or (iii) such other type of entity, as the Secretary determines appropriate; and (B) submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require. (c) Care coordination The Secretary shall award grants to eligible entities described in subsection (b)(2) to support care coordination and care planning activities, including such activities otherwise supported under this Act, and expand access to quality primary care and specialty care services to improve— (1) mid-life women’s health, including activities to support the integration of primary care and specialty care; (2) bone health and muscle loss; (3) mental and behavioral health care services; (4) joint, nerve, and muscle pain prevention services; (5) digestive and metabolic health; (6) prevention and management of multiple chronic conditions; (7) physical therapy and injury prevention support services for populations affected by acute and chronic menopausal symptoms; and (8) other services that address acute and chronic conditions that affect women’s health in perimenopause and menopause. (d) Mental health and substance use prevention The Secretary shall develop recommendations and best practices to— (1) increase access to mental and behavioral health care services and substance use disorder prevention services for women experiencing perimenopause or menopausal symptoms; and (2) expand substance use disorder treatment, recovery, and support services for women experiencing perimenopause, early menopause, premature menopause, and related conditions. (e) Health care delivery The Secretary shall develop recommendations and best practices for— (1) reducing disparities in the management of menopausal symptoms; (2) improving access to perimenopause and menopause health care services; and (3) providing patient-centered perimenopause and menopause counseling and treatment. (f) Safety and effectiveness The Secretary shall carry out and support— (1) outreach and engagement activities of the Food and Drug Administration with health care providers on perimenopause and menopause and mid-life women’s health; (2) oversight efforts to assess the safety and effectiveness of new diagnostic tools for perimenopause or menopausal symptoms, including devices that use artificial intelligence; and (3) support existing activities of the Department of Health and Human Services to enforce privacy protections for patients. (g) Authorization of appropriations To carry out this section, there are authorized to be appropriated $10,000,000 for each of fiscal years 2025 through 2029. . 4. Public health awareness, education, and outreach program on menopause and mid-life women’s health Part W of title III of the Public Health Service Act ( 42 U.S.C. 241 et seq. ), as added by section 3, is amended by adding at the end the following: 399OO–1. Public health awareness, education, and outreach program on menopause and mid-life women’s health (a) In general The Secretary shall develop and carry out a national awareness, education, and outreach program relating to menopausal symptoms, mid-life women’s health, and related care, treatment, and preventive services directed at patients, health care providers, first responders (such as emergency medical service providers), and related stakeholders. Such awareness, education, and outreach program shall— (1) disseminate educational materials and provide technical assistance for health care providers and patients to support engagement about perimenopause and menopause care and treatment options for menopausal symptoms; (2) help such providers to identify risk factors and prevent injury among women with menopausal symptoms; and (3) address barriers to related care and treatment services for women. (b) Outreach In carrying out this section, the Secretary shall— (1) conduct outreach and education activities related to perimenopause and menopause and mid-life women’s health that— (A) include evidence-based information; and (B) are culturally appropriate, in the case of such outreach and education activities for Indian Tribes; (2) provide opportunities for State, local, Tribal, and territorial public health departments to customize public health awareness, education, and outreach materials for their populations; and (3) prioritize populations in areas affected by barriers to care, including rural and underserved areas. (c) Coordination In carrying out this section, the Secretary shall coordinate with existing awareness, education, and outreach programs and activities of the Department of Health and Human Services. (d) Online resources The Secretary shall develop, operate, and maintain a website to provide educational materials in accessible formats for health care providers, patients, and caregivers, regarding perimenopause, menopause, and mid-life women’s health. Such educational materials may include— (1) webinars, continuing education modules, videos, fact sheets, infographics, stakeholder toolkits, or other materials in formats as appropriate and applicable; and (2) tailored for health care providers, patients, caregivers, and other audiences, as the Secretary determines appropriate. (e) Authorization of appropriations To carry out this section, there are authorized to be appropriated $10,000,000 for each of fiscal years 2025 through 2029. . 5. Training programs to improve care and treatment of menopausal symptoms Part D of title VII of the Public Health Service Act ( 42 U.S.C. 294 et seq. ) is amended by inserting after section 757 ( 42 U.S.C. 294f ) the following: 758. Training programs to improve care and treatment of menopausal symptoms (a) Grants To train health professionals (1) In general The Secretary shall award grants to eligible entities for the purpose described in paragraph (2). (2) Use of funds A grant awarded under this subsection shall be used to develop, establish, or expand training programs (including accredited residency programs, fellowships, or other related clinical training) for physicians, registered nurses, nurse practitioners, physician assistants, pharmacists, other health care providers, and students and trainees to improve care, treatment, or management services for perimenopause, menopausal symptoms, and related chronic conditions. (3) Eligibility To be eligible to receive a grant under this subsection, an entity shall— (A) be— (i) an accredited school of medicine or osteopathic medicine; (ii) an accredited nursing school; (iii) an accredited school of pharmacy; (iv) an accredited public or nonprofit private hospital; (v) an accredited medical residency program; (vi) an accredited nurse practitioner residency program; or (vii) a related training program for clinicians, allied health professionals, or social workers that interface with affected populations, which may include hospitals and research institutions, as determined by the Secretary; and (B) submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require. (b) Training opportunities The Secretary shall expand outreach activities to support and expand training programs, fellowships, and other opportunities for students, faculty, and trainees (including continuing medical education) or establish new training opportunities to address barriers to access to— (1) primary and specialty care services to support mid-life women’s health; and (2) early detection, diagnosis, treatment, and care services for perimenopause, menopausal symptoms, and related chronic conditions. (c) Coordination In carrying out this section, the Secretary shall coordinate with existing awareness, education, and outreach programs and activities of the Department of Health and Human Services. (d) Authorization of appropriations To carry out this section there are authorized to be appropriated $10,000,000 for each of fiscal years 2025 through 2029. . 6. Centers of excellence in menopause cause and mid-life women's health Part W of title III of the Public Health Service Act ( 42 U.S.C. 241 et seq. ), as amended by section 4, is further amended by adding at the end the following: 399OO–2. Centers of excellence in menopause care and mid-life women’s health (a) In general The Secretary shall designate eligible entities as Centers of Excellence in Menopause and Mid-Life Women’s Health, and award grants to such entities, for purposes of improving professional training resources for health care providers on mid-life women’s health with respect to the care, treatment, and management of perimenopause and menopausal symptoms, and related support services. (b) Eligibility To be eligible to receive a designation and grant under subsection (a), an entity shall― (1) be an accredited entity that offers education to students in various health professions, or such other type of entity, as the Secretary determines appropriate; (2) demonstrate community engagement and partnerships with community stakeholders, including entities that train health professionals, social workers, community health centers, health systems administrators, certified behavioral health clinics, and research institutions; and (3) submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require. (c) Activities An entity receiving an award under subsection (a) shall develop and distribute evidence-based resources to health care providers, patients, and public health departments regarding the care, treatment, and management of perimenopause and menopausal symptoms. Such resources may include information on— (1) advancements in the treatment or management of perimenopause and acute or chronic menopausal symptoms; (2) the prevention and treatment of related chronic conditions across different patient populations to support mid-life women’s health; and (3) other topic areas that are relevant to the objectives described in subsection (a). (d) Geographic distribution In awarding grants under subsection (a), the Secretary shall take into account regional differences among eligible entities and ensure equitable geographic distribution. (e) Priority In awarding grants under subsection (a), the Secretary shall prioritize eligible entities that provide services in a health professional shortage area designated under section 332 or to medically underserved populations, as defined in section 330(b)(3). (f) Evaluation Each entity receiving an award under subsection (a) shall submit an annual report to the Secretary on the activities carried out using such award. The Secretary shall evaluate each project carried out by an entity receiving an award under this section and shall report the findings with respect to each such evaluation to appropriate Federal agencies and public and private entities. (g) Authorization of appropriations To carry out this section, there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2025 through 2029. . 7. Reporting requirement (a) Report on activities carried out under this Act Not later than 2 years after the date of enactment of this Act, and every year thereafter, the Secretary of Health and Human Services shall submit to the Committee on Appropriations, the Committee on Health, Education, Labor, and Pensions, the Committee on Finance, the Committee on Homeland Security and Government Affairs, the Committee on Indian Affairs, the Committee on Veterans' Affairs, and the Special Committee on Aging of the Senate and the Committee on Appropriations, the Committee on Energy and Commerce, the Committee on Ways and Means, the Committee on Education and the Workforce, the Committee on Veterans' Affairs, the Committee on Natural Resources, and the Committee on Oversight and Accountability of the House of Representatives a report describing the progress of activities carried out under this Act and the amendments made by this Act. Each such report shall contain— (1) information with respect to Federal research activities related to perimenopause and menopause and mid-life women’s health, including information related public health awareness, education, and outreach activities, including— (A) data and knowledge gaps, or other barriers, related to research, diagnostic testing, and treatments with respect to perimenopause, menopause, menopausal symptoms, and related health outcomes; (B) data or information related to barriers to health care and support services among women experiencing perimenopause or menopausal symptoms in rural and underserved areas; and (C) data or information related to barriers to training opportunities and resources for health care providers serving women experiencing perimenopause or menopausal symptoms in rural and underserved areas; (2) recommendations and best practices for health care providers and public health departments to expand access to care and increase public awareness and understanding of menopausal symptoms and related chronic conditions; and (3) information about related Federal activities, as the Secretary determines appropriate. (b) Report on access to care and treatment Not later than 2 years after the date of enactment of this Act, the Secretary shall release a report on barriers to access to care and treatment services for perimenopause and menopausal symptoms, and recommendations to reduce any such barriers. (c) Authorization of appropriations To carry out this section, there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2025 through 2029. 8. Coordination The Secretary of Health and Human Services shall coordinate activities carried out under this Act (including the amendments made by this Act) with other existing Federal efforts relating to menopausal symptoms, mid-life women’s health, aging, or public health promotion carried out by the Department of Veterans Affairs, the Department of Defense, and other Federal departments and agencies, as appropriate.