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S. 5066 · Senate bill · 119th Congress
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(a) Sense of congress concerning investment in lung cancer research.— It is the sense of the Congress that—
(1) lung cancer mortality reduction should be made a national public health priority; and
(2) a comprehensive mortality reduction program coordinated by the Secretary of Health and Human Services is justified and necessary to adequately address and reduce lung cancer mortality.
(b) Lung cancer mortality reduction program.—
(1) In general.— Subpart 1 of part C of title IV of the Public Health Service Act (42 U.S.C. 285 et seq.) is amended by adding at the end the following:
“417H. Lung cancer mortality reduction program.—
(a) In general.— Not later than 6 months after the date of the enactment of the Health Equity and Accountability Act of 2026, the Secretary, in consultation with the Secretary of Defense, the Secretary of Veterans Affairs, the Director of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, the Commissioner of Food and Drugs, the Administrator of the Centers for Medicare & Medicaid Services, the Director of the National Institute on Minority Health and Health Disparities, the Administrator of the Environmental Protection Agency, and other members of the Lung Cancer Advisory Board established under section 7001(d) of the Health Equity and Accountability Act of 2026, shall implement a comprehensive program, to be known as the Lung Cancer Mortality Reduction Program, to achieve a reduction of at least 25 percent in the mortality rate of lung cancer by 2028.
(b) Requirements.— The Program shall include at least the following:
(1) With respect to the National Institutes of Health—
(A) a strategic review and prioritization by the National Cancer Institute of research grants to achieve the goal specified in subsection (a);
(B) the provision of funds to enable the Airway Biology and Disease Branch of the National Heart, Lung, and Blood Institute to expand its research programs to include predispositions to lung cancer, the interrelationship between lung cancer and other pulmonary and cardiac disease, the diagnosis and treatment of such diseases, and the investigation of rising rates of lung cancer in populations that have never smoked, such as among Asian American, Native Hawaiian, and Pacific Islander women;
(C) the provision of funds to enable the National Institute of Biomedical Imaging and Bioengineering to expedite the development of computer-assisted diagnostic, surgical, treatment, and drug-testing innovations to reduce lung cancer mortality, such as through expansion of the Institute’s Quantum Grant Program and Image-Guided Interventions program; and
(D) the provision of funds to enable the National Institute of Environmental Health Sciences to implement research programs relative to the lung cancer incidence.
(2) With respect to the Food and Drug Administration—
(A) activities under section 529B of the Federal Food, Drug, and Cosmetic Act; and
(B) activities under section 561 of the Federal Food, Drug, and Cosmetic Act to expand access to investigational drugs and devices for the diagnosis, monitoring, or treatment of lung cancer.
(3) With respect to the Centers for Disease Control and Prevention, the establishment of an early disease research and management program under section 1511.
(4) With respect to the Agency for Healthcare Research and Quality, the conduct of a biannual review of lung cancer screening, diagnostic, and treatment protocols, and the issuance of updated guidelines.
(5) The promotion (including education) of lung cancer screening within minority and rural populations and the study of the effectiveness of efforts to increase such screening.
(6) The cooperation and coordination of all minority and health disparity programs within the Department of Health and Human Services to ensure that all aspects of the Lung Cancer Mortality Reduction Program under this section adequately address the burden of lung cancer on minority and rural populations including among populations who have never smoked, such as Asian American, Native Hawaiian, and Pacific Islander women.
(7) The cooperation and coordination of all tobacco control and cessation programs within agencies of the Department of Health and Human Services to achieve the goals of the Lung Cancer Mortality Reduction Program under this section with particular emphasis on the coordination of drug and other cessation treatments with early detection protocols.”.
(2) Federal food, drug, and cosmetic act.— Subchapter B of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360aaa et seq.) is amended by adding at the end the following:
“529B. Drugs relating to lung cancer.—
(a) In general.— The provisions of this subchapter shall apply to a drug described in subsection (b) to the same extent and in the same manner as such provisions apply to a drug for a rare disease or condition (as defined in section 526).
(b) Qualified drugs.— A drug described in this subsection is—
(1) a chemoprevention drug for precancerous conditions of the lung;
(2) a drug for targeted therapeutic treatments, including any vaccine, for lung cancer; or
(3) a drug to curtail or prevent nicotine addiction.
(c) Board.— The Board established under section 7001(d) of the Health Equity and Accountability Act of 2026 shall monitor the program implemented under this section.”.
(3) Access to unapproved therapies.— Section 561(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb(e)) is amended by inserting before the period the following: “and shall include expanding access to drugs under section 529B, with substantial consideration being given to whether the totality of information available to the Secretary regarding the safety and effectiveness of an investigational drug, as compared to the risk of morbidity and death from the disease, indicates that a patient may obtain more benefit than risk if treated with the drug”.
(4) CDC.— Title XV of the Public Health Service Act (42 U.S.C. 300k et seq.) is amended by adding at the end the following:
“1511. Early disease research and management program.— The Secretary shall establish and implement an early disease research and management program targeted at the high incidence and mortality rates of lung cancer among minority and low-income populations.”.
(c) Department of defense and department of veterans affairs.— The Secretary of Defense and the Secretary of Veterans Affairs, each in coordination with the Secretary of Health and Human Services, shall engage—
(1) in the implementation within the Department of Defense and the Department of Veterans Affairs, as the case may be, of an early detection and disease management research program for members of the Armed Forces and veterans whose smoking history and exposure to carcinogens during service on active duty in the Armed Forces has increased their risk for lung cancer; and
(2) in the implementation of coordinated care programs for members of the Armed Forces and veterans diagnosed with lung cancer.
(d) Lung cancer advisory board.—
(1) In general.— The Secretary of Health and Human Services shall convene a Lung Cancer Advisory Board (referred to in this section as the “Board”)—
(A) to monitor the programs established under this section (and the amendments made by this section); and
(B) to provide annual reports to the Congress concerning benchmarks, expenditures, lung cancer statistics, and the public health impact of such programs.
(2) Composition.— The Board shall be composed of—
(A) the Secretary of Health and Human Services;
(B) the Secretary of Defense;
(C) the Secretary of Veterans Affairs; and
(D) 2 representatives each from the fields of clinical medicine focused on lung cancer, lung cancer research, imaging, drug development, and lung cancer advocacy, to be appointed by the Secretary of Health and Human Services.
(e) Authorization of appropriations.—
(1) In general.— To carry out this section (and the amendments made by this section), there are authorized to be appropriated $75,000,000 for fiscal year 2027 and such sums as may be necessary for each of fiscal years 2028 through 2029.
(2) Lung cancer mortality reduction program.— The amounts appropriated under paragraph (1) shall be allocated as follows:
(A) $25,000,000 for fiscal year 2027, and such sums as may be necessary for each of fiscal years 2028 through 2030, for the activities described in section 417H(b)(1)(B) of the Public Health Service Act, as added by subsection (b);
(B) $25,000,000 for fiscal year 2027, and such sums as may be necessary for each of fiscal years 2028 through 2030, for the activities described in section 417H(b)(1)(C) of the Public Health Service Act;
(C) $10,000,000 for fiscal year 2027, and such sums as may be necessary for each of fiscal years 2028 through 2030, for the activities described in section 417H(b)(1)(D) of the Public Health Service Act; and
(D) $15,000,000 for fiscal year 2027, and such sums as may be necessary for each of fiscal years 2028 through 2030, for the activities described in section 417H(b)(3) of the Public Health Service Act.
(a) Prostate cancer coordination and education.—
(1) Interagency Prostate Cancer Coordination and Education Task Force.— Not later than 180 days after the date of the enactment of this Act, the Secretary of Veterans Affairs, in cooperation with the Secretary of Defense and the Secretary of Health and Human Services, shall establish an Interagency Prostate Cancer Coordination and Education Task Force (in this section referred to as the “Prostate Cancer Task Force”).
(2) Duties.— The Prostate Cancer Task Force shall—
(A) develop a summary of advances in prostate cancer research supported or conducted by Federal agencies relevant to the diagnosis, prevention, and treatment of prostate cancer, including psychosocial impairments related to prostate cancer treatment, and compile a list of best practices that warrant broader adoption in health care programs;
(B) consider establishing, and advocating for, a guidance to enable physicians to allow screening of men who are age 74 or older, on a case-by-case basis, taking into account quality of life and family history of prostate cancer;
(C) share and coordinate information on research and health care program activities by the Federal Government, including activities related to—
(i) determining how to improve research and health care programs, including psychosocial impairments related to prostate cancer treatment;
(ii) identifying any gaps in the overall research inventory and in health care programs;
(iii) identifying opportunities to promote translation of research into practice; and
(iv) maximizing the effects of Federal Government efforts by identifying opportunities for collaboration and leveraging of resources in research and health care programs that serve individuals who are susceptible to or diagnosed with prostate cancer;
(D) develop a comprehensive interagency strategy and advise relevant Federal agencies in the solicitation of proposals for collaborative, multidisciplinary research and health care programs, including proposals to evaluate factors that may be related to the etiology of prostate cancer, that would—
(i) result in innovative approaches to study emerging scientific opportunities or eliminate knowledge gaps in research to improve the prostate cancer research portfolio of the Federal Government; and
(ii) outline key research questions, methodologies, and knowledge gaps;
(E) develop a coordinated message related to screening and treatment for prostate cancer to be reflected in educational and beneficiary materials for Federal health programs as such materials are updated; and
(F) not later than 2 years after the date of the establishment of the Prostate Cancer Task Force, submit to the expert advisory panels appointed under paragraph (4) to be reviewed and returned within 30 days, and then within 90 days submitted to Congress, recommendations—
(i) regarding any appropriate changes to research and health care programs, including recommendations to improve the research portfolio of the Department of Veterans Affairs, the Department of Defense, the National Institutes of Health, and other Federal agencies to ensure that scientifically based strategic planning is implemented in support of research and health care program priorities;
(ii) designed to ensure that the research and health care programs and activities of the Department of Veterans Affairs, the Department of Defense, the Department of Health and Human Services, and other Federal agencies are free of unnecessary duplication;
(iii) regarding public participation in decisions relating to prostate cancer research and health care programs to increase the involvement of patient advocates, community organizations, and medical associations representing a broad geographical area;
(iv) on how to best disseminate information on prostate cancer research and progress achieved by health care programs;
(v) on how to expand partnerships between public entities, including Federal agencies, and private entities to encourage collaborative, cross-cutting research and health care delivery;
(vi) assessing any cost savings and efficiencies realized through the efforts identified in, and supported through, this subsection and recommending expansion of those efforts that have proved most promising while also ensuring against any conflicts in directives in law;
(vii) identifying key priority action items from among the recommendations specified in clauses (i) through (vi); and
(viii) with respect to the level of funding needed by each agency to implement such recommendations.
(3) Members of the Prostate Cancer Task Force.— The Prostate Cancer Task Force shall be composed of representatives from such Federal agencies as the head of each such applicable agency determines necessary, so as to coordinate a uniform message relating to prostate cancer screening and treatment where appropriate, including representatives of each of the following:
(A) The Department of Veterans Affairs, including representatives of each relevant program area of the Department of Veterans Affairs.
(B) The Prostate Cancer Research Program of the Congressionally Directed Medical Research Program of the Department of Defense.
(C) The Department of Health and Human Services, including, at a minimum, representatives of each of the following:
(i) The National Institutes of Health.
(ii) National research institutes and centers, including the National Cancer Institute, the National Institute of Allergy and Infectious Diseases, and the Office of Minority Health.
(iii) The Centers for Medicare & Medicaid Services.
(iv) The Food and Drug Administration.
(v) The Centers for Disease Control and Prevention.
(vi) The Agency for Healthcare Research and Quality.
(vii) The Health Resources and Services Administration.
(4) Appointing expert advisory panels.— The Prostate Cancer Task Force shall appoint expert advisory panels, as the task force determines appropriate, to provide input and concurrence from—
(A) individuals and organizations from the medical, prostate cancer patient and advocate, research, and delivery communities with expertise in prostate cancer diagnosis, treatment, and research, including practicing urologists, primary care providers, and others; and
(B) individuals with expertise in education and outreach to underserved populations affected by prostate cancer.
(5) Meetings.— The Prostate Cancer Task Force shall convene not less frequently than twice each year, or more frequently as the Secretary of Veterans Affairs determines to be appropriate.
(6) Federal Advisory Committee Act.— The Federal Advisory Committee Act (5 U.S.C. App.) shall apply to the Prostate Cancer Task Force.
(7) Sunset date.— The Prostate Cancer Task Force shall terminate on September 30, 2028.
(b) Prostate cancer research.—
(1) Research coordination program.—
(A) In general.— The Secretary of Veterans Affairs, in coordination with the Secretary of Defense and the Secretary of Health and Human Services, shall establish and carry out a program to coordinate and intensify prostate cancer research.
(B) Elements.— The program established under subparagraph (A) shall—
(i) develop advances in diagnostic and prognostic methods and tests, including biomarkers and an improved prostate cancer screening blood test, including improvements or alternatives to the prostate specific antigen test and additional tests to distinguish indolent from aggressive disease;
(ii) develop a better understanding of the etiology of the disease (including an analysis of lifestyle factors proven to be involved in higher rates of prostate cancer, such as obesity and diet, and in different ethnic, racial, and socioeconomic groups, such as the African-American, Latino or Hispanic, Asian American, Native Hawaiian, Pacific Islander, and American Indian populations and men with a family history of prostate cancer) to improve prevention efforts;
(iii) expand basic research into prostate cancer, including studies of fundamental molecular and cellular mechanisms;
(iv) identify and provide clinical testing of novel agents for the prevention and treatment of prostate cancer;
(v) establish clinical registries for prostate cancer;
(vi) use the National Institute of Biomedical Imaging and Bioengineering and the National Cancer Institute for assessment of appropriate imaging modalities; and
(vii) address such other matters relating to prostate cancer research as may be identified by the Federal agencies participating in such program.
(C) Underserved minority grant program.—
(i) In general.— In carrying out the program established under subparagraph (A), the Secretary shall award grants to eligible entities—
(I) to carry out components of the research outlined in subparagraph (B);
(II) to integrate and build upon existing knowledge gained from comparative effectiveness research; and
(III) to recognize and address—
(aa) the racial and ethnic disparities in the incidence and mortality rates of prostate cancer and men with a family history of prostate cancer;
(bb) any barriers in access to care and participation in clinical trials that are specific to racial, ethnic, and other underserved minorities and men with a family history of prostate cancer;
(cc) outreach and educational efforts to raise awareness among the populations described in item (bb); and
(dd) appropriate access and utilization of imaging modalities.
(ii) Eligible entity defined.— In this subparagraph, the term eligible entity means any public, private, nonprofit, or for-profit organization that the Secretary determines would be capable to conduct medical research and other requirements under this paragraph and is otherwise eligible for research funding from the Federal Government.
(2) Prostate cancer advisory board.—
(A) In general.— There is established in the Office of the Chief Scientist of the Food and Drug Administration a Prostate Cancer Scientific Advisory Board.
(B) Duties.— The board established under subparagraph (A) shall be responsible for accelerating real-time sharing of the latest research data and accelerating movement of new medicines for the treatment of prostate cancer to patients.
(c) Telehealth and rural access pilot projects.—
(1) Establishment of pilot projects.—
(A) In general.— The Secretary of Veterans Affairs, in cooperation with the Secretary of Defense and the Secretary of Health and Human Services (referred to in this subsection collectively as the “Secretaries”) shall establish four-year telehealth pilot projects for the purpose of analyzing the clinical outcomes and cost-effectiveness associated with telehealth services in a variety of geographic areas that contain high proportions of medically underserved populations, including African Americans, Latinos or Hispanics, Asian Americans, Native Hawaiians, Pacific Islanders, American Indians, and Alaska Natives, and those in rural areas.
(B) Efficient and effective care.— Pilot projects established under subparagraph (A) shall promote efficient use of specialist care through better coordination of primary care and physician extender teams in underserved areas and more effectively employ tumor boards to better counsel patients.
(2) Eligible entities.—
(A) In general.— The Secretaries shall select eligible entities to participate in the pilot projects established under this subsection.
(B) Priority.— In selecting eligible entities to participate in the pilot projects under this subsection, the Secretaries shall give priority to entities located in medically underserved areas, particularly those that include African Americans, Asian Americans, Native Hawaiians, Pacific Islanders, Latinos and Hispanics, and facilities of the Indian Health Service, including facilities operated by the Indian Health Service, tribally operated facilities, and facilities administered by an Urban Indian organization (as defined in section 4 of the Indian Health Care Improvement Act (25 U.S.C. 1603)) pursuant to title V of that Act (25 U.S.C. 1651 et seq.), and those in rural areas.
(3) Evaluation.— The Secretaries shall, through the pilot projects established under this subsection, evaluate—
(A) the effective and economic delivery of care in diagnosing and treating prostate cancer with the use of telehealth services in medically underserved and Tribal areas including collaborative uses of health professionals and integration of the range of telehealth and other technologies;
(B) the effectiveness of improving the capacity of nonmedical providers and nonspecialized medical providers to provide health services for prostate cancer in medically underserved and Tribal areas, including the exploration of innovative medical home models with collaboration between urologists, other relevant medical specialists, including oncologists, radiologists, and primary care teams, and coordination of care through the efficient use of primary care teams and physician extenders; and
(C) the effectiveness of using telehealth services to provide prostate cancer treatment in medically underserved areas, including the use of tumor boards to facilitate better patient counseling.
(4) Report.— Not later than one year after the completion of the pilot projects under this subsection, the Secretaries shall submit to Congress a report describing the outcomes of such pilot projects, including any cost savings and efficiencies realized, and providing recommendations, if any, for expanding the use of telehealth services.
(d) Education and awareness.—
(1) Campaign.—
(A) In general.— The Secretary of Veterans Affairs shall develop a national education campaign for prostate cancer.
(B) Elements.— The campaign developed under subparagraph (A) shall involve the use of written educational materials and public service announcements consistent with the findings of the Prostate Cancer Task Force under subsection (a) that are intended to encourage men to seek prostate cancer screening when appropriate.
(2) Racial disparities and the population of men with a family history of prostate cancer.— In developing the campaign under paragraph (1), the Secretary of Veterans Affairs shall ensure that educational materials and public service announcements used in the campaign are more readily available in communities experiencing racial disparities in the incidence and mortality rates of prostate cancer and to men of any race classification with a family history of prostate cancer.
(3) Grants.— In carrying out the campaign under this subsection, the Secretary of Veterans Affairs shall award grants to nonprofit private entities to enable such entities to test alternative outreach and education strategies.
(e) Authorization of appropriations.— There is authorized to be appropriated to carry out this section for the period of fiscal years 2027 through 2031 an amount equal to the amount of savings for the Federal Government projected to be achieved over such period by implementation of this section.
(a) Research and development of prostate cancer imaging technologies.—
(1) Expansion of research.— The Secretary of Health and Human Services (referred to in this section as the “Secretary”), acting through the Director of the National Institutes of Health and the Administrator of the Health Resources and Services Administration, and in consultation with the Secretary of Defense, shall carry out a program to expand and intensify research to develop innovative advanced imaging technologies for prostate cancer detection, diagnosis, and treatment comparable to state-of-the-art mammography technologies.
(2) Early stage research.— In implementing the program under paragraph (1), the Secretary, acting through the Administrator of the Health Resources and Services Administration, shall carry out a grant program to encourage the early stages of research in prostate imaging to develop and implement new ideas, proof of concepts, and pilot studies for high-risk technologic innovation in prostate cancer imaging that would have a high potential impact for improving patient care, including individualized care, quality of life, and cost-effectiveness.
(3) Large scale later stage research.— In implementing the program under paragraph (1), the Secretary, acting through the Director of the National Institutes of Health, shall utilize the National Institute of Biomedical Imaging and Bioengineering and the National Cancer Institute for advanced stages of research in prostate imaging, including technology development and clinical trials for projects determined by the Secretary to have demonstrated promising preliminary results and proof of concept.
(4) Interdisciplinary private-public partnerships.— In developing the program under paragraph (1), the Secretary, acting through the Administrator of the Health Resources and Services Administration, shall establish interdisciplinary private-public partnerships to develop and implement research strategies for expedited innovation in imaging and image-guided treatment and to conduct such research.
(5) Racial disparities.— In developing the program under paragraph (1), the Secretary shall recognize and address—
(A) the racial disparities in the incidences of prostate cancer and mortality rates with respect to such disease; and
(B) any barriers in access to care and participation in clinical trials that are specific to racial minorities.
(6) Authorization of appropriations.—
(A) In general.— Subject to subparagraph (B), there is authorized to be appropriated to carry out this subsection, $100,000,000 for each of fiscal years 2027 through 2031.
(B) Specific allocations.— Of the amount authorized to be appropriated under subparagraph (A) for each of the fiscal years described in such subparagraph—
(i) no less than 10 percent may be used to carry out the grant program under paragraph (2); and
(ii) no more than 1 percent may be used to carry out paragraph (4).
(b) Public awareness and education campaign.—
(1) National campaign.— The Secretary shall carry out a national campaign to increase the awareness and knowledge of individuals in the United States with respect to the need for prostate cancer screening and for improved detection technologies.
(2) Requirements.— The national campaign conducted under this subsection shall include—
(A) roles for the Health Resources Services Administration, the Office of Minority Health of the Department of Health and Human Services, the Centers for Disease Control and Prevention, and the Office of Minority Health and Health Equity of the Centers for Disease Control and Prevention; and
(B) the development and distribution of written educational materials, and the development and placing of public service announcements, that are intended to encourage men to seek prostate cancer screening and to create awareness of the need for improved imaging technologies for prostate cancer screening and diagnosis, including in-vitro blood testing and imaging technologies.
(3) Racial disparities.— In developing the national campaign under paragraph (1), the Secretary shall recognize and address—
(A) the racial disparities in the incidences of prostate cancer and mortality rates with respect to such disease; and
(B) any barriers in access to care and participation in clinical trials that are specific to racial minorities.
(4) Grants.— The Secretary shall establish a program to award grants to nonprofit private entities to enable such entities to test alternative outreach and education strategies to increase the awareness and knowledge of individuals in the United States with respect to the need for prostate cancer screening and improved imaging technologies.
(5) Authorization of appropriations.— There is authorized to be appropriated to carry out this subsection $10,000,000 for each of fiscal years 2027 through 2031.
(c) Improving prostate cancer screening blood tests.—
(1) In general.— The Secretary, in coordination with the Secretary of Defense, shall support research to develop an improved prostate cancer screening blood test using in-vitro detection.
(2) Authorization of appropriations.— There is authorized to be appropriated to carry out this subsection, $20,000,000 for each of fiscal years 2027 through 2031.
(d) Reporting and compliance.—
(1) Report and strategy.— Not later than 12 months after the date of the enactment of this Act, the Secretary shall submit to Congress a report that details the strategy of the Secretary for implementing the requirements of this section and the status of such efforts.
(2) Full compliance.— Not later than 36 months after the date of the enactment of this Act, and annually thereafter, the Secretary shall submit to Congress a report that—
(A) describes the research and development and public awareness and education campaigns funded under this section;
(B) provides evidence that projects involving high-risk, high-impact technologic innovation, proof of concept, and pilot studies are prioritized;
(C) provides evidence that the Secretary recognizes and addresses any barriers in access to care and participation in clinical trials that are specific to racial minorities in the implementation of this section;
(D) contains assurances that all the other provisions of this section are fully implemented; and
(E) certifies compliance with the provisions of this section, or in the case of a Federal agency that has not complied with any of such provisions, an explanation as to such failure to comply.
(a) Plan to develop and validate a test or tests for prostate cancer.—
(1) In general.— The Secretary of Health and Human Services (referred to in this section as the “Secretary”), acting through the Director of the National Institutes of Health, shall establish an advisory council on prostate cancer (referred to in this section as the “advisory council”) to draft a plan for the development and validation of an accurate test or tests, such as biomarkers or imaging, to detect and diagnose prostate cancer.
(2) Advisory council.—
(A) Membership.—
(i) Federal members.— The advisory council shall be composed of the following experts:
(I) A designee of the Centers for Disease Control and Prevention.
(II) A designee of the Centers for Medicare & Medicaid Services.
(III) A designee of the Office of the Director of the National Cancer Institute.
(IV) A designee of the Director of the Department of Defense Congressionally Directed Medical Research Programs.
(V) A designee of the Director of the National Institute of Biomedical Imaging and Bioengineering.
(VI) A designee of the Director of the National Institute of General Medical Sciences.
(VII) A designee of the Director of the National Institute on Minority Health and Health Disparities.
(VIII) A designee of the Director of the National Institutes of Health.
(IX) A designee of the Commissioner of Food and Drugs.
(X) A designee of the Director of the Agency for Healthcare Research and Quality.
(XI) A designee of the Director of the Telemedicine and Advanced Technology Research Center of the Department of Defense.
(ii) Non-federal members.— In addition to the members described in clause (i), the advisory council shall include 8 expert members from outside the Federal Government to be appointed by the Secretary, which shall include—
(I) 2 prostate cancer patient advocates;
(II) 2 health care providers with a range of expertise and experience in prostate cancer; and
(III) 4 leading researchers with prostate cancer-related expertise in a range of clinical disciplines.
(B) Meetings.— The advisory council shall meet quarterly and such meetings shall be open to the public.
(C) Advice.— The advisory council shall advise the Secretary, or the Secretary’s designee.
(D) Annual report.— Not later than 1 year after the date of enactment of this Act, the advisory council shall provide to the Secretary, or the Secretary’s designee, and Congress—
(i) an initial evaluation of all federally funded efforts in prostate cancer research relating to the development and validation of an accurate test or tests to detect and diagnose prostate cancer;
(ii) a plan for the development and validation of a reliable test or tests for the detection and accurate diagnosis of prostate cancer; and
(iii) a set of standards for prostate cancer screening, developed in coordination with the United States Preventive Services Task Force, to ensure that any tools for screening, detection, and diagnosis developed in accordance with the plan under clause (ii) will meet the requirements of the Task Force for recommendation as a proven preventive or diagnostic service.
(E) Termination.— The advisory council shall terminate on December 31, 2028.
(3) Funding.— Notwithstanding any other provision of law, the Secretary may make available $1,000,000, from any unobligated amounts appropriated to the National Institutes of Health, for each of fiscal years 2027 through 2031 to carry out this subsection.
(b) Coordination and intensification of prostate cancer research.—
(1) In general.— The Director of the National Institutes of Health, in consultation with the Secretary of Defense, shall coordinate and intensify research in accordance with the plan provided under subsection (a)(2)(D)(ii), with particular attention provided to leveraging existing research to develop and validate a test or tests, such as biomarkers or imaging, to detect and accurately diagnose prostate cancer in order to improve quality of life for millions of individuals in the United States, and decrease health care system costs.
(2) Funding.— Notwithstanding any other provision of law, the Secretary may make available $30,000,000, from any unobligated amounts appropriated to the National Institutes of Health, for each of fiscal years 2027 through 2031 to carry out this subsection.
(a) National prostate cancer council.—
(1) Establishment.— There is established in the Office of the Secretary of Health and Human Services (referred to in this section as the “Secretary”) the National Prostate Cancer Council on Screening, Early Detection, Assessment, and Monitoring of Prostate Cancer (referred to in this section as the “Council”).
(2) Purpose of the council.— The Council shall—
(A) develop and implement a national strategic plan for the accelerated creation, advancement, and testing of diagnostic tools to improve screening, early detection, assessment, and monitoring of prostate cancer, including—
(i) early detection of aggressive prostate cancer to save lives;
(ii) monitoring of tumor response to treatment, including recurrence and progression; and
(iii) accurate assessment and surveillance of indolent disease to reduce unnecessary biopsies and treatment;
(B) provide information and coordination of prostate cancer research and services across all Federal agencies;
(C) review diagnostic tools and their overall effectiveness at screening, detecting, assessing, and monitoring of prostate cancer;
(D) evaluate all programs in prostate cancer that are in existence on the date of enactment of this Act, including Federal budget requests and approvals and public-private partnerships;
(E) submit an annual report to the Secretary and Congress on the creation and implementation of the national strategic plan under subparagraph (A); and
(F) ensure the inclusion of men at high risk for prostate cancer, including men from minority ethnic and racial populations and men who are least likely to receive care, in clinical, research, and service efforts, with the purpose of decreasing health disparities.
(3) Membership.—
(A) Federal members.— The Council shall be led by the Secretary or the Secretary’s designee and composed of the following experts:
(i) Two representatives of the National Institutes of Health, including 1 representative of the National Institute of Biomedical Imaging and Bioengineering and 1 representative of the National Cancer Institute.
(ii) A representative of the Centers for Disease Control and Prevention.
(iii) A representative of the Centers for Medicare & Medicaid Services.
(iv) A designee of the Director of the Department of Defense Congressionally Directed Medical Research Programs.
(v) A designee of the Director of the Office of Minority Health.
(vi) A representative of the Food and Drug Administration.
(vii) A representative of the Agency for Healthcare Research and Quality.
(B) Non-federal members.— In addition to the members described in subparagraph (A), the Council shall include 14 expert members from outside the Federal Government, which shall include—
(i) 6 prostate cancer patient advocates, including—
(I) 2 patient-survivors;
(II) 2 caregivers of prostate cancer patients; and
(III) 2 representatives from national prostate cancer disease organizations that fund research or have demonstrated experience in providing assistance to patients, families, and medical professionals, including information on health care options, education, and referral; and
(ii) 8 health care stakeholders with specific expertise in prostate cancer research in the critical areas of clinical expertise, including medical oncology, radiology, radiation oncology, urology, and pathology.
(4) Meetings.— The Council shall meet quarterly and meetings shall be open to the public.
(5) Advice.— The Council shall advise the Secretary, or the Secretary’s designee.
(6) Annual report.— The Council shall submit annual reports, beginning not later than 1 year after the date of enactment of this Act, to the Secretary or the Secretary’s designee and to Congress. The annual report shall include—
(A) in the first year—
(i) an evaluation of all Federally funded efforts in prostate cancer research and gaps relating to the development and validation of diagnostic tools for prostate cancer; and
(ii) recommendations for priority actions to expand, eliminate, coordinate, or condense programs based on the performance, mission, and purpose of the programs; and
(B) annually thereafter for 5 years—
(i) an outline for the development and implementation of a national research plan for creation and validation of accurate diagnostic tools to improve prostate cancer care in accordance with paragraph (1);
(ii) roles for the National Cancer Institute, National Institute on Minority Health and Health Disparities, and the Office of Minority Health of the Department of Health and Human Services;
(iii) an analysis of the disparities in the incidence and mortality rates of prostate cancer in men at high risk of the disease, including individuals with family history, increasing age, or African-American heritage; and
(iv) a review of the progress towards the realization of the proposed strategic plan.
(7) Termination.— The Council shall terminate on December 31, 2027.
(a) Elimination of funding limitations.— Section 1108(g)(4) of the Social Security Act (42 U.S.C. 1308(g)(4)) is amended—
(1) by striking “paragraphs (1), (2), (3), and (4) of”; and
(2) by adding at the end the following: “With respect to fiscal years beginning with fiscal year 2027, payment for medical assistance for individuals who are eligible for such assistance only on the basis of section 1902(a)(10)(A)(ii)(XVIII) shall not be taken into account in applying subsection (f) (as increased in accordance with this subsection) to Puerto Rico, the Virgin Islands, Guam, the Northern Mariana Islands, or American Samoa for such fiscal year.”.
(b) Application of enhanced fmap for highest state.— Section 1905(b) of such Act (42 U.S.C. 1396d(b)) is amended by adding at the end the following: “Notwithstanding the first sentence of this subsection, with respect to medical assistance described in clause (4) of such sentence that is furnished in Puerto Rico, the Virgin Islands, Guam, the Northern Mariana Islands, or American Samoa in a fiscal year, the Federal medical assistance percentage is equal to the highest such percentage applied under such clause for such fiscal year for any of the 50 States or the District of Columbia that provides such medical assistance for any portion of such fiscal year.”.
(c) Effective date.— The amendments made by this section shall apply to payment for medical assistance for items and services furnished on or after October 1, 2026.
(a) Demonstration.—
(1) In general.— The Secretary of Health and Human Services (in this section referred to as the “Secretary”) shall, consistent with subsection (b), conduct demonstration projects for the purpose of developing models and evaluating methods that—
(A) improve the quality of items and services provided to target individuals in order to facilitate reduced disparities in early detection and treatment of cancer;
(B) improve clinical outcomes, satisfaction, quality of life, appropriate use of items and services covered under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.), and referral patterns with respect to target individuals with cancer;
(C) eliminate disparities in the rate of preventive cancer screening measures, such as Pap smears, prostate cancer screenings, colon and colorectal cancer screenings, breast cancer screenings, and computed tomography scans, for lung cancer among target individuals;
(D) promote collaboration with community-based organizations to ensure cultural competency of health care professionals and linguistic access for target individuals with limited English proficiency; and
(E) encourage the incorporation of community health workers to increase the efficiency and appropriateness of cancer screening programs.
(2) Community health worker defined.— In this section, the term community health worker includes a community health advocate, a lay health worker, a community health representative, a peer health promoter, a community health outreach worker, and a promotore de salud, who promotes health or nutrition within the community in which the individual resides.
(3) Target individual defined.— In this section, the term target individual means an individual of a racial and ethnic minority group, as defined in section 1707(g)(1) of the Public Health Service Act (42 U.S.C. 300u–6(g)(1)), who is entitled to benefits under part A, and enrolled under part B, of title XVIII of the Social Security Act.
(b) Program design.—
(1) Initial design.— Not later than 1 year after the date of the enactment of this Act, the Secretary shall evaluate best practices in the private sector, community programs, and academic research of methods that reduce disparities among individuals of racial and ethnic minority groups in the prevention and treatment of cancer and shall design the demonstration projects based on such evaluation.
(2) Number and project areas.— Not later than 2 years after the date of the enactment of this Act, the Secretary shall implement at least 9 demonstration projects, including the following:
(A) Two projects, each of which shall target different ethnic subpopulations, for each racial and ethnic minority group described in clauses (i) through (vi) of section 1707(g)(1)(A) of the Public Health Service Act (42 U.S.C. 300u–6(g)(1)(A)).
(B) One project within the Pacific Islands or United States insular areas.
(C) At least 1 project in a rural area.
(D) At least 1 project in an inner-city area.
(3) Expansion of projects; implementation of demonstration project results.— The Secretary shall continue the demonstration projects and may expand the number of demonstration projects if the initial report under subsection (c) contains an evaluation that the demonstration projects—
(A) reduce expenditures under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.); or
(B) do not increase expenditures under such Medicare program and reduce racial and ethnic health disparities in the quality of health care services provided to target individuals and increase satisfaction of Medicare beneficiaries and health care providers.
(c) Report to congress.—
(1) In general.— Not later than 2 years after the date the Secretary implements the initial demonstration projects under this section, and biannually thereafter, the Secretary shall submit to Congress a report regarding the demonstration projects.
(2) Content of report.— Each report under paragraph (1) shall include the following:
(A) A description of the demonstration projects.
(B) An evaluation of—
(i) the cost-effectiveness of the demonstration projects;
(ii) the quality of the health care services provided to target individuals under the demonstration projects; and
(iii) beneficiary and health care provider satisfaction under the demonstration projects.
(C) Any other information regarding the demonstration projects that the Secretary determines to be appropriate.
(d) Waiver authority.— The Secretary shall waive compliance with the requirements of title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) to such extent and for such period as the Secretary determines is necessary to conduct the demonstration projects under this section.
(a) Development of measures of disparities in quality of cancer care.—
(1) Development of measures.— The Secretary of Health and Human Services (in this section referred to as the “Secretary”) shall enter into an agreement with an entity that specializes in developing quality measures for cancer care under which the entity shall develop a uniform set of measures to evaluate disparities in the quality of cancer care and annually update such set of measures.
(2) Measures to be included.— Such set of measures shall include, with respect to the treatment of cancer, measures of patient outcomes, the process for delivering medical care related to such treatment, patient counseling and engagement in decision making, patient experience of care, resource use, and practice capabilities, such as care coordination.
(b) Establishment of reporting process.—
(1) In general.— The Secretary shall establish a reporting process that requires, and provides for, a method for health care providers specified under paragraph (2) to submit to the Secretary and make public data on the performance of such providers during each reporting period through use of the measures developed pursuant to subsection (a). Such data shall be submitted in a form and manner and at a time specified by the Secretary.
(2) Specification of providers to report on measures.— The Secretary shall specify the classes of Medicare providers of services and suppliers, including hospitals, cancer centers, physicians, primary care providers, and specialty providers, that will be required under such process to publicly report on the measures specified under subsection (a).
(3) Assessment of changes.— Under such reporting process, the Secretary shall establish a format that assesses changes in both the absolute and relative disparities in cancer care over time. These measures shall be presented in an easily comprehensible format, such as those presented in the final publications relating to Healthy People 2010 or the National Healthcare Disparities Report.
(4) Initial implementation.— The Secretary shall implement the reporting process under this subsection for reporting periods beginning not later than 6 months after the date that measures are first established under subsection (a).
Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is amended—
(1) by striking section 317N (42 U.S.C. 247b–15); and
(2) by adding after part W the following:
“(a) In general.— The Secretary shall conduct a biennial assessment of the Secretary’s plan for the prevention, control, and medical management of, and education and research relating to, hepatitis B and hepatitis C, for the purposes of—
(1) incorporating into such plan new knowledge or observations relating to hepatitis B and hepatitis C (such as knowledge and observations that may be derived from clinical, laboratory, and epidemiological research and disease detection, prevention, and surveillance outcomes);
(2) addressing gaps in the coverage or effectiveness of the plan; and
(3) evaluating and, if appropriate, updating recommendations, guidelines, or educational materials of the Centers for Disease Control and Prevention or the National Institutes of Health for health care providers or the public on viral hepatitis in order to be consistent with the plan.
(b) Publication of notice of assessments.— Not later than October 1 of the first even-numbered year beginning after the date of the enactment of this part, and October 1 of each even-numbered year thereafter, the Secretary shall publish in the Federal Register a notice of the results of the assessments conducted under subsection (a). Such notice shall include—
(1) a description of any revisions to the plan referred to in subsection (a) as a result of the assessment;
(2) an explanation of the basis for any such revisions, including the ways in which such revisions can reasonably be expected to further promote the original goals and objectives of the plan; and
(3) in the case of a determination by the Secretary that the plan does not need revision, an explanation of the basis for such determination.
(a) Education and awareness programs.— The Secretary, acting through the Director of the Centers for Disease Control and Prevention, the Administrator of the Health Resources and Services Administration, and the Assistant Secretary for Mental Health and Substance Use, and in accordance with the plan referred to in section 399PP(a), shall implement programs to increase awareness and enhance knowledge and understanding of hepatitis B and hepatitis C. Such programs shall include—
(1) the conduct of culturally and linguistically appropriate health education in primary and secondary schools, college campuses, public awareness campaigns, and community outreach activities (especially to the ethnic communities with high rates of chronic hepatitis B and chronic hepatitis C and other high-risk groups) to promote public awareness and knowledge about—
(A) the value of hepatitis A and hepatitis B immunization, including the importance of universal birth dose hepatitis B vaccination and universal childhood and adult hepatitis B vaccination;
(B) risk factors, transmission, and prevention of hepatitis B and hepatitis C;
(C) the value of screening for the early detection of hepatitis B and hepatitis C; and
(D) options available for the treatment of chronic hepatitis B and chronic hepatitis C;
(2) the promotion of immunization programs that increase awareness and access to hepatitis A and hepatitis B vaccines for susceptible adults and children;
(3) the training of health care professionals regarding the importance of vaccinating individuals regarding the importance of hepatitis B screening in individuals infected with hepatitis C and the importance of vaccinating individuals who are at risk for hepatitis C infection against hepatitis A and hepatitis B;
(4) the training of health care professionals regarding the importance of vaccinating individuals chronically infected with hepatitis B and individuals who are at risk for chronic hepatitis B infection against the hepatitis A virus;
(5) the training of health care professionals and health educators to make them aware of the high rates of chronic hepatitis B and chronic hepatitis C in certain adult ethnic populations, and the importance of prevention, detection, and medical management of hepatitis B and hepatitis C and of liver cancer screening;
(6) the development and distribution of health education curricula (including information relating to the special needs of individuals infected with or at risk of hepatitis B and hepatitis C, such as the importance of prevention and early intervention, regular monitoring, the recognition of psychosocial needs, appropriate treatment, and liver cancer screening) for individuals providing hepatitis B and hepatitis C counseling; and
(7) support for the implementation of the curricula described in paragraph (6) by State and local public health agencies.
(b) Immunization, prevention, and control programs.—
(1) In general.— The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall support the integration of activities described in paragraph (3) into existing clinical and public health programs at State, local, territorial, and Tribal levels (including community health clinics, programs for the prevention and treatment of HIV/AIDS, sexually transmitted infections, and substance use disorder, and programs for individuals in correctional settings).
(2) Coordination of development of federal screening guidelines.—
(A) References.— For purposes of this subsection, the term CDC Director means the Director of the Centers for Disease Control and Prevention, and the term AHRQ Director means the Director of the Agency for Healthcare Research and Quality.
(B) Agency for healthcare research and quality.— Due to the rapidly evolving standard of care associated with diagnosing and treating viral hepatitis infection, the AHRQ Director shall convene the Preventive Services Task Force under section 915(a) to review its recommendation for screening for HBV and HCV infection every 3 years.
(3) Activities.—
(A) Voluntary testing programs.—
(i) In general.— The Secretary shall establish a mechanism by which to support and promote the development of State, local, territorial, and Tribal voluntary hepatitis B and hepatitis C testing programs to screen the high-prevalence populations to aid in the early identification of chronically infected individuals.
(ii) Confidentiality of the test results.— The Secretary shall prohibit the use of the results of a hepatitis B or hepatitis C test conducted by a testing program developed or supported under this subparagraph for any of the following:
(I) Issues relating to health insurance.
(II) To screen or determine suitability for employment.
(III) To discharge a person from employment with issues relating to immigration status.
(B) Counseling regarding viral hepatitis.— The Secretary shall support State, local, territorial, and Tribal programs in a wide variety of settings, including those providing primary and specialty health care services in nonprofit private and public sectors, to—
(i) provide individuals with ongoing risk factors for hepatitis B and hepatitis C infection with client-centered education and counseling which concentrates on—
(I) promoting testing of individuals that have been exposed to their blood, family members, and their sexual partners; and
(II) changing behaviors that place individuals at risk for infection;
(ii) provide individuals chronically infected with hepatitis B or hepatitis C with education, health information, and counseling to reduce their risk of—
(I) dying from end-stage liver disease and liver cancer; and
(II) transmitting viral hepatitis to others; and
(iii) provide people chronically infected with hepatitis B or hepatitis C who are pregnant or of childbearing age with culturally and linguistically appropriate health information, such as how to prevent hepatitis B perinatal infection, and to alleviate fears associated with pregnancy or raising a family.
(C) Immunization.— The Secretary shall support State, local, territorial, and Tribal efforts to expand the current vaccination programs to protect every child in the Nation and all susceptible adults, particularly those infected with hepatitis C and high-prevalence ethnic populations and other high-risk groups, from the risks of acute and chronic hepatitis B infection by—
(i) ensuring continued funding for hepatitis B vaccination for all children 18 years of age or younger through the Vaccines for Children program;
(ii) ensuring that the recommendations of the American Academy of Pediatrics and American College of Physicians are followed regarding hepatitis B vaccination for infants, children, and adults;
(iii) requiring proof of hepatitis B vaccination for entry into public or private daycare, preschool, elementary school, secondary school, and institutions of higher education for those not infected with hepatitis B;
(iv) expanding the availability of hepatitis B vaccination for all adults to protect them from becoming acutely or chronically infected, including ethnic and other populations with high prevalence rates of chronic hepatitis B infection;
(v) expanding the availability of hepatitis B vaccination for all adults, particularly those of reproductive age, to protect them from the risk of hepatitis B infection;
(vi) ensuring the vaccination of individuals infected, or at risk for infection, with hepatitis C against hepatitis A, hepatitis B, and other infectious diseases, as appropriate, for which such individuals may be at increased risk; and
(vii) ensuring the vaccination of individuals infected, or at risk for infection, with hepatitis B against hepatitis A virus and other infectious diseases, as appropriate, for which such individuals may be at increased risk.
(D) Medical referral.— The Secretary shall support State, local, territorial, and Tribal programs that support—
(i) referral of persons chronically infected with hepatitis B or hepatitis C—
(I) for medical evaluation to determine the appropriateness for antiviral treatment to reduce the risk of progression to cirrhosis and liver cancer; and
(II) for ongoing medical management including regular monitoring of liver function and screening for liver cancer; and
(ii) referral of persons infected with acute or chronic hepatitis B infection or acute or chronic hepatitis C infection for drug and alcohol abuse treatment where appropriate.
(4) Increased support for adult viral hepatitis prevention coordinators.— The Secretary, acting through the CDC Director, shall provide increased support to adult viral hepatitis prevention coordinators in State, local, territorial, and Tribal health departments in order to enhance the additional management, networking, and technical expertise needed to ensure successful integration of hepatitis B and hepatitis C prevention and control activities into existing public health programs.
(c) Epidemiological surveillance.—
(1) In general.— The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall support the establishment and maintenance of a national chronic and acute hepatitis B and hepatitis C surveillance program, in order to identify—
(A) trends in the incidence of acute and chronic hepatitis B and acute and chronic hepatitis C;
(B) trends in the prevalence of acute and chronic hepatitis B and acute and chronic hepatitis C infection among groups that may be disproportionately affected; and
(C) trends in liver cancer and end-stage liver disease incidence and deaths, caused by chronic hepatitis B and chronic hepatitis C in the high-risk ethnic populations.
(2) Seroprevalence and liver cancer studies.— The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall prepare a report outlining the population-based seroprevalence studies currently underway, future planned studies, the criteria involved in determining which seroprevalence studies to conduct, defer, or suspend, and the scope of those studies, the economic and clinical impact of hepatitis B and hepatitis C, and the impact of chronic hepatitis B and chronic hepatitis C infections on the quality of life. Not later than one year after the date of the enactment of this part, the Secretary shall submit the report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.
(3) Confidentiality.— The Secretary shall not disclose any individually identifiable information identified under paragraph (1) or derived through studies under paragraph (2).
(d) Research.— The Secretary, acting through the Director of the Centers for Disease Control and Prevention, the Director of the National Cancer Institute, and the Director of the National Institutes of Health, shall—
(1) conduct epidemiologic and community-based research to develop, implement, and evaluate best practices for hepatitis B and hepatitis C prevention especially in the ethnic populations with high rates of chronic hepatitis B and chronic hepatitis C and other high-risk groups;
(2) conduct research on hepatitis B and hepatitis C natural history, pathophysiology, improved treatments and prevention (such as the hepatitis C vaccine), and noninvasive tests that help to predict the risk of progression to liver cirrhosis and liver cancer;
(3) conduct research that will lead to better noninvasive or blood tests to screen for liver cancer, and more effective treatments of liver cancer caused by chronic hepatitis B and chronic hepatitis C; and
(4) conduct research comparing the effectiveness of screening, diagnostic, management, and treatment approaches for chronic hepatitis B, chronic hepatitis C, and liver cancer in the affected communities.
(e) Underserved and disproportionately affected populations.— In carrying out this section, the Secretary shall provide expanded support for individuals with limited access to health education, testing, and health care services and groups that may be disproportionately affected by hepatitis B and hepatitis C.
(f) Evaluation of program.— The Secretary shall develop benchmarks for evaluating the effectiveness of the programs and activities conducted under this section and make determinations as to whether such benchmarks have been achieved.
(a) In general.— The Secretary may award grants to, or enter into contracts or cooperative agreements with, States, political subdivisions of States, territories, Indian Tribes, or nonprofit entities that have special expertise relating to hepatitis B, hepatitis C, or both, to carry out activities under this part.
(b) Application.— To be eligible for a grant, contract, or cooperative agreement under subsection (a), an entity shall prepare and submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require.”.
There are authorized to be appropriated to carry out this part $90,000,000 for fiscal year 2027, $110,000,000 for fiscal year 2028, $130,000,000 for fiscal year 2029, and $150,000,000 for fiscal year 2030.
Subpart I of part D of title III of the Public Health Service Act (42 U.S.C. 254b et seq.) is amended by adding at the end the following:
“330Q. Liver cancer and disease prevention, awareness, and patient tracking grants.—
(a) Prevention initiative grant program.—
(1) In general.— The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may award grants and enter into cooperative agreements with entities for the purpose of expanding and supporting—
(A) prevention activities (including providing screenings, vaccinations, or other preventative interventions) for conditions known to increase an individual’s risk of developing a major liver disease, such as liver cancer, hepatitis B, hepatitis C, nonalcoholic fatty liver disease, nonalcoholic steatohepatitis, and cirrhosis of the liver;
(B) activities relating to detection and provision of guidance for individuals at high risk for contracting liver cancer and other liver diseases; and
(C) viral hepatitis surveillance to provide for timely and accurate information regarding progress to eliminate viral hepatitis.
(2) Report.— An entity that receives a grant or cooperative agreement under paragraph (1) shall submit to the Secretary, at a time specified by the Secretary, a report describing each activity carried out pursuant to such paragraph and evaluating the effectiveness of such activity in promoting prevention and treatment of liver cancer and other liver diseases.
(3) Authorization of appropriations.— For purposes of carrying out this subsection, there is authorized to be appropriated $90,000,000 for each of fiscal years 2027 through 2031.
(b) Awareness initiative grant program.—
(1) In general.— The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may award grants to eligible entities for the purpose of raising awareness for liver cancer and other liver diseases, which may include the production, dissemination, and distribution of informational materials targeted towards communities and populations with a higher risk for developing liver cancer and other liver diseases.
(2) Eligible entities.— To be eligible to receive a grant under paragraph (1), an entity shall submit to the Secretary an application, at such time, in such manner, and containing such information as the Secretary may require, including a description of how the entity, in disseminating information on liver cancer and other liver diseases pursuant to paragraph (1), will—
(A) with respect to any community or population, consult with members of such community or population and provide such information in a manner that is culturally and linguistically appropriate for such community or population;
(B) highlight the range of preventative measures and treatments available for liver cancer and other liver diseases;
(C) integrate information on available hepatitis B and hepatitis C testing programs into any liver cancer presentations carried out by the entity; and
(D) address communities and populations with a higher risk for contracting liver cancer and other liver diseases.
(3) Preference.— In awarding grants under paragraph (1), the Secretary shall give preference to entities that—
(A) work with a Federally qualified health center;
(B) are community-based organizations; or
(C) serve communities and populations with a higher risk for contracting liver cancer and other liver diseases.
(4) Report.— An entity that receives a grant under paragraph (1) shall submit to the Secretary, at a time specified by the Secretary, a report describing each activity carried out pursuant to such paragraph and evaluating the effectiveness of such activity in raising awareness for liver cancer and other liver diseases.
(5) Authorization of appropriations.— For purposes of carrying out this subsection, there is authorized to be appropriated $10,000,000 for each of fiscal years 2027 through 2031.”.
(a) National acquired bone marrow failure disease registry.— Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is amended by inserting after section 317W, as added by section 1009, the following:
“317X. National Acquired Bone Marrow Failure Disease Registry.—
(a) Establishment of registry.—
(1) In general.— Not later than 6 months after the date of the enactment of this section, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall—
(A) develop a system to collect data on acquired bone marrow failure diseases; and
(B) establish and maintain a national and publicly available registry, to be known as the National Acquired Bone Marrow Failure Disease Registry, in accordance with paragraph (3).
(2) Recommendations of advisory committee.— In carrying out this subsection, the Secretary shall take into consideration the recommendations of the Advisory Committee on Acquired Bone Marrow Failure Diseases established under subsection (b).
(3) Purposes of registry.— The National Acquired Bone Marrow Failure Disease Registry shall—
(A) identify the incidence and prevalence of acquired bone marrow failure diseases in the United States;
(B) be used to collect and store data on acquired bone marrow failure diseases, including data concerning—
(i) the age, race or ethnicity, general geographic location, sex, and family history of individuals who are diagnosed with acquired bone marrow failure diseases, and any other characteristics of such individuals determined appropriate by the Secretary;
(ii) the genetic and environmental factors that may be associated with developing acquired bone marrow failure diseases;
(iii) treatment approaches for dealing with acquired bone marrow failure diseases;
(iv) outcomes for individuals treated for acquired bone marrow failure diseases, including outcomes for recipients of stem cell therapeutic products as contained in the database established pursuant to section 379A; and
(v) any other factors pertaining to acquired bone marrow failure diseases determined appropriate by the Secretary; and
(C) be made available—
(i) to the general public; and
(ii) to researchers to facilitate further research into the causes of, and treatments for, acquired bone marrow failure diseases in accordance with standard practices of the Centers for Disease Control and Prevention.
(b) Advisory committee.—
(1) Establishment.— Not later than 6 months after the date of the enactment of this section, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish an advisory committee, to be known as the Advisory Committee on Acquired Bone Marrow Failure Diseases.
(2) Members.— The members of the Advisory Committee on Acquired Bone Marrow Failure Diseases shall be appointed by the Secretary, acting through the Director of the Centers for Disease Control and Prevention, and shall include at least one representative from each of the following:
(A) A national patient advocacy organization with experience advocating on behalf of patients suffering from acquired bone marrow failure diseases.
(B) The National Institutes of Health, including at least one representative from each of—
(i) the National Cancer Institute;
(ii) the National Heart, Lung, and Blood Institute; and
(iii) the Office of Rare Diseases.
(C) The Centers for Disease Control and Prevention.
(D) Clinicians with experience in—
(i) diagnosing or treating acquired bone marrow failure diseases; or
(ii) medical data registries.
(E) Epidemiologists who have experience with data registries.
(F) Publicly or privately funded researchers who have experience researching acquired bone marrow failure diseases.
(G) The entity operating the C.W. Bill Young Cell Transplantation Program established pursuant to section 379 and the entity operating the C.W. Bill Young Cell Transplantation Program Outcomes Database.
(3) Responsibilities.— The Advisory Committee on Acquired Bone Marrow Failure Diseases shall provide recommendations to the Secretary on the establishment and maintenance of the National Acquired Bone Marrow Failure Disease Registry, including recommendations on the collection, maintenance, and dissemination of data.
(4) Public availability.— The Secretary shall make the recommendations of the Advisory Committee on Acquired Bone Marrow Failure Disease publicly available.
(c) Grants.— The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may award grants to, and enter into contracts and cooperative agreements with, public or private nonprofit entities for the management of, as well as the collection, analysis, and reporting of data to be included in, the National Acquired Bone Marrow Failure Disease Registry.
(d) Definition.— In this section, the term acquired bone marrow failure disease means—
(1) myelodysplastic syndromes;
(2) aplastic anemia;
(3) paroxysmal nocturnal hemoglobinuria;
(4) pure red cell aplasia;
(5) acute myeloid leukemia that has progressed from myelodysplastic syndromes; or
(6) large granular lymphocytic leukemia.
(e) Authorization of appropriations.— There is authorized to be appropriated to carry out this section $3,000,000 for each of fiscal years 2027 through 2031.”.
(b) Pilot studies through the agency for toxic substances and disease registry.—
(1) Pilot studies.— The Secretary of Health and Human Services, acting through the Director of the Agency for Toxic Substances and Disease Registry, shall conduct pilot studies to determine which environmental factors, including exposure to toxins, may cause acquired bone marrow failure diseases.
(2) Collaboration with the radiation injury treatment network.— In carrying out the directives of this section, the Secretary of Health and Human Services may collaborate with the Radiation Injury Treatment Network of the C.W. Bill Young Cell Transplantation Program established pursuant to section 379 of the Public Health Service Act (42 U.S.C. 274k) to—
(A) augment data for the pilot studies authorized by this section;
(B) access technical assistance that may be provided by the Radiation Injury Treatment Network; or
(C) perform joint research projects.
(3) Authorization of appropriations.— There is authorized to be appropriated to carry out this subsection $1,000,000 for each of fiscal years 2027 through 2031.
(c) Minority-Focused programs on acquired bone marrow failure diseases.— Title XVII of the Public Health Service Act (42 U.S.C. 300u et seq.) is amended by inserting after section 1707A the following:
“1707B. Minority-focused programs on acquired bone marrow failure disease.—
(a) Information and referral services.—
(1) In general.— Not later than 6 months after the date of the enactment of this section, the Secretary, acting through the Deputy Assistant Secretary for Minority Health, shall establish and coordinate outreach and informational programs targeted to minority populations affected by acquired bone marrow failure diseases.
(2) Program requirements.— Minority-focused outreach and informational programs authorized by this section at the National Minority Health Resource Center supported under section 1707(b)(8) (including by means of the Center’s website, through appropriate locations such as the Center’s knowledge center, and through appropriate programs such as the Center’s resource persons network) and through minority health consultants located at each Department of Health and Human Services regional office—
(A) shall make information about treatment options and clinical trials for acquired bone marrow failure diseases publicly available; and
(B) shall provide referral services for treatment options and clinical trials.
(b) Hispanic and asian-American and pacific islander outreach.—
(1) In general.— The Secretary, acting through the Deputy Assistant Secretary for Minority Health, shall undertake a coordinated outreach effort to connect Hispanic, Asian-American, and Pacific Islander communities with comprehensive services focused on treatment of, and information about, acquired bone marrow failure diseases.
(2) Collaboration.— In carrying out this subsection, the Secretary may collaborate with public health agencies, nonprofit organizations, community groups, and online entities to disseminate information about treatment options and clinical trials for acquired bone marrow failure diseases.
(c) Grants and cooperative agreements.—
(1) In general.— Not later than 6 months after the date of the enactment of this section, the Secretary, acting through the Deputy Assistant Secretary for Minority Health, shall award grants to, or enter into cooperative agreements with, entities to perform research on acquired bone marrow failure diseases.
(2) Requirement.— Grants and cooperative agreements authorized by this subsection shall be awarded or entered into on a competitive, peer-reviewed basis.
(3) Scope of research.— Research funded under this subsection shall examine factors affecting the incidence of acquired bone marrow failure diseases in minority populations.
(d) Definition.— In this section, the term acquired bone marrow failure disease has the meaning given to such term in section 317X(d).
(e) Authorization of appropriations.— There is authorized to be appropriated to carry out this section $2,000,000 for each of fiscal years 2027 through 2031.”.
(d) Diagnosis and quality of care for acquired bone marrow failure diseases.—
(1) Grants.— The Secretary of Health and Human Services, acting through the Director of the Agency for Healthcare Research and Quality, shall award grants to entities to improve diagnostic practices and quality of care with respect to patients with acquired bone marrow failure diseases.
(2) Authorization of appropriations.— There is authorized to be appropriated to carry out this subsection $2,000,000 for each of fiscal years 2027 through 2031.
(e) Definition.— In this section, the term acquired bone marrow failure disease has the meaning given such term in section 317X(d) of the Public Health Service Act, as added by subsection (a).
(a) In general.— The Secretary of Health and Human Services (in this section referred to as the “Secretary”), acting through the Director of the Agency for Healthcare Research and Quality, shall convene a series of meetings to develop guidelines for disease screening for minority patient populations that have a higher than average risk for many chronic diseases and cancers.
(b) Participants.— In convening meetings under subsection (a), the Secretary shall ensure that meeting participants include representatives of—
(1) professional societies and associations;
(2) minority health organizations;
(3) health care researchers and providers, including those with expertise in minority health;
(4) Federal health agencies, including the Office of Minority Health, the National Institute on Minority Health and Health Disparities, and the National Institutes of Health; and
(5) other experts as the Secretary determines appropriate.
(c) Diseases.— Screening guidelines for minority populations shall be developed as appropriate under subsection (a) for—
(1) hypertension;
(2) hypercholesterolemia;
(3) diabetes;
(4) cardiovascular disease;
(5) cancers, including breast, prostate, colon, cervical, and lung cancer;
(6) other pulmonary problems including sleep apnea;
(7) asthma;
(8) kidney diseases;
(9) eye diseases and disorders, including glaucoma;
(10) HIV/AIDS and sexually transmitted infections;
(11) uterine fibroids;
(12) autoimmune diseases, including lupus;
(13) mental health conditions;
(14) dental health conditions and oral diseases, including oral cancer;
(15) environmental and related health illnesses and conditions;
(16) sickle cell disease and sickle cell trait;
(17) violence and injury prevention and control;
(18) genetic and related conditions;
(19) heart disease and stroke;
(20) tuberculosis;
(21) chronic obstructive pulmonary disease;
(22) musculoskeletal diseases, arthritis, and obesity; and
(23) other diseases determined appropriate by the Secretary.
(d) Dissemination.— Not later than 2 years after the date of enactment of this Act, the Secretary shall publish and disseminate to health care provider organizations the guidelines developed under subsection (a).
(e) Authorization of appropriations.— There are authorized to be appropriated to carry out this section such sums as may be necessary for each of fiscal years 2027 through 2031.
Section 1509 of the Public Health Service Act (42 U.S.C. 300n–4a) is amended—
(1) in subsection (a)—
(A) by striking the heading and inserting “In general”; and
(B) in the matter preceding paragraph (1), by striking “may make grants” and all that follows through “purpose” and inserting the following: “may make grants to such States for the purpose”; and
(2) in subsection (d)(1), by striking “there are authorized” and all that follows through the period and inserting “there are authorized to be appropriated $23,000,000 for fiscal year 2027, $25,300,000 for fiscal year 2028, $27,800,000 for fiscal year 2029, $30,800,000 for fiscal year 2030, and $34,000,000 for fiscal year 2031.”.
Part P of title III of the Public Health Service Act (42 U.S.C. 280g et seq.), as amended by section 5201(c)(3), is amended by adding at the end the following:
“399V–10. Report on cardiovascular care for women and minorities.— Not later than September 30, 2027, and annually thereafter, the Secretary shall prepare and submit to Congress a report on the quality of and access to care for women and minorities with heart disease, stroke, and other cardiovascular diseases. The report shall contain recommendations for eliminating disparities in, and improving the treatment of, heart disease, stroke, and other cardiovascular diseases in women, racial and ethnic minorities, those for whom English is not their primary language, and individuals with disabilities.”.
(a) In general.— Not later than September 30, 2027, the Comptroller General of the United States shall prepare and submit a report to Congress that contains the results of an investigation of—
(1) the structural and systemic factors that perpetuate disparities in access to screenings, care, and treatment of cardiovascular disease; and
(2) how care navigation, including community-based health workers, can improve cardiovascular disease management and improve health outcomes.
(b) Contents.— The report shall—
(1) identify the challenges and barriers facing health care providers and patients, which contribute to postponed, delayed, or suboptimal treatments for cardiovascular disease;
(2) examine efforts by Federal agencies and Federal programs to improve screening and management of patients with cardiovascular disease;
(3) identify and examine existing quality measures from the Centers for Medicare & Medicaid Services related to cholesterol management and whether these measures encourage providers and health systems to—
(A) perform appropriate and timely low-density-lipoprotein cholesterol (LDL-C) testing on patients at risk of a cardiovascular event; and
(B) better manage patients’ elevated LDL-C levels in concordance with clinical guidelines prescribing directives to ensure patients are progressing towards guideline-recommended LDL-C levels;
(4) identify actions the Federal Government could take to promote collaboration with community-based organizations to ensure improvement in clinical outcomes for patients with cardiovascular disease, including by building on recommendations from the National Academy of Medicine and the Centers for Disease Control to include community health workers to improve health care delivery for underserved and high-risk communities; and
(5) assess whether racial and ethnic minority groups, as defined in section 1707(g) of the Public Health Service Act (42 U.S.C. 300g–6(g)), have higher prior authorization rejection rates of prescription drugs to treat or prevent cardiovascular disease by health insurance providers and, if so, identify the resulting impacts on cardiovascular disease medication adherence, morbidity, and mortality, as well as resulting postponed, delayed, or suboptimal treatment prescribing for cardiovascular disease among racial and ethnic minorities.
(a) Requiring medicaid coverage of counseling and pharmacotherapy for cessation of tobacco use and temporary enhanced FMAP for coverage of tobacco cessation services.— Section 1905 of the Social Security Act (42 U.S.C. 1396d), as amended by section 5201(b)(2)(A)(i), is amended—
(1) in subsection (a)(4), by striking “(D)” and all that follows through “subsection (bb))” and inserting the following: “(D) counseling and pharmacotherapy for cessation of tobacco use by individuals who are eligible under the State plan (as defined in subsection (bb))”;
(2) in subsection (b), by inserting “(bb)(2),” after “(aa),”; and
(3) by striking subsection (bb) and inserting the following:
“(bb) Counseling and pharmacotherapy for cessation of tobacco use.—
(1) In general.— For purposes of this title, the term counseling and pharmacotherapy for cessation of tobacco use by individuals who are eligible under the State plan means diagnostic, therapy, and counseling services and pharmacotherapy (including the coverage of prescription and nonprescription tobacco cessation agents approved by the Food and Drug Administration) for the cessation of tobacco use by individuals who use tobacco products or who are being treated for tobacco use that is furnished—
(A) by or under the supervision of a physician; or
(B) by any other health care professional who—
(i) is legally authorized to furnish such services under State law (or the State regulatory mechanism provided by State law) of the State in which the services are furnished; and
(ii) is authorized to receive payment for other services under this title or is designated by the Secretary for this purpose, which is recommended in the guideline entitled, “Treating Tobacco Use and Dependence: 2008 Update: A Clinical Practice Guideline” published by the Public Health Service in May 2008 (or any subsequent modification of such guideline) or is recommended for the cessation of tobacco use by the United States Preventive Services Task Force or any additional intervention approved by the Food and Drug Administration as safe and effective in helping smokers quit.
(2) Temporary enhanced fmap for coverage of tobacco cessation services.— Notwithstanding subsection (b), for calendar quarters occurring during the period beginning on the date of the enactment of this paragraph and ending 5 years after the date of enactment of this paragraph, the Federal medical assistance percentage with respect to amounts expended by a State for medical assistance for counseling and pharmacotherapy for cessation of tobacco use by individuals who are eligible under the State plan (as defined in paragraph (1)) shall be equal to 90 percent.”.
(b) No cost sharing.—
(1) In general.— Subsections (a)(2) and (b)(2) of section 1916 of the Social Security Act (42 U.S.C. 1396o), as amended by section 2007(d)(4), are each amended—
(A) in subparagraph (B), by striking “, and counseling” and all that follows through “section 1905(bb)(2)(A)”;
(B) in subparagraph (J), by striking “or” after the comma;
(C) in subparagraph (K), by striking “; and” and inserting “, or”; and
(D) by adding at the end the following new subparagraph:
“(L) counseling and pharmacotherapy for cessation of tobacco use by individuals who are eligible under the State plan (as defined in section 1905(bb)) and covered outpatient drugs (as defined in subsection (k)(2) of section 1927 and including nonprescription drugs described in subsection (d)(2) of such section) that are prescribed for purposes of promoting tobacco cessation in accordance with the guideline specified in section 1905(bb); and”.
(2) Application to alternative cost sharing.— Section 1916A(b)(3)(B) of the Social Security Act (42 U.S.C. 1396o–1(b)(3)(B)) is amended—
(A) in clause (iii), by striking “, and counseling and pharmacotherapy for cessation of tobacco use by pregnant women (as defined in section 1905(bb))”; and
(B) by adding at the end the following new clause:
“(xv) Counseling and pharmacotherapy for cessation of tobacco use by individuals who are eligible under the State plan (as defined in section 1905(bb)) and covered outpatient drugs (as defined in subsection (k)(2) of section 1927 and including nonprescription drugs described in subsection (d)(2) of such section) that are prescribed for purposes of promoting tobacco cessation in accordance with the guideline specified in section 1905(bb).”.
(c) Exception from optional restriction under medicaid prescription drug coverage.— Section 1927(d)(2)(F) of the Social Security Act (42 U.S.C. 1396r–8(d)(2)(F)) is amended to read as follows:
“(F) Nonprescription drugs, except, when recommended in accordance with the guideline referred to in section 1905(bb), agents approved by the Food and Drug Administration under the over-the-counter monograph process for purposes of promoting tobacco cessation.”.
(d) State monitoring and promoting of comprehensive tobacco cessation services under medicaid.— Section 1902(a) of the Social Security Act (42 U.S.C. 1396a(a)), as amended by section 5201(c)(2)(B), is amended—
(1) in paragraph (90)(C), by striking “and” at the end;
(2) in paragraph (91), by striking the period at the end and inserting “; and”; and
(3) by inserting after paragraph (91) the following new paragraph:
“(92) provide that the State will monitor and promote the use of comprehensive tobacco cessation services under the State plan (including conducting an outreach campaign to increase awareness of the benefits of using such services) among—
(A) individuals entitled to medical assistance under the State plan who use tobacco products; and
(B) clinicians and others who provide services to individuals entitled to medical assistance under the State plan.”.
(e) Federal reimbursement for outreach campaign.— Section 1903(a) of the Social Security Act (42 U.S.C. 1396b(a)) is amended—
(1) in paragraph (6)(B), by striking “plus” at the end;
(2) in paragraph (7), by striking the period at the end and inserting “; plus”; and
(3) by inserting after paragraph (7) the following new paragraph:
“(8) with respect to the development, implementation, and evaluation of an outreach campaign to—
(A) increase awareness of comprehensive tobacco cessation services covered in the State plan among—
(i) individuals who are likely to be eligible for medical assistance under the State plan; and
(ii) clinicians and others who provide services to individuals who are likely to be eligible for medical assistance under the State plan; and
(B) increase awareness of the benefits of using comprehensive tobacco cessation services covered in the State plan among—
(i) individuals who are likely to be eligible for medical assistance under the State plan; and
(ii) clinicians and others who provide services to individuals who are likely to be eligible for medical assistance under the State plan about the benefits of using comprehensive tobacco cessation services, for calendar quarters occurring during the period beginning on the date of the enactment of this paragraph and ending on the date that is 5 years after the date of enactment of this paragraph, an amount equal to 90 percent of the sums expended during each quarter which are attributable to such development, implementation, and evaluation, and for calendar quarters succeeding such period, an amount equal to Federal medical assistance percentage determined under section 1905(b) of the sums expended during each quarter which are so attributable.”.
(f) No prior authorization for tobacco cessation drugs under medicaid.— Section 1927(d) of the Social Security Act (42 U.S.C. 1396r–8(d)) is amended—
(1) in paragraph (1)(A), by striking “A State” and inserting “Subject to paragraph (8), a State”; and
(2) by adding at the end the following new paragraph:
“(8) No prior authorization programs for tobacco cessation drugs.— A State plan may not require, as a condition of coverage or payment for a covered outpatient drug, the approval of an agent to promote smoking cessation (including agents approved by the Food and Drug Administration) or tobacco cessation.”.
(g) Exclusion of enhanced payments from territorial caps.— Notwithstanding any other provision of law, for purposes of section 1108 of the Social Security Act (42 U.S.C. 1308), with respect to any additional amount paid to a territory as a result of the application of section 1905(bb)(2) of the Social Security Act (42 U.S.C. 1396d(bb)(2))—
(1) the limitation on payments to territories under subsections (f) and (g) of such section 1108 shall not apply to such additional amounts; and
(2) such additional amounts shall be disregarded in applying such subsections.
(h) Requiring CHIP coverage of counseling and pharmacotherapy for cessation of tobacco use.—
(1) In general.— Section 2103(c)(2) of the Social Security Act (42 U.S.C. 1397cc(c)(2)) is amended by adding at the end the following new subparagraph:
“(D) Counseling and pharmacotherapy for cessation of tobacco use by individuals who are eligible under the State child health plan.”.
(2) Counseling and pharmacotherapy for cessation of tobacco use defined.— Section 2110(c) of the Social Security Act (42 U.S.C. 1397jj(c)) is amended by adding at the end the following new paragraph:
“(10) Counseling and pharmacotherapy for cessation of tobacco use.— The term counseling and pharmacotherapy for cessation of tobacco use means diagnostic, therapy, and counseling services and pharmacotherapy (including the coverage of prescription and nonprescription tobacco cessation agents approved by the Food and Drug Administration) for the cessation of tobacco use by individuals who use tobacco products or who are being treated for tobacco use that are furnished—
(A) by or under the supervision of a physician; or
(B) by any other health care professional who—
(i) is legally authorized to furnish such services under State law (or the State regulatory mechanism provided by State law) of the State in which the services are furnished; and
(ii) is authorized to receive payment for other services under this title or is designated by the Secretary for this purpose, which is recommended in the guideline entitled, “Treating Tobacco Use and Dependence: 2008 Update: A Clinical Practice Guideline” published by the Public Health Service in May 2008 (or any subsequent modification of such guideline) or is recommended for the cessation of tobacco use by the United States Preventive Services Task Force or any additional intervention approved by the Food and Drug Administration as safe and effective in helping smokers quit.”.
(i) No cost sharing.— Section 2103(e) of the Social Security Act (42 U.S.C. 1397cc(e)) is amended by adding at the end the following new paragraph:
“(5) No cost sharing on benefits for counseling and pharmacotherapy for cessation of tobacco use.— The State child health plan may not impose deductibles, coinsurance, or other cost sharing with respect to benefits for counseling and pharmacotherapy for cessation of tobacco use (as defined in section 2110(c)(10)) and prescription drugs that are covered under a State child health plan that are prescribed for purposes of promoting tobacco cessation in accordance with the guideline specified in section 2110(c)(10)(B).”.
(j) Exception from optional restriction under CHIP prescription drug coverage.— Section 2103 of the Social Security Act (42 U.S.C. 1397cc) is amended by adding at the end the following new subsection:
“(g) Exception from optional restriction under CHIP prescription drug coverage.— The State child health plan may exclude or otherwise restrict nonprescription drugs, except, in the case of—
(1) pregnant women when recommended in accordance with the guideline specified in section 2110(c)(10)(B), agents approved by the Food and Drug Administration under the over-the-counter monograph process for purposes of promoting tobacco cessation; and
(2) individuals who are eligible under the State child health plan when recommended in accordance with the Guideline referred to in section 2110(c)(10)(B), agents approved by the Food and Drug Administration under the over-the-counter monograph process for purposes of promoting tobacco cessation.”.
(k) State monitoring and promoting of comprehensive tobacco cessation services under CHIP.— Section 2102 of the Social Security Act (42 U.S.C. 1397bb) is amended by adding at the end the following new subsection:
“(e) State monitoring and promoting of comprehensive tobacco cessation services under CHIP.— A State child health plan shall include a description of the procedures to be used by the State to monitor and promote the use of comprehensive tobacco cessation services under the State plan (including conducting an outreach campaign to increase awareness of the benefits of using such services) among—
(1) individuals entitled to medical assistance under the State child health plan who use tobacco products; and
(2) clinicians and others who provide services to individuals entitled to medical assistance under the State child health plan.”.
(l) Federal reimbursement for CHIP coverage and outreach campaign.—
(1) In general.— Section 2105(a) of the Social Security Act (42 U.S.C. 1397ee(a)) is amended by adding at the end the following new paragraph:
“(5) Federal reimbursement for CHIP coverage of comprehensive tobacco cessation services and outreach campaign.— In addition to the payments made under paragraph (1) for calendar quarters occurring during the period beginning on the date of the enactment of this paragraph and ending 5 years after such date, the Secretary shall pay—
(A) an amount equal to 90 percent of the sums expended during each quarter which are attributable to the cost of furnishing counseling and pharmacotherapy for cessation of tobacco use by individuals who are eligible under the State child health plan (net of any payments made to the State under paragraph (1) with respect to such counseling and pharmacotherapy); plus
(B) an amount equal to 90 percent of the sums expended during each quarter which are attributable to the development, implementation, and evaluation of an outreach campaign to—
(i) increase awareness of comprehensive tobacco cessation services covered in the State child health plan among—
(I) individuals who are likely to be eligible for medical assistance under the State child health plan; and
(II) clinicians and others who provide services to individuals who are likely to be eligible for medical assistance under the State child health plan; and
(ii) increase awareness of the benefits of using comprehensive tobacco cessation services covered in the State child health plan among—
(I) individuals who are likely to be eligible for medical assistance under the State child health plan; and
(II) clinicians and others who provide services to individuals who are likely to be eligible for medical assistance under the State child health plan about the benefits of using comprehensive tobacco cessation services.”.
(2) Adjustment of CHIP allotments.— Section 2104(m) of the Social Security Act (42 U.S.C. 1397dd(m)) is amended—
(A) in paragraph (2)(B), by striking “and (12)” and inserting “(12), and (13)”; and
(B) by adding at the end the following new paragraph:
“(13) Adjusting allotments to account for federal payments for chip coverage of comprehensive tobacco cessation services and outreach campaign.— If a State (including the District of Columbia and each commonwealth and territory) receives a payment for a fiscal year under section 2105(a)(5), the allotment determined for the State for such fiscal year shall be increased by the amount of such payment.”.
(m) No prior authorization for tobacco cessation drugs under CHIP.— Section 2103 of the Social Security Act (42 U.S.C. 1397cc), as amended by subsection (h), is further amended—
(1) in subsection (c)(2)(A), by inserting “(in accordance with subsection (h))” after “Coverage of prescription drugs”; and
(2) by adding at the end the following new subsection:
“(h) No prior authorization programs for tobacco cessation drugs.— A State child health plan may not require, as a condition of coverage or payment for prescription drugs, the approval of an agent to promote smoking cessation (including agents approved by the Food and Drug Administration) or tobacco cessation.”.
(n) Comprehensive coverage of tobacco cessation coverage in private health insurance.— Section 2713 of the Public Health Service Act (42 U.S.C. 300gg–13) is amended by adding at the end the following:
“(d) No prior authorization.— A group health plan and a health insurance issuer offering group or individual health insurance coverage shall not impose any prior authorization requirement for tobacco cessation counseling and pharmacotherapy that has in effect a rating of “A” or “B” in the current recommendations of the United States Preventive Services Task Force.”.
(o) Rule of construction.— None of the amendments made by this section shall be construed to limit coverage of any counseling or pharmacotherapy for individuals under 18 years of age.
(p) Effective date.— The amendments made by this section shall take effect on the first day of the first fiscal year that begins on or after the date of enactment of this Act.
(a) In general.— The Secretary of Health and Human Services shall expand and intensify the conduct and support of the research activities of the National Institutes of Health and the National Institute of Dental and Craniofacial Research to improve the oral health of the population through the prevention and management of oral diseases and conditions.
(b) Included research activities.— Research activities under subsection (a) shall include—
(1) comparative effectiveness research and clinical disease management research addressing early childhood cancer and oral cancer; and
(2) awarding of grants and contracts to support the training and development of health services researchers, comparative effectiveness researchers, and clinical researchers whose research improves the oral health of the population.
(a) Development and dissemination of an evidence-Based strategies guide.— The Secretary of Health and Human Services (referred to in this section as the “Secretary”), acting through the Director of the Centers for Disease Control and Prevention, not later than 2 years after the date of enactment of this Act, shall—
(1) develop a guide on evidence-based strategies for State, territorial, and local health departments to use to build and maintain effective obesity prevention and reduction programs, and, in consultation with stakeholders that have expertise in Tribal health, a guide on such evidence-based strategies with respect to Indian Tribes and Tribal organizations for such Indian Tribes and Tribal organizations to use for such purpose, both of which guides shall—
(A) describe an integrated program structure for implementing interventions proven to be effective in preventing and reducing the incidence of obesity; and
(B) recommend—
(i) optimal resources, including staffing and infrastructure, for promoting nutrition and obesity prevention and reduction; and
(ii) strategies for effective obesity prevention programs for State and local health departments, Indian Tribes, and Tribal organizations, including strategies related to—
(I) the application of evidence-based and evidence-informed practices to prevent and reduce obesity rates;
(II) the development, implementation, and evaluation of obesity prevention and reduction strategies for specific communities and populations;
(III) demonstrated knowledge of obesity prevention practices that reduce associated preventable diseases, health conditions, death, and health care costs;
(IV) best practices for the coordination of efforts to prevent and reduce obesity and related chronic diseases;
(V) addressing the underlying risk factors and social determinants of health that impact obesity rates; and
(VI) interdisciplinary coordination between relevant public health officials specializing in fields such as nutrition, physical activity, epidemiology, communications, and policy implementation, and collaboration between public health officials and community-based organizations; and
(2) disseminate the guides and current research, evidence-based practices, tools, and educational materials related to obesity prevention, consistent with the guides, to State and local health departments, Indian Tribes, and Tribal organizations.
(b) Technical assistance.— The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall provide technical assistance to State and local health departments, Indian Tribes, and Tribal organizations to support such health departments in implementing the guides developed under subsection (a)(1).
(c) Indian tribes; tribal organizations.— In this section, the terms Indian Tribe and Tribal organization have the meanings given the terms in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304).
(a) Research with respect to uterine fibroids.—
(1) Research.— The Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall expand, intensify, and coordinate programs for the conduct and support of research with respect to uterine fibroids.
(2) Administration and coordination.— The Secretary shall carry out the conduct and support of research pursuant to paragraph (1), in coordination with the appropriate institutes, offices, and centers of the National Institutes of Health and any other relevant Federal agency, as determined by the Director of the National Institutes of Health.
(3) Authorization of appropriations.— For the purpose of carrying out this subsection, there are authorized to be appropriated $30,000,000 for each of fiscal years 2027 through 2031.
(b) Research with respect to medicaid coverage of uterine fibroids treatment.—
(1) Research.— The Secretary (or the Secretary’s designee) shall establish a research database, or expand an existing research database, to collect data on services furnished to individuals diagnosed with uterine fibroids under a State plan (or a waiver of such a plan) under the Medicaid program under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) or under a State child health plan (or a waiver of such a plan) under the Children’s Health Insurance Program under title XXI of such Act (42 U.S.C. 1397aa et seq.) for the treatment of such fibroids for purposes of assessing the frequency at which such individuals are furnished such services.
(2) Report.—
(A) In general.— Not later than 2 years after the date of enactment of this Act, the Secretary shall submit to Congress a report on the amount of Federal and State expenditures with respect to services furnished for the treatment of uterine fibroids under State plans (or waivers of such plans) under the Medicaid program under such title XIX and State child health plans (or waivers of such plans) under the Children’s Health Insurance Program under such title XXI.
(B) Coordination.— The Secretary shall coordinate the development and submission of the report required under paragraph (1) with any other relevant Federal agency, as determined by the Secretary.
(c) Education and dissemination of information with respect to uterine fibroids.—
(1) Uterine fibroids public education program.— The Secretary shall develop and disseminate to the public information regarding uterine fibroids, including information on—
(A) the awareness, incidence, and prevalence of uterine fibroids among individuals, including all minority individuals;
(B) the elevated risk for minority individuals to develop uterine fibroids; and
(C) the availability, as medically appropriate, of the range of treatment options for symptomatic uterine fibroids, including non-hysterectomy treatments and procedures.
(2) Dissemination of information.— The Secretary may disseminate information under paragraph (1) directly or through arrangements with intra-agency initiatives, nonprofit organizations, consumer groups, institutions of higher education (as defined in section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001)), or Federal, State, or local public private partnerships.
(3) Authorization of appropriations.— For the purpose of carrying out this subsection, there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2027 through 2031.
(d) Information to health care providers with respect to uterine fibroids.—
(1) Dissemination of information.— The Secretary shall, in consultation and in accordance with guidelines from relevant medical societies, work with health care-related specialty societies and health systems to promote evidence-based care for individuals with fibroids. Such efforts shall include minority individuals who have an elevated risk to develop uterine fibroids and the range of available options for the treatment of symptomatic uterine fibroids, including non-hysterectomy drugs and devices approved under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
(2) Authorization of appropriations.— For the purpose of carrying out this subsection, there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2027 through 2031.
(e) Definition.— In this section, the term minority individuals means individuals who are members of a racial and ethnic minority group, as defined in section 1707(g) of the Public Health Service Act (42 U.S.C. 300u–6(g)).
It is the policy of the United States to achieve an AIDS-free generation, and to—
(1) expand access to lifesaving antiretroviral therapy for people living with HIV and immediately link people to continuous and coordinated high-quality care when they learn they are living with HIV;
(2) expand targeted efforts to prevent HIV infection using a combination of effective, evidence-based approaches, including routine HIV screening, and universal access to HIV prevention tools, including preexposure prophylaxis, in communities disproportionately impacted by HIV, particularly communities of color;
(3) ensure laws, policies, and regulations do not impede access to prevention, treatment, and care for people living with HIV or disproportionately impacted by HIV;
(4) accelerate research for more efficacious HIV prevention and treatments, tools, a cure, and a vaccine; and
(5) respect the human rights and dignity of persons living with HIV.
Section 2623 of the Public Health Service Act (42 U.S.C. 300ff–31b) is amended by adding at the end the following:
“(c) Additional funding for AIDS drug assistance program treatments.— In addition to amounts otherwise authorized to be appropriated for carrying out this subpart, there are authorized to be appropriated such sums as may be necessary to carry out sections 2612(b)(3)(B) and 2616 for each of fiscal years 2027 through 2030.”.
(a) Grants.— The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, shall make grants to States to support integration of public health surveillance systems into all electronic health records in order to allow rapid communications between the clinical setting and health departments, by means that include—
(1) providing technical assistance and policy guidance to State and local health departments, clinical providers, and other agencies serving individuals with HIV to improve the interoperability of data systems relevant to monitoring HIV care and supportive services;
(2) capturing longitudinal data pertaining to the initiation and ongoing prescription or dispensing of antiretroviral therapy for individuals diagnosed with HIV (such as through pharmacy-based reporting);
(3) obtaining information—
(A) on a voluntary basis, on sexual orientation and gender identity; and
(B) on sources of coverage (or the lack of coverage) for medical treatment (including coverage through the Medicaid program under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.), the Medicare program under title XVIII of such Act (42 U.S.C. 1395 et seq.), the program under title XXVI of the Public Health Service Act (42 U.S.C. 300ff–11 et seq.; commonly referred to as the “Ryan White HIV/AIDS Program”), other public funding, private insurance, and health maintenance organizations); and
(4) obtaining and using current geographic markers of residence (such as current address, ZIP Code, partial ZIP Code, and census block).
(b) Privacy and security safeguards.— In carrying out this section, the Secretary of Health and Human Services shall ensure that appropriate privacy and security safeguards are met to prevent unauthorized disclosure of protected health information and compliance with the HIPAA privacy and security law (as defined in section 3009 of the Public Health Service Act (42 U.S.C. 300jj–19)) and other relevant laws and regulations.
(c) Prohibition against improper use of data.— No grant under this section may be used to allow or facilitate the collection or use of surveillance or clinical data or records—
(1) for punitive measures of any kind, civil or criminal, against the subject of such data or records; or
(2) for imposing any requirement or restriction with respect to an individual without the individual’s written consent.
(d) 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 2027 through 2030.
(a) Strategies.— The Secretary of Health and Human Services, in collaboration with the Director of the Centers for Disease Control and Prevention, the Assistant Secretary for Mental Health and Substance Use, the Director of the Office of AIDS Research, the Administrator of the Health Resources and Services Administration, and the Administrator of the Centers for Medicare & Medicaid Services, shall—
(1) identify evidence-based strategies most effective at addressing the multifaceted issues that impede disease status awareness with respect to HIV/AIDS and linkage to, and retention in, appropriate care, taking into consideration health care systems issues, clinic and provider issues, and individual psychosocial, environmental, and other contextual factors;
(2) support the wide-scale implementation of the evidence-based strategies identified pursuant to paragraph (1), including through incorporating such strategies into health care coverage supported by the Medicaid program under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.), the program under title XXVI of the Public Health Service Act (42 U.S.C. 300ff–11 et seq.; commonly referred to as the “Ryan White HIV/AIDS Program”), and health plans purchased through an Exchange established under title I of the Patient Protection and Affordable Care Act (Public Law 111–148); and
(3) not later than 1 year after the date of the enactment of this Act, submit a report to the Congress on the status of activities under paragraphs (1) and (2).
(b) Authorization of appropriations.— To carry out this section, there are authorized to be appropriated such sums as may be necessary for fiscal years 2027 through 2030.
(a) Sense of congress.— It is the sense of Congress that AIDS research has led to scientific advancements that have—
(1) saved the lives of millions of people living with HIV;
(2) prevented millions of individuals from receiving new diagnoses of HIV; and
(3) had broad benefits that extend far beyond helping people at risk for, or living with, HIV.
(b) In general.— The Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall expand, intensify, and coordinate operational and translational research and other activities of the National Institutes of Health regarding methods—
(1) to increase adoption of evidence-based adherence strategies within HIV care and treatment programs;
(2) to increase HIV testing and case detection rates;
(3) to reduce HIV-related health disparities;
(4) to ensure that research to improve adherence to HIV care and treatment programs address the unique concerns of women;
(5) to integrate HIV prevention and care services with mental health and substance use prevention and treatment delivery systems;
(6) to increase knowledge on the implementation of preexposure prophylaxis (referred to in this section as “PrEP”), including with respect to—
(A) who can benefit most from PrEP;
(B) how to provide PrEP safely and efficiently;
(C) how to integrate PrEP with other essential prevention methods such as condoms; and
(D) how to ensure high levels of adherence; and
(7) to increase knowledge of “undetectable and untransmittable”, when a person living with HIV who is on antiretroviral therapy and is durably virally suppressed (defined as having a consistent viral load of less than 200 copies/ml) cannot sexually transmit HIV.
(c) Authorization of appropriations.— To carry out this section, there are authorized to be appropriated such sums as may be necessary for fiscal years 2027 through 2030.
(a) In general.— For the purpose of reducing new HIV diagnoses in racial and ethnic minority communities, the Secretary of Health and Human Services, acting through the Deputy Assistant Secretary for Minority Health, may make grants to public health agencies and faith-based organizations to conduct—
(1) outreach activities related to HIV prevention and testing activities;
(2) HIV prevention activities;
(3) HIV testing activities; and
(4) public health education campaigns on accessing HIV prevention medication.
(b) Authorization of appropriations.— To carry out this section, there are authorized to be appropriated such sums as may be necessary for fiscal years 2027 through 2030.
(a) Expanded funding.— The Secretary of Health and Human Services, in collaboration with the Deputy Assistant Secretary for Minority Health, the Director of the Centers for Disease Control and Prevention, the Administrator of the Health Resources and Services Administration, and the Assistant Secretary for Mental Health and Substance Use, shall provide funds and carry out activities to expand the Minority AIDS Initiative.
(b) Use of funds.— The additional funds made available under this section may be used, through the Minority AIDS Initiative, to support the following activities:
(1) Providing technical assistance and infrastructure support to reduce HIV/AIDS in minority populations.
(2) Increasing minority populations’ access to HIV prevention and care services.
(3) Building strong community programs and partnerships to address HIV prevention and the health care needs of specific racial and ethnic minority populations.
(c) Priority interventions.— Within the racial and ethnic minority populations referred to in subsection (b), priority in conducting intervention services shall be given to—
(1) men who have sex with men;
(2) youth;
(3) persons who engage in intravenous drug abuse;
(4) women;
(5) homeless individuals;
(6) individuals incarcerated or in the penal system;
(7) transgender individuals; and
(8) nonbinary individuals.
(d) Authorization of appropriations.— For carrying out this section, there are authorized to be appropriated $610,000,000 for fiscal year 2027 and such sums as may be necessary for each of fiscal years 2028 through 2031.
(a) In general.— The Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration, shall expand, intensify, and coordinate workforce initiatives of the Health Resources and Services Administration to increase the capacity of the health workforce focusing primarily on HIV to meet the demand for culturally competent care, and may award grants for any of the following:
(1) Development of curricula for training primary care providers in HIV/AIDS prevention and care, including routine HIV testing.
(2) Support to expand access to culturally and linguistically accessible benefits counselors, trained peer navigators, and mental and behavioral health professionals with expertise in HIV.
(3) Training health care professionals to provide care to individuals living with HIV.
(4) Development by grant recipients under title XXVI of the Public Health Service Act (42 U.S.C. 300ff–11 et seq.; commonly referred to as the “Ryan White HIV/AIDS Program”) and other persons, of policies for providing culturally relevant and sensitive treatment to individuals living with HIV, with particular emphasis on treatment to racial and ethnic minorities, men who have sex with men, and women, young people, and children living with HIV.
(5) Development and implementation of programs to increase the use of telehealth to respond to HIV-specific health care needs in rural and minority communities, with particular emphasis given to medically underserved communities and insular areas.
(6) Evaluating interdisciplinary medical provider care team models that promote high-quality care, with particular emphasis on care to racial and ethnic minorities.
(7) Training health care professionals to make them aware of the high rates of chronic hepatitis B and chronic hepatitis C in adult racial and ethnic minority populations, and the importance of prevention, detection, and medical management of hepatitis B and hepatitis C and of liver cancer screening.
(8) Development of curricula for training primary care providers that HIV and tuberculosis are significant mutual comorbidities, and that a patient who tests positive for one disease should be offered and encouraged to receive testing for the other.
(b) Authorization of appropriations.— To carry out this section, there are authorized to be appropriated such sums as may be necessary for fiscal years 2027 through 2030.
(a) In general.— The Secretary may enter into an agreement with any physician, nurse practitioner, or physician assistant under which—
(1) the physician, nurse practitioner, or physician assistant agrees to serve as a medical provider for a period of not less than 2 years—
(A) at a Ryan White-funded or title X-funded facility with a critical shortage of doctors (as determined by the Secretary); or
(B) in an area with a high incidence of HIV/AIDS; and
(2) the Secretary agrees to make payments in accordance with subsection (b) on the professional education loans of the physician, nurse practitioner, or physician assistant.
(b) Manner of payments.— The payments described in subsection (a) shall be made by the Secretary as follows:
(1) Upon completion by the physician, nurse practitioner, or physician assistant for whom the payments are to be made of the first year of the service specified in the agreement entered into with the Secretary under subsection (a), the Secretary shall pay 30 percent of the principal of and the interest on the individual’s professional education loans.
(2) Upon completion by the physician, nurse practitioner, or physician assistant of the second year of such service, the Secretary shall pay another 30 percent of the principal of and the interest on such loans.
(3) Upon completion by that individual of a third year of such service, the Secretary shall pay another 25 percent of the principal of and the interest on such loans.
(c) Applicability of certain provisions.— Subpart III of part D of title III of the Public Health Service Act (42 U.S.C. 254l et seq.) shall, except as inconsistent with this section, apply to the program carried out under this section in the same manner and to the same extent as such provisions apply to the National Health Service Corps loan repayment program.
(d) Reports.— Not later than 18 months after the date of the enactment of this Act, and annually thereafter, the Secretary shall prepare and submit to Congress a report describing the program carried out under this section, including statements regarding the following:
(1) The number of physicians, nurse practitioners, and physician assistants enrolled in the program.
(2) The number and amount of loan repayments provided through the program.
(3) The placement location of loan repayment recipients at facilities described in subsection (a)(1).
(4) The default rate on such loans and actions required.
(5) The amount of outstanding default funds with respect to such loans.
(6) To the extent that it can be determined, the reason for the default on such a loan.
(7) The demographics of individuals participating in the program.
(8) An evaluation of the overall costs and benefits of the program.
(e) Definitions.— In this section:
(1) HIV/AIDS.— The term HIV/AIDS means human immunodeficiency virus and acquired immune deficiency syndrome.
(2) Nurse practitioner.— The term nurse practitioner means a registered nurse who has completed an accredited graduate degree program in advanced nurse practice and has successfully passed a national certification exam.
(3) Physician.— The term physician means a graduate of a school of medicine who has completed postgraduate training in general or pediatric medicine.
(4) Physician assistant.— The term physician assistant means a medical provider who completed an accredited physician assistant training program and successfully passed the Physician Assistant National Certifying Examination.
(5) Professional education loan.— The term professional education loan—
(A) means a loan that is incurred for the cost of attendance (including tuition, other reasonable educational expenses, and reasonable living costs) at a school of medicine, school of nursing, or physician assistant training program; and
(B) includes only the portion of the loan that is outstanding on the date the physician, nurse practitioner, or physician assistant involved begins the service specified in the agreement under subsection (a).
(6) Ryan white-funded.— The term Ryan White-funded means, with respect to a facility, receiving funds under title XXVI of the Public Health Service Act (42 U.S.C. 300ff–11 et seq.).
(7) Secretary.— The term Secretary means the Secretary of Health and Human Services.
(8) School of medicine.— The term school of medicine has the meaning given to that term in section 799B of the Public Health Service Act (42 U.S.C. 295p).
(9) Title x-funded.— The term title X-funded means, with respect to a facility, receiving funds under title X of the Public Health Service Act (42 U.S.C. 300 et seq.).
(f) Authorization of appropriations.— To carry out this section, there are authorized to be appropriated such sums as may be necessary for fiscal years 2027 through 2030.
(a) In general.— The Secretary may enter into an agreement with any dentist under which—
(1) the dentist agrees to serve as a dentist for a period of not less than 2 years at a facility with a critical shortage of dentists (as determined by the Secretary) in an area with a high incidence of HIV/AIDS; and
(2) the Secretary agrees to make payments in accordance with subsection (b) on the dental education loans of the dentist.
(b) Manner of payments.— The payments described in subsection (a) shall be made by the Secretary as follows:
(1) Upon completion by the dentist for whom the payments are to be made of the first year of the service specified in the agreement entered into with the Secretary under subsection (a), the Secretary shall pay 30 percent of the principal of and the interest on the dental education loans of the dentist.
(2) Upon completion by the dentist of the second year of such service, the Secretary shall pay another 30 percent of the principal of and the interest on such loans.
(3) Upon completion by that individual of a third year of such service, the Secretary shall pay another 25 percent of the principal of and the interest on such loans.
(c) Applicability of certain provisions.— Subpart III of part D of title III of the Public Health Service Act (42 U.S.C. 254l et seq.) shall, except as inconsistent with this section, apply to the program carried out under this section in the same manner and to the same extent as such provisions apply to the National Health Service Corps Loan Repayment Program.
(d) Reports.— Not later than 18 months after the date of the enactment of this Act, and annually thereafter, the Secretary shall prepare and submit to the Congress a report describing the program carried out under this section, including statements regarding the following:
(1) The number of dentists enrolled in the program.
(2) The number and amount of loan repayments provided through the program.
(3) The placement location of loan repayment recipients at facilities described in subsection (a)(1).
(4) The default rate on such loans and actions required.
(5) The amount of outstanding default funds with respect to such loans.
(6) To the extent that it can be determined, the reason for the default on such a loan.
(7) The demographics of individuals participating in the program.
(8) An evaluation of the overall costs and benefits of the program.
(e) Definitions.— In this section:
(1) Dental education loan.— The term dental education loan—
(A) means a loan that is incurred for the cost of attendance (including tuition, other reasonable educational expenses, and reasonable living costs) at a school of dentistry; and
(B) includes only the portion of the loan that is outstanding on the date the dentist involved begins the service specified in the agreement under subsection (a).
(2) Dentist.— The term dentist means a graduate of a school of dentistry who has completed postgraduate training in general or pediatric dentistry.
(3) HIV/AIDS.— The term HIV/AIDS means human immunodeficiency virus and acquired immune deficiency syndrome.
(4) School of dentistry.— The term school of dentistry has the meaning given to that term in section 799B of the Public Health Service Act (42 U.S.C. 295p).
(5) Secretary.— The term Secretary means the Secretary of Health and Human Services.
(f) 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 2027 through 2030.
(a) Sense of congress.— It is the sense of Congress that providing sterile syringes and sterilized equipment to injecting drug users substantially reduces risk of HIV infection, increases the probability that they will initiate drug treatment, and does not increase drug use.
(b) In general.— The Secretary of Health and Human Services may provide grants and technical assistance for the purpose of reducing the rate of HIV infections among injecting drug users through a comprehensive package of services for such users, including the provision of sterile syringes, education and outreach, access to infectious disease testing, overdose prevention, and treatment for drug dependence.
(c) Authorization of appropriations.— To carry out this section, there are authorized to be appropriated such sums as may be necessary for fiscal years 2027 through 2030.
(a) In general.— The Secretary of Health and Human Services shall submit to Congress and the President an annual report on the impact of HIV/AIDS for racial and ethnic minority communities, women, and youth aged 24 and younger.
(b) Contents.— The report under subsection (a) shall include information on the—
(1) progress that has been made in reducing the impact of HIV/AIDS in such communities;
(2) opportunities that exist to make additional progress in reducing the impact of HIV/AIDS in such communities;
(3) challenges that may impede such additional progress; and
(4) Federal funding necessary to achieve substantial reductions in HIV/AIDS in racial and ethnic minority communities.
(a) National observance days.— It is the sense of Congress that national observance days highlighting the impact of HIV on communities of color include the following:
(1) National Black HIV/AIDS Awareness Day.
(2) National Latino AIDS Awareness Day.
(3) National Asian and Pacific Islander HIV/AIDS Awareness Day.
(4) National Native American HIV/AIDS Awareness Day.
(5) National Youth HIV/AIDS Awareness Day.
(b) Call to action.— It is the sense of Congress that the President should call on members of communities of color—
(1) to become involved at the local community level in HIV testing, policy, and advocacy;
(2) to become aware, engaged, and empowered on the HIV epidemic within their communities; and
(3) to urge members of their communities to reduce risk factors, practice safe sex and other preventive measures, be tested for HIV, and seek care when appropriate.
(a) Sense of congress regarding laws or regulations directed at people living with HIV.— It is the sense of Congress that Federal and State laws, policies, and regulations regarding people living with HIV—
(1) should not place unique or additional burdens on such individuals solely as a result of their HIV status; and
(2) should instead demonstrate a public health-oriented, evidence-based, medically accurate, and contemporary understanding of—
(A) the multiple factors that lead to HIV transmission;
(B) the relative risk of demonstrated HIV transmission routes;
(C) the current health implications of living with HIV;
(D) the associated benefits of treatment and support services for people living with HIV; and
(E) the impact of punitive HIV-specific laws, policies, regulations, and judicial precedents and decisions on public health, on people living with or affected by HIV, and on their families and communities.
(b) Review of federal and state laws.—
(1) Review of federal and state laws.—
(A) In general.— Not later than 90 days after the date of the enactment of this Act, the Attorney General, the Secretary of Health and Human Services, and the Secretary of Defense acting jointly (in this section referred to as the “designated officials”) shall initiate a national review of Federal and State laws, including the Uniform Code of Military Justice (referred to in this section as the “UCMJ”), policies, regulations, and judicial precedents and decisions regarding criminal and related civil commitment cases involving people living with HIV/AIDS.
(B) Consultation.— In carrying out the review under subparagraph (A), the designated officials shall seek to include diverse participation from, and consultation with, each of the following:
(i) Each State.
(ii) State attorneys general (or their representatives).
(iii) State public health officials (or their representatives).
(iv) State judicial and court system officers, including judges, district attorneys, prosecutors, defense attorneys, law enforcement, and correctional officers.
(v) Members of the United States Armed Forces, including members of other Federal services subject to the UCMJ.
(vi) People living with HIV/AIDS, particularly those who have been subject to HIV-related prosecution or who are from minority communities whose members have been disproportionately subject to HIV-specific arrests and prosecution.
(vii) Legal advocacy and HIV/AIDS service organizations that work with people living with HIV/AIDS.
(viii) Nongovernmental health organizations that work on behalf of people living with HIV/AIDS, including syringe services programs, LGBTQ-focused health organizations, and organizations who serve people who engage in sex work.
(ix) Trade organizations or associations representing persons or entities described in clauses (i) through (vii).
(C) Relation to other reviews.— In carrying out the review under subparagraph (A), the designated officials may utilize other existing reviews of criminal and related civil commitment cases involving people living with HIV, including any such review conducted by any Federal or State agency or any public health, legal advocacy, or trade organization or association if the designated officials determines that such reviews were conducted in accordance with the principles set forth in subsection (a).
(2) Report.— Not later than 180 days after initiating the review required under paragraph (1), the Attorney General shall transmit to the Congress and make publicly available a report containing the results of the review, which includes the following:
(A) For each State and for the UCMJ, a summary of the relevant laws, policies, regulations, and judicial precedents and decisions regarding criminal cases involving people living with HIV, including the following:
(i) A determination of whether such laws, policies, regulations, and judicial precedents and decisions place any unique or additional burdens upon people living with HIV.
(ii) A determination of whether such laws, policies, regulations, and judicial precedents and decisions demonstrate a public health-oriented, evidence-based, medically accurate, and contemporary understanding of—
(I) the multiple factors that lead to HIV transmission;
(II) the relative risk of HIV transmission routes, including that a person that has an undetectable viral load cannot transmit HIV;
(III) the current health implications of living with HIV, including data disaggregated by race and ethnicity;
(IV) the current status of providing protection to people who engage in survival sex work against whom condom possession has been used as evidence of intent to commit a crime;
(V) States that have the classification of mandatory sex offenders;
(VI) the associated benefits of treatment and support services for people living with HIV; and
(VII) the impact of punitive HIV-specific laws and policies on public health, on people living with or affected by HIV, and on their families and communities, including people who are in abusive, dependent, violent, or nonconsensual relationships and are unable to both negotiate the use of condoms and status disclosure.
(iii) An analysis of the public health and legal implications of such laws, policies, regulations, and judicial precedents and decisions, including an analysis of the consequences of having a similar penal scheme applied to comparable situations involving other communicable diseases.
(iv) An analysis of the proportionality of punishments imposed under HIV-specific laws, policies, regulations, and judicial precedents, taking into consideration penalties attached to violation of State laws against similar degrees of endangerment or harm, such as driving while intoxicated or transmission of other communicable diseases, or more serious harms, such as vehicular manslaughter offenses.
(B) An analysis of common elements shared between State laws, policies, regulations, and judicial precedents.
(C) A set of best practice recommendations directed to State governments, including State attorneys general, public health officials, and judicial officers, in order to ensure that laws, policies, regulations, and judicial precedents regarding people living with HIV are in accordance with the principles set forth in subsection (a).
(D) Recommendations for adjustments to the UCMJ, including discontinuing the use of a service member’s HIV diagnosis as the basis for prosecution, enhanced penalties, or discharge from military service, in order to ensure that laws, policies, regulations, and judicial precedents regarding people living with HIV are in accordance with the principles set forth in subsection (a). Such recommendations should include any necessary and appropriate changes to “Orders to Follow Preventative Medicine Requirements”.
(3) Guidance.— Not later than 90 days after the date of the release of the report required by paragraph (2), the Attorney General and the Secretary of Health and Human Services shall jointly develop and publicly release updated guidance for States based on the set of best practice recommendations required under paragraph (2)(C) in order to assist States dealing with criminal and related civil commitment cases regarding people living with HIV.
(4) Monitoring and evaluation system.— Not later than 60 days after the date of the release of the guidance required under paragraph (3), the Attorney General and the Secretary of Health and Human Services shall jointly establish an integrated monitoring and evaluation system that includes, where appropriate, objective and quantifiable performance goals and indicators to measure progress toward statewide implementation in each State of the best practice recommendations required under paragraph (2)(C).
(5) Modernization of federal laws, policies, and regulations.— Not later than 90 days after the date of the release of the report required under paragraph (2), the designated officials shall develop and transmit to the President and the Congress, and make publicly available, such proposals as may be necessary to implement adjustments to Federal laws, policies, or regulations, including the UCMJ, based on the recommendations required under paragraph (2)(D), either through Executive order or through changes to statutory law.
(c) Rule of construction.— Nothing in this section shall be construed to discourage the prosecution of individuals who intentionally transmit or attempt to transmit HIV to another individual.
(d) No additional appropriations authorized.— This section shall not be construed to increase the amount of appropriations that are authorized to be appropriated for any fiscal year.
(a) Sense of congress regarding distribution of sexual barrier protection devices in state prison systems.— It is the sense of Congress that States shall allow for the legal distribution of sexual barrier protection devices in State correctional facilities to reduce the prevalence and spread of STIs in those facilities.
(b) Authority To allow community organizations To provide STI counseling, STI prevention education, and sexual barrier protection devices in federal correctional facilities.—
(1) Directive to attorney general.— Not later than 30 days after the date of enactment of this Act, the Attorney General shall direct the Director of the Bureau of Prisons to allow community organizations to, in accordance with all relevant Federal laws and regulations that govern visitation in Federal correctional facilities—
(A) distribute sexual barrier protection devices in Federal correctional facilities; and
(B) engage in STI counseling and STI prevention education in Federal correctional facilities.
(2) Information requirement.— Any community organization permitted to distribute sexual barrier protection devices under paragraph (1) shall ensure that the individuals to whom the devices are distributed are informed about the proper use and disposal of sexual barrier protection devices in accordance with established public health practices. Any community organization conducting STI counseling or STI prevention education under paragraph (1) shall offer comprehensive sexuality education.
(3) Possession of device protected.— A Federal correctional facility may not, because of the possession or use of a sexual barrier protection device—
(A) take adverse action against an incarcerated individual; or
(B) consider possession or use as evidence of prohibited activity for the purpose of any Federal correctional facility administrative proceeding.
(4) Implementation.— The Attorney General and the Director of the Bureau of Prisons shall implement this section according to established public health practices in a manner that protects the health, safety, and privacy of incarcerated individuals and of correctional facility staff.
(c) Survey of and report on correctional facility programs aimed at reducing the spread of STIs.—
(1) Survey.— Not later than 180 days after the date of enactment of this Act, and annually thereafter for 5 years, the Attorney General, after consulting with the Secretary of Health and Human Services, State officials, and community organizations, shall, to the maximum extent practicable, conduct a survey of all Federal and State correctional facilities, to determine the following:
(A) Counseling, treatment, and supportive services.— Whether the correctional facility—
(i) requires incarcerated individuals to participate in counseling, treatment, and supportive services relating to STIs; or
(ii) offers such programs to incarcerated individuals.
(B) Access to sexual barrier protection devices.— Whether incarcerated individuals can—
(i) possess sexual barrier protection devices;
(ii) purchase sexual barrier protection devices;
(iii) purchase sexual barrier protection devices at a reduced cost; or
(iv) obtain sexual barrier protection devices without cost.
(C) Incidence of sexual violence.— The incidence of sexual violence and assault committed by incarcerated individuals and by correctional facility staff.
(D) Prevention education offered.— The type of prevention education, information, or training offered to incarcerated individuals and correctional facility staff regarding sexual violence and the spread of STIs, including whether such education, information, or training—
(i) constitutes comprehensive sexuality education;
(ii) is compulsory for new incarcerated individuals and for new correctional facility staff; and
(iii) is offered on an ongoing basis.
(E) STI testing.— Whether the correctional facility tests incarcerated individuals for STIs or gives them the option to undergo such testing—
(i) at intake;
(ii) on a regular basis; and
(iii) prior to release.
(F) STI test results.— The number of incarcerated individuals who are tested for STIs and the outcome of such tests at each correctional facility, disaggregated to include results for—
(i) the type of STI tested for;
(ii) the race and ethnicity of an individual tested;
(iii) the age of an individual tested; and
(iv) the gender of the individual tested.
(G) Prerelease referral policy.— Whether incarcerated individuals are informed prior to release about STI-related services or other health services in their communities, including free and low-cost counseling and treatment options.
(H) Prerelease referrals made.— The number of referrals to community-based organizations or public health facilities offering STI-related or other health services provided to incarcerated individuals prior to release, and the type of counseling or treatment for which the referral was made.
(I) Reinstatement of medicaid benefits.— Whether—
(i) the correctional facility assists incarcerated individuals that were enrolled in the State Medicaid program prior to their incarceration in reinstating their enrollment upon release; and
(ii) such individuals receive referrals as described in subparagraph (G) to entities that accept the State Medicaid program, including, if applicable—
(I) the number of such individuals, including those diagnosed with HIV, that have been reinstated;
(II) a list of obstacles to reinstating enrollment or to making determinations of eligibility for reinstatement, if any; and
(III) the number of individuals denied enrollment.
(J) Other actions taken.— Whether the correctional facility has taken any other action, in conjunction with community organizations or otherwise, to reduce the prevalence and spread of STIs in that facility.
(2) Privacy.— In conducting the survey under paragraph (1), the Attorney General shall not request or retain the identity of any individual who has sought or been offered counseling, treatment, testing, or prevention education information regarding an STI (including information about sexual barrier protection devices), or who has tested positive for an STI.
(3) Report.—
(A) In general.— The Attorney General shall transmit to Congress and make publicly available the results of the survey required under paragraph (1), both for the United States as a whole and disaggregated as to each State and each correctional facility.
(B) Deadlines.— To the maximum extent possible, the Attorney General shall—
(i) issue the first report under subparagraph (A) not later than 1 year after the date of enactment of this Act; and
(ii) issue reports under subparagraph (A) annually thereafter for 5 years.
(d) Strategy.—
(1) Directive to attorney general.— The Attorney General, in consultation with the Secretary of Health and Human Services, State officials, and community organizations, shall develop and implement a 5-year strategy to reduce the prevalence and spread of STIs in Federal and State correctional facilities. To the maximum extent possible, the strategy shall be developed, transmitted to Congress, and made publicly available not later than 180 days after the transmission of the first report required under subsection (c)(3).
(2) Contents of strategy.— The strategy developed under paragraph (1) shall include the following:
(A) Prevention education.— A plan for improving prevention education, information, and training offered to incarcerated individuals and correctional facility staff, including information and training on sexual violence and the spread of STIs, and comprehensive sexuality education.
(B) Sexual barrier protection device access.— A plan for expanding access to sexual barrier protection devices in correctional facilities.
(C) Sexual violence reduction.— A plan for reducing the incidence of sexual violence among incarcerated individuals and correctional facility staff.
(D) Counseling and supportive services.— A plan for expanding access to counseling and supportive services related to STIs in correctional facilities.
(E) Testing.— A plan for testing incarcerated individuals for STIs during intake, during regular health exams, and prior to release that—
(i) is conducted in accordance with guidelines established by the Centers for Disease Control and Prevention;
(ii) includes pretest counseling;
(iii) requires that incarcerated individuals are notified of their option to decline testing at any time;
(iv) requires that incarcerated individuals are confidentially notified of their test results in a timely manner; and
(v) ensures that incarcerated individuals testing positive for STIs receive post-test counseling, care, treatment, and supportive services.
(F) Treatment.— A plan for ensuring that correctional facilities have the necessary medicine and equipment to treat and monitor STIs and for ensuring that incarcerated individuals living with or testing positive for STIs receive and have access to care and treatment services.
(G) Strategies for demographic groups.— A plan for developing and implementing culturally appropriate, sensitive, and specific strategies to reduce the spread of STIs among demographic groups heavily impacted by STIs.
(H) Linkages with communities and facilities.— A plan for establishing and strengthening linkages to local community and health facilities that—
(i) provide counseling, testing, care, and treatment services;
(ii) may receive individuals recently released from incarceration who are living with STIs; and
(iii) accept payment through the State Medicaid program.
(I) Enrollment in state medicaid programs.— Plans to ensure that—
(i) incarcerated individuals who were enrolled in their State Medicaid program prior to incarceration in a correctional facility are automatically reenrolled in such program upon their release; and
(ii) incarcerated individuals who were not enrolled in their State Medicaid program prior to incarceration, and who are diagnosed with HIV while incarcerated in a correctional facility, are automatically enrolled in such program upon their release.
(J) Other plans.— Any other plans developed by the Attorney General for reducing the spread of STIs or improving the quality of health care in correctional facilities.
(K) Monitoring system.— A monitoring system that establishes performance goals related to reducing the prevalence and spread of STIs in correctional facilities and which, where feasible, expresses such goals in quantifiable form.
(L) Monitoring system performance indicators.— Performance indicators that measure or assess the achievement of the performance goals described in subparagraph (K).
(M) Cost estimate.— A detailed estimate of the funding necessary to implement the strategy at the Federal and State levels for all 5 years, including the amount of funds required by community organizations to implement the parts of the strategy in which they take part.
(3) Report.— Not later than 1 year after the date of the enactment of this Act, and annually thereafter, the Attorney General shall transmit to Congress and make publicly available an annual progress report regarding the implementation and effectiveness of the strategy described in paragraph (1). The progress report shall include an evaluation of the implementation of the strategy using the monitoring system and performance indicators provided for in subparagraphs (K) and (L) of paragraph (2).
(e) Authorization of appropriations.—
(1) In general.— There are authorized to be appropriated such sums as may be necessary to carry out this section for each of fiscal years 2027 through 2031.
(2) Availability of funds.— Amounts made available under paragraph (1) are authorized to remain available until expended.
(f) Definitions.— In this section:
(1) Community organization.— The term community organization means a public health care facility or a nonprofit organization that provides health- or STI-related services according to established public health standards.
(2) Comprehensive sexuality education.— The term comprehensive sexuality education means sexuality education—
(A) that includes information about abstinence and about the proper use and disposal of sexual barrier protection devices; and
(B) that is—
(i) evidence based;
(ii) medically accurate;
(iii) age and developmentally appropriate;
(iv) gender and identity sensitive;
(v) culturally and linguistically appropriate; and
(vi) structured to promote critical thinking, self-esteem, respect for others, and the development of healthy attitudes and relationships.
(3) Correctional facility.— The term correctional facility means any prison, penitentiary, adult detention facility, juvenile detention facility, jail, or other facility to which individuals may be sent after conviction of a crime or act of juvenile delinquency within the United States.
(4) Incarcerated individual.— The term incarcerated individual means any individual who is serving a sentence in a correctional facility after conviction of a crime.
(5) Sexual barrier protection device.— The term sexual barrier protection device means any physical device approved, cleared, or otherwise authorized by the Food and Drug Administration that has not been tampered with and which reduces the probability of STI transmission or infection between sexual partners, including female condoms, male condoms, and dental dams.
(6) Sexually transmitted infection.— The term sexually transmitted infection or “STI” means any disease or infection that is commonly transmitted through sexual activity, including HIV, gonorrhea, chlamydia, syphilis, genital herpes, viral hepatitis, and human papillomavirus.
(7) State.— The term State includes the District of Columbia, American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, Puerto Rico, and the United States Virgin Islands.
(8) State medicaid program.— The term State Medicaid program means the State plan (or a waiver of such plan) under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.).
(a) In general.— Section 1902(e) of the Social Security Act (42 U.S.C. 1396a(e)) is amended by adding at the end the following:
“(17) Enrollment of ex-offenders.—
(A) Automatic enrollment or reinstatement.—
(i) In general.— The State plan shall provide for the automatic enrollment or reinstatement of enrollment of an eligible individual—
(I) if such individual is scheduled to be released from a public institution due to the completion of sentence, not less than 30 days prior to the scheduled date of the release; and
(II) if such individual is to be released from a public institution on parole or on probation, as soon as possible after the date on which the determination to release such individual was made, and before the date such individual is released.
(ii) Exception.— If a State makes a determination that an individual is not eligible to be enrolled under the State plan—
(I) on or before the date by which the individual would be enrolled under clause (i), such clause shall not apply to such individual; or
(II) after such date, the State may terminate the enrollment of such individual.
(B) Relationship of enrollment to payment for services.—
(i) In general.— Subject to subparagraph (A)(ii), an eligible individual who is enrolled, or whose enrollment is reinstated, under subparagraph (A) shall be eligible for all services for which medical assistance is provided under the State plan after the date that the eligible individual is released from the public institution.
(ii) Relationship to payment prohibition for inmates.— No provision of this paragraph may be construed to permit payment for care or services for which payment is excluded under subparagraph (A) following the last numbered paragraph of section 1905(a).
(C) Treatment of continuous eligibility.—
(i) Suspension for inmates.— Any period of continuous eligibility under this title shall be suspended on the date an individual enrolled under this title becomes an inmate of a public institution (except as a patient of a medical institution).
(ii) Determination of remaining period.— Notwithstanding any changes to State law related to continuous eligibility during the time that an individual is an inmate of a public institution (except as a patient of a medical institution), subject to clause (iii), with respect to an eligible individual who was subject to a suspension under clause (i), on the date that such individual is released from a public institution the suspension of continuous eligibility under such clause shall be lifted for a period that is equal to the time remaining in the period of continuous eligibility for such individual on the date that such period was suspended under such clause.
(iii) Exception.— If a State makes a determination that an individual is not eligible to be enrolled under the State plan—
(I) on or before the date that the suspension of continuous eligibility is lifted under clause (ii), such clause shall not apply to such individual; or
(II) after such date, the State may terminate the enrollment of such individual.
(D) Automatic enrollment or reinstatement of enrollment defined.— For purposes of this paragraph, the term automatic enrollment or reinstatement of enrollment means that the State determines eligibility for medical assistance under the State plan without a program application from, or on behalf of, the eligible individual, but an individual can only be automatically enrolled in the State Medicaid plan if the individual affirmatively consents to being enrolled through affirmation in writing, by telephone, orally, through electronic signature, or through any other means specified by the Secretary.
(E) Eligible individual defined.— For purposes of this paragraph, the term eligible individual means an individual who is an inmate of a public institution (except as a patient in a medical institution)—
(i) who was enrolled under the State plan for medical assistance immediately before becoming an inmate of such an institution; or
(ii) who is diagnosed with human immunodeficiency virus.”.
(b) Supplemental funding for state implementation of automatic reinstatement of medicaid benefits.—
(1) In general.— Subject to paragraph (3), with respect to a State, for each of the first 4 calendar quarters in which the State plan meets the requirements of paragraph (17) of section 1902(e) of the Social Security Act (42 U.S.C. 1396a(e)) (as added by subsection (a)), the Federal matching payments (including payments based on the Federal medical assistance percentage) made to such State under section 1903 of the Social Security Act (42 U.S.C. 1396b) for the State expenditures described in paragraph (2) shall be increased by 5 percentage points.
(2) Expenditures.— The expenditures described in this paragraph are the following:
(A) Expenditures for which payment is available under section 1903 of the Social Security Act (42 U.S.C. 1396b) and which are attributable to strengthening the State’s enrollment and administrative resources for the purpose of improving processes for enrolling (or reinstating the enrollment of) eligible individuals (as such term is defined in subparagraph (E) of paragraph (17) of section 1902(e) of the Social Security Act (42 U.S.C. 1396a(e)) (as amended by subsection (a))).
(B) Expenditures for medical assistance (as such term is defined in section 1905(a) of the Social Security Act (42 U.S.C. 1396d(a))) provided to such eligible individuals.
(3) Requirements; limitation.—
(A) Report.— A State is not eligible for an increase in its Federal matching payments under paragraph (1) unless the State agrees to submit to the Secretary of Health and Human Services, and make publicly available, a report that contains the information required under paragraph (4) by the end of the 1-year period during which the State receives increased Federal matching payments in accordance with that paragraph.
(B) Maintenance of eligibility.—
(i) In general.— Subject to clause (ii), a State is not eligible for an increase in its Federal matching payments under paragraph (1) if eligibility standards, methodologies, or procedures under its State plan under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.), or waiver of such a plan, are more restrictive than the eligibility standards, methodologies, or procedures, respectively, under such plan or waiver as in effect on the date of enactment of this Act.
(ii) State reinstatement of eligibility permitted.— A State that has restricted eligibility standards, methodologies, or procedures under its State plan under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.), or a waiver of such plan, after the date of enactment of this Act, is no longer ineligible under clause (i) beginning with the first calendar quarter in which the State has reinstated eligibility standards, methodologies, or procedures that are no more restrictive than the eligibility standards, methodologies, or procedures, respectively, under such plan (or waiver) as in effect on such date.
(C) Limitation of matching payments to 100 percent.— In no case shall an increase in Federal matching payments under paragraph (1) result in Federal matching payments that exceed 100 percent of State expenditures.
(4) Required report information.— The information that is required in the report under paragraph (3)(A) shall include—
(A) the results of an evaluation of the impact of the implementation of the requirements of paragraph (17) of section 1902(e) of the Social Security Act (42 U.S.C. 1396a(e)) on improving the State’s processes for enrolling individuals who are released from public institutions under the State Medicaid plan;
(B) the number of individuals who were automatically enrolled (or whose enrollment was reinstated) under such paragraph during the 1-year period during which the State received increased payments under this subsection; and
(C) any other information that is required by the Secretary of Health and Human Services.
(c) Effective date.—
(1) In general.— Except as provided in paragraph (2), the amendments made by subsection (a) shall take effect 180 days after the date of the enactment of this Act.
(2) Rule for changes requiring state legislation.— In the case of a State plan for medical assistance under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) which the Secretary of Health and Human Services determines requires State legislation (other than legislation appropriating funds) in order for the plan to meet the additional requirement imposed by the amendments made by subsection (a), the State plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet this additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature.
(a) HIV policy.— The Director of the Bureau of Prisons (referred to in this section as the “Director”) shall develop a comprehensive policy to provide HIV testing, treatment, and prevention for inmates within the correctional setting and upon reentry.
(b) Purpose.— The purposes of the policy required to be developed under subsection (a) shall be as follows:
(1) To stop the spread of HIV among inmates.
(2) To protect guards and other personnel at correctional facilities from HIV infection.
(3) To provide comprehensive medical treatment to inmates who are living with HIV.
(4) To promote HIV awareness and prevention among inmates.
(5) To encourage inmates to take personal responsibility for their health.
(6) To reduce the risk that inmates will transmit HIV to other persons in the community following their release from a correctional facility.
(c) Consultation.— The Director shall consult with appropriate officials of the Department of Health and Human Services, the Office of National Drug Control Policy, the Office of National AIDS Policy, and the Centers for Disease Control and Prevention regarding the development of the policy required under subsection (a).
(d) Time limit.— Not later than 1 year after the date of enactment of this Act, the Director shall draft appropriate regulations to implement the policy required to be developed under subsection (a).
(e) Requirements for policy.— The policy required to be developed under subsection (a) shall provide for the following:
(1) Testing and counseling upon intake.—
(A) Health care personnel shall provide routine HIV testing to all inmates as a part of a comprehensive medical examination immediately following admission to a facility. Health care personnel need not provide routine HIV testing to an inmate who is transferred to a facility from another facility if the inmate’s medical records are transferred with the inmate and indicate that the inmate has been tested previously.
(B) With respect to all inmates admitted to a facility prior to the effective date of the policy—
(i) health care personnel shall provide routine HIV testing by not later than 180 days after such effective date; and
(ii) HIV testing described in clause (i) may be performed in conjunction with other health services provided to these inmates by health care personnel.
(C) All HIV tests under this paragraph shall comply with the opt-out provision under paragraph (9).
(2) Pre-test and post-test counseling.— Health care personnel shall provide confidential pre-test and post-test counseling to all inmates who are tested for HIV. Counseling may be included with other general health counseling provided to inmates by health care personnel.
(3) HIV prevention education.—
(A) Health care personnel shall improve HIV awareness through frequent educational programs for all inmates. HIV educational programs may be provided by community-based organizations, local health departments, and inmate peer educators.
(B) HIV educational materials shall be made available to all inmates at orientation, at health care clinics, at regular educational programs, and prior to release. Both written and audiovisual materials shall be made available to all inmates.
(C)
(i) The HIV educational programs and materials under this paragraph shall include information on—
(I) modes of transmission, including transmission through tattooing, sexual contact, and intravenous drug use;
(II) prevention methods;
(III) treatment; and
(IV) disease progression.
(ii) The programs and materials shall be culturally sensitive, written or designed for low-literacy levels, available in a variety of languages, and present scientifically accurate information in a clear and understandable manner.
(4) HIV testing upon request.—
(A) Health care personnel shall allow inmates to obtain HIV tests upon request once per year or whenever an inmate has a reason to believe the inmate may have been exposed to HIV. Health care personnel shall, both orally and in writing, inform inmates, during orientation and periodically throughout incarceration, of their right to obtain HIV tests.
(B) Health care personnel shall encourage inmates to request HIV tests if the inmate is sexually active, has been raped, uses intravenous drugs, receives a tattoo, or if the inmate is concerned that the inmate may have been exposed to HIV.
(C) An inmate’s request for an HIV test shall not be considered an indication that the inmate has put themselves at risk of infection or committed a violation of the rules of the correctional facility.
(5) HIV testing of pregnant woman.—
(A) Health care personnel shall provide routine HIV testing to all inmates who become pregnant.
(B) All HIV tests under this paragraph shall comply with the opt-out provision under paragraph (9).
(6) Comprehensive treatment.—
(A) Health care personnel shall provide all inmates who test positive for HIV—
(i) timely, comprehensive medical treatment;
(ii) confidential counseling on managing their medical condition and preventing its transmission to other persons; and
(iii) voluntary partner notification services.
(B) Health care provided under this paragraph shall be consistent with Department of Health and Human Services guidelines and standard medical practice. Health care personnel shall discuss treatment options, the importance of adherence to antiretroviral therapy, and the side effects of medications with inmates receiving treatment.
(C) Health care personnel and pharmacy personnel shall ensure that the facility formulary contains all Food and Drug Administration-approved medications necessary to provide comprehensive treatment for inmates living with HIV, and that the facility maintains adequate supplies of such medications to meet inmates’ medical needs. Health care personnel and pharmacy personnel shall also develop and implement automatic renewal systems for these medications to prevent interruptions in care.
(D) Correctional staff, health care personnel, and pharmacy personnel shall develop and implement distribution procedures to ensure timely and confidential access to medications.
(7) Protection of confidentiality.—
(A) Health care personnel shall develop and implement procedures to ensure the confidentiality of inmate tests, diagnoses, and treatment. Health care personnel and correctional staff shall receive regular training on the implementation of these procedures. Penalties for violations of inmate confidentiality by health care personnel or correctional staff shall be specified and strictly enforced.
(B) HIV testing, counseling, and treatment shall be provided in a confidential setting where other routine health services are provided and in a manner that allows the inmate to request and obtain these services as routine medical services.
(8) Testing, counseling, and referral prior to reentry.—
(A) Health care personnel shall provide routine HIV testing to all inmates not earlier than 90 days prior to their release and reentry into the community. Inmates who are already known to be infected need not be tested again. This requirement may be waived if an inmate’s release occurs without sufficient notice to the Director to allow health care personnel to perform a routine HIV test and notify the inmate of the results.
(B) All HIV tests under this paragraph shall comply with the opt-out provision under paragraph (9).
(C) With respect to all inmates who test positive for HIV and all inmates who already are known to have HIV, health care personnel shall provide—
(i) confidential prerelease counseling on managing their medical condition in the community, accessing appropriate treatment and services in the community, and preventing the transmission of their condition to family members and other persons in the community;
(ii) referrals to appropriate health care providers and social service agencies in the community that meet the inmate’s individual needs, including voluntary partner notification services and prevention counseling services for people living with HIV; and
(iii) a 30-day supply of any medically necessary medications the inmate is currently receiving.
(9) Opt-out provision.— Inmates shall have the right to refuse routine HIV testing. Inmates shall be informed both orally and in writing of this right. Oral and written disclosure of this right may be included with other general health information and counseling provided to inmates by health care personnel. If an inmate refuses a routine test for HIV, health care personnel shall make a note of the inmate’s refusal in the inmate’s confidential medical records. However, the inmate’s refusal shall not be considered a violation of the rules of the correctional facility or result in disciplinary action.
(10) Exclusion of tests performed under section 4014(b) from the definition of routine HIV testing.— HIV testing of an inmate under section 4014(b) of title 18, United States Code, is not routine HIV testing for the purposes of the opt-out provision under paragraph (9). Health care personnel shall document the reason for testing under section 4014(b) of title 18, United States Code, in the inmate’s confidential medical records.
(11) Timely notification of test results.— Health care personnel shall provide timely notification to inmates of the results of HIV tests.
(f) Changes in existing law.—
(1) Screening in general.— Section 4014(a) of title 18, United States Code, is amended—
(A) by striking “for a period of 6 months or more”;
(B) by striking “, as appropriate,”; and
(C) by striking “if such individual is determined to be at risk for infection with such virus in accordance with the guidelines issued by the Bureau of Prisons relating to infectious disease management.” and inserting “unless the individual declines. The Attorney General shall also cause such individual to be so tested before release from that incarceration unless the individual declines.”.
(2) Inadmissibility of HIV test results in civil and criminal proceedings.— Section 4014(d) of title 18, United States Code, is amended by inserting “or under section 7417 of the Health Equity and Accountability Act of 2026” after “under this section”.
(3) Screening as part of routine screening.— Section 4014(e) of title 18, United States Code, is amended by adding at the end the following: “Such rules shall also provide that the initial test under this section be performed as part of the routine health screening conducted at intake.”.
(g) Reporting requirements.—
(1) Report on hepatitis, liver, and other diseases.— Not later than 1 year after the date of enactment of this Act, the Director shall submit to Congress a report on the policies and procedures of the Bureau of Prisons to provide testing, treatment, and prevention education programs for hepatitis, liver failure, and other liver-related diseases transmitted through sexual activity, intravenous drug use, or other means. The Director shall consult with appropriate officials of the Department of Health and Human Services, the Office of National Drug Control Policy, the Office of National AIDS Policy, and the Centers for Disease Control and Prevention regarding the development of this report.
(2) Annual reports.—
(A) Generally.— Not later than 2 years after the date of enactment of this Act, and annually thereafter, the Director submit to Congress a report on the incidence among inmates of diseases transmitted through sexual activity and intravenous drug use.
(B) Matters pertaining to various diseases.— Each report under subparagraph (A) shall discuss—
(i) the incidence among inmates of HIV, hepatitis, and other diseases transmitted through sexual activity and intravenous drug use; and
(ii) updates on the testing, treatment, and prevention education programs for these diseases conducted by the Bureau of Prisons.
(C) Matters pertaining to hiv only.— Each report under subparagraph (A) shall also include—
(i) the number of inmates who tested positive for HIV upon intake;
(ii) the number of inmates who tested positive for HIV prior to reentry;
(iii) the number of inmates who were not tested for HIV prior to reentry because they were released without sufficient notice;
(iv) the number of inmates who opted out of taking an HIV test;
(v) the number of inmates who were tested under section 4014(b) of title 18, United States Code; and
(vi) the number of inmates under treatment for HIV.
(D) Consultation.— The Director shall consult with appropriate officials of the Department of Health and Human Services, the Office of National Drug Control Policy, the Office of National AIDS Policy, and the Centers for Disease Control and Prevention regarding the development of each report under subparagraph (A).
Title II of the Public Health Service Act (42 U.S.C. 202 et seq.) is amended by inserting after section 241 (42 U.S.C. 238j) the following:
“241A. Transfer of funds for implementation of National HIV/AIDS Strategy.—
(a) Transfer authorization.— Of the discretionary appropriations made available to the Department of Health and Human Services for any fiscal year for programs and activities that, as determined by the Secretary, pertain to HIV, the Secretary may transfer up to 1 percent of such appropriations to the Office of the Assistant Secretary for Health for implementation of the Ending the HIV Epidemic: A Plan for America.
(b) Congressional notification.— Not less than 30 days before making any transfer under this section, the Secretary shall give notice of the transfer to the Congress.
(c) Definitions.— In this section, the term Ending the HIV Epidemic: A Plan for America means the initiative of the Department of Health and Human Services that seeks to reduce the number of new HIV infections in the United States by 75 percent by 2027, and then by at least 90 percent by 2032, for an estimated 250,000 total HIV infections averted.”.
(a) Coverage of HIV testing and prevention services.—
(1) Private insurance.—
(A) In general.— Section 2713(a) of the Public Health Service Act (42 U.S.C. 300gg–13(a)) is amended to read as follows:
“(a) Coverage of preventive health services.—
(1) In general.— A group health plan and a health insurance issuer offering group or individual health insurance coverage shall, at a minimum, provide coverage for and shall not impose any cost sharing requirements for—
(A) evidence-based items or services that have in effect a rating of “A” or “B” in the current recommendations of the United States Preventive Services Task Force;
(B) immunizations that have in effect a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention with respect to the individual involved;
(C) with respect to infants, children, and adolescents, evidence-informed preventive care and screenings provided for in the comprehensive guidelines supported by the Health Resources and Services Administration;
(D) with respect to women, such additional preventive care and screenings not described in subparagraph (A) as provided for in comprehensive guidelines supported by the Health Resources and Services Administration for purposes of this subparagraph;
(E) any prescription drug approved by the Food and Drug Administration for the prevention of HIV (other than a drug subject to preauthorization requirements consistent with section 2729A), administrative fees for such drugs, laboratory and other diagnostic procedures associated with the use of such drugs, and clinical follow-up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines, without limitation; and”.
(B) Prohibition on preauthorization requirements.—
(i) PHSA.— Part D of title XXVII of the Public Health Service Act (42 U.S.C. 300gg–111 et seq.) is amended by adding at the end the following:
“2799A–12. Prohibition on preauthorization requirements with respect to certain services.— A group health plan or a health insurance issuer offering group or individual health insurance coverage shall not impose any preauthorization requirements with respect to coverage of the services described in section 2713(a)(1)(E), except that a plan or issuer may impose preauthorization requirements with respect to coverage of a particular drug approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act or section 351(a) of this Act if such plan or issuer provides coverage without any preauthorization requirements for a drug that is therapeutically equivalent.”.
(ii) ERISA.—
(I) In general.— Subpart B of part 7 of subtitle B of title I of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1185 et seq.) is amended by adding at the end the following:
“727. Prohibition on preauthorization requirements with respect to certain services.— A group health plan or a health insurance issuer offering group health insurance coverage shall not impose any preauthorization requirements with respect to coverage of the services described in section 2713(a)(1)(E), except that a plan or issuer may impose preauthorization requirements with respect to coverage of a particular drug approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act or section 351(a) of this Act if such plan or issuer provides coverage without any preauthorization requirements for a drug that is therapeutically equivalent.”.
(II) Clerical amendment.— The table of contents in section 1 of such Act is amended by inserting after the item relating to section 726 the following new item:
(iii) IRC.—
(I) In general.— Subchapter B of chapter 100 of the Internal Revenue Code of 1986 is amended by adding at the end the following:
“9827. Prohibition on preauthorization requirements with respect to certain services.— A group health plan shall not impose any preauthorization requirements with respect to coverage of the services described in section 2713(a)(1)(E), except that a plan may impose preauthorization requirements with respect to coverage of a particular drug approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act or section 351(a) of this Act if such plan provides coverage without any preauthorization requirements for a drug that is therapeutically equivalent.”.
(C) Clerical amendment.— The table of sections for subchapter B of chapter 100 of the Internal Revenue Code of 1986 is amended by adding at the end the following new item:
(2) Coverage under federal employees health benefits program.— Section 8904 of title 5, United States Code, is amended by adding at the end the following:
“(c) Any health benefits plan offered under this chapter shall include benefits for, and may not impose any cost sharing requirements for, any prescription drug approved by the Food and Drug Administration for the prevention of HIV, administrative fees for such drugs, laboratory and other diagnostic procedures associated with the use of such drugs, and clinical follow-up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines, without limitation.”.
(3) Medicaid.—
(A) In general.— Section 1905 of the Social Security Act (42 U.S.C. 1396d), as amended by section 5201(b)(2)(A)(i) and 5406(f), is amended—
(i) in subsection (a)(4)—
(I) by striking “; and (G)” and inserting “; (G)”; and
(II) by striking the semicolon at the end and inserting “; and (H) HIV prevention services;”; and
(ii) by adding at the end the following new subsection:
“(rr) HIV prevention services.— For purposes of subsection (a)(4)(H), the term HIV prevention services means prescription drugs for the prevention of HIV acquisition, administrative fees for such drugs, laboratory and other diagnostic procedures associated with the use of such drugs, and clinical follow-up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines, without limitation.”.
(B) No cost-sharing.— Title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) is amended—
(i) in section 1916, by inserting “HIV prevention services described in section 1905(a)(4)(H),” after “section 1905(a)(4)(C),” each place it appears; and
(ii) in section 1916A(b)(3)(B), as amended by section 7305, by adding at the end the following new clause:
“(xvi) HIV prevention services described in section 1905(a)(4)(H).”.
(C) Inclusion in benchmark coverage.— Section 1937(b)(7) of the Social Security Act (42 U.S.C. 1396u–7(b)(7)) is amended—
(i) in the paragraph header, by inserting “and HIV prevention services” after “supplies”; and
(ii) by striking “includes for any individual described in section 1905(a)(4)(C), medical assistance for family planning services and supplies in accordance with such section” and inserting “includes medical assistance for HIV prevention services described in section 1905(a)(4)(H), and includes, for any individual described in section 1905(a)(4)(C), medical assistance for family planning services and supplies in accordance with such section”.
(4) CHIP.—
(A) In general.— Section 2103 of the Social Security Act (42 U.S.C. 1397cc), as amended by section 2007(d)(5), is amended—
(i) in subsection (a), by striking “through (13)” and inserting “through (14)”; and
(ii) in subsection (c), by adding at the end the following new paragraph:
“(14) HIV prevention services.— Regardless of the type of coverage elected by a State under subsection (a), the child health assistance provided for a targeted low-income child, and, in the case of a State that elects to provide pregnancy-related assistance pursuant to section 2112, the pregnancy-related assistance provided for a targeted low-income pregnant woman (as such terms are defined for purposes of such section), shall include coverage of HIV prevention services (as defined in section 1905(rr)).”.
(B) No cost-sharing.— Section 2103(e)(2) of the Social Security Act (42 U.S.C. 1397cc(e)(2)) is amended by inserting “HIV prevention services described in subsection (c)(14),” before “or for pregnancy-related assistance”.
(C) Effective date.—
(i) In general.— Subject to clause (ii), the amendments made by paragraph (3) and this paragraph shall take effect on January 1, 2027.
(ii) Delay permitted if state legislation required.— In the case of a State plan approved under title XIX or XXI of the Social Security Act which the Secretary of Health and Human Services determines requires State legislation (other than legislation appropriating funds) in order for the plan to meet the additional requirements imposed by this subsection, the State plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of the failure of the plan to meet such additional requirements before the 1st day of the 1st calendar quarter beginning after the close of the 1st regular session of the State legislature that ends after the 1-year period beginning with the date of the enactment of this Act. For purposes of the preceding sentence, in the case of a State that has a 2-year legislative session, each year of the session is deemed to be a separate regular session of the State legislature.
(5) Coverage and elimination of cost-sharing under Medicare.—
(A) Coverage of HIV prevention services under part B.—
(i) Coverage.—
(I) In general.— Section 1861(s)(2) of the Social Security Act (42 U.S.C. 1395x(s)(2)), as amended by section 4251(c)(1) and 6101(a)(1), is amended—
(aa) by striking “and” at the end of subparagraph (LL);
(bb) by inserting “and” at the end of subparagraph (MM); and
(cc) by adding at the end the following new subparagraph:
“(NN) HIV prevention services (as defined in subsection (sss));”.
(II) Definition.— Section 1861 of the Social Security Act (42 U.S.C. 1395x), as amended by sections 2007(b), 4221(a), 4251(c)(2), and 6101(a)(2), is amended by adding at the end the following new subsection:
“(sss) HIV prevention services.— The term HIV prevention services means—
(1) drugs or biologicals approved by the Food and Drug Administration for the prevention of HIV;
(2) administrative fees for such drugs;
(3) laboratory and other diagnostic procedures associated with the use of such drugs; and
(4) clinical follow-up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines, without limitation.”.
(ii) Elimination of coinsurance.— Section 1833(a)(1) of the Social Security Act (42 U.S.C. 1395l(a)(1)), as amended by sections 4251(c)(3) and 6101(a)(4), is amended—
(I) by striking “and” before “(JJ)”; and
(II) by inserting before the semicolon at the end the following: “and (KK) with respect to HIV prevention services (as defined in section 1861(sss)), the amount paid shall be 100 percent of (i) except as provided in clause (ii), the lesser of the actual charge for the service or the amount determined under the fee schedule that applies to such services under this part, and (ii) in the case of such services that are covered OPD services (as defined in subsection (t)(1)(B)), the amount determined under subsection (t)”.
(iii) Exemption from part B deductible.— Section 1833(b) of the Social Security Act (42 U.S.C. 1395l(b)) is amended—
(I) in paragraph (12), by striking “section 1861(s)(10)(A),, and” and inserting “section 1861(s)(10)(A),”;
(II) in paragraph (13), by striking “section 1861(n)..” and inserting “section 1861(n), and (14) such deductible shall not apply with respect to HIV prevention services (as defined in section 1861(sss).”.
(iv) Effective date.— The amendments made by this subparagraph shall apply to items and services furnished on or after January 1, 2027.
(B) Elimination of cost-sharing for drugs for the prevention of HIV under part D.—
(i) In general.— Section 1860D–2 of the Social Security Act (42 U.S.C. 1395w–102) is amended—
(I) in subsection (b)—
(aa) in paragraph (1)(A), in the matter preceding clause (i), by striking “(8) and (9)” and inserting “(8), (9), and (10)”;
(bb) in paragraph (2)(A), in subparagraph (A), in the matter preceding clause (i), by striking “(8) and (9)” and inserting “(8), (9), and (10)”; and
(cc) by adding at the end the following new paragraph:
“(10) Elimination of cost-sharing for drugs for the prevention of HIV.— For plan years beginning on or after January 1, 2027, with respect to a covered part D drug that is for the prevention of HIV—
(A) the deductible under paragraph (1) shall not apply; and
(B) there shall be no coinsurance or other cost-sharing under this part with respect to such drug.”; and
(II) in subsection (c), by adding at the end the following new paragraph:
“(7) Treatment of cost-sharing for drugs for the prevention of hiv.— The coverage is in accordance with subsection (b)(10).”.
(ii) Conforming amendments to cost-sharing for low-income individuals.— Section 1860D–14(a)(1)(D) of the Social Security Act (42 U.S.C. 1395w–114(a)(1)(D)) is amended in each of clauses (ii) and (iii), by striking “paragraph (6)” and inserting “paragraph (6) and section 1860D–2(b)(10)”.
(6) Coverage of HIV prevention treatment by Department of Veterans Affairs.—
(A) Elimination of medication copayments.— Section 1722A(a) of title 38, United States Code, is amended by adding at the end the following new paragraph:
“(5) Paragraph (1) does not apply to a medication for the prevention of HIV.”.
(B) Elimination of hospital care and medical services copayments.— Section 1710 of such title is amended—
(i) in subsection (f)—
(I) by redesignating paragraph (5) as paragraph (6); and
(II) by inserting after paragraph (4) the following new paragraph (5):
“(5) A veteran shall not be liable to the United States under this subsection for any amounts for laboratory and other diagnostic procedures associated with the use of any prescription drug approved by the Food and Drug Administration for the prevention of HIV, administrative fees for such drugs, or for laboratory or other diagnostic procedures associated with the use of such drugs, or clinical follow-up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines, without limitation.”; and
(ii) in subsection (g)(3), by adding at the end the following new subparagraph:
“(C) Any prescription drug approved by the Food and Drug Administration for the prevention of HIV, administrative fees for such drugs, laboratory and other diagnostic procedures associated with the use of such drugs, and clinical follow-up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines, without limitation.”.
(C) Inclusion as preventive health service.— Section 1701(9) of such title is amended—
(i) in subparagraph (K), by striking “; and” and inserting a semicolon;
(ii) by redesignating subparagraph (L) as subparagraph (M); and
(iii) by inserting after subparagraph (K) the following new subparagraph (L):
“(L) any prescription drug approved by the Food and Drug Administration for the prevention of HIV, administrative fees for such drugs, laboratory and other diagnostic procedures associated with the use of such drugs, and clinical follow-up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines, without limitation; and”.
(7) Coverage of HIV prevention treatment by Department of Defense.—
(A) In general.— Chapter 55 of title 10, United States Code, is amended by inserting after section 1079c the following new section:
“1079d. Coverage of HIV prevention treatment.—
(a) In general.— The Secretary of Defense shall ensure coverage under the TRICARE program of HIV prevention treatment described in subsection (b) for any beneficiary under section 1074(a) of this title.
(b) HIV prevention treatment described.— HIV prevention treatment described in this subsection includes any prescription drug approved by the Food and Drug Administration for the prevention of HIV, administrative fees for such drugs, laboratory and other diagnostic procedures associated with the use of such drugs, and clinical follow-up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines, without limitation.
(c) No cost-Sharing.— Notwithstanding section 1075, 1075a, or 1074g(a)(6) of this title or any other provision of law, there is no cost-sharing requirement for HIV prevention treatment covered under this section.”.
(B) Clerical amendment.— The table of sections at the beginning of such chapter is amended by inserting after the item relating to section 1079c the following new item:
(8) Indian health service testing, monitoring, and prescription drugs for the prevention of hiv.— Title II of the Indian Health Care Improvement Act is amended by inserting after section 223 (25 U.S.C. 1621v) the following:
“224. Testing, monitoring, and prescription drugs for the prevention of HIV.—
(a) In general.— The Secretary, acting through the Service, Indian tribes, and tribal organizations, shall provide, without limitation, funding for any prescription drug approved by the Food and Drug Administration for the prevention of human immunodeficiency virus (commonly known as “HIV”), administrative fees for that drug, laboratory and other diagnostic procedures associated with the use of that drug, and clinical follow-up and monitoring, including any related services recommended in current Public Health Service clinical practice guidelines.
(b) Authorization of appropriations.— There are authorized to be appropriated such sums as are necessary to carry out this section.”.
(b) Prohibition on denial of coverage or increase in premiums of life, disability, or long-Term care insurance for individuals taking medication for the prevention of HIV acquisition.—
(1) Prohibition.— Notwithstanding any other provision of law, it shall be unlawful to—
(A) decline or limit coverage of a person under any life insurance policy, disability insurance policy, or long-term care insurance policy, on account of the individual taking medication for the purpose of preventing the acquisition of HIV;
(B) preclude an individual from taking medication for the purpose of preventing the acquisition of HIV as a condition of receiving a life insurance policy, disability insurance policy, or long-term care insurance policy;
(C) consider whether an individual is taking medication for the purpose of preventing the acquisition of HIV in determining the premium rate for coverage of such individual under a life insurance policy, disability insurance policy, or long-term care insurance policy; or
(D) otherwise discriminate in the offering, issuance, cancellation, amount of such coverage, price, or any other condition of a life insurance policy, disability insurance policy, or long-term care insurance policy for an individual, based solely and without any additional actuarial risks upon whether the individual is taking medication for the purpose of preventing the acquisition of HIV.
(2) Enforcement.— A State insurance regulator may take such actions to enforce paragraph (1) as are specifically authorized under the laws of such State.
(3) Definitions.— In this subsection:
(A) Disability insurance policy.— The term disability insurance policy means a contract under which an entity promises to pay a person a sum of money in the event that an illness or injury resulting in a disability prevents such person from working.
(B) Life insurance policy.— The term life insurance policy means a contract under which an entity promises to pay a designated beneficiary a sum of money upon the death of the insured.
(C) Long-term care insurance policy.— The term long-term care insurance policy means a contract for which the only insurance protection provided under the contract is coverage of qualified long-term care services (as defined in section 7702B(c) of the Internal Revenue Code of 1986).
(c) Patient confidentiality.— The Secretary of Health and Human Services shall amend the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d–2 note), as necessary, to ensure that individuals are able to access the benefits described in section 2713(a)(1)(E) of the Public Health Service Act under a family plan without any other individual enrolled in such family plan, including a primary subscriber or policyholder of such plan, being informed of such use of such benefits.
(d) Pre-Exposure prophylaxis and post-Exposure prophylaxis funding.— Part P of title III of the Public Health Service Act (42 U.S.C. 280g et seq.), as amended by section 7303, is amended by adding at the end the following:
“399V–11. Pre-exposure prophylaxis and post-exposure prophylaxis funding.—
(a) In general.— Not later than 1 year after the date of enactment of this section, the Secretary shall establish a program that awards grants to States, territories, Indian Tribes, and directly eligible entities for the establishment and support of pre-exposure prophylaxis (referred to in this section as “PrEP”) and post-exposure prophylaxis (referred to in this section as “PEP”) HIV programs.
(b) Applications.— To be eligible to receive a grant under subsection (a), a State, territory, Indian Tribe, or directly eligible entity shall—
(1) submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require, including a plan describing how any funds awarded will be used to increase access to PrEP for uninsured and underinsured individuals and reduce disparities in access to PrEP and PEP for uninsured and underinsured individuals and reduce disparities in access to PrEP and PEP; and
(2) appoint a PrEP and PEP grant administrator to manage the program.
(c) Directly eligible entity.— For purposes of this section, the term directly eligible entity—
(1) means a Federally qualified health center or other nonprofit entity engaged in providing PrEP and PEP information and services; and
(2) may include—
(A) a Federally qualified health center (as defined in section 1861(aa)(4) of the Social Security Act);
(B) a family planning grantee (other than States) funded under section 1001;
(C) a rural health clinic (as defined in section 1861(aa)(2) of the Social Security Act);
(D) a health facility operated by or pursuant to a contract with the Indian Health Service;
(E) a community-based organization, clinic, hospital, or other health facility that provides services to individuals at risk for or living with HIV; and
(F) a nonprofit private entity providing comprehensive primary care to populations at risk of HIV, including faith-based and community-based organizations.
(d) Awards.— In determining whether to award a grant, and the grant amount for each grant awarded, the Secretary shall consider the grant application and the need for PrEP and PEP services in the area, the number of uninsured and underinsured individuals in the area, and how the State, territory, or Indian Tribe coordinates PrEP and PEP activities with the directly funded entity, if the State, territory, or Indian Tribe applies for the funds.
(e) Use of funds.—
(1) In general.— Any State, territory, Indian Tribe, or directly eligible entity that is awarded funds under subsection (a) shall use such funds for eligible PrEP and PEP expenses.
(2) Eligible prep expenses.— The Secretary shall publish a list of expenses that qualify as eligible PrEP and PEP expenses for purposes of this section, which shall include—
(A) any prescription drug approved by the Food and Drug Administration for the prevention of HIV, administrative fees for such drugs, laboratory and other diagnostic procedures associated with the use of such drugs, and clinical follow-up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines, without limitation;
(B) outreach and public education activities directed toward populations overrepresented in the domestic HIV epidemic that increase awareness about the existence of PrEP and PEP, provide education about access to and health care coverage of PrEP and PEP, PrEP and PEP adherence programs, and counter stigma associated with the use of PrEP and PEP; and
(C) outreach activities directed toward physicians and other providers that provide education about PrEP and PEP.
(f) Report to congress.— The Secretary shall, in each of the first 5 years beginning one year after the date of the enactment of this section, submit to Congress, and make public on the internet website of the Department of Health and Human Services, a report on the impact of any grants provided to States, territories, and Indian Tribes and directly eligible entities for the establishment and support of pre-exposure prophylaxis programs under this section.
(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 2027 through 2032.”.
(e) Clarification.— This section, including the amendments made by this section, shall apply notwithstanding any other provision of law, including Public Law 103–141.
(f) Private right of action.— Any person aggrieved by a violation of this section, including the amendments made by this section, may commence a civil action in an appropriate United States District Court or other court of competent jurisdiction to obtain relief as allowed by law as either an individual or member of a class. If the plaintiff is the prevailing party in such an action, the court shall order the defendant to pay the costs and reasonable attorney fees of the plaintiff.
Subpart 3 of part C of title IV of the Public Health Service Act (42 U.S.C. 285c et seq.) is amended by adding at the end the following:
“434B. Diabetes in minority populations.—
(a) In general.— The Director of NIH shall expand, intensify, and support ongoing research and other activities with respect to prediabetes and diabetes, particularly type 2, in minority populations.
(b) Research.—
(1) Description.— Research under subsection (a) shall include investigation into—
(A) the causes of diabetes, including socioeconomic, geographic, clinical, environmental, genetic, and other factors that may contribute to increased rates of diabetes in minority populations; and
(B) the causes of increased incidence of diabetes complications in minority populations, and possible interventions to decrease such incidence.
(2) Inclusion of minority participants.— In conducting and supporting research described in subsection (a), the Director of NIH shall seek to include minority participants as study subjects in clinical trials.
(c) Report; comprehensive plan.—
(1) In general.— The Diabetes Mellitus Interagency Coordinating Committee shall—
(A) prepare and submit to Congress, not later than 6 months after the date of enactment of this section, a report on Federal research and public health activities with respect to prediabetes and diabetes in minority populations; and
(B) develop and submit to Congress, not later than 1 year after the date of enactment of this section, an effective and comprehensive Federal plan (including all appropriate Federal health programs) to address prediabetes and diabetes in minority populations.
(2) Contents.— The report under paragraph (1)(A) shall at minimum address each of the following:
(A) Research on diabetes and prediabetes in minority populations, including such research on—
(i) genetic, behavioral, socioeconomic, and environmental factors;
(ii) prevention of diabetes within these populations and which of the populations have individuals at increased risk of developing diabetes;
(iii) prevention of complications among individuals in these populations who have already developed diabetes; and
(iv) barriers to health care access and diabetes treatment within populations at increased risk of developing diabetes.
(B) Surveillance and data collection on diabetes and prediabetes in minority populations, including with respect to—
(i) efforts to better determine the prevalence of diabetes among Asian-American, Native Hawaiian, and Pacific Islander subgroups; and
(ii) efforts to coordinate data collection on the American Indian population.
(C) Community-based interventions to address diabetes and prediabetes targeting minority populations, including—
(i) the evidence base for such interventions;
(ii) the cultural appropriateness of such interventions; and
(iii) efforts to educate the public on the causes and consequences of diabetes.
(D) Education and training programs for health professionals (including community health workers) on the prevention and management of diabetes and its related complications that is supported by the Health Resources and Services Administration, including such programs supported by—
(i) the National Health Service Corps; or
(ii) the community health centers program under section 330.
(d) Education.— The Director of NIH shall—
(1) through the National Institute on Minority Health and Health Disparities and the National Diabetes Education Program—
(A) make grants to programs funded under section 464z–4 for the purpose of establishing a medical education program for health care professionals to be more involved in weight counseling, obesity research, nutrition, and shared decision making; and
(B) provide for the participation of minority health professionals in diabetes-focused research programs; and
(2) make grants to programs that establish a professional pipeline that will increase the participation of minority individuals in diabetes-focused health fields by expanding Minority Access to Research Careers program internships and mentoring opportunities for the purposes of recruitment.
(e) Definitions.— For purposes of this section:
(1) Diabetes mellitus interagency coordinating committee.— The “Diabetes Mellitus Interagency Coordinating Committee” means the Diabetes Mellitus Interagency Coordinating Committee established under section 429.
(2) Minority population.— The term minority population means a racial and ethnic minority group, as defined in section 1707.”.
Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.), as amended by section 7201, is amended by inserting after section 317X the following:
“317Y. Diabetes in minority populations.—
(a) Research and other activities.—
(1) In general.— The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall conduct and support research and public health activities with respect to diabetes in minority populations.
(2) Certain activities.— Activities under paragraph (1) regarding diabetes in minority populations shall include the following:
(A) Further enhancing the National Health and Nutrition Examination Survey by oversampling Asian Americans, Native Hawaiians, and Pacific Islanders in appropriate geographic areas to better determine the prevalence of diabetes in such populations as well as to improve the data collection of diabetes penetration disaggregated into major ethnic groups within such populations. The Secretary shall ensure that any such oversampling does not reduce the oversampling of other minority populations including African-American and Latino populations.
(B) Through the Division of Diabetes Translation—
(i) providing for prevention research to better understand how to influence health care systems changes to improve quality of care being delivered to such populations;
(ii) carrying out model demonstration projects to design, implement, and evaluate effective diabetes prevention and control interventions for minority populations, including culturally appropriate community-based interventions;
(iii) developing and implementing a strategic plan to reduce diabetes in minority populations through applied research to reduce disparities and culturally and linguistically appropriate community-based interventions;
(iv) supporting, through the national diabetes prevention program under section 399V–3, diabetes prevention program sites in underserved regions highly impacted by diabetes; and
(v) implementing, through the national diabetes prevention program under section 399V–3, a demonstration program developing new metrics measuring health outcomes related to diabetes that can be stratified by specific minority populations.
(b) Education.— The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall direct the Division of Diabetes Translation to conduct and support both programs to educate the public on diabetes in minority populations and programs to educate minority populations about the causes and effects of diabetes.
(c) Diabetes; health promotion, prevention initiatives, and access.— The Secretary, acting through the Director of the Centers for Disease Control and Prevention and the National Diabetes Education Program, shall conduct and support programs to educate specific minority populations through culturally appropriate and linguistically appropriate information campaigns and initiatives about prevention of, and managing, diabetes.
(d) Definition.— For purposes of this section, the term minority population means a racial and ethnic minority group, as defined in section 1707.”.
Part P of title III of the Public Health Service Act (42 U.S.C. 280g et seq.), as amended by section 7419(d), is amended by adding at the end the following:
“399V–12. Programs to educate health providers on the causes and effects of diabetes in minority populations.—
(a) In general.— The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall conduct and support programs described in subsection (b) to educate health professionals on the causes and effects of diabetes in minority populations.
(b) Programs.— Programs described in this subsection, with respect to education on diabetes in minority populations, shall include the following:
(1) Giving priority, under the primary care training and enhancement program under section 747—
(A) to awarding grants to focus on or address diabetes; and
(B) to adding minority populations to the list of vulnerable populations that should be served by such grants.
(2) Providing additional funds for the Health Careers Opportunity Program and the Centers of Excellence to partner with the Office of Minority Health under section 1707 and the National Institutes of Health to strengthen programs for career opportunities focused on diabetes treatment and care within underserved regions highly impacted by diabetes.
(3) Developing a diabetes focus within, and providing additional funds for, the National Health Service Corps scholarship program—
(A) to place individuals in areas that are disproportionately affected by diabetes and to provide diabetes treatment and care in such areas; and
(B) to provide such individuals continuing medical education specific to diabetes care.”.
Part P of title III of the Public Health Service Act (42 U.S.C. 280g et seq.), as amended by section 7503, is amended by adding at the end the following:
“399V–13. Research, education, and other activities regarding diabetes in American Indian populations.— In addition to activities under sections 317X, 399V–12, and 434B, the Secretary, acting through the Indian Health Service and in collaboration with other appropriate Federal agencies, shall—
(1) conduct and support research and other activities with respect to diabetes; and
(2) coordinate the collection of data on clinically and culturally appropriate diabetes treatment, care, prevention, and services by health care professionals to the American Indian population.”.
The Secretary of Health and Human Services shall seek to enter into an arrangement with the National Academy of Medicine under which the National Academy will—
(1) not later than 1 year after the date of enactment of this Act, submit to Congress an updated version of the 2003 report entitled “Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care”; and
(2) in such updated version, address how racial and ethnic health disparities have changed since the publication of the original report.
Section 317I of the Public Health Service Act (42 U.S.C. 247b–10) is amended to read as follows:
“317I. Asthma-related activities of the Centers for Disease Control and Prevention.—
(a) Program for providing information and education to the public.— The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall collaborate with State and local health departments to conduct activities, including the provision of information and education to the public, regarding asthma including—
(1) deterring the harmful consequences of uncontrolled asthma; and
(2) disseminating health education and information regarding prevention of asthma episodes and strategies for managing asthma.
(b) Development of state asthma plans.— The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall collaborate with State and local health departments to develop State plans incorporating public health responses to reduce the burden of asthma, particularly regarding disproportionately affected populations.
(c) Compilation of data.— The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall, in cooperation with State and local public health officials—
(1) conduct asthma surveillance activities to collect data on the prevalence and severity of asthma, the effectiveness of public health asthma interventions, and the quality of asthma management, including—
(A) collection of data among people with asthma to monitor the impact on health and quality of life;
(B) surveillance of health care facilities; and
(C) collection of data not containing individually identifiable information from electronic health records or other electronic communications;
(2) compile and annually publish data regarding the prevalence and incidence of childhood asthma, the child mortality rate, and the number of hospital admissions and emergency department visits by children associated with asthma nationally and in each State and at the county level by age, sex, race, and ethnicity, as well as lifetime and current prevalence; and
(3) compile and annually publish data regarding the prevalence and incidence of adult asthma, the adult mortality rate, and the number of hospital admissions and emergency department visits by adults associated with asthma nationally and in each State and at the county level by age, sex, race, ethnicity, industry, and occupation, as well as lifetime and current prevalence.
(d) Coordination of data collection.— The Director of the Centers for Disease Control and Prevention, in conjunction with State and local health departments, shall coordinate data collection activities under paragraphs (2) and (3) of subsection (c) so as to maximize comparability of results.
(e) Collaboration.—
(1) In general.— The Centers for Disease Control and Prevention may collaborate with national, State, and local nonprofit organizations to provide information and education about asthma, and to strengthen such collaborations when possible.
(2) Specific activities.— The Director of the Centers for Disease Control and Prevention, acting through the Division of Population Health of the Centers, may expand activities relating to asthma with non-Federal partners, especially State-level entities.
(f) Reports to congress.—
(1) In general.— Not later than 3 years after the date of the enactment of the Health Equity and Accountability Act of 2026, and once 2 years thereafter, the Secretary shall, in consultation with patient groups, nonprofit organizations, medical societies, and other relevant governmental and nongovernmental entities, submit to Congress a report that—
(A) catalogs, with respect to asthma prevention, management, and surveillance—
(i) the activities of the Federal Government, including an assessment of the progress of the Federal Government and States, with respect to achieving the goals of the Healthy People 2030 initiative; and
(ii) the activities of other entities that participate in the program under this section, including nonprofit organizations, patient advocacy groups, and medical societies; and
(B) makes recommendations for the future direction of asthma activities, in consultation with researchers from the National Institutes of Health and other member bodies of the Asthma Disparities Subcommittee, including—
(i) a description of how the Federal Government may improve its response to asthma, including identifying any barriers that may exist;
(ii) a description of how the Federal Government may continue, expand, and improve its private-public partnerships with respect to asthma, including identifying any barriers that may exist;
(iii) identification of steps that may be taken to reduce the—
(I) morbidity, mortality, and overall prevalence of asthma;
(II) financial burden of asthma on society;
(III) burden of asthma on disproportionately affected areas, particularly those in medically underserved populations (as defined in section 330(b)(3)); and
(IV) burden of asthma as a chronic disease that can be worsened by environmental exposures;
(iv) the identification of programs and policies that have achieved the steps described under clause (iii), and steps that may be taken to expand such programs and policies to benefit larger populations; and
(v) recommendations for future research and interventions.
(2) Subsequent reports.—
(A) Congressional request.— During the 5-year period following the submission of the second report under paragraph (1), the Secretary shall submit updates and revisions of the report upon the request of the Congress.
(B) Five-year reevaluation.— At the end of the 5-year period referred to in subparagraph (A), the Secretary shall—
(i) evaluate the analyses and recommendations made in previous reports; and
(ii) determine whether an additional report is needed and if so submit such an updated report to the Congress, including appropriate recommendations.
(g) Authorization of appropriations funding.— In addition to any other authorization of appropriations that is available to the Centers for Disease Control and Prevention for the purpose of carrying out this section, there is authorized to be appropriated to such Centers $65,000,000 for the period of fiscal years 2027 through 2031 for the purpose of carrying out this section.”.
(a) In general.— The Secretary of Health and Human Services shall—
(1) enhance the annual campaign by the Department of Health and Human Services to increase the number of people vaccinated each year for influenza and pneumonia; and
(2) include in such campaign the use of written educational materials, public service announcements, physician education, and any other means which the Secretary determines effective.
(b) Materials and announcements.— In carrying out the annual campaign described in subsection (a), the Secretary of Health and Human Services shall ensure that—
(1) educational materials and public service announcements are readily and widely available in communities experiencing disparities in the incidence and mortality rates of influenza and pneumonia; and
(2) the campaign uses targeted, culturally appropriate messages and messengers to reach underserved communities.
(c) Authorization of appropriations.— There are authorized to be appropriated to carry out this section such sums as may be necessary for each of fiscal years 2027 through 2031.
(a) In general.— The Director of the Centers for Disease Control and Prevention shall conduct, support, and expand public health strategies and prevention, diagnosis, surveillance, and public and professional awareness activities regarding chronic obstructive pulmonary disease.
(b) Chronic disease prevention programs.— The Director of the National Heart, Lung, and Blood Institute shall carry out the following:
(1) Conduct public education and awareness activities with patient and professional organizations to stimulate earlier diagnosis and improve patient outcomes from treatment of chronic obstructive pulmonary disease. To the extent known and relevant, such public education and awareness activities shall reflect differences in chronic obstructive pulmonary disease by cause (tobacco, environmental, occupational, biological, and genetic) and include a focus on outreach to undiagnosed and, as appropriate, minority populations.
(2) Supplement and expand upon the activities of the National Heart, Lung, and Blood Institute by making grants to nonprofit organizations, State and local jurisdictions, and Indian Tribes for the purpose of reducing the burden of chronic obstructive pulmonary disease, especially in disproportionately impacted communities, through public health interventions and related activities.
(3) Coordinate with the Centers for Disease Control and Prevention, the Indian Health Service, the Health Resources and Services Administration, and the Department of Veterans Affairs to develop pilot programs to demonstrate best practices for the diagnosis and management of chronic obstructive pulmonary disease.
(4) Develop improved techniques and identify best practices, in coordination with the Secretary of Veterans Affairs, for assisting chronic obstructive pulmonary disease patients to successfully stop smoking, including identification of subpopulations with different needs. Initiatives under this paragraph may include research to determine whether successful smoking cessation strategies are different for chronic obstructive pulmonary disease patients compared to such strategies for patients with other chronic diseases.
(c) Environmental and occupational health programs.— The Director of the Centers for Disease Control and Prevention shall—
(1) support research into the environmental and occupational causes and biological mechanisms that contribute to chronic obstructive pulmonary disease; and
(2) develop and disseminate public health interventions that will lessen the impact of environmental and occupational causes of chronic obstructive pulmonary disease.
(d) Data collection.— Not later than 180 days after the date of enactment of this Act, the Director of the National Heart, Lung, and Blood Institute and the Director of the Centers for Disease Control and Prevention, acting jointly, shall assess the depth and quality of information on chronic obstructive pulmonary disease that is collected in surveys and population studies conducted by the Centers for Disease Control and Prevention, including whether there are additional opportunities for information to be collected in the National Health and Nutrition Examination Survey, the National Health Interview Survey, and the Behavioral Risk Factors Surveillance System surveys.
(e) Authorization of appropriations.— There are authorized to be appropriated to carry out this section such sums as may be necessary for each of fiscal years 2027 through 2031.
Section 104B of the Foreign Assistance Act of 1961 (22 U.S.C. 2151b–3) is amended to read as follows:
“104B. Assistance to combat tuberculosis.—
(a) Policy.—
(1) In general.— It is a major objective of the foreign assistance program of the United States to help end the TB public health emergency through accelerated actions—
(A) to support the diagnosis and treatment of all adults and children with all forms of TB; and
(B) to prevent new TB infections from occurring.
(2) Support for global plans and objectives.— In countries in which the United States Government has established foreign assistance programs under this Act, particularly in countries with the highest burden of TB and other countries with high rates of infection and transmission of TB, it is the policy of the United States—
(A) to support the objectives of the World Health Organization End TB Strategy, including its goals—
(i) to reduce TB deaths by 95 percent by 2035;
(ii) to reduce the TB incidence rate by 90 percent by 2035; and
(iii) to reduce the number of families facing catastrophic health costs due to TB by 100 percent by 2035;
(B) to support the Stop TB Partnership’s Global Plan to End TB 2023–2030, including by providing support for—
(i) developing and using innovative new technologies and therapies to increase active case finding and rapidly diagnose and treat children and adults with all forms of TB, alleviate suffering, and ensure TB treatment completion;
(ii) expanding diagnosis and treatment in line with the goals established by the Political Declaration of the High-Level Meeting of the General Assembly on the Fight Against Tuberculosis, including—
(I) successfully treating 40,000,000 people with active TB by 2023, including 3,500,000 children, and 1,500,000 people with drug-resistant TB; and
(II) diagnosing and treating latent tuberculosis infection, in support of the global goal of providing preventive therapy to at least 30,000,000 people by 2023, including 4,000,000 children younger than 5 years of age, 20,000,000 household contacts of people affected by TB, and 6,000,000 people living with HIV;
(iii) ensuring high-quality TB care by closing gaps in care cascades, implementing continuous quality improvement at all levels of care, and providing related patient support; and
(iv) sustainable procurements of TB commodities to avoid interruptions in supply, the procurement of commodities of unknown quality, or payment of excessive commodity costs in countries impacted by TB; and
(C) to ensure, to the greatest extent practicable, that United States funding supports activities that simultaneously emphasize—
(i) the development of comprehensive person-centered programs, including diagnosis, treatment, and prevention strategies to ensure that—
(I) all people sick with TB receive quality diagnosis and treatment through active case finding; and
(II) people at high risk for TB infection are found and treated with preventive therapies in a timely manner;
(ii) robust TB infection control practices are implemented in all congregate settings, including hospitals and prisons;
(iii) the deployment of diagnostic and treatment capacity—
(I) in areas with the highest TB burdens; and
(II) for highly at-risk and impoverished populations, including patient support services;
(iv) program monitoring and evaluation based on critical TB indicators, including indicators relating to infection control, the numbers of patients accessing TB treatment and patient support services, and preventative therapy for those at risk, including all close contacts, and treatment outcomes for all forms of TB;
(v) training and engagement of health care workers on the use of new diagnostic tools and therapies as they become available, and increased support for training frontline health care workers to support expanded TB active case finding, contact tracing, and patient support services;
(vi) coordination with domestic agencies and organizations to support an aggressive research agenda to develop vaccines as well as new tools to diagnose, treat, and prevent TB globally;
(vii) linkages with the private sector on—
(I) research and development of a vaccine, and on new tools for diagnosis and treatment of TB;
(II) improving current tools for diagnosis and treatment of TB, including telehealth solutions for prevention and treatment; and
(III) training healthcare professionals on use of the newest and most effective diagnostic and therapeutic tools;
(viii) the reduction of barriers to care, including stigma and treatment and diagnosis costs, including through—
(I) training health workers;
(II) sensitizing policy makers;
(III) requiring that all relevant grants and funding agreements include access and affordability provisions;
(IV) supporting education and empowerment campaigns for TB patients regarding local TB services;
(V) monitoring barriers to accessing TB services; and
(VI) increasing support for patient-led and community-led TB outreach efforts;
(ix) support for country-level, sustainable accountability mechanisms and capacity to measure progress and ensure that commitments made by governments and relevant stakeholders are met; and
(x) support for the integration of TB diagnosis, treatment, and prevention activities into primary health care, as appropriate.
(b) Definitions.— In this section:
(1) Appropriate congressional committees.— The term appropriate congressional committees means the Committee on Foreign Relations of the Senate and the Committee on Foreign Affairs of the House of Representatives.
(2) End tb strategy.— The term End TB Strategy means the strategy to eliminate TB that was approved by the World Health Assembly in May 2014, and is described in “The End TB Strategy: Global Strategy and Targets for Tuberculosis Prevention, Care and Control After 2015”.
(3) Global alliance for tuberculosis drug development.— The term Global Alliance for Tuberculosis Drug Development means the public-private partnership that bring together leaders in health, science, philanthropy, and private industry to devise new approaches to TB.
(4) Global tuberculosis drug facility.— The term Global Tuberculosis Drug Facility means the initiative of the Stop Tuberculosis Partnership to increase access to the most advanced, affordable, quality-assured TB drugs and diagnostics.
(5) MDR–TB.— The term MDR–TB means multi-drug-resistant TB.
(6) Stop tuberculosis partnership.— The term Stop Tuberculosis Partnership means the partnership of 1,600 organizations (including international and technical organizations, government programs, research and funding agencies, foundations, nongovernmental organizations, civil society and community groups, and the private sector), donors, including the United States, high TB burden countries, multilateral agencies, and nongovernmental and technical agencies, which is governed by the Stop TB Partnership Coordinating Board and hosted by a United Nations entity, committed to short- and long-term measures required to control and eventually eliminate TB as a public health problem in the world.
(7) XDR–TB.— The term XDR–TB means extensively drug-resistant TB.
(c) Authorization.— To carry out this section, the President is authorized, consistent with section 104(c), to furnish assistance, on such terms and conditions as the President may determine, for the prevention, treatment, control, and elimination of TB.
(d) Goals.— In consultation with the appropriate congressional committees, the President shall establish goals, based on the policy and indicators described in subsection (a), for—
(1) United States TB programs to detect, cure, and prevent all forms of TB globally for the period between 2023 and 2030 that are aligned with the End TB Strategy’s 2030 targets and the USAID’s Global Tuberculosis (TB) Strategy 2023–2030; and
(2) updating the National Action Plan for Combating Multidrug-Resistant Tuberculosis.
(e) Coordination.—
(1) In general.— In carrying out this section, the President shall coordinate with the World Health Organization, the Stop TB Partnership, the Global Fund to Fight AIDS, Tuberculosis, and Malaria, and other organizations with respect to the development and implementation of a comprehensive global TB response program.
(2) Bilateral assistance.— In providing bilateral assistance under this section, the President shall—
(A) catalyze support for research and development of new tools to prevent, diagnose, treat, and control TB worldwide, particularly to reduce the incidence of, and mortality from, all forms of drug-resistant TB;
(B) ensure United States programs and activities focus on finding individuals with active TB disease and provide quality diagnosis and treatment, including through digital health solutions, and reaching those at high risk with preventive therapy; and
(C) ensure coordination among relevant United States Government agencies, including the Department of State, the Centers for Disease Control and Prevention, the National Institutes of Health, the Biomedical Advanced Research and Development Authority, the Food and Drug Administration, the National Science Foundation, the Department of Defense (through its Congressionally Directed Medical Research Programs), and other relevant Federal departments and agencies that engage in international TB activities—
(i) to ensure accountability and transparency;
(ii) to reduce duplication of efforts; and
(iii) to ensure appropriate integration and coordination of TB services into other United States-supported health programs.
(f) Priority To end TB strategy.— In furnishing assistance under subsection (c), the President shall prioritize—
(1) building and strengthening TB programs—
(A) to increase the diagnosis and treatment of everyone who is sick with TB; and
(B) to ensure that such individuals have access to quality diagnosis and treatment;
(2) direct, high-quality integrated services for all forms of TB, as described by the World Health Organization, which call for the coordination of active case finding, treatment of all forms of TB disease and infection, patient support, and TB prevention;
(3) treating individuals co-infected with HIV and other co-morbidities, and other individuals with TB who may be at risk of stigma;
(4) strengthening the capacity of health systems to detect, prevent, and treat TB, including MDR–TB and XDR–TB, as described in the latest international guidance related to TB;
(5) researching and developing innovative diagnostics, drug therapies, and vaccines, and program-based research;
(6) support for the Stop Tuberculosis Partnership’s Global Drug Facility, the Global Alliance for Tuberculosis Drug Development, and other organizations promoting the development of new products and drugs for TB; and
(7) ensuring that TB programs can serve as key platforms for supporting national respiratory pandemic response against existing and new infectious respiratory disease.
(g) Assistance for the World Health Organization and the Stop Tuberculosis Partnership.— In carrying out this section, the President is authorized—
(1) to provide resources to the World Health Organization and the Stop Tuberculosis Partnership to improve the capacity of countries with high burdens or rates of TB and other affected countries to implement the End TB Strategy, the Stop TB Global Plan to End TB, their own national strategies and plans, other global efforts to control MDR–TB and XDR–TB; and
(2) to leverage the contributions of other donors for the activities described in paragraph (1).
(h) Annual report on TB activities.— Not later than December 15 of each year until the earlier of the date on which the goals specified in subsection (a)(2)(A) are met or the last day of 2032, the President shall submit an annual report to the appropriate congressional committees that describes United States foreign assistance to control TB and the impact of such efforts, including—
(1) the number of individuals with active TB disease that were diagnosed and treated, including the rate of treatment completion and the number receiving patient support;
(2) the number of persons with MDR–TB and XDR–TB that were diagnosed and treated, including the rate of completion, in countries receiving United States bilateral foreign assistance for TB control programs;
(3) the number of people trained by the United States Government in TB surveillance and control;
(4) the number of individuals with active TB disease identified as a result of engagement with the private sector and other nongovernmental partners in countries receiving United States bilateral foreign assistance for TB control programs;
(5) a description of the collaboration and coordination of United States anti-TB efforts with the World Health Organization, the Stop TB Partnership, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and other major public and private entities;
(6) a description of the collaboration and coordination among the United States Agency for International Development and other United States departments and agencies, including the Centers for Disease Control and Prevention and the Office of the Global AIDS Coordinator, for the purposes of combating TB and, as appropriate, its integration into primary care;
(7) the constraints on implementation of programs posed by health workforce shortages, health system limitations, barriers to digital health implementation, other challenges to successful implementation, and strategies to address such constraints;
(8) a breakdown of expenditures for patient services supporting TB diagnosis, treatment, and prevention, including procurement of drugs and other commodities, drug management, training in diagnosis and treatment, health systems strengthening that directly impacts the provision of TB services, and research; and
(9) for each country, and when practicable, each project site receiving bilateral United States assistance for the purpose of TB prevention, treatment, and control—
(A) a description of progress toward the adoption and implementation of the most recent World Health Organization guidelines to improve diagnosis, treatment, and prevention of TB for adults and children, disaggregated by sex, including the proportion of health facilities that have adopted the latest World Health Organization guidelines on strengthening monitoring systems and preventative, diagnostic, and therapeutic methods, including the use of rapid diagnostic tests and orally administered TB treatment regimens;
(B) the number of individuals screened for TB disease and the number evaluated for TB infection using active case finding outside of health facilities;
(C) the number of individuals with active TB disease that were diagnosed and treated, including the rate of treatment completion and the number receiving patient support;
(D) the number of adults and children, including people with HIV and close contacts, who are evaluated for TB infection, the number of adults and children started on treatment for TB infection, and the number of adults and children completing such treatment, disaggregated by sex and, as possible, income or wealth quintile;
(E) the establishment of effective TB infection control in all relevant congregant settings, including hospitals, clinics, and prisons;
(F) a description of progress in implementing measures to reduce TB incidence, including actions—
(i) to expand active case finding and contact tracing to reach vulnerable groups; and
(ii) to expand TB preventive therapy, engagement of the private sector, and diagnostic capacity;
(G) a description of progress to expand diagnosis, prevention, and treatment for all forms of TB, including in pregnant women, children, and individuals and groups at greater risk of TB, including migrants, prisoners, miners, people exposed to silica, and people living with HIV/AIDS, disaggregated by sex;
(H) the rate of successful completion of TB treatment for adults and children, disaggregated by sex, and the number of individuals receiving support for treatment completion;
(I) the number of people, disaggregated by sex, receiving treatment for MDR–TB, the proportion of those treated with the latest regimens endorsed by the World Health Organization, factors impeding scale up of such treatment, and a description of progress to expand community-based MDR–TB care;
(J) a description of TB commodity procurement challenges, including shortages, stockouts, or failed tenders for TB drugs or other commodities;
(K) the proportion of health facilities with specimen referral linkages to quality diagnostic networks, including established testing sites and reference labs, to ensure maximum access and referral for second line drug resistance testing, and a description of the turnaround time for test results;
(L) the number of people trained by the United States Government to deliver high-quality TB diagnostic, preventative, monitoring, treatment, and care services;
(M) a description of how supported activities are coordinated with—
(i) country national TB plans and strategies; and
(ii) TB control efforts supported by the Global Fund to Fight AIDS, Tuberculosis, and Malaria, and other international assistance programs and funds, including in the areas of program development and implementation; and
(N) for the first 3 years of the report required under this subsection, a description of the progress in recovering from the negative impact of COVID–19 on TB, including—
(i) whether there has been the development and implementation of a comprehensive plan to recover TB activities from diversion of resources;
(ii) the continued use of bidirectional TB–COVID testing; and
(iii) progress on increased diagnosis and treatment of active TB.
(i) Annual report on TB research and development.— The President, in coordination with the National Institutes of Health, the Centers for Disease Control and Prevention, the Biomedical Advanced Research and Development Authority, the Food and Drug Administration, the National Science Foundation, and the Office of the Global AIDS Coordinator, shall submit to the appropriate congressional committees until 2032 an annual report that—
(1) describes the current progress and challenges to the development of new tools for the purpose of TB prevention, treatment, and control;
(2) identifies critical gaps and emerging priorities for research and development, including for rapid and point-of-care diagnostics, shortened treatments and prevention methods, telehealth solutions for prevention and treatment, and vaccines; and
(3) describes research investments by type, funded entities, and level of investment.
(j) Evaluation report.— Not later than 3 years after the date of the enactment of the Health Equity and Accountability Act of 2026, and 5 years thereafter, the Comptroller General of the United States shall submit a report to the appropriate congressional committees that evaluates the performance and impact on TB prevention, diagnosis, treatment, and care efforts that are supported by United States bilateral assistance funding, including recommendations for improving such programs.”.
(a) Education and awareness activities.— The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, shall direct the National Center for Chronic Disease Prevention and Health Promotion to conduct and expand the Health Community Program and Arthritis Program to educate the public on—
(1) the causes of, preventive health actions for, and effects of arthritis, lupus, and other musculoskeletal conditions in minority patient populations; and
(2) the effects of such conditions on other comorbidities including obesity, hypertension, and cardiovascular disease.
(b) Programs on arthritis and musculoskeletal conditions.— Education and awareness programs of the Centers for Disease Control and Prevention on arthritis and other musculoskeletal conditions in minority communities shall—
(1) be culturally and linguistically appropriate to minority patients, targeting musculoskeletal health promotion and prevention programs of each major ethnic group, including—
(A) Native Americans and Alaska Natives;
(B) Asian Americans;
(C) African Americans and Blacks;
(D) Hispanic and Latino Americans; and
(E) Native Hawaiians and Pacific Islanders; and
(2) include public awareness campaigns directed toward these patient populations that emphasize the importance of musculoskeletal health, physical activity, diet and healthy lifestyle, and weight reduction for overweight and obese patients.
(c) Authorization of appropriations.— To carry out this section, there are authorized to be appropriated such sums as are necessary for fiscal year 2027 and each subsequent fiscal year.
(a) Program authorized.— The Secretary of Health and Human Services (in this section referred to as the “Secretary”), in coordination with the Secretary of Education, shall award grants, on a competitive basis, to academic health science centers, health professions schools, and institutions of higher education to enable such centers, schools, and institutions to provide people with comprehensive education on arthritis and musculoskeletal health, particularly—
(1) obesity-related musculoskeletal diseases;
(2) arthritis and osteoarthritis;
(3) arthritis and musculoskeletal health disparities; and
(4) the relationship between arthritis and musculoskeletal diseases and metabolic activity, psychological health, and comorbidities such as diabetes, cardiovascular disease, lupus, and hypertension.
(b) Duration.— Grants awarded under this section shall be for a period of 5 years.
(c) Applications.— An academic health science center, health professions school, or institution of higher education seeking a grant under this section shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require.
(d) Priority.— In awarding grants under this section, the Secretary shall give priority to an institution of higher education that—
(1) has an enrollment of needy students, as defined in section 318(b) of the Higher Education Act of 1965 (20 U.S.C. 1059e(b));
(2) is a Hispanic-serving institution, as defined in section 502(a) of such Act (20 U.S.C. 1101a(a));
(3) is a Tribal College or University, as defined in section 316(b) of such Act (20 U.S.C. 1059c(b));
(4) is an Alaska Native-serving institution, as defined in section 317(b) of such Act (20 U.S.C. 1059d(b));
(5) is a Native Hawaiian-serving institution, as defined in section 317(b) of such Act (20 U.S.C. 1059d(b));
(6) is a Predominately Black Institution, as defined in section 318(b) of such Act (20 U.S.C. 1059e(b));
(7) is a Native American-serving, nontribal institution, as defined in section 319(b) of such Act (20 U.S.C. 1059f(b));
(8) is an Asian American and Native American Pacific Islander-serving institution, as defined in section 320(b) of such Act (20 U.S.C. 1059g(b)); or
(9) is a minority institution, as defined in section 365 of such Act (20 U.S.C. 1067k), with an enrollment of needy students, as defined in section 312 of such Act (20 U.S.C. 1058).
(e) Uses of funds.— An academic health science center, health professions school, or institution of higher education receiving a grant under this section may use the grant funds to integrate issues relating to comprehensive arthritis and musculoskeletal health into the academic or support sectors of the center, school, or institution in order to reach a large number of students, by carrying out 1 or more of the following activities:
(1) Developing educational content for issues relating to comprehensive arthritis and musculoskeletal health education that will be incorporated into first-year orientation or core courses.
(2) Creating innovative technology-based approaches to deliver arthritis and musculoskeletal health education to students, faculty, and staff.
(3) Developing and employing peer-outreach and education programs to generate discussion, educate, and raise awareness among students about issues relating to arthritis and musculoskeletal health disorders, and their relationship to diabetes, hypertension, cardiovascular disease, psychological health, and other comorbid conditions.
(f) Report to congress.—
(1) In general.— Not later than 1 year after the date of the enactment of this Act, and annually thereafter for a period of 5 years, the Secretary shall prepare and submit to the appropriate committees of Congress a report on the activities to provide health professions students with comprehensive arthritis and musculoskeletal health education funded under this section.
(2) Report elements.— The report described in paragraph (1) shall include information about—
(A) the number of entities that are receiving a grant under this section;
(B) the specific activities supported by grants under this section;
(C) the number of students served by programs supported by grants under this section; and
(D) the status of evaluations of such programs.
(g) Definition of institution of higher education.— In this section, the term institution of higher education has the meaning given such term in section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001).
(a) In general.— The Director of the National Institutes of Health, acting through the Director of the National Heart, Lung, and Blood Institute, shall—
(1) continue to expand research activities addressing sleep health disparities; and
(2) continue implementation of the NIH Sleep Disorders Research Plan across all institutes and centers of the National Institutes of Health to improve treatment and prevention of sleep health disparities.
(b) Required research activities.— In conducting or supporting research relating to sleep and circadian rhythm, the Director of the National Heart, Lung, and Blood Institute shall—
(1) advance epidemiology and clinical research to achieve a more complete understanding of disparities in domains of sleep health and across population subgroups for which cardiovascular and metabolic health disparities exist, including—
(A) prevalence and severity of sleep apnea;
(B) habitual sleep duration;
(C) sleep timing and regularity; and
(D) insomnia;
(2) develop study designs and analytical approaches to explain and predict multilevel and life-course determinants of sleep health and to elucidate the sleep-related causes of cardiovascular and metabolic health disparities across the age spectrum, including such determinants and causes that are—
(A) environmental;
(B) biological or genetic;
(C) psychosocial;
(D) societal;
(E) political; or
(F) economic;
(3) determine the contribution of sleep impairments such as sleep apnea, insufficient sleep duration, irregular sleep schedules, and insomnia to unexplained disparities in cardiovascular and metabolic risk and disease outcomes;
(4) develop study designs, data sampling and collection tools, and analytical approaches to optimize understanding of mediating and moderating factors, and feedback mechanisms coupling sleep to cardiovascular and metabolic health disparities;
(5) advance research to understand cultural and linguistic barriers (on the person, provider, or system level) to access to care, medical diagnosis, and treatment of sleep disorders in diverse population groups;
(6) develop and test multilevel interventions (including sleep health education in diverse communities) to reduce disparities in sleep health that will impact the ability to improve disparities in cardiovascular and metabolic risk or disease;
(7) create opportunities to integrate sleep and health disparity science by strategically utilizing resources (involving existing or anticipated cohorts) and exchanging scientific data and ideas (including through cross-over into scientific meetings); and
(8) enhance the diversity and foster career development of young investigators involved in sleep and health disparities science.
(c) Authorization of appropriations.— To carry out this section, there are authorized to be appropriated such sums as may be necessary for fiscal year 2027 and each subsequent fiscal year.
(a) In general.— The Director of the Centers for Disease Control and Prevention shall conduct, support, and expand public health strategies and prevention, diagnosis, surveillance, and public and professional awareness activities regarding sleep and circadian rhythm disorders.
(b) Required surveillance and education awareness activities.— In conducting or supporting research relating to sleep and circadian rhythm disorders surveillance and education awareness activities, the Director of the Centers for Disease Control and Prevention shall—
(1) ensure that such activities are culturally and linguistically appropriate to minority patients, targeting sleep and circadian rhythm health promotion and prevention programs of each major ethnic group, including—
(A) Native Americans and Alaska Natives;
(B) Asian Americans;
(C) African Americans and Blacks;
(D) Hispanic and Latino-Americans; and
(E) Native Hawaiians and Pacific Islanders;
(2) collect and compile national and State surveillance data on sleep disorders health disparities;
(3) continue to develop and implement new sleep questions in public health surveillance systems to increase public awareness of sleep health and sleep disorders and their impact on health;
(4) publish monthly reports highlighting geographic, racial, and ethnic disparities in sleep health, as well as relationships between insufficient sleep and chronic disease, health risk behaviors, and other outcomes as determined necessary by the Director; and
(5) include public awareness campaigns that inform patient populations from major ethnic groups about the prevalence of sleep and circadian rhythm disorders and emphasize the importance of sleep health.
(c) Authorization of appropriations.— To carry out this section, there are authorized to be appropriated such sums as may be necessary for fiscal year 2027 and each subsequent fiscal year.
(a) Program authorized.— The Secretary of Health and Human Services (referred to in this section as the “Secretary”), in coordination with the Secretary of Education, shall award grants, on a competitive basis, to academic health science centers, health professions schools, and institutions of higher education to enable such centers, schools, and institutions to provide people with comprehensive education on sleep and circadian health, particularly—
(1) poor sleep health;
(2) sleep disorders;
(3) sleep health disparities; and
(4) the relationship between sleep and circadian health on metabolic activity, neurological activity, comorbidities, and other diseases.
(b) Duration.— Grants awarded under this section shall be for a period of 5 years.
(c) Applications.— An academic health science center, health professions school, or institution of higher education seeking a grant under this section shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require.
(d) Priority.— In awarding grants under this section, the Secretary shall give priority to an institution of higher education that—
(1) has an enrollment of needy students, as defined in section 318(b) of the Higher Education Act of 1965 (20 U.S.C. 1059e(b));
(2) is a Hispanic-serving institution, as defined in section 502(a) of such Act (20 U.S.C. 1101a(a));
(3) is a Tribal College or University, as defined in section 316(b) of such Act (20 U.S.C. 1059c(b));
(4) is an Alaska Native-serving institution, as defined in section 317(b) of such Act (20 U.S.C. 1059d(b));
(5) is a Native Hawaiian-serving institution, as defined in section 317(b) of such Act (20 U.S.C. 1059d(b));
(6) is a Predominately Black Institution, as defined in section 318(b) of such Act (20 U.S.C. 1059e(b));
(7) is a Native American-serving, nontribal institution, as defined in section 319(b) of such Act (20 U.S.C. 1059f(b));
(8) is an Asian American and Native American Pacific Islander-serving institution, as defined in section 320(b) of such Act (20 U.S.C. 1059g(b)); or
(9) is a minority institution, as defined in section 365 of such Act (20 U.S.C. 1067k), with an enrollment of needy students, as defined in section 312 of such Act (20 U.S.C. 1058).
(e) Uses of funds.— An academic health science center, health professions school, or institution of higher education receiving a grant under this section may use the grant funds to integrate issues relating to comprehensive sleep and circadian health into the academic or support sectors of the center, school, or institution, in order to reach a large number of students, by carrying out 1 or more of the following activities:
(1) Developing educational content for issues relating to comprehensive sleep and circadian health education that will be incorporated into first-year orientation or core courses.
(2) Creating innovative technology-based approaches to deliver sleep health education to students, faculty, and staff.
(3) Developing and employing peer-outreach and education programs to generate discussion, educate, and raise awareness among students about issues relating to poor quality sleep, sleep and circadian disorders, and the role sleep health plays in other diseases and comorbidities.
(f) Report to congress.—
(1) In general.— Not later than 1 year after the date of the enactment of this Act, and annually thereafter for a period of 5 years, the Secretary shall prepare and submit to the appropriate committees of Congress a report on the activities to provide health professions students with comprehensive sleep and circadian health education funded under this section.
(2) Report elements.— The report described in paragraph (1) shall include information about—
(A) the number of entities that are receiving a grant under this section;
(B) the specific activities supported by grants under this section;
(C) the number of students served by programs supported by grants under this section; and
(D) the status of evaluations of programs supported by such grants.
(g) Definition of institution of higher education.— In this section, the term institution of higher education has the meaning given such term in section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001).
(a) In general.— Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to Congress and the President a report on the impact of sleep and circadian health disorders for racial and ethnic minority communities and other vulnerable populations.
(b) Contents.— The report under subsection (a) shall include information on the—
(1) progress that has been made in reducing the impact of sleep and circadian health disorders in such communities and populations;
(2) opportunities that exist to make additional progress in reducing the impact of sleep and circadian health disorders in such communities and populations;
(3) challenges that may impede such additional progress; and
(4) Federal funding necessary to achieve substantial reductions in sleep and circadian health disorders in racial and ethnic minority communities.
(a) In general.—
(1) Research and training centers.— Section 431(c)(3) of the Public Health Service Act (42 U.S.C. 285c–5(c)(3)) is amended—
(A) in subparagraph (B), by striking “and” at the end;
(B) in subparagraph (C), by striking “and” at the end; and
(C) by adding at the end the following:
“(D) improving data science through improvement in bioinformatics, data integration, and data sharing;
(E) defining the chronic kidney disease mechanism and identifying new therapeutic targets for chronic kidney disease using specific tools, including mapping the genetic architecture of kidney function and disease and translating genetic maps to disease-causing genes and mechanisms, especially among minority populations;
(F) improving models of human disease including better humanized animal models, improved reproducibility, and functional characterization of kidney organoids, and accelerating the development of in vivo imaging technologies; and
(G) developing cell-specific drug delivery systems and gene editing, including targeted systems for the delivery of therapeutic compounds to specific kidney compartments or cell types and accelerating the implementation of gene editing and gene therapy for the treatment of kidney diseases in vivo; and”.
(2) Inclusion of minority participants.— In conducting and supporting research described in the amendment made by paragraph (1), the Director of the National Institutes of Health shall work with the Director of the National Institute on Minority Health and Health Disparities to improve the number of minority participants as study subjects in clinical trials. Such work may include—
(A) developing and sustaining clinical trial consortia that can recruit patients with chronic kidney disease to ensure adequate capacity for assessment of kidney outcomes and increase the enrollment of underrepresented populations;
(B) encouraging the use of novel designs in clinical trials to enhance the recruitment and retention of underrepresented populations which will enhance the generalizability of study findings;
(C) supporting outreach initiatives that incorporate acknowledgment of both historical and current grounds for participation reluctance, and that prioritize demonstrating trustworthiness, in order to enhance the ability to promote and effectively convey the benefits of clinical research participation;
(D) completing clinical trials that test interventions to improve patient quality of life and address patient-reported outcomes; and
(E) encouraging inclusion of persons with chronic kidney disease in clinical trials of treatments for nonkidney diseases.
(b) Report; comprehensive plan.— Section 429 of the Public Health Services Act (42 U.S.C. 285c–3) is amended by adding at the end the following:
“(c) Report by kidney, urologic, and hematologic diseases coordinating committee.—
(1) In general.— The Kidney, Urologic, and Hematologic Diseases Coordinating Committee, in coordination with the Chronic Kidney Disease Initiative at the Centers for Disease Control and Prevention, shall—
(A) prepare and submit to the Congress, not later than 6 months after the date of enactment of this subsection, a report on Federal research and public health activities with respect to kidney disease in minority populations; and
(B) develop and submit to the Congress, the Secretary, the Director of the National Institutes of Health, and the Advisory Board established under section 430 for the diseases for which the Committee was established, not later than 1 year after the date of enactment of this subsection, an effective and comprehensive Federal plan (including all appropriate Federal health programs) to address kidney disease in minority populations.
(2) Contents.— The report under paragraph (1)(A) shall at minimum address each of the following:
(A) Research on kidney disease in minority populations, including such research on—
(i) genetic, behavioral, and environmental factors;
(ii) prevention and complications among individuals within these populations who have already developed kidney disease;
(iii) the delivery of evidenced-based care for all chronic kidney disease stages, especially in underrepresented and underserved populations;
(iv) expanding support for a root-cause analysis approach to disparities, including causes, detection, and management of chronic kidney disease for underserved populations;
(v) developing research teams that engage with community organizations to develop and implement interventions which halt or delay development and progression of chronic kidney disease; and
(vi) continued support of observational studies of kidney disease measures and outcomes.
(B) Surveillance and data collection on kidney disease in minority populations, including with respect to—
(i) efforts to better determine the prevalence of kidney disease among Asian-American, Native Hawaiian, and Pacific Islander subgroups; and
(ii) efforts to coordinate data collection on the American Indian population.
(C) Community-based interventions to address kidney disease targeting minority populations, including—
(i) the evidence bases for such interventions;
(ii) the cultural appropriateness of such interventions; and
(iii) efforts to educate the public on the causes and consequences of kidney disease.
(D) Education and training programs for health professionals (including community health workers) on the prevention and management of kidney disease and its related complications that are supported by the Health Resources and Services Administration, including such programs supported by the Bureau of Health Workforce, the Bureau of Primary Health Care, and the Health Systems Bureau. This shall include—
(i) identification of effective strategies to increase implementation of proven therapies to slow chronic kidney disease incidence and progression, especially in high-risk underrepresented populations; and
(ii) identification of effective practice improvement strategies in large and small health systems to reduce chronic kidney disease incidence and progression.”.
(a) In general.— The Director of the Centers for Disease Control and Prevention shall conduct, support, and expand public health strategies, prevention, diagnosis, surveillance, and public and professional awareness activities regarding kidney disease.
(b) National action plan.—
(1) Development.— Pursuant to section 426 of the Public Health Service Act (42 U.S.C. 285c), not later than 2 years after the date of the enactment of this Act, the Director of the National Institute of Diabetes and Digestive and Kidney Diseases, in consultation with the Director of the National Institute on Minority Health and Health Disparities and the Director of the Centers for Disease Control and Prevention, shall develop a national action plan to address kidney disease in the United States with participation from patients, caregivers, health professionals, patient advocacy organizations, researchers, providers, public health professionals, and other stakeholders.
(2) Contents.— At a minimum, such plan shall include recommendations for—
(A) public health interventions for the purpose of implementation of the national plan;
(B) biomedical, health services, and public health research on kidney disease; and
(C) inclusion of kidney disease in the health data collections of all Federal agencies.
(c) Kidney disease prevention programs.— The Director of the Centers for Disease Control and Prevention, through the Chronic Kidney Disease Initiative, shall carry out the following:
(1) Conduct public education and awareness activities with patient and professional organizations to stimulate earlier diagnosis and improve patient outcomes from treatment of kidney disease. To the extent known and relevant, such public education and awareness activities shall reflect differences in kidney disease by cause (such as hypertension, diabetes, lupus nephritis, COVID–19, and polycystic kidney disease) and include a focus on outreach to undiagnosed and, as appropriate, minority populations.
(2) Supplement and expand upon the activities of the Centers for Disease Control and Prevention by making grants to nonprofit organizations, State and local jurisdictions, and Indian Tribes for the purpose of reducing the burden of kidney disease, especially in disproportionately impacted communities, through public health interventions and related activities.
(3) Coordinate with the National Institute of Diabetes and Digestive and Kidney Diseases, the Indian Health Service, the Health Resources and Services Administration, and the Department of Veterans Affairs to develop pilot programs to demonstrate best practices for the diagnosis and management of kidney disease.
(4) Develop improved techniques and identify best practices, in coordination with the Secretary of Veterans Affairs, for assisting kidney disease patients.
(d) Data collection.— Not later than 180 days after the date of enactment of this Act, the Director of the National Institute of Diabetes and Digestive and Kidney Diseases and the Director of the Centers for Disease Control and Prevention, acting jointly, shall assess the depth and quality of information on kidney disease that is collected in surveys and population studies conducted by the Centers for Disease Control and Prevention, including whether there are additional opportunities for information to be collected in the National Health and Nutrition Examination Survey, the National Health Interview Survey, and the Behavioral Risk Factor Surveillance System surveys. The Director of the National Institute of Diabetes and Digestive and Kidney Diseases shall include the results of such assessment in the national action plan under subsection (b).
(e) Authorization of appropriations.— There are authorized to be appropriated to carry out this section $1,000,000 for fiscal year 2027, $1,000,000 for fiscal year 2028, $1,000,000 for fiscal year 2029, $1,000,000 for fiscal year 2030, and $1,000,000 for fiscal year 2031.
(a) In general.— Section 1881(b)(14) of the Social Security Act (42 U.S.C. 1395rr(b)(14)) is amended by adding at the end the following new subparagraph:
“(J)
(i) With respect to staff-assisted home dialysis (as defined in clause (iv)(IV)) furnished on or after the date that is 1 year after the date of the enactment of this subparagraph, subject to the succeeding provisions of this subparagraph, the Secretary shall increase the single payment that would otherwise apply under this paragraph for renal dialysis services by the add-on payment amount established pursuant to clause (iii).
(ii)
(I) Subject to subclause (II), staff-assisted home dialysis may only be furnished—
(aa) with respect to an initializing patient (as defined in clause (iv)(I)) or a returning patient (as defined in clause (iv)(III)), for a period of up to 90 days, referred to as the “initial period” , which may be extended as determined necessary by the care team of the individual in not more than 2 intervals of up to 30 days each, each of which is referred to as an “extended interval”; and
(bb) with respect to a temporary assistance patient (as defined in clause (iv)(V)), for any 30-day period as determined necessary by the care team of the individual, notwithstanding whether such an individual receives any routine dialysis respite care during such period.
(II) Notwithstanding subclause (I), staff-assisted home dialysis may be furnished for as long as the Secretary determines appropriate to an individual who—
(aa) is blind;
(bb) has a cognitive or neurological impairment (including a stroke, Alzheimer’s Disease, dementia, amyotrophic lateral sclerosis, or any other impairment determined by the Secretary); or
(cc) has any other illness or injury that reduces mobility (including cerebral palsy, spinal cord injuries, an injury or illness that requires the individual to be on a ventilator, or any other illness or injury determined by the Secretary).
(iii) The Secretary shall, by regulation, establish an add-on payment amount for staff-assisted home dialysis to determine the amounts payable to a qualified provider (as defined in clause (iv)(II)) for assisting in the furnishing of staff-assisted home dialysis on a frequency as determined by the Secretary and in consultation with clinicians, patients, and care partners to ensure maximum patient choice, access, and flexibility. In establishing the add-on payment under this clause, the Secretary shall consult with stakeholders, including providers of renal dialysis services, individuals receiving home dialysis, qualified providers, private insurance payers, and Medicare Advantage plans under part C.
(iv) In this subparagraph:
(I) The term initializing patient means an individual who initiates a home dialysis modality, including home hemodialysis and peritoneal dialysis.
(II) The term qualified provider means a trained professional (as determined by the Secretary, including a registered or licensed practical nurse and a certified patient care technician) who—
(aa) furnishes renal dialysis services;
(bb) meets requirements (as determined by the Secretary) that ensure competency in patient care and modality usage; and
(cc) during a period described in clause (ii)(I), provides in-person assistance to an individual for an appropriate number of dialysis sessions, as determined by the care team of the individual based on the needs of the individual, caregiver availability, prescription, and mode of home dialysis.
(III) The term returning patient means an individual who is returning to home dialysis after a period of hospitalization or other non-home dialysis modality.
(IV)
(aa) The term staff-assisted home dialysis means dialysis furnished by the individual in a home, residence, or other approved setting with the assistance of a qualified provider, the frequency of which is determined by the qualified provider in coordination with the individual, the care partner, and the care team of the individual and outlined in a patient plan of care.
(bb) In this subclause, the term care partner means a friend or family member who is designated by the individual who is trained to assist the individual with the furnishing of home dialysis.
(cc) In this subclause, the term patient plan of care has the meaning given such term in section 494.90 of title 42, Code of Federal Regulations (or any successor regulations).
(V) The term temporary assistance patient means an individual who is receiving home dialysis and is temporarily unable to perform functions necessary to self-furnish unassisted home dialysis due to illness, injury, caregiver unavailability, or other temporary circumstances not to exceed 30 days.”.
(b) Patient education and training relating to staff-Assisted home dialysis.—
(1) In general.— Section 1881(b)(5) of the Social Security Act (42 U.S.C. 1395rr(b)(5)) is amended—
(A) in subparagraph (C), by striking at the end “and”;
(B) in subparagraph (D), by striking the period at the end and inserting a semicolon; and
(C) by adding at the end the following new subparagraphs:
“(E) educate individuals on the opportunity to receive staff-assisted home dialysis (as defined in paragraph (14)(J)(iv)(IV)) during the periods described in paragraph (14)(J)(ii); and
(F) provide for registered or licensed nurses, certified patient care technicians, or other qualified providers (as determined by a physician) to train individuals and their care partners in skills and procedures needed to furnish staff-assisted home dialysis, including—
(i) in a group-training environment with other individuals and their care partners when appropriate and in accordance with Federal regulations (concerning the privacy of individually identifiable health information) promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996;
(ii) via telehealth (following an initial period of in-person competency training, in accordance with standards specified by the Secretary);
(iii) through interdisciplinary team training (as described in the interpretive guidance relating to tag number V590 of “Advance Copy—End Stage Renal Disease (ESRD) Program Interpretive Guidance Version 1.1” (published on October 3, 2008)); and
(iv) in the home or residence of an individual, in a dialysis facility, in a stand-alone training facility, or the place in which the individual has been approved to perform home dialysis by the care team.”.
(2) Effective date.— The amendments made by this subsection shall take effect on the date that is 1 year after the date of the enactment of this Act.
(c) Other provisions.—
(1) Anti-kickback statute.— Section 1128B(b)(3) of the Social Security Act (42 U.S.C. 1320a–7b(b)(3)) is amended—
(A) by moving subparagraphs (J) and (K) 2 ems to the left;
(B) in subparagraph (K), by striking “and” at the end;
(C) in subparagraph (L), by striking the period at the end and inserting “; and”; and
(D) by adding at the end the following new subparagraph:
“(M) any remuneration relating to the furnishing of staff-assisted home dialysis (as defined in section 1881(b)(14)(J)(iv)(IV)).”.
(2) Study.— Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services (in this subsection referred to as the “Secretary”) shall submit to the Committee on Finance of the Senate and the Committees on Energy and Commerce and Ways and Means of the House of Representatives a report that—
(A) examines racial disparities in the utilization of home dialysis (as defined in section 1881(b)(14)(J)(iv)(IV) of the Social Security Act (42 U.S.C. 1395rr(b)(14)(J)(iv)(IV)), as added by subsection (a)), and makes recommendations on how to improve access to home dialysis for communities of color;
(B) examines coverage for, and utilization of, home dialysis in rural communities, and makes recommendations on how to improve access to home dialysis for such rural communities; and
(C) analyzes clinical and quality of life outcomes for patients, disaggregated by geographic and demographic indicators, who receive different dialysis modalities, including staff-assisted home dialysis, unassisted home dialysis, and dialysis furnished in a facility.
(3) Patient decision tool.— Not later than December 31, 2027, for the purposes of section 1881(b)(14)(J) of the Social Security Act (42 U.S.C. 1395rr(b)(14)(J)), as added by subsection (a), the Secretary shall convene a patient panel to develop a patient-centered decision tool to assist dialysis patients in evaluating their lifestyle and goals and in choosing the dialysis setting and modality. Such tool shall include an acknowledgment that the patient is capable of home dialysis and wants home dialysis, if that is the modality such patient chooses.
(4) Patient quality of life metric.— Section 1881(h)(2)(A)(iv) of the Social Security Act (42 U.S.C. 1395rr(h)(2)(A)(iv)) is amended—
(A) in subclause (II), by striking “and” at the end;
(B) in subclause (III), by striking the period at the end and inserting “; and”; and
(C) by adding at the end the following new subclause:
“(IV) patient quality of life for all individuals utilizing dialysis regardless of modality, with the intent of measuring and improving patient quality of life on dialysis.”.
(a) In general.— The Director of the National Institutes of Health shall expand, intensify, and support ongoing research and other activities with respect to kidney transplants in minority populations.
(b) CMS data collection and reporting.— The Centers for Medicare & Medicaid Services shall collect and report annual data on dialysis facility and nephrologist performance on transplant referral, with an emphasis on data relating to patients of color.
(c) OPTN data collection and reporting.— The Organ Procurement and Transplantation Network shall collect and the Scientific Registry of Transplant Recipients shall report annual data, broken down by demographic and socioeconomic characteristics, on individual transplant center performance as it relates to patients referred, evaluated, waitlisted, and successfully transplanted.
(d) Transplant center data.— Each organ transplant center shall report on the percent of appropriate waitlisted patients (including socioeconomic and demographic data) giving and receiving annual informed consent for offers for suboptimal kidneys (such as kidneys with a kidney donor profile index of greater than 85 percent or kidney age 50 with diabetes, or age greater than 60).
(e) Organ procurement organization data.— Each organ procurement organization shall report annual data on referrals, refusals (patient or doctor), and acceptance of organs by hospital, ZIP Code, race, ethnicity, and age strata except as prohibited by need for confidentiality.
(f) Data transparency for patients.— Each organ transplant center shall provide to each patient of such center, on an annual basis—
(1) the number of times an organ was offered to the patient, declined, and transplanted into another patient from organs within a 500-mile radius; and
(2) the number of times an organ was offered to and declined for the patient from a low-risk donor which was subsequently transplanted into another patient.
(g) Improved transplantation education.— The Centers for Medicare & Medicaid Services shall certify a nonbiased, third-party organization to accredit organ transplant education.
(h) Research.— Research under subsection (a) shall include investigation into—
(1) the causes of lower rates of kidney transplants in minority populations, including socioeconomic, geographic, clinical, environmental, genetic, and other factors that may contribute to lower rates of kidney transplants in minority populations; and
(2) possible interventions to increase kidney transplants.
(i) Report; comprehensive plan.—
(1) In general.— The Secretary of Health and Human Services shall—
(A) prepare and submit to the Congress, not later than 6 months after the date of enactment of this section, a report on Federal research and public health activities with respect to kidney transplants as a treatment for end-stage renal disease in minority populations; and
(B) develop and submit to the Congress, not later than 1 year after the date of enactment of this section, an effective and comprehensive Federal plan (including all appropriate Federal health programs) to increase the number of kidney transplants in minority populations.
(2) Contents.— The report under paragraph (1)(A) shall at a minimum address each of the following:
(A) Research on kidney transplants in minority populations, including such research on financial, insurance coverage, genetic, behavioral, and environmental factors.
(B) Surveillance and data collection on kidney transplants in minority populations, including with respect to—
(i) efforts to increase kidney transplants among Asian-American, Native Hawaiian, and Pacific Islander subgroups with end-stage renal disease; and
(ii) efforts to increase kidney transplants in the American Indian population.
(C) Community-based efforts to increase kidney transplants targeting minority populations, including—
(i) the evidence base for such increases;
(ii) the cultural appropriateness of such increases; and
(iii) efforts to educate the public on kidney transplants.
(D) Education and training programs for health professionals (including community health workers) on the kidney transplants that are supported by the Health Resources and Services Administration, including such programs supported by the Bureau of Health Workforce, the Bureau of Primary Health Care, and the Health Systems Bureau.
The Director of the Centers for Disease Control and Prevention shall—
(1) support research into the environmental and occupational causes and biological mechanisms that contribute to kidney disease; and
(2) develop and disseminate public health interventions that will lessen the impact of environmental and occupational causes of kidney disease.
(a) Study.— The Secretary of Health and Human Services (in this section referred to as the “Secretary”) shall conduct a study on treatment patterns associated with providing care, under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.), under the Medicaid program under title XIX of such Act (42 U.S.C. 1396 et seq.), and through private health insurance, to minority populations that are disproportionately affected by kidney failure.
(b) Report.— Not later than 1 year after the date of the enactment of this Act, the Secretary shall submit to Congress a report on the study conducted under subsection (a), together with such recommendations as the Secretary determines to be appropriate.
(a) Definition of primary health services.— Section 331(a)(3)(D) of the Public Health Service Act (42 U.S.C. 254d(a)(3)(D)) is amended by inserting “nephrology,” after “dentistry,”.
(b) National health service corps scholarship program.— Section 338A(a)(2) of the Public Health Service Act (42 U.S.C. 254l(a)(2)) is amended by inserting “, which may include kidney health professionals” before the period at the end.
(c) National health service corps loan repayment program.— Section 338B(a)(2) of the Public Health Service Act (42 U.S.C. 254l–1(a)(2)) is amended by inserting “, which may include kidney health professionals” before the period at the end.
(a) Guaranteed availability of medigap policies to all ESRD medicare beneficiaries.—
(1) In general.— Section 1882(s) of the Social Security Act (42 U.S.C. 1395ss(s)) is amended—
(A) in paragraph (2)—
(i) in subparagraph (A), by striking “is 65” and all that follows through the period at the end and inserting the following: “is—
“(i) 65 years of age or older and is enrolled for benefits under part B; or
(ii) is entitled to benefits under 226A(b) and is enrolled for benefits under part B.”; and
(ii) in subparagraph (D), in the matter preceding clause (i), by inserting “(or is entitled to benefits under 226A(b))” after “is 65 years of age or older”; and
(B) in paragraph (3)(B)—
(i) in clause (ii), by inserting “(or is entitled to benefits under 226A(b))” after “is 65 years of age or older”; and
(ii) in clause (vi), by inserting “(or under 226A(b))” after “at age 65”.
(2) Effective date.— The amendments made by paragraph (1) shall apply to Medicare supplemental policies effective on or after January 1, 2027.
(b) Additional enrollment period for certain individuals.—
(1) One-time enrollment period.—
(A) In general.— In the case of an individual described in paragraph (2), the Secretary of Health and Human Services shall establish a one-time enrollment period during which such an individual may enroll in any Medicare supplemental policy under section 1882 of the Social Security Act (42 U.S.C. 1395ss) of the individual’s choosing.
(B) Enrollment period.— The enrollment period established under subparagraph (A) shall begin on January 1, 2027, and shall end June 30, 2027.
(2) Individual described.— An individual described in this paragraph is an individual who—
(A) is entitled to hospital insurance benefits under part A of title XVIII of the Social Security Act (42 U.S.C. 1395c et seq.) or under section 226A(b) of such Act (42 U.S.C. 426–1(b));
(B) is enrolled for benefits under part B of such title XVIII (42 U.S.C. 1395j et seq.); and
(C) would not, but for the provisions of, and amendments made by, subsection (a) be eligible for the guaranteed issue of a Medicare supplemental policy under paragraph (2) or (3) of section 1882(s) of such Act (42 U.S.C. 1395ss(s)).
The Commissioner of Food and Drugs shall—
(1) aggregate information on the accumulated experience of sponsors of drugs that develop and execute clinical trial diversity plans during drug development;
(2) include in such aggregated information an analysis from the perspectives of the Food and Drug Administration and such sponsors of which actions worked or which did not work to enhance clinical trial diversity;
(3) not later than September 30, 2027, convene a public meeting, including representatives from the regulated industry and patient organizations, to discuss findings and recommendations for specific actions that have led to measurable improvements in the representation of racial and ethnic populations in clinical research; and
(4) not later than September 30, 2028, update the guidance of the Food and Drug Administration titled “Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs” to align such guidance with findings and recommendations that were discussed at the meeting under paragraph (3).
(a) Encouragement of clinical trial enrollment by racially and ethnically diverse populations.—
(1) No cost provision of digital health technologies.— The free provision of digital health technologies by drug or device manufacturers to their clinical trial participants shall not be considered a violation of section 1128A of the Social Security Act (commonly known as the “Civil Monetary Penalties Law”) (42 U.S.C. 1320a–7a), section 1128B of the Social Security Act (42 U.S.C. 1320a–7b), or sections 3729 through 3733 of title 31, United States Code (commonly known as the “False Claims Act”), provided that—
(A) the use of digital health technologies will facilitate in any phase of clinical development the inclusion of diversity of patient populations, such as underrepresented racial and ethnic minorities, low-income populations, and the elderly;
(B) the digital health technologies will facilitate individuals’ participation, or are necessary to such participation;
(C) all features of the digital health technologies that are unrelated to use in the clinical trial are disabled or only allowed to remain activated to model real-world usage of the digital technology; and
(D) the clinical trial sponsor requires participants to return, purchase, or disable the digital health technologies by the conclusion of the trial.
(2) Grants and contracts.—
(A) In general.— The Secretary of Health and Human Services (in this section referred to as the “Secretary”) may issue grants to, and enter into contracts with, entities to support community education, outreach, and recruitment activities for clinical trials with respect to drugs, including vaccines for diseases or conditions which have a disproportionate impact on underrepresented populations (including on racial and ethnic minority populations), including for the diagnosis, prevention, or treatment of COVID–19. Such activities may include—
(i) working with community clinical trial sites, including community health centers, academic health centers, and other facilities;
(ii) training health care personnel including potential clinical trial investigators, with a focus on significantly increasing the number of underrepresented racial and ethnic minority health care personnel who are clinical trial investigators at the community sites for ongoing clinical trials;
(iii) engaging community stakeholders to encourage participation in clinical trials, especially in underrepresented racial and ethnic minority communities; and
(iv) fostering partnerships with community-based organizations serving underrepresented racial and ethnic minority populations, including labor organizations and frontline health care workers.
(B) Priority for grant and contract awards.— In awarding grants and contracts under this paragraph, the Secretary shall prioritize entities that—
(i) develop educational, recruitment, and training materials in multiple languages; or
(ii) undertake clinical trial outreach efforts in more diverse racial and ethnic communities that are traditionally underrepresented in clinical trials, such as Tribal areas.
(C) Authorization of appropriations.— There is authorized to be appropriated for fiscal years 2027 and 2028 such sums as may be necessary to carry out this paragraph.
(b) Clarification that certain remuneration related to participation in clinical trials does not constitute remuneration under the federal civil money penalties law.—
(1) In general.— Section 1128A(i)(6)(F) of the Social Security Act (42 U.S.C. 1320a–7a(i)(6)(F)) is amended by inserting “(including remuneration offered or transferred to an individual to promote the participation in an approved clinical trial, as defined in subsection (d) of the first section 2709 of the Public Health Service Act (42 U.S.C. 300gg–8) (relating to coverage for individuals participating in approved clinical trials), as so designated by section 1563(c)(10)(C) of the Patient Protection and Affordable Care Act, that is registered with the database of clinical trials maintained by the National Library of Medicine (or any successor database), so long as such remuneration facilitates equitable inclusion of patients from all relevant demographic and socioeconomic populations and is related to patient participation in the approved clinical trial)” after “promotes access to care”.
(2) Effective date.— The amendment made by paragraph (1) shall apply to remuneration provided on or after the date of the enactment of this Act.
(c) National academy of medicine study.—
(1) In general.— The Secretary shall seek to enter into an arrangement with the National Academy of Medicine under which the National Academy agrees to study and propose a design for a national interoperable data platform to improve access to health data, and other relevant data needs, during public health emergencies.
(2) Report.— The arrangement under paragraph (1) shall provide that the National Academy of Medicine, not later than 180 days after the date of enactment of this Act, shall submit a report to the Secretary and Congress on the results of the study under paragraph (1) and the design proposed based on such study.
(a) Diversity requirements for applications for federal funding for clinical trials.—
(1) Applications.— Beginning on the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (in this subsection referred to as the “Secretary”), shall require that an entity seeking to conduct a clinical trial investigating a drug or device (as those terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)) or biological product (as defined in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i))) that is funded by the National Institutes of Health and conducted at any national research institute or national center, submit an application (or renewal thereof) for such funding that includes—
(A) clear and measurable goals for the recruitment and retention of participants that reflect—
(i) the race, ethnicity, age, and gender or sex of patients with the disease or condition being investigated; or
(ii) the race, ethnicity, age, and gender or sex of the general population of the United States if the prevalence of the disease or condition is not known;
(B) a rationale for the goals specified under subparagraph (A) that specifies—
(i) how investigators will calculate the number of participants for each population category that reflect the population groups specified in subparagraph (A); and
(ii) strategies that will be used to enroll and retain participants across the different racial, ethnic, age, and gender or sex categories;
(C) a detailed plan for how the clinical trial will achieve the goals specified under subparagraph (A) that specifies—
(i) the requirements for researchers, in conducting the trial to analyze the population groups specified in subparagraph (A) separately;
(ii) the role of community partners or community institutional review boards in reviewing the plans; and
(iii) how the trial will recruit a study population that is—
(I) in proportion to the prevalence of the disease or condition in such groups relative to the prevalence of the disease or condition in the overall population of the United States;
(II) in sufficient numbers to obtain clinically and statistically meaningful determinations of the safety and effectiveness of the drug being studied in the respective race, ethnicity, age, and gender or sex groups; and
(III) consistent with the guidance under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(1)) and guidance issued by the National Institutes of Health on the inclusion of women and minorities in clinical trials;
(D) the entity’s plan for implementing, or an explanation of why the entity cannot implement, alternative clinical trial follow-up requirements that are less burdensome for trial participants, such as—
(i) requiring fewer follow-up visits;
(ii) allowing phone follow-up or home visits by nurse trial coordinators (in lieu of in-person visits by patients);
(iii) allowing for online follow-up options;
(iv) permitting the patient’s primary care provider to perform some of the follow-up visit requirements and to reimburse the patient for any out-of-pocket costs incurred by the patient for such follow-up visits;
(v) allowing for weekend hours for required follow-up visits;
(vi) allowing virtual or telemedicine visits;
(vii) use of wearable technology to record key health parameters; and
(viii) use of alternate labs or imaging centers, which may be closer to the residence of the patients participating in the trial; and
(E) the entity’s education and training requirements for researchers and other individuals conducting or supporting the clinical trial with respect to diversity and health inequities in underrepresented populations, including a requirement to consult with, and review materials made available by, such committees, task forces, and working groups other entities the Secretary determines are appropriate, including the following:
(i) The Equity Committee of the National Institutes of Health.
(ii) The National Advisory Council on Minority Health and Health Disparities.
(iii) The Advisory Committee on Research on Women’s Health.
(iv) The Sexual & Gender Minority Research Coordinating Committee of the National Institutes of Health.
(v) The Tribal Health Research Coordinating Committee of the National Institutes of Health.
(2) Terms.—
(A) In general.— As a condition on the receipt of funding through the National Institutes of Health, as described in paragraph (1), with respect to a clinical trial, the sponsor of the clinical trial shall agree to terms requiring that—
(i) the aggregate demographic information of trial participants be shared on an annual basis with the Secretary while participant recruitment and data collection in such trial is ongoing, and that such information is provided with respect to—
(I) underrepresented populations, including populations grouped by race, ethnicity, age, sex, gender identity and expression, geographic region, primary written and spoken language, disability status, sexual orientation, socioeconomic status, occupation, and other relevant factors; and
(II) such populations that reflect the prevalence of the disease or condition that is the subject of the clinical trial involved (as available and as appropriate to the scientific objective for the study, as determined by the Director of the National Institutes of Health);
(ii) the sponsor submits to the program officer and grants management specialist of the specific National Institutes of Health national research institute or national center, as frequently as such officer or specialist determines necessary, the retention rate of participants in the clinical trial, disaggregated by race, ethnicity, gender or sex, and age;
(iii) both the clinical trial researchers and the applicant reviewers complete education and training programs on diversity in clinical trials; and
(iv) at the conclusion of the trial, the sponsor submits to the Secretary the number of participants in the trial, disaggregated by race, ethnicity, age, and gender or sex.
(B) Privacy protections.— Any data shared under subparagraph (A) may not include any individually identifiable information or protected health information with respect to clinical trial participants and shall only be disclosed to the extent allowed under Federal privacy laws.
(3) Exception.— In lieu of submitting an application under paragraph (1) and documentation of goals as required by subparagraph (A) of such paragraph, an applicant may provide reasoning (other than cost) for why the recruitment of each of the population groups specified in subparagraph (A) of paragraph (1) is not necessary and why such recruitment is not scientifically justified or possible.
(4) Publication.— The Secretary shall—
(A) publish on a public website of the National Institutes of Health, upon receipt of an application to which paragraph (1) applies or reasoning under paragraph (3)—
(i) a summary of the disease being targeted in the clinical trial that is the subject of the application and the prevalence of such disease across race, ethnicity, gender or sex, age, and clinical trial representation in each such category;
(ii) the goals specified in such application, as required by paragraph (1)(A); or
(iii) the reasoning described in paragraph (3); and
(B) ensure that, in publishing information relating to an application or reasoning under subparagraph (A), the design of the study involved is not disclosed.
(5) Remediation.—
(A) In general.— In the case of a clinical trial subject to paragraph (1) that fails to meet the condition specified pursuant to paragraph (1) by such date as may be agreed upon by the sponsor of the trial and the program officer and grants management specialist of the specific National Institutes of Health national research institute or national center, the Secretary shall require the sponsor of that clinical trial, not later than 60 days after such date occurs—
(i) to develop, in consultation with the Secretary and advocacy and community-based organizations representing individuals who are members of relevant demographic groups specified in paragraph (1)(A), a strategic plan to increase participation in such clinical trial of such individuals; and
(ii) to submit to the Secretary, such strategic plan.
(B) Publication.— The Secretary shall make publicly available on the website of the National Institutes of Health, the strategic plan received under subparagraph (A) as soon as possible after receipt. The Secretary shall ensure that, in publishing such plan under the preceding sentence, the design of the study involved is not disclosed.
(C) Implementation.— The sponsor of the clinical trial that is the subject of the strategic plan published under subparagraph (B), shall, not later than 60 days after such date as may be agreed upon by the sponsor of the trial and the appropriate program officer and grants management specialist of the National Institutes of Health, implement the strategic plan.
(D) Technical assistance.— The Secretary may provide technical assistance to a sponsor of a clinical trial, as necessary for the sponsor to meet the requirements of subparagraph (C).
(6) Penalties in case of failure of remediation.—
(A) In general.— In the case of a clinical trial subject to paragraph (1) that, after the close of the 60-day period specified in paragraph (5)(C), continues to fail to meet the condition specified pursuant to paragraph (1)(A), the Secretary shall—
(i) hold the noncompeting continuation of funding received through the grant involved;
(ii) apply specific conditions on the award of funds to such sponsor to conduct such clinical trial; or
(iii) terminate such funding.
(B) Waiver.—
(i) In general.— In the case of a clinical trial subject to the penalty under subparagraph (A) that fails to meet the condition referred to in such subparagraph, the sponsor of such clinical trial may, prior to the conclusion of the 60-day period referred to in subparagraph (A), submit an application to the relevant program officer and grants specialist requesting a waiver of such condition. Such an application shall specify reasoning for why the recruitment of each of the population groups specified in subparagraph (A) of paragraph (1) is not necessary or why such recruitment is not scientifically justified or possible.
(ii) Review.— Not later than 30 days after a date agreed upon by the sponsor of the trial and the appropriate program officer and grants management specialist of the National Institutes of Health, the Secretary shall—
(I) complete the review of such application; and
(II) make a determination to approve or deny the application.
(iii) No additional penalties.— No additional penalties may be applied with respect to a sponsor of a clinical trial under subparagraph (A) during the 30-day period specified in clause (ii).
(C) Termination of funding.— In the case of a clinical trial described in subparagraph (B)(i), the Secretary may elect to terminate funding described in paragraph (1) for the clinical trial if no request for a waiver under subparagraph (B) is received by the conclusion 60-day period referred to in subparagraph (A).
(7) Waiver for certain clinical trials.—
(A) In general.— In the case of a clinical trial that received funding through the National Institutes of Health and is ongoing as of the date of the enactment of this Act, the sponsor of such clinical trial is exempt from the requirements of (and associated penalties imposed by) this section.
(B) Report.— The Secretary shall include in the triennial report required to be submitted under section 403 of the Public Health Service Act (42 U.S.C. 283), a list of all clinical trials receiving funding through the National Institutes of Health—
(i) that requested and received waivers under this subsection; or
(ii) with respect to which funding has been terminated pursuant to this subsection.
(8) Nondiscrimination.— Section 1557 of the Patient Protection and Affordable Care Act (42 U.S.C. 18116) shall apply with respect to a clinical trial subject to paragraph (1).
(b) Eliminating cost barriers.—
(1) Study on modernization of human subject regulations.— Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (referred to in this subsection as the “Secretary”), shall conduct and complete a study on—
(A) the need for review of human subject regulations specified in part 46 of title 45, Code of Federal Regulations (or successor regulations), and related guidance;
(B) the modernization of such regulations and guidance to establish updated guidelines for reimbursement of out-of-pocket expenses of human subjects, compensation of human subjects for time spent participating in the clinical trial, and incentives for recruitment of human subjects; and
(C) the need for updated safe harbor rules under section 1001.952 of title 42, Code of Federal Regulations (or successor regulations), and section 1128B of the Social Security Act (commonly referred to as the Federal Anti-Kickback Statute (42 U.S.C. 1320a–7b)) with respect to the assistance provided under this subsection.
(2) Reimbursement for costs associated with clinical trial participation.— As a condition on receipt of any funding provided through the National Institutes of Health to conduct a clinical trial investigating a drug or device (as those terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)) or biological product (as defined in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i))), the Secretary shall require that the sponsor of such clinical trial—
(A) works with institutional review boards and program officers of the National Institutes of Health to determine when reimbursement for the costs associated with clinical trial participation is warranted; and
(B) subject to paragraph (3), provides to clinical trial participants reimbursement for expenses (using funds other than funds supplied through the National Institutes of Health) incurred as a result of that participation, which may include—
(i) missed or forgone salary;
(ii) language assistance, including interpreter services;
(iii) food expenses;
(iv) childcare expenses;
(v) lodging expenses;
(vi) transportation expenses; or
(vii) other expenses as identified by the participant, subject to review by the clinical trial sponsor, at its discretion, on a case-by-case basis.
(3) Provision of costs associated with clinical trial participation.—
(A) Application and documentation.—
(i) In general.— A sponsor of a clinical trial to which subsection (a)(1) applies, may require that, in order to receive reimbursement as described in paragraph (2), a participant complete an application and share with the sponsor such documentation of expenses described in such paragraph, as the sponsor may require.
(ii) Timing.— Not later than 30 days after the date on which a sponsor of a clinical trial receives an application under clause (i), the sponsor shall—
(I) review the application; and
(II) provide for reimbursement of eligible expenses documented in such application, as determined at the discretion of the clinical trial sponsor on a case-by-case basis.
(B) Enforcement.— A sponsor of a clinical trial to which subsection (a)(1) applies, shall submit on an annual basis, as part of the progress reports submitted to the Secretary pursuant to section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)), during the data collection period of the clinical trial, to the Secretary an accounting of the reimbursements made to clinical trial participants under subparagraph (A). Such data shall—
(i) include relevant aggregate data with respect to each population group specified in subsection (a)(2)(A)(i) when such data will not compromise the identities of study participants and in a manner consistent with applicable privacy protections; and
(ii) not later than 6 months after receipt by the Secretary, be published on a public website of the National Institutes of Health.
(c) Public awareness and education campaign.—
(1) National campaign.— The Secretary of Health and Human Services, acting through the Director of the National Institutes of Health and the Commissioner of Food and Drugs (referred to in this subsection as the “Secretary”), in consultation with the stakeholders specified in paragraph (5), shall carry out a national campaign to increase the awareness and knowledge of individuals in the United States with respect to the need for diverse clinical trials among the demographic groups identified pursuant to subsection (a)(1)(A).
(2) Requirements.— The national campaign conducted shall include—
(A) the development and distribution of written educational materials, and the development and placing of public service announcements, that are intended to encourage individuals who are members of the demographic groups identified pursuant to subsection (a)(2)(A)(i)(I) to seek to participate in clinical trials;
(B) such efforts as are reasonable and necessary to ensure meaningful access by consumers with limited English proficiency;
(C) the development and distribution of best practices and training for recruiting underrepresented study populations, including a method for sharing such best practices among clinical trial sponsors, providers, community-based organizations who assist with recruitment, and with the public; and
(D) the conduct of focus groups to better understand the concerns and fears of certain underrepresented groups who may be reluctant to participate in clinical trials.
(3) Health inequities.— In developing the national campaign under paragraph (1), the Secretary shall recognize and address—
(A) health inequities among individuals who are members of the population groups specified in subsection (a)(2)(A)(i) with respect to access to care and participation in clinical trials; and
(B) any barriers in access to care and participation in clinical trials that are specific to individuals who are members of such groups.
(4) Grants.— The Secretary shall establish a program to award grants to nonprofit private entities, including community-based organizations and faith communities, institutions of higher education eligible to receive funds under section 371 of the Higher Education Act of 1965 (20 U.S.C. 1067q) and national organizations that serve underrepresented populations and community pharmacies to enable such entities—
(A) to test alternative outreach and education strategies to increase the awareness and knowledge of individuals in the United States, with respect to the need for diverse clinical trials that reflect the race, ethnicity, age, and gender or sex of patients with the disease or condition being investigated; and
(B) to cover administrative costs of such entities in assisting in diversifying clinical trials subject to subsection (a).
(5) Stakeholders specified.— The stakeholders specified in this paragraph are the following:
(A) Representatives of the Health Resources Services Administration, the Office of Minority Health of the Department of Health and Human Services, the Centers for Disease Control and Prevention, and the National Institutes of Health.
(B) Community-based resources and advocates.
(6) Authorization of appropriations.— There is authorized to be appropriated to carry out this subsection $10,000,000 for each of fiscal years 2027 through 2031.
(d) Definitions.— In this section:
(1) Clinical trial.— The term clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
(2) Sponsor.— The term sponsor has the meaning given such term in section 50.3 of title 21, Code of Federal Regulations (or successor regulations).
(a) Policy.— Section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c) is amended—
(1) by redesignating subsections (b) and (c) as subsections (c) and (d), respectively; and
(2) by inserting after subsection (a) the following:
“(b) Collection, submission, and use of data.—
(1) In general.— The Secretary shall—
(A) for any drug for which an exemption is granted for investigational use under section 505(i) of this Act or section 351(a) of the Public Health Service Act, require the sponsor of the drug to collect standardized patient experience data as part of the clinical trials conducted pursuant to such exemption;
(B) require any application for the approval or licensing of such drug under section 505(b) of this Act or section 351(a) of the Public Health Service Act to include—
(i) the standardized patient experience data so collected; and
(ii) such related information as the Secretary may require; and
(C) consider patient experience data and related information that is submitted pursuant to subparagraph (B) in deciding whether to approve or license, as applicable, the drug involved.
(2) Applicability.— Paragraph (1) applies only with respect to drugs for which a request for an exemption described in paragraph (1)(A) is submitted on or after the date of the enactment of the Health Equity and Accountability Act of 2026, or an application under section 505(b) of this Act or section 351(a) of the Public Health Service Act is filed, as applicable, on or after the day that is 2 years after the date of the enactment of the Health Equity and Accountability Act of 2026.”.
(b) Regulations.— Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall promulgate final regulations to implement section 569C(b) of the Federal Food, Drug, and Cosmetic Act, as added by this section.
(a) Coverage.— Section 1861 of the Social Security Act (42 U.S.C. 1395x), as amended by sections 2007, 4221, 4251, 6101, and 7419, is amended—
(1) in subsection (s)(2)—
(A) in subparagraph (MM), by striking “and” at the end;
(B) by inserting “and” at the end of subparagraph (NN); and
(C) by adding at the end the following new subparagraph:
“(OO) multi-cancer early detection screening tests (as defined in subsection (ttt));”; and
(2) by adding at the end the following new subsection:
“(ttt) Multi-Cancer early detection screening tests.— The term multi-cancer early detection screening test means any of the following tests, approved or cleared by the Food and Drug Administration, furnished to an individual for the purpose of early detection of cancer across many cancer types (as categorized in the Annual Report to the Nation on the Status of Cancer issued by the National Cancer Institute):
(1) A genomic sequencing blood or blood product test that includes the analysis of cell-free nucleic acids.
(2) Such other equivalent tests (which are based on urine or another sample of biological material) as the Secretary determines appropriate.”.
(b) Payment and frequency limit.—
(1) Payment under fee schedule.— Section 1833(h) of the Social Security Act (42 U.S.C. 1395l(h)) is amended—
(A) in paragraph (1)(A), by inserting after “(including” the following: “multi-cancer early detection screening tests under section 1861(ttt) and including”; and
(B) by adding at the end the following new paragraph:
“(10) No payment may be made under this part for a multi-cancer early detection screening test (as defined in section 1861(ttt)) for an individual if such a test was furnished to the individual during the previous 11 months.”.
(2) Conforming amendment.— Section 1862(a) of the Social Security Act (42 U.S.C. 1395y(a)) is amended—
(A) in paragraph (1)—
(i) in subparagraph (O), by striking “and” at the end;
(ii) in subparagraph (P), by striking the semicolon at the end and inserting “, and”; and
(iii) by adding at the end the following new subparagraph:
“(Q) in the case of multi-cancer early detection screening tests (as defined in section 1861(ttt)), which are performed more frequently than is covered under section 1833(h)(10);”; and
(B) in paragraph (7), by striking “or (P)” and inserting “(P), or (Q)”.
(c) Rule of construction relating to other cancer screening tests.— Nothing in this section, including the amendments made by this section, shall be construed—
(1) in the case of an individual who undergoes a multi-cancer early detection screening test, to affect coverage under part B for other cancer screening tests covered under this section, such as screening tests for breast, cervical, colorectal, lung, or prostate cancer; or
(2) in the case of an individual who undergoes another cancer screening test, to affect coverage for a multi-cancer early detection screening test or the use of such a test as a diagnostic or confirmatory test for a result of the other cancer screening test.
(a) Peripheral artery disease education program.— Part P of title III of the Public Health Service Act (42 U.S.C. 280g et seq.), as amended by section 7504, is amended by adding at the end the following:
“399V–14. Peripheral artery disease education program.—
(a) Establishment.— The Secretary, acting through the Director of the Centers for Disease Control and Prevention, in collaboration with the Administrator of the Centers for Medicare & Medicaid Services and the Administrator of the Health Resources and Services Administration, shall establish and coordinate a peripheral artery disease education program to support, develop, and implement educational initiatives and outreach strategies that inform health care professionals and the public about the existence of peripheral artery disease and methods to reduce amputations related to such disease, particularly with respect to at-risk populations.
(b) Authorization of appropriations.— There is authorized to be appropriated to carry out this section such sums as may be necessary for each of fiscal years 2027 through 2031.”.
(b) Medicare coverage of peripheral artery disease screening tests furnished to at-Risk beneficiaries without imposition of cost sharing requirements.—
(1) In general.— Section 1861 of the Social Security Act (42 U.S.C. 1395x), as amended by sections 2007, 4221, 4251, 6101, 7419, and 7901C, is amended—
(A) in subsection (s)(2)—
(i) in subparagraph (NN), by striking “and” at the end;
(ii) in subparagraph (OO), by striking the period at the end and inserting “; and”; and
(iii) by adding at the end the following new subparagraph:
“(PP) peripheral artery disease screening tests furnished to at-risk beneficiaries (as such terms are defined in subsection (uuu)).”; and
(B) by adding at the end the following new subsection:
“(uuu) Peripheral artery disease screening test; at-Risk beneficiary.—
(1) The term peripheral artery disease screening test means—
(A) noninvasive physiologic studies of extremity arteries (commonly referred to as ankle-brachial index testing);
(B) arterial duplex scans of lower extremity arteries vascular; and
(C) such other items and services as the Secretary determines, in consultation with relevant stakeholders, to be appropriate for screening for peripheral artery disease for at-risk beneficiaries.
(2) The term at-risk beneficiary means an individual entitled to, or enrolled for, benefits under part A and enrolled for benefits under part B—
(A) who is 65 years of age or older;
(B) who is at least 50 years of age but not older than 64 years of age with risk factors for atherosclerosis (such as diabetes mellitus, a history of smoking, hyperlipidemia, and hypertension) or a family history of peripheral artery disease;
(C) who is younger than 50 years of age with diabetes mellitus and 1 additional risk factor for atherosclerosis; or
(D) with a known atherosclerotic disease in another vascular bed such as coronary, carotid, subclavian, renal, or mesenteric artery stenosis, or abdominal aortic aneurysm.
(3) The Secretary shall, in consultation with appropriate organizations, establish standards regarding the frequency for peripheral artery disease screening tests described in subsection (s)(2)(PP) for purposes of coverage under this title.”.
(2) Inclusion of peripheral artery disease screening tests in initial preventive physical examination.— Section 1861(ww)(2) of the Social Security Act (42 U.S.C. 1395x(ww)(2)) is amended—
(A) in subparagraph (N), by moving the margins of such subparagraph 2 ems to the left;
(B) by redesignating subparagraph (O) as subparagraph (P); and
(C) by inserting after subparagraph (N) the following new subparagraph:
“(O) Peripheral artery disease screening tests furnished to at-risk beneficiaries (as such terms are defined in subsection (uuu)).”.
(3) Payment.—
(A) In general.— Section 1833(a) of the Social Security Act (42 U.S.C. 1395l(a)), as amended by sections 4251(c)(3), 6101(a)(4), and 7419, is amended—
(i) in paragraph (1)—
(I) in subparagraph (N), by inserting “and other than peripheral artery disease screening tests furnished to at-risk beneficiaries (as such terms are defined in section 1861(uuu))” after “other than personalized prevention plan services (as defined in section 1861(hhh)(1))”;
(II) by striking “and” before “(KK)”; and
(III) by inserting before the semicolon at the end the following: “, and (LL) with respect to peripheral artery disease screening tests furnished to at-risk beneficiaries (as such terms are defined in section 1861(uuu)), the amount paid shall be 100 percent of the lesser of the actual charge for the services or the amount determined under the payment basis determined under section 1848”; and
(ii) in paragraph (2)—
(I) in subparagraph (G), by striking “and” at the end;
(II) in subparagraph (H), by inserting “ and” at the end; and
(III) by inserting after subparagraph (H) the following new subparagraph:
“(I) with respect to peripheral artery disease screening tests (as defined in paragraph (1) of section 1861(uuu)) furnished by an outpatient department of a hospital to at-risk beneficiaries (as defined in paragraph (2) of such section), the amount determined under paragraph (1)(EE),”.
(B) No deductible.— Section 1833(b) of the Social Security Act (42 U.S.C. 1395l(b)), as amended by section 7419(a)(5)(A)(iii), is amended, in the first sentence—
(i) by striking “and” before “(14)”; and
(ii) by inserting “, and (15) such deductible shall not apply with respect to peripheral artery disease screening tests furnished to at-risk beneficiaries (as such terms are defined in section 1861(uuu))” before the period at the end.
(C) Exclusion from prospective payment system for hospital outpatient department services.— Section 1833(t)(1)(B)(iv) of the Social Security Act (42 U.S.C. 1395l(t)(1)(B)(iv)) is amended—
(i) by striking “, or personalized” and inserting “, personalized”; and
(ii) by inserting “, or peripheral artery disease screening tests furnished to at-risk beneficiaries (as such terms are defined in section 1861(uuu))” after “personalized prevention plan services (as defined in section 1861(hhh)(1))”.
(D) Payment under physician fee schedule.— Section 1848(j)(3) of the Social Security Act (42 U.S.C. 1395w–4(j)(3)), as amended by section 4251(c)(4), is amended by inserting “, (2)(PP),” after “(2)(KK)”.
(4) Exclusion from coverage and medicare as secondary payer for tests performed more frequently than allowed.— Section 1862(a)(1) of the Social Security Act (42 U.S.C. 1395y(a)(1)), as amended by subsection (b)(2), is amended—
(A) in subparagraph (P), by striking “and” at the end;
(B) in subparagraph (Q), by striking the semicolon at the end and inserting “, and”; and
(C) by adding at the end the following new subparagraph:
“(R) in the case of peripheral artery disease screening tests furnished to at-risk beneficiaries (as such terms are defined in section 1861(uuu)), which are performed more frequently than is covered under such section;”.
(5) Authority to modify or eliminate coverage of certain preventive services.— Section 1834(n) of the Social Security Act (42 U.S.C. 1395m(n)) is amended—
(A) by redesignating subparagraphs (A) and (B) of paragraph (1) as clauses (i) and (ii), respectively, and moving the margins of such clauses, as so redesignated, 2 ems to the right;
(B) by redesignating paragraphs (1) and (2) as subparagraphs (A) and (B), respectively, and moving the margins of such subparagraphs, as so redesignated, 2 ems to the right;
(C) by striking “Certain Preventive Services” and all that follows through “any other provision of this title” and inserting:
“(1) In general.— Notwithstanding any other provision of this title”; and
(D) by adding at the end the following new paragraph:
“(2) Inapplicability.— The Secretarial authority described in paragraph (1) shall not apply with respect to preventive services described in section 1861(ww)(2)(O).”.
(6) Effective date.— The amendments made by this subsection shall apply with respect to items and services furnished on or after January 1, 2027.
(c) Medicaid coverage of peripheral artery disease screening tests furnished to at-Risk beneficiaries without imposition of cost sharing requirements.—
(1) In general.— Section 1905 of the Social Security Act (42 U.S.C. 1396d), as amended by section 5406(f) and 7419(a)(3)(A)(ii), is amended—
(A) in subsection (a)—
(i) in paragraph (33), by striking “and” after the semicolon;
(ii) by redesignating paragraph (34) as paragraph (35); and
(iii) by inserting after paragraph (33) the following new paragraph:
“(34) peripheral artery disease screening tests furnished to at-risk beneficiaries (as such terms are defined in subsection (ss)); and”; and
(B) by adding at the end the following new subsection:
“(ss) Peripheral artery disease screening test; at-Risk beneficiary.—
(1) Peripheral artery disease screening test.— The term peripheral artery disease screening test means—
(A) noninvasive physiologic studies of extremity arteries (commonly referred to as ankle-brachial index testing);
(B) arterial duplex scans of lower extremity arteries vascular; and
(C) such other items and services as the Secretary determines, in consultation with relevant stakeholders, to be appropriate for screening for peripheral artery disease for at-risk beneficiaries.
(2) At-risk beneficiary.— The term at-risk beneficiary means an individual enrolled under a State plan (or a waiver of such plan)—
(A) who is 65 years of age or older;
(B) who is at least 50 years of age but not older than 64 years of age with risk factors for atherosclerosis (such as diabetes mellitus, a history of smoking, hyperlipidemia, and hypertension) or a family history of peripheral artery disease;
(C) who is younger than 50 years of age with diabetes mellitus and one additional risk factor for atherosclerosis; or
(D) with a known atherosclerotic disease in another vascular bed such as coronary, carotid, subclavian, renal, or mesenteric artery stenosis, or abdominal aortic aneurysm.
(3) Frequency.— The Secretary shall, in consultation with appropriate organizations, establish standards regarding the frequency for peripheral artery disease screening tests described in subsection (a)(34) for purposes of coverage under a State plan under this title.”.
(2) No cost sharing.—
(A) In general.— Subsections (a)(2) and (b)(2) of section 1916 of the Social Security Act (42 U.S.C. 1396o), as amended by section 7305(b)(1), are each amended—
(i) in subparagraph (K), by striking “or” after the comma at the end;
(ii) in subparagraph (L), by striking “; and” and inserting “, or”; and
(iii) by adding at the end the following new subparagraph:
“(M) peripheral artery disease screening tests furnished to at-risk beneficiaries (as such terms are defined in section 1905(ss)); and”.
(B) Application to alternative cost sharing.— Section 1916A(b)(3)(B) of the Social Security Act (42 U.S.C. 1396o–1(b)(3)(B)), as amended by section 7305(b)(2), is amended by adding at the end the following new clause:
“(xv) Peripheral artery disease screening tests furnished to at-risk beneficiaries (as such terms are defined in section 1905(ss)).”.
(3) Mandatory coverage.— Section 1902(a)(10)(A) of the Social Security Act (42 U.S.C. 1396a(a)(10)(A)), as amended by section 2007(d)(2), is amended by striking “and (32)” and inserting “(32), and (34)”.
(d) Requirement for group health plans and health insurance issuers offering group or individual health insurance coverage To provide coverage for peripheral artery disease screening tests furnished to at-Risk enrollees without imposition of cost sharing requirements.—
(1) In general.— Section 2713 of the Public Health Service Act (42 U.S.C. 300gg–13), as amended by section 7419(a)(1)(A), is further amended—
(A) by adding at the end of subsection (a)(1) of such section, as redesignated by section 7419(a)(1)(A), the following:
“(F) with respect to at-risk enrollees, peripheral artery disease screening tests.
(2) Frequency.— The Secretary, in consultation with appropriate organizations, shall establish standards regarding the frequency for peripheral artery disease screening tests for purposes of coverage under this section.
(3) Clarification regarding breast cancer screening, mammography, and prevention recommendations.— For the purposes of this Act, and for the purposes of any other provision of law, the current recommendations of the United States Preventive Services Task Force regarding breast cancer screening, mammography, and prevention shall be considered the most current other than those issued in or around November 2009.
(4) Definitions.— In this subsection:
(A) At-risk enrollee.— The term at-risk enrollee means an individual enrolled in a group health plan or group or individual health insurance coverage—
(i) who is 65 years of age or older;
(ii) who is at least 50 years of age but not older than 64 years of age with risk factors for atherosclerosis (such as diabetes mellitus, a history of smoking, hyperlipidemia, and hypertension) or a family history of peripheral artery disease;
(iii) who is younger than 50 years of age with diabetes mellitus and one additional risk factor for atherosclerosis; or
(iv) with a known atherosclerotic disease in another vascular bed such as coronary, carotid, subclavian, renal, or mesenteric artery stenosis, or abdominal aortic aneurysm.
(B) Peripheral artery disease screening test.— The term peripheral artery disease screening test means—
(i) noninvasive physiologic studies of extremity arteries (commonly referred to as ankle-brachial index testing);
(ii) arterial duplex scans of lower extremity arteries vascular; and
(iii) such other items and services as the Secretary determines, in consultation with relevant stakeholders, to be appropriate for screening for peripheral artery disease for at-risk enrollees.
(5) Rule of construction.— Nothing in this subsection shall be construed to prohibit a plan or issuer from providing coverage for services in addition to those recommended by the United States Preventive Services Task Force or to deny coverage for services that are not recommended by such Task Force.”; and
(B) in subsection (b)(1)—
(i) by striking “subsection (a)(1) or (a)(2) or a guideline under subsection (a)(3)” and inserting “subparagraph (A) or (B) of subsection (a)(1) or a guideline under subparagraph (C) of such subsection”; and
(ii) by striking “described in subsection (a)” and inserting “described in subsection (a)(1)”.
(2) Effective date.— The amendments made by paragraph (1) shall apply with respect to plan years beginning on or after January 1, 2027.
(e) Disallowance of payment for nontraumatic amputation services furnished without anatomical testing services.— Section 1834 of the Social Security Act (42 U.S.C. 1395m), as amended by section 4221(b)(2), is amended by adding at the end the following new subsection:
“(bb) Disallowance of payment for nontraumatic amputation services furnished without anatomical testing services.—
(1) In general.— In the case of nontraumatic amputation services furnished by a supplier on or after January 1, 2027, to an individual entitled to, or enrolled for, benefits under part A and enrolled for benefits under this part, for which payment is made under this part, payment may only be made under this part if—
(A) such supplier furnishes anatomical testing services to such individual during the 3-month period preceding the date on which such nontraumatic amputation services is furnished; or
(B) such individual has a pre-existing dysfunctional or unsalvageable limb, life-threatening sepsis, intractable infection, extensive gangrene or necrotic tissue loss beyond salvage, a poor functional status, severe dementia, or a short life expectancy after shared decision making with a health care team and patient, family, or caregiver.
(2) Definitions.— In this subsection:
(A) Anatomical testing services.— The term anatomical testing services means arterial duplex scanning, computed tomography angiography, and magnetic resonance angiography.
(B) Nontraumatic amputation services.— The term nontraumatic amputation services means amputations as a result of atherosclerotic vascular disease or a related comorbidity of such disease (including diabetes).”.
(f) Development and implementation of quality measures.—
(1) Development.— The Secretary of Health and Human Services (in this subsection referred to as the “Secretary”) shall, in consultation with relevant stakeholders, develop quality measures for nontraumatic, lower-limb, major amputation that utilize appropriate diagnostic screening (including peripheral artery disease screening) in order to encourage alternative treatments (including revascularization) in lieu of such an amputation.
(2) Implementation.— After appropriate testing and validation of the measures developed under paragraph (1), the Secretary shall incorporate such measures in quality reporting programs for appropriate providers of services and suppliers under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.), including for purposes of—
(A) the merit-based incentive payment system under section 1848(q) of such Act (42 U.S.C. 1395w–4(q));
(B) incentive payments for participation in eligible alternative payment models under section 1833(z) of such Act (42 U.S.C. 1395l(z));
(C) the shared savings program under section 1899 of such Act (42 U.S.C. 1395jjj);
(D) models under section 1115A of such Act (42 U.S.C. 1315a); and
(E) such other payment systems or models as the Secretary may specify.
Section 1833(dd) of the Social Security Act (42 U.S.C. 1395l(dd)) is amended—
(1) in paragraph (1), by striking “and before January 1, 2030,”; and
(2) in paragraph (2), by striking subparagraph (C) and inserting the following:
“(C) for 2027 and each subsequent year, 100 percent.”.
(a) In general.— Section 1861 of the Social Security Act (42 U.S.C. 1395x) is amended—
(1) in subsection (s)(2)(V), by striking “in the case of” and all that follows through “organizations”; and
(2) in subsection (vv)—
(A) in paragraph (1)—
(i) by striking “disease management” and inserting “the prevention, management, or treatment of a disease or condition specified in paragraph (4)”; and
(ii) by striking “by a physician” and all that follows through the period at the end and inserting the following: “by a—
“(A) physician (as defined in subsection (r)(1));
(B) physician assistant;
(C) nurse practitioner;
(D) clinical nurse specialist (as defined in subsection (aa)(5)(B)); or
(E) in the case of such services furnished to manage such a disease or condition that is an eating disorder, a clinical psychologist (as defined by the Secretary).”; and
(B) by adding at the end the following new paragraph:
“(4) For purposes of paragraph (1), the diseases and conditions specified in this paragraph are the following:
(A) Diabetes and prediabetes.
(B) A renal disease.
(C) Obesity (as defined for purposes of subsection (yy)(2)(C) or as otherwise defined by the Secretary).
(D) Hypertension.
(E) Dyslipidemia.
(F) Malnutrition.
(G) Eating disorders.
(H) Cancer.
(I) Gastrointestinal diseases, including celiac disease.
(J) HIV.
(K) AIDS.
(L) Cardiovascular disease.
(M) Any other disease or condition—
(i) specified by the Secretary relating to unintentional weight loss;
(ii) for which the Secretary determines the services described in paragraph (1) to be medically necessary and appropriate for the prevention, management, or treatment of such disease or condition, consistent with any applicable recommendations of the United States Preventive Services Task Force; or
(iii) for which the Secretary determines the services described in paragraph (1) are medically necessary, consistent with either protocols established by registered dietitians or nutrition professional organizations or with accepted clinical guidelines identified by the Secretary.”.
(b) Exclusion modification.— Section 1862(a)(1) of the Social Security Act (42 U.S.C. 1395y(a)(1)), as amended by sections 7901C(b)(2) and 7901C–1(b)(4), is amended—
(1) in subparagraph (Q), by striking “and” at the end;
(2) in subparagraph (R), by striking the semicolon at the end and inserting “, and”; and
(3) by adding at the end the following new subparagraph:
“(S) in the case of medical nutrition therapy services (as defined in section 1861(vv)), which are not furnished for the prevention, management, or treatment of a disease or condition specified in paragraph (4) of such section;”.
(c) Effective date.— The amendments made by this section shall apply with respect to items and services furnished on or after January 1, 2027.
(a) Additional payment for disarm antimicrobial drugs under Medicare.—
(1) In general.— Section 1886(d)(5) of the Social Security Act (42 U.S.C. 1395ww(d)(5)) is amended by adding at the end the following new subparagraph:
“(N)
(i)
(I) Effective for discharges beginning on or after October 1, 2027, or such sooner date as specified by the Secretary, subject to subclause (II), the Secretary shall, after notice and opportunity for public comment (in the publications required by subsection (e)(5) for a fiscal year or otherwise), provide for an additional payment under a mechanism (separate from the mechanism established under subparagraph (K)), with respect to such discharges involving any DISARM antimicrobial drug, in an amount equal to—
(aa) the amount payable under section 1847A for such drug during the calendar quarter in which the discharge occurred; or
(bb) if no amount for such drug is determined under section 1847A, an amount to be determined by the Secretary in a manner similar to the manner in which payment amounts are determined under section 1847A based on information submitted by the manufacturer or sponsor of such drug (as required under clause (v)).
(II) In determining the amount payable under section 1847A for purposes of items (aa) and (bb) of subclause (I), subparagraphs (A) and (B) of subsection (b)(1) of such section shall be applied by substituting “102 percent” for “106 percent” each place it appears and paragraph (8)(B) of such section shall be applied by substituting “2 percent” for “6 percent”.
(ii) For purposes of this subparagraph, a DISARM antimicrobial drug is—
(I) a drug—
(aa) that—
(AA) is approved by the Food and Drug Administration;
(BB) is designated by the Food and Drug Administration as a qualified infectious disease product under subsection (d) of section 505E of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355f(d)); and
(CC) has received an extension of its exclusivity period pursuant to subsection (a) of such section; and
(bb) that has been designated by the Secretary pursuant to the process established under clause (iv)(I)(bb); or
(II) an antibacterial or antifungal biological product—
(aa) that is licensed for use, or an antibacterial or antifungal biological product for which an indication is first licensed for use, by the Food and Drug Administration on or after June 5, 2014, under section 351(a) of the Public Health Service Act for human use to treat serious or life-threatening infections, as determined by the Food and Drug Administration, including those caused by, or likely to be caused by—
(AA) an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens; or
(BB) a qualifying pathogen (as defined under section 505E(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355f(f))); and
(bb) has been designated by the Secretary pursuant to the process established under clause (iv)(I)(bb).
(iii) The mechanism established pursuant to clause (i) shall provide that the additional payment under clause (i) shall— For purposes of this clause, in the case of a similar reporting program described in item (aa), a subsection (d) hospital shall be treated as participating in such a program if the entity maintaining such program identifies to the Secretary such hospital as so participating.
(I) with respect to a discharge, only be made to a subsection (d) hospital that, as determined by the Secretary—
(aa) is participating in the National Healthcare Safety Network Antimicrobial Use and Resistance Module of the Centers for Disease Control and Prevention; and
(bb) has an antimicrobial stewardship program that aligns with the Core Elements of Hospital Antibiotic Stewardship Programs of the Centers for Disease Control and Prevention or the Antimicrobial Stewardship Standard set by the Joint Commission; and
(II) apply to discharges occurring on or after October 1 of the year in which the drug or biological product is designated by the Secretary as a DISARM antimicrobial drug.
(iv)
(I) The mechanism established pursuant to clause (i) shall provide for a process for—
(aa) a manufacturer or sponsor of a drug or biological product to request the Secretary to designate the drug or biological product as a DISARM antimicrobial drug; and
(bb) the designation (and removal of such designation) by the Secretary of drugs and biological products as DISARM antimicrobial drugs.
(II) A designation of a drug or biological product as a DISARM antimicrobial drug may be revoked by the Secretary if the Secretary determines that—
(aa) the drug or biological product no longer meets the requirements for a DISARM antimicrobial drug under clause (ii);
(bb) the request for such designation contained an untrue statement of material fact; or
(cc) clinical or other information that was not available to the Secretary at the time such designation was made shows that—
(AA) such drug or biological product is unsafe for use or not shown to be safe for use for individuals who are entitled to benefits under part A; or
(BB) an alternative to such drug or biological product is an advance that substantially improves the diagnosis or treatment of such individuals.
(III) Not later than October 1, 2026, the Secretary shall publish in the Federal Register a list of the DISARM antimicrobial drugs designated under this subparagraph pursuant to the process established under subclause (I)(bb). The Secretary shall annually update such list.
(v)
(I) For purposes of determining additional payment amounts under clause (i), a manufacturer or sponsor of a drug or biological product that submits a request described in clause (iv)(I)(aa) shall submit to the Secretary information described in section 1927(b)(3)(A)(iii).
(II) The penalties for failure to provide timely information under clause (i) of subparagraph (C) section 1927(b)(3) and for providing false information under clause (ii) of such subparagraph shall apply to manufacturers and sponsors of a drug or biological product under this section with respect to information under subclause (I) in the same manner as such penalties apply to manufacturers under such clauses with respect to information under subparagraph (A) of such section.
(vi)
(I) The mechanism established pursuant to clause (i) shall provide that—
(aa) except as provided in item (bb), no additional payment shall be made under this subparagraph for discharges involving a DISARM antimicrobial drug if any additional payments have been made for discharges involving such drug as a new medical service or technology under subparagraph (K);
(bb) additional payments may be made under this subparagraph for discharges involving a DISARM antimicrobial drug if any additional payments have been made for discharges occurring prior to the date of enactment of this subparagraph involving such drug as a new medical service or technology under subparagraph (K); and
(cc) no additional payment shall be made under subparagraph (K) for discharges involving a DISARM antimicrobial drug as a new medical service or technology if any additional payments for discharges involving such drug have been made under this subparagraph.
(2) Conforming amendment.— Section 1886(d)(5)(K)(ii)(III) of the Social Security Act (42 U.S.C. 1395ww(d)(5)(K)(ii)(III)) is amended by striking “provide” and inserting “subject to subparagraph (N)(vi), provide”.”.
(b) Authorization of appropriations for the centers for disease control and prevention.— There is authorized to be appropriated to the Centers for Disease Control and Prevention $500,000,000, to remain available until expended, to support the establishment and implementation of antimicrobial stewardship programs and data reporting capabilities to the Antimicrobial Use and Resistance option of the CDC National Healthcare Safety Network, especially in critical access hospitals, rural hospitals, and community hospitals, to support detection, surveillance, containment, and prevention of resistant pathogens in the United States and overseas.
(c) Study and reports on removing barriers to the development of disarm antimicrobial drugs.—
(1) Study.— The Comptroller General of the United States (in this subsection referred to as the “Comptroller General”), in consultation with the Director of the National Institutes of Health, the Commissioner of Food and Drugs, the Administrator of the Centers for Medicare & Medicaid Services, and the Director of the Centers for Disease Control and Prevention, shall conduct a study over a 5-year period of the barriers that prevent the development of DISARM antimicrobial drugs (as defined in section 1886(d)(5)(N)(ii) of the Social Security Act, as added by subsection (a)), including—
(A) patient outcomes in conjunction with the use of DISARM drugs, including—
(i) duration of stay in the intensive care unit;
(ii) recidivism within 30 days; and
(iii) measures of additional follow-up care;
(B) the effectiveness of antimicrobial stewardship and surveillance programs, including—
(i) changes in the percentage of hospitals in the United States with an antimicrobial stewardship program in place that aligns with the Core Elements of Hospital Antibiotic Stewardship Programs, as outlined by the Centers for Disease Control and Prevention;
(ii) changes in inpatient care of clostridioides difficile infection; and
(iii) changes in inpatient rates of resistance to key pathogens; and
(C) considerations relating to Medicare payment reform, including—
(i) changes in the number of qualified antimicrobial products approved;
(ii) changes in wholesale acquisition cost of individual qualified antimicrobial products over time;
(iii) changes in year-over-year volume of individual qualified antimicrobial products sold; and
(iv) the overall cost of qualified antimicrobial products to the Medicare program as a proportion of total Medicare part A spending.
(2) Report.— Not later than 5 years after the date of the enactment of this section, the Comptroller General shall submit to Congress a report containing the results of the study conducted under paragraph (1), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate.
(a) Authority To expand health care providers qualified To furnish intensive behavioral therapy.— Section 1861(ddd) of the Social Security Act (42 U.S.C. 1395x(ddd)) is amended by adding at the end the following new paragraph:
“(4)
(A) Subject to subparagraph (B), the Secretary may, in addition to qualified primary care physicians and other primary care practitioners, cover intensive behavioral therapy for obesity furnished by any of the following:
(i) A physician (as defined in subsection (r)(1)) who is not a qualified primary care physician.
(ii) Any other appropriate health care provider (including a physician assistant, nurse practitioner, or clinical nurse specialist (as those terms are defined in subsection (aa)(5)), a clinical psychologist, a registered dietitian or nutrition professional (as defined in subsection (vv))).
(iii) An evidence-based, community-based lifestyle counseling program approved by the Secretary.
(B) In the case of intensive behavioral therapy for obesity furnished by a provider described in clause (ii) or (iii) of subparagraph (A), the Secretary may only cover such therapy if such therapy is furnished—
(i) upon referral from, and in coordination with, a physician or primary care practitioner operating in a primary care setting or any other setting specified by the Secretary; and
(ii) in an office setting, a hospital outpatient department, a community-based site that complies with the Federal regulations concerning the privacy of individually identifiable health information promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996, or another setting specified by the Secretary.
(C) In order to ensure a collaborative effort, the coordination described in subparagraph (B)(i) shall include the health care provider or lifestyle counseling program communicating to the referring physician or primary care practitioner any recommendations or treatment plans made regarding the therapy.”.
(b) Medicare part d coverage of obesity medication.—
(1) In general.— Section 1860D–2(e)(2)(A) of the Social Security Act (42 U.S.C. 1395w–102(e)(2)(A)) is amended, in the first sentence—
(A) by striking “and other than” and inserting “other than”; and
(B) by inserting after “benzodiazepines),” the following: “and other than subparagraph (A) of such section if the drug is used for the treatment of obesity (as defined in section 1861(yy)(2)(C)) or for weight loss management for an individual who is overweight (as defined in section 1861(yy)(2)(F)(i)) and has 1 or more related comorbidities,”.
(2) Effective date.— The amendments made by paragraph (1) shall apply to plan years beginning on or after the date that is 2 years after the date of the enactment of this section.
(c) Report to congress.—
(1) In general.— Not later than the date that is 1 year after the date of the enactment of this section, and every 2 years thereafter, the Secretary of Health and Human Services shall submit a report to Congress describing the steps the Secretary has taken to implement the provisions of, and amendments made by, this section.
(2) Recommendations.— Such report shall also include recommendations for better coordination and leveraging of programs within the Department of Health and Human Services and other Federal agencies that relate in any way to supporting appropriate research and clinical care (such as any interactions between physicians and other health care providers and their patients) to treat, reduce, and prevent obesity in the adult population.
(a) Improving access for and outreach to underrepresented populations.—
(1) Expanding access to alzheimer’s research centers.—
(A) In general.— Section 445(a)(1) of the Public Health Service Act (42 U.S.C. 285e–2(a)(1)) is amended—
(i) by striking “(a)(1) The Director of the Institute may” and inserting the following:
“(a)
(1) The Director of the Institute—
(A) may;”.
(ii) by striking “disease.” and inserting “disease; and”; and
(iii) by adding at the end the following:
“(B) beginning January 1, 2027, shall enter into cooperative agreements and make grants to public or private nonprofit entities under this subsection for the planning, establishment, and operation of new such centers that are located in areas with a higher concentration of minority groups (as determined under section 444(d)(3)(D)), such as entities that are historically Black colleges and universities, Hispanic-serving institutions, Tribal colleges and universities, or centers of excellence for other minority populations.”.
(B) Use of funding for clinics to operate clinical trials.— Section 445(b) of the Public Health Service Act (42 U.S.C. 285e–2(b)) is amended by adding at the end the following:
“(3) Federal payments made under a cooperative agreement or grant under subsection (a) from funds made available under section 7901C–6(g) of the Health Equity and Accountability Act of 2026 shall, with respect to Alzheimer’s disease, be used in part to establish and operate diagnostic and treatment clinics designed—
(A) to meet the special needs of minority and rural populations and other underserved populations; and
(B) to operate clinical trials.”.
(2) Outreach.—
(A) Alzheimer’s disease centers.— Section 445(b) of the Public Health Service Act (42 U.S.C. 285e–2(b)), as amended by paragraph (1)(B), is amended by adding at the end the following:
“(4) Federal payments made under a cooperative agreement or grant under subsection (a) shall be used to establish engagement centers to carry out public outreach, education efforts, and dissemination of information for members of minority groups about clinical trial participation. Activities funded pursuant to the preceding sentence shall include—
(A) using established mechanisms to encourage members of minority groups to participate in clinical trials on Alzheimer’s disease;
(B) expanding education efforts to make members of minority groups aware of ongoing clinical trials;
(C) working with trial sponsors to increase the number of recruitment events for members of minority groups;
(D) conducting outreach to national, State, and local physician professional organizations, especially for members of such organizations who are primary care physicians or physicians who specialize in dementia, to increase awareness of clinical research opportunities for members of minority groups; and
(E) using community-based participatory research methodologies to engage with minority populations.”.
(B) Resource centers for minority aging research.— Section 444(c) of the Public Health Service Act (42 U.S.C. 285e–1(c)) is amended—
(i) by striking “(c) The Director” and inserting “(c)(1) The Director”; and
(ii) by adding at the end the following new paragraph:
“(2) The Director of the Institute, acting through the Resource Centers for Minority Aging Research of the Institute, shall carry out public outreach, education efforts, and dissemination of information for members of minority groups about participation in clinical research on Alzheimer’s disease carried out or supported under this subpart.”.
(b) Incentives To increase diversity in alzheimer’s disease research through principal investigators and researchers from underrepresented populations.—
(1) Alzheimer’s clinical research and training awards.— Section 445I of the Public Health Service Act (42 U.S.C. 285e–10a) is amended by adding at the end the following:
“(d) Enhancing the participation of principal investigators and researchers who are members of underrepresented populations.—
(1) In general.— The Director of the Institute shall enhance diversity in the conduct or support of clinical research on Alzheimer’s disease under this subpart by encouraging the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral, and social sciences as principal investigators of such clinical research, as researchers for such clinical research, or both.
(2) Training for principal investigators.— The Director of the Institute shall provide training for principal investigators who are members of a minority group with respect to skills for—
(A) the design and conduct of clinical research and clinical protocols;
(B) applying for grants for clinical research; and
(C) such other areas as the Director of the Institute determines to be appropriate.”.
(2) Senior researcher awards.— Section 445B(a) of the Public Health Service Act (42 U.S.C. 285e–4(a)) is amended by inserting “, including senior researchers who are members of a minority group” before the period at the end of the first sentence.
(c) Incentives To increase diversity in alzheimer’s disease research through trial sites.— Section 444(d) of the Public Health Service Act (42 U.S.C. 285e–1(d)) is amended—
(1) by striking “(d) The Director” and inserting “(d)(1) The Director”; and
(2) by adding at the end the following:
“(2) In conducting or supporting clinical research on Alzheimer’s disease for purposes of this subpart, in addition to requirements otherwise imposed under this title, including under section 492B, the Director of the Institute shall increase the participation of members of minority groups in such clinical research through one or more of the activities described in paragraph (3).
(3)
(A) The Director of the Institute shall provide incentives for the support of clinical research on Alzheimer’s disease with clinical trial sites established in areas with a higher concentration of minority groups, including rural areas if practicable.
(B) In determining whether to conduct or support clinical research on Alzheimer’s disease, the Director of the Institute shall encourage the conduct of clinical research with clinical trial sites in areas described in subparagraph (A) as a higher-level priority criterion among the criteria established to evaluate whether to conduct or support clinical research.
(C) In determining the amount of funding to be provided for the conduct or support of such clinical research, the Director of the Institute shall provide additional funding for the conduct of such clinical research with clinical trial sites in areas described in subparagraph (A).
(D) In determining whether an area is an area with a higher concentration of minority groups, the Director of the Institute—
(i) shall consider the most recent data collected by the Bureau of the Census; and
(ii) may also consider—
(I) data from the Centers for Medicare & Medicaid Services on the incidence of Alzheimer’s disease in the United States by region; and
(II) such other data as the Director determines appropriate.
(4) In order to facilitate the participation of members of minority groups in clinical research supported under this subpart, in addition to activities described in paragraph (3), the Director of the Institute shall—
(A) ensure that such clinical research uses community-based participatory research methodologies; and
(B) encourage the use of remote health technologies, including telehealth, remote patient monitoring, and mobile technologies, that reduce or eliminate barriers to participation of members of minority groups in such clinical research.
(5)
(A) Clinical research on Alzheimer’s disease conducted or supported under this subpart shall ensure that such research includes outreach activities designed to increase the participation of members of minority groups in such research.
(B)
(i) Each applicant for a grant under this subpart for clinical research on Alzheimer’s disease shall submit to the Director of the Institute in the application for such grant—
(I) a budget for outreach activities to members of minority populations with respect to participation in such clinical research; and
(II) a description of the plan to conduct such outreach.
(ii) The Director of the Institute shall encourage applicants for, and recipients of, grants under this subpart to conduct clinical research on Alzheimer’s disease to engage with community-based organizations to increase participation of minority populations in such research.
(6) For purposes of this subpart:
(A) The term clinical research includes a clinical trial.
(B) The term minority group has the meaning given such term under section 492B(g).”.
(d) Participant eligibility criteria.— Section 445I of the Public Health Service Act (42 U.S.C. 285e–10a), as amended by subsection (b)(1), is amended by adding at the end the following:
“(e) Participant eligibility criteria.— The Director of the Institute shall take such actions as are necessary to ensure that clinical research on Alzheimer’s disease conducted or supported under this subpart is designed with eligibility criteria that ensure the clinical trial population reflects the diversity of the prospective patient population. Such actions may include the following:
(1) Examination of criteria.—
(A) In general.— An examination of each exclusion criterion to determine if the criterion is necessary to ensure the safety of trial participants or to achieve the study objectives.
(B) Modification of criteria.— In the case of an exclusion criterion that is not necessary to ensure the safety of trial participants or to achieve the study objectives—
(i) encouraging the modification or elimination of the criterion; or
(ii) encouraging tailoring the criterion as narrowly as possible to avoid unnecessary limits to the population of the clinical study.
(2) Requirement for strong justification for exclusion.— A review of each exclusion criterion to ensure that populations are included in clinical trials, such as older adults, individuals with a mild form of disease, individuals at the extremes of the weight range, or children, unless there is a strong clinical or scientific justification to exclude them.
(3) Use of adaptive design.— Encouraging the use of an adaptive clinical trial design that—
(A) starts with a defined population where there are concerns about safety; and
(B) may expand to a broader population based on initial data from the trial and external data.”.
(e) Resource center for successful strategies To increase participation of underrepresented populations in alzheimer’s disease clinical research.— Section 444 of the Public Health Service Act (42 U.S.C. 285e–1) is amended by adding at the end the following:
“(e)
(1) The Director of the Institute, acting through the Office of Special Populations and in consultation with the Division of Extramural Activities, shall support resource information and technical assistance to grantees under section 445 (relating to Alzheimer’s disease centers), other grantees, and prospective grantees, designed to increase the participation of minority populations in clinical research on Alzheimer’s disease conducted or supported under this subpart.
(2) The resource information and technical assistance provided under paragraph (1) shall include the maintenance of a central resource library in order to collect, prepare, analyze, and disseminate information relating to strategies and best practices used by recipients of grants under this subpart and other researchers in the development of the clinical research designed to increase the participation of minority populations in such clinical research.”.
(f) Annual reports.— Section 444 of the Public Health Service Act (42 U.S.C. 285e–1), as amended by subsection (e), is amended by adding at the end the following:
“(f)
(1)
(A) The Director of the Institute shall submit annual reports to the Congress on the impact of the amendments made to this subpart by the Health Equity and Accountability Act of 2026.
(B) The Secretary shall transmit a copy of each such report to the Advisory Council on Alzheimer’s Research, Care, and Services established under section 2(e) of the National Alzheimer’s Project Act.
(2) In each report under paragraph (1), the Director of the Institute shall include information and data on the following matters with respect to clinical trials on Alzheimer’s disease conducted during the preceding year:
(A) The number of participants who are members of a minority group in such clinical trials.
(B) The number of such clinical trials for which incentives under subsection (d)(3) were made available, the nature of such incentives, the amount of increased funding (if any) made available for research on Alzheimer’s disease, and the training provided to principal investigators who are members of a minority group and the amount of funding (if any) for such training.
(C) The number of such clinical trials for which the principal investigator is a member of a minority group.
(D) The number of such clinical trials for which a significant percentage of researchers are members of a minority group.
(E) Modifications to patient eligibility criteria in clinical trial designs under section 445I(e).
(F) Outreach and education efforts conducted under section 445(b)(4).
(3) The Director of the Institute shall make each report under paragraph (1) available to the public, including through posting on the appropriate website of the Department of Health and Human Services.”.
(g) Authorization of appropriations.— For each of fiscal years 2027 through 2031, there is authorized to be appropriated to the Secretary of Health and Human Services $60,000,000 to carry out the amendments made by this section, to remain available until expended.
(a) NCI review on current state of stomach cancer incidence, prevention, screening, awareness, and future public health importance.—
(1) Review.— The Director of the National Cancer Institute shall conduct a review of—
(A) the current incidence of stomach cancer in the United States;
(B) the risk factors for stomach cancer, including the incidence of such risk factors among high-risk populations and the general public;
(C) the optimal age range to test for and treat Helicobacter pylori (H. pylori) infection, as a risk factor, for the purpose of primary prevention in high-risk populations and the general population;
(D) the availability and frequency of screening for stomach cancer, including utilization and effectiveness, among high-risk populations;
(E) the availability and effectiveness of endoscopic screenings in high-risk populations;
(F) the availability and effectiveness of endoscopic resection and surveillance endoscopy for patients with confirmed gastric intestinal metaplasia (GIM) with high-grade dysplasia and early gastric cancer;
(G) the benefits of surveillance endoscopy for patients at elevated risk, including patients with gastric intestinal metaplasia (GIM) who are at increased risk of gastric cancer due to ethnic background, family history, or other risk stratification parameters such as smoking and H. pylori infection;
(H) current awareness and education about stomach cancer risk factors, prevention, symptoms, screening, and treatment options among high-risk populations and the general public; and
(I) current Federal efforts to increase awareness and education of stomach cancer among high-risk populations and the general public.
(2) Report.— Not later than 18 months after the date of enactment of this Act, the Director of the National Cancer Institute shall—
(A) submit to the Congress a report on the results of the review under paragraph (1); and
(B) include in such report recommendations for—
(i) establishing a clear definition of high-risk populations in the United States;
(ii) informing researchers, clinicians, physicians, patients, and other relevant stakeholders on—
(I) identifying high-risk individuals; and
(II) effective methods for detecting precancerous lesions and early gastric cancer;
(iii) establishing routine screening guidelines for stomach cancer; and
(iv) actions to improve research on, prevention and early diagnosis of, and screening and treatment for stomach cancer.
(b) Department of Defense study on stomach cancer incidence and risk factors among military personnel.—
(1) Study.— The Secretary of Defense, in coordination with the Director of the National Cancer Institute and the Director of the Centers for Disease Control and Prevention, shall conduct a study on the incidence, risk factors, prevention, and early detection of stomach cancer among members of the Armed Forces and former members of the Armed Forces.
(2) Elements.— The study under paragraph (1) shall include—
(A) an examination of—
(i) the incidence, prevalence, and mortality rates of stomach cancer among members of the Armed Forces serving on active duty and former members of the Armed Forces who served on active duty;
(ii) the identification of service-related or deployment-related risk factors, including exposure to burn pits, hazardous chemicals, contaminated water, occupational hazards, and endemic infections such as Helicobacter pylori (H. pylori);
(iii) disparities in stomach cancer outcomes based on race, ethnicity, gender, Armed Force, or geographic deployment history within military populations;
(iv) the availability and use of stomach cancer screening, diagnostic, and treatment services within the military health system and the health system of the Department of Veterans Affairs; and
(v) opportunities to improve prevention and early detection strategies within the military health system and the health system of the Department of Veterans Affairs; and
(B) relevant coordination with the Surveillance, Epidemiology, and End Results Program and other national cancer registries to ensure comprehensive data collection and analysis.
(3) Report.— Not later than 18 months after the date of the enactment of this Act, the Secretary of Defense shall submit to Congress a report on the findings of the study under paragraph (1), including—
(A) policy and programmatic recommendations to reduce stomach cancer incidence and mortality among members of the Armed Forces and former members of the Armed Forces; and
(B) proposed strategies for integrating stomach cancer awareness, screening, and treatment protocols into the military health system and the health system of the Department of Veterans Affairs.
This subtitle may be cited as the “Health Equity and Rare Disease Act” or the “HEARD Act”.
Part B of title IV of the Public Health Service Act (42 U.S.C. 284 et seq.) is amended by adding at the end the following:
“409K. Rare diseases health equity.—
(a) Expansion, intensification, and coordination of activities.—
(1) In general.— The Director of NIH shall expand, intensify, and coordinate research and other activities of the National Institutes of Health with respect to rare diseases health equity.
(2) Allocations by Director of NIH.— With respect to amounts appropriated to carry out this section for a fiscal year, the Director of NIH shall allocate the amounts among the national research institutes that are carrying out paragraph (1).
(b) Coordinating Committee.—
(1) In general.— The Secretary shall maintain a coordinating committee with respect to rare diseases health equity (referred to in this section as the “Coordinating Committee”) to coordinate activities across the National Institutes and with other Federal health programs and activities relating to rare diseases health equity.
(2) Composition.— The Coordinating Committee shall be composed of—
(A) the directors (or their designees) of each of the national research institutes involved in research with respect to rare diseases and minority health or health equity; and
(B) representatives of all other Federal departments and agencies whose programs involve health functions or responsibilities relevant to such rare diseases, including the Centers for Disease Control and Prevention and the Food and Drug Administration.
(3) Chair.—
(A) In general.— With respect to rare diseases health equity, the Chair of the Coordinating Committee shall serve as the principal advisor to the Secretary, the Assistant Secretary for Health, and the Director of NIH, and shall provide advice to the Director of the Centers for Disease Control and Prevention, the Commissioner of Food and Drugs, and other relevant agencies.
(B) Director of NIH.— The Chair of the Coordinating Committee shall be directly responsible to the Director of NIH.
(c) Plan for NIH Activities.—
(1) In general.— Not later than 1 year after the date of the enactment of this section, the Coordinating Committee shall develop a plan for conducting and supporting research and education on rare diseases health equity, and rare diseases or conditions in minority populations, through the national research institutes. The Coordinating Committee shall periodically review and revise the plan. The plan shall—
(A) provide for a broad range of research and education activities relating to biomedical, psychosocial, and rehabilitative issues, including studies of the disproportionate impact of such diseases or conditions on minority populations;
(B) identify priorities among the programs and activities of the National Institutes of Health regarding such diseases or conditions; and
(C) reflect input from a broad range of scientists, patients, and advocacy groups.
(2) Certain elements of plan.— The plan under paragraph (1) shall, with respect to rare diseases or conditions in minority populations, provide for the following as appropriate:
(A) Research to determine the reasons underlying the incidence and prevalence of the diseases or conditions, including among subpopulations.
(B) Basic research concerning the etiology and causes of the diseases or conditions.
(C) Epidemiological studies to address the frequency and natural history of the diseases or conditions, including any differences among the sexes and among racial and ethnic groups.
(D) The development of improved screening techniques.
(E) Clinical research for the development and evaluation of new treatments, including new biological agents.
(F) Information and education programs for health care professionals and the public.
(3) Implementation of plan.— The Director of NIH shall ensure that programs and activities of the National Institutes of Health regarding rare diseases or conditions in minority populations are implemented in accordance with the plan under paragraph (1).
(d) Definitions.— In this section:
(1) The term minority has the meaning given such term in section 464z–3.
(2) The term rare disease or condition has the meaning given such term in section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb).”.
Subpart 20 of part C of title IV of the Public Health Service Act (42 U.S.C. 285t et seq.) is amended by adding at the end the following:
“464z–7. Collaborative comprehensive plan to address rare diseases and conditions in minority populations.— Not later than 180 days after the date of enactment of this section, the Director of NIH, the Director of the Institute, the Director of the National Center for Advancing Translational Sciences, the Director of the National Heart, Lung, and Blood Institute, and the directors of the other agencies of the National Institutes of Health in collaboration (and in consultation with the advisory council for the Institute) shall—
(1) develop a comprehensive Federal plan to address rare diseases and conditions in minority populations (as those terms are defined in section 409K), including a strategy to increase diversity in genetic programs at the program for Therapeutics for Rare and Neglected Diseases at the National Institutes of Health;
(2) conduct or support through grants or cooperative agreements basic, clinical, and translational research on rare diseases and conditions in minority populations, including research on—
(A) early detection, diagnosis, and treatment of such diseases and conditions in such populations; and
(B) improving the quality of life for individuals with rare diseases or conditions and their families;
(3) conduct or support clinical training programs for physicians and other health care practitioners with respect to detecting, diagnosing, and treating such diseases and conditions in such populations; and
(4) develop guidance for increasing participation of health professionals who are members of minority groups (as defined in section 464z–3) in research conducted or supported by the National Institutes of Health on such diseases and conditions in such populations.”.
Section 1707(b) of the Public Health Service Act (42 U.S.C. 300u–6(b)) is amended by adding at the end the following:
“(11) In coordination with the Director of the Centers for Disease Control and Prevention, award grants to public and private nonprofit entities to—
(A) collect, analyze, and report data on rare diseases and conditions in minority populations, including on epidemiological data with respect to incidence of such diseases and conditions in such populations;
(B) conduct outreach and engagement activities with the minority populations impacted by such rare diseases and conditions by—
(i) improving health literacy with respect to rare diseases and conditions;
(ii) disseminating information on health and community services related to rare diseases and conditions; and
(iii) providing information regarding the maintenance of rare diseases and conditions.
(12) Submit to Congress, on a biannual basis (beginning not later than 2 years after the date of the enactment of the HEARD Act), a report describing the activities carried out pursuant to paragraph (11).”.
Subpart II of part C of title VII of the Public Health Service Act (42 U.S.C. 293m et seq.), as amended by section 3016, is further amended by adding at the end the following:
“749D. Physician training programs with respect to rare diseases.—
(a) In general.— The Secretary shall establish a program to award grants to accredited schools of allopathic medicine, osteopathic medicine, and nursing, and other health professional training programs for the training of health care professionals—
(1) to improve the provision of care to individuals who have rare diseases or conditions (as defined in section 526 of the Federal Food, Drug, and Cosmetic Act);
(2) to improve the provision of care to such individuals via telehealth; and
(3) to conduct research relevant to rare diseases and conditions.
(b) Eligibility.— To be eligible for a grant under subsection (a), an entity described in such subsection shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require.
(c) Reporting requirements.—
(1) Periodic reports.— Each entity awarded a grant under this section shall periodically submit to the Secretary a report on the status of activities conducted using the grant, including a description of the impact of such training on patient outcomes, as applicable.
(2) Report to Congress.— Not later than 2 years after the date of enactment of this section, the Secretary shall submit a report to Congress on the activities conducted using grants under subsection (a) and any best practices identified and disseminated under subsection (d).
(d) Best practices.— The Secretary may identify and disseminate best practices for the training described in subsection (a).
749E. Health professionals education on rare diseases and conditions in minority populations.—
(a) In general.— The Secretary may award grants, cooperative agreements, and contracts to accredited schools of medicine and nursing, and other health professional training programs, for the development and implementation of programs to provide education and training to health care professionals on the causes and effects of rare diseases and conditions in minority populations.
(b) Definitions.— In this section:
(1) The term minority has the meaning given such term in section 464z–3.
(2) The term rare disease or condition has the meaning given such term in section 526 of the Federal Food, Drug, and Cosmetic Act.
749F. Mentoring program for health care professionals seeking to work in rare diseases and conditions.— The Secretary, acting through the Administrator of the Health Resources and Services Administration, may award grants, contracts, or cooperative agreements to public and nonprofit private entities (including Tribal entities) for the establishment of a mentoring program for health care professionals seeking to treat patients with rare diseases and conditions.
749G. Scholarship and loan repayment program for physicians and genetic counselors serving populations with rare diseases and conditions.—
(a) Loan repayment program.—
(1) In general.— The Secretary shall establish a program of entering into contracts with eligible individuals under which the individuals agree to serve as health care professionals serving populations with rare diseases or conditions in consideration of the Federal Government agreeing to pay, for each year of such service, up to $50,000 (plus an amount determined by the Secretary on an annual basis to reflect inflation) of the principal and interest of the educational loans of such individuals.
(2) Determination of amount.— In making a determination of the amount to pay for a year of such service by an individual, the Secretary shall consider the extent to which each such determination—
(A) affects the ability of the Secretary to maximize the number of contracts that can be provided under the program from the amounts appropriated for such contracts;
(B) provides an incentive to serve as health care professionals serving populations with rare diseases or conditions; and
(C) provides an incentive with respect to the health professional involved to remain serving populations with rare diseases or conditions, including after the completion of the period of obligated service under the program.
(3) Eligible individuals.— In this subsection, the term eligible individual means an individual who is enrolled or accepted for enrollment as a full-time or part-time student in a school of medicine.
(4) Applicability of certain provisions.— With respect to the National Health Service Corps Loan Repayment Program established in subpart III of part D of title III of this Act, the provisions of such subpart shall, except as inconsistent with paragraph (1), apply to the program established in this section in the same manner and to the same extent as such provisions apply to the National Health Service Corps Loan Repayment Program.
(b) Scholarship program.—
(1) In general.— The Secretary shall carry out a program of entering into contracts with eligible individuals under which each such individual agrees to serve, for a period of not less than 5 years, as a health care professional primarily serving populations with rare diseases or conditions, in consideration of the Federal Government agreeing to provide to the individual a scholarship for attendance at a school of medicine.
(2) Eligible individuals.— In this subsection, the term eligible individual means an individual who is enrolled or accepted for enrollment as a full-time or part-time student in a school of medicine.
(3) Applicability of certain provisions.— The provisions of subpart III of part D of title III shall, except as inconsistent with this section, apply to the program established in paragraph (1) in the same manner and to the same extent as such provisions apply to the National Health Service Corps Scholarship Program established in such subpart.”.
Part G of title IV of the Public Health Service Act (42 U.S.C. 288 et seq.) is amended by adding at the end the following:
“487E. Increasing minority representation in research on rare diseases and conditions.—
(a) Grant program.— In carrying out section 487, the Secretary may award grants to eligible entities involved in research on rare diseases and minority health to establish programs to increase the recruitment and retention of members of minority groups to conduct research in matters relating to the cause, diagnosis, prevention, and treatment of rare diseases or conditions, including by expanding the number of internships and mentoring opportunities.
(b) Eligible entities.— In subsection (a), the term eligible entities means accredited schools of allopathic medicine, osteopathic medicine, and nursing, and other health professional training programs.”.
Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health and in consultation with the Director of the Centers for Disease Control and Prevention, shall submit to Congress—
(1) a report on research and public health activities carried out by the Federal Government with respect to rare diseases or conditions in minority populations (as those terms are defined in section 409K of the Public Health Service Act, as added by section 7901D–1 of this Act);
(2) a comprehensive list of known rare diseases and conditions that impact minority populations heavily or disproportionately; and
(3) an analysis of data gaps with respect to rare diseases and conditions and the effect of such diseases and conditions on minority populations.
Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.) is amended by inserting after section 317Y of such Act, as added by section 7502, the following:
“317Z. Research and awareness campaigns with respect to rare diseases and conditions in minority populations.—
(a) Research.— The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall conduct or support research and carry out public health awareness campaigns with respect to rare diseases and conditions in minority populations (as defined in section 409K).
(b) Awareness campaign.— The Secretary shall, directly or through grants or contracts, establish a public education program in cooperation with existing national public awareness campaigns to increase awareness about rare diseases and conditions in minority populations through culturally and linguistically appropriate information campaigns about prevention and management of rare diseases and conditions.”.
Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall—
(1) conduct a survey of policies and programs of the Food and Drug Administration to support an increase the availability of clinical trial data on minority populations, with an emphasis on minority populations with rare diseases and conditions; and
(2) submit to Congress a report containing—
(A) the findings of such survey;
(B) the Secretary’s recommendations for statutory or regulatory changes to increase the availability of such data;
(C) the Secretary’s recommendations for strategies to encourage drug manufacturers to address racial equity and inclusion in research and development of treatments of rare diseases or conditions that disproportionately impact minority populations; and
(D) the Secretary's recommendations for strategies to address research and development of treatments of rare diseases or conditions that disproportionately impact minority populations.
Title II of the Indian Health Care Improvement Act (25 U.S.C. 1621 et seq.) is amended by adding at the end the following:
“227. Tribal epidemiology center grant program.—
(a) In general.— The Secretary, acting through the Service, shall award grants to Tribal Epidemiology Centers and Tribal and Urban Indian Health Centers to support clinically and culturally appropriate research and other activities with respect to rare diseases and conditions in Native American or Tribal communities.
(b) Permissible activities.— The activities funded through a grant under subsection (a) may include coordination of data collection on the prevention, diagnosis, treatment, and care of rare diseases and conditions by health care professionals serving American Indian and Alaska Native populations.”.
Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Service shall conduct a review of and submit to Congress a report on the following: Such report shall include any recommendations determined appropriate by the Secretary based on such review.
(1) Regulatory barriers under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) that inhibit access to the treatment of rare diseases for Medicare beneficiaries of color, including barriers that inhibit health care providers from improving care related to such diseases for such beneficiaries.
(2) Requirements relating to the furnishing of telehealth services under such title insofar as such services relate to the treatment of rare diseases.
Each employer shall—
(1) furnish employment and a place of employment free from conditions that may reasonably be anticipated to cause death or serious physical harm from heat stress; and
(2) comply with standards, regulations, rules, and orders promulgated under this subtitle.
(a) Design of standards.—
(1) In general.— The Secretary shall promulgate a worker heat protection standard that, in accordance with the best available evidence, establishes the maximum protective program of measures an employer shall implement to regulate employees’ exposure to heat stress and prevent heat-related illness and injury that attains the highest degree of health and safety protection to the extent feasible.
(2) Considerations.—
(A) Demonstrably achievable measures.— The Secretary may presume that any requirement substantially equivalent to a requirement adopted by a State plan approved by the Occupational Safety and Health Administration pursuant to section 18(c) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 667(c)) and that has been in effect for at least 1 year is feasible.
(B) Prioritizing worker protection.— In weighing any considerations during rulemaking, the Secretary shall place preeminent value on assuring employees a safe and healthful working environment.
(C) Available expertise.— If the Secretary adopts any finding or recommendation by the Institute, the American Conference of Governmental Industrial Hygienists, or the National Academies of Sciences, Engineering, and Medicine relevant to heat stress in a rulemaking pursuant to this subtitle, such finding or recommendation shall be considered the best available evidence.
(D) Employer categories.— The Secretary may, in any rulemaking analysis or design of standards, cluster relevant employers in any categories such as standard industry or occupational classifications or any common or related features of heat sources, conditions of employment, employer practices, employee characteristics, or nature of place of employment that, in the Secretary’s reasonable determination, are useful for designing an effective and practicable program of standards, regulations, and enforcement that maximizes the health and safety of employees.
(3) Protective programs.—
(A) In general.— In addition to measures specified by this subtitle, the Secretary may develop a worker heat protection standard with such additional requirements that, in the Secretary’s reasonable judgment, are necessary or appropriate to achieve the purposes of this subtitle. Such measures may include the following:
(i) Engineering controls.— Requirements to eliminate hazardous levels of heat stress through engineering controls, such as isolation or shielding of employees from sources of heat, exhaust ventilation, insulation of hot surfaces, or climate-control technologies, as well as technology-based standards that encourage the development of such controls.
(ii) Administrative controls.— Requirements to limit exposure to hazardous levels of heat stress by adjustment of work procedures, work schedules, or other work practices.
(iii) Personal protective equipment.— Requirements to provide, at the employer’s expense, personal protective equipment such as water-cooled garments, air-cooled garments, heat-reflective clothing, and cooling vests.
(iv) Health-related protocols.— Requirements to conduct medical symptom monitoring, emergency response protocols, medical removal protection, or training of employees and supervisors in recognition of symptoms of heat-related illness and appropriate responses.
(v) Training requirements.— Requirements to train employees and supervisors in topics reasonable or necessary to achieve the implementation of the requirements of a standard or the purposes of this subtitle, including—
(I) training of employees in signs and symptoms of heat-related illness, emergency response procedures, and their rights under this subtitle; and
(II) training of supervisors in monitoring heat conditions and environmental forecasts, recognizing signs of heat-related illness, and protocols for responding to likely heat-related illness.
(vi) Planning requirements.— Requirements for a heat illness and injury prevention plan that—
(I) is of sufficient quality to effectuate the purposes of this subtitle and to effectuate the requirements of the standard that apply to the employer;
(II) is developed, updated, and implemented with the meaningful participation of the employer’s employees and, where applicable, such employees’ representatives, for all aspects of the plan;
(III) is produced and maintained in writing and updated in light of changing conditions or practices; and
(IV) is made available, upon request, to any employee, the employee’s representative, and the Secretary.
(vii) Standard health and safety measures.— Any measures described in section 6(B)(7) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 655(B)(7)).
(B) Innovative solutions.— As the relevant scientific evidence develops, technological solutions improve, and environmental conditions or new work practices aggravate the risk of heat-related illness or injury, the Secretary may modify, supplement, or revise a worker heat protection standard by rule in order to improve such standard in light of such changes, even if it departs from long-standing past practice, provided that the resulting standard is consistent with this subtitle.
(C) Core practices.— The Secretary shall establish criteria under which an employer who exposes or may reasonably be anticipated to expose an employee to heat or heat stress that is not reduced below hazardous levels by engineering controls or personal protective equipment shall implement a reasonable program that includes—
(i) suitably cool potable water or appropriate hydration, provided at employer expense;
(ii) periodic paid rest breaks scheduled to reduce heat stress below hazardous levels;
(iii) access to shade or suitable cool-down spaces;
(iv) acclimatization policies; and
(v) such measures that are necessary or appropriate to ensure effective implementation of the requirements of this subparagraph.
(4) Other specifications.—
(A) Protection of pay.— The Secretary shall require that, for any required duration such as rest breaks, medical removal protection, and training, an employee shall receive compensation at the regular rate at which such employee is employed.
(B) Language access.— Any required training, poster, label, hazard alert, or written plan shall be provided in English and a language understood by the employees, if such is not English, and prepared appropriately for the vocabulary, educational level, and literacy of the employees.
(C) Temporary labor camps.— The Secretary shall revise the Secretary’s standard for temporary labor camps to the extent necessary to achieve the purposes of this subtitle.
(5) Maintaining protection.— No worker heat protection standard promulgated under this subtitle may reduce the protection afforded employees by an existing worker heat protection standard.
(b) Initial standards.— Not later than 1 year after the date of enactment of this Act, the Secretary shall promulgate, without regard to the requirements of chapters 5 and 6 of title 5, United States Code, subchapter I of chapter 35 of title 44, United States Code (commonly known as the “Paperwork Reduction Act”), or the National Environmental Policy Act of 1969 (42 U.S.C. 431 et seq.), an interim final rule establishing a worker heat protection standard and related recordkeeping and reporting requirements. Such rule shall take effect upon issuance (except that it may include a reasonable delay in the effective date), shall have the legal effect of an occupational safety and health standard as defined by section 3(8) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 652(8)), and shall remain in effect until superseded by a final rule promulgated pursuant to this subtitle.
(c) Rulemaking procedures.— For any rulemaking pursuant to this subtitle after publication of the interim final rule in subsection (b), the following procedures shall apply:
(1) In general.— The Secretary shall, upon a showing by a petitioner pursuant to paragraph (2) or the Secretary’s own determination that a worker heat protection standard is necessary or appropriate to regulate employees’ exposure to conditions known to cause or that may reasonably be anticipated to cause heat-related illness or injury, promulgate any worker heat protection standard in accordance with the policies set forth in this section and in accordance with section 553 of title 5, United States Code (without regard to any reference in such section to sections 556 and 557 of such title).
(2) Petitions for rulemaking.— Any person may petition the Secretary to promulgate or modify a worker heat protection standard. Not later than 18 months after receipt of a petition, the Secretary shall either grant or deny the petition by publishing a written explanation of the reasons for the Secretary’s decision. The Secretary may not deny a petition solely on the basis of inadequate resources or insufficient time for review.
(3) Timelines.— Except as otherwise provided in subsection (b), the Secretary shall observe the following schedule for rulemaking:
(A) Proposed standards.— Not later than one year after granting a petition for rulemaking under paragraph (2), the Secretary shall publish a proposed worker heat protection standard consistent with this section.
(B) Final standards.— The Secretary shall promulgate, not later than one year after such publication, such standards with such modifications as the Secretary determines appropriate.
(C) Effect.— Standards or revisions thereof shall become effective upon promulgation, except that the Secretary may include a reasonable delay in the effective date.
(4) Transparency in rulemaking.— For any rulemaking notice pursuant to this subtitle, the Secretary shall place in the public record not later than the date of such rulemaking notice the following:
(A) The drafts of such rulemakings prepared before publication and submitted by the Secretary to the Office of Management and Budget for any interagency review process prior to publication, all documents accompanying such drafts, all written comments thereon by other agencies, and all written responses to such written comments by the Secretary.
(B) A summary of the substance of any changes between the text of the draft rulemaking that the agency provided to the Office of Management and Budget under section 6(a)(3)(B)(i) of Executive Order 12866 (58 Fed. Reg. 51735; relating to regulatory planning and review) and the text published in the Federal Register, excluding any non-substantive changes such as spelling or grammatical corrections or re-ordering of text that has no legal effect.
(C) A statement identifying any party or entity at whose request any such change was made.
(5) Judicial review.—
(A) Filing of petition.— A petition for review in accordance with section 702 of title 5, United States Code, of action of the Secretary in promulgating any worker heat protection standard or any other nationally applicable regulation or final action taken by the Secretary pursuant to this subtitle may be filed only in the United States Court of Appeals for the District of Columbia. The filing of a petition for review shall not postpone the effectiveness of such rule or action.
(B) Timely filing.— Any petition for review under this paragraph shall be filed not later than sixty days after the date notice of such promulgation, approval, or action appears in the Federal Register.
(C) Not subject to review.— Action of the Secretary with respect to which review could have been obtained under this paragraph shall not be subject to judicial review in civil or criminal proceedings for enforcement. Failure to promulgate any standard pursuant to the schedule established by this section shall be subject to review.
(a) In general.— Except as otherwise provided by this section—
(1) a worker heat protection standard shall have the same legal effect as an occupational safety and health standard as defined by section 3(8) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 652(8)); and
(2) any rule, regulation, or order promulgated pursuant to this subtitle shall have the same legal effect as a rule, regulation, or order promulgated pursuant to the Occupational Safety and Health Act of 1970 (29 U.S.C. 651 et seq.).
(b) Enforcement.—
(1) Statute of limitations for citation.— No citation for any violation of section 7901E or any standard, rule, regulation, or order pursuant to this subtitle may be issued under this section later than 4 years after the occurrence of any violation.
(2) Review.— The Commission shall grant substantial deference to any reasonable interpretation by the Secretary of this subtitle or any standard, regulation, or order pursuant to this subtitle.
(c) Recordkeeping and reporting.—
(1) In general.— With regard to recordkeeping and reporting, the Secretary and Secretary of Health and Human Services shall have the same authority to prescribe regulations related to this subtitle as under section 8 of the Occupational Safety and Health Act (29 U.S.C. 657).
(2) Consolidating requirements.— The Secretary may incorporate recordkeeping and reporting requirements under this section into existing recordkeeping and reporting requirements promulgated pursuant to section 8 of the Occupational Safety and Health Act (29 U.S.C. 657), provided that a violation of such a requirement with regard to implementation of this subtitle shall be enforced as a distinct violation separate and apart from any other simultaneous violation of a requirement pursuant to the Occupational Safety and Health Act.
(d) Whistleblower protections.—
(1) Complaint.— Any employee who believes that such employee has been discharged or otherwise discriminated against by any person in violation of section 11(c)(1) of the Occupational Safety and Health Act (29 U.S.C. 660(c)(1)) with regard to any matter under or related to this subtitle may, not later than 180 days after such violation occurs, file a complaint with the Secretary following the procedures in paragraph (2) of such section alleging such discrimination.
(2) Action.— If the Secretary fails to notify the complainant of the Secretary’s determination on the complaint within 90 days after such determination pursuant to section 11(c)(3) of the Occupational Safety and Health Act (29 U.S.C. 660(c)(3)) or determines not to bring an action pursuant to paragraph (2) of such section, such employee may bring an action in any appropriate United States District Court against such person for all appropriate relief in accordance with paragraph (2) of such section as well as reasonable attorney’s fees and costs.
(a) Severability.— If any provision of this subtitle is held invalid, the remainder of this subtitle shall not be affected thereby. If the application of any provision of this subtitle to any person or circumstance is held invalid, the application of such provision to other persons or circumstances shall not be affected thereby.
(b) Authorization of appropriations.— There are authorized to be appropriated from sums not otherwise appropriated, for each fiscal year, such sums as may be necessary to carry out this subtitle.
The Secretary shall update the National Agricultural Workers Survey with such questions that, in the Secretary’s judgment, are useful to identify the incidence and prevalence of heat-related illness and injury and assess the impact of standards and enforcement pursuant to this subtitle. Not later than one year after the date of enactment of this Act, the Secretary shall submit to the Committee on Education and Workforce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the Secretary’s implementation of this section.
For purposes of this subtitle:
(1) The term Commission means the Occupational Safety and Health Review Commission.
(2) The term employee has the meaning given such term in section 3 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 652).
(3) The term employer has the meaning given such term in section 3 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 652).
(4) The term heat stress means the load of heat that a person experiences due to—
(A) sources of heat or heat retention (including the combined contributions of metabolic heat, environmental factors, and clothing or personal protective equipment); or
(B) the presence of heat in a work setting.
(5) The term heat-related illness means a material impairment of health that occurs due to heat stress.
(6) The term heat-related injury means an injury caused by exposure to heat or sources of heat or occurring as a result of heat stress.
(7) The term Institute means the National Institute for Occupational Safety and Health.
(8) The term Secretary means the Secretary of Labor.
(9) The term worker heat protection standard means a standard that regulates employee exposure to heat stress and prevents heat-related illness and injury by requiring conditions or the adoption or use of one or more practices, means, methods, operations, or processes reasonably necessary or appropriate to provide employment and places of employment that are safe or healthful.
Subpart 3 of part C of title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) is amended by inserting after section 426 (42 U.S.C. 285c) the following new section:
“426A. Centers of Excellence on Rare Kidney Disease Research in the National Institute of Diabetes and Digestive and Kidney Diseases.—
(a) Cooperative agreements and grants.—
(1) In general.— The Director of the Institute may enter into cooperative agreements with, and make grants to, public and private nonprofit entities to pay all or part of the cost of planning, establishing, or strengthening, and providing basic operating support for, regional centers of excellence for rare kidney diseases, including primary glomerular disease. Such centers of excellence shall be known as NIDDK Centers of Excellence on Rare Kidney Disease Research (referred to in this section as “Centers of Excellence”).
(2) Purposes of centers.— The purposes of the Centers of Excellence funded pursuant to paragraph (1) shall be—
(A) to conduct research on the causes, etiology, symptoms, diagnosis, progression, and treatment of rare kidney diseases, including glomerular diseases;
(B) to increase public awareness of rare kidney diseases, particularly in rural and underserved communities; and
(C) to develop resources for clinical research into, training in, and demonstration of diagnostic, prevention, control, and treatment methods for, rare kidney diseases.
(3) Policies.— A cooperative agreement or grant under paragraph (1) shall be entered into in accordance with policies established by the Director of the National Institutes of Health.
(b) Coordination with other institutes.— The Director of the Institute shall coordinate the activities under this section with similar activities that are related to rare kidney disease and conducted by other national research institutes, centers, and agencies of the National Institutes of Health and by the Food and Drug Administration.
(c) Use of funds.— An entity that enters into a cooperative agreement or receives a grant under subsection (a) may use funds received through such agreement or grant—
(1) to cover patient care costs required to conduct research described in subsection (a)(2)(A);
(2) to provide, for the purpose described in subsection (a)(2)(B)—
(A) clinical training and continuing education for health professionals and related personnel with respect to rare kidney diseases; and
(B) information programs for the public, with respect to rare kidney diseases; and
(3) to provide, for the purpose described in subsection (a)(2)(B)—
(A) for education of members of the public, particularly through outreach to rural and underserved communities, on the diagnosis (including through routine urinalysis and through genetic testing), prevention, control, and treatment of rare kidney diseases; and
(B) for education of individuals diagnosed with rare kidney diseases on renal diet and lifestyle, genetic testing, and programs to promote urinalysis, and on mental and emotional health resources for families of rare kidney disease patients.
(d) Research funded.— Research conducted using funds awarded through a cooperative agreement or grant under this section—
(1) shall include study of genotype-phenotype relation to disease progression; and
(2) with respect the populations studied in such research, may not include any consideration of quality-adjusted life years or disability adjusted life years, or other similar mechanisms that discriminate against individuals with disabilities in value and cost-effectiveness assessments.
(e) Period of support; additional periods.— The period of support for a center of excellence under subsection (a) may not exceed 5 years, except that such period may be extended by the Director of the Institute for additional periods of not more than 5 years for each center if—
(1) the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director of the Institute; and
(2) such group has recommended to the Director of the Institute that such period should be extended.
(f) Authorization of appropriations.— To carry out this section, there are authorized to be appropriated $6,000,000 for each of fiscal years 2027 through 2031.”.
(a) In general.— The Secretary of Health and Human Services (in this section referred to as the “Secretary”) shall conduct a study on testing, preventative care, precision medicine, and treatment, with respect to rare kidney disease. Such study shall review—
(1) the impact of routine urinalysis on the timely diagnosis of rare kidney disease and on the quality of patient care following a diagnosis of such disease;
(2) the quality and reliability of kidney biopsy in the diagnosis of rare kidney disease;
(3) the utility and appropriate use of genetic and genomic tests in detecting kidney disease, including—
(A) advances in genetic and genomic testing, and in particular testing of the APOL1 gene, and whether such testing may improve the diagnosis and treatment of rare kidney disease;
(B) barriers to genetic and genomic testing, such as diagnostic, predictive, presymptomatic testing, and DNA sequencing clinical services, including an analysis of any existing barriers related to health insurance coverage of such testing and access to genetic counselors, pathologists, and other relevant professions; and
(C) strategies to increase routine urinalysis and other diagnostic testing and to improve technologies to diagnose such disease, including genetic testing, and to improve access to health insurance coverage of such diagnostic testing and technologies;
(4) the social, behavioral, and biological factors leading to rare kidney disease;
(5) treatment patterns associated with providing care, under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.), the Medicaid program under title XIX of such Act (42 U.S.C. 1396 et seq.), and through private health insurance, to populations that are disproportionately affected by such disease;
(6) access to nephrologists among populations that are disproportionately affected by such disease;
(7) ongoing efforts and recommendations to slow the progression of end-stage kidney disease in populations that are disproportionately affected by rare kidney disease; and
(8) patient trust of treating providers among populations that are disproportionately affected by such disease.
(b) Report.—
(1) In general.— Not later than 18 months after the date of the enactment of this Act, the Secretary shall submit to Congress a report on the results of the study under subsection (a), together with such recommendations as the Secretary determines to be appropriate.
(2) Consultation.— In conducting the study under subsection (a) and developing the report required by paragraph (1), the Secretary shall consult with relevant stakeholders, including health care providers, medical professional societies, State-based societies, public health experts, health educators, health professional organizations, drug and device manufacturers, patient organizations, pharmacists, payors, State and local public health departments, State medical boards, and other entities with experience in health care, public health, nephrology, and rare disease, as appropriate.
(c) Coordination.— In carrying out the activities under subsections (a) and (b), the Secretary shall coordinate with the Director of NIH, the Administrator of the Centers for Medicare & Medicaid Services, the Administrator of the Health Resources and Services Administration, and the Director of the Center for Medicare and Medicaid Innovation.
(d) Authorization of appropriations.— To carry out this section, there is authorized to be appropriated $1,000,000 for each of fiscal years 2027 through 2031.
(a) Primary care training.— Section 747(b)(3)(E) of the Public Health Service Act (42 U.S.C. 293k(b)(3)(E)) is amended—
(1) by striking “and individuals” and inserting “, individuals”; and
(2) by inserting “, and individuals with kidney disease (including rare kidney disease)” after “disabilities”.
(b) Nephrology fellowships.— Section 736(b) of the Public Health Service Act (42 U.S.C. 293) is amended—
(1) by redesignating paragraph (7) as paragraph (8);
(2) in paragraph (6)(B), by striking “; and” and inserting a semicolon; and
(3) by inserting after paragraph (6) the following:
“(7) to award fellowships, which may include stipends, for postgraduate training in the field of nephrology, for the purposes of—
(A) increasing providers’ knowledge of issues related to prevention, diagnosis, and treatment of rare kidney disease for populations disproportionately impacted by the disease, including the prevalence of the gene APOL1;
(B) improving the quality of rare kidney disease prevention, diagnosis, and treatment delivered to racial and ethnic minorities; and
(C) increasing the number of nephrologists trained to provide care to such populations; and”.
Section 1881(f) of the Social Security Act (42 U.S.C. 1395rr(f)) is amended by adding at the end the following new paragraph:
“(9)
(A) The Secretary shall conduct experiments to evaluate methods for treating rare kidney disease, giving particular attention to treatments that would delay or eliminate the need for dialysis and transplant.
(B) The Secretary shall conduct a comprehensive study of methods to increase public awareness of rare kidney disease.
(C) The Secretary shall submit to Congress, not later than 24 months after the date of the enactment of the Health Equity and Accountability Act of 2026, a report on the experiments and study conducted under subparagraphs (A) and (B). Such report shall include recommendations for legislative changes that the Secretary finds necessary or desirable as a result of such experiments and study.”.