I 116th CONGRESS 2d Session H. R. 8658 IN THE HOUSE OF REPRESENTATIVES October 23, 2020 Mr. Crenshaw (for himself and Mr. Ruiz ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To establish a Federal strategy for preventing, diagnosing, and treating nonalcoholic steatohepatitis, commonly referred to as NASH .

1. Short title; table of contents (a) Short title This Act may be cited as the Nonalcoholic Steatohepatitis Care Act of 2020 or the NASH Care Act of 2020 . (b) Table of contents The table of contents for this Act is as follows: Sec. 1. Short title; table of contents. Sec. 2. National prevention program for diabetes, nonalcoholic fatty liver disease, and metabolic syndrome. Sec. 3. Grants for community-based patient education and provider training and outreach. Sec. 4. National Academies of Sciences study on education and policy needs for nonalcoholic steatohepatitis and nonalcoholic fatty liver disease. Sec. 5. National surveillance program for nonalcoholic fatty liver disease and nonalcoholic steatohepatitis. Sec. 6. Recommendations for the prevention, screening, diagnosis, and treatment of interrelated conditions developed by multidisciplinary task force. Sec. 7. Renaming of NIH institute to reflect liver diseases and creation of division of liver diseases. 2. National prevention program for diabetes, nonalcoholic fatty liver disease, and metabolic syndrome Section 399V–3 of the Public Health Service Act (280g–14) is amended— (1) in subsection (a)— (A) by inserting or continue after establish ; (B) by striking national diabetes ; (C) by inserting , nonalcoholic fatty liver disease, and metabolic syndrome after high risk for diabetes ; and (D) by striking burden of diabetes and inserting such conditions ; (2) in subsection (b)— (A) by striking paragraph (1) (B) by redesignating paragraphs (2) through (4) as paragraphs (3) through (5); and (C) by inserting before paragraph (3) (as so redesignated) the following; (1) competitive grants to eligible entities for the purposes of identifying, developing, or disseminating best practices on the prevention, detection, and treatment of diabetes, nonalcoholic fatty liver disease, and metabolic syndrome; (2) competitive grants for eligible entities for the development of community-based prevention program model sites; ; (3) by redesignating subsection (d) as subsection (e); (4) by inserting after subsection (c) the following: (d) Preference In awarding grants under subsection (b), the Secretary may give preference to eligible entities that— (1) provide lifestyle interventions, including nutrition and exercise consultation; and (2) serve racial and ethnic minority communities with high rates of diabetes, nonalcoholic fatty liver disease, and metabolic syndrome. ; and (5) in subsection (e) (as redesignated by paragraph (3)), by striking such sums as may be necessary for each of fiscal years 2010 through 2014 and inserting $27,300,000 for each of fiscal years 2021 through 2025 . 3. Grants for community-based patient education and provider training and outreach (a) In general The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, shall establish a grant program under which the Secretary may award grants to eligible entities to provide education in the prevention of nonalcoholic steatohepatitis (referred to in this Act as NASH ), which shall be know as the National NASH Prevention and Education Program (referred to in this section as the Program ). To the extent practicable, the Secretary shall align such program with the eligibility criteria to receive grants under the National Diabetes Prevention Program of the Centers for Disease Control and Prevention. (b) Eligible entities An entity is eligible to received a grant under the Program if such entity— (1) (A) provides lifestyle interventions such as promotion of liver health interventions or nutrition and exercise consultation; or (B) serves racial and ethnic minority communities with high rates of nonalcoholic fatty liver disease (as determined by Secretary); and (2) is a community-based, nonprofit organization located in any state or is an experienced organization in developing liver health education and awareness programs. (c) Application An eligible entity 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) Term The term of a grant awarded under this section shall not exceed 5 years. (e) Curriculum development (1) In general The Secretary shall develop, taking into consideration the best practices developed by grantees under section 399V–3(b)(1) of the Public Health Service Act, as amended by section 2 of this Act, directly or through grants to eligible entities , a curriculum to provide education in NASH prevention for use by recipients of grants under this section. (2) Focus areas The curriculum shall provide for consistency in— (A) application of screening and diagnostic recommendations; (B) collection of population data and quality measures; and (C) delivery of recommended evidence-based lifestyle interventions specific to nutrition and exercise. (f) Populations considered In carrying out this section, the Secretary shall consider the needs of pediatric and minority populations at risk for NASH. (g) Coordination with continuing medical education The task force established under section 6 shall, to the extent practicable, coordinate the availability of training and outreach under this subsection with the opportunity for providers receiving training pursuant to this section to earn continuing medical education credits. (h) 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 2021 through 2025. 4. National Academies of Sciences study on education and policy needs for nonalcoholic steatohepatitis and nonalcoholic fatty liver disease (a) In general Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall offer to enter into a contract with the National Academies of Sciences to conduct a study on nonalcoholic fatty liver disease and nonalcoholic steatohepatitis in the United States. (b) Focus areas The study conducted pursuant to subsection (a) shall focus on education and policy needs involving nonalcoholic fatty liver disease and nonalcoholic steatohepatitis, including— (1) opportunities to strengthen prevention of nonalcoholic fatty liver disease and nonalcoholic steatohepatitis, including through enhanced delivery of nutrition services; (2) barriers to diagnosis and treatment of nonalcoholic fatty liver disease and nonalcoholic steatohepatitis, including opportunities to strengthen coverage 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.), group health plans (as defined in section 2791 of the Public Health Service Act ( 42 U.S.C. 300gg–91 )), and group or individual health insurance coverage (as such terms are defined in such section 2791); (3) recommendations for enhancing provider education on nonalcoholic fatty liver disease and nonalcoholic steatohepatitis; and (4) recommendations for enhancing patient awareness of nonalcoholic fatty liver disease and nonalcoholic steatohepatitis, including early identification of risk factors and linkage to appropriate care. (c) Report The agreement entered into under subsection (a) shall require the National Academies of Sciences to, not later than January 1, 2022, submit a report on the findings of the study to the Secretary and the Chairman and Ranking Member of each of the following committees: (1) The Committee on Energy and Commerce of the House of Representatives. (2) The Committee on Ways and Means of the House of Representatives. (3) The Committee on Finance of the Senate. (4) The Committee on Health, Education, Labor, and Pensions of the Senate. (d) Authorization of appropriations There are authorized to be appropriated to carry out this section $1,000,000 for each of fiscal years 2021 and 2022. 5. National surveillance program for nonalcoholic fatty liver disease and nonalcoholic steatohepatitis (a) In general The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, shall establish a program to provide for surveillance on the prevalence of nonalcoholic fatty liver disease and nonalcoholic steatohepatitis in the United States. (b) Program activities (1) Surveillance activities The program established under subsection (a) shall include, at a minimum, each of the following surveillance activities: (A) Conducting local surveillance activities to collect data on the prevalence and severity of nonalcoholic fatty level disease and nonalcoholic steatohepatitis. (B) Compiling and annually publishing data on the number of individuals with nonalcoholic fatty level disease and nonalcoholic steatohepatitis nationally as well as in each state. (C) To the extent practicable, providing data on the general population at risk of developing the conditions. (2) Technical assistance on vital statistics In carrying out the program under subsection (a), the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, shall issue guidance that provides technical assistance to health care providers and State and local health departments on best practices to ensure appropriate collection of vital statistics for purposes of birth and death certificates, including vital statistics on populations with nonalcoholic fatty level disease and nonalcoholic steatohepatitis. (c) Authorization of appropriations There are authorized to be appropriated— (1) to carry out surveillance activities described in subsection (b)(1), $10,000,000 for each of fiscal years 2021 and 2022; (2) to carry out technical assistance activities described in subsection (b)(3), $10,000,000 for each of fiscal years 2021 and 2022; and (3) to carry out the activities described in subsection (b)(2), $5,000,000 for each of fiscal years 2021 through 2025. 6. Recommendations for the prevention, screening, diagnosis, and treatment of interrelated conditions developed by multidisciplinary task force (a) In general Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall establish a multidisciplinary task force, and appoint members to such task force, to develop recommendations for the prevention, screening, diagnosis, and treatment for several interrelated conditions, including, at a minimum— (1) nonalcoholic fatty liver disease; (2) nonalcoholic steatohepatitis; (3) obesity; (4) diabetes and other metabolic disorders; and (5) any other conditions determined appropriate by the Secretary. (b) Membership The task force established under subsection (a) shall be composed of not more than 12 members to be appointed by the Secretary and shall include representatives of each of the following groups: (1) Physician specialists, including in hepatology, gastroenterology, endocrinology, cardiology, and endocrinology. (2) Experts in public health and epidemiology. (3) Patient advocates. (4) Non-voting representatives of Federal agencies, including the Food and Drug Administration, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Office of the Assistant Secretary for Health of the Department of Health and Human Services. (5) Non-voting representatives of manufacturers of drugs, devices, or diagnostic tools approved by the Food and Drug Administration for the treatment of any of the conditions specified in subsection (a). (c) Development of recommendations In developing the recommendations under subsection (a), the task force established under such subsection shall consider— (1) guidelines issued by the American Association for the Study of Liver Diseases, published evidence, recommendations of the United States Preventive Services Task Force, and other information it determines appropriate in developing such recommendations; and (2) whether a combined protocol addressing a range of conditions specified in such subsection is advised for populations affected by more than one condition for which such recommendations are being developed. (d) Deadline for compiling recommendations The task force shall compile screening and diagnosis recommendations developed under subsection (a) not later than 18 months after the date on which the first meeting of the task force concludes. (e) Public health action plan (1) In general Not later than 1 year after the date of the enactment of this Act, the task force shall develop an action plan to combat nonalcoholic steatohepatitis (referred to in this section as the Action Plan ). (2) Issues addressed The Action Plan shall identify key goals and implementation strategies for— (A) assuring appropriate surveillance of the public health impact in the United States of nonalcoholic steatohepatitis; (B) increasing awareness among the general public of the United States of risk factors; (C) enhancing clinical education on the prevention, diagnosis, and treatment of nonalcoholic steatohepatitis among physicians and health care professionals within the United States; (D) supporting research on therapies and cures for nonalcoholic steatohepatitis; and (E) other areas determined appropriate by the Secretary. (3) Evaluation and report (A) Evaluation The Secretary shall, at least every 2 years, evaluate the implementation of the Action Plan under this section to provide any updates or modifications to such plan. (B) Report Not later than 18 months after the date on which the Action Plan developed under paragraph (1) is released, the Secretary shall submit to Congress a report that discusses any updated recommendations for updates or modifications considering initial progress made in advancing the action plan's goals or barriers to attaining such goals. (f) Report regarding liver cancer Not later than 1 year after the date on which the first meeting of the working group is held, the working group shall transmit to the Director of the NIH a report providing recommendations with respect to preventive and diagnostic measures that could, in consideration of the relationship between the prevalence of liver cancer and the prevalence of certain liver diseases, help reduce liver cancer rates and make liver cancer more treatable when detected. 7. Renaming of NIH institute to reflect liver diseases and creation of division of liver diseases (a) Institute renamed Effective on January 1, 2021, title IV of the Public Health Service Act is amended by striking National Institute for Diabetes and Digestive and Kidney Diseases each place it appears in section 401(b) ( 42 U.S.C. 281(b) ), in section 409A(a) ( 42 U.S.C. 284a(a) ), in the heading of subpart 3 of part C, in section 426 ( 42 U.S.C. 285c ), and section 430 ( 42 U.S.C. 285c–4 ) and inserting The National Institute of Diabetes and Digestive, Kidney, and Liver Diseases . (b) Conforming changes Effective on January 1, 2021, any reference to the National Institute for Diabetes and Digestive and Kidney Diseases in any law, regulation, document, record, or other paper of the United States shall be deemed to be a reference to the National Institute of Diabetes and Digestive, Kidney, and Liver Diseases. (c) Establishment of Division for Liver Diseases (1) In general Section 428 of the Public Health Service Act ( 42 U.S.C. 285c–2 ) is amended— (A) in subsection (a)(1)— (i) in the matter preceding subparagraph (A), by inserting a Division Director for Liver Diseases, after and Nutrition, ; and (ii) in subparagraph (A), by inserting liver diseases, after and nutrition, ; and (B) in subsection (b)— (i) in the matter preceding paragraph (1), by inserting the Division Director for Liver Diseases, after and Nutrition, ; and (ii) in paragraph (1), by inserting liver diseases, after and nutritional disorders, . (2) Transfer of authority Effective on January 1, 2021, the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall transfer to the Division Director of Liver Diseases of the National Institute of Diabetes and Digestive, Kidney, and Liver Diseases, the authorities (including all budget authorities, available appropriations, and personnel), duties, obligations, and related legal and administrative functions prescribed by law or otherwise previously granted to the Liver Disease Research Branch within the Division of Digestive Diseases and Nutrition of the National Institute for Diabetes and Digestive and Kidney Diseases.