[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8658 Introduced in House (IH)]

<DOC>






116th CONGRESS
  2d Session
                                H. R. 8658

    To establish a Federal strategy for preventing, diagnosing, and 
    treating nonalcoholic steatohepatitis, commonly referred to as 
                               ``NASH''.


_______________________________________________________________________


                    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''.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 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.

SEC. 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''.

SEC. 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.

SEC. 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.

SEC. 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.

SEC. 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.

SEC. 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.
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