[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.
<all>