I 

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’’. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Nonalcoholic Steatohepatitis Care Act of 2020’’ or the 

6 ‘‘NASH Care Act of 2020’’. 

7 (b) TABLE OF CONTENTS.—The table of contents for 

8 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. 


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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. 

1 SEC. 2. NATIONAL PREVENTION PROGRAM FOR DIABETES, 

2 NONALCOHOLIC FATTY LIVER DISEASE, AND 

3 METABOLIC SYNDROME. 

4 Section 399V–3 of the Public Health Service Act 

5 (280g–14) is amended— 

6 (1) in subsection (a)— 

7 (A) by inserting ‘‘or continue’’ after ‘‘es8 tablish’’; 

9 (B) by striking ‘‘national diabetes’’; 

10 (C) by inserting ‘‘, nonalcoholic fatty liver 

11 disease, and metabolic syndrome’’ after ‘‘high 

12 risk for diabetes’’; and 

13 (D) by striking ‘‘burden of diabetes’’ and 

14 inserting ‘‘such conditions’’; 

15 (2) in subsection (b)— 

16 (A) by striking paragraph (1) 

17 (B) by redesignating paragraphs (2) 

18 through (4) as paragraphs (3) through (5); and 

19 (C) by inserting before paragraph (3) (as 

20 so redesignated) the following; 


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1 ‘‘(1) competitive grants to eligible entities for 

2 the purposes of identifying, developing, or dissemi3 nating best practices on the prevention, detection, 

4 and treatment of diabetes, nonalcoholic fatty liver 

5 disease, and metabolic syndrome; 

6 ‘‘(2) competitive grants for eligible entities for 

7 the development of community-based prevention pro8 gram model sites;’’; 

9 (3) by redesignating subsection (d) as sub10 section (e); 

11 (4) by inserting after subsection (c) the fol12 lowing: 

13 ‘‘(d) PREFERENCE.—In awarding grants under sub14 section (b), the Secretary may give preference to eligible 

15 entities that— 

16 ‘‘(1) provide lifestyle interventions, including 

17 nutrition and exercise consultation; and 

18 ‘‘(2) serve racial and ethnic minority commu19 nities with high rates of diabetes, nonalcoholic fatty 

20 liver disease, and metabolic syndrome.’’ ; and 

21 (5) in subsection (e) (as redesignated by para22 graph (3)), by striking ‘‘such sums as may be nec23 essary for each of fiscal years 2010 through 2014’’ 

24 and inserting ‘‘$27,300,000 for each of fiscal years 

25 2021 through 2025’’. 


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1 SEC. 3. GRANTS FOR COMMUNITY-BASED PATIENT EDU2 CATION AND PROVIDER TRAINING AND OUT3 REACH. 

4 (a) IN GENERAL.—The Secretary of Health and 

5 Human Services, acting through the Director of the Cen6 ters for Disease Control and Prevention, shall establish 

7 a grant program under which the Secretary may award 

8 grants to eligible entities to provide education in the pre9 vention of nonalcoholic steatohepatitis (referred to in this 

10 Act as ‘‘NASH’’), which shall be know as the National 

11 NASH Prevention and Education Program (referred to in 

12 this section as ‘‘the Program’’). To the extent practicable, 

13 the Secretary shall align such program with the eligibility 

14 criteria to receive grants under the National Diabetes Pre15 vention Program of the Centers for Disease Control and 

16 Prevention. 

17 (b) ELIGIBLE ENTITIES.—An entity is eligible to re18 ceived a grant under the Program if such entity— 

19 (1)(A) provides lifestyle interventions such as 

20 promotion of liver health interventions or nutrition 

21 and exercise consultation; or 

22 (B) serves racial and ethnic minority commu23 nities with high rates of nonalcoholic fatty liver dis24 ease (as determined by Secretary); and 

25 (2) is a community-based, nonprofit organiza26 tion located in any state or is an experienced organiVerDate Sep 11 2014 21:52 Nov 13, 2020 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H8658.IH H8658

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1 zation in developing liver health education and 

2 awareness programs. 

3 (c) APPLICATION.—An eligible entity seeking a grant 

4 under this section shall submit an application to the Sec5 retary at such time, in such manner, and containing such 

6 information as the Secretary may require. 

7 (d) TERM.—The term of a grant awarded under this 

8 section shall not exceed 5 years. 

9 (e) CURRICULUM DEVELOPMENT.— 

10 (1) IN GENERAL.—The Secretary shall develop, 

11 taking into consideration the best practices devel12 oped by grantees under section 399V–3(b)(1) of the 

13 Public Health Service Act, as amended by section 2 

14 of this Act, directly or through grants to eligible en15 tities, a curriculum to provide education in NASH 

16 prevention for use by recipients of grants under this 

17 section. 

18 (2) FOCUS AREAS.—The curriculum shall pro19 vide for consistency in— 

20 (A) application of screening and diagnostic 

21 recommendations; 

22 (B) collection of population data and qual23 ity measures; and 


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1 (C) delivery of recommended evidence2 based lifestyle interventions specific to nutrition 

3 and exercise. 

4 (f) POPULATIONS CONSIDERED.—In carrying out 

5 this section, the Secretary shall consider the needs of pedi6 atric and minority populations at risk for NASH. 

7 (g) COORDINATION WITH CONTINUING MEDICAL

8 EDUCATION.—The task force established under section 6 

9 shall, to the extent practicable, coordinate the availability 

10 of training and outreach under this subsection with the 

11 opportunity for providers receiving training pursuant to 

12 this section to earn continuing medical education credits. 

13 (h) AUTHORIZATION OF APPROPRIATIONS.—There 

14 are authorized to be appropriated to carry out this section 

15 such sums as may be necessary for each of fiscal years 

16 2021 through 2025. 

17 SEC. 4. NATIONAL ACADEMIES OF SCIENCES STUDY ON 

18 EDUCATION AND POLICY NEEDS FOR NON19 ALCOHOLIC STEATOHEPATITIS AND NON20 ALCOHOLIC FATTY LIVER DISEASE. 

21 (a) IN GENERAL.—Not later than 180 days after the 

22 date of the enactment of this Act, the Secretary of Health 

23 and Human Services shall offer to enter into a contract 

24 with the National Academies of Sciences to conduct a 


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1 study on nonalcoholic fatty liver disease and nonalcoholic 

2 steatohepatitis in the United States. 

3 (b) FOCUS AREAS.—The study conducted pursuant 

4 to subsection (a) shall focus on education and policy needs 

5 involving nonalcoholic fatty liver disease and nonalcoholic 

6 steatohepatitis, including— 

7 (1) opportunities to strengthen prevention of 

8 nonalcoholic fatty liver disease and nonalcoholic 

9 steatohepatitis, including through enhanced delivery 

10 of nutrition services; 

11 (2) barriers to diagnosis and treatment of non12 alcoholic fatty liver disease and nonalcoholic 

13 steatohepatitis, including opportunities to strengthen 

14 coverage under the Medicare program under title 

15 XVIII of the Social Security Act (42 U.S.C. 1395 et 

16 seq.), the Medicaid program under title XIX of such 

17 Act (42 U.S.C. 1396 et seq.), group health plans (as 

18 defined in section 2791 of the Public Health Service 

19 Act (42 U.S.C. 300gg–91)), and group or individual 

20 health insurance coverage (as such terms are defined 

21 in such section 2791); 

22 (3) recommendations for enhancing provider 

23 education on nonalcoholic fatty liver disease and 

24 nonalcoholic steatohepatitis; and 


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1 (4) recommendations for enhancing patient 

2 awareness of nonalcoholic fatty liver disease and 

3 nonalcoholic steatohepatitis, including early identi4 fication of risk factors and linkage to appropriate 

5 care. 

6 (c) REPORT.—The agreement entered into under sub7 section (a) shall require the National Academies of 

8 Sciences to, not later than January 1, 2022, submit a re9 port on the findings of the study to the Secretary and the 

10 Chairman and Ranking Member of each of the following 

11 committees: 

12 (1) The Committee on Energy and Commerce 

13 of the House of Representatives. 

14 (2) The Committee on Ways and Means of the 

15 House of Representatives. 

16 (3) The Committee on Finance of the Senate. 

17 (4) The Committee on Health, Education, 

18 Labor, and Pensions of the Senate. 

19 (d) AUTHORIZATION OF APPROPRIATIONS.—There 

20 are authorized to be appropriated to carry out this section 

21 $1,000,000 for each of fiscal years 2021 and 2022. 


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1 SEC. 5. NATIONAL SURVEILLANCE PROGRAM FOR NON2 ALCOHOLIC FATTY LIVER DISEASE AND NON3 ALCOHOLIC STEATOHEPATITIS. 

4 (a) IN GENERAL.—The Secretary of Health and 

5 Human Services, acting through the Director of the Cen6 ters for Disease Control and Prevention, shall establish 

7 a program to provide for surveillance on the prevalence 

8 of nonalcoholic fatty liver disease and nonalcoholic 

9 steatohepatitis in the United States. 

10 (b) PROGRAM ACTIVITIES.— 

11 (1) SURVEILLANCE ACTIVITIES.—The program 

12 established under subsection (a) shall include, at a 

13 minimum, each of the following surveillance activi14 ties: 

15 (A) Conducting local surveillance activities 

16 to collect data on the prevalence and severity of 

17 nonalcoholic fatty level disease and nonalcoholic 

18 steatohepatitis. 

19 (B) Compiling and annually publishing 

20 data on the number of individuals with non21 alcoholic fatty level disease and nonalcoholic 

22 steatohepatitis nationally as well as in each 

23 state. 

24 (C) To the extent practicable, providing 

25 data on the general population at risk of devel26 oping the conditions. 


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1 (2) TECHNICAL ASSISTANCE ON VITAL STATIS2 TICS.—In carrying out the program under sub3 section (a), the Secretary of Health and Human 

4 Services, acting through the Director of the Centers 

5 for Disease Control and Prevention, shall issue guid6 ance that provides technical assistance to health care 

7 providers and State and local health departments on 

8 best practices to ensure appropriate collection of 

9 vital statistics for purposes of birth and death cer10 tificates, including vital statistics on populations 

11 with nonalcoholic fatty level disease and nonalcoholic 

12 steatohepatitis. 

13 (c) AUTHORIZATION OF APPROPRIATIONS.—There 

14 are authorized to be appropriated— 

15 (1) to carry out surveillance activities described 

16 in subsection (b)(1), $10,000,000 for each of fiscal 

17 years 2021 and 2022; 

18 (2) to carry out technical assistance activities 

19 described in subsection (b)(3), $10,000,000 for each 

20 of fiscal years 2021 and 2022; and 

21 (3) to carry out the activities described in sub22 section (b)(2), $5,000,000 for each of fiscal years 

23 2021 through 2025. 


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1 SEC. 6. RECOMMENDATIONS FOR THE PREVENTION, 

2 SCREENING, DIAGNOSIS, AND TREATMENT OF 

3 INTERRELATED CONDITIONS DEVELOPED BY 

4 MULTIDISCIPLINARY TASK FORCE. 

5 (a) IN GENERAL.—Not later than 180 days after the 

6 date of the enactment of this Act, the Secretary of Health 

7 and Human Services shall establish a multidisciplinary 

8 task force, and appoint members to such task force, to 

9 develop recommendations for the prevention, screening, di10 agnosis, and treatment for several interrelated conditions, 

11 including, at a minimum— 

12 (1) nonalcoholic fatty liver disease; 

13 (2) nonalcoholic steatohepatitis; 

14 (3) obesity; 

15 (4) diabetes and other metabolic disorders; and 

16 (5) any other conditions determined appropriate 

17 by the Secretary. 

18 (b) MEMBERSHIP.—The task force established under 

19 subsection (a) shall be composed of not more than 12 

20 members to be appointed by the Secretary and shall in21 clude representatives of each of the following groups: 

22 (1) Physician specialists, including in 

23 hepatology, gastroenterology, endocrinology, cardi24 ology, and endocrinology. 

25 (2) Experts in public health and epidemiology. 

26 (3) Patient advocates. 


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1 (4) Non-voting representatives of Federal agen2 cies, including the Food and Drug Administration, 

3 the National Institutes of Health, the Centers for 

4 Disease Control and Prevention, and the Office of 

5 the Assistant Secretary for Health of the Depart6 ment of Health and Human Services. 

7 (5) Non-voting representatives of manufactur8 ers of drugs, devices, or diagnostic tools approved by 

9 the Food and Drug Administration for the treat10 ment of any of the conditions specified in subsection 

11 (a). 

12 (c) DEVELOPMENT OF RECOMMENDATIONS.—In de13 veloping the recommendations under subsection (a), the 

14 task force established under such subsection shall con15 sider— 

16 (1) guidelines issued by the American Associa17 tion for the Study of Liver Diseases, published evi18 dence, recommendations of the United States Pre19 ventive Services Task Force, and other information 

20 it determines appropriate in developing such rec21 ommendations; and 

22 (2) whether a combined protocol addressing a 

23 range of conditions specified in such subsection is 

24 advised for populations affected by more than one 


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1 condition for which such recommendations are being 

2 developed. 

3 (d) DEADLINE FOR COMPILING RECOMMENDA4 TIONS.—The task force shall compile screening and diag5 nosis recommendations developed under subsection (a) not 

6 later than 18 months after the date on which the first 

7 meeting of the task force concludes. 

8 (e) PUBLIC HEALTH ACTION PLAN.— 

9 (1) IN GENERAL.—Not later than 1 year after 

10 the date of the enactment of this Act, the task force 

11 shall develop an action plan to combat nonalcoholic 

12 steatohepatitis (referred to in this section as ‘‘the 

13 Action Plan’’). 

14 (2) ISSUES ADDRESSED.—The Action Plan 

15 shall identify key goals and implementation strate16 gies for— 

17 (A) assuring appropriate surveillance of 

18 the public health impact in the United States of 

19 nonalcoholic steatohepatitis; 

20 (B) increasing awareness among the gen21 eral public of the United States of risk factors; 

22 (C) enhancing clinical education on the 

23 prevention, diagnosis, and treatment of non24 alcoholic steatohepatitis among physicians and 


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1 health care professionals within the United 

2 States; 

3 (D) supporting research on therapies and 

4 cures for nonalcoholic steatohepatitis; and 

5 (E) other areas determined appropriate by 

6 the Secretary. 

7 (3) EVALUATION AND REPORT.— 

8 (A) EVALUATION.—The Secretary shall, at 

9 least every 2 years, evaluate the implementation 

10 of the Action Plan under this section to provide 

11 any updates or modifications to such plan. 

12 (B) REPORT.—Not later than 18 months 

13 after the date on which the Action Plan devel14 oped under paragraph (1) is released, the Sec15 retary shall submit to Congress a report that 

16 discusses any updated recommendations for up17 dates or modifications considering initial 

18 progress made in advancing the action plan’s 

19 goals or barriers to attaining such goals. 

20 (f) REPORT REGARDING LIVER CANCER.—Not later 

21 than 1 year after the date on which the first meeting of 

22 the working group is held, the working group shall trans23 mit to the Director of the NIH a report providing rec24 ommendations with respect to preventive and diagnostic 

25 measures that could, in consideration of the relationship 


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1 between the prevalence of liver cancer and the prevalence 

2 of certain liver diseases, help reduce liver cancer rates and 

3 make liver cancer more treatable when detected. 

4 SEC. 7. RENAMING OF NIH INSTITUTE TO REFLECT LIVER 

5 DISEASES AND CREATION OF DIVISION OF 

6 LIVER DISEASES. 

7 (a) INSTITUTE RENAMED.—Effective on January 1, 

8 2021, title IV of the Public Health Service Act is amended 

9 by striking ‘‘National Institute for Diabetes and Digestive 

10 and Kidney Diseases’’ each place it appears in section 

11 401(b) (42 U.S.C. 281(b)), in section 409A(a) (42 U.S.C. 

12 284a(a)), in the heading of subpart 3 of part C, in section 

13 426 (42 U.S.C. 285c), and section 430 (42 U.S.C. 285c– 

14 4) and inserting ‘‘The National Institute of Diabetes and 

15 Digestive, Kidney, and Liver Diseases’’. 

16 (b) CONFORMING CHANGES.—Effective on January 

17 1, 2021, any reference to the National Institute for Diabe18 tes and Digestive and Kidney Diseases in any law, regula19 tion, document, record, or other paper of the United 

20 States shall be deemed to be a reference to the National 

21 Institute of Diabetes and Digestive, Kidney, and Liver 

22 Diseases. 

23 (c) ESTABLISHMENT OF DIVISION FOR LIVER DIS24 EASES.— 


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1 (1) IN GENERAL.—Section 428 of the Public 

2 Health Service Act (42 U.S.C. 285c–2) is amend3 ed— 

4 (A) in subsection (a)(1)— 

5 (i) in the matter preceding subpara6 graph (A), by inserting ‘‘a Division Direc7 tor for Liver Diseases,’’ after ‘‘and Nutri8 tion,’’; and 

9 (ii) in subparagraph (A), by inserting 

10 ‘‘liver diseases,’’ after ‘‘and nutrition,’’; 

11 and 

12 (B) in subsection (b)— 

13 (i) in the matter preceding paragraph 

14 (1), by inserting ‘‘the Division Director for 

15 Liver Diseases,’’ after ‘‘and Nutrition,’’; 

16 and 

17 (ii) in paragraph (1), by inserting 

18 ‘‘liver diseases,’’ after ‘‘and nutritional dis19 orders,’’. 

20 (2) TRANSFER OF AUTHORITY.—Effective on 

21 January 1, 2021, the Secretary of Health and 

22 Human Services, acting through the Director of the 

23 National Institutes of Health, shall transfer to the 

24 Division Director of Liver Diseases of the National 

25 Institute of Diabetes and Digestive, Kidney, and 


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1 Liver Diseases, the authorities (including all budget 

2 authorities, available appropriations, and personnel), 

3 duties, obligations, and related legal and administra4 tive functions prescribed by law or otherwise pre5 viously granted to the Liver Disease Research 

6 Branch within the Division of Digestive Diseases 

7 and Nutrition of the National Institute for Diabetes 

8 and Digestive and Kidney Diseases. 

Æ 


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