NASH Care Act of 2020

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 re- ferred to as ‘‘NASH’’. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 3 (a) SHORT TITLE.—This Act may be cited as the 4 ‘‘Nonalcoholic Steatohepatitis Care Act of 2020’’ or the 5 ‘‘NASH Care Act of 2020’’. 6 (b) TABLE OF CONTENTS.—The table of contents for 7 this Act is as follows: 8 Sec. 1. Short title; table of contents. Sec. 2. National prevention program for diabetes, nonalcoholic fatty liver dis- ease, and metabolic syndrome. VerDate Sep 11 2014 21:52 Nov 13, 2020 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6211 E:\BILLS\H8658.IH H8658 jbell on DSKJLSW7X2PROD with BILLS 2 •HR 8658 IH 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 treat- ment of interrelated conditions developed by multidisciplinary task force. Sec. 7. Renaming of NIH institute to reflect liver diseases and creation of divi- sion of liver diseases. SEC. 2. NATIONAL PREVENTION PROGRAM FOR DIABETES, 1 NONALCOHOLIC FATTY LIVER DISEASE, AND 2 METABOLIC SYNDROME. 3 Section 399V–3 of the Public Health Service Act 4 (280g–14) is amended— 5 (1) in subsection (a)— 6 (A) by inserting ‘‘or continue’’ after ‘‘es- 7 tablish’’; 8 (B) by striking ‘‘national diabetes’’; 9 (C) by inserting ‘‘, nonalcoholic fatty liver 10 disease, and metabolic syndrome’’ after ‘‘high 11 risk for diabetes’’; and 12 (D) by striking ‘‘burden of diabetes’’ and 13 inserting ‘‘such conditions’’; 14 (2) in subsection (b)— 15 (A) by striking paragraph (1) 16 (B) by redesignating paragraphs (2) 17 through (4) as paragraphs (3) through (5); and 18 (C) by inserting before paragraph (3) (as 19 so redesignated) the following; 20 VerDate Sep 11 2014 21:52 Nov 13, 2020 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H8658.IH H8658 jbell on DSKJLSW7X2PROD with BILLS 3 •HR 8658 IH ‘‘(1) competitive grants to eligible entities for 1 the purposes of identifying, developing, or dissemi- 2 nating best practices on the prevention, detection, 3 and treatment of diabetes, nonalcoholic fatty liver 4 disease, and metabolic syndrome; 5 ‘‘(2) competitive grants for eligible entities for 6 the development of community-based prevention pro- 7 gram model sites;’’; 8 (3) by redesignating subsection (d) as sub- 9 section (e); 10 (4) by inserting after subsection (c) the fol- 11 lowing: 12 ‘‘(d) PREFERENCE.—In awarding grants under sub- 13 section (b), the Secretary may give preference to eligible 14 entities that— 15 ‘‘(1) provide lifestyle interventions, including 16 nutrition and exercise consultation; and 17 ‘‘(2) serve racial and ethnic minority commu- 18 nities with high rates of diabetes, nonalcoholic fatty 19 liver disease, and metabolic syndrome.’’ ; and 20 (5) in subsection (e) (as redesignated by para- 21 graph (3)), by striking ‘‘such sums as may be nec- 22 essary for each of fiscal years 2010 through 2014’’ 23 and inserting ‘‘$27,300,000 for each of fiscal years 24 2021 through 2025’’. 25 VerDate Sep 11 2014 21:52 Nov 13, 2020 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H8658.IH H8658 jbell on DSKJLSW7X2PROD with BILLS 4 •HR 8658 IH SEC. 3. GRANTS FOR COMMUNITY-BASED PATIENT EDU- 1 CATION AND PROVIDER TRAINING AND OUT- 2 REACH. 3 (a) IN GENERAL.—The Secretary of Health and 4 Human Services, acting through the Director of the Cen- 5 ters for Disease Control and Prevention, shall establish 6 a grant program under which the Secretary may award 7 grants to eligible entities to provide education in the pre- 8 vention of nonalcoholic steatohepatitis (referred to in this 9 Act as ‘‘NASH’’), which shall be know as the National 10 NASH Prevention and Education Program (referred to in 11 this section as ‘‘the Program’’). To the extent practicable, 12 the Secretary shall align such program with the eligibility 13 criteria to receive grants under the National Diabetes Pre- 14 vention Program of the Centers for Disease Control and 15 Prevention. 16 (b) ELIGIBLE ENTITIES.—An entity is eligible to re- 17 ceived a grant under the Program if such entity— 18 (1)(A) provides lifestyle interventions such as 19 promotion of liver health interventions or nutrition 20 and exercise consultation; or 21 (B) serves racial and ethnic minority commu- 22 nities with high rates of nonalcoholic fatty liver dis- 23 ease (as determined by Secretary); and 24 (2) is a community-based, nonprofit organiza- 25 tion located in any state or is an experienced organi- 26 VerDate Sep 11 2014 21:52 Nov 13, 2020 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H8658.IH H8658 jbell on DSKJLSW7X2PROD with BILLS 5 •HR 8658 IH zation in developing liver health education and 1 awareness programs. 2 (c) APPLICATION.—An eligible entity seeking a grant 3 under this section shall submit an application to the Sec- 4 retary at such time, in such manner, and containing such 5 information as the Secretary may require. 6 (d) TERM.—The term of a grant awarded under this 7 section shall not exceed 5 years. 8 (e) CURRICULUM DEVELOPMENT.— 9 (1) IN GENERAL.—The Secretary shall develop, 10 taking into consideration the best practices devel- 11 oped by grantees under section 399V–3(b)(1) of the 12 Public Health Service Act, as amended by section 2 13 of this Act, directly or through grants to eligible en- 14 tities, a curriculum to provide education in NASH 15 prevention for use by recipients of grants under this 16 section. 17 (2) FOCUS AREAS.—The curriculum shall pro- 18 vide for consistency in— 19 (A) application of screening and diagnostic 20 recommendations; 21 (B) collection of population data and qual- 22 ity measures; and 23 VerDate Sep 11 2014 21:52 Nov 13, 2020 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H8658.IH H8658 jbell on DSKJLSW7X2PROD with BILLS 6 •HR 8658 IH (C) delivery of recommended evidence- 1 based lifestyle interventions specific to nutrition 2 and exercise. 3 (f) POPULATIONS CONSIDERED.—In carrying out 4 this section, the Secretary shall consider the needs of pedi- 5 atric and minority populations at risk for NASH. 6 (g) COORDINATION WITH CONTINUING MEDICAL 7 EDUCATION.—The task force established under section 6 8 shall, to the extent practicable, coordinate the availability 9 of training and outreach under this subsection with the 10 opportunity for providers receiving training pursuant to 11 this section to earn continuing medical education credits. 12 (h) AUTHORIZATION OF APPROPRIATIONS.—There 13 are authorized to be appropriated to carry out this section 14 such sums as may be necessary for each of fiscal years 15 2021 through 2025. 16 SEC. 4. NATIONAL ACADEMIES OF SCIENCES STUDY ON 17 EDUCATION AND POLICY NEEDS FOR NON- 18 ALCOHOLIC STEATOHEPATITIS AND NON- 19 ALCOHOLIC FATTY LIVER DISEASE. 20 (a) IN GENERAL.—Not later than 180 days after the 21 date of the enactment of this Act, the Secretary of Health 22 and Human Services shall offer to enter into a contract 23 with the National Academies of Sciences to conduct a 24 VerDate Sep 11 2014 21:52 Nov 13, 2020 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H8658.IH H8658 jbell on DSKJLSW7X2PROD with BILLS 7 •HR 8658 IH study on nonalcoholic fatty liver disease and nonalcoholic 1 steatohepatitis in the United States. 2 (b) FOCUS AREAS.—The study conducted pursuant 3 to subsection (a) shall focus on education and policy needs 4 involving nonalcoholic fatty liver disease and nonalcoholic 5 steatohepatitis, including— 6 (1) opportunities to strengthen prevention of 7 nonalcoholic fatty liver disease and nonalcoholic 8 steatohepatitis, including through enhanced delivery 9 of nutrition services; 10 (2) barriers to diagnosis and treatment of non- 11 alcoholic fatty liver disease and nonalcoholic 12 steatohepatitis, including opportunities to strengthen 13 coverage under the Medicare program under title 14 XVIII of the Social Security Act (42 U.S.C. 1395 et 15 seq.), the Medicaid program under title XIX of such 16 Act (42 U.S.C. 1396 et seq.), group health plans (as 17 defined in section 2791 of the Public Health Service 18 Act (42 U.S.C. 300gg–91)), and group or individual 19 health insurance coverage (as such terms are defined 20 in such section 2791); 21 (3) recommendations for enhancing provider 22 education on nonalcoholic fatty liver disease and 23 nonalcoholic steatohepatitis; and 24 VerDate Sep 11 2014 21:52 Nov 13, 2020 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H8658.IH H8658 jbell on DSKJLSW7X2PROD with BILLS 8 •HR 8658 IH (4) recommendations for enhancing patient 1 awareness of nonalcoholic fatty liver disease and 2 nonalcoholic steatohepatitis, including early identi- 3 fication of risk factors and linkage to appropriate 4 care. 5 (c) REPORT.—The agreement entered into under sub- 6 section (a) shall require the National Academies of 7 Sciences to, not later than January 1, 2022, submit a re- 8 port on the findings of the study to the Secretary and the 9 Chairman and Ranking Member of each of the following 10 committees: 11 (1) The Committee on Energy and Commerce 12 of the House of Representatives. 13 (2) The Committee on Ways and Means of the 14 House of Representatives. 15 (3) The Committee on Finance of the Senate. 16 (4) The Committee on Health, Education, 17 Labor, and Pensions of the Senate. 18 (d) AUTHORIZATION OF APPROPRIATIONS.—There 19 are authorized to be appropriated to carry out this section 20 $1,000,000 for each of fiscal years 2021 and 2022. 21 VerDate Sep 11 2014 21:52 Nov 13, 2020 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H8658.IH H8658 jbell on DSKJLSW7X2PROD with BILLS 9 •HR 8658 IH SEC. 5. NATIONAL SURVEILLANCE PROGRAM FOR NON- 1 ALCOHOLIC FATTY LIVER DISEASE AND NON- 2 ALCOHOLIC STEATOHEPATITIS. 3 (a) IN GENERAL.—The Secretary of Health and 4 Human Services, acting through the Director of the Cen- 5 ters for Disease Control and Prevention, shall establish 6 a program to provide for surveillance on the prevalence 7 of nonalcoholic fatty liver disease and nonalcoholic 8 steatohepatitis in the United States. 9 (b) PROGRAM ACTIVITIES.— 10 (1) SURVEILLANCE ACTIVITIES.—The program 11 established under subsection (a) shall include, at a 12 minimum, each of the following surveillance activi- 13 ties: 14 (A) Conducting local surveillance activities 15 to collect data on the prevalence and severity of 16 nonalcoholic fatty level disease and nonalcoholic 17 steatohepatitis. 18 (B) Compiling and annually publishing 19 data on the number of individuals with non- 20 alcoholic fatty level disease and nonalcoholic 21 steatohepatitis nationally as well as in each 22 state. 23 (C) To the extent practicable, providing 24 data on the general population at risk of devel- 25 oping the conditions. 26 VerDate Sep 11 2014 21:52 Nov 13, 2020 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H8658.IH H8658 jbell on DSKJLSW7X2PROD with BILLS 10 •HR 8658 IH (2) TECHNICAL ASSISTANCE ON VITAL STATIS- 1 TICS.—In carrying out the program under sub- 2 section (a), the Secretary of Health and Human 3 Services, acting through the Director of the Centers 4 for Disease Control and Prevention, shall issue guid- 5 ance that provides technical assistance to health care 6 providers and State and local health departments on 7 best practices to ensure appropriate collection of 8 vital statistics for purposes of birth and death cer- 9 tificates, including vital statistics on populations 10 with nonalcoholic fatty level disease and nonalcoholic 11 steatohepatitis. 12 (c) AUTHORIZATION OF APPROPRIATIONS.—There 13 are authorized to be appropriated— 14 (1) to carry out surveillance activities described 15 in subsection (b)(1), $10,000,000 for each of fiscal 16 years 2021 and 2022; 17 (2) to carry out technical assistance activities 18 described in subsection (b)(3), $10,000,000 for each 19 of fiscal years 2021 and 2022; and 20 (3) to carry out the activities described in sub- 21 section (b)(2), $5,000,000 for each of fiscal years 22 2021 through 2025. 23 VerDate Sep 11 2014 21:52 Nov 13, 2020 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H8658.IH H8658 jbell on DSKJLSW7X2PROD with BILLS 11 •HR 8658 IH SEC. 6. RECOMMENDATIONS FOR THE PREVENTION, 1 SCREENING, DIAGNOSIS, AND TREATMENT OF 2 INTERRELATED CONDITIONS DEVELOPED BY 3 MULTIDISCIPLINARY TASK FORCE. 4 (a) IN GENERAL.—Not later than 180 days after the 5 date of the enactment of this Act, the Secretary of Health 6 and Human Services shall establish a multidisciplinary 7 task force, and appoint members to such task force, to 8 develop recommendations for the prevention, screening, di- 9 agnosis, and treatment for several interrelated conditions, 10 including, at a minimum— 11 (1) nonalcoholic fatty liver disease; 12 (2) nonalcoholic steatohepatitis; 13 (3) obesity; 14 (4) diabetes and other metabolic disorders; and 15 (5) any other conditions determined appropriate 16 by the Secretary. 17 (b) MEMBERSHIP.—The task force established under 18 subsection (a) shall be composed of not more than 12 19 members to be appointed by the Secretary and shall in- 20 clude representatives of each of the following groups: 21 (1) Physician specialists, including in 22 hepatology, gastroenterology, endocrinology, cardi- 23 ology, and endocrinology. 24 (2) Experts in public health and epidemiology. 25 (3) Patient advocates. 26 VerDate Sep 11 2014 21:52 Nov 13, 2020 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H8658.IH H8658 jbell on DSKJLSW7X2PROD with BILLS 12 •HR 8658 IH (4) Non-voting representatives of Federal agen- 1 cies, including the Food and Drug Administration, 2 the National Institutes of Health, the Centers for 3 Disease Control and Prevention, and the Office of 4 the Assistant Secretary for Health of the Depart- 5 ment of Health and Human Services. 6 (5) Non-voting representatives of manufactur- 7 ers of drugs, devices, or diagnosti [Text truncated for display. 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