I 

108TH CONGRESS 

1ST SESSION H. R. 3539

To amend the Public Health Service Act to direct the Secretary of Health 

and Human Services to establish, promote, and support a comprehensive 

prevention, research, and medical management referral program for hepatitis C virus infection. 

IN THE HOUSE OF REPRESENTATIVES 

NOVEMBER 19, 2003

Mrs. WILSON of New Mexico (for herself and Mr. TOWNS) introduced the 

following bill; which was referred to the Committee on Energy and Commerce 

A BILL

To amend the Public Health Service Act to direct the Secretary of Health and Human Services to establish, promote, and support a comprehensive prevention, research, 

and medical management referral program for hepatitis 

C virus infection.

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. 

4 This Act may be cited as the ‘‘Hepatitis C Epidemic 

5 Control and Prevention Act’’. 

6 SEC. 2. FINDINGS. 

7 Congress makes the following findings: 
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1 (1) Over 3,000,000 individuals in the United 

2 States are chronically infected with the hepatitis C 

3 virus (referred to in this section as ‘‘HCV’’), making 

4 it the Nation’s most common blood-borne viral infec5 tion. 

6 (2) Nearly 2 percent of the population of the 

7 United States has been infected with HCV. 

8 (3) Conservative estimates indicate that ap9 proximately 35,000 Americans are newly infected 

10 with HCV each year. 

11 (4) HCV infection can cause life-threatening 

12 liver disease. 

13 (5) Individuals infected with HCV serve as a 

14 source of transmission to others and, since few indi15 viduals are aware they are infected, are unlikely to 

16 take precautions to prevent the spread or exacer17 bation of their infection. 

18 (6) There is no vaccine available to prevent 

19 HCV infection. 

20 (7) Treatments are available to slow the pro21 gression of chronic HCV. 

22 (8) An estimated 2,400,000 to 2,700,000 peo23 ple who are chronically infected with HCV are re24 ceiving no treatment. 
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1 (9) Conservative estimates place the costs of 

2 lost productivity and medical care arising from 

3 chronic HCV in the United States at more than 

4 $600,000,000 annually, and such costs will undoubt5 edly increase in the absence of expanded prevention 

6 and treatment efforts. 

7 (10) To combat the HCV epidemic in the 

8 United States, the Centers for Disease Control and 

9 Prevention developed Recommendations for Preven10 tion and Control of Hepatitis C Virus (HCV) Infec11 tion and HCV-Related Chronic Disease in 1998 and 

12 the National Hepatitis C Prevention Strategy in 

13 2001, and the National Institutes of Health con14 vened Consensus Development Conferences on the 

15 Management of Hepatitis C in 1997 and 2002. 

16 These recommendations and guidelines provide a 

17 framework for HCV prevention, control, research, 

18 and medical management referral programs. 

19 (11) Federal support is necessary to increase 

20 knowledge and awareness of HCV and to assist 

21 State and local prevention and control efforts. 
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1 SEC. 3. PREVENTION, CONTROL, AND MEDICAL MANAGE2 MENT OF HEPATITIS C. 

3 Title III of the Public Health Service Act (42 U.S.C. 

4 241 et seq.) is amended by adding at the end the fol5 lowing: 

6 ‘‘PART R—PREVENTION, CONTROL, AND MEDICAL 

7 MANAGEMENT OF HEPATITIS C 

8 ‘‘SEC. 399AA. FEDERAL PLAN FOR THE PREVENTION, CON9 TROL, AND MEDICAL MANAGEMENT OF HEPA10 TITIS C. 

11 ‘‘(a) IN GENERAL.—The Secretary shall develop and 

12 implement a plan for the prevention, control, and medical 

13 management of hepatitis C (referred to in this part as 

14 ‘HCV’) which includes strategies for education and train15 ing, surveillance and early detection, and research. 

16 ‘‘(b) INPUT IN DEVELOPMENT OF PLAN.—In devel17 oping the plan under subsection (a), the Secretary shall—

18 ‘‘(1) be guided by existing recommendations of 

19 the Centers for Disease Control and Prevention and 

20 the National Institutes of Health; and 

21 ‘‘(2) consult with—

22 ‘‘(A) the Director of the Centers for Dis23 ease Control and Prevention; 

24 ‘‘(B) the Director of the National Insti25 tutes of Health; 
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1 ‘‘(C) the Director of the Health Resources 

2 and Services Administration; 

3 ‘‘(D) the heads of other Federal agencies 

4 or offices providing services to individuals with 

5 HCV infections or the functions of which other6 wise involve HCV; 

7 ‘‘(E) medical advisory bodies that address 

8 issues related to HCV; and 

9 ‘‘(F) the public, including—

10 ‘‘(i) individuals infected with HCV; 

11 and 

12 ‘‘(ii) advocates concerned with issues 

13 related to HCV. 

14 ‘‘(c) BIENNIAL UPDATE OF PLAN.—

15 ‘‘(1) IN GENERAL.—The Secretary shall con16 duct a biennial assessment of the plan developed 

17 under subsection (a) for the purpose of incor18 porating into such plan new knowledge or observa19 tions relating to HCV and chronic HCV (such as 

20 knowledge and observations that may be derived 

21 from clinical, laboratory, and epidemiological re22 search and disease detection, prevention, and surveil23 lance outcomes) and addressing gaps in the coverage 

24 or effectiveness of the plan. 
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1 ‘‘(2) PUBLICATION OF NOTICE OF ASSESS2 MENTS.—Not later than October 1 of the first even3 numbered year beginning after the date of enact4 ment of this part, and October 1 of each even-num5 bered year thereafter, the Secretary shall publish in 

6 the Federal Register a notice of the results of the 

7 assessments conducted under paragraph (1). Such 

8 notice shall include—

9 ‘‘(A) a description of any revisions to the 

10 plan developed under subsection (a) as a result 

11 of the assessment; 

12 ‘‘(B) an explanation of the basis for any 

13 such revisions, including the ways in which such 

14 revisions can reasonably be expected to further 

15 promote the original goals and objectives of the 

16 plan; and 

17 ‘‘(C) in the case of a determination by the 

18 Secretary that the plan does not need revision, 

19 an explanation of the basis for such determina20 tion. 

21 ‘‘SEC. 399BB. ELEMENTS OF THE FEDERAL PLAN FOR THE 

22 PREVENTION, CONTROL, AND MEDICAL MAN23 AGEMENT OF HEPATITIS C. 

24 ‘‘(a) EDUCATION AND TRAINING.—The Secretary, 

25 acting through the Director of the Centers for Disease 
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1 Control and Prevention, shall implement programs to in2 crease awareness and enhance knowledge and under3 standing of HCV. Such programs shall include—

4 ‘‘(1) the conduct of health education, public 

5 awareness campaigns, and community outreach ac6 tivities to promote public awareness and knowledge 

7 about risk factors, the transmission and prevention 

8 of infection with HCV, the value of screening for the 

9 early detection of HCV infection, and options avail10 able for the treatment of chronic HCV; 

11 ‘‘(2) the training of health care professionals 

12 regarding the prevention, detection, and medical 

13 management of hepatitis B (referred to in this part 

14 as ‘HBV’) and HCV, and the importance of vacci15 nating HCV-infected individuals and those at risk 

16 for HCV infection against the hepatitis A virus and 

17 hepatitis B virus; and 

18 ‘‘(3) the development and distribution of cur19 ricula (including information relating to the special 

20 needs of individuals infected with HBV or HCV, 

21 such as the importance of early intervention and 

22 treatment and the recognition of psychosocial needs) 

23 for individuals providing hepatitis counseling, as well 

24 as support for the implementation of such curricula 

25 by State and local public health agencies. 
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1 ‘‘(b) EARLY DETECTION AND SURVEILLANCE.—

2 ‘‘(1) IN GENERAL.—The Secretary, acting 

3 through the Director of the Centers for Disease 

4 Control and Prevention, shall support activities de5 scribed in paragraph (2) to promote the early detec6 tion of HCV infection, identify risk factors for infec7 tion, and conduct surveillance of HCV infection 

8 trends. 

9 ‘‘(2) ACTIVITIES.—

10 ‘‘(A) VOLUNTARY TESTING PROGRAMS.—

11 ‘‘(i) IN GENERAL.—The Secretary 

12 shall support and promote the development 

13 of State, local, and tribal voluntary HCV 

14 testing programs to aid in the early identi15 fication of infected individuals. 

16 ‘‘(ii) CONFIDENTIALITY OF TEST RE17 SULTS.—The results of an HCV test con18 ducted by a testing program developed or 

19 supported under this subparagraph shall 

20 be considered protected health information 

21 (in a manner consistent with regulations 

22 promulgated under section 264(c) of the 

23 Health Insurance Portability and Account24 ability Act of 1996) and may not be used 

25 for any of the following: 
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1 ‘‘(I) Issues relating to health in2 surance. 

3 ‘‘(II) To screen or determine 

4 suitability for employment. 

5 ‘‘(III) To discharge a person 

6 from employment. 

7 ‘‘(B) COUNSELING REGARDING VIRAL HEP8 ATITIS.—The Secretary shall support State, 

9 local, and tribal programs in a wide variety of 

10 settings, including those providing primary and 

11 specialty health care services in the private and 

12 the public sectors, to—

13 ‘‘(i) provide individuals with informa14 tion about ongoing risk factors for HCV 

15 infection with client-centered education 

16 and counseling which concentrates on 

17 changing behaviors that place them at risk 

18 for infection; and 

19 ‘‘(ii) provide individuals infected with 

20 HCV with education and counseling to re21 duce the risk of harm to themselves and 

22 transmission of the virus to others. 

23 ‘‘(C) VACCINATION AGAINST VIRAL HEPA24 TITIS.—With respect to individuals infected, or 
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1 at risk for infection, with HCV, the Secretary 

2 shall provide for—

3 ‘‘(i) the vaccination of such individ4 uals against hepatitis A virus, HBV, and 

5 other infectious diseases, as appropriate, 

6 for which such individuals may be at in7 creased risk; and 

8 ‘‘(ii) the counseling of such individuals 

9 regarding hepatitis A, hepatitis B, and 

10 other viral hepatides. 

11 ‘‘(D) MEDICAL REFERRAL.—The Secretary 

12 shall support—

13 ‘‘(i) referral of persons infected with 

14 or at risk for HCV, for drug or alcohol 

15 abuse treatment where appropriate; and 

16 ‘‘(ii) referral of persons infected with 

17 HCV—

18 ‘‘(I) for medical evaluation to de19 termine their stage of chronic HCV 

20 and suitability for antiviral treatment; 

21 and 

22 ‘‘(II) for ongoing medical man23 agement of HCV. 

24 ‘‘(3) HEPATITIS C COORDINATORS.—The Sec25 retary, acting through the Director of the Centers 
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1 for Disease Control and Prevention, shall, upon re2 quest, provide a Hepatitis C Coordinator to a State 

3 health department in order to enhance the additional 

4 management, networking, and technical expertise 

5 needed to ensure successful integration of HCV pre6 vention and control activities into existing public 

7 health programs. 

8 ‘‘(c) SURVEILLANCE AND EPIDEMIOLOGY.—

9 ‘‘(1) IN GENERAL.—The Secretary shall pro10 mote and support the establishment and mainte11 nance of State HCV surveillance databases, in order 

12 to—

13 ‘‘(A) identify risk factors for HCV infec14 tion; 

15 ‘‘(B) identify trends in the incidence of 

16 acute and chronic HCV; 

17 ‘‘(C) identify trends in the prevalence of 

18 HCV infection among groups that may be dis19 proportionately affected by HCV, including in20 dividuals living with HIV, military veterans, 

21 emergency first responders, racial or ethnic mi22 norities, and individuals who engage in high 

23 risk behaviors, such as intravenous drug use; 

24 and 
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1 ‘‘(D) assess and improve HCV infection 

2 prevention programs. 

3 ‘‘(2) SEROPREVALENCE STUDIES.—The Sec4 retary shall conduct a population-based 

5 seroprevalence study to estimate the current and fu6 ture impact of HCV. Such studies shall consider the 

7 economic and clinical impacts of HCV, as well as the 

8 impact of HCV on quality of life. 

9 ‘‘(3) CONFIDENTIALITY.—Information con10 tained in the databases under paragraph (1) or de11 rived through studies under paragraph (2) shall be 

12 de-identified in a manner consistent with regulations 

13 under section 264(c) of the Health Insurance Port14 ability and Accountability Act of 1996. 

15 ‘‘(d) RESEARCH NETWORK.—The Secretary, acting 

16 through the Director of the Centers for Disease Control 

17 and Prevention and the Director of the National Institutes 

18 of Health, shall—

19 ‘‘(1) conduct epidemiologic research to identify 

20 best practices for HCV prevention; 

21 ‘‘(2) establish and support a Hepatitis C Clin22 ical Research Network for the purpose of conducting 

23 research related to the treatment and medical man24 agement of HCV; and 
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1 ‘‘(3) conduct basic research to identify new ap2 proaches to prevention (such as vaccines) and treat3 ment for HCV. 

4 ‘‘(e) REFERRAL FOR MEDICAL MANAGEMENT OF

5 CHRONIC HEPATITIS C.—The Secretary shall support and 

6 promote State, local, and tribal programs to provide HCV7 positive individuals with referral for medical evaluation 

8 and management, including currently recommended 

9 antiviral therapy when appropriate. 

10 ‘‘(f) UNDERSERVED AND DISPROPORTIONATELY AF11 FECTED POPULATIONS.—In carrying out this section, the 

12 Secretary shall provide expanded support for individuals 

13 with limited access to health education, testing, and health 

14 care services and groups that may be disproportionately 

15 affected by HCV. 

16 ‘‘(g) EVALUATION OF PROGRAM.—The Secretary 

17 shall develop benchmarks for evaluating the effectiveness 

18 of the programs and activities conducted under this sec19 tion and make determinations as to whether such bench20 marks have been achieved. 

21 ‘‘SEC. 399CC. GRANTS. 

22 ‘‘(a) IN GENERAL.—The Secretary may award grants 

23 to, or enter into contracts or cooperative agreements with, 

24 States, political subdivisions of States, Indian tribes, or 
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1 nonprofit entities that have special expertise relating to 

2 HCV, to carry out activities under this part. 

3 ‘‘(b) APPLICATION.—To be eligible for a grant, con4 tract, or cooperative agreement under subsection (a), an 

5 entity shall prepare and submit to the Secretary an appli6 cation at such time, in such manner, and containing such 

7 information as the Secretary may require. 

8 ‘‘SEC. 399DD. AUTHORIZATION OF APPROPRIATIONS. 

9 ‘‘There are authorized to be appropriated to carry out 

10 this part $90,000,000 for fiscal year 2004, and such sums 

11 as may be necessary for each of fiscal years 2005 through 

12 2008.’’. 

13 SEC. 4. LIVER DISEASE RESEARCH ADVISORY BOARD. 

14 Part B of title IV of the Public Health Service Act 

15 (42 U.S.C. 284 et seq.) is amended by adding at the end 

16 the following: 

17 ‘‘SEC. 409J. LIVER DISEASE RESEARCH ADVISORY BOARD. 

18 ‘‘(a) ESTABLISHMENT.—Not later than 90 days after 

19 the date of enactment of this section, the Director of the 

20 National Institutes of Health shall establish a board to 

21 be known as the Liver Disease Research Advisory Board 

22 (referred to in this section as the ‘Advisory Board’). 

23 ‘‘(b) DUTIES.—The Advisory Board shall advise and 

24 assist the Director of the National Institutes of Health 

25 concerning matters relating to liver disease research, in-
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1 cluding by developing and revising the Liver Disease Re2 search Action Plan. 

3 ‘‘(c) VOTING MEMBERS.—The Advisory Board shall 

4 be composed of 18 voting members to be appointed by the 

5 Director of the National Institutes of Health, in consulta6 tion with the Director of the National Institute of Diabe7 tes and Digestive and Kidney Diseases, of whom 12 such 

8 individuals shall be eminent scientists and 6 such individ9 uals shall be lay persons. The Director of the National 

10 Institutes of Health, in consultation with the Director of 

11 the Institute, shall select 1 of the members to serve as 

12 the Chair of the Advisory Board. 

13 ‘‘(d) EX OFFICIO MEMBERS.—The Director of the 

14 National Institutes of Health shall appoint each director 

15 of a national research institute that funds liver disease re16 search to serve as a nonvoting, ex officio member of the 

17 Advisory Board. The Director of the National Institutes 

18 of Health shall invite 1 representative of the Centers for 

19 Disease Control and Prevention, 1 representative of the 

20 Food and Drug Administration, and 1 representative of 

21 the Department of Veterans Affairs to serve as such a 

22 member. Each ex officio member of the Advisory Board 

23 may appoint an individual to serve as that member’s rep24 resentative on the Advisory Board. 

25 ‘‘(e) LIVER DISEASE RESEARCH ACTION PLAN.—
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1 ‘‘(1) DEVELOPMENT.—Not later than 15 

2 months after the date of the enactment of this sec3 tion, the Advisory Board shall develop (with appro4 priate support from the Director) a comprehensive 

5 plan for the conduct and support of liver disease re6 search to be known as the Liver Disease Research 

7 Action Plan. The Advisory Board shall submit the 

8 Plan to the Director of NIH and the head of each 

9 institute or center within the National Institutes of 

10 Health that funds liver disease research. 

11 ‘‘(2) CONTENT.—The Liver Disease Research 

12 Action Plan shall identify scientific opportunities 

13 and priorities of liver disease research necessary to 

14 increase understanding of and to prevent, cure, and 

15 develop better treatment protocols for liver diseases. 

16 ‘‘(3) REVISION.—The Advisory Board shall re17 vise every 2 years the Liver Disease Research Action 

18 Plan, but shall meet annually to review progress and 

19 to amend the Plan as may be appropriate because 

20 of new scientific discoveries.’’.

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