II 

109TH CONGRESS 

1ST SESSION S. 521 

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 SENATE OF THE UNITED STATES 

MARCH 3, 2005 

Mrs. HUTCHISON (for herself, Mr. KENNEDY, Mr. CORNYN, and Mr. SCHUMER) introduced the following bill; which was read twice and referred to 

the Committee on Health, Education, Labor, and Pensions 

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) Approximately 5,000,000 Americans are in2 fected with the hepatitis C virus (referred to in this 

3 section as ‘‘HCV’’), and more than 3,000,000 Amer4 icans are chronically infected, making HCV the Na5 tion’s most common chronic blood borne virus infec6 tion. 

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

8 United States have been infected with HCV. 

9 (3) Conservative estimates indicate that ap10 proximately 30,000 Americans are newly infected 

11 with HCV each year, and that number has been 

12 growing since 2001. 

13 (4) HCV infection, in the United States, is the 

14 most common cause of chronic liver disease, liver 

15 cirrhosis, and liver cancer, the most common indica16 tion for liver transplant, and the leading cause of 

17 death in people with HIV/AIDS. In addition, there 

18 may be links between HCV and certain other dis19 eases, given that a high number of people infected 

20 with HCV also suffer from type 2 diabetes, 

21 lymphoma, thyroid and certain blood disorders, and 

22 autoimmune disease. 

23 (5) The majority of individuals infected with 

24 HCV are unaware of their infection. Individuals in25 fected with HCV serve as a source of transmission 
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1 to others and, since few individuals are aware they 

2 are infected, they are unlikely to take precautions to 

3 prevent the spread or exacerbation of their infection. 

4 (6) There is no vaccine available to prevent 

5 HCV infection. 

6 (7) Treatments are available that can eradicate 

7 the disease in approximately 50 percent of those who 

8 are treated, and behavioral changes can slow the 

9 progression of the disease. 

10 (8) Conservative estimates place the costs of di11 rect medical expenses for HCV at more than 

12 $1,000,000,000 in the United States annually, and 

13 such costs will undoubtedly increase in the absence 

14 of expanded prevention and treatment efforts. 

15 (9) To combat the HCV epidemic in the United 

16 States, the Centers for Disease Control and Preven17 tion developed Recommendations for Prevention and 

18 Control of Hepatitis C Virus (HCV) Infection and 

19 HCV-Related Chronic Disease in 1998 and the Na20 tional Hepatitis C Prevention Strategy in 2001, and 

21 the National Institutes of Health convened Con22 sensus Development Conferences on the Manage23 ment of Hepatitis C in 1997 and 2002. These rec24 ommendations and guidelines provide a framework 
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1 for HCV prevention, control, research, and medical 

2 management referral programs. 

3 (10) The Department of Veterans Affairs (re4 ferred to in this paragraph as the ‘‘VA’’), which 

5 cares for more people infected with HCV than any 

6 other health care system, is the Nation’s leader in 

7 HCV screening, testing, and treatment. Since 1998, 

8 it has been the VA’s policy to screen for HCV risk 

9 factors all veterans receiving VA health care, and 

10 the VA currently recommends testing for all those 

11 who are found to be ‘‘at risk’’ for the virus and for 

12 all others who wish to be tested. In fiscal year 2004, 

13 over 98 percent of VA patients had been screened 

14 for HCV risk factors, and over 90 percent of those 

15 ‘‘at risk’’ were tested. For all veterans who test posi16 tive for HCV and enroll in VA medical care, the VA 

17 offers medications that can help HCV or its com18 plications. The VA also has programs for HCV pa19 tient and provider education, clinical care, data20 based quality improvement, and research, and it has 

21 4 Hepatitis C Resource Centers to develop and dis22 seminate innovative practices and tools to improve 

23 patient care. This comprehensive program should be 

24 commended and could potentially serve as a model 

25 for future HCV programs. 
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1 (11) Federal support is necessary to increase 

2 knowledge and awareness of HCV and to assist 

3 State and local prevention and control efforts. 

4 SEC. 3. PREVENTION, CONTROL, AND MEDICAL MANAGE5 MENT OF HEPATITIS C. 

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

7 241 et seq.) is amended by adding at the end the fol8 lowing: 

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

10 MANAGEMENT OF HEPATITIS C 

11 ‘‘SEC. 399AA. FEDERAL PLAN FOR THE PREVENTION, CON12 TROL, AND MEDICAL MANAGEMENT OF HEPA13 TITIS C. 

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

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

16 management of the hepatitis C virus (referred to in this 

17 part as ‘HCV’) that includes strategies for education and 

18 training, surveillance and early detection, and research. 

19 ‘‘(b) INPUT IN DEVELOPMENT OF PLAN.—In devel20 oping the plan under subsection (a), the Secretary shall— 

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

22 the Centers for Disease Control and Prevention and 

23 the National Institutes of Health; and 

24 ‘‘(2) consult with— 
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1 ‘‘(A) the Director of the Centers for Dis2 ease Control and Prevention; 

3 ‘‘(B) the Director of the National Insti4 tutes of Health; 

5 ‘‘(C) the Administrator of the Health Re6 sources and Services Administration; 

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

8 or offices providing services to individuals with 

9 HCV infections or the functions of which other10 wise involve HCV; 

11 ‘‘(E) medical advisory bodies that address 

12 issues related to HCV; and 

13 ‘‘(F) the public, including— 

14 ‘‘(i) individuals infected with the 

15 HCV; and 

16 ‘‘(ii) advocates concerned with issues 

17 related to HCV. 

18 ‘‘(c) BIENNIAL ASSESSMENT OF PLAN.— 

19 ‘‘(1) IN GENERAL.—The Secretary shall con20 duct a biennial assessment of the plan developed 

21 under subsection (a) for the purpose of incor22 porating into such plan new knowledge or observa23 tions relating to HCV and chronic HCV (such as 

24 knowledge and observations that may be derived 

25 from clinical, laboratory, and epidemiological re-
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1 search and disease detection, prevention, and surveil2 lance outcomes) and addressing gaps in the coverage 

3 or effectiveness of the plan. 

4 ‘‘(2) PUBLICATION OF NOTICE OF ASSESS5 MENTS.—Not later than October 1 of the first even 

6 numbered year beginning after the date of enact7 ment of the Hepatitis C Epidemic Control and Pre8 vention Act, and October 1 of each even numbered 

9 year thereafter, the Secretary shall publish in the 

10 Federal Register a notice of the results of the as11 sessments conducted under paragraph (1). Such no12 tice shall include— 

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

14 plan developed under subsection (a) as a result 

15 of the assessment; 

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

17 such revisions, including the ways in which such 

18 revisions can reasonably be expected to further 

19 promote the original goals and objectives of the 

20 plan; and 

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

22 Secretary that the plan does not need revision, 

23 an explanation of the basis for such determina24 tion. 
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1 ‘‘SEC. 399BB. ELEMENTS OF THE FEDERAL PLAN FOR THE 

2 PREVENTION, CONTROL, AND MEDICAL MAN3 AGEMENT OF HEPATITIS C. 

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

5 acting through the Director of the Centers for Disease 

6 Control and Prevention, shall implement programs to in7 crease awareness and enhance knowledge and under8 standing of HCV. Such programs shall include— 

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

10 awareness campaigns, and community outreach ac11 tivities to promote public awareness and knowledge 

12 about risk factors, the transmission and prevention 

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

14 early detection of HCV infection, and options avail15 able for the treatment of chronic HCV; 

16 ‘‘(2) the training of healthcare professionals re17 garding the prevention, detection, and medical man18 agement of the hepatitis B virus (referred to in this 

19 part as ‘HBV’) and HCV, and the importance of 

20 vaccinating HCV-infected individuals and those at 

21 risk for HCV infection against the hepatitis A virus 

22 and HBV; and 

23 ‘‘(3) the development and distribution of cur24 ricula (including information relating to the special 

25 needs of individuals infected with HBV or HCV, 

26 such as the importance of early intervention and 
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1 treatment and the recognition of psychosocial needs) 

2 for individuals providing hepatitis counseling, as well 

3 as support for the implementation of such curricula 

4 by State and local public health agencies. 

5 ‘‘(b) EARLY DETECTION AND SURVEILLANCE.— 

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

7 through the Director of the Centers for Disease 

8 Control and Prevention, shall support activities de9 scribed in paragraph (2) to promote the early detec10 tion of HCV infection, identify risk factors for infec11 tion, and conduct surveillance of HCV infection 

12 trends. 

13 ‘‘(2) ACTIVITIES.— 

14 ‘‘(A) VOLUNTARY TESTING PROGRAMS.— 

15 ‘‘(i) IN GENERAL.—The Secretary 

16 shall support and promote the development 

17 of State, local, and tribal voluntary HCV 

18 testing programs to aid in the early identi19 fication of infected individuals. 

20 ‘‘(ii) CONFIDENTIALITY OF TEST RE21 SULTS.—The results of a HCV test con22 ducted by a testing program developed or 

23 supported under this subparagraph shall 

24 be considered protected health information 

25 (in a manner consistent with regulations 
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1 promulgated under section 264(c) of the 

2 Health Insurance Portability and Account3 ability Act of 1996 (42 U.S.C. 1320d–2 

4 note)) and may not be used for any of the 

5 following: 

6 ‘‘(I) Issues relating to health in7 surance. 

8 ‘‘(II) To screen or determine 

9 suitability for employment. 

10 ‘‘(III) To discharge a person 

11 from employment. 

12 ‘‘(B) COUNSELING REGARDING VIRAL HEP13 ATITIS.—The Secretary shall support State, 

14 local, and tribal programs in a wide variety of 

15 settings, including those providing primary and 

16 specialty healthcare services in nonprofit private 

17 and public sectors, to— 

18 ‘‘(i) provide individuals with informa19 tion about ongoing risk factors for HCV 

20 infection with client-centered education 

21 and counseling that concentrates on chang22 ing behaviors that place them at risk for 

23 infection; and 

24 ‘‘(ii) provide individuals infected with 

25 HCV with education and counseling to re-
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1 duce the risk of harm to themselves and 

2 transmission of the virus to others. 

3 ‘‘(C) VACCINATION AGAINST VIRAL HEPA4 TITIS.—With respect to individuals infected, or 

5 at risk for infection, with HCV, the Secretary 

6 shall provide for— 

7 ‘‘(i) the vaccination of such individ8 uals against hepatitis A virus, HBV, and 

9 other infectious diseases, as appropriate, 

10 for which such individuals may be at in11 creased risk; and 

12 ‘‘(ii) the counseling of such individuals 

13 regarding hepatitis A, HBV, and other 

14 viral hepatides. 

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

16 shall support— 

17 ‘‘(i) referral of persons infected with 

18 or at risk for HCV, for drug or alcohol 

19 abuse treatment where appropriate; and 

20 ‘‘(ii) referral of persons infected with 

21 HCV— 

22 ‘‘(I) for medical evaluation to de23 termine their stage of chronic HCV 

24 and suitability for antiviral treatment; 

25 and 
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1 ‘‘(II) for ongoing medical man2 agement of HCV. 

3 ‘‘(3) HEPATITIS C COORDINATORS.—The Sec4 retary, acting through the Director of the Centers 

5 for Disease Control and Prevention, shall, upon re6 quest, provide a Hepatitis C Coordinator to a State 

7 health department in order to enhance the manage8 ment, networking, and technical expertise needed to 

9 ensure successful integration of HCV prevention and 

10 control activities into existing public health pro11 grams. 

12 ‘‘(c) SURVEILLANCE AND EPIDEMIOLOGY.— 

13 ‘‘(1) IN GENERAL.—The Secretary shall pro14 mote and support the establishment and mainte15 nance of State HCV surveillance databases, in order 

16 to— 

17 ‘‘(A) identify risk factors for HCV infec18 tion; 

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

20 acute and chronic HCV; 

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

22 HCV infection among groups that may be dis23 proportionately affected by HCV, including in24 dividuals living with HIV, military veterans, 

25 emergency first responders, racial or ethnic mi-
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1 norities, and individuals who engage in high 

2 risk behaviors, such as intravenous drug use; 

3 and 

4 ‘‘(D) assess and improve HCV infection 

5 prevention programs. 

6 ‘‘(2) SEROPREVALENCE STUDIES.—The Sec7 retary shall conduct a population-based 

8 seroprevalence study to estimate the current and fu9 ture impact of HCV. Such studies shall consider the 

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

11 impact of HCV on quality of life. 

12 ‘‘(3) CONFIDENTIALITY.—Information con13 tained in the databases under paragraph (1) or de14 rived through studies under paragraph (2) shall be 

15 de-identified in a manner consistent with regulations 

16 under section 264(c) of the Health Insurance Port17 ability and Accountability Act of 1996. 

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

19 through the Director of the Centers for Disease Control 

20 and Prevention and the Director of the National Institutes 

21 of Health, shall— 

22 ‘‘(1) conduct epidemiologic research to identify 

23 best practices for HCV prevention; 

24 ‘‘(2) establish and support a Hepatitis C Clin25 ical Research Network for the purpose of conducting 
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1 research related to the treatment and medical man2 agement of HCV; and 

3 ‘‘(3) conduct basic research to identify new ap4 proaches to prevention (such as vaccines) and treat5 ment for HCV. 

6 ‘‘(e) REFERRAL FOR MEDICAL MANAGEMENT OF

7 CHRONIC HCV.—The Secretary shall support and pro8 mote State, local, and tribal programs to provide HCV9 positive individuals with referral for medical evaluation 

10 and management, including currently recommended 

11 antiviral therapy when appropriate. 

12 ‘‘(f) UNDERSERVED AND DISPROPORTIONATELY AF13 FECTED POPULATIONS.—In carrying out this section, the 

14 Secretary shall provide expanded support for individuals 

15 with limited access to health education, testing, and 

16 healthcare services and groups that may be disproportion17 ately affected by HCV. 

18 ‘‘(g) STUDY AND REPORT REGARDING VA PROGRAM

19 AND FEDERAL PLAN.— 

20 ‘‘(1) STUDY.—The Secretary shall conduct a 

21 study to examine the comprehensive HCV programs 

22 that have been implemented by the Department of 

23 Veterans Affairs (referred to in this subsection as 

24 the ‘VA’), including the Hepatitis C Resource Center 

25 program, to determine whether any of these pro-
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1 grams, or components of these programs, should be 

2 part of the Federal plan to combat HCV. 

3 ‘‘(2) REPORT.—Not later than 12 months after 

4 date of enactment of the Hepatitis C Epidemic Con5 trol and Prevention Act, the Secretary shall submit 

6 to Congress a report that describes the results of the 

7 study required under paragraph (1). 

8 ‘‘(3) CONSIDERATION OF REPORT.—The Sec9 retary shall take into consideration the content of 

10 the report required under paragraph (2) in con11 ducting the biennial assessment required under sec12 tion 399AA(c). 

13 ‘‘(h) EVALUATION OF PROGRAM.—The Secretary 

14 shall develop benchmarks for evaluating the effectiveness 

15 of the programs and activities conducted under this sec16 tion and make determinations as to whether such bench17 marks have been achieved. 

18 ‘‘SEC. 399CC. GRANTS. 

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

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

21 States, political subdivisions of States, Indian tribes, or 

22 nonprofit entities that have special expertise relating to 

23 HCV, to carry out activities under this part. 

24 ‘‘(b) APPLICATION.—To be eligible for a grant, con25 tract, or cooperative agreement under subsection (a), an 
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1 entity shall prepare and submit to the Secretary an appli2 cation at such time, in such manner, and containing such 

3 information as the Secretary may require. 

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

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

6 this part $90,000,000 for fiscal year 2006, and such sums 

7 as may be necessary for each of fiscal years 2007 through 

8 2010.’’. 

9 SEC. 4. LIVER DISEASE RESEARCH ADVISORY BOARD. 

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

11 (42 U.S.C. 284 et seq.) is amended by adding at the end 

12 the following: 

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

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

15 the date of enactment of the Hepatitis C Epidemic Control 

16 and Prevention Act, the Director of the National Insti17 tutes of Health shall establish a board to be known as 

18 the Liver Disease Research Advisory Board (referred to 

19 in this section as the ‘Advisory Board’). 

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

21 assist the Director of the National Institutes of Health 

22 concerning matters relating to liver disease research, in23 cluding by developing and revising the Liver Disease Re24 search Action Plan. 
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1 ‘‘(c) VOTING MEMBERS.—The Advisory Board shall 

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

3 Director of the National Institutes of Health, in consulta4 tion with the Director of the National Institute of Diabe5 tes and Digestive and Kidney Diseases (referred to in this 

6 subsection as the ‘NIDDK’), of whom 12 such individuals 

7 shall be eminent scientists and 6 such individuals shall be 

8 lay persons. The Director of the National Institutes of 

9 Health, in consultation with the Director of the NIDDK, 

10 shall select 1 of the members to serve as the Chair of the 

11 Advisory Board. 

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

13 National Institutes of Health shall appoint each director 

14 of a national research institute that funds liver disease re15 search to serve as a nonvoting, ex officio member of the 

16 Advisory Board. The Director of the National Institutes 

17 of Health shall invite 1 representative of the Centers for 

18 Disease Control and Prevention, 1 representative of the 

19 Food and Drug Administration, and 1 representative of 

20 the Department of Veterans Affairs to serve as such a 

21 member. Each ex officio member of the Advisory Board 

22 may appoint an individual to serve as that member’s rep23 resentative on the Advisory Board. 

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

2 months after the date of enactment of the Hepatitis 

3 C Epidemic Control and Prevention Act, the Advi4 sory Board shall develop (with appropriate support 

5 from the Director) a comprehensive plan for the con6 duct and support of liver disease research to be 

7 known as the Liver Disease Research Action Plan. 

8 The Advisory Board shall submit the Plan to the Di9 rector of National Institutes of Health and the head 

10 of each institute or center within the National Insti11 tutes of Health that funds liver disease research. 

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

13 Action Plan shall identify scientific opportunities 

14 and priorities for liver disease research necessary to 

15 increase understanding of and to prevent, cure, and 

16 develop better treatment protocols for liver diseases. 

17 ‘‘(3) REVISION.—The Advisory Board shall re18 vise every 2 years the Liver Disease Research Action 

19 Plan, but shall meet annually to review progress and 

20 to amend the Plan as may be appropriate because 

21 of new scientific discoveries.’’. 

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