II 

110TH CONGRESS 

1ST SESSION S. 1445 

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 

MAY 22, 2007 

Mr. KENNEDY (for himself and Mrs. HUTCHISON) 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, leading the Centers 

5 for Disease Control and Prevention (referred to in 

6 this section as the ‘‘CDC’’) to recognize HCV as the 

7 Nation’s most common chronic blood-borne virus in8 fection. 

9 (2) According to the CDC, nearly 2 percent of 

10 the population of the United States have been in11 fected with HCV. 

12 (3) The CDC conservatively estimates that ap13 proximately 30,000 Americans are newly infected 

14 with HCV each year, and that number has been 

15 growing since 2001. 

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

17 most common cause of chronic liver disease, liver 

18 cirrhosis, and liver cancer, the most common indica19 tion for liver transplant, and the leading cause of 

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

21 may be links between HCV and certain other dis22 eases, given that a high number of people infected 

23 with HCV also suffer from type 2 diabetes, 

24 lymphoma, thyroid and certain blood disorders, and 

25 autoimmune disease. Moreover, methamphetamine 


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1 abuse—which is a matter of increasing concern to 

2 Congress and public health officials across the coun3 try—is recognized by the National Institute on Drug 

4 Abuse to be inextricably linked to HCV. 

5 (5) The majority of individuals infected with 

6 HCV are unaware of their infection. Individuals in7 fected with HCV serve as a source of transmission 

8 to others and, since few individuals are aware they 

9 are infected, they are unlikely to take precautions to 

10 prevent the spread or exacerbation of their infection. 

11 (6) There is no vaccine available to prevent 

12 HCV infection. 

13 (7) Treatments are available that can eradicate 

14 the disease in approximately 50 percent of those who 

15 are treated, and behavioral changes can slow the 

16 progression of the disease. 

17 (8) Conservative estimates place the costs of di18 rect medical expenses for HCV at more than 

19 $1,000,000,000 in the United States annually, and 

20 such costs will undoubtedly increase in the absence 

21 of expanded prevention and treatment efforts. 

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

23 States, the CDC developed Recommendations for 

24 Prevention and Control of Hepatitis C Virus (HCV) 

25 Infection and HCV-Related Chronic Disease in 1998 


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1 and the National Hepatitis C Prevention Strategy in 

2 2001, and the National Institutes of Health con3 vened Consensus Development Conferences on the 

4 Management of Hepatitis C in 1997 and 2002. 

5 These recommendations and guidelines provide a 

6 framework for HCV prevention, control, research, 

7 and medical management referral programs. 

8 (10) The Department of Veterans Affairs (re9 ferred to in this paragraph as the ‘‘VA’’), which 

10 cares for more people infected with HCV than any 

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

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

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

14 factors all veterans receiving VA health care, and 

15 the VA currently recommends testing for all those 

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

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

18 over 98 percent of VA patients had been screened 

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

20 ‘‘at risk’’ were tested. For all veterans who test posi21 tive for HCV and enroll in VA medical care, the VA 

22 offers medications that can help HCV or its com23 plications. The VA also has programs for HCV pa24 tient and provider education, clinical care, data25 based quality improvement, and research, and it has 


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1 4 Hepatitis C Resource Centers to develop and dis2 seminate innovative practices and tools to improve 

3 patient care. This comprehensive program should be 

4 commended and could potentially serve as a model 

5 for future HCV programs. 

6 (11) Federal support is necessary to increase 

7 knowledge and awareness of HCV and to assist 

8 State and local prevention and control efforts. 

9 SEC. 3. PREVENTION, CONTROL, AND MEDICAL MANAGE10 MENT OF HEPATITIS C. 

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

12 241 et seq.) is amended by adding at the end the fol13 lowing: 

14 ‘‘PART S—PREVENTION, CONTROL, AND MEDICAL 

15 MANAGEMENT OF HEPATITIS C 

16 ‘‘SEC. 399II. FEDERAL PLAN FOR THE PREVENTION, CON17 TROL, AND MEDICAL MANAGEMENT OF HEPA18 TITIS C. 

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

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

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

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

23 training, surveillance and early detection, and research. 

24 ‘‘(b) INPUT IN DEVELOPMENT OF PLAN.—In devel25 oping the plan under subsection (a), the Secretary shall— 


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

2 the Centers for Disease Control and Prevention (re3 ferred to in this part as the ‘CDC’) and the National 

4 Institutes of Health, and the comprehensive HCV 

5 programs that have been implemented by the De6 partment of Veterans Affairs, including the Hepa7 titis C Resource Center program; and 

8 ‘‘(2) consult with— 

9 ‘‘(A) the Director of the CDC; 

10 ‘‘(B) the Director of the National Insti11 tutes of Health; 

12 ‘‘(C) the Administrator of the Health Re13 sources and Services Administration; 

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

15 or offices providing services to individuals with 

16 HCV infections or the functions of which other17 wise involve HCV; 

18 ‘‘(E) medical advisory bodies that address 

19 issues related to HCV; and 

20 ‘‘(F) the public, including— 

21 ‘‘(i) individuals infected with the 

22 HCV; and 

23 ‘‘(ii) advocates concerned with issues 

24 related to HCV. 

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


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1 ‘‘(1) IN GENERAL.—The Secretary shall con2 duct a biennial assessment of the plan developed 

3 under subsection (a) for the purpose of incor4 porating into such plan new knowledge or observa5 tions relating to HCV and chronic HCV (such as 

6 knowledge and observations that may be derived 

7 from clinical, laboratory, and epidemiological re8 search and disease detection, prevention, and surveil9 lance outcomes) and addressing gaps in the coverage 

10 or effectiveness of the plan. 

11 ‘‘(2) PUBLICATION OF NOTICE OF ASSESS12 MENTS.—Not later than October 1 of the first even 

13 numbered year beginning after the date of enact14 ment of the Hepatitis C Epidemic Control and Pre15 vention Act, and October 1 of each even numbered 

16 year thereafter, the Secretary shall publish in the 

17 Federal Register a notice of the results of the as18 sessments conducted under paragraph (1). Such no19 tice shall include— 

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

21 plan developed under subsection (a) as a result 

22 of the assessment; 

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

24 such revisions, including the ways in which such 

25 revisions can reasonably be expected to further 


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1 promote the original goals and objectives of the 

2 plan; and 

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

4 Secretary that the plan does not need revision, 

5 an explanation of the basis for such determina6 tion. 

7 ‘‘SEC. 399JJ. ELEMENTS OF THE FEDERAL PLAN FOR THE 

8 PREVENTION, CONTROL, AND MEDICAL MAN9 AGEMENT OF HEPATITIS C. 

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

11 acting through the Director of the CDC, shall implement 

12 programs to increase awareness and enhance knowledge 

13 and understanding of HCV. Such programs shall in14 clude— 

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

16 awareness campaigns, and community outreach ac17 tivities to promote public awareness and knowledge 

18 about risk factors, the transmission and prevention 

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

20 early detection of HCV infection, and options avail21 able for the treatment of chronic HCV; 

22 ‘‘(2) the training of healthcare professionals re23 garding the prevention, detection, and medical man24 agement of the hepatitis B virus (referred to in this 

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


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1 vaccinating HCV-infected individuals and those at 

2 risk for HCV infection against the hepatitis A virus 

3 and HBV; and 

4 ‘‘(3) the development and distribution of cur5 ricula (including information relating to the special 

6 needs of individuals infected with HBV or HCV, 

7 such as the importance of early intervention and 

8 treatment and the recognition of psychosocial needs) 

9 for individuals providing hepatitis counseling, as well 

10 as support for the implementation of such curricula 

11 by State and local public health agencies. 

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

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

14 through the Director of the CDC, shall support ac15 tivities described in paragraph (2) to promote the 

16 early detection of HCV infection, identify risk fac17 tors for infection, and conduct surveillance of HCV 

18 infection trends. 

19 ‘‘(2) ACTIVITIES.— 

20 ‘‘(A) VOLUNTARY TESTING PROGRAMS.— 

21 ‘‘(i) IN GENERAL.—The Secretary 

22 shall support and promote the development 

23 of State, local, and tribal voluntary HCV 

24 testing programs to aid in the early identi25 fication of infected individuals. 


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1 ‘‘(ii) CONFIDENTIALITY OF TEST RE2 SULTS.—The results of a HCV test con3 ducted by a testing program developed or 

4 supported under this subparagraph shall 

5 be considered protected health information 

6 (in a manner consistent with regulations 

7 promulgated under section 264(c) of the 

8 Health Insurance Portability and Account9 ability Act of 1996 and may not be used 

10 for any of the following: 

11 ‘‘(I) Issues relating to health in12 surance. 

13 ‘‘(II) To screen or determine 

14 suitability for employment. 

15 ‘‘(III) To discharge a person 

16 from employment. 

17 ‘‘(B) COUNSELING REGARDING VIRAL HEP18 ATITIS.—The Secretary shall support State, 

19 local, and tribal programs in a wide variety of 

20 settings, including those providing primary and 

21 specialty healthcare services in nonprofit private 

22 and public sectors, to— 

23 ‘‘(i) provide individuals with informa24 tion about ongoing risk factors for HCV 

25 infection with client-centered education 


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1 and counseling that concentrates on chang2 ing behaviors that place them at risk for 

3 infection; and 

4 ‘‘(ii) provide individuals infected with 

5 HCV with education and counseling to re6 duce the risk of harm to themselves and 

7 transmission of the virus to others. 

8 ‘‘(C) VACCINATION AGAINST VIRAL HEPA9 TITIS.—With respect to individuals infected, or 

10 at risk for infection, with HCV, the Secretary 

11 shall provide for— 

12 ‘‘(i) the vaccination of such individ13 uals against hepatitis A virus, HBV, and 

14 other infectious diseases, as appropriate, 

15 for which such individuals may be at in16 creased risk; and 

17 ‘‘(ii) the counseling of such individuals 

18 regarding hepatitis A, HBV, and other 

19 viral hepatides. 

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

21 shall support— 

22 ‘‘(i) referral of persons infected with 

23 or at risk for HCV, for drug or alcohol 

24 abuse treatment where appropriate; and 


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1 ‘‘(ii) referral of persons infected with 

2 HCV— 

3 ‘‘(I) for medical evaluation to de4 termine their stage of chronic HCV 

5 and suitability for antiviral treatment; 

6 and 

7 ‘‘(II) for ongoing medical man8 agement of HCV. 

9 ‘‘(3) HEPATITIS C COORDINATORS.—The Sec10 retary, acting through the Director of the CDC, 

11 shall, upon request, provide a Hepatitis C Coordi12 nator to a State health department in order to en13 hance the management, networking, and technical 

14 expertise needed to ensure successful integration of 

15 HCV prevention and control activities into existing 

16 public health programs. 

17 ‘‘(c) SURVEILLANCE AND EPIDEMIOLOGY.— 

18 ‘‘(1) IN GENERAL.—The Secretary shall pro19 mote and support the establishment and mainte20 nance of State HCV surveillance databases, in order 

21 to— 

22 ‘‘(A) identify risk factors for HCV infec23 tion; 

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

25 acute and chronic HCV; 


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

2 HCV infection among groups that may be dis3 proportionately affected by HCV, including in4 dividuals living with HIV, military veterans, 

5 emergency first responders, racial or ethnic mi6 norities, and individuals who engage in high 

7 risk behaviors, such as intravenous drug use; 

8 and 

9 ‘‘(D) assess and improve HCV infection 

10 prevention programs. 

11 ‘‘(2) CONFIDENTIALITY.—Information con12 tained in the databases under paragraph (1) shall be 

13 de-identified in a manner consistent with regulations 

14 under section 264(c) of the Health Insurance Port15 ability and Accountability Act of 1996. 

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

17 through the Director of the CDC and the Director of the 

18 National Institutes 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 HCV.—The Secretary shall support and pro6 mote 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 

14 healthcare services and groups that may be disproportion15 ately 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. 399KK. 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. 399LL. AUTHORIZATION OF APPROPRIATIONS. 

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

10 this part $90,000,000 for fiscal year 2008, and 

11 $72,000,000 for each of fiscal years 2009 through 2012.’’. 

Æ 


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