I 

110TH CONGRESS 

1ST SESSION H. R. 2552 

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 

MAY 24, 2007 

Mr. TOWNS (for himself and Mrs. WILSON of New Mexico) 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 of 2007’’. 

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 

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1 1998 and the National Hepatitis C Prevention 

2 Strategy in 2001, and the National Institutes of 

3 Health convened Consensus Development Con4 ferences on the Management of Hepatitis C in 1997 

5 and 2002. These recommendations and guidelines 

6 provide a framework for HCV prevention, control, 

7 research, and medical management referral pro8 grams. 

9 (10) The Department of Veterans Affairs (re10 ferred to in this paragraph as the ‘‘VA’’), which 

11 cares for more people infected with HCV than any 

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

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

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

15 factors all veterans receiving VA health care, and 

16 the VA currently recommends testing for all those 

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

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

19 over 98 percent of VA patients had been screened 

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

21 ‘‘at risk’’ were tested. For all veterans who test posi22 tive for HCV and enroll in VA medical care, the VA 

23 offers medications that can help HCV or its com24 plications. The VA also has programs for HCV pa25 tient and provider education, clinical care, datamstockstill on PROD1PC66 with BILLS

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1 based quality improvement, and research, and it has 

2 4 Hepatitis C Resource Centers to develop and dis3 seminate innovative practices and tools to improve 

4 patient care. This comprehensive program should be 

5 commended and could potentially serve as a model 

6 for future HCV programs. 

7 (11) Federal support is necessary to increase 

8 knowledge and awareness of HCV and to assist 

9 State and local prevention and control efforts. 

10 SEC. 3. PREVENTION, CONTROL, AND MEDICAL MANAGE11 MENT OF HEPATITIS C. 

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

13 241 et seq.) is amended by adding at the end the fol14 lowing: 

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

16 MANAGEMENT OF HEPATITIS C 

17 ‘‘SEC. 399II. FEDERAL PLAN FOR THE PREVENTION, CON18 TROL, AND MEDICAL MANAGEMENT OF HEPA19 TITIS C. 

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

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

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

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

24 training, surveillance and early detection, and research. 

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1 ‘‘(b) INPUT IN DEVELOPMENT OF PLAN.—In devel2 oping the plan under subsection (a), the Secretary shall— 

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

4 the Centers for Disease Control and Prevention (re5 ferred to in this part as the ‘CDC’) and the National 

6 Institutes of Health, and the comprehensive HCV 

7 programs that have been implemented by the De8 partment of Veterans Affairs, including the Hepa9 titis C Resource Center program; and 

10 ‘‘(2) consult with— 

11 ‘‘(A) the Director of the CDC; 

12 ‘‘(B) the Director of the National Insti13 tutes of Health; 

14 ‘‘(C) the Administrator of the Health Re15 sources and Services Administration; 

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

17 or offices providing services to individuals with 

18 HCV infections or the functions of which other19 wise involve HCV; 

20 ‘‘(E) medical advisory bodies that address 

21 issues related to HCV; and 

22 ‘‘(F) the public, including— 

23 ‘‘(i) individuals infected with the 

24 HCV; and 

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1 ‘‘(ii) advocates concerned with issues 

2 related to HCV. 

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

4 ‘‘(1) IN GENERAL.—The Secretary shall con5 duct a biennial assessment of the plan developed 

6 under subsection (a) for the purpose of incor7 porating into such plan new knowledge or observa8 tions relating to HCV and chronic HCV (such as 

9 knowledge and observations that may be derived 

10 from clinical, laboratory, and epidemiological re11 search and disease detection, prevention, and surveil12 lance outcomes) and addressing gaps in the coverage 

13 or effectiveness of the plan. 

14 ‘‘(2) PUBLICATION OF NOTICE OF ASSESS15 MENTS.—Not later than October 1 of the first even 

16 numbered year beginning after the date of the enact17 ment of the Hepatitis C Epidemic Control and Pre18 vention Act, and October 1 of each even numbered 

19 year thereafter, the Secretary shall publish in the 

20 Federal Register a notice of the results of the as21 sessments conducted under paragraph (1). Such no22 tice shall include— 

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

24 plan developed under subsection (a) as a result 

25 of the assessment; 

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

2 such revisions, including the ways in which such 

3 revisions can reasonably be expected to further 

4 promote the original goals and objectives of the 

5 plan; and 

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

7 Secretary that the plan does not need revision, 

8 an explanation of the basis for such determina9 tion. 

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

11 PREVENTION, CONTROL, AND MEDICAL MAN12 AGEMENT OF HEPATITIS C. 

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

14 acting through the Director of the CDC, shall implement 

15 programs to increase awareness and enhance knowledge 

16 and understanding of HCV. Such programs shall in17 clude— 

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

19 awareness campaigns, and community outreach ac20 tivities to promote public awareness and knowledge 

21 about risk factors, the transmission and prevention 

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

23 early detection of HCV infection, and options avail24 able for the treatment of chronic HCV; 

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

2 regarding the prevention, detection, and medical 

3 management of the hepatitis B virus (referred to in 

4 this part as ‘HBV’) and HCV, and the importance 

5 of vaccinating HCV-infected individuals and those at 

6 risk for HCV infection against the hepatitis A virus 

7 and HBV; and 

8 ‘‘(3) the development and distribution of cur9 ricula (including information relating to the special 

10 needs of individuals infected with HBV or HCV, 

11 such as the importance of early intervention and 

12 treatment and the recognition of psychosocial needs) 

13 for individuals providing hepatitis counseling, as well 

14 as support for the implementation of such curricula 

15 by State and local public health agencies. 

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

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

18 through the Director of the CDC, shall support ac19 tivities described in paragraph (2) to promote the 

20 early detection of HCV infection, identify risk fac21 tors for infection, and conduct surveillance of HCV 

22 infection trends. 

23 ‘‘(2) ACTIVITIES.— 

24 ‘‘(A) VOLUNTARY TESTING PROGRAMS.— 

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1 ‘‘(i) IN GENERAL.—The Secretary 

2 shall support and promote the development 

3 of State, local, and tribal voluntary HCV 

4 testing programs to aid in the early identi5 fication of infected individuals. 

6 ‘‘(ii) CONFIDENTIALITY OF TEST RE7 SULTS.—The results of a HCV test con8 ducted by a testing program developed or 

9 supported under this subparagraph shall 

10 be considered protected health information 

11 (in a manner consistent with regulations 

12 promulgated under section 264(c) of the 

13 Health Insurance Portability and Account14 ability Act of 1996) and may not be used 

15 for any of the following: 

16 ‘‘(I) Issues relating to health in17 surance. 

18 ‘‘(II) To screen or determine 

19 suitability for employment. 

20 ‘‘(III) To discharge a person 

21 from employment. 

22 ‘‘(B) COUNSELING REGARDING VIRAL HEP23 ATITIS.—The Secretary shall support State, 

24 local, and tribal programs in a wide variety of 

25 settings, including those providing primary and 

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1 specialty health care services in nonprofit pri2 vate and public sectors, to— 

3 ‘‘(i) provide individuals with informa4 tion about ongoing risk factors for HCV 

5 infection with client-centered education 

6 and counseling that concentrates on chang7 ing behaviors that place them at risk for 

8 infection; and 

9 ‘‘(ii) provide individuals infected with 

10 HCV with education and counseling to re11 duce the risk of harm to themselves and 

12 transmission of the virus to others. 

13 ‘‘(C) VACCINATION AGAINST VIRAL HEPA14 TITIS.—With respect to individuals infected, or 

15 at risk for infection, with HCV, the Secretary 

16 shall provide for— 

17 ‘‘(i) the vaccination of such individ18 uals against hepatitis A virus, HBV, and 

19 other infectious diseases, as appropriate, 

20 for which such individuals may be at in21 creased risk; and 

22 ‘‘(ii) the counseling of such individuals 

23 regarding hepatitis A, HBV, and other 

24 viral hepatides. 

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

2 shall support— 

3 ‘‘(i) referral of persons infected with 

4 or at risk for HCV, for drug or alcohol 

5 abuse treatment where appropriate; and 

6 ‘‘(ii) referral of persons infected with 

7 HCV— 

8 ‘‘(I) for medical evaluation to de9 termine their stage of chronic HCV 

10 and suitability for antiviral treatment; 

11 and 

12 ‘‘(II) for ongoing medical man13 agement of HCV. 

14 ‘‘(3) HEPATITIS C COORDINATORS.—The Sec15 retary, acting through the Director of the CDC, 

16 shall, upon request, provide a Hepatitis C Coordi17 nator to a State health department in order to en18 hance the management, networking, and technical 

19 expertise needed to ensure successful integration of 

20 HCV prevention and control activities into existing 

21 public health programs. 

22 ‘‘(c) SURVEILLANCE AND EPIDEMIOLOGY.— 

23 ‘‘(1) IN GENERAL.—The Secretary shall pro24 mote and support the establishment and maintemstockstill on PROD1PC66 with BILLS

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1 nance of State HCV surveillance databases, in order 

2 to— 

3 ‘‘(A) identify risk factors for HCV infec4 tion; 

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

6 acute and chronic HCV; 

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

8 HCV infection among groups that may be dis9 proportionately affected by HCV, including in10 dividuals living with HIV, military veterans, 

11 emergency first responders, racial or ethnic mi12 norities, and individuals who engage in high 

13 risk behaviors, such as intravenous drug use; 

14 and 

15 ‘‘(D) assess and improve HCV infection 

16 prevention programs. 

17 ‘‘(2) CONFIDENTIALITY.—Information con18 tained in the databases under paragraph (1) shall be 

19 de-identified in a manner consistent with regulations 

20 under section 264(c) of the Health Insurance Port21 ability and Accountability Act of 1996. 

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

23 through the Director of the CDC and the Director of the 

24 National Institutes of Health, shall— 

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1 ‘‘(1) conduct epidemiologic research to identify 

2 best practices for HCV prevention; 

3 ‘‘(2) establish and support a Hepatitis C Clin4 ical Research Network for the purpose of conducting 

5 research related to the treatment and medical man6 agement of HCV; and 

7 ‘‘(3) conduct basic research to identify new ap8 proaches to prevention (such as vaccines) and treat9 ment for HCV. 

10 ‘‘(e) REFERRAL FOR MEDICAL MANAGEMENT OF

11 CHRONIC HCV.—The Secretary shall support and pro12 mote State, local, and tribal programs to provide HCV13 positive individuals with referral for medical evaluation 

14 and management, including currently recommended 

15 antiviral therapy when appropriate. 

16 ‘‘(f) UNDERSERVED AND DISPROPORTIONATELY AF17 FECTED POPULATIONS.—In carrying out this section, the 

18 Secretary shall provide expanded support for individuals 

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

20 care services and groups that may be disproportionately 

21 affected by HCV. 

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

23 shall develop benchmarks for evaluating the effectiveness 

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1 tion and make determinations as to whether such bench2 marks have been achieved. 

3 ‘‘SEC. 399KK. GRANTS. 

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

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

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

7 nonprofit entities that have special expertise relating to 

8 HCV, to carry out activities under this part. 

9 ‘‘(b) APPLICATION.—To be eligible for a grant, con10 tract, or cooperative agreement under subsection (a), an 

11 entity shall prepare and submit to the Secretary an appli12 cation at such time, in such manner, and containing such 

13 information as the Secretary may require. 

14 ‘‘SEC. 399LL. AUTHORIZATION OF APPROPRIATIONS. 

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

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

17 $72,000,000 for each of fiscal years 2009 through 2012.’’. 

Æ 

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