II 

109TH CONGRESS 

2D SESSION S. 3558 

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

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

prevention, education, research, and medical management program that 

will lead to a marked reduction in liver cirrhosis and a reduction in 

the cases of, and improved survival of, liver cancer caused by chronic 

hepatitis B infection. 

IN THE SENATE OF THE UNITED STATES 

JUNE 22, 2006 

Mr. SANTORUM (for himself and Mrs. FEINSTEIN) 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, education, research, and medical management program that 

will lead to a marked reduction in liver cirrhosis and 

a reduction in the cases of, and improved survival of, 

liver cancer caused by chronic hepatitis B infection. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


Hmoore on PROD1PC68 with HMBILLS
2 

•S 3558 IS

1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘National Hepatitis B 

3 Act’’. 

4 SEC. 2. FINDINGS. 

5 Congress makes the following findings: 

6 (1) Approximately 1,400,000 Americans are 

7 chronically infected with hepatitis B. The number of 

8 chronically infected persons in the United States is 

9 believed to be increasing each year with the influx of 

10 new immigrants from areas where it is endemic. 

11 (2) Hepatitis B is extremely infectious. In fact, 

12 the disease is 100 times more infectious than HIV. 

13 The hepatitis B virus (HBV) is transmitted the 

14 same way as HIV: from mother to newborn at birth, 

15 from infected blood or injections contaminated by in16 fected blood, and from unprotected sex. 

17 (3) Chronic hepatitis B usually does not cause 

18 any symptoms early in the course of the disease, but 

19 after many years of a clinically ‘‘silent’’ phase, as 

20 many as 25 percent of infected individuals may de21 velop end-stage liver disease or liver cancer. 

22 (4) The major burden of hepatitis B infection 

23 in the United States is from chronic hepatitis B in24 fection. Persons chronically infected with hepatitis B 

25 are at higher risk of developing cirrhosis (scarring) 

26 of the liver and liver cancer, both of which can lead 


Hmoore on PROD1PC68 with HMBILLS
3 

•S 3558 IS

1 to premature death. About 5,000 deaths per year in 

2 the United States can be attributed to chronic hepa3 titis B infection. 

4 (5) Chronic hepatitis B infection disproportion5 ately affects certain occupations and populations in 

6 the United States. Although representing only four 

7 percent of the population, Asian Americans and Pa8 cific Islanders account for over half of the 1,400,000 

9 chronic hepatitis B cases in the United States. 

10 (6) Hepatitis B infection is preventable through 

11 currently available vaccinations and by reducing 

12 high-risk behavior. The hepatitis B vaccine is safe 

13 and effective and has the designation of being the 

14 ‘‘first anti-cancer vaccine’’. 

15 (7) The diagnosis of chronic hepatitis B infec16 tion can be made with a simple blood test that is in17 expensive and widely available. The early diagnosis 

18 of chronic hepatitis B can reduce the risk of further 

19 transmission of the virus through harm reduction 

20 education and the vaccination of household members 

21 and other susceptible persons at risk. 

22 (8) If the diagnosis of hepatitis B infection is 

23 made at an early stage of the infection, treatment of 

24 chronic hepatitis B infection with antiviral therapy 

25 similar to that employed in HIV, when appropriate, 


Hmoore on PROD1PC68 with HMBILLS
4 

•S 3558 IS

1 can reduce the risk of progression to liver cancer 

2 and cirrhosis. 

3 (9) For those who are chronically infected, reg4 ular monitoring can lead to the early detection of 

5 liver cancer at a stage where cure is still possible. 

6 Liver cancer is one of the deadliest types of cancer 

7 and one that has received little funding for research 

8 and prevention. 

9 (10) Although the costs of education, research, 

10 and treatment are not trivial, they are substantially 

11 less than the annual health care cost attributable to 

12 hepatitis B in the Unites States, which is estimated 

13 to be approximately $2,500,000,000 ($2000 per in14 fected person). The lifetime cost of the hepatitis B 

15 virus in 2000—before the availability of most of the 

16 current therapies—was approximately $80,000 per 

17 person chronically infected, or more than 

18 $100,000,000,000. 

19 SEC. 3. COMPREHENSIVE HEPATITIS B PREVENTION, EDU20 CATION, RESEARCH, AND MEDICAL MANAGE21 MENT PROGRAM. 

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

23 241 et seq.) is amended by adding at the end of the fol24 lowing: 


Hmoore on PROD1PC68 with HMBILLS
5 

•S 3558 IS

1 ‘‘PART R—COMPREHENSIVE HEPATITIS B PRE2 VENTION, EDUCATION, RESEARCH, AND 

3 MEDICAL MANAGEMENT PROGRAM 

4 ‘‘SEC. 399AA. PROGRAM DEVELOPMENT. 

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

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

7 management of hepatitis B, which includes strategies for 

8 expanded vaccination programs, primary and secondary 

9 preventive education and training, surveillance and early 

10 detection, and research. 

11 ‘‘(b) INPUT IN DEVELOPMENT OF PLAN.—In devel12 oping the plan under subsection (a), the Secretary shall— 

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

14 the Department of Health and Human Services, the 

15 Centers for Disease Control and Prevention, and the 

16 National Institutes of Health; and 

17 ‘‘(2) consult with— 

18 ‘‘(A) the Director of the Centers for Dis19 ease Control and Prevention; 

20 ‘‘(B) the Director of the National Insti21 tutes of Health; 

22 ‘‘(C) the Director of the National Cancer 

23 Institute; 

24 ‘‘(D) the Administrator of the Health Re25 sources and Services Administration; 


Hmoore on PROD1PC68 with HMBILLS
6 

•S 3558 IS

1 ‘‘(E) the Administrator of the Substance 

2 Abuse and Mental Health Services Administra3 tion; 

4 ‘‘(F) the heads of other Federal agencies 

5 or offices providing education services to indi6 viduals with viral hepatitis; 

7 ‘‘(G) medical advisory bodies, such as the 

8 National Task Force on Hepatitis B: Focus on 

9 Asian and Pacific Islander Americans, the Na10 tional Viral Hepatitis Roundtable, the Asian 

11 Liver Center at Stanford University, the Hepa12 titis B Foundation, the American Liver Foun13 dation, Hepatitis Foundation International, and 

14 the Center for the Study of Asian American 

15 Health; and 

16 ‘‘(H) the public, including— 

17 ‘‘(i) individuals infected with hepatitis 

18 B; and 

19 ‘‘(ii) advocates concerned with issues 

20 related to hepatitis B. 

21 ‘‘(c) BIENNIAL UPDATE OF THE PLAN.— 

22 ‘‘(1) IN GENERAL.—The Secretary shall con23 duct a biennial assessment of the plan developed 

24 under subsection (a) for the purposes of— 


Hmoore on PROD1PC68 with HMBILLS
7 

•S 3558 IS

1 ‘‘(A) incorporating into such plan new 

2 knowledge or observations relating to hepatitis 

3 B (such as knowledge and observations that 

4 may be derived from clinical, laboratory, and 

5 epidemiological research and disease detection, 

6 prevention, and surveillance outcomes); and 

7 ‘‘(B) addressing gaps in the coverage or ef8 fectiveness of the plan. 

9 ‘‘(2) PUBLICATION OF NOTICE OF ASSESS10 MENTS.—Not later than October 1 of the first even 

11 numbered year beginning after the date of enact12 ment of this part, and October 1 of each even num13 bered year thereafter, the Secretary shall publish in 

14 the Federal Register a notice of the results of the 

15 assessments conducted under paragraph (1). Such 

16 notice shall include— 

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

18 plan developed under subsection (a) as a result 

19 of the assessment; 

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

21 such revisions, including the ways in which such 

22 revisions can reasonably be expected to further 

23 promote the original goals and objectives of the 

24 plan; and 


Hmoore on PROD1PC68 with HMBILLS
8 

•S 3558 IS

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

2 Secretary that the plan does not need revision, 

3 an explanation of the basis for such determina4 tion. 

5 ‘‘SEC. 399BB. ELEMENTS OF PROGRAM. 

6 ‘‘(a) IMMUNIZATION, PREVENTION, AND CONTROL

7 PROGRAMS.— 

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

9 through the Director of the Centers for Disease 

10 Control and Prevention, shall support the integra11 tion of activities described in paragraph (2) into ex12 isting clinical and public health programs at State, 

13 local, and tribal levels (including Asian and non14 Asian community health clinics, programs for the 

15 prevention and treatment of HIV/AIDS, sexually 

16 transmitted diseases, and substance abuse, and pro17 grams for individuals in correctional settings). 

18 ‘‘(2) ACTIVITIES.— 

19 ‘‘(A) VOLUNTARY TESTING PROGRAMS.— 

20 ‘‘(i) IN GENERAL.—The Secretary 

21 shall establish a mechanism by which to 

22 support and promote the development of 

23 State, local, and tribal voluntary hepatitis 

24 B testing programs to screen the high 

25 chronic hepatitis B prevalence populations 


Hmoore on PROD1PC68 with HMBILLS
9 

•S 3558 IS

1 (such as Asian Americans, new immigrants 

2 or foreign-born United States residents, 

3 and persons with one or both foreign-born 

4 parents) to aid in the early identification 

5 of chronically infected individuals. 

6 ‘‘(ii) CONFIDENTIALITY OF THE TEST

7 RESULTS.—The Secretary shall prohibit 

8 the use of the results of a hepatitis B test 

9 conducted by a testing program developed 

10 or supported under this subparagraph for 

11 any of the following: 

12 ‘‘(I) Issues relating to health in13 surance. 

14 ‘‘(II) To screen or determine 

15 suitability for employment. 

16 ‘‘(III) To discharge a person 

17 from employment. 

18 ‘‘(B) COUNSELING.—The Secretary shall 

19 support State, local, and tribal programs in a 

20 wide variety of settings, including those pro21 viding primary and specialty health care serv22 ices in the private and public sectors, to— 

23 ‘‘(i) provide individuals with ongoing 

24 risk factors for hepatitis B infection with 


Hmoore on PROD1PC68 with HMBILLS
10 

•S 3558 IS

1 client-centered education and counseling 

2 which concentrates on— 

3 ‘‘(I) promoting testing of family 

4 members and their sexual partners; 

5 and 

6 ‘‘(II) changing behaviors that 

7 place individuals at risk for infection; 

8 ‘‘(ii) provide individuals chronically in9 fected with hepatitis B with education, 

10 health information, and counseling to re11 duce their risk of— 

12 ‘‘(I) dying from end stage liver 

13 disease and liver cancer; and 

14 ‘‘(II) transmitting viral hepatitis 

15 to others; and 

16 ‘‘(iii) provide women chronically in17 fected with hepatitis B who are pregnant 

18 or in their child bearing age with culturally 

19 appropriate health information to alleviate 

20 their fears of becoming pregnant or raising 

21 a family. 

22 ‘‘(C) IMMUNIZATION.—The Secretary shall 

23 support State, local, and tribal efforts to ex24 pand the current vaccination programs to pro25 tect every child in the country and all suscepVerDate Aug 31 2005 01:39 Jun 24, 2006 Jkt 049200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S3558.IS S3558

Hmoore on PROD1PC68 with HMBILLS
11 

•S 3558 IS

1 tible adults, particularly those from the high2 prevalence ethnic populations and other high 

3 risk groups, from the risks of acute and chronic 

4 hepatitis B infection by— 

5 ‘‘(i) ensuring continued funding for 

6 hepatitis B vaccination for all children 19 

7 years of age or under through the Vaccines 

8 for Children Program; 

9 ‘‘(ii) ensuring that the recommenda10 tions of the Advisory Committee on Immu11 nization Practices are followed regarding 

12 hepatitis B vaccinations for newborns; 

13 ‘‘(iii) expanding the availability of vac14 cines for all susceptible adults to protect 

15 them from becoming acutely or chronically 

16 infected, including ethnic populations with 

17 high prevalence rates of chronic hepatitis 

18 B infection; and 

19 ‘‘(iv) expanding the availability of vac20 cines for all susceptible adults, particularly 

21 those in their reproductive age (women and 

22 men less than 45 years of age), from the 

23 risk of hepatitis B infection. 


Hmoore on PROD1PC68 with HMBILLS
12 

•S 3558 IS

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

2 shall support State, local, and tribal programs 

3 that support— 

4 ‘‘(i) referral of persons chronically in5 fected with hepatitis B— 

6 ‘‘(I) for medical evaluation to de7 termine the appropriateness for 

8 antiviral treatment to reduce the risk 

9 of progression to cirrhosis and liver 

10 cancer; and 

11 ‘‘(II) for regular monitoring of 

12 liver function and screening for liver 

13 cancer; and 

14 ‘‘(ii) referral of persons infected with 

15 acute or chronic hepatitis B for drug and 

16 alcohol abuse treatment where appropriate. 

17 ‘‘(3) INCREASED SUPPORT FOR HEPATITIS B

18 COORDINATORS.—The Secretary, acting through the 

19 Director of the Centers for Disease Control and Pre20 vention, shall provide hepatitis B coordinators to 

21 State, local, and tribal health departments in order 

22 to enhance the additional management, networking, 

23 and technical expertise needed to ensure successful 

24 integration of hepatitis B prevention and control ac25 tivities into existing public health programs. 


Hmoore on PROD1PC68 with HMBILLS
13 

•S 3558 IS

1 ‘‘(b) EDUCATION AND AWARENESS PROGRAMS.—The 

2 Secretary, acting through the Director of the Centers for 

3 Disease Control and Prevention, the Administrator of the 

4 Health Resources and Services Administration, and the 

5 Administrator of the Substance Abuse and Mental Health 

6 Services Administration, and in accordance with the plan 

7 developed under section 399AA, shall implement programs 

8 to increase awareness and enhance knowledge and under9 standing of hepatitis B. Such programs shall include— 

10 ‘‘(1) the conduct of culturally and language ap11 propriate health education, public awareness cam12 paigns, and community outreach activities (especially 

13 to the ethnic communities with high rates of chronic 

14 hepatitis B and other high-risk groups) to promote 

15 public awareness and knowledge about the value of 

16 hepatitis B immunization, risk factors, the trans17 mission and prevention of hepatitis B, and the value 

18 of screening for the early detection of hepatitis B in19 fection; 

20 ‘‘(2) the promotion of immunization programs 

21 that increase awareness and access to hepatitis B 

22 vaccines for susceptible adults and children; 

23 ‘‘(3) the training of health care professionals 

24 and health educators to make them aware of the 

25 high rates of chronic hepatitis B in certain adult 


Hmoore on PROD1PC68 with HMBILLS
14 

•S 3558 IS

1 ethnic populations, and the importance of preven2 tion, detection, and medical management of hepatitis 

3 B and of liver cancer screening; 

4 ‘‘(4) the development and distribution of health 

5 education curricula (including information relating 

6 to the special needs of individuals infected with hep7 atitis B, such as the importance of prevention and 

8 early intervention, regular monitoring, and appro9 priate treatment and liver cancer screening) for indi10 viduals providing hepatitis B counseling; 

11 ‘‘(5) support for the implementation curricula 

12 described in paragraph (4) by State and local public 

13 health agencies; and 

14 ‘‘(6) the provision of grants for the inclusion of 

15 viral hepatitis and liver wellness education curricula 

16 in elementary and secondary school health education 

17 programs. 

18 ‘‘(c) EPIDEMIOLOGICAL SURVEILLANCE.— 

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

20 through the Director of the Centers for Disease 

21 Control and Prevention, shall support the establish22 ment and maintenance of a national chronic and 

23 acute hepatitis B surveillance program, in order to 

24 identify— 


Hmoore on PROD1PC68 with HMBILLS
15 

•S 3558 IS

1 ‘‘(A) trends in the incidence of acute and 

2 chronic hepatitis B; 

3 ‘‘(B) trends in the prevalence of acute and 

4 chronic hepatitis B infection among groups that 

5 may be disproportionately affected by hepatitis 

6 B; and 

7 ‘‘(C) liver cancer and end stage liver dis8 ease incidence and deaths, caused by chronic 

9 hepatitis B in the various ethnic populations. 

10 ‘‘(2) SEROPREVALENCE AND LIVER CANCER

11 STUDIES.—The Secretary, acting through the Direc12 tor of the Centers for Disease Control and Preven13 tion, shall prepare a report outlining the population14 based seroprevalence studies currently under way, 

15 future planned studies, the criteria involved in deter16 mining which seroprevalence studies to conduct, 

17 defer, or suspend, and the scope of those studies, the 

18 economic and clinical impact of hepatitis B, and the 

19 impact of hepatitis B on quality of life. Not later 

20 than one year after the date of enactment of this 

21 part, the Secretary shall submit the report to the 

22 Committee on Energy and Commerce of the House 

23 of Representatives and the Committee on Health, 

24 Education, Labor, and Pensions of the Senate. 


Hmoore on PROD1PC68 with HMBILLS
16 

•S 3558 IS

1 ‘‘(3) CONFIDENTIALITY.—The Secretary shall 

2 not disclose any individually identifiable information 

3 identified under paragraph (1) or derived through 

4 studies under paragraph (2). 

5 ‘‘(d) RESEARCH.—The Secretary, acting through the 

6 Director of the Centers for Disease Control and Preven7 tion, the Director of the National Cancer Institute, and 

8 the Director of the National Institutes of Health, shall— 

9 ‘‘(1) conduct community-based research to de10 velop, implement, and evaluate best practices for 

11 hepatitis B prevention especially in the ethnic popu12 lations with high rates of chronic hepatitis B and 

13 other high-risk groups; 

14 ‘‘(2) conduct research on hepatitis B natural 

15 history, pathophysiology, improved treatments, and 

16 non-invasive tests that helps to predict the risk of 

17 progression to liver cirrhosis and liver cancer; and 

18 ‘‘(3) conduct research that will lead to better 

19 non-invasive or blood tests to screen for liver cancer, 

20 and more effective treatments of liver cancer caused 

21 by chronic hepatitis. 

22 ‘‘(e) EXPANDED SUPPORT FOR UNDERSERVED AND

23 DISPROPORTIONATELY AFFECTED POPULATIONS CHRON24 ICALLY INFECTED WITH HBV.—In carrying out this sec25 tion, the Secretary shall give priority to individuals with 


Hmoore on PROD1PC68 with HMBILLS
17 

•S 3558 IS

1 limited access to health education, testing, and health care 

2 services and groups that may be disproportionately af3 fected by hepatitis B, including populations such as Asian 

4 Americans with a high incidence of chronic hepatitis B 

5 and liver cancer.’’. 

Æ 


Hmoore on PROD1PC68 with HMBILLS