[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 3558 Introduced in Senate (IS)]








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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``National Hepatitis B Act''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) Approximately 1,400,000 Americans are chronically 
        infected with hepatitis B. The number of chronically infected 
        persons in the United States is believed to be increasing each 
        year with the influx of new immigrants from areas where it is 
        endemic.
            (2) Hepatitis B is extremely infectious. In fact, the 
        disease is 100 times more infectious than HIV. The hepatitis B 
        virus (HBV) is transmitted the same way as HIV: from mother to 
        newborn at birth, from infected blood or injections 
        contaminated by infected blood, and from unprotected sex.
            (3) Chronic hepatitis B usually does not cause any symptoms 
        early in the course of the disease, but after many years of a 
        clinically ``silent'' phase, as many as 25 percent of infected 
        individuals may develop end-stage liver disease or liver 
        cancer.
            (4) The major burden of hepatitis B infection in the United 
        States is from chronic hepatitis B infection. Persons 
        chronically infected with hepatitis B are at higher risk of 
        developing cirrhosis (scarring) of the liver and liver cancer, 
        both of which can lead to premature death. About 5,000 deaths 
        per year in the United States can be attributed to chronic 
        hepatitis B infection.
            (5) Chronic hepatitis B infection disproportionately 
        affects certain occupations and populations in the United 
        States. Although representing only four percent of the 
        population, Asian Americans and Pacific Islanders account for 
        over half of the 1,400,000 chronic hepatitis B cases in the 
        United States.
            (6) Hepatitis B infection is preventable through currently 
        available vaccinations and by reducing high-risk behavior. The 
        hepatitis B vaccine is safe and effective and has the 
        designation of being the ``first anti-cancer vaccine''.
            (7) The diagnosis of chronic hepatitis B infection can be 
        made with a simple blood test that is inexpensive and widely 
        available. The early diagnosis of chronic hepatitis B can 
        reduce the risk of further transmission of the virus through 
        harm reduction education and the vaccination of household 
        members and other susceptible persons at risk.
            (8) If the diagnosis of hepatitis B infection is made at an 
        early stage of the infection, treatment of chronic hepatitis B 
        infection with antiviral therapy similar to that employed in 
        HIV, when appropriate, can reduce the risk of progression to 
        liver cancer and cirrhosis.
            (9) For those who are chronically infected, regular 
        monitoring can lead to the early detection of liver cancer at a 
        stage where cure is still possible. Liver cancer is one of the 
        deadliest types of cancer and one that has received little 
        funding for research and prevention.
            (10) Although the costs of education, research, and 
        treatment are not trivial, they are substantially less than the 
        annual health care cost attributable to hepatitis B in the 
        Unites States, which is estimated to be approximately 
        $2,500,000,000 ($2000 per infected person). The lifetime cost 
        of the hepatitis B virus in 2000--before the availability of 
        most of the current therapies--was approximately $80,000 per 
        person chronically infected, or more than $100,000,000,000.

SEC. 3. COMPREHENSIVE HEPATITIS B PREVENTION, EDUCATION, RESEARCH, AND 
              MEDICAL MANAGEMENT PROGRAM.

    Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) 
is amended by adding at the end of the following:

 ``PART R--COMPREHENSIVE HEPATITIS B PREVENTION, EDUCATION, RESEARCH, 
                     AND MEDICAL MANAGEMENT PROGRAM

``SEC. 399AA. PROGRAM DEVELOPMENT.

    ``(a) In General.--The Secretary shall develop and implement a plan 
for the prevention, control, and medical management of hepatitis B, 
which includes strategies for expanded vaccination programs, primary 
and secondary preventive education and training, surveillance and early 
detection, and research.
    ``(b) Input in Development of Plan.--In developing the plan under 
subsection (a), the Secretary shall--
            ``(1) be guided by existing recommendations of the 
        Department of Health and Human Services, the Centers for 
        Disease Control and Prevention, and the National Institutes of 
        Health; and
            ``(2) consult with--
                    ``(A) the Director of the Centers for Disease 
                Control and Prevention;
                    ``(B) the Director of the National Institutes of 
                Health;
                    ``(C) the Director of the National Cancer 
                Institute;
                    ``(D) the Administrator of the Health Resources and 
                Services Administration;
                    ``(E) the Administrator of the Substance Abuse and 
                Mental Health Services Administration;
                    ``(F) the heads of other Federal agencies or 
                offices providing education services to individuals 
                with viral hepatitis;
                    ``(G) medical advisory bodies, such as the National 
                Task Force on Hepatitis B: Focus on Asian and Pacific 
                Islander Americans, the National Viral Hepatitis 
                Roundtable, the Asian Liver Center at Stanford 
                University, the Hepatitis B Foundation, the American 
                Liver Foundation, Hepatitis Foundation International, 
                and the Center for the Study of Asian American Health; 
                and
                    ``(H) the public, including--
                            ``(i) individuals infected with hepatitis 
                        B; and
                            ``(ii) advocates concerned with issues 
                        related to hepatitis B.
    ``(c) Biennial Update of the Plan.--
            ``(1) In general.--The Secretary shall conduct a biennial 
        assessment of the plan developed under subsection (a) for the 
        purposes of--
                    ``(A) incorporating into such plan new knowledge or 
                observations relating to hepatitis B (such as knowledge 
                and observations that may be derived from clinical, 
                laboratory, and epidemiological research and disease 
                detection, prevention, and surveillance outcomes); and
                    ``(B) addressing gaps in the coverage or 
                effectiveness of the plan.
            ``(2) Publication of notice of assessments.--Not later than 
        October 1 of the first even numbered year beginning after the 
        date of enactment of this part, and October 1 of each even 
        numbered year thereafter, the Secretary shall publish in the 
        Federal Register a notice of the results of the assessments 
        conducted under paragraph (1). Such notice shall include--
                    ``(A) a description of any revisions to the plan 
                developed under subsection (a) as a result of the 
                assessment;
                    ``(B) an explanation of the basis for any such 
                revisions, including the ways in which such revisions 
                can reasonably be expected to further promote the 
                original goals and objectives of the plan; and
                    ``(C) in the case of a determination by the 
                Secretary that the plan does not need revision, an 
                explanation of the basis for such determination.

``SEC. 399BB. ELEMENTS OF PROGRAM.

    ``(a) Immunization, Prevention, and Control Programs.--
            ``(1) In general.--The Secretary, acting through the 
        Director of the Centers for Disease Control and Prevention, 
        shall support the integration of activities described in 
        paragraph (2) into existing clinical and public health programs 
        at State, local, and tribal levels (including Asian and non-
        Asian community health clinics, programs for the prevention and 
        treatment of HIV/AIDS, sexually transmitted diseases, and 
        substance abuse, and programs for individuals in correctional 
        settings).
            ``(2) Activities.--
                    ``(A) Voluntary testing programs.--
                            ``(i) In general.--The Secretary shall 
                        establish a mechanism by which to support and 
                        promote the development of State, local, and 
                        tribal voluntary hepatitis B testing programs 
                        to screen the high chronic hepatitis B 
                        prevalence populations (such as Asian 
                        Americans, new immigrants or foreign-born 
                        United States residents, and persons with one 
                        or both foreign-born parents) to aid in the 
                        early identification of chronically infected 
                        individuals.
                            ``(ii) Confidentiality of the test 
                        results.--The Secretary shall prohibit the use 
                        of the results of a hepatitis B test conducted 
                        by a testing program developed or supported 
                        under this subparagraph for any of the 
                        following:
                                    ``(I) Issues relating to health 
                                insurance.
                                    ``(II) To screen or determine 
                                suitability for employment.
                                    ``(III) To discharge a person from 
                                employment.
                    ``(B) Counseling.--The Secretary shall support 
                State, local, and tribal programs in a wide variety of 
                settings, including those providing primary and 
                specialty health care services in the private and 
                public sectors, to--
                            ``(i) provide individuals with ongoing risk 
                        factors for hepatitis B infection with client-
                        centered education and counseling which 
                        concentrates on--
                                    ``(I) promoting testing of family 
                                members and their sexual partners; and
                                    ``(II) changing behaviors that 
                                place individuals at risk for 
                                infection;
                            ``(ii) provide individuals chronically 
                        infected with hepatitis B with education, 
                        health information, and counseling to reduce 
                        their risk of--
                                    ``(I) dying from end stage liver 
                                disease and liver cancer; and
                                    ``(II) transmitting viral hepatitis 
                                to others; and
                            ``(iii) provide women chronically infected 
                        with hepatitis B who are pregnant or in their 
                        child bearing age with culturally appropriate 
                        health information to alleviate their fears of 
                        becoming pregnant or raising a family.
                    ``(C) Immunization.--The Secretary shall support 
                State, local, and tribal efforts to expand the current 
                vaccination programs to protect every child in the 
                country and all susceptible adults, particularly those 
                from the high-prevalence ethnic populations and other 
                high risk groups, from the risks of acute and chronic 
                hepatitis B infection by--
                            ``(i) ensuring continued funding for 
                        hepatitis B vaccination for all children 19 
                        years of age or under through the Vaccines for 
                        Children Program;
                            ``(ii) ensuring that the recommendations of 
                        the Advisory Committee on Immunization 
                        Practices are followed regarding hepatitis B 
                        vaccinations for newborns;
                            ``(iii) expanding the availability of 
                        vaccines for all susceptible adults to protect 
                        them from becoming acutely or chronically 
                        infected, including ethnic populations with 
                        high prevalence rates of chronic hepatitis B 
                        infection; and
                            ``(iv) expanding the availability of 
                        vaccines for all susceptible adults, 
                        particularly those in their reproductive age 
                        (women and men less than 45 years of age), from 
                        the risk of hepatitis B infection.
                    ``(D) Medical referral.--The Secretary shall 
                support State, local, and tribal programs that 
                support--
                            ``(i) referral of persons chronically 
                        infected with hepatitis B--
                                    ``(I) for medical evaluation to 
                                determine the appropriateness for 
                                antiviral treatment to reduce the risk 
                                of progression to cirrhosis and liver 
                                cancer; and
                                    ``(II) for regular monitoring of 
                                liver function and screening for liver 
                                cancer; and
                            ``(ii) referral of persons infected with 
                        acute or chronic hepatitis B for drug and 
                        alcohol abuse treatment where appropriate.
            ``(3) Increased support for hepatitis b coordinators.--The 
        Secretary, acting through the Director of the Centers for 
        Disease Control and Prevention, shall provide hepatitis B 
        coordinators to State, local, and tribal health departments in 
        order to enhance the additional management, networking, and 
        technical expertise needed to ensure successful integration of 
        hepatitis B prevention and control activities into existing 
        public health programs.
    ``(b) Education and Awareness Programs.--The Secretary, acting 
through the Director of the Centers for Disease Control and Prevention, 
the Administrator of the Health Resources and Services Administration, 
and the Administrator of the Substance Abuse and Mental Health Services 
Administration, and in accordance with the plan developed under section 
399AA, shall implement programs to increase awareness and enhance 
knowledge and understanding of hepatitis B. Such programs shall 
include--
            ``(1) the conduct of culturally and language appropriate 
        health education, public awareness campaigns, and community 
        outreach activities (especially to the ethnic communities with 
        high rates of chronic hepatitis B and other high-risk groups) 
        to promote public awareness and knowledge about the value of 
        hepatitis B immunization, risk factors, the transmission and 
        prevention of hepatitis B, and the value of screening for the 
        early detection of hepatitis B infection;
            ``(2) the promotion of immunization programs that increase 
        awareness and access to hepatitis B vaccines for susceptible 
        adults and children;
            ``(3) the training of health care professionals and health 
        educators to make them aware of the high rates of chronic 
        hepatitis B in certain adult ethnic populations, and the 
        importance of prevention, detection, and medical management of 
        hepatitis B and of liver cancer screening;
            ``(4) the development and distribution of health education 
        curricula (including information relating to the special needs 
        of individuals infected with hepatitis B, such as the 
        importance of prevention and early intervention, regular 
        monitoring, and appropriate treatment and liver cancer 
        screening) for individuals providing hepatitis B counseling;
            ``(5) support for the implementation curricula described in 
        paragraph (4) by State and local public health agencies; and
            ``(6) the provision of grants for the inclusion of viral 
        hepatitis and liver wellness education curricula in elementary 
        and secondary school health education programs.
    ``(c) Epidemiological Surveillance.--
            ``(1) In general.--The Secretary, acting through the 
        Director of the Centers for Disease Control and Prevention, 
        shall support the establishment and maintenance of a national 
        chronic and acute hepatitis B surveillance program, in order to 
        identify--
                    ``(A) trends in the incidence of acute and chronic 
                hepatitis B;
                    ``(B) trends in the prevalence of acute and chronic 
                hepatitis B infection among groups that may be 
                disproportionately affected by hepatitis B; and
                    ``(C) liver cancer and end stage liver disease 
                incidence and deaths, caused by chronic hepatitis B in 
                the various ethnic populations.
            ``(2) Seroprevalence and liver cancer studies.--The 
        Secretary, acting through the Director of the Centers for 
        Disease Control and Prevention, shall prepare a report 
        outlining the population-based seroprevalence studies currently 
        under way, future planned studies, the criteria involved in 
        determining which seroprevalence studies to conduct, defer, or 
        suspend, and the scope of those studies, the economic and 
        clinical impact of hepatitis B, and the impact of hepatitis B 
        on quality of life. Not later than one year after the date of 
        enactment of this part, the Secretary shall submit the report 
        to the Committee on Energy and Commerce of the House of 
        Representatives and the Committee on Health, Education, Labor, 
        and Pensions of the Senate.
            ``(3) Confidentiality.--The Secretary shall not disclose 
        any individually identifiable information identified under 
        paragraph (1) or derived through studies under paragraph (2).
    ``(d) Research.--The Secretary, acting through the Director of the 
Centers for Disease Control and Prevention, the Director of the 
National Cancer Institute, and the Director of the National Institutes 
of Health, shall--
            ``(1) conduct community-based research to develop, 
        implement, and evaluate best practices for hepatitis B 
        prevention especially in the ethnic populations with high rates 
        of chronic hepatitis B and other high-risk groups;
            ``(2) conduct research on hepatitis B natural history, 
        pathophysiology, improved treatments, and non-invasive tests 
        that helps to predict the risk of progression to liver 
        cirrhosis and liver cancer; and
            ``(3) conduct research that will lead to better non-
        invasive or blood tests to screen for liver cancer, and more 
        effective treatments of liver cancer caused by chronic 
        hepatitis.
    ``(e) Expanded Support for Underserved and Disproportionately 
Affected Populations Chronically Infected With HBV.--In carrying out 
this section, the Secretary shall give priority to individuals with 
limited access to health education, testing, and health care services 
and groups that may be disproportionately affected by hepatitis B, 
including populations such as Asian Americans with a high incidence of 
chronic hepatitis B and liver cancer.''.
                                 <all>