[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 3711 Introduced in Senate (IS)]

111th CONGRESS
  2d Session
                                S. 3711

   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 
  referral program for viral hepatitis infection that will lead to a 
 marked reduction in the disease burden associated with chronic viral 
                      hepatitis and liver cancer.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             August 5, 2010

   Mr. Kerry 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 
  referral program for viral hepatitis infection that will lead to a 
 marked reduction in the disease burden associated with chronic viral 
                      hepatitis and liver cancer.

    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 ``Viral Hepatitis and Liver Cancer 
Control and Prevention Act of 2010''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) Approximately 5,300,000 Americans are chronically 
        infected with the hepatitis B virus (referred to in this 
        section as ``HBV''), the hepatitis C virus (referred to in this 
        section as ``HCV''), or both.
            (2) In the United States, chronic viral hepatitis is the 
        most common cause of liver cancer, one of the most lethal and 
        fastest growing cancers in this country. It is the most common 
        cause of chronic liver disease, liver cirrhosis, and the most 
        common indication for liver transplantation. It is also a 
        leading cause of death in Americans living with HIV/AIDS, many 
        of whom are coinfected with chronic hepatitis B, hepatitis C, 
        or both. At least 15,000 deaths per year in the United States 
        can be attributed to chronic viral hepatitis.
            (3) According to the Centers for Disease Control and 
        Prevention (referred to in this section as the ``CDC''), 
        approximately 2 percent of the population of the United States 
        is living with chronic hepatitis B, hepatitis C, or both. The 
        CDC has recognized HCV as the Nation's most common chronic 
        bloodborne virus infection.
            (4) Hepatitis B is easily transmitted and is 100 times more 
        infectious than HIV. According to the CDC, HBV is transmitted 
        through percutaneous (i.e., puncture through the skin) or 
        mucosal contact with infectious blood or body fluids. Hepatitis 
        C is transmitted by percutaneous (i.e., passage through the 
        skin) exposures to infectious blood.
            (5) The CDC conservatively estimates that in 2007 
        approximately 17,000 Americans were newly infected with HCV and 
        more than 40,000 Americans were newly infected with HBV. The 
        number of people in the United States with chronic hepatitis B 
        and chronic hepatitis C is believed to be increasing each year.
            (6) Chronic hepatitis B and chronic hepatitis C usually do 
        not cause 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 cirrhosis, end-
        stage liver disease, or liver cancer. Since most of those with 
        chronic viral hepatitis are unaware of their infection, they do 
        not know to take precautions to prevent the spread of their 
        infection and can unknowingly exacerbate their own disease 
        progression.
            (7) Hepatitis B and hepatitis C disproportionately affect 
        certain populations in the United States. Although representing 
        only 4 percent of the population, Asian and Pacific Islanders 
        account for over half of the 1,400,000 domestic chronic 
        hepatitis B cases. Baby boomers (those born between 1946 and 
        1964) account for more than half of domestic chronic hepatitis 
        C cases. In addition, African-Americans, Latinos, and American 
        Indian/Native Alaskans are among the groups which have 
        disproportionately high rates of HBV and HCV infections in the 
        United States.
            (8) Hepatitis A (referred to in this section as ``HAV'') 
        and HBV infection are preventable through currently available 
        vaccinations. The hepatitis B vaccine is safe and effective and 
        has the designation of being the ``first anti-cancer vaccine'' 
        since prevention of HBV infection also prevents HBV-related 
        liver cancer. There is currently no vaccine available to 
        prevent HCV infection.
            (9) For both chronic hepatitis B and chronic hepatitis C, 
        behavioral changes can slow disease progression if diagnosis is 
        made early. Early diagnosis, which is available through simple 
        tests, can reduce the risk of transmission and disease 
        progression through education and vaccination of household 
        members and other susceptible persons at risk.
            (10) For those chronically infected with HBV or HCV, 
        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, prevention, and treatment.
            (11) Treatment for chronic hepatitis C is curative and can 
        eradicate the disease in approximately 50 percent of those who 
        are treated. Treatment for chronic hepatitis B is not curative, 
        but can reduce the level of virus in about 50 percent of those 
        treated. Treatment for both chronic hepatitis B and chronic 
        hepatitis C can reduce the risk of progression to cirrhosis and 
        liver cancer.
            (12) To combat the HCV epidemic in the United States, the 
        CDC developed Recommendations for Prevention and Control of 
        Hepatitis C Virus (HCV) Infection and HCV-Related Chronic 
        Disease in 1998 and the National Hepatitis C Prevention 
        Strategy in 2001. To combat the HBV epidemic, the CDC developed 
        Recommendations for Identification and Public Health Management 
        of Persons with Chronic Hepatitis B Virus Infection in 2008. 
        The National Institutes of Health convened Consensus 
        Development Conferences on the Management of Hepatitis C in 
        1997 and 2002 and the Management of Hepatitis B in 2008. These 
        recommendations and guidelines provide a framework for HBV and 
        HCV prevention, education, control, research, and medical 
        management referral programs.
            (13) Although the costs of education, research, and 
        treatment are not trivial, they are substantially less than the 
        annual health care cost attributable to viral hepatitis in the 
        United States. For HBV, it is estimated to be approximately 
        $2,500,000,000 ($2,000 per infected person). The lifetime cost 
        of HBV 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. For HCV, medical costs 
        alone for patients are expected to increase from 
        $30,000,000,000 in 2009 to over $85,000,000,000 in 2024. Such 
        costs will undoubtedly increase in the absence of expanded 
        prevention and treatment efforts.
            (14) Federal support is necessary to increase knowledge and 
        awareness of HBV and HCV and to assist State and local 
        prevention and control efforts in reducing the morbidity and 
        mortality of these epidemics.

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

    Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) 
is amended--
            (1) by striking section 317N (42 U.S.C. 247b-15); and
            (2) by adding at the end the following:

    ``PART S--COMPREHENSIVE HEPATITIS B AND HEPATITIS C PREVENTION, 
      EDUCATION, RESEARCH, AND MEDICAL MANAGEMENT REFERRAL PROGRAM

``SEC. 399FF. PROGRAM DEVELOPMENT.

    ``(a) In General.--The Secretary shall develop and implement a plan 
for the prevention, control, and medical management of hepatitis B and 
hepatitis C, which includes strategies for expanded vaccination 
programs for hepatitis B in adults, primary and secondary preventive 
education and training, surveillance, screening, 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 Director of the Agency for Healthcare 
                Research and Quality;
                    ``(G) the heads of other Federal agencies or 
                offices providing education services to individuals 
                with viral hepatitis;
                    ``(H) the director of the Department of Veterans 
                Affairs;
                    ``(I) medical advisory bodies that address issues 
                related to viral hepatitis; and
                    ``(J) the public, including--
                            ``(i) individuals infected with hepatitis 
                        B, hepatitis C, or both; and
                            ``(ii) advocates concerned with issues 
                        related to chronic hepatitis B and chronic 
                        hepatitis C.
    ``(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 and hepatitis C 
                (such as knowledge and observations that may be derived 
                from clinical, laboratory, and epidemiological research 
                and disease detection, prevention, and surveillance 
                outcomes);
                    ``(B) addressing gaps in the coverage or 
                effectiveness of the plan; and
                    ``(C) evaluating and, if appropriate, updating 
                recommendations, guidelines, or educational materials 
                of the Centers for Disease Control and Prevention or 
                the National Institutes of Health for health care 
                providers or the public on viral hepatitis in order to 
                be consistent with the plan.
            ``(2) Publication of notice of assessments.--Not later than 
        October 1 of the first even numbered year beginning after the 
        date of the 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. 399GG. ELEMENTS OF PROGRAM.

    ``(a) 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 
399FF, shall implement programs to increase awareness and enhance 
knowledge and understanding of hepatitis B and hepatitis C. Such 
programs shall include--
            ``(1) the conduct of culturally and language appropriate 
        health education in primary and secondary schools, college 
        campuses, public awareness campaigns, and community outreach 
        activities (especially to the ethnic communities with high 
        rates of chronic hepatitis B and chronic hepatitis C and other 
        high-risk groups) to promote public awareness and knowledge 
        about the value of hepatitis A and hepatitis B immunization, 
        risk factors, the transmission and prevention of hepatitis B 
        and hepatitis C, the value of screening for the early detection 
        of hepatitis B and hepatitis C, and options available for the 
        treatment of chronic hepatitis B and chronic hepatitis C;
            ``(2) the promotion of immunization programs that increase 
        awareness and access to hepatitis A and hepatitis B vaccines 
        for susceptible adults and children;
            ``(3) the training of health care professionals regarding 
        the importance of vaccinating individuals infected with 
        hepatitis C and individuals who are at risk for hepatitis C 
        infection against hepatitis A and hepatitis B;
            ``(4) the training of health care professionals regarding 
        the importance of vaccinating individuals chronically infected 
        with hepatitis B and individuals who are at risk for chronic 
        hepatitis B infection against the hepatitis A virus;
            ``(5) the training of health care professionals and health 
        educators to make them aware of the high rates of chronic 
        hepatitis B and chronic hepatitis C in certain adult ethnic 
        populations, and the importance of prevention, detection, and 
        medical management of hepatitis B and hepatitis C and of liver 
        cancer screening;
            ``(6) the development and distribution of health education 
        curricula (including information relating to the special needs 
        of individuals infected with hepatitis B and hepatitis C, such 
        as the importance of prevention and early intervention, regular 
        monitoring, the recognition of psychosocial needs, appropriate 
        treatment, and liver cancer screening) for individuals 
        providing hepatitis B and hepatitis C counseling; and
            ``(7) support for the implementation curricula described in 
        paragraph (6) by State and local public health agencies.
    ``(b) 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, territorial, and tribal levels (including 
        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, 
                        territorial, and tribal voluntary hepatitis B 
                        and hepatitis C testing programs to screen the 
                        high-prevalence populations 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 or hepatitis C 
                        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 regarding viral hepatitis.--The 
                Secretary shall support State, local, territorial, and 
                tribal programs in a wide variety of settings, 
                including those providing primary and specialty health 
                care services in nonprofit private and public sectors, 
                to--
                            ``(i) provide individuals with ongoing risk 
                        factors for hepatitis B and hepatitis C 
                        infection with client-centered education and 
                        counseling which concentrates on--
                                    ``(I) promoting testing of 
                                individuals that have been exposed to 
                                their blood, 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 or hepatitis C 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 or hepatitis C who are 
                        pregnant or of childbearing age with culturally 
                        and language appropriate health information, 
                        such as how to prevent hepatitis B perinatal 
                        infection, and to alleviate fears associated 
                        with pregnancy or raising a family.
                    ``(C) Immunization.--The Secretary shall support 
                State, local, territorial, and tribal efforts to expand 
                the current vaccination programs to protect every child 
                in the country and all susceptible adults, particularly 
                those infected with hepatitis C and 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 younger through the Vaccines 
                        for Children Program;
                            ``(ii) ensuring that the recommendations of 
                        the Advisory Committee on Immunization 
                        Practices are followed regarding the birth dose 
                        of hepatitis B vaccinations for newborns;
                            ``(iii) requiring proof of hepatitis B 
                        vaccination for entry into public or private 
                        daycare, preschool, elementary school, 
                        secondary school, and institutions of higher 
                        education;
                            ``(iv) expanding the availability of 
                        hepatitis B vaccination for all susceptible 
                        adults to protect them from becoming acutely or 
                        chronically infected, including ethnic and 
                        other populations with high prevalence rates of 
                        chronic hepatitis B infection;
                            ``(v) expanding the availability of 
                        hepatitis B vaccination for all susceptible 
                        adults, particularly those in their 
                        reproductive age (women and men less than 45 
                        years of age), to protect them from the risk of 
                        hepatitis B infection;
                            ``(vi) ensuring the vaccination of 
                        individuals infected, or at risk for infection, 
                        with hepatitis C against hepatitis A, hepatitis 
                        B, and other infectious diseases, as 
                        appropriate, for which such individuals may be 
                        at increased risk; and
                            ``(vii) ensuring the vaccination of 
                        individuals infected, or at risk for infection, 
                        with hepatitis B against hepatitis A virus and 
                        other infectious diseases, as appropriate, for 
                        which such individuals may be at increased 
                        risk.
                    ``(D) Medical referral.--The Secretary shall 
                support State, local, territorial, and tribal programs 
                that support--
                            ``(i) referral of persons chronically 
                        infected with hepatitis B or hepatitis C--
                                    ``(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 ongoing medical 
                                management including regular monitoring 
                                of liver function and screening for 
                                liver cancer; and
                            ``(ii) referral of persons infected with 
                        acute or chronic hepatitis B infection or acute 
                        or chronic hepatitis C infection for drug and 
                        alcohol abuse treatment where appropriate.
            ``(3) Increased support for adult viral hepatitis 
        coordinators.--The Secretary, acting through the Director of 
        the Centers for Disease Control and Prevention, shall provide 
        increased support to Adult Viral Hepatitis Coordinators in 
        State, local, territorial, and tribal health departments in 
        order to enhance the additional management, networking, and 
        technical expertise needed to ensure successful integration of 
        hepatitis B and hepatitis C prevention and control activities 
        into existing public health 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 and hepatitis C surveillance 
        program, in order to identify--
                    ``(A) trends in the incidence of acute and chronic 
                hepatitis B and acute and chronic hepatitis C;
                    ``(B) trends in the prevalence of acute and chronic 
                hepatitis B and acute and chronic hepatitis C infection 
                among groups that may be disproportionately affected; 
                and
                    ``(C) trends in liver cancer and end-stage liver 
                disease incidence and deaths, caused by chronic 
                hepatitis B and chronic hepatitis C in the high-risk 
                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 
        underway, 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 hepatitis C, and the impact 
        of chronic hepatitis B and chronic hepatitis C infections on 
        the quality of life. Not later than one year after the date of 
        the 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 epidemiologic and community-based research to 
        develop, implement, and evaluate best practices for hepatitis B 
        and hepatitis C prevention especially in the ethnic populations 
        with high rates of chronic hepatitis B and chronic hepatitis C 
        and other high-risk groups;
            ``(2) conduct research on hepatitis B and hepatitis C 
        natural history, pathophysiology, improved treatments and 
        prevention (such as the hepatitis C vaccine), and noninvasive 
        tests that help to predict the risk of progression to liver 
        cirrhosis and liver cancer;
            ``(3) conduct research that will lead to better noninvasive 
        or blood tests to screen for liver cancer, and more effective 
        treatments of liver cancer caused by chronic hepatitis B and 
        chronic hepatitis C; and
            ``(4) conduct research comparing the effectiveness of 
        screening, diagnostic, management, and treatment approaches for 
        chronic hepatitis B, chronic hepatitis C, and liver cancer in 
        the affected communities.
    ``(e) Underserved and Disproportionately Affected Populations.--In 
carrying out this section, the Secretary shall provide expanded support 
for individuals with limited access to health education, testing, and 
health care services and groups that may be disproportionately affected 
by hepatitis B and hepatitis C.
    ``(f) Evaluation of Program.--The Secretary shall develop 
benchmarks for evaluating the effectiveness of the programs and 
activities conducted under this section and make determinations as to 
whether such benchmarks have been achieved.

``SEC. 399HH. GRANTS.

    ``(a) In General.--The Secretary may award grants to, or enter into 
contracts or cooperative agreements with, States, political 
subdivisions of States, territories, Indian tribes, or nonprofit 
entities that have special expertise relating to hepatitis B, hepatitis 
C, or both, to carry out activities under this part.
    ``(b) Application.--To be eligible for a grant, contract, or 
cooperative agreement under subsection (a), an entity shall prepare and 
submit to the Secretary an application at such time, in such manner, 
and containing such information as the Secretary may require.

``SEC. 399II. AUTHORIZATION OF APPROPRIATIONS.

    ``There are authorized to be appropriated to carry out this part 
$90,000,000 for fiscal year 2011, $90,000,000 for fiscal year 2012, 
$110,000,000 for fiscal year 2013, $130,000,000 for fiscal year 2014, 
and $150,000,000 for fiscal year 2015.''.

SEC. 4. ENHANCING SAMHSA'S ROLE IN HEPATITIS ACTIVITIES.

    Paragraph (6) of section 501(d) of the Public Health Service Act 
(42 U.S.C. 290aa(d)) is amended by striking ``HIV or tuberculosis'' and 
inserting ``HIV, tuberculosis, or hepatitis''.
                                 <all>