[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 521 Introduced in Senate (IS)]







109th CONGRESS
  1st Session
                                 S. 521

   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

                             March 3, 2005

Mrs. Hutchison (for herself, Mr. Kennedy, Mr. Cornyn, and Mr. Schumer) 
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.

    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 ``Hepatitis C Epidemic Control and 
Prevention Act''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) Approximately 5,000,000 Americans are infected with the 
        hepatitis C virus (referred to in this section as ``HCV''), and 
        more than 3,000,000 Americans are chronically infected, making 
        HCV the Nation's most common chronic blood borne virus 
        infection.
            (2) Nearly 2 percent of the population of the United States 
        have been infected with HCV.
            (3) Conservative estimates indicate that approximately 
        30,000 Americans are newly infected with HCV each year, and 
        that number has been growing since 2001.
            (4) HCV infection, in the United States, is the most common 
        cause of chronic liver disease, liver cirrhosis, and liver 
        cancer, the most common indication for liver transplant, and 
        the leading cause of death in people with HIV/AIDS. In 
        addition, there may be links between HCV and certain other 
        diseases, given that a high number of people infected with HCV 
        also suffer from type 2 diabetes, lymphoma, thyroid and certain 
        blood disorders, and autoimmune disease.
            (5) The majority of individuals infected with HCV are 
        unaware of their infection. Individuals infected with HCV serve 
        as a source of transmission to others and, since few 
        individuals are aware they are infected, they are unlikely to 
        take precautions to prevent the spread or exacerbation of their 
        infection.
            (6) There is no vaccine available to prevent HCV infection.
            (7) Treatments are available that can eradicate the disease 
        in approximately 50 percent of those who are treated, and 
        behavioral changes can slow the progression of the disease.
            (8) Conservative estimates place the costs of direct 
        medical expenses for HCV at more than $1,000,000,000 in the 
        United States annually, and such costs will undoubtedly 
        increase in the absence of expanded prevention and treatment 
        efforts.
            (9) To combat the HCV epidemic in the United States, the 
        Centers for Disease Control and Prevention 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, and the 
        National Institutes of Health convened Consensus Development 
        Conferences on the Management of Hepatitis C in 1997 and 2002. 
        These recommendations and guidelines provide a framework for 
        HCV prevention, control, research, and medical management 
        referral programs.
            (10) The Department of Veterans Affairs (referred to in 
        this paragraph as the ``VA''), which cares for more people 
        infected with HCV than any other health care system, is the 
        Nation's leader in HCV screening, testing, and treatment. Since 
        1998, it has been the VA's policy to screen for HCV risk 
        factors all veterans receiving VA health care, and the VA 
        currently recommends testing for all those who are found to be 
        ``at risk'' for the virus and for all others who wish to be 
        tested. In fiscal year 2004, over 98 percent of VA patients had 
        been screened for HCV risk factors, and over 90 percent of 
        those ``at risk'' were tested. For all veterans who test 
        positive for HCV and enroll in VA medical care, the VA offers 
        medications that can help HCV or its complications. The VA also 
        has programs for HCV patient and provider education, clinical 
        care, data-based quality improvement, and research, and it has 
        4 Hepatitis C Resource Centers to develop and disseminate 
        innovative practices and tools to improve patient care. This 
        comprehensive program should be commended and could potentially 
        serve as a model for future HCV programs.
            (11) Federal support is necessary to increase knowledge and 
        awareness of HCV and to assist State and local prevention and 
        control efforts.

SEC. 3. PREVENTION, CONTROL, AND MEDICAL MANAGEMENT OF HEPATITIS C.

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

  ``PART R--PREVENTION, CONTROL, AND MEDICAL MANAGEMENT OF HEPATITIS C

``SEC. 399AA. FEDERAL PLAN FOR THE PREVENTION, CONTROL, AND MEDICAL 
              MANAGEMENT OF HEPATITIS C.

    ``(a) In General.--The Secretary shall develop and implement a plan 
for the prevention, control, and medical management of the hepatitis C 
virus (referred to in this part as `HCV') that includes strategies for 
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 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 Administrator of the Health Resources and 
                Services Administration;
                    ``(D) the heads of other Federal agencies or 
                offices providing services to individuals with HCV 
                infections or the functions of which otherwise involve 
                HCV;
                    ``(E) medical advisory bodies that address issues 
                related to HCV; and
                    ``(F) the public, including--
                            ``(i) individuals infected with the HCV; 
                        and
                            ``(ii) advocates concerned with issues 
                        related to HCV.
    ``(c) Biennial Assessment of Plan.--
            ``(1) In general.--The Secretary shall conduct a biennial 
        assessment of the plan developed under subsection (a) for the 
        purpose of incorporating into such plan new knowledge or 
        observations relating to HCV and chronic HCV (such as knowledge 
        and observations that may be derived from clinical, laboratory, 
        and epidemiological research and disease detection, prevention, 
        and surveillance outcomes) and 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 the Hepatitis C Epidemic Control and 
        Prevention Act, 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 THE FEDERAL PLAN FOR THE PREVENTION, CONTROL, 
              AND MEDICAL MANAGEMENT OF HEPATITIS C.

    ``(a) Education and Training.--The Secretary, acting through the 
Director of the Centers for Disease Control and Prevention, shall 
implement programs to increase awareness and enhance knowledge and 
understanding of HCV. Such programs shall include--
            ``(1) the conduct of health education, public awareness 
        campaigns, and community outreach activities to promote public 
        awareness and knowledge about risk factors, the transmission 
        and prevention of infection with HCV, the value of screening 
        for the early detection of HCV infection, and options available 
        for the treatment of chronic HCV;
            ``(2) the training of healthcare professionals regarding 
        the prevention, detection, and medical management of the 
        hepatitis B virus (referred to in this part as `HBV') and HCV, 
        and the importance of vaccinating HCV-infected individuals and 
        those at risk for HCV infection against the hepatitis A virus 
        and HBV; and
            ``(3) the development and distribution of curricula 
        (including information relating to the special needs of 
        individuals infected with HBV or HCV, such as the importance of 
        early intervention and treatment and the recognition of 
        psychosocial needs) for individuals providing hepatitis 
        counseling, as well as support for the implementation of such 
        curricula by State and local public health agencies.
    ``(b) Early Detection and Surveillance.--
            ``(1) In general.--The Secretary, acting through the 
        Director of the Centers for Disease Control and Prevention, 
        shall support activities described in paragraph (2) to promote 
        the early detection of HCV infection, identify risk factors for 
        infection, and conduct surveillance of HCV infection trends.
            ``(2) Activities.--
                    ``(A) Voluntary testing programs.--
                            ``(i) In general.--The Secretary shall 
                        support and promote the development of State, 
                        local, and tribal voluntary HCV testing 
                        programs to aid in the early identification of 
                        infected individuals.
                            ``(ii) Confidentiality of test results.--
                        The results of a HCV test conducted by a 
                        testing program developed or supported under 
                        this subparagraph shall be considered protected 
                        health information (in a manner consistent with 
                        regulations promulgated under section 264(c) of 
                        the Health Insurance Portability and 
                        Accountability Act of 1996 (42 U.S.C. 1320d-2 
                        note)) and may not be used 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, and tribal 
                programs in a wide variety of settings, including those 
                providing primary and specialty healthcare services in 
                nonprofit private and public sectors, to--
                            ``(i) provide individuals with information 
                        about ongoing risk factors for HCV infection 
                        with client-centered education and counseling 
                        that concentrates on changing behaviors that 
                        place them at risk for infection; and
                            ``(ii) provide individuals infected with 
                        HCV with education and counseling to reduce the 
                        risk of harm to themselves and transmission of 
                        the virus to others.
                    ``(C) Vaccination against viral hepatitis.--With 
                respect to individuals infected, or at risk for 
                infection, with HCV, the Secretary shall provide for--
                            ``(i) the vaccination of such individuals 
                        against hepatitis A virus, HBV, and other 
                        infectious diseases, as appropriate, for which 
                        such individuals may be at increased risk; and
                            ``(ii) the counseling of such individuals 
                        regarding hepatitis A, HBV, and other viral 
                        hepatides.
                    ``(D) Medical referral.--The Secretary shall 
                support--
                            ``(i) referral of persons infected with or 
                        at risk for HCV, for drug or alcohol abuse 
                        treatment where appropriate; and
                            ``(ii) referral of persons infected with 
                        HCV--
                                    ``(I) for medical evaluation to 
                                determine their stage of chronic HCV 
                                and suitability for antiviral 
                                treatment; and
                                    ``(II) for ongoing medical 
                                management of HCV.
            ``(3) Hepatitis c coordinators.--The Secretary, acting 
        through the Director of the Centers for Disease Control and 
        Prevention, shall, upon request, provide a Hepatitis C 
        Coordinator to a State health department in order to enhance 
        the management, networking, and technical expertise needed to 
        ensure successful integration of HCV prevention and control 
        activities into existing public health programs.
    ``(c) Surveillance and Epidemiology.--
            ``(1) In general.--The Secretary shall promote and support 
        the establishment and maintenance of State HCV surveillance 
        databases, in order to--
                    ``(A) identify risk factors for HCV infection;
                    ``(B) identify trends in the incidence of acute and 
                chronic HCV;
                    ``(C) identify trends in the prevalence of HCV 
                infection among groups that may be disproportionately 
                affected by HCV, including individuals living with HIV, 
                military veterans, emergency first responders, racial 
                or ethnic minorities, and individuals who engage in 
                high risk behaviors, such as intravenous drug use; and
                    ``(D) assess and improve HCV infection prevention 
                programs.
            ``(2) Seroprevalence studies.--The Secretary shall conduct 
        a population-based seroprevalence study to estimate the current 
        and future impact of HCV. Such studies shall consider the 
        economic and clinical impacts of HCV, as well as the impact of 
        HCV on quality of life.
            ``(3) Confidentiality.--Information contained in the 
        databases under paragraph (1) or derived through studies under 
        paragraph (2) shall be de-identified in a manner consistent 
        with regulations under section 264(c) of the Health Insurance 
        Portability and Accountability Act of 1996.
    ``(d) Research Network.--The Secretary, acting through the Director 
of the Centers for Disease Control and Prevention and the Director of 
the National Institutes of Health, shall--
            ``(1) conduct epidemiologic research to identify best 
        practices for HCV prevention;
            ``(2) establish and support a Hepatitis C Clinical Research 
        Network for the purpose of conducting research related to the 
        treatment and medical management of HCV; and
            ``(3) conduct basic research to identify new approaches to 
        prevention (such as vaccines) and treatment for HCV.
    ``(e) Referral for Medical Management of Chronic HCV.--The 
Secretary shall support and promote State, local, and tribal programs 
to provide HCV-positive individuals with referral for medical 
evaluation and management, including currently recommended antiviral 
therapy when appropriate.
    ``(f) 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 
healthcare services and groups that may be disproportionately affected 
by HCV.
    ``(g) Study and Report Regarding VA Program and Federal Plan.--
            ``(1) Study.--The Secretary shall conduct a study to 
        examine the comprehensive HCV programs that have been 
        implemented by the Department of Veterans Affairs (referred to 
        in this subsection as the `VA'), including the Hepatitis C 
        Resource Center program, to determine whether any of these 
        programs, or components of these programs, should be part of 
        the Federal plan to combat HCV.
            ``(2) Report.--Not later than 12 months after date of 
        enactment of the Hepatitis C Epidemic Control and Prevention 
        Act, the Secretary shall submit to Congress a report that 
        describes the results of the study required under paragraph 
        (1).
            ``(3) Consideration of report.--The Secretary shall take 
        into consideration the content of the report required under 
        paragraph (2) in conducting the biennial assessment required 
        under section 399AA(c).
    ``(h) 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. 399CC. GRANTS.

    ``(a) In General.--The Secretary may award grants to, or enter into 
contracts or cooperative agreements with, States, political 
subdivisions of States, Indian tribes, or nonprofit entities that have 
special expertise relating to HCV, 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. 399DD. AUTHORIZATION OF APPROPRIATIONS.

    ``There are authorized to be appropriated to carry out this part 
$90,000,000 for fiscal year 2006, and such sums as may be necessary for 
each of fiscal years 2007 through 2010.''.

SEC. 4. LIVER DISEASE RESEARCH ADVISORY BOARD.

    Part B of title IV of the Public Health Service Act (42 U.S.C. 284 
et seq.) is amended by adding at the end the following:

``SEC. 409J. LIVER DISEASE RESEARCH ADVISORY BOARD.

    ``(a) Establishment.--Not later than 90 days after the date of 
enactment of the Hepatitis C Epidemic Control and Prevention Act, the 
Director of the National Institutes of Health shall establish a board 
to be known as the Liver Disease Research Advisory Board (referred to 
in this section as the `Advisory Board').
    ``(b) Duties.--The Advisory Board shall advise and assist the 
Director of the National Institutes of Health concerning matters 
relating to liver disease research, including by developing and 
revising the Liver Disease Research Action Plan.
    ``(c) Voting Members.--The Advisory Board shall be composed of 18 
voting members to be appointed by the Director of the National 
Institutes of Health, in consultation with the Director of the National 
Institute of Diabetes and Digestive and Kidney Diseases (referred to in 
this subsection as the `NIDDK'), of whom 12 such individuals shall be 
eminent scientists and 6 such individuals shall be lay persons. The 
Director of the National Institutes of Health, in consultation with the 
Director of the NIDDK, shall select 1 of the members to serve as the 
Chair of the Advisory Board.
    ``(d) Ex Officio Members.--The Director of the National Institutes 
of Health shall appoint each director of a national research institute 
that funds liver disease research to serve as a nonvoting, ex officio 
member of the Advisory Board. The Director of the National Institutes 
of Health shall invite 1 representative of the Centers for Disease 
Control and Prevention, 1 representative of the Food and Drug 
Administration, and 1 representative of the Department of Veterans 
Affairs to serve as such a member. Each ex officio member of the 
Advisory Board may appoint an individual to serve as that member's 
representative on the Advisory Board.
    ``(e) Liver Disease Research Action Plan.--
            ``(1) Development.--Not later than 15 months after the date 
        of enactment of the Hepatitis C Epidemic Control and Prevention 
        Act, the Advisory Board shall develop (with appropriate support 
        from the Director) a comprehensive plan for the conduct and 
        support of liver disease research to be known as the Liver 
        Disease Research Action Plan. The Advisory Board shall submit 
        the Plan to the Director of National Institutes of Health and 
        the head of each institute or center within the National 
        Institutes of Health that funds liver disease research.
            ``(2) Content.--The Liver Disease Research Action Plan 
        shall identify scientific opportunities and priorities for 
        liver disease research necessary to increase understanding of 
        and to prevent, cure, and develop better treatment protocols 
        for liver diseases.
            ``(3) Revision.--The Advisory Board shall revise every 2 
        years the Liver Disease Research Action Plan, but shall meet 
        annually to review progress and to amend the Plan as may be 
        appropriate because of new scientific discoveries.''.
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