[Congressional Record Volume 151, Number 23 (Thursday, March 3, 2005)]
[Senate]
[Pages S2027-S2029]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mrs. HUTCHISON (for herself, Mr. Kennedy, Mr. Cornyn, and Mr. 
        Schumer):
  S. 521. 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; to the Committee on 
Health, Education, Labor, and Pensions.
  Mrs. HUTCHISON. Mr. President, I ask unanimous consent that the text 
of the bill be printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                 S. 521

       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

[[Page S2028]]

     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.

[[Page S2029]]

       ``(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.''.

  Mr. KENNEDY. Mr. President, it is a privilege to join Senators 
Hutchinson, Schumer, and Cornyn in introducing the Hepatitis C Epidemic 
Control and Prevention Act. Our goal is to provide for the prevention, 
control, and treatment of Hepatitis C viral infection through 
education, surveillance, early detection, and research.
  Hepatitis C is the most common, chronic, blood-borne infection in the 
United States. An estimated 5 million Americans are now infected with 
the Hepatitis C virus, and 30,000 more are infected every year. The 
rate of infection continues to rise--between 1990 and 2015, the Centers 
for Disease Control and Prevention project a 4-fold increase in the 
number of persons with chronic infection of the virus.
  Persons infected with the Hepatitis C virus come from all walks of 
life, but those at greatest risk include health workers, emergency 
service personnel, and drug users. Tragically, the majority of infected 
individuals are unaware of their infection, are not receiving 
treatment, and are sources of transmission of the virus to others.
  Infection with the Hepatitis C virus has serious health effects. It 
can cause liver disease, including cirrhosis and liver cancer, and is 
the leading indicator for liver transplants. The illnesses are often 
life-threatening--up to 10,000 Americans die yearly from Hepatitis C 
complications, and it is the 7th leading cause of death for men between 
the ages of 25 and 64. In addition to the human costs, the disease has 
massive financial implications. Direct costs associated with care are 
expected to exceed $1 billion a year by 2010. Without intervention, the 
epidemic is projected to result in costs of over $54 billion by the 
year 2019.
  Greater Federal investment will have a critical role in reversing 
this silent epidemic. Our Hepatitis C bill will increase public 
awareness of the dangers of Hepatitis C, and make testing widely 
available. For those already infected, it will provide counseling, 
referrals, and vaccination against Hepatitis A and B and other 
infectious diseases. It will also support research to develop a vaccine 
against Hepatitis C, just as we now have for Hepatitis A and B. It will 
create a multiagency Liver Disease Research Advisory Board and mandate 
a study of programs used by the Veteran's Administration, in order to 
provide important lessons and models of care for the nation. The 
Centers for Disease Control and Prevention will increase surveillance 
activities, and provide Hepatitis C coordinators to provide technical 
assistance and training to state public health agencies.
  This bill will have a major impact on the lives of millions of 
Americans who are infected by Hepatitis C, and the families and loved 
ones who care for them. I look forward to working closely with my 
colleagues to act quickly to pass this needed legislation. I especially 
commend the impressive work of the students at Robinson Secondary 
School in Fairfax, VA, for their continuing dedication to informing 
Members of Congress about this important issue and bringing national 
attention to it.
                                 ______