[Congressional Record Volume 149, Number 78 (Friday, May 23, 2003)]
[Senate]
[Pages S7142-S7145]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mrs. HUTCHISON (for herself, Mr. Kennedy, Mr. Campbell, Mr. 
        Biden, Mr. Smith, Mr. Dodd, Mr. Cornyn, Mr. Bingaman, Mr. 
        Daschle, Mr. Breaux, Mr. Johnson, Mr. Schumer, Mrs. Clinton, 
        and Mr. Jeffords):
  S. 1143. 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. 1143

       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) Over 3,000,000 individuals in the United States are 
     chronically infected with the hepatitis C virus (referred to 
     in this section as ``HCV''), making it the Nation's most 
     common 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 
     35,000 Americans are newly infected with HCV each year.
       (4) HCV infection can cause life-threatening liver disease.
       (5) Individuals infected with HCV serve as a source of 
     transmission to others and, since few individuals are aware 
     they are infected, 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 to slow the progression of 
     chronic hepatitis C.
       (8) An estimated 2,400,000 to 2,700,000 people who are 
     chronically infected with hepatitis C are receiving no 
     treatment.
       (9) Conservative estimates place the costs of lost 
     productivity and medical care arising from chronic hepatitis 
     C in the United States at more than $600,000,000 annually and 
     such costs will undoubtedly increase in the absence of 
     expanded prevention and treatment efforts.
       (10) 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 hepatitis C prevention, control, research, and 
     medical management referral programs.
       (11) Federal support is necessary to increase knowledge and 
     awareness of hepatitis C 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 hepatitis C which 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 Director of the Health Resources and Services 
     Administration;
       ``(D) the heads of other Federal agencies or offices 
     providing services to individuals with hepatitis C virus 
     (referred to in this part as `HCV') infections or the 
     functions of which otherwise involve hepatitis C;
       ``(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 Update of Plan.--

[[Page S7143]]

       ``(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 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 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 hepatitis C. 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 hepatitis C;
       ``(2) the training of health care professionals regarding 
     the prevention, detection, and medical management of 
     hepatitis B and hepatitis C, and the importance of 
     vaccinating HCV-infected individuals and those at risk for 
     HCV infection against the hepatitis A virus and hepatitis B 
     virus (referred to in this part as `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 
     hepatitis C testing programs to aid in the early 
     identification of infected individuals.
       ``(ii) Confidentiality of test results.--The results of a 
     hepatitis C 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 health care services in the private and the public 
     sectors, to--
       ``(i) provide individuals with information about ongoing 
     risk factors for hepatitis C virus infection with client-
     centered education and counseling which concentrates on 
     changing behaviors that place them at risk for infection; and
       ``(ii) provide individuals infected with hepatitis C virus 
     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, hepatitis B, 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 hepatitis C and suitability for antiviral treatment; 
     and
       ``(II) for ongoing medical management of hepatitis C.

       ``(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 additional management, networking, and technical 
     expertise needed to ensure successful integration of 
     hepatitis C 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 
     hepatitis C, 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 hepatitis C. Such studies shall 
     consider the economic and clinical impacts of hepatitis C, as 
     well as the impact of hepatitis C 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 hepatitis C; 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 Hepatitis 
     C.--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 health care services 
     and groups that may be disproportionately affected by 
     hepatitis C.
       ``(g) 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 non-
     profit 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 2004, and such sums as may 
     be necessary for each of fiscal years 2005 through 2008.''.

     SEC. 4. LIVER DISEASE RESEARCH ADVISORY BOARD.

       Part A of title IV of the Public Health Service Act (42 
     U.S.C. 281 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 this section, 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 Centers for Disease Control and 
     Prevention 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

[[Page S7144]]

     National Institutes of Health, in consultation with the 
     Director of the Institute of Allergy and Infectious Diseases, 
     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 Institute, 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 the enactment of this section, the Advisory Board shall 
     develop (with appropriate support from the Director and staff 
     of the Center) 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 NIH 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 of 
     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 3 
     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's a privilege to join my colleague, 
Senator Kay Bailey Hutchison, in introducing this legislation to 
address the growing problem of Hepatitis C. Senator Hutchison's 
leadership has been essential in preparing this proposal to help 
establish nationwide programs for Hepatitis C that have been so 
effective in Texas. We are also indebted to the leadership of Senator 
Smith, Senator Campbell, Senator Daschle, and many other colleagues on 
both sides of the aisle for taking action to reduce the serious toll of 
Hepatitis C on so many of our fellow citizens.
  Hepatitis C is a rapidly growing health care crisis. More than 3.9 
million Americans are infected with the virus, making it the nation's 
most common blood-borne viral illness, and the numbers continue to 
rise. 10,000 Americans die each year of chronic complications related 
to the virus. Hepatitis C virus infection is a major cause of death in 
AIDS patients, and nearly 40 percent of all HIV-positive people are 
also infected with Hepatitis C virus.
  Hepatitis C leads to life-threatening conditions, including cirrhosis 
and liver cancer, which cost our country more than $600 million every 
year. This bill supports liver disease research to encourage the 
development of an effective vaccine against the virus.
  Unlike Hepatitis A and B, there is currently no vaccine available to 
prevent this epidemic. It is critical that infected individuals are 
identified early, so that they can obtain treatment and take other 
steps to reduce the likelihood that the disease will lead to permanent 
liver damage or spread of the virus to others.
  The bill we are introducing today takes a new approach to fighting 
this virus by establishing a nationwide plan to provide the most 
effective ways of prevention, control and medical management of 
Hepatitis C. The bill also seeks to increase knowledge and awareness of 
the infection by patients, health care professionals, and the public.
  This strategy was successfully implemented in Texas. Public health 
counseling and testing sites were established to reach people at high 
risk for Hepatitis C, and to make referrals to health and social 
services. In the first year, more than 13,000 clients received 
counseling services, one-third of whom tested positive for Hepatitis C. 
In addition, media campaigns were conducted to alert the public to the 
dangers of Hepatitis C. The savings for Texas were estimated to be 
almost $500,000 a year.
  Using this model, the Department of Health and Human Service will 
develop a plan to combat the Hepatitis C epidemic, with advice from the 
public including physicians, researchers, patients, and advocates. 
Confidential counseling and voluntary testing programs will be offered, 
as well as immunization against Hepatitis A and B. Individuals at high 
risk will be referred for further evaluation and management, including 
treatment with anti-viral therapy.
  Our bill calls for Hepatitis C coordinators, to be assigned by CDC, 
at state, local, and tribal levels to carry out education and 
supervision of local health care workers. The Liver Disease Research 
Advisory Board will be established to assist and advise CDC on liver 
disease research. A confidential database will be created to enhance 
studies the epidemiology of the illness.
  The fight against Hepatitis C must begin with the underserved 
populations who are disproportionately affected by the virus, 
especially minority populations, the uninsured, and veterans. We must 
also do all we can to protect hemophiliacs, renal dialysis patients, 
and AIDS patients.
  Hepatitis C is a devastating disease, and this bill can be a major 
step in fighting it. I look forward to working with my colleagues to 
enact this bill into law.
  Mr. JOHNSON. Mr. President, I rise today with my colleagues, Senators 
Kennedy, Clinton, Daschle, Breaux, Jeffords, Biden, Dodd, Bingaman, 
Hutchison, Campbell, Schumer, and Smith to introduce the Hepatitis C 
Epidemic Control and Prevention Act of 2003. I thank my colleagues for 
joining me in introducing this legislation that will improve the 
prevention, control, and medical management of hepatitis C.
  Hepatitis C is the most common chronic bloodborne viral infection in 
the United States, and it is the seventh leading cause of death in our 
country. Almost 4 million U.S. citizens are infected with hepatitis C, 
and of those 2.7 million are chronically infected and at least 2.5 
million do not receive any treatment, which results in the continued 
spread of this devastating, yet preventable illness. The estimated 
direct and indirect costs of hepatitis C infection are at least $600 
million annually.
  Symptoms of hepatitis C can include jaundice, fatigue, loss of 
appetite, and abdominal pain. While this disease may be asymptomatic in 
most patients initially, between 50 and 80 percent will develop a 
chronic infection, and of these half will eventually develop cirrhosis 
or cancer of the liver. While diagnostic tests are available to 
identify the disease, there is no vaccine to prevent hepatitis C, which 
makes prevention and control measures crucial to reducing its incidence 
and prevalence.
  The importance of improving hepatitis C prevention and control 
activities was brought to my attention this past year by the family of 
Christen Graeber Winter. Christen was from Aberdeen, SD, and passed 
away 5 years ago at the age of 42. She had been very ill two decades 
earlier and required a blood transfusion. Christen became very sick a 
little over 5 years ago and was diagnosed with hepatitis C, a disease 
that she had contracted from that blood transfusion that she had so 
many years earlier. Christen died in 1998, and during the last months 
of her life she remained as active as possible and was committed to 
finishing up her bachelor's degree at Presentation College, even though 
she was very ill.
  Everyone who knew Christen said she was a warm and caring person, and 
even towards the end of her life, she remained strong and was 
determined not to burden others with her deteriorating health. After 
her death, Christen's sister Carey started conducting research to learn 
about hepatitis C. She knew nothing of the disease and was surprised to 
learn how many people suffered from it. She learned that physicians are 
largely unaware of hepatitis C and therefore cases often go undetected. 
Carey is now a strong advocate of promoting increased funding for 
education, treatment, and prevention of this disease and has helped me 
understand how important it is that we in Congress establish the 
programs and appropriate the funds necessary to prevent needless deaths 
like the death of Christen.
  The hepatitis C Epidemic Prevention and Control Act will help reduce 
the number of people affected by this horrible illness and prevent 
stories like Carey's sister from continuing. The bill requires that the 
Department of Health and Human Services develop and implement an 
integrated plan to combat

[[Page S7145]]

hepatitis C. While we know how to prevent the spread of this disease, 
there have been limited programs to educate health professionals, at-
risk populations, and the general public on how to do so. This bill 
will focus on increasing knowledge and awareness of such infections 
among providers and patients.
  In addition to education, surveillance, early detection, and 
counseling are important tools that must be used in order to control 
this disease. Less than 50 percent of local health departments 
providing counseling and only 23 percent provide testing for hepatitis 
C. This bill will require that CDC promote confidential testing 
programs by working with State and local governments in order to catch 
hepatitis C cases early. It will also provide access to important 
counseling activities in a variety of private and public health care 
settings to help patients reduce the risk of harm to themselves and 
others.
  This important legislation is supported by a tripartisan coalition of 
my colleagues. We have recognized that hepatitis C is a preventable 
disease that can be halted with a strong emphasis on prevention and 
control. I do not want to see more cases like that of Carey's sister. 
We have an opportunity to make a real difference here, and I urge the 
Senate to support this bill.
                                 ______