Directs the Secretary to support the development of voluntary State, local, and tribal HCV testing programs and counseling. Provides for the vaccination of individuals infected with HCV against hepatitis A and B and other infectious diseases.
Directs the Secretary to support the establishment and maintenance of HCV surveillance databases and to establish and support a Hepatitis C Clinical Research Network.
Allows the Secretary to award grants to States, political subdivisions of States, Indian tribes, or non-profit entities that have special expertise relating to HCV, to carry out activities under this Act.
Directs the Director of the National Institutes of Health to establish a Liver Disease Research Advisory Board.
[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 1143 Introduced in Senate (IS)]
108th CONGRESS
1st Session
S. 1143
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
May 23, 2003
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) 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) 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.--
``(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 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.''.
<all>
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S7142-7144)
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