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Hepatitis C Epidemic Control and Prevention Act (Introduced in Senate)


S 1143 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.'.
 

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