I 
108TH CONGRESS 
1ST SESSION H. R. 3539
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 hepa-
titis C virus infection. 
IN THE HOUSE OF REPRESENTATIVES 
NOVEMBER 19, 2003
Mrs. WILSON of New Mexico (for herself and Mr. TOWNS) introduced the 
following bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Public Health Service Act to direct the Sec-
retary of Health and Human Services to establish, pro-
mote, 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 Representa-
tives 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 viral infec-
tion. 
(2) Nearly 2 percent of the population of the 
United States has been infected with HCV. 
(3) Conservative estimates indicate that ap-
proximately 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 indi-
viduals are aware they are infected, are unlikely to 
take precautions to prevent the spread or exacer-
bation of their infection. 
(6) There is no vaccine available to prevent 
HCV infection. 
(7) Treatments are available to slow the pro-
gression of chronic HCV. 
(8) An estimated 2,400,000 to 2,700,000 peo-
ple who are chronically infected with HCV are re-
ceiving no treatment.
‘‘(C) the Director 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 other-
wise involve HCV; 
‘‘(E) medical advisory bodies that address 
issues related to HCV; and 
‘‘(F) the public, including—
‘‘(i) individuals infected with HCV; 
and 
‘‘(ii) advocates concerned with issues 
related to HCV. 
‘‘(c) BIENNIAL UPDATE OF PLAN.—
‘‘(1) IN GENERAL.—The Secretary shall con-
duct a biennial assessment of the plan developed 
under subsection (a) for the purpose of incor-
porating into such plan new knowledge or observa-
tions relating to HCV and chronic HCV (such as 
knowledge and observations that may be derived 
from clinical, laboratory, and epidemiological re-
search and disease detection, prevention, and surveil-
lance outcomes) and addressing gaps in the coverage 
or effectiveness of the plan.
‘‘(2) PUBLICATION
OF
NOTICE
OF
ASSESS-
MENTS.—Not later than October 1 of the first even-
numbered year beginning after the date of enact-
ment of this part, and October 1 of each even-num-
bered 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 determina-
tion. 
‘‘SEC. 399BB. ELEMENTS OF THE FEDERAL PLAN FOR THE 
PREVENTION, CONTROL, AND MEDICAL MAN-
AGEMENT 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 in-
crease awareness and enhance knowledge and under-
standing of HCV. Such programs shall include—
‘‘(1) the conduct of health education, public 
awareness campaigns, and community outreach ac-
tivities 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 avail-
able for the treatment of chronic HCV; 
‘‘(2) the training of health care professionals 
regarding the prevention, detection, and medical 
management of hepatitis B (referred to in this part 
as ‘HBV’) and HCV, and the importance of vacci-
nating HCV-infected individuals and those at risk 
for HCV infection against the hepatitis A virus and 
hepatitis B virus; and 
‘‘(3) the development and distribution of cur-
ricula (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 de-
scribed in paragraph (2) to promote the early detec-
tion of HCV infection, identify risk factors for infec-
tion, 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 identi-
fication of infected individuals. 
‘‘(ii) CONFIDENTIALITY OF TEST RE-
SULTS.—The results of an HCV test con-
ducted 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 Account-
ability Act of 1996) and may not be used 
for any of the following:
‘‘(I) Issues relating to health in-
surance. 
‘‘(II) To screen or determine 
suitability for employment. 
‘‘(III) To discharge a person 
from employment. 
‘‘(B) COUNSELING REGARDING VIRAL HEP-
ATITIS.—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 informa-
tion about ongoing risk factors for HCV 
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 
HCV with education and counseling to re-
duce the risk of harm to themselves and 
transmission of the virus to others. 
‘‘(C) VACCINATION AGAINST VIRAL HEPA-
TITIS.—With respect to individuals infected, or
at risk for infection, with HCV, the Secretary 
shall provide for—
‘‘(i) the vaccination of such individ-
uals against hepatitis A virus, HBV, and 
other infectious diseases, as appropriate, 
for which such individuals may be at in-
creased 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 de-
termine their stage of chronic HCV 
and suitability for antiviral treatment; 
and 
‘‘(II) for ongoing medical man-
agement of HCV. 
‘‘(3) HEPATITIS C COORDINATORS.—The Sec-
retary, acting through the Director of the Centers
for Disease Control and Prevention, shall, upon re-
quest, 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 HCV pre-
vention and control activities into existing public 
health programs. 
‘‘(c) SURVEILLANCE AND EPIDEMIOLOGY.—
‘‘(1) IN GENERAL.—The Secretary shall pro-
mote and support the establishment and mainte-
nance of State HCV surveillance databases, in order 
to—
‘‘(A) identify risk factors for HCV infec-
tion; 
‘‘(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 dis-
proportionately affected by HCV, including in-
dividuals living with HIV, military veterans, 
emergency first responders, racial or ethnic mi-
norities, 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 Sec-
retary 
shall 
conduct 
a 
population-based 
seroprevalence study to estimate the current and fu-
ture 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 
con-
tained in the databases under paragraph (1) or de-
rived through studies under paragraph (2) shall be 
de-identified in a manner consistent with regulations 
under section 264(c) of the Health Insurance Port-
ability 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 Clin-
ical Research Network for the purpose of conducting 
research related to the treatment and medical man-
agement of HCV; and
‘‘(3) conduct basic research to identify new ap-
proaches to prevention (such as vaccines) and treat-
ment 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 AF-
FECTED 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 HCV. 
‘‘(g) EVALUATION
OF PROGRAM.—The Secretary 
shall develop benchmarks for evaluating the effectiveness 
of the programs and activities conducted under this sec-
tion and make determinations as to whether such bench-
marks 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, con-
tract, or cooperative agreement under subsection (a), an 
entity shall prepare and submit to the Secretary an appli-
cation 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 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 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 National Institutes of Health 
concerning matters relating to liver disease research, in-
cluding by developing and revising the Liver Disease Re-
search 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 consulta-
tion with the Director of the National Institute of Diabe-
tes and Digestive and Kidney Diseases, of whom 12 such 
individuals shall be eminent scientists and 6 such individ-
uals 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 re-
search 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 rep-
resentative on the Advisory Board. 
‘‘(e) LIVER DISEASE RESEARCH ACTION PLAN.—
‘‘(1) 
DEVELOPMENT.—Not 
later 
than 
months after the date of the enactment of this sec-
tion, the Advisory Board shall develop (with appro-
priate support from the Director) a comprehensive 
plan for the conduct and support of liver disease re-
search 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 re-
vise 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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