I 
109TH CONGRESS 
1ST SESSION H. R. 1290 
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 
MARCH 14, 2005 
Mrs. WILSON of New Mexico (for herself, Mr. TOWNS, Mr. ABERCROMBIE, 
Mr. MEEKS of New York, Mr. DOGGETT, Mr. MCNULTY, Mr. PAYNE, 
Mr. MCGOVERN, Ms. ROS-LEHTINEN, Mr. OWENS, and Mr. BERMAN) in-
troduced the following bill; which was referred to the Committee on En-
ergy 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) Approximately 5,000,000 Americans are in-
fected with the hepatitis C virus (referred to in this 
section as ‘‘HCV’’), and more than 3,000,000 Amer-
icans are chronically infected, making HCV the Na-
tion’s most common chronic blood borne virus infec-
tion. 
(2) Nearly 2 percent of the population of the 
United States have been infected with HCV. 
(3) Conservative estimates indicate that ap-
proximately 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 indica-
tion 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 dis-
eases, 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 in-
fected 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 di-
rect 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 Preven-
tion developed Recommendations for Prevention and 
Control of Hepatitis C Virus (HCV) Infection and 
HCV-Related Chronic Disease in 1998 and the Na-
tional Hepatitis C Prevention Strategy in 2001, and 
the National Institutes of Health convened Con-
sensus Development Conferences on the Manage-
ment of Hepatitis C in 1997 and 2002. These rec-
ommendations and guidelines provide a framework
for HCV prevention, control, research, and medical 
management referral programs. 
(10) The Department of Veterans Affairs (re-
ferred 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 posi-
tive for HCV and enroll in VA medical care, the VA 
offers medications that can help HCV or its com-
plications. The VA also has programs for HCV pa-
tient and provider education, clinical care, data- 
based quality improvement, and research, and it has 
4 Hepatitis C Resource Centers to develop and dis-
seminate 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 MANAGE-
MENT 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 fol-
lowing: 
‘‘PART R—PREVENTION, CONTROL, AND MEDICAL 
MANAGEMENT OF HEPATITIS C 
‘‘SEC. 399AA. FEDERAL PLAN FOR THE PREVENTION, CON-
TROL, AND MEDICAL MANAGEMENT OF HEPA-
TITIS 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 devel-
oping 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 Dis-
ease Control and Prevention; 
‘‘(B) the Director of the National Insti-
tutes of Health; 
‘‘(C) the Administrator of the Health Re-
sources 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 the 
HCV; and 
‘‘(ii) advocates concerned with issues 
related to HCV. 
‘‘(c) BIENNIAL ASSESSMENT 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 the Hepatitis C Epidemic Control and Pre-
vention 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 as-
sessments conducted under paragraph (1). Such no-
tice 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 healthcare professionals re-
garding the prevention, detection, and medical man-
agement 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 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 a 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 (42 U.S.C. 1320d–2 
note)) 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 healthcare services in nonprofit private 
and public sectors, to— 
‘‘(i) provide individuals with informa-
tion about ongoing risk factors for HCV 
infection with client-centered education 
and counseling that concentrates on chang-
ing 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, 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 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 manage-
ment, networking, and technical expertise needed to 
ensure successful integration of HCV prevention and 
control activities into existing public health pro-
grams. 
‘‘(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 HCV.—The Secretary shall support and pro-
mote 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 
healthcare services and groups that may be disproportion-
ately 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 pro-
grams, 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 Con-
trol 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 Sec-
retary shall take into consideration the content of 
the report required under paragraph (2) in con-
ducting the biennial assessment required under sec-
tion 399AA(c). 
‘‘(h) 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 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 Insti-
tutes 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 (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 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 enactment of the Hepatitis 
C Epidemic Control and Prevention Act, the Advi-
sory Board shall develop (with appropriate support 
from the Director) a comprehensive plan for the con-
duct 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 Di-
rector of National Institutes of Health and the head 
of each institute or center within the National Insti-
tutes 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 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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