1.
This Act may be cited as the
Hepatitis C Epidemic Control and
Prevention Act
.
2.
Congress makes the following
findings:
(1)
Approximately 5,000,000
Americans are infected with the hepatitis C virus (referred to in this section
as HCV
), and more than 3,000,000 Americans are chronically
infected, making HCV the Nation's most common chronic 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 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 indication 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 diseases, 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 infected 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 direct 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 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 HCV prevention,
control, research, and medical management referral programs.
(10)
The Department of Veterans
Affairs (referred 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 positive for HCV and enroll
in VA medical care, the VA offers medications that can help HCV or its
complications. The VA also has programs for HCV patient and provider education,
clinical care, data-based quality improvement, and research, and it has 4
Hepatitis C Resource Centers to develop and disseminate 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.
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:
R
Prevention, control, and medical management of hepatitis
c
399AA.
Federal Plan for the prevention, control, and medical
management of hepatitis c
(a)
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 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 Administrator 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 otherwise 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)
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 the
Hepatitis C Epidemic Control and Prevention
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
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.
399BB.
Elements of the Federal Plan for the prevention, control, and
medical management of hepatitis c
(a)
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 HCV. 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
HCV;
(2)
the training of healthcare
professionals regarding the prevention, detection, and medical management 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 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)
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)
(A)
Voluntary testing programs
(i)
The Secretary shall support
and promote the development of State, local, and tribal voluntary HCV testing
programs to aid in the early identification of infected individuals.
(ii)
Confidentiality of test results
The results of a HCV 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 healthcare services in nonprofit private
and public sectors, to—
(i)
provide individuals with
information about ongoing risk factors for HCV infection with client-centered
education and counseling that concentrates on changing behaviors that place
them at risk for infection; and
(ii)
provide individuals
infected with HCV 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, HBV, and other viral hepatides.
(D)
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 HCV and suitability for antiviral treatment;
and
(II)
for ongoing medical
management of HCV.
(3)
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 management, networking, and technical expertise needed to
ensure successful integration of HCV prevention and control activities into
existing public health programs.
(c)
Surveillance and epidemiology
(1)
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 HCV, 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)
The Secretary shall conduct
a population-based seroprevalence study to estimate the current and future
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)
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)
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 HCV; 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 HCV
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 healthcare services and groups
that may be disproportionately affected by HCV.
(g)
Study and report regarding VA program and Federal
plan
(1)
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 programs, or components of these programs,
should be part of the Federal plan to combat HCV.
(2)
Not later than 12 months
after date of enactment of the Hepatitis C
Epidemic Control and Prevention Act, the Secretary shall submit
to Congress a report that describes the results of the study required under
paragraph (1).
(3)
The Secretary shall take
into consideration the content of the report required under paragraph (2) in
conducting the biennial assessment required under section 399AA(c).
(h)
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.
399CC.
(a)
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)
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.
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.
.
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:
409J.
Liver Disease Research Advisory Board
(a)
Not later than 90 days
after the date of enactment of the Hepatitis
C Epidemic Control and Prevention Act, 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)
The Advisory Board shall
advise and assist the Director of the National Institutes of Health concerning
matters relating to liver disease research, including by developing and
revising the Liver Disease Research Action Plan.
(c)
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 National
Institute of Diabetes 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)
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)
Not later than 15 months
after the date of enactment of the Hepatitis
C Epidemic Control and Prevention Act, the Advisory Board shall
develop (with appropriate support from the Director) 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 National Institutes of Health and the head of each institute or
center within the National Institutes of Health that funds liver disease
research.
(2)
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)
The Advisory Board shall
revise 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.
.