S 1445 IS - May 22, 2007
As retrieved on Mar 5, 2008
Hepatitis C Epidemic Control and Prevention Act
(Introduced in Senate)
S 1445 IS
110th CONGRESS
1st Session
S. 1445
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 22, 2007
Mr. KENNEDY (for himself and Mrs. HUTCHISON) 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) 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,
leading the Centers for Disease Control and Prevention
(referred to in this section as the `CDC') to recognize HCV
as the Nation's most common chronic blood-borne virus
infection.
(2) According to the CDC, nearly 2 percent of the population
of the United States have been infected with HCV.
(3) The CDC conservatively estimates 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. Moreover,
methamphetamine abuse--which is a matter of increasing
concern to Congress and public health officials across the
country--is recognized by the National Institute on Drug
Abuse to be inextricably linked to HCV.
(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 CDC
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.
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 S--PREVENTION, CONTROL, AND MEDICAL MANAGEMENT OF
HEPATITIS C
`SEC. 399II. 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
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 (referred to in this part
as the `CDC') and the National Institutes of Health, and the
comprehensive HCV programs that have been implemented by the
Department of Veterans Affairs, including the Hepatitis C
Resource Center program; and
`(2) consult with--
`(A) the Director of the CDC;
`(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) 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 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.
`SEC. 399JJ. 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 CDC, 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) IN GENERAL- The Secretary, acting through the Director
of the CDC, 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 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 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) 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 HCV and suitability for antiviral treatment; and
`(II) for ongoing medical management of HCV.
`(3) HEPATITIS C COORDINATORS- The Secretary, acting through
the Director of the CDC, 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) 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 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) CONFIDENTIALITY- Information contained in the databases
under paragraph (1) 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 CDC 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) 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. 399KK. 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, 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. 399LL. AUTHORIZATION OF APPROPRIATIONS.
`There are authorized to be appropriated to carry out this
part $90,000,000 for fiscal year 2008, and $72,000,000 for
each of fiscal years 2009 through 2012.'.
Home