National Hepatitis B Act - Amends the Public Health Service Act to require the Secretary of Health and Human Services to develop a plan for hepatitis B prevention, control, and medical management.
Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to: (1) support the integration of testing, counseling, immunization, and medical referral activities into existing clinical and public health programs at state, local, and tribal levels; and (2) provide hepatitis B coordinators to health departments in order to ensure the success of such integration.
Requires the Secretary, acting through the Director of CDC, the Administrator of the Health Resources and Services Administration (HRSA), and the Administrator of the Substance Abuse and Mental Health Services Administration, to implement programs to increase awareness and enhance knowledge and understanding of hepatitis B.
Requires the Secretary, acting through the Director of CDC, to: (1) support the establishment of a national hepatitis B surveillance program; and (2) report on population-based seroprevalence studies and hepatitis B's economic and clinical impact and its impact on quality of life.
Requires the Secretary, acting through the Directors of CDC, the National Cancer Institute, and the National Institutes of Health (NIH), to conduct research on hepatitis B.
Requires the Secretary to give priority in carrying out this Act to individuals with limited access to health education, testing, and health care services and groups that may be disproportionately affected by hepatitis B.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4550 Introduced in House (IH)]
109th CONGRESS
1st Session
H. R. 4550
To amend the Public Health Service Act to direct the Secretary of
Health and Human Services to establish, promote, and support a
comprehensive prevention, education, research, and medical management
program that will lead to a marked reduction in liver cirrhosis and a
reduction in the cases of, and improved survival of, liver cancer
caused by chronic hepatitis B infection.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 15, 2005
Mr. Dent (for himself and Mr. Honda) 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 Secretary of
Health and Human Services to establish, promote, and support a
comprehensive prevention, education, research, and medical management
program that will lead to a marked reduction in liver cirrhosis and a
reduction in the cases of, and improved survival of, liver cancer
caused by chronic hepatitis B 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 ``National Hepatitis B Act''.
SEC. 2. FINDINGS.
The Congress makes the following findings:
(1) Approximately 1.4 million Americans are chronically
infected with hepatitis B. The number of chronically infected
persons in the United States is believed to be increasing each
year with the influx of new immigrants from areas where it is
endemic.
(2) Hepatitis B is extremely infectious. In fact, the
disease is 100 times more infectious than HIV. The hepatitis B
virus (HBV) is transmitted the same way as HIV: from mother to
newborn at birth, from infected blood or injections
contaminated by infected blood, and from unprotected sex.
(3) Chronic hepatitis B usually does not cause any symptoms
early in the course of the disease, but after many years of a
clinically ``silent'' phase, as many as 25 percent of infected
individuals may develop end-stage liver disease or liver
cancer.
(4) The major burden of hepatitis B infection in the United
States is from chronic hepatitis B infection. Persons
chronically infected with hepatitis B are at higher risk of
developing cirrhosis (scarring) of the liver and liver cancer,
both of which can lead to premature death. About 5,000 deaths
per year in the United States can be attributed to chronic
hepatitis B infection.
(5) Chronic hepatitis B infection disproportionately
affects certain occupations and populations in the United
States. Although representing only four percent of the
population, Asian Americans and Pacific Islanders account for
over half of the 1.4 million chronic hepatitis B cases in the
United States.
(6) Hepatitis B infection is preventable through currently
available vaccinations and by reducing high-risk behavior. The
hepatitis B vaccine is safe and effective and has the
designation of being the ``first anti-cancer vaccine''.
(7) The diagnosis of chronic hepatitis B infection can be
made with a simple blood test that is inexpensive and widely
available. The early diagnosis of chronic hepatitis B can
reduce the risk of further transmission of the virus through
harm reduction education and the vaccination of household
members and other susceptible persons at risk.
(8) If the diagnosis of hepatitis B infection is made at an
early stage of the infection, treatment of chronic hepatitis B
infection with antiviral therapy similar to that employed in
HIV, when appropriate, can reduce the risk of progression to
liver cancer and cirrhosis.
(9) For those who are chronically infected, regular
monitoring can lead to the early detection of liver cancer at a
stage where cure is still possible. Liver cancer is one of the
deadliest types of cancer and one that has received little
funding for research and prevention.
(10) Although the costs of education, research, and
treatment are not trivial, they are substantially less than the
annual health care cost attributable to hepatitis B in the
Unites States, which is estimated to be approximately $2.5
billion ($2000 per infected person). The lifetime cost of the
hepatitis B virus in 2000--before the availability of most of
the current therapies--was approximately $80,000 per person
chronically infected, or more than $100 billion.
SEC. 3. COMPREHENSIVE HEPATITIS B PREVENTION, EDUCATION, RESEARCH, AND
MEDICAL MANAGEMENT PROGRAM.
Title III of the Public Health Service Act (42 U.S.C. 241 et seq.)
is amended by adding at the end of the following:
``PART R--COMPREHENSIVE HEPATITIS B PREVENTION, EDUCATION, RESEARCH,
AND MEDICAL MANAGEMENT PROGRAM
``SEC. 399AA. PROGRAM DEVELOPMENT.
``(a) In General.--The Secretary shall develop and implement a plan
for the prevention, control, and medical management of hepatitis B,
which includes strategies for expanded vaccination programs, primary
and secondary preventive 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
Department of Health and Human Services, 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 National Cancer
Institute;
``(D) the Administrator of the Health Resources and
Services Administration;
``(E) the Administrator of the Substance Abuse and
Mental Health Services Administration;
``(F) the heads of other Federal agencies or
offices providing education services to individuals
with viral hepatitis;
``(G) medical advisory bodies, such as the National
Task Force on Hepatitis B: Focus on Asian and Pacific
Islander Americans, the National Viral Hepatitis
Roundtable, the Asian Liver Center at Stanford
University, the Hepatitis B Foundation, the American
Liver Foundation, Hepatitis Foundation International,
and the Center for the Study of Asian American Health;
and
``(H) the public, including--
``(i) individuals infected with hepatitis
B; and
``(ii) advocates concerned with issues
related to hepatitis B.
``(c) Biennial Update of the Plan.--
``(1) In general.--The Secretary shall conduct a biannual
assessment of the plan developed under subsection (a) for the
purposes of--
``(A) incorporating into such plan new knowledge or
observations relating to hepatitis B (such as knowledge
and observations that may be derived from clinical,
laboratory, and epidemiological research and disease
detection, prevention, and surveillance outcomes); and
``(B) 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 PROGRAM.
``(a) Immunization, Prevention, and Control Programs.--
``(1) In general.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention,
shall support the integration of activities described in
paragraph (2) into existing clinical and public health programs
at State, local, and tribal levels (including Asian and non-
Asian community health clinics, programs for the prevention and
treatment of HIV/AIDS, sexually transmitted diseases, and
substance abuse, and programs for individuals in correctional
settings).
``(2) Activities.--
``(A) Voluntary testing programs.--
``(i) In general.--The Secretary shall
establish a mechanism by which to support and
promote the development of State, local, and
tribal voluntary hepatitis B testing programs
to screen the high chronic hepatitis B
prevalence populations (such as Asian
Americans, new immigrants or foreign-born
United States residents, and persons with one
or both foreign-born parents) to aid in the
early identification of chronically infected
individuals.
``(ii) Confidentiality of the test
results.--The Secretary shall prohibit the use
of the results of a hepatitis B test conducted
by a testing program developed or supported
under this subparagraph 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.--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
public sectors, to--
``(i) provide individuals with ongoing risk
factors for hepatitis B infection with client-
centered education and counseling which
concentrates on--
``(I) promoting testing of family
members and their sexual partners; and
``(II) changing behaviors that
place individuals at risk for
infection;
``(ii) provide individuals chronically
infected with hepatitis B with education,
health information, and counseling to reduce
their risk of--
``(I) dying from end stage liver
disease and liver cancer; and
``(II) transmitting viral hepatitis
to others; and
``(iii) provide women chronically infected
with hepatitis B who are pregnant or in their
child bearing age with culturally appropriate
health information to alleviate their fears of
becoming pregnant or raising a family.
``(C) Immunization.--The Secretary shall support
State, local, and tribal efforts to expand the current
vaccination programs to protect every child in the
country and all susceptible adults, particularly those
from the high-prevalence ethnic populations and other
high risk groups, from the risks of acute and chronic
hepatitis B infection by--
``(i) ensuring continued funding for
hepatitis B vaccination for all children 19
years of age or under through the Vaccines for
Children Program;
``(ii) ensuring that the recommendations of
the Advisory Committee on Immunization
Practices are followed regarding hepatitis B
vaccinations for newborns;
``(iii) requiring proof of hepatitis B
vaccination for entry into public or private
day care, preschool, elementary school,
secondary school, and institutions of higher
education;
``(iv) expanding the availability of
vaccines for all susceptible adults to protect
them from becoming acutely or chronically
infected, including ethnic populations with
high prevalence rates of chronic hepatitis B
infection; and
``(v) expanding the availability of
vaccines for all susceptible adults,
particularly those in their reproductive age
(women and men less than 45 years of age), from
the risk of hepatitis B infection.
``(D) Medical referral.--The Secretary shall
support State, local, and tribal programs that
support--
``(i) referral of persons chronically
infected with hepatitis B--
``(I) for medical evaluation to
determine the appropriateness for
antiviral treatment to reduce the risk
of progression to cirrhosis and liver
cancer; and
``(II) for regular monitoring of
liver function and screening for liver
cancer; and
``(ii) referral of persons infected with
acute or chronic hepatitis B for drug and
alcohol abuse treatment where appropriate.
``(3) Increased support for hepatitis b coordinators.--The
Secretary, acting through the Director of the Centers for
Disease Control and Prevention, shall provide hepatitis B
coordinators to State, local, and tribal health departments in
order to enhance the additional management, networking, and
technical expertise needed to ensure successful integration of
hepatitis B prevention and control activities into existing
public health programs.
``(b) Education and Awareness Programs.--The Secretary, acting
through the Director of the Centers for Disease Control and Prevention,
the Administrator of the Health Resources and Services Administration,
and the Administrator of the Substance Abuse and Mental Health Services
Administration, and in accordance with the plan developed under section
399AA, shall implement programs to increase awareness and enhance
knowledge and understanding of hepatitis B. Such programs shall
include--
``(1) the conduct of culturally and language appropriate
health education, public awareness campaigns, and community
outreach activities (especially to the ethnic communities with
high rates of chronic hepatitis B and other high-risk groups)
to promote public awareness and knowledge about the value of
hepatitis B immunization, risk factors, the transmission and
prevention of hepatitis B, and the value of screening for the
early detection of hepatitis B infection;
``(2) the promotion of immunization programs that increase
awareness and access to hepatitis B vaccines for susceptible
adults and children;
``(3) the training of health care professionals and health
educators to make them aware of the high rates of chronic
hepatitis B in certain adult ethnic populations, and the
importance of prevention, detection, and medical management of
hepatitis B and of liver cancer screening;
``(4) the development and distribution of health education
curricula (including information relating to the special needs
of individuals infected with hepatitis B, such as the
importance of prevention and early intervention, regular
monitoring, and appropriate treatment and liver cancer
screening) for individuals providing hepatitis B counseling;
``(5) support for the implementation curricula described in
paragraph (4) by State and local public health agencies; and
``(6) the provision of grants for the inclusion of viral
hepatitis and liver wellness education curricula in elementary
and secondary school health education programs.
``(c) Epidemiological Surveillance.--
``(1) In general.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention,
shall support the establishment and maintenance of a national
chronic and acute hepatitis B surveillance program, in order to
identify--
``(A) trends in the incidence of acute and chronic
hepatitis B;
``(B) trends in the prevalence of acute and chronic
hepatitis B infection among groups that may be
disproportionately affected by hepatitis B; and
``(C) liver cancer and end stage liver disease
incidence and deaths, caused by chronic hepatitis B in
the various ethnic populations.
``(2) Seroprevalence and liver cancer studies.--The
Secretary, acting through the Director of the Centers for
Disease Control and Prevention, shall prepare a report
outlining the population-based seroprevalence studies currently
under way, future planned studies, the criteria involved in
determining which seroprevalence studies to conduct, defer, or
suspend, and the scope of those studies, the economic and
clinical impact of hepatitis B, and the impact of hepatitis B
on quality of life. Not later than one year after the date of
enactment of this part, the Secretary shall submit the report
to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate.
``(3) Confidentiality.--The Secretary shall not disclose
any individually identifiable information identified under
paragraph (1) or derived through studies under paragraph (2).
``(d) Research.--The Secretary, acting through the Director of the
Centers for Disease Control and Prevention, the Director of the
National Cancer Institute, and the Director of the National Institutes
of Health, shall--
``(1) conduct community-based research to develop,
implement, and evaluate best practices for hepatitis B
prevention especially in the ethnic populations with high rates
of chronic hepatitis B and other high-risk groups;
``(2) conduct research on hepatitis B natural history,
pathophysiology, improved treatments, and non-invasive tests
that helps to predict the risk of progression to liver
cirrhosis and liver cancer; and
``(3) conduct research that will lead to better non-
invasive or blood tests to screen for liver cancer, and more
effective treatments of liver cancer caused by chronic
hepatitis.
``(e) Expanded Support for Underserved and Disproportionately
Affected Populations Chronically Infected With HBV.--In carrying out
this section, the Secretary shall give priority to individuals with
limited access to health education, testing, and health care services
and groups that may be disproportionately affected by hepatitis B,
including populations such as Asian Americans with a high incidence of
chronic hepatitis B and liver cancer.''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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