1.This Act may be cited as the
National Hepatitis B
Act
.
2.Congress makes the following
findings:
(1)Approximately
1,400,000 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 1,400,000
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 $2,500,000,000 ($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 $100,000,000,000.
3.Comprehensive
hepatitis b prevention, education, research, and medical management
programTitle III of the
Public Health Service Act (42 U.S.C. 241 et seq.) is amended by adding at the
end of the following:
RComprehensive
hepatitis B prevention, education, research, and medical management
program
399AA.
(a)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 planIn 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)The Secretary shall conduct a biennial 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 assessmentsNot 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.
399BB.
(a)Immunization,
prevention, and control programs
(1)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)
(A)Voluntary
testing programs
(i)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 resultsThe 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)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)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)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
(iv)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)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 coordinatorsThe 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 programsThe 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)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 studiesThe 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)The
Secretary shall not disclose any individually identifiable information
identified under paragraph (1) or derived through studies under paragraph
(2).
(d)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 HBVIn 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.
.