Viral Hepatitis Testing Act of 2013 - Amends the Public Health Service Act to require the Secretary of Health and Human Services (HHS) to carry out surveillance, education, and testing programs with respect to hepatitis B (HBV) and hepatitis C (HCV) virus infections.
Requires the Secretary to establish a national system with respect to HBV and HCV to: (1) determine the prevalence of such infections; (2) carry out testing programs to increase the number of individuals who are aware of their infection; (3) disseminate public information and education programs for the detection and control of such infections; (4) improve the training of health professionals in the detection, control, and treatment of such infections; and (5) provide referrals for counseling and medical treatment and ensure the provision of follow-up services. Directs the Secretary to determine the populations that are considered at high risk.
Directs the Secretary to establish and support public-private partnerships that facilitate such HBV and HCV surveillance, education, screening, testing, and linkage to care programs.
Requires the Director of the Agency for Healthcare Research and Quality (AHRQ) to convene the Preventive Services Task Force every three years to review its recommendation for HBV and HCV screening.
Directs the Secretary of Veterans Affairs (VA) to establish and carry out a plan to provide veterans who were born between 1945 and 1965 with an HBC risk assessment and, if they are diagnosed with such virus, a thorough evaluation of, and information regarding, their need for treatment, vaccination, or other therapy.
Requires the VA to use compliance with such plan as a key performance measure under the VA Handbook Performance Management System or its successor, including by giving the director of a VA medical facility that is not fully compliant a less than fully successful performance appraisal.
[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3723 Introduced in House (IH)]
113th CONGRESS
1st Session
H. R. 3723
To amend the Public Health Service Act to revise and extend the program
for viral hepatitis surveillance, education, and testing in order to
prevent deaths from chronic liver disease and liver cancer, and for
other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 12, 2013
Mr. Cassidy (for himself, Mr. Guthrie, and Mr. Dent) introduced the
following bill; which was referred to the Committee on Energy and
Commerce, and in addition to the Committee on Veterans' Affairs, for a
period to be subsequently determined by the Speaker, in each case for
consideration of such provisions as fall within the jurisdiction of the
committee concerned
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to revise and extend the program
for viral hepatitis surveillance, education, and testing in order to
prevent deaths from chronic liver disease and liver cancer, and for
other purposes.
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 ``Viral Hepatitis Testing Act of
2013''.
SEC. 2. FINDINGS.
Congress finds the following:
(1) Approximately 5,300,000 Americans are chronically
infected with the hepatitis B virus (referred to in this
section as ``HBV''), the hepatitis C virus (referred to in this
section as ``HCV''), or both.
(2) In the United States, chronic HBV and HCV are among the
most common causes of liver cancer, one of the most lethal and
fastest growing cancers in the United States. Chronic HBV and
HCV are among the most common causes of chronic liver disease,
liver cirrhosis, and the most common indication for liver
transplantation. More than 15,000 deaths per year in the United
States can be attributed to chronic HBV and HCV. Chronic HCV is
also a leading cause of death in Americans living with HIV/
AIDS. Many of those living with HIV/AIDS are coinfected with
chronic HBV, HCV, or both.
(3) According to the Centers for Disease Control and
Prevention (referred to in this section as the ``CDC''),
approximately 2 percent of the population of the United States
is living with chronic HBV, HCV, or both. The CDC has
recognized HCV as the Nation's most common chronic bloodborne
virus infection.
(4) HBV is easily transmitted and is 100 times more
infectious than HIV. According to the CDC, HBV is transmitted
through contact with infectious blood, semen, or other body
fluids. HCV is transmitted by contact with infectious blood,
particularly through percutaneous exposures (i.e. puncture
through the skin).
(5) The CDC conservatively estimates that in 2011
approximately 16,600 Americans were newly infected with HCV and
more than 18,800 Americans were newly infected with HBV. These
estimates could be much higher due to many reasons, including
lack of screening education and awareness, and perceived
marginalization of the populations at risk.
(6) In 2012 CDC released new guidelines recommending every
person born from 1945 through 1965 receive a one-time HCV test.
Among the estimated 102 million (1.6 million chronically HCV-
infected) eligible for screening, birth-cohort screening leads
to 74,000 fewer cases of decompensated cirrhosis, 46,000 fewer
cases of hepatocellular carcinoma, 15,000 fewer liver
transplants and 120,000 fewer HCV-related deaths versus risk-
based screening.
(7) In 2013, the United States Preventative Task Force
(USPSTF) issued a Grade B rating for screening for hepatitis C
virus (HCV) infection in persons at high risk for infection and
adults born between 1945 and 1965. In 2009, the USPSTF issued a
Grade A for screening pregnant women for the hepatitis B virus
(HBV) during their first prenatal visit.
(8) There were 35 outbreaks (19 of HBV, 16 of HCV) reported
to CDC for investigation from 2008-2012 related to healthcare
acquired infection of HBV and HCV, 33 of which occurred in non-
hospital settings. There were more than 99,975 patients
potentially exposed to one of the viruses.
(9) Chronic HBV and chronic HCV usually do not cause
symptoms early in the course of the disease, but after many
years of a clinically ``silent'' phase, CDC estimates show more
than 33 percent of infected individuals will develop cirrhosis,
end-stage liver disease, or liver cancer. Since most
individuals with chronic HBV, HCV, or both are unaware of their
infection, they do not know to take precautions to prevent the
spread of their infection and can unknowingly exacerbate their
own disease progression.
(10) HBV and HCV disproportionately affect certain
populations in the United States. Although representing about 6
percent of the population, Asian and Pacific Islanders account
for over half of up to 1,400,000 domestic chronic HBV cases.
Baby boomers (those born between 1945 and 1965) account for
more than 75 percent of domestic chronic HCV cases. In
addition, African-Americans, Latinos (Latinas), and American
Indian/Native Alaskans are among the groups which have
disproportionately high rates of HBV infections, HCV
infections, or both in the United States.
(11) For both chronic HBV and chronic HCV, behavioral
changes can slow disease progression if a diagnosis is made
early. Early diagnosis, which is determined through simple
diagnostic tests, can also reduce the risk of transmission and
disease progression through education and vaccination of
household members and other susceptible persons at risk.
(12) Advancements have led to the development of improved
diagnostic tests for viral hepatitis. These tests, including
rapid, point of care testing and others in development, can
facilitate testing, notification of results and post-test
counseling, and referral to care at the time of the testing
visit. In particular, these tests are also advantageous because
they can be used simultaneously with HIV rapid testing for
persons at risk for both HCV and HIV infections.
(13) For those chronically infected with HBV or HCV,
regular monitoring can lead to the early detection of liver
cancer at a stage where a cure is still possible. Liver cancer
is the second deadliest cancer in the United States; however,
liver cancer has received little funding for research,
prevention, or treatment.
(14) Treatment for chronic HCV can eradicate the disease in
approximately 75 percent of those currently treated. The
treatment of chronic HBV can effectively suppress viral
replication in the overwhelming majority (over 80 percent) of
those treated, thereby reducing the risk of transmission and
progression to liver scarring or liver cancer, even though a
complete cure is much less common than for HCV.
(15) To combat the viral hepatitis epidemic in the United
States, in May 2011, the Department of Health and Human
Services released, Combating the Silent Epidemic of Viral
Hepatitis: Action Plan for the Prevention, Care & Treatment of
Viral Hepatitis. The Institute of Medicine of the National
Academies produced a 2010 report on the Federal response to HBV
and HCV titled: Hepatitis and Liver Cancer: A National Strategy
for Prevention and Control of Hepatitis B and C. The
recommendations and guidelines provide a framework for HBV and
HCV prevention, education, control, research, and medical
management programs.
(16) The annual health care costs attributable to viral
hepatitis in the United States are significant. For HBV, it is
estimated to be approximately $2,500,000,000 ($2,000 per
infected person). In 2000, the lifetime cost of HBV--before the
availability of most current therapies--was approximately
$80,000 per chronically infected person, totaling more than
$100,000,000,000. For HCV, medical costs for patients are
expected to increase from $30,000,000,000 in 2009 to over
$85,000,000,000 in 2024. Avoiding these costs by screening and
diagnosing individuals earlier--and connecting them to
appropriate treatment and care will save lives and critical
health care dollars. Currently, without a comprehensive
screening, testing and diagnosis program, most patients are
diagnosed too late when they need a liver transplant costing at
least $314,000 for uncomplicated cases or when they have liver
cancer or end stage liver disease which costs between $30,980
to $110,576 per hospital admission. As health care costs
continue to grow, it is critical that the Federal Government
invests in effective mechanisms to avoid documented cost
drivers.
(17) According to the Institute of Medicine report in 2010
(described in paragraph (13)), chronic HBV and HCV infections
cause substantial morbidity and mortality despite being
preventable and treatable. Deficiencies in the implementation
of established guidelines for the prevention, diagnosis, and
medical management of chronic HBV and HCV infections perpetuate
personal and economic burdens. Existing grants are not
sufficient to address the scale of the health burden presented
by HBV and HCV.
(18) The Secretary of Health and Human Services has the
discretion to carry out this Act directly and through whichever
of the agencies of the Public Health Service the Secretary
determines to be appropriate, which may (in the Secretary's
discretion) include the Centers for Disease Control and
Prevention, the Health Resources and Services Administration,
the Substance Abuse and Mental Health Services Administration,
the National Institutes of Health (including the National
Institute on Minority Health and Health Disparities), and other
agencies of such Service.
(19) For over a decade, the Centers for Disease Control and
Prevention's Viral Hepatitis Prevention Coordinator (VHPC)
program has been the only national program dedicated to the
prevention and control of the viral hepatitis epidemics
administering the duties currently specified by Section 317N of
the Public Health Service Act (42 U.S.C. 247b-15) at State and
local health departments. VHPCs provide the technical expertise
necessary for the management and coordination of activities to
prevent viral hepatitis infection and disease with little to no
Federal funding for program implementation or development.
Further, these coordinators help integrate viral hepatitis
prevention services into health care settings and public health
programs that serve adults at risk for viral hepatitis.
SEC. 3. REVISION AND EXTENSION OF HEPATITIS SURVEILLANCE, EDUCATION,
AND TESTING PROGRAM.
(a) In General.--Section 317N of the Public Health Service Act (42
U.S.C. 247b-15) is amended--
(1) by amending the section heading to read as follows:
``surveillance, education, testing, and linkage to care
regarding hepatitis virus'';
(2) by redesignating subsections (b) and (c) as subsections
(d) and (e), respectively; and
(3) by striking subsection (a) and inserting the following:
``(a) In General.--The Secretary shall, in accordance with this
section, carry out surveillance, education, and testing programs with
respect to hepatitis B and hepatitis C virus infections (referred to in
this section as `HBV' and `HCV', respectively). The Secretary may carry
out such programs directly and through grants to public and nonprofit
private entities, including States, political subdivisions of States,
territories, Indian tribes, and public-private partnerships.
``(b) National System.--In carrying out subsection (a), the
Secretary shall, in consultation with States and other public or
nonprofit private entities and public-private partnerships described in
subsection (d), establish a national system with respect to HBV and HCV
with the following goals:
``(1) To determine the incidence and prevalence of such
infections, including providing for the reporting of acute and
chronic cases.
``(2) With respect to the population of individuals who
have such an infection, to carry out testing programs to
increase the number of individuals who are aware of their
infection to 50 percent by December 31, 2014, and to 75 percent
by December 31, 2016.
``(3) To develop and disseminate public information and
education programs for the detection and control of such
infections.
``(4) To improve the education, training, and skills of
health professionals in the detection, control, and care and
treatment, of such infections.
``(5) To provide appropriate referrals for counseling and
medical care and treatment of infected individuals and to
ensure, to the extent practicable, the provision of appropriate
follow-up services.
``(c) High-Risk Populations; Chronic Cases.--
``(1) In general.--The Secretary shall determine the
populations that, for purposes of this section, are considered
at high-risk for HBV or HCV. The Secretary shall include the
following among those considered at high-risk:
``(A) For HBV, individuals born in countries in
which 2 percent or more of the population has HBV or
who are a part of a high-risk category as identified by
the Centers for Disease Control and Prevention.
``(B) For HCV, individuals born between 1945 and
1965 or who are a part of a high-risk category as
identified by the Centers for Disease Control and
Prevention.
``(C) Those who have been exposed to the blood of
infected individuals or of high-risk individuals or who
are family members of such individuals.
``(2) Priority in programs.--In providing for programs
under this section, the Secretary shall give priority--
``(A) to early diagnosis of chronic cases of HBV or
HCV in high-risk populations under paragraph (1); and
``(B) to education, and referrals for counseling
and medical care and treatment, for individuals
diagnosed under subparagraph (A) in order to--
``(i) reduce their risk of dying from end-
stage liver disease and liver cancer, and of
transmitting the infection to others;
``(ii) determine the appropriateness for
treatment to reduce the risk of progression to
cirrhosis and liver cancer;
``(iii) receive ongoing medical management,
including regular monitoring of liver function
and screenings for liver cancer;
``(iv) receive, as appropriate, drug,
alcohol abuse, and mental health treatment;
``(v) in the case of women of childbearing
age, receive education on how to prevent HBV
perinatal infection, and to alleviate fears
associated with pregnancy or raising a family;
and
``(vi) receive such other services as the
Secretary determines to be appropriate.
``(3) Cultural context.--In providing for services pursuant
to paragraph (2) for individuals who are diagnosed under
subparagraph (A) of such paragraph, the Secretary shall seek to
ensure that the services are provided in a culturally and
linguistically appropriate manner.
``(d) Public-Private Partnerships.--
``(1) In general.--In carrying out this section, and not
later than 60 days after the date of the enactment of the Viral
Hepatitis Testing Act of 2013, the Secretary shall, in
consultation with the Assistant Secretary for Health, the
Director of the Centers for Disease Control and Prevention, the
Health Resources and Services Administration, the Substance
Abuse and Mental Health Services Administration, the Office of
Minority Health, the Indian Health Service, other relevant
agencies, and non-government stakeholder entities, establish
and support public-private partnerships that facilitate the
surveillance, education, screening, testing, and linkage to
care programs authorized by this section.
``(2) Duties.--Public-private partnerships established or
supported under paragraph (1) shall--
``(A) focus primarily on the surveillance,
education, screening, testing, and linkage to care
programs authorized by this section;
``(B) generate resources, in addition to the funds
made available pursuant to subsection (f), to carry out
the surveillance, education, screening, testing, and
linkage to care programs authorized in this section by
leveraging Federal funding with non-Federal funding and
support;
``(C) allow for investments in such programs of
financial or in-kind resources by each of the partners
involved in the partnership;
``(D) include corporate and industry entities,
academic institutions, public and non-profit
organizations, community and faith-based organizations,
foundations, and other governmental and non-
governmental organizations; and
``(E) advance the core goals of each of the
partners of the partnership as determined by the
Secretary in development of the partnership.
``(3) Annual reports.--The Secretary shall provide to the
Congress an annual report on the public-private partnerships
established under this subsection. Each such report shall
include--
``(A) the number of public-private partnerships
established;
``(B) specific and quantifiable information on the
surveillance, education, screening, testing, and
linkage to care activities conducted as well as the
outcomes achieved through each of the public-private
partnerships;
``(C) the amount of Federal funding or resources
dedicated to the public-private partnerships;
``(D) the amount of non-Federal funding or
resources leveraged through the public-private
partnerships; and
``(E) a plan for the following year that outlines
future activities.
``(4) Limitation.--No more than 25 percent of the funds
made available to carry out this section may be used for
public-private partnerships established or supported under this
subsection.
``(5) Linkage to care.--For purposes of this section, the
term `linkage to care' means, with respect to an individual
with a diagnosis of HBV or HCV, the referral of such individual
to clinical care for a thorough evaluation of their clinical
status to determine the need for treatment, vaccination for
HBV, or other therapy.
``(e) Agency for Healthcare Research and Quality HBV and HCV
Guidelines.--Due to the rapidly evolving standard of care associated
with diagnosing and treating viral hepatitis infection, the Director of
the Agency for Healthcare Research and Quality shall convene the
Preventive Services Task Force under section 915(a) to review its
recommendation for screening for HBV and HCV infection every 3 years.
``(f) Funding.--
``(1) In general.--In addition to any amounts otherwise
authorized by this Act, there are authorized to be appropriated
to carry out this section--
``(A) $25,000,000 for fiscal year 2014;
``(B) $35,000,000 for fiscal year 2015; and
``(C) $20,000,000 for fiscal year 2016.
``(2) Grants.--Of the amounts appropriated pursuant to
paragraph (1) for a fiscal year, the Secretary shall reserve
not less than 80 percent for making grants under subsection
(a).
``(3) Source of funds.--The funds made available to carry
out this section shall be derived exclusively from the funds
appropriated or otherwise made available for planning and
evaluation under this Act.''.
(b) Savings Provision.--The amendments made by this section shall
not be construed to require termination of any program or activity
carried out by the Secretary of Health and Human Services under section
317N of the Public Health Service Act (42 U.S.C. 247b-15) as in effect
on the day before the date of the enactment of this Act.
SEC. 4. HEPATITIS C SCREENING AND EVALUATION OF NEEDED CARE FOR
VETERANS.
(a) In General.--Subchapter II of chapter 17 of title 38, United
States Code, is amended by adding at the end the following:
``Sec. 1720H. Hepatitis C screening and evaluation of needed care for
veterans
``(a) In General.--(1) The Secretary shall establish and carry out
a plan to provide veterans described in paragraph (2) with--
``(A) a risk assessment for the hepatitis C virus; and
``(B) if a veteran is diagnosed with such virus--
``(i) a thorough evaluation of the clinical status
of the veteran to determine the need for treatment,
vaccination, or other therapy; and
``(ii) information with respect to the needs
determined under clause (i).
``(2) Veterans described in this paragraph are veterans who--
``(A) are enrolled in the health care system established
under section 1705(a) of this title; and
``(B) were born between 1945 and 1965.
``(b) Compliance.--(1) The Secretary shall use the plan established
under subsection (a)(1) as a key measure in determining performance
under the VA Handbook Performance Management System, or the successor
to such handbook, to ensure the compliance of such plan.
``(2) If the Secretary determines that a medical facility of the
Department complies with the plan established under subsection (a)(1)
at a rate less than 100 percent, the Secretary shall treat the director
of such medical facility as `less than fully successful'with respect to
the performance appraisal that is used for the basis for determining
performance awards under the handbook described in paragraph (1).
``(c) Annual Report.--The Secretary shall submit annually to
Congress a report on the compliance of each medical facility of the
Department with the plan established under subsection (a)(1).''.
(b) Clerical Amendment.--The table of sections at the beginning of
such chapter is amended by inserting after the item relating to section
1720G the following new item:
``1720H. Hepatitis C screening and evaluation of needed care for
veterans.''.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Veterans' Affairs, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Veterans' Affairs, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
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