[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3381 Introduced in House (IH)]

112th CONGRESS
  1st Session
                                H. R. 3381

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 liver cancer, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            November 4, 2011

Mr. Cassidy (for himself, Mr. Honda, Mr. Johnson of Georgia, Mr. Dent, 
 and Mr. Bilbray) introduced the following bill; which was referred to 
                  the Committee on Energy and Commerce

_______________________________________________________________________

                                 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 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 
2011''.

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 the most 
        common cause of liver cancer, one of the most lethal and 
        fastest growing cancers in the United States. Chronic HBV and 
        HCV are the most common cause of chronic liver disease, liver 
        cirrhosis, and the most common indication for liver 
        transplantation. Chronic HCV is also a leading cause of death 
        in Americans living with HIV/AIDS, many of whom are coinfected 
        with chronic HBV, HCV, or both. At least 15,000 deaths per year 
        in the United States can be attributed to chronic HBV and HCV.
            (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 and HBV as the deadliest vaccine-preventable 
        disease.
            (4) HBV is easily transmitted and is 100 times more 
        infectious than HIV. According to the CDC, HBV is transmitted 
        through percutaneous (i.e., puncture through the skin) or 
        mucosal contact with infectious blood or body fluids. HCV is 
        transmitted by percutaneous exposures to infectious blood.
            (5) The CDC conservatively estimates that in 2008 
        approximately 18,000 Americans were newly infected with HCV and 
        more than 38,000 Americans were newly infected with HBV.
            (6) There were 10 outbreaks reported to CDC for 
        investigation in 2009 related to healthcare acquired infection 
        of HBV and HCV. There were another 6,748 patients potentially 
        exposed to one of the viruses.
            (7) 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.
            (8) HBV and HCV disproportionately affect certain 
        populations in the United States. Although representing only 5 
        percent of the population, Asian and Pacific Islanders account 
        for over half of the 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.
            (9) For both chronic HBV and chronic HCV, behavioral 
        changes can slow disease progression if diagnosis is made 
        early. Early diagnosis, which is determined through simple 
        diagnostic tests, can reduce the risk of transmission and 
        disease progression through education and vaccination of 
        household members and other susceptible persons at risk.
            (10) 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.
            (11) 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.
            (12) 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.
            (13) 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.
            (14) 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 of the current therapies--was 
        approximately $80,000 per chronically infected person, or 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.
            (15) 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 for the scale of the health burden presented by HBV 
        and HCV.
            (16) Screening and testing for chronic HBV and HCV are 
        aligned with the Healthy People 2020 goal to increase 
        immunization rates and reduce preventable infectious diseases. 
        Awareness of disease and access to prevention and treatment 
        remain essential components for reducing infectious disease 
        transmission.
            (17) Federal support is necessary to increase knowledge and 
        awareness of HBV and HCV and to assist State and local 
        prevention and control efforts in reducing the morbidity and 
        mortality of these epidemics.
            (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.

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 heading to read as follows: 
        ``surveillance, education, and testing 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 cooperate with States and other public or nonprofit 
private entities to seek to 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 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 2014 and to 75 percent by 2016.
            ``(3) To develop and disseminate public information and 
        education programs for the detection and control of such 
        infections, with priority given to changing behaviors that 
        place individuals at risk of infection.
            ``(4) To provide appropriate referrals for counseling and 
        medical treatment of infected individuals and to ensure, to the 
        extent practicable, the provision of appropriate follow-up 
        services.
            ``(5) To improve the education, training, and skills of 
        health professionals in the detection, control, and treatment 
        of such infections, with priority given to pediatricians and 
        other primary care physicians, and obstetricians and 
        gynecologists.
    ``(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.
                    ``(B) For HCV, individuals born between 1945 and 
                1965.
                    ``(C) Those who have been exposed to the blood of 
                infected individuals or of high-risk individuals, are 
                family members of such individuals, or are sexual 
                partners of such individuals.
            ``(2) Priority in programs.--In providing for programs 
        under subsection (b), 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 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.''.
    (b) Coordination of Development of Federal Screening Guidelines.--
            (1) References.--For purposes of this subsection, the term 
        ``CDC Director'' means the Director of the Centers for Disease 
        Control and Prevention, and the term ``AHRQ Director'' means 
        the Director of the Agency for Healthcare Research and Quality.
            (2) HCV guidelines; centers for disease control and 
        prevention.--
                    (A) In general.--Not later than March 1, 2012, the 
                CDC Director shall complete the revision of the 
                guidelines of the Centers for Disease Control and 
                Prevention for screening individuals for the hepatitis 
                C virus infection (in this section referred to as 
                ``HCV''), and shall transmit a copy of the guidelines 
                to the AHRQ Director. The scope of the revised 
                guidelines shall include testing for HCV that is 
                carried out under section 317N of the Public Health 
                Service Act (42 U.S.C. 247b-15), as amended by 
                subsection (a).
                    (B) Certain factors.--In revising guidelines 
                pursuant to subparagraph (A), the CDC Director shall 
                take into account--
                            (i) the effectiveness issues that have been 
                        raised with respect to the current guidelines 
                        of the Centers for Disease Control and 
                        Prevention for screenings for HCV;
                            (ii) the importance of responding to the 
                        perception that receiving such screenings may 
                        be stigmatizing; and
                            (iii) whether age-based screenings would be 
                        effective, considering the use of that approach 
                        in breast and colon cancer screenings.
            (3) Agency for healthcare research and quality.--
                    (A) HCV guidelines.--The AHRQ Director shall, in 
                developing the recommendations for screenings for HCV 
                that the AHRQ Director will provide to the Preventive 
                Services Task Force under section 915(a) of the Public 
                Health Service Act (42 U.S.C. 299b-4(a)), take into 
                account--
                            (i) the guidelines established pursuant to 
                        paragraph (2) by the CDC Director; and
                            (ii) new and improved treatments for HCV.
                    (B) HBV guidelines.--The AHRQ Director shall, in 
                developing the recommendations for screenings for the 
                hepatitis B virus infection (in this section referred 
                to as ``HBV'') that the AHRQ Director will provide to 
                the Preventive Services Task Force referred to in 
                subparagraph (A), take into account the guidelines for 
                screenings for HBV that the CDC Director recommended in 
                2008.
    (c) Authorization of Appropriations.--Subsection (e) of section 
317N of the Public Health Service Act (42 U.S.C. 247b-15), as 
redesignated by subsection (a)(2) of this section, is amended to read 
as follows:
    ``(e) Authorization of Appropriations.--
            ``(1) In general.--For the purpose of testing, education, 
        and referrals under this section, there are authorized to be 
        appropriated $25,000,000 for fiscal year 2012, $35,000,000 for 
        fiscal year 2013, $20,000,000 for fiscal year 2014, and 
        $15,000,000 for each of the fiscal years 2015 and 2016.
            ``(2) Grants.--Of the amounts appropriated under paragraph 
        (1) for a fiscal year, the Secretary shall reserve not less 
        than 80 percent for making grants under subsection (a).''.
    (d) 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.
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