[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 1287 Introduced in Senate (IS)]

114th CONGRESS
  1st Session
                                S. 1287

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 SENATE OF THE UNITED STATES

                              May 12, 2015

 Mr. Kirk (for himself, Ms. Hirono, Mr. Cassidy, Mr. Schumer, and Mr. 
   Merkley) 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 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 
2015''.

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. Current 
        information indicates these represent a fraction of deaths 
        attributable in whole or in part to chronic hepatitis C. From 
        2007 through 2011, mortality rates of persons with hepatitis C 
        increased 39 percent among persons aged 55-64 years to a rate 
        of 21.9 deaths per 100,000 population in 2011. In 2011, the 
        highest mortality rates of persons with hepatitis C by race/
        ethnicity and sex were observed among American Indians and 
        Alaska Natives (10.6 deaths per 100,000 population) and males 
        (7.1 deaths per 100,000 population) respectively. Mortality 
        data from 2011, the latest year for which these data were 
        available, reveal the serious health consequences associated 
        with viral hepatitis: chronic liver disease, including 
        cirrhosis, was the 12th leading cause of death in the United 
        States in 2011. 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 16,500 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. According to the 
        CDC, from 2010 to 2011 there was a 45 percent increase in the 
        number of reported acute hepatitis C cases (from 850 to 1,229 
        cases) and another 45 percent increase from 2011 to 2012 (from 
        1,229 to 1,778 cases), representing a 75 percent increase from 
        2010-2012. In 2012, the rate of acute hepatitis C increased in 
        every age group when compared with 2010 and 2011, with the 
        largest increases among persons aged 0-19 years (from 0.05 to 
        0.11 cases per 100,000 population) and 20-29 years (from 0.75 
        to 1.73 cases per 100,000 population).
            (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 Services 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. In 
        2014, the USPSTF issued a Grade B for screening for HBV in 
        individuals at high risk.
            (8) There were 35 outbreaks (19 of HBV, 16 of HCV) reported 
        to CDC for investigation from 2008-2012 related to health care 
        acquired infection of HBV and HCV, 33 of which occurred in 
        nonhospital 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 
        Indians/Alaskan Natives 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 posttest 
        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 world; however, liver 
        cancer has received little funding for research, prevention, or 
        treatment.
            (14) Treatment for chronic HCV can eradicate the disease in 
        approximately 95 percent or more 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''.
            (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, 
        ``Hepatitis and Liver Cancer: A National Strategy for 
        Prevention and Control of Hepatitis B and C'', 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.
            (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 individuals who are tested for 
        such an infection, to demonstrate success in increasing the 
        number of individuals tested and made aware of their status, 
        including those who test positive.
            ``(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 
        followup 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 and the 
                United States Preventive Services Task Force.
                    ``(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 and the United States Preventive Services 
                Task Force.
                    ``(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) Action Plan Implementation.--
            ``(1) Benchmarks.--The Secretary shall develop benchmarks 
        for evaluating the effectiveness of the programs and activities 
        conducted under the `Action Plan for the Prevention, Care, & 
        Treatment of Viral Hepatitis' of the Department of Health and 
        Human Services and make determinations as to whether such 
        benchmarks have been achieved.
            ``(2) Annual reporting.--
                    ``(A) In general.--The Secretary shall report 
                annually to the Congress on the benchmarks developed 
                under paragraph (1), including the amount of funding 
                used by each agency of the Department of Health and 
                Human Services to achieve each benchmark.
                    ``(B) Contents.--Each report under subparagraph (A) 
                shall include reporting on--
                            ``(i) the number of people tested for 
                        hepatitis B and hepatitis C;
                            ``(ii) the number of individuals who test 
                        positive for hepatitis B and C;
                            ``(iii) the number of individuals who are 
                        tested and then made aware of their health 
                        status;
                            ``(iv) the number of individuals referred 
                        to care or treatment followup;
                            ``(v) improvements in surveillance 
                        activities;
                            ``(vi) provider and community education 
                        activities;
                            ``(vii) the reduction in the number of 
                        infants born with hepatitis B;
                            ``(viii) estimates on the reduction, as a 
                        result of prevention measures, in the number of 
                        new hepatitis B and hepatitis C infections; and
                            ``(ix) estimates on the reduction in liver 
                        cancer resulting from hepatitis B or hepatitis 
                        C infection.
    ``(e) 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 2015, 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 nongovernment 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 nonprofit 
                organizations, community and faith-based organizations, 
                foundations, and other governmental and nongovernmental 
                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.
    ``(f) 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 United 
States Preventive Services Task Force under section 915(a) to review 
its recommendation for screening for HBV and HCV infection every 3 
years.
    ``(g) 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 2016;
                    ``(B) $35,000,000 for fiscal year 2017; and
                    ``(C) $20,000,000 for fiscal year 2018.
            ``(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 B AND 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 B and 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 B and 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;
            ``(B) were born between 1945 and 1965; and
            ``(C) are considered a high-risk group for hepatitis B or 
        hepatitis C infection.
    ``(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 B and Hepatitis C screening and evaluation of needed 
                            care for veterans.''.
                                 <all>