Sec. 711. Viral hepatitis and liver cancer control and prevention
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This subtitle may be cited as the . Viral Hepatitis and Liver Cancer Control and Prevention Act of 2014 Congress finds the following: 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. 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 this country.
It is the most common cause of chronic liver disease, liver cirrhosis, and the most common indication for liver transplantation. At least 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, chronic HCV, or both. 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, chronic 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. 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). The CDC conservatively estimates that in 2010 approximately 17,000 Americans were newly infected with HCV and more than 35,000 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. In 2012, CDC released new guidelines recommending every person born between 1945 and 1965 receive a one-time test. Among the estimated 102 million (1.6 million chronically HCV-infected) eligible for screening, birth-cohort screening leads to 84,000 fewer cases of decompensated cirrhosis, 46,000 fewer cases of hepatocellular carcinoma, 10,000 fewer liver transplants, and 78,000 fewer HCV-related deaths gained versus risk-based screening.
In 2013, the United States Preventive Task Force (USPSTF) issued a Grade B rating for screening for the hepatitis C virus
(HCV)infection in persons at high risk for infection and adults born between 1945 and 1965. In 2014, the USPSTF issued a Grade B for screening for the hepatitis B virus
(HBV)in persons at high-risk of hepatitis B infection. In 2009, the USPSTF issued a Grade A for screening pregnant women for the hepatitis B virus
(HBV)during their first prenatal visit. There were 35 outbreaks (19 of HBV, 16 of HCV) reported to CDC for investigation from 2008 through 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. 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. HBV and HCV disproportionately affect certain populations in the United States. Although representing only 6 percent of the population, Asian-Americans 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 half of domestic chronic hepatitis C cases. In addition, African-Americans, Latinos (Latinas), and American Indian/Native Alaskans are among the groups which have disproportionately high rates of HBV and/or HCV infections in the United States. 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 blood tests, can reduce the risk of transmission and disease progression through education and vaccination of household members and other susceptible persons at risk. 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. 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. 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. 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 (hereafter referred to as the HHS Action Plan). The Institute of Medicine
(IOM)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 . These recommendations and guidelines provide a framework for HBV and HCV prevention, education, control, research, and medical management programs. The annual health care costs attributable to HBV and HCV 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 $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. According to the IOM report in 2010 (described in paragraph (15)), 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. Screening and testing for HBV and HCV is 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. 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. 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. Title III of the Public Health Service Act ( 42 U.S.C. 241 et seq. ) is amended— by striking section 317N ( 42 U.S.C. 247b–15 ); and by adding at the end the following: The Secretary shall conduct a biennial assessment of the Secretary’s plan for the prevention, control, and medical management of, and education and research relating to, hepatitis B and hepatitis C, for the purposes of— incorporating into such plan new knowledge or observations relating to hepatitis B and hepatitis C (such as knowledge and observations that may be derived from clinical, laboratory, and epidemiological research and disease detection, prevention, and surveillance outcomes); addressing gaps in the coverage or effectiveness of the plan; and evaluating and, if appropriate, updating recommendations, guidelines, or educational materials of the Centers for Disease Control and Prevention or the National Institutes of Health for health care providers or the public on viral hepatitis in order to be consistent with the plan. Not later than October 1 of the first even-numbered year beginning after the date of the 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 description of any revisions to the plan referred to in subsection
(a)as a result of the assessment; 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 in the case of a determination by the Secretary that the plan does not need revision, an explanation of the basis for such determination. 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 referred to in section 399NN(a), shall implement programs to increase awareness and enhance knowledge and understanding of hepatitis B and hepatitis C. Such programs shall include— the conduct of culturally and language appropriate health education in primary and secondary schools, college campuses, public awareness campaigns, and community outreach activities (especially to the ethnic communities with high rates of chronic hepatitis B and chronic hepatitis C and other high-risk groups) to promote public awareness and knowledge about the value of hepatitis A and hepatitis B immunization, risk factors, the transmission and prevention of hepatitis B and hepatitis C, the value of screening for the early detection of hepatitis B and hepatitis C, and options available for the treatment of chronic hepatitis B and chronic hepatitis C; the promotion of immunization programs that increase awareness and access to hepatitis A and hepatitis B vaccines for susceptible adults and children; the training of health care professionals regarding the importance of vaccinating individuals infected with hepatitis C and individuals who are at risk for hepatitis C infection against hepatitis A and hepatitis B; the training of health care professionals regarding the importance of vaccinating individuals chronically infected with hepatitis B and individuals who are at risk for chronic hepatitis B infection against the hepatitis A virus; the training of health care professionals and health educators to make them aware of the high rates of chronic hepatitis B and chronic hepatitis C in certain adult ethnic populations, and the importance of prevention, detection, and medical management of hepatitis B and hepatitis C and of liver cancer screening; the development and distribution of health education curricula (including information relating to the special needs of individuals infected with hepatitis B and hepatitis C, such as the importance of prevention and early intervention, regular monitoring, the recognition of psychosocial needs, appropriate treatment, and liver cancer screening) for individuals providing hepatitis B and hepatitis C counseling; and support for the implementation curricula described in paragraph
(6)by State and local public health agencies. The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall support the integration of activities described in paragraph
(3)into existing clinical and public health programs at State, local, territorial, and tribal levels (including 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). 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. Due to the rapidly evolving standard of care associated with diagnosing and treating viral hepatitis infection, the AHRQ Director shall convene the Preventive Services Task Force under section 915(a) of the Public Health Service Act to review its recommendation for screening for HBV and HCV infection every 3 years. The Secretary shall establish a mechanism by which to support and promote the development of State, local, territorial, and tribal voluntary hepatitis B and hepatitis C testing programs to screen the high-prevalence populations to aid in the early identification of chronically infected individuals. The Secretary shall prohibit the use of the results of a hepatitis B or hepatitis C test conducted by a testing program developed or supported under this subparagraph for any of the following: Issues relating to health insurance. To screen or determine suitability for employment. To discharge a person from employment. The Secretary shall support State, local, territorial, and tribal programs in a wide variety of settings, including those providing primary and specialty health care services in nonprofit private and public sectors, to— provide individuals with ongoing risk factors for hepatitis B and hepatitis C infection with client-centered education and counseling which concentrates on— promoting testing of individuals that have been exposed to their blood, family members, and their sexual partners; and changing behaviors that place individuals at risk for infection; provide individuals chronically infected with hepatitis B or hepatitis C with education, health information, and counseling to reduce their risk of— dying from end-stage liver disease and liver cancer; and transmitting viral hepatitis to others; and provide women chronically infected with hepatitis B or hepatitis C who are pregnant or of childbearing age with culturally and language appropriate health information, such as how to prevent hepatitis B perinatal infection, and to alleviate fears associated with pregnancy or raising a family. The Secretary shall support State, local, territorial, and tribal efforts to expand the current vaccination programs to protect every child in the country and all susceptible adults, particularly those infected with hepatitis C and high-prevalence ethnic populations and other high-risk groups, from the risks of acute and chronic hepatitis B infection by— ensuring continued funding for hepatitis B vaccination for all children 19 years of age or younger through the Vaccines for Children Program; ensuring that the recommendations of the Advisory Committee on Immunization Practices are followed regarding the birth dose of hepatitis B vaccinations for newborns; requiring proof of hepatitis B vaccination for entry into public or private daycare, preschool, elementary school, secondary school, and institutions of higher education; expanding the availability of hepatitis B vaccination for all susceptible adults to protect them from becoming acutely or chronically infected, including ethnic and other populations with high prevalence rates of chronic hepatitis B infection; expanding the availability of hepatitis B vaccination for all susceptible adults, particularly those in their reproductive age (women and men less than 45 years of age), to protect them from the risk of hepatitis B infection; ensuring the vaccination of individuals infected, or at risk for infection, with hepatitis C against hepatitis A, hepatitis B, and other infectious diseases, as appropriate, for which such individuals may be at increased risk; and ensuring the vaccination of individuals infected, or at risk for infection, with hepatitis B against hepatitis A virus and other infectious diseases, as appropriate, for which such individuals may be at increased risk. The Secretary shall support State, local, territorial, and tribal programs that support— referral of persons chronically infected with hepatitis B or hepatitis C— for medical evaluation to determine the appropriateness for antiviral treatment to reduce the risk of progression to cirrhosis and liver cancer; and for ongoing medical management including regular monitoring of liver function and screening for liver cancer; and referral of persons infected with acute or chronic hepatitis B infection or acute or chronic hepatitis C infection for drug and alcohol abuse treatment where appropriate. The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall provide increased support to Adult Viral Hepatitis Coordinators in State, local, territorial, and tribal health departments in order to enhance the additional management, networking, and technical expertise needed to ensure successful integration of hepatitis B and hepatitis C prevention and control activities into existing public health programs. 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 and hepatitis C surveillance program, in order to identify— trends in the incidence of acute and chronic hepatitis B and acute and chronic hepatitis C; trends in the prevalence of acute and chronic hepatitis B and acute and chronic hepatitis C infection among groups that may be disproportionately affected; and trends in liver cancer and end-stage liver disease incidence and deaths, caused by chronic hepatitis B and chronic hepatitis C in the high-risk ethnic populations. 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 underway, 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 hepatitis C, and the impact of chronic hepatitis B and chronic hepatitis C infections on the quality of life. Not later than one year after the date of the 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. The Secretary shall not disclose any individually identifiable information identified under paragraph
(1)or derived through studies under paragraph (2). 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— conduct epidemiologic and community-based research to develop, implement, and evaluate best practices for hepatitis B and hepatitis C prevention especially in the ethnic populations with high rates of chronic hepatitis B and chronic hepatitis C and other high-risk groups; conduct research on hepatitis B and hepatitis C natural history, pathophysiology, improved treatments and prevention (such as the hepatitis C vaccine), and noninvasive tests that help to predict the risk of progression to liver cirrhosis and liver cancer; conduct research that will lead to better noninvasive or blood tests to screen for liver cancer, and more effective treatments of liver cancer caused by chronic hepatitis B and chronic hepatitis C; and conduct research comparing the effectiveness of screening, diagnostic, management, and treatment approaches for chronic hepatitis B, chronic hepatitis C, and liver cancer in the affected communities. In carrying out this section, the Secretary shall provide expanded support for individuals with limited access to health education, testing, and health care services and groups that may be disproportionately affected by hepatitis B and hepatitis C. The Secretary shall develop benchmarks for evaluating the effectiveness of the programs and activities conducted under this section and make determinations as to whether such benchmarks have been achieved. The Secretary may award grants to, or enter into contracts or cooperative agreements with, States, political subdivisions of States, territories, Indian tribes, or nonprofit entities that have special expertise relating to hepatitis B, hepatitis C, or both, to carry out activities under this part. To be eligible for a grant, contract, or cooperative agreement under subsection (a), an entity shall prepare and submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require. There are authorized to be appropriated to carry out this part $90,000,000 for fiscal year 2015, $90,000,000 for fiscal year 2016, $110,000,000 for fiscal year 2017, $130,000,000 for fiscal year 2018, and $150,000,000 for fiscal year 2019. . Paragraph
(6)of section 501(d) of the Public Health Service Act ( 42 U.S.C. 290aa(d) ) is amended by striking HIV or tuberculosis and inserting HIV, tuberculosis, or hepatitis .
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- 42 USC 247b–15
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Sec. 711
Viral hepatitis and liver cancer control and prevention
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