I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Viral Hepatitis Testing 

5 Act of 2011’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds the following: 


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1 (1) Approximately 5,300,000 Americans are 

2 chronically infected with the hepatitis B virus (re3 ferred to in this section as ‘‘HBV’’), the hepatitis C 

4 virus (referred to in this section as ‘‘HCV’’), or 

5 both. 

6 (2) In the United States, chronic HBV and 

7 HCV are the most common cause of liver cancer, 

8 one of the most lethal and fastest growing cancers 

9 in the United States. Chronic HBV and HCV are 

10 the most common cause of chronic liver disease, liver 

11 cirrhosis, and the most common indication for liver 

12 transplantation. Chronic HCV is also a leading 

13 cause of death in Americans living with HIV/AIDS, 

14 many of whom are coinfected with chronic HBV, 

15 HCV, or both. At least 15,000 deaths per year in 

16 the United States can be attributed to chronic HBV 

17 and HCV. 

18 (3) According to the Centers for Disease Con19 trol and Prevention (referred to in this section as 

20 the ‘‘CDC’’), approximately 2 percent of the popu21 lation of the United States is living with chronic 

22 HBV, HCV, or both. The CDC has recognized HCV 

23 as the Nation’s most common chronic bloodborne 

24 virus infection and HBV as the deadliest vaccine25 preventable disease. 


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1 (4) HBV is easily transmitted and is 100 times 

2 more infectious than HIV. According to the CDC, 

3 HBV is transmitted through percutaneous (i.e., 

4 puncture through the skin) or mucosal contact with 

5 infectious blood or body fluids. HCV is transmitted 

6 by percutaneous exposures to infectious blood. 

7 (5) The CDC conservatively estimates that in 

8 2008 approximately 18,000 Americans were newly 

9 infected with HCV and more than 38,000 Americans 

10 were newly infected with HBV. 

11 (6) There were 10 outbreaks reported to CDC 

12 for investigation in 2009 related to healthcare ac13 quired infection of HBV and HCV. There were an14 other 6,748 patients potentially exposed to one of 

15 the viruses. 

16 (7) Chronic HBV and chronic HCV usually do 

17 not cause symptoms early in the course of the dis18 ease, but after many years of a clinically ‘‘silent’’ 

19 phase, CDC estimates show more than 33 percent of 

20 infected individuals will develop cirrhosis, end-stage 

21 liver disease, or liver cancer. Since most individuals 

22 with chronic HBV, HCV, or both are unaware of 

23 their infection, they do not know to take precautions 

24 to prevent the spread of their infection and can un25 knowingly exacerbate their own disease progression. 


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1 (8) HBV and HCV disproportionately affect 

2 certain populations in the United States. Although 

3 representing only 5 percent of the population, Asian 

4 and Pacific Islanders account for over half of the 

5 1,400,000 domestic chronic HBV cases. Baby 

6 boomers (those born between 1945 and 1965) ac7 count for more than 75 percent of domestic chronic 

8 HCV cases. In addition, African-Americans, Latinos 

9 (Latinas), and American Indian/Native Alaskans are 

10 among the groups which have disproportionately 

11 high rates of HBV infections, HCV infections, or 

12 both in the United States. 

13 (9) For both chronic HBV and chronic HCV, 

14 behavioral changes can slow disease progression if 

15 diagnosis is made early. Early diagnosis, which is 

16 determined through simple diagnostic tests, can re17 duce the risk of transmission and disease progres18 sion through education and vaccination of household 

19 members and other susceptible persons at risk. 

20 (10) Advancements have led to the development 

21 of improved diagnostic tests for viral hepatitis. 

22 These tests, including rapid, point of care testing 

23 and others in development can facilitate testing, no24 tification of results and post-test counseling, and re25 ferral to care at the time of the testing visit. In parVerDate Mar 15 2010 01:37 Nov 08, 2011 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3381.IH H3381

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1 ticular, these tests are also advantageous because 

2 they can be used simultaneously with HIV rapid 

3 testing for persons at risk for both HCV and HIV 

4 infections. 

5 (11) For those chronically infected with HBV 

6 or HCV, regular monitoring can lead to the early de7 tection of liver cancer at a stage where a cure is still 

8 possible. Liver cancer is the second deadliest cancer 

9 in the United States however, liver cancer has re10 ceived little funding for research, prevention, or 

11 treatment. 

12 (12) Treatment for chronic HCV can eradicate 

13 the disease in approximately 75 percent of those cur14 rently treated. The treatment of chronic HBV can 

15 effectively suppress viral replication in the over16 whelming majority (over 80 percent) of those treated 

17 thereby reducing the risk of transmission and pro18 gression to liver scarring or liver cancer even though 

19 a complete cure is much less common than for HCV. 

20 (13) To combat the viral hepatitis epidemic in 

21 the United States, in May 2011, the Department of 

22 Health and Human Services released, Combating the 

23 Silent Epidemic of Viral Hepatitis: Action Plan for 

24 the Prevention, Care & Treatment of Viral Hepa25 titis. The Institute of Medicine of the National 


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1 Academies produced a 2010 report on the Federal 

2 response to HBV and HCV titled: Hepatitis and 

3 Liver Cancer: A National Strategy for Prevention 

4 and Control of Hepatitis B and C. The recommenda5 tions and guidelines provide a framework for HBV 

6 and HCV prevention, education, control, research, 

7 and medical management programs. 

8 (14) The annual health care costs attributable 

9 to viral hepatitis in the United States are signifi10 cant. For HBV, it is estimated to be approximately 

11 $2,500,000,000 ($2,000 per infected person). In 

12 2000, the lifetime cost of HBV—before the avail13 ability of most of the current therapies—was ap14 proximately $80,000 per chronically infected person, 

15 or more than $100,000,000,000. For HCV, medical 

16 costs for patients are expected to increase from 

17 $30,000,000,000 in 2009 to over $85,000,000,000 

18 in 2024. Avoiding these costs by screening and diag19 nosing individuals earlier—and connecting them to 

20 appropriate treatment and care will save lives and 

21 critical health care dollars. Currently, without a 

22 comprehensive screening, testing and diagnosis pro23 gram, most patients are diagnosed too late when 

24 they need a liver transplant costing at least 

25 $314,000 for uncomplicated cases or when they have 


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1 liver cancer or end stage liver disease which costs 

2 between $30,980 to $110,576 per hospital admis3 sion. As health care costs continue to grow, it is crit4 ical that the Federal Government invests in effective 

5 mechanisms to avoid documented cost drivers. 

6 (15) According to the Institute of Medicine re7 port in 2010 (described in paragraph (13)), chronic 

8 HBV and HCV infections cause substantial mor9 bidity and mortality despite being preventable and 

10 treatable. Deficiencies in the implementation of es11 tablished guidelines for the prevention, diagnosis, 

12 and medical management of chronic HBV and HCV 

13 infections perpetuate personal and economic bur14 dens. Existing grants are not sufficient for the scale 

15 of the health burden presented by HBV and HCV. 

16 (16) Screening and testing for chronic HBV 

17 and HCV are aligned with the Healthy People 2020 

18 goal to increase immunization rates and reduce pre19 ventable infectious diseases. Awareness of disease 

20 and access to prevention and treatment remain es21 sential components for reducing infectious disease 

22 transmission. 

23 (17) Federal support is necessary to increase 

24 knowledge and awareness of HBV and HCV and to 

25 assist State and local prevention and control efforts 


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1 in reducing the morbidity and mortality of these 

2 epidemics. 

3 (18) The Secretary of Health and Human Serv4 ices has the discretion to carry out this Act directly 

5 and through whichever of the agencies of the Public 

6 Health Service the Secretary determines to be ap7 propriate, which may (in the Secretary’s discretion) 

8 include the Centers for Disease Control and Preven9 tion, the Health Resources and Services Administra10 tion, the Substance Abuse and Mental Health Serv11 ices Administration, the National Institutes of 

12 Health (including the National Institute on Minority 

13 Health and Health Disparities), and other agencies 

14 of such Service. 

15 SEC. 3. REVISION AND EXTENSION OF HEPATITIS SURVEIL16 LANCE, EDUCATION, AND TESTING PROGRAM. 

17 (a) IN GENERAL.—Section 317N of the Public 

18 Health Service Act (42 U.S.C. 247b–15) is amended— 

19 (1) by amending the heading to read as follows: 

20 ‘‘SURVEILLANCE, EDUCATION, AND TESTING

21 REGARDING HEPATITIS VIRUS’’; 

22 (2) by redesignating subsections (b) and (c) as 

23 subsections (d) and (e), respectively; and 

24 (3) by striking subsection (a) and inserting the 

25 following: 


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1 ‘‘(a) IN GENERAL.—The Secretary shall, in accord2 ance with this section, carry out surveillance, education, 

3 and testing programs with respect to hepatitis B and hep4 atitis C virus infections (referred to in this section as 

5 ‘HBV’ and ‘HCV’, respectively). The Secretary may carry 

6 out such programs directly and through grants to public 

7 and nonprofit private entities, including States, political 

8 subdivisions of States, territories, Indian tribes, and pub9 lic-private partnerships. 

10 ‘‘(b) NATIONAL SYSTEM.—In carrying out subsection 

11 (a), the Secretary shall cooperate with States and other 

12 public or nonprofit private entities to seek to establish a 

13 national system with respect to HBV and HCV with the 

14 following goals: 

15 ‘‘(1) To determine the incidence and prevalence 

16 of such infections, including providing for the report17 ing of chronic cases. 

18 ‘‘(2) With respect to the population of individ19 uals who have such an infection, to carry out testing 

20 programs to increase the number of individuals who 

21 are aware of their infection to 50 percent by 2014 

22 and to 75 percent by 2016. 

23 ‘‘(3) To develop and disseminate public infor24 mation and education programs for the detection 

25 and control of such infections, with priority given to 


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1 changing behaviors that place individuals at risk of 

2 infection. 

3 ‘‘(4) To provide appropriate referrals for coun4 seling and medical treatment of infected individuals 

5 and to ensure, to the extent practicable, the provi6 sion of appropriate follow-up services. 

7 ‘‘(5) To improve the education, training, and 

8 skills of health professionals in the detection, con9 trol, and treatment of such infections, with priority 

10 given to pediatricians and other primary care physi11 cians, and obstetricians and gynecologists. 

12 ‘‘(c) HIGH-RISK POPULATIONS; CHRONIC CASES.— 

13 ‘‘(1) IN GENERAL.—The Secretary shall deter14 mine the populations that, for purposes of this sec15 tion, are considered at high-risk for HBV or HCV. 

16 The Secretary shall include the following among 

17 those considered at high-risk: 

18 ‘‘(A) For HBV, individuals born in coun19 tries in which 2 percent or more of the popu20 lation has HBV. 

21 ‘‘(B) For HCV, individuals born between 

22 1945 and 1965. 

23 ‘‘(C) Those who have been exposed to the 

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1 dividuals, are family members of such individ2 uals, or are sexual partners of such individuals. 

3 ‘‘(2) PRIORITY IN PROGRAMS.—In providing for 

4 programs under subsection (b), the Secretary shall 

5 give priority— 

6 ‘‘(A) to early diagnosis of chronic cases of 

7 HBV or HCV in high-risk populations under 

8 paragraph (1); and 

9 ‘‘(B) to education, and referrals for coun10 seling and medical treatment, for individuals di11 agnosed under subparagraph (A) in order to— 

12 ‘‘(i) reduce their risk of dying from 

13 end-stage liver disease and liver cancer, 

14 and of transmitting the infection to others; 

15 ‘‘(ii) determine the appropriateness 

16 for treatment to reduce the risk of progres17 sion to cirrhosis and liver cancer; 

18 ‘‘(iii) receive ongoing medical manage19 ment, including regular monitoring of liver 

20 function and screenings for liver cancer; 

21 ‘‘(iv) receive, as appropriate, drug, al22 cohol abuse, and mental health treatment; 

23 ‘‘(v) in the case of women of child24 bearing age, receive education on how to 

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1 leviate fears associated with pregnancy or 

2 raising a family; and 

3 ‘‘(vi) receive such other services as the 

4 Secretary determines to be appropriate. 

5 ‘‘(3) CULTURAL CONTEXT.—In providing for 

6 services pursuant to paragraph (2) for individuals 

7 who are diagnosed under subparagraph (A) of such 

8 paragraph, the Secretary shall seek to ensure that 

9 the services are provided in a culturally and linguis10 tically appropriate manner.’’. 

11 (b) COORDINATION OF DEVELOPMENT OF FEDERAL

12 SCREENING GUIDELINES.— 

13 (1) REFERENCES.—For purposes of this sub14 section, the term ‘‘CDC Director’’ means the Direc15 tor of the Centers for Disease Control and Preven16 tion, and the term ‘‘AHRQ Director’’ means the Di17 rector of the Agency for Healthcare Research and 

18 Quality. 

19 (2) HCV GUIDELINES; CENTERS FOR DISEASE

20 CONTROL AND PREVENTION.— 

21 (A) IN GENERAL.—Not later than March 

22 1, 2012, the CDC Director shall complete the 

23 revision of the guidelines of the Centers for Dis24 ease Control and Prevention for screening indi25 viduals for the hepatitis C virus infection (in 


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1 this section referred to as ‘‘HCV’’), and shall 

2 transmit a copy of the guidelines to the AHRQ 

3 Director. The scope of the revised guidelines 

4 shall include testing for HCV that is carried 

5 out under section 317N of the Public Health 

6 Service Act (42 U.S.C. 247b–15), as amended 

7 by subsection (a). 

8 (B) CERTAIN FACTORS.—In revising guide9 lines pursuant to subparagraph (A), the CDC 

10 Director shall take into account— 

11 (i) the effectiveness issues that have 

12 been raised with respect to the current 

13 guidelines of the Centers for Disease Con14 trol and Prevention for screenings for 

15 HCV; 

16 (ii) the importance of responding to 

17 the perception that receiving such 

18 screenings may be stigmatizing; and 

19 (iii) whether age-based screenings 

20 would be effective, considering the use of 

21 that approach in breast and colon cancer 

22 screenings. 

23 (3) AGENCY FOR HEALTHCARE RESEARCH AND

24 QUALITY.— 


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1 (A) HCV GUIDELINES.—The AHRQ Di2 rector shall, in developing the recommendations 

3 for screenings for HCV that the AHRQ Direc4 tor will provide to the Preventive Services Task 

5 Force under section 915(a) of the Public 

6 Health Service Act (42 U.S.C. 299b–4(a)), take 

7 into account— 

8 (i) the guidelines established pursuant 

9 to paragraph (2) by the CDC Director; 

10 and 

11 (ii) new and improved treatments for 

12 HCV. 

13 (B) HBV GUIDELINES.—The AHRQ Di14 rector shall, in developing the recommendations 

15 for screenings for the hepatitis B virus infection 

16 (in this section referred to as ‘‘HBV’’) that the 

17 AHRQ Director will provide to the Preventive 

18 Services Task Force referred to in subpara19 graph (A), take into account the guidelines for 

20 screenings for HBV that the CDC Director rec21 ommended in 2008. 

22 (c) AUTHORIZATION OF APPROPRIATIONS.—Sub23 section (e) of section 317N of the Public Health Service 

24 Act (42 U.S.C. 247b–15), as redesignated by subsection 

25 (a)(2) of this section, is amended to read as follows: 


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1 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.— 

2 ‘‘(1) IN GENERAL.—For the purpose of testing, 

3 education, and referrals under this section, there are 

4 authorized to be appropriated $25,000,000 for fiscal 

5 year 2012, $35,000,000 for fiscal year 2013, 

6 $20,000,000 for fiscal year 2014, and $15,000,000 

7 for each of the fiscal years 2015 and 2016. 

8 ‘‘(2) GRANTS.—Of the amounts appropriated 

9 under paragraph (1) for a fiscal year, the Secretary 

10 shall reserve not less than 80 percent for making 

11 grants under subsection (a).’’. 

12 (d) SAVINGS PROVISION.—The amendments made by 

13 this section shall not be construed to require termination 

14 of any program or activity carried out by the Secretary 

15 of Health and Human Services under section 317N of the 

16 Public Health Service Act (42 U.S.C. 247b–15) as in ef17 fect on the day before the date of the enactment of this 

18 Act. 

Æ 


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