I 

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. 

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 2013’’. 


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1 SEC. 2. FINDINGS. 

2 Congress finds the following: 

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

4 chronically infected with the hepatitis B virus (re5 ferred to in this section as ‘‘HBV’’), the hepatitis C 

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

7 both. 

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

9 HCV are among the most common causes of liver 

10 cancer, one of the most lethal and fastest growing 

11 cancers in the United States. Chronic HBV and 

12 HCV are among the most common causes of chronic 

13 liver disease, liver cirrhosis, and the most common 

14 indication for liver transplantation. More than 

15 15,000 deaths per year in the United States can be 

16 attributed to chronic HBV and HCV. Chronic HCV 

17 is also a leading cause of death in Americans living 

18 with HIV/AIDS. Many of those living with HIV/ 

19 AIDS are coinfected with chronic HBV, HCV, or 

20 both. 

21 (3) According to the Centers for Disease Con22 trol and Prevention (referred to in this section as 

23 the ‘‘CDC’’), approximately 2 percent of the popu24 lation of the United States is living with chronic 

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


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1 as the Nation’s most common chronic bloodborne 

2 virus infection. 

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

4 more infectious than HIV. According to the CDC, 

5 HBV is transmitted through contact with infectious 

6 blood, semen, or other body fluids. HCV is trans7 mitted by contact with infectious blood, particularly 

8 through percutaneous exposures (i.e. puncture 

9 through the skin). 

10 (5) The CDC conservatively estimates that in 

11 2011 approximately 16,600 Americans were newly 

12 infected with HCV and more than 18,800 Americans 

13 were newly infected with HBV. These estimates 

14 could be much higher due to many reasons, includ15 ing lack of screening education and awareness, and 

16 perceived marginalization of the populations at risk. 

17 (6) In 2012 CDC released new guidelines rec18 ommending every person born from 1945 through 

19 1965 receive a one-time HCV test. Among the esti20 mated 102 million (1.6 million chronically HCV-in21 fected) eligible for screening, birth-cohort screening 

22 leads to 74,000 fewer cases of decompensated cir23 rhosis, 46,000 fewer cases of hepatocellular car24 cinoma, 15,000 fewer liver transplants and 120,000 


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1 fewer HCV-related deaths versus risk-based screen2 ing. 

3 (7) In 2013, the United States Preventative 

4 Task Force (USPSTF) issued a Grade B rating for 

5 screening for hepatitis C virus (HCV) infection in 

6 persons at high risk for infection and adults born 

7 between 1945 and 1965. In 2009, the USPSTF 

8 issued a Grade A for screening pregnant women for 

9 the hepatitis B virus (HBV) during their first pre10 natal visit. 

11 (8) There were 35 outbreaks (19 of HBV, 16 

12 of HCV) reported to CDC for investigation from 

13 2008–2012 related to healthcare acquired infection 

14 of HBV and HCV, 33 of which occurred in non-hos15 pital settings. There were more than 99,975 patients 

16 potentially exposed to one of the viruses. 

17 (9) Chronic HBV and chronic HCV usually do 

18 not cause symptoms early in the course of the dis19 ease, but after many years of a clinically ‘‘silent’’ 

20 phase, CDC estimates show more than 33 percent of 

21 infected individuals will develop cirrhosis, end-stage 

22 liver disease, or liver cancer. Since most individuals 

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

24 their infection, they do not know to take precautions 


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1 to prevent the spread of their infection and can un2 knowingly exacerbate their own disease progression. 

3 (10) HBV and HCV disproportionately affect 

4 certain populations in the United States. Although 

5 representing about 6 percent of the population, 

6 Asian and Pacific Islanders account for over half of 

7 up to 1,400,000 domestic chronic HBV cases. Baby 

8 boomers (those born between 1945 and 1965) ac9 count for more than 75 percent of domestic chronic 

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

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

12 among the groups which have disproportionately 

13 high rates of HBV infections, HCV infections, or 

14 both in the United States. 

15 (11) For both chronic HBV and chronic HCV, 

16 behavioral changes can slow disease progression if a 

17 diagnosis is made early. Early diagnosis, which is 

18 determined through simple diagnostic tests, can also 

19 reduce the risk of transmission and disease progres20 sion through education and vaccination of household 

21 members and other susceptible persons at risk. 

22 (12) Advancements have led to the development 

23 of improved diagnostic tests for viral hepatitis. 

24 These tests, including rapid, point of care testing 

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1 tification of results and post-test counseling, and re2 ferral to care at the time of the testing visit. In par3 ticular, these tests are also advantageous because 

4 they can be used simultaneously with HIV rapid 

5 testing for persons at risk for both HCV and HIV 

6 infections. 

7 (13) For those chronically infected with HBV 

8 or HCV, regular monitoring can lead to the early de9 tection of liver cancer at a stage where a cure is still 

10 possible. Liver cancer is the second deadliest cancer 

11 in the United States; however, liver cancer has re12 ceived little funding for research, prevention, or 

13 treatment. 

14 (14) Treatment for chronic HCV can eradicate 

15 the disease in approximately 75 percent of those cur16 rently treated. The treatment of chronic HBV can 

17 effectively suppress viral replication in the over18 whelming majority (over 80 percent) of those treat19 ed, thereby reducing the risk of transmission and 

20 progression to liver scarring or liver cancer, even 

21 though a complete cure is much less common than 

22 for HCV. 

23 (15) To combat the viral hepatitis epidemic in 

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

25 Health and Human Services released, Combating the 


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1 Silent Epidemic of Viral Hepatitis: Action Plan for 

2 the Prevention, Care & Treatment of Viral Hepa3 titis. The Institute of Medicine of the National 

4 Academies produced a 2010 report on the Federal 

5 response to HBV and HCV titled: Hepatitis and 

6 Liver Cancer: A National Strategy for Prevention 

7 and Control of Hepatitis B and C. The recommenda8 tions and guidelines provide a framework for HBV 

9 and HCV prevention, education, control, research, 

10 and medical management programs. 

11 (16) The annual health care costs attributable 

12 to viral hepatitis in the United States are signifi13 cant. For HBV, it is estimated to be approximately 

14 $2,500,000,000 ($2,000 per infected person). In 

15 2000, the lifetime cost of HBV—before the avail16 ability of most current therapies—was approximately 

17 $80,000 per chronically infected person, totaling 

18 more than $100,000,000,000. For HCV, medical 

19 costs for patients are expected to increase from 

20 $30,000,000,000 in 2009 to over $85,000,000,000 

21 in 2024. Avoiding these costs by screening and diag22 nosing individuals earlier—and connecting them to 

23 appropriate treatment and care will save lives and 

24 critical health care dollars. Currently, without a 

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1 gram, most patients are diagnosed too late when 

2 they need a liver transplant costing at least 

3 $314,000 for uncomplicated cases or when they have 

4 liver cancer or end stage liver disease which costs 

5 between $30,980 to $110,576 per hospital admis6 sion. As health care costs continue to grow, it is crit7 ical that the Federal Government invests in effective 

8 mechanisms to avoid documented cost drivers. 

9 (17) According to the Institute of Medicine re10 port in 2010 (described in paragraph (13)), chronic 

11 HBV and HCV infections cause substantial mor12 bidity and mortality despite being preventable and 

13 treatable. Deficiencies in the implementation of es14 tablished guidelines for the prevention, diagnosis, 

15 and medical management of chronic HBV and HCV 

16 infections perpetuate personal and economic bur17 dens. Existing grants are not sufficient to address 

18 the scale of the health burden presented by HBV 

19 and HCV. 

20 (18) The Secretary of Health and Human Serv21 ices has the discretion to carry out this Act directly 

22 and through whichever of the agencies of the Public 

23 Health Service the Secretary determines to be ap24 propriate, which may (in the Secretary’s discretion) 

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1 tion, the Health Resources and Services Administra2 tion, the Substance Abuse and Mental Health Serv3 ices Administration, the National Institutes of 

4 Health (including the National Institute on Minority 

5 Health and Health Disparities), and other agencies 

6 of such Service. 

7 (19) For over a decade, the Centers for Disease 

8 Control and Prevention’s Viral Hepatitis Prevention 

9 Coordinator (VHPC) program has been the only na10 tional program dedicated to the prevention and con11 trol of the viral hepatitis epidemics administering 

12 the duties currently specified by Section 317N of the 

13 Public Health Service Act (42 U.S.C. 247b–15) at 

14 State and local health departments. VHPCs provide 

15 the technical expertise necessary for the manage16 ment and coordination of activities to prevent viral 

17 hepatitis infection and disease with little to no Fed18 eral funding for program implementation or develop19 ment. Further, these coordinators help integrate 

20 viral hepatitis prevention services into health care 

21 settings and public health programs that serve 

22 adults at risk for viral hepatitis. 


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1 SEC. 3. REVISION AND EXTENSION OF HEPATITIS SURVEIL2 LANCE, EDUCATION, AND TESTING PROGRAM. 

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

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

5 (1) by amending the section heading to read as 

6 follows: ‘‘SURVEILLANCE, EDUCATION, TESTING, 

7 AND LINKAGE TO CARE REGARDING HEPATITIS

8 VIRUS’’; 

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

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

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

12 following: 

13 ‘‘(a) IN GENERAL.—The Secretary shall, in accord14 ance with this section, carry out surveillance, education, 

15 and testing programs with respect to hepatitis B and hep16 atitis C virus infections (referred to in this section as 

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

18 out such programs directly and through grants to public 

19 and nonprofit private entities, including States, political 

20 subdivisions of States, territories, Indian tribes, and pub21 lic-private partnerships. 

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

23 (a), the Secretary shall, in consultation with States and 

24 other public or nonprofit private entities and public-pri25 vate partnerships described in subsection (d), establish a 


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1 national system with respect to HBV and HCV with the 

2 following goals: 

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

4 of such infections, including providing for the report5 ing of acute and chronic cases. 

6 ‘‘(2) With respect to the population of individ7 uals who have such an infection, to carry out testing 

8 programs to increase the number of individuals who 

9 are aware of their infection to 50 percent by Decem10 ber 31, 2014, and to 75 percent by December 31, 

11 2016. 

12 ‘‘(3) To develop and disseminate public infor13 mation and education programs for the detection 

14 and control of such infections. 

15 ‘‘(4) To improve the education, training, and 

16 skills of health professionals in the detection, con17 trol, and care and treatment, of such infections. 

18 ‘‘(5) To provide appropriate referrals for coun19 seling and medical care and treatment of infected in20 dividuals and to ensure, to the extent practicable, 

21 the provision of appropriate follow-up services. 

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

23 ‘‘(1) IN GENERAL.—The Secretary shall deter24 mine the populations that, for purposes of this sec25 tion, are considered at high-risk for HBV or HCV. 


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1 The Secretary shall include the following among 

2 those considered at high-risk: 

3 ‘‘(A) For HBV, individuals born in coun4 tries in which 2 percent or more of the popu5 lation has HBV or who are a part of a high6 risk category as identified by the Centers for 

7 Disease Control and Prevention. 

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

9 1945 and 1965 or who are a part of a high-risk 

10 category as identified by the Centers for Dis11 ease Control and Prevention. 

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

13 blood of infected individuals or of high-risk in14 dividuals or who are family members of such in15 dividuals. 

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

17 programs under this section, the Secretary shall give 

18 priority— 

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

20 HBV or HCV in high-risk populations under 

21 paragraph (1); and 

22 ‘‘(B) to education, and referrals for coun23 seling and medical care and treatment, for indi24 viduals diagnosed under subparagraph (A) in 

25 order to— 


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

2 end-stage liver disease and liver cancer, 

3 and of transmitting the infection to others; 

4 ‘‘(ii) determine the appropriateness 

5 for treatment to reduce the risk of progres6 sion to cirrhosis and liver cancer; 

7 ‘‘(iii) receive ongoing medical manage8 ment, including regular monitoring of liver 

9 function and screenings for liver cancer; 

10 ‘‘(iv) receive, as appropriate, drug, al11 cohol abuse, and mental health treatment; 

12 ‘‘(v) in the case of women of child13 bearing age, receive education on how to 

14 prevent HBV perinatal infection, and to al15 leviate fears associated with pregnancy or 

16 raising a family; and 

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

18 Secretary determines to be appropriate. 

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

20 services pursuant to paragraph (2) for individuals 

21 who are diagnosed under subparagraph (A) of such 

22 paragraph, the Secretary shall seek to ensure that 

23 the services are provided in a culturally and linguis24 tically appropriate manner. 

25 ‘‘(d) PUBLIC-PRIVATE PARTNERSHIPS.— 


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1 ‘‘(1) IN GENERAL.—In carrying out this sec2 tion, and not later than 60 days after the date of 

3 the enactment of the Viral Hepatitis Testing Act of 

4 2013, the Secretary shall, in consultation with the 

5 Assistant Secretary for Health, the Director of the 

6 Centers for Disease Control and Prevention, the 

7 Health Resources and Services Administration, the 

8 Substance Abuse and Mental Health Services Ad9 ministration, the Office of Minority Health, the In10 dian Health Service, other relevant agencies, and 

11 non-government stakeholder entities, establish and 

12 support public-private partnerships that facilitate 

13 the surveillance, education, screening, testing, and 

14 linkage to care programs authorized by this section. 

15 ‘‘(2) DUTIES.—Public-private partnerships es16 tablished or supported under paragraph (1) shall— 

17 ‘‘(A) focus primarily on the surveillance, 

18 education, screening, testing, and linkage to 

19 care programs authorized by this section; 

20 ‘‘(B) generate resources, in addition to the 

21 funds made available pursuant to subsection 

22 (f), to carry out the surveillance, education, 

23 screening, testing, and linkage to care programs 

24 authorized in this section by leveraging Federal 

25 funding with non-Federal funding and support; 


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1 ‘‘(C) allow for investments in such pro2 grams of financial or in-kind resources by each 

3 of the partners involved in the partnership; 

4 ‘‘(D) include corporate and industry enti5 ties, academic institutions, public and non-prof6 it organizations, community and faith-based or7 ganizations, foundations, and other govern8 mental and non-governmental organizations; 

9 and 

10 ‘‘(E) advance the core goals of each of the 

11 partners of the partnership as determined by 

12 the Secretary in development of the partner13 ship. 

14 ‘‘(3) ANNUAL REPORTS.—The Secretary shall 

15 provide to the Congress an annual report on the 

16 public-private partnerships established under this 

17 subsection. Each such report shall include— 

18 ‘‘(A) the number of public-private partner19 ships established; 

20 ‘‘(B) specific and quantifiable information 

21 on the surveillance, education, screening, test22 ing, and linkage to care activities conducted as 

23 well as the outcomes achieved through each of 

24 the public-private partnerships; 


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1 ‘‘(C) the amount of Federal funding or re2 sources dedicated to the public-private partner3 ships; 

4 ‘‘(D) the amount of non-Federal funding 

5 or resources leveraged through the public-pri6 vate partnerships; and 

7 ‘‘(E) a plan for the following year that out8 lines future activities. 

9 ‘‘(4) LIMITATION.—No more than 25 percent of 

10 the funds made available to carry out this section 

11 may be used for public-private partnerships estab12 lished or supported under this subsection. 

13 ‘‘(5) LINKAGE TO CARE.—For purposes of this 

14 section, the term ‘linkage to care’ means, with re15 spect to an individual with a diagnosis of HBV or 

16 HCV, the referral of such individual to clinical care 

17 for a thorough evaluation of their clinical status to 

18 determine the need for treatment, vaccination for 

19 HBV, or other therapy. 

20 ‘‘(e) AGENCY FOR HEALTHCARE RESEARCH AND

21 QUALITY HBV AND HCV GUIDELINES.—Due to the rap22 idly evolving standard of care associated with diagnosing 

23 and treating viral hepatitis infection, the Director of the 

24 Agency for Healthcare Research and Quality shall convene 

25 the Preventive Services Task Force under section 915(a) 


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1 to review its recommendation for screening for HBV and 

2 HCV infection every 3 years. 

3 ‘‘(f) FUNDING.— 

4 ‘‘(1) IN GENERAL.—In addition to any amounts 

5 otherwise authorized by this Act, there are author6 ized to be appropriated to carry out this section— 

7 ‘‘(A) $25,000,000 for fiscal year 2014; 

8 ‘‘(B) $35,000,000 for fiscal year 2015; and 

9 ‘‘(C) $20,000,000 for fiscal year 2016. 

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

11 pursuant to paragraph (1) for a fiscal year, the Sec12 retary shall reserve not less than 80 percent for 

13 making grants under subsection (a). 

14 ‘‘(3) SOURCE OF FUNDS.—The funds made 

15 available to carry out this section shall be derived 

16 exclusively from the funds appropriated or otherwise 

17 made available for planning and evaluation under 

18 this Act.’’. 

19 (b) SAVINGS PROVISION.—The amendments made by 

20 this section shall not be construed to require termination 

21 of any program or activity carried out by the Secretary 

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

23 Public Health Service Act (42 U.S.C. 247b–15) as in ef24 fect on the day before the date of the enactment of this 

25 Act. 


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1 SEC. 4. HEPATITIS C SCREENING AND EVALUATION OF 

2 NEEDED CARE FOR VETERANS. 

3 (a) IN GENERAL.—Subchapter II of chapter 17 of 

4 title 38, United States Code, is amended by adding at the 

5 end the following: 

6 ‘‘§ 1720H. Hepatitis C screening and evaluation of 

7 needed care for veterans 

8 ‘‘(a) IN GENERAL.—(1) The Secretary shall establish 

9 and carry out a plan to provide veterans described in para10 graph (2) with— 

11 ‘‘(A) a risk assessment for the hepatitis C 

12 virus; and 

13 ‘‘(B) if a veteran is diagnosed with such virus— 

14 ‘‘(i) a thorough evaluation of the clinical 

15 status of the veteran to determine the need for 

16 treatment, vaccination, or other therapy; and 

17 ‘‘(ii) information with respect to the needs 

18 determined under clause (i). 

19 ‘‘(2) Veterans described in this paragraph are vet20 erans who— 

21 ‘‘(A) are enrolled in the health care system es22 tablished under section 1705(a) of this title; and 

23 ‘‘(B) were born between 1945 and 1965. 

24 ‘‘(b) COMPLIANCE.—(1) The Secretary shall use the 

25 plan established under subsection (a)(1) as a key measure 

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1 formance Management System, or the successor to such 

2 handbook, to ensure the compliance of such plan. 

3 ‘‘(2) If the Secretary determines that a medical facil4 ity of the Department complies with the plan established 

5 under subsection (a)(1) at a rate less than 100 percent, 

6 the Secretary shall treat the director of such medical facil7 ity as ‘less than fully successful’with respect to the per8 formance appraisal that is used for the basis for deter9 mining performance awards under the handbook described 

10 in paragraph (1). 

11 ‘‘(c) ANNUAL REPORT.—The Secretary shall submit 

12 annually to Congress a report on the compliance of each 

13 medical facility of the Department with the plan estab14 lished under subsection (a)(1).’’. 

15 (b) CLERICAL AMENDMENT.—The table of sections 

16 at the beginning of such chapter is amended by inserting 

17 after the item relating to section 1720G the following new 

18 item: 

‘‘1720H. Hepatitis C screening and evaluation of needed care for veterans.’’. 

Æ 


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