II 113th CONGRESS 2d Session S. 2538 IN THE SENATE OF THE UNITED STATES June 26, 2014 Mr. Kirk (for himself and Ms. Hirono ) 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.

1. Short title This Act may be cited as the Viral Hepatitis Testing Act of 2014 . 2. 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 population of individuals who have such an infection, to carry out testing programs to increase the number of individuals who are aware of their infection to 50 percent by December 31, 2014, and to 75 percent by December 31, 2016. (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 follow-up 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. (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. (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) 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 2014 , 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 non-government 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 non-profit organizations, community and faith-based organizations, foundations, and other governmental and non-governmental 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. (e) 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 Preventive Services Task Force under section 915(a) to review its recommendation for screening for HBV and HCV infection every 3 years. (f) 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 2014; (B) $35,000,000 for fiscal year 2015; and (C) $20,000,000 for fiscal year 2016. (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.