To amend the Public Health Service Act to direct the Secretary of Health and Human Services to establish, promote, and support a comprehensive prevention, research, and medical management referral program for hepatitis C virus infection.

November 19, 2003

Mrs. WILSON of New Mexico (for herself and Mr. TOWNS) introduced the following bill; which was referred to the Committee on Energy and Commerce

To amend the Public Health Service Act to direct the Secretary of Health and Human Services to establish, promote, and support a comprehensive prevention, research, and medical management referral program for hepatitis C virus infection.

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 `Hepatitis C Epidemic Control and Prevention Act'.

SEC. 2. FINDINGS.

Congress makes the following findings:

(1) Over 3,000,000 individuals in the United States are chronically infected with the hepatitis C virus (referred to in this section as `HCV'), making it the Nation's most common blood-borne viral infection.

(2) Nearly 2 percent of the population of the United States has been infected with HCV.

(3) Conservative estimates indicate that approximately 35,000 Americans are newly infected with HCV each year.

(4) HCV infection can cause life-threatening liver disease.

(5) Individuals infected with HCV serve as a source of transmission to others and, since few individuals are aware they are infected, are unlikely to take precautions to prevent the spread or exacerbation of their infection.

(6) There is no vaccine available to prevent HCV infection.

(7) Treatments are available to slow the progression of chronic HCV.

(8) An estimated 2,400,000 to 2,700,000 people who are chronically infected with HCV are receiving no treatment.

(9) Conservative estimates place the costs of lost productivity and medical care arising from chronic HCV in the United States at more than $600,000,000 annually, and such costs will undoubtedly increase in the absence of expanded prevention and treatment efforts.

(10) To combat the HCV epidemic in the United States, the Centers for Disease Control and Prevention developed Recommendations for Prevention and Control of Hepatitis C Virus (HCV) Infection and HCV-Related Chronic Disease in 1998 and the National Hepatitis C Prevention Strategy in 2001, and the National Institutes of Health convened Consensus Development Conferences on the Management of Hepatitis C in 1997 and 2002. These recommendations and guidelines provide a framework for HCV prevention, control, research, and medical management referral programs.

(11) Federal support is necessary to increase knowledge and awareness of HCV and to assist State and local prevention and control efforts.

SEC. 3. PREVENTION, CONTROL, AND MEDICAL MANAGEMENT OF HEPATITIS C.

Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is amended by adding at the end the following:

`PART R--PREVENTION, CONTROL, AND MEDICAL MANAGEMENT OF HEPATITIS C

`SEC. 399AA. FEDERAL PLAN FOR THE PREVENTION, CONTROL, AND MEDICAL MANAGEMENT OF HEPATITIS C.

`(a) IN GENERAL- The Secretary shall develop and implement a plan for the prevention, control, and medical management of hepatitis C (referred to in this part as `HCV') which includes strategies for education and training, surveillance and early detection, and research.

`(b) INPUT IN DEVELOPMENT OF PLAN- In developing the plan under subsection (a), the Secretary shall--

`(1) be guided by existing recommendations of the Centers for Disease Control and Prevention and the National Institutes of Health; and

`(2) consult with--

`(A) the Director of the Centers for Disease Control and Prevention;

`(B) the Director of the National Institutes of Health;

`(C) the Director of the Health Resources and Services Administration;

`(D) the heads of other Federal agencies or offices providing services to individuals with HCV infections or the functions of which otherwise involve HCV;

`(E) medical advisory bodies that address issues related to HCV; and

`(F) the public, including--

`(i) individuals infected with HCV; and

`(ii) advocates concerned with issues related to HCV.

`(c) BIENNIAL UPDATE OF PLAN-

`(1) IN GENERAL- The Secretary shall conduct a biennial assessment of the plan developed under subsection (a) for the purpose of incorporating into such plan new knowledge or observations relating to HCV and chronic HCV (such as knowledge and observations that may be derived from clinical, laboratory, and epidemiological research and disease detection, prevention, and surveillance outcomes) and addressing gaps in the coverage or effectiveness of the plan.

`(2) PUBLICATION OF NOTICE OF ASSESSMENTS- Not later than October 1 of the first even-numbered year beginning after the date of 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) a description of any revisions to the plan developed under subsection (a) as a result of the assessment;

`(B) 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

`(C) in the case of a determination by the Secretary that the plan does not need revision, an explanation of the basis for such determination.

`SEC. 399BB. ELEMENTS OF THE FEDERAL PLAN FOR THE PREVENTION, CONTROL, AND MEDICAL MANAGEMENT OF HEPATITIS C.

`(a) EDUCATION AND TRAINING- The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall implement programs to increase awareness and enhance knowledge and understanding of HCV. Such programs shall include--

`(1) the conduct of health education, public awareness campaigns, and community outreach activities to promote public awareness and knowledge about risk factors, the transmission and prevention of infection with HCV, the value of screening for the early detection of HCV infection, and options available for the treatment of chronic HCV;

`(2) the training of health care professionals regarding the prevention, detection, and medical management of hepatitis B (referred to in this part as `HBV') and HCV, and the importance of vaccinating HCV-infected individuals and those at risk for HCV infection against the hepatitis A virus and hepatitis B virus; and

`(3) the development and distribution of curricula (including information relating to the special needs of individuals infected with HBV or HCV, such as the importance of early intervention and treatment and the recognition of psychosocial needs) for individuals providing hepatitis counseling, as well as support for the implementation of such curricula by State and local public health agencies.

`(b) EARLY DETECTION AND SURVEILLANCE-

`(1) IN GENERAL- The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall support activities described in paragraph (2) to promote the early detection of HCV infection, identify risk factors for infection, and conduct surveillance of HCV infection trends.

`(2) ACTIVITIES-

`(A) VOLUNTARY TESTING PROGRAMS-

`(i) IN GENERAL- The Secretary shall support and promote the development of State, local, and tribal voluntary HCV testing programs to aid in the early identification of infected individuals.

`(ii) CONFIDENTIALITY OF TEST RESULTS- The results of an HCV test conducted by a testing program developed or supported under this subparagraph shall be considered protected health information (in a manner consistent with regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996) and may not be used for any of the following:

`(I) Issues relating to health insurance.

`(II) To screen or determine suitability for employment.

`(III) To discharge a person from employment.

`(B) COUNSELING REGARDING VIRAL HEPATITIS- The Secretary shall support State, local, and tribal programs in a wide variety of settings, including those providing primary and specialty health care services in the private and the public sectors, to--

`(i) provide individuals with information about ongoing risk factors for HCV infection with client-centered education and counseling which concentrates on changing behaviors that place them at risk for infection; and

`(ii) provide individuals infected with HCV with education and counseling to reduce the risk of harm to themselves and transmission of the virus to others.

`(C) VACCINATION AGAINST VIRAL HEPATITIS- With respect to individuals infected, or at risk for infection, with HCV, the Secretary shall provide for--

`(i) the vaccination of such individuals against hepatitis A virus, HBV, and other infectious diseases, as appropriate, for which such individuals may be at increased risk; and

`(ii) the counseling of such individuals regarding hepatitis A, hepatitis B, and other viral hepatides.

`(D) MEDICAL REFERRAL- The Secretary shall support--

`(i) referral of persons infected with or at risk for HCV, for drug or alcohol abuse treatment where appropriate; and

`(ii) referral of persons infected with HCV--

`(I) for medical evaluation to determine their stage of chronic HCV and suitability for antiviral treatment; and

`(II) for ongoing medical management of HCV.

`(3) HEPATITIS C COORDINATORS- The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall, upon request, provide a Hepatitis C Coordinator to a State health department in order to enhance the additional management, networking, and technical expertise needed to ensure successful integration of HCV prevention and control activities into existing public health programs.

`(c) SURVEILLANCE AND EPIDEMIOLOGY-

`(1) IN GENERAL- The Secretary shall promote and support the establishment and maintenance of State HCV surveillance databases, in order to--

`(A) identify risk factors for HCV infection;

`(B) identify trends in the incidence of acute and chronic HCV;

`(C) identify trends in the prevalence of HCV infection among groups that may be disproportionately affected by HCV, including individuals living with HIV, military veterans, emergency first responders, racial or ethnic minorities, and individuals who engage in high risk behaviors, such as intravenous drug use; and

`(D) assess and improve HCV infection prevention programs.

`(2) SEROPREVALENCE STUDIES- The Secretary shall conduct a population-based seroprevalence study to estimate the current and future impact of HCV. Such studies shall consider the economic and clinical impacts of HCV, as well as the impact of HCV on quality of life.

`(3) CONFIDENTIALITY- Information contained in the databases under paragraph (1) or derived through studies under paragraph (2) shall be de-identified in a manner consistent with regulations under section 264(c) of the Health Insurance Portability and Accountability Act of 1996.

`(d) RESEARCH NETWORK- The Secretary, acting through the Director of the Centers for Disease Control and Prevention and the Director of the National Institutes of Health, shall--

`(1) conduct epidemiologic research to identify best practices for HCV prevention;

`(2) establish and support a Hepatitis C Clinical Research Network for the purpose of conducting research related to the treatment and medical management of HCV; and

`(3) conduct basic research to identify new approaches to prevention (such as vaccines) and treatment for HCV.

`(e) REFERRAL FOR MEDICAL MANAGEMENT OF CHRONIC HEPATITIS C- The Secretary shall support and promote State, local, and tribal programs to provide HCV-positive individuals with referral for medical evaluation and management, including currently recommended antiviral therapy when appropriate.

`(f) UNDERSERVED AND DISPROPORTIONATELY AFFECTED POPULATIONS- 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 HCV.

`(g) EVALUATION OF PROGRAM- 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.

`SEC. 399CC. GRANTS.

`(a) IN GENERAL- The Secretary may award grants to, or enter into contracts or cooperative agreements with, States, political subdivisions of States, Indian tribes, or nonprofit entities that have special expertise relating to HCV, to carry out activities under this part.

`(b) APPLICATION- 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.

`SEC. 399DD. AUTHORIZATION OF APPROPRIATIONS.

`There are authorized to be appropriated to carry out this part $90,000,000 for fiscal year 2004, and such sums as may be necessary for each of fiscal years 2005 through 2008.'.

SEC. 4. LIVER DISEASE RESEARCH ADVISORY BOARD.

Part B of title IV of the Public Health Service Act (42 U.S.C. 284 et seq.) is amended by adding at the end the following:

`SEC. 409J. LIVER DISEASE RESEARCH ADVISORY BOARD.

`(a) ESTABLISHMENT- Not later than 90 days after the date of enactment of this section, the Director of the National Institutes of Health shall establish a board to be known as the Liver Disease Research Advisory Board (referred to in this section as the `Advisory Board').

`(b) DUTIES- The Advisory Board shall advise and assist the Director of the National Institutes of Health concerning matters relating to liver disease research, including by developing and revising the Liver Disease Research Action Plan.

`(c) VOTING MEMBERS- The Advisory Board shall be composed of 18 voting members to be appointed by the Director of the National Institutes of Health, in consultation with the Director of the National Institute of Diabetes and Digestive and Kidney Diseases, of whom 12 such individuals shall be eminent scientists and 6 such individuals shall be lay persons. The Director of the National Institutes of Health, in consultation with the Director of the Institute, shall select 1 of the members to serve as the Chair of the Advisory Board.

`(d) EX OFFICIO MEMBERS- The Director of the National Institutes of Health shall appoint each director of a national research institute that funds liver disease research to serve as a nonvoting, ex officio member of the Advisory Board. The Director of the National Institutes of Health shall invite 1 representative of the Centers for Disease Control and Prevention, 1 representative of the Food and Drug Administration, and 1 representative of the Department of Veterans Affairs to serve as such a member. Each ex officio member of the Advisory Board may appoint an individual to serve as that member's representative on the Advisory Board.

`(e) LIVER DISEASE RESEARCH ACTION PLAN-

`(1) DEVELOPMENT- Not later than 15 months after the date of the enactment of this section, the Advisory Board shall develop (with appropriate support from the Director) a comprehensive plan for the conduct and support of liver disease research to be known as the Liver Disease Research Action Plan. The Advisory Board shall submit the Plan to the Director of NIH and the head of each institute or center within the National Institutes of Health that funds liver disease research.

`(2) CONTENT- The Liver Disease Research Action Plan shall identify scientific opportunities and priorities of liver disease research necessary to increase understanding of and to prevent, cure, and develop better treatment protocols for liver diseases.

`(3) REVISION- The Advisory Board shall revise every 2 years the Liver Disease Research Action Plan, but shall meet annually to review progress and to amend the Plan as may be appropriate because of new scientific discoveries.'.

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