S. 521Senate109th Congress (2005-2007)In Committee

Hepatitis C Epidemic Control and Prevention Act

Introduced March 3, 2005

Legislative Activity

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SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S2027-2029)

March 3, 2005

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SenateIntro Referral

Introduced in Senate

March 3, 2005

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S2027-2029)

March 3, 2005

Floor Debate

21 members

What members said about S. 521 on the floor

13 Republicans8 Democrats
Robert C. Byrd
Sen. Robert C. ByrdD-WV · Mar 3, 2005

Mr. President, today I am, again, introducing legislation designed to fulfill an important promise made by the Federal Government to the people of my State and my region some 40 years ago. That…

Dianne Feinstein
Sen. Dianne FeinsteinD-CA · Mar 3, 2005

Mr. President, in light of the most recent evidence uncovered about Enron's participation in the Western Energy Crisis, I rise today to introduce the Energy Market Oversight Bill with Senators Levin,…

Edward M. Kennedy
Sen. Edward M. KennedyD-MA · Mar 3, 2005

Mr. President, it is a privilege to join Senator Sessions, Senator Durbin and Senator Dodd in introducing the ``National All Schedules Prescription Electronic Reporting Act.'' Our goal is to help…

Mike DeWine
Sen. Mike DeWineR-OH · Mar 3, 2005

Mr. President, today, I am pleased to join with Senators Levin, Stabenow, Reed, and Voinovich to introduce the National Invasive Species Council Act--a bill to permanently establish the National…

Ron Wyden
Sen. Ron WydenD-OR · Mar 3, 2005

Mr. President, the pace of technological innovation offers American consumers an eye-catching array of electronic gadgets. But for every new lap top or HDTV that goes home from the store with a…

Show 8 more
Lamar Alexander
Sen. Lamar AlexanderR-TN · Mar 3, 2005

Mr. President, today I am here with Senator Dodd and on behalf of Senator Enzi and Senator Kennedy to introduce the Caring for Children Act of 2005 which reauthorizes the Child Care and Development…

Norm Coleman
Sen. Norm ColemanR-MN · Mar 3, 2005

Mr. President, traveling throughout rural Minnesota, I see a very real need for the revitalization and rebuilding of Main Streets, and this is why today I am introducing the Rural Renaissance Act…

Susan M. Collins
Sen. Susan M. CollinsR-ME · Mar 3, 2005

Mr. President, today I am introducing the National Women's History Museum Act of 2005. I appreciate the support of my colleagues who have helped in this important effort and who have agreed to be…

Christopher S. Bond
Sen. Christopher S. BondR-MO · Mar 3, 2005

Mr. President, I introduced S. 503, the Education Begins At Home Act. It is at the desk. It is cosponsored by Senators Talent and DeWine. I invite my colleagues to look at it and join with me in this…

Michael B. Enzi
Sen. Michael B. EnziR-WY · Mar 3, 2005

Mr. President, today I am pleased to be joined by Senators Kennedy, Alexander and Dodd in introducing the ``Caring for Children Act of 2005'' which reauthorizes the Child Care and Development Block…

Chuck Grassley
Sen. Chuck GrassleyR-IA · Mar 3, 2005

Mr. President, America is a nation of sports fans and sports players. In fact, it is hard to imagine something more influential in today's society than athletics. As children, we grow up emulating…

Rick Santorum
Sen. Rick SantorumR-PA · Mar 3, 2005

I rise today to introduce with Senator Rockefeller the bipartisan Fire Sprinkler Incentive Act of 2005. Passage of this Act would serve greatly to help reduce the tremendous annual economic and human…

Tom Harkin
Sen. Tom HarkinD-IA · Mar 3, 2005

Mr. President, today I, along with Senator Smith, introduce the Money Follows the Person Act of 2005. This legislation is needed to truly bring people with disabilities into the mainstream of society…

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Judd Gregg
Sen. Judd GreggR-NH · Mar 3, 2005

Mr. President, today I am pleased to be joined by Senators Kennedy, Mikulski, Harkin, Bingaman, Reed, Murray, Lincoln, Kerry and Durbin in introducing the Public Safety Employer-Employee Cooperation…

Jack Reed
Sen. Jack ReedD-RI · Mar 3, 2005

Mr. President, I am pleased to be joined today by Senators Dodd, Kennedy, and Murray in once again introducing the Child Care Quality Incentive Act, which seeks to redouble our child care efforts and…

Edward M. Kennedy
Sen. Edward M. KennedyD-MA · Mar 3, 2005

Mr. President, it is a privilege to join Senators Hutchinson, Schumer, and Cornyn in introducing the Hepatitis C Epidemic Control and Prevention Act. Our goal is to provide for the prevention,…

Frank R. Lautenberg
Sen. Frank R. LautenbergD-NJ · Mar 3, 2005

Mr. President, the tragic attacks of September 11, 2001 reminded us that police are heroes who risk their lives to protect us. That's why it's so outrageous that a gun manufacturer would design and…

Ken Salazar
Sen. Ken SalazarD-CO · Mar 3, 2005

Mr. President, I rise to introduce a simple piece of legislation. The idea underlying this bill is simple: words matter. How we characterize what we do sends a message, and nowhere is that more clear…

Kay Bailey Hutchison
Sen. Kay Bailey HutchisonR-TX · Mar 3, 2005

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record. Mr. President, I rise today to offer a bill that is vital for water conservation in my home State of Texas.…

Jon Kyl
Sen. Jon KylR-AZ · Mar 3, 2005

Mr. President, I am pleased to join today with Senator McCain to introduce the Yuma Crossing National Heritage Area Boundary Adjustment Act. This legislation would amend the Yuma Crossing National…

Chuck Hagel
Sen. Chuck HagelR-NE · Mar 3, 2005

Mr. President, I rise today with Senator Durbin to introduce the Public Health Preparedness Workforce Development Act of 2005. This legislation aims to increase the pipeline of qualified public…

Jim DeMint
Sen. Jim DeMintR-SC · Mar 3, 2005

Mr. President, I rise today to reintroduce ``Holly's Law,'' a bill that would suspend FDA's approval of RU-486 and direct the GAO to conduct an independent review of the process used by the FDA to…

Kay Bailey Hutchison
Sen. Kay Bailey HutchisonR-TX · Mar 3, 2005

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Bill Text

Latest available legislative text

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Introduced in SenateIssued March 3, 2005

II

109th CONGRESS

1st Session

S. 521

IN THE SENATE OF THE UNITED STATES

March 3, 2005

Mrs. Hutchison (for herself, Mr. Kennedy, Mr. Cornyn, and Mr. Schumer) 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 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.

1.

Short title

This Act may be cited as the Hepatitis C Epidemic Control and Prevention Act.

2.

Findings

Congress makes the following findings:

(1)

Approximately 5,000,000 Americans are infected with the hepatitis C virus (referred to in this section as HCV), and more than 3,000,000 Americans are chronically infected, making HCV the Nation's most common chronic blood borne virus infection.

(2)

Nearly 2 percent of the population of the United States have been infected with HCV.

(3)

Conservative estimates indicate that approximately 30,000 Americans are newly infected with HCV each year, and that number has been growing since 2001.

(4)

HCV infection, in the United States, is the most common cause of chronic liver disease, liver cirrhosis, and liver cancer, the most common indication for liver transplant, and the leading cause of death in people with HIV/AIDS. In addition, there may be links between HCV and certain other diseases, given that a high number of people infected with HCV also suffer from type 2 diabetes, lymphoma, thyroid and certain blood disorders, and autoimmune disease.

(5)

The majority of individuals infected with HCV are unaware of their infection. Individuals infected with HCV serve as a source of transmission to others and, since few individuals are aware they are infected, they 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 that can eradicate the disease in approximately 50 percent of those who are treated, and behavioral changes can slow the progression of the disease.

(8)

Conservative estimates place the costs of direct medical expenses for HCV at more than $1,000,000,000 in the United States annually, and such costs will undoubtedly increase in the absence of expanded prevention and treatment efforts.

(9)

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.

(10)

The Department of Veterans Affairs (referred to in this paragraph as the VA), which cares for more people infected with HCV than any other health care system, is the Nation’s leader in HCV screening, testing, and treatment. Since 1998, it has been the VA’s policy to screen for HCV risk factors all veterans receiving VA health care, and the VA currently recommends testing for all those who are found to be at risk for the virus and for all others who wish to be tested. In fiscal year 2004, over 98 percent of VA patients had been screened for HCV risk factors, and over 90 percent of those at risk were tested. For all veterans who test positive for HCV and enroll in VA medical care, the VA offers medications that can help HCV or its complications. The VA also has programs for HCV patient and provider education, clinical care, data-based quality improvement, and research, and it has 4 Hepatitis C Resource Centers to develop and disseminate innovative practices and tools to improve patient care. This comprehensive program should be commended and could potentially serve as a model for future HCV programs.

(11)

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

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:

R

Prevention, control, and medical management of hepatitis c

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 the hepatitis C virus (referred to in this part as HCV) that 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 Administrator 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 the HCV; and

(ii)

advocates concerned with issues related to HCV.

(c)

Biennial assessment 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 the Hepatitis C Epidemic Control and Prevention Act, 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.

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 healthcare professionals regarding the prevention, detection, and medical management of the hepatitis B virus (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 HBV; 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 a 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 (42 U.S.C. 1320d–2 note)) 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 healthcare services in nonprofit private and public sectors, to—

(i)

provide individuals with information about ongoing risk factors for HCV infection with client-centered education and counseling that 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, HBV, 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 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 HCV

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 healthcare services and groups that may be disproportionately affected by HCV.

(g)

Study and report regarding VA program and Federal plan

(1)

Study

The Secretary shall conduct a study to examine the comprehensive HCV programs that have been implemented by the Department of Veterans Affairs (referred to in this subsection as the VA), including the Hepatitis C Resource Center program, to determine whether any of these programs, or components of these programs, should be part of the Federal plan to combat HCV.

(2)

Report

Not later than 12 months after date of enactment of the Hepatitis C Epidemic Control and Prevention Act, the Secretary shall submit to Congress a report that describes the results of the study required under paragraph (1).

(3)

Consideration of report

The Secretary shall take into consideration the content of the report required under paragraph (2) in conducting the biennial assessment required under section 399AA(c).

(h)

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.

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.

399DD.

Authorization of appropriations

There are authorized to be appropriated to carry out this part $90,000,000 for fiscal year 2006, and such sums as may be necessary for each of fiscal years 2007 through 2010.

.

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:

409J.

Liver Disease Research Advisory Board

(a)

Establishment

Not later than 90 days after the date of enactment of the Hepatitis C Epidemic Control and Prevention Act, 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 (referred to in this subsection as the NIDDK), 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 NIDDK, 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 enactment of the Hepatitis C Epidemic Control and Prevention Act, 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 National Institutes of Health 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 for 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.

.