Health Acts 2000: Summary
The Public Health Improvement Act
February 8, 2001
AFI Health Committee Officers
Representative Garnet Coleman (D-Texas), Chair
Senator Thomas Libous (R-New York), Vice Chair
Senator Nadine Thomas (D-Georgia), Vice Chair
Senator Charles Scott (R-Wyoming), Vice Chair
The Public Health Improvement Act
Table of Contents
I. Emerging Threats to Public Health
II. Clinical Research Enhancement
III. Research Laboratory Infrastructure
IV. Cardiac Arrest Survival
V. Lupus Research and Care
VI. Prostate Cancer Research and Prevention
VII. Organ Procurement and Donation
VIII. Alzheimer's Clinical Research and Training
IX. Sexually Transmitted Disease Clinical Research and Training
X. Miscellaneous Provision
Background
The Public Health Improvement Act is a comprehensive package of public health bills. The Act was signed into law on November 13, 2000 as P.L. 106-505. The Act authorizes funding for a wide range of public health initiatives. The public health community is likely to make the funding of these initiatives a very high priority in the coming months.
Grants to State and Local Governments
State and local public health officials are particularly excited about Title I of the Act, the Public Health Threats and Emergencies Act, which will provide grants to state and local governments to help them prepare for public health emergencies, including emergencies resulting from acts of bioterrorism. Title IV, the Cardiac Arrest Survival Act, provides for grants to community partnerships to increase the number of automated external defibrillators (AEDs) in rural areas. Title V, the Lupus Research Act, authorizes funding for states to develop systems for the delivery of services to individuals with lupus and their families. Finally, Title VI, Prostate Cancer Research and Protection Act, authorizes grants to state and local governments to improve on prostate cancer prevention and treatment efforts.
Brief Summary by Title
Below is a brief summary of the Public Health Improvement Act:
Title I - (S. 2731), the "Public Health Threats and Emergencies Act," strengthens the nation's capacity to detect and respond to serious public health threats, including antimicrobial resistance and bioterrorist attacks.
Title II - S. 1813, the "Clinical Research Enhancement Act," addresses the insufficient support for patient-oriented research by establishing intramural and extramural clinical research fellowship programs and a continuing education clinical research training program at the National Institutes of Health (NIH).
Title III - S. 1268, the "Twenty-First Century Research Laboratories Act," will help improve the infrastructure of research institutions by renovating biomedical and behavioral research facilities through grants from the NIH.
Title IV - Part A - H.R. 2498, the "Cardiac Arrest Survival Act," authorizes the U.S. Department of Health and Human Services (HHS) to make recommendations with respect to the placement of automated external defibrillators (AEDs) in federal buildings. Part B - S. 2528, the "Rural Access to Emergency Devices Act," authorizes HHS to award grants to community partnerships to enable them to purchase (AEDs) for use in rural areas.
Title V - H.R. 762, the "Lupus Research Act," requires the NIH to expand and intensify research and related activities regarding lupus.
Title VI - S. 1243, the "Prostate Cancer Research and Protection Act," expands the authority of the Centers for Disease Control and Prevention (CDC) to carry out activities related to prostate cancer and the NIH to conduct basic and clinical research to combat prostate cancer.
Title VII - S. 2625, the " Organ Procurement Organization Certification Act," requires HHS to change the standards for recertification of Organ Procurement Organizations. Title VII also includes the provisions of S. Res 225, a resolution to designate November 23, 2000, Thanksgiving Day, as a day to "Give Thanks, Give Life" and to discuss organ and tissue donation with other family members.
Titles VIII and Title IX contain provisions, not previously included in legislation to address Alzheimer's disease and to develop treatment for sexually transmitted diseases through NIH research. Title X is a technical amendment to the "Children's Health Act of 2000" which corrects an inaccurate citation to a provision in the Code of Federal Regulations.
Summary of major provisions
- Emerging Threats to Public Health
Public Health Emergencies
The Act authorizes the HHS Secretary to take appropriate actions, if it is determined after consultation with the CDC Director and other public health officials, that: (1) a disease or disorder presents a public health emergency; or (2) a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists. Appropriate actions includes making grants and entering into contracts and conducting and supporting investigations into the cause, treatment, or prevention of a disease or disorder.
The Act establishes a "Public Health Emergency Fund" in the U.S. Treasury that is to be made available to the Secretary, without fiscal year limitation, to carry out appropriate actions if a public health emergency is declared.
The Secretary must submit a report to Congress, no later than 90 days after the end of each fiscal year, describing: (1) the expenditures made from the Fund in such fiscal year; and (2) each public health emergency for which the expenditures were made and the activities undertaken with respect to each emergency which was conducted or supported by expenditures from the Fund.
Authorization
Funds appropriated must to be used to supplement, not supplant other federal, state, and local public funds. The Act authorizes such sums as may be necessary to be appropriated to the Fund.
National Need to Combat Threats to Public Health
Capacities
The Secretary, and other appropriate HHS officials, in collaboration with state and local health officials, are directed to establish, within one year after the date of enactment, reasonable capacities that are appropriate for national, state, and local public health systems and the personnel or work forces of these systems.
The capacities established must improve, enhance or expand the capacity of national, state and local public health agencies to detect and respond effectively to significant public health threats, including major outbreaks of infectious disease, pathogens resistant to antimicrobial agents and acts of bioterrorism. The capacities should include the capacity to:
- recognize the clinical signs and epidemiological characteristics of significant outbreaks of infectious disease;
- identify disease-causing pathogens rapidly and accurately;
- develop and implement plans to provide medical care for persons infected with disease-causing agents and to provide preventive care as needed for individuals likely to be exposed to disease-causing agents;
- communicate information relevant to significant public health threats rapidly to local, State and national health agencies; or
- develop or implement policies to prevent the spread of infectious disease or antimicrobial resistance.
The capacities are to be revised every 10 years, or more frequently if the Secretary deems necessary. The Secretary is to prepare and submit to Congress, within one year of enactment and every 10 years thereafter, a report describing the capacities established.
Technical Assistance
The Secretary is directed to provide technical assistance to the states to assist them in fulfilling the requirements of the Act.
Authorization
Appropriated funds must be used to supplement, not supplant other federal, state, and local public funds. Authorizes appropriations of $4 million in FY 2001 and such sums as may be necessary for each of FY 2002 - FY 2006.
Assessment of Public Health Needs
The Secretary is authorized to award grants to states to perform, in collaboration with local public health agencies, an evaluation to determine the extent to which the states or local public health agencies can achieve the capacities applicable to state and local public health agencies. The Secretary must provide technical assistance to states in addition to awarding grants.
The Act permits states to contract with an outside entity to perform the evaluation. The evaluation is to be completed by using methods, to be developed by the Secretary, in collaboration with state and local health officials, that facilitate the comparison of evaluations conducted by a state to those conducted by other states receiving funds, to the extent practicable. States must prepare and submit to the Secretary a report describing the results of the evaluation no later than one year after the date, the state receives a grant.
Authorization
Funds appropriated must be used to supplement, not supplant other federal, state, and local public funds. Authorizes appropriations of $45 million in FY 2001 and such sums as may be necessary for each of FY 2002 - FY 2003.
Grants to Improve State and Local Public Health Agencies
The Secretary is authorized to award competitive grants to states, local governments, or a consortium of two or more states or local governments, that has completed an evaluation, or an evaluation that is substantially equivalent as determined by the Secretary, to address core public health capacity needs with a particular focus on building capacity to identify, detect, monitor, and respond to threats to the public health.
Grantees may use the funds to:
- train public health personnel;
- develop, enhance, coordinate, or improve participation in an electronic network by which disease detection and public health related information can be rapidly shared among national, regional, state, and local public health agencies and health care providers;
- develop a plan for responding to public health emergencies, including significant outbreaks of infectious diseases or bioterrorism attacks, which is coordinated with the capacities of applicable national, state, local, and national health agencies; and
- enhance laboratory capacity and facilities.
The Secretary is required to prepare and submit to Congress a report that describes the activities carried out under this section of the Act, no later than January 1, 2005.
Authorization
Funds appropriated must to be used to supplement, not supplant other federal, state, and local public funds. Authorizes appropriations of $50 million in FY 2001 and such sums as may be necessary for each of FY 2002 - FY 2006.
Revitalizing the Centers for Disease Control and Prevention
The Act authorizes $180 million in FY 2001 and such sums as may be necessary for each of FY 2002 - FY 2010 for the construction of new facilities and the renovation of existing facilities at CDC, including laboratories, laboratory support buildings, health communication facilities, office buildings and other facilities and infrastructure.
Combating Antimicrobial Resistance
Antimicrobial Resistance Task Force
Directs the Secretary to establish an Antimicrobial Resistance Task Force to provide advice and recommendations to the Secretary and to coordinate federal programs relating to antimicrobial resistance. The Secretary may appoint or select an existing committee, or other organization, to serve as the a task force, if it meets the requirements of the Act..
Directs the task force is to be composed of representatives from the Federal agencies, public health constituencies, manufacturers, medical professional societies and others as determined to be necessary by the Secretary, provide advice and recommendations regarding a comprehensive strategic plan to address the public health threat of antimicrobial resistance. The task force is to convene at least twice annually.
The task force is to consider factors the Secretary considers appropriate, including:
- public health factors contributing to increasing antimicrobial resistance;
- public health needs to detect and monitor antimicrobial resistance;
- detection, prevention, and control strategies for resistant pathogens;
- the need for improved information and data collection;
- the assessment of the risk imposed by pathogens presenting a threat to the public health; and
- any other issues the Secretary determines are relevant to antimicrobial resistance.
The Secretary, in consultation with the task force and State and local public health officials, is directed to develop, improve, coordinate or enhance participation in: (1) a surveillance plan to detect and monitor emerging antimicrobial resistance; and (2) an integrated information system to assimilate, analyze, and exchange antimicrobial resistance data between public health departments.
Research and Development of New Antimicrobial Drugs and Diagnostics
The Secretary and the Director of the Agricultural Research Services, consistent with the task force recommendations, is directed to conduct and support research, investigation, experiments, demonstrations, and studies in the health sciences related to:
- the development of new therapeutics, including vaccines and antimicrobials, against resistant pathogens;
- the development or testing of medical diagnostics to detect pathogens resistant to antimicrobials;
- the epidemiology, mechanisms, and pathogenesis of antimicrobial resistance;
- the sequencing of the genomes of priority pathogens as determined by the NIH Director in consultation with the task force established
- other relevant research areas.
Education of Medical and Public Health Personnel
Directs the Secretary, after consultation with the Surgeon General, the CDC Director, the HRSA Administrator, the Director of the Agency for Healthcare Research and Quality (AHRQ), members of the task force, and professional organizations and societies, to develop and implement:
- educational programs to increase the awareness of the general public with respect to the public health threat of antimicrobial resistance and the appropriate use of antibiotics;
- educational programs to instruct health care professionals in the prudent use of antibiotics; and
- programs to train laboratory personnel in the recognition or identification of resistance in pathogens.
Grants
Authorizes the Secretary to award competitive grants to state and local health agencies, Indian tribes, and tribal organizations, to enable them to increase their capacity to detect, monitor, and combat antimicrobial resistance. Funds may be used to:
- provide training to enable such entity to identify patterns of resistance rapidly and accurately;
- develop, improve, coordinate or enhance participation in information systems by which data on resistant infections can be shared rapidly among relevant national, State, and local health agencies and health care providers; and
- develop and implement policies to control the spread of antimicrobial resistance.
Grants for Demonstration Programs
Directs the Secretary to award competitive grants to hospitals, clinics, institutions of long-term care, professional medical societies, or other public or private nonprofit to establish demonstration programs to promote the judicious use of antimicrobial drugs or control the spread of antimicrobial-resistant pathogens.
Authorization
Authorizes appropriations of $40 million in FY 2001 and such sums as may be necessary in FY 2002 - FY 2006. Funds must be used to supplement, not supplant other federal, state, and local public funds provided for these.
Public Health Countermeasures to a Bioterrorist Attack
Working Group on Preparedness for Acts of Bioterrorism
Directs the Secretary, in coordination with the Secretary of Defense, to establish a joint interdepartmental working group on preparedness and readiness for the medical and public health effects of a bioterrorist attack on the civilian population. This joint working group will:
- coordinate research on pathogens likely to be used in a bioterrorist attack on the civilian population as well as therapies to treat such pathogens;
- coordinate research and development into equipment to detect pathogens likely to be used in a bioterrorist attack on the civilian population and protect against infection from such pathogens;
- develop shared standards for equipment to detect and to protect against infection from pathogens likely to be used in a bioterrorist attack on the civilian population; and
- coordinate the development, maintenance, and procedures for the release of, strategic reserves of vaccines, drugs, and medical supplies which may be needed rapidly after a bioterrorist attack upon the civilian population.
Working Group On The Public Health And Medical Consequences Of Bioterrorism
Directs the Secretary, in collaboration with the Director of the Federal Emergency Management Agency and the Attorney General, to establish a joint interdepartmental working group to address the public health and medical consequences of a bioterrorist attack on the civilian population.
Directs the Comptroller General to submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Commerce of the House of Representatives a report that describes--
- Federal activities primarily related to research on, preparedness for, and the management of the public health and medical consequences of a bioterrorist attack against the civilian population;
- the coordination of the activities
- the amount of Federal funds authorized or appropriated for the activities and
- the effectiveness of such efforts in preparing national, State, and local authorities to address the public health and medical consequences of a potential bioterrorist attack against the civilian population, not later than 180 days after the date of enactment of this section.
Requires funds appropriated under this section to be used to supplement and not supplant other federal, state, and local public funds provided for activities under this section. Authorizes to be appropriated to carry out this section such sums as may be necessary for each of the fiscal years 2001 through 2000.
Grants to Increase Capacity to Detect, Diagnose, and Respond to Acts of Terrorism
The Secretary, in coordination with the Working Group on the Public Health and Medical Consequences of Bioterrorism, is directed to award grants, on a competitive basis, to states, local governments, a consortium of two or more states or local governments, a hospital, clinic, or primary care facility, to increase their capacity to detect, diagnose, or respond to acts of bioterrorism.
The funds may be used to:
- train health care professionals and public health personnel to recognize the symptoms and epidemiological characteristics of exposure to a potential bioweapon;
- address rapid and accurate identification of potential bioweapons;
- coordinate medical care for individuals exposed to bioweapons; and
- facilitate and coordinate rapid communication of data generated from a bioterrorist attack between national, state, and local health agencies, and health care providers.
The Secretary must notify the Director of the Office of Justice Programs and the Director of the National Domestic Preparedness Office annually regarding the status and amount of grants awarded. The Office of Emergency Preparedness and the CDC to improve the capacity of health care providers and public health agencies to respond to bioterrorist attacks to coordinates the grants. Grantees are to coordinate activities with the local Metropolitan Medical Response System to the greatest extent practicable.
Federal Assistance
Directs the Secretary to ensure that HHS is able to provide whatever assistance may be needed by sate and local government agencies to enable them to effectively respond to a bioterrorist attack.
Education
The Secretary, in collaboration with member of the Working Group on the Public Health and Medical Consequences o Bioterrorism, professional organizations and societies, is to develop and implement: (1) educational programs to instruct public health officials, medical professionals, and other working in health facilities to recognize and care for victims of bioterrorism attacks; and ( personnel in the recognition and care of victims of bioterrorism attacks.
Future Resource Development
Directs the Secretary, in collaboration with the Working Group on Preparedness for Acts of Bioterrorism, to develop priorities and conduct research, investigations, experiments, demonstrations related to: (1) the epidemiology and pathogenesis of potential bioweapons, and (2) the development of appropriate vaccines, medical diagnostics, and therapeutic agents.
Report
Requires General Accounting Office (GAO) to submit to a report to Congress describing the federal activities related to research on, preparedness for, and management of the public health and medical consequences of a bioterrorist attack, the coordination of these activities, the federal funds authorized or appropriated for these activities, and the effectiveness of the efforts.
Authorization
Authorizes $215 million in FY 2001 and such sums as may be necessary in FY 2002 - FY 2006. Appropriated funds must supplement, not supplant other federal, state or local public funds provided for these activities.
Demonstration Program to Enhance Bioterrorism Training, Coordination, and Readiness
Directs the Secretary to make up to three competitive grants to states, local governments, or public or private non-profit entities to carry out demonstration programs to improve: (1) the development of plans and measures to respond to bioterrorist attacks, and (2) the training of personnel involved with the various responsibilities and capabilities needed to respond to acts of bioterrorism.
The Secretary must consider whether the prospective grantee:
- is proximate to, and collaborates with, a major research university with expertise in scientific training, identification of biological agents, medicine, and life sciences;
- is proximate to, and collaborates with, a laboratory that has expertise in the identification of biological agents;
- demonstrates, in the application, support and participation of state and local governments and research institutions in the conduct of the program;
- is proximate to, and collaborates with, or is, an academic medical center that has the capacity to serve an uninsured or underserved population, and is equipped to educate medical personnel;
The grant period cannot exceed five years. The GAO is directed to submit a report to Congress no later than 6 months after the conclusion of the demonstration programs. The report is to describe the ability of grantees to carryout the goals of the demonstration program.
Authorization
Authorizes appropriations of $6 million in FY 2001 and such sums as may be necessary for FY 2002 - FY 2006. Appropriated funds must supplement, not supplant other federal, state and local government funds provided for these activities.
- Clinical Research Enhancement
Increasing the Involvement of the National Institutes of Health in Clinical Research
Directs the NIH Director to undertake activities to support and expand the involvement of NIH in clinical research. The GAO is required to submit a report to Congress describing the extent to which NIH has complied with the amendments made by this Title within 18 months after the date of enactment.
Clinical Research
The Director of the National Center for Research Resources is authorized to award grants for the establishment of general clinical research centers to provide the infrastructure for clinical research including clinical research training and career enhancement. These centers will support clinical studies and career development in all settings of the hospital or academic medical center. The NIH Director is authorized to make the following awards:
- "Mentored Patient-Oriented Research Career Development Awards" - supports individual careers in clinical research at general clinical research centers or at other institutions that have the infrastructure and resources deemed appropriate for conducting patient-oriented clinical research.
- "Mid-Career Investigator Awards in Patient- Oriented Research." - supports individual clinical research projects at general clinical research centers or at other institutions that have the infrastructure and resources deemed appropriate for conducting patient-oriented clinical research.
- "Graduate Training in Clinical Investigation Awards" - supports individuals pursuing master's or doctoral degrees in clinical investigation.
- "Clinical Research Curriculum Awards" - supports institutions for the development and support of programs of core curricula for training clinical investigators, including medical students grants.
Loan Repayment Program for Clinical Researchers
The Secretary, acting through the NIH Director, is authorized to establish a program to enter into contracts with qualified health professionals under which such health professionals agree to conduct clinical research, in consideration of the federal government agreeing to repay not more than $35,000 of the principal and interest of their educational loans, for each year of service conducting research.
Authorization
Authorizes appropriations of such sums as may be necessary for each fiscal year.
- Research Laboratory Infrastructure
Biomedical and Behavioral Research Facilities
Authorizes the NIH Director, acting through the Director of the National Center for Research Resources, to make grants or contracts to public and nonprofit private entities to expand, remodel, renovate, or alter existing research facilities or construct new research facilities.
Establishes within the Center a Scientific and Technical Review Board on Biomedical and Behavioral Research Facilities. Authorizes the Center Director to approve an application for a grant only if the Board has recommended the application for approval.
Institutions of Emerging Excellence
To support Institutions of Emerging Excellence, the Act provides that from the amounts up to $50 million appropriated for this section, that the Center Director make available 25 percent of those funds for these institutions. From appropriations that exceed $50 million, the Center Director is to make available 25 percent of that amount for these institutions.
The Director of the Center must prepare and submit to Congress a biennial report concerning the status of the biomedical and behavioral research facilities and the availability and condition of technologically sophisticated laboratory equipment in the United States. These reports are to be developed in concert with the report prepared by the National Science Foundation on the needs of research facilities of universities.
Authorization
Authorizes appropriations of $250 million for fiscal year 2001, and such sums as may be necessary for each of FY 2002 and FY 2003.
Construction Program for the National Primate Research Centers
The Act reauthorizes and extends the construction programs for the regional primate research centers.
Shared Instrument Grant Program
The Act permanently reauthorizes the Shared Instrumentation Grant Program and authorizes appropriations of $100 million for FY 2000, and such sums as may be necessary for each subsequent fiscal year, to enable the Secretary, acting through the Director of the National Center for Research Resources, to provide for the continued operation of the program.
- Cardiac Arrest Survival
Recommendations and Guidelines for Federal Buildings
Authorizes the Secretary to establish guidelines with respect to the placement of automated external defibrillator devices (AEDs) in federal buildings. The guidelines are to take into account the:
- extent to which the devices may be used by lay persons;
- typical number of employees and visitors in the buildings;
- extent of the need for security measures regarding the buildings, buildings or portions of buildings in which there are special circumstances such as high electrical voltage or extreme heat or cold; and
- other factors the Secretary determines to be appropriate.
The Secretary must publish the recommendations of the Secretary on the appropriate implementation of the placement of automated external defibrillator devices in the Federal Register. The recommendations must include procedures for:
- Implementing appropriate training courses in the use of such devices, including the role of cardiopulmonary resuscitation
- Maintaining and testing of devices;
- Ensuring coordination with the appropriate licensed professionals in the oversight of training; and
- Ensuring coordination with local emergency medical systems regarding the placement and incidents of use of the devices.
The Secretary must: (1) consult with the appropriate public and private entities; (2) consider the recommendations of national and local public health organizations for improving the survival rates of individuals who experience cardiac arrest in non-hospital settings by minimizing the time elapsing between the onset of cardiac arrest and the initial medical response, including defibrillation as necessary; and (3) consult with and counsel other federal agencies where the devices are to be used. The Secretary must comply with this section within 180 days after the date of enactment.
Good Samaritan Protections
Any person who uses or attempts to use an AED device on a victim of a perceived medical emergency is immune from civil liability for any harm resulting from the use or attempted use of the device. Any person who acquired the device is immune from liability if the harm was not due to failure of such acquirer of the device to:
- notify local emergency response personnel or other appropriate entities of the most recent placement of the device within a reasonable period of time after the device was placed;
- properly maintain and test the device; and
- provide appropriate training in the use of the device to an employee or agent of the acquirer when the employee or agent was the person who used the device on the victim, except that the training requirement does not apply if:
- the employee or agent was not an employee or agent who would have been reasonably expected to use the device; or
- the period of time elapsing between the engagement of the person as an employee or agent and the occurrence of the harm (or between the acquisition of the device and the occurrence of the harm was not a reasonably sufficient period in which to provide the training.
Provides that immunity does not apply to a person if:
- the harm involved was caused by willful or criminal misconduct, gross negligence, reckless misconduct, or a conscious, flagrant indifference to the rights or safely of the victim who was harmed;
- the person is a licensed or certified health professional who used the AED device while acting within the scope of the license or certification of the professional and within the scope of the employment or agency of the professional;
- the person is a hospital, clinic, or other entity whose purpose is providing health care directly to patient, and the harm was caused by an employee or agent of the entity who used the device while acting within the scope of the employment or agency of the employee or agent;
- the person leased the device to a health care entity ( or who otherwise provided the device to the entity for compensation without selling the device to the entity) and the harm was caused by an employee or agent of the entity who used the device while acting within the scope of the employment of agency of the employee or agent.
This section does not establish any cause of action, or require that an AED device be placed at any building or other location.
Good Samaritan Provisions and State Law
For individuals who are provided immunity from civil liability , this section supersedes sate law only to the extent that the state has no statute or regulations that provide persons in with immunity for civil liability arising from the use of AED devices in emergency situations.
Civil Actions under Federal Law
Additional existing protections from liability for federal employees are not affected by this Act, including those in the Federal Tort Claims Act. However, the additional protections provided by this Act do apply to any action for civil liability arising under Federal law.
Federal Areas Adopting State Law
The protections also apply to users and acquirers in military bases and other Federal jurisdictions that have adopted the laws of a surrounding State regarding matters where no other applicable Federal law exists.
Federal Jurisdiction
Directs that with any civil action arising under State law, the courts of the State involved have jurisdiction to apply the provisions of this section exclusive of the jurisdiction of the courts of the United States.
Rural Access to Emergency Devices
Grants
The Secretary, acting through the Rural Health Outreach Office of the Health Resources and Services Administration (HRSA) is authorized to award grants to community partnerships to purchase automated external defibrillators that have been approved for marketing by the FDA and to provide defibrillator and basic life support training in AED usage through a nationally recognized training course. Community partnerships must be composed of local emergency response entities concerned about cardiac arrest survival rates; and must evaluate the local community emergency response times to assess whether they meet they meet the standards established by national public health organizations.
Authorization
Authorizes appropriations of $25,000,000 for FY 2001- FT 2003.
- Lupus Research and Care
Directs the NIH Director to expand and intensify research and related activities of the NIH with respect to lupus. Directs the NIH Director to coordinate the activities of the Director's Office with similar activities conducted by the other national research institutes and agencies of the NIH to the extent that they have responsibilities that are related to lupus. Authorizes to be appropriated such sums as may be necessary for each of the FY 2001 - FY 2003.
Research
Authorizes the NIH Director to conduct or support research to expand the understanding of the causes of, and to find a cure for, lupus. Activities must include conducting and supporting the following:
- Research to determine the reasons underlying the elevated prevalence of lupus in women, including African- American women.
- Basic research concerning the etiology and causes of the disease.
- Epidemiological studies to address the frequency and natural history of the disease and the differences among the sexes; and among racial and ethnic groups with respect to the disease.
- The development of improved diagnostic techniques.
- Clinical research for the development and evaluation of new treatments, including new biological agents.
- Information and education programs for health care professionals and the public.
Authorization
Authorizes to be appropriated such sums as may be necessary for each of FY 2001 - FY 2003.
Service Delivery
Grants
Authorizes grants to a state or local government; a public or nonprofit private hospital, community-based organization, hospice, ambulatory care facility, community health center, migrant health center, or homeless health center; or other appropriate public or nonprofit private entity, for projects for the establishment, operation, and coordination of effective and cost-efficient systems for the delivery of essential services to individuals with lupus and their families.
Grantees may use the funding to:
- Deliver or enhance outpatient, ambulatory, and home-based health and support services, including case management and comprehensive treatment services, for individuals with lupus; and delivering or enhancing support services for their families;
- Deliver or enhance inpatient care management services that prevent unnecessary hospitalization or that expedite discharge, as medically appropriate, from inpatient facilities of individuals with lupus; and
- Improve the quality, availability, and organization of health care and support services (including transportation services, attendant care, homemaker services, day or respite care, and providing counseling on financial assistance and insurance) for individuals with lupus and support services for their families.
The Secretary is directed to ensure that this program is integrated with other HHS-supported programs. In addition, for funding to be considered, grantees must agree to:
- limit administrative cost to not more than five percent of the grant;
- use the grant funds to supplement, not supplant funds from other sources related to the treatment of lupus;
- abide by any limitations deemed appropriate by the Secretary on any charges to individuals receiving services pursuant to the grant. As deemed appropriate by the Secretary, limitations on charges may vary based on the financial circumstances of the individual receiving services.
- not be expend grant funds to make payment for services to the extent that payment has been made, or can reasonably be expected to be made, under any state compensation program, under an insurance policy, or under any federal or state health benefits program; or by an entity that provides health services on a prepaid basis.
- post a conspicuous notice informing individuals who receive the services of any Federal policies that apply to the applicant with respect to the imposition of charges on the individual.
Technical Assistance
Authorizes the Secretary to provide technical assistance to assist entities in complying with the requirements of this section.
Authorization
Authorizes to be appropriated such sums as may be necessary for each of FY 2001 - FY 2003.
- Prostate Cancer Research and Prevention
Grants to State and Local Health Departments
Authorizes the Secretary, acting through the CDC Director, to make grants to states and local health departments for the purpose of enabling such States and departments to carry out programs that may:
- identify factors that influence the attitudes or levels of awareness of men and health care practitioners regarding screening for prostate cancer.
- evaluate, in consultation with the Agency for Health Care Policy and Research and the National Institutes of Health, the effectiveness of screening strategies for prostate cancer.
- identify, in consultation with the Agency for Health Care Policy and Research, issues related to the quality of life for men after prostrate cancer screening and follow-up.
- develop and disseminate public information and education programs for prostate cancer, including appropriate messages about the risks and benefits of prostate cancer screening for the general public, health care providers, policy makers and other appropriate individuals.
- improve surveillance for prostate cancer.
- address the needs of underserved and minority populations regarding prostate cancer.
- Upon determination by the Secretary about the effectiveness of prostate cancer screening, grantees may:
- screen men for prostate cancer as a preventive measure;
- provide referrals for medical treatment of men who were screened under this program, and to ensure to the extent practicable, the provision of follow-up and support services;
- establish mechanisms through which state and local health departments can monitor the quality of screening procedures for prostate cancer; and
- improve, in consultation with HRSA, the education, training and skills of health practitioners in the detection and control of prostate cancer.
- Organ Procurement and Donation
Organ Procurement Organization Certification
The Act requires organ procurement organizations to have been certified or recertified, meeting performance standards established by the Secretary within the past four years. Organ procurement organizations that currently require certification or recertification must obtain certification through the process which was in place as of January 1, 2000 and remains in effect through January 1, 2002.
The Secretary is directed to establish a new certification process in regulations no later than January 1, 2002. If the regulations are promulgated prior to the January 2002 deadline, it will supercede any interim certification or recertification process.
Give Thanks, Give Life Day
Established November 23, 2000, Thanksgiving Day, to be designated as a day to ``Give Thanks, Give Life'' and to discuss organ and tissue donation with other family members so that informed decisions can be made if the occasion to donate arises.
- Alzheimer's Clinical Research and Training
Authorizes the NIH Director to establish and maintain a program to enhance and promote the translation of new scientific knowledge into clinical practice related to the diagnosis, care and treatment of individuals with Alzheimer's. Authorizes $2.25 million in FY 2001 and such sums as may be necessary in FY 2002 - FY 2005.
- Sexually Transmitted Disease Clinical Research and Training
Authorizes the NIH Director to establish and maintain a program to enhance and promote the translation of new scientific knowledge into clinical practice related to the diagnosis, care and treatment of individuals with sexually transmitted diseases. Authorizes $2.25 million in FY 2001 and such sums as may be necessary in FY 2002 - FY 2005.
- Miscellaneous Provision
A technical amendment to the Children's Health Act (P.L. 106-310).
Vital Statistics
The Public Health Improvement Act of 2000 is an omnibus health bill that is a compilation of several free-standing bills in addition to some provisions that were added to the package at the last minute that were not previously in the form of a bill. Below is a summary of the bills that were incorporated in the Act.
Title I - The Public Health Threats and Emergencies Act was introduced as S. 2731 by Senator Bill Frist of Tennessee.
Title II - The Clinical Research Enhancement Act was introduced as H.R. 1798 by Representative James Greenwood of Pennsylvania and as S. 1813 by Senator Edward Kennedy of Massachusetts.
Title III - The Twenty-First Century Research Laboratories Act was introduced as S. 1268 by Senator Tom Harkin of Iowa.
Title IV - Cardiac Arrest Survival. The Cardiac Arrest Survival Act of 2000 was introduced as H.R. 2498 by Representative Cliff Stearns of Florida. The Rural Access to Emergency Devices Act or the Rural AED Act was introduced as S. 2528 by Senator Susan Collins of Maine and as H.R. 4953 by Representative Ron Kind of Wisconsin.
Title V - The Lupus Research and Care Act of 2000 was introduced as H.R. 762 by Representative Carrie Meek of Florida.
Title VI - The Prostate Cancer Research and Prevention Act was introduced as S. 1243 by Senator Bill Frist of Tennessee.
Title VII - Organ Procurement and Donation was introduced as S. 2625 by Senator Susan Collins of Maine. Senator Richard Durbin of Illinois introduced S. Res. 225 establishing the "Give Thanks, Give Life" day.
Title VIII and Title IX - The Alzheimer's Clinical Research and Training Act and the Sexually Transmitted Disease Clinical Research and Training Act had not been previously introduced.
This summary is an information service provided by NCSL's Assembly on Federal Issues' Health Committee. For more up-to-date information on federal issues, visit our website at: http://www.ncsl.org/statefed/afihlth.htm
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