GENERAL PROVISIONS.

SEC. 401. GENERAL PROVISIONS. Title XXVI of the Public Health Service Act (as added by section 101 and amended by sections 201 and 301) is further amended by adding at the end thereof the following new part: “Part D— General Provisions “SEC. 2671. DEMONSTRATION GRANTS FOR RESEARCH AND SERVICES FOR PEDIATRIC PATIENTS REGARDING ACQUIRED IMMUNE DEFICIENCY SYNDROME. “(a) In General.— The Secretary, acting through the Administrator of the Health Resources and Services Administration and the Director of the National Institutes of Health, shall make demonstration grants to community health centers, and other appropriate public or nonprofit private entities that provide primary health care to the public, for the purpose of— “(1) conducting, at the health facilities of such entities, clinical research on therapies for pediatric patients with HIV disease as well as pregnant women with HIV disease; and “(2) with respect to the pediatric patients who participate in such research, providing health care on an outpatient basis to such patients and the families of such patients. “(b) Minimum Qualifications of Grantees.— The Secretary may not make a grant under subsection (a) unless the health facility operated by the applicant for the grant serves a significant number of pediatric patients and pregnant women with HIV disease. “(c) Cooperation With Biomedical Institutions.— “(1) Design of research protocol.— The Secretary may not make a grant under subsection (a) unless the applicant for the grant— 104 STAT. 618 “(A) has entered into a cooperative agreement or contract with an appropriately qualified entity with expertise in biomedical research under which the entity will assist the applicant in designing and conducting a protocol for the research to be conducted pursuant to the grant; and “(B) agrees to provide the clinical data developed in the research to the Director of the National Institutes of Health. “(2) Analysis and evaluation.— The Secretary, acting through the Director of the National Institutes of Health— “(A) may assist grantees under subsection (a) in designing and conducting protocols described in subparagraph (A) of paragraph (1); and “(B) shall analyze and evaluate the data submitted to the Director pursuant to subparagraph (B) of such paragraph. “(d) Case Management.— The Secretary may not make a grant under subsection (a) unless the applicant for the grant agrees to provide for the case management of the pediatric patient involved and the family of the patient. “(e) Referrals for Additional Services.— The Secretary may not make a grant under subsection (a) unless the applicant for the grant agrees to provide for the pediatric patient involved and the family of the patient— “(1) referrals for inpatient hospital services, treatment for substance abuse, and mental health services; and “(2) referrals for other social and support services, as appropriate. “(f) Incidental Services.— The Secretary may not make a grant under subsection (a) unless the applicant for the grant agrees to provide the family of the pediatric patient involved with such transportation, child care, and other incidental services as may be necessary to enable the pediatric patient and the family of the patient to participate in the program established by the applicant pursuant to such subsection. “(g) Application.— The Secretary may not make a grant under subsection (a) unless an application for the grant is submitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section. “(h) Evaluations.— The Secretary shall, directly or through contracts with public and private entities, provide for evaluations of programs carried out pursuant to subsection (a). “(i) Definition.— For purposes of this section, the term ‘community health center’ has the meaning given such term in section 330(a). “(j) Authorization of Appropriations.—For the purpose of carrying out this section, there are authorized to be appropriated $20,000,000 for fiscal year 1991, and such sums as may be necessary for each of the fiscal years 1992 through 1995. “SEC. 2672. PROVISIONS RELATING TO BLOOD BANKS. “(a) Informational and Training Programs.— The Secretary shall— “(1) develop and make available to technical and supervisory personnel employed at blood banks and facilities that produce blood products, materials and information concerning measures that may be implemented to protect the safety of the blood 104 STAT. 619supply with respect to the activities of such personnel, including— “(A) state-of-the-art diagnostic and testing procedures relating to pathogens in the blood supply; and “(B) quality assurance procedures relating to the safety of the blood supply and of blood products; and “(2) develop and implement a training program that is designed to increase the number of employees of the Department of Health and Human Services who are qualified to conduct inspections of blood banks and facilities that produce blood products. “(b) Updates.— The Secretary shall periodically review and update the materials and information made available under informational or training programs conducted under subsection (a). “(c) Authorization of Appropriations.— There are authorized to be appropriated to carry out this section, $1,500,000 for fiscal year 1991, and such sums as may be necessary in each of the fiscal years 1992 through 1995. “SEC. 2673. RESEARCH, EVALUATION, AND ASSESSMENT PROGRAM. “(a) Establishment.— The Secretary, acting through the Agency for Health Care Policy and Research, shall establish a program to enable independent research to be conducted by individuals and organizations with appropriate expertise in the fields of health, health policy, and economics (particularly health care economics) to develop— “(1) a comparative assessment of the impact and cost-effectiveness of major models for organizing and delivering HIV-related health care, mental health care, early intervention, and support services, that shall include a report concerning patient outcomes, satisfaction, perceived quality of care, and total cumulative cost, and a review of the appropriateness of such models for the delivery of health and support services to infants, children, women, and families with HIV disease; “(2) through a review of private sector financing mechanisms for the delivery of HIV-related health and support services, an assessment of strategies for maintaining private health benefits for individuals with HIV disease and an assessment of specific business practices or regulatory barriers that could serve to reduce access to private sector benefit programs; “(3) an assessment of the manner in which different pointsof-entry to the health care system affect the cost, quality, and outcome of the care and treatment of individuals and families with HIV disease; and “(4) a summary report concerning the major and continuing unmet needs in health care, mental health care, early intervention, and support services for individuals and families with HIV disease in urban and rural areas. “(b) Report.— Not later than 2 years after the date of enactment of this title, and periodically thereafter, the Secretary shall prepare and submit, to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate, a progress report that contains the findings and assessments developed under subsection (a). “(c) Authorization of Appropriations.— There are authorized to be appropriated to carry out this section, such sums as may be necessary for each of the fiscal years 1991 through 1995. 104 STAT. 620 “SEC. 2674. EVALUATIONS AND REPORTS. “(a) Evaluations.— The Secretary shall, directly or through grants and contracts, evaluate programs carried out under this title. “(b) Report to Congress.— The Secretary shall, not later than 1 year after the date on which amounts are first appropriated under this title, and annually thereafter, prepare and submit to the appropriate Committees of Congress a report— “(1) summarizing all of the reports that are required to be submitted to the Secretary under this title; “(2) recommending criteria to be used in determining the geographic areas with the most substantial need for HIV-related health services; “(3) summarizing all of the evaluations carried out pursuant to subsection (a) during the period for which the report under this subsection is prepared; and “(4) making such recommendations for administrative and legislative initiatives with respect to this title as the Secretary determines to be appropriate. “(c) Authorization of Appropriations.— There are authorized to be appropriated to carry out this section, such sums as may be necessary for each of the fiscal years 1991 through 1995. “SEC. 2675. COORDINATION. “(a) Requirement.— The Secretary shall assure that the Health Resources and Services Administration and the Centers for Disease Control will coordinate the planning of the funding of programs authorized under this title to assure that health support services for individuals with HIV disease are integrated with each other and that the continuity of care of individuals with HIV disease is enhanced. In coordinating the allocation of funds made available under this title the Health Resources and Services Administration and the Centers for Disease Control shall utilize planning information submitted to such agencies by the States and entities eligible for support. “(b) Integration by State.— As a condition of receipt of funds under this title, a State shall assure the Secretary that health support services funded under this title will be integrated with each other, that programs will be coordinated with other available programs (including Medicaid) and that the continuity of care of individuals with HIV disease is enhanced. “(c) Integration by Local or Private Entities.— As a condition of receipt of funds under this title, a local government or private nonprofit entity shall assure the Secretary that services funded under this title will be integrated with each other, that programs will be coordinated with other available programs (including Medic-aid) and that the continuity of care of individuals with HIV is enhanced. “SEC. 2676. DEFINITIONS. “For purposes of this title: “(1) Counseling.— The term ‘counseling’ means such counseling provided by an individual trained to provide such counseling. (2) Designated officer of emergency response employees.— The term ‘designated officer of emergency response employees’ means an individual designated under section 26 by the public health officer of the State involved. 104 STAT. 621 “(3) Emergency.— The term ‘emergency’ means an emergency involving injury or illness. “(4) Emergency response employee.— The term ‘emergency response employees’ means firefighters, law enforcement officers, paramedics, emergency medical technicians, and other individuals (including employees of legally organized and recognized volunteer organizations, without regard to whether such employees receive nominal compensation) who, in the course of professional duties, respond to emergencies in the geographic area involved. “(5) Employer of emergency response employees.— The term ‘employer of emergency response employees’ means an organization that, in the course of professional duties, responds to emergencies in the geographic area involved. “(6) Exposed.— The term ‘exposed’, with respect to HIV disease or any other infectious disease, means to be in circumstances in which there is a significant risk of becoming infected with the etiologic agent for the disease involved. “(7) Families with hiv disease.— The term ‘families with HIV disease’ means families in which one or more members have HIV disease. “(8) HIV.— The term ‘HIV’ means infection with the etiologic agent for acquired immune deficiency syndrome. “(9) HIV disease.— The term ‘HIV disease’ means infection with the etiologic agent for acquired immune deficiency syndrome, and includes any condition arising from such syndrome. “(10) Official poverty line.— The term ‘official poverty line’ means the poverty line established by the Director of the Office of Management and Budget and revised by the Secretary in accordance with section 673(a) of the Omnibus Budget Reconciliation Act of 1981. “(11) Person.— The term ‘person’ includes one or more individuals, governments (including the Federal Government and the governments of the States), governmental agencies, political subdivisions, labor unions, partnerships, associations, corporations, legal representatives, mutual companies, joint-stock companies, trusts, unincorporated organizations, receivers, trustees, and trustees in cases under title 11, United States Code. “(12) State.— The term ‘State’, except as otherwise specifically provided, means each of the 50 States, the District of Columbia, the Virgin Islands, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, Puerto Rico, and the Republic of the Marshall Islands.”.