The National Academies: Advisers to the Nation on Science, Engineering, and Medicine
NATIONAL ACADEMY OF SCIENCES NATIONAL ACADEMY OF ENGINEERING INSTITUTE OF MEDICINE NATIONAL RESEARCH COUNCIL
Current Operating Status

The National Academies Testimony before Congress

Public Laws Containing Studies for the National Academies

Briefings to Congress

Congressionally Mandated Reports

Policy Statements and Historical Documents

The OCGA staff

Request a Report (Congressional and Government Staff Only)


Mailing Address:
The Office of Congressional and Government Affairs
The Keck Center of the National Academies
Keck WS1008
500 Fifth Street, NW
Washington, DC 20001
Tel: (202) 334-1601
Fax: (202) 334-2419

Back to Main Page


Title of Law:Ryan White CARE Act Amendments of 2000
Law #:Public Law 106-345
Passed by Congress:106th Congress (2nd Session)

The following are excerpts, highlighted in red, from the final legislation and/or conference report which contain National Academies' studies. (Pound signs [##] between passages denote the deletion of unrelated text.)

S2311 Jeffords (R-Vt.) 10/05/00
Enrolled (finally passed both houses)

To amend the Public Health Service Act to revise and extend programs established under the Ryan White Comprehensive AIDS Resources Emergency Act of 1990, and for other purposes.
--- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- ---

######

Subtitle B-Provisions Concerning Pregnancy and Perinatal Transmission of HIV

Sec. 211. Repeals.

Sec. 212. Grants.

Sec. 213. Study by Institute of Medicine.

######

TITLE V-GENERAL PROVISIONS

Sec. 501. Studies by Institute of Medicine.

Sec. 502. Development of rapid HIV test.

Sec. 503. Technical corrections.

######

Subtitle B-Provisions Concerning Pregnancy and Perinatal Transmission of HIV

######

SEC. 212. GRANTS.

(a) IN GENERAL.-Section 2625(c) of the Public Health Service Act (42 U.S.C. 300ff-33) is amended-

(1) in paragraph (1), by inserting at the end the following subparagraph:

"(F) Making available to pregnant women with HIV disease, and to the infants of women with such disease, treatment services for such disease in accordance with applicable recommendations of the Secretary.";

(2) by amending paragraph (2) to read as follows:

"(2) FUNDING.-

"(A) AUTHORIZATION OF APPROPRIATIONS.-For the purpose of carrying out this subsection, there are authorized to be appropriated $30,000,000 for each of the fiscal years 2001 through 2005. Amounts made available under section 2677 for carrying out this part are not available for carrying out this section unless otherwise authorized.

"(B) ALLOCATIONS FOR CERTAIN STATES.-

"(i) IN GENERAL.-Of the amounts appropriated under subparagraph (A) for a fiscal year in excess of $10,000,000-

"(I) the Secretary shall reserve the applicable percentage under clause (iv) for making grants under paragraph (1) both to States described in clause (ii) and States described in clause (iii); and

"(II) the Secretary shall reserve the remaining amounts for other States, taking into consideration the factors described in subparagraph (C)(iii), except that this subclause does not apply to any State that for the fiscal year involved is receiving amounts pursuant to subclause (I).

"(ii) REQUIRED TESTING OF NEWBORNS.-For purposes of clause (i)(I), the States described in this clause are States that under law (including under regulations or the discretion of State officials) have-

"(I) a requirement that all newborn infants born in the State be tested for HIV disease and that the biological mother of each such infant, and the legal guardian of the infant (if other than the biological mother), be informed of the results of the testing; or

"(II) a requirement that newborn infants born in the State be tested for HIV disease in circumstances in which the attending obstetrician for the birth does not know the HIV status of the mother of the infant, and that the biological mother of each such infant, and the legal guardian of the infant (if other than the biological mother), be informed of the results of the testing.

"(iii) MOST SIGNIFICANT REDUCTION IN CASES OF PERINATAL TRANSMISSION.-For purposes of clause (i)(I), the States described in this clause are the following (exclusive of States described in clause (ii)), as applicable:

"(I) For fiscal years 2001 and 2002, the two States that, relative to other States, have the most significant reduction in the rate of new cases of the perinatal transmission of HIV (as indicated by the number of such cases reported to the Director of the Centers for Disease Control and Prevention for the most recent periods for which the data are available).

"(II) For fiscal years 2003 and 2004, the three States that have the most significant such reduction.

"(III) For fiscal year 2005, the four States that have the most significant such reduction.

"(iv) APPLICABLE PERCENTAGE.-For purposes of clause (i), the applicable amount for a fiscal year is as follows:

"(I) For fiscal year 2001, 33 percent.

"(II) For fiscal year 2002, 50 percent.

"(III) For fiscal year 2003, 67 percent.

"(IV) For fiscal year 2004, 75 percent.

"(V) For fiscal year 2005, 75 percent.

"(C) CERTAIN PROVISIONS.-With respect to grants under paragraph (1) that are made with amounts reserved under subparagraph (B) of this paragraph:

"(i) Such a grant may not be made in an amount exceeding $4,000,000.

"(ii) If pursuant to clause (i) or pursuant to an insufficient number of qualifying applications for such grants (or both), the full amount reserved under subparagraph (B) for a fiscal year is not obligated, the requirement under such subparagraph to reserve amounts ceases to apply.

"(iii) In the case of a State that meets the conditions to receive amounts reserved under subparagraph (B)(i)(II), the Secretary shall in making grants consider the following factors:

"(I) The extent of the reduction in the rate of new cases of the perinatal transmission of HIV.

"(II) The extent of the reduction in the rate of new cases of perinatal cases of acquired immune deficiency syndrome.

"(III) The overall incidence of cases of infection with HIV among women of childbearing age.

"(IV) The overall incidence of cases of acquired immune deficiency syndrome among women of childbearing age.

"(V) The higher acceptance rate of HIV testing of pregnant women.

"(VI) The extent to which women and children with HIV disease are receiving HIV-related health services.

"(VII) The extent to which HIV-exposed children are receiving health services appropriate to such exposure."; and

(3) by adding at the end the following paragraph:

"(4) MAINTENANCE OF EFFORT.-A condition for the receipt of a grant under paragraph (1) is that the State involved agree that the grant will be used to supplement and not supplant other funds available to the State to carry out the purposes of the grant.".

(b) SPECIAL FUNDING RULE FOR FISCAL YEAR 2001.-

(1) IN GENERAL.-If for fiscal year 2001 the amount appropriated under paragraph (2)(A) of section 2625(c) of the Public Health Service Act is less than $14,000,000-

(A) the Secretary of Health and Human Services shall, for the purpose of making grants under paragraph (1) of such section, reserve from the amount specified in paragraph (2) of this subsection an amount equal to the difference between $14,000,000 and the amount appropriated under paragraph (2)(A) of such section for such fiscal year (notwithstanding any other provision of this Act or the amendments made by this Act);

(B) the amount so reserved shall, for purposes of paragraph (2)(B)(i) of such section, be considered to have been appropriated under paragraph(2)(A) of such section; and

(C) the percentage specified in paragraph (2)(B)(iv)(I) of such section is deemed to be 50 percent.

(2) ALLOCATION FROM INCREASES IN FUNDING FOR PART B.-For purposes of paragraph (1), the amount specified in this paragraph is the amount by which the amount appropriated under section 2677 of the Public Health Service Act for fiscal year 2001 and available for grants under section 2611 of such Act is an increase over the amount so appropriated and available for fiscal year 2000.

SEC. 213. STUDY BY INSTITUTE OF MEDICINE.

Subpart II of part B of title XXVI of the Public Health Service Act, as amended by section 211(3), is amended by adding at the end the following section:

"SEC. 2628. RECOMMENDATIONS FOR REDUCING INCIDENCE OF PERINATAL TRANSMISSION.

"(a) STUDY BY INSTITUTE OF MEDICINE.-

"(1) IN GENERAL.-The Secretary shall request the Institute of Medicine to enter into an agreement with the Secretary under which such Institute conducts a study to provide the following:

"(A) For the most recent fiscal year for which the information is available, a determination of the number of newborn infants with HIV born in the United States with respect to whom the attending obstetrician for the birth did not know the HIV status of the mother.

"(B) A determination for each State of any barriers, including legal barriers, that prevent or discourage an obstetrician from making it a routine practice to offer pregnant women an HIV test and a routine practice to test newborn infants for HIV disease in circumstances in which the obstetrician does not know the HIV status of the mother of the infant.

"(C) Recommendations for each State for reducing the incidence of cases of the perinatal transmission of HIV, including recommendations on removing the barriers identified under subparagraph (B).

If such Institute declines to conduct the study, the Secretary shall enter into an agreement with another appropriate public or nonprofit private entity to conduct the study.

"(2) REPORT.-The Secretary shall ensure that, not later than 18 months after the effective date of this section, the study required in paragraph (1) is completed and a report describing the findings made in the study is submitted to the appropriate committees of the Congress, the Secretary, and the chief public health official of each of the States.

"(b) PROGRESS TOWARD RECOMMENDATIONS.-In fiscal year 2004, the Secretary shall collect information from the States describing the actions taken by the States toward meeting the recommendations specified for the States under subsection (a)(1)(C).

"(c) SUBMISSION OF REPORTS TO CONGRESS.-The Secretary shall submit to the appropriate committees of the Congress reports describing the information collected under subsection (b).".

######

TITLE V-GENERAL PROVISIONS

SEC. 501. STUDIES BY INSTITUTE OF MEDICINE.

(a) STATE SURVEILLANCE SYSTEMS ON PREVALENCE OF HIV.-The Secretary of Health and Human Services (referred to in this section as the "Secretary") shall request the Institute of Medicine to enter into an agreement with the Secretary under which such Institute conducts a study to provide the following:

(1) A determination of whether the surveillance system of each of the States regarding the human immunodeficiency virus provides for the reporting of cases of infection with the virus in a manner that is sufficient to provide adequate and reliable information on the number of such cases and the demographic characteristics of such cases, both for the State in general and for specific geographic areas in the State.

(2) A determination of whether such information is sufficiently accurate for purposes of formula grants under parts A and B of title XXVI of the Public Health Service Act.

(3) With respect to any State whose surveillance system does not provide adequate and reliable information on cases of infection with the virus, recommendations regarding the manner in which the State can improve the system.

(b) RELATIONSHIP BETWEEN EPIDEMIOLOGICAL MEASURES AND HEALTH CARE FOR CERTAIN INDIVIDUALS WITH HIV DISEASE.-

(1) IN GENERAL.-The Secretary shall request the Institute of Medicine to enter into an agreement with the Secretary under which such Institute conducts a study concerning the appropriate epidemiological measures and their relationship to the financing and delivery of primary care and health-related support services for low-income, uninsured, and under-insured individuals with HIV disease.

(2) ISSUES TO BE CONSIDERED.-The Secretary shall ensure that the study under paragraph (1) considers the following:

(A) The availability and utility of health outcomes measures and data for HIV primary care and support services and the extent to which those measures and data could be used to measure the quality of such funded services.

(B) The effectiveness and efficiency of service delivery (including the quality of services, health outcomes, and resource use) within the context of a changing health care and therapeutic environment, as well as the changing epidemiology of the epidemic, including determining the actual costs, potential savings, and overall financial impact of modifying the program under title XIX of the Social Security Act to establish eligibility for medical assistance under such title on the basis of infection with the human immunodeficiency virus rather than providing such assistance only if the infection has progressed to acquired immune deficiency syndrome.

(C) Existing and needed epidemiological data and other analytic tools for resource planning and allocation decisions, specifically for estimating severity of need of a community and the relationship to the allocations process.

(D) Other factors determined to be relevant to assessing an individual´s or community´s ability to gain and sustain access to quality HIV services.

(c) OTHER ENTITIES.-If the Institute of Medicine declines to conduct a study under this section, the Secretary shall enter into an agreement with another appropriate public or nonprofit private entity to conduct the study.

(d) REPORT.-The Secretary shall ensure that-

(1) not later than 3 years after the date of the enactment of this Act, the study required in subsection (a) is completed and a report describing the findings made in the study is submitted to the appropriate committees of the Congress; and

(2) not later than 2 years after the date of the enactment of this Act, the study required in subsection (b) is completed and a report describing the findings made in the study is submitted to such committees.

SEC. 502. DEVELOPMENT OF RAPID HIV TEST.

(a) EXPANSION, INTENSIFICATION, AND COORDINATION OF RESEARCH AND OTHER ACTIVITIES.-

(1) IN GENERAL.-The Director of NIH shall expand, intensify, and coordinate research and other activities of the National Institutes of Health with respect to the development of reliable and affordable tests for HIV disease that can rapidly be administered and whose results can rapidly be obtained (in this section referred to as "rapid HIV test").

(2) REPORT TO CONGRESS.-The Director of NIH shall periodically submit to the appropriate committees of Congress a report describing the research and other activities conducted or supported under paragraph (1).

(3) AUTHORIZATION OF APPROPRIATIONS.-For the purpose of carrying out this subsection, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.

(b) PREMARKET REVIEW OF RAPID HIV TESTS.-

(1) IN GENERAL.-Not later than 90 days after the date of the enactment of this Act, the Secretary, in consultation with the Director of the Centers for Disease Control and Prevention and the Commissioner of Food and Drugs, shall submit to the appropriate committees of the Congress a report describing the progress made towards, and barriers to, the premarket review and commercial distribution of rapid HIV tests. The report shall-

(A) assess the public health need for and public health benefits of rapid HIV tests, including the minimization of false positive results through the availability of multiple rapid HIV tests;

(B) make recommendations regarding the need for the expedited review of rapid HIV test applications submitted to the Center for Biologics Evaluation and Research and, if such recommendations are favorable, specify criteria and procedures for such expedited review; and

(C) specify whether the barriers to the premarket review of rapid HIV tests include the unnecessary application of requirements-

(i) necessary to ensure the efficacy of devices for donor screening to rapid HIV tests intended for use in other screening situations; or

(ii) for identifying antibodies to HIV subtypes of rare incidence in the United States to rapid HIV tests intended for use in screening situations other than donor screening.

(c) GUIDELINES OF CENTERS FOR DISEASE CONTROL AND PREVENTION.-Promptly after commercial distribution of a rapid HIV test begins, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish or update guidelines that include recommendations for States, hospitals, and other appropriate entities regarding the ready availability of such tests for administration to pregnant women who are in labor or in the late stage of pregnancy and whose HIV status is not known to the attending obstetrician.

######

RSS News Feed | Subscribe to e-newsletters | Feedback | Back to Top