S 2311 IS

To revise and extend the Ryan White CARE Act programs under title XXVI of the Public Health Service Act, to improve access to health care and the quality of care under such programs, and to provide for the development of increased capacity to provide health care and related support services to individuals and families with HIV disease, and for other purposes.

March 29, 2000

Mr. JEFFORDS (for himself, Mr. KENNEDY, Mr. FRIST, Mr. HATCH, Mr. DODD, Mr. ENZI, Mr. HARKIN, Ms. MIKULSKI, Mr. BINGAMAN, Mr. WELLSTONE, Mr. REED, Mr. BIDEN, and Mr. DURBIN) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

To revise and extend the Ryan White CARE Act programs under title XXVI of the Public Health Service Act, to improve access to health care and the quality of care under such programs, and to provide for the development of increased capacity to provide health care and related support services to individuals and families with HIV disease, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the `Ryan White CARE Act Amendments of 2000'.

SEC. 2. REFERENCES; TABLE OF CONTENTS.

(a) REFERENCES- Except as otherwise expressly provided, whenever in this Act an amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference shall be considered to be made to a section or other provision of the Public Health Service Act (42 U.S.C. 201 et seq.).

(b) Table of Contents- The table of contents of this Act is as follows:

Sec. 1. Short title.

Sec. 2. References; table of contents.

TITLE I--AMENDMENTS TO HIV HEALTH CARE PROGRAM

Subtitle A--Purpose; Amendments to Part A (Emergency Relief Grants)

Sec. 101. Duties of planning council, funding priorities, quality assessment.

Sec. 102. Quality management.

Sec. 103. Funded entities required to have health care relationships.

Sec. 104. Support services required to be health care-related.

Sec. 105. Use of grant funds for early intervention services.

Sec. 106. Replacement of specified fiscal years regarding the sunset on expedited distribution requirement.

Sec. 107. Hold harmless provision.

Sec. 108. Set-aside for infants, children, and women.

Subtitle B--Amendments to Part B (Care Grant Program)

Sec. 121. State requirements concerning identification of need and allocation of resources.

Sec. 122. Quality management.

Sec. 123. Funded entities required to have health care referral relationships.

Sec. 124. Support services required to be health care-related.

Sec. 125. Use of grant funds for early intervention services.

Sec. 126. Authorization of appropriations for HIV-related services for women and children.

Sec. 127. Repeal of requirement for completed Institute of Medicine report.

Sec. 130. Supplement grants for certain States.

Sec. 131. Use of treatment funds.

Sec. 132. Increase in minimum allotment.

Sec. 133. Set-aside for infants, children, and women.

Subtitle C--Amendments to Part C (Early Intervention Services)

Sec. 141. Amendment of heading; repeal of formula grant program.

Sec. 142. Planning and development grants.

Sec. 143. Authorization of appropriations for categorical grants.

Sec. 144. Administrative expenses ceiling; quality management program.

Sec. 145. Preference for certain areas.

Subtitle D--Amendments to Part D (General Provisions)

Sec. 151. Research involving women, infants, children, and youth.

Sec. 152. Limitation on administrative expenses.

Sec. 153. Evaluations and reports.

Sec. 154. Authorization of appropriations for grants under parts A and B.

Subtitle E--Amendments to Part F (Demonstration and Training)

Sec. 161. Authorization of appropriations.

TITLE II--MISCELLANEOUS PROVISIONS

Sec. 201. Institute of Medicine study.

TITLE I--AMENDMENTS TO HIV HEALTH CARE PROGRAM

Subtitle A--Purpose; Amendments to Part A (Emergency Relief Grants)

SEC. 101. DUTIES OF PLANNING COUNCIL, FUNDING PRIORITIES, QUALITY ASSESSMENT.

Section 2602 (42 U.S.C. 300ff-12) is amended--

(1) in subsection (b)--

(A) in paragraph (2)(C), by inserting before the semicolon the following: `, including providers of housing and homeless services'; and

(B) in paragraph (4), by striking `shall--' and all that follows and inserting `shall have the responsibilities specified in subsection (d).'; and

(2) by adding at the end the following:

`(d) DUTIES OF PLANNING COUNCIL- The planning council established under subsection (b) shall have the following duties:

`(1) PRIORITIES FOR ALLOCATION OF FUNDS- The council shall establish priorities for the allocation of funds within the eligible area, including how best to meet each such priority and additional factors that a grantee should consider in allocating funds under a grant, based on the following factors:

`(A) The size and demographic characteristics of the population with HIV disease to be served, including, subject to subsection (e), the needs of individuals living with HIV infection who are not receiving HIV-related health services.

`(B) The documented needs of the population with HIV disease with particular attention being given to disparities in health services among affected subgroups within the eligible area.

`(C) The demonstrated or probable cost and outcome effectiveness of proposed strategies and interventions, to the extent that data are reasonably available.

`(D) Priorities of the communities with HIV disease for whom the services are intended.

`(E) The availability of other governmental and non-governmental resources, including the State medicaid plan under title XIX of the Social Security Act and the State Children's Health Insurance Program under title XXI of such Act to cover health care costs of eligible individuals and families with HIV disease.

`(F) Capacity development needs resulting from gaps in the availability of HIV services in historically underserved low-income communities.

`(2) COMPREHENSIVE SERVICE DELIVERY PLAN- The council shall develop a comprehensive plan for the organization and delivery of health and support services described in section 2604. Such plan shall be compatible with any existing State or local plans regarding the provision of such services to individuals with HIV disease.

`(3) ASSESSMENT OF FUND ALLOCATION EFFICIENCY- The council shall assess the efficiency of

the administrative mechanism in rapidly allocating funds to the areas of greatest need within the eligible area.

`(4) STATEWIDE STATEMENT OF NEED- The council shall participate in the development of the Statewide coordinated statement of need as initiated by the State public health agency responsible for administering grants under part B.

`(5) COORDINATION WITH OTHER FEDERAL GRANTEES- The council shall coordinate with Federal grantees providing HIV-related services within the eligible area.

`(6) COMMUNITY PARTICIPATION- The council shall establish methods for obtaining input on community needs and priorities which may include public meetings, conducting focus groups, and convening ad-hoc panels.

`(e) PROCESS FOR ESTABLISHING ALLOCATION PRIORITIES-

`(1) IN GENERAL- Not later than 24 months after the date of enactment of the Ryan White CARE Act Amendments of 2000, the Secretary shall--

`(A) consult with eligible metropolitan areas, affected communities, experts, and other appropriate individuals and entities, to develop epidemiologic measures for establishing the number of individuals living with HIV disease who are not receiving HIV-related health services; and

`(B) provide advice and technical assistance to planning councils with respect to the process for establishing priorities for the allocation of funds under subsection (d)(1).

`(2) EXCEPTION- Grantees under subsection (d)(1)(A) shall not be required to establish priorities for individuals not in care until epidemiologic measures are developed under paragraph (1).'.

SEC. 102. QUALITY MANAGEMENT.

(a) FUNDS AVAILABLE FOR QUALITY MANAGEMENT- Section 2604 (42 U.S.C. 300ff-14) is amended--

(1) by redesignating subsections (c) through (f) as subsections (d) through (g), respectively; and

(2) by inserting after subsection (b) the following:

`(c) QUALITY MANAGEMENT-

`(1) REQUIREMENT- The chief elected official of an eligible area that receives a grant under this part shall provide for the establishment of a quality management program to assess the extent to which medical services provided to patients under the grant are consistent with the most recent Public Health Service guidelines for the treatment of HIV disease and related opportunistic infection and to develop strategies for improvements in the access to and quality of medical services.

`(2) USE OF FUNDS- From amounts received under a grant awarded under this part, the chief elected official of an eligible area may use, for activities associated with its quality management program, not more than the lesser of--

`(A) 5 percent of amounts received under the grant; or

`(B) $3,000,000.'.

(b) QUALITY MANAGEMENT REQUIRED FOR ELIGIBILITY FOR GRANTS- Section 2605(a) (42 U.S.C. 300ff-15(a)) is amended--

(1) by redesignating paragraphs (3) through (6) as paragraphs (5) through (8), respectively; and

(2) by inserting after paragraph (2) the following:

`(3) that the chief elected official of the eligible area will satisfy all requirements under section 2604(c);'.

SEC. 103. FUNDED ENTITIES REQUIRED TO HAVE HEALTH CARE RELATIONSHIPS.

(a) USE OF AMOUNTS- Section 2604(e)(1) (42 U.S.C. 300ff-14(d)(1)) (as so redesignated by section 102(a)) is amended by inserting `and the State Children's Health Insurance Program under title XXI of such Act' after `Social Security Act'.

(b) APPLICATIONS- Section 2605(a) (42 U.S.C. 300ff-15(a)) is amended by inserting after paragraph (3), as added by section 102(b), the following:

`(4) that funded entities within the eligible area that receive funds under a grant under section 2601(a) shall maintain appropriate relationships with entities in the area served that constitute key points of access to the health care system for individuals with HIV disease (including emergency rooms, substance abuse treatment programs, detoxification centers, adult and juvenile detention facilities, sexually transmitted disease clinics, HIV counseling and testing sites, and homeless shelters) and other entities under section 2652(a) for the purpose of facilitating early intervention for individuals newly diagnosed with HIV disease and individuals knowledgeable of their status but not in care;'.

SEC. 104. SUPPORT SERVICES REQUIRED TO BE HEALTH CARE-RELATED.

(a) IN GENERAL- Section 2604(b)(1) (42 U.S.C. 300ff-14(b)(1)) is amended--

(1) in the matter preceding subparagraph (A), by striking `HIV-related--' and inserting `HIV-related services, as follows:';

(2) in subparagraph (A)--

(A) by striking `outpatient' and all that follows through `substance abuse treatment and' and inserting the following: `OUTPATIENT HEALTH SERVICES- Outpatient and ambulatory health services, including substance abuse treatment,'; and

(B) by striking `; and' and inserting a period;

(3) in subparagraph (B), by striking `(B) inpatient case management' and inserting `(C) INPATIENT CASE MANAGEMENT SERVICES- Inpatient case management'; and

(4) by inserting after subparagraph (A) the following:

`(B) OUTPATIENT SUPPORT SERVICES- Outpatient and ambulatory support services (including case management), to the extent that such services facilitate, enhance, support, or

sustain the delivery, continuity, or benefits of health services for individuals and families with HIV disease.'.

(b) CONFORMING AMENDMENT TO APPLICATION REQUIREMENTS- Section 2605(a) (42 U.S.C. 300ff-15(a)), as amended by section 102(b), is further amended--

(1) in paragraph (6) (as so redesignated), by striking `and' at the end thereof;

(2) in paragraph (7) (as so redesignated), by striking the period and inserting `; and'; and

(3) by adding at the end the following:

`(8) that the eligible area has procedures in place to ensure that services provided with funds received under this part meet the criteria specified in section 2604(b)(1).'.

SEC. 105. USE OF GRANT FUNDS FOR EARLY INTERVENTION SERVICES.

(a) IN GENERAL- Section 2604(b)(1) (42 U.S.C. 300ff-14(b)(1)), as amended by section 104(a), is further amended by adding at the end the following:

`(D) EARLY INTERVENTION SERVICES- Early intervention services as described in section 2651(b)(2), with follow-through referral, provided for the purpose of facilitating the access of individuals receiving the services to HIV-related health services, but only if the entity providing such services--

`(i)(I) is receiving funds under subparagraph (A) or (C); or

`(II) is an entity constituting a point of access to services, as described in paragraph (2)(C), that maintains a relationship with an entity described in subclause (I) and that is serving individuals at elevated risk of HIV disease; and

`(ii) demonstrates to the satisfaction of the chief elected official that no other Federal, State, or local funds are available for the early intervention services the entity will provide with funds received under this paragraph.'.

(b) CONFORMING AMENDMENTS TO APPLICATION REQUIREMENTS- Section 2605(a)(1) (42 U.S.C. 300ff-15(a)(1)) is amended--

(1) in subparagraph (A), by striking `services to individuals with HIV disease' and inserting `services as described in section 2604(b)(1)'; and

(2) in subparagraph (B), by striking `services for individuals with HIV disease' and inserting `services as described in section 2604(b)(1)'.

SEC. 106. REPLACEMENT OF SPECIFIED FISCAL YEARS REGARDING THE SUNSET ON EXPEDITED DISTRIBUTION REQUIREMENTS.

Section 2603(a)(2) (42 U.S.C. 300ff-13(a)(2)) is amended by striking `for each of the fiscal years 1996 through 2000' and inserting `for a fiscal year'.

SEC. 107. HOLD HARMLESS PROVISION.

Section 2603(a)(4) (42 U.S.C. 300ff-13(a)(4)) is amended to read as follows:

`(4) LIMITATIONS-

`(A) IN GENERAL- With respect to each of fiscal years 2001 through 2005, the Secretary shall ensure that the amount of a grant made to an eligible area under paragraph (2) for such a fiscal year is not less than an amount equal to 98 percent of the amount the eligible area received for the fiscal year preceding the year for which the determination is being made.

`(B) APPLICATION OF PROVISION- Subparagraph (A) shall only apply with respect to those eligible areas receiving a grant under paragraph (2) for fiscal year 2000 in an amount that has been adjusted in accordance with paragraph (4) of this subsection (as in effect on the day before the date of enactment of the Ryan White CARE Act Amendments of 2000).'.

SEC. 108. SET-ASIDE FOR INFANTS, CHILDREN, AND WOMEN.

Section 2604(b)(3) (42 U.S.C. 300ff-14(b)(3)) is amended--

(1) by inserting `for each population under this subsection' after `established priorities'; and

(2) by striking `ratio of the' and inserting `ratio of each'.

Subtitle B--Amendments to Part B (Care Grant Program)

SEC. 121. STATE REQUIREMENTS CONCERNING IDENTIFICATION OF NEED AND ALLOCATION OF RESOURCES.

(a) GENERAL USE OF GRANTS- Section 2612 (42 U.S.C. 300ff-22) is amended--

(1) by striking `A State' and inserting `(a) IN GENERAL- A State'; and

(2) in the matter following paragraph (5)--

(A) by striking `paragraph (2)' and inserting `subsection (a)(2) and section 2613';

(b) APPLICATION- Section 2617(b) (42 U.S.C. 300ff-27(b)) is amended--

(1) in paragraph (1)(C)--

(A) by striking clause (i) and inserting the following:

`(i) the size and demographic characteristics of the population with HIV disease to be served, except that by not later than October 1, 2002, the State shall take into account the needs of individuals not in care, based on epidemiologic measures developed by the Secretary in consultation with the State, affected communities, experts, and other appropriate individuals (such State shall not be required to establish priorities for individuals not in care until such epidemiologic measures are developed);';

(B) in clause (iii), by striking `and' at the end; and

(C) by adding at the end the following:

`(v) the availability of other governmental and non-governmental resources;

`(vi) the capacity development needs resulting in gaps in the provision of HIV services in historically underserved low-income and rural low-income communities; and

`(vii) the efficiency of the administrative mechanism in rapidly allocating funds to the areas of greatest need within the State;'; and

(2) in paragraph (2)--

(A) in subparagraph (B), by striking `and' at the end;

(B) by redesignating subparagraph (C) as subparagraph (F); and

(C) by inserting after subparagraph (B), the following:

`(C) an assurance that capacity development needs resulting from gaps in the provision of services in underserved low-income and rural low-income communities will be addressed; and

`(D) with respect to fiscal year 2003 and subsequent fiscal years, assurances that, in the planning and allocation of resources, the State, through systems of HIV-related health services provided under paragraphs (1), (2), and (3) of section 2612(a), will make appropriate provision for the HIV-related health and support service needs of individuals who have been diagnosed with HIV disease but who are not currently receiving such services, based on the epidemiologic measures developed under paragraph (1)(C)(i);'.

SEC. 122. QUALITY MANAGEMENT.

(a) STATE REQUIREMENT FOR QUALITY MANAGEMENT- Section 2617(b)(4) (42 U.S.C. 300ff-27(b)(4)) is amended--

(1) by striking subparagraph (C) and inserting the following:

`(C) the State will provide for--

`(i) the establishment of a quality management program to assess the extent to which medical services provided to patients under the grant are consistent with the most recent Public Health Service guidelines for the treatment of HIV disease and related opportunistic infections and to develop strategies for improvements in the access to and quality of medical services; and

`(ii) a periodic review (such as through an independent peer review) to assess the quality and appropriateness of HIV-related health and support services provided by entities that receive funds from the State under this part;';

(2) by redesignating subparagraphs (E) and (F) as subparagraphs (F) and (G), respectively;

(3) by inserting after subparagraph (D), the following:

`(E) an assurance that the State, through systems of HIV-related health services provided under paragraphs (1), (2), and (3) of section 2612(a), has considered strategies for working with providers to make optimal use of financial assistance under the State medicaid plan under title XIX of the Social Security Act, the State Children's Health Insurance Program under title XXI of such Act, and other Federal grantees that provide HIV-related services, to maximize access to quality HIV-related health and support services;

(4) in subparagraph (F), as so redesignated, by striking `and' at the end; and

(5) in subparagraph (G), as so redesignated, by striking the period and inserting `; and'.

(b) AVAILABILITY OF FUNDS FOR QUALITY MANAGEMENT-

(1) AVAILABILITY OF GRANT FUNDS FOR PLANNING AND EVALUATION- Section 2618(c)(3) (42 U.S.C. 300ff-28(c)(3)) is amended by inserting before the period `, including not more than $3,000,000 for all activities associated with its quality management program'.

(2) EXCEPTION TO COMBINED CEILING ON PLANNING AND ADMINISTRATION FUNDS FOR STATES WITH SMALL GRANTS- Paragraph (6) of section 2618(c) (42 U.S.C. 300ff-28(c)(6)) is amended to read as follows:

`(6) EXCEPTION FOR QUALITY MANAGEMENT- Notwithstanding paragraph (5), a State whose grant under this part for a fiscal year does not exceed $1,500,000 may use not to exceed 20 percent of the amount of the grant for the purposes described in paragraphs (3) and (4) if--

`(A) that portion of such amount in excess of 15 percent of the grant is used for its quality management program; and

`(B) the State submits and the Secretary approves a plan (in such form and containing such information as the Secretary may prescribe) for use of funds for its quality management program.'.

SEC. 123. FUNDED ENTITIES REQUIRED TO HAVE HEALTH CARE RELATIONSHIPS.

Section 2617(b)(4) (42 U.S.C. 300ff-27(b)(4)), as amended by section 122(a), is further amended by adding at the end the following:

`(H) that funded entities maintain appropriate relationships with entities in the area served that constitute key points of access to the health care system for individuals with HIV disease (including emergency rooms, substance abuse treatment programs, detoxification centers, adult and juvenile detention facilities, sexually transmitted disease clinics, HIV counseling and testing sites, and homeless shelters), and other entities under section 2652(a), for the purpose of facilitating early intervention for individuals newly diagnosed with HIV disease and individuals knowledgeable of their status but not in care.'.

SEC. 124. SUPPORT SERVICES REQUIRED TO BE HEALTH CARE-RELATED.

(a) TECHNICAL AMENDMENT- Section 3(c)(2)(A)(iii) of the Ryan White CARE Act Amendments of 1996 (Public Law 104-146) is amended by inserting `before paragraph (2) as so redesignated' after `inserting'.

(b) SERVICES- Section 2612(a)(1) (42 U.S.C. 300ff-22(a)(1)), as so designated by section 121(a), is amended by striking `for individuals with HIV disease' and inserting `, subject to the conditions and limitations that apply under such section'.

(c) CONFORMING AMENDMENT TO STATE APPLICATION REQUIREMENT- Section 2617(b)(2) (42 U.S.C. 300ff-27(b)(2)), as amended by section 121(b), is further amended by adding at the end the following:

`(F) an assurance that the State has procedures in place to ensure that services provided with funds received under this section meet the criteria specified in section 2604(b)(1)(B); and'.

SEC. 125. USE OF GRANT FUNDS FOR EARLY INTERVENTION SERVICES.

Section 2612(a) (42 U.S.C. 300ff-22(a)), as amended by section 121, is further amended by adding at the end the following:

`(6) EARLY INTERVENTION SERVICES- The State, through systems of HIV-related health services provided under paragraphs (1), (2), and (3) of section 2612(a), may provide early intervention services, as described in section 2651(b)(2), with follow-up referral, provided for the purpose of facilitating the access of individuals receiving the services to HIV-related health services, but only if the entity providing such services--

`(A)(i) is receiving funds under section 2612(a)(1); or

`(ii) is an entity constituting a point of access to services, as described in section 2617(b)(4), that maintains a referral relationship with an entity described in clause (i) and that is serving individuals at elevated risk of HIV disease; and

`(B) demonstrates to the State's satisfaction that no other Federal, State, or local funds are available for the early intervention services the entity will provide with funds received under this paragraph.'.

SEC. 126. AUTHORIZATION OF APPROPRIATIONS FOR HIV-RELATED SERVICES FOR WOMEN AND CHILDREN.

Section 2625(c)(2) (42 U.S.C. 300ff-33(c)(2)) is amended by striking `fiscal years 1996 through 2000' and inserting `fiscal years 2001 through 2005'.

SEC. 127. REPEAL OF REQUIREMENT FOR COMPLETED INSTITUTE OF MEDICINE REPORT.

Section 2628 (42 U.S.C. 300ff-36) is repealed.

SEC. 128. SUPPLEMENT GRANTS FOR CERTAIN STATES.

Subpart I of part B of title XXVI of the Public Health Service Act (42 U.S.C. 300ff-11 et seq.) is amended by adding at the end the following:

`SEC. 2622. SUPPLEMENTAL GRANTS.

`(a) IN GENERAL- The Secretary shall award supplemental grants to States determined to be eligible under subsection (b) to enable such States to provide comprehensive services of the type described in section 2612(a) to supplement the services otherwise provided by the State under a grant under this subpart in areas within the State that are not eligible to receive grants under part A.

`(b) ELIGIBILITY- To be eligible to receive a supplemental grant under subsection (a) a State shall--

`(1) be eligible to receive a grant under this subpart; and

`(2) demonstrate to the Secretary that there is severe need (as defined for purposes of section 2603(b)(2)(A) for supplemental financial assistance in areas in the State that are not served through grants under part A.

`(c) APPLICATION- A State that desires a grant under this section shall, as part of the State application submitted under section 2617, submit a detailed description of the manner in which the State will use amounts received under the grant and of the severity of need. Such description shall include--

`(1) a report concerning the dissemination of supplemental funds under this section and the plan for the utilization of such funds;

`(2) a demonstration of the existing commitment of local resources, both financial and in-kind;

`(3) a demonstration that the State will maintain HIV-related activities at a level that is equal to not less than the level of such activities in the State for the 1-year period preceding the fiscal year for which the State is applying to receive a grant under this part;

`(4) a demonstration of the ability of the State to utilize such supplemental financial resources in a manner that is immediately responsive and cost effective;

`(5) a demonstration that the resources will be allocated in accordance with the local demographic incidence of AIDS including appropriate allocations for services for infants, children, women, and families with HIV disease;

`(6) a demonstration of the inclusiveness of the planning process, with particular emphasis on affected communities and individuals with HIV disease; and

`(7) a demonstration of the manner in which the proposed services are consistent with local needs assessments and the statewide coordinated statement of need.

`(d) AMOUNT RESERVED FOR EMERGING COMMUNITIES-

`(1) IN GENERAL- For awarding grants under this section for each fiscal year, the Secretary shall reserve the greater of 50 percent of the amount to be utilized under subsection (e) for such fiscal year or $5,000,000, to be provided to States that contain emerging communities for use in such communities.

`(2) DEFINITION- In paragraph (1), the term `emerging community' means a metropolitan area--

`(A) that is not eligible for a grant under part A; and

`(B) for which there has been reported to the Director of the Centers for Disease Control and Prevention a cumulative total of between 1000 and 1999 cases of acquired immune deficiency syndrome for the most recent period of 5 calendar years for which such data are available.

`(e) APPROPRIATIONS- With respect to each fiscal year beginning with fiscal year 2001, the Secretary, to carry out this section, shall utilize 50 percent of the amount appropriated under section 2677 to carry out part B for such fiscal year that is in excess of the amount appropriated to carry out such part in fiscal year preceding the fiscal year involved.

SEC. 129. USE OF TREATMENT FUNDS.

(a) STATE DUTIES- Section 2616(c) (42 U.S.C. 300ff-26(c)) is amended--

(1) in the matter preceding paragraph (1), by striking `shall--' and inserting `shall use funds made available under this section to--';

(2) by redesignating paragraphs (1) through (5) as subparagraphs (A) through (E), respectively and realigning the margins of such subparagraphs appropriately;

(3) in subparagraph (D) (as so redesignated), by striking `and' at the end;

(4) in subparagraph (E) (as so redesignated), by striking the period and `; and'; and

(5) by adding at the end the following:

`(F) encourage, support, and enhance adherence to and compliance with treatment regimens, including related medical monitoring.';

(6) by striking `In carrying' and inserting the following:

`(1) IN GENERAL- In carrying'; and

(7) by adding at the end the following:

`(2) LIMITATIONS-

`(A) IN GENERAL- No State shall use funds under paragraph (1)(F) unless the limitations on access to HIV/AIDS therapeutic regimens as defined in subsection (e)(2) are eliminated.

`(B) AMOUNT OF FUNDING- No State shall use in excess of 10 percent of the amount set-aside for use under this section in any fiscal year to carry out activities under paragraph (1)(F) unless the State demonstrates to the Secretary that such additional services are essential and in no way diminish access to therapeutics.'.

(b) SUPPLEMENT GRANTS- Section 2616 (42 U.S.C. 300ff-26(c)) is amended by adding at the end the following:

`(e) SUPPLEMENTAL GRANTS FOR THE PROVISION OF TREATMENTS-

`(1) IN GENERAL- From amounts made available under paragraph (5), the Secretary shall award supplemental grants to States determined to be eligible under paragraph (2) to enable such States to provide access to therapeutics to treat HIV disease as provided by the State under subsection (c)(1)(B) for individuals at or below 200 percent of the Federal poverty line.

`(2) CRITERIA- The Secretary shall develop criteria for the awarding of grants under paragraph (1) to States that demonstrate a severe need. In determining the criteria for demonstrating State severity of need (as defined for purposes of section 2603(b)(2)(A)), the Secretary shall consider whether limitation to access exist such that--

`(A) the State programs under this section are unable to provide HIV/AIDS therapeutic regimens to all eligible individuals living at or below 200 percent of the Federal poverty line; and

`(B) the State programs under this section are unable to provide to all eligible individuals appropriate HIV/AIDS therapeutic regimens as recommended in the most recent Federal treatment guidelines.

`(3) STATE REQUIREMENT- The Secretary may not make a grant to a State under this subsection unless the State agrees that--

`(A) the State will make available (directly or through donations from public or private entities) non-Federal contributions toward the activities to be carried out under the grant in an amount equal to $1 for each $4 of Federal funds provided in the grant; and

`(B) the State will not impose eligibility requirements for services or scope of benefits limitations under subsection (a) that are more restrictive than such requirements in effect as of January 1, 2000.

`(4) USE AND COORDINATION- Amounts made available under a grant under this subsection shall only be used by the State to provide AIDS/HIV-related medications. The State shall coordinate the use of such amounts with the amounts otherwise provided under this section in order to maximize drug coverage.

`(5) FUNDING-

`(A) RESERVATION OF AMOUNT- The Secretary may reserve not to exceed 4 percent, but not less than 2 percent, of any amount referred to in section 2618(b)(2)(H) that is appropriated for a fiscal year, to carry out this subsection.

`(B) MINIMUM AMOUNT- In providing grants under this subsection, the Secretary shall ensure that the amount of a grant to a State under this part is not less than the amount the State received under this part in the previous fiscal year, as a result of grants provided under this subsection.'.

(c) SUPPLEMENT AND NOT SUPPLANT- Section 2616 (42 U.S.C. 300ff-26(c)), as amended by subsection (b), is further amended by adding at the end the following:

`(f) SUPPLEMENT NOT SUPPLANT- Notwithstanding any other provision of law, amounts made available under this section shall be used to supplement and not supplant other funding available to provide treatments of the type that may be provided under this section.'.

SEC. 130. INCREASE IN MINIMUM ALLOTMENT.

(a) IN GENERAL- Section 2618(b)(1)(A)(i) (42 U.S.C. 300ff-28(b)(1)(A)(i)) is amended--

(1) in subclause (I), by striking `$100,000' and inserting `$200,000'; and

(2) in subclause (II), by striking `$250,000' and inserting `$500,000'.

(b) TECHNICAL AMENDMENT- Section 2618(b)(3)(B) (42 U.S.C. 300ff-28(b)(3)(B)) is amended by striking `and the Republic of the Marshall Islands' and inserting `, the Republic of the Marshall Islands, the Federated States of Micronesia, and the Republic of Palau'.

SEC. 131. SET-ASIDE FOR INFANTS, CHILDREN, AND WOMEN.

Section 2611(b) (42 U.S.C. 300ff-21(b)) is amended--

(1) by inserting `for each population under this subsection' after `State shall use'; and

(2) by striking `ratio of the' and inserting `ratio of each'.

Subtitle C--Amendments to Part C (Early Intervention Services)

SEC. 141. AMENDMENT OF HEADING; REPEAL OF FORMULA GRANT PROGRAM.

(a) AMENDMENT OF HEADING- The heading of part C of title XXVI is amended to read as follows:

`Part C--Early Intervention and Primary Care Services'.

(b) REPEAL- Part C of title XXVI (42 U.S.C. 300ff-41 et seq.) is amended--

(1) by repealing subpart I; and

(2) by redesignating subparts II and III as subparts I and II.

(c) CONFORMING AMENDMENTS-

(1) INFORMATION REGARDING RECEIPT OF SERVICES- Section 2661(a) (42 U.S.C. 300ff-61(a)) is amended by striking `unless--' and all that follows through `(2) in the case of' and inserting `unless, in the case of'.

(2) ADDITIONAL AGREEMENTS- Section 2664 (42 U.S.C. 300ff-64) is amended--

(A) in subsection (e)(5), by striking `2642(b) or';

(B) in subsection (f)(2), by striking `2642(b) or'; and

(C) by striking subsection (h).

SEC. 142. PLANNING AND DEVELOPMENT GRANTS.

(a) ALLOWING PLANNING AND DEVELOPMENT GRANT TO EXPAND ABILITY TO PROVIDE PRIMARY CARE SERVICES- Section 2654(c) (42 U.S.C. 300ff-54(c)) is amended--

(1) in paragraph (1), to read as follows:

`(1) IN GENERAL- The Secretary may provide planning and development grants to public and nonprofit private entities for the purpose of--

`(A) enabling such entities to provide HIV early intervention services; or

`(B) assisting such entities to expand the capacity, preparedness, and expertise to deliver primary care services to individuals with HIV disease in underserved low-income communities on the condition that the funds are not used to purchase or improve land or to purchase, construct, or permanently improve (other than minor remodeling) any building or other facility.'; and

(2) in paragraphs (2) and (3) by striking `paragraph (1)' each place that such appears and inserting `paragraph (1)(A)'.

(b) AMOUNT; DURATION- Section 2654(c) (42 U.S.C. 300ff-54(c)), as amended by subsection (a), is further amended--

(1) by redesignating paragraph (4) as paragraph (5); and

(2) by inserting after paragraph (3) the following:

`(4) AMOUNT AND DURATION OF GRANTS-

`(A) EARLY INTERVENTION SERVICES- A grant under paragraph (1)(A) may be made in an amount not to exceed $50,000.

`(B) CAPACITY DEVELOPMENT-

`(i) AMOUNT- A grant under paragraph (1)(B) may be made in an amount not to exceed $150,000.

`(ii) DURATION- The total duration of a grant under paragraph (1)(B), including any renewal, may not exceed 3 years.'.

(c) INCREASE IN LIMITATION- Section 2654(c)(5) (42 U.S.C. 300ff-54(c)(5)), as so redesignated by subsection (b), is amended by striking `1 percent' and inserting `5 percent'.

SEC. 143. AUTHORIZATION OF APPROPRIATIONS FOR CATEGORICAL GRANTS.

Section 2655 (42 U.S.C. 300ff-55) is amended by striking `1996' and all that follows through `2000' and inserting `2001 through 2005'.

SEC. 144. ADMINISTRATIVE EXPENSES CEILING; QUALITY MANAGEMENT PROGRAM.

Section 2664(g) (42 U.S.C. 300ff-64(g)) is amended--

(1) in paragraph (3), to read as follows:

`(3) the applicant will not expend more than 10 percent of the grant for costs of administrative activities with respect to the grant;';

(2) in paragraph (4), by striking the period and inserting `; and'; and

(3) by adding at the end the following:

`(5) the applicant will provide for the establishment of a quality management program to assess the extent to which medical services funded under this title that are provided to patients are consistent with the most recent Public Health Service guidelines for the treatment of HIV disease and related opportunistic infections and that improvements in the access to and quality of medical services are addressed.'.

SEC. 145. PREFERENCE FOR CERTAIN AREAS.

Section 2651 (42 U.S.C. 300ff-51) is amended by adding at the end the following:

`(d) PREFERENCE IN AWARDING GRANTS- Beginning in fiscal year 2001, in awarding new grants under this section, the Secretary shall give preference to applicants that will use amounts received under the grant to serve areas that are otherwise not eligible to receive assistance under part A.'.

Subtitle D--Amendments to Part D (General Provisions)

SEC. 151. RESEARCH INVOLVING WOMEN, INFANTS, CHILDREN, AND YOUTH.

(a) ELIMINATION OF REQUIREMENT TO ENROLL SIGNIFICANT NUMBERS OF WOMEN AND CHILDREN- Section 2671(b) (42 U.S.C. 300ff-71(b)) is amended--

(1) in paragraph (1), by striking subparagraphs (C) and (D); and

(2) by striking paragraphs (3) and (4).

(b) INFORMATION AND EDUCATION- Section 2671(d) (42 U.S.C. 300ff-71(d)) is amended by adding at the end the following:

`(4) The applicant will provide individuals with information and education on opportunities to participate in HIV/AIDS-related clinical research.'.

(c) QUALITY MANAGEMENT; ADMINISTRATIVE EXPENSES CEILING- Section 2671(f) (42 U.S.C. 300ff-71(f)) is amended--

(1) by striking the subsection heading and designation and inserting the following:

`(f) ADMINISTRATION-

`(1) APPLICATION- '; and

(2) by adding at the end the following:

`(2) QUALITY MANAGEMENT PROGRAM- A grantee under this section shall implement a quality management program.'.

(d) COORDINATION- Section 2671(g) (42 U.S.C. 300ff-71(g)) is amended by adding at the end the following: `The Secretary acting through the Director of NIH, shall examine the distribution and availability of ongoing and appropriate HIV/AIDS-related research projects to existing sites under this section for purposes of enhancing and expanding voluntary access to HIV-related research, especially within communities that are not reasonably served by such projects.'.

(e) AUTHORIZATION OF APPROPRIATIONS- Section 2671(j) (42 U.S.C. 300ff-71(j)) is amended by striking `fiscal years 1996 through 2000' and inserting `fiscal years 2001 through 2005'.

SEC. 152. LIMITATION ON ADMINISTRATIVE EXPENSES.

Section 2671 (42 U.S.C. 300ff-71) is amended--

(1) by redesignating subsections (i) and (j), as subsections (j) and (k), respectively; and

(2) by inserting after subsection (h), the following:

`(i) LIMITATION ON ADMINISTRATIVE EXPENSES-

`(1) DETERMINATION BY SECRETARY- Not later than 12 months after the date of enactment of the Ryan White Care Act Amendments of 2000, the Secretary, in consultation with grantees under this part, shall conduct a review of the administrative, program support, and direct service-related activities that are carried out under this part to ensure that eligible individuals have access to quality, HIV-related health and support services and research opportunities under this part, and to support the provision of such services.

`(2) REQUIREMENTS-

`(A) IN GENERAL- Not later than 180 days after the expiration of the 12-month period referred to in paragraph (1) the Secretary, in consultation with grantees under this part, shall determine the relationship between the costs of the activities referred to in paragraph (1) and the access of eligible individuals to the services and research opportunities described in such paragraph.

`(B) LIMITATION- After a final determination under subparagraph (A), the Secretary may not make a grant under this part unless the grantee complies with such requirements as may be included in such determination.'.

SEC. 153. EVALUATIONS AND REPORTS.

Section 2674(c) (42 U.S.C. 399ff-74(c)) is amended by striking `1991 through 1995' and inserting `2001 through 2005'.

SEC. 154. AUTHORIZATION OF APPROPRIATIONS FOR GRANTS UNDER PARTS A AND B.

Section 2677 (42 U.S.C. 300ff-77) is amended to read as follows:

`SEC. 2677. AUTHORIZATION OF APPROPRIATIONS.

`There are authorized to be appropriated--

`(1) such sums as may be necessary to carry out part A for each of the fiscal years 2001 through 2005; and

`(2) such sums as may be necessary to carry out part B for each of the fiscal years 2001 through 2005.'.

Subtitle E--Amendments to Part F (Demonstration and Training)

SEC. 161. AUTHORIZATION OF APPROPRIATIONS.

(a) SCHOOLS; CENTERS- Section 2692(c)(1) (42 U.S.C. 300ff-111(c)(1)) is amended by striking `fiscal years 1996 through 2000' and inserting `fiscal years 2001 through 2005'.

(b) DENTAL SCHOOLS- Section 2692(c)(2) (42 U.S.C. 300ff-111(c)(2)) is amended by striking `fiscal years 1996 through 2000' and inserting `fiscal years 2001 through 2005'.

TITLE II--MISCELLANEOUS PROVISIONS

SEC. 201. INSTITUTE OF MEDICINE STUDY.

(a) IN GENERAL- Not later than 120 days after the date of enactment of this Act, the Secretary of Health and Human Services shall enter into a contract with the Institute of Medicine for the conduct of 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.

(b) REQUIREMENTS-

(1) COMPLETION- The study under subsection (a) shall be completed not later than 21 months after the date on which the contract referred to in such subsection is entered into.

(2) ISSUES TO BE CONSIDERED- The study conducted under subsection (a) shall consider--

(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;

(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; and

(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) REPORT- Not later than 90 days after the date on which the study is completed under subsection (a), the Secretary of Health and Human Services shall prepare and submit to the appropriate committees of Congress a report describing the manner in which the conclusions and recommendations of the Institute of Medicine can be addressed and implemented.

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