PUBLIC LAW 106–345—OCT. 20, 2000 114 STAT. 1319

Public Law 106–345

106th Congress

An Act

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.

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. TABLE OF CONTENTS.

The table of contents for this Act is as follows:

Sec. 1. Short title.

Sec. 2. Table of contents.

TITLE I—EMERGENCY RELIEF FOR AREAS WITH SUBSTANTIAL NEED FOR

SERVICES

Subtitle A—HIV Health Services Planning Councils

Sec. 101. Membership of councils.

Sec. 102. Duties of councils.

Sec. 103. Open meetings; other additional provisions.

Subtitle B—Type and Distribution of Grants

Sec. 111. Formula grants.

Sec. 112. Supplemental grants.

Subtitle C—Other Provisions

Sec. 121. Use of amounts.

Sec. 122. Application.

TITLE II—CARE GRANT PROGRAM

Subtitle A—General Grant Provisions

Sec. 201. Priority for women, infants, and children.

Sec. 202. Use of grants.

Sec. 203. Grants to establish HIV care consortia.

Sec. 204. Provision of treatments.

Sec. 205. State application.

Sec. 206. Distribution of funds.

Sec. 207. Supplemental grants for certain States.

Subtitle B—Provisions Concerning Pregnancy and Perinatal Transmission of HIV

Sec. 211. Repeals.

Sec. 212. Grants.

Sec. 213. Study by Institute of Medicine.

Subtitle C—Certain Partner Notification Programs

Sec. 221. Grants for compliant partner notification programs.

42 USC 201 note.

Ryan White

CARE Act

Amendments of

2000.

Oct. 20, 2000

[S. 2311]

114 STAT. 1320 PUBLIC LAW 106–345—OCT. 20, 2000

TITLE III—EARLY INTERVENTION SERVICES

Subtitle A—Formula Grants for States

Sec. 301. Repeal of program.

Subtitle B—Categorical Grants

Sec. 311. Preferences in making grants.

Sec. 312. Planning and development grants.

Sec. 313. Authorization of appropriations.

Subtitle C—General Provisions

Sec. 321. Provision of certain counseling services.

Sec. 322. Additional required agreements.

TITLE IV—OTHER PROGRAMS AND ACTIVITIES

Subtitle A—Certain Programs for Research, Demonstrations, or Training

Sec. 401. Grants for coordinated services and access to research for women, infants,

children, and youth.

Sec. 402. AIDS education and training centers.

Subtitle B—General Provisions in Title XXVI

Sec. 411. Evaluations and reports.

Sec. 412. Data collection through Centers for Disease Control and Prevention.

Sec. 413. Coordination.

Sec. 414. Plan regarding release of prisoners with HIV disease.

Sec. 415. Audits.

Sec. 416. Administrative simplification.

Sec. 417. Authorization of appropriations for parts A and B.

TITLE V—GENERAL PROVISIONS

Sec. 501. Studies by Institute of Medicine.

Sec. 502. Development of rapid HIV test.

Sec. 503. Technical corrections.

TITLE VI—EFFECTIVE DATE

Sec. 601. Effective date.

TITLE I—EMERGENCY RELIEF FOR

AREAS WITH SUBSTANTIAL NEED FOR

SERVICES

Subtitle A—HIV Health Services Planning

Councils

SEC. 101. MEMBERSHIP OF COUNCILS.

(a) IN GENERAL.—Section 2602(b) of the Public Health Service

Act (42 U.S.C. 300ff–12(b)) is amended—

(1) in paragraph (1), by striking ‘‘demographics of the epidemic in the eligible area involved,’’ and inserting ‘‘demographics of the population of individuals with HIV disease

in the eligible area involved,’’; and

(2) in paragraph (2)—

(A) in subparagraph (C), by inserting before the semicolon the following: ‘‘, including providers of housing and

homeless services’’;

(B) in subparagraph (G), by striking ‘‘or AIDS’’;

(C) in subparagraph (K), by striking ‘‘and’’ at the end;

(D) in subparagraph (L), by striking the period and

inserting the following: ‘‘, including but not limited to providers of HIV prevention services; and’’; and

PUBLIC LAW 106–345—OCT. 20, 2000 114 STAT. 1321

(E) by adding at the end the following subparagraph:

‘‘(M) representatives of individuals who formerly were

Federal, State, or local prisoners, were released from the

custody of the penal system during the preceding 3 years,

and had HIV disease as of the date on which the individuals

were so released.’’.

(b) CONFLICTS OF INTERESTS.—Section 2602(b)(5) of the Public

Health Service Act (42 U.S.C. 300ff–12(b)(5)) is amended by adding

at the end the following subparagraph:

‘‘(C) COMPOSITION OF COUNCIL.—The following applies

regarding the membership of a planning council under

paragraph (1):

‘‘(i) Not less than 33 percent of the council shall

be individuals who are receiving HIV-related services

pursuant to a grant under section 2601(a), are not

officers, employees, or consultants to any entity that

receives amounts from such a grant, and do not represent any such entity, and reflect the demographics

of the population of individuals with HIV disease as

determined under paragraph (4)(A). For purposes of

the preceding sentence, an individual shall be considered to be receiving such services if the individual

is a parent of, or a caregiver for, a minor child who

is receiving such services.

‘‘(ii) With respect to membership on the planning

council, clause (i) may not be construed as having

any effect on entities that receive funds from grants

under any of parts B through F but do not receive

funds from grants under section 2601(a), on officers

or employees of such entities, or on individuals who

represent such entities.’’.

SEC. 102. DUTIES OF COUNCILS.

(a) IN GENERAL.—Section 2602(b)(4) of the Public Health

Service Act (42 U.S.C. 300ff–12(b)(4)) is amended—

(1) by redesignating subparagraphs (A) through (E) as subparagraphs (C) through (G), respectively;

(2) by inserting before subparagraph (C) (as so redesignated) the following subparagraphs:

‘‘(A) determine the size and demographics of the population of individuals with HIV disease;

‘‘(B) determine the needs of such population, with particular attention to—

‘‘(i) individuals with HIV disease who know their

HIV status and are not receiving HIV-related services;

and

‘‘(ii) disparities in access and services among

affected subpopulations and historically underserved

communities;’’;

(3) in subparagraph (C) (as so redesignated), by striking

clauses (i) through (iv) and inserting the following:

‘‘(i) size and demographics of the population of

individuals with HIV disease (as determined under

subparagraph (A)) and the needs of such population

(as determined under subparagraph (B));

‘‘(ii) demonstrated (or probable) cost effectiveness

and outcome effectiveness of proposed strategies and

114 STAT. 1322 PUBLIC LAW 106–345—OCT. 20, 2000

interventions, to the extent that data are reasonably

available;

‘‘(iii) priorities of the communities with HIV disease for whom the services are intended;

‘‘(iv) coordination in the provision of services to

such individuals with programs for HIV prevention

and for the prevention and treatment of substance

abuse, including programs that provide comprehensive

treatment for such abuse;

‘‘(v) availability of other governmental and nongovernmental 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; and

‘‘(vi) capacity development needs resulting from

disparities in the availability of HIV-related services

in historically underserved communities;’’;

(4) in subparagraph (D) (as so redesignated), by amending

the subparagraph to read as follows:

‘‘(D) develop a comprehensive plan for the organization

and delivery of health and support services described in

section 2604 that—

‘‘(i) includes a strategy for identifying individuals

who know their HIV status and are not receiving such

services and for informing the individuals of and

enabling the individuals to utilize the services, giving

particular attention to eliminating disparities in access

and services among affected subpopulations and

historically underserved communities, and including

discrete goals, a timetable, and an appropriate allocation of funds;

‘‘(ii) includes a strategy to coordinate the provision

of such services with programs for HIV prevention

(including outreach and early intervention) and for

the prevention and treatment of substance abuse

(including programs that provide comprehensive treatment services for such abuse); and

‘‘(iii) is compatible with any State or local plan

for the provision of services to individuals with HIV

disease;’’;

(5) in subparagraph (F) (as so redesignated), by striking

‘‘and’’ at the end;

(6) in subparagraph (G) (as so redesignated)—

(A) by striking ‘‘public meetings,’’ and inserting ‘‘public

meetings (in accordance with paragraph (7)),’’; and

(B) by striking the period and inserting ‘‘; and’’; and

(7) by adding at the end the following subparagraph:

‘‘(H) coordinate with Federal grantees that provide

HIV-related services within the eligible area.’’.

(b) PROCESS FOR ESTABLISHING ALLOCATION PRIORITIES.—Section 2602 of the Public Health Service Act (42 U.S.C. 300ff–12)

is amended by adding at the end the following subsection:

‘‘(d) PROCESS FOR ESTABLISHING ALLOCATION PRIORITIES.—

Promptly after the date of the submission of the report required

in section 501(b) of the Ryan White CARE Act Amendments of

2000 (relating to the relationship between epidemiological measures

PUBLIC LAW 106–345—OCT. 20, 2000 114 STAT. 1323

and health care for certain individuals with HIV disease), the

Secretary, in consultation with planning councils and entities that

receive amounts from grants under section 2601(a) or 2611, shall

develop epidemiologic measures—

‘‘(1) for establishing the number of individuals living with

HIV disease who are not receiving HIV-related health services;

and

‘‘(2) for carrying out the duties under subsection (b)(4)

and section 2617(b).’’.

(c) TRAINING.—Section 2602 of the Public Health Service Act

(42 U.S.C. 300ff–12), as amended by subsection (b) of this section,

is amended by adding at the end the following subsection:

‘‘(e) TRAINING GUIDANCE AND MATERIALS.—The Secretary shall

provide to each chief elected official receiving a grant under section

2601(a) guidelines and materials for training members of the planning council under paragraph (1) regarding the duties of the

council.’’.

(d) CONFORMING AMENDMENT.—Section 2603(c) of the Public

Health Service Act (42 U.S.C. 300ff–12(b)) is amended by striking

‘‘section 2602(b)(3)(A)’’ and inserting ‘‘section 2602(b)(4)(C)’’.

SEC. 103. OPEN MEETINGS; OTHER ADDITIONAL PROVISIONS.

Section 2602(b) of the Public Health Service Act (42 U.S.C.

300ff–12(b)) is amended—

(1) in paragraph (3), by striking subparagraph (C); and

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

‘‘(7) PUBLIC DELIBERATIONS.—With respect to a planning

council under paragraph (1), the following applies:

‘‘(A) The council may not be chaired solely by an

employee of the grantee under section 2601(a).

‘‘(B) In accordance with criteria established by the

Secretary:

‘‘(i) The meetings of the council shall be open to

the public and shall be held only after adequate notice

to the public.

‘‘(ii) The records, reports, transcripts, minutes,

agenda, or other documents which were made available

to or prepared for or by the council shall be available

for public inspection and copying at a single location.

‘‘(iii) Detailed minutes of each meeting of the

council shall be kept. The accuracy of all minutes shall

be certified to by the chair of the council.

‘‘(iv) This subparagraph does not apply to any

disclosure of information of a personal nature that

would constitute a clearly unwarranted invasion of

personal privacy, including any disclosure of medical

information or personnel matters.’’.

Subtitle B—Type and Distribution of

Grants

SEC. 111. FORMULA GRANTS.

(a) EXPEDITED DISTRIBUTION.—Section 2603(a)(2) of the Public

Health Service Act (42 U.S.C. 300ff–13(a)(2)) is amended in the

first sentence by striking ‘‘for each of the fiscal years 1996 through

2000’’ and inserting ‘‘for a fiscal year’’.

Records.

Reports.

Public notice.

42 USC 300ff–13.

114 STAT. 1324 PUBLIC LAW 106–345—OCT. 20, 2000

(b) AMOUNT OF GRANT; ESTIMATE OF LIVING CASES.—

(1) IN GENERAL.—Section 2603(a)(3) of the Public Health

Service Act (42 U.S.C. 300ff–13(a)(3)) is amended—

(A) in subparagraph (C)(i), by inserting before the semicolon the following: ‘‘, except that (subject to subparagraph

(D)), for grants made pursuant to this paragraph for fiscal

year 2005 and subsequent fiscal years, the cases counted

for each 12-month period beginning on or after July 1,

2004, shall be cases of HIV disease (as reported to and

confirmed by such Director) rather than cases of acquired

immune deficiency syndrome’’; and

(B) in subparagraph (C), in the matter after and below

clause (ii)(X)—

(i) in the first sentence, by inserting before the

period the following: ‘‘, and shall be reported to the

congressional committees of jurisdiction’’; and

(ii) by adding at the end the following sentence:

‘‘Updates shall as applicable take into account the

counting of cases of HIV disease pursuant to clause

(i).’’.

(2) DETERMINATION OF SECRETARY REGARDING DATA ON HIV

CASES.—Section 2603(a)(3) of the Public Health Service Act

(42 U.S.C. 300ff–13(a)(3)) is amended—

(A) by redesignating subparagraph (D) as subparagraph (E); and

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

subparagraph:

‘‘(D) DETERMINATION OF SECRETARY REGARDING DATA

ON HIV CASES.—

‘‘(i) IN GENERAL.—Not later than July 1, 2004,

the Secretary shall determine whether there is data

on cases of HIV disease from all eligible areas (reported

to and confirmed by the Director of the Centers for

Disease Control and Prevention) sufficiently accurate

and reliable for use for purposes of subparagraph (C)(i).

In making such a determination, the Secretary shall

take into consideration the findings of the study under

section 501(b) of the Ryan White CARE Act Amendments of 2000 (relating to the relationship between

epidemiological measures and health care for certain

individuals with HIV disease).

‘‘(ii) EFFECT OF ADVERSE DETERMINATION.—If

under clause (i) the Secretary determines that data

on cases of HIV disease is not sufficiently accurate

and reliable for use for purposes of subparagraph (C)(i),

then notwithstanding such subparagraph, for any fiscal

year prior to fiscal year 2007 the references in such

subparagraph to cases of HIV disease do not have

any legal effect.

‘‘(iii) GRANTS AND TECHNICAL ASSISTANCE

REGARDING COUNTING OF HIV CASES.—Of the amounts

appropriated under section 318B for a fiscal year, the

Secretary shall reserve amounts to make grants and

provide technical assistance to States and eligible areas

with respect to obtaining data on cases of HIV disease

to ensure that data on such cases is available from

Deadline.

PUBLIC LAW 106–345—OCT. 20, 2000 114 STAT. 1325

all States and eligible areas as soon as is practicable

but not later than the beginning of fiscal year 2007.’’.

(c) INCREASES IN GRANT.—Section 2603(a)(4) of the Public

Health Service Act (42 U.S.C. 300ff–13(a)(4)) is amended to read

as follows:

‘‘(4) INCREASES IN GRANT.—

‘‘(A) IN GENERAL.—For each fiscal year in a protection

period for an eligible area, the Secretary shall increase

the amount of the grant made pursuant to paragraph (2)

for the area to ensure that—

‘‘(i) for the first fiscal year in the protection period,

the grant is not less than 98 percent of the amount

of the grant made for the eligible area pursuant to

such paragraph for the base year for the protection

period;

‘‘(ii) for any second fiscal year in such period, the

grant is not less than 95 percent of the amount of

such base year grant;

‘‘(iii) for any third fiscal year in such period, the

grant is not less than 92 percent of the amount of

the base year grant;

‘‘(iv) for any fourth fiscal year in such period, the

grant is not less than 89 percent of the amount of

the base year grant; and

‘‘(v) for any fifth or subsequent fiscal year in such

period, if, pursuant to paragraph (3)(D)(ii), the references in paragraph (3)(C)(i) to HIV disease do not

have any legal effect, the grant is not less than 85

percent of the amount of the base year grant.

‘‘(B) SPECIAL RULE.—If for fiscal year 2005, pursuant

to paragraph (3)(D)(ii), data on cases of HIV disease are

used for purposes of paragraph (3)(C)(i), the Secretary shall

increase the amount of a grant made pursuant to paragraph

(2) for an eligible area to ensure that the grant is not

less than 98 percent of the amount of the grant made

for the area in fiscal year 2004.

‘‘(C) BASE YEAR; PROTECTION PERIOD.—With respect to

grants made pursuant to paragraph (2) for an eligible

area:

‘‘(i) The base year for a protection period is the

fiscal year preceding the trigger grant-reduction year.

‘‘(ii) The first trigger grant-reduction year is the

first fiscal year (after fiscal year 2000) for which the

grant for the area is less than the grant for the area

for the preceding fiscal year.

‘‘(iii) A protection period begins with the trigger

grant-reduction year and continues until the beginning

of the first fiscal year for which the amount of the

grant determined pursuant to paragraph (2) for the

area equals or exceeds the amount of the grant determined under subparagraph (A).

‘‘(iv) Any subsequent trigger grant-reduction year

is the first fiscal year, after the end of the preceding

protection period, for which the amount of the grant

is less than the amount of the grant for the preceding

fiscal year.’’.

114 STAT. 1326 PUBLIC LAW 106–345—OCT. 20, 2000

SEC. 112. SUPPLEMENTAL GRANTS.

(a) IN GENERAL.—Section 2603(b)(2) of the Public Health

Service Act (42 U.S.C. 300ff–13(b)(2)) is amended—

(1) in the heading for the paragraph, by striking ‘‘DEFINI- TION’’ and inserting ‘‘AMOUNT OF GRANT’’;

(2) by redesignating subparagraphs (A) through (C) as subparagraphs (B) through (D), respectively;

(3) by inserting before subparagraph (B) (as so redesignated) the following subparagraph:

‘‘(A) IN GENERAL.—The amount of each grant made

for purposes of this subsection shall be determined by

the Secretary based on a weighting of factors under paragraph (1), with severe need under subparagraph (B) of

such paragraph counting one-third.’’;

(4) in subparagraph (B) (as so redesignated)—

(A) in clause (ii), by striking ‘‘and’’ at the end;

(B) in clause (iii), by striking the period and inserting

a semicolon; and

(C) by adding at the end the following clauses:

‘‘(iv) the current prevalence of HIV disease;

‘‘(v) an increasing need for HIV-related services,

including relative rates of increase in the number of

cases of HIV disease; and

‘‘(vi) unmet need for such services, as determined

under section 2602(b)(4).’’;

(5) in subparagraph (C) (as so redesignated)—

(A) by striking ‘‘subparagraph (A)’’ each place such

term appears and inserting ‘‘subparagraph (B)’’;

(B) in the second sentence, by striking ‘‘2 years after

the date of enactment of this paragraph’’ and inserting

‘‘18 months after the date of the enactment of the Ryan

White CARE Act Amendments of 2000’’; and

(C) by inserting after the second sentence the following

sentence: ‘‘Such a mechanism shall be modified to reflect

the findings of the study under section 501(b) of the Ryan

White CARE Act Amendments of 2000 (relating to the

relationship between epidemiological measures and health

care for certain individuals with HIV disease).’’; and

(6) in subparagraph (D) (as so redesignated), by striking

‘‘subparagraph (B)’’ and inserting ‘‘subparagraph (C)’’.

(b) REQUIREMENTS FOR APPLICATION.—Section 2603(b)(1)(E) of

the Public Health Service Act (42 U.S.C. 300ff–13(b)(1)(E)) is

amended by inserting ‘‘youth,’’ after ‘‘children,’’.

(c) TECHNICAL AND CONFORMING AMENDMENT.—Section 2603(b)

of the Public Health Service Act (42 U.S.C. 300ff–13(b)) is

amended—

(1) by striking paragraph (4);

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

(3) in paragraph (4) (as so redesignated), in subparagraph

(B), by striking ‘‘grants’’ and inserting ‘‘grant’’.

Subtitle C—Other Provisions

SEC. 121. USE OF AMOUNTS.

(a) PRIMARY PURPOSES.—Section 2604(b)(1) of the Public Health

Service Act (42 U.S.C. 300ff–14(b)(1)) is amended—

PUBLIC LAW 106–345—OCT. 20, 2000 114 STAT. 1327

(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 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’’;

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

subparagraph:

‘‘(B) 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.’’; and

(5) by adding at the end the following:

‘‘(D) Outreach activities that are intended to identify

individuals with HIV disease who know their HIV status

and are not receiving HIV-related services, and that are—

‘‘(i) necessary to implement the strategy under section 2602(b)(4)(D), including activities facilitating the

access of such individuals to HIV-related primary care

services at entities described in paragraph (3)(A);

‘‘(ii) conducted in a manner consistent with the

requirements under sections 2605(a)(3) and 2651(b)(2);

and

‘‘(iii) supplement, and do not supplant, such activities that are carried out with amounts appropriated

under section 317.’’.

(b) EARLY INTERVENTION SERVICES.—Section 2604(b) (42 U.S.C.

300ff–14(b)) of the Public Health Service Act is amended—

(1) by redesignating paragraph (3) as paragraph (4); and

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

‘‘(3) EARLY INTERVENTION SERVICES.—

‘‘(A) IN GENERAL.—The purposes for which a grant

under section 2601 may be used include providing to

individuals with HIV disease early intervention services

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. The

entities through which such services may be provided under

the grant include public health departments, emergency

rooms, substance abuse and mental health treatment programs, detoxification centers, detention facilities, clinics

regarding sexually transmitted diseases, homeless shelters,

HIV disease counseling and testing sites, health care points

of entry specified by eligible areas, federally qualified

health centers, and entities described in section 2652(a)

that constitute a point of access to services by maintaining

referral relationships.

‘‘(B) CONDITIONS.—With respect to an entity that proposes to provide early intervention services under subparagraph (A), such subparagraph applies only if the entity

114 STAT. 1328 PUBLIC LAW 106–345—OCT. 20, 2000

demonstrates to the satisfaction of the chief elected official

for the eligible area involved that—

‘‘(i) Federal, State, or local funds are otherwise

inadequate for the early intervention services the

entity proposes to provide; and

‘‘(ii) the entity will expend funds pursuant to such

subparagraph to supplement and not supplant other

funds available to the entity for the provision of early

intervention services for the fiscal year involved.’’.

(c) PRIORITY FOR WOMEN, INFANTS, AND CHILDREN.—Section

2604(b) (42 U.S.C. 300ff–14(b)) of the Public Health Service Act

is amended in paragraph (4) (as redesignated by subsection (b)(1)

of this section) by amending the paragraph to read as follows:

‘‘(4) PRIORITY FOR WOMEN, INFANTS AND CHILDREN.—

‘‘(A) IN GENERAL.—For the purpose of providing health

and support services to infants, children, youth, and women

with HIV disease, including treatment measures to prevent

the perinatal transmission of HIV, the chief elected official

of an eligible area, in accordance with the established priorities of the planning council, shall for each of such populations in the eligible area use, from the grants made

for the area under section 2601(a) for a fiscal year, not

less than the percentage constituted by the ratio of the

population involved (infants, children, youth, or women

in such area) with acquired immune deficiency syndrome

to the general population in such area of individuals with

such syndrome.

‘‘(B) WAIVER.—With respect to the population involved,

the Secretary may provide to the chief elected official of

an eligible area a waiver of the requirement of subparagraph (A) if such official demonstrates to the satisfaction

of the Secretary that the population is receiving HIVrelated health services through the State medicaid program

under title XIX of the Social Security Act, the State children’s health insurance program under title XXI of such

Act, or other Federal or State programs.’’.

(d) QUALITY MANAGEMENT.—Section 2604 of the Public Health

Service Act (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 HIV health 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 as applicable, to develop

strategies for ensuring that such services are consistent with

the guidelines for improvement in the access to and quality

of HIV health services.

‘‘(2) USE OF FUNDS.—From amounts received under a grant

awarded under this part for a fiscal year, the chief elected

official of an eligible area may (in addition to amounts to

which subsection (f)(1) applies) use for activities associated

PUBLIC LAW 106–345—OCT. 20, 2000 114 STAT. 1329

with the quality management program required in paragraph

(1) not more than the lesser of—

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

or

‘‘(B) $3,000,000.’’.

SEC. 122. APPLICATION.

(a) IN GENERAL.—Section 2605(a) of the Public Health Service

Act (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 paragraphs:

‘‘(3) that entities within the eligible area that receive funds

under a grant under this part will maintain appropriate relationships with entities in the eligible 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, mental health programs, and

homeless shelters), and other entities under section 2604(b)(3)

and 2652(a), for the purpose of facilitating early intervention

for individuals newly diagnosed with HIV disease and individuals knowledgeable of their HIV status but not in care;

‘‘(4) that the chief elected official of the eligible area will

satisfy all requirements under section 2604(c);’’.

(b) CONFORMING AMENDMENTS.—Section 2605(a) (42 U.S.C.

300ff–15(a)(1)) is amended—

(1) in paragraph (1)—

(A) in subparagraph (A), by striking ‘‘services to

individuals with HIV disease’’ and inserting ‘‘services as

described in section 2604(b)(1)’’; and

(B) in subparagraph (B), by striking ‘‘services for

individuals with HIV disease’’ and inserting ‘‘services as

described in section 2604(b)(1)’’;

(2) in paragraph (7) (as redesignated by subsection (a)(1)

of this section), by striking ‘‘and’’ at the end;

(3) in paragraph (8) (as so redesignated), by striking the

period and inserting ‘‘; and’’; and

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

‘‘(9) 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).’’.

TITLE II—CARE GRANT PROGRAM

Subtitle A—General Grant Provisions

SEC. 201. PRIORITY FOR WOMEN, INFANTS, AND CHILDREN.

Section 2611(b) of the Public Health Service Act (42 U.S.C.

300ff–21(b)) is amended to read as follows:

‘‘(b) PRIORITY FOR WOMEN, INFANTS AND CHILDREN.—

‘‘(1) IN GENERAL.—For the purpose of providing health and

support services to infants, children, youth, and women with

HIV disease, including treatment measures to prevent the

114 STAT. 1330 PUBLIC LAW 106–345—OCT. 20, 2000

perinatal transmission of HIV, a State shall for each of such

populations use, of the funds allocated under this part to the

State for a fiscal year, not less than the percentage constituted

by the ratio of the population involved (infants, children, youth,

or women in the State) with acquired immune deficiency syndrome to the general population in the State of individuals

with such syndrome.

‘‘(2) WAIVER.—With respect to the population involved, the

Secretary may provide to a State a waiver of the requirement

of paragraph (1) if the State demonstrates to the satisfaction

of the Secretary that the population is receiving HIV-related

health services through the State medicaid program under title

XIX of the Social Security Act, the State children’s health

insurance program under title XXI of such Act, or other Federal

or State programs.’’.

SEC. 202. USE OF GRANTS.

Section 2612 of the Public Health Service Act (42 U.S.C. 300ff–

22) is amended—

(1) by striking ‘‘A State may use’’ and inserting ‘‘(a) IN

GENERAL.—A State may use’’; and

(2) by adding at the end the following subsections:

‘‘(b) SUPPORT SERVICES; OUTREACH.—The purposes for which

a grant under this part may be used include delivering or enhancing

the following:

‘‘(1) Outpatient and ambulatory support services under section 2611(a) (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.

‘‘(2) Outreach activities that are intended to identify

individuals with HIV disease who know their HIV status and

are not receiving HIV-related services, and that are—

‘‘(A) necessary to implement the strategy under section

2617(b)(4)(B), including activities facilitating the access of

such individuals to HIV-related primary care services at

entities described in subsection (c)(1);

‘‘(B) conducted in a manner consistent with the requirement under section 2617(b)(6)(G) and 2651(b)(2); and

‘‘(C) supplement, and do not supplant, such activities

that are carried out with amounts appropriated under section 317.

‘‘(c) EARLY INTERVENTION SERVICES.—

‘‘(1) IN GENERAL.—The purposes for which a grant under

this part may be used include providing to individuals with

HIV disease early intervention services 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. The entities through which such

services may be provided under the grant include public health

departments, emergency rooms, substance abuse and mental

health treatment programs, detoxification centers, detention

facilities, clinics regarding sexually transmitted diseases, homeless shelters, HIV disease counseling and testing sites, health

care points of entry specified by States or eligible areas, federally qualified health centers, and entities described in section

PUBLIC LAW 106–345—OCT. 20, 2000 114 STAT. 1331

2652(a) that constitute a point of access to services by

maintaining referral relationships.

‘‘(2) CONDITIONS.—With respect to an entity that proposes

to provide early intervention services under paragraph (1), such

paragraph applies only if the entity demonstrates to the satisfaction of the State involved that—

‘‘(A) Federal, State, or local funds are otherwise inadequate for the early intervention services the entity proposes to provide; and

‘‘(B) the entity will expend funds pursuant to such

paragraph to supplement and not supplant other funds

available to the entity for the provision of early intervention

services for the fiscal year involved.

‘‘(d) QUALITY MANAGEMENT.—

‘‘(1) REQUIREMENT.—Each State that receives a grant under

this part shall provide for the establishment of a quality

management program to assess the extent to which HIV health

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 as applicable, to develop strategies for ensuring that such

services are consistent with the guidelines for improvement

in the access to and quality of HIV health services.

‘‘(2) USE OF FUNDS.—From amounts received under a grant

awarded under this part for a fiscal year, the State may (in

addition to amounts to which section 2618(b)(5) applies) use

for activities associated with the quality management program

required in paragraph (1) not more than the lesser of—

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

or

‘‘(B) $3,000,000.’’.

SEC. 203. GRANTS TO ESTABLISH HIV CARE CONSORTIA.

Section 2613 of the Public Health Service Act (42 U.S.C. 300ff–

23) is amended—

(1) in subsection (b)(1)—

(A) in subparagraph (A), by inserting before the semicolon the following: ‘‘, particularly those experiencing

disparities in access and services and those who reside

in historically underserved communities’’; and

(B) in subparagraph (B), by inserting after ‘‘by such

consortium’’ the following: ‘‘is consistent with the comprehensive plan under section 2617(b)(4) and’’;

(2) in subsection (c)(1)—

(A) in subparagraph (D), by striking ‘‘and’’ after the

semicolon at the end;

(B) in subparagraph (E), by striking the period and

inserting ‘‘; and’’; and

(C) by adding at the end the following subparagraph:

‘‘(F) demonstrates that adequate planning occurred to

address disparities in access and services and historically

underserved communities.’’; and

(3) in subsection (c)(2)—

(A) in subparagraph (B), by striking ‘‘and’’ after the

semicolon;

(B) in subparagraph (C), by striking the period and

inserting ‘‘; and’’; and

114 STAT. 1332 PUBLIC LAW 106–345—OCT. 20, 2000

(C) by inserting after subparagraph (C) the following

subparagraph:

‘‘(D) the types of entities described in section

2602(b)(2).’’.

SEC. 204. PROVISION OF TREATMENTS.

(a) IN GENERAL.—Section 2616(c) of the Public Health Service

Act (42 U.S.C. 300ff–26(c)) is amended—

(1) in paragraph (4), by striking ‘‘and’’ after the semicolon

at the end;

(2) in paragraph (5), by striking the period and inserting

‘‘; and’’; and

(3) by inserting after paragraph (5) the following:

‘‘(6) encourage, support, and enhance adherence to and

compliance with treatment regimens, including related medical

monitoring.

Of the amount reserved by a State for a fiscal year for use under

this section, the State may not use more than 5 percent to carry

out services under paragraph (6), except that the percentage

applicable with respect to such paragraph is 10 percent if the

State demonstrates to the Secretary that such additional services

are essential and in no way diminish access to the therapeutics

described in subsection (a).’’.

(b) HEALTH INSURANCE AND PLANS.—Section 2616 of the Public

Health Service Act (42 U.S.C. 300ff–26) is amended by adding

at the end the following subsection:

‘‘(e) USE OF HEALTH INSURANCE AND PLANS.—

‘‘(1) IN GENERAL.—In carrying out subsection (a), a State

may expend a grant under this part to provide the therapeutics

described in such subsection by paying on behalf of individuals

with HIV disease the costs of purchasing or maintaining health

insurance or plans whose coverage includes a full range of

such therapeutics and appropriate primary care services.

‘‘(2) LIMITATION.—The authority established in paragraph

(1) applies only to the extent that, for the fiscal year involved,

the costs of the health insurance or plans to be purchased

or maintained under such paragraph do not exceed the costs

of otherwise providing therapeutics described in subsection (a).’’.

SEC. 205. STATE APPLICATION.

(a) DETERMINATION OF SIZE AND NEEDS OF POPULATION; COMPREHENSIVE PLAN.—Section 2617(b) of the Public Health Service

Act (42 U.S.C. 300ff–27(b)) is amended—

(1) by redesignating paragraphs (2) through (4) as paragraphs (4) through (6), respectively;

(2) by inserting after paragraph (1) the following paragraphs:

‘‘(2) a determination of the size and demographics of the

population of individuals with HIV disease in the State;

‘‘(3) a determination of the needs of such population, with

particular attention to—

‘‘(A) individuals with HIV disease who know their HIV

status and are not receiving HIV-related services; and

‘‘(B) disparities in access and services among affected

subpopulations and historically underserved communities;’’;

and

(3) in paragraph (4) (as so redesignated)—

PUBLIC LAW 106–345—OCT. 20, 2000 114 STAT. 1333

(A) by striking ‘‘comprehensive plan for the organization’’ and inserting ‘‘comprehensive plan that describes the

organization’’;

(B) by striking ‘‘, including—’’ and inserting ‘‘, and

that—’’;

(C) by redesignating subparagraphs (A) through (C)

as subparagraphs (D) through (F), respectively;

(D) by inserting before subparagraph (C) the following

subparagraphs:

‘‘(A) establishes priorities for the allocation of funds

within the State based on—

‘‘(i) size and demographics of the population of

individuals with HIV disease (as determined under

paragraph (2)) and the needs of such population (as

determined under paragraph (3));

‘‘(ii) availability of other governmental and nongovernmental 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;

‘‘(iii) capacity development needs resulting from

disparities in the availability of HIV-related services

in historically underserved communities and rural

communities; and

‘‘(iv) the efficiency of the administrative mechanism of the State for rapidly allocating funds to the

areas of greatest need within the State;

‘‘(B) includes a strategy for identifying individuals who

know their HIV status and are not receiving such services

and for informing the individuals of and enabling the

individuals to utilize the services, giving particular attention to eliminating disparities in access and services among

affected subpopulations and historically underserved

communities, and including discrete goals, a timetable, and

an appropriate allocation of funds;

‘‘(C) includes a strategy to coordinate the provision

of such services with programs for HIV prevention

(including outreach and early intervention) and for the

prevention and treatment of substance abuse (including

programs that provide comprehensive treatment services

for such abuse);’’;

(E) in subparagraph (D) (as redesignated by subparagraph (C) of this paragraph), by inserting ‘‘describes’’ before

‘‘the services and activities’’;

(F) in subparagraph (E) (as so redesignated), by

inserting ‘‘provides’’ before ‘‘a description’’; and

(G) in subparagraph (F) (as so redesignated), by

inserting ‘‘provides’’ before ‘‘a description’’.

(b) PUBLIC PARTICIPATION.—Section 2617(b) of the Public

Health Service Act, as amended by subsection (a) of this section,

is amended—

(1) in paragraph (5), by striking ‘‘HIV’’ and inserting ‘‘HIV

disease’’; and

(2) in paragraph (6), by amending subparagraph (A) to

read as follows:

42 USC 300ff–27.

114 STAT. 1334 PUBLIC LAW 106–345—OCT. 20, 2000

‘‘(A) the public health agency that is administering

the grant for the State engages in a public advisory planning process, including public hearings, that includes the

participants under paragraph (5), and the types of entities

described in section 2602(b)(2), in developing the comprehensive plan under paragraph (4) and commenting on

the implementation of such plan;’’.

(c) HEALTH CARE RELATIONSHIPS.—Section 2617(b) of the Public

Health Service Act, as amended by subsection (a) of this section,

is amended in paragraph (6)—

(1) in subparagraph (E), by striking ‘‘and’’ at the end;

(2) in subparagraph (F), by striking the period and inserting

‘‘; and’’; and

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

‘‘(G) entities within areas in which activities under

the grant are carried out will 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, mental

health programs, and homeless shelters), and other entities

under section 2612(c) and 2652(a), for the purpose of facilitating early intervention for individuals newly diagnosed

with HIV disease and individuals knowledgeable of their

HIV status but not in care.’’.

SEC. 206. DISTRIBUTION OF FUNDS.

(a) MINIMUM ALLOTMENT.—Section 2618 of the Public Health

Service Act (42 U.S.C. 300ff–28) is amended—

(1) by redesignating subsections (b) through (e) as subsections (a) through (d), respectively; and

(2) in subsection (a) (as so redesignated), in paragraph

(1)(A)(i)—

(A) in subclause (I), by striking ‘‘$100,000’’ and

inserting ‘‘$200,000’’; and

(B) in subclause (II), by striking ‘‘$250,000’’ and

inserting ‘‘$500,000’’.

(b) AMOUNT OF GRANT; ESTIMATE OF LIVING CASES.—Section

2618(a) of the Public Health Service Act (as redesignated by subsection (a)(1) of this section) is amended in paragraph (2)—

(1) in subparagraph (D)(i), by inserting before the semicolon

the following: ‘‘, except that (subject to subparagraph (E)), for

grants made pursuant to this paragraph or section 2620 for

fiscal year 2005 and subsequent fiscal years, the cases counted

for each 12-month period beginning on or after July 1, 2004,

shall be cases of HIV disease (as reported to and confirmed

by such Director) rather than cases of acquired immune deficiency syndrome’’;

(2) by redesignating subparagraphs (E) through (H) as

subparagraphs (F) through (I), respectively; and

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

subparagraph:

‘‘(E) DETERMINATION OF SECRETARY REGARDING DATA

ON HIV CASES.—If under section 2603(a)(3)(D)(i) the Secretary determines that data on cases of HIV disease are

42 USC 300ff–27.

PUBLIC LAW 106–345—OCT. 20, 2000 114 STAT. 1335

not sufficiently accurate and reliable, then notwithstanding

subparagraph (D) of this paragraph, for any fiscal year

prior to fiscal year 2007 the references in such subparagraph to cases of HIV disease do not have any legal effect.’’.

(c) INCREASES IN FORMULA AMOUNT.—Section 2618(a) of the

Public Health Service Act (as redesignated by subsection (a)(1)

of this section) is amended—

(1) in paragraph (1)(A)(ii), by inserting before the semicolon

the following: ‘‘and then, as applicable, increased under paragraph (2)(H)’’; and

(2) in paragraph (2)—

(A) in subparagraph (A)(i), by striking ‘‘subparagraph

(H)’’ and inserting ‘‘subparagraphs (H) and (I)’’; and

(B) in subparagraph (H) (as redesignated by subsection

(b)(2) of this section), by amending the subparagraph to

read as follows:

‘‘(H) LIMITATION.—

‘‘(i) IN GENERAL.—The Secretary shall ensure that

the amount of a grant awarded to a State or territory

under section 2611 or subparagraph (I)(i) for a fiscal

year is not less than—

‘‘(I) with respect to fiscal year 2001, 99 percent;

‘‘(II) with respect to fiscal year 2002, 98 percent;

‘‘(III) with respect to fiscal year 2003, 97 percent;

‘‘(IV) with respect to fiscal year 2004, 96 percent; and

‘‘(V) with respect to fiscal year 2005, 95 percent,

of the amount such State or territory received for fiscal

year 2000 under section 2611 or subparagraph (I)(i),

respectively (notwithstanding such subparagraph). In

administering this subparagraph, the Secretary shall,

with respect to States or territories that will under

such section receive grants in amounts that exceed

the amounts that such States received under such

section or subparagraph for fiscal year 2000, proportionally reduce such amounts to ensure compliance

with this subparagraph. In making such reductions,

the Secretary shall ensure that no such State receives

less than that State received for fiscal year 2000.

‘‘(ii) RATABLE REDUCTION.—If the amount appropriated under section 2677 for a fiscal year and available for grants under section 2611 or subparagraph

(I)(i) is less than the amount appropriated and available for fiscal year 2000 under section 2611 or subparagraph (I)(i), respectively, the limitation contained in

clause (i) for the grants involved shall be reduced by

a percentage equal to the percentage of the reduction

in such amounts appropriated and available.’’.

(d) TERRITORIES.—Section 2618(a) of the Public Health Service

Act (as redesignated by subsection (a)(1) of this section) is amended

in paragraph (1)(B) by inserting ‘‘the greater of $50,000 or’’ after

‘‘shall be’’.

(e) SEPARATE TREATMENT DRUG GRANTS.—Section 2618(a) of

the Public Health Service Act (as redesignated by subsection (a)(1)

42 USC 300ff–28.

114 STAT. 1336 PUBLIC LAW 106–345—OCT. 20, 2000

of this section and amended by subsection (b)(2) of this section)

is amended in paragraph (2)(I)—

(1) by redesignating clauses (i) and (ii) as subclauses (I)

and (II), respectively;

(2) by striking ‘‘(I) APPROPRIATIONS’’ and all that follows

through ‘‘With respect to’’ and inserting the following:

‘‘(I) APPROPRIATIONS FOR TREATMENT DRUG PROGRAM.—

‘‘(i) FORMULA GRANTS.—With respect to’’;

(3) in subclause (I) of clause (i) (as designated by paragraphs (1) and (2)), by inserting before the semicolon the following: ‘‘, less the percentage reserved under clause (ii)(V)’’;

and

(4) by adding at the end the following clause:

‘‘(ii) SUPPLEMENTAL TREATMENT DRUG GRANTS.—

‘‘(I) IN GENERAL.—From amounts made available under subclause (V), the Secretary shall make

supplemental grants to States described in subclause (II) to enable such States to increase access

to therapeutics described in section 2616(a), as

provided by the State under section 2616(c)(2).

‘‘(II) ELIGIBLE STATES.—For purposes of subclause (I), a State described in this subclause is

a State that, in accordance with criteria established by the Secretary, demonstrates a severe

need for a grant under such subclause. In developing such criteria, the Secretary shall consider

eligibility standards, formulary composition, and

the number of eligible individuals at or below 200

percent of the official poverty line to whom the

State is unable to provide therapeutics described

in section 2616(a).

‘‘(III) STATE REQUIREMENTS.—The Secretary

may not make a grant to a State under this clause

unless the State agrees that—

‘‘(aa) 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

‘‘(bb) the State will not impose eligibility

requirements for services or scope of benefits

limitations under section 2616(a) that are

more restrictive than such requirements in

effect as of January 1, 2000.

‘‘(IV) USE AND COORDINATION.—Amounts

made available under a grant under this

clause shall only be used by the State to provide HIV/AIDS-related medications. The State

shall coordinate the use of such amounts with

the amounts otherwise provided under section

2616(a) in order to maximize drug coverage.

‘‘(V) FUNDING.—For the purpose of making

grants under this clause, the Secretary shall each

fiscal year reserve 3 percent of the amount referred

Effective date.

PUBLIC LAW 106–345—OCT. 20, 2000 114 STAT. 1337

to in clause (i) with respect to section 2616, subject

to subclause (VI).

‘‘(VI) LIMITATION.—In reserving amounts

under subclause (V) and making grants under this

clause for a fiscal year, the Secretary shall ensure

for each State that the total of the grant under

section 2611 for the State for the fiscal year and

the grant under clause (i) for the State for the

fiscal year is not less than such total for the State

for the preceding fiscal year.’’.

(f) TECHNICAL AMENDMENT.—Section 2618(a) of the Public

Health Service Act (as redesignated by subsection (a)(1) of this

section) is amended in paragraph (3)(B) 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, and only for purposes of paragraph (1) the

Commonwealth of Puerto Rico’’.

SEC. 207. SUPPLEMENTAL 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—

(1) by striking section 2621; and

(2) by inserting after section 2619 the following section:

‘‘SEC. 2620. 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

emerging communities 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;

‘‘(2) demonstrate the existence in the State of an emerging

community as defined in subsection (d)(1); and

‘‘(3) submit the information described in subsection (c).

‘‘(c) REPORTING REQUIREMENTS.—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 in the emerging community;

‘‘(2) a demonstration of the existing commitment of local

resources, both financial and in-kind;

‘‘(3) a demonstration that the State will maintain HIVrelated 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

Reports.

42 USC 300ff–30.

42 USC 300ff–31.

42 USC 300ff–28.

114 STAT. 1338 PUBLIC LAW 106–345—OCT. 20, 2000

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) DEFINITION OF EMERGING COMMUNITY.—In this section,

the term ‘emerging community’ means a metropolitan area—

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

‘‘(2) for which there has been reported to the Director

of the Centers for Disease Control and Prevention a cumulative

total of between 500 and 1,999 cases of acquired immune deficiency syndrome for the most recent period of 5 calendar years

for which such data are available (except that, for fiscal year

2005 and subsequent fiscal years, cases of HIV disease shall

be counted rather than cases of acquired immune deficiency

syndrome if cases of HIV disease are being counted for purposes

of section 2618(a)(2)(D)(i)).

‘‘(e) FUNDING.—

‘‘(1) IN GENERAL.—Subject to paragraph (2), with respect

to each fiscal year beginning with fiscal year 2001, the Secretary, to carry out this section, shall utilize—

‘‘(A) the greater of—

‘‘(i) 25 percent of the amount appropriated under

section 2677 to carry out part B, excluding the amount

appropriated under section 2618(a)(2)(I), for such fiscal

year that is in excess of the amount appropriated to

carry out such part in the fiscal year preceding the

fiscal year involved; or

‘‘(ii) $5,000,000,

to provide funds to States for use in emerging communities

with at least 1,000, but less than 2,000, cases of AIDS

as reported to and confirmed by the Director of the Centers

for Disease Control and Prevention for the five year period

preceding the year for which the grant is being awarded;

and

‘‘(B) the greater of—

‘‘(i) 25 percent of the amount appropriated under

section 2677 to carry out part B, excluding the amount

appropriated under section 2618(a)(2)(I), for such fiscal

year that is in excess of the amount appropriated to

carry out such part in the fiscal year preceding the

fiscal year involved; or

‘‘(ii) $5,000,000,

to provide funds to States for use in emerging communities

with at least 500, but less than 1,000, cases of AIDS

reported to and confirmed by the Director of the Centers

for Disease Control and Prevention for the five year period

preceding the year for which the grant is being awarded.

‘‘(2) TRIGGER OF FUNDING.—This section shall be effective

only for fiscal years beginning in the first fiscal year in which

the amount appropriated under section 2677 to carry out part

B, excluding the amount appropriated under section

2618(a)(2)(I), exceeds by at least $20,000,000 the amount appropriated under section 2677 to carry out part B in fiscal year

Effective date.

PUBLIC LAW 106–345—OCT. 20, 2000 114 STAT. 1339

2000, excluding the amount appropriated under section

2618(a)(2)(I).

‘‘(3) MINIMUM AMOUNT IN FUTURE YEARS.—Beginning with

the first fiscal year in which amounts provided for emerging

communities under paragraph (1)(A) equals $5,000,000 and

under paragraph (1)(B) equals $5,000,000, the Secretary shall

ensure that amounts made available under this section for

the types of emerging communities described in each such

paragraph in subsequent fiscal years is at least $5,000,000.

‘‘(4) DISTRIBUTION.—Grants under this section for emerging

communities shall be formula grants. There shall be two categories of such formula grants, as follows:

‘‘(A) One category of such grants shall be for emerging

communities for which the cumulative total of cases for

purposes of subsection (d)(2) is 999 or fewer cases. The

grant made to such an emerging community for a fiscal

year shall be the product of—

‘‘(i) an amount equal to 50 percent of the amount

available pursuant to this subsection for the fiscal

year involved; and

‘‘(ii) a percentage equal to the ratio constituted

by the number of cases for such emerging community

for the fiscal year over the aggregate number of such

cases for such year for all emerging communities to

which this subparagraph applies.

‘‘(B) The other category of formula grants shall be

for emerging communities for which the cumulative total

of cases for purposes of subsection (d)(2) is 1,000 or more

cases. The grant made to such an emerging community

for a fiscal year shall be the product of—

‘‘(i) an amount equal to 50 percent of the amount

available pursuant to this subsection for the fiscal

year involved; and

‘‘(ii) a percentage equal to the ratio constituted

by the number of cases for such community for the

fiscal year over the aggregate number of such cases

for the fiscal year for all emerging communities to

which this subparagraph applies.’’.

Subtitle B—Provisions Concerning Pregnancy and Perinatal Transmission of

HIV

SEC. 211. REPEALS.

Subpart II of part B of title XXVI of the Public Health Service

Act (42 U.S.C. 300ff–33 et seq.) is amended—

(1) in section 2626, by striking each of subsections (d)

through (f);

(2) by striking sections 2627 and 2628; and

(3) by redesignating section 2629 as section 2627.

SEC. 212. GRANTS.

(a) IN GENERAL.—Section 2625(c) of the Public Health Service

Act (42 U.S.C. 300ff–33) is amended—

42 USC 300ff–37.

42 USC 300ff–35,

300ff–36.

42 USC 300ff–34.

114 STAT. 1340 PUBLIC LAW 106–345—OCT. 20, 2000

(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

PUBLIC LAW 106–345—OCT. 20, 2000 114 STAT. 1341

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.—

114 STAT. 1342 PUBLIC LAW 106–345—OCT. 20, 2000

(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

Deadline.

42 USC 300ff–

37a.

PUBLIC LAW 106–345—OCT. 20, 2000 114 STAT. 1343

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).’’.

Subtitle C—Certain Partner Notification

Programs

SEC. 221. GRANTS FOR COMPLIANT PARTNER NOTIFICATION PROGRAMS.

Part B of title XXVI of the Public Health Service Act (42

U.S.C. 300ff–21 et seq.) is amended by adding at the end the

following subpart:

‘‘Subpart III—Certain Partner Notification

Programs

‘‘SEC. 2631. GRANTS FOR PARTNER NOTIFICATION PROGRAMS.

‘‘(a) IN GENERAL.—In the case of States whose laws or regulations are in accordance with subsection (b), the Secretary, subject

to subsection (c)(2), may make grants to the States for carrying

out programs to provide partner counseling and referral services.

‘‘(b) DESCRIPTION OF COMPLIANT STATE PROGRAMS.—For purposes of subsection (a), the laws or regulations of a State are

in accordance with this subsection if under such laws or regulations

(including programs carried out pursuant to the discretion of State

officials) the following policies are in effect:

‘‘(1) The State requires that the public health officer of

the State carry out a program of partner notification to inform

partners of individuals with HIV disease that the partners

may have been exposed to the disease.

‘‘(2)(A) In the case of a health entity that provides for

the performance on an individual of a test for HIV disease,

or that treats the individual for the disease, the State requires,

subject to subparagraph (B), that the entity confidentially

report the positive test results to the State public health officer

in a manner recommended and approved by the Director of

the Centers for Disease Control and Prevention, together with

such additional information as may be necessary for carrying

out such program.

‘‘(B) The State may provide that the requirement of

subparagraph (A) does not apply to the testing of an individual

for HIV disease if the individual underwent the testing through

a program designed to perform the test and provide the results

to the individual without the individual disclosing his or her

identity to the program. This subparagraph may not be construed as affecting the requirement of subparagraph (A) with

respect to a health entity that treats an individual for HIV

disease.

42 USC 300ff–38.

114 STAT. 1344 PUBLIC LAW 106–345—OCT. 20, 2000

‘‘(3) The program under paragraph (1) is carried out in

accordance with the following:

‘‘(A) Partners are provided with an appropriate opportunity to learn that the partners have been exposed to

HIV disease, subject to subparagraph (B).

‘‘(B) The State does not inform partners of the identity

of the infected individuals involved.

‘‘(C) Counseling and testing for HIV disease are made

available to the partners and to infected individuals, and

such counseling includes information on modes of transmission for the disease, including information on prenatal

and perinatal transmission and preventing transmission.

‘‘(D) Counseling of infected individuals and their partners includes the provision of information regarding therapeutic measures for preventing and treating the deterioration of the immune system and conditions arising from

the disease, and the provision of other prevention-related

information.

‘‘(E) Referrals for appropriate services are provided

to partners and infected individuals, including referrals

for support services and legal aid.

‘‘(F) Notifications under subparagraph (A) are provided

in person, unless doing so is an unreasonable burden on

the State.

‘‘(G) There is no criminal or civil penalty on, or civil

liability for, an infected individual if the individual chooses

not to identify the partners of the individual, or the individual does not otherwise cooperate with such program.

‘‘(H) The failure of the State to notify partners is

not a basis for the civil liability of any health entity who

under the program reported to the State the identity of

the infected individual involved.

‘‘(I) The State provides that the provisions of the program may not be construed as prohibiting the State from

providing a notification under subparagraph (A) without

the consent of the infected individual involved.

‘‘(4) The State annually reports to the Director of the Centers for Disease Control and Prevention the number of individuals from whom the names of partners have been sought under

the program under paragraph (1), the number of such individuals who provided the names of partners, and the number

of partners so named who were notified under the program.

‘‘(5) The State cooperates with such Director in carrying

out a national program of partner notification, including the

sharing of information between the public health officers of

the States.

‘‘(c) REPORTING SYSTEM FOR CASES OF HIV DISEASE; PREFERENCE IN MAKING GRANTS.—In making grants under subsection

(a), the Secretary shall give preference to States whose reporting

systems for cases of HIV disease produce data on such cases that

is sufficiently accurate and reliable for use for purposes of section

2618(a)(2)(D)(i).

‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of

carrying out this section, there are authorized to be appropriated

$30,000,000 for fiscal year 2001, and such sums as may be necessary

for each of the fiscal years 2002 through 2005.’’.

PUBLIC LAW 106–345—OCT. 20, 2000 114 STAT. 1345

TITLE III—EARLY INTERVENTION

SERVICES

Subtitle A—Formula Grants for States

SEC. 301. REPEAL OF PROGRAM.

(a) REPEAL.—Subpart I of part C of title XXVI of the Public

Health Service Act (42 U.S.C. 300ff–41 et seq.) is repealed.

(b) CONFORMING AMENDMENTS.—Part C of title XXVI of the

Public Health Service Act (42 U.S.C. 300ff–41 et seq.), as amended

by subsection (a) of this section, is amended—

(1) by redesignating subparts II and III as subparts I

and II, respectively;

(2) in section 2661(a), by striking ‘‘unless—’’ and all that

follows through ‘‘(2) in the case of’’ and inserting ‘‘unless, in

the case of’’; and

(3) in section 2664—

(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).

Subtitle B—Categorical Grants

SEC. 311. PREFERENCES IN MAKING GRANTS.

Section 2653 of the Public Health Service Act (42 U.S.C. 300ff–

53) is amended by adding at the end the following subsection:

‘‘(d) CERTAIN AREAS.—Of the applicants who qualify for preference under this section—

‘‘(1) the Secretary shall give preference to applicants that

will expend the grant under section 2651 to provide early

intervention under such section in rural areas; and

‘‘(2) the Secretary shall give special consideration to areas

that are underserved with respect to such services.’’.

SEC. 312. PLANNING AND DEVELOPMENT GRANTS.

(a) IN GENERAL.—Section 2654(c)(1) of the Public Health Service

Act (42 U.S.C. 300ff–54(c)(1)) is amended by striking ‘‘planning

grants’’ and all that follows and inserting the following: ‘‘planning

grants to public and nonprofit private entities for purposes of—

‘‘(A) enabling such entities to provide HIV early intervention services; and

‘‘(B) assisting the entities in expanding their capacity

to provide HIV-related health services, including early

intervention services, in low-income communities and

affected subpopulations that are underserved with respect

to such services (subject to the condition that a grant

pursuant to this subparagraph may not be expended to

purchase or improve land, or to purchase, construct, or

permanently improve, other than minor remodeling, any

building or other facility).’’.

(b) AMOUNT; DURATION.—Section 2654(c) of the Public Health

Service Act (42 U.S.C. 300ff–54(c)) 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.—

42 USC 300ff–64.

42 USC 300ff–61.

114 STAT. 1346 PUBLIC LAW 106–345—OCT. 20, 2000

‘‘(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) of the Public

Health Service Act (42 U.S.C. 300ff–54(c)(5)), as redesignated by

subsection (b), is amended by striking ‘‘1 percent’’ and inserting

‘‘5 percent’’.

SEC. 313. AUTHORIZATION OF APPROPRIATIONS.

Section 2655 of the Public Health Service Act (42 U.S.C. 300ff–

55) is amended by striking ‘‘in each of’’ and all that follows and

inserting ‘‘for each of the fiscal years 2001 through 2005.’’.

Subtitle C—General Provisions

SEC. 321. PROVISION OF CERTAIN COUNSELING SERVICES.

Section 2662(c)(3) of the Public Health Service Act (42 U.S.C.

300ff–62(c)(3)) is amended—

(1) in the matter preceding subparagraph (A), by striking

‘‘counseling on—’’ and inserting ‘‘counseling—’’;

(2) in each of subparagraphs (A), (B), and (D), by inserting

‘‘on’’ after the subparagraph designation; and

(3) in subparagraph (C)—

(A) by striking ‘‘(C) the benefits’’ and inserting ‘‘(C)(i)

that explains the benefits’’; and

(B) by inserting after clause (i) (as designated by

subparagraph (A) of this paragraph) the following clause:

‘‘(ii) that emphasizes it is the duty of infected individuals to disclose their infected status to their sexual partners

and their partners in the sharing of hypodermic needles;

that provides advice to infected individuals on the manner

in which such disclosures can be made; and that emphasizes that it is the continuing duty of the individuals to

avoid any behaviors that will expose others to HIV.’’.

SEC. 322. ADDITIONAL REQUIRED AGREEMENTS.

Section 2664(g) of the Public Health Service Act (42 U.S.C.

300ff–64(g)) is amended—

(1) in paragraph (3)—

(A) by striking ‘‘7.5 percent’’ and inserting ‘‘10 percent’’;

and

(B) by striking ‘‘and’’ after the semicolon at the end;

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

‘‘; and’’; and

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

‘‘(5) the applicant will provide for the establishment of

a quality management program—

‘‘(A) 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

PUBLIC LAW 106–345—OCT. 20, 2000 114 STAT. 1347

opportunistic infections, and as applicable, to develop

strategies for ensuring that such services are consistent

with the guidelines; and

‘‘(B) to ensure that improvements in the access to

and quality of HIV health services are addressed.’’.

TITLE IV—OTHER PROGRAMS AND

ACTIVITIES

Subtitle A—Certain Programs for

Research, Demonstrations, or Training

SEC. 401. GRANTS FOR COORDINATED SERVICES AND ACCESS TO

RESEARCH FOR 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 inserting the following:

‘‘(C) The applicant will demonstrate linkages to

research and how access to such research is being offered

to patients.’’; 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/AIDSrelated 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

to assess the extent to which HIV health 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 as applicable,

to develop strategies for ensuring that such services are consistent with the guidelines for improvement in the access to

and quality of HIV health services.’’.

(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. Not later than 12 months after the date of the

enactment of the Ryan White CARE Act Amendments of 2000,

the Secretary shall prepare and submit to the appropriate committees of Congress a report that describes the findings made by

Deadline.

Reports.

114 STAT. 1348 PUBLIC LAW 106–345—OCT. 20, 2000

the Director and the manner in which the conclusions based on

those findings can be addressed.’’.

(e) ADMINISTRATIVE EXPENSES.—Section 2671 of the Public

Health Service Act (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 subsection:

‘‘(i) LIMITATION ON ADMINISTRATIVE EXPENSES.—

‘‘(1) DETERMINATION BY SECRETARY.—Not later than 12

months after the date of the 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.’’.

(f) AUTHORIZATION OF APPROPRIATIONS.—Section 2671 of the

Public Health Service Act (42 U.S.C. 300ff–71) is amended in subsection (j) (as redesignated by subsection (e)(1) of this section)

by striking ‘‘fiscal years 1996 through 2000’’ and inserting ‘‘fiscal

years 2001 through 2005’’.

SEC. 402. AIDS EDUCATION AND TRAINING CENTERS.

(a) SCHOOLS; CENTERS.—

(1) IN GENERAL.—Section 2692(a)(1) of the Public Health

Service Act (42 U.S.C. 300ff–111(a)(1)) is amended—

(A) in subparagraph (A)—

(i) by striking ‘‘training’’ and inserting ‘‘to train’’;

(ii) by striking ‘‘and including’’ and inserting ‘‘,

including’’; and

(iii) by inserting before the semicolon the following:

‘‘, and including (as applicable to the type of health

professional involved), prenatal and other gynecological

care for women with HIV disease’’;

(B) in subparagraph (B), by striking ‘‘and’’ after the

semicolon at the end;

(C) in subparagraph (C), by striking the period and

inserting ‘‘; and’’; and

(D) by adding at the end the following:

‘‘(D) to develop protocols for the medical care of women

with HIV disease, including prenatal and other gynecological care for such women.’’.

Deadlines.

PUBLIC LAW 106–345—OCT. 20, 2000 114 STAT. 1349

(2) DISSEMINATION OF TREATMENT GUIDELINES; MEDICAL

CONSULTATION ACTIVITIES.—Not later than 90 days after the

date of the enactment of this Act, the Secretary of Health

and Human Services shall issue and begin implementation

of a strategy for the dissemination of HIV treatment information to health care providers and patients.

(b) DENTAL SCHOOLS.—Section 2692(b) of the Public Health

Service Act (42 U.S.C. 300ff–111(b)) is amended—

(1) by amending paragraph (1) to read as follows:

‘‘(1) IN GENERAL.—

‘‘(A) GRANTS.—The Secretary may make grants to

dental schools and programs described in subparagraph

(B) to assist such schools and programs with respect to

oral health care to patients with HIV disease.

‘‘(B) ELIGIBLE APPLICANTS.—For purposes of this subsection, the dental schools and programs referred to in

this subparagraph are dental schools and programs that

were described in section 777(b)(4)(B) as such section was

in effect on the day before the date of the enactment

of the Health Professions Education Partnerships Act of

1998 (Public Law 105–392) and in addition dental hygiene

programs that are accredited by the Commission on Dental

Accreditation.’’;

(2) in paragraph (2), by striking ‘‘777(b)(4)(B)’’ and inserting

‘‘the section referred to in paragraph (1)(B)’’; and

(3) by inserting after paragraph (4) the following paragraph:

‘‘(5) COMMUNITY-BASED CARE.—The Secretary may make

grants to dental schools and programs described in paragraph

(1)(B) that partner with community-based dentists to provide

oral health care to patients with HIV disease in unserved

areas. Such partnerships shall permit the training of dental

students and residents and the participation of community

dentists as adjunct faculty.’’.

(c) AUTHORIZATION OF APPROPRIATIONS.—

(1) SCHOOLS; CENTERS.—Section 2692(c)(1) of the Public

Health Service Act (42 U.S.C. 300ff–111(c)(1)) is amended by

striking ‘‘fiscal years 1996 through 2000’’ and inserting ‘‘fiscal

years 2001 through 2005’’.

(2) DENTAL SCHOOLS.—Section 2692(c)(2) of the Public

Health Service Act (42 U.S.C. 300ff–111(c)(2)) is amended to

read as follows:

‘‘(2) DENTAL SCHOOLS.—

‘‘(A) IN GENERAL.—For the purpose of grants under

paragraphs (1) through (4) of subsection (b), there are

authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.

‘‘(B) COMMUNITY-BASED CARE.—For the purpose of

grants under subsection (b)(5), there are authorized to be

appropriated such sums as may be necessary for each of

the fiscal years 2001 through 2005.’’.

42 USC 300ff–

111 note.

Deadline.

114 STAT. 1350 PUBLIC LAW 106–345—OCT. 20, 2000

Subtitle B—General Provisions in Title

XXVI

SEC. 411. EVALUATIONS AND REPORTS.

Section 2674(c) of the Public Health Service Act (42 U.S.C.

300ff–74(c)) is amended by striking ‘‘1991 through 1995’’ and

inserting ‘‘2001 through 2005’’.

SEC. 412. DATA COLLECTION THROUGH CENTERS FOR DISEASE CONTROL AND PREVENTION.

Part B of title III of the Public Health Service Act (42 U.S.C.

243 et seq.) is amended by inserting after section 318A the following

section:

‘‘DATA COLLECTION REGARDING PROGRAMS UNDER TITLE XXVI

‘‘SEC. 318B. For the purpose of collecting and providing data

for program planning and evaluation activities under title XXVI,

there are authorized to be appropriated to the Secretary (acting

through the Director of the Centers for Disease Control and Prevention) such sums as may be necessary for each of the fiscal years

2001 through 2005. Such authorization of appropriations is in addition to other authorizations of appropriations that are available

for such purpose.’’.

SEC. 413. COORDINATION.

Section 2675 of the Public Health Service Act (42 U.S.C. 300ff–

75) is amended—

(1) by amending subsection (a) to read as follows:

‘‘(a) REQUIREMENT.—The Secretary shall ensure that the Health

Resources and Services Administration, the Centers for Disease

Control and Prevention, the Substance Abuse and Mental Health

Services Administration, and the Health Care Financing Administration coordinate the planning, funding, and implementation of

Federal HIV programs to enhance the continuity of care and prevention services for individuals with HIV disease or those at risk

of such disease. The Secretary shall consult with other Federal

agencies, including the Department of Veterans Affairs, as needed

and utilize planning information submitted to such agencies by

the States and entities eligible for support.’’;

(2) by redesignating subsections (b) and (c) as subsections

(c) and (d), respectively;

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

‘‘(b) REPORT.—The Secretary shall biennially prepare and

submit to the appropriate committees of the Congress a report

concerning the coordination efforts at the Federal, State, and local

levels described in this section, including a description of Federal

barriers to HIV program integration and a strategy for eliminating

such barriers and enhancing the continuity of care and prevention

services for individuals with HIV disease or those at risk of such

disease.’’; and

(4) in each of subsections (c) and (d) (as redesignated by

paragraph (2) of this section), by inserting ‘‘and prevention

services’’ after ‘‘continuity of care’’ each place such term

appears.

42 USC 247c–2.

PUBLIC LAW 106–345—OCT. 20, 2000 114 STAT. 1351

SEC. 414. PLAN REGARDING RELEASE OF PRISONERS WITH HIV DISEASE.

Section 2675 of the Public Health Service Act, as amended

by section 413(2) of this Act, is amended by adding at the end

the following subsection:

‘‘(e) RECOMMENDATIONS REGARDING RELEASE OF PRISONERS.— After consultation with the Attorney General and the Director

of the Bureau of Prisons, with States, with eligible areas under

part A, and with entities that receive amounts from grants under

part A or B, the Secretary, consistent with the coordination required

in subsection (a), shall develop a plan for the medical case management of and the provision of support services to individuals who

were Federal or State prisoners and had HIV disease as of the

date on which the individuals were released from the custody of

the penal system. The Secretary shall submit the plan to the

Congress not later than 2 years after the date of the enactment

of the Ryan White CARE Act Amendments of 2000.’’.

SEC. 415. AUDITS.

Part D of title XXVI of the Public Health Service Act (42

U.S.C. 300ff–71 et seq.) is amended by inserting after section 2675

the following section:

‘‘SEC. 2675A. AUDITS.

‘‘For fiscal year 2002 and subsequent fiscal years, the Secretary

may reduce the amounts of grants under this title to a State

or political subdivision of a State for a fiscal year if, with respect

to such grants for the second preceding fiscal year, the State or

subdivision fails to prepare audits in accordance with the procedures

of section 7502 of title 31, United States Code. The Secretary

shall annually select representative samples of such audits, prepare

summaries of the selected audits, and submit the summaries to

the Congress.’’.

SEC. 416. ADMINISTRATIVE SIMPLIFICATION.

Part D of title XXVI of the Public Health Service Act, as

amended by section 415 of this Act, is amended by inserting after

section 2675A the following section:

‘‘SEC. 2675B. ADMINISTRATIVE SIMPLIFICATION REGARDING PARTS A

AND B.

‘‘(a) COORDINATED DISBURSEMENT.—After consultation with the

States, with eligible areas under part A, and with entities that

receive amounts from grants under part A or B, the Secretary

shall develop a plan for coordinating the disbursement of appropriations for grants under part A with the disbursement of appropriations for grants under part B in order to assist grantees and

other recipients of amounts from such grants in complying with

the requirements of such parts. The Secretary shall submit the

plan to the Congress not later than 18 months after the date

of the enactment of the Ryan White CARE Act Amendments of

2000. Not later than 2 years after the date on which the plan

is so submitted, the Secretary shall complete the implementation

of the plan, notwithstanding any provision of this title that is

inconsistent with the plan.

‘‘(b) BIENNIAL APPLICATIONS.—After consultation with the

States, with eligible areas under part A, and with entities that

receive amounts from grants under part A or B, the Secretary

Deadline.

42 USC 300ff–

75b.

42 USC 300ff–

75a.

Deadline.

42 USC 300ff–75.

114 STAT. 1352 PUBLIC LAW 106–345—OCT. 20, 2000

shall make a determination of whether the administration of parts

A and B by the Secretary, and the efficiency of grantees under

such parts in complying with the requirements of such parts, would

be improved by requiring that applications for grants under such

parts be submitted biennially rather than annually. The Secretary

shall submit such determination to the Congress not later than

2 years after the date of the enactment of the Ryan White CARE

Act Amendments of 2000.

‘‘(c) APPLICATION SIMPLIFICATION.—After consultation with the

States, with eligible areas under part A, and with entities that

receive amounts from grants under part A or B, the Secretary

shall develop a plan for simplifying the process for applications

under parts A and B. The Secretary shall submit the plan to

the Congress not later than 18 months after the date of the enactment of the Ryan White CARE Act Amendments of 2000. Not

later than 2 years after the date on which the plan is so submitted,

the Secretary shall complete the implementation of the plan, notwithstanding any provision of this title that is inconsistent with

the plan.’’.

SEC. 417. AUTHORIZATION OF APPROPRIATIONS FOR PARTS A

AND B.

Section 2677 of the Public Health Service Act (42 U.S.C. 300ff–

77) is amended to read as follows:

‘‘SEC. 2677. AUTHORIZATION OF APPROPRIATIONS.

‘‘(a) PART A.—For the purpose of carrying out part A, there

are authorized to be appropriated such sums as may be necessary

for each of the fiscal years 2001 through 2005.

‘‘(b) PART B.—For the purpose of carrying out part B, there

are authorized to be appropriated such sums as may be necessary

for each of the fiscal years 2001 through 2005.’’.

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.—

42 USC 300ff–11

note.

Deadline.

Deadline.

PUBLIC LAW 106–345—OCT. 20, 2000 114 STAT. 1353

(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’’).

42 USC 300cc

note.

Deadline.

114 STAT. 1354 PUBLIC LAW 106–345—OCT. 20, 2000

(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.

SEC. 503. TECHNICAL CORRECTIONS.

(a) PUBLIC HEALTH SERVICE ACT.—Title XXVI of the Public

Health Service Act (42 U.S.C. 300ff–11 et seq.) is amended—

(1) in section 2605(d)—

(A) in paragraph (1), by striking ‘‘section 2608’’ and

inserting ‘‘section 2677’’; and

(B) in paragraph (4), by inserting ‘‘section’’ before

‘‘2601(a)’’; and

(2) in section 2673(a), in the matter preceding paragraph

(1), by striking ‘‘the Agency for Health Care Policy and

42 USC 300ff–73.

42 USC 300ff–15.

Deadline.

PUBLIC LAW 106–345—OCT. 20, 2000 114 STAT. 1355

LEGISLATIVE HISTORY—S. 2311 (H.R. 4807):

HOUSE REPORTS: No. 106–788 accompanying H.R. 4807 (Comm. on Commerce).

SENATE REPORTS: No. 106–294 (Comm. on Health, Education, Labor, and Pensions).

CONGRESSIONAL RECORD, Vol. 146 (2000):

June 6, considered and passed Senate.

Oct. 5, considered and passed House, amended. Senate concurred in House

amendments.

WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 36 (2000):

Oct. 20, Presidential statement.

Æ

Research’’ and inserting ‘‘the Director of the Agency for

Healthcare Research and Quality’’.

(b) RELATED ACT.—The first paragraph (2) of section 3(c) of

the Ryan White CARE Act Amendments of 1996 (Public Law 104–

146; 110 Stat. 1354) is amended in subparagraph (A)(iii) by striking

‘‘by inserting the following new paragraph:’’ and inserting ‘‘by

inserting before paragraph (2) (as so redesignated) the following

new paragraph’’.

TITLE VI—EFFECTIVE DATE

SEC. 601. EFFECTIVE DATE.

This Act and the amendments made by this Act take effect

October 1, 2000, or upon the date of the enactment of this Act,

whichever occurs later.

Approved October 20, 2000.

42 USC 300ff–12

note.

42 USC 300ff–22.