TITLE XXVI—HIV HEALTH CARE SERVICES PROGRAM 1

F:\COMP\PHSA\PHSA-MERGED.XML

1351

PUBLIC HEALTH SERVICE ACT

Sec. 2602

PUBLIC HEALTH SERVICE ACT

[As

Amended Through

P.L.

114–113, Enacted December

18,

2015]

øReferences

in

brackets

ø¿ are to

title

42,

United States

Code

¿

TITLE

XXVI—HIV

HEALTH CARE

SERVICES PROGRAM

1

P

ART

A—E

MERGENCY

R

ELIEF FOR

A

REAS

W

ITH

S

UBSTANTIAL

N

EED

FOR

S

ERVICES

2

Subpart I—General Grant

Provisions

SEC.

2601.

ø

300ff–11

¿

ESTABLISHMENT

OF

PROGRAM

OF

GRANTS.

(a)

E

LIGIBLE

A

REAS

.—The Secretary, acting through

the

Ad-

ministrator

of the

Health Resources

and

Services Administration,

shall, subject

to

subsections

(b)

through

(c),

make grants

in

accord-

ance

with section

2603 for the

purpose

of

assisting

in the

provision

of the

services specified

in

section

2604 in any

metropolitan area

for which

there

has been

reported

to and

confirmed

by the

Director

of the

Centers

for

Disease Control

and

Prevention

a

cumulative

total

of more

than

2,000 cases of AIDS

during

the most

recent pe-

riod of 5

calendar years

for which such

data

are

available.

(b)

C

ONTINUED

S

TATUS

AS

E

LIGIBLE

A

REA

.—Notwithstanding

any

other provision

of

this section,

a

metropolitan area that

is

an

eligible area

for a fiscal

year continues

to be an

eligible

area until

the

metropolitan area

fails, for

three consecutive

fiscal

years—

(1) to

meet

the

requirements

of

subsection

(a);

and

(2) to

have

a

cumulative total

of 3,000 or more living

cases

of AIDS

(reported

to and

confirmed

by the

Director

of the

Cen-

ters

for

Disease Control

and

Prevention)

as of

December

31 of

the most

recent calendar year

for which such

data

is

available.

(c)

B

OUNDARIES

.—For purposes

of

determining eligibility

under

this subpart—

(1)

with respect

to a

metropolitan area that received fund-

ing

under this subpart

in fiscal

year

2006, the

boundaries

of

such

metropolitan area shall

be the

boundaries that

were in

ef-

fect for such

area

for fiscal

year

1994;

or

(2)

with respect

to a

metropolitan area that becomes eligi-

ble to

receive funding under this subpart

in any fiscal

year

after

fiscal

year

2006, the

boundaries

of such

metropolitan

area

shall

be the

boundaries that

are in effect for such

area when

such

area initially receives funding

under this subpart.

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1351

PUBLIC HEALTH SERVICE ACT

Sec. 2602

SEC.

2602.

ø

300ff–12

¿

ADMINISTRATION

AND

PLANNING COUNCIL.

(a) A

DMINISTRATION

.—

1

This

title

was

added

by

Public

Law

101–381. Section

2 of

that Public

Law

provides

as fol-

lows: ‘‘It is the

purpose

of

this

Act to

provide emergency assistance

to

localities that

are

dis-

proportionately affected

by the

Human Immunodeficiency Virus epidemic

and to

make financial

assistance available

to

States

and

other

public or

private nonprofit entities

to

provide

for

the

development, organization, coordination

and

operation

of more

effective

and cost

efficient sys-

tems

for the

delivery

of

essential services

to

individuals

and

families with

HIV

disease.’’.

2

Section

502 of

Public

Law

106–345

(114

Stat.

1353)

relates

to the

development

of

reliable

and

affordable tests

for HIV

disease that

can

rapidly

be

administered

and whose

results can

rapidly

be

obtained.

With

respect

to

information

for

determining formula grants under parts

A and B,

section

501(a) of

Public

Law

106–345

(114

Stat.

1352)

provides

for a

study

of

State surveillance systems

regarding

cases of

infection with

the

human immunodeficiency virus. Section

501(d)(1) of

such

Law

requires that

a

report

of the

findings

of the

study

be

submitted

not

later than

3

years after

the

date

of the

enactment

of the Law, which was

enacted October

20,

2000.

F:\COMP\PHSA\PHSA-MERGED.XML

Sec. 2602

PUBLIC HEALTH SERVICE ACT

1352

(1) IN

GENERAL

.—Assistance made available

under grants

awarded under this subpart shall

be

directed

to the chief

elect-

ed official of the city or

urban county that administers

the

pub-

lic

health agency that provides outpatient

and

ambulatory

services

to the

greatest number

of

individuals with

AIDS,

as

reported

to and

confirmed

by the

Centers

for

Disease Control

and

Prevention,

in the

eligible area that

is

awarded

such

a

grant.

(2)

R

EQUIREMENTS

.—

(A) IN

GENERAL

.—To receive assistance under section

2601(a),

the chief

elected

official of the

eligible area in-

volved

shall—

(i)

establish, through intergovernmental agree-

ments with

the chief

elected

officials of the

political

subdivisions described

in

subparagraph

(B), an

admin-

istrative mechanism

to

allocate funds

and

services

based on—

(I) the

number

of AIDS cases in such

subdivi-

sions;

(II) the

severity

of need for

outpatient and

ambulatory

care

services

in such

subdivisions;

and

(III) the

health

and

support services per-

sonnel needs

of such

subdivisions;

and

(ii)

establish

an HIV

health services planning

council in

accordance with subsection (b).

(B)

L

OCAL POLITICAL SUBDIVISION

.—The political sub-

divisions referred

to in

subparagraph

(A) are

those polit-

ical

subdivisions

in the

eligible area—

(i)

that provide HIV-related health services;

and

(ii) for which the

number

of cases

reported for

purposes

of

section 2601(a) constitutes

not less

than

10

percent

of the

number

of such cases

reported for

the

eligible

area.

(b) HIV

H

EALTH

S

ERVICES

P

LANNING

C

OUNCIL

.—

(1)

E

STABLISHMENT

.—To

be

eligible

for

assistance under

this subpart,

the chief

elected

official

described

in

subsection

(a)(1)

shall establish

or

designate

an HIV

health services plan-

ning council

that shall reflect

in its

composition

the

demo-

graphics

of the

population

of

individuals with HIV/AIDS

in

the

eligible area involved, with particular consideration

given

to

disproportionately affected

and

historically underserved groups

and

subpopulations. Nominations

for

membership

on the

coun-

cil

shall

be

identified through

an open

process

and

candidates

shall

be

selected based

on locally

delineated

and

publicized cri-

teria.

Such

criteria shall include

a

conflict-of-interest

standard

that

is in

accordance with paragraph (5).

(2)

R

EPRESENTATION

.—The

HIV

health services planning

council

shall include representatives

of—

(A)

health

care

providers, including federally qualified

health centers;

(B)

community-based organizations serving affected

populations

and AIDS

service organizations;

(C) social

service providers, including providers

of

housing

and

homeless services;

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1353

PUBLIC HEALTH SERVICE ACT

Sec. 2602

(D)

mental health

and

substance abuse providers;

(E) local public

health agencies;

(F)

hospital planning agencies

or

health

care

planning

agencies;

(G)

affected communities, including

people

with HIV/

AIDS,

members

of a

Federally recognized

Indian tribe as

represented

in the

population, individuals co-infected

with

hepatitis

B or C and

historically underserved groups and

subpopulations;

(H)

nonelected community leaders;

(I)

State government (including

the

State medicaid

agency

and the

agency administering

the

program under

part B);

(J)

grantees under subpart

II of

part C;

(K)

grantees under section

2671, or, if none are

oper-

ating

in the

area, representatives

of

organizations with

a

history

of

serving children, youth, women,

and

families liv-

ing

with

HIV and

operating

in the

area;

(L)

grantees under other Federal

HIV

programs, in-

cluding

but not

limited

to

providers

of HIV

prevention

services;

and

(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/AIDS

as of the

date

on which the

individuals

were so

released.

(3)

M

ETHOD

OF

PROVIDING FOR COUNCIL

.—

(A) IN

GENERAL

.—In providing

for a council for

pur-

poses of

paragraph

(1), a chief

elected

official

receiving

a

grant under section 2601(a)

may

establish

the council

di-

rectly

or

designate

an

existing entity

to

serve

as the

coun-

cil,

subject

to

subparagraph (B).

(B)

C

ONSIDERATION REGARDING DESIGNATION

OF

COUN

-

CIL

.—In making

a

determination

of

whether

to

establish or

designate

a council

under subparagraph

(A), a chief

elected

official

receiving

a

grant under section 2601(a) shall give

priority

to the

designation

of an

existing entity that has

demonstrated experience

in

planning

for the HIV

health

care

service needs within

the

eligible area

and in the

im-

plementation

of such

plans

in

addressing those needs. Any

existing entity

so

designated shall

be

expanded

to

include

a

broad representation

of the full

range

of

entities that

provide

such

services within

the

geographic area

to

be

served.

(4)

D

UTIES

.—The planning

council

established

or

des-

ignated under paragraph

(1)

shall—

(A)

determine

the size and

demographics

of the

popu-

lation

of

individuals with HIV/AIDS,

as well as the

size

and

demographics

of the

estimated population

of

individ-

uals with HIV/AIDS

who are

unaware

of

their

HIV

status;

(B)

determine

the

needs

of such

population, with par-

ticular attention to—

(i)

individuals with HIV/AIDS

who know

their

HIV

status

and are not

receiving HIV-related services;

F:\COMP\PHSA\PHSA-MERGED.XML

Sec. 2602

PUBLIC HEALTH SERVICE ACT

1354

(ii)

disparities

in

access

and

services among af-

fected

subpopulations

and

historically underserved

communities;

and

(iii)

individuals with HIV/AIDS

who do not

know

their

HIV

status;

(C)

establish priorities

for the

allocation

of

funds with-

in the

eligible area, including

how best to

meet

each

such

priority

and

additional factors that

a

grantee should con-

sider

in

allocating funds under

a

grant based

on

the—

(i) size and

demographics

of the

population

of

indi-

viduals with HIV/AIDS

(as

determined under subpara-

graph

(A)) and the

needs

of such

population

(as

deter-

mined under subparagraph (B));

(ii)

demonstrated

(or

probable)

cost

effectiveness

and

outcome effectiveness

of

proposed strategies and

interventions,

to the

extent that data

are

reasonably

available;

(iii)

priorities

of the

communities with HIV/AIDS

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

non-

governmental resources, including

the

State medicaid

plan under title

XIX of the Social

Security

Act and

the

State Children’s

Health Insurance Program under title

XXI of such Act to cover

health

care costs of

eligible

individuals

and

families with HIV/AIDS;

and

(vi)

capacity development needs resulting from

disparities

in the

availability

of

HIV-related services

in

historically underserved communities;

(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

ena-

bling the

individuals

to

utilize

the

services,

giving

par-

ticular attention

to

eliminating disparities

in

access

and

services among affected subpopulations

and

his-

torically underserved communities,

and

including dis-

crete

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 (in-

cluding outreach

and

early intervention)

and for

the

prevention

and

treatment

of

substance abuse (includ-

ing

programs that provide comprehensive

treatment

services

for such

abuse);

(iii) is

compatible with

any

State

or local

plan for

the

provision

of

services

to

individuals with HIV/AIDS;

and

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1355

PUBLIC HEALTH SERVICE ACT

Sec. 2602

(iv)

includes

a

strategy, coordinated

as

appro-

priate with other community strategies

and

efforts, in-

cluding discrete

goals, a

timetable,

and

appropriate

funding,

for

identifying individuals with HIV/AIDS

who do not know

their

HIV

status, making

such

indi-

viduals aware

of such

status,

and

enabling

such

indi-

viduals

to use the

health

and

support services de-

scribed

in

section

2604,

with particular attention

to

re-

ducing barriers

to

routine testing

and

disparities in

access

and

services among affected subpopulations

and

historically underserved communities;

(E)

assess

the

efficiency

of the

administrative mecha-

nism

in

rapidly allocating funds

to the

areas

of

greatest

need

within

the

eligible area,

and

at

the

discretion

of

the

planning council, assess

the

effectiveness, either directly or

through contractual arrangements,

of the

services offered

in

meeting

the

identified needs;

(F)

participate

in the

development

of the

statewide

co-

ordinated statement

of need

initiated

by the

State public

health agency responsible

for

administering grants under

part B;

(G)

establish methods

for

obtaining input

on

commu-

nity

needs

and

priorities

which may

include

public

meet-

ings (in

accordance with paragraph

(7)),

conducting focus

groups,

and

convening

ad-hoc

panels; and

(H)

coordinate with Federal grantees that provide

HIV-related services within

the

eligible

area.

(5)

C

ONFLICTS

OF

INTEREST

.—

(A) IN

GENERAL

.—The planning

council

under para-

graph

(1) may not be

directly involved

in the

administra-

tion of a

grant under section 2601(a).

With

respect

to

com-

pliance with

the

preceding sentence,

the

planning council

may not

designate

(or

otherwise

be

involved

in the

selec-

tion of)

particular entities

as

recipients

of any of

the

amounts provided

in the

grant.

(B)

R

EQUIRED AGREEMENTS

.—An individual

may

serve

on the

planning

council

under paragraph

(1) only if the

in-

dividual agrees that

if the

individual

has a

financial inter-

est in an

entity,

if the

individual

is an

employee

of a

public

or

private entity,

or if the

individual

is a

member

of a

pub-

lic or

private organization,

and such

entity

or

organization

is

seeking amounts

from a

grant under section 2601(a),

the

individual

will not,

with respect

to the

purpose

for

which

the

entity seeks

such

amounts, participate (directly

or

in

an

advisory capacity)

in the

process

of

selecting entities to

receive

such

amounts

for such

purpose.

(C)

C

OMPOSITION

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 offi-

cers,

employees,

or

consultants

to any

entity that re-

ceives

amounts

from such a

grant,

and do not

rep-

F:\COMP\PHSA\PHSA-MERGED.XML

Sec. 2602

PUBLIC HEALTH SERVICE ACT

1356

resent

any such

entity,

and

reflect

the

demographics

of

the

population

of

individuals with HIV/AIDS

as

deter-

mined 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

par-

ent of, or a

caregiver

for, a

minor

child who is

receiv-

ing 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

em-

ployees

of such

entities,

or on

individuals

who

rep-

resent

such

entities.

(6)

G

RIEVANCE PROCEDURES

.—A planning

council

under

paragraph

(1)

shall develop procedures

for

addressing griev-

ances with respect

to

funding under this subpart, including

procedures

for

submitting grievances that cannot

be

resolved to

binding arbitration.

Such

procedures shall

be

described

in

the

by-laws

of the

planning

council and be

consistent with

the

re-

quirements

of

subsection (c).

(7)

P

UBLIC DELIBERATIONS

.—With respect

to a

planning

council

under paragraph

(1), the

following

applies:

(A) The council may not be

chaired

solely by an

em-

ployee of the

grantee under section 2601(a).

(B) In

accordance with criteria established

by the

Sec-

retary:

(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

category

of

HIV-re-

lated health services

and the

extent

to which such cost is

paid

by

third-party payors;

(4) the

aggregate amounts expended

for each such

category

of

services;

(5) the

manner

in which the

expected expenditures

are

re-

lated

to the

planning process

for

States that receive funding

under part

B

(including

the

planning process described

in

sec-

tion 2617(b));

and

(6) the

expected expenditures

and how

those expenditures

will

improve overall client outcomes,

as

described under the

State plan under section 2617(b),

and

through additional out-

comes

measures

as

identified

by the HIV

health services plan-

ning council

under section 2602(b).

(c)

S

INGLE

A

PPLICATION AND

G

RANT

A

WARD

.—

(1)

A

PPLICATION

.—The Secretary

may

phase

in the use of

a

single application that meets

the

requirements

of

subsections

(a) and (b) of

section

2603

with respect

to an

eligible

area that

desires

to

receive grants under section

2603 for a fiscal

year.

(2)

G

RANT AWARD

.—The Secretary

may

phase

in

the

awarding

of a

single grant

to an

eligible

area that submits an

approved application under paragraph

(1) for a fiscal

year.

(d)

D

ATE

C

ERTAIN FOR

S

UBMISSION

.—

(1)

R

EQUIREMENT

.—Except

as

provided

in

paragraph

(2),

to

be

eligible

to

receive

a

grant under section 2601(a)

for a

fiscal

year,

an

application under subsection

(a)

shall

be

submitted

not

later than

45 days

after

the

date

on which

appropriations

are

made under section

2677 for the fiscal

year.

(2)

E

XCEPTION

.—The Secretary

may

extend

the

time for

the

submission

of an

application under paragraph

(1) for a

pe-

riod of not to exceed 60 days if the

Secretary determines

that

the

eligible area

has

made

a good

faith

effort to comply

with

the

requirement

of such

paragraph

but has

otherwise

been

un-

able to

submit

its

application.

(3)

D

ISTRIBUTION

BY

S

ECRETARY

.—Not later than

45

days

after receiving

an

application that meets

the

requirements

of

subsection

(a) from an

eligible area,

the

Secretary shall dis-

tribute

to such

eligible area

the

amounts awarded under the

grant

for which the

application

was

submitted.

(4)

R

EDISTRIBUTION

.—Any amounts appropriated

in

any

fiscal

year under this subpart

and not

obligated

to an

eligible

January 28, 2016

As Amended Through P.L. 114-113, Enacted December 18, 2015

F:\COMP\PHSA\PHSA-MERGED.XML

1375

PUBLIC HEALTH SERVICE ACT

Sec. 2605

entity

as a

result

of the

failure

of such

entity

to

submit

an

ap-

plication shall

be

redistributed

by the

Secretary

to

other eligi-

ble

entities

in

proportion

to the

original grants made

to

such

eligible areas under section 2601(a).

(e)

R

EQUIREMENTS

R

EGARDING

I

MPOSITION

OF

C

HARGES FOR

S

ERVICES

.—

(1) IN

GENERAL

.—The Secretary

may not

make

a

grant

under section

2601 to an

eligible area unless

the

eligible

area

provides assurances that

in the

provision

of

services with as-

sistance provided under

the

grant—

(A) in the case of

individuals with

an income less

than

or

equal

to 100

percent

of the official

poverty

line, the

pro-

vider

will not

impose charges

on any such

individual for

the

provision

of

services under

the

grant;

(B) in the case of

individuals with

an income

greater

than

100

percent

of the official

poverty

line, the

provider—

(i) will

impose

a

charge

on each such

individual

for the

provision

of such

services;

and

(ii) will

impose

the

charge according

to a

schedule

of

charges that

is

made available

to the

public;

(C) in the case of

individuals with

an income

greater

than

100

percent

of the official

poverty

line and not

ex-

ceeding

200

percent

of such

poverty

line, the

provider will

not, for any

calendar year, impose charges

in an

amount

exceeding

5

percent

of the

annual

gross income of the

indi-

vidual involved;

(D) in the case of

individuals with

an income

greater

than

200

percent

of the official

poverty

line and not

ex-

ceeding

300

percent

of such

poverty

line, the

provider will

not, for any

calendar year, impose charges

in an

amount

exceeding

7

percent

of the

annual

gross income of the

indi-

vidual involved;

and

(E) in the case of

individuals with

an income

greater

than

300

percent

of the official

poverty

line, the

provider

will not, for any

calendar year, impose charges

in

an

amount exceeding

10

percent

of the

annual

gross

income

of the

individual involved.

(2)

A

SSESSMENT

OF

CHARGE

.—With respect

to

compliance

with

the

assurance made under paragraph

(1), a

grantee

or

en-

tity

receiving assistance under this subpart

may, in the case of

individuals subject

to a

charge

for

purposes

of such

para-

graph—

(A)

assess

the

amount

of the

charge

in the

discretion

of the

grantee, including imposing

only a

nominal charge

for the

provision

of

services, subject

to the

provisions

of

such

paragraph regarding

public

schedules

and

regarding

limitations

on the

maximum amount

of

charges; and

(B)

take

into

consideration

the

medical expenses

of

in-

dividuals

in

assessing

the

amount

of the

charge, subject to

such

provisions.

(3)

A

PPLICABILITY

OF

LIMITATION

ON

AMOUNT

OF

CHARGE

.—

The

Secretary

may not

make

a

grant under section

2601 to

an

eligible area unless

the

eligible area agrees that

the

limitations

established

in

subparagraphs

(C), (D) and (E) of

paragraph (1)

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Sec. 2606

PUBLIC HEALTH SERVICE ACT

1376

regarding

the

imposition

of

charges

for

services applies

to

the

annual aggregate

of

charges imposed

for such

services, without

regard

to

whether they

are

characterized

as

enrollment fees,

premiums, deductibles,

cost

sharing, copayments, coinsurance,

or

other charges.

(4)

W

AIVER REGARDING SECONDARY AGREEMENTS

.—The re-

quirements established

in

paragraphs

(1)

through

(3)

shall be

waived

in

accordance with section 2604(d)(2).

SEC.

2606.

ø

300ff–16

¿

TECHNICAL ASSISTANCE.

The

Administrator

of the

Health Resources

and

Services Ad-

ministration shall, beginning

on the

date

of

enactment

of

this title,

provide technical assistance, including assistance

from

other grant-

ees,

contractors

or

subcontractors under this title

to

assist newly

eligible metropolitan areas

in the

establishment

of HIV

health

services planning councils and,

to

assist entities

in

complying

with

the

requirements

of

this subpart

in

order

to

make

such

entities eli-

gible to

receive

a

grant under this subpart.

The

Administrator may

make planning grants available

to

metropolitan areas,

in

an

amount

not to exceed

$75,000

for any

metropolitan area, projected

to be

eligible

for

funding under section

2601 in the

following fiscal

year.

Such

grant amounts shall

be

deducted

from the

first year for-

mula award

to

eligible areas accepting

such

grants.

Not to

exceed

1

percent

of the

amount appropriated

for a fiscal

year under section

2677 for

grants under part

A may be

used

to

carry

out

this section.

SEC.

2607.

ø

300ff–17

¿

DEFINITIONS.

For

purposes

of

this subpart:

(1)

E

LIGIBLE AREA

.—The term

‘‘eligible area’’

means

a

met-

ropolitan area meeting

the

requirements

of

section

2601

that

are

applicable

to the

area.

(2)

M

ETROPOLITAN AREA

.—The term ‘‘metropolitan area’’

means

an

area that

is

referred

to in the

HIV/AIDS Surveil-

lance

Report

of the

Centers

for

Disease Control

and

Prevention

as a

metropolitan area,

and

that

has a

population

of

50,000 or

more

individuals.

Subpart II—Transitional Grants

SEC.

2609.

ø

300ff–19

¿

ESTABLISHMENT

OF

PROGRAM.

(a) IN

G

ENERAL

.—The Secretary, acting through

the

Adminis-

trator

of the

Health Resources

and

Services Administration, shall

make grants

for the

purpose

of

providing services described

in

sec-

tion 2604 in

transitional areas, subject

to the

same provisions re-

garding

the

allocation

of

grant funds

as

apply under subsection

(c)

of such

section.

(b)

T

RANSITIONAL

A

REAS

.—For purposes

of

this section, the

term ‘‘transitional

area’’

means, subject

to

subsection

(c), a

metro-

politan area

for which

there

has been

reported

to and

confirmed by

the

Director

of the

Centers

for

Disease Control

and

Prevention

a

cumulative total

of

at least

1,000, but fewer

than

2,000, cases of

AIDS

during

the most

recent period

of 5

calendar years

for

which

such

data

are

available.

(c)

C

ERTAIN

E

LIGIBILITY

R

ULES

.—

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F:\COMP\PHSA\PHSA-MERGED.XML

1377

PUBLIC HEALTH SERVICE ACT

Sec. 2609

(1)

F

ISCAL YEAR 2011

.—With respect

to

grants under sub-

section

(a) for fiscal

year

2011, a

metropolitan area that re-

ceived

funding under subpart

I for fiscal

year

2010 but

does

not for fiscal

year

2011

qualify under

such

subpart

as an

eligi-

ble

area

and does not

qualify under subsection

(b) as a

transi-

tional area shall, notwithstanding subsection

(b), be

considered

a

transitional area.

(2)

C

ONTINUED STATUS

AS

TRANSITIONAL

AREA

.—

(A) IN

GENERAL

.—Notwithstanding subsection

(b),

a

metropolitan area that

is a

transitional area

for a

fiscal

year continues, except

as

provided

in

subparagraph

(B),

to

be a

transitional area until

the

metropolitan area

fails,

for

three consecutive

fiscal

years—

(i) to

qualify under

such

subsection

as a

transi-

tional area; and

(ii)

subject

to

subparagraphs

(B) and (C), to

have

a

cumulative total

of 1,500 or more living cases of

AIDS

(reported

to and

confirmed

by the

Director

of

the

Centers

for

Disease Control

and

Prevention)

as of

De-

cember

31 of the most

recent calendar year

for

which

such

data

is

available.

(B)

P

ERMITTING MARGIN

OF

ERROR APPLICABLE

TO

CER

-

TAIN METROPOLITAN AREAS

.—In applying subparagraph

(A)(ii) for a fiscal

year after

fiscal

year

2008, in the

case

of a

metropolitan area that

has a

cumulative total

of

at

least

1,400 (and fewer

than

1,500) living cases of AIDS

as

of

December

31 of the most

recent calendar year

for

which

such

data

is

available,

such

area shall

be

treated

as

having

met the

criteria

of such

subparagraph

if not more

than 5

percent

of the

total

from

grants awarded

to such

area

under this part

is

unobligated

as of the end of the most

re-

cent fiscal

year

for which such

data

is

available.

(C)

E

XCEPTION REGARDING STATUS

AS

ELIGIBLE

AREA

.—

Subparagraphs

(A) and (B) do not

apply

for a fiscal

year

if the

metropolitan area involved qualifies

under subpart

I as an

eligible

area.

(d)

A

PPLICATION

OF

C

ERTAIN

P

ROVISIONS

OF

S

UBPART

I.—

(1)

A

DMINISTRATION

;

PLANNING COUNCIL

.—

(A) IN

GENERAL

.—The provisions

of

section

2602

apply

with respect

to a

grant under subsection

(a) for a

transi-

tional area

to the

same extent

and in the

same manner as

such

provisions apply with respect

to a

grant under sub-

part

I for an

eligible area, except that, subject

to

subpara-

graph

(B), the chief

elected

official of the

transitional area

may elect not to comply

with

the

provisions

of

section

2602(b) if the official

provides documentation

to the

Sec-

retary that details

the

process used

to

obtain community

input (particularly

from

those with

HIV) in the

transi-

tional area

for

formulating

the

overall plan

for

priority set-

ting and

allocating funds

from the

grant under subsection

(a).

(B)

E

XCEPTION

.—For

each of the fiscal

years 2007

through

2013, the

exception described

in

subparagraph

(A)

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Sec. 2610

PUBLIC HEALTH SERVICE ACT

1378

does not

apply

if the

transitional area involved received

funding under subpart

I for fiscal

year 2006.

(2)

T

YPE AND DISTRIBUTION

OF

GRANTS

;

TIMEFRAME FOR

OB

-

LIGATION AND EXPENDITURE

OF

GRANT

FUNDS

.—

(A)

F

ORMULA GRANTS

;

SUPPLEMENTAL

GRANTS

.—The

provisions

of

section

2603

apply with respect

to

grants

under subsection

(a) to the

same extent

and in the

same

manner

as such

provisions apply with respect

to

grants

under subpart

I,

subject

to

subparagraphs

(B) and

(C).

(B)

F

ORMULA GRANTS

;

INCREASE

IN

GRANT

.—For pur-

poses of

subparagraph

(A),

section 2603(a)(4)

does

not

apply.

(C)

S

UPPLEMENTAL GRANTS

;

SINGLE PROGRAM WITH

SUBPART I PROGRAM

.—With respect

to

section

2603(b)

as

applied

for

purposes

of

subparagraph

(A):

(i) The

Secretary shall combine amounts available

pursuant

to such

subparagraph with amounts avail-

able for

carrying

out

section

2603(b) and

shall admin-

ister

the two

programs

as a

single program.

(ii) In the

single program,

the

Secretary

has

dis-

cretion

in

allocating amounts between eligible areas

under subpart

I and

transitional areas under this sec-

tion,

subject

to the

eligibility criteria that

apply under

such

section,

and

subject

to

section 2603(b)(2)(C) (re-

lating

to

priority

in

making grants).

(iii)

Pursuant

to

section 2603(b)(1), amounts for

the

single program

are

subject

to use

under sections

2603(a)(4)

and

2610(d)(1).

(3)

A

PPLICATION

;

TECHNICAL ASSISTANCE

;

DEFINITIONS

.—

The

provisions

of

sections

2605, 2606, and 2607

apply with re-

spect

to

grants under subsection

(a) to the

same extent

and

in

the

same manner

as such

provisions apply with respect to

grants under subpart I.

Subpart III—General

Provisions

SEC.

2610.

ø

300ff–20

¿

AUTHORIZATION

OF

APPROPRIATIONS.

(a) IN

G

ENERAL

.—For

the

purpose

of

carrying

out

this part,

there

are

authorized

to be

appropriated $604,000,000

for fiscal

year

2007,

$626,300,000

for fiscal

year

2008,

$649,500,000

for fiscal

year

2009,

$681,975,000

for fiscal

year

2010,

$716,074,000

for fiscal

year

2011,

$751,877,000

for fiscal

year

2012, and

$789,471,000

for

fiscal

year

2013.

Amounts appropriated under

the

preceding sentence for

a fiscal

year

are

available

for

obligation

by the

Secretary until the

end of the

second succeeding

fiscal

year.

(b)

R

ESERVATION

OF A

MOUNTS

.—

(1)

F

ISCAL YEAR 2007

.—Of

the

amount appropriated under

subsection

(a) for fiscal

year

2007, the

Secretary shall re-

serve—

(A)

$458,310,000

for

grants under subpart

I;

and

(B)

$145,690,000

for

grants under section 2609.

(2)

S

UBSEQUENT FISCAL YEARS

.—Of

the

amount appro-

priated under subsection

(a) for fiscal

year

2008 and each

sub-

sequent

fiscal

year—

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PUBLIC HEALTH SERVICE ACT

Sec. 2610

(A) the

Secretary shall reserve

an

amount

for

grants

under subpart

I;

and

(B) the

Secretary shall reserve

an

amount

for

grants

under section 2609.

(c)

T

RANSFER

OF

C

ERTAIN

A

MOUNTS

; C

HANGE

IN

S

TATUS

AS

E

L

-

IGIBLE

AREA OR

T

RANSITIONAL

A

REA

.—Notwithstanding subsection

(b):

(1) If a

metropolitan area

is an

eligible

area under subpart

I for a fiscal

year,

but for a

subsequent

fiscal

year ceases to

be an

eligible area

by

reason

of

section 2601(b)—

(A)(i) the

amount reserved under paragraph

(1)(A)

or

(2)(A) of

subsection

(b) of

this section

for the

first

such

sub-

sequent year

of not being an

eligible area

is

deemed

to

be

reduced

by an

amount equal

to the

amount

of the

grant

made pursuant

to

section 2603(a)

for the

metropolitan

area

for the

preceding

fiscal year;

and

(ii)(I) if the

metropolitan area qualifies

for such

first

subsequent

fiscal

year

as a

transitional area under 2609,

the

amount reserved under paragraph

(1)(B) or (2)(B) of

subsection

(b) for such fiscal

year

is

deemed

to be

in-

creased

by an

amount equal

to the

amount

of the

reduction

under subparagraph

(A) for such year;

or

(II) if the

metropolitan area

does not

qualify

for

such

first subsequent

fiscal

year

as a

transitional area under

2609, an

amount equal

to the

amount

of such

reduction is,

notwithstanding subsection

(a),

transferred

and

made

available

for

grants pursuant

to

section 2618(a)(1),

in

addi-

tion to

amounts available

for such

grants under section

2623;

and

(B) if a

transfer under subparagraph

(A)(ii)(II) is

made

with respect

to the

metropolitan area

for such

first subse-

quent

fiscal

year, then—

(i) the

amount reserved under paragraph

(1)(A)

or

(2)(A) of

subsection

(b) of

this section

for such

year is

deemed

to be

reduced

by an

additional $500,000;

and

(ii) an

amount equal

to the

amount

of such

addi-

tional reduction

is,

notwithstanding subsection

(a),

transferred

and

made available

for

grants pursuant

to

section 2618(a)(1),

in

addition

to

amounts available

for

such

grants under section 2623.

(2) If a

metropolitan area

is a

transitional area under sec-

tion 2609 for a fiscal

year,

but for a

subsequent

fiscal

year

ceases

to be a

transitional area

by

reason

of

section 2609(c)(2)

(and does not

qualify

for such

subsequent

fiscal

year

as an

eli-

gible

area under subpart I)—

(A) the

amount reserved under subsection

(b)(2)(B) of

this section

for the

first

such

subsequent

fiscal

year

of

not

being a

transitional area

is

deemed

to be

reduced

by

an

amount equal

to the

total

of—

(i) the

amount

of the

grant that, pursuant

to

sec-

tion

2603(a),

was

made under section 2609(d)(2)(A) for

the

metropolitan area

for the

preceding

fiscal

year;

and

(ii)

$500,000;

and

January 28, 2016

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F:\COMP\PHSA\PHSA-MERGED.XML

Sec. 2610

PUBLIC HEALTH SERVICE ACT

1380

(B)(i)

subject

to

clause

(ii), an

amount equal

to

the

amount

of the

reduction under subparagraph

(A) for

such

year

is,

notwithstanding subsection

(a),

transferred and

made available

for

grants pursuant

to

section 2618(a)(1),

in

addition

to

amounts available

for such

grants under sec-

tion 2623;

and

(ii) for each of fiscal

years

2010

through

2013,

notwith-

standing subsection (a)—

(I)

there shall

be

transferred

to the

State con-

taining

the

metropolitan area,

for

purposes described

in

section 2612(a),

an

amount (which shall

not

be

taken

into

account

in

applying section 2618(a)(2)(H))

equal to—

(aa) for the

first

fiscal

year

of the

metropoli-

tan area

not being a

transitional area,

75

percent

of the

amount described

in

subparagraph

(A)(i)

for

such

area;

(bb) for the

second

fiscal

year

of the

metro-

politan area

not being a

transitional area,

50

per-

cent of such

amount; and

(cc) for the

third

fiscal

year

of the

metropoli-

tan area

not being a

transitional area,

25

percent

of such

amount; and

(II)

there shall

be

transferred

and

made available

for

grants pursuant

to

section 2618(a)(1)

for the

fiscal

year,

in

addition

to

amounts available

for such

grants

under section

2623, an

amount equal

to the

total

amount

of the

reduction

for such fiscal

year under

subparagraph

(A), less the

amount transferred for

such fiscal

year under subclause (I).

(3) If a

metropolitan area

is a

transitional area under sec-

tion 2609 for a fiscal

year,

but for a

subsequent

fiscal

year

qualifies

as an

eligible area under subpart I—

(A) the

amount reserved under subsection

(b)(2)(B) of

this section

for the

first

such

subsequent

fiscal

year

of

be-

coming an

eligible area

is

deemed

to be

reduced

by

an

amount equal

to the

amount

of the

grant that, pursuant

to

section 2603(a),

was

made under section

2609(d)(2)(A)

for the

metropolitan area

for the

preceding

fiscal year;

and

(B) the

amount reserved under subsection

(b)(2)(A)

for

such fiscal

year

is

deemed

to be

increased

by an

amount

equal

to the

amount

of the

reduction under subparagraph

(A) for such

year.

(d)

C

ERTAIN

T

RANSFERS

; A

LLOCATIONS

B

ETWEEN

P

ROGRAMS

U

NDER

S

UBPART

I.—With respect

to

paragraphs

(1)(B)(i)

and

(2)(A)(ii) of

subsection

(c), the

Secretary shall administer

any

re-

ductions under

such

paragraphs

for a fiscal

year

in

accordance

with

the

following:

(1) The

reductions shall

be

made

from

amounts available

for the

single program referred

to in

section 2609(d)(2)(C) (re-

lating

to

supplemental grants).

(2) The

reductions shall

be

made

before the

amounts re-

ferred

to in

paragraph

(1) are

used

for

purposes

of

section

2603(a)(4).

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PUBLIC HEALTH SERVICE ACT

Sec. 2612

(3) If the

amounts referred

to in

paragraph

(1) are not

suf-

ficient

for

making

all the

reductions,

the

reductions shall

be

re-

duced until

the

total amount

of the

reductions equals

the

total

of the

amounts referred

to in such

paragraph.

(e)

R

ULES

OF

C

ONSTRUCTION

R

EGARDING

F

IRST

S

UBSEQUENT

F

ISCAL

Y

EAR

.—Paragraphs

(1) and (2) of

subsection

(c)

apply with

respect

to each

series

of fiscal

years during

which a

metropolitan

area

is an

eligible area under subpart

I or a

transitional area

under section

2609 for a fiscal

year

and

then

for a

subsequent fis-

cal

year ceases

to be such an

area

by

reason

of

section

2601(b)

or

2609(c)(2),

respectively, rather than applying

to a

single

such

se-

ries. Paragraph

(3) of

subsection

(c)

applies with respect

to each

se-

ries of fiscal

years during

which a

metropolitan area

is a

transi-

tional area under section

2609 for a fiscal

year

and

then

for a

sub-

sequent

fiscal

year becomes

an

eligible area under subpart

I,

rather

than applying

to a

single

such

series.

P

ART

B—C

ARE

G

RANT

P

ROGRAM

6

Subpart I—General Grant

Provisions

SEC.

2611.

ø

300ff–21

¿

GRANTS.

The

Secretary shall, subject

to the

availability

of

appropria-

tions, make grants

to

States

to

enable

such

States

to

improve

the

quality, availability

and

organization

of

health

care and

support

services

for

individuals

and

families with HIV/AIDS.

The

authority

of the

Secretary

to

provide grants under part

B is

subject

to

section

2626(e)(2)

(relating

to the

decrease

in

perinatal transmission

of

HIV/AIDS).

SEC.

2612.

ø

300ff–22

¿

GENERAL USE

OF

GRANTS.

(a) IN

G

ENERAL

.—A State

may use

amounts provided under

grants made under section

2611

for—

(1) core

medical services described

in

subsection (b);

(2)

support services described

in

subsection

(c);

and

(3)

administrative expenses described

in

section 2618(b)(3).

(b)

R

EQUIRED

F

UNDING FOR

C

ORE

M

EDICAL

S

ERVICES

.—

(1) IN

GENERAL

.—With respect

to a

grant under section

2611 for a

State

for a

grant year,

the

State shall,

of the

portion

of the

grant remaining after reserving amounts

for

purposes

of

subparagraphs

(A) and (E)(ii)(I) of

section 2618(b)(3),

use

not

less

than

75

percent

to

provide

core

medical services that are

needed

in the

State

for

individuals with HIV/AIDS

who

are

identified

and

eligible under this title (including services re-

garding

the

co-occurring conditions

of the

individuals).

(2) W

AIVER

.—

(A) IN

GENERAL

.—The Secretary shall

waive the

appli-

cation

of

paragraph

(1)

with respect

to a

State

for a

grant

year

if the

Secretary determines that, within

the

State—

(i)

there

are no

waiting lists

for AIDS

Drug Assist-

ance

Program services under section

2616;

and

6

See

footnote at

the

beginning

of

part A.

Section

8(a) of

Public

Law

104–146

(110

Stat.

1372)

establishes

a

condition

for the

receipt

of

grants under part

B. The

condition relates

to

notification

of

spouses

of

HIV-infected

patients.

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F:\COMP\PHSA\PHSA-MERGED.XML

Sec. 2612

PUBLIC HEALTH SERVICE ACT

1382

(ii) core

medical services

are

available

to all

indi-

viduals with HIV/AIDS identified

and

eligible under

this title.

(B)

N

OTIFICATION

OF

WAIVER STATUS

.—When inform-

ing a

State that

a

grant under section

2611 is being

made

to the

State

for a fiscal

year,

the

Secretary shall inform

the

State whether

a

waiver under subparagraph

(A) is

in

effect for the fiscal

year.

(3)

C

ORE MEDICAL SERVICES

.—For purposes

of

this sub-

section,

the

term

‘‘core

medical

services’’,

with respect

to an

in-

dividual infected with HIV/AIDS (including

the

co-occurring

conditions

of the

individual) means

the

following services:

(A)

Outpatient

and

ambulatory health services.

(B) AIDS

Drug Assistance Program treatments

in

ac-

cordance with section 2616.

(C) AIDS

pharmaceutical assistance.

(D)

Oral health care.

(E)

Early intervention services described

in

subsection

(d).

(F)

Health insurance premium

and cost

sharing assist-

ance for

low-income individuals

in

accordance with section

2615.

(G) Home

health care.

(H)

Medical

nutrition therapy.

(I)

Hospice services.

(J) Home and

community-based health services

as

de-

fined

under section 2614(c).

(K)

Mental health services.

(L)

Substance abuse outpatient care.

(M)

Medical

case

management, including treatment

adherence services.

(c)

S

UPPORT

S

ERVICES

.—

(1) IN

GENERAL

.—For purposes

of

this subsection,

the

term

‘‘support services’’

means services, subject

to the

approval

of

the

Secretary, that

are

needed

for

individuals with HIV/AIDS

to

achieve their medical outcomes

(such as

respite

care for

per-

sons

caring

for

individuals with HIV/AIDS, outreach services,

medical transportation, linguistic services,

and

referrals for

health

care and

support services).

(2)

D

EFINITION

OF

MEDICAL OUTCOMES

.—In this subsection,

the

term

‘‘medical outcomes’’

means those outcomes affecting

the

HIV-related clinical status

of an

individual with HIV/AIDS.

(d)

E

ARLY

I

NTERVENTION

S

ERVICES

.—

(1) IN

GENERAL

.—For purposes

of

this section,

the

term

‘‘early

intervention

services’’

means HIV/AIDS

early interven-

tion

services described

in

section 2651(e), with

follow-up

refer-

ral

provided

for the

purpose

of

facilitating

the

access

of

individ-

uals 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, de-

toxification centers, detention facilities,

clinics

regarding sexu-

ally

transmitted diseases, homeless shelters,

HIV/AIDS coun-

seling

and

testing sites, health

care

points

of

entry specified by

January 28, 2016

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F:\COMP\PHSA\PHSA-MERGED.XML

1383

PUBLIC HEALTH SERVICE ACT

Sec. 2613

States, federally qualified health centers,

and

entities de-

scribed

in

section 2652(a) that constitute

a

point

of

access to

services

by

maintaining referral relationships.

(2)

C

ONDITIONS

.—With respect

to an

entity that proposes

to

provide early intervention services under paragraph (1),

such

paragraph shall apply

only if the

entity demonstrates to

the

satisfaction

of the chief

elected

official for the

State in-

volved

that—

(A)

Federal, State,

or local

funds

are

otherwise inad-

equate

for the

early intervention services

the

entity pro-

poses to

provide;

and

(B) the

entity

will

expend funds pursuant

to such

sub-

paragraph

to

supplement

and not

supplant other funds

available

to the

entity

for the

provision

of

early interven-

tion

services

for the fiscal

year involved.

(e)

P

RIORITY FOR

W

OMEN

, I

NFANTS

, C

HILDREN

,

AND

Y

OUTH

.—

(1) IN

GENERAL

.—For

the

purpose

of

providing

health and

support services

to

infants, children, youth,

and

women with

HIV/AIDS, including treatment measures

to

prevent the

perinatal transmission

of HIV, a

State 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 in-

volved

(infants, children, youth,

or

women

in such

area) with

HIV/AIDS

to the

general population

in such

area

of

individuals

with HIV/AIDS.

(2)

W

AIVER

.—With respect

to the

population involved,

the

Secretary

may

provide

to a

State

a

waiver

of the

requirement

of

paragraph

(1) if such

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 in-

surance program under title

XXI of such Act, or

other Federal

or

State programs.

(f)

C

ONSTRUCTION

.—A State

may not use

amounts received

under

a

grant awarded under section

2611 to

purchase

or

improve

land,

or to

purchase, construct,

or

permanently improve (other

than

minor remodeling)

any

building

or

other facility,

or to

make cash

payments

to

intended recipients

of

services.

SEC.

2613.

ø

300ff–23

¿

GRANTS

TO

ESTABLISH

HIV CARE

CONSORTIA.

(a)

C

ONSORTIA

.—A State

may,

subject

to

subsection

(f),

use

amounts provided under

a

grant awarded under section

2611

to

provide assistance under section 2612(a)

to an

entity that—

(1) is an

association

of one or more

public,

and one or

more

nonprofit private,

(or

private for-profit providers

or

organiza-

tions

if such

entities

are the only

available providers

of

quality

HIV care in the

area) health

care and

support service providers

and

community based organizations operating within areas

de-

termined

by the

State

to be most

affected

by

HIV/AIDS;

and

(2)

agrees

to use such

assistance

for the

planning, develop-

ment

and

delivery, through

the

direct provision

of

services or

through entering

into

agreements with other entities

for

the

provision

of such

services,

of

comprehensive

outpatient health

January 28, 2016

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F:\COMP\PHSA\PHSA-MERGED.XML

Sec. 2613

PUBLIC HEALTH SERVICE ACT

1384

and

support services

for

individuals with

HIV

disease, that

may

include—

(A)

essential health services

such as case

management

services, medical, nursing, substance abuse treatment,

mental health treatment,

and

dental care, diagnostics,

monitoring, prophylactic treatment

for

opportunistic infec-

tions, treatment education

to

take

place in the

context

of

health

care

delivery,

and

medical

follow-up

services, men-

tal health, developmental,

and

rehabilitation services,

home

health

and

hospice

care;

and

(B)

essential support services

such as

transportation

services, attendant care, homemaker services,

day or

res-

pite

care, benefits advocacy, advocacy services provided

through

public and

nonprofit private entities,

and

services

that

are

incidental

to the

provision

of

health

care

services

for

individuals with HIV/AIDS including

nutrition services,

housing referral services,

and child

welfare

and

family

services (including foster

care and

adoption services).

An

entity

or

entities

of the type

described

in

this subsection shall

hereinafter

be

referred

to in

this title

as a ‘‘consortium’’ or ‘‘con-

sortia’’.

(b) A

SSURANCES

.—

(1)

R

EQUIREMENT

.—To receive assistance

from a

State

under subsection

(a), an

applicant consortium shall provide

the

State with assurances that—

(A)

within

any

locality

in which such

consortium

is

to

operate,

the

populations

and

subpopulations

of

individuals

and

families with HIV/AIDS have

been

identified

by

the

consortium, particularly those experiencing disparities in

access

and

services

and

those

who

reside

in

historically

underserved communities;

(B) the

service plan established under subsection (c)(2)

by such

consortium

is

consistent with

the

comprehensive

plan under section 2617(b)(4)

and

addresses

the

special

care and

service needs

of the

populations

and

subpopula-

tions identified under subparagraph

(A);

and

(C)

except

as

provided

in

paragraph

(2), the

consor-

tium

will be a

single coordinating entity that

will

integrate

the

delivery

of

services among

the

populations

and

sub-

populations identified under subparagraph (A).

(2)

E

XCEPTION

.—Subparagraph

(C) of

paragraph

(1)

shall

not

apply

to any

applicant consortium that

the

State deter-

mines

will

operate

in a

community

or

locality

in which

it has

been

demonstrated

by the

applicant consortium that—

(A)

subpopulations exist within

the

community

to

be

served that have unique service

requirements; and

(B) such

unique service requirements cannot

be

ade-

quately

and

efficiently addressed

by a

single consortium

serving

the

entire community

or

locality.

(c) A

PPLICATION

.—

(1) IN

GENERAL

.—To receive assistance

from the

State

under subsection

(a), a

consortium shall prepare

and

submit to

the

State,

an

application that—

January 28, 2016

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F:\COMP\PHSA\PHSA-MERGED.XML

1385

PUBLIC HEALTH SERVICE ACT

Sec. 2613

(A)

demonstrates that

the

consortium includes agen-

cies and

community-based organizations—

(i)

with

a

record

of

service

to

populations

and

sub-

populations with HIV/AIDS requiring

care

within the

community

to be

served; and

(ii)

that

are

representative

of

populations

and

sub-

populations reflecting

the local

incidence

of HIV

and

that

are

located

in

areas

in which such

populations re-

side;

(B)

demonstrates that

the

consortium

has

carried out

an

assessment

of

service needs within

the

geographic

area

to be

served and, after consultation with

the

entities de-

scribed

in

paragraph

(2), has

established

a

plan

to

ensure

the

delivery

of

services

to

meet

such

identified needs

that

shall include—

(i)

assurances that service needs

will be

addressed

through

the

coordination

and

expansion

of

existing

programs

before new

programs

are

created;

(ii)

assurances that,

in

metropolitan areas,

the

ge-

ographic area

to be

served

by the

consortium cor-

responds

to the

geographic boundaries

of local

health

and

support services delivery systems

to the

extent

practicable;

(iii)

assurances that,

in the case of

services

for

in-

dividuals residing

in

rural areas,

the

applicant consor-

tium shall deliver

case

management services that link

available community support services

to

appropriate

specialized medical services;

and

(iv)

assurances that

the

assessment

of

service

needs

and the

planning

of the

delivery

of

services will

include participation

by

individuals with HIV/AIDS;

(C)

demonstrates that adequate planning

has

occurred

to

meet

the

special needs

of

families with HIV/AIDS, in-

cluding family centered

and

youth centered care;

(D)

demonstrates that

the

consortium

has

created a

mechanism

to

evaluate periodically—

(i) the

success

of the

consortium

in

responding to

identified needs;

and

(ii) the

cost-effectiveness

of the

mechanisms em-

ployed by the

consortium

to

deliver comprehensive

care;

(E)

demonstrates that

the

consortium

will

report to

the

State

the

results

of the

evaluations described

in

sub-

paragraph

(D) and

shall make available

to the

State

or

the

Secretary,

on

request,

such

data

and

information

on

the

program methodology that

may be

required

to

perform

an

independent evaluation; and

(F)

demonstrates that adequate planning occurred to

address disparities

in

access

and

services

and

historically

underserved communities.

(2)

C

ONSULTATION

.—In establishing

the

plan required

under paragraph

(1)(B), the

consortium shall consult with—

January 28, 2016

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F:\COMP\PHSA\PHSA-MERGED.XML

Sec. 2614

PUBLIC HEALTH SERVICE ACT

1386

(A)(i) the public

health agency that provides

or

sup-

ports ambulatory

and

outpatient HIV-related health care

services within

the

geographic area

to be

served; or

(ii) in the case of a public

health agency that

does

not

directly provide

such

HIV-related health

care

services such

agency shall consult with

an

entity

or

entities that directly

provide ambulatory

and

outpatient HIV-related health

care

services within

the

geographic area

to be

served;

(B) not less

than

one

community-based organization

that

is

organized

solely for the

purpose

of

providing HIV-

related support services

to

individuals with HIV/AIDS;

(C)

grantees under section

2671, or, if none are

oper-

ating

in the

area, representatives

in the

area

of

organiza-

tions with

a

history

of

serving children, youth, women,

and

families

living

with

HIV;

and

(D) the

types

of

entities

described

in

section

2602(b)(2).

The

organization

to be

consulted under subparagraph

(B)

shall

be

at

the

discretion

of the

applicant consortium.

(d)

D

EFINITION

.—As used

in

section

2611, the

term

‘‘family

cen-

tered

care’’

means

the

system

of

services described

in

this section

that

is

targeted specifically

to the

special needs

of

infants, children,

women,

and

families. Family centered

care

shall

be

based

on

a

partnership between parents, professionals,

and the

community de-

signed

to

ensure

an

integrated, coordinated, culturally sensitive,

and

community-based continuum

of care for

children, women,

and

families with HIV/AIDS.

(e)

P

RIORITY

.—In providing assistance under subsection

(a),

the

State shall, among applicants that meet

the

requirements

of

this

section,

give

priority—

(1)

first

to

consortia that

are

receiving assistance

from

the

Health Resources

and

Services Administration

for

adult and

pediatric HIV-related

care

demonstration projects;

and

then

(2) to any

other existing

HIV care

consortia.

(f)

A

LLOCATION

OF

F

UNDS

; T

REATMENT

AS

S

UPPORT

S

ERVICES

.—

For

purposes

of the

requirement

of

section 2612(b)(1),

expenditures

of

grants under section

2611 for or

through consortia under this

section

are

deemed

to be

support services,

not core

medical serv-

ices. The

preceding sentence

may not be

construed

as

having any

legal effect on the

provisions

of

subsection

(a)

that relate

to

author-

ized

expenditures

of the

grant.

SEC.

2614.

ø

300ff–24

¿

GRANTS

FOR HOME- AND

COMMUNITY-BASED

CARE.

(a)

U

SES

.—A State

may use

amounts provided under

a

grant

awarded under section

2611 to

make grants under section

2612(b)(3)(J)

to

entities to—

(1)

provide

home- and

community-based health services for

individuals with HIV/AIDS pursuant

to

written plans

of

care

prepared

by a case

management team, that shall include ap-

propriate health

care

professionals,

in such

State

for

providing

such

services

to such

individuals;

(2)

provide outreach services

to

individuals with HIV/

AIDS,

including those individuals

in

rural areas; and

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F:\COMP\PHSA\PHSA-MERGED.XML

1387

PUBLIC HEALTH SERVICE ACT

Sec. 2615

(3)

provide

for the

coordination

of the

provision

of

services

under this section with

the

provision

of

HIV-related health

services, including specialty

care and

vaccinations

for

hepatitis

co-infection, provided

by public and

private entities.

(b)

P

RIORITY

.—In awarding grants under subsection

(a),

a

State shall

give

priority

to

entities that provide assurances

to

the

State that—

(1) such

entities

will

participate

in HIV care

consortia if

such

consortia exist within

the

State; and

(2) such

entities

will

utilize amounts provided under such

grants

for the

provision

of home- and

community-based serv-

ices to

low-income individuals with HIV/AIDS.

(c)

D

EFINITION

.—As used

in

section

2611, the

term

‘‘home-

and

community-based health services’’—

(1)

means, with respect

to an

individual with HIV/AIDS,

skilled health services furnished

to the

individual

in the

indi-

vidual’s

home

pursuant

to a

written plan

of care

established by

a case

management team, that shall include

appropriate health

care

professionals,

for the

provision

of such

services

and

items

described

in

paragraph (2);

(2)

includes—

(A)

durable medical equipment;

(B) home

health

aide

services

and

personal

care

serv-

ices

furnished

in the home of the

individual;

(C) day

treatment

or

other partial hospitalization serv-

ices;

(D) home

intravenous

and

aerosolized drug therapy

(including prescription drugs administered

as

part

of

such

therapy);

(E)

routine diagnostic testing administered

in

the

home of the

individual;

and

(F)

appropriate mental health, developmental,

and

re-

habilitation services;

and

(3) does not

include—

(A)

inpatient hospital services;

and

(B)

nursing

home and

other

long

term

care

facilities.

SEC.

2615.

ø

300ff–25

¿

CONTINUUM

OF

HEALTH INSURANCE COVERAGE.

(a) IN

G

ENERAL

.—A State

may use

amounts received

under a

grant awarded under section

2611 to

establish

a

program

of

finan-

cial

assistance under section 2612(b)(3)(F)

to

assist

eligible low-in-

come

individuals with

HIV/AIDS in—

(1)

maintaining

a

continuity

of

health insurance; or

(2)

receiving medical benefits under

a

health insurance

program, including risk-pools.

(b)

L

IMITATIONS

.—Assistance shall

not be

utilized under sub-

section (a)—

(1) to pay any costs

associated with

the

creation, capital-

ization,

or

administration

of a

liability risk

pool

(other than

those

costs paid on

behalf

of

individuals

as

part

of

premium

contributions

to

existing liability risk

pools);

and

(2) to pay any

amount expended

by a

State under title XIX

of the Social

Security Act.

January 28, 2016

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F:\COMP\PHSA\PHSA-MERGED.XML

Sec. 2616

PUBLIC HEALTH SERVICE ACT

1388

SEC.

2616.

ø

300ff–26

¿

PROVISION

OF

TREATMENTS.

(a) IN

G

ENERAL

.—A State shall

use a

portion

of the

amounts

provided under

a

grant awarded under section

2611 to

establish a

program under section 2612(b)(3)(B)

to

provide therapeutics to

treat HIV/AIDS

or

prevent

the

serious deterioration

of

health aris-

ing from

HIV/AIDS

in

eligible individuals, including measures for

the

prevention

and

treatment

of

opportunistic infections.

(b)

E

LIGIBLE

I

NDIVIDUAL

.—To

be

eligible

to

receive assistance

from a

State under this section

an

individual shall—

(1)

have

a

medical diagnosis

of

HIV/AIDS;

and

(2) be a

low-income individual,

as

defined

by the

State.

(c)

S

TATE

D

UTIES

.—In carrying

out

this section

the

State

shall—

(1)

ensure that

the

therapeutics included

on the list of

classes

of core

antiretroviral therapeutics established

by

the

Secretary under subsection

(e) are,

at

a

minimum,

the

treat-

ments provided

by the

State pursuant

to

this section;

(2)

provide assistance

for the

purchase

of

treatments deter-

mined

to be

eligible under paragraph

(1), and the

provision

of

such

ancillary devices that

are

essential

to

administer such

treatments;

(3)

provide outreach

to

individuals with HIV/AIDS,

and

as

appropriate

to the

families

of such

individuals;

(4)

facilitate access

to

treatments

for such

individuals;

(5)

document

the

progress made

in

making therapeutics

described

in

subsection

(a)

available

to

individuals eligible for

assistance under this section;

and

(6)

encourage, support,

and

enhance adherence

to and

com-

pliance 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 appli-

cable

with respect

to such

paragraph

is 10

percent

if the

State

demonstrates

to the

Secretary that

such

additional services

are

es-

sential

and in no way

diminish access

to the

therapeutics described

in

subsection (a).

(d)

D

UTIES

OF

THE

S

ECRETARY

.—In carrying

out

this section,

the

Secretary shall review

the

current status

of

State drug reim-

bursement programs established under section

2612(2) and

assess

barriers

to the

expanded availability

of the

treatments described in

subsection

(a). The

Secretary shall

also

examine

the

extent to

which

States coordinate with other grantees under this title

to

re-

duce

barriers

to the

expanded availability

of the

treatments de-

scribed

in

subsection (a).

(e)

L

IST

OF

C

LASSES

OF

C

ORE

A

NTIRETROVIRAL

T

HERA

-

PEUTICS

.—

For purposes

of

subsection

(c)(1), the

Secretary shall de-

velop and

maintain

a list of

classes

of core

antiretroviral thera-

peutics,

which list

shall

be

based

on the

therapeutics included in

the

guidelines

of the

Secretary known

as the

Clinical Practice

Guidelines

for Use of

HIV/AIDS Drugs, relating

to

drugs needed to

manage symptoms associated with

HIV. The

preceding sentence

does not affect the

authority

of the

Secretary

to modify such

Guide-

lines.

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F:\COMP\PHSA\PHSA-MERGED.XML

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PUBLIC HEALTH SERVICE ACT

Sec. 2617

(f)

U

SE

OF

H

EALTH

I

NSURANCE AND

P

LANS

.—

(1) IN

GENERAL

.—In carrying

out

subsection

(a), a

State

may

expend

a

grant under section

2611 to

provide

the

thera-

peutics described

in such

subsection

by

paying

on

behalf

of

in-

dividuals with HIV/AIDS

the costs of

purchasing

or

maintain-

ing

health insurance

or

plans

whose

coverage includes

a

full

range

of such

therapeutics

and

appropriate primary

care

serv-

ices.

(2)

L

IMITATION

.—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).

(g)

D

RUG

R

EBATE

P

ROGRAM

.—A

State shall ensure that any

drug rebates received

on

drugs purchased

from

funds provided pur-

suant

to

this section

are

applied

to

activities supported under this

subpart, with priority

given to

activities described under this sec-

tion.

SEC.

2617.

ø

300ff–27

¿

STATE APPLICATION.

(a) IN

G

ENERAL

.—The Secretary shall

not

make

a

grant

to

a

State under section

2611 for a fiscal

year unless

the

State prepares

and

submits,

to the

Secretary,

an

application at

such

time,

in

such

form, and

containing

such

agreements, assurances,

and

information

as the

Secretary determines

to be

necessary

to

carry

out

section

2611.

(b)

D

ESCRIPTION

OF

I

NTENDED

U

SES AND

A

GREEMENTS

.—The

application submitted under subsection

(a)

shall contain—

(1) a

detailed description

of the

HIV-related services pro-

vided in the

State

to

individuals

and

families with HIV/AIDS

during

the

year preceding

the

year

for which the

grant

is

re-

quested,

and the

number

of

individuals

and

families receiving

such

services, that shall include—

(A) a

description

of the

types

of

programs operated or

funded

by the

State

for the

provision

of

HIV-related serv-

ices

during

the

year preceding

the

year

for which the

grant

is

requested

and the

methods utilized

by the

State

to fi-

nance

such

programs;

(B) an

accounting

of the

amount

of

funds that the

State

has

expended

for such

services

and

programs during

the

year preceding

the

year

for which the

grant

is

re-

quested; and

(C)

information concerning—

(i) the

number

of

individuals

to be

served with as-

sistance provided under

the

grant;

(ii)

demographic data

on the

population

of the

in-

dividuals

to be

served;

(iii) the

average

cost of

providing

each

category

of

HIV-related health services

and the

extent

to

which

such cost is paid by

third-party payors;

and

(iv) the

aggregate amounts expended

for each

such

category

of

services;

(2) a

determination

of the size and

demographics

of

the

population

of

individuals with HIV/AIDS

in the

State;

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Sec. 2617

PUBLIC HEALTH SERVICE ACT

1390

(3) a

determination

of the

needs

of such

population, with

particular attention to—

(A)

individuals with HIV/AIDS

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;

(4) the

designation

of a lead

State agency that shall—

(A)

administer

all

assistance received under section

2611;

(B)

conduct

the

needs assessment

and

prepare the

State plan under paragraph (3);

(C)

prepare

all

applications

for

assistance under sec-

tion

2611;

(D)

receive notices with respect

to

programs

under this

title;

(E) every 2

years,

collect and

submit

to the

Secretary

all

audits, consistent with

Office of

Management and

Budget circular

A133, from

grantees within

the

State, in-

cluding audits regarding funds expended

in

accordance

with section

2611;

and

(F)

carry

out any

other duties determined appropriate

by the

Secretary

to

facilitate

the

coordination

of

programs

under this title.

(5) a

comprehensive plan that describes

the

organization

and

delivery

of HIV

health

care and

support services

to

be

funded with assistance received under section

2611

that shall

include

a

description

of the

purposes

for which the

State in-

tends

to use such

assistance,

and

that—

(A)

7

establishes priorities

for the

allocation

of

funds

within

the

State based on—

(i) size and

demographics

of the

population

of

indi-

viduals with HIV/AIDS

(as

determined under para-

graph

(2)) and the

needs

of such

population

(as

deter-

mined under paragraph (3));

(ii)

availability

of

other governmental

and

non-

governmental resources, including

the

State medicaid

plan under title

XIX of the Social

Security

Act and

the

State Children’s

Health Insurance Program under title

XXI of such Act to cover

health

care costs of

eligible

individuals

and

families with HIV/AIDS;

(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;

7

The

placement

of

subparagraphs

(A)

through

(C) is

according

to the

probable intent

of

the

Congress. Section 205(a)(3)

of

Public

Law

106–345

(114

Stat.

1332, 1333)

amended paragraph

(4) by

redesignating subparagraphs

(A)

through

(C) as

subparagraphs

(D)

through

(F), and

then

instructed that

new

subparagraphs

(A)

through

(C) be

inserted

before

‘‘subparagraph

(C)’’.

The

amendment probably should have instructed that

the new

subparagraphs

be

inserted

before

sub-

paragraph

(D), as

redesignated.

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1391

PUBLIC HEALTH SERVICE ACT

Sec. 2617

(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

indi-

viduals

to

utilize

the

services,

giving

particular attention

to

eliminating disparities

in

access

and

services among af-

fected

subpopulations

and

historically underserved commu-

nities,

and

including discrete

goals, a

timetable,

and an

ap-

propriate 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);

(D)

describes

the

services

and

activities

to be

provided

and an

explanation

of the

manner

in which the

elements

of the

program

to be

implemented

by the

State with such

assistance

will

maximize

the

quality

of

health

and

support

services available

to

individuals with HIV/AIDS

through-

out the

State;

(E)

provides

a

description

of the

manner

in

which

services funded with assistance provided under section

2611 will be

coordinated with other available related serv-

ices for

individuals with HIV/AIDS;

(F)

provides

a

description

of how the

allocation and

utilization

of

resources

are

consistent with

the

statewide

coordinated statement

of need

(including traditionally un-

derserved populations

and

subpopulations) developed in

partnership with other grantees

in the

State that receive

funding under this title; and

(G)

includes

key

outcomes

to be

measured

by all

enti-

ties in the

State receiving

assistance under this title; and

(6) an

assurance that

the public

health agency admin-

istering

the

grant

for the

State

will

periodically convene

a

meeting

of

individuals with HIV/AIDS, members

of a

Federally

recognized Indian tribe

as

represented

in the

State, represent-

atives

of

grantees under

each

part under this title, providers,

and public

agency representatives

for the

purpose

of

developing

a

statewide coordinated statement

of

need;

(7) an

assurance

by the

State that—

(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

par-

ticipants under paragraph

(6), and the

types

of

entities de-

scribed

in

section 2602(b)(2),

in

developing

the

comprehen-

sive

plan under paragraph

(5) and

commenting

on the

im-

plementation

of such

plan;

(B) the

State will—

(i) to the

maximum extent practicable, ensure

that

HIV-related health

care and

support services delivered

pursuant

to a

program established with assistance

provided under section

2611 will be

provided without

regard

to the

ability

of the

individual

to pay for

such

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Sec. 2617

PUBLIC HEALTH SERVICE ACT

1392

services

and

without regard

to the

current

or

past

health condition

of the

individual with HIV/AIDS;

(ii)

ensure that

such

services

will be

provided in

a

setting that

is

accessible

to

low-income

individuals

with HIV/AIDS;

(iii)

provide outreach

to

low-income individuals

with HIV/AIDS

to

inform

such

individuals

of the

serv-

ices

available under section

2611;

and

(iv) in the case of a

State that intends

to

use

amounts provided under

the

grant

for

purposes de-

scribed

in 2615

8

, submit

a

plan

to the

Secretary

that

demonstrates that

the

State

has

established

a

pro-

gram that assures that—

(I) such

amounts

will be

targeted

to

individ-

uals

who would not

otherwise

be able to

afford

health insurance coverage;

and

(II)

income, asset,

and

medical expense cri-

teria

will be

established

and

applied

by the

State

to

identify those individuals

who

qualify

for

assist-

ance

under

such

program,

and

information con-

cerning

such

criteria shall

be

made available to

the

public;

(C) the

State

will

provide

for

periodic independent

peer

review

to

assess

the

quality

and

appropriateness

of

health

and

support services provided

by

entities that re-

ceive

funds

from the

State under section 2611;

(D) the

State

will

permit

and

cooperate with

any

Fed-

eral investigations undertaken regarding programs con-

ducted under section 2611;

(E) the

State

will

maintain HIV-related activities

at a

level

that

is

equal

to not less

than

the level of such

ex-

penditures

by the

State

for the

1-year period preceding

the

fiscal

year

for which the

State

is

applying

to

receive a

grant under section 2611;

(F) the

State

will

ensure that grant funds

are not

uti-

lized to

make payments

for any

item

or

service

to the

ex-

tent that payment

has been

made,

or can

reasonably

be

ex-

pected

to be

made, with respect

to

that item

or

service—

(i)

under

any

State compensation program,

under

an

insurance

policy, or

under

any

Federal

or

State

health benefits program; or

(ii) by an

entity that provides health services on

a

prepaid basis (except

for a

program administered by

or

providing

the

services

of the

Indian Health Service);

and

(G)

entities within areas

in which

activities under the

grant

are

carried

out will

maintain appropriate relation-

ships with entities

in the

area served that constitute key

points

of

access

to the

health

care

system

for

individuals

8

The word ‘‘section’’

probably should appear

before

‘‘2615’’.

Section

12(c)(3) of

Public

Law

104–

146 (110

Stat.

1373)

provides that subsection

(b)(3)(B)(iv) is

amended

by

inserting

‘‘section’’

be-

fore ‘‘2615’’, but the

amendment cannot

be

executed because

the

term

‘‘2615’’ does not

appear

in

paragraph

(3)(B)(iv). The

term formerly

did

appear

in such

paragraph,

but

former paragraph

(3) was

redesignated

as

paragraph

(4) by

section

3(c)(4)(B) of such

Public

Law (110

Stat. 1355).

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1393

PUBLIC HEALTH SERVICE ACT

Sec. 2617

with HIV/AIDS (including emergency rooms, substance

abuse treatment programs, detoxification centers, adult

and

juvenile detention facilities, sexually transmitted dis-

ease

clinics,

HIV

counseling

and

testing sites, mental

health programs,

and

homeless shelters),

and

other enti-

ties

under section

2612(c) and

2652(a),

for the

purpose

of

facilitating early intervention

for

individuals

newly

diag-

nosed with HIV/AIDS

and

individuals knowledgeable

of

their

HIV

status

but not in care;

and

(8) a

comprehensive plan—

(A)

containing

an

identification

of

individuals with

HIV/AIDS

as

described

in

clauses

(i)

through

(iii) of

section

2603(b)(2)(A) and the

strategy required under section

2602(b)(4)(D)(iv);

(B)

describing

the

estimated number

of

individuals

within

the

State with HIV/AIDS

who do not know

their

status;

(C)

describing activities undertaken

by the

State to

find the

individuals described

in

subparagraph

(A) and

to

make

such

individuals aware

of

their status;

(D)

describing

the

manner

in which the

State

will

pro-

vide

undiagnosed individuals

who are

made aware

of

their

status with access

to

medical treatment

for

their HIV/

AIDS;

and

(E)

describing efforts

to

remove

legal

barriers, includ-

ing

State

laws and

regulations,

to

routine testing.

(c)

R

EQUIREMENTS

R

EGARDING

I

MPOSITION

OF

C

HARGES FOR

S

ERVICES

.—

(1) IN

G

ENERAL

.—The Secretary

may not

make

a

grant

under section

2611 to a

State unless

the

State provides assur-

ances that

in the

provision

of

services with assistance provided

under

the

grant—

(A) in the case of

individuals with

an income less

than

or

equal

to 100

percent

of the official

poverty

line, the

pro-

vider

will not

impose charges

on any such

individual for

the

provision

of

services under

the

grant;

(B) in the case of

individuals with

an income

greater

than

100

percent

of the official

poverty

line, the

provider—

(i) will

impose charges

on each such

individual for

the

provision

of such

services;

and

(ii) will

impose charges according

to a

schedule

of

charges that

is

made available

to the

public;

(C) in the case of

individuals with

an income

greater

than

100

percent

of the official

poverty

line and not

ex-

ceeding

200

percent

of such

poverty

line, the

provider will

not, for any

calendar year, impose charges

in an

amount

exceeding

5

percent

of the

annual

gross income of the

indi-

vidual involved;

(D) in the case of

individuals with

an income

greater

than

200

percent

of the official

poverty

line and not

ex-

ceeding

300

percent

of such

poverty

line, the

provider will

not, for any

calendar year, impose charges

in an

amount

exceeding

7

percent

of the

annual

gross income of the

indi-

vidual involved;

and

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Sec. 2617

PUBLIC HEALTH SERVICE ACT

1394

(E) in the case of

individuals with

an income

greater

than

300

percent

of the official

poverty

line, the

provider

will not, for any

calendar year, impose charges

in

an

amount exceeding

10

percent

of the

annual

gross

income

of the

individual involved.

(2)

A

SSESSMENT

OF

CHARGE

.—With respect

to

compliance

with

the

assurance made under paragraph

(1), a

grantee under

section

2611 may, in the case of

individuals subject

to a

charge

for

purposes

of such

paragraph—

(A)

assess

the

amount

of the

charge

in the

discretion

of the

grantee, including imposing

only a

nominal charge

for the

provision

of

services, subject

to the

provisions

of

such

paragraph regarding

public

schedules regarding limi-

tation

on the

maximum amount

of

charges; and

(B)

take

into

consideration

the

medical expenses

of

in-

dividuals

in

assessing

the

amount

of the

charge, subject to

such

provisions.

(3)

A

PPLICABILITY

OF

LIMITATION

ON

AMOUNT

OF

CHARGE

.—

The

Secretary

may not

make

a

grant under section

2611

unless

the

applicant

of the

grant agrees that

the

limitations estab-

lished

in

subparagraphs

(C), (D), and (E) of

paragraph

(1)

re-

garding

the

imposition

of

charges

for

services applies

to the

an-

nual aggregate

of

charges imposed

for such

services, without

regard

to

whether they

are

characterized

as

enrollment fees,

premiums, deductibles,

cost

sharing, copayments, coinsurance,

or

other charges.

(4) W

AIVER

.—

(A) IN

GENERAL

.—The State shall

waive the

require-

ments established

in

paragraphs

(1)

through

(3) in

the

case of an

entity that

does not, in

providing health care

services, impose

a

charge

or

accept reimbursement from

any

third-party payor, including reimbursement under any

insurance

policy or

under

any

Federal

or

State health ben-

efits

program.

(B)

D

ETERMINATION

.—A determination

by the

State

of

whether

an

entity referred

to in

subparagraph

(A)

meets

the

criteria

for a

waiver under

such

subparagraph shall be

made without regard

to

whether

the

entity accepts vol-

untary donations regarding

the

provision

of

services

to

the

public.

(d)

R

EQUIREMENT

OF

M

ATCHING

F

UNDS

R

EGARDING

S

TATE

A

L

-

LOTMENTS

.—

(1) IN

GENERAL

.—In

the case of any

State

to which the

cri-

terion described

in

paragraph

(3)

applies,

the

Secretary may

not

make

a

grant under section

2611

unless

the

State agrees

that, with respect

to the costs to be

incurred

by the

State in

carrying

out the

program

for which the

grant

was

awarded, the

State

will,

subject

to

subsection

(b)(2),

make available (directly

or

through donations

from public or

private entities) non-Fed-

eral contributions toward

such costs in an

amount equal to—

(A) for the

first

fiscal

year

of

payments under the

grant,

not less

than

16

2

⁄

3

percent

of such costs ($1 for

each

$5 of

Federal funds provided

in the

grant);

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PUBLIC HEALTH SERVICE ACT

Sec. 2617

(B) for any

second

fiscal

year

of such

payments, not

less

than

20

percent

of such costs ($1 for each $4 of

Fed-

eral funds provided

in the

grant);

(C) for any

third

fiscal

year

of such

payments,

not

less

than

25

percent

of such costs ($1 for each $3 of

Federal

funds provided

in the

grant);

(D) for any

fourth

fiscal

year

of such

payments, not

less

than

33

1

⁄

3

percent

of such costs ($1 for each $2 of

Fed-

eral funds provided

in the

grant); and

(E) for any

subsequent

fiscal

year

of such

payments,

not less

than

33

1

⁄

3

percent

of such costs ($1 for each $2 of

Federal funds provided

in the

grant).

(2)

D

ETERMINATION

OF

AMOUNT

OF

NON

-

FEDERAL CON

-

TRIBUTION

.—

(A) IN

GENERAL

.—Non-Federal

contributions required

in

paragraph

(1) may be in cash or in

kind, fairly evalu-

ated, including plant, equipment,

or

services. Amounts

provided

by the

Federal Government,

and any

portion

of

any

service subsidized

by the

Federal Government, may

not be

included

in

determining

the

amount

of such

non-

Federal contributions.

(B)

I

NCLUSION

OF

CERTAIN

AMOUNTS

.—

(i) In

making

a

determination

of the

amount

of

non-Federal contributions made

by a

State

for

pur-

poses of

paragraph

(1), the

Secretary shall, subject to

clause

(ii),

include

any

non-Federal contributions pro-

vided by the

State

for

HIV-related services, without

regard

to

whether

the

contributions

are

made

for

pro-

grams established pursuant

to

this title;

(ii) In

making

a

determination

for

purposes

of

clause

(i), the

Secretary

may not

include

any

non-Fed-

eral contributions provided

by the

State

as a

condition

of

receiving Federal funds under

any

program under

this title (except

for the

program established

in

section

2611) or

under other provisions

of

law.

(3)

A

PPLICABILITY

OF

REQUIREMENT

.—

(A)

N

UMBER

OF

CASES

.—A State referred

to in

para-

graph

(1) is any

State

for which the

number

of cases of

HIV/AIDS reported

to and

confirmed

by the

Director

of

the

Centers

for

Disease Control

and

Prevention

for the

period

described

in

subparagraph

(B)

constitutes

in excess of

1

percent

of the

aggregate number

of such cases

reported to

and

confirmed

by the

Director

for such

period

for

the

United States.

(B)

P

ERIOD

OF

TIME

.—The period referred

to in

sub-

paragraph

(A) is the

2-year period preceding

the fiscal

year

for which the

State involved

is

applying

to

receive

a

grant

under subsection (a).

(C)

P

UERTO

R

ICO

.—For purposes

of

paragraph

(1),

the

number

of cases of

HIV/AIDS reported

and

confirmed for

the

Commonwealth

of

Puerto

Rico for any fiscal

year shall

be

deemed

to be less

than

1

percent.

(4)

D

IMINISHED STATE CONTRIBUTION

.—With respect

to

a

State that

does not

make available

the

entire amount

of

the

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PUBLIC HEALTH SERVICE ACT

1396

non-Federal contribution referred

to in

paragraph

(1),

the

State shall continue

to be

eligible

to

receive Federal funds

under

a

grant under section

2611,

except that

the

Secretary in

providing Federal funds under

the

grant shall provide such

funds

(in

accordance with

the

ratios prescribed

in

paragraph

(1)) only

with respect

to the

amount

of

funds contributed by

such

State.

SEC.

2618.

ø

300ff–28

¿

DISTRIBUTION

OF

FUNDS.

(a)

A

MOUNT

OF

G

RANT

TO

S

TATE

.—

(1)

M

INIMUM ALLOTMENT

.—Subject

to the

extent

of

amounts made available under section

2623, the

amount

of

a

grant

to be

made under section

2611

for—

(A) each of the 50

States,

the

District

of

Columbia,

Guam,

and the

Virgin Islands (referred

to in

this para-

graph

as a ‘‘covered State’’) for a fiscal

year shall

be

the

greater

of—

(i)(I)

with respect

to a

covered State that

has

less

than

90 living cases of AIDS, as

determined under

paragraph

(2)(D),

$200,000; or

(II)

with respect

to a

covered State that

has 90

or

more living cases of AIDS, as

determined under para-

graph

(2)(D),

$500,000;

and

(ii) an

amount determined under paragraph (2)

and

then,

as

applicable, increased under paragraph

(2)(H);

and

(B) each

territory other than Guam

and the

Virgin Is-

lands shall

be the

greater

of

$50,000

or an

amount deter-

mined under paragraph (2).

(2)

D

ETERMINATION

.—

(A)

F

ORMULA

.—For purposes

of

paragraph

(1),

the

amount referred

to in

this paragraph

for a

State (including

a

territory)

for a fiscal

year

is,

subject

to

subparagraphs

(E) and

(F)—

(i) an

amount equal

to the

amount made available

under section

2623 for the fiscal

year involved for

grants pursuant

to

paragraph

(1),

subject

to

subpara-

graph

(F);

and

(ii) the

percentage constituted

by the sum of—

(I) the

product

of 0.75 and the

ratio

of

the

State distribution factor

for the

State

or

territory

(as

determined under subsection

(B)) to the sum of

the

respective State distribution factors

for

all

States

or

territories;

(II) the

product

of .20 and the

ratio

of

the

non-EMA distribution factor

for the

State

or

terri-

tory (as

determined under subparagraph

(C))

to

the sum of the

respective non-EMA distribution

factors

for all

States

or

territories; and

(III) if the

State

does not for such fiscal

year

contain

any

area that

is an

eligible area under

subpart

I of

part

A or any

area that

is a

transi-

tional area under section

2609

(referred

to in

this

subclause

as a ‘‘no-EMA State’’), the

product

of

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PUBLIC HEALTH SERVICE ACT

Sec. 2618

0.05 and the

ratio

of the

number

of cases

that ap-

plies for the

State under subparagraph

(D) to

the

sum of the

respective numbers

of cases

that so

apply

for all no-EMA

States.

(B)

S

TATE DISTRIBUTION FACTOR

.—For purposes

of

sub-

paragraph

(A)(ii)(I), the

term

‘‘State

distribution factor’’

means

an

amount equal

to the

number

of living cases of

HIV/AIDS

in the

State involved,

as

determined under sub-

paragraph (D).

(C)

N

ON

-

EMA DISTRIBUTION FACTOR

.—For purposes

of

subparagraph

(A)(ii)(II), the

term

‘‘non-ema

distribution

factor’’

means

an

amount equal

to the sum of—

(i) the

number

of living cases of

HIV/AIDS

in

the

State involved,

as

determined under subparagraph

(D);

less

(ii) a

number equal

to the sum of—

(I) the

total number

of living cases of

HIV/

AIDS

that

are

within areas

in such

State that are

eligible areas under subpart

I of

part

A for the

fis-

cal

year involved,

which

individual number

for

an

area

is the

number that applies under section

2601 for the

area

for such fiscal year;

and

(II) the

total number

of such cases

that are

within areas

in such

State that

are

transitional

areas under section

2609 for such fiscal

year,

which

individual number

for an

area

is the

num-

ber

that applies under

such

section

for the

fiscal

year.

(D)

L

IVING CASES

OF

HIV

/

AIDS

.—

(i)

R

EQUIREMENT

OF

NAMES

-

BASED

REPORTING

.—

Except

as

provided

in

clause

(ii), the

number deter-

mined under this subparagraph

for a

State

for a

fiscal

year

for

purposes

of

subparagraph

(B) is the

number

of living

names-based

cases of

HIV/AIDS

in the

State

that,

as of

December

31 of the most

recent calendar

year

for which such

data

is

available, have

been

re-

ported

to and

confirmed

by the

Director

of the

Centers

for

Disease Control

and

Prevention.

(ii)

T

RANSITION PERIOD

;

EXEMPTION REGARDING

NON

-

AIDS CASES

.—For

each of the fiscal

years 2007

through

2012, a

State

is,

subject

to

clauses (iii)

through

(v),

exempt

from the

requirement under

clause

(i)

that

living

non-AIDS names-based

cases of

HIV be

reported unless—

(I) a

system

was in

operation

as of

December

31, 2005,

that provides sufficiently accurate and

reliable names-based reporting

of such

cases

throughout

the

State, subject

to

clause

(vii);

or

(II) no

later than

the

beginning

of fiscal

year

2008 or a

subsequent

fiscal

year through fiscal

year

2012, the

Secretary, after consultation with

the chief

executive

of the

State, determines

that a

system

has become

operational

in the

State that

provides sufficiently accurate

and

reliable names-

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PUBLIC HEALTH SERVICE ACT

1398

based reporting

of such cases

throughout the

State.

(iii)

R

EQUIREMENTS FOR EXEMPTION FOR FISCAL

YEAR 2007

.—For

fiscal

year

2007, an

exemption under

clause

(ii) for a

State applies

only if, by

October 1,

2006—

(I)(aa) the

State

had

submitted

to the

Sec-

retary

a

plan

for

making

the

transition

to

suffi-

ciently accurate

and

reliable names-based report-

ing of living

non-AIDS

cases of HIV;

or

(bb) all

statutory changes necessary

to

provide

for

sufficiently accurate

and

reliable reporting

of

such cases had been

made; and

(II) the

State

had

agreed that,

by April

1,

2008, the

State

will begin

accurate

and

reliable

names-based reporting

of such

cases, except

that

such

agreement

is not

required

to

provide

that, as

of such

date,

the

system

for such

reporting be

fully

sufficient with respect

to

accuracy

and

reli-

ability throughout

the

area.

(iv)

R

EQUIREMENT FOR EXEMPTION

AS OF

FISCAL

YEAR 2008

.—For

each of the fiscal

years

2008

through

2012, an

exemption under clause

(ii) for a

State ap-

plies only if, as of April 1, 2008, the

State

is

substan-

tially

in

compliance with

the

agreement under clause

(iii)(II).

(v)

P

ROGRESS TOWARD NAMES

-

BASED

REPORTING

.—

For fiscal

year

2009 or a

subsequent

fiscal

year, the

Secretary

may

terminate

an

exemption under clause

(ii) for a

State

if the

State submitted

a

plan under

clause (iii)(I)(aa)

and the

Secretary determines

that

the

State

is not

substantially

following

the

plan.

(vi)

C

OUNTING

OF

CASES

IN

AREAS WITH EXEMP

-

TIONS

.—

(I) IN

GENERAL

.—With respect

to a

State that

is

under

a

reporting system

for living

non-AIDS

cases of HIV

that

is not

names-based (referred to

in

this subparagraph

as ‘‘code-based

reporting’’),

the

Secretary shall,

for

purposes

of

this subpara-

graph,

modify the

number

of such cases

reported

for the

State

in

order

to

adjust

for

duplicative re-

porting

in and

among systems that

use

code-based

reporting.

(II)

A

DJUSTMENT RATE

.—The

adjustment rate

under subclause

(I) for a

State shall

be a

reduc-

tion of 5

percent

for fiscal

years

before fiscal

year

2012 (and 6

percent

for fiscal

year

2012) in

the

number

of living

non-AIDS

cases of HIV

reported

for the

State.

(III)

I

NCREASED ADJUSTMENT FOR CERTAIN

STATES PREVIOUSLY USING CODE

-

BASED REPORT

-

ING

.—For purposes

of

this subparagraph

for

each

of fiscal

years

2010

through

2012, the

Secretary

shall

deem the

applicable number

of living

cases

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PUBLIC HEALTH SERVICE ACT

Sec. 2618

of

HIV/AIDS

in a

State that

were

reported

to

and

confirmed

by the

Centers

for

Disease Control and

Prevention

to be 3

percent higher than

the

actual

number if—

(aa)

there

is an

area

in such

State that

satisfies

all of the

conditions described in

items

(aa)

through

(cc) of

section

2603(a)(3)(C)(vi)(III);

or

(bb)(AA) fiscal

year

2007 was the

first

year

in which the

count

of living

non-AIDS

cases of HIV in such

area,

for

purposes

of

this

part,

was

based

on a

names-based reporting

system; and

(BB) the

amount

of

funding that such

State received under this part

for fiscal

year

2007 was less

than

70

percent

of the

amount

of

funding that

such

State received under

such

part

for fiscal

year 2006.

(vii)

L

IST

OF

STATES MEETING STANDARD

REGARD

-

ING DECEMBER

31,

2005

.—

(I) IN

GENERAL

.—If

a

State

is

specified

in

sub-

clause

(II), the

State shall

be

considered

to

meet

the

standard described

in

clause

(ii)(I). No

other

State

may be

considered

to

meet

such

standard.

(II)

R

ELEVANT STATES

.—For purposes

of

sub-

clause

(I), the

States specified

in

this subclause

are the following:

Alaska, Alabama, Arkansas, Ar-

izona, Colorado, Florida, Indiana,

Iowa,

Idaho,

Kansas, Louisiana, Michigan, Minnesota, Mis-

souri, Mississippi, North Carolina, North Dakota,

Nebraska,

New

Jersey,

New Mexico, New

York,

Nevada,

Ohio,

Oklahoma, South Carolina, South

Dakota, Tennessee, Texas, Utah, Virginia, Wis-

consin,

West

Virginia, Wyoming, Guam,

and

the

Virgin Islands.

(viii)

R

ULES

OF

CONSTRUCTION REGARDING ACCEPT

-

ANCE

OF

REPORTS

.—

(I)

C

ASES

OF

AIDS

.—With respect

to a

State

that

is

subject

to the

requirement under clause (i)

and is not in

compliance with

the

requirement for

names-based reporting

of living

non-AIDS

cases of

HIV, the

Secretary shall, notwithstanding such

noncompliance, accept reports

of living cases of

AIDS

that

are in

accordance with

such

clause.

(II)

A

PPLICABILITY

OF

EXEMPTION

REQUIRE

-

MENTS

.—The provisions

of

clauses

(ii)

through (vii)

may not be

construed

as

having

any legal

effect

for fiscal

year

2013 or any

subsequent

fiscal

year,

and

accordingly,

the

status

of a

State

for

purposes

of such

clauses

may not be

considered after fiscal

year 2012.

(ix)

P

ROGRAM FOR DETECTING INACCURATE OR

FRAUDULENT COUNTING

.—The Secretary shall carry

out a

program

to

monitor

the

reporting

of

names-

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PUBLIC HEALTH SERVICE ACT

1400

based

cases for

purposes

of

this subparagraph

and

to

detect instances

of

inaccurate reporting, including

fraudulent reporting.

(x)

F

UTURE FISCAL YEARS

.—For

fiscal

years begin-

ning

with

fiscal

year

2013,

determinations under

this

paragraph shall

be

based

only on living

names-based

cases of

HIV/AIDS with respect

to the

State involved.

(E)

C

ODE

-

BASED STATES

;

LIMITATION

ON

INCREASE IN

GRANT

.—

(i) IN

GENERAL

.—For

each of the fiscal

years 2007

through

2012, if

code-based reporting (within the

meaning

of

subparagraph

(D)(vi))

applies

in a

State as

of the

beginning

of the fiscal

year involved, then not-

withstanding

any

other provision

of

this paragraph,

the

amount

of the

grant pursuant

to

paragraph

(1)

for

the

State

may not for the fiscal

year involved exceed

by more

than

5

percent

the

amount

of the

grant pur-

suant

to

this paragraph

for the

State

for the

preceding

fiscal

year, except that

the

limitation under this clause

may not

result

in a

grant pursuant

to

paragraph (1)

for a fiscal

year that

is less

than

the

minimum amount

that applies

to the

State under

such

paragraph for

such fiscal

year.

(ii)

U

SE

OF

AMOUNTS INVOLVED

.—For

each of

the

fiscal

years

2007

through

2012,

amounts available as

a

result

of the

limitation under clause

(i)

shall be

made available

by the

Secretary

as

additional

amounts

for

grants pursuant

to

section

2620,

subject

to

subparagraph (H).

(F)

9

A

PPROPRIATIONS FOR TREATMENT DRUG

PRO

-

GRAM

.—

(i)

F

ORMULA GRANTS

.—With respect

to the

fiscal

year involved,

if

under section

2623 an

appropriations

Act

provides

an

amount exclusively

for

carrying out

section

2616, the

portion

of such

amount allocated to

a

State shall

be the

product

of—

(I)

10

100

percent

of such

amount,

less the

percent-

age

reserved under clause

(ii)(V);

and

(II)

10

the

percentage constituted

by the

ratio

of

the

State distribution factor

for the

State

(as

deter-

mined under subparagraph

(B)) to the sum of

the

State distribution factors

for all

States;

which

product shall then,

as

applicable,

be

increased

under subparagraph (H).

(ii)

S

UPPLEMENTAL TREATMENT DRUG

GRANTS

.—

(I) IN

GENERAL

.—From amounts made avail-

able

under subclause

(V), the

Secretary shall

award supplemental grants

to

States described in

subclause

(II) to

enable

such

States

to

purchase

9

The

amendments made

by

section

203(c) of

Public

Law

109–415

to

section 2618(a)(2)(G)

have

been

carried

out to

subparagraph

(F), as

redesignated

by

subsection

(b)(4) of such

Public Law,

in

order

to

reflect

the

probable intent

of

Congress.

10

Indentation

of

subclauses

(I) and (II) are so in law. See

section

206(e)(1) of

Public

Law

106–

345 (114

Stat. 1336).

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PUBLIC HEALTH SERVICE ACT

Sec. 2618

and

distribute

to

eligible individuals under section

2616(b)

pharmaceutical therapeutics described

under subsections

(c)(2) and (e) of such

section.

(II)

E

LIGIBLE STATES

.—For purposes

of

sub-

clause

(I), a

State shall

be an

eligible State

if

the

State

did not

have unobligated funds subject

to

re-

allocation under section

2618(d) in the

year and,

in

accordance with criteria estab-

lished

by the

Secretary, demonstrates

a

severe

need for a

grant under this clause.

For

purposes

of

determining severe need,

the

Secretary shall

consider eligibility standards, formulary composi-

tion, the

number

of

eligible individuals

to whom

a

State

is

unable

to

provide therapeutics described

in

section 2616(a),

and an

unanticipated increase

of

eligible individuals with HIV/AIDS.

(III)

S

TATE REQUIREMENTS

.—The Secretary

may not

make

a

grant

to a

State under this clause

unless

the

State agrees that

the

State

will

make

available (directly

or

through donations

of

public

or

private entities) non-Federal contributions to-

ward

the

activities

to be

carried

out

under the

grant

in an

amount equal

to $1 for each $4 of

Fed-

eral funds provided

in the

grant, except that the

Secretary

may waive

this subclause

if the

State

has

otherwise

fully

complied with section 2617(d)

with respect

to the

grant year involved.

The

provi-

sions of

this subclause shall apply

to

States that

are not

required

to comply

with

such

section

2617(d).

(IV)

U

SE AND COORDINATION

.—Amounts

made

available under

a

grant under this clause shall

only be

used

by the

State

to

provide HIV/AIDS-re-

lated medications.

The

State shall coordinate

the

use of such

amounts with

the

amounts otherwise

provided under section 2616(a)

in

order

to

maxi-

mize

drug coverage.

(V)

F

UNDING

.—For

the

purpose

of

making

grants under this clause,

the

Secretary shall each

fiscal

year reserve

5

percent

of the

amount re-

ferred

to in

clause

(i)

with respect

to

section 2616.

(iii)

C

ODE

-

BASED STATES

;

LIMITATION

ON

INCREASE

IN

FORMULA GRANT

.—The limitation under subpara-

graph

(E)(i)

applies

to

grants pursuant

to

clause

(i) of

this subparagraph

to the

same extent

and in the

same

manner

as such

limitation applies

to

grants pursuant

to

paragraph

(1),

except that

the

reference

to

min-

imum grants

does not

apply

for

purposes

of

this

clause. Amounts available

as a

result

of the

limitation

under

the

preceding sentence shall

be

made available

by the

Secretary

as

additional amounts

for

grants

under clause

(ii) of

this subparagraph.

January 28, 2016

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F:\COMP\PHSA\PHSA-MERGED.XML

Sec. 2618

PUBLIC HEALTH SERVICE ACT

1402

(H)

11

I

NCREASE

IN

FORMULA GRANTS

.—

(i)

A

SSURANCE

OF

AMOUNT

.—

(I)

G

ENERAL RULE

.—For

fiscal

year

2010,

the

Secretary shall ensure, subject

to

clauses (ii)

through

(iv),

that

the

total

for a

State

of the

grant

pursuant

to

paragraph

(1) and the

grant pursuant

to

subparagraph

(F) is not less

than

95

percent

of

such

total

for the

State

for fiscal

year 2009.

(II)

R

ULE

OF

CONSTRUCTION

.—With respect to

the

application

of

subclause

(I), the 95

percent re-

quirement under

such

subclause shall apply with

respect

to each

grant awarded under paragraph

(1) and

with respect

to each

grant awarded under

subparagraph (F).

(ii)

F

ISCAL YEARS 2011 AND 2012

.—For

each of

the

fiscal

years

2011 and 2012, the

Secretary shall ensure

that

the

total

for a

State

of the

grant pursuant to

paragraph

(1) and the

grant pursuant

to

subparagraph

(F) is not less

than

100

percent

of such

total

for

the

State

for fiscal

year 2010.

(iii)

F

ISCAL YEAR 2013

.—For

fiscal

year

2013,

the

Secretary shall ensure that

the

total

for a

State

of

the

grant pursuant

to

paragraph

(1) and the

grant pursu-

ant

to

subparagraph

(F) is not less

than

92.5

percent

of such

total

for the

State

for fiscal

year 2012.

(iv)

S

OURCE

OF

FUNDS FOR INCREASE

.—

(I) IN

GENERAL

.—From

the

amount reserved

under section 2623(b)(2)

for a fiscal

year,

and

from

amounts available

for such

section pursuant to

subsection

(d) of

this section,

the

Secretary shall

make available

such

amounts

as may be

necessary

to comply

with clause (i).

(II)

P

RO

RATA

REDUCTION

.—If

the

amounts re-

ferred

to in

subclause

(I) for a fiscal

year

are

in-

sufficient

to fully comply

with clause

(i) for

the

year,

the

Secretary,

in

order

to

provide

the

addi-

tional funds necessary

for such

compliance,

shall

reduce

on a pro

rata basis

the

amount

of

each

grant pursuant

to

paragraph

(1) for the

fiscal

year, other than grants

for

States

for which

in-

creases under clause

(i)

apply

and

other than

States described

in

paragraph

(1)(A)(i)(I). A

reduc-

tion

under

the

preceding sentence

may not

be

made

in an

amount that

would

result

in the

State

involved becoming eligible

for such an

increase.

(v)

A

PPLICABILITY

.—This paragraph

may not

be

construed

as

having

any

applicability after

fiscal

year

2013.

(b)

A

LLOCATION

OF

A

SSISTANCE

BY

S

TATES

.—

(1)

A

LLOWANCES

.—Prior

to

allocating

assistance under this

subsection,

a

State shall consider

the

unmet needs

of

those

areas that have

not

received financial assistance under part A.

11

So in law.

There

is no

subparagraph (G).

January 28, 2016

As Amended Through P.L. 114-113, Enacted December 18, 2015

F:\COMP\PHSA\PHSA-MERGED.XML

1403

PUBLIC HEALTH SERVICE ACT

Sec. 2618

(2)

P

LANNING AND EVALUATIONS

.—Subject

to

paragraph (4)

and

except

as

provided

in

paragraph

(5), a

State

may not

use

more

than

10

percent

of

amounts received under

a

grant

awarded under section

2611 for

planning

and

evaluation activi-

ties.

(3) A

DMINISTRATION

.—

(A) IN

GENERAL

.—Subject

to

paragraph

(4), and

except

as

provided

in

paragraph

(5), a

State

may not use

more

than

10

percent

of

amounts received under

a

grant award-

ed

under section

2611 for

administration.

(B)

A

LLOCATIONS

.—In

the case of

entities

and

sub-

contractors

to which a

State allocates amounts received by

the

State under

a

grant under section

2611, the

State shall

ensure that,

of the

aggregate amount

so

allocated,

the

total

of the

expenditures

by such

entities

for

administrative ex-

penses

does not exceed 10

percent (without regard to

whether particular entities expend

more

than

10

percent

for such

expenses).

(C)

A

DMINISTRATIVE ACTIVITIES

.—For

the

purposes

of

subparagraph

(A),

amounts

may be

used

for

administrative

activities that include routine grant administration and

monitoring activities, including

a

clinical quality manage-

ment program under subparagraph (E).

(D)

S

UBCONTRACTOR ADMINISTRATIVE COSTS

.—For

the

purposes

of

this paragraph, subcontractor administrative

activities include—

(i)

usual

and

recognized overhead, including

estab-

lished indirect rates

for

agencies;

(ii)

management oversight

of specific

programs

funded under this title; and

(iii)

other types

of

program support

such as

qual-

ity

assurance, quality control,

and

related activities.

(E)

C

LINICAL QUALITY MANAGEMENT

.—

(i)

R

EQUIREMENT

.—Each State that

receives a

grant under section

2611

shall provide

for the

estab-

lishment

of a

clinical quality management program to

assess

the

extent

to which HIV

health services pro-

vided to

patients under

the

grant

are

consistent with

the most

recent Public Health Service guidelines for

the

treatment

of

HIV/AIDS

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

qual-

ity of HIV

health services.

(ii)

U

SE

OF

FUNDS

.—

(I) IN

GENERAL

.—From amounts received

under

a

grant awarded under section

2611 for

a

fiscal

year,

a

State

may use for

activities associ-

ated with

the

clinical quality management pro-

gram required

in

clause

(i) not to exceed the

lesser

of—

(aa) 5

percent

of

amounts received under

the

grant; or

(bb)

$3,000,000.

January 28, 2016

As Amended Through P.L. 114-113, Enacted December 18, 2015

F:\COMP\PHSA\PHSA-MERGED.XML

Sec. 2619

PUBLIC HEALTH SERVICE ACT

1404

(II)

R

ELATION

TO

LIMITATION

ON

ADMINISTRA

-

TIVE EXPENSES

.—The

costs of a

clinical quality

management program under clause

(i) may not

be

considered administrative expenses

for

purposes

of the

limitation established

in

subparagraph (A).

(4)

L

IMITATION

ON

USE

OF

FUNDS

.—Except

as

provided in

paragraph

(5), a

State

may not use more

than

a

total

of 15

per-

cent of

amounts received under

a

grant awarded under section

2611 for the

purposes described

in

paragraphs

(2) and

(3).

(5)

E

XCEPTION

.—With respect

to a

State that receives

the

minimum allotment under subsection

(a)(1) for a fiscal

year,

such

State,

from the

amounts received under

a

grant awarded

under section

2611 for such fiscal

year

for the

activities de-

scribed

in

paragraphs

(2) and (3), may,

notwithstanding para-

graphs

(2)

through

(4)

12

,

use not more

than that amount re-

quired

to

support

one

full-time-equivalent employee.

(6)

C

ONSTRUCTION

.—A State

may not use

amounts re-

ceived

under

a

grant awarded under section

2611 to

purchase

or

improve land,

or to

purchase, construct,

or

permanently im-

prove

(other than minor remodeling)

any

building

or

other fa-

cility, or to

make

cash

payments

to

intended recipients

of

serv-

ices.

(c)

E

XPEDITED

D

ISTRIBUTION

.—

(1) IN

GENERAL

.—Not

less

than

75

percent

of the

amounts

received under

a

grant awarded

to a

State under section 2611

shall

be

obligated

to specific

programs

and

projects

and

made

available

for

expenditure

not

later than—

(A) in the case of the

first

fiscal

year

for

which

amounts

are

received,

150 days

after

the

receipt

of

such

amounts

by the

State; and

(B) in the case of

succeeding

fiscal

years,

120

days

after

the

receipt

of such

amounts

by the

State.

(2)

P

UBLIC COMMENT

.—Within

the

time periods referred to

in

paragraph

(1), the

State shall invite

and

receive

public

com-

ment concerning methods

for the

utilization

of such

amounts.

(d)

R

EALLOCATION

.—Any portion

of a

grant made

to a

State

under section

2611 for a fiscal

year that

has not been

obligated

as

described

in

subsection

(c)

ceases

to be

available

to the

State and

shall

be

made available

by the

Secretary

for

grants under section

2620, in

addition

to

amounts made available

for such

grants under

section 2623(b)(2).

SEC.

2619.

ø

300ff–29

¿

TECHNICAL ASSISTANCE.

The

Secretary shall provide technical assistance

in

admin-

istering

and

coordinating

the

activities authorized under section

2612,

including technical assistance

for the

development

and

imple-

mentation

of

statewide coordinated statements

of

need.

12

Section

203(e)(5) of

Public

Law

109–415

(120

Stat.

2795)

struck ‘‘paragraphs

(3)’’ and

all

that

follows

through

‘‘(5),’’

and

inserted revised text. There

were two

references

to

‘‘paragraphs

(3)’’. The

amendment

was

executed

to the

first

such

reference

to

reflect

the

probable intent

of

Congress.

January 28, 2016

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F:\COMP\PHSA\PHSA-MERGED.XML

1405

PUBLIC HEALTH SERVICE ACT

Sec. 2620

SEC.

2620.

ø

300ff–29a

¿

SUPPLEMENTAL GRANTS.

(a) IN

G

ENERAL

.—For

the

purpose

of

providing services de-

scribed

in

section 2612(a),

the

Secretary shall make grants to

States—

(1) whose

applications under section

2617

have dem-

onstrated

the need in the

State,

on an

objective

and

quantified

basis,

for

supplemental financial assistance

to

provide such

services;

and

(2)

that

did not, for the most

recent grant year pursuant

to

section 2618(a)(1)

or

2618(a)(2)(F)(i)

for which

data

is

avail-

able,

have

more

than

5

percent

of

grant funds under

such

sec-

tions canceled,

offset

under section 2622(e),

or

covered

by

any

waivers under section 2622(c).

(b)

D

EMONSTRATED

N

EED

.—The factors considered

by the

Sec-

retary

in

determining whether

an

eligible area

has a

demonstrated

need for

purposes

of

subsection

(a)(1) may

include

any or all of

the

following:

(1) The

unmet

need for such

services,

as

determined under

section 2617(b).

(2) An

increasing

need for

HIV/AIDS-related services, in-

cluding relative rates

of

increase

in the

number

of cases of

HIV/AIDS.

(3) The

relative rates

of

increase

in the

number

of

cases

of

HIV/AIDS within

new or

emerging subpopulations.

(4) The

current prevalence

of

HIV/AIDS.

(5)

Relevant factors related

to the cost and

complexity

of

delivering health

care to

individuals with HIV/AIDS

in the

eli-

gible

area.

(6) The

impact

of

co-morbid factors, including co-occurring

conditions, determined relevant

by the

Secretary.

(7) The

prevalence

of

homelessness.

(8) The

prevalence

of

individuals described under section

2602(b)(2)(M).

(9) The

relevant factors that limit access

to

health care, in-

cluding geographic variation, adequacy

of

health insurance cov-

erage,

and

language

barriers.

(10) The

impact

of a

decline

in the

amount received pursu-

ant

to

section

2618 on

services available

to all

individuals with

HIV/AIDS identified

and

eligible

under this title.

(c)

P

RIORITY

IN

M

AKING

G

RANTS

.—The Secretary shall provide

funds under this section

to a

State

to

address

the

decline

in

serv-

ices

decline

in the

amounts received pursuant

to

sec-

tion 2618

consistent with

the

grant award

to the

State

for

fiscal

year

2006, to the

extent that

the

factor under subsection

(b)(10)

(re-

lating

to a

decline

in

funding) applies

to the

State.

(d)

R

EPORT

ON

THE

A

WARDING

OF

S

UPPLEMENTAL

F

UNDS

.—Not

later than

45 days

after

the

awarding

of

supplemental funds under

this section,

the

Secretary shall submit

to

Congress

a

report con-

cerning

such

funds.

Such

report shall include information detail-

ing—

(1) the

total amount

of

supplemental funds available under

this section

for the

year involved;

(2) the

amount

of

supplemental funds used

in

accordance

with

the hold

harmless provisions

of

section 2618(a)(2);

January 28, 2016

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F:\COMP\PHSA\PHSA-MERGED.XML

Sec. 2621

PUBLIC HEALTH SERVICE ACT

1406

(3) the

amount

of

supplemental funds disbursed pursuant

to

subsection

(c);

(4) the

disbursement

of the

remainder

of the

supplemental

funds after taking

into

account

the

uses described

in

para-

graphs

(2) and (3);

and

(5) the

rationale used

for the

amount

of

funds disbursed as

described under paragraphs

(2), (3), and

(4).

(e)

C

ORE

M

EDICAL

S

ERVICES

.—The provisions

of

section 2612(b)

apply with respect

to a

grant under this section

to the

same extent

and in the

same manner

as such

provisions apply with respect to

a

grant made pursuant

to

section 2618(a)(1).

(f)

A

PPLICABILITY

OF

G

RANT

A

UTHORITY

.—The authority to

make grants under this section applies beginning with

the

first fis-

cal

year

for which

amounts

are

made available

for such

grants

under section 2623(b)(1).

SEC.

2621.

ø

300ff–30

¿

EMERGING COMMUNITIES.

(a) IN

G

ENERAL

.—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

emerg-

ing

communities within

the

State that

are not

eligible

to

receive

grants under part A.

(b)

E

LIGIBILITY

.—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);

(3)

agree that

the

grant

will be

used

to

provide funds di-

rectly

to

emerging communities

in the

State, separately from

other funds under this title that

are

provided

by the

State to

such

communities;

and

(4)

submit

the

information described

in

subsection

(c).

(c)

R

EPORTING

R

EQUIREMENTS

.—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

re-

sources,

both

financial

and

in-kind;

(3) a

demonstration that

the

State

will

maintain HIV-re-

lated 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 section 2611;

(4) a

demonstration

of the

ability

of the

State

to

utilize

such

supplemental financial resources

in a

manner that

is

im-

mediately responsive

and cost

effective;

(5) a

demonstration that

the

resources

will be

allocated in

accordance with

the local

demographic incidence

of AIDS

in-

January 28, 2016

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F:\COMP\PHSA\PHSA-MERGED.XML

1407

PUBLIC HEALTH SERVICE ACT

Sec. 2622

cluding appropriate allocations

for

services

for

infants, chil-

dren, women,

and

families with HIV/AIDS;

(6) a

demonstration

of the

inclusiveness

of the

planning

process, with particular emphasis

on

affected communities

and

individuals with HIV/AIDS;

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)

D

EFINITIONS

OF

E

MERGING

C

OMMUNITY

.—For purposes

of

this section,

the

term

‘‘emerging

community’’ means

a

metropolitan

area

(as

defined

in

section

2607) for which

there

has been

reported

to and

confirmed

by the

Director

of the

Centers

for

Disease Control

and

Prevention

a

cumulative total

of

at least

500, but fewer

than

1,000, cases of AIDS

during

the most

recent period

of 5

calendar

years

for which such

data

are

available.

(e)

C

ONTINUED

S

TATUS

AS

E

MERGING

C

OMMUNITY

.—Notwith-

standing

any

other provision

of

this section,

a

metropolitan area

that

is an

emerging community

for a fiscal

year continues

to be

an

emerging community until

the

metropolitan area

fails, for

three

consecutive

fiscal

years—

(1) to

meet

the

requirements

of

subsection

(d);

and

(2) to

have

a

cumulative total

of 750 or more living

cases

of AIDS

(reported

to and

confirmed

by the

Director

of the

Cen-

ters

for

Disease Control

and

Prevention)

as of

December

31 of

the most

recent calendar year

for which such

data

is

available.

(f)

D

ISTRIBUTION

.—The amount

of a

grant under subsection (a)

for a

State

for a fiscal

year shall

be an

amount equal

to the

product

of—

(1) the

amount available under section 2623(b)(1)

for

the

fiscal year;

and

(2) a

percentage equal

to the

ratio constituted

by the

num-

ber of living cases of

HIV/AIDS

in

emerging communities in

the

State

to the sum of the

respective numbers

of such

cases

in such

communities

for all

States.

SEC.

2622.

ø

300ff–31a

¿

TIMEFRAME

FOR

OBLIGATION

AND

EXPENDI-

TURE

OF

GRANT

FUNDS.

(a)

O

BLIGATION

BY

END

OF

G

RANT

Y

EAR

.—Effective

for

fiscal

year

2007 and

subsequent

fiscal

years, funds

from a

grant award

made

to a

State

for a fiscal

year pursuant

to

section 2618(a)(1) or

2618(a)(2)(F),

or

under section

2620 or 2621, are

available

for

obli-

gation

by the

State through

the end of the

one-year period begin-

ning on the

date

in such fiscal

year

on which

funds

from the

award

first

become

available

to the

State (referred

to in

this section

as

the

‘‘grant

year

for the award’’),

except

as

provided

in

subsection

(c)(1).

(b)

S

UPPLEMENTAL

G

RANTS

; C

ANCELLATION

OF

U

NOBLIGATED

B

ALANCE

OF

G

RANT

A

WARD

.—Effective

for fiscal

year

2007 and

sub-

sequent

fiscal

years,

if a

grant award made

to a

State

for a

fiscal

year pursuant

to

section 2618(a)(2)(F)(ii),

or

under section

2620

or

2621, has an

unobligated balance

as of the end of the

grant year

for the

award—

(1) the

Secretary shall cancel that unobligated balance

of

the

award,

and

shall require

the

State

to

return

any

amounts

from such

balance that have

been

disbursed

to the

State; and

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Sec. 2622

PUBLIC HEALTH SERVICE ACT

1408

(2) the

funds involved shall

be

made available

by the

Sec-

retary

as

additional amounts

for

grants pursuant

to

section

2620 for the

first

fiscal

year beginning after

the fiscal

year in

which the

Secretary obtains

the

information necessary

for

de-

termining that

the

balance

is

required under paragraph

(1)

to

be

canceled, except that

the

availability

of the

funds

for

such

grants

is

subject

to

section 2618(a)(2)(H)

as

applied

for

such

year.

(c)

F

ORMULA

G

RANTS

; C

ANCELLATION

OF

U

NOBLIGATED

B

AL

-

ANCE

OF

G

RANT

AWARD;

W

AIVER

P

ERMITTING

C

ARRYOVER

.—

(1) IN

GENERAL

.—Effective

for fiscal

year

2007 and

subse-

quent

fiscal

years,

if a

grant award made

to a

State

for a

fiscal

year pursuant

to

section 2618(a)(1)

or

2618(a)(2)(F)(i)

has

an

unobligated balance

as of the end of the

grant year

for

the

award,

the

Secretary shall cancel that unobligated balance

of

the

award,

and

shall require

the

State

to

return

any

amounts

from such

balance that have

been

disbursed

to the

State, un-

less—

(A) before the end of the

grant year,

the

State submits

to the

Secretary

a

written application

for a

waiver

of

the

cancellation,

which

application includes

a

description

of

the

purposes

for which the

State intends

to

expend the

funds involved;

and

(B) the

Secretary approves

the

waiver.

(2)

E

XPENDITURE

BY

END

OF

CARRYOVER YEAR

.—With re-

spect

to a

waiver under paragraph

(1)

that

is

approved

for

a

balance that

is

unobligated

as of the end of a

grant year for

an

award:

(A) The

unobligated funds

are

available

for

expendi-

ture

by the

State involved

for the

one-year period begin-

ning upon the

expiration

of the

grant year (referred

to

in

this section

as the

‘‘carryover year’’).

(B) If the

funds

are not

expended

by the end of

the

carryover year,

the

Secretary shall cancel that unexpended

balance

of the

award,

and

shall require

the

State

to

return

any

amounts

from such

balance that have

been

disbursed

to the

State.

(3)

U

SE

OF

CANCELLED BALANCES

.—In

the case of any

bal-

ance of a

grant award that

is

cancelled under paragraph

(1)

or

(2)(B), the

grant funds involved shall

be

made available

by

the

Secretary

as

additional amounts

for

grants under section 2620

for the

first

fiscal

year beginning after

the fiscal

year

in

which

the

Secretary obtains

the

information necessary

for

deter-

mining that

the

balance

is

required under

such

paragraph to

be

canceled, except that

the

availability

of the

funds

for

such

grants

is

subject

to

section 2618(a)(2)(H)

as

applied

for

such

year.

(4)

C

ORRESPONDING REDUCTION

IN

FUTURE

GRANT

.—

(A) IN

GENERAL

.—In

the case of a

State

for which

a

balance

from a

grant award made pursuant

to

section

2618(a)(1)

or

2618(a)(2)(F)(i)

is

unobligated

as of the

end

of the

grant year

for the

award—

(i) the

Secretary shall reduce,

by the

same amount

as such

unobligated balance

(less any

amount

of

such

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1409

PUBLIC HEALTH SERVICE ACT

Sec. 2622

balance that

is the

subject

of a

waiver

of

cancellation

under paragraph

(1)), the

amount

of the

grant under

such

section

for the

first

fiscal

year beginning after

the fiscal

year

in which the

Secretary obtains

the

in-

formation necessary

for

determining that

such

balance

was

unobligated

as of the end of the

grant year (which

requirement

for a

reduction applies without regard to

whether

a

waiver under paragraph

(1) has been

ap-

proved with respect

to such

balance);

and

(ii) the

grant funds involved

in such

reduction

shall

be

made available

by the

Secretary

as

additional

funds

for

grants under section

2620 for such

first fiscal

year, subject

to

section 2618(a)(2)(H);

except that this subparagraph

does not

apply

to the

State

if the

amount

of the

unobligated balance

was 5

percent or

less.

(B)

R

ELATION

TO

INCREASES

IN

GRANT

.—A reduction

under subparagraph

(A) for a

State

for a fiscal

year may

not be

taken

into

account

in

applying section 2618(a)(2)(H)

with respect

to the

State

for the

subsequent

fiscal

year.

(d)

T

REATMENT

OF

D

RUG

R

EBATES

.—For purposes

of

this sec-

tion,

funds that

are

drug rebates referred

to in

section

2616(g)

may

not be

considered part

of any

grant award referred

to in

subsection

(a). If an

expenditure

of ADAP

rebate funds

would

trigger

a

pen-

alty

under this section

or a

higher penalty than

would

otherwise

have applied,

the

State

may

request that

for

purposes

of

this sec-

tion, the

Secretary

deem the

State’s unobligated balance

to be

re-

duced

by the

amount

of

rebate funds

in the

proposed expenditure.

Notwithstanding 2618(a)(2)(F),

any

unobligated amount under sec-

tion

2618(a)(2)(F)(ii)(V) that

is

returned

to the

Secretary

for

re-

allocation shall

be

used

by the

Secretary for—

(1) the ADAP

supplemental program

if the

Secretary de-

termines appropriate; or

(2) for

additional amounts

for

grants pursuant

to

section

2620.

(e)

A

UTHORITY

R

EGARDING

A

DMINISTRATION

OF

P

ROVISIONS

.—

In

administering subsections

(b) and (c)

with respect

to the

unobli-

gated balance

of a

State,

the

Secretary

may elect to

reduce the

amount

of

future grants

to the

State under section

2618, 2620,

or

2621, as

applicable,

by the

amount

of any such

unobligated balance

in lieu of

cancelling

such

amount

as

provided

for in

subsection (b)

or (c)(1). In such case, the

Secretary

may

permit

the

State

to

use

such

unobligated balance

for

purposes

of any such

future grant. An

amount equal

to such

reduction shall

be

available

for use as

addi-

tional amounts

for

grants pursuant

to

section

2620,

subject

to

sec-

tion

2618(a)(2)(H). Nothing

in

this paragraph shall

be

construed to

affect the

authority

of the

Secretary under subsections

(b) and (c),

including

the

authority

to

grant waivers under subsection (c)(1).

The

reduction

in

future grants authorized under this subsection

shall

be

notwithstanding

the

penalty required under subsection

(c)(4)

with respect

to

unobligated funds.

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F:\COMP\PHSA\PHSA-MERGED.XML

Sec. 2623

PUBLIC HEALTH SERVICE ACT

1410

SEC.

2623. AUTHORIZATION

OF

APPROPRIATIONS.

(a) IN

G

ENERAL

.—For

the

purpose

of

carrying

out

this subpart,

there

are

authorized

to be

appropriated $1,195,500,000

for

fiscal

year

2007,

$1,239,500,000

for fiscal

year

2008,

$1,285,200,000 for

fiscal

year

2009,

$1,349,460,000

for fiscal

year

2010,

$1,416,933,000

for fiscal

year

2011,

$1,487,780,000

for fiscal

year

2012,

and

$1,562,169,000

for fiscal

year

2013.

Amounts appropriated under

the

preceding sentence

for a fiscal

year

are

available

for

obligation

by the

Secretary until

the end of the

second succeeding

fiscal

year.

(b)

R

ESERVATION

OF A

MOUNTS

.—

(1)

E

MERGING COMMUNITIES

.—Of

the

amount appropriated

under subsection

(a) for a fiscal

year,

the

Secretary shall re-

serve $5,000,000

for

grants under section 2621.

(2)

S

UPPLEMENTAL

GRANTS

.—

(A) IN

GENERAL

.—Of

the

amount appropriated under

subsection

(a) for a fiscal

year

in excess of the 2006

ad-

justed amount,

the

Secretary shall reserve

1

⁄

3

for

grants

under section

2620,

except that

the

availability

of the

re-

served funds

for such

grants

is

subject

to

section

2618(a)(2)(H)

as

applied

for such

year,

and

except that any

amount appropriated exclusively

for

carrying

out

section

2616

(and,

accordingly,

distributed

under

section

2618(a)(2)(F))

is not

subject

to

this subparagraph.

(B) 2006

ADJUSTED AMOUNT

.—For purposes

of

sub-

paragraph

(A), the

term

‘‘2006

adjusted

amount’’

means

the

amount appropriated

for fiscal

year

2006

under section

2677(b) (as such

section

was in effect for such fiscal

year),

excluding

any

amount appropriated

for such

year exclu-

sively for

carrying

out

section

2616

(and, accordingly, dis-

tributed under

section 2618(a)(2)(I),

as so in

effect).

Subpart II—Provisions Concerning

Pregnancy

and Perinatal Transmission

of

HIV

SEC.

2625.

ø

300ff–33

¿

EARLY

DIAGNOSIS GRANT PROGRAM.

(a) IN

G

ENERAL

.—In

the case of

States

whose laws or

regula-

tions

are in

accordance with subsection

(b), the

Secretary, acting

through

the

Centers

for

Disease Control

and

Prevention, shall

make grants

to such

States

for the

purposes described

in

sub-

section (c).

(b)

D

ESCRIPTION

OF

C

OMPLIANT

S

TATES

.—For purposes

of

sub-

section

(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),

both of the

policies described

in

paragraph

(1) are in effect, or

both

of the

policies described

in

paragraph

(2) are in effect, as

follows:

(1)(A)

Voluntary opt-out testing

of

pregnant women.

(B)

Universal testing

of

newborns.

(2)(A)

Voluntary opt-out testing

of

clients at sexually

transmitted disease clinics.

(B)

Voluntary opt-out testing

of

clients at substance abuse

treatment centers.

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1411

PUBLIC HEALTH SERVICE ACT

Sec. 2626

The

Secretary shall periodically ensure that

the

applicable policies

are being

carried

out and

recertify compliance.

(c)

U

SE

OF

F

UNDS

.—A State

may use

funds provided under

subsection

(a) for

HIV/AIDS testing (including rapid testing), pre-

vention counseling, treatment

of

newborns exposed

to

HIV/AIDS,

treatment

of

mothers infected with HIV/AIDS,

and costs

associated

with linking those diagnosed with HIV/AIDS

to care and

treatment

for

HIV/AIDS.

(d)

A

PPLICATION

.—A State that

is

eligible

for the

grant under

subsection

(a)

shall submit

an

application

to the

Secretary,

in

such

form, in such

manner,

and

containing

such

information

as the

Sec-

retary

may

require.

(e)

L

IMITATION

ON

A

MOUNT

OF

G

RANT

.—A grant under sub-

section

(a) to a

State

for a fiscal

year

may not be

made

in

an

amount exceeding $10,000,000.

(f)

R

ULE

OF

C

ONSTRUCTION

.—Nothing

in

this section shall be

construed

to

pre-empt State

laws

regarding HIV/AIDS counseling

and

testing.

(g)

D

EFINITIONS

.—In this section:

(1) The

term ‘‘voluntary opt-out

testing’’

means HIV/AIDS

testing—

(A)

that

is

administered

to an

individual seeking other

health

care

services;

and

(B) in

which—

(i)

pre-test counseling

is not

required

but the

indi-

vidual

is

informed that

the

individual

will

receive

an

HIV/AIDS test

and the

individual

may opt out of

such

testing; and

(ii) for

those individuals with

a

positive test re-

sult, post-test counseling (including referrals

for

care)

is

provided

and

confidentiality

is

protected.

(2) The

term ‘‘universal testing

of newborns’’

means HIV/

AIDS

testing that

is

administered within

48

hours

of

delivery

to—

(A) all

infants

born in the

State; or

(B) all

infants

born in the

State

whose

mother’s HIV/

AIDS

status

is

unknown at

the

time

of

delivery.

(h)

A

UTHORIZATION

OF

A

PPROPRIATIONS

.—Of

the

funds appro-

priated annually

to the

Centers

for

Disease Control

and

Prevention

for

HIV/AIDS prevention activities, $30,000,000 shall

be

made

available

for each of the fiscal

years

2007

through

2009 for

grants

under subsection

(a), of which

$20,000,000 shall

be

made available

for

grants

to

States with

the

policies described

in

subsection (b)(1),

and

$10,000,000 shall

be

made available

for

grants

to

States with

the

policies described

in

subsection

(b)(2).

Funds provided under

this section

are

available until expended.

SEC.

2626.

ø

300ff–34

¿

PERINATAL TRANSMISSION

OF HIV

DISEASE; CON-

TINGENT REQUIREMENT REGARDING STATE GRANTS

UNDER THIS PART.

(a)

A

NNUAL

D

ETERMINATION

OF

R

EPORTED

C

ASES

.—A

State

shall annually determine

the

rate

of

reported

cases of AIDS as

a

result

of

perinatal transmission among residents

of the

State.

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F:\COMP\PHSA\PHSA-MERGED.XML

Sec. 2627

PUBLIC HEALTH SERVICE ACT

1412

(b)

C

AUSES

OF

P

ERINATAL

T

RANSMISSION

.—In determining

the

rate under subsection

(a), a

State shall

also

determine

the

possible

causes

of

perinatal transmission.

Such

causes

may

include—

(1) the

inadequate provision within

the

State

of

prenatal

counseling

and

testing

in

accordance with

the

guidelines issued

by the

Centers

for

Disease Control

and

Prevention;

(2) the

inadequate provision

or

utilization within

the

State

of

appropriate therapy

or

failure

of such

therapy

to

reduce

perinatal transmission

of HIV,

including—

(A)

that therapy

is not

available, accessible

or

offered

to

mothers; or

(B)

that available therapy

is offered but not

accepted

by

mothers; or

(3)

other factors (which

may

include

the lack of

prenatal

care)

determined relevant

by the

State.

(c) CDC

R

EPORTING

S

YSTEM

.—Not later than

4

months after

the

date

of

enactment

of

this subpart,

the

Director

of the

Centers

for

Disease Control

and

Prevention shall develop

and

implement

a

system

to be

used

by

States

to comply

with

the

requirements

of

subsections

(a) and (b). The

Director shall issue guidelines

to

en-

sure that

the

data collected

is

statistically valid.

SEC.

2627.

ø

300ff–37

¿

STATE

HIV

TESTING PROGRAMS ESTABLISHED

PRIOR

TO OR

AFTER ENACTMENT.

Nothing

in

this subpart shall

be

construed

to

disqualify

a

State

from

receiving grants under this title

if such

State

has

established

at

any

time prior

to or

after

the

date

of

enactment

of

this subpart

a

program

of

mandatory

HIV

testing.

SEC.

2628.

ø

300ff–37a

¿

RECOMMENDATIONS

FOR

REDUCING INCIDENCE

OF

PERINATAL TRANSMISSION.

(a)

S

TUDY

BY

I

NSTITUTE

OF

M

EDICINE

.—

(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 fol-

lowing:

(A) For the most

recent

fiscal

year

for which the

infor-

mation

is

available,

a

determination

of the

number

of

new-

born

infants with

HIV born in the

United States with re-

spect

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, in-

cluding

legal

barriers, that prevent

or

discourage

an

obste-

trician

from

making it

a

routine practice

to offer

pregnant

women

an HIV

test

and a

routine practice

to

test newborn

infants

for

HIV/AIDS

in

circumstances

in which the

obste-

trician

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,

in-

cluding recommendations

on

removing

the

barriers identi-

fied

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.

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1413

PUBLIC HEALTH SERVICE ACT

Sec. 2631

(2)

R

EPORT

.—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 de-

scribing

the

findings made

in the

study

is

submitted

to the

ap-

propriate committees

of the

Congress,

the

Secretary,

and

the

chief public

health

official of each of the

States.

(b)

P

ROGRESS

T

OWARD

R

ECOMMENDATIONS

.—In

fiscal

year

2004, the

Secretary shall

collect

information

from the

States de-

scribing

the

actions taken

by the

States toward meeting

the

rec-

ommendations specified

for the

States under subsection (a)(1)(C).

(c)

S

UBMISSION

OF

R

EPORTS

TO

C

ONGRESS

.—The Secretary

shall submit

to the

appropriate committees

of the

Congress

reports

describing

the

information collected under subsection (b).

Subpart III—Certain

Partner Notification

Programs

SEC.

2631.

ø

300ff–38

¿

GRANTS

FOR

PARTNER NOTIFICATION PRO-

GRAMS.

(a) IN

G

ENERAL

.—In

the case of

States

whose laws or

regula-

tions

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)

D

ESCRIPTION

OF

C

OMPLIANT

S

TATE

P

ROGRAMS

.—For pur-

poses of

subsection

(a), the laws or

regulations

of a

State

are in

ac-

cordance with this subsection

if

under

such laws or

regulations (in-

cluding programs carried

out

pursuant

to the

discretion

of

State

of-

ficials) 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/AIDS 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/AIDS,

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

man-

ner

recommended

and

approved

by the

Director

of the

Centers

for

Disease Control

and

Prevention, together with

such

addi-

tional information

as may be

necessary

for

carrying

out

such

program.

(B) The

State

may

provide that

the

requirement

of

sub-

paragraph

(A) does not

apply

to the

testing

of an

individual for

HIV/AIDS

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

con-

strued

as

affecting

the

requirement

of

subparagraph

(A)

with

respect

to a

health entity that treats

an

individual

for

HIV/

AIDS.

(3) The

program under paragraph

(1) is

carried

out in

ac-

cordance with

the

following:

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F:\COMP\PHSA\PHSA-MERGED.XML

Sec. 2631

PUBLIC HEALTH SERVICE ACT

1414

(A)

Partners

are

provided with

an

appropriate oppor-

tunity

to

learn that

the

partners have

been

exposed to

HIV/AIDS, 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/AIDS

are

made

available

to the

partners

and to

infected individuals, and

such

counseling includes information

on

modes

of

trans-

mission

for the

disease, including information

on

prenatal

and

perinatal transmission

and

preventing transmission.

(D)

Counseling

of

infected individuals

and

their part-

ners includes

the

provision

of

information regarding

thera-

peutic measures

for

preventing

and

treating

the

deteriora-

tion of the

immune system

and

conditions arising

from

the

disease,

and the

provision

of

other prevention-related in-

formation.

(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

li-

ability

for, an

infected individual

if the

individual chooses

not to

identify

the

partners

of the

individual,

or the

indi-

vidual

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

in-

fected

individual involved.

(I) The

State provides that

the

provisions

of the

pro-

gram

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

Cen-

ters

for

Disease Control

and

Prevention

the

number

of

individ-

uals

from whom the

names

of

partners have

been

sought under

the

program under paragraph

(1), the

number

of such

individ-

uals

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

shar-

ing of

information between

the public

health

officers of

the

States.

(c)

R

EPORTING

S

YSTEM FOR

C

ASES

OF HIV

D

ISEASE

;

P

REF

-

ERENCE

IN

M

AKING

G

RANTS

.—In making grants under subsection

(a), the

Secretary shall

give

preference

to

States

whose

reporting

systems

for cases of

HIV/AIDS produce data

on such cases

that is

sufficiently accurate

and

reliable

for use for

purposes

of

section

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

(d)

A

UTHORIZATION

OF

A

PPROPRIATIONS

.—For

the

purpose

of

carrying

out

this section, there

is

authorized

to be

appropriated

$10,000,000

for each of the fiscal

years

2007

through 2009.

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F:\COMP\PHSA\PHSA-MERGED.XML

1415

PUBLIC HEALTH SERVICE ACT

Sec. 2651

P

ART

C—E

ARLY

I

NTERVENTION

S

ERVICES

Subpart I—Categorical

Grants

SEC.

2651.

ø

300ff–51

¿

ESTABLISHMENT

OF A

PROGRAM.

(a) IN

G

ENERAL

.—For

the

purposes described

in

subsection (b),

the

Secretary, acting through

the

Administrator

of the

Health Re-

sources

and

Services Administration,

may

make grants

to

public

and

nonprofit private entities specified

in

section 2652(a).

(b)

R

EQUIREMENTS

.—

(1) IN

GENERAL

.—The Secretary

may not

make

a

grant

under subsection

(a)

unless

the

applicant

for the

grant agrees

to

expend

the

grant

only

for—

(A) core

medical services described

in

subsection

(c);

(B)

support services described

in

subsection

(d);

and

(C)

administrative expenses

as

described

in

section

2664(g)(3).

(2)

E

ARLY INTERVENTION SERVICES

.—An applicant

for

a

grant under subsection

(a)

shall expend

not less

than

50

per-

cent of the

amount received under

the

grant

for the

services

described

in

subparagraphs

(B)

through

(E) of

subsection (e)(1)

for

individuals with HIV/AIDS.

(c)

R

EQUIRED

F

UNDING FOR

C

ORE

M

EDICAL

S

ERVICES

.—

(1) IN

GENERAL

.—With respect

to a

grant under subsection

(a) to an

applicant

for a fiscal

year,

the

applicant shall,

of

the

portion

of the

grant remaining after reserving amounts

for

pur-

poses of

paragraphs

(3) and (5) of

section

2664(g), use not

less

than

75

percent

to

provide

core

medical services that

are

need-

ed in the

area involved

for

individuals with HIV/AIDS

who

are

identified

and

eligible under this title (including services re-

garding

the

co-occurring conditions

of the

individuals).

(2) W

AIVER

.—

(A) The

Secretary shall

waive the

application

of

para-

graph

(1)

with respect

to an

applicant

for a

grant

if

the

Secretary determines that, within

the

service area

of

the

applicant—

(i)

there

are no

waiting lists

for AIDS

Drug Assist-

ance

Program services under section

2616;

and

(ii) core

medical services

are

available

to all

indi-

viduals with HIV/AIDS identified

and

eligible under

this title.

(B)

N

OTIFICATION

OF

WAIVER STATUS

.—When inform-

ing an

applicant that

a

grant under subsection

(a) is

being

made

for a fiscal

year,

the

Secretary shall inform

the

ap-

plicant whether

a

waiver under subparagraph

(A) is in

ef-

fect for the fiscal

year.

(3)

C

ORE MEDICAL SERVICES

.—For purposes

of

this sub-

section,

the

term

‘‘core

medical

services’’,

with respect

to an

in-

dividual with HIV/AIDS (including

the

co-occurring conditions

of the

individual) means

the

following services:

(A)

Outpatient

and

ambulatory health services.

(B) AIDS

Drug Assistance Program treatments under

section 2616.

(C) AIDS

pharmaceutical assistance.

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F:\COMP\PHSA\PHSA-MERGED.XML

Sec. 2651

PUBLIC HEALTH SERVICE ACT

1416

(e).

(D)

Oral health care.

(E)

Early intervention services described

in

subsection

(F)

Health insurance premium

and cost

sharing assist-

ance for

low-income individuals

in

accordance with section

2615.

(G) Home

health care.

(H)

Medical

nutrition therapy.

(I)

Hospice services.

(J) Home and

community-based health services

as

de-

fined

under section 2614(c).

(K)

Mental health services.

(L)

Substance abuse outpatient care.

(M)

Medical

case

management, including treatment

adherence services.

(d)

S

UPPORT

S

ERVICES

.—

(1) IN

GENERAL

.—For purposes

of

this section,

the

term

‘‘support services’’

means services, subject

to the

approval

of

the

Secretary, that

are

needed

for

individuals with HIV/AIDS

to

achieve their medical outcomes

(such as

respite

care for

per-

sons

caring

for

individuals with HIV/AIDS, outreach services,

medical transportation, linguistic services,

and

referrals for

health

care and

support services).

(2)

D

EFINITION

OF

MEDICAL OUTCOMES

.—In this section,

the

term

‘‘medical outcomes’’

means those outcomes affecting

the

HIV-related clinical status

of an

individual with HIV/AIDS.

(e)

S

PECIFICATION

OF

E

ARLY

I

NTERVENTION

S

ERVICES

.—

(1) IN

GENERAL

.—The early intervention services referred

to in

this section are—

(A)

counseling individuals with respect

to

HIV/AIDS

in

accordance with section 2662;

(B)

testing individuals with respect

to

HIV/AIDS, in-

cluding tests

to

confirm

the

presence

of the

disease, tests

to

diagnose

the

extent

of the

deficiency

in the

immune sys-

tem, and

tests

to

provide information

on

appropriate

therapeutic measures

for

preventing

and

treating

the

dete-

rioration

of the

immune system

and for

preventing and

treating conditions arising

from

HIV/AIDS;

(C)

referrals described

in

paragraph (2);

(D)

other clinical

and

diagnostic services regarding

HIV/AIDS,

and

periodic medical evaluations

of

individuals

with HIV/AIDS;

and

(E)

providing

the

therapeutic measures described in

subparagraph (B).

(2)

R

EFERRALS

.—The services referred

to in

paragraph

(1)(C) are

referrals

of

individuals with HIV/AIDS

to

appro-

priate providers

of

health

and

support services, including, as

appropriate—

(A) to

entities receiving amounts under part

A or B

for

the

provision

of such

services;

(B) to

biomedical research facilities

of

institutions

of

higher education that

offer

experimental treatment for

such

disease,

or to

community-based organizations

or

other

entities that provide

such

treatment; or

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F:\COMP\PHSA\PHSA-MERGED.XML

1417

PUBLIC HEALTH SERVICE ACT

Sec. 2652

(C) to

grantees under section

2671, in the case of

a

pregnant woman.

(3)

R

EQUIREMENT

OF

AVAILABILITY

OF ALL

EARLY

INTERVEN

-

TION SERVICES THROUGH EACH GRANTEE

.—

(A) IN

GENERAL

.—The Secretary

may not

make a

grant under subsection

(a)

unless

the

applicant

for

the

grant agrees that

each of the

early intervention services

specified

in

paragraph

(2) will be

available through the

grantee.

With

respect

to

compliance with

such

agreement,

such a

grantee

may

expend

the

grant

to

provide

the

early

intervention services directly,

and may

expend

the

grant to

enter

into

agreements with

public or

nonprofit private en-

tities,

or

private for-profit entities

if such

entities

are

the

only

available provider

of

quality

HIV care in the

area,

under

which the

entities provide

the

services.

(B)

O

THER REQUIREMENTS

.—Grantees described

in—

(i)

subparagraphs

(A), (D), (E), and (F) of

section

2652(a)(1) shall

use not less

than

50

percent

of

the

amount

of such a

grant

to

provide

the

services de-

scribed

in

subparagraphs

(A), (B), (D), and (E) of

para-

graph

(1)

directly

and

on-site

or

at sites where other

primary

care

services

are

rendered; and

(ii)

subparagraphs

(B) and (C) of

section 2652(a)(1)

shall ensure

the

availability

of

early intervention serv-

ices

through

a

system

of

linkages

to

community-based

primary

care

providers,

and to

establish mechanisms

for the

referrals described

in

paragraph

(1)(C), and

for

follow-up

concerning

such

referrals.

SEC.

2652.

ø

300ff–52

¿

MINIMUM QUALIFICATIONS

OF

GRANTEES.

(a)

E

LIGIBLE

E

NTITIES

.—

(1) IN

GENERAL

.—The entities referred

to in

section 2651(a)

are public

entities

and

nonprofit private entities that are—

(A)

federally-qualified health centers under section

1905(l)(2)(B)

of the Social

Security Act;

(B)

grantees under section

1001

(regarding family

planning) other than States;

(C)

comprehensive hemophilia diagnostic

and

treat-

ment centers;

(D)

rural health clinics;

(E)

health facilities operated

by or

pursuant

to a

con-

tract with

the

Indian Health Service;

(F)

community-based organizations, clinics, hospitals

and

other health facilities that provide early intervention

services

to

those persons infected with HIV/AIDS

through

intravenous drug

use;

or

(G)

nonprofit private entities that provide comprehen-

sive

primary

care

services

to

populations at risk

of

HIV/

AIDS,

including faith-based

and

community-based organi-

zations.

(2)

U

NDERSERVED POPULATIONS

.—Entities described in

paragraph

(1)

shall serve underserved populations

which

may

include minority populations

and

Native American populations,

ex-offenders, individuals with comorbidities including

hepatitis

January 28, 2016

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F:\COMP\PHSA\PHSA-MERGED.XML

Sec. 2653

PUBLIC HEALTH SERVICE ACT

1418

B or C,

mental illness,

or

substance abuse, low-income popu-

lations, inner

city

populations,

and

rural populations.

13

;

(b)

S

TATUS

AS

M

EDICAID

P

ROVIDER

.—

(1) IN

GENERAL

.—Subject

to

paragraph

(2), the

Secretary

may not

make

a

grant under section

2651 for the

provision

of

services described

in

subsection

(b) of such

section

in a

State

unless,

in the case of any such

service that

is

available pursu-

ant

to the

State plan approved under title

XIX of the Social

Se-

curity

Act for the

State—

(A) the

applicant

for the

grant

will

provide

the

service

directly,

and the

applicant

has

entered

into a

participation

agreement under

the

State plan

and is

qualified

to

receive

payments under

such

plan; or

(B) the

applicant

for the

grant

will

enter

into

an

agreement with

a public or

nonprofit private entity,

or

a

private for-profit entity

if such

entity

is the only

available

provider

of

quality

HIV care in the

area, under

which

the

entity

will

provide

the

service,

and the

entity

has

entered

into such a

participation agreement

and is

qualified

to

re-

ceive such

payments.

(2)

W

AIVER

REGARDING

CERTAIN

SECONDARY

AGREE

-

MENTS

.—

(A) In the case of an

entity making

an

agreement pur-

suant

to

paragraph

(1)(B)

regarding

the

provision

of

serv-

ices, the

requirement established

in such

paragraph re-

garding

a

participation agreement shall

be

waived

by

the

Secretary

if the

entity

does not, in

providing health care

services, impose

a

charge

or

accept reimbursement avail-

able from any

third-party payor, including reimbursement

under

any

insurance

policy or

under

any

Federal

or

State

health benefits program.

(B) A

determination

by the

Secretary

of

whether an

entity referred

to in

subparagraph

(A)

meets

the

criteria

for a

waiver under

such

subparagraph shall

be

made with-

out

regard

to

whether

the

entity accepts voluntary dona-

tions regarding

the

provision

of

services

to the

public.

SEC.

2653.

ø

300ff–53

¿

PREFERENCES

IN

MAKING GRANTS.

(a) IN

G

ENERAL

.—In making grants under section

2651,

the

Secretary shall

give

preference

to any

qualified applicant experi-

encing

an

increase

in the

burden

of

providing services regarding

HIV/AIDS,

as

indicated

by the

factors specified

in

subsection (b).

(b)

S

PECIFICATION

OF

F

ACTORS

.—

(1) IN

GENERAL

.—In

the case of the

geographic area with

respect

to which the

entity involved

is

applying

for a

grant

under section

2651, the

factors referred

to in

subsection

(a),

as

determined

for the

period specified

in

paragraph

(2),

are—

(A) the

number

of cases of

HIV/AIDS;

(B) the

rate

of

increase

in such

cases;

(C) the lack of

availability

of

early intervention serv-

ices;

(D) the

number

of

other

cases of

sexually transmitted

diseases,

and the

number

of cases of

tuberculosis

and of

13

See

footnote

for

section 217(a).

January 28, 2016

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F:\COMP\PHSA\PHSA-MERGED.XML

1419

PUBLIC HEALTH SERVICE ACT

Sec. 2654

drug abuse

and the

number

of cases of

individuals co-in-

fected

with HIV/AIDS

and

hepatitis

B or

C;

(E) the

rate

of

increase

in each of the cases

specified

in

subparagraph (D);

(F) the lack of

availability

of

primary health services

from

providers other than

such

applicant; and

(G) the

distance between

such

area

and the

nearest

community that

has an

adequate

level of

availability

of

ap-

propriate HIV-related services,

and the

length

of

time re-

quired

to

travel

such

distance.

(2)

R

ELEVANT PERIOD

OF

TIME

.—The period referred

to

in

paragraph

(1) is the

2-year period preceding

the fiscal

year for

which the

entity involved

is

applying

to

receive

a

grant under

section 2651.

(c)

E

QUITABLE

A

LLOCATIONS

.—In providing preferences

for

pur-

poses of

subsection

(b), the

Secretary shall equitably allocate the

preferences among urban

and

rural areas.

(d)

C

ERTAIN

A

REAS

.—Of

the

applicants

who

qualify

for

pref-

erence 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

preference

to

areas that are

underserved with respect

to such

services.

SEC.

2654.

ø

300ff–54

¿

MISCELLANEOUS PROVISIONS.

(a)

S

ERVICES FOR

I

NDIVIDUALS

W

ITH

H

EMOPHILIA

.—In making

grants under section

2651, the

Secretary shall ensure that any

such

grants made regarding

the

provision

of

early intervention

services

to

individuals with hemophilia

are

made through

the

net-

work of

comprehensive hemophilia diagnostic

and

treatment cen-

ters.

(b)

T

ECHNICAL

A

SSISTANCE

.—The Secretary

may,

directly or

through grants

or

contracts, provide technical assistance

to

non-

profit private entities regarding

the

process

of

submitting

to

the

Secretary applications

for

grants under section

2651, and may

pro-

vide

technical assistance with respect

to the

planning, develop-

ment,

and

operation

of any

program

or

service carried

out

pursuant

to such

section.

(c)

P

LANNING AND

D

EVELOPMENT

G

RANTS

.—

(1) IN

GENERAL

.—The Secretary

may

provide planning

grants

to public and

nonprofit private entities

for

purposes

of—

(A)

enabling

such

entities

to

provide early intervention

services;

and

(B)

assisting

the

entities

in

expanding their capacity

to

provide HIV/AIDS-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 pur-

suant

to

this subparagraph

may not be

expended

to

pur-

chase

or

improve land,

or to

purchase, construct,

or

perma-

nently improve, other than minor remodeling,

any

building

or

other facility).

January 28, 2016

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F:\COMP\PHSA\PHSA-MERGED.XML

Sec. 2655

PUBLIC HEALTH SERVICE ACT

1420

(2)

R

EQUIREMENT

.—The Secretary

may only

award

a

grant

to an

entity under paragraph

(1) if the

Secretary determines

that

the

entity

will use such

grant

to

assist

the

entity

in

quali-

fying for a

grant under section 2651.

(3)

P

REFERENCE

.—In awarding grants under paragraph

(1), the

Secretary shall

give

preference

to

entities that provide

primary

care

services

in

rural areas

or to

underserved popu-

lations.

(4)

A

MOUNT AND DURATION

OF

GRANTS

.—

(A)

E

ARLY INTERVENTION SERVICES

.—A grant under

paragraph

(1)(A) may be

made

in an

amount

not to

exceed

$50,000.

(B)

C

APACITY

DEVELOPMENT

.—

(i)

A

MOUNT

.—A

grant under paragraph

(1)(B)

may

be

made

in an

amount

not to exceed

$150,000.

(ii)

D

URATION

.—The total duration

of a

grant

under paragraph

(1)(B),

including

any

renewal, may

not exceed 3

years.

(5)

L

IMITATION

.—Not

to exceed 5

percent

of the

amount

appropriated

for a fiscal

year under section

2655 may be

used

to

carry

out

this section.

SEC.

2655.

ø

300ff–55

¿

AUTHORIZATION

OF

APPROPRIATIONS.

For the

purpose

of

making grants under section

2651,

there

are

authorized

to be

appropriated, $218,600,000

for fiscal

year

2007,

$226,700,000

for fiscal

year

2008,

$235,100,000

for fiscal

year

2009,

$246,855,000

for fiscal

year

2010,

$259,198,000

for fiscal

year

2011,

$272,158,000

for fiscal

year

2012, and

$285,766,000

for

fiscal

year 2013.

Subpart II—General Provisions

SEC.

2661.

ø

300ff–61

¿

CONFIDENTIALITY

AND

INFORMED CONSENT.

(a)

C

ONFIDENTIALITY

.—The Secretary

may not

make

a

grant

under this part unless,

in the case of any

entity applying

for

a

grant under section

2651, the

entity agrees

to

ensure that informa-

tion

regarding

the

receipt

of

early intervention services pursuant to

the

grant

is

maintained confidentially

in a

manner

not

inconsistent

with applicable law.

(b)

I

NFORMED

C

ONSENT

.—The Secretary

may not

make

a

grant

under this part unless

the

applicant

for the

grant agrees that, in

testing

an

individual

for

HIV/AIDS,

the

applicant

will

test

an

indi-

vidual

only

after

the

individual confirms that

the

decision

of the

in-

dividual with respect

to

undergoing

such

testing

is

voluntarily

made.

SEC.

2662.

ø

300ff–62

¿

PROVISION

OF

CERTAIN COUNSELING SERVICES.

(a)

C

OUNSELING

OF

I

NDIVIDUALS

W

ITH

N

EGATIVE

T

EST

R

E

-

SULTS

.—The Secretary

may not

make

a

grant under this part un-

less the

applicant

for the

grant agrees that,

if the

results

of

testing

conducted

for

HIV/AIDS indicate that

an

individual

does not

have

such

condition,

the

applicant

will

provide

the

individual informa-

tion,

including—

(1)

measures

for

prevention

of,

exposure

to, and

trans-

mission

of

HIV/AIDS, hepatitis

B,

hepatitis

C, and

other sexu-

ally

transmitted diseases;

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F:\COMP\PHSA\PHSA-MERGED.XML

1421

PUBLIC HEALTH SERVICE ACT

Sec. 2662

(2) the

accuracy

and

reliability

of

results

of

testing for

HIV/AIDS,

hepatitis

B, and

hepatitis C;

(3) the

significance

of the

results

of such

testing, including

the

potential

for

developing

AIDS,

hepatitis

B, or

hepatitis C;

(4) the

appropriateness

of

further counseling,

testing, and

education

of the

individual regarding HIV/AIDS

and

other sex-

ually transmitted diseases;

(5) if

diagnosed with chronic hepatitis

B or

hepatitis

C co-

infection,

the

potential

of

developing hepatitis-related

liver

dis-

ease and its

impact

on

HIV/AIDS;

and

(6)

information regarding

the

availability

of

hepatitis B

vaccine

and

information about

hepatitis treatments.

(b)

C

OUNSELING

OF

I

NDIVIDUALS

W

ITH

P

OSITIVE

T

EST

R

E

-

SULTS

.—The Secretary

may not

make

a

grant under this part un-

less the

applicant

for the

grant agrees that,

if the

results

of

testing

for

HIV/AIDS indicate that

the

individual

has such

condition,

the

applicant

will

provide

to the

individual appropriate counseling re-

garding

the

condition, including—

(1)

information regarding—

(A)

measures

for

prevention

of,

exposure

to, and

trans-

mission

of

HIV/AIDS,

hepatitis

B, and

hepatitis C;

(B) the

accuracy

and

reliability

of

results

of

testing for

HIV/AIDS,

hepatitis

B, and

hepatitis

C;

and

(C) the

significance

of the

results

of such

testing, in-

cluding

the

potential

for

developing

AIDS,

hepatitis

B,

or

hepatitis C;

(2)

reviewing

the

appropriateness

of

further counseling,

testing,

and

education

of the

individual regarding HIV/AIDS

and

other sexually transmitted diseases; and

(3)

providing counseling—

(A) on the

availability, through

the

applicant,

of

early

intervention services;

(B) on the

availability

in the

geographic area

of

appro-

priate health care, mental health care,

and social and

sup-

port

services, including providing referrals

for such

serv-

ices, as

appropriate;

(C)(i)

that explains

the

benefits

of

locating

and

coun-

seling

any

individual

by whom the

infected individual may

have

been

exposed

to

HIV/AIDS, hepatitis

B, or

hepatitis

C and any

individual

whom the

infected individual may

have exposed

to

HIV/AIDS,

hepatitis

B, or

hepatitis

C;

and

(ii)

that emphasizes it

is the

duty

of

infected individ-

uals

to

disclose their infected status

to

their sexual part-

ners

and

their partners

in the

sharing

of

hypodermic nee-

dles;

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

individ-

uals

to avoid any

behaviors that

will expose

others

to

HIV/

AIDS,

hepatitis

B, or

hepatitis

C;

and

(D) on the

availability

of the

services

of public

health

authorities with respect

to

locating

and

counseling

any

in-

dividual described

in

subparagraph (C);

January 28, 2016

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F:\COMP\PHSA\PHSA-MERGED.XML

Sec. 2663

PUBLIC HEALTH SERVICE ACT

1422

(4) if

diagnosed with chronic hepatitis

B or

hepatitis

C co-

infection,

the

potential

of

developing hepatitis-related

liver

dis-

ease and its

impact

on

HIV/AIDS;

and

(5)

information regarding

the

availability

of

hepatitis B

vaccine.

(c)

A

DDITIONAL

R

EQUIREMENTS

R

EGARDING

A

PPROPRIATE

C

OUN

-

SELING

.—The Secretary

may not

make

a

grant under this part un-

less the

applicant

for the

grant agrees that,

in

counseling individ-

uals with respect

to

HIV/AIDS,

the

applicant

will

ensure that the

counseling

is

provided under conditions appropriate

to the

needs

of

the

individuals.

(d)

C

OUNSELING

OF

E

MERGENCY

R

ESPONSE

E

MPLOYEES

.—The

Secretary

may not

make

a

grant under this part

to a

State unless

the

State agrees that,

in

counseling individuals with respect to

HIV/AIDS,

the

State

will

ensure that,

in the case of

emergency re-

sponse employees,

the

counseling

is

provided

to such

employees

under conditions appropriate

to the

needs

of the

employees

regard-

ing the

counseling.

(e)

R

ULE

OF

C

ONSTRUCTION

R

EGARDING

C

OUNSELING

W

ITHOUT

T

ESTING

.—Agreements made pursuant

to

this section

may not

be

construed

to

prohibit

any

grantee under this part

from

expending

the

grant

for the

purpose

of

providing counseling services described

in

this section

to an

individual

who does not

undergo testing for

HIV/AIDS

as a

result

of the

grantee

or the

individual determining

that

such

testing

of the

individual

is not

appropriate.

SEC.

2663.

ø

300ff–63

¿

APPLICABILITY

OF

REQUIREMENTS REGARDING

CONFIDENTIALITY, INFORMED CONSENT,

AND

COUN-

SELING.

The

Secretary

may not

make

a

grant under this part unless

the

applicant

for the

grant agrees that, with respect

to

testing for

HIV/AIDS,

any such

testing carried

out by the

applicant with funds

appropriated through this

Act will be

carried

out in

accordance

with conditions described

in

sections

2661 and

2662.

SEC.

2664.

ø

300ff–64

¿

ADDITIONAL REQUIRED AGREEMENTS.

(a)

R

EPORTS

TO

S

ECRETARY

.—The Secretary

may not

make a

grant under this part unless—

(1) the

applicant submits

to the

Secretary—

(A) a

specification

of the

expenditures made

by the

ap-

plicant

for

early intervention services

for the fiscal

year

preceding

the fiscal

year

for which the

applicant

is

apply-

ing to

receive

the

grant;

(B) an

estimate

of the

number

of

individuals

to

whom

the

applicant

has

provided

such

services

for such

fiscal

year;

(C)

information regarding

how the

expected expendi-

tures

of the

grant

are

planning process for

localities funded under part

A

(including

the

planning

process described

in

section

2602) and for

States funded

under part

B

(including

the

planning process described in

section

2617(b));

and

(D) a

specification

of the

expected expenditures and

how

those expenditures

will

improve overall client out-

January 28, 2016

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F:\COMP\PHSA\PHSA-MERGED.XML

1423

PUBLIC HEALTH SERVICE ACT

Sec. 2664

comes, as

described

in the

State plan under section

2617(b);

(2) the

applicant agrees

to

submit

to the

Secretary

a

report

providing—

(A) the

number

of

individuals

to whom the

applicant

provides early intervention services pursuant

to the

grant;

(B)

epidemiological

and

demographic data

on the

pop-

ulation

of such

individuals;

(C) the

extent

to which the costs of

HIV-related

health

care for such

individuals

are paid by

third-party payors;

(D) the

average

costs of

providing

each

category

of

early intervention service;

and

(E) the

aggregate amounts expended

for each such

cat-

egory;

(3) the

applicant agrees

to

provide additional documenta-

tion to the

Secretary regarding

the

process used

to

obtain com-

munity input

into the

design

and

implementation

of

activities

grant; and

(4) the

applicant agrees

to

submit,

every 2

years,

to

the

lead

State agency under section 2617(b)(4)

audits, consistent

with

Office of

Management

and

Budget circular

A133,

regard-

ing

funds expended

in

accordance with this title

and

shall in-

clude

necessary client

level

data

to

complete unmet

need

cal-

culations

and

Statewide coordinated statements

of need

proc-

ess.

(b)

P

ROVISION

OF

O

PPORTUNITIES FOR

A

NONYMOUS

C

OUNSELING

AND

T

ESTING

.—The Secretary

may not

make

a

grant under this

part unless

the

applicant

for the

grant agrees that,

to the

extent

permitted under State

law,

regulation

or

rule,

the

applicant will

offer

substantial opportunities

for an

individual—

(1) to

undergo counseling

and

testing regarding HIV/AIDS

without

being

required

to

provide

any

information relating to

the

identity

of the

individual;

and

(2) to

undergo

such

counseling

and

testing through

the

use

of a

pseudonym.

(c)

P

ROHIBITION

A

GAINST

R

EQUIRING

T

ESTING

AS

C

ONDITION OF

R

ECEIVING

O

THER

H

EALTH

S

ERVICES

.—The Secretary

may

not

make

a

grant under this part unless

the

applicant

for the

grant

agrees that, with respect

to an

individual seeking health services

from the

applicant,

the

applicant

will not

require

the

individual to

undergo testing

for HIV as a

condition

of

receiving

any

health serv-

ices

unless

such

testing

is

medically indicated

in the

provision

of

the

health services sought

by the

individual.

(d)

M

AINTENANCE

OF

S

UPPORT

.—The Secretary

may not

make

a

grant under this part unless

the

applicant

for the

grant agrees

to

maintain

the

expenditures

of the

applicant

for

early intervention

services at

a level

equal

to not less

than

the level of such

expendi-

tures maintained

by the

State

for the fiscal

year preceding

the

fis-

cal

year

for which the

applicant

is

applying

to

receive

the

grant.

(e)

R

EQUIREMENTS

R

EGARDING

I

MPOSITION

OF

C

HARGES FOR

S

ERVICES

.—

(1) IN

GENERAL

.—The Secretary

may not

make

a

grant

under this part unless, subject

to

paragraph

(5), the

applicant

for the

grant agrees that—

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F:\COMP\PHSA\PHSA-MERGED.XML

Sec. 2664

PUBLIC HEALTH SERVICE ACT

1424

(A) in the case of

individuals with

an income less

than

or

equal

to 100

percent

of the official

poverty

line, the

ap-

plicant

will not

impose

a

charge

on any such

individual for

the

provision

of

early intervention services under the

grant;

(B) in the case of

individuals with

an income

greater

than

100

percent

of the official

poverty

line, the

appli-

cant—

(i) will

impose

a

charge

on each such

individual

for the

provision

of such

services;

and

(ii) will

impose

the

charge according

to a

schedule

of

charges that

is

made available

to the

public.

(2)

L

IMITATION

ON

CHARGES REGARDING INDIVIDUALS SUB

-

JECT

TO

CHARGES

.—With respect

to the

imposition

of a

charge

for

purposes

of

paragraph

(1)(B)(ii), the

Secretary

may

not

make

a

grant under this part unless, subject

to

paragraph (5),

the

applicant

for the

grant agrees that—

(A) in the case of

individuals with

an income

greater

than

100

percent

of the official

poverty

line and not

ex-

ceeding

200

percent

of such

poverty

line, the

applicant will

not, for any

calendar year, impose charges

in an

amount

exceeding

5

percent

of the

annual

gross income of the

indi-

vidual involved;

(B) in the case of

individuals with

an income

greater

than

200

percent

of the official

poverty

line and not

ex-

ceeding

300

percent

of such

poverty

line, the

applicant will

not, for any

calendar year, impose charges

in an

amount

exceeding

7

percent

of the

annual

gross income of the

indi-

vidual involved;

and

(C) in the case of

individuals with

an income

greater

than

300

percent

of the official

poverty

line, the

applicant

will not, for any

calendar year, impose charges

in

an

amount exceeding

10

percent

of the

annual

gross

income

of the

individual involved.

(3)

A

SSESSMENT

OF

CHARGE

.—With respect

to

compliance

with

the

agreement made under paragraph

(1), a

grantee

under this part

may, in the case of

individuals subject

to

a

charge

for

purposes

of such

paragraph—

(A)

assess

the

amount

of the

charge

in the

discretion

of the

grantee, including imposing

only a

nominal charge

for the

provision

of

services, subject

to the

provisions

of

such

paragraph regarding

public

schedules

and of

para-

graph

(2)

regarding limitations

on the

maximum amount

of

charges; and

(B)

take

into

consideration

the

medical expenses

of

in-

dividuals

in

assessing

the

amount

of the

charge, subject to

such

provisions.

(4)

A

PPLICABILITY

OF

LIMITATION

ON

AMOUNT

OF

CHARGE

.—

The

Secretary

may not

make

a

grant under this part unless

the

applicant

for the

grant agrees that

the

limitations estab-

lished

in

paragraph

(2)

regarding

the

imposition

of

charges for

services applies

to the

annual aggregate

of

charges imposed for

such

services, without regard

to

whether they

are

character-

January 28, 2016

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F:\COMP\PHSA\PHSA-MERGED.XML

1425

PUBLIC HEALTH SERVICE ACT

Sec. 2664

ized as

enrollment

fees,

premiums, deductibles,

cost

sharing,

copayments, coinsurance,

or

similar charges.

(5)

W

AIVER REGARDING CERTAIN SECONDARY AGREE

-

MENTS

.—The requirement established

in

paragraph

(1)(B)(i)

shall

be

waived

by the

Secretary

in the case of any

entity for

whom the

Secretary

has

granted

a

waiver under section

2652(b)(2).

(f)

R

ELATIONSHIP

TO

I

TEMS AND

S

ERVICES

U

NDER

O

THER

P

RO

-

GRAMS

.—

(1) IN

GENERAL

.—The Secretary

may not

make

a

grant

under this part unless

the

applicant

for the

grant agrees

that,

subject

to

paragraph

(2), the

grant

will not be

expended

by

the

applicant,

or by any

entity receiving amounts

from the

appli-

cant

for the

provision

of

early intervention services,

to

make

payment

for any such

service

to the

extent that payment has

been

made,

or can

reasonably

be

expected

to be

made, with re-

spect

to such

service—

(A)

under

any

State compensation program,

under an

insurance

policy, or

under

any

Federal

or

State health

benefits program (except

for a

program administered

by

or

providing

the

services

of the

Indian Health Service); or

(B) by an

entity that provides health services

on a

pre-

paid

basis.

(2)

A

PPLICABILITY

TO

CERTAIN SECONDARY AGREEMENTS

FOR PROVISION

OF

SERVICES

.—An

agreement made under para-

graph

(1)

shall

not

apply

in the case of an

entity through

which a

grantee under this part provides early intervention

services

if the

Secretary

has

provided

a

waiver under section

2652(b)(2) regarding

the

entity.

(g)

A

DMINISTRATION

OF

G

RANT

.—The Secretary

may not

make

a

grant under this part unless

the

applicant

for the

grant agrees

that—

(1) the

applicant

will not

expend amounts received pursu-

ant

to

this part

for any

purpose other than

the

purposes de-

scribed

in the

subpart under

which the

grant involved

is

made;

(2) the

applicant

will

establish

such

procedures

for

fiscal

control

and fund

accounting

as may be

necessary

to

ensure

proper disbursement

and

accounting with respect

to the

grant;

(3) the

applicant

will not

expend

more

than

10

percent

of

the

grant

for

administrative expenses with respect

to

the

grant, including planning

and

evaluation, except that

the

costs

of a

clinical quality management program under paragraph (5)

may not be

considered administrative expenses

for

purposes

of

such

limitation;

(4) the

applicant

will

submit evidence that

the

proposed

program

is

consistent with

the

statewide coordinated state-

ment

of need and

agree

to

participate

in the

ongoing revision

of such

statement

of need;

and

(5) the

applicant

will

provide

for the

establishment

of

a

clinical 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/AIDS

and

related op-

January 28, 2016

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F:\COMP\PHSA\PHSA-MERGED.XML

Sec. 2665

PUBLIC HEALTH SERVICE ACT

1426

portunistic infections,

and as

applicable,

to

develop

strate-

gies 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.

SEC.

2665.

ø

300ff–65

¿

REQUIREMENT

OF

SUBMISSION

OF

APPLICATION

CONTAINING CERTAIN AGREEMENTS

AND

ASSURANCES.

The

Secretary

may not

make

a

grant under this part unless—

(1) an

application

for the

grant

is

submitted

to the

Sec-

retary containing agreements

and

assurances

in

accordance

with this part

and

containing

the

information specified

in

sec-

tion

2664(a)(1);

(2)

with respect

to such

agreements,

the

application pro-

vides

assurances

of

compliance satisfactory

to the

Secretary;

and

(3) the

application otherwise

is in such form, is

made in

such

manner,

and

contains

such

agreements, assurances, and

information

as the

Secretary determines

to be

necessary to

carry

out

this part.

SEC.

2666.

ø

300ff–66

¿

PROVISION

BY

SECRETARY

OF

SUPPLIES AND

SERVICES

IN LIEU OF

GRANT

FUNDS.

(a) IN

G

ENERAL

.—Upon

the

request

of a

grantee under this

part,

the

Secretary

may,

subject

to

subsection

(b),

provide supplies,

equipment,

and

services

for the

purpose

of

aiding

the

grantee in

providing early intervention services and,

for such

purpose, may

detail

to the

State

any officer or

employee

of the

Department

of

Health

and

Human Services.

(b)

L

IMITATION

.—With respect

to a

request described

in

sub-

section

(a), the

Secretary shall reduce

the

amount

of

payments

under

the

grant involved

by an

amount equal

to the costs of

detail-

ing

personnel

and the fair

market value

of any

supplies, equip-

ment,

or

services provided

by the

Secretary.

The

Secretary shall,

for the

payment

of

expenses incurred

in

complying with

such

re-

quest, expend

the

amounts withheld.

SEC.

2667.

ø

300ff–67

¿

USE

OF

FUNDS.

Counseling programs carried

out

under this part—

(1)

shall

not be

designed

to

promote

or

encourage, directly,

intravenous drug abuse

or

sexual activity, homosexual

or

het-

erosexual;

(2)

shall

be

designed

to

reduce exposure

to and

trans-

mission

of

HIV/AIDS

by

providing accurate information;

(3)

shall provide information

on the

health risks

of

promis-

cuous

sexual activity

and

intravenous drug abuse; amd

(4)

shall provide information

on the

transmission

and

pre-

vention

of

hepatitis

A, B, and C,

including education about

the

availability

of

hepatitis

A and B

vaccines

and

assisting pa-

tients

in

identifying vaccination

sites.

January 28, 2016

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1427

PUBLIC HEALTH SERVICE ACT

Sec. 2671

PART D—WOMEN,

INFANTS, CHILDREN, AND

YOUTH

SEC.

2671.

ø

300ff–71

¿

GRANTS

FOR

COORDINATED SERVICES

AND

AC-

CESS

TO

RESEARCH

FOR WOMEN,

INFANTS, CHILDREN,

AND

YOUTH.

(a) IN

G

ENERAL

.—The Secretary, acting through

the

Adminis-

trator

of the

Health Resources

and

Services Administration, shall

award grants

to public and

nonprofit private entities (including

a

health facility operated

by or

pursuant

to a

contract with

the

In-

dian Health Service)

for the

purpose

of

providing family-centered

care

involving outpatient

or

ambulatory

care

(directly

or

through

contracts

or

memoranda

of

understanding)

for

women, infants, chil-

dren,

and

youth with HIV/AIDS.

(b)

A

DDITIONAL

S

ERVICES FOR

P

ATIENTS AND

F

AMILIES

.—Funds

provided under grants awarded under subsection

(a) may be

used

for the

following support services:

(1)

Family-centered

care

including

case

management.

(2)

Referrals

for

additional services including—

(A)

referrals

for

inpatient hospital services,

treatment

for

substance abuse,

and

mental health services;

and

(B)

referrals

for

other

social and

support services, as

appropriate.

(3)

Additional services necessary

to

enable

the

patient and

the

family

to

participate

in the

program established

by the

ap-

plicant pursuant

to such

subsection including services designed

to

recruit

and

retain youth with HIV.

(4) The

provision

of

information

and

education

on

opportu-

nities

to

participate

in

HIV/AIDS-related clinical

research.

(c)

C

OORDINATION

W

ITH

O

THER

E

NTITIES

.—A grant awarded

under subsection

(a) may be

made

only if the

applicant provides

an

agreement that includes

the

following:

(1) The

applicant

will

coordinate activities under

the

grant

with other providers

of

health

care

services under this

Act,

and

under title

V of the Social

Security

Act,

including programs

promoting

the

reduction

and

elimination

of

risk

of

HIV/AIDS

for

youth.

(2) The

applicant

will

participate

in the

statewide coordi-

nated statement

of need

under part

B

(where it

has been

initi-

ated

by the public

health agency responsible

for

administering

grants under part

B) and in

revisions

of such

statement.

(3) The

applicant

will every 2

years submit

to the

lead

State agency under section 2617(b)(4)

audits regarding funds

expended

in

accordance with this title

and

shall include nec-

essary client-level data

to

complete unmet

need

calculations

and

Statewide coordinated statements

of need

process.

(d)

A

DMINISTRATION

; A

PPLICATION

.—A grant

may only

be

awarded

to an

entity under subsection

(a) if an

application

for

the

grant

is

submitted

to the

Secretary

and the

application

is in

such

form, is

made

in such

manner,

and

contains

such

agreements, as-

surances,

and

information

as the

Secretary determines

to be

nec-

essary

to

carry

out

this section.

Such

application shall include

the

following:

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Sec. 2671

PUBLIC HEALTH SERVICE ACT

1428

(1)

Information regarding

how the

expected expenditures

of the

grant

are

planning process

for

localities

funded under part

A

(including

the

planning process outlined

in

section

2602) and for

States funded under part

B

(including

the

planning process outlined

in

section 2617(b)).

(2) A

specification

of the

expected expenditures

and

how

those expenditures

will

improve overall patient outcomes,

as

outlined

as

part

of the

State plan (under section

2617(b))

or

through additional outcome

measures.

(e)

A

NNUAL

R

EVIEW

OF

P

ROGRAMS

;

E

VALUATIONS

.—

(1)

R

EVIEW REGARDING ACCESS

TO

AND PARTICIPATION IN

PROGRAMS

.—With respect

to a

grant under subsection

(a)

for

an

entity

for a fiscal

year,

the

Secretary shall,

not

later than

180 days

after

the end of the fiscal

year, provide

for the

con-

duct and

completion

of a

review

of the

operation during the

year

of the

program carried

out

under

such

subsection

by

the

entity.

The

purpose

of such

review shall

be the

development

of

recommendations,

as

appropriate,

for

improvements

in the fol-

lowing:

(A)

Procedures used

by the

entity

to

allocate opportu-

nities

and

services under subsection

(a)

among patients

of

the

entity

who are

women, infants, children,

or

youth.

(B)

Other procedures

or

policies

of the

entity regarding

the

participation

of such

individuals

in such

program.

(2)

E

VALUATIONS

.——

14

The Secretary shall, directly or

through contracts with

public and

private entities, provide for

evaluations

of

programs carried

out

pursuant

to

subsection (a).

(f)

A

DMINISTRATIVE

E

XPENSES

.—

(1)

L

IMITATION

.—A grantee

may not use more

than

10

per-

cent of

amounts received under

a

grant awarded under this

section

for

administrative expenses.

(2)

C

LINICAL QUALITY MANAGEMENT PROGRAM

.—A

grantee

under this section shall implement

a

clinical quality manage-

ment program

to

assess

the

extent

to which HIV

health serv-

ices

provided

to

patients under

the

grant

are

consistent with

the most

recent Public Health Service guidelines

for the

treat-

ment

of

HIV/AIDS

and

related opportunistic infection,

and

as

applicable,

to

develop strategies

for

ensuring that

such

services

are

consistent with

the

guidelines

for

improvement

in the

ac-

cess to and

quality

of HIV

health services.

(g)

T

RAINING AND

T

ECHNICAL

A

SSISTANCE

.—From

the

amounts

appropriated under subsection

(j) for a fiscal

year,

the

Secretary

may use not more

than

5

percent

to

provide, directly

or

through

contracts with

public and

private entities (which

may

include

grantees under subsection

(a)),

training

and

technical assistance to

assist applicants

and

grantees under subsection

(a) in

complying

with

the

requirements

of

this section.

(h)

D

EFINITIONS

.—In this section:

(1)

A

DMINISTRATIVE EXPENSES

.—The term ‘‘administrative

expenses’’

means funds that

are to be

used

by

grantees for

grant management

and

monitoring activities, including costs

14

Dash

so in

law.

January 28, 2016

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F:\COMP\PHSA\PHSA-MERGED.XML

1429

PUBLIC HEALTH SERVICE ACT

Sec. 2681

activity unrelated

to

services

or

indirect

costs.

(2)

I

NDIRECT COSTS

.—The term

‘‘indirect costs’’

means costs

included

in a

Federally negotiated indirect

rate.

(3)

S

ERVICES

.—The term

‘‘services’’

means—

(A)

services that

are

provided

to

clients

to

meet the

goals and

objectives

of the

program under this section, in-

cluding

the

provision

of

professional, diagnostic,

and

thera-

peutic services

by a

primary

care

provider

or a

referral to

and

provision

of

specialty

care;

and

(B)

services that sustain program activity

and

con-

tribute

to or help

improve services under subparagraph

(A).

(i)

A

PPLICATION

TO

P

RIMARY

C

ARE

S

ERVICES

.—Nothing

in

this

part shall

be

construed

as

requiring funds under this part

to

be

used

for

primary

care

services when payments

are

available for

such

services

from

other sources (including under titles

XVIII, XIX,

and XXI of the Social

Security Act).

(j)

A

UTHORIZATION

OF

A

PPROPRIATIONS

.—For

the

purpose

of

carrying

out

this section, there

are

authorized

to be

appropriated,

$71,800,000

for each of the fiscal

years

2007

through 2009,

$75,390,000

for fiscal

year

2010,

$79,160,000

for fiscal

year 2011,

$83,117,000

for fiscal

year

2012, and

$87,273,000

for fiscal

year

2013.

PART E—GENERAL

PROVISIONS

SEC.

2681.

ø

300ff–81

¿

COORDINATION.

(a)

R

EQUIREMENT

.—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

Centers

for

Medicare

&

Medicaid

Services coordinate

the

planning, funding,

and

implementation

of

Federal

HIV

programs (including

all

minority

AIDS

initiatives

of

the

Public Health Service, including under section

2693) to

enhance

the

continuity

of care and

prevention services

for

individuals with

HIV/AIDS

or

those at risk

of such

disease.

The

Secretary shall con-

sult with other Federal agencies, including

the

Department

of

Vet-

erans Affairs,

as

needed

and

utilize planning information sub-

mitted

to such

agencies

by the

States

and

entities eligible

for

as-

sistance under this title.

(b)

R

EPORT

.—The Secretary shall biennially prepare

and

sub-

mit to the

appropriate committees

of the

Congress

a

report con-

cerning

the

coordination efforts at

the

Federal, State,

and local

lev-

els

described

in

this section, including

a

description

of

Federal bar-

riers

to HIV

program integration

and a

strategy

for

eliminating

such

barriers

and

enhancing

the

continuity

of care and

prevention

services

for

individuals with HIV/AIDS

or

those at risk

of such

dis-

ease.

(c)

I

NTEGRATION

BY

S

TATE

.—As

a

condition

of

receipt

of

funds

under this title,

a

State shall provide assurances

to the

Secretary

that health support services funded under this title

will be

inte-

grated with other

such

services, that programs

will be

coordinated

with other available programs (including Medicaid),

and

that the

January 28, 2016

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Sec. 2682

PUBLIC HEALTH SERVICE ACT

1430

continuity

of care and

prevention services

of

individuals with HIV/

AIDS is

enhanced.

(d)

I

NTEGRATION

BY

L

OCAL

OR

P

RIVATE

E

NTITIES

.—As

a

condi-

tion of

receipt

of

funds under this title,

a local

government

or

pri-

vate

nonprofit entity shall provide assurances

to the

Secretary

that

services funded under this title

will be

integrated with other such

services, that programs

will be

coordinated with other available

programs (including Medicaid),

and

that

the

continuity

of care

and

prevention services

of

individuals with

HIV is

enhanced.

SEC.

2682.

ø

300ff–82

¿

AUDITS.

(a) IN

G

ENERAL

.—For

fiscal

year

2009, and each

subsequent

fiscal

year,

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.

(b)

P

OSTING

ON

THE

I

NTERNET

.—All audits that

the

Secretary

receives

from the

State

lead

agency under section 2617(b)(4)

shall

be

posted,

in

their entirety,

on the

Internet website

of the

Health

Resources

and

Services Administration.

SEC.

2683.

ø

300ff–83

¿

PUBLIC HEALTH EMERGENCY.

(a) IN

G

ENERAL

.—In

an

emergency area

and

during

an

emer-

gency

period,

the

Secretary shall have

the

authority

to waive

such

requirements

of

this title

to

improve

the

health

and

safety

of

those

receiving

care

under this title

and the

general public, except

that

the

Secretary

may not

expend

more

than

5

percent

of the

funds al-

located under this title

for

sections

2620 and

section 2603(b).

(b)

E

MERGENCY

AREA

AND

E

MERGENCY

P

ERIOD

.—In this sec-

tion:

(1)

E

MERGENCY AREA

.—The term

‘‘emergency

area’’

means

a

geographic area

in which

there exists—

(A) an

emergency

or

disaster declared

by the

President

pursuant

to the

National Emergencies

Act or the

Robert T.

Stafford Disaster

Relief and

Emergency Assistance

Act;

or

(B) a public

health emergency declared

by the

Sec-

retary pursuant

to

section 319.

(2)

E

MERGENCY PERIOD

.—The term ‘‘emergency period’’

means

the

period

in which

there exists—

(A) an

emergency

or

disaster declared

by the

President

pursuant

to the

National Emergencies

Act or the

Robert T.

Stafford Disaster

Relief and

Emergency Assistance

Act;

or

(B) a public

health emergency declared

by the

Sec-

retary pursuant

to

section 319.

(c)

U

NOBLIGATED

F

UNDS

.—If funds under

a

grant under this

section

are not

expended

for an

emergency

in the fiscal

year in

which the

emergency

is

declared,

such

funds shall

be

returned to

the

Secretary

for

reallocation under sections

2603(b) and

2620.

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F:\COMP\PHSA\PHSA-MERGED.XML

1431

PUBLIC HEALTH SERVICE ACT

Sec. 2687

SEC.

2684.

ø

300ff–84

¿

PROHIBITION

ON

PROMOTION

OF

CERTAIN AC-

TIVITIES.

None of the

funds appropriated under this title shall

be

used

to fund AIDS

programs,

or to

develop materials, designed

to

pro-

mote or

encourage, directly, intravenous drug

use or

sexual activ-

ity,

whether homosexual

or

heterosexual. Funds authorized under

this title

may be

used

to

provide medical treatment

and

support

services

for

individuals with HIV.

SEC.

2685.

ø

300ff–85

¿

PRIVACY PROTECTIONS.

(a) IN

G

ENERAL

.—The Secretary shall ensure that

any

informa-

tion

submitted

to, or

collected

by, the

Secretary under this title ex-

cludes

any

personally identifiable information.

(b)

D

EFINITION

.—In this section,

the

term ‘‘personally identifi-

able

information’’

has the

meaning

given such

term under

the

regu-

lations promulgated under section

264(c) of the

Health Insurance

Portability

and

Accountability

Act of

1996.

SEC.

2686.

ø

300ff–86

¿

GAO

REPORT.

The

Comptroller General

of the

Government Accountability Of-

fice

shall,

not less

than

1

year after

the

date

of

enactment

of

the

Ryan

White HIV/AIDS

Treatment Extension

Act of 2009,

submit to

the

appropriate committees

of

Congress

a

report describing Minor-

ity AIDS

Initiative activities across

the

Department

of

Health and

Human Services, including programs under this title

and

programs

at

the

Centers

for

Disease Control

and

Prevention,

the

Substance

Abuse and

Mental Health Services Administration,

and

other de-

partmental agencies.

Such

report shall include

a

history

of

program

activities within

each

relevant agency

and a

description

of

activi-

ties

conducted,

people

served

and

types

of

grantees funded, and

shall

collect and

describe

best

practices

in

community

outreach and

capacity-building

of

community based organizations serving the

communities that

are

disproportionately affected

by

HIV/AIDS.

SEC.

2687.

ø

300ff–87

¿

SEVERITY

OF

NEED INDEX.

(a)

D

EVELOPMENT

OF

I

NDEX

.—Not later than September 30,

2008, the

Secretary shall develop

and

submit

to the

appropriate

committees

of

Congress

a

severity

of need

index

in

accordance

with

subsection (c).

(b)

D

EFINITION

OF

S

EVERITY

OF

N

EED

I

NDEX

.—In this section,

the

term

‘‘severity of need index’’

means

the

index

of the

relative

needs

of

individuals within

a

State

or

area,

as

identified

by a

num-

ber of

different factors,

and is a

factor

or set of

factors that

is

mul-

tiplied

by the

number

of living

HIV/AIDS

cases in a

State

or

area,

providing different weights

to

those

cases

based

on

needs.

Such

fac-

tors or set of

factors

may be

different

for

different components

of

the

provisions

under this title.

(c)

R

EQUIREMENTS FOR

S

ECRETARIAL

S

UBMISSION

.—When

the

Secretary submits

to the

appropriate committees

of

Congress the

severity

of need

index under subsection

(a), the

Secretary shall pro-

vide the

following:

(1)

Methodology

for and

rationale behind developing

the

severity

of need

index, including information related

to

the

field

testing

of the

severity

of need

index.

(2) An

independent contractor analysis

of

activities carried

out

under paragraph (1).

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Sec. 2688

PUBLIC HEALTH SERVICE ACT

1432

(3)

Information regarding

the

process

by which the

Sec-

retary received community input regarding

the

application

and

development

of the

severity

of need

index.

(d)

A

NNUAL

R

EPORTS

.—If

the

Secretary

fails to

submit

the

se-

verity

of need

index under subsection

(a) in

either

of fiscal

years

2007 or 2008, the

Secretary shall prepare

and

submit

to the

appro-

priate committees

of

Congress

a

report

for such fiscal

year—

(1)

that updates progress toward having client

level

data;

(2)

that updates

the

progress toward having

a

severity

of

need

index, including information related

to the

methodology

and

process

for

obtaining community

input; and

(3)

that,

as

applicable, states whether

the

Secretary could

develop

a

severity

of need

index

before fiscal

year 2009.

SEC.

2688.

ø

300ff–87a

¿

NATIONAL HIV/AIDS TESTING GOAL.

(a) IN

G

ENERAL

.—Not later than January

1, 2010, the

Sec-

retary shall establish

a

national HIV/AIDS testing

goal of

5,000,000 tests

for

HIV/AIDS

annually through federally-supported

HIV/AIDS prevention, treatment,

and care

programs, including

programs under this title

and

other programs administered

by

the

Centers

for

Disease Control

and

Prevention.

(b)

A

NNUAL

R

EPORT

.—Not later than January

1, 2011, and

an-

nually thereafter,

the

Secretary, acting through

the

Director

of

the

Centers

for

Disease Control

and

Prevention, shall submit

to

Con-

gress

a

report describing, with regard

to the

preceding 12-month

reporting period—

(1)

whether

the

testing

goal

described

in

subsection

(a)

has

been

met;

(2) the

total number

of

individuals tested through feder-

ally-supported

and

other HIV/AIDS

prevention, treatment, and

care

programs

in each

State;

(3) the

number

of

individuals who—

(A)

prior

to such

12-month period,

were

unaware

of

their

HIV

status; and

(B)

through federally-supported

and

other HIV/AIDS

prevention, treatment,

and care

programs,

were

diagnosed

and

referred

into

treatment

and care

during

such

period;

(4) any

barriers, including State

laws and

regulations,

that

the

Secretary determines

to be a

barrier

to

meeting

the

testing

goal

described

in

subsection (a);

(5) the

amount

of

funding

the

Secretary determines nec-

essary

to

meet

the

annual testing

goal in the

following 12

months

and the

amount

of

Federal funding expended

to

meet

the

testing

goal in the

prior 12-month period;

and

(6) the most

cost-effective strategies

for

identifying

and

di-

agnosing individuals

who were

unaware

of

their

HIV

status,

including voluntary testing with pre-test counseling, routine

screening including opt-out testing, partner counseling

and

re-

ferral services,

and

mass media campaigns.

(c)

R

EVIEW

OF

P

ROGRAM

E

FFECTIVENESS

.—Not later than 1

year after

the

date

of

enactment

of

this section,

the

Secretary, in

consultation with

the

Director

of the

Centers

for

Disease Control

and

Prevention, shall submit

a

report

to

Congress based

on a

com-

prehensive review

of each of the

programs

and

activities conducted

January 28, 2016

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F:\COMP\PHSA\PHSA-MERGED.XML

1433

PUBLIC HEALTH SERVICE ACT

Sec. 2689

by the

Centers

for

Disease Control

and

Prevention

as

part

of

the

Domestic HIV/AIDS Prevention Activities, including

the

following:

(1) The

amount

of

funding provided

for each

program or

activity.

(2) The

primary purpose

of each

program

or

activity.

(3) The

annual

goals for each

program

or

activity.

(4) The

relative effectiveness

of each

program

or

activity

with relation

to the

other programs

and

activities conducted by

the

Centers

for

Disease Control

and

Prevention, based

on

the—

(A)

number

of

previously undiagnosed individuals with

HIV/AIDS made aware

of

their status

and

referred into

the

appropriate treatment;

(B)

amount

of

funding provided

for each

program or

activity compared

to the

number

of

undiagnosed individ-

uals with HIV/AIDS made aware

of

their status;

(C)

program’s contribution

to the

National

HIV/AIDS

testing

goal;

and

(D)

progress made toward

the goals

described

in

para-

graph (3).

(5)

Recommendations

if any to

Congress

on ways to

allo-

cate

funding

for

domestic HIV/AIDS

prevention activities and

programs

in

order

to

achieve

the

National HIV/AIDS

testing

goal.

(d)

C

OORDINATION

W

ITH

O

THER

F

EDERAL

A

CTIVITIES

.—In pur-

suing

the

National HIV/AIDS testing

goal, the

Secretary, where ap-

propriate, shall consider

and

coordinate with other national

strate-

gies

conducted

by the

Federal Government

to

address

HIV/AIDS.

SEC.

2689.

ø

300ff–88

¿

DEFINITIONS.

For

purposes

of

this title:

(1)

AIDS.—The term

‘‘AIDS’’

means acquired immune defi-

ciency

syndrome.

(2)

C

O

-

OCCURRING CONDITIONS

.—The term ‘‘co-occurring

conditions’’

means

one or more

adverse health conditions

in

an

individual with HIV/AIDS, without regard

to

whether

the

indi-

vidual

has AIDS and

without regard

to

whether

the

conditions

arise

from

HIV.

(3)

C

OUNSELING

.—The term

‘‘counseling’’

means

such

coun-

seling provided

by an

individual trained

to

provide

such

coun-

seling.

(4)

F

AMILY

-

CENTERED CARE

.—The term ‘‘family-centered

care’’

means

the

system

of

services described

in

this title that

is

targeted specifically

to the

special needs

of

infants, children,

women

and

families. Family-centered

care

shall

be

based

on

a

partnership between parents, professionals,

and the

commu-

nity

designed

to

ensure

an

integrated, coordinated, culturally

sensitive,

and

community-based continuum

of care for

children,

women,

and

families with HIV/AIDS.

(5)

F

AMILIES WITH HIV

/

AIDS

.—The term

‘‘families

with HIV/

AIDS’’

means families

in which one or more

members have

HIV/AIDS.

(6)

HIV.—The term

‘‘HIV’’

means infection with

the

human

immunodeficiency

virus.

(7)

HIV/AIDS.—

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F:\COMP\PHSA\PHSA-MERGED.XML

Sec. 2691

PUBLIC HEALTH SERVICE ACT

1434

(A) IN

GENERAL

.—The term

‘‘HIV/AIDS’’

means HIV,

and

includes

AIDS and any

condition arising

from

AIDS.

(B)

C

OUNTING

OF

CASES

.—The term

‘‘living cases of

HIV/AIDS’’,

with respect

to the

counting

of cases in a

geo-

graphic area during

a

period

of

time, means

the sum of—

(i) the

number

of living

non-AIDS

cases of HIV

in

the

area; and

(ii) the

number

of living cases of AIDS in the

area.

(C)

N

ON

-

AIDS CASES

.—The term

‘‘non-AIDS’’,

with re-

spect

to a case of HIV,

means that

the

individual involved

has HIV but does not

have AIDS.

(8)

H

UMAN IMMUNODEFICIENCY VIRUS

.—The term ‘‘human

immunodeficiency

virus’’

means

the

etiologic agent

for

AIDS.

(9)

O

FFICIAL POVERTY LINE

.—The term

‘‘official

poverty

line’’

means

the

poverty

line

established

by the

Director

of

the

Office of

Management

and

Budget

and

revised

by the

Secretary

in

accordance with section

673(2) of the

Omnibus Budget Rec-

onciliation

Act of

1981.

(10)

P

ERSON

.—The term

‘‘person’’

includes

one or more

in-

dividuals, governments (including

the

Federal Government

and

the

governments

of the

States), governmental agencies, polit-

ical

subdivisions, labor unions, partnerships, associations, cor-

porations,

legal

representatives, mutual companies, joint-stock

companies, trusts, unincorporated organizations, receivers,

trustees,

and

trustees

in cases

under title

11,

United States

Code.

(11)

S

TATE

.—

(A) IN

GENERAL

.—The term

‘‘State’’

means

each of

the

50

States,

the

District

of

Columbia,

and each of the

terri-

tories.

(B)

T

ERRITORIES

.—The term

‘‘territory’’

means

each of

American Samoa, Guam,

the

Commonwealth

of

Puerto

Rico, the

Commonwealth

of the

Northern Mariana Islands,

the

Virgin Islands,

the

Republic

of the

Marshall Islands,

the

Federated States

of

Micronesia,

and

Palau.

(12)

Y

OUTH WITH HIV

.—The term

‘‘youth

with

HIV’’

means

individuals

who are 13

through

24

years

old and who

have

HIV/AIDS.

PART F—DEMONSTRATION

AND

TRAINING

Subpart I—Special Projects

of

National

Significance

SEC.

2691.

ø

300ff–101

¿

SPECIAL PROJECTS

OF

NATIONAL SIGNIFI-

CANCE.

(a) IN

G

ENERAL

.—Of

the

amount appropriated under

each of

parts

A, B, C, and D for each fiscal

year,

the

Secretary shall use

the

greater

of

$20,000,000

or an

amount equal

to 3

percent

of

such

amount appropriated under

each such

part,

but not to

exceed

$25,000,000,

to

administer special projects

of

national significance

to—

January 28, 2016

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F:\COMP\PHSA\PHSA-MERGED.XML

1435

PUBLIC HEALTH SERVICE ACT

Sec. 2692

(1)

quickly respond

to

emerging needs

of

individuals re-

ceiving

assistance under this title; and

(2) to fund

special programs

to

develop

a

standard elec-

tronic client information data system

to

improve

the

ability

of

grantees under this title

to

report client-level data

to the

Sec-

retary.

(b)

G

RANTS

.—The Secretary shall award grants under sub-

section

(a) to

entities eligible

for

funding under parts

A, B, C,

and

D

based on—

(1)

whether

the

funding

will

promote obtaining client level

data

as

it relates

to the

creation

of a

severity

of need

index,

including funds

to

facilitate

the

purchase

and

enhance

the

uti-

lization

of

qualified health information technology systems;

(2)

demonstrated ability

to

create

and

maintain

a

qualified

health information technology system;

(3) the

potential replicability

of the

proposed activity in

other similar localities

or

nationally;

(4) the

demonstrated reliability

of the

proposed qualified

health information technology system across

a

variety

of

pro-

viders, geographic regions,

and

clients; and

(5) the

demonstrated ability

to

maintain

a safe and

secure

qualified health information system; or

(6) newly

emerging needs

of

individuals receiving assist-

ance

under this title.

(c)

C

OORDINATION

.—The Secretary

may not

make

a

grant

under this section unless

the

applicant submits evidence

that the

proposed program

is

consistent with

the

statewide coordinated

statement

of

need,

and the

applicant agrees

to

participate

in

the

ongoing revision process

of such

statement

of

need.

(d)

P

RIVACY

P

ROTECTION

.—The Secretary

may not

make a

grant under this section

for the

development

of a

qualified health

information technology system unless

the

applicant provides

assur-

ances

to the

Secretary that

the

system

will,

at

a

minimum, comply

with

the

privacy regulations promulgated under section

264(c) of

the

Health Insurance Portability

and

Accountability

Act of

1996.

(e)

R

EPLICATION

.—The Secretary shall make information con-

cerning successful models

or

programs developed

under this part

available

to

grantees under this title

for the

purpose

of

coordina-

tion,

replication,

and

integration.

To

facilitate efforts under this

subsection,

the

Secretary

may

provide

for

peer-based technical as-

sistance

for

grantees funded

under this part.

Subpart II—AIDS

Education and Training Centers

SEC.

2692.

ø

300ff–111

¿

HIV/AIDS COMMUNITIES, SCHOOLS,

AND

CEN-

TERS.

(a)

S

CHOOLS

;

C

ENTERS

.—

(1) IN

GENERAL

.—The Secretary

may

make grants and

enter

into

contracts

to

assist

public and

nonprofit private enti-

ties and schools and

academic health science centers

in

meet-

ing the costs of

projects—

(A) to

train health personnel, including practitioners

in

programs under this title

and

other community pro-

viders,

in the

diagnosis, treatment,

and

prevention

of

HIV/

January 28, 2016

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F:\COMP\PHSA\PHSA-MERGED.XML

Sec. 2692

PUBLIC HEALTH SERVICE ACT

1436

AIDS,

including

the

prevention

of the

perinatal trans-

mission

of the

disease, including measures

for the

preven-

tion and

treatment

of

opportunistic infections,

and

includ-

ing (as

applicable

to the type of

health professional in-

volved),

prenatal

and

other gynecological

care for

women

with HIV/AIDS;

(B) to

train

the

faculty

of schools of, and

graduate de-

partments

or

programs

of,

medicine, nursing, osteopathic

medicine, dentistry,

public

health, allied health,

and

men-

tal health practice

to

teach health professions students to

provide

for the

health

care

needs

of

individuals with HIV/

AIDS;

(C) to

develop

and

disseminate curricula

and

resource

materials relating

to the care and

treatment

of

individuals

with

such

disease

and the

prevention

of the

disease among

individuals

who are

at risk

of

contracting

the

disease; and

(D) to

develop protocols

for the

medical

care of

women

with HIV/AIDS, including

prenatal

and

other gynecological

care for such

women.

(2)

P

REFERENCE

IN

MAKING GRANTS

.—In making grants

under paragraph

(1), the

Secretary shall

give

preference to

qualified projects

which

will—

(A)

train,

or

result

in the

training

of,

health profes-

sionals

who will

provide treatment

for

minority individuals

and

Native Americans with HIV/AIDS

and

other individ-

uals

who are

at

high

risk

of

contracting

such

disease;

(B)

train,

or

result

in the

training

of,

minority health

professionals

and

minority allied health professionals to

provide treatment

for

individuals with

such

disease; and

(C)

train

or

result

in the

training

of

health profes-

sionals

and

allied health professionals

to

provide treat-

ment

for

hepatitis

B or C

co-infected

individuals.

(3)

A

PPLICATION

.—No grant

or

contract

may be

made

under paragraph

(1)

unless

an

application

is

submitted

to

the

Secretary

in such form,

at

such

time,

and

containing

such

in-

formation,

as the

Secretary

may

prescribe.

(b)

D

ENTAL

S

CHOOLS

.—

(1) IN

GENERAL

.—

(A)

G

RANTS

.—The Secretary

may

make grants

to

den-

tal

schools and

programs described

in

subparagraph

(B)

to

assist

such schools and

programs with respect

to

oral

health

care to

patients with HIV/AIDS.

(B)

E

LIGIBLE APPLICANTS

.—For purposes

of

this sub-

section,

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

ef-

fect 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 pro-

grams that

are

accredited

by the

Commission

on

Dental

Accreditation.

January 28, 2016

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F:\COMP\PHSA\PHSA-MERGED.XML

1437

PUBLIC HEALTH SERVICE ACT

Sec. 2693

(2)

A

PPLICATION

.—Each dental

school or

program described

in

section

15

the

section referred

to in

paragraph

(1)(B) may

an-

nually submit

an

application documenting

the

unreimbursed

costs of oral

health

care

provided

to

patients with HIV/AIDS

by

that

school or

hospital during

the

prior year.

(3)

D

ISTRIBUTION

.—The Secretary shall distribute the

available funds among

all

eligible applicants, taking

into

ac-

count

the

number

of

patients with HIV/AIDS served

and

the

unreimbursed

oral

health

care costs

incurred

by each

institu-

tion as

compared with

the

total number

of

patients served and

costs

incurred

by all

eligible applicants.

(4)

M

AINTENANCE

OF

EFFORT

.—The Secretary shall not

make

a

grant under this subsection

if doing so would

result in

any

reduction

in

State funding allotted

for such

purposes.

(5)

C

OMMUNITY

-

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/AIDS

in

unserved areas.

Such

partnerships shall permit

the

training

of

dental students

and

residents

and the

participation

of

community

dentists as

adjunct faculty.

(c)

A

UTHORIZATION

OF A

PPROPRIATIONS

.—

(1)

S

CHOOLS

;

CENTERS

.—For

the

purpose

of

awarding

grants under subsection

(a),

there

are

authorized

to be

appro-

priated $34,700,000

for each of the fiscal

years

2007

through

2009,

$36,535,000

for fiscal

year

2010,

$38,257,000

for

fiscal

year

2011,

$40,170,000

for fiscal

year

2012, and

$42,178,000

for fiscal

year 2013.

(2)

D

ENTAL SCHOOLS

.—For

the

purpose

of

awarding grants

under subsection

(b),

there

are

authorized

to be

appropriated

$13,000,000

for each of the fiscal

years

2007

through 2009,

$13,650,000

for fiscal

year

2010,

$14,333,000

for fiscal

year

2011,

$15,049,000

for fiscal

year

2012, and

$15,802,000

for

fis-

cal

year 2013.

Subpart III—Minority AIDS

Initiative

SEC.

2693.

ø

300ff–121

¿

MINORITY AIDS INITIATIVE.

(a) IN

G

ENERAL

.—For

the

purpose

of

carrying

out

activities

under this section

to

evaluate

and

address

the

disproportionate im-

pact of

HIV/AIDS

on, and the

disparities

in

access, treatment, care,

and

outcomes

for,

racial

and

ethnic minorities (including African

Americans, Alaska Natives, Latinos, American Indians, Asian

Americans, Native Hawaiians,

and Pacific

Islanders), there

are

au-

thorized

to be

appropriated $131,200,000

for fiscal

year 2007,

$135,100,000

for fiscal

year

2008,

$139,100,000

for fiscal

year 2009,

$146,055,000

for fiscal

year

2010,

$153,358,000

for fiscal

year 2011,

$161,026,000

for fiscal

year

2012, and

$169,077,000

for fiscal

year

2013. The

Secretary shall develop

a

formula

for the

awarding

of

grants under subsections

(b)(1)(A) and (b)(1)(B)

that ensures that

funding

is

provided based

on the

distribution

of

populations dis-

proportionately impacted

by

HIV/AIDS.

15

So in law. See

section

402(b)(2) of

Public

Law

106–345

(114

Stat. 1349).

January 28, 2016

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F:\COMP\PHSA\PHSA-MERGED.XML

Sec. 2693

PUBLIC HEALTH SERVICE ACT

1438

(b)

C

ERTAIN

A

CTIVITIES

.—

(1) IN

GENERAL

.—In carrying

out the

purpose described in

subsection

(a), the

Secretary shall provide for—

(A)

emergency assistance under part

A;

(B) care

grants under part B;

(C)

early intervention services under part C;

(D)

services through projects

for

HIV-related care

under part

D;

and

(E)

activities through education

and

training centers

under section 2692.

(2)

A

LLOCATIONS AMONG ACTIVITIES

.—Activities under

paragraph

(1)

shall

be

carried

out by the

Secretary

in

accord-

ance

with

the

following:

(A) For

supplemental grants

to

improve HIV-related

health outcomes

to

reduce existing racial

and

ethnic health

disparities,

the

Secretary shall,

of the

amount appro-

priated under subsection

(a) for a fiscal

year, reserve the

following,

as

applicable:

(i) For fiscal

year

2007,

$43,800,000.

(ii) For fiscal

year

2008,

$45,400,000.

(iii) For fiscal

year

2009,

$47,100,000.

(iv) For fiscal

year

2010,

$46,738,000.

(v) For fiscal

year

2011,

$49,075,000.

(vi) For fiscal

year

2012,

$51,528,000.

(vii) For fiscal

year

2013,

$54,105,000.

(B) For

grants used

for

supplemental support edu-

cation

and

outreach services

to

increase

the

number

of

eli-

gible

racial

and

ethnic minorities

who

have access

to

treat-

ment through

the

program under section

2616 for

thera-

peutics,

the

Secretary shall,

of the

amount appropriated

for a fiscal

year under subsection

(a),

reserve

the

following,

as

applicable:

(i) For fiscal

year

2007,

$7,000,000. (ii)

For fiscal

year

2008,

$7,300,000. (iii)

For fiscal

year

2009,

$7,500,000. (iv)

For fiscal

year

2010,

$8,763,000. (v)

For

fiscal

year

2011,

$9,202,000. (vi)

For fiscal

year

2012,

$9,662,000. (vii)

For fiscal

year

2013,

$10,145,000.

(C) For

planning grants, capacity-building

grants, and

services grants

to

health

care

providers

who

have

a

history

of

providing culturally

and

linguistically appropriate care

and

services

to

racial

and

ethnic minorities,

the

Secretary

shall,

of the

amount appropriated

for a fiscal

year under

subsection

(a),

reserve

the

following,

as

applicable:

(i) For fiscal

year

2007,

$53,400,000.

(ii) For fiscal

year

2008,

$55,400,000.

(iii) For fiscal

year

2009,

$57,400,000.

(iv) For fiscal

year

2010,

$61,343,000.

(v) For fiscal

year

2011,

$64,410,000.

(vi) For fiscal

year

2012,

$67,631,000.

(vii) For fiscal

year

2013,

$71,012,000.

(D) For

eliminating racial

and

ethnic disparities

in

the

delivery

of

comprehensive, culturally

and

linguistically ap-

January 28, 2016

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F:\COMP\PHSA\PHSA-MERGED.XML

1439

PUBLIC HEALTH SERVICE ACT

Sec. 2693

propriate

care

services

for HIV

disease

for

women,

infants,

children,

and

youth,

the

Secretary shall,

of the

amount ap-

propriated under subsection

(a),

reserve

the

following,

as

applicable:

(i) For fiscal

year

2010,

$20,448,000.

(ii) For fiscal

year

2011,

$21,470,000.

(iii) For fiscal

year

2012,

$22,543,000.

(iv) For fiscal

year

2013,

$23,671,000.

(E) For

increasing

the

training capacity

of

centers to

expand

the

number

of

health

care

professionals with

treat-

ment expertise

and

knowledge about

the most

appropriate

standards

of HIV

disease-related treatments

and

medical

care for

racial

and

ethnic minority adults, adolescents,

and

children with

HIV

disease,

the

Secretary shall,

of

the

amount appropriated under subsection

(a),

reserve

the fol-

lowing,

as

applicable:

(i) For fiscal

year

2010,

$8,763,000.

(ii)

For fiscal

year

2011,

$9,201,000.

(iii) For fiscal

year

2012,

$9,662,000.

(iv) For fiscal

year

2013,

$10,144,000.

(c)

C

ONSISTENCY

W

ITH

P

RIOR

P

ROGRAM

.—With respect

to

the

purpose described

in

subsection

(a), the

Secretary shall carry out

this section consistent with

the

activities carried

out

under this

title

by the

Secretary pursuant

to the

Departments

of

Labor,

Health

and

Human Services,

and

Education,

and

Related Agencies

Appropriations

Act, 2002

(Public

Law

107–116).

(d)

S

YNCHRONIZATION

OF

M

INORITY

AIDS

I

NITIATIVE

.—For fis-

cal

year

2010 and each

subsequent

fiscal

year,

the

Secretary shall

incorporate

and

synchronize

the

schedule

of

application submis-

sions and

funding availability under this section with

the

schedule

of

application submissions

and

funding availability under

the

cor-

responding provisions

of

this title

XXVI as

follows:

(1) The

schedule

for

carrying

out

subsection

(b)(1)(A)

shall

be the

same

as the

schedule applicable

to

emergency

assistance

under part A.

(2) The

schedule

for

carrying

out

subsection

(b)(1)(B)

shall

be the

same

as the

schedule applicable

to care

grants under

part B.

(3) The

schedule

for

carrying

out

subsection

(b)(1)(C)

shall

be the

same

as the

schedule applicable

to

grants

for

early

intervention services under part C.

(4) The

schedule

for

carrying

out

subsection

(b)(1)(D)

shall

be the

same

as the

schedule applicable

to

grants

for

services

through projects

for

HIV-related

care

under part D.

(5) The

schedule

for

carrying

out

subsection

(b)(1)(E)

shall

be the

same

as the

schedule applicable

to

grants

and

contracts

for

activities through education

and

training centers under sec-

tion

2692.

January 28, 2016

As Amended Through P.L. 114-113, Enacted December 18, 2015

F:\COMP\PHSA\PHSA-MERGED.XML

Sec. 2695

PUBLIC HEALTH SERVICE ACT

1440

PART G—NOTIFICATION

OF

POSSIBLE

EXPOSURE

TO

INFECTIOUS DISEASES

SEC.

2695.

ø

300ff–131

¿

INFECTIOUS DISEASES

AND

CIRCUMSTANCES

RELEVANT

TO

NOTIFICATION REQUIREMENTS.

(a) IN

G

ENERAL

.—Not later than

180 days

after

the

date

of

the

enactment

of

this part,

the

Secretary shall complete

the

develop-

ment

of—

(1) a list of

potentially life-threatening infectious diseases,

including emerging infectious diseases,

to which

emergency re-

sponse employees

may be

exposed

in

responding

to

emer-

gencies;

(2)

guidelines describing

the

circumstances

in which

such

employees

may be

exposed

to such

diseases, taking

into

ac-

count

the

conditions under

which

emergency response

is

pro-

vided;

and

(3)

guidelines describing

the

manner

in which

medical fa-

cilities should make determinations

for

purposes

of

section

2695B(d).

(b)

S

PECIFICATION

OF

A

IRBORNE

I

NFECTIOUS

D

ISEASES

.—The

list

developed

by the

Secretary under subsection

(a)(1)

shall include

a

specification

of

those infectious diseases

on the list

that

are

rou-

tinely transmitted through airborne

or

aerosolized

means.

(c)

D

ISSEMINATION

.—The Secretary shall—

(1)

transmit

to

State

public

health

officers copies of the

list

and

guidelines developed

by the

Secretary under subsection (a)

with

the

request that

the officers

disseminate

such copies

as

appropriate throughout

the

States; and

(2)

make

such copies

available

to the

public.

SEC.

2695A.

ø

300ff–132

¿

ROUTINE NOTIFICATIONS

WITH

RESPECT TO

AIRBORNE INFECTIOUS DISEASES

IN

VICTIMS ASSISTED.

(a)

R

OUTINE

N

OTIFICATION

OF

D

ESIGNATED

O

FFICER

.—

(1)

D

ETERMINATION

BY

TREATING FACILITY

.—If

a

victim

of

an

emergency

is

transported

by

emergency response employees

to a

medical facility

and the

medical facility makes

a

deter-

mination that

the

victim

has an

airborne infectious disease,

the

medical facility shall

notify the

designated

officer of

the

emergency response employees

who

transported

the

victim to

the

medical facility

of the

determination.

(2)

D

ETERMINATION

BY

FACILITY ASCERTAINING CAUSE OF

DEATH

.—If

a

victim

of an

emergency

is

transported

by

emer-

gency

response employees

to a

medical facility

and the

victim

dies

at

or before

reaching

the

medical facility,

the

medical fa-

cility

ascertaining

the

cause

of

death shall

notify the

des-

ignated

officer of the

emergency response employees

who

trans-

ported

the

victim

to the

initial medical facility

of any

deter-

mination

by the

medical facility that

the

victim

had an

air-

borne infectious disease.

(b)

R

EQUIREMENT

OF

P

ROMPT

N

OTIFICATION

.—With respect to

a

determination described

in

paragraph

(1) or (2) of

subsection (a),

the

notification required

in each of such

paragraphs shall

be

made

as soon as is

practicable,

but not

later than

48

hours after

the

de-

termination

is

made.

January 28, 2016

As Amended Through P.L. 114-113, Enacted December 18, 2015

F:\COMP\PHSA\PHSA-MERGED.XML

1441

PUBLIC HEALTH SERVICE ACT

Sec. 2695B

SEC.

2695B.

ø

300ff–133

¿

REQUEST

FOR

NOTIFICATION

WITH

RESPECT

TO

VICTIMS ASSISTED.

(a)

I

NITIATION

OF

P

ROCESS

BY

E

MPLOYEE

.—If

an

emergency re-

sponse employee believes that

the

employee

may

have

been

ex-

posed to an

infectious disease

by a

victim

of an

emergency

who

was

transported

to a

medical facility

as a

result

of the

emergency,

and

if the

employee attended, treated, assisted,

or

transported

the

vic-

tim

pursuant

to the

emergency, then

the

designated

officer of

the

employee shall,

upon the

request

of the

employee, carry

out the

du-

ties

described

in

subsection

(b)

regarding

a

determination

of

wheth-

er the

employee

may

have

been

exposed

to an

infectious disease by

the

victim.

(b)

I

NITIAL

D

ETERMINATION

BY

D

ESIGNATED

O

FFICER

.—The du-

ties

referred

to in

subsection

(a) are

that—

(1) the

designated

officer

involved

collect the facts

relating

to the

circumstances under which,

for

purposes

of

subsection

(a), the

employee involved

may

have

been

exposed

to an

infec-

tious disease; and

(2) the

designated

officer

evaluate

such facts and

make a

determination

of

whether,

if the

victim involved

had any

infec-

tious disease included

on the list

issued under paragraph (1)

of

section 2695(a),

the

employee

would

have

been

exposed to

the

disease under

such

facts,

as

indicated

by the

guidelines

issued under paragraph

(2) of such

section.

(c)

S

UBMISSION

OF

R

EQUEST

TO

M

EDICAL

F

ACILITY

.—

(1) IN

GENERAL

.—If

a

designated

officer

makes

a

deter-

mination under subsection

(b)(2)

that

an

emergency response

employee

may

have

been

exposed

to an

infectious disease,

the

designated

officer

shall submit

to the

medical facility

to

which

the

victim involved

was

transported

a

request

for a

response

under subsection

(d)

regarding

the

victim

of the

emergency in-

volved.

(2)

F

ORM

OF

REQUEST

.—A request under paragraph (1)

shall

be in

writing

and be

signed

by the

designated

officer

in-

volved, and

shall contain

a

statement

of the facts

collected

pur-

suant

to

subsection (b)(1).

(d)

E

VALUATION AND

R

ESPONSE

R

EGARDING

R

EQUEST

TO

M

ED

-

ICAL

F

ACILITY

.—

(1) IN

GENERAL

.—If

a

medical facility receives

a

request

under subsection

(c), the

medical facility shall evaluate the

facts

submitted

in the

request

and

make

a

determination

of

whether,

on the

basis

of the

medical information possessed by

the

facility regarding

the

victim involved,

the

emergency re-

sponse employee

was

exposed

to an

infectious disease included

on the list

issued under paragraph

(1) of

section 2695(a),

as

in-

dicated

by the

guidelines issued under paragraph

(2) of

such

section.

(2)

N

OTIFICATION

OF

EXPOSURE

.—If

a

medical facility

makes

a

determination under paragraph

(1)

that

the

emer-

gency

response employee involved

has been

exposed

to an

in-

fectious disease,

the

medical facility shall,

in

writing,

notify

the

designated

officer who

submitted

the

request under subsection

(c) of the

determination.

January 28, 2016

As Amended Through P.L. 114-113, Enacted December 18, 2015

F:\COMP\PHSA\PHSA-MERGED.XML

Sec. 2695B

PUBLIC HEALTH SERVICE ACT

1442

(3)

F

INDING

OF NO

EXPOSURE

.—If

a

medical facility makes

a

determination under paragraph

(1)

that

the

emergency re-

sponse employee involved

has not been

exposed

to an

infectious

disease,

the

medical facility shall,

in

writing, inform

the

des-

ignated

officer who

submitted

the

request under subsection

(c)

of the

determination.

(4)

I

NSUFFICIENT

INFORMATION

.—

(A) If a

medical facility

finds in

evaluating

facts

for

purposes

of

paragraph

(1)

that

the facts are

insufficient to

make

the

determination described

in such

paragraph, the

medical facility shall,

in

writing, inform

the

designated

of-

ficer who

submitted

the

request under subsection

(c) of

the

insufficiency

of the

facts.

(B)(i) If a

medical facility

finds in

making

a

deter-

mination under paragraph

(1)

that

the

facility possesses no

information

on

whether

the

victim involved

has an

infec-

tious disease included

on the list

under section 2695(a),

the

medical facility shall,

in

writing, inform

the

designated

officer who

submitted

the

request under subsection

(c) of

the

insufficiency

of such

medical information.

(ii) If

after making

a

response under clause

(i) a

med-

ical

facility determines that

the

victim involved

has an

in-

fectious disease,

the

medical facility shall make

the

deter-

mination described

in

paragraph

(1) and

provide

the

appli-

cable

response specified

in

this subsection.

(e)

T

IME FOR

M

AKING

R

ESPONSE

.—After receiving

a

request

under subsection

(c)

(including

any such

request resubmitted under

subsection

(g)(2)), a

medical facility shall make

the

applicable re-

sponse specified

in

subsection

(d) as soon as is

practicable,

but

not

later than

48

hours after receiving

the

request.

(f)

D

EATH

OF

V

ICTIM

OF

E

MERGENCY

.—

(1)

F

ACILITY ASCERTAINING CAUSE

OF

DEATH

.—If

a

victim

described

in

subsection

(a) dies

at

or before

reaching

the

med-

ical

facility involved,

and the

medical facility receives

a

request

under subsection

(c), the

medical facility shall provide

a

copy

of the

request

to the

medical facility ascertaining

the

cause

of

death

of the

victim,

if such

facility

is a

different medical facil-

ity

than

the

facility that received

the

original request.

(2)

R

ESPONSIBILITY

OF

FACILITY

.—Upon

the

receipt

of

a

copy of a

request

for

purposes

of

paragraph

(1), the

duties oth-

erwise established

in

this part regarding medical facilities

shall apply

to the

medical facility ascertaining

the

cause

of

death

of the

victim

in the

same manner

and to the

same extent

as such

duties apply

to the

medical facility originally receiving

the

request.

(g)

A

SSISTANCE

OF

P

UBLIC

H

EALTH

O

FFICER

.—

(1)

E

VALUATION

OF

RESPONSE

OF

MEDICAL FACILITY

RE

-

GARDING INSUFFICIENT FACTS

.—

(A) In the case of a

request under subsection

(c)

to

which a

medical facility

has

made

the

response specified

in

subsection

(d)(4)(A)

regarding

the

insufficiency

of

facts, the

public

health

officer for the

community

in which the

med-

ical

facility

is

located shall evaluate

the

request

and

the

response,

if the

designated

officer

involved submits such

January 28, 2016

As Amended Through P.L. 114-113, Enacted December 18, 2015

F:\COMP\PHSA\PHSA-MERGED.XML

1443

PUBLIC HEALTH SERVICE ACT

Sec. 2695C

documents

to the officer

with

the

request that

the

officer

make

such an

evaluation.

(B) As soon as is

practicable after

a public

health offi-

cer

receives

a

request under subparagraph

(A), but

not

later than

48

hours after receipt

of the

request,

the

public

health

officer

shall complete

the

evaluation required in

such

paragraph

and

inform

the

designated

officer of the

re-

sults

of the

evaluation.

(2)

F

INDINGS

OF

EVALUATION

.—

(A) If an

evaluation under paragraph

(1)(A)

indicates

that

the facts

provided

to the

medical facility pursuant to

subsection

(c) were

sufficient

for

purposes

of

determina-

tions under subsection (d)(1)—

(i) the public

health

officer

shall,

on

behalf

of

the

designated

officer

involved, resubmit

the

request to

the

medical facility;

and

(ii) the

medical facility shall provide

to the

des-

ignated

officer the

applicable response specified in

subsection (d).

(B) If an

evaluation under paragraph

(1)(A)

indicates

that

the facts

provided

in the

request

to the

medical facil-

ity were

insufficient

for

purposes

of

determinations speci-

fied in

subsection

(c)—

(i) the public

health

officer

shall provide advice to

the

designated

officer

regarding

the

collection

and

de-

scription

of

appropriate

facts;

and

(ii) if

sufficient

facts are

obtained

by the

des-

ignated officer—

(I) the public

health

officer

shall,

on

behalf

of

the

designated

officer

involved, resubmit

the

re-

quest

to the

medical facility;

and

(II) the

medical facility shall provide

to

the

designated

officer the

appropriate response under

subsection (c).

SEC.

2695C.

ø

300ff–134

¿

PROCEDURES

FOR

NOTIFICATION

OF

EXPO-

SURE.

(a)

C

ONTENTS

OF

N

OTIFICATION

TO

O

FFICER

.—In making

a

no-

tification required under section

2695A or

section 2695B(d)(2),

a

medical facility shall provide—

(1) the

name

of the

infectious disease involved;

and

(2) the

date

on which the

victim

of the

emergency involved

was

transported

by

emergency response employees

to the

med-

ical

facility involved.

(b)

M

ANNER

OF

N

OTIFICATION

.—If

a

notification under section

2695A or

section 2695B(d)(2)

is

mailed

or

otherwise indirectly

made—

(1) the

medical facility sending

the

notification shall, upon

sending

the

notification, inform

the

designated

officer to

whom

the

notification

is

sent

of the fact

that

the

notification

has

been

sent; and

(2) such

designated

officer

shall,

not

later than

10

days

after

being

informed

by the

medical facility that

the

notifica-

tion has been

sent, inform

such

medical facility whether the

designated

officer has

received

the

notification.

January 28, 2016

As Amended Through P.L. 114-113, Enacted December 18, 2015

F:\COMP\PHSA\PHSA-MERGED.XML

Sec. 2695D

PUBLIC HEALTH SERVICE ACT

1444

SEC.

2695D.

ø

300ff–135

¿

NOTIFICATION

OF

EMPLOYEE.

(a) IN

G

ENERAL

.—After receiving

a

notification

for

purposes

of

section

2695A or

2695B(d)(2),

a

designated

officer of

emergency re-

sponse employees shall,

to the

extent practicable, immediately no-

tify each of such

employees who—

(1)

responded

to the

emergency involved;

and

(2) as

indicated

by

guidelines developed

by the

Secretary,

may

have

been

exposed

to an

infectious disease.

(b)

C

ERTAIN

C

ONTENTS

OF

N

OTIFICATION

TO

E

MPLOYEE

.—A no-

tification under this subsection

to an

emergency response employee

shall inform

the

employee

of—

(1) the fact

that

the

employee

may

have

been

exposed to

an

infectious disease

and the

name

of the

disease involved;

(2) any

action

by the

employee that,

as

indicated

by

guide-

lines developed

by the

Secretary,

is

medically

appropriate; and

(3) if

medically appropriate under

such

criteria,

the

date

of

such

emergency.

(c)

R

ESPONSES

O

THER

T

HAN

N

OTIFICATION

OF

E

XPOSURE

.—

After

receiving

a

response under paragraph

(3) or (4) of

subsection

(d) of

section

2695B, or a

response under subsection

(g)(1) of

such

section,

the

designated

officer for the

employee shall,

to the

extent

practicable, immediately inform

the

employee

of the

response.

SEC.

2695E.

ø

300ff–136

¿

SELECTION

OF

DESIGNATED OFFICERS.

(a) IN

G

ENERAL

.—For

the

purposes

of

receiving notifications

and

responses

and

making requests under this part

on

behalf

of

emergency response employees,

the public

health

officer of

each

State shall designate

1 official or officer of each

employer

of

emer-

gency

response employees

in the

State.

(b)

P

REFERENCE

IN

M

AKING

D

ESIGNATIONS

.—In making

the

designations required

in

subsection

(a), a public

health

officer

shall

give

preference

to

individuals

who are

trained

in the

provision

of

health

care or in the

control

of

infectious diseases.

SEC.

2695F.

ø

300ff–137

¿

LIMITATION

WITH

RESPECT

TO

DUTIES OF

MEDICAL FACILITIES.

The

duties established

in

this part

for a

medical facility—

(1)

shall apply

only to

medical information possessed by

the

facility during

the

period

in which the

facility

is

treating

the

victim

for

conditions arising

from the

emergency,

or

during

the

60-day period beginning

on the

date

on which the

victim

is

transported

by

emergency response employees

to the

facility,

whichever period expires first;

and

(2)

shall

not

apply

to any

extent after

the

expiration

of

the

30-day period beginning

on the

expiration

of the

applicable pe-

riod

referred

to in

paragraph

(1),

except that

such

duties shall

apply with respect

to any

request under section

2695B(c)

re-

ceived by a

medical facility

before the

expiration

of such

30-day

period.

SEC.

2695G.

ø

300ff–138

¿

MISCELLANEOUS PROVISIONS.

(a)

L

IABILITY

OF

M

EDICAL

F

ACILITIES

, D

ESIGNATED

O

FFICERS

,

P

UBLIC

H

EALTH

O

FFICERS

,

AND

G

OVERNING

E

NTITIES

.—This

part

may not be

construed

to

authorize

any

cause

of

action

for

damages

or any civil

penalty against

any

medical facility,

any

designated

of-

ficer, any

other

public

health

officer, or any

governing entity

of

January 28, 2016

As Amended Through P.L. 114-113, Enacted December 18, 2015

such

facility

or officer for

failure

to comply

with

the

duties estab-

lished

in

this part.

(b)

T

ESTING

.—This part

may not,

with respect

to

victims

of

emergencies,

be

construed

to

authorize

or

require

a

medical facility

to

test

any such

victim

for any

infectious disease.

(c)

C

ONFIDENTIALITY

.—This part

may not be

construed

to

au-

thorize

or

require

any

medical facility,

any

designated

officer of

emergency response employees,

or any such

employee,

to

disclose

identifying information with respect

to a

victim

of an

emergency or

with respect

to an

emergency response employee.

(d)

F

AILURE

TO

P

ROVIDE

E

MERGENCY

S

ERVICES

.—This

part

may not be

construed

to

authorize

any

emergency response em-

ployee to fail to

respond,

or to deny

services,

to any

victim

of

an

emergency.

(e)

N

OTIFICATION AND

R

EPORTING

D

EADLINES

.—In

any case

in

which the

Secretary determines that,

wholly or

partially

as a

result

of a public

health emergency that

has been

determined pursuant

to

section

319(a),

individuals

or public or

private entities

are

un-

able to comply

with

the

requirements

of

this part,

the

Secretary

may,

notwithstanding

any

other provision

of law,

temporarily sus-

pend,

in whole or in

part,

the

requirements

of

this part

as the

cir-

cumstances reasonably require.

Before or

promptly after

such

a

suspension,

the

Secretary shall

notify the

Congress

of such

action

and

publish

in the

Federal Register

a notice of the

suspension.

(f)

C

ONTINUED

A

PPLICATION

OF

S

TATE AND

L

OCAL

L

AW

.—Noth-

ing in

this part shall

be

construed

to

limit

the

application

of

State

or local laws

that require

the

provision

of

data

to public

health au-

thorities.

SEC.

2695H.

ø

300ff–139

¿

INJUNCTIONS REGARDING VIOLATION

OF

PRO-

HIBITION.

(a) IN

G

ENERAL

.—The Secretary

may, in any

court

of

com-

petent jurisdiction, commence

a civil

action

for the

purpose

of

ob-

taining temporary

or

permanent injunctive

relief

with respect to

any

violation

of

this part.

(b)

F

ACILITATION

OF

I

NFORMATION

ON

V

IOLATIONS

.—The Sec-

retary shall establish

an

administrative process

for

encouraging

emergency response employees

to

provide information

to the

Sec-

retary regarding violations

of

this part.

As

appropriate,

the

Sec-

retary shall investigate alleged

such

violations

and seek

appro-

priate injunctive relief.

SEC.

2695I.

ø

300ff–140

¿

APPLICABILITY

OF

PART.

This

part shall

not

apply

in a

State

if the chief

executive officer

of the

State certifies

to the

Secretary that

the law of the

State is

substantially consistent with

this part.