Title 42, The Public Health and WelfareRelease 119-110

§300ff–64 Additional Required Agreements

Title 42 › CHAPTER 6A — PUBLIC HEALTH SERVICE › SUBCHAPTER XXIV — HIV HEALTH CARE SERVICES PROGRAM › Part C — Early Intervention Services › subpart ii — general provisions › § 300ff–64

Last updated Sep 22, 2026|Official source

Summary

To get a grant, an applicant must give the Secretary detailed papers about past and planned early intervention spending, who was served, and how the money fits into local and State planning. The applicant must also promise to send reports showing how many people were served, basic epidemiological and demographic data, how much third parties pay, average and total costs by service type, and proof of community input into program design. Every 2 years the applicant must send audits, consistent with Office of Management and Budget circular A–133, to the lead State agency under section 300ff–27(b)(4), including client-level data needed for unmet-need calculations and the statewide coordinated statement of need. Applicants must offer, where State law allows, substantial chances for anonymous HIV counseling and testing and let people use a pseudonym. They cannot require HIV testing to get other health services unless the test is medically needed. They must keep spending on early intervention at least at the prior fiscal year’s level. For charges, people at or below 100 percent of the official poverty line must not be charged. People above 100 percent may be charged under a public schedule, but total annual charges cannot exceed 5 percent of annual gross income for those 100–200 percent of poverty, 7 percent for those 200–300 percent, and 10 percent for those over 300 percent. Grantees may set the exact charge and consider medical bills, and the limits apply to all kinds of fees. Funds cannot pay for services that are paid or expected to be paid by insurance, State programs, Federal or State health benefits (except Indian Health Service), or prepaid providers, unless a waiver under section 300ff–52(b)(2) applies. Grant money must be used only for the program, be tracked with proper fiscal controls, have no more than 10 percent spent on administration (clinical quality management costs excluded), be shown to fit the statewide statement of need, and include a clinical quality management program to check that services follow the most recent Public Health Service guidelines and to improve access and quality.

Full Legal Text

Title 42, §300ff–64

The Public Health and Welfare, Source: USLM XML via OLRC

(a)Reports to Secretary
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 applicant for early intervention services for the fiscal year preceding the fiscal year for which the applicant is applying 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 expenditures of the grant are related to the planning process for localities funded under part A (including the planning process described in section 300ff–12 of this title) and for States funded under part B (including the planning process described in section 300ff–27(b) of this title); and
(D)a specification of the expected expenditures and how those expenditures will improve overall client outcomes, as described in the State plan under section 300ff–27(b) of this title;
(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 population 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 category;
(3)the applicant agrees to provide additional documentation to the Secretary regarding the process used to obtain community input into the design and implementation of activities related to such grant; and
(4)the applicant agrees to submit, every 2 years, to the lead State agency under section 300ff–27(b)(4) of this title audits, consistent with Office of Management and Budget circular A133, regarding funds expended in accordance with this subchapter and shall include necessary client level data to complete unmet need calculations and Statewide coordinated statements of need process.
(b)Provision of opportunities for anonymous counseling and testing
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)Prohibition against requiring testing as condition of receiving other health services
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 services unless such testing is medically indicated in the provision of the health services sought by the individual.
(d)Maintenance of support
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 expenditures maintained by the State for the fiscal year preceding the fiscal year for which the applicant is applying to receive the grant.
(e)Requirements regarding imposition of charges for services
(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—
(A)in the case of individuals with an income less than or equal to 100 percent of the official poverty line, the applicant 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 applicant—
(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)Limitation on charges regarding individuals subject 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 exceeding 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 individual involved;
(B)in the case of individuals with an income greater than 200 percent of the official poverty line and not exceeding 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 individual 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)Assessment 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)
(B)take into consideration the medical expenses of individuals in assessing the amount of the charge, subject to such provisions.
(4)Applicability 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 established 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 characterized as enrollment fees, premiums, deductibles, cost sharing, copayments, coinsurance, or similar charges.
(5)Waiver regarding certain secondary agreements
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 300ff–52(b)(2) of this title.
(f)Relationship to items and services under other programs
(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 applicant 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 respect 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 prepaid basis.
(2)Applicability to certain secondary agreements for provision of services
An agreement made under paragraph (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 300ff–52(b)(2) of this title regarding the entity.
(g)Administration of grant
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 pursuant to this part for any purpose other than the purposes described 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 statement 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 subchapter that are provided to patients are consistent with the most recent Public Health Service guidelines for the treatment of HIV/AIDS and related opportunistic infections, and as applicable, to develop strategies for ensuring that such services are consistent with the guidelines; and
(B)to ensure that improvements in the access to and quality of HIV health services are addressed.

Legislative History

Notes & Related Subsidiaries

Editorial Notes

Amendments

2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and revived the provisions of this section as in effect on Sept. 30, 2009. See 2006 Amendment note and

Effective Date

of 2009 Amendment; Revival of Section note below. 2006—Pub. L. 109–415, § 703, which directed repeal of this section effective Oct. 1, 2009, was itself repealed by Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009. Subsec. (a)(1)(C), (D). Pub. L. 109–415, § 306(b)(1), added subpars. (C) and (D). Subsec. (a)(3), (4). Pub. L. 109–415, § 306(b)(2), (3), added pars. (3) and (4). Subsec. (b)(1). Pub. L. 109–415, § 702(3), substituted “HIV/AIDS” for “HIV disease”. Subsec. (f)(1)(A). Pub. L. 109–415, § 306(c), inserted “(except for a program administered by or providing the services of the Indian Health Service)” before semicolon. Subsec. (g)(3). Pub. L. 109–415, § 301(b)(1), amended par. (3) generally. Prior to amendment, par. (3) read as follows: “the applicant will not expend more than 10 percent including planning and evaluation of the grant for administrative expenses with respect to the grant;”. Subsec. (g)(5). Pub. L. 109–415, § 301(b)(2), inserted “clinical” before “quality management” in introductory provisions. Subsec. (g)(5)(A). Pub. L. 109–415, § 702(3), substituted “HIV/AIDS” for “HIV disease”. 2000—Subsecs. (e)(5), (f)(2). Pub. L. 106–345, § 301(b)(3)(A), (B), struck out “300ff–42(b) or” after “a waiver under section”. Subsec. (g)(3). Pub. L. 106–345, § 322(1)(A), substituted “10 percent” for “7.5 percent”. Subsec. (g)(5). Pub. L. 106–345, § 322(1)(B), (2), (3), added par. (5). Subsec. (h). Pub. L. 106–345, § 301(b)(3)(C), struck out heading and text of subsec. (h). Text read as follows: “A State may not use amounts received under a grant awarded under section 300ff–41 of this title 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.” 1996—Subsec. (g)(3). Pub. L. 104–146, § 3(d)(5)(B)(i), substituted “7.5 percent including planning and evaluation” for “5 percent”. Subsec. (g)(4). Pub. L. 104–146, § 3(d)(5)(A), (B)(ii), (C), added par. (4).

Statutory Notes and Related Subsidiaries

Effective Date

of 2009 Amendment; Revival of SectionFor provisions that repeal by section 2(a)(1) of Pub. L. 111–87 of section 703 of Pub. L. 109–415 be effective Sept. 30, 2009, and that the provisions of this section as in effect on Sept. 30, 2009, be revived, see section 2(a)(2), (3)(A) of Pub. L. 111–87, set out as a note under section 300ff–11 of this title.

Effective Date

of 1996 AmendmentAmendment by Pub. L. 104–146 effective Oct. 1, 1996, see section 13 of Pub. L. 104–146, set out as a note under section 300ff–11 of this title.

Reference

Citations & Metadata

Citation

42 U.S.C. § 300ff–64

Title 42, The Public Health and Welfare

Last Updated

Sep 22, 2026

Release point: 119-110