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Confidentiality and informed consent

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subpart ii—general provisions

Codification

Pub. L. 106–345, title III, §301(b)(1), Oct. 20, 2000, 114 Stat. 1345, redesignated subpart III "General Provisions" as subpart II.

Prior Provisions

A prior subpart II, consisting of sections 300ff–51 to 300ff–55, was redesignated subpart I of this part by Pub. L. 106–345, title III, §301(b)(1), Oct. 20, 2000, 114 Stat. 1345.

§300ff–61. Confidentiality and informed consent

(a) Confidentiality

The Secretary may not make a grant under this part unless, in the case of any entity applying for a grant under section 300ff–51 of this title, the entity agrees to ensure that information regarding the receipt of early intervention services pursuant to the grant is maintained confidentially in a manner not inconsistent with applicable law.

(b) Informed consent

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 individual only after the individual confirms that the decision of the individual with respect to undergoing such testing is voluntarily made.

(July 1, 1944, ch. 373, title XXVI, §2661, as added Pub. L. 101–381, title III, §301(a), Aug. 18, 1990, 104 Stat. 609; amended Pub. L. 106–345, title III, §301(b)(2), Oct. 20, 2000, 114 Stat. 1345; Pub. L. 109–415, title III, §304, title VII, §703, Dec. 19, 2006, 120 Stat. 2807, 2820; Pub. L. 111–87, §2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat. 2885.)

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 L. 111–87 repealed Pub.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 L. 109–415, §703, which directed repeal of this section effective Oct. 1, 2009, was itself repealed by Pub.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.

Pub. L. 109–415, §304, reenacted section catchline without change and amended text generally, substituting provisions relating to confidentiality and informed consent for provisions relating to confidentiality, informed written consent, and anonymous testing.

2000—Subsec. (a). Pub. L. 106–345 struck out par. (1) and par. (2) designation. Prior to amendment, par. (1) read as follows: "in the case of any State applying for a grant under section 300ff–41 of this title, the State agrees to ensure that information regarding the receipt of early intervention services is maintained confidentially pursuant to law or regulations in a manner not inconsistent with applicable law; and".

Effective Date of 2009 Amendment; Revival of Section

For 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.

§300ff–62. Provision of certain counseling services

(a) Counseling of individuals with negative test results

The Secretary may not make a grant under this part unless 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 information, including—

(1) measures for prevention of, exposure to, and transmission of HIV/AIDS, hepatitis B, hepatitis C, and other sexually transmitted diseases;

(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 sexually transmitted diseases;

(5) if diagnosed with chronic hepatitis B or hepatitis C co-infection, the potential of developing hepatitis-related liver disease and its impact on HIV/AIDS; and

(6) information regarding the availability of hepatitis B vaccine and information about hepatitis treatments.

(b) Counseling of individuals with positive test results

The Secretary may not make a grant under this part unless 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 regarding the condition, including—

(1) information regarding—

(A) measures for prevention of, exposure to, and transmission 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, including 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 appropriate health care, mental health care, and social and support services, including providing referrals for such services, as appropriate;

(C)(i) that explains the benefits of locating and counseling 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 individuals to disclose their infected status to their sexual partners and their partners in the sharing of hypodermic needles; that provides advice to infected individuals on the manner in which such disclosures can be made; and that emphasizes that it is the continuing duty of the individuals to avoid any behaviors that will expose others to HIV/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 individual described in subparagraph (C);

(4) if diagnosed with chronic hepatitis B or hepatitis C co-infection, the potential of developing hepatitis-related liver disease and its impact on HIV/AIDS; and

(5) information regarding the availability of hepatitis B vaccine.

(c) Additional requirements regarding appropriate counseling

The Secretary may not make a grant under this part unless the applicant for the grant agrees that, in counseling individuals with respect to HIV/AIDS, the applicant will ensure that the counseling is provided under conditions appropriate to the needs of the individuals.

(d) Counseling of emergency response employees

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 response employees, the counseling is provided to such employees under conditions appropriate to the needs of the employees regarding the counseling.

(e) Rule of construction regarding counseling without testing

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.

(July 1, 1944, ch. 373, title XXVI, §2662, as added Pub. L. 101–381, title III, §301(a), Aug. 18, 1990, 104 Stat. 610; amended Pub. L. 106–345, title III, §321, Oct. 20, 2000, 114 Stat. 1346; Pub. L. 109–415, title III, §305, title VII, §703, Dec. 19, 2006, 120 Stat. 2807, 2820; Pub. L. 111–87, §2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat. 2885.)

Amendments

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.

Pub. L. 109–415, §305, reenacted heading without change and amended text generally, substituting provisions relating to counseling of individuals after testing for HIV/AIDS, appropriateness of conditions, counseling of emergency response employees, and counseling without testing, for provisions relating to counseling of individuals before and after testing, appropriateness of conditions, counseling of emergency response employees, and counseling without testing.

2000—Subsec. (c)(3). Pub. L. 106–345, §321(1), in introductory provisions struck out "on" after "counseling".

Subsec. (c)(3)(A), (B). Pub. L. 106–345, §321(2), inserted "on" before "the availability".

Subsec. (c)(3)(C). Pub. L. 106–345, §321(3), designated existing provisions as cl. (i), inserted "that explains" before "the benefits", and added cl. (ii).

Subsec. (c)(3)(D). Pub. L. 106–345, §321(2), inserted "on" before "the availability".

Effective Date of 2009 Amendment; Revival of Section

§300ff–63. Applicability of requirements regarding confidentiality, informed consent, and counseling

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 chapter will be carried out in accordance with conditions described in sections 300ff–61 and 300ff–62 of this title.

(July 1, 1944, ch. 373, title XXVI, §2663, as added Pub. L. 101–381, title III, §301(a), Aug. 18, 1990, 104 Stat. 611; amended Pub. L. 109–415, title III, §306(a), title VII, §§702(3), 703, Dec. 19, 2006, 120 Stat. 2809, 2820; Pub. L. 111–87, §2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat. 2885.)

Amendments

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.

Pub. L. 109–415, §702(3), substituted "HIV/AIDS" for "HIV disease".

Pub. L. 109–415, §306(a), substituted "with funds appropriated through this chapter will be carried" for "will, without regard to whether such testing is carried out with Federal funds, be carried".

Effective Date of 2009 Amendment; Revival of Section

§300ff–64. Additional required agreements

(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;

(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) 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 paragraph (2) regarding limitations on the maximum amount of charges; and

(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.

(July 1, 1944, ch. 373, title XXVI, §2664, as added Pub. L. 101–381, title III, §301(a), Aug. 18, 1990, 104 Stat. 611; amended Pub. L. 104–146, §3(d)(5), May 20, 1996, 110 Stat. 1358; Pub. L. 106–345, title III, §§301(b)(3), 322, Oct. 20, 2000, 114 Stat. 1345, 1346; Pub. L. 109–415, title III, §§301(b), 306(b), (c), title VII, §§702(3), 703, Dec. 19, 2006, 120 Stat. 2806, 2809, 2820; Pub. L. 111–87, §2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat. 2885.)

Amendments

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).

Effective Date of 2009 Amendment; Revival of Section

Effective Date of 1996 Amendment

Amendment 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.

§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 Secretary containing agreements and assurances in accordance with this part and containing the information specified in section 300ff–64(a)(1) of this title;

(2) with respect to such agreements, the application provides 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.

(July 1, 1944, ch. 373, title XXVI, §2665, as added Pub. L. 101–381, title III, §301(a), Aug. 18, 1990, 104 Stat. 614; amended Pub. L. 109–415, title VII, §703, Dec. 19, 2006, 120 Stat. 2820; Pub. L. 111–87, §2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat. 2885.)

Amendments

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.

Effective Date of 2009 Amendment; Revival of Section

§300ff–66. Provision by Secretary of supplies and services in lieu of grant funds

(a) In general

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) Limitation

With respect to a request described in subsection (a), the Secretary shall reduce the amount of payments under the grant involved by an amount equal to the costs of detailing personnel and the fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld.

(July 1, 1944, ch. 373, title XXVI, §2666, as added Pub. L. 101–381, title III, §301(a), Aug. 18, 1990, 104 Stat. 614; amended Pub. L. 109–415, title VII, §703, Dec. 19, 2006, 120 Stat. 2820; Pub. L. 111–87, §2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat. 2885.)

Amendments

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.

Effective Date of 2009 Amendment; Revival of Section

§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 heterosexual;

(2) shall be designed to reduce exposure to and transmission of HIV/AIDS by providing accurate information;

(3) shall provide information on the health risks of promiscuous sexual activity and intravenous drug abuse; and

(4) shall provide information on the transmission and prevention of hepatitis A, B, and C, including education about the availability of hepatitis A and B vaccines and assisting patients in identifying vaccination sites.

(July 1, 1944, ch. 373, title XXVI, §2667, as added Pub. L. 101–381, title III, §301(a), Aug. 18, 1990, 104 Stat. 614; amended Pub. L. 109–415, title VII, §§701, 702(3), 703, Dec. 19, 2006, 120 Stat. 2819, 2820; Pub. L. 111–87, §2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat. 2885.)

Amendments

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.

Par. (2). Pub. L. 109–415, §702(3), substituted "HIV/AIDS" for "HIV disease".

Par. (4). Pub. L. 109–415, §701, added par. (4).

Effective Date of 2009 Amendment; Revival of Section

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