42 U.S.C. § 300cc–18: Development of model…

Summary

The Secretary, working through the Director of the National Institutes of Health and after talking with the Director of the Agency for Healthcare Research and Quality, can give grants to public or nonprofit groups to create model clinical care plans for people infected with the germ that causes AIDS, including treatment and prevention of HIV and related conditions in women. Grants can only go to applicants that are comprehensive primary care providers or that agree to partner with such a provider. Recipients must provide lab monitoring, clinical care and prevention, counseling about available and experimental treatments and about related advisory reports, support groups, and referrals to social services. If the grantee normally charges for services, it must not charge anyone who cannot pay. Grantees must give information so the model can be copied and must send reports the Secretary asks for. The Secretary will evaluate projects and send Congress an annual report with findings and any recommendations. Money may be appropriated as needed for fiscal years 1989 through 1991 and 1994 through 1996.

Title 42, §300cc–18

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

(a)In general

(1)The Secretary, acting through the Director of the National Institutes of Health and after consultation with the Director of the Agency for Healthcare Research and Quality, may make grants to public and nonprofit private entities for the establishment of projects to develop model protocols for the clinical care of individuals infected with the etiologic agent for acquired immune deficiency syndrome, including treatment and prevention of HIV infection and related conditions among women.

(2)The Secretary may not make a grant under paragraph (1) unless—

(A)the applicant for the grant is a provider of comprehensive primary care; or

(B)the applicant for the grant agrees, with respect to the project carried out pursuant to paragraph (1), to enter into a cooperative arrangement with an entity that is a provider of comprehensive primary care.

(b)Requirement of provision of certain services

The Secretary may not make a grant under subsection (a) unless the applicant for the grant agrees that, with respect to patients participating in the project carried out with the grant, services provided pursuant to the grant will include—

(1)monitoring, in clinical laboratories, of the condition of such patients;

(2)clinical intervention for infection with the etiologic agent for acquired immune deficiency syndrome, including measures for the prevention of conditions arising from the infection;

(3)information and counseling on the availability of treatments for such infection approved by the Commissioner of Food and Drugs, on the availability of treatments for such infection not yet approved by the Commissioner, and on the reports issued by the AIDS Research Advisory Committee under section 300cc–3(c)(2)(B) of this title;

(4)support groups; and

(5)information on, and referrals to, entities providing appropriate social support services.

(c)Limitation on imposition of charges for services

The Secretary may not make a grant under subsection (a) unless the applicant for the grant agrees that, if the applicant will routinely impose a charge for providing services pursuant to the grant, the applicant will not impose the charge on any individual seeking such services who is unable to pay the charge.

(d)Evaluation and reports

(1)The Secretary may not make a grant under subsection (a) unless the applicant for the grant agrees, with respect to the project carried out pursuant to subsection (a), to submit to the Secretary—

(A)information sufficient to assist in the replication of the model protocol developed pursuant to the project; and

(B)such reports as the Secretary may require.

(2)The Secretary shall provide for evaluations of projects carried out pursuant to subsection (a) and shall annually submit to the Congress a report describing such projects. The report shall include the findings made as a result of such evaluations and may include any recommendations of the Secretary for appropriate administrative and legislative initiatives with respect to the program established in this section.

(e)Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1989 through 1991, and such sums as may be necessary for each of the fiscal years 1994 through 1996.

Notes & Related Subsidiaries

Editorial Notes

Amendments

1999—Subsec. (a)(1). Pub. L. 106–129 substituted “Director of the Agency for Healthcare Research and Quality” for “Administrator for Health Care Policy and Research”. 1993—Subsec. (a)(1). Pub. L. 103–43, § 1811(4)(A), inserted “, acting through the Director of the National Institutes of Health and after consultation with the Administrator for Health Care Policy and Research,” after “The Secretary” and “, including treatment and prevention of HIV infection and related conditions among women” after “syndrome”. Subsec. (b)(3). Pub. L. 103–43, § 2008(d)(5), substituted “AIDS Research Advisory Committee” for “Clinical Research Review Committee”. Subsec. (e). Pub. L. 103–43, § 1811(4)(B), inserted before period at end “, and such sums as may be necessary for each of the fiscal years 1994 through 1996”.

Statutory Notes and Related Subsidiaries

Termination of Reporting RequirementsFor termination, effective May 15, 2000, of provisions in subsec. (d)(2) of this section relating to annual submission to Congress of reports describing projects carried out pursuant to subsec. (a) of this section, see section 3003 of Pub. L. 104–66, as amended, set out as a note under section 1113 of Title 31, Money and Finance, and page 94 of House Document No. 103–7.

§300cc–18 Development of Model Protocols for Clinical Care of Infected Individuals