§299b–3. Additional requirements

(a) Program agenda

(1) In general

The Administrator shall provide for an agenda for the development of the guidelines, standards, performance measures, and review criteria described in section 299b–1(a) of this title, including-

(A) with respect to the guidelines, identifying specific diseases, disorders, and other health conditions for which the guidelines are to be developed and those that are to be given priority in the development of the guidelines; and

(B) with respect to the standards, performance measures, and review criteria, identifying specific aspects of health care for which the standards, performance measures, and review criteria are to be developed and those that are to be given priority in the development of the standards, performance measures, and review criteria.

(2) Consideration of certain factors in establishing priorities

(A) Factors considered by the Administrator in establishing priorities for purposes of paragraph (1) shall include consideration of the extent to which the guidelines, standards, performance measures, and review criteria involved can be expected-

(i) to improve methods for disease prevention;

(ii) to improve methods of diagnosis, treatment, and clinical management for the benefit of a significant number of individuals;

(iii) to reduce clinically significant variations among physicians in the particular services and procedures utilized in making diagnoses and providing treatments; and

(iv) to reduce clinically significant variations in the outcomes of health care services and procedures.

(B) In providing for the agenda required in paragraph (1), including the priorities, the Administrator shall consult with the Administrator of the Health Care Financing Administration and otherwise act consistent with section 1320b–12(b)(3) of this title.

(C) The Administrator shall develop and publish a methodology for establishing priorities for guideline topics. Such methodology may include the considerations described in section 299a–2(d)(2) of this title or this paragraph, and other considerations determined by the Administrator to be appropriate. Using such methodology, the Administrator shall establish and publish annually in the Federal Register a list of guideline topics under consideration.

(b) Standards and criteria

(1) Process for development, review, and updating

The Administrator shall establish standards and criteria to be utilized by the recipients of contracts under section 299b–2 of this title, and by the expert panels convened under such section, with respect to the development and periodic review and updating of the guidelines, standards, performance measures, and review criteria described in section 299b–1(a) of this title.

(2) Award of contracts

The Administrator shall establish standards and criteria to be utilized for the purpose of ensuring that contracts entered into for the development or periodic review or updating of the guidelines, standards, performance measures, and review criteria described in section 299b–1(a) of this title will be entered into only with appropriately qualified entities.

(3) Certain requirements for standards and criteria

The Administrator shall ensure that the standards and criteria established under paragraphs (1) and (2) specify that-

(A) appropriate consultations with interested individuals and organizations are to be conducted in the development of the guidelines, standards, performance measures, and review criteria described in section 299b–1(a) of this title; and

(B) such development may be accomplished through the adoption, with or without modification, of guidelines, standards, performance measures, and review criteria that-

(i) meet the requirements of this part; and

(ii) are developed by entities independently of the program established in this part.

(4) Improvements of standards and criteria

The Administrator shall conduct and support research with respect to improving the standards and criteria developed under this subsection.

(c) Dissemination

The Administrator shall promote and support the dissemination of the guidelines, standards, performance measures, and review criteria described in section 299b–1(a) of this title. Such dissemination shall be carried out through organizations representing health care providers, organizations representing health care consumers, peer review organizations, accrediting bodies, and other appropriate entities.

(d) Pilot testing

The Administrator may conduct or support pilot testing of the guidelines, standards, performance measures, and review criteria developed under section 299b–1(a) of this title. Any such pilot testing may be conducted prior to, or concurrently with, their dissemination under subsection (c) of this section.

(e) Evaluations

The Administrator shall conduct and support evaluations of the extent to which the guidelines, standards, performance standards, and review criteria developed under section 299b–1 of this title have had an effect on the clinical practice of medicine. Evaluations shall be developed prior to the completion and release of the guideline, so that baseline data concerning practice patterns and health care costs may be obtained as part of the evaluation.

(f) Recommendations to Administrator

The Director shall make recommendations to the Administrator on activities that should be carried out under section 299a(a)(2) of this title and under section 1320b–12 of this title, including recommendations of particular research projects that should be carried out with respect to-

(1) evaluating the outcomes of health care services and procedures;

(2) developing the standards and criteria required in subsection (b) of this section; and

(3) promoting the utilization of the guidelines, standards, performance standards, and review criteria developed under section 299b–1(a) of this title.

(July 1, 1944, ch. 373, title IX, §914, as added Dec. 19, 1989, Pub. L. 101–239, title VI, §6103(a), 103 Stat. 2193 ; amended Oct. 13, 1992, Pub. L. 102–410, §§5(c)(3), 6(a), 7, 106 Stat. 2097 , 2099, 2100; June 10, 1993, Pub. L. 103–43, title XX, §2013(2), 107 Stat. 215 .)

Amendments

1993-Subsec. (a)(2)(C). Pub. L. 103–43 substituted "section 299a–2(d)(2)" for "section 299a–2(c)(2)".

1992-Subsec. (a)(2)(A). Pub. L. 102–410, §6(a), added cls. (i) and (ii), redesignated former cls. (ii) and (iii) as (iii) and (iv), respectively, and struck out former cl. (i) which read as follows: "to improve methods of prevention, diagnosis, treatment, and clinical management for the benefit of a significant number of individuals;".

Subsec. (a)(2)(C). Pub. L. 102–410, §7(1), added subpar. (C).

Subsecs. (b) to (d). Pub. L. 102–410, §5(c)(3)(A)–(C), substituted "Administrator" for "Director" wherever appearing.

Subsec. (e). Pub. L. 102–410, §§5(c)(3)(D), 7(2), substituted "Administrator" for "Director" and inserted at end "Evaluations shall be developed prior to the completion and release of the guideline, so that baseline data concerning practice patterns and health care costs may be obtained as part of the evaluation."

Section Referred to in Other Sections

This section is referred to in sections 299b–2, 1320b–12 of this title.