§299b–2. Process for development of guidelines and standards

(a) Development through contracts and panels

The Administrator shall-

(1) enter into contracts with public and nonprofit private entities for the purpose of developing and periodically reviewing and updating the guidelines, standards, performance measures, and review criteria described in section 299b–1(a) of this title; and

(2) convene panels of appropriately qualified experts (including practicing physicians with appropriate expertise) and health care consumers for the purpose of-

(A) developing and periodically reviewing and updating the guidelines, standards, performance measures, and review criteria described in section 299b–1(a) of this title; and

(B) reviewing the guidelines, standards, performance measures, and review criteria developed under contracts under paragraph (1).

(b) Authority for additional panels

The Administrator may convene panels of appropriately qualified experts (including practicing physicians with appropriate expertise) and health care consumers for the purpose of-

(1) developing the standards and criteria described in section 299b–3(b) of this title; and

(2) providing advice to the Administrator and the Director with respect to any other activities carried out under this part or under section 299a(a)(2) of this title.

(c) Selection of panel members

The Administrator shall select the chairpersons and the members of the panels convened as well as other participants in the guideline process under this section. In selecting individuals to serve on panels convened under this section, the Administrator shall consult with a broad range of interested individuals and organizations, including organizations representing physicians in the general practice of medicine and organizations representing physicians in specialties and subspecialties pertinent to the purposes of the panel involved. The Administrator shall seek to appoint physicians reflecting a variety of practice settings. In making such selections, the Administrator shall ensure that a balance is maintained between individuals selected from academic settings and individuals selected without full-time academic appointments. At least two other members of such panels shall be individuals who do not derive their primary source of revenue directly from the performance of procedures discussed in the guideline. The Administrator shall ensure that at least one participant in the guideline process shall have expertise in epidemiology as well as familiarity with the clinical condition or treatment in question. The Administrator shall also ensure that at least one participant in the guideline process shall have expertise in health services research or health economics as well as familiarity with the clinical condition or treatment in question.

(July 1, 1944, ch. 373, title IX, §913, 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)(2), (f)(1)(A), 106 Stat. 2097 , 2098.)

Amendments

1992-Subsecs. (a), (b). Pub. L. 102–410, §5(c)(2)(A), (B), substituted "Administrator" for "Director" in introductory provisions.

Subsec. (c). Pub. L. 102–410, §5(f)(1)(A), inserted after subsec. designation "The Administrator shall select the chairpersons and the members of the panels convened as well as other participants in the guideline process under this section." and inserted at end "In making such selections, the Administrator shall ensure that a balance is maintained between individuals selected from academic settings and individuals selected without full-time academic appointments. At least two other members of such panels shall be individuals who do not derive their primary source of revenue directly from the performance of procedures discussed in the guideline. The Administrator shall ensure that at least one participant in the guideline process shall have expertise in epidemiology as well as familiarity with the clinical condition or treatment in question. The Administrator shall also ensure that at least one participant in the guideline process shall have expertise in health services research or health economics as well as familiarity with the clinical condition or treatment in question."

Pub. L. 102–410, §5(c)(2)(C), substituted "Administrator" for "Director" in two places.

Effective Date of 1992 Amendment

Section 5(f)(1)(B) of Pub. L. 102–410 provided that: "The amendments made by subparagraph (A) [amending this section] shall apply only with respect to panels convened under section 913 of the Public Health Service Act [this section] on or after the date of enactment of this Act [Oct. 13, 1992]."

Study of Process

Section 5(f)(2) of Pub. L. 102–410 provided that:

"(A) The Administrator for Health Care Policy and Research shall conduct or support a study to evaluate the process described in section 913 of the Public Health Service Act [this section] for the development of guidelines, standards, and review criteria. The evaluation shall address-

"(i) the optimal methods for setting priorities for guideline topics;

"(ii) the different methods for generating guidelines, comparing the cost of producing the guidelines and the validity and utility of the guidelines produced; and

"(iii) the methods for assessing the quality of practice guidelines, including an evaluation of the validity, reliability, and impact of the guidelines.

"(B) Not later than June 1, 1995, the Administrator for Health Care Policy and Research shall submit to the Committee on Energy and Commerce [now Committee on Commerce] of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report concerning the study conducted under subparagraph (A)."

Section Referred to in Other Sections

This section is referred to in sections 299b–1, 299b–3, 1320b–12 of this title.