---
kind: "section"
citation: "42 U.S.C. § 1320b–12"
title: "42"
title_heading: "The Public Health and Welfare"
number: "1320b–12"
heading: "Research on outcomes of health care services and procedures"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/1320b-12"
units:
  - "Chapter 7 — Social Security"
  - "Subchapter XI — General Provisions, Peer Review, and Administrative Simplification"
  - "Part A — General Provisions"
---

# §1320b–12. Research on outcomes of health care services and procedures

- (a) **Establishment of program—**
  - (1) **In general—** The [Secretary](/usc/42/1301.md?p=a-6), acting through the [Director](/usc/42/11851.md?p=5) of the [Agency](/usc/42/1397n–12.md?p=1) for Healthcare Research and Quality, shall—
    - (A) conduct and support research with respect to the outcomes, effectiveness, and appropriateness of health care services and procedures in order to identify the manner in which diseases, disorders, and other health conditions can most effectively and appropriately be prevented, diagnosed, treated, and managed clinically; and
    - (B) assure that the needs and priorities of the program under subchapter XVIII are appropriately reflected in the development and periodic review and updating (through the process set forth in [section 299b–2](/usc/42/299b–2.md)[^1] of this title) of [treatment](/usc/42/11851.md?p=11)-specific or condition-specific practice guidelines for clinical [treatments](/usc/42/11851.md?p=11) and conditions in forms appropriate for use in clinical practice, for use in educational programs, and for use in reviewing quality and appropriateness of [medical care](/usc/42/1301.md?p=a-7).
  - (2) **Evaluations of alternative services and procedures—** In carrying out [paragraph (1)](#a-1), the [Secretary](/usc/42/1301.md?p=a-6) shall conduct or support evaluations of the comparative effects, on health and functional capacity, of alternative services and procedures utilized in preventing, diagnosing, treating, and clinically managing diseases, disorders, and other health conditions.
  - (3) **Initial guidelines—**
    - (A) In carrying out paragraph (1)(B) of this subsection, and [section 299b–1(d)](/usc/42/299b–1.md)[^1] of this title, the [Secretary](/usc/42/1301.md?p=a-6) shall, by not later than January 1, 1991, assure the development of an initial set of the guidelines specified in [paragraph (1)(B)](#a-1-B) that shall include not less than 3 clinical [treatments](/usc/42/11851.md?p=11) or conditions that—
      - (i)
        - (I) account for a significant portion of expenditures under subchapter XVIII; and
        - (II) have a significant variation in the frequency or the type of [treatment](/usc/42/11851.md?p=11) provided; or
      - (ii) otherwise meet the needs and priorities of the program under subchapter XVIII, as set forth under [subsection (b)(3)](#b-3).
    - (B)
      - (i) The [Secretary](/usc/42/1301.md?p=a-6) shall provide for the use of guidelines developed under subparagrah[^2] (A) to improve the quality, effectiveness, and appropriateness of care provided under subchapter XVIII. The [Secretary](/usc/42/1301.md?p=a-6) shall determine the impact of such use on the quality, appropriateness, effectiveness, and cost of [medical care](/usc/42/1301.md?p=a-7) provided under such subchapter and shall report to the Congress on such determination by not later than January 1, 1993.
      - (ii) For the purpose of carrying out [clause (i)](#a-3-B-i), the [Secretary](/usc/42/1301.md?p=a-6) shall expend, from the amounts specified in [clause (iii)](#a-3-B-iii), $1,000,000 for [fiscal year](/usc/42/619.md?p=3) 1990 and $1,500,000 for each of the [fiscal years](/usc/42/619.md?p=3) 1991 and 1992.
      - (iii) For each [fiscal year](/usc/42/619.md?p=3), for purposes of expenditures required in [clause (ii)](#a-3-B-ii)—
        - (I) 60 percent of an amount equal to the expenditure involved is appropriated from the Federal [Hospital](/usc/42/300s–3.md?p=1) Insurance Trust Fund (established under [section 1395i of this title](/usc/42/1395i.md)); and
        - (II) 40 percent of an amount equal to the expenditure involved is appropriated from the Federal Supplementary Medical Insurance Trust Fund (established under [section 1395t of this title](/usc/42/1395t.md)).
- (b) **Priorities—**
  - (1) **In general—** The [Secretary](/usc/42/1301.md?p=a-6) shall establish priorities with respect to the diseases, disorders, and other health conditions for which research and evaluations are to be conducted or supported under [subsection (a)](#a). In establishing such priorities, the [Secretary](/usc/42/1301.md?p=a-6) shall, with respect to a disease, disorder, or other health condition, consider the extent to which—
    - (A) improved methods of prevention, diagnosis, [treatment](/usc/42/11851.md?p=11), and clinical management can benefit a significant number of individuals;
    - (B) there is significant variation among [physicians](/usc/42/1301.md?p=a-7) in the particular services and procedures utilized in making diagnoses and providing [treatments](/usc/42/11851.md?p=11) or there is significant variation in the outcomes of health care services or procedures due to different patterns of diagnosis or [treatment](/usc/42/11851.md?p=11);
    - (C) the services and procedures utilized for diagnosis and [treatment](/usc/42/11851.md?p=11) result in relatively substantial expenditures; and
    - (D) the data necessary for such evaluations are readily available or can readily be developed.
  - (2) **Preliminary assessments—** For the purpose of establishing priorities under [paragraph (1)](#b-1), the [Secretary](/usc/42/1301.md?p=a-6) may, with respect to services and procedures utilized in preventing, diagnosing, treating, and clinically managing diseases, disorders, and other health conditions, conduct or support assessments of the extent to which—
    - (A) rates of utilization vary among similar populations for particular diseases, disorders, and other health conditions;
    - (B) uncertainties exist on the effect of utilizing a particular service or procedure; or
    - (C) inappropriate services and procedures are provided.
  - (3) **Relationship with medicare program—** In establishing priorities under [paragraph (1)](#b-1) for research and evaluation, and under [section 299b–3(a)](/usc/42/299b–3.md?p=a)[^1] of this title for the agenda under such section, the [Secretary](/usc/42/1301.md?p=a-6) shall assure that such priorities appropriately reflect the needs and priorities of the program under subchapter XVIII, as set forth by the [Administrator](/usc/42/4005.md?p=1) of the Centers for Medicare & Medicaid Services.
- (c) **Methodologies and criteria for evaluations—** For the purpose of facilitating research under [subsection (a)](#a), the [Secretary](/usc/42/1301.md?p=a-6) shall—
  - (1) conduct and support research with respect to the improvement of methodologies and criteria utilized in conducting research with respect to outcomes of health care services and procedures;
  - (2) conduct and support reviews and evaluations of existing research findings with respect to such [treatment](/usc/42/11851.md?p=11) or conditions;
  - (3) conduct and support reviews and evaluations of the existing methodologies that use large data bases in conducting such research and shall develop new research methodologies, [including](/usc/42/1301.md?p=b) data-based methods of advancing knowledge and methodologies that measure clinical and functional status of patients, with respect to such research;
  - (4) provide [grants](/usc/42/1397j.md?p=10) and contracts to research centers, and contracts to other entities, to conduct such research on such [treatment](/usc/42/11851.md?p=11) or conditions, [including](/usc/42/1301.md?p=b) research on the appropriate use of prescription [drugs](/usc/42/11851.md?p=4);
  - (5) conduct and support research and demonstrations on the use of claims data and data on clinical and functional status of patients in determining the outcomes, effectiveness, and appropriateness of such [treatment](/usc/42/11851.md?p=11); and
  - (6) conduct and support supplementation of existing data bases, [including](/usc/42/1301.md?p=b) the collection of new information, to enhance data bases for research purposes, and the design and development of new data bases that would be used in outcomes and effectiveness research.
- (d) **Standards for data bases—** In carrying out this section, the [Secretary](/usc/42/1301.md?p=a-6) shall develop—
  - (1) uniform definitions of data to be collected and used in describing a patient’s clinical and functional status;
  - (2) common reporting formats and linkages for such data; and
  - (3) [standards](/usc/42/1320d.md?p=7) to assure the security, confidentiality, accuracy, and appropriate maintenance of such data.
- (e) **Dissemination of research findings and guidelines—**
  - (1) **In general—** The [Secretary](/usc/42/1301.md?p=a-6) shall provide for the dissemination of the findings of research and the guidelines described in [subsection (a)](#a), and for the education of providers and others in the application of such research findings and guidelines.
  - (2) **Cooperative educational activities—** In disseminating findings and guidelines under [paragraph (1)](#e-1), and in providing for education under such paragraph, the [Secretary](/usc/42/1301.md?p=a-6) shall work with professional associations, medical specialty and subspecialty organizations, and other relevant groups to identify and implement effective means to educate [physicians](/usc/42/1301.md?p=a-7), other providers, consumers, and others in using such findings and guidelines, [including](/usc/42/1301.md?p=b) training for [physician](/usc/42/1301.md?p=a-7) managers within provider organizations.
- (f) **Evaluations—** The [Secretary](/usc/42/1301.md?p=a-6) shall conduct and support evaluations of the activities carried out under this section to determine the extent to which such activities have had an effect on the [practices](/usc/42/17061.md?p=19) of [physicians](/usc/42/1301.md?p=a-7) in providing medical [treatment](/usc/42/11851.md?p=11), the delivery of health care, and the outcomes of health care services and procedures.
- (g) **Research with respect to dissemination—** The [Secretary](/usc/42/1301.md?p=a-6) may conduct or support research with respect to improving methods of disseminating information on the effectiveness and appropriateness of health care services and procedures.
- (h) **Omitted—**
- (i) **Authorization of appropriations—**
  - (1) **In general—** There are authorized to be appropriated to carry out this section—
    - (A) $50,000,000 for [fiscal year](/usc/42/619.md?p=3) 1990;
    - (B) $75,000,000 for [fiscal year](/usc/42/619.md?p=3) 1991;
    - (C) $110,000,000 for [fiscal year](/usc/42/619.md?p=3) 1992;
    - (D) $148,000,000 for [fiscal year](/usc/42/619.md?p=3) 1993; and
    - (E) $185,000,000 for [fiscal year](/usc/42/619.md?p=3) 1994.
  - (2) **Specifications—** For the purpose of carrying out this section, for each of the [fiscal years](/usc/42/619.md?p=3) 1990 through 1992 an amount equal to two-thirds of the amounts authorized to be appropriated under [paragraph (1)](#i-1), and for each of the [fiscal years](/usc/42/619.md?p=3) 1993 and 1994 an amount equal to 70 percent of such amounts, are to be appropriated in the following proportions from the following trust funds:
    - (A) 60 percent from the Federal [Hospital](/usc/42/300s–3.md?p=1) Insurance Trust Fund (established under [section 1395i of this title](/usc/42/1395i.md)).
    - (B) 40 percent from the Federal Supplementary Medical Insurance Trust Fund (established under [section 1395t of this title](/usc/42/1395t.md)).
  - (3) **Allocations—**
    - (A) For each [fiscal year](/usc/42/619.md?p=3), of the amounts transferred or otherwise appropriated to carry out this section, the [Secretary](/usc/42/1301.md?p=a-6) shall reserve appropriate amounts for each of the purposes specified in clauses [(i)](#i-3-B-i) through [(iv)](#i-3-B-iv) of subparagraph (B).
    - (B) The purposes referred to in [subparagraph (A)](#i-3-A) are—
      - (i) the development of guidelines, [standards](/usc/42/1320d.md?p=7), performance measures, and review criteria;
      - (ii) research and evaluation;
      - (iii) data-base [standards](/usc/42/1320d.md?p=7) and development; and
      - (iv) education and information dissemination.

## Footnotes

[^1]: See References in Text note below.
[^2]: So in original. Probably should be “subparagraph”.

## Source credit

(Aug. 14, 1935, ch. 531, title XI, § 1142, as added Pub. L. 101–239, title VI, § 6103(b)(1), Dec. 19, 1989, 103 Stat. 2195; amended Pub. L. 106–129, § 2(b)(2), Dec. 6, 1999, 113 Stat. 1670; Pub. L. 108–173, title IX, § 900(e)(1)(C), Dec. 8, 2003, 117 Stat. 2371.)

## Notes

### Editorial Notes

### References in Text

Sections 299b–1 to 299b–3 of this title, referred to in subsecs. (a) and (b), were in the original references to sections 912 to 914 of act July 1, 1944, which were omitted in the general amendment of subchapter VII of chapter 6A of this title by Pub. L. 106–129, § 2(a), Dec. 6, 1999, 113 Stat. 1653. Section 2(a) of Pub. L. 106–129 enacted new sections 912 to 914 of act July 1, 1944, which are classified to sections 299b–1 to 299b–3, respectively, of this title.

### Codification

Subsec. (h) of this section, which required the Secretary to report biennially to Congress on the progress of the activities under this section during the preceding 2 fiscal years, including the impact of such activities on medical care (particularly medical care for individuals receiving benefits under subchapter XVIII of this chapter), terminated, effective May 15, 2000, pursuant to section 3003 of Pub. L. 104–66, as amended, set out as a note under section 1113 of Title 31, Money and Finance. See, also, item 10 on page 94 of House Document No. 103–7.

Another section 1142 of act Aug. 14, 1935, was renumbered section 1143 by Pub. L. 101–508, title V, § 5111(a)(1), Nov. 5, 1990, 104 Stat. 1388–272, and is classified to section 1320b–13 of this title.

### Amendments

2003—Subsec. (b)(3). Pub. L. 108–173, § 900(e)(1)(C), substituted “Centers for Medicare & Medicaid Services” for “Health Care Financing Administration”.

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” in introductory provisions.

### Statutory Notes and Related Subsidiaries

### AHCPR Study on Effect of Credentialing of Technologists and Sonographers on Quality of Ultrasound

Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 229(b)], Nov. 29, 1999, 113 Stat. 1536, 1501A–357, required a study on the effect of credentialing of technologists and sonographers on the quality of ultrasounds and submission of a report to Congress no later than two years after Nov. 29, 1999.

### Report on Linkage of Public and Private Research Related Data

Pub. L. 101–239, title VI, § 6103(b)(2), Dec. 19, 1989, 103 Stat. 2198, provided that, no later than 1 year after Dec. 19, 1989, the Secretary of Health and Human Services would report to Congress on the feasibility of linking research-related data described in subsec. (d) of this section with similar data collected or maintained by non-Federal entities and by Federal agencies other than the Department of Health and Human Services (including the Departments of Defense and Veterans Affairs and the Office of Personnel Management).