---
kind: "section"
citation: "42 U.S.C. § 299b–7"
title: "42"
title_heading: "The Public Health and Welfare"
number: "299b–7"
heading: "Research on outcomes of health care items and services"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/299b-7"
units:
  - "Chapter 6A — Public Health Service"
  - "Subchapter VII — Agency for Healthcare Research and Quality"
  - "Part B — Health Care Improvement Research"
---

# §299b–7. Research on outcomes of health care items and services

- (a) **Research, demonstrations, and evaluations—**
  - (1) **Improvement of effectiveness and efficiency—**
    - (A) **In general—** To improve the quality, effectiveness, and efficiency of health care delivered pursuant to the [programs](/usc/42/274l–1.md?p=4) established under titles XVIII, XIX, and XXI of the Social Security Act [[42 U.S.C. 1395](/usc/42/1395.md) et seq., 1396 et seq., 1397aa et seq.], the [Secretary](/usc/42/201.md?p=c)[^1] acting through the [Director](/usc/42/11851.md?p=5) of the [Agency](/usc/42/8262.md?p=1) for Healthcare Research and Quality (in this section referred to as the “[Director](/usc/42/11851.md?p=5)”), shall conduct and support research to meet the priorities and requests for scientific evidence and information identified by such [programs](/usc/42/274l–1.md?p=4) with respect to—
      - (i) the outcomes, comparative clinical effectiveness, and appropriateness of health care items and [services](/usc/42/201.md?p=a) (including prescription [drugs](/usc/42/11851.md?p=4)); and
      - (ii) strategies for improving the efficiency and effectiveness of such [programs](/usc/42/274l–1.md?p=4), including the ways in which such items and [services](/usc/42/201.md?p=a) are organized, managed, and delivered under such [programs](/usc/42/274l–1.md?p=4).
    - (B) **Specification—** To respond to priorities and information requests in [subparagraph (A)](#a-1-A), the [Secretary](/usc/42/201.md?p=c) may conduct or support, by grant, contract, or interagency agreement, research, demonstrations, evaluations, technology assessments, or other activities, including the provision of technical assistance, scientific expertise, or methodological assistance.
  - (2) **Priorities—**
    - (A) **In general—** The [Secretary](/usc/42/201.md?p=c) shall establish a process to develop priorities that will guide the research, demonstrations, and evaluation activities undertaken pursuant to this section.
    - (B) **Initial list—** Not later than 6 months after December 8, 2003, the [Secretary](/usc/42/201.md?p=c) shall establish an initial list of priorities for research related to health care items and [services](/usc/42/201.md?p=a) (including prescription [drugs](/usc/42/11851.md?p=4)).
    - (C) **Process—** In carrying out [subparagraph (A)](#a-2-A), the [Secretary](/usc/42/201.md?p=c)—
      - (i) shall ensure that there is broad and ongoing consultation with relevant stakeholders in identifying the highest priorities for research, demonstrations, and evaluations to support and improve the [programs](/usc/42/274l–1.md?p=4) established under titles XVIII, XIX, and XXI of the Social Security Act [[42 U.S.C. 1395](/usc/42/1395.md) et seq., 1396 et seq., 1397aa et seq.];
      - (ii) may include health care items and [services](/usc/42/201.md?p=a) which impose a high cost on such [programs](/usc/42/274l–1.md?p=4), as well as those which may be underutilized or overutilized and which may significantly improve the prevention, [treatment](/usc/42/11851.md?p=11), or cure of diseases and conditions (including chronic conditions) which impose high direct or indirect costs on patients or society; and
      - (iii) shall ensure that the research and activities undertaken pursuant to this section are responsive to the specified priorities and are conducted in a timely manner.
  - (3) **Evaluation and synthesis of scientific evidence—**
    - (A) **In general—** The [Secretary](/usc/42/201.md?p=c) shall—
      - (i) evaluate and synthesize available scientific evidence related to health care items and [services](/usc/42/201.md?p=a) (including prescription [drugs](/usc/42/11851.md?p=4)) identified as priorities in accordance with [paragraph (2)](#a-2) with respect to the comparative clinical effectiveness, outcomes, appropriateness, and provision of such items and [services](/usc/42/201.md?p=a) (including prescription [drugs](/usc/42/11851.md?p=4));
      - (ii) identify issues for which existing scientific evidence is insufficient with respect to such health care items and [services](/usc/42/201.md?p=a) (including prescription [drugs](/usc/42/11851.md?p=4));
      - (iii) disseminate to prescription [drug](/usc/42/11851.md?p=4) plans and MA–PD plans under part D of title XVIII of the Social Security Act [[42 U.S.C. 1395w–101](/usc/42/1395w–101.md) et seq.], other health plans, and the public the findings made under clauses [(i)](#a-3-A-i) and [(ii)](#a-3-A-ii); and
      - (iv) work in voluntary collaboration with public and private sector entities to facilitate the development of new scientific knowledge regarding health care items and [services](/usc/42/201.md?p=a) (including prescription [drugs](/usc/42/11851.md?p=4)).
    - (B) **Initial research—** The [Secretary](/usc/42/201.md?p=c) shall complete the evaluation and synthesis of the initial research required by the priority list developed under [paragraph (2)(B)](#a-2-B) not later than 18 months after the development of such list.
    - (C) **Dissemination—**
      - (i) **In general—** To enhance patient safety and the quality of health care, the [Secretary](/usc/42/201.md?p=c) shall make available and disseminate in appropriate formats to prescription [drugs](/usc/42/11851.md?p=4) plans under part D, and MA–PD plans under part C, of title XVIII of the Social Security Act [[42 U.S.C. 1395w–101](/usc/42/1395w–101.md) et seq., 1395w–21 et seq.], other health plans, and the public the evaluations and syntheses prepared pursuant to [subparagraph (A)](#a-3-A) and the findings of research conducted pursuant to [paragraph (1)](#a-1). In carrying out this clause the [Secretary](/usc/42/201.md?p=c), in order to facilitate the availability of such evaluations and syntheses or findings at every decision point in the health care system, shall—
        - (I) present such evaluations and syntheses or findings in a form that is easily understood by the individuals receiving health care items and [services](/usc/42/201.md?p=a) (including prescription [drugs](/usc/42/11851.md?p=4)) under such plans and periodically assess that the requirements of this subclause have been met; and
        - (II) provide such evaluations and syntheses or findings and other relevant information through easily accessible and searchable electronic mechanisms, and in hard copy formats as appropriate.
      - (ii) **Rule of construction—** Nothing in this section shall be construed as—
        - (I) affecting the authority of the [Secretary](/usc/42/201.md?p=c) or the Commissioner of Food and [Drugs](/usc/42/11851.md?p=4) under the Federal Food, [Drug](/usc/42/11851.md?p=4), and Cosmetic Act [[21 U.S.C. 301](/usc/21/301.md) et seq.] or the Public Health Service Act [[42 U.S.C. 201](/usc/42/201.md) et seq.]; or
        - (II) conferring any authority referred to in [subclause (I)](#a-3-C-ii-I) to the [Director](/usc/42/11851.md?p=5).
    - (D) **Accountability—** In carrying out this paragraph, the [Secretary](/usc/42/201.md?p=c) shall implement activities in a manner that—
      - (i) makes publicly available all scientific evidence relied upon and the methodologies employed, provided such evidence and method are not protected from public disclosure by [section 1905 of title 18](/usc/18/1905.md) or other applicable law so that the results of the research, analyses, or syntheses can be evaluated or replicated; and
      - (ii) ensures that any information needs and unresolved issues identified in [subparagraph (A)(ii)](#a-3-A-ii) are taken into account in priority-setting for future research conducted by the [Secretary](/usc/42/201.md?p=c).
  - (4) **Confidentiality—**
    - (A) **In general—** In making use of administrative, clinical, and [program](/usc/42/274l–1.md?p=4) data and information developed or collected with respect to the [programs](/usc/42/274l–1.md?p=4) established under titles XVIII, XIX, and XXI of the Social Security Act [[42 U.S.C. 1395](/usc/42/1395.md) et seq., 1396 et seq., 1397aa et seq.], for purposes of carrying out the requirements of this section or the activities authorized under title IX of the Public Health Service Act ([42 U.S.C. 299](/usc/42/299.md) et seq.), such data and information shall be protected in accordance with the confidentiality requirements of title IX of the Public Health Service Act.
    - (B) **Rule of construction—** Nothing in this section shall be construed to require or permit the disclosure of data provided to the [Secretary](/usc/42/201.md?p=c) that is otherwise protected from disclosure under the Federal Food, [Drug](/usc/42/11851.md?p=4), and Cosmetic Act [[21 U.S.C. 301](/usc/21/301.md) et seq.], [section 1905 of title 18](/usc/18/1905.md), or other applicable law.
  - (5) **Evaluations—** The [Secretary](/usc/42/201.md?p=c) 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 outcomes and utilization of health care items and [services](/usc/42/201.md?p=a).
  - (6) **Improving information available to health care providers, patients, and policymakers—** Not later than 18 months after December 8, 2003, the [Secretary](/usc/42/201.md?p=c) shall identify options that could be undertaken in voluntary collaboration with private and public entities (as appropriate) for the—
    - (A) provision of more timely information through the [programs](/usc/42/274l–1.md?p=4) established under titles XVIII, XIX, and XXI of the Social Security Act [[42 U.S.C. 1395](/usc/42/1395.md) et seq., 1396 et seq., 1397aa et seq.], regarding the outcomes and quality of patient care, including clinical and patient-reported outcomes, especially with respect to interventions and conditions for which clinical trials would not be feasible or raise ethical concerns that are difficult to address;
    - (B) acceleration of the adoption of innovation and quality improvement under such [programs](/usc/42/274l–1.md?p=4); and
    - (C) development of management tools for the [programs](/usc/42/274l–1.md?p=4) established under titles XIX and XXI of the Social Security Act [[42 U.S.C. 1396](/usc/42/1396.md) et seq., 1397aa et seq.], and with respect to the [programs](/usc/42/274l–1.md?p=4) established under such titles, assess the feasibility of using administrative or claims data, to—
      - (i) improve oversight by [State](/usc/42/201.md?p=f) officials;
      - (ii) support Federal and [State](/usc/42/201.md?p=f) initiatives to improve the quality, safety, and efficiency of [services](/usc/42/201.md?p=a) provided under such [programs](/usc/42/274l–1.md?p=4); and
      - (iii) provide a basis for estimating the fiscal and coverage impact of Federal or [State](/usc/42/201.md?p=f) [program](/usc/42/274l–1.md?p=4) and policy changes.
- (b) **Recommendations—**
  - (1) **Disclaimer—** In carrying out this section, the [Director](/usc/42/11851.md?p=5) shall—
    - (A) not mandate national standards of clinical practice or quality health care standards; and
    - (B) include in any recommendations resulting from [projects](/usc/42/13641.md?p=2) funded and published by the [Director](/usc/42/11851.md?p=5), a corresponding reference to the prohibition described in [subparagraph (A)](#b-1-A).
  - (2) **Requirement for implementation—** Research, evaluation, and communication activities performed pursuant to this section shall reflect the principle that clinicians and patients should have the best available evidence upon which to make choices in health care items and [services](/usc/42/201.md?p=a), in [providers](/usc/42/299b–21.md?p=8), and in health care delivery systems, recognizing that patient subpopulations and patient and physician preferences may vary.
  - (3) **Rule of construction—** Nothing in this section shall be construed to provide the [Director](/usc/42/11851.md?p=5) with authority to mandate a national standard or require a specific approach to quality measurement and reporting.
- (c) **Research with respect to dissemination—** The [Secretary](/usc/42/201.md?p=c), acting through the [Director](/usc/42/11851.md?p=5), may conduct or support research with respect to improving methods of disseminating information in accordance with [subsection (a)(3)(C)](#a-3-C).
- (d) **Limitation on CMS—** The [Administrator](/usc/42/4005.md?p=1) of the Centers for Medicare & Medicaid [Services](/usc/42/201.md?p=a) may not use data obtained in accordance with this section to withhold coverage of a prescription [drug](/usc/42/11851.md?p=4).
- (e) **Authorization of appropriations—** There is authorized to be appropriated to carry out this section, $50,000,000 for fiscal year 2004, and such sums as may be necessary for each fiscal year thereafter.

## Footnotes

[^1]: So in original. Probably should be followed by a comma.

## Source credit

(Pub. L. 108–173, title X, § 1013, Dec. 8, 2003, 117 Stat. 2438.)

## Notes

### Editorial Notes

### References in Text

The Social Security Act, referred to in subsec. (a)(1)(A), (2)(C)(i), (3)(A)(iii), (C)(i), (4)(A), (6)(A), (C), is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Titles XVIII, XIX, and XXI of the Act are classified generally to subchapters XVIII (§ 1395 et seq.), XIX (§ 1396 et seq.), and XXI (§ 1397aa et seq.), respectively, of chapter 7 of this title. Parts C and D of title XVIII of the Act are classified generally to parts C (§ 1395w–21 et seq.) and D (§ 1395w–101 et seq.), respectively, of subchapter XVIII of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this title and Tables.

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a)(3)(C)(ii)(I), (4)(B), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see section 301 of Title 21 and Tables.

The Public Health Service Act, referred to in subsec. (a)(3)(C)(ii)(I), (4)(A), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to this chapter. Title IX of the Act is classified generally to this subchapter. For complete classification of this Act to the Code, see Short Title note set out under section 201 of this title and Tables.

### Codification

Section was enacted as part of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, and not as part of the Public Health Service Act which comprises this chapter.

### Statutory Notes and Related Subsidiaries

### Definition of “Secretary”

“Secretary” means the Secretary of Health and Human Services, see section 1(c)(2) of Pub. L. 108–173, set out as a note under section 1301 of this title.