42 USC 1320e - Comparative clinical effectiveness research

U.S Code last checked for updates: Jan 18, 2025

§ 1320e.

Comparative clinical effectiveness research

(a)

Definitions

In this section:

(1)

Board

(2)

Comparative clinical effectiveness research; research

(A)

In general

(B)

Medical treatments, services, and items described

(3)

Conflict of interest

(4)

Real conflict of interest

The term “real conflict of interest” means any instance where a member of the Board, the methodology committee established under subsection (d)(6), or an advisory panel appointed under subsection (d)(4), or a close relative of such member, has received or could receive either of the following:

(A)

A direct financial benefit of any amount deriving from the result or findings of a study conducted under this section.

(B)

A financial benefit from individuals or companies that own or manufacture medical treatments, services, or items to be studied under this section that in the aggregate exceeds $10,000 per year. For purposes of the preceding sentence, a financial benefit includes honoraria, fees, stock, or other financial benefit and the current value of the member or close relative’s already existing stock holdings, in addition to any direct financial benefit deriving from the results or findings of a study conducted under this section.

(b)

Patient-Centered Outcomes Research Institute

(1)

Establishment

(2)

Application of provisions

(3)

Funding of comparative clinical effectiveness research

(c)

Purpose

(d)

Duties

(1)

Identifying research priorities and establishing research project agenda

(A)

Identifying research priorities

(B)

Establishing research project agenda

(2)

Carrying out research project agenda

(A)

Research

The Institute shall carry out the research project agenda established under paragraph (1)(B) in accordance with the methodological standards adopted under paragraph (9) using methods, including the following:

(i)

Systematic reviews and assessments of existing and future research and evidence including original research conducted subsequent to March 23, 2010.

(ii)

Primary research, such as randomized clinical trials, molecularly informed trials, and observational studies.

(iii)

Any other methodologies recommended by the methodology committee established under paragraph (6) that are adopted by the Board under paragraph (9).

(B)

Contracts for the management of funding and conduct of research

(i)

Contracts

(I)

In general

In accordance with the research project agenda established under paragraph (1)(B), the Institute shall enter into contracts for the management of funding and conduct of research in accordance with the following:

(aa)

Appropriate agencies and instrumentalities of the Federal Government.

(bb)

Appropriate academic research, private sector research, or study-conducting entities.

(II)

Preference

(ii)

Conditions for contracts

A contract entered into under this subparagraph shall require that the agency, instrumentality, or other entity—

(I)

abide by the transparency and conflicts of interest requirements under subsection (h) that apply to the Institute with respect to the research managed or conducted under such contract;

(II)

comply with the methodological standards adopted under paragraph (9) with respect to such research;

(III)

consult with the expert advisory panels for clinical trials and rare disease appointed under clauses (ii) and (iii), respectively, of paragraph (4)(A);

(IV)

subject to clause (iv), permit a researcher who conducts original research, as described in subparagraph (A)(ii), under the contract for the agency, instrumentality, or other entity to have such research published in a peer-reviewed journal or other publication, as long as the researcher enters into a data use agreement with the Institute for use of the data from the original research, as appropriate;

(V)

have appropriate processes in place to manage data privacy and meet ethical standards for the research;

(VI)

comply with the requirements of the Institute for making the information available to the public under paragraph (8); and

(VII)

comply with other terms and conditions determined necessary by the Institute to carry out the research agenda adopted under paragraph (2).

(iii)

Coverage of copayments or coinsurance

(iv)

Subsequent use of the data

(C)

Review and update of evidence

(D)

Taking into account potential differences

(E)

Differences in treatment modalities

(F)

Consideration of full range of outcomes data

(3)

Data collection

(A)

In general

(B)

Use of data

(4)

Appointing expert advisory panels

(A)

Appointment

(i)

In general

(ii)

Expert advisory panels for clinical trials

(iii)

Expert advisory panel for rare disease

(B)

Composition

(5)

Supporting patient and consumer representatives

(6)

Establishing methodology committee

(A)

In general

(B)

Appointment and composition

(C)

Functions

Subject to subparagraph (D), the methodology committee shall work to develop and improve the science and methods of comparative clinical effectiveness research by, not later than 18 months after the establishment of the Institute, directly or through subcontract, developing and periodically updating the following:

(i)

Methodological standards for research. Such methodological standards shall provide specific criteria for internal validity, generalizability, feasibility, and timeliness of research and for health outcomes measures, risk adjustment, and other relevant aspects of research and assessment with respect to the design of research. Any methodological standards developed and updated under this subclause 3

shall be scientifically based and include methods by which new information, data, or advances in technology are considered and incorporated into ongoing research projects by the Institute, as appropriate. The process for developing and updating such standards shall include input from relevant experts, stakeholders, and decisionmakers, and shall provide opportunities for public comment. Such standards shall also include methods by which patient subpopulations can be accounted for and evaluated in different types of research. As appropriate, such standards shall build on existing work on methodological standards for defined categories of health interventions and for each of the major categories of comparative clinical effectiveness research methods (determined as of

(ii)

A translation table that is designed to provide guidance and act as a reference for the Board to determine research methods that are most likely to address each specific research question.

(D)

Consultation and conduct of examinations

(E)

Reports

(7)

Providing for a peer-review process for primary research

(A)

In general

The Institute shall ensure that there is a process for peer review of primary research described in subparagraph (A)(ii) of paragraph (2) that is conducted under such paragraph. Under such process—

(i)

evidence from such primary research shall be reviewed to assess scientific integrity and adherence to methodological standards adopted under paragraph (9); and

(ii)

a list of the names of individuals contributing to any peer-review process during the preceding year or years shall be made public and included in annual reports in accordance with paragraph (10)(D).

(B)

Composition

(C)

Use of existing processes

(i)

Processes of another entity

(ii)

Processes of appropriate medical journals

(8)

Release of research findings

(A)

In general

The Institute shall, not later than 90 days after the conduct or receipt of research findings under this part, make such research findings available to clinicians, patients, and the general public. The Institute shall ensure that the research findings—

(i)

convey the findings of research in a manner that is comprehensible and useful to patients and providers in making health care decisions;

(ii)

fully convey findings and discuss considerations specific to certain subpopulations, risk factors, and comorbidities, as appropriate;

(iii)

include limitations of the research and what further research may be needed as appropriate;

(iv)

do not include practice guidelines, coverage recommendations, payment, or policy recommendations; and

(v)

not include any data which would violate the privacy of research participants or any confidentiality agreements made with respect to the use of data under this section.

(B)

Definition of research findings

(9)

Adoption

(10)

Annual reports

The Institute shall submit an annual report to Congress and the President, and shall make the annual report available to the public. Such report shall contain—

(A)

a description of the activities conducted under this section, research priorities identified under paragraph (1)(A) and methodological standards developed and updated by the methodology committee under paragraph (6)(C)(i) that are adopted under paragraph (9) during the preceding year;

(B)

the research project agenda and budget of the Institute for the following year;

(C)

any administrative activities conducted by the Institute during the preceding year;

(D)

the names of individuals contributing to any peer-review process under paragraph (7), without identifying them with a particular research project; and

(E)

any other relevant information (including information on the membership of the Board, expert advisory panels, methodology committee, and the executive staff of the Institute, any conflicts of interest with respect to these individuals, and any bylaws adopted by the Board during the preceding year).

(e)

Administration

(1)

In general

(2)

Nondelegable duties

(f)

Board of Governors

(1)

In general

The Institute shall have a Board of Governors, which shall consist of the following members:

(A)

The Director of Agency 4

 So in original. Probably should be preceded by “the”.

for Healthcare Research and Quality (or the Director’s designee).

(B)

The Director of the National Institutes of Health (or the Director’s designee).

(C)

At least nineteen, but no more than twenty-one members appointed by the Comptroller General of the United States as follows:

(i)

3 members representing patients and health care consumers.

(ii)

7 members representing physicians and providers, including 4 members representing physicians (at least 1 of whom is a surgeon), 1 nurse, 1 State-licensed integrative health care practitioner, and 1 representative of a hospital.

(iii)

at least 3, but no more than 5 members representing private payers, of whom at least 1 member shall represent health insurance issuers and at least 1 member shall represent employers who self-insure employee benefits.

(iv)

3 members representing pharmaceutical, device, and diagnostic manufacturers or developers.

(v)

1 member representing quality improvement or independent health service researchers.

(vi)

2 members representing the Federal Government or the States, including at least 1 member representing a Federal health program or agency.

(2)

Qualifications

(3)

Terms; vacancies

(4)

Chairperson and Vice-Chairperson

(5)

Compensation

(6)

Director and staff; experts and consultants

(7)

Meetings and hearings

(g)

Financial and governmental oversight

(1)

Contract for audit

(2)

Review and annual reports

(A)

Review

The Comptroller General of the United States shall review the following:

(i)

Not less frequently than on an annual basis, the financial audits conducted under paragraph (1).

(ii)

Not less frequently than every 5 years, the processes established by the Institute, including the research priorities and the conduct of research projects, in order to determine whether information produced by such research projects is objective and credible, is produced in a manner consistent with the requirements under this section, and is developed through a transparent process.

(iii)

Not less frequently than every 5 years, the dissemination and training activities and data networks established under section 937 of the Public Health Service Act [42 U.S.C. 299b–37], including the methods and products used to disseminate research, the types of training conducted and supported, and the types and functions of the data networks established, in order to determine whether the activities and data are produced in a manner consistent with the requirements under such section.

(iv)

Not less frequently than every 5 years, the overall effectiveness of activities conducted under this section and the dissemination, training, and capacity building activities conducted under section 299b–37 of this title. Such review shall include the following:

(I)

A description of those activities and the financial commitments related to research, training, data capacity building, and dissemination and uptake of research findings.

(II)

The extent to which the Institute and the Agency for Healthcare Research and Quality have collaborated with stakeholders, including provider and payer organizations, to facilitate the dissemination and uptake of research findings.

(III)

An analysis of available data and performance metrics, such as the estimated public availability and dissemination of research findings and uptake and utilization of research findings in clinical guidelines and decision support tools, on the extent to which such research findings are used by health care decision-makers, the effect of the dissemination of such findings on changes in medical practice and reducing practice variation and disparities in health care, and the effect of the research conducted and disseminated on innovation and the health care economy of the United States.

(v)

Not later than 8 years after March 23, 2010, the adequacy and use of the funding for the Institute and the activities conducted under section 937 of the Public Health Service Act, including a determination as to whether, based on the utilization of research findings by public and private payers, funding sources for the Patient-Centered Outcomes Research Trust Fund under section 9511 of the Internal Revenue Code of 1986 are appropriate and whether such sources of funding should be continued or adjusted.

(vi)

Not less frequently than every 5 years, any barriers that researchers funded by the Institute have encountered in conducting studies or clinical trials, including challenges covering the cost of any medical treatments, services, and items described in subsection (a)(2)(B) for purposes of the research study.

(B)

Annual reports

(h)

Ensuring transparency, credibility, and access

The Institute shall establish procedures to ensure that the following requirements for ensuring transparency, credibility, and access are met:

(1)

Public comment periods

(2)

Additional forums

(3)

Public availability

The Institute shall make available to the public and disclose through the official public Internet website of the Institute the following:

(A)

Information contained in research findings as specified in subsection (d)(9).

(B)

The process and methods for the conduct of research, including the identity of the entity and the investigators conducing 6

 So in original. Probably should be “conducting”.

such research and any conflicts of interests of such parties, any direct or indirect links the entity has to industry, and research protocols, including measures taken, methods of research and analysis, research results, and such other information the Institute determines appropriate) ⁵ concurrent with the release of research findings.

(C)

Notice of public comment periods under paragraph (1), including deadlines for public comments.

(D)

Subsequent comments received during each of the public comment periods.

(E)

In accordance with applicable laws and processes and as the Institute determines appropriate, proceedings of the Institute.

(4)

Disclosure of conflicts of interest

(A)

In general

A conflict of interest shall be disclosed in the following manner:

(i)

By the Institute in appointing members to an expert advisory panel under subsection (d)(4), in selecting individuals to contribute to any peer-review process under subsection (d)(7), and for employment as executive staff of the Institute.

(ii)

By the Board in appointing members of the methodology committee under subsection (d)(6);

(iii)

By the Institute in the annual report under subsection (d)(10), except that, in the case of individuals contributing to any such peer review process, such description shall be in a manner such that those individuals cannot be identified with a particular research project.

(B)

Manner of disclosure

(i)

Rules

(j)

Rules of construction

(1)

 So in original. No par. (2) has been enacted.

Coverage

Nothing in this section shall be construed—

(A)

to permit the Institute to mandate coverage, reimbursement, or other policies for any public or private payer; or

(B)

as preventing the Secretary from covering the routine costs of clinical care received by an individual entitled to, or enrolled for, benefits under subchapter XVIII, XIX, or XXI in the case where such individual is participating in a clinical trial and such costs would otherwise be covered under such subchapter with respect to the beneficiary.

(Aug. 14, 1935, ch. 531, title XI, § 1181, as added and amended Pub. L. 111–148, title VI, § 6301(a), title X, § 10602, Mar. 23, 2010, 124 Stat. 727, 1005; Pub. L. 116–94, div. N, title I, § 104(d)–(h), Dec. 20, 2019, 133 Stat. 3098, 3099.)

cite as: 42 USC 1320e