42 USC 1320 - Comparative clinical effectiveness research

1 So in original. Probably should be “has”.

the potential to bias or have 

2 See References in Text note below.

of the Public Health Service Act that are consistent with this section. Such national priorities shall include research with respect to intellectual and developmental disabilities and maternal mortality. Such priorities should reflect a balance between long-term priorities and short-term priorities, and be responsive to changes in medical evidence and in health care treatments.

3 So in original. Probably should be “clause”.

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

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

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

5 So in original.

Any member appointed to fill a vacancy occurring before the expiration of the term for which the member’s predecessor was appointed shall be appointed for the remainder of that term and thereafter may be eligible for reappointment to a full term. A member may serve after the expiration of that member’s term until a successor has been appointed. No individual shall be appointed to the Board for more than 2 terms. Vacancies shall be filled in the same manner as the original appointment was made.

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) 

7 So in original. Probably should be “bequests”.

or donations of services or property. In addition, the Institute shall be prohibited from establishing a corporation or generating revenues from activities other than as provided under this section.

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

Coverage

Editorial Notes

References in Text

The District of Columbia Nonprofit Corporation Act, referred to in subsec. (span)(2), is Puspan. L. 87–569, Aug. 6, 1962, 76 Stat. 265, which is not classified to the Code.

The Internal Revenue Code of 1986, referred to in subsecs. (span)(3) and (g)(2)(A)(v), is classified generally to Title 26, Internal Revenue Code.

Section 399H of the Public Health Service Act, referred to in subsec. (d)(1)(A), probably means section 399HH of act July 1, 1944, which is classified to section 280j of this title.

Amendments

2019—Subsec. (d)(1)(A). Puspan. L. 116–94, § 104(d), inserted at end “Such national priorities shall include research with respect to intellectual and developmental disabilities and maternal mortality. Such priorities should reflect a balance between long-term priorities and short-term priorities, and be responsive to changes in medical evidence and in health care treatments.”

Subsec. (d)(2)(F). Puspan. L. 116–94, § 104(e), added subpar. (F).

Subsec. (d)(6)(B). Puspan. L. 116–94, § 104(g)(1), substituted “Board” for “Comptroller General of the United States”.

Subsec. (f)(1)(C). Puspan. L. 116–94, § 104(f)(1)(A)(i), substituted in introductory provisions “At least nineteen, but no more than twenty-one members appointed” for “Seventeen members appointed, not later than 6 months after March 23, 2010,”.

Subsec. (f)(1)(C)(iii). Puspan. L. 116–94, § 104(f)(1)(A)(ii), substituted “at least 3, but no more than 5” for “3”.

Subsec. (f)(3). Puspan. L. 116–94, § 104(f)(2), in first sentence, substituted “members” for “the members” and inserted “to the extent necessary to preserve the evenly staggered terms of the Board.” before the period at end of first sentence, and inserted “Any member appointed to fill a vacancy occurring before the expiration of the term for which the member’s predecessor was appointed shall be appointed for the remainder of that term and thereafter may be eligible for reappointment to a full term. A member may serve after the expiration of that member’s term until a successor has been appointed.” after first sentence.

Subsec. (g)(2)(A)(iv). Puspan. L. 116–94, § 104(h)(1), added cl. (iv) and struck out former cl. (iv) which read as follows: “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 937 of the Public Health Service Act. Such review shall include an analysis of the extent to which research findings are used by health care decision-makers, the effect of the dissemination of such findings on 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.”

Subsec. (g)(2)(A)(vi). Puspan. L. 116–94, § 104(h)(2), added cl. (vi).

Subsec. (h)(4)(A)(ii). Puspan. L. 116–94, § 104(g)(2)(A), substituted “Board” for “Comptroller General”.

Subsec. (h)(4)(B). Puspan. L. 116–94, § 104(g)(2)(B), struck out “and of the Government Accountability Office” after “Institute”.

2010—Subsec. (d)(2)(B)(ii)(IV). Puspan. L. 111–148, § 10602(1)(A), inserted “, as described in subparagraph (A)(ii),” after “original research” and “, 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” after “publication”.

Subsec. (d)(2)(B)(iv). Puspan. L. 111–148, § 10602(1)(B), amended cl. (iv) generally. Prior to amendment, text read as follows: “Any research published under clause (ii)(IV) shall be within the bounds of and entirely consistent with the evidence and findings produced under the contract with the Institute under this subparagraph. If the Institute determines that those requirements are not met, the Institute shall not enter into another contract with the agency, instrumentality, or entity which managed or conducted such research for a period determined appropriate by the Institute (but not less than 5 years).”

Subsec. (d)(8)(A)(iv). Puspan. L. 111–148, § 10602(2), substituted “do not include” for “not be construed as mandates for”.

Subsec. (f)(1)(C)(ii). Puspan. L. 111–148, § 10602(3), amended cl. (ii) generally. Prior to amendment, cl. (ii) read as follows: “5 members representing physicians and providers, including at least 1 surgeon, nurse, State-licensed integrative health care practitioner, and representative of a hospital.”