§ 1320e. Comparative clinical effectiveness research

(a) Definitions In this section:

(1) Board

The term “Board” means the Board of Governors established under subsection (f).

(2) Comparative clinical effectiveness research; research

(A) In general

The terms “comparative clinical effectiveness research” and “research” mean research evaluating and comparing health outcomes and the clinical effectiveness, risks, and benefits of 2 or more medical treatments, services, and items described in subparagraph (B).

(B) Medical treatments, services, and items described

The medical treatments, services, and items described in this subparagraph are health care interventions, protocols for treatment, care management, and delivery, procedures, medical devices, diagnostic tools, pharmaceuticals (including drugs and biologicals), integrative health practices, and any other strategies or items being used in the treatment, management, and diagnosis of, or prevention of illness or injury in, individuals.

(3) Conflict of interest

The term “conflict of interest” means an association, including a financial or personal association, that have CoverageNothing 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.)

References In Text

References in Text

The District of Columbia Nonprofit Corporation Act, referred to in subsec. (b)(2), is Pub. 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. (b)(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

Amendments

2010—Subsec. (d)(2)(B)(ii)(IV). Pub. 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). Pub. 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). Pub. L. 111–148, § 10602(2), substituted “do not include” for “not be construed as mandates for”.

Subsec. (f)(1)(C)(ii). Pub. 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.”