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42 U.S.C. § 1320e–1 — Limitations on certain uses of comparative clinical effectiveness research
Federal law — U.S. Code and appendices · legal_authorities
**(a)** The Secretary may only use evidence and findings from research conducted under [section 1320e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1320e&num=0&edition=prelim) to make a determination regarding coverage under subchapter XVIII if such use is through an iterative and transparent process which includes public comment and considers the effect on subpopulations.
**(b)** Nothing in [section 1320e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1320e&num=0&edition=prelim) shall be construed as—
(1) superceding or modifying the coverage of items or services under subchapter XVIII that the Secretary determines are reasonable and necessary under section 1395y(l)(1) of this title; or
(2) authorizing the Secretary to deny coverage of items or services under such subchapter solely on the basis of comparative clinical effectiveness research.
**(c)**
(1) The Secretary shall not use evidence or findings from comparative clinical effectiveness research conducted under [section 1320e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1320e&num=0&edition=prelim) in determining coverage, reimbursement, or incentive programs under subchapter XVIII in a manner that treats extending the life of an elderly, disabled, or terminally ill individual as of lower value than extending the life of an individual who is younger, nondisabled, or not terminally ill.
(2) Paragraph (1) shall not be construed as preventing the Secretary from using evidence or findings from such comparative clinical effectiveness research in determining coverage, reimbursement, or incentive programs under subchapter XVIII based upon a comparison of the difference in the effectiv
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 1320e–1
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Stable record: federal_law:legal_authorities:record_usc_e707c4180b573a7a5b870f90
Source file: Laws/federal/codes/united-states-code/title-42/section-1320e1-limitations-on-certain-uses-of-comparative-clinical-effectiveness-resear--3ee95a6287.md
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Source location: Title 42, Chapter 7, § 1320e–1; chapter-007-social-security.md
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**(a)** The Secretary may only use evidence and findings from research conducted under [section 1320e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1320e&num=0&edition=prelim) to make a determination regarding coverage under subchapter XVIII if such use is through an iterative and transparent process which includes public comment and considers the effect on subpopulations.
**(b)** Nothing in [section 1320e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1320e&num=0&edition=prelim) shall be construed as—
(1) superceding or modifying the coverage of items or services under subchapter XVIII that the Secretary determines are reasonable and necessary under section 1395y(l)(1) of this title; or
(2) authorizing the Secretary to deny coverage of items or services under such subchapter solely on the basis of comparative clinical effectiveness research.
**(c)**
(1) The Secretary shall not use evidence or findings from comparative clinical effectiveness research conducted under [section 1320e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1320e&num=0&edition=prelim) in determining coverage, reimbursement, or incentive programs under subchapter XVIII in a manner that treats extending the life of an elderly, disabled, or terminally ill individual as of lower value than extending the life of an individual who is younger, nondisabled, or not terminally ill.
(2) Paragraph (1) shall not be construed as preventing the Secretary from using evidence or findings from such comparative clinical effectiveness research in determining coverage, reimbursement, or incentive programs under subchapter XVIII based upon a comparison of the difference in the effectiveness of alternative treatments in extending an individual’s life due to the individual’s age, disability, or terminal illness.
**(d)**
(1) The Secretary shall not use evidence or findings from comparative clinical effectiveness research conducted under [section 1320e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1320e&num=0&edition=prelim) in determining coverage, reimbursement, or incentive programs under subchapter XVIII in a manner that precludes, or with the intent to discourage, an individual from choosing a health care treatment based on how the individual values the tradeoff between extending the length of their life and the risk of disability.
(2)
(A) 11 So in original. No subpar. (B) has been enacted. Paragraph (1) shall not be construed to—
(i) limit the application of differential copayments under subchapter XVIII based on factors such as cost or type of service; or
(ii) prevent the Secretary from using evidence or findings from such comparative clinical effectiveness research in determining coverage, reimbursement, or incentive programs under such subchapter based upon a comparison of the difference in the effectiveness of alternative health care treatments in extending an individual’s life due to that individual’s age, disability, or terminal illness.
(3) Nothing in the provisions of, or amendments made by the Patient Protection and Affordable Care Act, shall be construed to limit comparative clinical effectiveness research or any other research, evaluation, or dissemination of information concerning the likelihood that a health care treatment will result in disability.
**(e)** The Patient-Centered Outcomes Research Institute established under [section 1320e(b)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1320e/b/1&num=0&edition=prelim) shall not develop or employ a dollars-per-quality adjusted life year (or similar measure that discounts the value of a life because of an individual’s disability) as a threshold to establish what type of health care is cost effective or recommended. The Secretary shall not utilize such an adjusted life year (or such a similar measure) as a threshold to determine coverage, reimbursement, or incentive programs under subchapter XVIII.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** Not later than 90 days after March 23, 2010, the Secretary shall establish a temporary high risk health insurance pool program to provide health insurance coverage for eligible individuals during the period beginning on the date on which such program is established and ending on January 1, 2014.
**(b) Administration**
(1) **In general** — The Secretary may carry out the program under this section directly or through contracts to eligible entities.
(2) **Eligible entities** — To be eligible for a contract under paragraph (1), an entity shall—
(A) be a State or nonprofit private entity;
(B) submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require; and
(C) agree to utilize contract funding to establish and administer a qualified high risk pool for eligible individuals.
(3) **Maintenance of effort** — To be eligible to enter into a contract with the Secretary under this subsection, a State shall agree not to reduce the annual amount the State expended for the operation of one or more State high risk pools during the year preceding the year in which such contract is entered into.
**(c) Qualified high risk pool**
(1) **In general** — Amounts made available under this section shall be used to establish a qualified high risk pool that meets the requirements of paragraph (2).
(2) **Requirements** — A qualified high risk pool meets the requirements of this paragraph if such pool—
(A) provides to all eligible individuals health insurance coverage that does not impose any preexisting condition exclusion with respect to such coverage;
(B) provides health insurance coverage—
(i) in which the issuer’s share of the total allowed costs of benefits provided under such co
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 18001
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Federal law — U.S. Code and appendices · legal_authorities
**(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 11 So in original. Probably should be “has”. the potential to bias or have 1 the appearance of biasing an individual’s decisions in matters related to the Institute or the conduct of activities under this section.
(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
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 1320e
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