42-U.S.C.-1320E-1
§1320E-1 – §1320E-1. Limitations On Certain Uses of Comparative Clinical Effectiveness Research
Pathway
Title 42 > Chapter 7 > Subchapter XI > Part D > Section 1320e-1
Details
- Reference: Section 1320e-1
- Legend: §1320E-1 – §1320E-1. Limitations On Certain Uses of Comparative Clinical Effectiveness Research
- USCode Year: 2011
Provision Content
(a) The Secretary may only use evidence and findings from research conducted under section 1320e of this title 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 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 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 individuals life due to the individuals 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 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) 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 individuals life due to that individuals 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 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 individuals 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.
(Aug. 14, 1935, ch. 531, title XI, §1182, as added Pub. L. 111–148, title VI, §6301(c), Mar. 23, 2010, 124 Stat. 740.)
References in Text
The Patient Protection and Affordable Care Act, referred to in subsec. (d)(3), is Pub. L. 111–148, Mar. 23, 2010, 124 Stat. 119. For complete classification of this Act to the Code, see Short Title note set out under section 18001 of this title and Tables.
U.S. Encyclopedia of Law Coverage
42-U.S.C.-1320C-6 in the Legal Encyclopedia: Social Security
In this entry about 42-U.S.C.-1320C-6, find legal reference material, bibliographies and premiere content related to social security in the American Encyclopedia of Law, presenting a comprehensive view of the United States social security-specific issues, written by authorities in the field.
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