{"identifier":"/us/usc/t42/s1320e\u20131","title":42,"num":"\u00a7\u202f1320e\u20131.","heading":"Limitations on certain uses of comparative clinical effectiveness research","text":"\u00a7\u202f1320e\u20131.\nLimitations on certain uses of comparative clinical effectiveness research\n(a) The Secretary may only use evidence and findings from research conducted under\nsection 1320e of this title\n(b) Nothing in\n(1) superceding or modifying the coverage of items or services under subchapter XVIII that the Secretary determines are reasonable and necessary under section 1395y(\nl\n(2) authorizing the Secretary to deny coverage of items or services under such subchapter solely on the basis of comparative clinical effectiveness research.\n(c)\n(1) The Secretary shall not use evidence or findings from comparative clinical effectiveness research conducted under\nsection 1320e of this title\n(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\u2019s life due to the individual\u2019s age, disability, or terminal illness.\n(d)\n(1) The Secretary shall not use evidence or findings from comparative clinical effectiveness research conducted under\nsection 1320e of this title\n(2)\n(A)\n(i) limit the application of differential copayments under subchapter XVIII based on factors such as cost or type of service; or\n(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\u2019s life due to that individual\u2019s age, disability, or terminal illness.\n(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.\n(e) The Patient-Centered Outcomes Research Institute established under\nsection 1320e(b)(1) of this title","url":"https://projectusc.org/usc/t42/s1320e\u20131.html","content":[{"t":"sec","id":"/us/usc/t42/s1320e\u20131","children":[{"t":"num","text":"\u00a7\u202f1320e\u20131."},{"t":"heading","text":"Limitations on certain uses of comparative clinical effectiveness research"},{"t":"subsec","id":"/us/usc/t42/s1320e\u20131/a","children":[{"t":"num","text":"(a)"},{"t":"content","text":" The Secretary may only use evidence and findings from research conducted under ","children":[{"t":"ref","text":"section 1320e of this title","href":"/us/usc/t42/s1320e","tail":" 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."}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t42/s1320e\u20131/b","children":[{"t":"num","text":"(b)"},{"t":"chapeau","text":" Nothing in ","children":[{"t":"ref","text":"section 1320e of this title","href":"/us/usc/t42/s1320e","tail":" shall be construed as\u2014"}]},{"t":"para","id":"/us/usc/t42/s1320e\u20131/b/1","children":[{"t":"num","text":"(1)"},{"t":"content","text":" superceding or modifying the coverage of items or services under subchapter XVIII that the Secretary determines are reasonable and necessary under section 1395y(","children":[{"t":"text","text":"l","tail":")(1) of this title; or"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t42/s1320e\u20131/b/2","children":[{"t":"num","text":"(2)"},{"t":"content","text":" authorizing the Secretary to deny coverage of items or services under such subchapter solely on the basis of comparative clinical effectiveness research.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t42/s1320e\u20131/c","children":[{"t":"num","text":"(c)"},{"t":"para","id":"/us/usc/t42/s1320e\u20131/c/1","children":[{"t":"num","text":"(1)"},{"t":"content","text":" The Secretary shall not use evidence or findings from comparative clinical effectiveness research conducted under ","children":[{"t":"ref","text":"section 1320e of this title","href":"/us/usc/t42/s1320e","tail":" 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."}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t42/s1320e\u20131/c/2","children":[{"t":"num","text":"(2)"},{"t":"content","text":" 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\u2019s life due to the individual\u2019s age, disability, or terminal illness.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t42/s1320e\u20131/d","children":[{"t":"num","text":"(d)"},{"t":"para","id":"/us/usc/t42/s1320e\u20131/d/1","children":[{"t":"num","text":"(1)"},{"t":"content","text":" The Secretary shall not use evidence or findings from comparative clinical effectiveness research conducted under ","children":[{"t":"ref","text":"section 1320e of this title","href":"/us/usc/t42/s1320e","tail":" 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."}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t42/s1320e\u20131/d/2","children":[{"t":"num","text":"(2)"},{"t":"subpara","id":"/us/usc/t42/s1320e\u20131/d/2/A","children":[{"t":"num","text":"(A)"},{"t":"chapeau","text":"\u202f","children":[{"t":"ref","text":"1"},{"t":"num","text":"1","tail":"\u202fSo in original. No subpar. (B) has been enacted."},{"t":"text","text":"\u202fSo in original. No subpar. (B) has been enacted.","tail":" Paragraph (1) shall not be construed to\u2014"}]},{"t":"clause","id":"/us/usc/t42/s1320e\u20131/d/2/A/i","children":[{"t":"num","text":"(i)"},{"t":"content","text":" limit the application of differential copayments under subchapter XVIII based on factors such as cost or type of service; or","tail":"\n"}],"tail":"\n"},{"t":"clause","id":"/us/usc/t42/s1320e\u20131/d/2/A/ii","children":[{"t":"num","text":"(ii)"},{"t":"content","text":" 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\u2019s life due to that individual\u2019s age, disability, or terminal illness.","tail":"\n"}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t42/s1320e\u20131/d/3","children":[{"t":"num","text":"(3)"},{"t":"content","text":" 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.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t42/s1320e\u20131/e","children":[{"t":"num","text":"(e)"},{"t":"content","text":" The Patient-Centered Outcomes Research Institute established under ","children":[{"t":"ref","text":"section 1320e(b)(1) of this title","href":"/us/usc/t42/s1320e/b/1","tail":" 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\u2019s 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."}],"tail":"\n"}],"tail":"\n"},{"t":"text","text":"\n"},{"t":"text","text":"\n"}]}]}