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Title 42, The Public Health and WelfareRelease 119-73not60

§1320e–1 Limitations on Certain Uses of Comparative Clinical Effectiveness Research

Title 42 › Chapter 7— SOCIAL SECURITY › Subchapter XI— GENERAL PROVISIONS, PEER REVIEW, AND ADMINISTRATIVE SIMPLIFICATION › Part D— Comparative Clinical Effectiveness Research › § 1320e–1

Last updated Apr 5, 2026|Official source

Summary

The Secretary may only use research done under section 1320e to make Medicare (subchapter XVIII) coverage decisions if the use comes from an open, step-by-step process that allows public comment and looks at how results affect different groups of people. That research cannot replace or change items already judged “reasonable and necessary” under section 1395y(l)(1), and it cannot be the only reason to deny coverage. The Secretary must not treat extending the life of an elderly, disabled, or terminally ill person as worth less than extending the life of a younger or healthier person. The Secretary can still compare how well treatments extend life for different ages or health conditions, and can set different copays by cost or type of service. The Patient-Centered Outcomes Research Institute (created under section 1320e(b)(1)) must not use a dollars-per-quality-adjusted-life-year (QALY) or similar measure that lowers value because of disability, and the Secretary must not use such a measure to set Medicare coverage, payment, or incentives.

Full Legal Text

Title 42, §1320e–1

The Public Health and Welfare, Source: USLM XML via OLRC

(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 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 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 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.

Legislative History

Notes & Related Subsidiaries

Editorial Notes

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.

Reference

Citations & Metadata

Citation

42 U.S.C. § 1320e–1

Title 42, The Public Health and Welfare

Last Updated

Apr 5, 2026

Release point: 119-73not60