42 U.S.C. § 1320e–1: Limitations on certain…

Summary

The Secretary may only use study results from research done under section 1320e to decide coverage under subchapter XVIII if the decision comes from a clear, step-by-step process that is open to public comment and that looks at how different groups of people are affected. Using that research must not change or override items the Secretary already finds “reasonable and necessary” under section 1395y(l)(1), and the Secretary cannot deny coverage only because of the comparative research. The Secretary must not treat extending life for an elderly, disabled, or terminally ill person as less valuable than extending life for someone younger or not disabled. The Secretary also must not use the research to stop or discourage a person from choosing treatment based on their own tradeoff between longer life and risk of disability. The Patient-Centered Outcomes Research Institute (section 1320e(b)(1)) must not use dollars-per-quality-adjusted-life-year or similar measures that lower the value of life because of disability as a cutoff for what is cost effective or recommended, and the Secretary must not use those measures as a coverage or payment threshold under subchapter XVIII.

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)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.

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.

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

Summary

Title 42, §1320e–1

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