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Appendix E: Affordable Care Act (ACA) (2010) Provisions for the Patient-Centered Outcomes Research Institute (PCORI)
Appendix E: Affordable Care Act (ACA) (2010) Provisions for the Patient-Centered Outcomes Research Institute (PCORI)
Pages 519-540
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From page 519... ...
‘‘(B) MEDICAL TREATMENTS, SERVICES, AND ITEMS DESCRIBED. -- The medical treatments, services, and items described in this subparagraph are health care interven tions, protocols for treatment, care management, and delivery, procedures, medical devices, diagnostic tools, pharmaceuticals (including drugs and biologicals)
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From page 520... ...
IDENTIFYING RESEARCH PRIORITIES AND ESTABLISHING RESEARCH PROJECT AGENDA. -- ‘‘(A) IDENTIFYING RESEARCH PRIORITIES. -- The Institute shall identify national priorities for research, taking into account factors of disease incidence, prevalence, and burden in the United States (with emphasis on chronic conditions)
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From page 521... ...
23, 2010 124 STAT. 729 variations and health disparities in terms of delivery and outcomes of care, the potential for new evidence to improve patient health, well-being, and the quality of care, the effect on national expenditures associated with a health care treatment, strategy, or health conditions, as well as patient needs, outcomes, and preferences, the relevance to patients and clinicians in making informed health decisions, and priorities in the National Strategy for quality care established under section 399H of the Public Health Service Act that are consistent with this section.
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From page 522... ...
‘‘(D) TAKING INTO ACCOUNT POTENTIAL DIFFERENCES. -- Research shall be designed, as appropriate, to take into account the potential for differences in the effectiveness of health care treatments, services, and items as used with various subpopulations, such as racial and ethnic minorities, women, age, and groups of individuals with different comorbidities, genetic and molecular sub-types, ate Nov 24 2008 02:40 May 24, 2010 Jkt 089139 PO 00148 Frm 00612 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL148.111 GPO1 PsN: PUBL148
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From page 523... ...
APPOINTMENT. -- ‘‘(i) IN GENERAL. -- The Institute may appoint permanent or ad hoc expert advisory panels as deter mined appropriate to assist in identifying research priorities and establishing the research project agenda under paragraph (1)
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From page 524... ...
shall be composed of not more than 15 members appointed by the Comptroller General of the United States. Members appointed to the methodology committee shall be experts in their scientific field, such as health services research, clinical research, comparative clinical effectiveness research, biostatistics, genomics, and research methodolo gies.
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From page 525... ...
23, 2010 124 STAT. 733 comparative clinical effectiveness research methods (determined as of the date of enactment of the Patient Protection and Affordable Care Act)
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From page 526... ...
The Institute shall ensure that the research findings -- ‘‘(i) convey the findings of research in a manner that is comprehensible and useful to patients and pro viders in making health care decisions; ‘‘(ii)
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From page 527... ...
months after the date of enactment of this section, by the Comptroller General of the United States as follows: ‘‘(i) 3 members representing patients and health care consumers.
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From page 528... ...
Such review shall include an analysis of the extent to which research findings are used by health care decision-makers, the effect of the dissemination of such findings on reducing prac tice variation and disparities in health care, and the effect of the research conducted and disseminated on ate Nov 24 2008 02:40 May 24, 2010 Jkt 089139 PO 00148 Frm 00618 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL148.111 GPO1 PsN: PUBL148
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From page 529... ...
‘‘(v) Not later than 8 years after the date of enact ment of this section, the adequacy and use of the funding for the Institute and the activities conducted under section 937 of the Public Health Service Act, including a determination as to whether, based on the utilization of research findings by public and pri vate payers, funding sources for the Patient-Centered Outcomes Research Trust Fund under section 9511 of the Internal Revenue Code of 1986 are appropriate and whether such sources of funding should be contin ued or adjusted.
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From page 531... ...
‘‘(2) REQUIREMENTS. -- The Office shall provide for the dissemination of the Institute's research findings and govern ment-funded research relevant to comparative clinical effective ness research to physicians, health care providers, patients, vendors of health information technology focused on clinical decision support, appropriate professional associations, and Federal and private health plans.
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From page 532... ...
(1) The Secretary shall not use evidence or findings from comparative clinical effectiveness research conducted under section 1181 in determining coverage, reimbursement, or incentive pro grams under title 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.
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From page 533... ...
‘‘(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.
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From page 534... ...
‘‘(a) CREATION OF TRUST FUND. -- There is established in the Treasury of the United States a trust fund to be known as the ‘Patient-Centered Outcomes Research Trust Fund' (hereafter in this section referred to as the ‘PCORTF')
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From page 535... ...
, amounts in the PCORTF are available, without further appro priation, to the Patient-Centered Outcomes Research Institute established under section 1181(b) of the Social Security Act for carrying out part D of title XI of the Social Security Act (as in effect on the date of enactment of such Act)
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From page 536... ...
‘‘(d) ADJUSTMENTS FOR INCREASES IN HEALTH CARE SPENDING. -- In the case of any policy year ending in any fiscal year beginning after September 30, 2014, the dollar amount in effect under subsection (a)
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From page 537... ...
‘‘(d) ADJUSTMENTS FOR INCREASES IN HEALTH CARE SPENDING. -- In the case of any plan year ending in any fiscal year beginning after September 30, 2014, the dollar amount in effect under subsection (a)
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From page 538... ...
any insurance program established under title XVIII of the Social Security Act, ‘‘(B) the medical assistance program established by title XIX or XXI of the Social Security Act, ‘‘(C)
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From page 539... ...
The Patient-Centered Outcomes Research Institute established under section 1181(b) of the Social Security Act.''.
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