Title XI of the Social Security Act
Sec. 1181 [42 USC 1320e] Comparative clinical effectiveness research
Definitions – Defines “comparative clinical effectiveness research”as research evaluating and comparing health outcomes and the clinical effectiveness, risks, and benefits of two or more medical treatments, services, and items. Also defines “medical treatments, services, and items,” “conflict of interest,” and “real conflict of interest.”
Patient-Centered Outcomes Research Institute – Establishes a private, nonprofit entity called the Patient‐Centered Outcomes Research Institute (PCORI)
Purpose –Definesthe purpose of PCORI, which is to improve the quality and relevance of evidence available to help patients, caregivers, clinicians, employers, insurers, and policy makers make informed health decisions.
- Identifying Research Priorities and Establishing Research Project Agenda– &
- Carrying Out Research Project Agenda– Requires PCORI to identify research priorities, establish a research agenda, and carry out the research agenda using specific methodological standards. Established that PCORI can enter into research contracts with Federal agencies and appropriate academic research, private sector research, or study‐conducting entities, with preference for working with the National Institutes of Health (NIH) andAgency for Healthcare Research and Quality (AHRQ). Requires that research be designed to take into account the potential for differences in the effectiveness of health care treatments, services, and items as used with various subpopulations. In addition, research to be designed to take into account different characteristics of treatment modalities that may affect research outcomes.
- Data Collection – Prohibits PCORI from allowing the subsequent use of data from original research in contracts with individuals, entities, or instrumentalities that have a financial interest in the results, unless approved under a data use agreement. Allows CMS to provide specific data to PCORI, and PCORI may also request and obtain data from Federal, State, or private entities.
- Appointing Expert Advisory Panels – Allows PCORI to appoint permanent or expert advisory panels for identifying research priorities and establishing the research project agenda. Includes requirements for composition of panels. Requires PCORI to appoint expert advisory panels for randomized clinical trials under the research project agenda and expert advisory panels for rare diseases to assist in the design of the research.
- Supporting Patient and Consumer Representatives – Requires PCORI to provide support and resources to help patient and consumer representatives effectively participate on the Board and expert advisory panels.
- Establishing Methodology Committee – Requires PCORI to establish a standing methodology committee of not more than 15 members appointed by the Comptroller General (CG) of the United States, which must also include the Directors of the NIH and AHRQ or their designees. The CG must consider and disclose any conflicts of interest of potential Board appointees and in appointing members of the methodology committee.The Committee shall report recommendations to the Board for the adoption of methodological standards.
- Providing a Peer-review Process for Primary Research – RequiresPCORI to establish a process of peer review of primary research to avoid bias and conflicts of interest on the part of the reviewers and composed of experts in the scientific field relevant to the research under review.
- Release of Research Findings – Requires PCORI tomake research findings publicly available within 90 days and provides specifications for what should and should not be included.
- Adoption– Requires Board to adopt national priorities, the research project agenda, the methodological standards, and a peer-review process by majority vote.
- Annual Reports– Requires PCORI to submit to Congress and the President (and make available to the public) an annual report and includes what elements should be included in the report.
Administration– Requires the Board to carry out the duties of PCORI and they may not delegate certain tasks, including identifying national research priorities and adopting methodological standards.
Board of Governors– Mandates PCORI be governed by a twenty-one member public-private sector board that consists of the Directors of NIH and AHRQ, or their designees, and 19 members appointed by the Comptroller General. Includes specifications and qualifications for the 19 appointees, board terms, vacancies, chair and vice-chair, board compensation, executive director, staff, and board meetings.
Financial and Governmental Oversight – Requires PCORI to have annual financial audits by a private entity. Requires the Comptroller General to review PCORI’s audit (annually), processes (every 5 years), dissemination and training activities and data networks (every 5 years), effectiveness of activities (every 5 years), and adequacy and use of funding (within 8 years of enactment).
Ensuring Transparency, Credibility, and Access – Requires PCORI to provide public comment periods of 45-60 days prior to adoption of national priorities, the research project agenda, the methodological standards, and the peer review process, and after the release of draft findings with respect to systematic reviews of existing research and evidence. Also requires PCORI to make all processes, notices, and public comments available to the public through their website.
Rules– Prohibits Board or staff from accepting gifts or donations of services or property.
Rules of Construction – Prohibits PCORI from mandating coverage, reimbursement, or other policies for any public or private payer. Nothing prevents the Secretary from covering the routine costs of clinical care received by an individual entitled to, or enrolled in a public insurance program participating in a clinical trial and such costs would otherwise be covered.
Section 1320e–1. Limitations on certain uses of comparative clinical effectiveness research
The Secretary may only use evidence and findings from PCORI-funded research to make a coverage determination under Medicare through an iterative and transparent process that includes public comment and considers the effect on subpopulations. PCORI’s research may not supercede or modify coverage of items that are reasonable and necessary, nor may PCORI’s research be the sole source of a coverage decision.
The Secretary is prohibited from using comparative clinical effectiveness research in determining coverage, reimbursement or incentive programs under Medicare 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, non- disabled, or not terminally ill.
Prohibits any findings to be construed as mandates on practice guidelines or coverage decisions and contains patient safeguards to protect against discriminatory coverage decisions by the Department of Health and Human Services (HHS) based on age, disability, terminal illness, or an individual’s quality of life preference.
Prohibits PCORI from developing or using a dollars‐per‐quality‐adjusted‐life‐year or other similar methodology.
Section 1320e–2. Trust Fund transfers to Patient-Centered Outcomes Research Trust Fund
Creation of Trust Fund – Creates a Patient‐Centered Outcomes Research Trust Fund (PCORTF)
Transfers to Fund– PCORTF receives appropriations from the general fund of the Treasury, beginning with $10 million for FY 2010, rising to $150 million per year for FY 2012 through FY 2019. In addition, PCORTF receives contributions from Medicare, private health insurers and self‐insured health plans beginning at $1 per capita for FY 2013, rising to $2 per capita for FY 2014 (then indexed by the percentage increase in the projected per capita amount of National Health Expenditures for FY 2015 through FY 2019).
Expenditures from Fund– Authorizes 80 percent of PCORTF to PCORI to support its research funding and operations. Authorizes 20 percent to HHS, specifically Agency for Health Research and Quality (AHRQ) and the Assistant Secretary for Planning and Evaluation (ASPE), to disseminate research findings of PCORI, as well as other government‐funded research, to train researchers in comparative research methods and to build data capacity for comparative effectiveness research.
Termination– Prohibits expenditure from the PCORTF after September 30, 2019, and any amounts in the Trust Fund after that date shall be transferred to the general fund of the Treasury.
Title 7 of the Public Health Service Act
Sec. 937 [42 USC 299b-37] Dissemination and Building Capacity For Research
Requires the Office of Communication and Knowledge Transfer at AHRQ, in consultation with NIH, to disseminate research findings of PCORI, as well as other government‐funded research, and to train researchers in comparative research methods. Requires the Secretary to build data capacity for comparative effectiveness research, including the development and use of clinical registries and health outcomes research data networks.