Table 1

Framework for conducting comparative effectiveness reviews: stakeholder involvement

ACA'S patient centered outcomes researchARRA'S comparative effectiveness researchMMA'S effective health care program

  • PCORI Board of Governors

    • – 21 members

    • – AHRQ Director and NIH Director specified in law

    • – 19 members appointed by the Comptroller General

    • – Composition of 19 appointed members specified in law: 3 patient reps/consumers; 7 physician/provider reps; 3 payer reps; 3 industry reps; 1 rep for quality improvement or health service researchers; 2 federal government/state reps [Sec. 1181(f)]

  • Federal Coordinating Council

    • – specified in law

    • – “not more than 15 members, all of whom are senior Federal officers or employees with responsibility for health related programs, appointed by the President, acting through the Secretary of Health and Human Services”

  • Stakeholder group

    • – not FACA compliant; not required in law; no votes taken; serves as a sounding board

    • – AHRQ is flexible regarding the number of members

    • – AHRQ provides only general selection criteria in public notices soliciting nominations

  • PCORI Expert Advisory Panels

    • – may be permanent or ad hoc

    • – will assist in identifying research priorities, establishing the research project agenda and for other purposes.

  • Two required panels:

    • 1. Clinical Trials Expert Advisory Panel

    • 2. Expert Advisory Panel for Rare Disease

  • Composition of panels:

    • – practicing and research physicians, patients, experts with experience in the topic

    • – may include a technical expert of each manufacturer or each medical technology included in the study

  • IOM Priority Setting Committee

    • – IOM appointed members

    • – no statutory requirement for broad stakeholder representation on panel

  • Support for patient and consumer reps

    • – institute must “provide support and resources” to help reps participate effectively

  • Methodology Committee

    • – required by statute

    • – standing committee

    • – 15 members appointed by Comptroller General

    • – composition: experts in their field; stakeholders with expertise; Directors of NIH and AHRQ

    • – function: to develop and improve science and methods of research by developing and updating methodological standards [Sec. 1181(d)(6)]

  • ARRA funding

    • – US$1.1 billion in CER spending

    • – ARRA provides funding for AHRQ Citizen Forum Contract

  • AHRQ citizen forum contract

    • – AHRQ solicited contracts for a Citizen Forum to engage stakeholders in CER activities

    • – funded by ARRA; US$10 million over 5 years

    • – contractor selection forthcoming

  • Adapted and modified from: Partnership to improve patient care. A procedural framework for the conduct of comparative clinical effectiveness research. November 2010. http://www.improvepatientcare.org/sites/default/files/CER_Procedure-PIPC_Whitepaper.pdf.

  • ACA, Affordable Care Act; AHRQ, Agency for Healthcare Research and Quality; ARRA, American Recovery and Reinvestment Act; CER, comparative effectiveness research; IOM, Institute of Medicine; MMA, Medicare Modernization Act; NIH, National Institutes of Health; PCORI, Patient-Centered Outcomes Research Institute.