Web Exclusive: Healthcare reform, new comparative effectiveness research institute established

By Emily Wilson, director of government relations

As part of the recently enacted Patient Protection and Affordable Care Act, a new entity was established to lead comparative effectiveness efforts called the Center for Patient-Centered Outcomes Research Institute. This institute, a new D.C. nonprofit corporation, was created to identify national priorities for research and to establish, update and carry out a national comparative outcomes research project agenda. The institute will be governed by a public-private sector board of governors appointed by the Government Accountability Office (GAO). The institute is neither an agency nor establishment of the U.S. government; however, it is funded with monies from the Treasury Department as well as from fees on private health plans. In addition to its Board of Directors, the institute will have expert advisory panels that will assist in identifying research priorities and contributing to the research project agenda. The Institute will release an annual report to Congress each year on the work accomplished in the previous year. We will be monitoring closely for developments and wanted to provide an overview based on the authority the institute is given by the health reform legislation.

Institute Purpose  
The law defines “comparative clinical effectiveness research” and “research” in this context to mean research evaluating and comparing health outcomes and the clinical effectiveness, risks and benefits of two or more medical treatments or services. The purpose of the institute is to assist patients, clinicians, purchasers and policy-makers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored and managed through research and evidence synthesis that considers variations in patient subpopulations and the dissemination of research findings with respect to the relative health outcomes, clinical effectiveness and appropriateness of the medical treatments or services.

Funding
The institute has a number of funding streams. The Medicare program will transfer funds to the Institute in 2013 equal to $1 for each Medicare beneficiary; in 2014-2019 Medicare payments will equal $2 per beneficiary. Additionally, transfers from the general fund of the Treasury Department to the institute for $10 million in 2010, $50 million in 2011 and $150 million in 2012-2019. Finally, a tax will be placed on health plans and self-insured plans equal to $1 to $2 for each covered life; these funds will also be transferred to the institute.  Based on this funding schedule, it seems that congressional intention is for this institute to be launched in late 2010 with prioritization efforts to take place in 2011 and funding for CER projects available in 2012 and beyond.

Subcontracting
The institute is allowed to subcontract to other organizations to conduct the work; NIH and AHRQ are recognized as preferred subcontractors by the legislation.

Board Composition
The board of governors shall consist of the following members:

• The director of Agency for Healthcare Research and Quality (AHRQ) (or the director's designee).
• The director of the National Institutes of Health (NIH) (or the director's designee).
• Seventeen members appointed by the comptroller general will be delineated as follows:
  • Three members representing patients and healthcare consumers.
  • Five members representing physicians and providers, including at least one surgeon, nurse, state-licensed integrative healthcare practitioner and representative of a hospital.
  • Three members representing private payers, of whom at least one member shall represent health insurance issuers and at least one member shall represent employers who self-insure employee benefits.
  • Three members representing pharmaceutical, device and diagnostic manufacturers or developers.
  • One member representing quality improvement or independent health service researchers.
  • Two members representing the federal government or the states, including at least one member representing a federal health program or agency.

Finally, the GAO will designate a chairperson and vice chairperson from among the members of the board. These members will serve as chairperson or vice chairperson for a period of three years. The board will be comprised of a broad range of perspectives and collectively have scientific expertise in clinical health sciences research, including epidemiology, decisions sciences, health economics and statistics. A member of the board shall be appointed for a term of six years, except with respect to the members first appointed, whose terms of appointment shall be staggered evenly over two-year increments. No individual shall be appointed to the board for more than two terms.

How does this institute intersect with current ARRA CER funding?
As you’ll recall, the American Recovery and Reinvestment Act (ARRA) of 2009 included $1.1 billion for CER. AHRQ received $300 million, the National Institutes of Health (NIH) received $400 million (appropriated to AHRQ and transferred to NIH) and the Office of the Secretary received $400 million.  Prior to receiving the ARRA money, the Effective Health Care (EHC) Program was established at AHRQ. This program was created in 2005 and authorized through the Medicare Modernization Act (MMA) of 2003. The mandate of this program was to improve the quality, effectiveness and efficiency of healthcare delivered through Medicare, Medicaid and S-CHIP programs. In large part, AHRQ is using the structure of EHC to manage CER activities funded through ARRA.

Congressional staff members view the ARRA CER funding as an initial infusion of funds; however, because ARRA was an appropriations bill, they could only provide funding and were not able to provide the framework for how they envisioned CER to be conducted. The new Center for Patient-Centered Outcomes Research Institute will supersede the AHRQ/EHC as the entity setting the agenda and providing funding for additional research.

Where is the ARRA money going?
At a recent meeting, AHRQ provided a snapshot on where their investments have gone from fiscal year 2008 to 2010:

• Evidence generation – 57 percent.
• Evidence synthesis – 13 percent.
• Dissemination and Translation – 12 percent.
• Evidence Need Identification – 6 percent.
• Career Development – 6 percent.
• Horizon Scanning – 3 percent.
• Stakeholder Input and Involvement – 3 percent

Priority areas and Research Challenge
AHRQ has 14 priority condition areas of which cancer is included. These priority conditions factor into where ARHQ allocates its resources, and it is likely that cancer will remain on the agenda as a priority issue. Health system reform, which was a priority area for CER identified by the Institute of Medicine (IOM), is another topic considered by AHRQ as an important area for research. AHRQ has also identified areas with significant deficits in CER that need to be addressed. The deficit areas include: methodology development, training of professionals and the future of electronic records. AHRQ staff indicated that they would also like to focus on these deficit areas as well; again, it is likely that the new institute will similarly view these to be areas where investment is needed. 

Current RFPs

AHRQ has posted a new database of grant awards online at www.effectivehealthcare.ahrq.gov/index.cfm.