As part of the ongoing congressional health care reform debate, there are several competing proposals regarding the creation of a comparative effectiveness research (CER) entity. Details must still be worked out on how a CER entity would be structured, the type of research it would conduct, and how health care decision makers would use the information generated. Perhaps even more important, policy makers must determine whether a public-private CER entity would be established, or whether existing governmental agencies would be used to facilitate publicly funded CER and how such a CER entity would interface with various stakeholders in the health care delivery system.
Most recently, the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee took the latter approach by approving comprehensive health reform legislation to establish a “Center for Health Outcomes Research and Evaluation” within the Agency for Healthcare Research and Quality (AHRQ). Under the proposed legislation, the Center would “coordinate, conduct, support and synthesize research relevant to the comparative health outcomes and effectiveness of the full spectrum of health care treatments.” It would be governed by an advisory council composed of the AHRQ director, the chief medical officer of the Centers for Medicare and Medicaid Services, and “19 additional members” who “collectively have experience” in epidemiology, health services research, bioethics, communication and decision sciences, health economics, and safe use of medical products.1
Similar legislation that places a CER entity under AHRQ’s purview was introduced as a U.S. House of Representatives Tri-Committee bill, a group comprising the Energy and Commerce, Ways and Means, and Education and Labor Committees. Among its sweeping changes to the health care system, the “America’s Affordable Health Choices Act” would create a “Center for Comparative Effectiveness Research" also within AHRQ. Instead of the 21 members proposed by the Senate bill, a 17-member commission would be appointed by the HHS Secretary, and members would include “the Director of AHRQ, the Chief Medical Officer of the Centers for Medicare and Medicaid Services, and stakeholders including clinicians, patients, researchers, third-party payers and consumers. Clinical perspective advisory panels [would] provide advice on specific research questions, methods and gaps in evidence in terms of clinical outcomes for priorities identified by the commission in order to ensure that the research is clinically relevant.”2
Although the Senate measure was approved by the HELP Committee, Senators are currently working to modify the bill in an attempt to lower the overall costs. It is not clear whether the CER provisions in the bill will be modified since while program costs are not a factor, there are Senators who favor a different approach: a public-private CER entity, instead of a government agency within AHRQ.
This approach was outlined in June by U.S. Senate Finance Committee Chairman Max Baucus (D-MT) and U.S. Senate Budget Committee Chairman Kent Conrad (D-ND) when they introduced legislation, “The Patient‐Centered Outcomes Research Act of 2009,” to establish a “private, nonprofit corporation, called the Patient‐Centered Outcomes Research Institute, to generate scientific evidence and new information on how diseases, disorders and other health conditions can be treated to achieve the best clinical outcome for patients.”3
The Institute would "be governed by a multi‐stakeholder Board of Governors” and would “establish a national agenda of research priorities.” It could "contract with federal agencies, such as AHRQ, and appropriate private entities to conduct the research, which would include both systematic reviews and primary research. The Institute and its activities would be funded by contributions from both public and private payers, made available to the Institute through a Patient‐Centered Outcomes Research Trust Fund.”4
Chairman Baucus said that he intends for this legislation, which is similar to legislation he introduced last year, to be included as part of a comprehensive health reform bill that will be considered by his committee.5
In May, U.S. Representatives Kurt Schrader (D-OR) and Allyson Schwartz (D-PA) introduced similar legislation to create a Health Care Comparative Effectiveness Research Institute “responsible for managing and guiding health research programs.” This institute will be governed by a 21-member board that would include representatives from government agencies, state health agencies, and the insurance and pharmaceutical industries, along with physicians, patients, researchers and other experts. Public comment will be solicited prior to establishing research guidelines, and all research would have to account for patients’ gender, race, age and ethnicity and be subject to a peer-review process. Their legislation also will establish a research fund paid for with unspent stimulus money and fees on Medicare and private health plans.6
There is much for policymakers to debate in the health care reform bills, and the creation of a CER entity is just one piece of the puzzle. However, it is an important piece, as it may have a significant impact on the future of physician-patient relations, health care outcomes, and pharmaceutical innovation. The pharmaceutical industry sponsors approximately 75% of all clinical trials and industry participation as part of the governance process of a publicly funded CER entity will help to ensure its efficient implementation and long term success. Certainly, the decision on whether to place a new CER Institute under an existing federal agency or to establish a new public-private entity to serve as a trusted scientific intermediary will be foundational to the publicly funded CER effort moving forward.
1 Affordable Health Choices Act, Section , “Center for Health Outcomes Research and Evaluation.”
2 Tri-Committee Summary of America’s Affordable Health Choices Act, July 14, 2009, pgs. 18-19.
3 Baucus, Conrad Introduce Bill to Invest in Research on Best Practices in Health Care, press release, June 9, 2009. http://www.finance.senate.gov/newsroom/chairman/download/?id=96c8e812-5824-4a4a-9487-11e4436264d0, accessed June 11, 2009.
5 U.S. Senate Finance Committee Chairman Max Baucus, comments at the Brookings Institution, June 9, 2009, http://www.brookings.edu/events/2009/0609_health_care_cer.aspx, accessed June 11, 2009.
6 Schrader, New Dems Introduce Bill Empowering Doctors, Nurses to Make the Best Patient Care Decisions, press release, May 19, 2009. http://newdemocratcoalition-kind.house.gov/press-release/new-dems-introduce-bill-empowering-doctors-nurses-make-best-patient-care-decisions, accessed May 19, 2009.