On February 17, 2009, President Obama signed into law the American Recovery and Reinvestment Act of 2009, commonly referred to as the media as the Stimulus Bill.

Among its many provisions, the Act provided $1.1 billion for comparative effectiveness research (CER). This expansion of funding for CER, the largest ever federal investment in CER, carries significant potential opportunities and risks for industry, patients, and doctors.

Overview of the CER Provisions of the Act

• $400 million to National Institutes of Health (NIH), which may be transferred to the Institutes and Centers of the NIH and to the Common Fund.
• $300 million to the Agency for Healthcare Research and Quality (AHRQ).
• $400 million to be allocated at the discretion of Secretary of Health & Human Services (“the Secretary”).
• These funds may be dispersed through grants and contracts with appropriate entities, including agencies within the Department of Health and Human Services (HHS), other government agencies, and private sector entities that have demonstrated the experience and capacity to carry out CE research.
• To the extent feasible, the Secretary will ensure that recipients of these funds offer an opportunity for public comment on the research.

• Conduct, support, or synthesize research that compares the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, disorders, and other health conditions;
• Encourage the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data.

• The IOM must provide an opportunity for stakeholders to provide input on its recommendations, and the Secretary must consider the IOM recommendations when disbursing the discretionary funds.

• The purpose of the Council is to coordinate CE research and related health services research supported by federal agencies, including HHS, Veterans Affairs, and Defense.
• The goal is to reduce duplicative efforts and encourage coordinated and complementary use of resources.

• The Council, appointed by the President through the Secretary, all of whom will be senior federal officers or employees responsible for health related programs.
• The Council will include one senior officer or employee from AHRQ, the Centers for Medicare and Medicaid Services, NIH, the Office of the National Coordinator for Health Information Technology, the Food and Drug Administration (FDA), the Veterans Health Administration, and the office responsible for management of the Department ofDefense Military Health Care System.
• At least half of the Council’s members will be physicians or other experts with clinical expertise.

• Submit operating plans to Congress;
• Publish information on grants and contracts;
• Disseminate research findings to clinicians, patients, and the general public, as appropriate;
• Report to Congress annually on the research conducted or supported through the funds; and
• Report to Congress on obligations, expenditures, and unobligated balances for each activity funded, not later than  November 1, 2009, and every 6 months thereafter, as long as funds are available.