On May 19, 2009, Rep. Kurt Schrader (D-OH), joined by 11 co-sponsors, introduced H.R. 2502, "The Comparative Effectiveness Research Act of 2009." This legislation would establish a private, non-profit organization, the Health Care Comparative Effectiveness Research Institute, to conduct research evaluating and comparing the implications and outcomes of two or more health care therapies in treating a particular medical condition. The Institute will not conduct the research itself, but research projects will be contracted to Federal and private entities. View H.R. 2502 (PDF, 245K)

This legislation, which builds upon the work (S. 3408) of Senate Finance Committee Chairman Max Baucus (D-MT) and Budget Committee Chairman Kent Conrad (D-ND) introduced in the last Congress, has at least three elements that are critical for comparative effectiveness research:

1. It recognizes that this research should be focused on informing doctor and patient decisions, not focusing on cost issues. Specifically, it focuses on “comparative clinical effectiveness.” In addition, it includes a rule of construction stating that none of the research and reports can be construed to prevent physicians and patients from determining the best course of treatment, given individual circumstances.
2. The legislation provides a clear, transparent process for the research development. For example, in order to carry out this research, the new Institute must make available on a public website the process and methods for the conduct of research, the identity of entities and investigators conducting research, draft study designs, research protocols, proceedings of the institute, and all reports, findings and results. In addition, the Institute is required to establish public comment periods and to transmit these comments to the entity conducting research. The Institute will also periodically host public forums to increase public awareness and better incorporate public feedback.
3. Finally, it ensures that the research is not used for coverage decisions. Beyond a rule of construction prohibiting the Institute from mandating coverage, reimbursement, or other policies for any public or private payer, none of the research findings disseminated by the Institute should be policy recommendations or coverage guidelines for payment or treatment.

The duties of the Health Care Comparative Effectiveness Research Institute include the following:

• Identifying national research priorities and establishing a research project agenda
• Carrying out the research project agenda
• Establishing standing methodology committee which would evaluate the standards used in conducting of research. 
• Providing a peer review process for evaluation of research
• Disseminating the research findings to clinicians, patients, and the general public
• Submitting annual reports to Congress, the President, and the public describing activities conducted and amounts appropriated for the current and upcoming year .

The Institute's 21-member Board of Governors would include the Secretary of the Department of Health and Human Services (HHS) and the Directors of the Agency for Healthcare Research and Quality (AHRQ) and the National Institutes of Health (NIH). The remaining 18 members would include three representatives each from the following entities:

• private payers; pharmaceutical, device and technology companies
• patients and health care consumers
• physicians, including surgeons
• agencies administering public health programs
• one representative each from
• • a non-profit representing health services research
  • an organization providing quality measurement and improvement or decision support
  • an independent heath services researcher

In FY 2009, the Institute would be funded with the remaining money from the $1.1 billion included in the economic stimulus package. In FY2010, private insurers would pay 50 cents per insures person and Medicare trust found will provide 50 cents per beneficiary. From FY 2011 through FY 2020, private insurers would pay $1 per insured person per year and Medicare trust funds would provide $1 per beneficiary each year.

The Heart Rhythm Society wrote a a letter of support for this legislation. Read the Society letter (PDF, 112K)