Senate Finance Committee Chairman Max Baucus (D-MT) and Budget Committee Chairman Kent Conrad (D-ND) introduced S. 3408, the Comparative Effectiveness Research Act of 2008 on August 1. This bill would establish a private, non-profit institute to conduct research evaluating and comparing the implications and outcomes of two or more health care therapies in treating a particular medical condition.

Under the proposal, the Health Care Comparative Effectiveness Research Institute would identify the research priorities and establish the research project agenda, taking into account the following factors:

• disease prevalence and burden
• evidence gaps in terms of clinical outcomes
• practice variations in delivery and outcomes by geography, treatment site, provider type and patient subgroup
• the potential for new evidence in certain categories of treatments and services to improve patient health and quality of care
• the effect on health care expenditures associated with a health condition and its therapies

The Institute would also be tasked with disseminating its findings to the clinicians, patients and the general public. However, it would be prohibited from issuing guidelines related to practice guidelines or policy recommendations. The bill also establishes:

• a standing methodology committee which would evaluate the standards used in conducting of research
• peer review process for evaluation of research
• public availability of information throughout the research process, with 30-60 day comment periods

The Institute's 21-member Board of Governors would include the Secretary of the Department of Health and Human Services and the Directors of the Agency for Healthcare Research and Quality and the National Institutes of Health. The Board's other 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

The Institute budget would be $5 million in FY 2009 and increase to $300 million by FY 2013. By 2011 the Institute would become an "all-payer" system, in which the federal treasury would provide $75 million annually from FY 2011 through FY 2018, private insurers would pay $1 per insured person per year and Medicare trust funds would provide $1 per beneficiary each year.

Most stakeholders agree that the findings of such comparative effectiveness research could be used to better inform clinical care. However, some industry and patient groups are concerned that this information may be used to inappropriately restrict reimbursement and/or coverage of certain services, not taking into account that the final determination of what works best for an individual patient should be decided by the clinician.

While the bill is not likely to pass this year, a similar bill will be reintroduced next year to high interest. The Society will work with other medical societies to review the impact.