The Institute of Medicine (IOM) has been asked by Congress in the American Recovery and Reinvestment Act (ARRA) of 2009 to recommend to the Secretary of Health and Human Services priorities for spending on comparative effectiveness research (CER). The report is scheduled to be released on June 30, 2009. An IOM ad hoc committee was formed for this purpose, and Harold C. Sox, M.D., editor of the Annals of Internal Medicine, was named committee chair. A complete listing of the committee membership is available here on the IOM website.

Congress required that the committee’s recommendations be informed by input from stakeholders. To this end, on March 20, 2009, the IOM held an open meeting in Washington, D.C., at which a limited number of organizations were invited to give their views on CER in three-minute oral presentations.

Presenters represented physician providers, non-physician providers, insurers, the medical device and pharmaceutical industries, researchers and consumer/patient representatives. A list of presenters, their submitted recommendations and the meeting agenda is available here on the IOM website.

Key Themes From the Open Meeting

Most presentations did not emphasize a specific clinical condition for the committee to consider but instead focused on broader principles for CER. Several themes emerged during the day, including the following:

• The emphasis should be on high-volume and high-cost services.
• It is important to consider populations not typically considered in clinical research (e.g., racial minorities, children and women).
• In addition to clinical research, research on health system infrastructure and payment methodologies is required.
• Clinical registries and other health information technology infrastructure are necessary in order to perform CER correctly.
• A means of linking clinical and administrative data is needed, as are public-private collaborations.
• In general, CER should be a transparent process and should include patient/consumer input.

In addition, several existing organizations received support and endorsement at the meeting (e.g., the National Quality Forum (NQF) and the Physician Consortium for Performance Improvement (PCPI)).

Also, with the exception of the insurers and one research organization, most speakers did not support the transition from comparative effectiveness to cost effectiveness (i.e., most of the presenters said that this information should not be used to make coverage decisions). And several speakers raised concerns about the adequacy of current CER methodologies and the need for greater discussion on what are appropriate CER methodologies.

Questions From Committee Members

Throughout the day, members of the IOM ad hoc committee were given opportunities to pose questions to the speakers. The questions focused on the following:

• the desire for more specific recommendations (specific clinical conditions)
• an interest in defining different populations that in the past have not been included in clinical research
• exploring the roles of different stakeholders (industry, insurers, providers, etc.) and their willingness to support CER initiatives (financially and in other ways)

Additional information about IOM activities related to this project is available here on the IOM website.

For more information, contact:

Sheila J. Madhani
202.419.2510
sheila.madhani@hklaw.com

Ellen Riker
202.419.2506
ellen.riker@hklaw.com

toll free: 1.888.688.8500

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