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Comparative Effectiveness Council Urges Infrastructure Improvements

This article was originally published in The Pink Sheet Daily

Executive Summary

Federal Coordinating Council for Comparative Effectiveness Research also recommends HHS money focus on dissemination of research results.

The Federal Coordinating Council for Comparative Effectiveness Research is recommending that HHS use its stimulus package funds to build a data infrastructure.

"The primary investment for this funding should be data infrastructure," the council said in a June 29 report recommending how HHS should spend the $400 million allocated to it as part of the comparative effectiveness research funded by the American Recovery and Reinvestment Act (1 , p. 25).

"Data infrastructure could include linking current data sources to enable answering CER questions, development of distributed electronic data networks and patient registries, and partnerships with the private sector," the report states.

The recommendations to HHS do not include specific areas of study. Agency for Healthcare Research and Quality Director Carolyn Clancy said during a June 29 conference call with press that the report was meant to be more complimentary to a report from the Institute of Medicine, scheduled for release on June 30, which will also offer recommendations on how CER funding should be spent.

"I think what you will see is that the Institute of Medicine report has very specific questions in it and we were more focused on the infrastructure and laying a very broad framework and criteria for making decisions," Clancy said. "So you'll see the two reports are highly complimentary. But the ultimate end - the specific recommendations part - will come at the end of July." She noted that the FCCfCER report include an inventory of current comparative effectiveness research underway.

An overall plan on how the total fund allocated by ARRA for comparative effectiveness research will be spent - $1.1 billion - is due by the end of July (2 (Also see "Where’s The Comparative Effectiveness Money Going? Plan Is Due July 30" - Pink Sheet, 23 Feb, 2009.), p. 5).

That the coordinating council recommended infrastructure spending as the top priority for the funding left to HHS' discretion should not come as a surprise. At an IOM public forum in March, Clancy described the $400 million as representing "a significant down payment on the science of the infrastructure we're going to need" for such research (3 (Also see "Comparative Effectiveness “Infrastructure” Could Get Discretionary Funding" - Pink Sheet, 30 Mar, 2009.), p. 23).

As a secondary recommendation, the report targets improvements in dissemination and translation of CER findings, as well determining priority populations and priority types of interventions.

"The priority populations identified that could be the focus of cross-cutting themes were racial and ethnic minorities, persons with disabilities, persons with multiple chronic conditions (including co-existing mental illness), the elderly, and children," the report states. "CER will be an important tool to inform decisions for these populations and reduce health disparities."

The recommendation emphasizing the needs of the subpopulations could help alleviate fears that comparative effectiveness will drive a "one size fits all" approach to medicine.

Connecting Existing Databases

Neera Tanden, counselor to HHS Secretary Kathleen Sebelius, said during the call that the infrastructure envisioned by the recommendation would encompass a wide array of existing databases from both the public and private sectors.

"There has been a lot of discussion recently about hospital networks that have access to information," Tanden said, "and with privacy protections ensuring that you can mine the hospital network claims data as well as the actual practice patterns," quick research can be done. "Obviously there is tremendous potential with electronic health records in combination with some of these strategies."

Tanden added that funding could be well spent if it were to bridge various federal databases such as the CMS claims database.

"CMS has a rich claims database, and ... has been very difficult for researchers to really access is this information," she said. "So part of this is ensuring that there's funding available to make this research more available to people so that there can be a good analysis done of procedures, protocols, etcetera, so you can measure how one procedure is really doing up against another."

-Gregory Twachtman ([email protected])

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