This time, White House receives kudos for participation

An advisory council report on health care research released last month by the Health and Human Services Department marks an exception to the White House's closed-door decision-making on how to spend stimulus funds, which critics said run counter to the president's pledge to bring transparency, public participation and collaboration to policymaking.

HHS released a report on June 30 that presented recommendations on how the department secretary should spend $400 million in stimulus funds to expand comparative effectiveness research, which are studies on what types of medical interventions work best for certain individuals and are aimed at improving health outcomes and cutting costs.

The 2009 American Recovery and Reinvestment Act earmarked $1.1 billion for the research, and Congress directed $400 million of the funds to the Office of the Secretary at HHS to expedite development and distribution of the research.

Many citizens outside Washington wanted to weigh in on how the hundreds of millions of dollars should be spent on medical treatment data. In interviews with Nextgov, they said the administration accommodated their desire to speak through e-mail, conference calls and out-of-state meetings, and their advice was included in the final recommendations.

To prepare the report, HHS created a Web site to invite Americans to apply to speak on panels in front of council members in Washington and Chicago. Ninety-two who applied were selected to testify based on criteria, including the timeliness of their requests, the size of the organizations they represented, the diversity of viewpoints and their expertise. The names of the speakers and almost their entire testimonies are available online, providing the public with insight into how the report was conceived.

The panelists the department chose said the report includes key themes that emerged at the meetings, such as the need to establish public-private collaborations and to evaluate diverse patient populations. Separate from the live testimonials, more than 300 individuals submitted comments online for the record, according to HHS. The department has yet to publish the statements or identify the respondents. An HHS spokesman said they are working to make the comments public.

The report proposed investing the funds primarily in data infrastructure. Suggestions for linking relevant data include medical practice networks, longitudinal administrative claims repositories, electronic health record databases and other patient-data registries.

"I thought the process was a very open process, and I think the report was responsive to the testimony that was heard," said John Lewis, a vice president at the Association of Clinical Research Organizations.

He said the association welcomes the idea of using the money to build an infrastructure and was pleased to see a concept he broached represented in the report. At an April session in Washington, Lewis advised that whatever organization is chosen "to oversee comparative effectiveness research should be a public-private board. . . . It's clear that it's endorsed" in the report.

At a May session in Chicago, Cynthia Reilly, director of the American Society of Health-System Pharmacists, dialed in to participate. Her organization represents pharmacists who work in hospitals and clinics. Reilly wanted the stimulus money to support information technology and dissemination so research findings can be shared. "You can create all this evidence, but unless you put it in the hands of the clinicians and the patients, it's limited in its value," she said.

The definition of comparative effectiveness research that the council established partly states, "The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information . . . about which interventions are most effective for which patients under specific circumstances. . . . This research necessitates the development, expansion and use of a variety of data sources and methods to assess comparative effectiveness and actively disseminate the results."

But Justin Starren, director of the Biomedical Informatics Research Center at the Wisconsin-based Marshfield Clinic, was disappointed that the description stops short of including health information technology or electronic health records as an intervention. The report states, "Defined interventions compared may include medications, procedures, medical and assistive devices, and technologies, diagnostic testing, behavioral change, and delivery system strategies."

Still, Starren, whose clinic is a private, multispecialty group practice, was pleased to simply have a seat at the table at the April 14 meeting in Washington. Initially, he was not picked for a scheduled panel because HHS primarily selected participants based on the size of the organizations they were representing, he said. Instead, Starren entered and won a lottery to speak during an open-mike panel at the end.

"Certainly, if you look at the people who were chosen in those scheduled sections, virtually every one of them was speaking for a fairly large interest group," he said. "It's very clear that they got a bigger response than they were expecting."

Officials from the National Alliance on Mental Illness of Greater Chicago and the AIDS Institute based in Washington and Tampa, Fla., applauded the report's recognition of their constituents.

A secondary area of investment, the report states, should be the distribution of findings related to "priority populations," including people with chronic conditions such as co-existing mental illness. The recommendations also note that the infrastructure should tap into existing databases hosted by agencies, including two that store AIDS statistics.

Some participants said they identified issues that the report overlooks, such as data quality. "What they are going to do is take as many of the databases and information on patient outcomes that they can get their hands on and integrate that as best they can," said Steven Mersch, president of Point Source, a manufacturer of electronic and optical instruments in Germantown, Ohio. "But bad data is worse than no data at all. If they create this database they're going to have bad data and if they base decisions on this data . . . they are going to lose a bit of credibility."

Overall, he said he admired the report's findings.

Zoe Bolton, a partner at AnalytiCare, which provides business intelligence software to the long-term care industry, agrees with the infrastructure proposal, but said, "what we don't see is anything acknowledging that there are already toolsets available" for collecting and analyzing treatment information.

The advisory council's recommendations are intended to help the HHS secretary develop a plan that is due on July 30 for the total $1.1 billion of stimulus research funding.