By Ramsey Baghdadi, Senate Finance Committee Chairman Max Baucus, D-Mont., plans to propose patient protections for federal comparative effectiveness research

that draw a clear line separating information gathering and coverage decisions.

The “pro-patient safeguards,” as they’re being called, would take the next step after previous Baucus statements that seek to distance comparative effectiveness from insurance coverage decisions, according to Finance Committee staffer Shawn Bishop.

For example, one provision would bar CMS from having “automatic links to a study” in a coverage decision, Bishop said.

Creating safeguards via legislation suggests Baucus is taking seriously opposition to comparative effectiveness research and is sensitive to criticism that comparative studies could lead to a “one-size-fits-all” health care system.

Such concerns arose during debate on provisions in the economic stimulus package to add $1.1 billion for effectiveness research. A Finance Committee “options paper” on health reform includes establishing a more permanent structure for comparative effectiveness, and the paper notes concerns that research results not be “fast tracked” to coverage decisions (1“The Pink Sheet,” May 4, 2009, p. 30)

“Coverage is not on the table,” a House Energy and Commerce staffer maintained, referring to conversations between staff in both chambers of Congress. “This is not about coverage decisions – I want to be 100 percent clear about that.” I’m also not going to promise there won’t be coverage controversies,” the Energy and Commerce staffer conceded. Bishop also added that Baucus “will not bar any government agency from using this research.”

The congressional staffers were speaking at a May 13 event sponsored by the Friends of Cancer Research to unveil their report, “Improving Medical Decisions Through Comparative Effectiveness Research.”

The report was authored by an independent committee of 25 leading biomedical researchers, health economists and oncologists from cancer centers across the U.S., and endorsed by over 25 advocacy organizations. It looks at cancer as a case study but is applicable to other disease areas and makes a number of recommendations on best practices going forward.

The report makes four key recommendations:

1) A comprehensive comparative effectiveness research program should be developed to identify the most effective health options.

2) The program should link data from public and private entities.

3) CER studies should support the development of personalized medicine.

4) Processes should be developed to ensure information from CER is incorporated into clinical practice.

“The big opportunity will be in infrastructure,” according to FOCR Chair Ellen Sigal. FOCR Executive Director Jeff Allen maintained that CER and personalized medicine can work hand in hand. “Our therapeutics are becoming more and more targeted – one can inform the other.”

FDA Center for Drug Evaluation and Research Director Janet Woodcock advised policymakers to include a key coordinating component as part of any upcoming bill: a clinical trial network.

“I have a lot of experience in this,” Woodcock said. “A clinical trial network needs to be set up” in order to increase the number of trial investigators participating in CER studies.

“We need to lower those barriers in order to get more participants,” Woodcock said, adding that a “first-time investigator is also a last-time investigator” due to the red tape involved in conducting a clinical study in the U.S.

Lawmakers on Capitol Hill are still grappling with exactly how to craft legislation that will make comparative research an enduring piece of the health care system. In 2008, Baucus and Sen. Kent Conrad, D-N.D., introduced the Comparative Effectiveness Research Act, which called for funding and the creation of a CER institute

The most vocal opponent to CER in the Senate has been Arizona Republican Jon Kyl. The Finance Committee member has introduced anti-CER amendments and used the committee vote on HHS Secretary Kathleen Sebelius to voice his displeasure on the issue; Kyl’s “no” vote on her confirmation was rooted in his discontent with her written answers to questions about CER.

“Comparative effectiveness has come up in every single meeting related to this [health reform] bill,” Bishop remarked. “It’s not at the staff level, it’s at the member level.” Members “want to have a permanent structure in place to conduct comparative effectiveness research,” Bishop said.

– Ramsey Baghdadi (r.baghdadi@elsevier.com)

[Editor’s note: this story was updated May 14.]