Comparative effectiveness research led by a non-government institute with funding from public and private sources, as envisioned by Sen. Max Baucus, D-Mont., is among the provisions for health care reform that are being debated by the Senate, but some changes to CER provisions were made as the bill moved from the Finance Committee to its current iteration on the Senate floor.

Among the key substantive changes were: how research results are disseminated, specifics of the conflict of interest policy and details of the government's participation in the proposed not-for-profit CER institute.

AHRQ To Handle Dissemination

Baucus, as chairman of the Finance Committee, has been a key proponent of an independent CER entity with a public-private funding mechanism. But when it comes to how research results will be disseminated to the public, it is the plan of the other committee of jurisdiction in health care reform - the Health, Education, Labor and Pensions Committee - that won out in melding the two committees' bills.

Information dissemination under the Finance Committee's bill was to be one of the functions of a newly created Patient-Centered Outcomes Research Institute, but the final bill follows a different route that draws on the CER provisions in HELP's version of the bill.

While, in the final bill, the institute would still be responsible for contracting CER studies, the responsibility for dissemination goes to the Office of Communication and Knowledge Transfer at the Agency of Healthcare Research and Quality. The change nudges the bill a little closer to the vision for CER in the House reform bill, which places the running and oversight of the program completely in AHRQ's hands (see chart: " ¹ Comparative Effectiveness Research - A Tale Of Two Bills ").

The office, "in consultation with the National Institutes of Health, shall broadly disseminate the research findings that are published by the Patient-Centered Outcomes Research Institute ... and other government-funded research relevant to comparative clinical effectiveness research," the bill says.

Language in the bill instructs the office to "create informational tools that organize and disseminate research findings for physicians, health care providers, patients, payers and policy makers."

A publicly available database that includes government-funded evidence and research from public, private, not-for-profit and academic sources also is to be developed by the office.

The office could face a difficult balancing act in fulfilling its dissemination mission, since it is charged with ensuring that research findings are incorporated into medical practice without making the information come across as a government recommendation for how to treat patients.

On one hand, the bill clearly states that "the office, in consultation with relevant medical and clinical associations, shall assist users of health information technology focused on clinical decision support to promote the timely incorporation of research findings disseminated ... into clinical practice and to promote the ease of use of such incorporations."

However, the information should "not be construed as mandates, guidelines or recommendations for payment, coverage or treatment."

New Conflict Of Interest Rules

Another section added to the bill put before the full Senate provides details on the conflict of interest policy that were not present in either the Finance or HELP bills.

The section refers to "real conflict of interest," which means potential benefits received by a member of the outcomes research institute's board, methodology committee or advisory board, or a close relative to such a member.

Conflict of interest is defined as "a direct financial benefit of any amount from the result of findings of a study" or "a financial benefit from individuals or companies that own or manufacture medical treatments, services, or items to be studied ... that in the aggregate exceeds $10,000 per year."

Financial benefit is defined to include "honoraria, fees, stock, or other financial benefit and the current value of the member or close relative's already existing stock holdings, in addition to any direct financial benefit deriving from the results or findings of a study."

The Finance bill simply defined conflict of interest as meaning "associations, including financial and personal, that may be reasonably assumed to have the potential to bias an individual's decisions in matters related to the institute or the conduct of activities." It did not offer further definitions on what would constitute conflict of interest.

AHRQ, NIH Given Contract Preference

In terms of offering contracts for research, the combined bill singles out two government entities as preferred recipients of contracts - AHRQ and the National Institutes of Health. In general, the bill calls for contracts to be issued to appropriate agencies and instrumentalities of the federal government or appropriate academic research, private sector research or study-conducting entities.

However, the bill states that the institute "shall give preference to [AHRQ and NIH], but only if the research to be conducted or managed under such contract is authorized by the governing statutes" of AHRQ or NIH.

NIH and AHRQ will also be represented on the institute's board under the combined bill. An amendment approved in the Finance Committee's markup removed government representation from the institute's governing board, but the combined bill places the AHRQ and NIH directors on the board of governors.

On the research front, one thing the institute will not be asked to do is determine whether research can be done in-house. The Finance Committee's version called on the institute to study the feasibility of in-house research and give a report to Congress within five years on the results of that study, but that provision was dropped in the final bill.

The institute also was relieved of having to perform a study on the comparative effectiveness of delivery system designs. Finance's version had called for the institute's methods committee to look at "methods by which various aspects of the health care delivery system (such as benefit design and performance, management, information communication and delivery) could be assessed and compared."

The combined bill, however, does not abandon research into improving the health care delivery system. Instead of the institute, the bill charges AHRQ's Center for Quality Improvement and Patient Safety to identify "best practices for quality improvements in the delivery of health care services."

- Gregory Twachtman ( ² g.twachtman@elsevier.com )

Senate Considers Revised Comparative Effectiveness Plan In Reform Bill

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