Senators Propose Nonprofit Institute to Study Comparative Effectiveness

published in "Quality"

Democratic Senate leaders July 31 introduced legislation that would create a comparative effectiveness institute dedicated to researching and disseminating information about which health care treatments work best, without evaluating cost or health plan design factors.
The proposed Comparative Effectiveness Research Act of 2008 (S. 3408) would establish the Health Care Comparative Effectiveness Research Institute, a private nonprofit corporation that would study which medical treatments--including surgeries, pharmaceuticals, and medical devices--have the best clinical outcomes.

"Doctors and patients need reliable, unbiased information about the effectiveness of treatments to determine the best care possible, but right now that data is scarce and unorganized," Sen. Max Baucus (D-Mont.), chairman of the Senate Finance Committee, said in a statement. "This bill will advance the process of reviewing and producing valuable information and making it available to health care providers, and to all Americans."

Baucus introduced the bill, along with Sen. Kent Conrad (D-N.D.), chairman of the Senate Budget Committee. Conrad said that with the research generated by the institute "patients and their doctors can make better decisions on treatment--meaning we could lower costs and improve health care outcomes."

The institute would be funded by both private and public entities through the creation of a Comparative Effectiveness Research Trust Fund (CERTF). If the legislation is enacted, total funding for the institute would exceed $300 million after five years, according to a Finance Committee summary of the bill.

Insurers and industry groups Aug. 1 weighed in with support for the proposed legislation, saying it is a needed first step in improving the heath care system.


Institute Structure, Responsibilities

The institute would be responsible for establishing research priorities based on the need for better evidence, the burdens of a particular disease, practice variations, the potential for improved care, and the expenses associated with a given condition or care strategy, according to the summary.
The research itself would be conducted by both public and private entities, which would be approved by the institute's board of governors. The research would be peer-reviewed and include systematic reviews, observational studies, clinical trials, and randomized controlled trials.

The board of governors would include 18 public and private stakeholders, as well as the secretary of the Department of Health and Human Services, and the directors of the Agency for Healthcare Research and Quality and the National Institutes of Health.

The institute also would establish an expert methodology committee responsible for developing standards for any research the institute uses. The committee would also be responsible for studying whether cost and health plan design could eventually be incorporated into comparative effectiveness research.

Although the institute would not take costs and health plan design into consideration, a future Congress could incorporate those factors into the research, according to the Finance Committee's summary.

The institute would be required to establish public comment periods, allowed to establish additional advisory committees, and encouraged to study the differences in clinical outcomes for patient subgroups, such as racial and ethnic minorities, according to the committee summary.

Funding for the institute would come from general revenues, the Medicare Trust Funds, and from fees assessed on health plans. The Medicare Trust Funds would contribute $1 per beneficiary annually and health plans would be assessed $1 per-covered-life annually, according to the committee summary.


Industry Reactions

Insurers and other industry groups applauded the intent of the legislation, with some emphasizing the importance of excluding cost-effectiveness analyses from the research.
The Advanced Medical Technology Association (AdvaMed), device industry group, said it is pleased that, although the bill does allow for the study of cost-effectiveness, it does not authorize such study as a part of the institute's research.

"As Congress considers comparative effectiveness legislation, we believe safeguards should be included to ensure that the final determination of what treatment option works best for each patient should be made by individuals and their physicians," Stephen J. Ubl, president and chief executive officer of AdvaMed, said in a statement. "It is also essential that research recognize the unique iterative nature of device innovation when establishing research priorities and conducting studies."

The Pharmaceutical Care Management Association--which represents pharmacy benefit managers--and the Pharmaceutical Research and Manufacturers of America (PhRMA)--which represents drug manufacturers--also voiced their support for the bill, as did the Blue Cross and Blue Shield Association.

In an Aug. 1 statement, PhRMA Senior Vice President Ken Johnson said the drug industry group "supports the development and use of high-quality evidence, including comparative clinical effectiveness evidence, for healthcare decision-making. Proposals to expand government-supported comparative clinical effectiveness research should be structured to promote better patient health and timely patient access to needed therapies, and avoid denying or delaying patients' access to beneficial care, as what often occurs in Europe and Australia."

Scott P. Serota, president and chief executive officer of the Blue Cross and Blue Shield Association (BCBSA), said in a statement, "To improve tomorrow's healthcare coverage we need to change the incentives in today's healthcare system." Serota added that comparative effectiveness research "will empower patients and providers by providing information on quality and value, and improve safety and affordability of healthcare for everyone."

America's Health Insurance Plans also issued a statement commending the bill's introduction. The organization has previously indicated its support for including cost considerations in comparative effectiveness research (96 HCDR, 5/19/08 ).

"Senators Baucus and Conrad took an important step by introducing legislation to create an independent entity to give patients and their doctors the information they need to make health care decisions based on safety, effectiveness, and value. We believe this is the right time for this proposal and pledge to work with the Senators to advance comparative effectiveness legislation," Karen Ignagni, president and chief executive officer of AHIP.

The bill was referred to the Senate Finance Committee.

The text of the bill is available at http://finance.senate.gov/sitepages/leg/LEG%202008/080108%20Comparative%20Effectiveness%20Leg%20text.pdf.

A section-by-section summary of the bill is available at http://finance.senate.gov/sitepages/leg/LEG%202008/080108%20CE%20Section-by-Section.pdf.