Government

Liability reform demos must have patient safety element

It's not clear how closely projects must focus on medical errors in order to qualify for some of the $25 million in federal grants.

By Amy Lynn Sorrel — Posted Nov. 9, 2009

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The competition will begin in December for states and health systems seeking federal grant money designed to improve patient safety and reduce medical liability pressures on physicians through innovative approaches.

While considering recommendations from a recent advisory committee meeting, Agency for Healthcare Research and Quality officials made it clear that patient safety will be an essential element of any liability proposal they will consider for grant dollars.

States and health systems "will have to collect data to show the innovation worked and had an impact on liability claims and the cost of malpractice insurance, as well as on patient safety. So we are looking at both sides of the equation," said AHRQ Director Carolyn M. Clancy, MD. "Ultimately, to get a grant under this program, applicants have to evaluate the impact on patient safety. That is the overarching objective."

In September, President Obama authorized the Dept. of Health and Human Services to set aside $25 million for the pilot projects. Demonstration grants of up to three years and $3 million each will be awarded on a competitive basis to states and health systems whose programs are primed for implementation and evaluation. Applicants also may qualify for up to $300,000 for a one-year planning grant for an innovation that is still being developed.

Proposals may be submitted beginning Dec. 20 and are due by Jan. 20, 2010. Projects that undergo an AHRQ peer review and are approved could launch within the next year.

The agency will look at a number of criteria to determine who receives the money. "But in terms of specific innovations, we are not being prescriptive here," Dr. Clancy said.

That's a good thing, said American Medical Association Board of Trustees member William A. Hazel Jr., MD. He served on the AHRQ National Advisory Council's Subcommittee on Patient Safety and Medical Liability Reform, which met Oct. 26 to advise the agency on promising approaches.

"The criteria should be broad in order to bring in innovation, and we think it's important that everything is on the table," Dr. Hazel said.

Exploring new ideas

The AMA continues to favor noneconomic damage caps. But it also supports the testing of a range of alternatives to help cut down on defensive medicine practices and costs -- and ultimately improve health care quality and safety, Dr. Hazel said.

The subcommittee discussed some of those ideas, including health courts and early disclosure and compensation programs. The panel also heard from state health officials and hospital systems who were invited to share their experiences with existing programs. For instance, some programs require the reporting of adverse medical events and seek to identify high-risk practices.

The AMA has long advocated for patient safety improvements, Dr. Hazel said. But he added that medical liability reform plays an equally important role in bettering the health care system.

"If we are just doing patient safety, we are not taking advantage of the grants to address the medical liability issues that President Obama has said need to be addressed," he said. "And if we just do what we are already doing in another setting, we are going to lose the opportunity to tie these things together to really achieve reform."

But some medical liability proposals would not fit the bill, according to some participants in the debate.

"The idea is that these projects should be directly related to reducing medical errors and an analysis of how to reduce systemic errors in general," said Susan Steinman, director of policy for the American Assn. for Justice. The national trial lawyers trade group participated on the AHRQ subcommittee.

"Not a lot of liability projects would fall into that category. Some are simply designed to take away patients' rights," such as specialized health courts, she said. A focus on liability claims also may not be what the administration intended.

"That's a legitimate concern if we're talking about insurance reform, but that's not what HHS was directed to do," Steinman said.

Tying liability to safety

Just how tight the connection between patient safety and medical liability will have to be for a grant proposal to pass muster remains unclear, said Michelle Mello, a professor of law and public health at Harvard University School of Public Health in Boston. She also served on the AHRQ subcommittee but spoke on her own behalf.

In addition, applicants face a rather ambitious three-year timetable in which to show an impact on patient outcomes as well as on liability claims, both of which take time to process, she said. "There are some measures we can use, though, that might be more likely to measure the culture of patient safety. You can reasonably expect when an institution is going to do something good, doctors might feel more confident."

Collaboration and creativity will be key, said Janet Corcoran, a senior consultant with Common Good, a nonpartisan coalition that developed the health court concept. Because grants are open only to states and health systems, the organization would partner with other interested parties not only to implement models for resolving disputes more efficiently, but also to find ways to share any relevant information about medical errors.

Likewise, state medical societies are not eligible for individual grants but may participate in programs launched by others.

Given the limited time and funding, applicants might consider building on existing structures, Dr. Hazel said. If a particular project requires a statutory change, for instance, that could pose a barrier to approval. At the same time, however, brand-new ideas may require testing in a different, more unconventional setting.

"We want to make sure these are set up to be good, successful projects and not set up to fail," he said.

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ADDITIONAL INFORMATION

Criteria for grants

Beginning in December, states and health systems may start applying for federal grants to launch patient safety and medical liability reform demonstration projects. The Agency for Healthcare Research and Quality will determine whether a project would improve patient safety and will also look at several other criteria to decide if a proposal should be approved.

Significance: Does the proposal address an important problem?

Approach: Does the proposal have a design appropriate to the aims of the project?

Innovation: Does the proposal show originality?

Investigators: Are appropriately trained personnel available to carry out the proposal?

Environment: Does the proposal have institutional support?

Collaborative research experience: Is the team able and willing to adopt standard operating procedures?

Stakeholder involvement: Does the proposal address an issue important to all stakeholders, and are they involved in the plan?

Source: "Medical Liability Reform and Patient Safety Planning Grants (R18)," Agency for Healthcare Research and Quality (link); "Medical Liability Reform and Patient Safety Demonstration Projects (R21)," Agency for Healthcare Research and Quality (link)

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