Research News

Law School, VUMC team up on DHHS grant to develop and test “safe harbor” standards of care

By Grace Renshaw

Three emergency medical workers rushing patient in gurney down hall past sign reading "Emergency"

A team of researchers from Vanderbilt University’s schools of Law, Medicine and Management has received a five-year research grant from the Agency for Healthcare Research and Quality of the Department of Health and Human Services to develop and test “safe harbor” standards of care based on scientific evidence.

A goal of the project is to reduce the number of unnecessary medical procedures performed primarily to reduce legal liability, a practice known as “defensive medicine.” Benefits could include lower costs and improved quality of care, resulting from medical patients’ reduced exposure to radiation.

The multi-disciplinary project team is headed by James Blumstein, University Professor of Constitutional Law and Health Law and Policy, and Associate Professor of Emergency Medicine Alan Storrow and includes University Distinguished Professor of Law, Economics and Management W. Kip. Viscusi,Associate Professor of Management R. Lawrence Van Horn, Assistant Professor Benjamin McMichael, JD/PhD’17, of the University of Alabama School of Law, Professor of Emergency Medicine Sean Collins, Associate Professor of Radiology and Radiological Sciences Jake Block and Research Coordinator Jakea Johnson. The team will be joined by investigators from Northwestern University Feinberg School of Medicine and Harvard Medical School.

“Our project integrates the perspectives of experts in law and policy, emergency medicine and risk management to examine medical liability with the aim of developing medical malpractice ‘safe harbors’ by establishing standards of care that are accepted by both medical and legal policy makers.” Blumstein said. “We will focus on the legal, policy and empirical dimensions of defensive medicine and develop medical practice protocols with the goal of reducing unnecessary medical procedures that represent a risk to the patient and drive up health care costs.”

Storrow, who practices in Vanderbilt Medical Center’s adult emergency department, notes that the Choosing Wisely campaign, an American Board of Internal Medicine initiative, has issued detailed guidelines to help patients and providers reduce overuse of potentially harmful diagnostic tests and procedures by engaging in a frank discussion of their risks and benefits in advance. However, the guidelines do not address liability risks, which Storrow believes is why they have yet to be widely adopted by doctors and other providers. “Until these liability issues are addressed, fear of litigation will continue to drive providers to perform more tests and procedures than may be truly necessary,” he said.

The project will be completed in three phases. To complete phase one, the research team will assemble a representative group of technical experts and advisors to define safe-harbor standards for a narrow set of distinct clinical conditions within emergency medicine. The safe-harbor standards they develop will include both medical and legal components and will be reviewed and considered for approval and adoption by the appropriate Quality Improvement Organizations. During phase two, emergency medicine practitioners will deploy the safe-harbor protocols at Vanderbilt University Medical Center. Their efficacy in reducing unnecessary medical procedures, including the effects of the safe-harbor protocols on clinical decision making, adverse reporting, utilization, radiation exposure, patient satisfaction and clinical outcomes, will be examined and evaluated in phase three. Northwestern University Medical Center is also participating in the study to provide a basis for comparison.

Blumstein has envisioned such an interdisciplinary research project for more than a decade, having proposed the development of safe-harbor standards of care as a means of curtailing “defensive medicine” in his 2006 Vanderbilt Law Review article,“Medical Malpractice Standard-Setting: Developing Malpractice ‘Safe Harbors’ as a New Role for QIOs.” He argues that diagnostic and other procedures performed primarily to reduce potential legal liability not only increase the cost of medical care, but also expose patients to radiation and other risks of medical treatment unnecessarily.

In his article, Blumstein proposed the establishment of science-based standards of care which, if rigorously followed by medical practitioners, would represent a “safe harbor”―a legal defense against malpractice lawsuits. “Juries are currently determining the standard of care, which means non-experts end up deciding what the standard of care should be long after it’s delivered,” Blumstein said. “Plaintiffs and defendants in malpractice lawsuits bring in competing medical experts who testify in court that a doctor did or did not follow prevailing standards of care, and the jury must decide which story they believe. If we develop detailed standards of care that are accepted in advance by both medical practitioners and legal policy makers, and rely on those standards to deliver care and establish liability, we can reduce the practice of defensive medicine and the cost of care and reduce risks to patients.”

The Vanderbilt team engaged in the standard-setting process funded by the AHRQ will adopt a set of standards, test them at Vanderbilt, compare the results with practices at Northwestern, and examine the overall results. Blumstein believes that, by providing clear guidance in advance regarding the standards of care needed to mitigate legal risk and liability, the standards will reduce physician uncertainty and improve the quality of patient care. “This study, which will focus on emergency care, affords us an opportunity to pick off the low-hanging fruit, and it will also help us develop the approach, methodology and analysis to extend safe-harbor standards to other practice areas where defensive medicine drives up costs and increases patient risk,” he said.

The study funded by the AHRQ grant, which is in excess of $1.7 million, is slated to begin in April 2019.