Adverse-event reporting is a hot topic on the state and federal level, and where reporting is required, failure can result in criminal or civil penalties and licensure problems. Now it turns out that the Department of Justice sees fertile grounds for False Claims Act cases in this area as well.

“Many assistant U.S. attorneys say ‘we have all these federal and state mandatory reporting regimes, and if hospitals have quality-of-care issues and we go back and see they never reported an adverse event, that is fairly strong evidence of reckless disregard about the quality of care they deliver,” said former federal prosecutor Michael Morse. “I hear more and more from assistant U.S. attorneys across the country that they will look for that as evidence of intent” to defraud in a false claims case.

Hospitals should grab the bull by the horns in this area because all of them make medical errors and the government is cracking down, said Morse, who’s now with Pietragallo Gordon Alfano Bosick & Raspanti in Philadelphia. “There are a wide range of reporting requirements,” he says. “It’s very complex for health care providers.”

States Have Widely Differing Reporting Mandates

For starters, there are 26 states with reporting mandates for adverse medical events, Morse said. “They differ widely,” he says. Some require hospitals to immediately inform the state when there’s been an adverse event; Texas, in contrast, mandates annual reporting. Some states require hospitals to conduct a root-cause analysis to determine the origin of the adverse event. The content of the mandatory reports also varies.

States take dissimilar approaches to punishing hospitals for failure to report adverse events. California can charge a hospital with a misdemeanor, Morse says, although most states impose civil fines. Some states use administrative sanctions (e.g., Medicaid termination). For example, New York state Medicaid Inspector General Jim Sheehan has said repeatedly that providers may be expelled from Medicaid for substandard care.

Adverse events are defined differently by various states. Morse says most states require hospitals to report on many adverse events, and it’s some version that’s similar to the National Quality Forum’s 27 adverse events that are “serious and largely preventable.” To name a few: surgery performed on the wrong body part or patient or the wrong surgery altogether (Medicare doesn’t pay for those same three surgical “never events”); artificial insemination with the wrong donor sperm or donor egg; unintended retention of a foreign object in a patient after surgery or other procedure; patient death or serious disability associated with patient elopement (disappearance); patient death or serious disability associated with a medication error; patient death or serious disability associated with a fall while being cared for in a health care facility; and stage 3 or 4 pressure ulcers acquired after admission to a health care facility.

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