A federal agency has fined eClinicalWorks $132,500 for failing to report patient safety issues with its software.

The timely release of this type of information is required of the electronic health records system vendor as part of a corporate integrity agreement with the Department of Health and Human Services’ Office of Inspector General.

eClinicalWorks paid the penalty for “failure to comply with its obligation to timely report Patient Safety Issues as Reportable Events” under a five-year corporate integrity agreement signed by the vendor, according to an announcement from the OIG.

The May 2017 corporate integrity agreement with OIG states that a penalty of $2,500 “shall begin to accrue on the day after the date the obligation became due) for each day eCW fails to establish and effectively implement” reporting of patient safety issues as reportable events.

The agreement was part of a settlement with the Department of Justice in which eClinicalWorks and three of its founding executives agreed to pay $155 million for allegedly violating the False Claims Act by misrepresenting the capabilities of its software. According to OIG Senior Counsel John O’Brien, based on the DOJ allegation, eClinicalWorks caused providers using its software—which did not meet Meaningful Use certification requirements—to unknowingly submit false claims to the Medicare and Medicaid EHR Incentive Program.

HHS Headquarters in Washington, D.C.
Brian M. Kalish/Employee Benefit Adviser

Also See: OIG puts EHR vendors on notice in wake of eClinicalWorks settlement

Under the corporate integrity agreement, eClinicalWorks must submit in writing to the OIG the following information:

  • A complete description of a reportable event, including the relevant facts, persons involved and legal, regulatory or other requirements implicated (including applicable federal healthcare program and ONC Health IT Certification Program requirements).
  • A description of eClinicalWorks’ actions taken to correct the reportable event.
  • Any further steps eClinicalWorks plans to take to address the reportable event and prevent it from recurring.

Among the reportable events defined in the agreement are those that involve “a patient safety issue or any identified instance of actual or suspected patient harm related to the EHR software.”

“Under our corporate integrity agreement (CIA), certain events must be reported to the OIG,” said eClinicalWorks in a written statement. “We have consistently sought to do so in a complete and timely manner to comply with the CIA, including by reporting such events to customers on our portal. The OIG determined that certain reports were not timely provided to it and assessed this penalty. We have paid the penalty and enhanced our processes to ensure timely reporting going forward.”

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