Back in mid-2017, EHR maker eClinicalWorks agreed to pay $155 million to settle a whistleblower lawsuit accusing it of a broad list of violations. In addition to paying the fine, eCW was required to sign a Corporate Integrity Agreement (CIA) essentially requiring the vendor to keep its nose clean on several levels. Given the extent of its scheme to defeat the certification process, the settlement was big news.
In most cases, that would be the last we’d hear of the matter. After all, once a vendor is forced to pay a big-ticket settlement you don’t hear about it again. Oddly enough, when they shell out multiple millions of dollars they try to stay out of trouble from that point on. However, eClinicalWorks offers a conspicuous exception to the rule.
Originally, in 2017, the Department of Justice alleged that eCW managed to get federal certification for its non-compliant EHR by covering up a multitude of problems. For example, the vendor met the certification criteria for standardized drug codes by hardcoding only the drug codes required for testing.
One year after its initial settlement, eCW incurred a $132,500 fine for failing to comply with terms related to establishing and implementing patient safety issues as reportable events.
Now, just a few years after agreeing to the massive settlement and signing off on the CIA, plus incurring an additional fine, eCW faces more problems with the Department of Justice. This time, the DoJ is demanding that eCW take on additional compliance obligations requested by the Office of Inspector General, including a range of patient safety-related problems.
Among other steps, the DOJ is requiring eCW to send a patient safety issue advisory to the designated Patient Safety Officer of each of its customers or primary contacts for customers that have not designated a Patient Safety Officer.
The OIG is also requiring the EHR vendor to submit monthly progress reports on the status of its implementation and remediation and corrective actions on critical issues related to the safety of its platform.
For what it’s worth, the feds don’t seem to be suggesting that eCW’s recent descent into non-compliance has actually harmed patients or even stands in immediate risk of doing so. These requests read more like the agencies seeing to it that the administrative processes they’ve put in place are followed scrupulously.
That being said, it’s never a good look for an EHR vendor to have claims of patient safety violations floating around in its wake. To my knowledge, none of this has caused an exodus by customers, but that may be a greater testament to the risks and expenses companies face when switching platforms than a high level of faith in eCW.
In any event, eCW is lucky that administrative and financial costs providers would face switching to a competing platform are so high. Otherwise, it might be running out of luck at this point.