The US Department of Justice (“DOJ”) is currently weighing whether to intervene in a whistleblower suit brought against Community Health Systems (“CHS”), a Tennessee-based hospital system, by two former employees alleging that CHS covered up potentially dangerous flaws in their Electronic Health Records (“EHR”) system. This comes on the heels of two other similar cases, ultimately resulting in EHR vendors reaching settlement agreements with the DOJ.
In 2011, the Centers for Medicare and Medicaid Services (“CMS”) established the Electronic Health Record Incentive Program, an effort intended to bring to a close the use of paper medical records, and the medical errors associated with it, by encouraging healthcare providers and hospitals to “adopt, implement, upgrade and successfully demonstrate meaningful use” of certified EHRs. The program provided healthcare providers and hospitals with incentives to pay vendors to install EHRs. EHR vendors had to meet certification standards provided by the Department of Health and Human Services National Coordinator for Health Information Technology, while providers had to attest that their EHR software could perform a variety of specified functions to demonstrate “meaningful use” of the software.
Unfortunately, according to the DOJ, some EHR vendors gamed the system. For instance, in February 2019, the DOJ announced that it had reached a settlement agreement with Greenway Health, of Tampa, Florida, over False Claims Act (“FCA”) allegations involving the company’s EHR software. Specifically, the DOJ alleged that Greenway falsely obtained certification for its software, which did not fully comply with certification standards and was capable of causing patient safety related errors. The DOJ further alleged that Greenway accomplished this by modifying its prototype software so that it appeared to meet the requirements. To settle the suit, Greenway agreed to pay $57.25 million, and entered into a 5-year Corporate Integrity Agreement.
In a similar case in 2017, the DOJ announced that it reached a settlement agreement with eClinicalWorks, of Westborough, Massachusetts, also over FCA allegations. In that case, the DOJ alleged that eClinicalWorks misrepresented the capabilities of and falsely obtained certification for its EHR software, and paid kickbacks to customers in exchange for promoting its products. eClinicalWorks agreed to pay $155 million to resolve the suit, and also entered into a Corporate Integrity Agreement.
In the present case, the whistleblowers allege that the CHS EHR software failed to track prescriptions or dosages properly, posing a “significant safety concern.” Further, the suit alleges that CHS knew about the flaws and covered them up, so that they could fraudulently receive over $450 million in federal “meaningful use” incentive payments.
It remains to be seen if DOJ will intervene in the CHS case, but they are clearly paying attention. Meanwhile these FCA actions add another layer of complexity to the EHR incentive programs, which has been fraught with confusion and delays for some time now.