Electronic health record (EHR) vendor eClinicalWorks (eCW) recently entered into a settlement with the US Department of Justice (DOJ) and the Department of Health and Human Services’ Office of Inspector General (OIG) to resolve allegations under the federal False Claims Act (FCA) that eCW misrepresented its software and paid customers kickbacks to promote its products. The settlement imposes joint and several liability for payment on the EHR Vendor and three of its founders for $154.92 million, and liability for settlement payments individually by a developer ($50,000) and two project managers ($15,000 each). The settlement resolves a qui tam whistleblower action and the government’s complaint-in-intervention in United States ex rel. Delaney v. eClinicalWorks LLC, 2:15-CV-00095 (D. Vt.).
The settlement stems from allegations that eCW hid from its certifying entity that its software did not meet the EHR certification requirements under the Meaningful Use program. Among other things, the government alleged that eCW included drug code functionality to satisfy the 16 drug codes required for the testing, but that the software could not retrieve any other drug codes. The OIG alleged that eCW did not include the ability to transfer patient data to other EHR software vendors, a practice which is commonly referred to as “information blocking” and which was recently addressed in the 21st Century Cures Act, as well as in several state legislatures. Furthermore, the eCW software also apparently lacked an audit log function and did not perform drug-to-drug interaction checks.
The settlement included a corporate integrity agreement (CIA) that was described by the Department of Justice in its announcement as “innovative.” In addition to fairly typical requirements of retaining an independent oversight organization to assess quality control systems and provide semi-annual reports to the OIG and eCW, and promptly notifying customers on safety-related issues, eCW agreed to several unique conditions. The CIA requires eCW to:
- provide its customers with an updated version of eCW’s EHR software, as well as updated to the drug databases that the software supports;
- provide its customers all updates, upgrades and fixes that are necessary to comply with the ONC Health IT Certification Program requirements;
- allow its customers to obtain the updates free of charge;
- provide customers with the option to have their data transferred to another EHR vendor without service charges or penalties, and the data must be structured in a format that permits the data to be usable by the other vendor’s software; and
- retain an Independent Review Organization to review its arrangements with health care providers to assure compliance with the Anti-Kickback Statute.
The CIA also makes clear that eCW cannot restrict the ability of its customers to share information with each other regarding their experiences with eCW’s software, such as reporting issues related to interoperability or information blocking, sharing user experiences that may affect patient care and participating in cyber-threat sharing activities.
According to DOJ, the matter was jointly handled by it Civil Division, the U.S. Attorney’s Office for the District of Vermont, the OIG, and multiple HHS agencies and components.