Electronic Health Records Vendor to Pay $155 Million False Claims Penalty
As FDA extends its medical product safety-effectiveness intelligence gathering into private sector “real world evidence,’ a False Claims Act settlement by one of the nation’s largest vendors of electronic health records (EHR) software, eClinicalWorks, could cast a shadow on the reliability of such data. FDA sees its ongoing real world evidence initiative as a potential source of additional information about the benefits and risks of medical products, different from data collected through randomized controlled clinical trials. The hope is that it could supplement and, in some cases, replace clinical trial data to identify new treatment uses that can benefit patients.
Under the settlement, eClinicalWorks and certain employees will pay a total of $155 million to resolve a False Claims Act lawsuit alleging that it misrepresented the capabilities of its software, according to the Justice Department. The settlement also resolves allegations that the company paid kickbacks to certain customers in exchange for promoting its product.
“Every day, millions of Americans rely on the accuracy of their electronic health records to record and transmit their vital health information,” a Justice release says. “This resolution is a testament to our deep commitment to public health and our determination to hold accountable those whose conduct results in improper payments by the federal government.”
In its complaint-in-intervention, the government contends that eClinicalWorks (ECW) falsely obtained a certification for its EHR software when it concealed from its certifying entity that its software did not comply with the requirements for certification. “For example, in order to pass certification testing without meeting the certification criteria for standardized drug codes, the company modified its software by ‘hardcoding’ only the drug codes required for testing,” the government says. “In other words, rather than programming the capability to retrieve any drug code from a complete database, ECW simply typed the 16 codes necessary for certification testing directly into its software. ECW’s software also did not accurately record user actions in an audit log and in certain situations did not reliably record diagnostic imaging orders or perform drug interaction checks. In addition, ECW’s software failed to satisfy data portability requirements intended to permit healthcare providers to transfer patient data from ECW’s software to the software of other vendors. As a result of these and other deficiencies in its software, ECW caused the submission of false claims for federal incentive payments based on the use of ECW’s software.”