Konica Minolta Healthcare Americas will pay $500,000 to settle a whistleblower case that alleged its Viztek electronic health record subsidiary had falsified data for certification tests.

WHY IT MATTERS
In the qui tam complaint, filed in 2017 in U.S. District Court in New Jersey – where Konica Minolta is based – was filed by whistleblower Leighsa Wilson, who worked for two years at Viztek, best known for its PACS and imaging technologies, as a project manager for its EXA EHR product.

In mid-2015, the complaint alleges, Viztek, which was in negotiations to be acquired by Konica Minolta, worked together with InfoGard Laboratories (which was then an ONC-authorized certification and testing body) to make false representations that the EHR software complied with requirements for certification – and qualified for receipt of incentive payments under the federal meaningful use program.

"To ensure that their product was certified and that their customers received incentive payments, Viztek and Konica Minolta: (a) falsely attested to InfoGard that their software met the certification criteria; (b) hard-coded their software to pass certification testing requirements temporarily without ensuring that the software released to customers met certification criteria; and (c) caused their users to falsely attest to using a certified EHR technology, when their software could not support the applicable certification criteria in the field," according to the complaint, which also alleges that InfoGard "facilitated and participated in" these false attestations, "knowingly or with reckless disregard," certifying the EHR software despite its inability to meet ONC's certification criteria.

The flaws in Viztek's software "not only rendered the system unreliable and unable to meet meaningful use standards, but the flaws also created a risk to patient health and safety. Rather than spend the time and resources necessary to correct the flaws in its EHR software, the EHR defendants opted to do nothing."

THE LARGER TREND
This is only the most recent settlement of this type from health IT vendors accused of False Claims Act violations, of course.

Most notable, was the case of eClinicalWorks, which was alleged by the Department of Justice to have falsely claimed meaningful use certification, to have neglected to have safety addressed issues in its software and to have paid kickbacks to clients. That case was settled in 2017 for $155 million.

More recently, similar complaints were lodged against companies such as Practice Fusion and Greenway Health. They settled with DOJ for $145 million and $57 million, respectively.

"We will be unflagging in our efforts to preserve the accuracy and reliability of Americans’ health records and guard the public against corporate greed," said U.S. Attorney for the District of Vermont Christina Nolan after the Greenway case this past year. "EHR companies should consider themselves on notice."

ON THE RECORD
"The lives of patients depend upon the information processed by electronic health records," said Wilson – who, as a qui tam whistleblower will receive 20% of the financial settlement – in a statement. "Functionality testing and subsequent certification must be performed and obtained through a reliable, measurable process."

"Filing a qui tam lawsuit is a powerful and effective way to report problems with EHR software purchased with federal funds and get the problems fixed when they are ignored," said Luke Diamond, an associate at Phillips & Cohen. "The False Claims Act protects whistleblowers from job retaliation and offers rewards if the government recovers funds as a result of the qui tam case."

"Our client was concerned about possible patient harm that can occur if EHR software isn't properly certified, so she stepped forward to inform the government about what she had witnessed," said Colette Matzzie, a partner and whistleblower attorney with Phillips & Cohen, which brought the case. "Ensuring that EHR software meets all governmental requirements is important to safeguard both patient care and federal funds."