- eClinicalWorks has agreed to pay $155 million to resolve allegations that the EHR company misled consumers about the certification of its EHR technology and paid some customers kickbacks in return for positive promotion of its product, the Department of Justice announced midweek.
“Every day, millions of Americans rely on the accuracy of their electronic health records to record and transmit their vital health information,” Acting Assistant Attorney General for the Civil Division Chad A. Readler said in a public statement. “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.”
Brendan Delaney, a former employee of the New York City Division of Health Care Access and Improvement, filed the lawsuit in the District of Vermont under the qui tam provision of the False Claims Act and will receive $30 million as part of the resolution.
“This settlement is the largest False Claims Act recovery in the District of Vermont and we believe the largest financial recovery in the history of the State of Vermont,” Acting United States Attorney for the District of Vermont Eugenia Cowles stated.
“This significant recovery is a testament to the hard work and dedication of this office and our partners in the Commercial Litigation Branch of the Civil Division and at HHS,” she continued. “This resolution demonstrates that EHR companies will not succeed in flouting the certification requirements.”
According to the lawsuit, the government alleges that eClinicalWorks obtained EHR certification illegally by concealing from its certification body the inability of its EHR technology to comply with certification criteria:
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. 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.
Additional allegations contend that the EHR company’s “certified” technology failed to meet data portability requirements.
As a result of falsely certified EHR technology, the federal government paid out millions in EHR incentive payments to eClinicalWorks users that attested successfully for meaningful use.
The company and its three founders — CEO Girish Navani, CMO Rajesh Dharampuriya, MD, and COO Mahesh Navani — will be responsible for paying $154.9 million to the federal government. One developer and two project managers are on the hook for a combined $80,000.
Under the settlement, the EHR company headquartered in central Massachusetts will enter into a five-year Corporate Integrity Agreement (CIA) with the Office of Inspector General (OIG), which includes a provision that eClinicalWorks “retain an Independent Software Quality Oversight Organization to assess ECW’s software quality control systems and provide written semi-annual reports to OIG and ECW documenting its reviews and recommendations.”
Customers of the EHR company will be able to obtain updated versions of eClinicalWorks at no cost or transfer their data to another EHR software free of charge.
eClinicalWorks has denied all allegations.