03 June, 2017
To obtain certification for their product, companies that develop and market EHR software must attest that their product satisfies applicable HHS-adopted criteria and pass testing by an accredited independent certifying entity approved by HHS.
The government's settlement agreement holds eCW and eCW's founders and executives Girish Navani, Dr. Rajesh Dharampuriya, and Mahesh Navani liable for payment.
Brendan Delaney, a software technician, uncovered the alleged fraud while working for the New York City Division of Health Care Access implementing eClinicalWorks systems for the Rikers Island prison, according to his private attorney.
A whistleblower represented by law firm of Phillips & Cohen LLP provided key information to the government that led to eClinicalWorks (eCW ) settlement of civil fraud and kickback charges for $155 million, Phillips & Cohen LLP said in a statement.
EClinicalWorks said it disputed the DOJ's allegations, yet made a decision to settle to avoid the cost and uncertainty inherent in protracted litigation.
The company disputes the Justice Department's allegations and denies any wrongdoing, saying in a statement on Wednesday that it ensured that its software met Meaningful Use program requirements before its release and addressed certification issues according to the process established by the government.
ECW also allegedly failed to properly test the software before it was released, failed to meet data portability requirements, and paid kickbacks totaling more than $392,000 to some customers in exchange for promoting the software.
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. But Black Book Research Managing Partner Doug Brown has ranked the vendors most likely to gain from eClinicalWorks' small providers and physician practice clients. A developer and two project managers will pay $80,000. It also says the flaws were brought to the company's attention but it continued to sell its software without fixing them.
The case represents the first time the government has held an electronic health records vendor accountable for failure to meet federal standards, said Colette Matzzie, a Phillips & Cohen attorney. The company also noted that it had discontinued its customer referral program, adding that such programs are "common in the industry".
It is the largest False Claims Act recovery ever in the district of Vermont, said Eugenia Cowles, acting USA attorney for Vermont.
"Today's settlement recognizes that we have addressed the issues raised and have taken significant measures to promote compliance and transparency", said CEO Girish Navani, who will pay part of the settlement.
"This resolution demonstrates that EHR companies will not succeed in flouting the certification requirements", she said in a release. "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".
And it might be a shoutout to other EHR vendors, too. The vendor has also entered into a Corporate Integrity Agreement with the Department of Health and Human Services Office of Inspector General to retain an independent organization to assess software quality, and give consumers the option to update their versions of the software for free, or transfer to another provider without penalty.
The case was initially filed as a whistleblower suit in Vermont in May 2015, according to court documents.
This matter was jointly handled by Assistant United States Attorneys Owen C.J. Foster and Nikolas P. Kerest of the U.S. Attorney's Office for the District of Vermont, Kelley Hauser and Edward Crooke of the Commercial Litigation Branch of the Civil Division, the HHS Office of Inspector General, and multiple HHS agencies and components.
