On July 13, NextGen Healthcare Inc. (NextGen), an electronic health record (EHR) software vendor, reached an agreement with the Department of Justice (DOJ) and the Office of Inspector General of the Department of Health and Human Services (HHS) to pay $31 million to resolve alleged False Claims Act and Anti-Kickback Statute violations.^[1] The settlement is the latest in a series of enforcement actions brought by DOJ against EHR vendors, and reflects DOJ’s continued scrutiny of health care technology companies as networks and providers increasingly rely on third-party software to support patient care.

DOJ’s Recent Settlement With NextGen

The allegations regarding NextGen’s EHR system pertain to the Center for Medicare & Medicaid Services’ (CMS) EHR Incentive Program.^[2] That program made incentive payments to eligible health care providers that adopted certified EHR technology and demonstrated their “meaningful use” of that technology by meeting certain requirements. To obtain certification, the EHR developer must show that their product satisfies the applicable HHS-adopted certification criteria. The developer must also identify any software components on which their EHR system relies to meet criteria. An independent, accredited testing laboratory authorized by HHS tests the EHR’s capabilities. If the software passes that testing, a separate independent, accredited certification body decides whether to certify the EHR and conducts ongoing surveillance of its capabilities....

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