The Department of Justice (DOJ) recently announced a $57.25 million settlement with an electronic health records (EHR) vendor to resolve allegations of False Claims Act (FCA) violations. Greenway Health LLC (Greenway), a Tampa, Florida-based developer of EHR software, allegedly sold EHR software to health care providers that did not satisfy federal health care program standards. In addition, Greenway allegedly caused its users to submit false claims to the government that misrepresented the capabilities of its EHR product, “Prime Suite,” and provided unlawful remuneration to users to induce them to recommend Prime Suite. The government also claims that Greenway violated the federal Anti-Kickback Statute (AKS) through incentives it paid its client providers to recommend the use of Prime Suite to prospective new customers.
Under the American Recovery and Reinvestment Act of 2009 (ARRA), which established the Medicare and Medicaid EHR Incentive Program, the Department of Health and Human Services (HHS) made incentive payments available to eligible providers that adopted certified EHR technology and met certain technology use requirements. Companies that develop and market the EHR technology are required to demonstrate that their product(s) satisfy HHS certification requirements to obtain certification for their product(s). To do so, developers must first pass independent, accredited laboratory performance testing, then obtain and maintain certification from an independent, accredited certification body that HHS has authorized. Additionally, for health care providers to receive incentive payments under ARRA, they must meet certain targets for EHR-related activities.
The government contends that Greenway falsely obtained 2014 Edition certification for Prime Suite by concealing from its certifying entity that Prime Suite did not comply with certification requirements. In addition, Prime Suite did not incorporate the necessary standardized clinical terminology to ensure reciprocal flow of information concerning patients and the accuracy of electronic prescriptions. Greenway allegedly modified its test-run software to deceive the company hired to certify that Prime Suite could use the required clinical vocabulary. Further, the government claims that an earlier version of Prime Suite, certified to the 2011 Edition criteria, did not correctly calculate the percentage of office visits for which users distributed clinical summaries. This caused certain Prime Suite users to falsely attest that they were eligible for EHR incentive payments. The government alleges that Greenway purposely did not rectify this error in order to obtain incentive payments.
Greenway entered into a five-year Corporate Integrity Agreement (CIA) with the HHS Office of Inspector General, to address the allegations regarding the company’s EHR software. Under the CIA, Greenway must, among other requirements, retain an Independent Review Organization to assess its software quality control and compliance systems and review its arrangements with health care providers to ensure AKS compliance. In addition, Greenway must provide its customers with prompt notice of any patient safety related issues. The company must maintain a comprehensive list of such issues and outline steps that users can take to mitigate potential patient safety risks on its customer portal. The CIA also requires Greenway to provide its customers with the following options, at no additional cost: 1) Obtain the most recent version of Prime Suite; 2) Migrate their data from Prime Suite to another Greenway-developed software product; and 3) Allow Greenway to transfer their data to another EHR software vendor.
The DOJ press release is available at: