Greenway Health LLC (Greenway), a Tampa, Florida-based developer of electronic health records (EHR) software, will pay $57.25 million to resolve allegations in a complaint filed by the United States under the False Claims Act alleging that Greenway caused its users to submit false claims to the government by misrepresenting the capabilities of its EHR product “Prime Suite” and providing unlawful remuneration to users to induce them to recommend Prime Suite, the Justice Department announced today.
“Electronic health records are critically important to the health care decision process, and both patients and providers rely on these technologies to safely and accurately record and transmit vital health information,” said Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division. “This resolution demonstrates our continued commitment to pursue EHR vendors who misrepresent the capabilities of their products, and our determination to promote public health while holding accountable those who seek to abuse the government’s trust.”
The American Recovery and Reinvestment Act of 2009 established the Medicare and Medicaid EHR Incentive Program to encourage healthcare providers to adopt and demonstrate their “meaningful use” of EHR technology. Under the program, the U.S. Department of Health and Human Services (HHS) made incentive payments available to eligible healthcare providers that adopted certified EHR technology and met certain requirements relating to their use of the technology. To obtain certification for their product, companies that develop and market EHR technology are required to demonstrate that their product(s) satisfies all applicable HHS-adopted certification criteria. Developers must first pass testing performed by an independent, accredited testing laboratory authorized by HHS, and then obtain and maintain certification by an independent, accredited certification body authorized by HHS.
In its complaint, the government contends that Greenway falsely obtained 2014 Edition certification for its product Prime Suite when it concealed from its certifying entity that Prime Suite did not fully comply with the requirements for certification. Among other things, Greenway’s product did not incorporate the standardized clinical terminology necessary to ensure the reciprocal flow of information concerning patients and the accuracy of electronic prescriptions. Greenway accomplished its deception by modifying its test-run software to deceive the company hired to certify Prime Suite into believing that it could use the requisite clinical vocabulary.
Additionally, in order to be eligible to receive incentive payments, healthcare providers were required to meet certain targets for EHR-related activities. For example, at certain times providers were required to provide patients with clinical summaries following office visits. In its complaint, the government further alleges that Greenway was aware that an earlier version of Prime Suite, which was certified to 2011 Edition criteria, did not correctly calculate the percentage of office visits for which its users distributed clinical summaries and thereby caused certain Prime Suite users to falsely attest that they were eligible for EHR incentive payments. Greenway refrained from rectifying this error in order to ensure that its users would receive incentive payments. As a result, numerous users of this earlier version of Prime Suite falsely attested that they were eligible for EHR incentive payments when, in fact, they had not met all necessary use requirements
Finally, the government also alleged that Greenway violated the Anti-Kickback Statute by paying money and incentives to its client providers to recommend Prime Suite to prospective new customers.
As part of the settlement, Greenway entered into a five-year Corporate Integrity Agreement (CIA) with the HHS Office of Inspector General (HHS-OIG) covering the company’s EHR software. This innovative five-year CIA requires, among other things, that Greenway retain an Independent Review Organization to assess Greenway’s software quality control and compliance systems and to review Greenway’s arrangements with health care providers to ensure compliance with the Anti-Kickback Statute. Greenway must provide prompt notice to its customers of any patient safety related issues and maintain on its customer portal a comprehensive list of such issues and any steps users should take to mitigate potential patient safety risks. The CIA also requires Greenway to allow Prime Suite customers to obtain the latest versions of Prime Suite at no additional charge, the opportunity to migrate their data from Prime Suite to another Greenway-developed software product also at no additional charge, and to give Prime Suite customers the option to have Greenway transfer their data to another EHR software vendor without penalties, service charges, or any other fees other than contractual amounts still owed in connection with goods or services already provided.
“Electronic Health Records can be key to an integrated health system providing improved care” said Derrick Jackson, Special Agent in Charge for the Office of Inspector General of the U.S. Department of Health and Human Services. “Putting patients at risk will result in intensive investigation and compliance obligations such as those in OIG’s comprehensive five-year Corporate Integrity Agreement.”
This matter was jointly handled by the Civil Division’s Commercial Litigation Branch, the U.S. Attorney’s Offices for the District of Vermont and Northern District of Georgia, the HHS Office of Inspector General, and multiple HHS agencies and components. The Federal Bureau of Investigation’s field office in Atlanta, Georgia provided significant investigative support to the investigation.
The case is captioned United States v. Greenway Health, LCC, 2:19-CV-20 (D. Vt.). The claims resolved by the settlement are allegations only, and there has been no determination of liability.