Description: Burlington, Vermont civil litigation lawyers represented Defendant accused of violating the False Claims Act by misrepresenting the capabilities of certain versions of its EHR software and providing unlawful remuneration to its users to induce them to recommend NextGen’s software.
“Electronic health records are an essential part of our healthcare system” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Department of Justice’s Civil Division. “Every day, millions of patients and healthcare providers across the country rely on such records to accurately identify and transmit vital health information. The Civil Division is committed to protecting the integrity of the electronic health records software that is available to providers and the process by which they decide which software to select.”
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 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; the company must also identify any software components on which their EHR relies to perform the 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 a complaint filed in conjunction with the settlement, the United States contends that NextGen falsely obtained certification for its software in connection with the 2014 Edition certification criteria published by HHS’s Office of the National Coordinator. Specifically, the government alleges that NextGen relied on an auxiliary product designed only to perform the certification test scripts, which concealed from the certifying entity that NextGen’s EHR lacked critical functionality. The government alleges that, consequently, the EHR that NextGen ultimately released to its users lacked certain required functionalities, including the ability to record vital sign data, translate data into required medical vocabularies, and create complete clinical summaries.
In its complaint, the government also alleges that NextGen violated the Anti-Kickback Statute, which prohibits anyone from offering or paying, directly or indirectly, any remuneration to induce referrals of items or services covered by Medicare, Medicaid, and other federally funded programs. In its complaint, the government contends that, notwithstanding this prohibition, NextGen knowingly gave credits, often worth as much as $10,000, to current customers whose recommendation of NextGen’s EHR software led to a new sale. The government alleges that other remuneration, including tickets to sporting events and entertainment, was also provided to induce purchases and referrals.
“Electronic health records play a pivotal role in the provision of safe, effective healthcare, and the testing and certification process of the EHR Incentive Program was intended to provide assurances to providers that their EHR can perform certain important functions,” said United States Attorney for the District of Vermont, Nikolas P. Kerest. “With this settlement, our office has now resolved five investigations into misconduct by EHR companies, demonstrating our commitment to ensuring that EHR companies are held responsible for their misrepresentations.”
“Medical providers must be able to rely on electronic health records systems to correctly document and process important health data for continuity of patient care,” said Maureen R. Dixon, Special Agent in Charge for the U.S. Department of Health and Human Services, Office of the Inspector General. “We will continue to work with our valuable law enforcement partners to evaluate allegations brought under the False Claims Act and ensure the integrity of Medicare programs.”
The civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by Toby Markowitz and Elizabeth Ringold, healthcare professionals at a facility that used NextGen’s software. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. The whistleblowers in this case will receive $5,580,000. The qui tam case is captioned United States ex rel. Markowitz et al. v. NextGen Healthcare, Inc., Case No. 2:18-cv-195 (D. Vt.).
The investigation and pursuit of this matter illustrate the government’s emphasis on combating healthcare fraud, including in the healthcare technology arena. One of the most powerful tools in this effort is the FCA. Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement, can be reported to the Department of Health and Human Services at 800-HHS-TIPS (800-447-8477).
The resolution obtained in this matter was the result of a coordinated effort between the Justice Department’s Civil Division, Commercial Litigation Branch, Fraud Section, and the United States Attorney’s Office for the District of Vermont. Investigative support and assistance was provided by the Department of Health and Human Services, Office of Counsel to the Inspector General and OIG Office of Investigations.
The matter was handled by Assistant U.S. Attorney Lauren Almquist Lively and Fraud Section Attorneys Christelle Klovers and Kelley Hauser.
Outcome: Settled for $31 million.
The claims in the Relators’ and the government’s complaints are allegations only and there has been no determination of liability.
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