NextGen Healthcare Inc. (NextGen), an digital well being document (EHR) know-how vendor, has agreed to pay $31 million to resolve allegations that NextGen violated the False Claims Act (FCA) by misrepresenting the capabilities of sure variations of its EHR software program and offering illegal remuneration to its customers to induce them to advocate NextGen’s software program.
“Digital well being data are a vital a part of our well being care system” stated Principal Deputy Assistant Legal professional Common Brian M. Boynton, head of the Justice Division’s Civil Division. “Every single day, thousands and thousands of sufferers and well being care suppliers throughout the nation depend on such data to precisely establish and transmit very important well being info. The Civil Division is dedicated to defending the integrity of the digital well being data software program that’s accessible to suppliers and the method by which they determine which software program to pick out.”
The American Restoration and Reinvestment Act of 2009 established the Medicare and Medicaid EHR Incentive Program to encourage well being care suppliers to undertake and exhibit their “significant use” of EHR know-how. Underneath this system, the U.S. Division of Well being and Human Companies (HHS) made incentive funds to eligible well being care suppliers that adopted licensed EHR know-how and met sure necessities regarding their use of the know-how. To acquire certification for his or her product, corporations that develop and market EHR know-how are required to exhibit that their product(s) satisfies all relevant HHS-adopted certification standards; the corporate should additionally establish any software program parts on which their EHR depends to carry out the standards. Builders should first go testing carried out by an impartial, accredited testing laboratory licensed by HHS, after which get hold of and preserve certification by an impartial, accredited certification physique licensed by HHS.
In a criticism filed along with the settlement, the USA contends that NextGen falsely obtained certification for its software program in reference to the 2014 Version certification standards printed by HHS’s Workplace of the Nationwide Coordinator. Particularly, the federal government alleges that NextGen relied on an auxiliary product designed solely to carry out the certification take a look at scripts, which hid from the certifying entity that NextGen’s EHR lacked essential performance. The federal government alleges that, consequently, the EHR that NextGen finally launched to its customers lacked sure required functionalities, together with the power to document very important signal information, translate information into required medical vocabularies, and create full scientific summaries.
In its criticism, the federal government additionally alleges that NextGen violated the Anti-Kickback Statute, which prohibits anybody from providing or paying, immediately or not directly, any remuneration to induce referrals of things or providers lined by Medicare, Medicaid, and different federally funded packages. In its criticism, the federal government contends that, however this prohibition, NextGen knowingly gave credit, usually value as a lot as $10,000, to present clients whose advice of NextGen’s EHR software program led to a brand new sale. The federal government alleges that different remuneration, together with tickets to sporting occasions and leisure, was additionally supplied to induce purchases and referrals.
“Digital well being data play a pivotal function within the provision of protected, efficient well being care, and the testing and certification strategy of the EHR Incentive Program was supposed to supply assurances to suppliers that their EHR can carry out sure necessary features,” stated U.S. Legal professional Nikolas P. Kerest for the District of Vermont. “With this settlement, our workplace has now resolved 5 investigations into misconduct by EHR corporations, demonstrating our dedication to making sure that EHR corporations are held chargeable for their misrepresentations.”
“Medical suppliers should be capable of depend on digital well being data techniques to accurately doc and course of necessary well being information for continuity of affected person care,” stated Particular Agent in Cost Maureen R. Dixon for the HHS, Workplace of the Inspector Common (HHS-OIG). “We’ll proceed to work with our worthwhile regulation enforcement companions to guage allegations introduced beneath the False Claims Act and make sure the integrity of Medicare packages.”
The civil settlement contains the decision of claims introduced beneath the qui tam or whistleblower provisions of the False Claims Act by Toby Markowitz and Elizabeth Ringold, well being care professionals at a facility that used NextGen’s software program. Underneath these provisions, a personal celebration can file an motion on behalf of the USA and obtain a portion of any restoration. The whistleblowers on this case will obtain $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 federal government’s emphasis on combating well being care fraud, together with within the well being care know-how area. One of the vital highly effective instruments on this effort is the FCA. Suggestions and complaints from all sources about potential fraud, waste, abuse, and mismanagement could be reported to the Division of Well being and Human Companies at 800-HHS-TIPS (800-447-8477).
The decision obtained on this matter was the results of a coordinated effort between the Justice Division’s Civil Division, Industrial Litigation Department, Fraud Part, and the U.S. Legal professional’s Workplace for the District of Vermont. Investigative help and help was supplied by the Division of Well being and Human Companies, Workplace of Counsel to the Inspector Common and OIG Workplace of Investigations.
The matter was dealt with by Fraud Part Attorneys Christelle Klovers and Kelley Hauser and Assistant U.S. Legal professional Lauren Almquist Energetic for the District of Vermont.
The claims within the relators’ and the federal government’s complaints are allegations solely and there was no dedication of legal responsibility.