The Department of Health and Human Services’ Office of Inspector General is sending a cautionary note to electronic health record (EHR) software vendors that it takes the EHR certification process “very seriously” and will investigate any alleged misconduct.
In a video posted to the OIG’s website, as well as on Twitter, the agency underscores that accurate medical records, including EHRs, are the foundation of providing quality healthcare to patients. “If an EHR company falsely represents that it’s software has functions that it actually lacks, patient safety could be at risk,” the agency stated in the video.
— OIG at HHS (@OIGatHHS) July 30, 2017
The video specifically cites the federal government’s case against eClinicalWorks and the broader impact of the case. In May, eClinicalWorks, one of the largest EHR vendors in the country as well as three of its employees, agreed to a $155 million settlement with the U.S. Department of Justice to resolve False Claims Act allegations. eClinicalWorks is an ambulatory EHR vendor, and according to the DOJ, the company allegedly violated federal law by misrepresenting the capabilities of its software and for allegedly paying kickbacks to certain customers in exchange for promoting its product.
In the video, OIG Senior Counsel John O’Brien stated in the video, “eClinicalWorks was causing healthcare providers who use its software to submit false claims to the Medicare and Medicaid EHR incentive program and it was doing this because its software didn’t meet the criteria required for software to be certified in this program.”
Further, O’Brien said, “This settlement is important as it’s the first settlement with an EHR software company, so we’re entering into an entirely new era of healthcare fraud.”
“The message OIG wants to send to the healthcare community is that we take the certification process for EHR software very seriously,” O’Brien said in the video, “There is no room for manipulating this process and making false statements during the certification process. OIG will vigilantly, along with law enforcement partners, investigate any conduct that places patient safety at risk and causes losses to the federal healthcare programs.”
As previously reported by Healthcare Informatics, at the time that the settlement was announced, eClinicalWorks issued a statement: “eCW fully cooperated with the DOJ civil investigation, which centered on technical certification requirements of the Federal government’s ‘Meaningful Use’ EHR program, and the company denies any wrongdoing. The claims settled by the agreement are allegations only and there has been no determination of liability.”
In a recent interview with Healthcare Informatics Associate Editor Heather Landi, eClinicalWorks CEO Girish Navani said the company has implemented a tighter compliance program and is focused on moving forward.
“The company still has to continue to innovate and satisfy its customers, that is its foremost responsibility, and especially a company our size. We are one of the largest EHR companies, and the largest in terms of the physician practice space; we do have that responsibility of innovating and making sure that our customers continue to be satisfied with what we are doing for them,” Navani said. “In parallel, I would add the regulatory compliance pieces to the puzzle. Companies that develop EHRs, including eCW, but you can’t just say eCW, its everyone, has to add as much focus on regulatory compliance as possible. We need to take into account all regulatory aspects of what we participate in and making sure that we have a strong program in place. So, going forward, part of our day-to-day culture, is to do both—you innovate and a very strong compliance program to meet the regulatory requirements of the industry.”
Navani said that all EHR vendors should focus on strengthening their compliance programs.
At the time the settlement was announced, eClinicalWorks said it disputed the DOJ's allegations, yet decided to settle to avoid the cost and uncertainty inherent in protracted litigation. “eCW has consistently maintained that it conducted testing of its software prior to release to ensure that it met applicable Meaningful Use program requirements, and that any certification issues were addressed in accordance with the administrative process established by the government. eCW’s software remains certified for use in connection with the Meaningful Use program,” the company said in a statement.
What’s more, Navani issued a statement at the time, saying, “Today’s settlement recognizes that we have addressed the issues raised, and have taken significant measures to promote compliance and transparency. We are pleased to put this matter behind us and concentrate all of our efforts on our customers and continued innovations to enhance patient care delivery.”
When asked during the recent interview if he believes that there are flaws with EHR certification process as part of the EHR Incentive program, Navani replied, “I don’t like to speculate going into the past; it makes no difference at this stage. We have to move forward. The ‘what’ and the ‘why’ doesn’t help any of us; what’s important is going forward. The company has a much stronger compliance program and we are asking questions internally and externally about any interpretations that need to be made. We are lot more diligent in requesting answers from third-party entities if they can help us; that is what everybody will have to do. We already adopted that model.”
As part of the settlement, eClinicalWorks entered into a Corporate Integrity Agreement (CIA) with the HHS Office of Inspector General (HHS-OIG) covering the company’s EHR software. The five-year CIA requires, among other things, that ECW retain an Independent Software Quality Oversight Organization to assess ECW’s software quality control systems and provide written semi-annual reports to OIG and ECW documenting its reviews and recommendations, according to the Justice Department press release.
Further, the agreement also requires eClinicalWorks to allow customers to obtain updated versions of their software free of charge and to give customers the option to transfer their data to another EHR software provider, without penalties or service charges. The vendor must also retain an Independent Review Organization to review its arrangements with healthcare providers to ensure compliance with the Anti-Kickback Statute.
O’Brien also said on the video, “Data is inputted into an EHR software system that reflects the care that is provided and it’s very critical, just like in the old written medical records, that everything be accurate. If there are any defects in that software program, then critical tests, medical prescriptions, may not be accurately processed, and that could have detrimental effects on patient care.”
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