The $155M settlement reached between DOJ and eClinicalWorks (eCW) is the largest False Claims Act recovery in the state of Vermont and the first of its kind for the government to hold an Electronic Health Record (EHR) vendor accountable for failing to meet federal certification standards.
1- “eCW must provide prompt notice to its customers of any 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.”
2- Accountability and oversight: “eCW entered into a Corporate Integrity Agreement (CIA) with the HHS Office of Inspector General (HHS-OIG) covering the company’s EHR software.” This provides “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.”
3- “The CIA also requires eCW to allow customers to obtain updated versions of their software free of charge and to give customers the option to have ECW transfer their data to another EHR software provider without penalties or service charges.”
4- “eCW must also retain an Independent Review Organization to review eCW’s arrangements with health care providers to ensure compliance with the Anti-Kickback Statute.”
5- Under the terms of the settlement agreements, eCW and three of its executive/founders are jointly and severally liable for the payment of $155 million to the United States, of which $30M will be awarded to the Brendon Delaney, software technician, who brought the allegation to light under the whistleblower provisions of the False Claim Act.
The settlement highlights the urgency to act based upon patient safety risks implications. For more information, please download the complaint-in-intervention summary
Simply stated, eCW clients have the option to:
With the anticipated demand on the eCW organization to fix the software programing and thus potential patient safety issues, clients must carefully manage their own expectations in receiving timely and satisfactorily response. If you were already considering a change, though the risks highlighted in the findings are totally unacceptable, the requirement under the settlement for eCW to extract and deliver your data without penalties or services charges will work to your advantage. Whether you chose the option to change or upgrade your eCW solution, the question will be centered around capacity and resource availability to execute. External third-party help might be an option to expedite a resolution for your organization and patients.
This is indeed a wake-up call to all EHR vendors, and indirectly clients, to ensure the accuracy and integrity of their software solutions meant to deliver safe and reliable care to patients and their families.
“Electronic Health Records Vendor to Pay $155 Million to Settle False Claims Act Allegations” Justice.gov. The United States Department of Justice, 31 May 2017. Web. 10 May 2017.
United States of America, ex rel. Brendan Delaney vs. eClinical Works, LLC. No. 2:15-CV-00095-WKS. United States District Court for The District of Vermont. 12 May 2017. Web. Justice.gov.