Urgency To Act: What You Need To Know From The $155M eClinicalWorks-DOJ Settlement

By Sulaiman H. Sulaiman, CIO and chief consulting officer, iMethods

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 EHR vendor accountable for failing to meet federal certification standards. Let me start with the settlement summary and the options you have if you are an eClinicalWorks customer:

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 review “complaint-in-intervention” summary below, or visit the complete complaint-in-intervention online filing document.

What Does This Mean?
Simply stated, eCW clients have the option to pursue an upgrade of their current software product at no cost to them or request eCW to provide their data to transition to another EHR vendor of their choice without penalties or service charges.

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 wakeup 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.

Complaint-In-Intervention Summary

1. eCW falsely attested to compliance with certification requirements and hardcoded its software to pass certification testing.
   1. eCW hardcoded specific list of medications to pass the testing requirements rather than implement Rx.Norm vocabulary into its electronic prescription function.
   2. eCW also failed to transmit patient education materials through the required database and universal standard for identifying medical laboratory tests, measurements, and observations.
   3. eCW failed the requirement to use the Systematized Nomenclature of Medicine - Clinical Terminology (SNOMED-CT) to specify the medical conditions on a patient's problem list when transmitting a patient's chart.

2. eCW Failed to satisfy the required certification criteria (dealing with software bugs), mostly having direct impact on patient safety:
   • In certain scenarios, displaying incorrect information relating to labs and diagnostic imaging orders.
   • In certain scenarios, overwriting and/or improperly replicating medication dose, route, frequency, and formulation information.
   • Periodically displaying "[m]ultiple patients' information ... concurrently."
   • In specific workflows, failing to accurately display medical history on progress note.
   • Others…

As a result of the above examples eCW failed to satisfy certification requirement for both 2011 and 2014 editions:

1. eCW failed to satisfy data portability requirements
2. eCW's software failed to satisfy audit log requirements
3. eCW's software failed to reliably record diagnostic imaging orders
4. Did not reliably perform Drug-Drug and Drug-Allergy checks

3. eCW caused its customers to submit false information in attestation to CMS.

eCW payments violated the Anti-Kickback Statue.

Works Cited
“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.