eClinicalWorks’ electronic health records are once again raising patient safety concerns, despite a corporate integrity agreement that eCW made with the government as part of the settlement in a ground-breaking whistleblower case brought by Phillips & Cohen LLP.
The Office of Inspector General (OIG) for the Department of Health and Human Services has imposed additional compliance obligations on EHR vendor eClinicalWorks as a result of OIG’s “significant concerns regarding not only Patient Safety Issues that have been identified under the corporate integrity agreement, but also eCW’s compliance with its obligations under that agreement,” according to a letter from OIG to eCW dated Oct. 30.
The additional compliance measures include sending a Patient Safety Issue Advisory to each customer using wording specified by OIG. The advisory must state that eCW is notifying them because of “defects, deficiencies, design flaws, usability problems, or other conditions . . . that reasonably present a material risk of harm to patients [and] have resulted in clinical data loss, prescription errors, and clinical information from different patients appearing within one record.”
In addition, eCW must submit monthly reports to OIG and the HHS Office of the National Coordinator for Health Information Technology (ONC) of all calls and messages received in response to the advisory and any corrective actions taken in response.
OIG also is requiring that eCW send improved patient safety notifications to customers when issues arise. The notifications must include “a plain language description of the problem that exists in the software and why it presents a Patient Safety Issue,” OIG says, and note that the problem presents a “Patient Safety Issue.” eCW also must provide specific steps that customers and users have to take to mitigate or correct the issue.
OIG’s letter says that eCW will be required to submit to OIG monthly progress reports on its compliance and corrective measures.
The whistleblower lawsuit against eCW, which settled in 2017, alleged a number of flaws with eCW’s EHR software that potentially jeopardized patient health, including:
- Failure to sufficiently test software before it was released.
- Long-standing failure to correct critical and urgent problems and bugs in eCW’s software for months and even years.
- Failure to ensure data portability and audit log requirements.
- Failed to reliably record pharmaceutical, laboratory and diagnostic imaging orders.
The story of the eClinicalWorks whistleblower, Brendan Delaney, and his efforts to get eCW’s EHR problems fixed was the focus of an episode of the CBS program, “Whistleblower.” eCW paid $155 million to the federal government and agreed to a corporate integrity agreement to settle the case.
Fraud involving electronic health records can have serious consequences for patients’ health and treatment. EHR fraud also may cheat a government EHR incentive payment program designed to encourage the adoption of EHR systems, as well as defraud government healthcare programs with crooked billing.
Whistleblowers are playing a crucial role in exposing flawed and fraudulent EHR implementation by filing “qui tam” lawsuits under the False Claims Act. The law rewards whistleblowers with a share of the money the government recovers as a result of their case and provides protection from job retaliation.
If you know of fraud or kickbacks in the EHR industry and are considering reporting it, contact Phillips & Cohen to discuss your options and to protect yourself and your rights to a reward.
About Phillips & Cohen LLP
Phillips & Cohen is the nation’s most successful law firm representing whistleblowers, with more than $12.3 billion recovered as a result of its cases, including $155 million from the qui tam case against eClinicalWorks. (See “Why we win.”) The firm’s whistleblower attorneys have won more than $1 billion in rewards for its clients. Phillips & Cohen represents whistleblowers in qui tam lawsuits (False Claims Act cases) as well as cases brought under the whistleblower programs of the Securities Exchange Commission, the Commodity Futures Trading Commission and the IRS. Contact us for a free, confidential consultation.