Lance Bellers - Fotolia
Health IT vendors need to take seriously the False Claims Act violation case against eClinicalWorks and ensure they don't make the same mistakes.
That's the message delivered in a video by John O'Brien, senior counsel for the Department of Health and Human Services' Office of the Inspector General (OIG).
"This settlement is important because it's the first settlement with an electronic health record software company," O'Brien said in the video. "We are entering an entirely new area of healthcare fraud."
The Department of Justice (DOJ) U.S. Attorney's Office of the District of Vermont charged eClinicalWorks with a False Claims Act violation, alleging the company's EHR software did not comply with the certified EHR requirements. EClinicalWorks, which declined comment for this article, agreed to pay $155 million to resolve the lawsuit.
"We take very seriously the certification process and the allegations that a vendor manipulated that process to improperly obtain certification. We have real concerns with that, and we will definitely be looking at any allegations that raise that same concern," O'Brien said in a phone interview with SearchHealthIT.
O'Brien explained that this settlement is significant for two reasons:
- It's the first civil settlement to resolve a False Claims Act violation alleged against an EHR software company.
- As a result, OIG has entered into a first-of-its-kind quality of EHR corporate integrity agreement with eClinicalWorks.
The effect on providers and patients
John O'Briensenior counsel at the Office of the Inspector General
"EClinicalWorks was causing healthcare providers who used its software to submit false claims to what is called the Medicare and Medicaid EHR Incentive Program," O'Brien said in the video. "And it was doing this because its software actually didn't meet the criteria required for software to be certified in this program."
O'Brien told SearchHealthIT that OIG was especially concerned with some of the allegations detailed in the DOJ's complaint, including:
- The software did not accurately record user action.
- It did not always reliably record diagnostic imaging order.
- It did not always perform drug interaction checks.
- And eClinicalWorks allegedly failed to meet data portability requirements when the company was supposed to permit healthcare providers to transfer patient data from one software to another.
"Because of these deficiencies, and others described in the United States' complaint, the United States alleged that the company violated the False Claims Act by causing healthcare providers to request incentive payments from the Medicare and Medicaid programs for using [eClinicalWorks'] software that was not properly certified," O'Brien said.
OIG takes allegations such as the ones brought against eClinicalWorks very seriously, O'Brien said, "because they potentially could place patient safety at risk."
"It's important that [EHR] software accurately reflect the care that's provided," he said, adding that OIG is focused on "protecting patient safety".
"We're [also] very concerned about any kind of conduct that causes monetary losses to Medicare and Medicaid, or any other federal healthcare program," O'Brien said.
OIG will be watching eClinicalWorks carefully
As a result of the settlement, eClinicalWorks has entered into a five-year corporate integrity agreement (CIA) with OIG, which requires the EHR vendor to meet certain compliance obligations and retain an independent software quality oversight organization that will assess eClinicalWorks' quality-control systems and report back to OIG every six months for the next five years.
"This particular CIA is unique because it's the first ... quality of EHR software CIA," O'Brien said. "[It's] unusual in that it's looking at the quality of the company's EHR software."
O'Brien explained that companies are concerned about being excluded from federal healthcare programs because, although eClinicalWorks doesn't bill Medicare and Medicaid directly, the company contracts with healthcare providers that do.
OIG released eClinicalWorks from facing permissive exclusion from federal health programs under the condition that the vendor enter into the five-year CIA.
"If eCW was excluded, then those healthcare providers could not contract with eClinicalWorks, because they could be subject to federal money penalties or exclusions if they contract with an excluded entity," he said.
Copying and pasting EHR data could lead to fraud
APIs are a requirement for certified health IT
Epic's EHR: The challenges and lessons learned at MGH