A D.C. whistleblower attorney involved in the eClinicalWorks case expects to see more lawsuits filed against other EHR vendors that are skirting meaningful use requirements.
EHR developers could be staring down some of the same allegations that federal prosecutors levied against eClinicalWorks involving hard-coding drug codes and flaws in the software that impact patient safety. There are also potential concerns surrounding payments made to promote EHR software that could violate the Anti-Kickback Statute.
“Those are out there,” Colette G. Matzzie, an attorney with Phillips & Cohen LLP that represented the whistleblower in the case against eClinicalWorks, told FierceHealthcare.
“I think the issues that were identified in both the government’s complaint and the corporate integrity agreement that eClinicalWorks signed are potentially issues with a number of the other vendors as well,” she added.
Matzzie said the OIG’s recent video highlighting the case as a new area of healthcare fraud is a clear warning that the government is looking into this area of fraud. OIG senior counsel said the agency will “vigilantly” investigate EHR vendors that compromise patient safety or trigger false claims through the EHR incentive program.
The OIG has also scheduled a new audit of Medicare EHR incentive payments after identifying $729 million in inappropriate payments made through the program over the last 6 years.
“OIG is encouraging providers and vendors to be aware of the issues and I think that likely means there will be more cases,” Matzzie said.
Another potential legal wrinkle dates back to last year’s Supreme Court ruling that upheld the “implied certification” theory under the False Claims Act. The decision codified a long-held position by plaintiffs’ attorneys that false claims liability doesn’t require expressly stated conditions of payment. Instead, defendants can be liable for knowingly violating a requirement that is “material” to the government’s payment decision.
“The allegations have to identify a violation that is material to payment, meaning the government wouldn’t have authorized subsidy payments if it had known this software violated federal laws in the following ways,” Matzzie said.
But that doesn’t mean new cases will crop up anytime soon—it took nearly two years for the government to intervene on the eClinicalWorks case. At the same time, it’s clear government prosecutors are targeting EHR software that raises patient safety concerns, while also trying to claw back improper payments from a program that has shelled out more than $30 billion.