Legal experts believe the recent $155 million settlement with EHR vendor eClinicalWorks in a False Claims Act case may be the start of greater Department of Justice (DOJ) activity in the EHR field.
FierceHealthcare reported that eClinicalWorks isn’t the only vendor that has “taken liberties with certification criteria” and Healthcare IT News predicted DOJ will shine the light on other EHR vendors for false claims.
- The DOJ obtained more than $4.7 billion in settlements and judgments from civil cases that involved the False Claims Act last fiscal year. The DOJ has averaged nearly $4 billion on False Claims Act cases since fiscal year 2009 and has collected $31.3 billion during that period.
In the eClinicalWorks case, the company reportedly misrepresented software capabilities and gave $392,000 in kickbacks to customers who promoted the product. The case began from a 2015 whistleblower complaint that alleged eClinicalWorks falsely obtained certification for its EHR software by manipulating data and hiding that it did not meet federal standards.
The dollar amount in the settlement made news, but there were other aspects of the agreement that will surely interest EHR vendors. The settlement includes a Corporate Integrity Agreement with the HHS Office of Inspector General that requires that eClinicalWorks retain an Independent Software Quality Oversight Organization, which will assess the company's software quality control systems. The company will also need to provide written semi-annual reports to OIG.
The settlement includes a CIA provision that requires eClinicalWorks “to allow customers to obtain updated versions of their software free of charge and to give customers the option to have [eClinicalWorks] transfer their data to another EHR software provider without penalties or service charges.”
Also, eClinicalWorks must have an independent organization review the company's arrangements with healthcare providers “to ensure compliance with the Anti-Kickback Statute.”
The case was the first time the DOJ held an EHR vendor accountable for not meeting federal standards pertaining to patient safety and quality patient care — and it’s clear from the settlement that the feds wanted to make a statement.
The DOJ has gone after other parts of the industry for fraud. Recently, the DOJ got involved in two cases involving UnitedHealth Group and its alleged overpayments for Medicare Advantage. In one of the cases, the DOJ alleges that UHG overbilled CMS by $1 billion. In that case, former UnitedHealth executive Benjamin Poehling said UnitedHealth changed diagnosis codes to make patients seem sicker.
Now that EHRs are on DOJ’s radar you can expect more scrutiny of other vendors.
“Electronic health records have the potential to improve the care provided to Medicare and Medicaid beneficiaries, but only if the information is accurate and accessible,” said Special Agent in Charge Phillip Coyne of HHS-OIG in announcing the settlement with eClinicalWorks. “Those who engage in fraud that undermines the goals of EHR or puts patients at risk can expect a thorough investigation and strong remedial measures such as those in the novel and innovative Corporate Integrity Agreement in this case."