- EHR vendor eClinicalWorks and certain employees will pay $155 million to settle False Claims Act (FCA) allegations around misrepresentation of software capabilities and $392,000 in kickbacks to customers who promoted the product, the Department of Justice (DOJ) announced Wednesday.
- The settlement stems from a 2015 whistleblower complaint that claimed eClinicalWorks falsely obtained certification for its EHR software by manipulating data and hiding the fact it did not meet federal standards.
This is "the first time that the government has held an electronic health records vendor accountable for failing to meet federal standards designed to ensure patient safety and quality patient care,” said Colette G. Matzzie, a whistleblower attorney and partner at Phillips & Cohen.
The settlement sends a strong warning to EHR vendors that might try to skirt certification requirements. It is the largest False Claims Act recovery and largest financial recovery in Vermont, according to DOJ. 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,” Phillip Coyne, a special agent in OIG, said in a statement.
The government joined the qui tam lawsuit, alleging false certification, including failure to adequately test software and correct problems that cropped up, sometimes for years. There were also problems with laboratory and imaging orders and data portability. As part of the settlement, the Westborough, MA-based firm agreed to retain an independent software quality oversight organization to assess the quality of its software quality controls and report the results semi-annually to the HHS’ Office of Inspector General.
It's no secret that fraud has been prevalent in the U.S. healthcare industry across different sectors. Payers and care providers have already been facing large settlement amounts this year due to FCA allegations made by whistleblowers, who are receiving more protection from the federal government as it continues to undertake the different forms that fraud can take. Among one of the most recent payers currently in whistleblower cases is UnitedHealth Group, which the DOJ is suing for overbilling Medicare. In 2016, device companies in the healthcare spaces that settled FCA allegations include Olympus Corp.
However, there are several steps providers can take to help prevent medical device fraud, as outlined in a toolkit created by the CMS. “Most organizations have recognized the need to have strong training and effective policies and procedures,” Sara Lord, a partner at Arnall Golden Gregory and former Justice Department attorney. recently told Healthcare Dive. “Once those mechanisms are in place, they need to be refreshed to reflect any changes or developments from the previous year.”