ARTICLE IN BRIEF
One of the top three electronic health record vendors used by neurologists was the subject of a lawsuit — and subsequent settlement. The investigation triggered discussion among practice managers about the questions clinicians must ask regarding the integrity of electronic medical records systems and vendors.
Neurology practices that spent millions of dollars acquiring and implementing electronic health records (EHR) software from eClinicalWorks are evaluating their options in light of the company's settlement in a False Claims Act settlement.
The Department of Justice (DOJ) contends that eClinicalWorks concealed information about its software, allowing it to falsely obtain certification needed to participate in the federal government's EHR Incentive Program. Thousands of health care providers relied on eClinicalWorks' certification to demonstrate their “meaningful use” of EHR technology and receive financial incentives for doing so.
One of the nation's largest EHR vendors, eClinicalWorks has been particularly popular among outpatient neurology practices. Indeed, AAN surveys have identified eClinicalWorks among the top three EHR vendors used by Academy members, according to David Evans, MBA, chair of the AAN Practice Management and Technology Subcommittee.
Dr. Evans, chief executive officer for Texas Neurology in Dallas, and other eClinicalWorks clients were shocked when the Justice Department announced on May 31 that the company and a few of its employees will pay a total of $155 million to resolve the government's lawsuit alleging that they had misrepresented the software's capabilities.
The government contends that eClinicalWorks software did not meet the certification criteria for standardized drug codes. Instead, the company modified its software by “hardcoding” only the drug codes required for testing rather than programming it to retrieve any drug code from a complete database.
Among other allegations, the government said the company did not accurately record user actions in an audit log, did not reliably record diagnostic imaging orders or perform drug interaction checks, and failed to satisfy data portability requirements intended to allow health care providers to transfer patient data from eClinicalWorks' software to the software of other vendors.
The eClinicalWorks situation is emerging as neurologists are identifying EHR technology as a significant cause of burnout; Neurology published survey findings among AAN members earlier this year.
Joseph V. Fritz, PhD, chief executive officer of Dent Neurologic Institute in western New York, called the burden of electronic documentation “the #1 hardship on our physicians” and hopes a $150 million settlement to one of the industry's high-profile players will spark long-needed change.
“I hope that type of penalty will prompt eClinicalWorks and others to really put some focus on cleaning up how these electronic medical record (EMR) systems work,” he said.
FRAUD OR INCOMPETENCE?
In early July, the Centers for Medicare & Medicaid Services (CMS), which runs the EHR Incentive Program, reassured eClinicalWorks' clients that they will not be held accountable for the company's problems. Providers that received incentive payments based on their attestation that they used eClinicalWorks software will not have to repay the government.
As they breathe a sigh of relief, physician practice leaders are unsure how to assess the situation, however. The DOJ settlement does not affirm that the government's allegations were proven, only that eClinicalWorks agreed to pay $150 million to make the lawsuit go away.
At the time the settlement was announced, eClinicalWorks issued a prepared statement to media outlets in which CEO Girish Navani said “...we have addressed the issues raised, and have taken significant measures to promote compliance and transparency.”
At Dent Institute, EHR users have been frustrated with some aspects of eClinicalWorks' functionality and a slow response to some of their concerns, but Dr. Fritz never had any reason to suspect malfeasance.
“I think they are probably representative of others that are caught up in a rapid development cycle, with many demands, many new customers, and many variables in how providers practice and document,” he said. “It became very hard to keep up.”
Brad Klein, MD, a partner in Abington Neurological Associates in suburban Philadelphia, said one of the DOJ's complaints — the software did not accurately record user actions in an audit log — reminded him of a specific problem that his practice encountered. Abington Neurological wanted to test its EHR system to make sure that, if there was concern about a violation of patient privacy under the Health Insurance Portability and Accountability Act (HIPAA), it could track every patient record that an employee had accessed.
The practice sought help to conduct a “breach scenario” test from eClinicalWorks' staff members, some of whom were stumped by the request. After several weeks, one staff member was able to provide the information for a specific employee, but only by using that employee's login information.
“It was striking that, in a breach scenario, you may not have immediate access and, if you don't get to the right (eClinicalWorks) employee, you would have no ability to get that information even in the context of a concern,” Dr. Klein said.
Meanwhile, Evans is worried about the DOJ's allegation the software did not reliably perform drug interaction checks. After the settlement, Texas Neurology providers started getting more safety alerts about possible drug interactions than they had in the past.
“That's a little alarming because why were we not getting them previously?” he said.
TIME FOR ANOTHER VENDOR?
Under the settlement, eClinicalWorks and three of its founders must pay $154.92 million to the United States. In addition, one of its developers will pay $50,000, and two project managers will each pay $15,000.
In addition, the company entered into a five-year Corporate Integrity Agreement with the Department of Health and Human Services Office of Inspector General (OIG). According to that agreement, the company must retain an Independent Software Quality Oversight Organization to assess its software quality control systems and provide semi-annual reports to the OIG; provide prompt notice to its customers of any safety-related issues; and maintain on its customer portal a comprehensive list of safety-related issues and how its clients can mitigate potential patient safety risks. In addition, it must allow clients to obtain updated versions of the software free of charge, and give clients the option of having eClinicalWorks transfer their data to another EHR software provider without penalties or service charges.
The settlement is triggering many discussions about whether medical practices should move to another EHR vendor.
“We have lost confidence in the company, and we're starting to look at potential other vendors to see what options there are,” Dr. Klein said.
Evans, at Texas Neurology, shares that concern. Physicians must be able to have a trustworthy relationship with their EHR vendor since the electronic record influences the care they deliver.
“We are questioning that relationship at this time,” he said. “But once you're on an EMR, it's not so easy to switch.”
For one thing, medical practices are worried about whether the years of patient data in their current eClinicalWorks system would be transferred to another vendor's software in a way that it can be easily used.
In response to a question from Neurology Today, the company sent a list of data transfer options that includes (1) a free self-service export “without any assistance from eCW” and (2) a full-service data extraction at a cost of $5,000 per provider.
Thus, the services that are free would not produce a workable porting of data, Dr. Fritz said. Even if data can be successfully transferred to another EHR system, the cost, learning curve and lost productivity associated with acquiring a new system is daunting to consider.
“The cost of transitioning to an EMR for a group our size would be dramatically expensive, and the loss of revenue during the transition could be tremendous to us,” Evans said.
Moreover, moving to another vendor may be moving to another set of frustrations. “The problem that I'm worried about is whether the other EMRs are any better,” Dr. Klein said. “I've heard mixed responses from colleagues with respect to all those vendors.”
Theoretically, with the government's eyes on its operations, eClinicalWorks should be motivated to improve its performance, Evans said.
“We do feel somewhat satisfied that the Corporate Integrity Agreement would give us something we can rely on and that the government will have appropriate oversight,” he said.
