The first part of this two-part article was published on Wednesday and can be read here.
Some health IT leaders view the recent settlement of a False Claims Act lawsuit against electronic health records software vendor eClinicalWorks as shining a spotlight on the need for a stronger focus on health IT-related patient safety, and on the lack of interoperability within the industry. What are the potential policy implications of the eClinicalWorks settlement? And, what could be the ripple effects in the EHR vendor market?
Last month, the U.S. Department of Justice announced a settlement that holds eClinicalWorks, and the company’s founders and executives—Chief Executive Officer Girish Navani, Chief Medical Officer Rajesh Dharampuriya, M.D., and Chief Operating Officer Mahesh Navani—liable for payment of $155 million to resolve a False Claims Act lawsuit. The company allegedly violated federal law by misrepresenting the capabilities of its software and for allegedly paying kickbacks to certain customers in exchange for promoting its product, according to the Justice Department. Separately, an eClinicalWorks developer and two project managers were also found liable and will pay separate fines.
It is important to note that the Westborough, Mass.-based EHR vendor has not admitted any fault or wrongdoing and its software remains fully certified under the Meaningful Use program.
In response to a media request for an interview about the settlement, an eClinicalWorks spokesperson sent a letter that was sent to the company’s customers. In that letter, eClinicalWorks stated that it would, in addition to paying $155 million, bolster its compliance program. “The inquiry leading to the settlement primarily centered on technical aspects of the Meaningful Use program and allegations that eClinicalWorks software had technical non-conformities related to some of the criteria, all of which have since been addressed,” eClinicalWorks’ CEO Girish Navani stated in the letter.
As noted in the previous story, the Justice Department’s settlement with eClinicalWorks resolves allegations in a lawsuit filed in the District of Vermont by Brendan Delaney, a software technician formerly employed by the New York City Division of Health Care Access and Improvement. The lawsuit was filed under the whistleblower provisions of the False Claims Act.
Delaney was, at the time, a New York City government employee implementing the eClinicalWorks EHR system at Riker’s Island for prisoner healthcare when he first became aware of numerous software problems that he alleged put patients at risk, according to a press release issued by a law firm, Phillips & Cohen, representing Delaney.
According to the allegations in the whistleblower complaint, problems that were caused by eClinicalWorks EHR software included failure to keep an accurate record of current medications administered to patients, mistakenly including in a patient’s medical record information from another patient’s record, multiple errors with medication module, including failure to ensure proper dosages, errors with start/stop dates, failure to record changes to medications, duplicate orders for certain prescription drugs, and failure to display current medication at all in some instances and inaccurate tracking of laboratory results.
Many health IT industry leaders believe the eClinicalWorks case once again highlights the need for a federal patient safety center focused on health IT-related issues, a project proposed by the Office of the National Coordinator for Health Information Technology (ONC). In fact, two years ago, a task force of experts and health IT safety stakeholders convened by ONC crafted a roadmap to guide the development of a proposed national Health IT Safety Center, however, the initiative has not yet received federal funding.
Jeffrey Smith, vice president of public policy at the Washington, D.C.-based American Medical Informatics Association (AMIA), says, “This is something that AMIA has been advocating for a number of years, along with others, but we have yet to conjure the political will and the money to support a national health IT safety center.” He adds that the case puts a spotlight on the patient safety issues that arise at the intersection of health IT and healthcare. “It gets to the notion of shared responsibility; you can have a perfect system in the lab and it can do wonderfully in a testing scenario, but when you send it out to the real world and hook it up to other systems in a complex IT environment, there is no telling how many things can go wrong. I’m hopeful that as we learn more [about the eClinicalWorks case] it will encourage honest conversation around the need for a national health IT safety center.”
The False Claims Act case against eClinicalWorks also highlights problems in health IT that center on interoperability. The Justice Department, in its case against eClinicalWorks, contends that the vendor’s software failed to satisfy data portability requirements intended to permit healthcare providers to transfer patient data from eClinicalWorks’ software to the software of other vendors.
In the eClinicalWorks letter sent to customers, Navani also addressed this issue. He wrote, “Another technical non-conformity identified by the government involved data portability. The 2014 Edition certification criteria require EHR software to "batch export" patient records. There was confusion about the meaning of this requirement, however, prompting ONC in 2015 to issue a clarifying FAQ. When eClinicalWorks was tested for certification in 2013, its authorized certification body (ACB) at the time, CCHIT, determined that our software satisfied this requirement. In 2015, our new ACB, Drummond Group, disagreed and identified this as a non-conformity. eClinicalWorks resolved the non-conformity in 2015, and our software meets all MU Stage 2 data portability requirements.”
Later in the letter, Navani wrote, “There is a silver lining to this settlement. Today, eClinicalWorks has a more robust compliance program.”
Many health IT stakeholders contend that the issue of data portability goes beyond compliance, or non-compliance, with health IT certification requirements. The ability to share patient data among clinical IT tools, and the technical and financial obstacles to interoperability, are critical issues among healthcare providers. “The inability of providers to get their data out of one system and into another system, this notion of vendor lock-in, is fundamentally problematic,” Smith says. “And this is where the focus needs to turn in terms of policy and functionality.”
Smith continues, “I don’t know how eClinicalWorks performs on data portability compared to other vendors, but, even if the vendors are simply meeting the letter of the law, what that means is that when a physician wants to switch vendors, then the best outcome that physician can have is that their vendor gives them summary of care records for all their patients, and that is not equal to all of the data on their patients. The technical side of it is daunting, but I have to say, from a patent safety perspective, we should demand nothing less.”
He adds, “I think that’s another area that policymakers should be focusing on because I feel that is an important use case, which is that we need all the data; we essentially need a digital print-all that allows physicians to get all of the patients’ data from one system to another, not just a summary of care record. And, I would be surprised, quite frankly, if every certified system was able to even produce summary of care records on a consistent basis.”
Bob Ramsey, an attorney who focuses on healthcare as a shareholder/partner at the Pittsburgh, Pa.-based law firm Buchanan, Ingersoll & Rooney, says the allegations against eClinicalWorks might represent “an extreme case. “Interoperability and data portability is something that is viewed as necessary in the health world, but it’s easier said than done. Everyone is grappling with it.”
Smith acknowledges that are significant technical challenges with interoperability, “but never in the history of health IT, probably in the history of our technological evolution, has the technical challenge been the thing that keeps us from achieving a goal. I think if we live in a market environment that is not going to go above and beyond what the government is going to require, and if the vendors are essentially going to say that all of their time is tied up in meeting government requirements, then maybe we focus on data portability, a complete digital print-all button, maybe that’s where the focus of government requirements needs to move.”
Other health IT leaders see a silver lining to this case. Aneesh Chopra, who served as the first U.S. Chief Technology Officer and is now president of health IT company NavHealth, responded to news of the eClinicalWorks settlement by tweeting, “Let me sound hopeful. The settlement agreement might catalyze adoption and use of open APIs for patients and providers."
What are the Potential Ripple Effects in the EHR Vendor Market?
As part of the settlement, eClinicalWorks, as noted above, entered into a Corporate Integrity Agreement with the HHS Office of the Inspector General. Stipulations in the agreement require eClinicalWorks to give customers the option to transfer their data to another EHR software provider, without penalties or service charges. Also, eClinicalWorks is obligated to give current customers updated versions of the company’s EHR software free of charge.
How many customers will leave eClinicalWorks and switch to another EHR? “It still up in the air,” notes Erik Bermudez, research director, acute care EMR, ambulatory EMR/PM at Orem, Utah-based KLAS Research. “I could see this going a number of ways—folks could look at this and say I was already satisfied, so absolutely I’m going to stick with eClinicalWorks. But if there are folks already on the fence, and we know from tracking eClinicalWorks for a decade that there’s a percentage of customers already thinking that eClinicalWorks is not part of their long-term plan, then this could potentially speed up the decision for those clients, absolutely.”
He added, “I imagine the customer makeup will be altered in a year from today. It’s going to look a little bit different. Now, how much different? I’m not sure.”
Epic, Cerner and athenahealth are all competitors to eClinicalWorks in the ambulatory space, so time will tell how eClinicalWorks customers will react and if there will be any shifts in competitors’ customer bases.
In response to the news of the eClinicalWorks settlement, athenahealth issued a statement regarding the role of technology to be a partner for providers in navigating ongoing regulatory changes, including Meaningful Use. “Any vendor in the health tech space lives a constant balancing act of innovating, serving clients, and complying with government regulation. It’s a complex job,” Todd Rothenhaus, athenahealth’s chief medical officer, said in the statement. Rothenhaus also noted that athenahealth’s platform and services has enabled the company’s ambulatory clients to achieve an industry leading attestation rate of 97 percent. “We believe that any healthcare provider or organization in the market for an EHR should demand this type of partnership,” Rothenhaus said.
eClinicalWorks started in the physician practice space, and while it has expanded to the small hospital market, the company’s footprint remains in the medical group/ambulatory space, Bermudez says. In KLAS’s 2015-2016 Best in KLAS Awards Software and Services report, eClinicalWorks ranked fifth, with a score of 69.1, in the overall physician practice vendor rankings.
“When we interview an eClinicalWorks client, their EHR is perceived as relatively easy to use, streamlined, has a good look and feel to it and the user interface is pleasant to use. But the challenges for eClinicalWorks, based on what customers report to us, isn’t necessarily from a technology standpoint, it ties back to more of the services and relationship,” Bermudez says.
According to Bermudez, eClinicalWorks customers report that they typically have to pay for software upgrades, so the stipulation in the settlement that the vendor must offer current customers software upgrades, at no charge, is significant news for the current client base. “There are going to be short-term implications, and there will absolutely be long-term implications to this,” he said.