- The recent $155-million settlement between the federal government and eClinicalWorks sent reverberations throughout the healthcare industry and raised concerns about the capabilities of even certified EHR technology. If one of the more popular EHR technologies could allegedly game health IT certification, what then others?
While the EHR company admits of no wrongdoing and has avoided going to trial in federal court, it still faces the challenge of explaining itself to current and future users of its EHR products and services.
As the Department of Justice (DoJ) announced a week ago, the qui tam (i.e., whistleblower) lawsuit against eClinicalWorks included allegations that the EHR company had hardcoded drug codes into its EHR software to comply with certification testing, did not adequately manage imaging orders or drug interactions, and failed to meet data portability requirements. Based on the allegations, eClinicalWorks users that had attested to meaningful use received millions of EHR incentive payments using a non-compliant EHR technology.
“Every day, millions of Americans rely on the accuracy of their electronic health records to record and transmit their vital health information,” DoJ Acting Assistant Attorney General for the Civil Division Chad A. Readler stated publicly. “This resolution is a testament to our deep commitment to public health and our determination to hold accountable those whose conduct results in improper payments by the federal government.”
According to court documents, the legal action against eClinicalWorks began in 2015, brought forward former employee of the New York City Division of Health Care Access and Improvement. Those documents also noted a series of advisories issued by the EHR company throughout 2016 addressing patient safety risks associated with its technology specifically related to medications and labs.
In December 2016, eClinicalWorks voiced its commitment to patient safety by calling the attention of end-users to risks associated with the use of its technology and recommendations for mitigating those risks.
“The use of eCW’s EHR software carries with it risks related to medication management, electronic prescribing, and the ordering process for tests and procedures, which are among the most complex functions performed by any EHR system,” the company reminded clinicians.
Likewise, the EHR company called on clinicians to be “vigilant about medication management, e-prescribing and the ordering of tests and procedures” and adopt several measures outlined in a December 2015 advisory:
- Upgrade to the most current version of its software
- Upgrade to the most current version of the Multum or Medispan drug databases
- Designate a patient safety officer
- Read every patient safety notice
- Confirm order accuracy
- Encourage patients to confirm accuracy
- Follow correct steps for modifying medications
- Exercise caution in the use of custom medications
The company called on concerned parties to report patient safety concerns or software issues to eClinicalWorks, ONC, or both.
The big issue of trust
As a result of the settlement, EHR company has entered into a Corporate Integrity Agreement that includes the requirement that eClinicalWorks customers can obtain updated versions of eClinicalWorks at no cost or transfer their data to another EHR software free of charge.
The settlement resolves a lawsuit filed under seal on May 12, 2017, stemming from legal action begun on May 1, 2015. The federal government ultimately made the allegations against the EHR company public by May 31, 2017.
Based on the timeline, eClinicalWorks customers are likely left wondering if they were left in the dark.
According to some healthcare CIOs, the news calls into question the company’s business relationships with its customers.
“Relationships are based on trust,” Ed Marx, CIO of The Advisory Board Company, tells EHRIntelligence.com. “Trust is something that takes an inordinate amount of time to build but tumbles down with a single blow of this magnitude. If you don’t have trust you don’t have a relationship. No relationship, no business.”
Spaulding Rehabilitation Network at Partners Healthcare CIO John Campbell considers trust to be the biggest issue facing eClinicalWorks and its customers.
“We put a lot of trust in the vendors and products we choose to partner with,” he explains. “There is a lot at stake — we have not only invested significant dollars in the product, but we also are jointly on the hook for the safety of our patients and the compliance of our revenue cycle activities for starters.”
“Both our reputations are in the middle of this relationship,” he continued. “If I am an existing eClinicalWorks customer, I need to assess whether the risk outweighs my investment; and if I am considering eClinicalWorks, this is an almost insurmountable barrier to cementing this relationship.”
While trust is the biggest issue for these two healthcare CIOs (neither of whom is an eClinicalWorks customer), it is one of several that they both observe.
First, there is the matter of EHR incentive payments. “It would seem overly punitive for the federal governments to go after eClinicalWorks customers. There is no criminal liability to its customers I assume, but the submissions may be considered tainted therefore the incentive dollars could be at risk,” adds Campbell.
Second, the settlement raises questions about health IT certifications in general: “As a customer of any vendor, do I have any responsibility or liability to verify certifications; can or should we simply accept that the vendor has attested to? Is it even possible to verify? What would be considered reasonable efforts to verify?” Campbell speculated.
Finally, the allegations against eClinicalWorks point to a potential lack of corporate leadership and ethical business practices at the EHR company that negatively impact its financial future and any investments made by customers in its products.
With the $155-million settlement, eClinicalWorks avoids a date in court with the federal government. Now it must begin work repairing whatever damage these recent developments have inflicted on its partnerships, current and future.