The pain radiated from the top of Annette Monachelli’s head, and it got worse when she changed positions. It didn’t feel like her usual migraine. The 47-year-old Vermont attorney turned innkeeper visited her local doctor at the Stowe Family Practice twice about the problem in late November 2012, but got little relief.
Two months later, Monachelli was dead of an aneurysm, a condition that, despite the symptoms and the appointments, had never been tested for or diagnosed until she turned up in the emergency room days before her death.
Monachelli’s husband sued Stowe, the federally qualified health center the physician worked for. Owen Foster, a newly hired assistant U.S. attorney with the District of Vermont, was assigned to defend the government. Though it looked to be a standard medical malpractice case, Foster was on the cusp of discovering something much bigger – what his boss, U.S. Attorney Christina Nolan, calls the “frontier of health care fraud” – and prosecuting a first-of-its-kind case that landed the largest-ever financial recovery in Vermont’s history.
Foster began with Monachelli’s medical records, which offered a puzzle. Her doctor had considered the possibility of an aneurysm and, to rule it out, had ordered a head scan through the clinic’s software system, the government alleged in court filings. The test, in theory, would have caught the bleeding in Monachelli’s brain. But the order never made it to the lab; it had never been transmitted.
The software in question was an electronic health records system, or EHR, made by eClinicalWorks (eCW), one of the leading sellers of record-keeping software for physicians in America, currently used by 850,000 health professionals in the U.S. It didn’t take long for Foster to assemble– Better Business Bureau complaints, issues flagged on an eCW user board, and legal cases filed around the country – suggesting the company’s technology didn’t work quite the way it said it did.
Until this point, Foster, like most Americans, knew next to nothing about electronic medical records, but he was quickly amassing clues that eCW’s software had major problems – some of which put patients, like Annette Monachelli, at risk.
Damning evidence came from a whistleblower claim filed in 2011 against the company. Brendan Delaney, a British cop turned EHR expert, was hired in 2010 by New York City to work on the eCW implementation at Rikers Island, a jail complex that then had more than 100,000 inmates. But soon after he was hired, Delaney noticed scores of troubling problems with the system, which became the basis for his lawsuit. The patient medication lists weren’t reliable; prescribed drugs would not show up, while discontinued drugs would appear as current, according to the complaint. The EHR would sometimes display one patient’s medication profile accompanied by the physician’s note for a different patient, making it easy to misdiagnose or prescribe a drug to the wrong individual. Prescriptions, some 30,000 of them in 2010, lacked proper start and stop dates, introducing the opportunity for under- or overmedication. The eCW system did not reliably track lab results, concluded Delaney, who tallied 1,884 tests for which they had never gotten outcomes.
The District of Vermont launched an official federal investigation in 2015.
The eCW spaghetti code was so buggy that when one glitch got fixed, another would develop, the government found. The user interface offered a few ways to order a lab test or diagnostic image, for example, but not all of them seemed to function. The software would detect and warn users of dangerous drug interactions, but unbeknownst to physicians, the alerts stopped if the drug order was customized. “It would be like if I was driving with the radio on and the windshield wipers going and when I hit the turn signal, the brakes suddenly didn’t work,” said Foster.
The eCW system also failed to use the standard drug codes and, in some instances, lab and diagnosis codes as well, the government alleged.
The case never got to a jury. In May 2017, eCW paid a $155 million settlement to the government over alleged “false claims” and kickbacks – one physician made tens of thousands of dollars – to clients who promoted its product. Despite the record settlement, the company denied wrongdoing; eCW did not respond to numerous requests for comment.
If there is a kicker to this tale, it is this: The U.S. government bankrolled the adoption of this software – and continues to pay for it. Or we should say: You do.
Which brings us to the strange, sad, and aggravating story that unfolds below. It is not about one lawsuit or a piece of sloppy technology. Rather, it’s about a trouble-prone industry that intersects, in the most personal way, with every one of our lives. It’s about a $3.7 trillion health care system idling at the crossroads of progress. And it’s about a slew of unintended consequences – the surprising casualties of a big idea whose time had seemingly come.