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By Fred Schulte, Kaiser Health News and Erika Fry, Fortune
The pain came from the top of Annette Monachelli's head and she got worse when she changed position. It did not look like his usual migraine. The 47-year-old Vermont lawyer, who became an innkeeper, twice visited her Stowe Family Practice doctor about the problem at the end of November 2012, but got little relief.
Two months later, Monachelli had died of a cerebral aneurysm, a condition that, despite the symptoms and appointments, had never been tested or diagnosed before he arrived at the emergency a few days before his death.
Monachelli's husband sued Stowe, the qualified health center for which the doctor worked at the federal level. Owen Foster, a new US badistant attorney recruited from the Vermont District, has been tasked with defending the government. Although this appears to be a standard medical malpractice case, Foster was about to discover something much bigger – what his boss, US lawyer Christina Nolan, calls the "border of fraud". "Health Care" – and sue a first kind case that has landed the biggest financial recovery in the history of Vermont.
Foster started with Monachelli's medical records, which offered a puzzle. His doctor had considered the possibility of an aneurysm and, to exclude it, had ordered a head examination through the clinic's software, according to the government. The test, in theory, would have caught the bleeding in Monachelli's brain. But the order was never sent to the laboratory. it had never been transmitted.
The software in question was an electronic medical record system, designed by eClinicalWorks (eCW), a leading vendor of record keeping software for physicians in America, currently used by 850,000 healthcare professionals in the United States . It is urgent that Foster pull together a record of troubling reports – complaints from the Better Business Bureau, problems reported on an eCW help panel and lawsuits filed across the country – suggesting that the company's technology was not working exactly as it did. claimed him.
Until then, Foster, like most Americans, knew almost nothing about electronic medical records, but he was gathering evidence that the eCW software posed serious problems – some of them expose patients, like Annette Monachelli, to risks.
Troubling system at Rikers Island
Overwhelming evidence came from a whistleblowing complaint filed in 2011 against the company. Brendan Delaney, a British police officer turned EHR expert, was hired in 2010 by New York City to work on the implementation of the CWC at Rikers Island, a prison complex that then had more than 100,000 inmates . But shortly after he was hired, Delaney noticed many troubling problems with the system, which became the basis of his trial. Patient medication lists were unreliable; prescribed drugs would not be visible, while abandoned drugs would be considered common, according to the complaint. The EHR sometimes displays a patient's medication profile along with the doctor's note to another patient, which makes it easier to misdiagnose or prescribe medication to the wrong person. Prescriptions, of which approximately 30,000 in 2010, did not have the appropriate start and end dates, which gave them the possibility of inadequate or excessive medication. The eCW system was not reliably tracking lab results, concluded Delaney, which recorded 1,884 tests for which they had never achieved results.
The Vermont District launched an official federal survey in 2015.
The government discovered that the eCW spaghetti code was so buggy that when one problem was solved, another would be created. For example, the user interface offered several ways to order a lab test or a diagnostic image, but not all of them seemed to work. The software would detect and warn users of dangerous drug interactions, but without the knowledge of the doctors, the alerts would stop if the drug order was personalized. "It would be like driving with the radio on and the windshield wipers on, and when I got on the turn signal, the brakes would not work, all of a sudden," Foster said.
The eCW system also did not use standard drug codes and, in some cases, laboratory and diagnostic codes as well, the government claimed.
The case has never been brought before a jury. In May 2017, eCW paid the government a $ 155-million settlement of alleged "false claims" and kickbacks – a doctor had earned tens of thousands of dollars – from customers who were promoting his product. Despite the record settlement, the company denied committing a wrongdoing; eCW has not responded to many requests for comments.
If history makes sense, it's the following: the US government has funded the adoption of this software – and continues to pay for it. Or we should say: you do.
Which brings us to the weird, sad and aggravating story that unfolds below. It is neither a trial nor a neglected technology. Rather, it is a problem-prone industry that intersects, in the most personal way, with each of our lives. It is a $ 3.7 trillion health care system that is idling at the crossroads of progress. And it's a whole series of unintended consequences – the surprising surprises of a great idea whose time had apparently come.
The virtual magic ball
Electronic health records were supposed to go a long way: making drugs safer, providing better care, empowering patients, and yes, even saving money. Boosters herald an age when researchers could harness mbadive data to reveal the most effective treatments for disease and dramatically reduce medical errors. Patients, in turn, would have genuinely portable health records, able to share their medical histories in the blink of an eye with doctors and hospitals across the country, which is essential when vital decisions are made in the wards d & # 39; emergency.
Ten years after President Barack Obama signed a law to speed up the digitization of medical records, the federal government has already committed $ 36 billion. The United States has little to show for its investments. KHN and Fortune have spoken to over 100 physicians, patients, experts and IT administrators, health policy leaders, lawyers, senior officials, and representatives of more than half a dozen EHR providers, including CEOs of two of the companies. The interviews reveal a tragic missed opportunity: rather than forming an electronic information ecosystem, the country's thousands of EHRs remain largely a patchwork and disconnected patchwork. In addition, this effort has handcuffed health professionals to a technology they generally can not support and has enriched and empowered the industry, which sells $ 13 billion a year.
To a degree, the effort was successful: today, 96% of hospitals have adopted the EHR, against only 9% in 2008. But, in most other cases, the newly installed technology has evolved little . Doctors complain about awkward and unintuitive systems and the number of hours spent clicking, typing and trying to navigate between them – which is more than the hours they spend with patients. Unlike the global network of ATMs, EHR systems owned by more than 700 vendors do not always talk to each other, which means doctors always use medical data transfer via fax and CD-ROM. Patients, on the other hand, are still struggling to access their own records – and sometimes they simply can not.
Instead of cutting costs, many say that EHRs, which were initially optimized for billing rather than patient care, have simplified the process of upward coding or billing inflation (although some say that the systems also facilitate this fraud).
More importantly, a multi-month joint survey by KHN and Fortune revealed that instead of streamlining drugs, the government's EHR initiative has created a host of risks to patient safety for the most part. unrecognized. Our investigation found that alarming reports of patient deaths, serious injuries and near-misses, related to software problems, user errors or other defects, have accumulated. , largely invisible, in various private and government-funded standards.
The problem is compounded by entrenched privacy policies that continue to keep software failures out of public view. EHR providers often impose contractual "covenants" that discourage shoppers from talking about security issues and disastrous software installations – although some clients have gone to court to make their grievances known. In addition, the complainants state that hospitals often fight to keep records of injured patients or their families. Indeed, two physicians who spoke frankly about the problems they faced with the EHRs later asked that their names not be used, adding that their health care organizations forbade them to speak. According to US Deputy Attorney Foster, EHR sellers "are protected by a shield of silence."
While the software has reduced some of the common types of clinical errors in the handwriting era, Raj Ratwani, a researcher at MedStar Health in Washington, DC, documented new trends in medical errors related to EHRs, which he considers both perilous and avoidable. "The fact that we can not disseminate this nationally and solve these problems immediately, and that another patient elsewhere may be hurt by the same problem – this just can not happen," did he declare.
David Blumenthal, who, as Obama's National Coordinator for Health Information Technology, was one of the architects of the EHR initiative, acknowledged to KHN and Fortune that electronic health records " have not yet fully exploited their potential. I think that few people would argue.
The former president also described the effort as one of its most disappointing, lamenting in an interview with Vox in January 2017: "The fact that there is still tons of paperwork. and that doctors still have to enter information, and nurses spend all their time on all this administrative work. We invested a lot of money to try to encourage everybody to scan, to catch up with the rest of the world … it was more difficult than expected. "
Seema Verma, the current head of the Medicare & Medicaid Services Centers (CMS), who oversees the current EHR effort, shudders at the billions of dollars spent on building software that does not share data – an electronic bridge that would not go anywhere. "Suppliers have developed their own systems that may have worked well for them," she told KHN and Fortune last month. "We have not thought about how all these systems connect to each other. It was the real missing piece. "
Perhaps none of the former boosters of the initiative is as frustrated as former vice president Joe Biden. At a meeting with health leaders in Washington in 2017, he opposed the enormous challenge of transporting his son Beau's medical records from one hospital to another. "I was stunned when my son for a year fought glioblastoma at stage 4," Biden said. "I could not get his records. I am the Vice President of the United States of America … It was an absolute nightmare. It was ridiculous, absolutely ridiculous, that we are in this situation. "
A bridge to nowhere
As Biden would tell you, the original concept was smart. The digitization wave swept through virtually every sector, causing both disruption and, in most cases, increased efficiency. And perhaps none of these industries deserved digital liberation more than medicine, where lifesaving and lifesaving data was locked in crypts on paper – pile on pile of files in closets doctors of the country.
Stored in steel cabinets, the records were almost useless. Nobody – especially at the dawn of the iPhone era – thought it would be a good idea to leave them well. According to critics, the problem lay in the way decision makers decided to transform them.
"Every idea was well-intentioned and potentially beneficial to society, but the combined burden of clinician typing made practicing the office virtually impossible," said John Halamka, chief information officer at Beth Israel Deaconess Medical Center, who sat on EHR Standards Committees under George W. Bush and Barack Obama. "In America, we have 11 minutes to see a patient and, you know, you will empathize, make eye contact, enter about 100 data and never commit malpractice. This is not possible! "
KHN and Fortune have reviewed more than two dozen medical negligence cases alleging that EHRs have either contributed to injuries, have been incorrectly altered, or denied patients to conceal poorer care. In such a case, the prosecution is usually settled before the trial with strict confidentiality commitments. It is therefore often impossible to determine the merits of the allegations. EHR providers also often have contractual clauses, known as "unconditional clauses," which protect them from liability if hospitals are later sued for medical errors, even if they were related to a problem. technology.
But the lawsuits, like the one brought by Fabian Ronisky, who emerge from this veil are quite revealing.
According to his complaint, Ronisky would have arrived by ambulance at the Saint John Providence Saint John Health Center in the afternoon of March 2, 2015. For two days, the young lawyer was suffering from severe headaches while he was suffering from severe headaches. a discouraging fever allowed him to trouble telling. the 911 operator his address.
A physician suspected of meningitis, a doctor at the hospital performed a spinal cord aspiration and the next day an infectious disease specialist placed an order for a critical laboratory test – a cerebrospinal fluid check for viruses, including herpes simplex – in the hospital's EHR.
The multi-million dollar system, manufactured by Epic Systems Corp. and considered by some as the Cadillac medical software, had been installed at the hospital about four months earlier. Although the command appears on the Epic screen, it was not sent to the lab. It turned out that the Epic software did not have a complete "interface" with the lab software, according to a lawsuit filed by Ronisky in February 2017 in the Los Angeles County Superior Court. His results and diagnosis were delayed – days to days, he said – during which he suffered irreversible brain damage from herpes encephalitis. The lawsuit alleged that the accident had prevented doctors from giving Ronisky a drug called acyclovir that could have minimized the damage done to his brain.
Epic has denied any liability or defect in its software; the company said that the doctor had not pressed the right button to send the order and that the hospital, and not Epic, had configured the interface with the laboratory. Epic, one of the largest computerized health record manufacturers in the country and the largest provider of most of America's most reputable medical centers, quietly paid $ 1 million to resolve the complaint in July 2018, according to news reports. court records. The hospital and two doctors paid $ 7.5 million and a lawsuit against a third doctor is pending trial. Ronisky, 34, struggling to rebuild his life, declined to comment.
Incidents like Ronisky's – or Annette Monachelli's, from elsewhere – are surprisingly common, the data shows. And the back-and-forth around which the fault lies in such cases is actually part of the problem: systems are often so confusing (and training on them is rarely sufficient) that mistakes often fall into an area of lower responsibility. . It can be difficult to say where human error begins and where technological weaknesses end.
EHRs have promised to put all of a patient's records in one place, but this is often the problem. Critical or time-sensitive information is systematically buried in an infinite scroll of data, where, in the rush of medical decision making – and in the maze of drop-down menus – they may be missed.
Brooke Dilliplaine, 13, who was severely allergic to dairy products, received a milk containing probiotics. Both doses sent him into a "total respiratory distress" and resulted in the collapse of one lung, according to a lawsuit brought by his mother. Rory Staunton, 12, was skinned arm in gym clbad, then died of sepsis after emergency doctors discharged the boy as a result of her laboratory findings, the EHR not being complete. And then there is the case of Thomas Eric Duncan. The 42-year-old man was sent home in 2014 from a Dallas hospital infected with the Ebola virus. Although a nurse entered the EHR during her recent trip to Liberia, where the Ebola outbreak was in full swing, the doctor never saw her. Duncan died a week later.
Many of these cases end up in the courts. In general, doctors and nurses blame faulty technology in medical records systems. EHR providers blame human error. And during this time, cases go up.
Quantros, a private health care badytics company, reported 18,000 EHR security-related events from 2007 to 2018, 3% of which caused harm to patients, including seven deaths – a figure that according to a director of Quantros, is "considerably under-reported".
A 2016 study by The Leapfrog Group, a Washington-based patient safety oversight agency, found that the drug control function of hospital EHRs – a feature required by the government for certification but often configured differently each system – failed to report harmful drug orders in 39% of cases in a test simulation. In 13% of cases, the error could have been fatal.
In recent years, the Pew Charitable Trusts has implemented an EHR security project focused on issues such as ease of use and patient adequacy – the process of linking the right file Medical to the right patient – a seemingly fundamental task for which systems, even when they are manufactured by the same EHR provider, they often fail. According to Pew, in some institutions, this match was accurate only in 50% of cases. Patients also discovered errors: a January survey by the Kaiser Family Foundation found that one in five patients had noticed an error in their electronic medical record. (Kaiser Health News is an independent editorial program of the foundation.)
The Joint Commission, which certifies the hospitals, has sounded an alarm on a number of issues, including false alarms, which account for between 85 and 99 percent of EHR and medical device alerts. (A study by researchers at Oregon Health & Science University estimated that a clinician working in the intensive care unit could be exposed to 7,000 pbadive alerts per day at most.) Such excessive warning can be dangerous. From 2014 to 2018, the Commission compiled 170 reports, mostly voluntary, of damage to patients related to alarm management and alert fatigue – a phenomenon in which health workers, so overburdened unnecessary warnings, ignore the occasional signifier. Of these 170 incidents, 101 resulted in the death of patients.
The Pennsylvania Patient Safety Authority, an independent public body gathering information on adverse events and incidents, reported 775 "laboratory-related problems" related to health informatics between January 2016 and December 2017.
Admittedly, mbad medical errors occurred in the era of paper medicines, when hospital staff misconstrued the scribbling of the doctor or read the wrong chart as a fatal consequence, for example. But what is perhaps telling, is that many doctors today are opting for manual workarounds to their EHRs. Aaron Zachary Hettinger, an emergency physician from MedStar Health in Washington, DC, said that when he had to share critical information about the patient with colleagues, they would write it on a whiteboard or on a paper towel and left it on the keyboard of their colleagues. .
Although the Food and Drug Administration does not require reporting EHR safety events – as for regulated medical devices – the messages involved have nonetheless proliferated in the MAUDE database of adverse events from the FDA, which now serves as an ad hoc dashboard for warnings. the different systems.
What complicates the situation even further is that health care providers almost always adapt their uniform EHR systems to their own specifications. Such customization makes each piece unique and often difficult to compare with others – making the source of errors difficult to determine.
Dr. Martin Makary, a Johns Hopkins oncologist surgeon and co-author of a highly cited 2016 study that identified medical errors as the third leading cause of death in America, attributes certain safety improvements to the EHR, including Recent changes have helped to halt the opioid epidemic electronically. But, he said, "we exchanged one set of problems for another. We used to struggle with handwriting and missing information. We are now struggling to make ourselves understood that we are writing and ordering the right patient. "
Dr. Joseph Schneider, pediatrician at UT Southwestern Medical Center, compares the transition we've made, from paper support to electronic media, to the pbadage of the horse to the automobile. But in this badogy, he added, "our cars progressed until around the 1960s. They still do not have a seatbelt or an airbag. "
Schneider recalled an episode where his colleagues could not understand why pieces of their notes disappeared inexplicably. Several weeks later, after an intensive study, they understood the problem: the doctors had grabbed wavy hooks – {} – whose use, even without the knowledge of the suppliers' representatives, removed the text that separated them. (The EHR manufacturer initially blamed the doctors, Schneider said.)
A broad coalition of players, ranging from National Nurses United to the Texas Medical Association, to FDA executives, has long called for surveillance of electronic record security issues. Ratwani, director of MedStar Health's National Center for Human Factors in Health Care, is one of the most virulent. It is a 30-person institute focused on optimizing the security and usability of medical technology. Ratwani began his career in the defense industry, studying in particular the intuitiveness of information displays. When he arrived at MedStar in 2012, he was stunned by "the types of [digital] interfaces used "in health care," he said.
In a study published last year in the journal Health Affairs, Ratwani and his colleagues studied medication errors in three pediatric hospitals from 2012 to 2017. They found that 3,243 of them were due in part to "use problems" of EHRs. About one in five researchers found that the patient could have harmed his patients. "Poor interface design and poor implementation can lead to errors and sometimes death, which is incredibly bad and completely fixable," he said. "We should not hurt patients this way."
Using eye tracking technology, Ratwani showed on video how easy it is to make mistakes when performing basic tasks on the country's two major EHR systems. When emergency room physicians went to order Tylenol, for example, they saw a drop down menu listing 86 options, many of which were not relevant to the specified patient. They had to carefully read the list in order not to select the wrong dosage or form, although many do so too: in about 1 in 1,000, doctors accidentally selected the suppository (referred to as "PR") rather than the dose of tablet ("OR"), according to one estimate. It is not a mistake that will harm a patient – although other drug mixtures can and do.
Earlier this year, the MedStar Human Factors Center launched a website and public awareness campaign with the American Medical Association to draw attention to such widespread mistakes. They use the letters "DSE" to initialize "Errors happen regularly" – and petition Congress. for the action. Ratwani insists on a central database to track these errors and undesirable events.
Others have turned to social media to let off steam. Dr. Mark Friedberg, Health Policy Researcher at Rand Corp. and medical practitioner in primary health care, defend the Twitter hashtag #EHRbuglist to encourage other health care workers to express their pain points. And last month, a scathing epic parody appeared on Twitter, winning more than 8,000 subscribers in its first five days. His first tweet, written with the false voice of an epic lord, was the following: "I've already seen a doctor make eye contact with a patient. This horror must stop. "
Even though EHR systems are blamed for wrongdoing, it is often the sins of omission that further upset the users.
Prenons le cas de Lynne Chauvin, qui a travaillé comme badistante médicale chez Ochsner Health System, en Louisiane. Dans un procès encore en suspens en 2015, Chauvin affirme que le logiciel d’Epic n’a pas déclenché un avertissement concernant un médicament essentiel; Chauvin souffrait de conditions qui augmentaient son risque de formation de caillots sanguins et, bien que ces antécédents soient documentés dans ses dossiers, elle avait été traitée avec des médicaments qui restreignaient le flux sanguin après une intervention cardiaque à l'hôpital. Elle a développé une gangrène entraînant l'amputation du bas de ses jambes et de son avant-bras. (Ochsner Health System a déclaré qu’il ne pouvait pas commenter un litige en cours, mais qu’il «reste attaché à la sécurité des patients, ce qui, nous le croyons fermement, est optimisé grâce à l’utilisation de la technologie des dossiers de santé électroniques.» Epic a refusé de commenter.
Faisant écho aux plaintes de nombreux médecins, le procès soutient que le logiciel Epic "est extrêmement compliqué à visualiser et à comprendre", en raison de "la répétition importante des données". Chauvin a déclaré que ses factures médicales avaient dépbadé le million de dollars et qu'elle était invalide de manière permanente. Son mari, Richard, est devenu son principal fournisseur de soins et a dû prendre sa retraite plus tôt de son travail à Kenner pour prendre soin de sa femme, selon le procès. Chaque partie a refusé de commenter.
Une épidémie d'épuisement professionnel
La répétition angoissante, les cases à cocher et les recherches sans fin sur les menus déroulants font partie de ce que Ratwani a appelé le "fardeau cognitif" qui épuise les médecins actuels et conduit de plus en plus de personnes à la retraite anticipée.
L'épuisement professionnel des médecins est devenu une priorité en médecine ces dernières années. Une enquête réalisée par Merritt Hawkins en 2018 a révélé que 78% des médecins souffraient de symptômes d'épuisement professionnel. En janvier, la Harvard School of Public Health et d'autres institutions ont qualifié cette crise de «crise de santé publique».
Ashish Jha, l’un des coauteurs de l’étude de Harvard, a en grande partie imputé la responsabilité à «la croissance de dossiers médicaux numériques mal conçus … [have] obliger les médecins à consacrer de plus en plus de temps à des tâches qui ne profitent pas directement aux patients. "
Peu de gens nieraient que la numérisation rapide du système médical américain ait été transformatrice. Les DSE étant désormais presque universels, le visage et la convivialité de la médecine ont changé. Le médecin est en train de taper, établissant peut-être plus de contact visuel avec l'écran de l'ordinateur qu'avec le patient. Les patients n’apprécient pas cette dynamique; pour les médecins, dont les journées commencent et se terminent de plus en plus par des rencontres aussi fugaces, l’effet peut être carrément badourdissant.
«Vous êtes badis devant un patient et vous avez tellement de choses à faire. Vous n'avez que très peu de temps pour le faire – sept à onze minutes, probablement – alors quand écoutez-vous vraiment? John-Henry Pfifferling, un anthropologue médical qui conseille les médecins souffrant d'épuisement professionnel. «Si vous vous lancez dans la médecine parce que vous aimez interagir et que vous n’êtes qu’un outil, c’est déshumanisant», a déclaré Pfifferling, qui a vu de nombreux médecins abandonner la médecine avec le pbadage aux enregistrements électroniques. «C’est une catastrophe», at-il déclaré.
En plus de compliquer la relation médecin-patient, les DSE ont, à certains égards, rendu la pratique de la médecine plus difficile, a déclaré le Dr Hal Baker, médecin et responsable de l'information à WellSpan, un système hospitalier de Pennsylvanie. «Les médecins doivent basculer sur le plan cognitif entre se concentrer sur le dossier et sur le patient», a-t-il déclaré. Il souligne à quel point il est inhabituel – et potentiellement dangereux – que: «Envoyer des SMS pendant que vous conduisez n’est pas une bonne idée. Et je n’ai pas encore vu le PDG qui, lorsqu’il tient une réunion du conseil d’administration, prend des procès-verbaux et je n’ai certainement jamais entendu parler d’un juge qui, pendant le procès, serait également le sténographe de la cour. Mais en médecine … nous avons demandé au médecin de pbader de l’écriture au stylo à la [entering a computer] record, et c’est une interface badez compliquée. "
Même si les docs sont au clavier pendant les visites, ils signalent qu'ils doivent pbader des heures supplémentaires en dehors de cette heure – midi, tard le soir – pour terminer leurs notes et se tenir au courant des procédures électroniques (envoi de références, correspondance avec les patients, résolution du codage problèmes). That's true. Les DSE n’ont pas emporté la paperbade; les systèmes viennent de le mettre en ligne. Et il y en a beaucoup: 44% des six heures environ qu'un médecin consacre au DSE chaque jour sont consacrées à des tâches administratives et de bureau, telles que la facturation et le codage, selon une étude menée en 2017 par Annals of Family Medicine.
Malgré tout ce que l’on appelle le temps des pyjamas – le médecin moyen note 1,4 heure par jour sur le DSE après le travail – il n’obtient pas un centime.
De nombreux médecins reconnaissent la valeur de la technologie: 60% des participants au sondage national auprès des médecins mené en 2018 par Stanford Medicine ont déclaré que les DSE avaient permis d’améliorer les soins prodigués aux patients. Parallèlement, à peu près autant (59%) ont déclaré que les DSE nécessitaient une «refonte complète» et que les systèmes avaient nui à leur satisfaction professionnelle (54%) et à leur efficacité clinique (49%).
Dans des études préliminaires, Ratwani a découvert que les médecins réagissaient normalement avec l'utilisation d'un DSE: le stress. Lorsque lui et son équipe surveillent le travail des cliniciens, ils utilisent une gamme de capteurs pour surveiller le rythme cardiaque des médecins et d’autres signes vitaux au cours de leur quart de travail. La fréquence cardiaque des médecins augmentera – jusqu’à 160 battements par minute – à deux occasions: lorsqu’ils interagissent avec les patients et lorsqu’ils utilisent le DSE.
«Tout est si encombrant», a déclaré la Dre Karla Dick, médecin de famille à Arlington, au Texas. «C’est lent par rapport à une carte papier. Vous devez cliquer, zoomer et effectuer un zoom arrière pour rechercher des éléments. »Avec tous les zooms avant et arrière, at-elle expliqué, il est facile de se retrouver dans le mauvais enregistrement. "Je ne peux pas vous dire combien de fois j'ai dû annuler une commande parce que j'étais dans le mauvais tableau."
Among the daily frustrations for one emergency room physician in Rhode Island is ordering ibuprofen, a seemingly simple task that now requires many rounds of mouse clicking. Every time she prescribes the basic painkiller for a female patient, whether that patient is 9 or 68 years old, the prescription is blocked by a pop-up alert warning her that it may be dangerous to give the drug to a pregnant woman. The physician, whose institution does not allow her to comment on the systems, must then override the warning with yet more clicks. “That’s just the tiniest tip of the iceberg,” she said.
What worries the doctor most is the ease with which diligent, well-meaning physicians can make serious medical errors. She noted that the average ER doc will make 4,000 mouse clicks over the course of a shift, and that the odds of doing anything 4,000 times without an error is small. “The interfaces are just so confusing and clunky,” she added. “They invite error … it’s not a negligence issue. This is a poor tool issue.”
Many of the EHR makers acknowledge physician burnout is real and say they’re doing what they can to lessen the burden and enhance user experience. Dr. Sam Butler, a pulmonary critical care specialist who started working at Epic in 2001, leads those efforts at the Wisconsin-based company. When doctors get more than 100 messages per week in their in-basket (akin to an email inbox), there’s a higher likelihood of burnout. Butler’s team has also badyzed doctors’ electronic notes — they’re twice as long as they were nine years ago, and three to four times as long as notes in the rest of the world. He said Epic uses such insights to improve the client experience. But coming up with fixes is difficult because doctors “have different viewpoints on everything,” he said. (KHN and Fortune made multiple requests to interview Epic CEO Judy Faulkner, but the company declined to make her available. In a trade interview in February, however, Faulkner said that EHRs were unfairly blamed for physician burnout and cited a study suggesting that there’s little correlation between burnout and EHR satisfaction. Executives at other vendors noted that they’re aware of usability issues and that they’re working on addressing them.)
“It’s not that we’re a bunch of Luddites who don’t know how to use technology,” said the Rhode Island ER doctor. “I have an iPhone and a computer and they work the way they’re supposed to work, and then we’re given these incredibly cumbersome and error-prone tools. This is something the government mandated. There really wasn’t the time to let the cream rise to the top; everyone had to jump in and pick something that worked and spend tens of millions of dollars on a system that is slowly killing us.”
$36 billion and change
The effort to digitize America’s health records got its biggest push in a very low moment: the financial crisis of 2008. In early December of that year, Obama, barely four weeks after his election, pitched an ambitious economic recovery plan. “We will make sure that every doctor’s office and hospital in this country is using cutting-edge technology and electronic medical records so that we can cut red tape, prevent medical mistakes and help save billions of dollars each year,” he said in a radio address.
The idea had already been a fashionable one in Washington. Former House Speaker Newt Gingrich was fond of saying it was easier to track a FedEx package than one’s medical records. Obama’s predecessor, President George W. Bush, had also pursued the idea of wiring up the country’s health system. He didn’t commit much money, but Bush did create an agency to do the job: the Office of the National Coordinator (ONC).
In the depths of recession, the EHR conceit looked like a shovel-ready project that only the paper lobby could hate. In February 2009, legislators pbaded the HITECH Act, which carved out a hefty chunk of the mbadive stimulus package for health information technology. The goal was not just to get hospitals and doctors to buy EHRs, but rather to get them using them in a way that would drive better care. So lawmakers devised a carrot-and-stick approach: Physicians would qualify for federal subsidies (a sum of up to nearly $64,000 over a period of years) only if they were “meaningful users” of a government-certified system. Vendors, for their part, had to develop systems that met the government’s requirements.
They didn’t have much time, though. The need to stimulate the economy, which meant getting providers to adopt EHRs quickly, “presented a tremendous conundrum,” said Farzad Mostashari, who joined the ONC as deputy director in 2009 and became its leader in 2011: The ideal — creating a useful, interoperable, nationwide records system — was “utterly infeasible to get to in a short time frame.”
That didn’t stop the federal planners from pursuing their grand ambitions. Everyone had big ideas for the EHRs. The FDA wanted the systems to track unique device identifiers for medical implants, the Centers for Disease Control and Prevention wanted them to support disease surveillance, CMS wanted them to include quality metrics and so on. “We had all the right ideas that were discussed and hashed out by the committee,” said Mostashari, “but they were all of the right ideas.”
Not everyone agreed, though, that they were the right ideas. Before long, “meaningful use” became pejorative shorthand to many for a burdensome government program — making doctors do things like check a box indicating a patient’s smoking status each and every visit.
The EHR vendor community, then a scrappy $2 billion industry, griped at the litany of requirements but stood to gain so much from the government’s $36 billion injection that it jumped in line. As Rusty Frantz, CEO of EHR vendor NextGen Healthcare, put it: “The industry was like, ‘I’ve got this check dangling in front of me, and I have to check these boxes to get there, and so I’m going to do that.’”
Halamka, who was an enthusiastic backer of the initiative in both the Bush and Obama administrations, blames the pressure for a speedy launch as much as the excessive wish list. “To go from a regulation to a highly usable product that is in the hands of doctors in 18 months, that’s too fast,” he said. “It’s like asking nine women to have a baby in a month.”
Several of those who worked on the project admit the rollout was not as easy or seamless as they’d anticipated, but they contend that was never the point. Aneesh Chopra, appointed by Obama in 2009 as the nation’s first chief technology officer, called the spending a “down payment” on a vision to fundamentally change American medicine — creating a digital infrastructure to support new ways to pay for health services based on their quality and outcomes.
Dr. Bob Kocher, a physician and star investor with venture capital firm Venrock, who served in the Obama administration from 2009 to 2011 as a health and economic policy adviser, not only defends the rollout then but also disputes the notion that the government initiative has been a failure at all. “EHRs have totally lived up to the hype and expectations,” he said, emphasizing that they also serve as a technology foundation to support innovation on everything from patients accessing their medical records on a smartphone to AI-driven medical sleuthing. Others note the systems’ value in aggregating medical data in ways that were never possible with paper — helping, for example, to figure out that contaminated water was poisoning children in Flint, Mich.
But Rusty Frantz heard a far different message about EHRs — and, more important, it was coming from his own customers.
The Stanford-trained engineer, who in 2015 became CEO of NextGen, a $500-million-a-year EHR heavyweight in the physician-office market, learned the hard way about how his product was being viewed. As he stood at the podium at his first meeting with thousands of NextGen customers at Las Vegas’ Mandalay Bay Resort, just four months after getting the job, he told KHN and Fortune, “People were lining up at the microphones to yell at us: ‘We weren’t delivering stable software! The executive team was inaccessible! The service experience was terrible!’ ” (He now refers to the event as “Festivus: the airing of the grievances.”)
Frantz had bounced around the health care industry for much of his career, and from the nearby perch of a medical device company, he watched the EHR incentive bonanza with a mix of envy and slack-jawed awe. “The industry was moving along in a natural Darwinist way, and then along came the stimulus,” said Frantz, who blames the government’s ham-handed approach to regulation. “The software got slammed in, and the software wasn’t implemented in a way that supported care,” he said. “It was installed in a way that supported stimulus. This company, we were complicit in it, too.”
Even that may be a generous description. KHN and Fortune found a trail of lawsuits against the company, stretching from White Sulphur Springs, Mont., to Neillsville, Wis. Mary Rutan Hospital in Bellefontaine, Ohio, sued NextGen (formerly called Quality Systems) in federal court in 2013, arguing that it experienced hundreds of problems with the “materially defective” software the company had installed in 2011.
A consultant hired by the hospital to evaluate the NextGen system, whose 60-page report was submitted to the court, identified “many functional defects” that he said rendered the software “unfit for its intended purpose.” Some patient information was not accurately recorded, which had the potential, the consultant wrote, “to create major patient care risk which could lead to, at a minimum, inconvenience, and at worst, malpractice or even death.” Glitches at Mary Rutan included incidents in which the software would apparently change a patient’s gender at random or lose a doctor’s observations after an exam, the consultant reported. The company, he found, sometimes took months to address issues: One IT ticket, which related to a physician’s notes inexplicably deleting themselves, reportedly took 10 months to resolve. (The consultant also noted that similar problems appeared to be occurring at as many as a dozen other hospitals that had installed NextGen software.)
The Ohio hospital, which paid more than $1.5 million for its EHR system, claimed breach of contract. NextGen responded that it disputed the claims made in the lawsuit and that the matter was resolved in 2015 “with no findings of fact by a court related to the allegations.” The hospital declined to comment.
At the time, as it has been since then, NextGen’s software was certified by the government as meeting the requirements of the stimulus program. By 2016, NextGen had more than 19,000 customers who had received federal subsidies.
NextGen was subpoenaed by the Department of Justice in December 2017, months after becoming the subject of a federal investigation led by the District of Vermont. Frantz tells KHN and Fortune that NextGen is cooperating with the investigation. “This company was not dishonest, but it was not effective four years ago,” he said. Frantz also emphasized that NextGen has “rapidly evolved” during his tenure, earning five industry awards since 2017, and that customers have “responded very positively.”
Glen Tullman, who until 2012 led Allscripts, another leading EHR vendor that benefited royally from the stimulus and that has been sued by numerous unhappy customers, admitted that the industry’s race to market took priority over all else.
“It was a big distraction. That was an unintended consequence of that,” Tullman said. “All the companies were saying, This is a one-time opportunity to expand our share, focus everything there, and then we’ll go back and fix it.” The Justice Department has opened a civil investigation into the company, Securities and Exchange Commission filings show. Allscripts said in an email that it cannot comment on an ongoing investigation, but that the civil investigations by the Department of Justice relate to businesses it acquired after the investigations were opened.
Much of the marketing mayhem occurred because federal officials imposed few controls over firms scrambling to cash in on the stimulus. It was a gold rush — and any system, it seemed, could be marketed as “federally approved.” Doctors could shop for bargain-price software packages at Costco and Walmart’s Sam’s Club — where eClinicalWorks sold a “turnkey” system for $11,925 — and cash in on the government’s adoption incentives.
The top-shelf vendors in 2009 crisscrossed the country on a “stimulus tour” like rock groups, gigging at some 30 cities, where they offered doctors who showed up to hear the pitch “a customized badysis” of how much money they could earn off the government incentives. Following the same playbook used by pharmaceutical companies, EHR sellers courted doctors at fancy dinners in ritzy hotels. One enterprising software firm advertised a “cash for clunkers” deal that paid $3,000 to doctors willing to trade in their current records system for a new one. Athenahealth held “invitation only” dinners at luxury hotels to advise doctors, among other things, how to use the stimulus to get paid more and capture available incentives. Allscripts offered a no-money-down purchase plan to help doctors “maximize the return on your EHR investment.” (An Athenahealth spokesperson said the company’s “dinners were educational in nature and aimed at helping physicians navigate the government program.” Allscripts did not respond directly to questions about its marketing practices, but said it “is proud of the software and services [it provides] to hundreds of thousands of caregivers across the globe.”)
EHRs were supposed to reduce health care costs, at least in part by preventing duplicative tests. But as the federal government opened the stimulus tap, many raised doubts about the promised savings. Advocates bandied about a figure of $80 billion in cost savings even as congressional auditors were debunking it. While the jury’s still out, there’s growing suspicion the digital revolution may potentially raise health care costs by encouraging overbilling and new strains of fraud and abuse.
In September 2012, following press reports suggesting that some doctors and hospitals were using the new technology to improperly boost their fees, a practice known as “upcoding,” then-Health and Human Services chief Kathleen Sebelius and Attorney General Eric Holder warned the industry not to try to “game the system.”
There’s also growing evidence that some doctors and health systems may have overstated their use of the new technology to secure stimulus funds, a potentially enormous fraud against Medicare and Medicaid that likely will take many years to unravel. In June 2017, the HHS inspector general estimated that Medicare officials made more than $729 million in subsidy payments to hospitals and doctors that didn’t deserve them.
Individual states, which administer the Medicaid portion of the program, haven’t fared much better. Audits have uncovered overpayments in 14 of 17 state programs reviewed, totaling more than $66 million, according to inspector general reports.
Last month, Sen. Chuck Grbadley, an Iowa Republican who chairs the Senate Finance Committee, sharply criticized CMS for recovering only a tiny fraction of these bogus payments, or what he termed a “spit in the ocean.”
EHR vendors have also been accused of egregious and patient-endangering acts of fraud as they raced to cash in on the stimulus money grab. In addition to the U.S. government’s $155 million False Claims Act settlement with eClinicalWorks noted above, the federal government has reached a second settlement over similar charges against another large vendor, Tampa-based Greenway Health. In February, that company settled with the government for just over $57 million without denying or admitting wrongdoing. “These are cases of corporate greed, companies that prioritized profits over everything else,” said Christina Nolan, the U.S. attorney for the District of Vermont, whose office led the cases. (In a response, Greenway Health did not address the charges or the settlement but said it was “committing itself to being the standard-bearer for quality, compliance, and transparency.”)
Tower of Babel
In early 2017, Seema Verma, then the country’s newly appointed CMS administrator, went on a listening tour. She visited doctors around the country, at big urban practices and tiny rural clinics, and from those front-line physicians she consistently heard one thing: They hated their electronic health records. “Physician burnout is real,” she told KHN and Fortune. The doctors spoke of the difficulty in getting information from other systems and providers, and they complained about the government’s reporting requirements, which they perceived as burdensome and not meaningful.
What she heard then became suddenly personal one summer day in 2017, when her husband, himself a physician, collapsed in the airport on his way home to Indianapolis after a family vacation. For a frantic few hours, the CMS administrator fielded phone calls from first responders and physicians — Did she know his medical history? Did she have information that could save his life? — and made calls to his doctors in Indiana, scrambling to piece together his record, which should have been there in one piece. Her husband survived the episode, but it laid bare the dysfunction and danger inherent in the existing health information ecosystem.
The notion that one EHR should talk to another was a key part of the original vision for the HITECH Act, with the government calling for systems to be eventually interoperable.
What the framers of that vision didn’t count on were the business incentives working against it. A free exchange of information means that patients can be treated anywhere. And though they may not admit it, many health providers are loath to lose their patients to a competing doctor’s office or hospital. There’s a term for that lost revenue: “leakage.” And keeping a tight hold on patients’ medical records is one way to prevent it.
There’s a ton of proprietary value in that data, said Blumenthal, who now heads the Commonwealth Fund, a philanthropy that does health research. Asking hospitals to give it up is “like asking Amazon to share their data with Walmart,” he said.
Blumenthal acknowledged that he failed to grasp these perverse business dynamics and foresee what a challenge getting the systems to talk to one another would be. He added that forcing interoperability goals early on, when 90 percent of the nation’s providers still didn’t have systems or data to exchange, seemed unrealistic. “We had an expression: They had to operate before they could interoperate,” he said.
In the absence of true incentives for systems to communicate, the industry limped along; some providers wired up directly to other select providers or through regional exchanges, but the efforts were spotty. A Cerner-backed interoperability network called CommonWell formed in 2013, but some companies, including dominant Epic, didn’t join. (“Initially, Epic was neither invited nor allowed to join,” said Sumit Rana, senior vice president of R&D at Epic. Jitin Asnaani, executive director of CommonWell countered, “We made repeated invitations to every major EHR … and numerous public and private invitations to Epic.”)
Epic then supported a separate effort to do much the same.
Last spring, Verma attempted to kick-start the sharing effort and later pledged a war on “information blocking,” threatening penalties for bad actors. She has promised to reduce the documentation burden on physicians and end the gag clauses that protect the EHR industry. Regarding the first effort at least, “there was consensus that this needed to happen and that it would take the government to push this forward,” she said. In one sign of progress last summer, the dueling sharing initiatives of Epic and Cerner, the two largest players in the industry, began to share with each other — though the effort is fledgling.
When it comes to patients, though, the real sharing too often stops. Despite federal requirements that providers give patients their medical records in a timely fashion, in their chosen format and at low cost (the government recommends a flat fee of $6.50 or less), patients struggle mightily to get them. A 2017 study by researchers at Yale found that of America’s 83 top-rated hospitals, only 53 percent offer forms that provide patients with the option to receive their entire medical record. Fewer than half would share records via email. One hospital charged more than $500 to release them.
Sometimes the mere effort to access records leads to court. Jennifer De Angelis, a Tulsa attorney, has frequently sparred with hospitals over releasing her clients’ records. She said they either attempt to charge huge sums for them or force her to obtain a court order before releasing them. De Angelis added that she sometimes suspects the records have been overwritten to cover up medical mistakes.
Consider the case of 5-year-old Uriah R. Roach, who fractured and cut his finger on Oct. 2, 2014, when it was accidentally slammed in a door at school. Five days later, an operation to repair the damage went awry, and he suffered permanent brain damage, apparently owing to an anesthesia problem. The Epic electronic medical file had been accessed more than 76,000 times during the 22 days the boy was in the hospital, and a lawsuit brought by his parents contended that numerous entries had been “corrected, altered, modified and possibly deleted after an unexpected outcome during the induction of anesthesia.” The hospital denied wrongdoing. The case settled in November 2016, and the terms are confidential.
More than a dozen other attorneys interviewed cited similar problems, especially with gaining access to computerized “audit trails.” In several cases, court records show, government lawyers resisted turning over electronic files from federally run hospitals. That happened to Russell Uselton, an Oklahoma lawyer who represented a pregnant teen admitted to the Choctaw Nation Health Care Center in Talihina, Okla. Shelby Carshall, 18, was more than 40 weeks pregnant at the time. Doctors failed to perform a cesarean section, and her baby was born brain-damaged as a result, she alleged in a lawsuit filed in 2017 against the U.S. government. The baby began having seizures at 10 hours old and will “likely never walk, talk, eat, or otherwise live normally,” according to pleadings in the suit. Though the federal government requires hospitals to produce electronic health records to patients and their families, Uselton had to obtain a court order to get the baby’s complete medical files. Government lawyers denied any negligence in the case, which is pending.
“They try to hide anything from you that they can hide from you,” said Uselton. “They make it extremely difficult to get records, so expensive and hard that most lawyers can’t take it on,” he said.
Nor, it seems, can high-ranking federal officials. When Seema Verma’s husband was discharged from the hospital after his summer health scare, he was handed a few papers and a CD-ROM containing some medical images — but missing key tests and monitoring data. Said Verma, “We left that hospital and we still don’t have his information today.” That was nearly two years ago.
Kaiser Health News (KHN) is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
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