Death By 1,000 Clicks: Where Electronic Health Records Went Wrong

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 a brain 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 a dossier of troubling reports — 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.

The Virtual Magic Bullet

Electronic health records were supposed to do a lot: make medicine safer, bring higher-quality care, empower patients, and yes, even save money. Boosters heralded an age when researchers could harness the big data within to reveal the most effective treatments for disease and sharply reduce medical errors. Patients, in turn, would have truly portable health records, being able to share their medical histories in a flash with doctors and hospitals anywhere in the country — essential when life-and-death decisions are being made in the ER.

But 10 years after President Barack Obama signed a law to accelerate the digitization of medical records — with the federal government, so far, sinking $36 billion into the effort — America has little to show for its investment. KHN and Fortune spoke with more than 100 physicians, patients, IT experts and administrators, health policy leaders, attorneys, top government officials and representatives at more than a half-dozen EHR vendors, including the CEOs of two of the companies. The interviews reveal a tragic missed opportunity: Rather than an electronic ecosystem of information, the nation’s thousands of EHRs largely remain a sprawling, disconnected patchwork. Moreover, the effort has handcuffed health providers to technology they mostly can’t stand and has enriched and empowered the $13-billion-a-year industry that sells it.

By one measure, certainly, the effort has achieved what it set out to do: Today, 96 percent of hospitals have adopted EHRs, up from just 9 percent in 2008. But on most other counts, the newly installed technology has fallen well short. Physicians complain about clumsy, unintuitive systems and the number of hours spent clicking, typing and trying to navigate them — which is more than the hours they spend with patients. Unlike, say, with the global network of ATMs, the proprietary EHR systems made by more than 700 vendors routinely don’t talk to one another, meaning that doctors still resort to transferring medical data via fax and CD-ROM. ­Patients, meanwhile, still struggle to access their own records — and, sometimes, just plain can’t.

Instead of reducing costs, many say, EHRs, which were originally optimized for billing rather than for patient care, have instead made it easier to engage in “upcoding” or bill inflation (though some say the systems also make such fraud easier to catch).
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More gravely still, a months-long joint investigation by KHN and Fortune has found that instead of streamlining medicine, the government’s EHR initiative has created a host of largely unacknowledged patient safety risks. Our investigation found that alarming reports of patient deaths, serious injuries and near misses — thousands of them — tied to software glitches, user errors or other flaws have piled up, largely unseen, in various government-funded and private repositories.

Compounding the problem are entrenched secrecy policies that continue to keep software failures out of public view. EHR vendors often impose contractual “gag clauses” that discourage buyers from speaking out about safety issues and disastrous software installations — though some customers have taken to the courts to air their grievances. Plaintiffs, moreover, say hospitals often fight to withhold records from injured patients or their families. Indeed, two doctors who spoke candidly about the problems they faced with EHRs later asked that their names not be used, adding that they were forbidden by their health care organizations to talk. Says Assistant U.S. Attorney Foster, the EHR vendors “are protected by a shield of silence.”

Though the software has reduced some types of clinical mistakes common in the era of handwritten notes, Raj Ratwani, a researcher at MedStar Health in Washington, D.C., has documented new patterns of medical errors tied to EHRs that he believes are both perilous and preventable. “The fact that we’re not able to broadcast that nationally and solve these issues immediately, and that another patient somewhere else may be harmed by the very same issue — that just can’t happen,” he said.

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 fulfilled their potential. I think few would argue they have.”

The former president has likewise singled out the effort as one of his most disappointing, bemoaning in a January 2017 interview with Vox “the fact that there are still just mountains of paperwork … and the doctors still have to input stuff, and the nurses are spending all their time on all this administrative work. We put a big slug of money into trying to encourage everyone to digitalize, to catch up with the rest of the world … that’s been harder than we expected.”

Seema Verma, the current chief of the Centers for Medicare & Medicaid Services (CMS), which oversees the EHR effort today, shudders at the billions of dollars spent building software that doesn’t share data — an electronic bridge to nowhere. “Providers developed their own systems that may or may not even have worked well for them,” she told KHN and Fortune in an interview last month, “but we didn’t think about how all these systems connect with one another. That was the real missing piece.”

Perhaps none of the initiative’s former boosters is quite as frustrated as former Vice President Joe Biden. At a 2017 meeting with health care leaders in Washington, he railed against the infuriating challenge of getting his son Beau’s medical records from one hospital to another. “I was stunned when my son for a year was battling stage 4 glioblastoma,” said Biden. “I couldn’t get his records. I’m the vice president of the United States of America.  … It was an absolute nightmare. It was ridiculous, absolutely ridiculous, that we’re in that circumstance.”

A Bridge To Nowhere

As Biden would tell you, the original concept was a smart one. The wave of digitization had swept up virtually every industry, bringing both disruption and, in most cases, greater efficiency. And perhaps none of these industries was more deserving of digital liberation than medicine, where life-measuring and potentially lifesaving data was locked away in paper crypts — stack upon stack of file folders at doctors’ offices across the country.

Stowed in steel cabinets, the records were next to useless. Nobody — particularly at the dawn of the age of the iPhone — thought it was a good idea to leave them that way. The problem, say critics, was in the way that policy­makers set about to transform them.

“Every single idea was well-meaning and potentially of societal benefit, but the combined burden of all of them hitting clinicians simultaneously made office practice basically impossible,” said John Halamka, chief information officer at Beth Israel Deaconess Medical Center, who served on the EHR standards committees under both George W. Bush and Barack Obama. “In America, we have 11 minutes to see a patient, and, you know, you’re going to be empathetic, make eye contact, enter about 100 pieces of data, and never commit malpractice. It’s not possible!”

KHN and Fortune examined more than two dozen medical negligence cases that have alleged that EHRs either contributed to injuries, had been improperly altered, or were withheld from patients to conceal substandard care. In such cases, the suits typically settle prior to trial with strict confidentiality pledges, so it’s often not possible to determine the merits of the allegations. EHR vendors also frequently have contract stipulations, known as “hold harmless clauses,” that protect them from liability if hospitals are later sued for medical errors — even if they relate to an issue with the technology.

But lawsuits, like that filed by Fabian ­Ronisky, which do emerge from this veil, are quite telling.

Ronisky, according to his complaint, arrived by ambulance at Providence Saint John’s Health Center in Santa Monica on the afternoon of March 2, 2015. For two days, the young lawyer had been suffering from severe headaches while a disorienting fever left him struggling to tell the 911 operator his address.

Suspecting meningitis, a doctor at the hospital performed a spinal tap, and the next day an infectious disease specialist typed in an order for a critical lab test — a check of the spinal fluid for viruses, including herpes simplex — into the hospital’s EHR.

The multimillion-dollar system, manufactured by Epic Systems Corp. and considered by some to be the Cadillac of medical software, had been installed at the hospital about four months earlier. Although the order appeared on Epic’s screen, it was not sent to the lab. It turned out, Epic’s software didn’t fully “interface” with the lab’s software, according to a lawsuit Ronisky filed in February 2017 in Los Angeles County Superior Court. His results and diagnosis were delayed — by days, he claimed — during which time he suffered irreversible brain damage from herpes encephalitis. The suit alleged the mishap delayed doctors from giving Ronisky a drug called acyclovir that might have minimized damage to his brain.

 

Epic denied any liability or defects in its software; the company said the doctor failed to push the right button to send the order and that the hospital, not Epic, had configured the interface with the lab. Epic, among the nation’s largest manufacturers of computerized health records and the leading provider to most of America’s most elite medical centers, quietly paid $1 million to settle the suit in July 2018, according to court records. The hospital and two doctors paid a total of $7.5 million, and a case against a third doctor is pending trial. Ronisky, 34, who is fighting to rebuild his life, declined to comment.

Incidents like that which happened to Ronisky — or to Annette Monachelli, for that matter — are surprisingly common, data show. And the back-and-forth about where the fault lies in such cases is actually part of the problem: The systems are often so confusing (and training on them seldom sufficient) that errors frequently fall into a nether zone of responsibility. It can be hard to tell where human error begins and the technological short­comings end.

EHRs promised to put all of a patient’s records in one place, but often that’s the problem. Critical or time-sensitive information routinely gets buried in an endless scroll of data, where in the rush of medical decision-making — and amid the maze of pulldown menus — it can be missed.

Thirteen-year-old Brooke Dilliplaine, who was severely allergic to dairy, was given a probiotic containing milk. The two doses sent her into “complete respiratory distress” and resulted in a collapsed lung, according to a lawsuit filed by her mother. Rory Staunton, 12, scraped his arm in gym class and then died of sepsis after ER doctors discharged the boy on the basis of lab results in the EHR that weren’t complete. And then there’s the case of Thomas Eric Duncan. The 42-year-old man was sent home in 2014 from a Dallas hospital infected with Ebola virus. Though a nurse had entered in the EHR his recent travel to Liberia, where an Ebola epidemic was then in full swing, the doctor never saw it. Duncan died a week later.

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Many such cases end up in court. Typically, doctors and nurses blame faulty technology in the medical-records systems. The EHR vendors blame human error. And meanwhile, the cases mount.

Quantros, a private health care analytics firm, said it has logged 18,000 EHR-related safety events from 2007 through 2018, 3 percent of which resulted in patient harm, including seven deaths — a figure that a Quantros director said is “drastically underreported.”

A 2016 study by The Leapfrog Group, a patient-safety watchdog based in Washington, D.C., found that the medication-ordering function of hospital EHRs — a feature required by the government for certification but often configured differently in each system — failed to flag potentially harmful drug orders in 39 percent of cases in a test simulation. In 13 percent of those cases, the mistake could have been fatal.

The Pew Charitable Trusts has, for the past few years, run an EHR safety project, taking aim at issues like usability and patient matching — the process of linking the correct medical record to the correct patient — a seemingly basic task at which the systems, even when made by the same EHR vendor, often fail. At some institutions, according to Pew, such matching was accurate only 50 percent of the time. Patients have discovered mistakes as well: A January survey by the Kaiser Family Foundation found that 1 in 5 patients spotted an error in their electronic medical records. (Kaiser Health News is an editorially independent program of the foundation.)

The Joint Commission, which certifies hospitals, has sounded alarms about a number of issues, including false alarms — which account for between 85 and 99 percent of EHR and medical device alerts. (One study by researchers at Oregon Health & Science University estimated that the average clinician working in the intensive care unit may be exposed to up to 7,000 passive alerts per day.) Such over-warning can be dangerous. From 2014 to 2018, the commission tallied 170 mostly voluntary reports of patient harm related to alarm management and alert fatigue — the phenomenon in which health workers, so overloaded with unnecessary warnings, ignore the occasional meaningful one. Of those 170 incidents, 101 resulted in patient deaths.fortunegraphic3_brokenrecords2

The Pennsylvania Patient Safety Authority, an independent state agency that collects information about adverse events and incidents, counted 775 “laboratory-test problems” related to health IT from January 2016 to December 2017.

To be sure, medical errors happened en masse in the age of paper medicine, when hospital staffers misinterpreted a physician’s scrawl or read the wrong chart to deadly consequence, for instance. But what is perhaps telling is how many doctors today opt for manual workarounds to their EHRs. Aaron Zachary Hettinger, an emergency medicine physician with MedStar Health in Washington, D.C., said that when he and fellow clinicians need to share critical patient information, they write it on a whiteboard or on a paper towel and leave it on their colleagues’ computer keyboards.

While the Food and Drug Administration doesn’t mandate reporting of EHR safety events — as it does for regulated medical devices — concerned posts have nonetheless proliferated in the FDA MAUDE database of adverse events, which now serves as an ad hoc bulletin board of warnings about the various systems.

Further complicating the picture is that health providers nearly always tailor their one-size-fits-all EHR systems to their own specifications. Such customization makes every one unique and often hard to compare with others — which, in turn, makes the source of mistakes difficult to determine.

Dr. Martin Makary, a surgical oncologist at Johns Hopkins and the co-author of a much-cited 2016 study that identified medical errors as the third-leading cause of death in America, credits EHRs for some safety improvements — including recent changes that have helped put electronic brakes on the opioid epidemic. But, he said, “we’ve swapped one set of problems for another. We used to struggle with handwriting and missing information. We now struggle with a lack of visual cues to know we’re writing and ordering on the correct patient.”

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Dr. Joseph Schneider, a pediatrician at UT Southwestern Medical Center, compares the transition we’ve made, from paper records to electronic ones, to moving from horses to automobiles. But in this analogy, he added, “our cars have advanced to about the 1960s. They still don’t have seat belts or air bags.”

Schneider recalled one episode when his colleagues couldn’t understand why chunks of their notes would inexplicably disappear. They figured out the problem weeks later after intense study: Physicians had been inputting squiggly brackets — {} — the use of which, unbeknownst to even vendor representatives, deleted the text between them. (The EHR maker initially blamed the doctors, said Schneider.)

A broad coalition of actors, from National Nurses United to the Texas Medical Association to leaders within the FDA, has long called for oversight on electronic-record safety issues. Among the most outspoken is Ratwani, who directs MedStar Health’s National Center on Human Factors in Healthcare, a 30-­person institute focused on optimizing the safety and usability of medical technology. Ratwani spent his early career in the defense industry, studying things like the intuitiveness of information displays. When he got to MedStar in 2012, he was stunned by “the types of [digital] interfaces being used” in health care, he said.

Raj Ratwani, director of the MedStar Health National Center for Human Factors in Healthcare, works with Dr. Zach Hettinger, wearing an eye tracking headset, in the Simulation Training and Education Lab at the MedStar Institute for Innovation in Washington, D.C., on February 26, 2019. (Photo by: T.J. Kirkpatrick/Redux)

Raj Ratwani, director of the MedStar Health National Center for Human Factors in Healthcare, works with Dr. Zach Hettinger, wearing an eye tracking headset, in the Simulation Training and Education Lab at the MedStar Institute for Innovation in Washington, D.C., on February 26, 2019.
(Photo by: T.J. Kirkpatrick/Redux)

In a study published last year in the journal Health Affairs, Ratwani and colleagues studied medication errors at three pediatric hospitals from 2012 to 2017. They discovered that 3,243 of them were owing in part to EHR “usability issues.” Roughly 1 in 5 of these could have resulted in patient harm, the researchers found. “Poor interface design and poor implementations can lead to errors and sometimes death, and that is just unbelievably bad as well as completely fixable,” he said. “We should not have patients harmed this way.”

Using eye-tracking technology, Ratwani has demonstrated on video just how easy it is to make mistakes when performing basic tasks on the nation’s two leading EHR systems. When emergency room doctors went to order Tylenol, for example, they saw a drop-down menu listing 86 options, many of which were irrelevant for the specified patient. They had to read the list carefully, so as not to click the wrong dosage or form — though many do that too: In roughly 1 out of 1,000 orders, physicians accidentally select the suppository (designated “PR”) rather than the tablet dose (“OR”), according to one estimate. That’s not an error that will harm a patient — though other medication mix-ups can and do.

Earlier this year, MedStar’s human-factors center launched a website and public awareness campaign with the American Medical Association to draw attention to such rampant mistakes — they use the letters “EHR” as an initialism for “Errors Happen Regularly” — and to petition Congress for action. Ratwani is pushing for a central database to track such errors and adverse events.

Others have turned to social media to vent. Dr. Mark Friedberg, a health-policy researcher with the Rand Corp. who is also a practicing primary care physician, champions the Twitter hashtag ­#EHRbuglist to encourage fellow health care workers to air their pain points. And last month, a scathing Epic parody account cropped up on Twitter, earning more than 8,000 followers in its first five days. Its maiden tweet, written in the mock voice of an Epic overlord, read: “I once saw a doctor make eye contact with a patient. This horror must stop.”

As much as EHR systems are blamed for sins of commission, it is often the sins of omission that trip up users even more.

Consider the case of Lynne Chauvin, who worked as a medical assistant at Ochsner Health System, in Louisiana. In a still-pending 2015 lawsuit, Chauvin alleges that Epic’s software failed to fire a critical medication warning; Chauvin suffered from conditions that heightened her risk for blood clots, and though that history was documented in her records, she was treated with drugs that restricted blood flow after a heart procedure at the hospital. She developed gangrene, which led to the amputation of her lower legs and forearm. (Ochsner Health System said that while it cannot comment on ongoing litigation, it “remains committed to patient safety which we strongly believe is optimized through the use of electronic health record technology.” Epic declined to comment.)

Echoing the complaints of many doctors, the suit argues that Epic software “is extremely complicated to view and understand,” owing to “significant repetition of data.” Chauvin said that her medical bills have topped $1 million and that she is permanently disabled. Her husband, Richard, has become her primary caregiver and had to retire early from his job with the city of Kenner to care for his wife, according to the suit. Each party declined to comment.

An Epidemic Of Burnout

The numbing repetition, the box-ticking and the endless searching on pulldown menus are all part of what Ratwani called the “cognitive burden” that’s wearing out today’s physicians and driving increasing numbers into early retirement.

In recent years, “physician burnout” has skyrocketed to the top of the agenda in medicine. A 2018 Merritt Hawkins survey found a staggering 78 percent of doctors suffered symptoms of burnout, and in January the Harvard School of Public Health and other institutions deemed it a “public health crisis.”

One of the co-authors of the Harvard study, Ashish Jha, pinned much of the blame on “the growth in poorly designed digital health records … that [have] required that physicians spend more and more time on tasks that don’t directly benefit patients.”

Few would deny that the swift digitization of America’s medical system has been transformative. With EHRs now nearly universal, the face and feel of medicine has changed. The doctor is now typing away, making more eye contact with the computer screen, perhaps, than with the patient. Patients don’t like that dynamic; for doctors, whose days increasingly begin and end with such fleeting encounters, the effect can be downright deadening.

“You’re sitting in front of a patient, and there are so many things you have to do, and you only have so much time to do it in — seven to 11 minutes, probably — so when do you really listen?” asked John-Henry Pfifferling, a medical anthropologist who counsels physicians suffering from burnout. “If you go into medicine because you care about interacting, and then you’re just a tool, it’s dehumanizing,” said Pfifferling, who has seen many physicians leave medicine over the shift to electronic records. “It’s a disaster,” he said.

Beyond complicating the physician-patient relationship, EHRs have in some ways made practicing medicine harder, said Dr. Hal Baker, a physician and the chief information officer at WellSpan, a Pennsylvania hospital system. “Physicians have to cognitively switch between focusing on the record and focusing on the patient,” he said. He points out how unusual — and potentially dangerous — this is: “Texting while you’re driving is not a good idea. And I have yet to see the CEO who, while running a board meeting, takes minutes, and certainly I’ve never heard of a judge who, during the trial, would also be the court stenographer. But in medicine … we’ve asked the physician to move from writing in pen to [entering a computer] record, and it’s a pretty complicated interface.”

Even if docs may be at the keyboard during visits, they report having to spend hours more outside that time — at lunch, late at night — in order to finish notes and keep up with electronic paperwork (sending referrals, corresponding with patients, resolving coding issues). That’s right. EHRs didn’t take away paperwork; the systems just moved it online. And there’s a lot of it: 44 percent of the roughly six hours a physician spends on the EHR each day is focused on clerical and administrative tasks, like billing and coding, according to a 2017 Annals of Family Medicine study.

For all that so-called pajama time — the average physician logs 1.4 hours per day on the EHR after work — they don’t get a cent.

Many doctors do recognize the value in the technology: 60 percent of participants in Stanford Medicine’s 2018 National Physician Poll said EHRs had led to improved patient care. At the same time, about as many (59 percent) said EHRs needed a “complete overhaul” and that the systems had detracted from their professional satisfaction (54 percent) as well as from their clinical effectiveness (49 percent).

In preliminary studies, Ratwani has found that doctors have a typical physiological reaction to using an EHR: stress. When he and his team shadow clinicians on the job, they use a range of sensors to monitor the doctors’ heart rate and other vital signs over the course of their shift. The physicians’ heart rates will spike — as high as 160 beats per minute — on two sorts of occasions: when they are interacting with patients and when they’re using the EHR.
“Everything is so cumbersome,” said Dr. Karla Dick, a family medicine physician in Arlington, Texas. “It’s slow compared to a paper chart. You’re having to click and zoom in and zoom out to look for stuff.” With all the zooming in and out, she explained, it’s easy to end up in the wrong record. “I can’t tell you how many times I’ve had to cancel an order because I was in the wrong chart.”

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 analyzed 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 passed the HITECH Act, which carved out a hefty chunk of the massive 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.

US Vice President Joe Biden (L) stands with US President Barack Obama (R) as he signs the American Recovery and Reinvestment Act at the Denver Museum of Nature and Science in Denver, Colorado, on February 17, 2009. Obama signed into law his 787-billion-dollar stimulus bill, designed to create or save 3.5 million jobs and end the worst US economic crisis since the 1930s. AFP PHOTO/Jim WATSON (Photo credit should read JIM WATSON/AFP/Getty Images)

US Vice President Joe Biden (L) stands with US President Barack Obama (R) as he signs the American Recovery and Reinvestment Act at the Denver Museum of Nature and Science in Denver, Colorado, on February 17, 2009. Obama signed into law his 787-billion-dollar stimulus bill, designed to create or save 3.5 million jobs and end the worst US economic crisis since the 1930s. AFP PHOTO/Jim WATSON (Photo credit should read JIM WATSON/AFP/Getty Images)

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.

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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 analysis” 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 Grassley, 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.

Seema Verma, a health policy consultant and administrator of the Centers for Medicare and Medicaid Services within the U.S. Department of Health and Human Services, at the HHS headquarters in Washington, D.C., on March 8, 2019. (Photo by: T.J. Kirkpatrick/Redux)

Seema Verma, a health policy consultant and administrator of the Centers for Medicare and Medicaid Services within the U.S. Department of Health and Human Services, at the HHS headquarters in Washington, D.C., on March 8, 2019.
(Photo by: T.J. Kirkpatrick/Redux)

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.

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eData Specialty EHR

What is missing from compliance

The integration for a “smart” software system that will allow and promote compliance in a fast pace industry is completely absent from the Long-Term Care Community, especially Assisted Living. The ongoing and constant need to have records updated and communicated to a vast number of providers on the daily basis is required in order to keep the operators in business.

Marrying a software with a group of providers whose age, background and literacy varies broadly has not been found until eData Platform was introduced to the South Florida market. ALF Software Solutions that can be used for facilities ranging from few beds to large number of beds have been unheard of before.

According to Senior Living and the Affordable Act, April 2015 edition, technology, increasingly, plays a crucial role in delivering senior health and wellness services, as well as providing data that organizations need as they discuss opportunities to collaborate with other providers along the care continuum. A growing number of Senior Care Facilities are incorporating technology that enables caregivers to monitor real-time changes in daily activities and detect symptoms in residents who might not be able to report those symptoms themselves. The benefits range from lower rates of hospitalization to increased lengths of stay to the potential for increased revenue through additional services. These systems can even be life-saving, especially for the memory-impaired and other frail patients.

There are more than 28,000 assisted living residences in the U.S., housing more than one million people, according to the National Center for Assisted Living (NCAL), In the South Florida area, we have over 1,500 active operators who are dependent on paper and pencil when the rest of the world is relying more and more on electronics to save time.

The fear of using something that moves faster than a thought scares many of the small and mid-size operators in South Florida. However, their fines average anywhere from $3,000.00 to $10,000 dollars within a bi-ennial period. For this reason, they are slowly giving to the use eData Platform which is very user friendly. It has captured the means in a very user-friendly way to convert paper and pencil into touch button. This has seemingly reduced the fear of using an ALF Software Solution that will result in a more comprehensive system. Most favored is the vast potential for reducing fines which will lead to increasing profits for the provider.

The ALF Software Solution

Assisted living and similar residential care communitiesAssisted living and similar residential care communities are a critical component of the long-term care services and supports spectrum for older adults and younger adults with disabilities who cannot live independently in their home. Residential care communities serve residents with increasingly complex care needs. There are more than 28,000 assisted living residences in the U.S., housing more than one million people, according to the National Center for Assisted Living (NCAL). As the U.S. senior population grows, there will be increased pressure from the quantity and quality of long-term health care facilities. Currently, around one million Americans live in some type of senior living community, and that number is expected to double by the year 2030. After all, with innovations in healthcare and today’s seniors living longer, more active and healthier lives, “80 is the new 65.” By the year 2040, the 85+ population is expected to triple from the 5.7 million there were in 2011 to 14.1 million. Such a complex and important operations must have an adequate ALF Software solution to support and monitor daily operations. Major aspects to consider when considering ALF software solution:

  • HIPPA and ACHA Compliance;
  • Quality of Care;
  • Time Management;
  • Coordination with Community Providers: (doctors, nurses, social workers and other third-party providers);
  • Reduces Budget;
  • Serves as a Reminder for Critical Deadlines and Events.

This is what majority of the existing ALF software solutions lack:

  • No training
  • Hidden Fees
  • None Compliant
  • Support Cost
  • Limited Knowledge of the Industry
  • Managed by corporate staff
  • Increase cost with resident admission
  • Charge per users
  • Require use of multiple systems
  • No modular approach

Why choose our ALF software solution over a number of other competitors?

  • Includes annual staff and admin training
  • Direct fees (no hidden cost)
  • HIPAA Compliant
  • Support included
  • Written by ALF core matter experts
  • Managed by ALF admins or consultants
  • No cost adjustment with resident admission
  • Unlimited users
  • Comprehensive solution
  • Purchase and use only what is utilized

EMR Software Solutions

Incredibly, there are over 1,000 EMR software solutions out on the market today. There are the big players with recognizable names – Cerner, Epic, Allscripts, NextGen, athenaClinicals – but there are also countless smaller vendors, some of which provide customized EMR software solutions for specialists. Functionality varies greatly with each system: data entry can be inefficient and time-consuming for certain systems, but not others. Other functionality issues can include slow processing, formats that are not user-friendly, or limited capabilities.

EMR-Software-SolutionsMost of these EMR software solutions are also highly proprietary and may not communicate well with each other. This lack of interoperability presents a barrier to the transparent communication of health information, preventing adequate coordination of care on the small scale and obstructing population health management on a larger scale.

Physicians are concerned that current EMR software solutions are interfering with physician-patient and physician-to-physician relationship. Providers often complain that EMRs interfere with clinical care, making interactions more impersonal and less face-to-face, while also degrading clinical documentation. And disparate systems with poor interoperability make it difficult to communicate with other providers as well.

Additionally, as organizations adopt legacy EMR software solutions, referral patterns change, favoring those providers that are network-enabled and putting other, independent providers at risk of being marginalized. There’s also the growing pressure for physicians to meet state and federal health IT mandates. In an environment where there is already a shortage of primary care physicians, there is concern that EMRs will heighten physician dissatisfaction and drive a further shortage of physicians.

Specialty EMR software solution eData Specialty EMR software solution is a cost effective and comprehensive solution built by physicians. eData Specialty EMR software solution addresses most of the reported issues. Use of cutting edge technological solutions and tools, healthcare providers as core matter expert contributors to the systems functional specifications and usability design, eData team was able to create scalable, cost effective, easy to use and intuitive software solution capable to solve issues currently impeding on improving healthcare and reducing the cost.

 

    1. Enabling quick access to patient records for more coordinated yet efficient care
    2. Making prescribing safer and more reliable
    3. Reducing costs through decreased paperwork and reduce duplication of testing
    4. Lab and Imaging Integrations
    5. Online Appointment Booking
    6. Patient Portal With Secure Messaging

The EMR software solutions market is changing and physicians have more “buying-power” than ever when it comes to building their perfect EHR system. eData Specialty EMR software solution improve all aspects of patient care, including safety, communication, timeliness while helping healthcare providers make better clinical decisions by integrating patient information across various parts.

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eData is MACRA Compliant

MACRA COMPLIANCE

The goal of this new quality program is to streamline reporting to CMS and improve care. But a tangle of evolving rules is giving clinicians a headache. eData partnership with industry leading EHS Solutions provide complete easy to use and intuitive toolset to handle MACRA as part of the office workflow without interruptions and extra cost. Furthermore it provides additional ways to improve patient care.

It’s Time To Fix Meaningful Use

With the release of the final rule for Stage 3 of Meaningful Use (MU) of health information technology (IT), and modifications to Stage 2 of MU for 2015 – 2017, the Centers for Medicare and Medicaid Services (CMS) has taken the unusual step of asking for a second round of comments on Stage 3. Their rationale: their first request for comments was made prior to the passage of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).

This post draws from this second round of comments submitted in December 2015, on behalf of the American College of Physicians. We argue that, rather than tinkering around the edges, CMS should completely reconceptualize the program. A new MU program should focus on specialty-specific measures of quality and be based in normal clinical work patterns, rather than rewarding clinicians for meeting artificial “one size fits none” threshold requirements for specific functional uses of electronic health records (EHRs) and health IT.

On January 11, 2016, CMS Acting Administrator Andy Slavitt announced, “The meaningful use program as it has existed will now be effectively over and replaced with something better.”

The Advent Of Merit-Based Incentive Payment System Offers A Window For Rethinking MU

MACRA combines three existing programs—the Physician Quality Reporting System (PQRS), the Value-Based Payment Modifier (VBM), and MU (enacted in the Health Information Technology for Economic and Clinical Health (HITECH) Act), along with a new program—clinical practice improvement activities, into a single program, the Merit-Based Incentive Payment System (MIPS). Rule making is soon to be underway for this value-modified continuation of fee-for-service Medicare; thus, all components of MIPS are on the table for reconsideration.”

With MIPS on the near-term horizon, why not just drop MU? Several prominent thought-leaders have made this suggestion, and it’s not an unreasonable idea. One could make a strong case that, with a much clearer set of specific quality and cost objectives (PQRS and VBM), MU is not only no longer needed — it could only get in the way.

We share this concern. To stand a chance of successful participation in MIPS, clinicians need to begin the process now of constructively engaging with their technology and workflows. From what clinician survey data tell us, that will not happen as long as clinicians have a visceral, negative reaction to leveraging their electronic health records (EHRs) and other health IT.

Further, in our view, clinicians who excel in quality and cost savings, but fail MU because of missing a threshold of an EHR-use measure (such as ePrescribing 59.9 percent of the time), are more likely to react to this “gotcha” by leaving the Medicare program, rather than shifting their focus from quality and costs to compliance on EHR-use thresholds.

Just dropping MU could resolve all of these negatives. But that can’t be done without having Congress amend MACRA, as MACRA explicitly calls for a MU component within MIPS. Additionally, we believe there is still a need for a federal role within health IT, but ONLY if Stage 3 of MU looks very different from what has been proposed.

Others have called for CMS to delay final rulemaking on MU Stage 3. We believe this would be a mistake. Given that CMS is soon to be engaged in a rulemaking attempt to weave the existing PQRS, VBM, and MU programs into one, delaying rulemaking on the MU Stage 3 component would likely result in the existing, inadequate Stage 2 rules being cobbled into MIPS.

That said, we do believe that a stand-alone MU program should end in 2018 (if not before), and a very different and more appropriate MU program should emerge in 2019 for those clinicians participating in the MIPS program. Our recommendation is thus not a delay in finalizing Stage 3, but rather a transition from Stage 2 to implementation of MIPS in 2019, with a more appropriate and integrated MU component.

Part 2: Where Meaningful Use Went Off Course

At the outset, MU could not be judged on outcomes; neither the measures—eClinical Quality Measures (eCQMs)—nor clinicians were ready. Hence the construct of a dual measurement system—pay-for-reporting of quality measures and pay-for-performance of EHR-functional-use measures—was developed. EHR-functional-use measures are measures of how the EHR was used, such as what percent of patients seen in a given period were sent a secure electronic message.

While this construct held appeal, as it was based on activities that were measurable (EHR-functional-use), it was predicated on an idea that we believe was fundamentally wrong — that the potential value of EHRs and other health IT is the same for all specialties and in all settings of care. What followed was the development of a single set of EHR-functional-use measures across specialties and care settings. This is the polar opposite of eCQMs, which are more narrowly applicable, based on specialty and setting of care.

The eCQM ecosystem also includes a process for eCQM development, stewardship, and evolution, all of which is done by organizations with specific competencies and supported by evidence. eCQMs are expected to evolve over time, or even disappear, depending on evolving science. In contrast to this independent and evidence-based process for eCQMs, EHR-functional-use measures were developed via a political process, and largely supported by belief and/or self-referential logic. Thus, if the Health IT Policy Committee (HITPC) believed an EHR function was important, CMS proposed and then finalized a rule.

As only a few functions were left as professional attestations, CMS then had to define EHR-functional-use measures. In the interests of fairness to EHR vendors and clinicians, these quickly became highly prescriptive. What was conceptually a poor fit for many clinicians became an extremely poor fit; it was at this point that MU became widely derided as “one-size-fits-none.”

Further, clinicians regularly discovered that even when they performed an activity that satisfied the objective of an EHR-functional-use measure (such as providing patients with appropriate and specific educational resources), this activity did not count unless it was done in a highly specific way. This “gotcha” debacle arose from measures being over-defined and/or from the approach that EHR vendors had to take to document that a highly defined activity occurred.

With strictly defined EHR-functional-use measures in place, even highly functional EHRs had to be re-engineered. And those that couldn’t be easily re-engineered had MU EHR-functional-use measure checkboxes added, in some cases appearing as a parallel and duplicative process in a left or right column. EHR usability began to suffer, and satisfaction with EHRs, which had been steadily improving, now began to plummet.

To make things worse, CMS applied threshold requirements to EHR-functional-use measures. And where the functional-use measure did not fit into normal workflow, clinicians began to develop workarounds and gimmicks to satisfy thresholds. Since CMS considers a score above the threshold as validation that the measure is appropriate, whether the score results from gimmicks or clinically appropriate activity, EHR functional-use measures are blind to the very learning health care system that they were built to support. Unlike eCQMs, which will be withdrawn or modified if the clinical practices they support are no longer valid (or even harmful), CMS will only remove an EHR-functional-use measure if it is “topped out, redundant, or duplicative.”

Moreover, time wasted on deriving and using such gimmicks has taken its toll: Clinicians are angry, and even worse, where they should be engaging with health IT as a valuable tool, they are disengaged. From a perspective of readiness for value-based care, this is exactly the opposite of where they should be.

If MIPS was not on the near term horizon, one solution would be to redo EHR-functional-use measures in collaboration with medical professional and specialty societies, such that functional requirements made sense. And EHR-functional-use measures could then be subject to scientific study and emerging evidence, as eCQMs are. But with MIPS ready to start in just a few years and with the ongoing maturation of clinical quality and value measures, it makes more sense to conclude that EHR-functional-use measures as a vehicle for judging performance, once needed, are no longer necessary.

This is then the right time, as the PQRS and VBM programs are being re-conceptualized into the MIPS program, to course correct MU into something that will help to support the other components. And in our view, it doesn’t matter if one’s opinion is “MU, good riddance;” or “MU, time to declare victory and move on” — it is time to dramatically change the MU program.

Part 3: Guiding Principles For Meaningful Use Within The MIPS Program

While MACRA mandates an MU component within MIPS, it does not specify what that component should look like. We believe that CMS thus has a golden opportunity for an MU “do-over,” rather than merely making incremental changes in the current program. With a truer “north star” of evolving specialty-specific clinical quality measures combined with cost-of-care and relevant clinical practice improvement activities, there would no longer be the need for paying (or penalizing) clinicians based on their threshold performance on a “one-size-fits-none” set of EHR-functional-use measures.

We believe the relevant question for CMS then becomes, “What would otherwise be missing from technology or workflow if EHR technology and use were only incented by quality and resource use measures (as per the current PQRS and VBM programs), as well as by clinical practice improvement activities?” This is where a new, more relevant MU program should be focused.

MU should follow its own advice and avoid requiring duplicative activities. Patient-centered quality and value measures should be the primary drivers of how EHRs and other health IT are used. A new MU within MIPS should aim only to fill in key gaps and strive to incent optimization of value from health IT (based on specialty and setting of care). MU must permit and even encourage flexibility and innovation.

MU measures should not be burdensome and should be built into existing or emerging workflows, such that as care is provided process or activity measurements can be auto-generated. Processes and/or activities would then be determined by specialty-specific best practices or even self-determined, as are quality improvement or value improvement projects.

When clinicians within MIPS need to satisfy the quality, resource use, and clinical practice improvement categories, as well as MU, their MU activities should be in support of these MIPS activities and not an additional set of unrelated requirements.

In defining new, more appropriate MU measures and activities, CMS and the Office of the National Coordinator for Health IT (ONC) should set a new tone by collaborating with physicians and other clinicians to determine the key tasks that clinicians and staff will need to perform to improve care. This further flips the existing paradigm from “health IT as an end point to health IT as enabling infrastructure” — a means to an end.

While some tasks could be performed more efficiently with better technology and standards, physicians should have opportunities to work on these tasks now, with currently available technology. There should not be requirements for mature standards and certification criteria before practices can begin work on activities such as smoothing out the wrinkles in care coordination and chronic care management.

MU measures should not be defined only where standards and certification criteria exist. MU measures and activities should challenge practices to work on solutions in advance of standards and certification criteria so that the learnings from the activities can better inform future standards and certification criteria.

If this approach is taken now, it may not be too late to turn around clinician anger and disengagement. Clinicians engaged with meaningful and helpful health IT will be better prepared for the future of health care delivery.

Meaningful Use Within MIPS

1. Eliminate All EHR-Functional-Use Measure Thresholds

We believe there is no place for the continuation of EHR-functional-use measure thresholds in this last stage of MU. As noted above, there is no EHR-functional-use process that is or should be the same for all specialties and settings of care. And where functional use measures are not consistent with what physicians naturally do, physicians see them as annoying distractions and develop workarounds and/or gimmicks merely to achieve the thresholds.

EHR-functional-use data are most useful when they reflect actual workflow, not contrived attempts to achieve a performance threshold. Learning is enhanced when reported data include naturally occurring variance and are not restricted to CMS’s prescriptive definition of threshold achievement. Furthermore, due to the threshold requirements, CMS only gets data from the relatively few successful attesters — we learn absolutely nothing from those who fail to attest because they have not met the thresholds.

If thresholds were not required, we would have data from far more practices. These data could tell us volumes about what works and what doesn’t, and the possible causes of variation. With health IT, as with clinical medicine, we can learn a great deal from the near misses.

2. Judiciously Continue EHR-Functional-Use Measurement Reporting (Without Thresholds) To Develop New Learnings On Health IT-Enabled Care And Improve EHR Usability

Where key questions as to health IT processes persist, data collection and analysis should continue. This approach to EHR-functional-use measurement must avoid the prior pitfall of narrow and/or overly prescriptive definitions that have been the cause of compliance-driven and/or duplicative clinical workflows, poor EHR usability, and distraction from the development of more usable and useful software.

Less prescriptive EHR-functional-use measures would free up EHR developer time, allowing them to be both innovative and responsive to their customers (physicians), as well as permitting physicians to be innovative and more responsive to their customers, patients. It would additionally permit physicians to use the next several years to develop and test “advanced clinical processes” so that they are better prepared for clinical practice and practice improvement, under either MIPS or an Alternative Payment Model.

We believe this approach is responsive to HITECH and MACRA. Workflow processes that CMS, ONC, professional/specialty societies, or researchers believe hold the potential for improving care can be engineered into EHRs and auto-reported. CMS and ONC could then collaborate on using these process data to learn, rather than to grade.

3. Demonstrate Continuing Education Within The Domains Of Health IT

While it is now common for health system leaders to be physicians and other clinicians with advanced training in clinical informatics (Chief Medical Information Officers and Chief Nursing Information Officers), medical and graduate medical education does not yet consistently impart basic and specialty-specific education on health IT. More than anything else, physicians now need health IT guidance, best practices, implementation strategies, and new ideas. One new meaningful activity should involve continuing medical education (CME) on health IT and data management topics.

To that end, we propose that CMS and ONC work with the physician professional and specialty societies to create or endorse relevant continuing education, and to jointly determine the amount and frequency of such health IT-related education. We suggest the following as examples of relevant modules for continuing education:

  • Health IT to improve quality of care for patients, and where appropriate, to improve quality for select populations;
  • Safe use of health IT, with a focus on reducing errors of both omission and commission;
  • Health IT to improve value; and,
  • Health IT to engage patients and families

4. Advance Meaningful And Practical Interoperability

Interoperability is meaningful when it supports the liquidity of relevant narrative and structured sets of contextual data, so that the data can support clinical needs. Interoperability is practical when it is meaningful and it further supports the needs of the participants in data exchange. Interoperability is neither meaningful nor practical when the content of every exchange is predetermined and mandated by regulations.

Many thought leaders have speculated that health information exchanges have had difficulty staying in business not because of technological challenges, but rather due to the lack of a sustainable business case. The introduction of MIPS and APMs should present a real business opportunity for relevant data exchange and thus meaningful and practical interoperability.

5. Support Bi-Directional And Less Burdensome Reporting To Public Health

We appreciate the need for clinicians and public health authorities to share relevant data. We believe that this has been seen as burdensome only because it has been presented historically as a one-sided requirement on clinicians. Also, we believe that all data recipients have an obligation to supply clinically valuable information resulting from the reporting activity back to the reporting clinicians. Reporting clinicians should receive the benefit of bi-directional data exchange for their reporting activities.

The requirement becomes yet more burdensome when the obligation to report is not necessarily satisfied via a standard report into a single utility. As currently proposed for Stage 3, clinicians may have to create and support multiple interfaces to public health entities; each public health entity may require custom changes to reports and/or duplicative entry into unique forms.

These practices must stop. We believe that significant cost and effort could be saved through the development of a standard Application Programming Interface (API) for all public health, quality, and registry reporting.

6. Develop And Use Flexible Measures Of Patient Engagement That Respect Patient And Family Needs And Preferences

We recommend that measures of patient engagement shift from a singular set of prescriptive EHR-functional-use measures to attestations of patient engagement activities that reflect the setting of care, context, and patient needs and preferences. Clinicians should have the option to develop a case report describing a patient engagement problem and the actions the practice took, including use of health IT, to resolve the problem.

7. Encourage Clinician Engagement And Innovation By Allowing For New Types Of Activities To Replace Existing Measures

The MIPS program requires that CMS assess clinician performance along a linear scale (from 0-100), and this variable scoring is meant for all scorable activities within MIPS, including MU. This opens the door even further for a truly flexible MU program within MIPS. And while MACRA includes practice improvement as a component of MIPS, we feel that health IT-related practice improvement projects should count as meaningful use of health IT. Here are several examples:

  • Precision Medicine / Learning Health System: participation in practice-based research or other observational study efforts.
  • Clinical Informatics: support of iterative improvement in practical informatics via use of an “EHR Feedback” application or via participation in EHR user groups.
  • Local Quality, Safety, or Value Improvement Projects Leveraging Health IT: several specialty societies have similar requirements for board certification (but without specification of IT use).
  • Patient Safety and Near-Miss Reporting: done locally, as part of a professional or specialty society effort, or more formally with a patient safety organization.
  • Development of eCQMs that Support Quality Improvement: done locally, as part of one’s engagement with a Qualified Clinical Data Registry, or as part of a quality improvement community of interest (such as the Million Heartsâ„¢ Initiative).

CMS FACT SHEET: EHR Incentive Programs in 2015 and Beyond

The Centers for Medicare & Medicaid Services (CMS) released final rules that simplify requirements and add new flexibilities for providers to make, electronic health information available when and where it matters most and for health care providers and consumers to be able to readily, safely, and securely exchange that information. The final rules for 2015 Edition Health IT Certification Criteria (2015 Edition) and final rules with comment period for the Medicare and Medicaid Electronic Health Records (EHRs) Incentive Programs will help continue to move the health care industry from a paper-based system, where a doctor’s hand-writing had to be interpreted and patient files could be misplaced.

CMS heard from physicians and other providers about the challenges and burdens they face making this technology work well for their individual practices and for their patients. In recognition of these concerns, the final regulations make significant changes to current requirements by easing the reporting burden for providers, supporting interoperability, and improving patient outcomes. CMS is also encouraging providers to apply for exemptions if they had difficulty with or needed to switch their EHR vendor or experienced challenges due to the timing of the rules and EHR implementation. Additionally, the new rules will enable the development of user-friendly technology, allowing individuals easier access to their information so they can be engaged and empowered in their care.

Overview of Rule Provisions

CMS reviewed and considered more than 2,500 comments on the two proposed rules to create the final policies, with the opportunity for additional comment, for participation in the EHR Incentive Programs.  In recognition of the issues raised, CMMS made significant changes to ease reporting burden for all providers, supporting health information exchange, and improving patient outcomes. For example, the regulations:

  • Shift the paradigm so health IT becomes a tool for care improvement, not an end in itself.
  • Provide simplicity and flexibility so that providers can choose measures that use in their practices and report progress that are most meaningful to their practice.
  • Give providers and state Medicaid agencies more time – 27 months, until January 1, 2018 – to comply with the new requirements and prepare for the next set of system improvements.
  • Give developers more time to create the next advancements in technology that will be easier to use and more appropriate to new models of care and access to data by consumers.
  • Support provider exchange of health information and a more useful interoperable infrastructure for information exchange between providers and with patients
  • Give developers more time to create the next advancements in technology that will be easier to use and more appropriate to new models of care and access to data by consumers.
  • Address health information blocking and interoperability between providers and with patients.

For the EHR Incentive Programs in 2015 through 2017, major provisions include:

  • 10 objectives for eligible professionals including one public health reporting objective, down from 18 total objectives in prior stages.
  • 9 objectives for eligible hospitals and critical access hospitals (CAHs) including one public health reporting objective, down from 20 total objectives in prior stages.
  • Clinical Quality Measures (CQM) reporting for both eligible professionals (EPs) and eligible hospitals/CAHs remains as previously finalized.

CMS evaluated the current programs and identified areas where modifications could be made to align with the long-term vision and goals for Stage 3. CMS restructured the objectives and measures of the EHR Incentive Programs in 2015 through 2017 to align with Stage 3, and modified “patient action” measures in Stage 2 objectives.  These changes recognize the progress providers have made and realign with long term goals.

For Stage 3 of the EHR Incentive Programs in 2017 and subsequent years, major provisions include:

  • 8 objectives for eligible professionals, eligible hospitals, and CAHs:  In Stage 3, more than 60 percent of the proposed measures require interoperability, up from 33 percent in Stage 2.
  • Public health reporting with flexible options for measure selection.
  • CQM reporting aligned with the CMS quality reporting programs.
  • Finalize the use of application program interfaces (APIs) that enable the development of new functionalities to build bridges across systems and provide increased data access. This will help patients have unprecedented access to their own health records, empowering individuals to make key health decisions.

The Stage 3 requirements are optional in 2017. Providers who choose to begin Stage 3 in 2017 will have a 90-day reporting period. All providers will be required to comply with Stage 3 requirements beginning in 2018 using EHR technology certified to the 2015 Edition. Objectives and measures for Stage 3 include increased thresholds, advanced use of health information exchange functionality, and an overall focus on continuous quality improvement.

In addition, the final rule adopts flexible reporting periods that are aligned with other programs to reduce burden, including moving from fiscal year to calendar year reporting for all providers beginning in 2015, and offering a 90-day reporting period in 2015 for all providers, for new participants in 2016 and 2017, and for any provider moving to Stage 3 in 2017.

As part of today’s regulations, CMS announced a 60-day public comment period to facilitate additional feedback about Stage 3 of the EHR Incentive Programs going forward, in particular with the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which established the Merit-based Incentive Payment System (MIPS) and consolidates certain aspects of a number of quality measurement and federal incentive programs into one more efficient framework. We will use this feedback to inform future policy developments for the EHR Incentive Programs, as well as consider it during rulemaking to implement MACRA, which we expect to release in the spring of 2016.

More information on the rule can be found at the CMS EHR Incentive Programs website at www.cms.gov/EHRIncentivePrograms. A general fact sheet is also available on this rule.