Lawsuits filed by whistleblowers, doctors, and hospitals allege EHR software used by hospitals, clinical laboratories, and medical offices may ‘pose danger to patients’

Where have all the federal incentives for meaningful use of health information technology (HIT) gone? Pathologists and clinical laboratory leaders caught up in medical error investigations are not the only healthcare providers asking this question.

Since the start of the 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act—which provided billions of dollars in federal incentives to stimulate use of electronic health record (EHR) systems to improve quality of care—about $38 billion in subsidies and incentives have been paid out by the Centers for Medicare and Medicaid Services, Becker’s Hospital Review reported.

Now, an ongoing investigation by Fortune and Kaiser Health News (KHN) indicates some EHR software vendors and healthcare providers were paid hundreds of millions of dollars in federal subsidies that they should not have received. Furthermore, EHRs are apparently associated with thousands of mistakes and medical errors, the Fortune and KHN investigation revealed.

In “Electronic Health Records Creating a ‘New Era’ of Health Care Fraud,” KHN wrote that “The federal government funneled billions in subsidies to software vendors who overstated or deceived the government about what their products could do, according to whistleblowers.”

Was Software Really Certified to Begin With?

As part of the new Merit-Based Incentive Payment System (MIPS), which itself is part the Medicare Access and CHIP Reauthorization Act (MACRA), meaningful use (formerly the Medicare EHR Incentive Program) refers in part to using certified EHR and HIT technology in a “meaningful” manner as defined by the Office of the National Coordinator for Health Information Technology (ONC).

However, MIPS and MACRA are only recent updates to the original federal legislation that launched the drive to incentivize hospitals, physicians and other providers to adopt and use EHR systems that met defined criteria. It was the $787-billion stimulus bill—the American Recovery and Reinvestment Act of 2009 (ARRA)—that actually defined the incentive program and allotted an initial $17 billion specifically to encourage adoption of EHR systems.

Now, more than a decade later, there is growing evidence that many EHR vendors and providers took advantage of the EHR incentives without meeting both the intent and requirements of this federal program. For example, government reviewers found that some providers and vendors collected their federal EHR subsidy payments and then “gamed” the system by programming the software to appear to meet incentive criteria, even though it had not, Becker’s Hospital Review reported.

“The only problem (with software certification) is that it presupposed that the [EHR] product [certified by a] vendor would be the same product it sold. It presupposes that people will go into the certification process and participate in good faith,” John Halamka, MD, a Professor of Medicine at Harvard Medical School, Chief Information Officer at Beth Israel Deaconess Medical Center, and Co-Chairman of the national HIT Standards Committee, told KHN.

According to FortuneKHN study findings:

  • Lawsuits filed by “dozens” of whistleblowers, doctors, and hospitals allege EHR software used by hospitals and medical offices may “pose danger to patients;”
  • Some of the $38 billion in federal EHR subsidies went to companies that “deceived the government about the quality of their products;”
  • Three EHR vendors were part of settlement deals totaling $357 million with the US Department of Justice (DOJ); 
  • 28% of doctors and 5% of hospitals who said they met government standards for EHR adoption and use were later found to have not done so, audits showed;
  • $941 million in inappropriately released EHR subsidies were recovered by federal officials.

Investigation Suggests EHRs Linked to Medical Errors

Fortune-KHN also investigated medical errors and omissions related to software failure and user errors. Fortune published these finds and others in a series of investigative articles beginning with: “Death by a Thousand Clicks: Where Electronic Health Records Went Wrong.”

In one case, a patient had gone to the emergency room with severe headaches and a high fever. During the diagnostic process, a doctor performed a spinal tap to rule out meningitis, an inflammation of the tissue covering the brain and spinal cord. Later, through the hospital’s new EHR system, an infectious disease specialist ordered a clinical laboratory test to check the spinal fluid for viruses, including herpes simplex. Unfortunately, the lab test order did not make it to the lab.  

A lawsuit later filed by the patient stated that the hospital’s EHR didn’t “interface” with the hospital medical laboratory, delaying results of the lab test, resulting in brain damage due to herpes encephalitis, Fortune reported. In the lawsuit, the patient alleges the missed order meant he did not receive an antiviral medication (aciclovir) that could have minimized the brain damage.

The graphic above is based on data from the Kaiser Family Foundation (KFF) study. In the first article of its investigative series, Fortune wrote, “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.” Some of these errors involved delayed clinical laboratory test results, resulting in severe patient injury. (Graphic copyright: Kaiser Family Foundation.)

After interviewing 100 doctors, patients, IT experts, health policy leaders, attorneys and government officials, FortuneKHN found:

  • “Thousands of deaths, serious injuries, and near misses tied to software glitches, user errors, or other flaws;”
  • EHRs enabled “upcoding” or inflating a bill instead of improving billing;
  • A “disconnected patchwork” instead of an electronic superhighway.
“How is it in the public interest for medical records software to have flaws that lead to deaths? These incidents should be fully understood and investigated and not be able to be buried,” said Joshua Sharfstein, MD (above), Former Principal Deputy Commissions of the Food and Drug Administration (FDA) and Vice Dean Public Health Practice at John Hopkins Bloomberg School of Public Health, in, “No Safety Switch: How Lax Oversight of Electronic Health Records Puts Patients at Risk,” the second article in the Fortune-KHN investigative series. (Photo copyright: Baltimore Sun.)

Doctors Give EHRs an ‘F’

Frustrated physicians gave EHRs a grade of “F” for usability, according to an American Medical Association (AMA) study published in Mayo Clinic Proceedings, titled, “The Association Between Perceived Electronic Health Record Usability and Professional Burnout Among US Physicians.”

The researchers found that “The usability of current EHR systems received a grade of F by physician users when evaluated using a standardized metric of technology usability. A strong dose-response relationship between EHR usability and the odds of burnout was observed.”

In their survey of 870 doctors, the researchers asked for a ranking of EHR system usability on a scale of 0 to 100. The mean score of 45.9 was deemed an “F,” Becker’s Hospital Review explained.

The researchers suggested that “Given the association between EHR usability and physician burnout, improving EHR usability may be an important approach to help reduce health care professional burnout.”

That could be the understatement of the decade.

“It is a national imperative to overhaul the design and use of EHRs and reframe the technology to focus primarily on its most critical function—helping physicians care for their patients. Significantly enhancing EHR usability is key,” said Patrice Harris, MD, President of the American Medical Association, in a statement.

All is not well with the EHR segment of healthcare information technology, as attested to by the number of lawsuits, complaints, and news accounts of patient harm due to misperforming EHR systems and user error. Because of the growing number of lawsuits involving the function and use of different EHR products, clinical laboratory leaders would be wise to ensure their EHR interfaces to healthcare providers function correctly and check them often.

—Donna Marie Pocius

Related Information:

Defective EHRs Suffer Little in Fraud Probes: “They’re Almost Too Big to Fail”  

Electronic Health Records Creating a New Era of Healthcare Fraud, Officials Say

Death by a Thousand Clicks: Where Electronic Health Records Went Wrong

No Safety Switch: How Lax Oversight of Electronic Health Records Puts Patients at Risk

The Association Between Perceived Health Record Usability and Professional Burnout Among U.S. Physicians

AMA Study: Physicians Give EHR Usability an ‘F’ Rating

New Research Intensifies AMA’s Call for Improved EHR Usability