Tech

Tech

Is eClinicalWorks the Next Volkswagen?

11

Since the Department of Justice announced the ground-breaking $155 MM settlement with eClinicalWorks (ECW) on Wednesday, industry response has been dizzying.  Let’s collect the facts and review what it means.  I reviewed it all in greater detail yesterday here.

A short summary:  EHR developer eClinicalWorks settled a legal dispute with the Department of Justice that commits them to pay $155 Million, provide free services to customers, and undergo oversight for five years.  The government found that ECW faked certification testing: the EHR software was certified as having capabilities that it didn’t have. Tens of thousands of care providers collected millions of dollars when they attested to the meaningful use of a certified EHR. DOJ therefore states that “ECW caused the submission of false claims for federal incentive payments based on the use of ECW’s software.”

Through social media and (gastp!) real-life conversations, we’ve heard:

  1. Too hot: This is evidence that ONC’s certification program isn’t working and should be rolled back
  2. Too cold:  This is evidence that ONC’s certification program is too easy and should be enhanced
  3. Just right:  This is evidence that ONC’s certification program is appropriate, and expects participants to have integrity

And we’ve heard the analogies:

  1. ECW is the health IT version of Volkswagen:  they faked a test, got caught, and have to pay the price.  Shame on them.
  2. ECW is the health IT version of Uber:  they developed shady software, used it to make millions of dollars, got caught, and have to pay the price.  Shame on them.
  3. ECW is Ray Stoller the car salesman, who sold cars that weren’t safe to unsuspecting purchasers and refused to make good on their commitments.  Shame on them.

Is this an indictment of the certification program?  Not at all.  While the program may not yet be “just right,” without certification, there would be no basis for any legal complaint against ECW, and this would all have remained hidden.  Despite the persistent calls for ONC to roll back the program, this case makes it clear that such a move would be a direct threat to public safety, and would invite more of these shenanigans.  ECW is indeed the VW/Ray Stoller of health IT (I don’t think the Uber metaphor sticks) but just as there are more car manufacturers than just VW who cheated on diesel emissions, there are more health IT developers who cheated too.  Perhaps not so boldly or carelessly as ECW, but I am 100% certain that there are other companies who have done this, and I’m confident that the government is investigating these others.

Parsing eCW’s $155 Million Payment to the Government

5

UPDATE:  Here are the public records for the case.  More details there about the original complaint.  Excerpt:

What we’re talking about

The purpose of any certification program is to create a method for the purchasers of a product to have confidence that the product safely and reliably does what it is supposed to do.  One example from USDA:

Turning Point for Meat Inspection  In 1905, author Upton Sinclair published the novel titled The Jungle, taking aim at the poor working conditions in a Chicago meatpacking house. However, it was the filthy conditions, described in nauseating detail—and the threat they posed to meat consumers—that caused a public furor. Sinclair urged President Theodore Roosevelt to require federal inspectors in meat-packing houses.The Pure Food and Drug Act and the Federal Meat Inspection Act (FMIA) became law on the same day in 1906. The Pure Food and Drug Act prevented the manufacture, sale, or transportation of adulterated or misbranded foods, drugs, medicines, and liquors. The FMIA prohibited the sale of adulterated or misbranded meat and meat products for food, and ensured that meat and meat products were slaughtered and processed under sanitary conditions.

In this case, the government moved to protect the public because a subset of meat packers was putting profit above public health.  After The Jungle was published, public outcry caused the government to step in and regulate the industry.  Regulation is not, therefore, a four letter word.  It’s there to protect us from evildoers.

Before Health IT Certification

You may not remember this, but I do.  Before there was certification, Health IT development companies (some people call them “vendors”) created software and sold the software with claims of improved provider productivity, improved public health, and (yup) improved billing (among other impressive capabilities). Sometimes these claims were completely valid.  Sometimes they were not.  In the case where the developers’ functional claims were not quite valid, buyers had little recourse.  One might say “well, the markets will take care of that.  Bad actors will lose sales.”  But that’s not the case here for several reasons:

  1. The buyer may not be the one using the software.  A hospital buys software for clinicians.  Clinicians complain to hospital.  Hospital may or may not be a strong advocate with developer.
  2. It’s very hard to migrate from one system to another.  EHR purchase / deployment / optimization is a multi-year initiative.  If you bought a lemon, you may try to make lemonade as the though of migrating to something else will give you R11.0.
  3. Shame.  You don’t want your patients / competitors / peers to know that your EHR doesn’t work as expected.  You made a mistake.  Human nature is to hide our mistakes rather than treasure them as educational opportunities.

Information Blocking Under Attack: The Challenges Facing EHR Developers and Vendors

6

In March 2017 Milbank Quarterly, researchers Julia Adler-Milstein and Eric Pfeifer found that information blocking — which they define as a set of practices in which “providers or vendors knowingly and unreasonably interfere with the exchange or use of electronic health information in ways that harm policy goals” – occurs frequently, and is motivated by revenue gain and market-share protection.

Among the practices most often cited were deployment of products with limited interoperability (49%) and high fees for health information exchange unrelated to [actual] cost (47%).  Of note: This is the first empirical research identifying and quantifying the specific information blocking practices reported by a group of information exchange experts.

The authors concluded “Information blocking appears to be real and fairly widespread. Policymakers have some existing levers that can be used to curb information blocking and help information flow to where it is needed to improve patient care. However, because information blocking is largely legal today, a strong response will involve new legislation and associated enforcement actions.”

The legal situation regarding the controversial subject of information blocking may have already changed dramatically.  Two important events occurred since this research was undertaken.  First, the strongly bipartisan-backed 21st Century Cures Act was signed into law by President Obama late last year.  The health information technology (HIT) provisions of the law now make it illegal for a vendor or provider to engage in information blocking. Second, the new law provides the nation with a new and comprehensive statutory definition of information blocking:

The Delta of Discomfort and
the Agony of Despair

1

I’m a radiologist. I spend my day looking at CT scans and MRI scans. When it’s a good day, I have interesting scans to review, but much of my work is not too dissimilar from a TSA screener’s. One normal scan after the next, it’s akin to trying to stay alert so that the gun someone’s trying to sneak through in their luggage isn’t missed. In my case, of course, it’s a cancer or other unexpected medical abnormality finding.

Computer-Assisted Diagnosis

Most of my day I work on a computer workstation presenting the exams. In my dream, my workstation does more than simply display the exam. It assists in reading the case. If there’s an abnormality, I can click on the area, and the workstation takes the image and compares it to millions of other cases in the cloud. It tells me, based on that patient’s age and sex and other information, how likely it is the finding is a tumor and maybe even, if so, what kind of tumor. At other times the workstation tells me whether a study is normal or not, freeing me to do other activities. However, this dream is not shared by all of my colleagues.

When I mentioned this work-flow scenario to one of my residents—this idea of computer-assisted diagnosis with constant improvement, or what is known as artificial intelligence, or AI—he said it sounded awesome, but he really didn’t want to have it if it was available to everyone. His comment is something of a mixed message: Yes, I see value but no, I don’t want it.

It’s largely based on fear of being replaced by computers. And it’s a song I’ve heard before.

Is Health Privacy a Human Right?

5

Health privacy sits at an uncomfortable junction between three interests: individual human rights, public / population health, and private business interests. There’s no obvious reason for these three interests to be misaligned but a lot of pain and money are involved so either politics or competition are typically in the picture.

Health privacy is a subset of the human right to privacy, what Supreme Court Justice Brandeis called “the right to be left alone”. But privacy has never been defined, and is seldom enforced, in health care because of the competing interests of society to manage populations, and a $100 Billion industry in data brokerage that’s hidden from public view. Big Healthcare business seeks our trust on the one hand while doing their best to manipulate prices on the other.

Failure to Translate: Why Have Evidence-Based EHR Interventions Not Generalized?

24

The adoption of electronic health records (EHRs) has increased substantially in hospitals and clinician offices in large part due to the “meaningful use” program of the Health Information Technology for Clinical and Economic Health (HITECH) Act. The motivation for increasing EHR use in the HITECH Act was supported by evidence-based interventions for known significant problems in healthcare.

In spite of widespread adoption, EHRs have become a significant burden to physicians in terms of time and dissatisfaction with practice. This raises a question as to why EHR interventions have been difficult to generalize across the health care system, despite evidence that they contribute to addressing major challenges in health care.

Bob Wachter’s 2017 Penn Med Commencement Address “Go to Radiology”

4


Dean Jameson, Trustees, Faculty, Family and Friends, and most of all, Graduates of the Class of 2017:

Standing before you on this wonderful day, seeing all the proud parents and significant others, I can’t help but think about my father. My dad didn’t go to college; he joined the Air Force right after high school, then entered the family business, which manufactured women’s clothing. He did reasonably well, and my folks ended up moving to a New York City suburb, where I grew up.

There were a lot of professionals in the neighborhood, but my dad admired the doctors the most. He was even a little envious of them. This became obvious on weekend evenings when he’d get dressed to go out to a neighborhood party. He’d look perfectly fine – slacks, collared shirt, maybe a sweater. But there was one thing out of place: he’d be wearing our garage door opener on his belt. “Dad, what exactly are you doing?” I would ask, somewhat mortified.

“There’ll be lots of doctors at the party tonight,” he’d reply. “They all have beepers, I have nothing.” The strangest part was when the party was next door, the garage door would sometimes go up and down, as dad showed off his “beeper.”

Lessons From the 100 Nation Ransomware Attack

8

The world is reeling from the massive ransomware attack on at least a hundred nations’ computer systems. The unprecedented malware spasm infected hundreds of thousands of computers, and would have infected millions more but for a 22-year old computer science student who found a vulnerability in the malware that he used to curtail the infection. He found it looked for a non-existent URL, so he a set up that URL and found he could stop it spreading. Of course, now the hackers know that, it is an easy matter to update the malware to use other URLs and other techniques. Clearly, this iconic malware attack is not going to be the last.

Electronic Medical Records 2017: Science Ignored, Opportunity Lost

5

My big brother Bill, may he rest in peace, taught me a valuable lesson four decades ago. We were gearing up for an extended Alaskan wilderness trip and were having trouble with a piece of equipment. When we finally rigged up a solution, I said “that was harder than it should have been” and he quipped in his wry monotone delivery, “There are no hard jobs, only the wrong tools.”

That lesson has stuck in my mind all these years because, as simple as it seems, it carries a large truth. It rings of Archimedes when he was speaking about the simple tool known as the lever: “Give me but one firm spot on which to stand, and I will move the earth.”

Enter the Electronic Medical or Health Record (EMR or EHR) as it exists in most forms today. As information tools for clinicians, most EMRs have been purchased by administrators who know nothing of patient care or workflow, and most of these EMRs have been reverse engineered from billing and collection systems, because the dollar drives all.

Building Boats and EHRS

6

Imagine that you want a boat. You tell someone to build or buy you a boat, and tell them to send you a bill. What would you get? A kayak? A windsurfer? A boat for waterskiing? A sailboat. A party boat? A cruise ship? A submarine? A battleship or destroyer? You probably would not get what you want. Very likely you would end up with something expensive – that you cannot use.