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Is eClinicalWorks the Next Volkswagen?

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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

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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.

Doctors Should Also Be Fighting
“Fake News”

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I see them every time I wait in the inescapably long lines at grocery store. They’re offering me so much. Fat-melting foods that “work like gastric bypass.” Sleep masks that prevent breast cancer. One day diets. And, of course, the perennial “medical miracles.” All these revelations can be mine with a simple magazine purchase.

It’s easy to dismiss the medical advice being propagated through the supermarket checkout aisle. Who would take health advice from a magazine sitting next to a box of Snickers and the National Enquirer? This visceral elitism, however, is causing doctors and scientists to miss out on a powerful avenue for improving people’s health.

Mainstream health advice was “fake news” before it had a name.

It has remained rampant and popular because doctors have refused to engage with the popular press, except for their own profit. When we reject bringing our ideas to the most unpretentious of media outlets, then only mercenaries like Drs. Mehmet Oz and Andrew Weil adorn the covers of these rags. We cannot always stop quackery from being disseminated, but we can drown it out with accurate and nuanced information.

Winning the Doctor Lottery

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A poignant piece recently appeared in the journal Health Affairs and was rapidly devoured on social media by the health policy community. The story is a harrowing first person account of a woman’s multiple interactions with doctors. The doctors in the story are either very good or very bad. One pediatrician turns the author and her sick son away on three consecutive days with colic, only to have a more careful partner sound the alarm and discover pyloric stenosis. The author then recounts the tale of her father’s death at age 42 due to a surgeon who operated for diverticulitis unnecessarily.

My family and I haven’t always won The Doctor Lottery. My father’s surgeon, for instance, had pushed him to have the bowel resection to “cure” him of diverticulitis, a disease in which the colon’s lining becomes inflamed. He stitched up my father’s intestines with a suture known to dissolve in patients who’ve been on steroids and hadn’t read my father’s chart to see that his internist had recently had him on cortisone. Nor did he look at the list of medications my father had carefully written down on his patient intake forms. When the sutures dissolved, my father, who had a bleeding disorder, went into shock. His abdomen was distended and hard.

My mother asked the nurse to page the surgeon. “My husband is in so much pain!” she said. The surgeon, who was playing golf, told the nurse to tell my mother, “Pain after surgery is normal.” By the time my father developed a fever, and peritonitis, it was too late. He died of a heart attack.

MD vs. DNP: Why 20,000 Hours of Training and Experience Matters

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As southern states entertain legislation granting nurse practitioners independent practice rights, there are some finer details which deserve careful deliberation. While nurse practitioners are intelligent, capable, and contribute much to our healthcare system, they are not physicians and lack the same training and knowledge base. They should not identify themselves as “doctors” despite having a Doctor of Nursing Practice (DNP) degree. It is misleading to patients, as most do not realize the difference in education necessary for an MD or DO compared to a DNP. Furthermore, until they are required to pass the same rigorous board certification exams as physicians, they should refrain from asserting they are “doctors” in a society which equates that title with being a physician.

After residency, a physician has accrued a minimum of 20,000 or more hours of clinical experience, while a DNP only needs 1,000 patient contact hours to graduate. As healthcare reform focuses on cost containment, the notion of independent nurse practitioners resulting in lower healthcare spending overall should be revisited. While mid-level providers cost less on the front end; the care they deliver may ultimately cost more when all is said and done.

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

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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:

How CMS Undermines ACOs and What to do About It

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In my first post  in this three-part series, I documented three problems with Pioneer ACOs: High churn rates among patients and doctors; assignment to ACOs of healthy patients; and assignment of so few ACO patients to each ACO doctor that ACO “attributees” constitute just 5 percent of each doctor’s panel. I noted that these problems could explain why Medicare ACOs have been so ineffective.

These problems are the direct result of CMS’s strange method of assigning patients to ACOs. Patients do not decide to enroll in ACOs. CMS assigns patients to ACOs based on a two-step process: (1) CMS first determines whether a doctor has a contract with an ACO; (2) CMS then determines which patients “belong” to that doctor, and assigns all patients “belonging” to that doctor to that doctor’s ACO. This method is invisible to patients; they don’t know they have been assigned to an ACO unless an ACO doctor tells them, which happens rarely, and when it does patients have no idea what the doctor is talking about. [1]

This raises an obvious question: If CMS’s method of assigning patients to ACOs is a significant reason why ACOs are not succeeding, why do it? There is no easy way to explain CMS’s answer to this question because it isn’t rational. The best way to explain why CMS adopted the two-step attribution method is to explain the method’s history.

What’s Behind the Spike in Food Allergies?

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We are surrounded by evidence of the enormous impact food allergies are making in our society. The peanut butter and jelly sandwich, once a staple of elementary school lunchboxes, has been banned in numerous school districts across the country. Candy bars are required to alert consumers about any other products processed in the factories where they were made. Gluten-free diets are trumpeted by celebrities and have spawned communities of devoted followers (there’s even a “gluten-free” dating site – I’m not making this up).

However, the spectrum of food allergies is still poorly understood by the general public. The phrase “food allergy” conjures one image: a child who, after eating, say, a kiwi, becomes flushed and has trouble breathing until an Epi-pen can be administered. While certainly dangerous, that scenario represents only one aspect of what may be called modern food allergy (or the broader spectrum of food intolerance). Other, milder-appearing food allergies may exist in a larger percentage of the population than previously thought. These mild intolerances can still cause a great deal of discomfort, and when they go unrecognized, may lead to years of expensive and unnecessary testing.

Open Season on Health Privacy in Washington DC

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With Senate bill S.3530, data brokers would remove the last shreds of transparency and control that patients still have over our health data and drive healthcare costs even higher in the process. Will hospitals and the pharmaceutical industry go along?

It’s been 17 years since patients lost control over how our hospitals and insurance companies use our personal health data without any consent or a convenient accounting for disclosures. HIPAA allows so-called Covered Entities to use and sell our data without consent and, separately, often under the pretense of de-identification, through a $100 Billion network of hidden data brokers that we know don’t know about, choose, or oversee. Our data is worth $100 Billion because it helps health businesses to maximize profits and it contributes to an unknown extent to the uniquely high cost of healthcare in the US.

The Delta of Discomfort and
the Agony of Despair

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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.