Vaccines: Influence, Not Mandate

The vaccines against SARS-CoV-2, the organism that causes COVID-19, are a slam-dunk, whether in terms of their economic impact, a humanistic perspective, or an observed reduction in morbidity and mortality. And the United States as a whole is doing reasonably well in getting people vaccinated (although Sedgwick County is a little behind the national average). As of the writing of this blog post, more than half of US adults have received full vaccination, and a large additional fraction has received at least partial vaccination. And while I’m not particularly interested in the pursuit of a theoretical threshold like “herd immunity,” most everyone agrees that the more people we can get vaccinated before this fall, the better. After all, the virus is still spreading among the unvaccinated population as quickly as it was at its peak.

Some universities are mandating vaccination. I can understand why. But my instincts always trend more toward influencing decisions rather than mandating behaviors. So it was helpful (and, I’ll admit, a little discouraging) to see that the Equal Employment Opportunity Commission (EEOC) recently ruled on using incentives to get employees vaccinated. In short, and to steal from our frequent collaborator Al Lewis:

“If employers set up a system in which they administer the vaccine themselves on a voluntary basis, businesses can also offer employees incentives — be they perks or penalties — so long as they are “not so substantial as to be coercive.”

If the process of setting up vaccine distribution yourself sounds tricky, you’re right. The new mRNA-based vaccines, in particular, while scientific marvels, are pretty delicate and require special handling. So we anticipate most of our members will utilize more traditional routes to vaccination, like clinics and health departments. How can we get our employees to take that leap?

In thinking out loud about this question, I’m cross-tabulating two sources. Source one is the new edition of Influence by Robert Cialdini, a seminal text in the science of persuasion. Source two is a summary by German Lopez, based mainly on Kaiser Family Foundation survey data, on the six overarching reasons some Americans are slow to be vaccinated: lack of access, lack of fear of COVID-19, fear of side effects, lack of trust in vaccines, lack of confidence in institutions, and conspiracy theories.

Let’s discuss how Cialdini’s Seven Keys to Influence might address those six big reasons for slow vaccination and how we can apply them to get more people immunized:

1. Reciprocity. Pharmaceutical representatives don’t give out medication samples, tchotchkes, and meals to doctors’ offices out of charity or even advertising. They do it to cause a feeling of indebtedness on the part of the clinical staff. Doctors who receive these gifts are far more likely to prescribe medications represented by salespeople than are doctors who don’t receive the gifts. The same goes for people who’ve received free address labels from a charity. We can copy this strategy in our employee populations by pointing out the generosity of our leave policies around COVID-19 infections or exposures. The company is doing this for you. All we ask in return is that you do your part by reducing everyone’s risk by getting vaccinated. And we’ll even help give you time off and help you get to the vaccination distribution center!

2. Commitment. When a company asks you to sign up for their newsletter, “club,” or punchcard, they’re trying to get a commitment from you, however small it may be. Consider asking your employees to sign up for a newsletter from your wellness department or vendor, and make sure vaccines are mentioned in nearly every edition.

3. Social proof. Colleges and universities once tried to discourage binge drinking by pointing out how many students were injured or killed by binge drinking behavior. It didn’t work. When those same colleges and universities pivoted to a strategy of showing how many students did not binge drink, they saw results. People do what they see others doing. So once you have an idea that a big chunk of your employees has already been vaccinated, point this out in a campaign and emphasize how proud the company is of its employees’ contribution to safety. Even an employee who doesn’t particularly fear infection may want to be part of a positive culture.

4. Authority. People trust authority figures. In the vaccine world, people trust their personal physicians most of all. So if you feel your vaccine push is falling short, encourage employees to see their doctor to talk about the minimal risks and potentially huge benefits of vaccination.

5. Liking. People prefer to be seen positively by their peers. This desire can often override other emotions or beliefs like a lack of trust. If we can make vaccination the norm in our workplace and point out the positive effect of people who’ve received the vaccine, a certain number of people will experience a change of heart.

6. Scarcity. When Amazon alerts you, “Only two remaining in stock,” they’re taking advantage of our attraction to scarce resources. Gold and platinum would not be expensive and desired if you could dig them out of your backyard with a shovel. So this summer, as we anticipate another rise in COVID-19 cases in the fall, we should point out the scarcity of time to take advantage of vaccination. Only three months left!

7. Unity. This principle takes advantage of our natural tribal instinct toward “Us versus Them.” When the anti-smoking Truth Initiative debuted, it used this exact trick by casting Big Tobacco as an opponent to be defeated by a unified, righteous group of young nonsmokers. The effect on the youth smoking rate, pre-vaping, was astonishing. By one estimate, it prevented 300,000 kids per year from smoking. The Truth Initiative essentially turned the Big Tobacco companies into conspirators and encouraged kids to rebel. And it worked.

Our goal shouldn’t be to trick anyone into doing something they don’t want to do. But in working to get the largest possible fraction of the population vaccinated, we should use the best, most scientifically sound arguments and strategies we can.

As the Medical Director of the Kansas Business Group on Health, I’m sometimes asked to weigh in on hot topics that might affect employers or employees. This is a reprint of a blog post from KBGH.

Doctors, like orange juice, are better with breakfast

When I was a medical student, I thought I wanted to be a radiologist. I love the science. I like the physics of radiation, and my ego was invested in the idea of being a “doctor’s doctor” that other doctors looked to for wisdom and interpretation of diagnostic testing. Radiology checked all those boxes without the ooey-gooey autopsies and whatnot that are part of the daily routine of pathologists.

Then I did a radiology rotation.

I truly did like the science of x-rays and the conversations with other doctors and all the rest. I discovered one problem, though: I could not stay alert for hours at a time in a dark room looking at films. Come two or three o’clock in the afternoon, I would inevitably start to fade. Once, I even nodded off in the radiology suite. So, with the safety of future patients in mind, I decided to go a decidedly more well-lit and upright route, eventually completing a residency in internal medicine and a fellowship in endocrinology, diabetes, and metabolism. If nothing else, the work in endocrinology was ambulatory. If I’m moving, I can’t fall asleep.

I review my personal history as a wind-up for a research paper in JAMA Health Policy this last week (paywall). Investigators looked at records from primary care practices–these studies always pick on primary care docs–to see how likely a patient was to receive a “statin” medication depending on the time of day of his or her appointment. This is no casual question. Viral pandemics aside, cardiovascular disease remains the leading cause of death in the United States. Appropriate use of statin medications like atorvastatin (Lipitor), rosuvastatin (Crestor), and others dramatically reduce the risk of death from any cause in people at risk for heart disease.

Using United States Preventive Services Task Force (USPSTF) guidelines, which state that we should offer statins to anyone with known vascular disease, anyone with a diagnosis of a genetic problem called “familial hypercholesterolemia,” or anyone with a low-density lipoprotein (LDL) cholesterol level of 190 mg/dL or more (among other diseases like diabetes), the researchers found a disturbing trend. Compared with 8 am appointments, which the investigators used as their reference group, the likelihood of getting a statin was lower at all hours except 9 am. And the likelihood of getting a statin pretty consistently fell as the day went on: 88% at 9 am, 63% at 12 pm, and 69% at 3 pm. Overall, you were only 69% as likely to get an appropriate statin prescription in an afternoon appointment as you were in a morning appointment. Here’s the raw, “unadjusted” data:

JAMA Health Policy

And yes, radiologists make more mistakes later in their shifts, too. But this phenomenon is not limited to doctors. Judges sentence defendants more harshly just before lunch, when they’re hungry, and sentence more leniently after a break. Car crashes peak between 5 and 7 pm. Students taking standardized tests perform better earlier in the day and recover performance after rest. If you’re like me, you may have found that you do your best creative work earlier in the day, and you’re better off going to meetings or working on a task list later in the day.

The wellness industry has long coached patients to get the earliest available appointment of the day, but our reasoning has had more to do with the fact that if you go earlier in the day, you’re less likely to have to wait. With this data, we have to consider not only the time in the waiting room but the outcome of the visit.

[Disclaimer: the Kansas Business Group on Health has CDC funding to encourage appropriate use of statin medications.]

As the Medical Director of the Kansas Business Group on Health, I’m sometimes asked to weigh in on hot topics that might affect employers or employees. This is a reprint of a blog post from KBGH.

What Health Care Can Learn From Netflix

Streaming video over the internet is a memory hog. If Netflix were to simply store movie files as mp4s and send them out to subscribers on-demand, Stranger Things fans would crash the internet in minutes. Software engineers have solved this problem by creating “compression algorithms” to reduce the file sizes of the transmitted movies. Compression algorithms work by mostly ignoring each frame's composition and instead storing only the changes in the video from frame to frame, so-called “diffs.”

 The transition from one frame to the next is compressible, then, to the extent that it is predictable. Fast movies with a lot of action and cuts, like superhero spectaculars, are hard to compress because of the extra diffs. Slower movies with subtle changes frame-to-frame are easier to compress since the memory required to store and transmit the diffs is small.

 This is analogous to how our own minds work. When we’re left to a single, focused task, we can be remarkably productive. But in the modern workplace, emails, Slack messages, and texts interrupt us more than 150 times a day, and our productivity suffers. Computer engineers call the switch from one task to another a “context switch,” and they don’t like it. Thus, the compression algorithms above. But humans are subject to these context switches, too. Experiments have shown that the average time to recover brain function after a context switch, like interrupting writing this blog post to check an email, is more than 20 minutes. Multitasking is a myth, and most of us spend most of our days in constant recovery from these context switches.

 Now think of how interactions with doctors tend to go. After you’ve traveled 37 minutes traveling to the appointment and spent 64 minutes waiting for her, your doctor enters the room to greet you, often without having reviewed your chart ahead of time. She asks you an open-ended question about how you’re doing, and after a few seconds of pleasantries, you get to your chief complaint for the visit, like your stuffy nose or your back pain or your constipation. The doctor, who is likely trying to type into an electronic health record as you speak, interrupts you after an average of 11 seconds. Then, a nurse knocks on the door to tell your doctor that she has a call from the hospital radiology department on the line. Your doctor leaves the room and comes back a few minutes later, visibly frazzled. You do your best to get the rest of your constipation story out before your doctor sets down her laptop and asks you to climb onto the exam table for an exam. She mostly makes small-talk during the brief exam, then takes a minute to record her findings in the EHR while you wonder if you should peruse the two-year-old copy of People magazine hanging on the wall. You are left to accept the doctor’s recommendations that are based more on pattern recognition and a knowledge of disease epidemiology than any deep thinking about your specific pathology. So she’s wrong about five percent of the time.

 Don’t think of this scenario as a mark against your doctor. Think instead of the system in which she works. How many context switches did your doctor have to navigate to get to the end of your visit? When we point out negative health outcomes in this blog, like the fact that only half of indicated care is delivered to a given patient or that a quarter of care that is delivered may be unnecessary, we’re not out to get doctors. A doctor writes many of these blog posts, and reads all of them. What we’re trying to illuminate are systemic problems.

 Let’s magically teleport you and your doctor into a different system. This time, your doctor has reviewed your chart prior to your visit in a preplanned team “huddle” with her nurses and staff in which your preventive needs have been thoroughly reviewed according to USPSTF guidelines. Your chronic care needs have been addressed mostly outside the clinic visit by periodic communication with a community health worker and a nurse. You’ve sent important biometric information like blood pressures, weights, blood glucose levels, or peak airflow testing, to your doctor’s office already through a secure device or portal. When you get to the clinic, a medical assistant spends twenty minutes with you confirming critical elements of your history, sending predictable refill authorizations to the pharmacy, and predicting changes to your medications based both on the information you’ve sent and on your conversation. Your doctor enters the room knowing that most of your predictable care has been addressed already, and she can confirm or reject the changes in your predictable care that have been “compressed” by the clinical processes in place. Then, she can use most of her brainpower to take care of any unpredictable changes, what the software engineers might call “diffs,” like your new back pain or constipation. And this time, your doctor comes with a medical scribe to take notes for her, so that she doesn’t have to “text and drive” with you in the passenger seat. (in the future, she’ll likely rely on an “ambient” artificial intelligence program to document your visit, but that’s a topic for another day)

Maybe it’s not a surprise that multi-hundred-billion dollar companies get things right sometimes. Netflix has invented a better way for doctors’ offices to function. They just don’t know it.

[disclosure: KBGH receives funding from the Centers for Disease Control and the Kansas Department of Health and Environment to promote team-based care, including community health workers]

As the Medical Director of the Kansas Business Group on Health, I’m sometimes asked to weigh in on hot topics that might affect employers or employees. This is a reprint of a blog post from KBGH.

How Do Doctors Self-Refer?

In my full-time clinical practice days, other practitioners often referred patients to me for accidental findings on x-rays, ultrasounds, or MRI exams. Sometimes a patient would have had a CT scan of her abdomen that revealed an asymptomatic tumor inside her adrenal gland. More often, an ultrasound of the carotid arteries or an MRI of the spine uncovered a mass within the thyroid gland. This phenomenon is so common that these discoveries have a name: “incidentalomas.” Never accuse doctors of not being wordsmiths.

For thyroid incidentalomas, I would usually drag a portable ultrasound machine into the patient’s room and get a quick look at the lesion with my own eyes. Through reasonably straightforward criteria, the patient and I could choose whether or not to biopsy, to repeat an ultrasound in a year or two, or to forget we ever saw the lesion. I never charged extra for these informal bedside exams. I considered this particular use of the ultrasound machine akin to a 21st-century stethoscope. I wouldn’t charge a patient an additional fee for listening to her heart or lungs, so it didn’t seem proper to charge them for this use of ultrasound. That wasn’t charity on my part; this philosophy is becoming so prevalent as to have guidelines crop up around it.

But sometimes, I saw features in a thyroid nodule or a lymph node that made me think the lesion should be biopsied, usually by me. And I was paid well for these procedures (technically, the University of Kansas was well-paid since I was salaried. I made the same amount of money whether I did the procedure or not). A thyroid biopsy, which takes maybe ten minutes, pays about the same amount as caring for a diabetic patient for a year (thank the RUC). The revenue from diagnostic studies comes not only from the professional fee, which pays the doctor for her interpretation and consulting regarding the study but also from a “facility fee” meant to cover technical costs surrounding the maintenance and use of special equipment. A physician who owns the equipment needed to perform labs or imaging can profit by collecting both of these fees. So the incentive for me or any other doctor to do imaging or procedures in our own practices–so-called “physician self-referral”–is considerable.

Stark laws arose a few decades ago to discourage physician self-referral and kickbacks from referrals to other physicians, but they made specific exceptions to allow “necessary testing” in physician offices. Once upon a time, the American Medical Association Code of Ethics prohibited doctors from owning imaging or lab equipment. The AMA said doctors should not have a financial interest in testing. But that rule eventually changed, and now, the AMA is much softer on physician-owned testing, insisting only that doctors make diagnostic and treatment decisions without taking financial issues into account. The trouble is, from a financial standpoint, that philosophy probably doesn’t work.

Doctors are human, and physician-owned imaging and lab centers unequivocally appear to drive up the cost of care by increasing the likelihood of getting additional procedures without improving outcomes. In a tiny sample of the literature on this topic, a group of researchers has shown that MRI scans of the neck, lower back, knee, and shoulder, when performed in physician-owned machines, are much more likely to be normal, indicating overuse by the physicians who own the machines and bill for their use. Multiple studies show that physician-owned hospitals are associated with an increase in spending without a corresponding increase in quality, a phenomenon that leaks into the outpatient setting as well. For example, physicians, particularly those treating immune or malignant diseases, routinely sell drugs to their patients at a small markup. Some physicians make more of their income from such practices than they do by seeing patients. Their incentive is naturally toward using more expensive drugs, whether they consciously intend to or not.

This is the part of the post where I propose a brilliant policy strategy. Except I’m not sure there is one, apart from the transparency rules we’ve discussed at length on this blog. Physician-owned testing, after all, does come with some benefits. Patients can often get the test performed on the same day and in the same location. Since doctors are so powerful, there’s likely not a movement afoot to take their radiology machines away.

But by using more direct contracting with physicians, we could limit the incentive for doctors to overuse certain diagnostic and therapeutic procedures. If I had been paid a flat monthly rate to take care of the endocrine needs of Corporation X in my example in the intro, I would have simply done the necessary procedures on patients without even thinking of the cost to the employer or the patient or thinking of my potential income. The few hundred bucks I might have made from a couple of thyroid biopsies would have been folded into my fee for caring for the entire population.

If you have past experience with direct physician contracting (or with frustrating up-charges from doctors self-referring), please let us know. We would love to better understand the experiences of our members around this issue.

As the Medical Director of the Kansas Business Group on Health, I’m sometimes asked to weigh in on hot topics that might affect employers or employees. This is a reprint of a blog post from KBGH.

How Much Health Should Flow Through Your Smartphone?

We at KBGH get pitched a lot of apps. Apps for blood pressure, apps for blood sugars, apps for lab and imaging pricing. Lots of apps. In the roughly two years that the current staff has been at KBGH, I think pitches from outside companies have covered most of medicine in apps, save a few small nooks and crannies. I don’t think we’ve been pitched a fertility app yet, for example, but I might be mistaken. And this isn’t an ivory tower problem for us; we’re in on the creation of apps as well. We’re working with WSU’s College of Innovation & Design on a Rural Health Challenge to, in part, help connect rural patients with their doctors via technology. That technology may include smartphone apps since, according to a Cochrane review, there is “low-certainty evidence of the effects of mobile phone-delivered interventions to increase adherence to medication prescribed for the primary prevention of [cardiovascular disease].”

But, as we’ve blogged about before, your computer or smartphone may not be the most direct route to a healthy, happy life. Excess time on devices, particularly that spent on social media, may be bad for us and may paradoxically exacerbate loneliness and isolation. So how much of our medical care should run through our phones? I’m generally optimistic about the future of telemedicine, but I’m pessimistic about the attention economy, in which companies are incentivized to grab increasingly big chunks of our time.

Regardless of my opinion, though, people have thought hard about what should go into a good medical application. Here are four elements paraphrased from Swiss investigators Kenny R. Lienhard and Christine Legne:

1. Mobile medical apps should guide a patient through every step of instruction, setup, clinical measurement, and analysis and feedback. Imagine that you just downloaded an app to your smartphone to help communicate blood pressures to your doctor. The app shouldn’t just tell you how to send the blood pressure. It should give you instructions on the technique for where to place the cuff. It should provide feedback if it senses your technique is wrong, like if different readings get very different results. It should help you analyze the numbers; if your blood pressure is consistently high or low, it should prompt you to talk to your doctor about it.

2. The user interface should be adapted to cope with patients’ physical and cognitive restrictions. This goes without saying. The American Medical Association (AMA) recommends that health care materials be written at or below a sixth-grade reading level. But the interface should also account for people with impaired vision or hearing or differences in dexterity, to name a few.

3. A mobile medical app should build on a robust medical knowledge base, ensuring an evidence-based approach to mobile app design. This one is tougher because most of us–present company included–don’t necessarily know the ins and outs of app design. But manufacturers can search out the best medical advice for many circumstances and account for those in the testing of the app.

4. Mobile medical apps should facilitate both patients’ and physicians’ routines. This is crucial, and it applies directly to work we’ve done at KBGH. It is great to get blood pressure results to your doctor. But it’s even better if the app, upon seeing those blood pressure results, can make a treatment recommendation to your doctor. We call this “decision support.” The app may give bad advice once in a while, like recommending a thiazide diuretic for a gout patient, but making more sophisticated decisions is what the doctor is there for.

What experiences have you had with medical apps? Let us know!

As the Medical Director of the Kansas Business Group on Health I’m sometimes asked to weigh in on hot topics that might affect employers or employees. This is a reprint of a blog post from KBGH.

Health Care Proxy Shoppers

Over the weekend, I was listening to some health policy podcasts while gardening, as one does, and the surgeon and medical waste researcher Dr. Marty Makary was interviewed on Freakonomics. He mostly didn’t talk about surgical techniques or hardcore quantitative measures of wasted health care dollars, though. Instead, he outlined his mother’s strategy in grocery shopping. Mrs. Makary is a bargain shopper. While I might just grab a couple of lemons from whichever store I’m in when I think of it, she carefully compares prices between stores and buys the cheapest option. People like Dr. Makary’s mom make up only 10-20% of all shoppers, he said, but they hold down the price of lemons for the rest of us. Economists call them “proxy shoppers.” Just like proxy voters, they make decisions about the cost of lemons for all of us.

Dr. Makary shared this vignette to illustrate how price transparency may help contain costs in medicine. It got me thinking: Who are the proxy shoppers in medicine? Price transparency is increasing, after all, but patients still don’t use it as much as one might expect. And while there are ways to encourage patients to use price transparency, especially as it relates to their out-of-pocket expenses and deductibles, ultimately, the contract they’re working with barely involves them. As Larry Van Horn says in the Freakonomics episode, business-to-business contracts in medicine between a payer and a health system include a third party (the patient) who has no say in the contract at all.

So the proxy shoppers in medicine mostly are not patients. The actual proxy shoppers are the people most likely to be reading this blog post, like the HR professionals and benefits specialists who plan, coordinate, and pay for their employees’ health care. And we should use our power as proxy shoppers carefully.

That’s it. That’s my post. I don’t mean to be a downer. I know you have a lot on your plate already, trying to manage the benefits of dozens or hundreds or even thousands of employees’ benefits. But the next time you sit down to negotiate a contract, I hope this is in the back of your mind: You have a power like almost no one else’s to hold down the cost of medical care in a country where it’s genuinely out of control. You can pick up the lemon that’s closest to you and pay whatever it costs, or you can check the price of that lemon in the grocery store down the street.

As the Medical Director of the Kansas Business Group on Health I’m sometimes asked to weigh in on hot topics that might affect employers or employees. This is a reprint of a blog post from KBGH.

Can We Trust Information on YouTube?

Once upon a time, in my academic career, I worried that inaccurate mass media depictions of, say, diabetics would cause people to make bad care choices. If you’re thinking of Julia Roberts in Steel Magnolias right now, trust me: Julia Roberts in Dolly Parton’s hair salon is the tippy-tip of the iceberg. Now I worry more about YouTube, the modern-day Library of Alexandria of instructional videos.

In the past year or so I have watched YouTube videos, off the top of my head, to learn to: change a blinker bulb in my car, fix my thermostat, learn to run specific reports within Quickbooks, refresh my memory on how to do certain math problems for helping with my daughter’s homework, and shut off the “move to wake” feature in my iPhone. And dozens more.

But I’ve also used YouTube in the past to remind myself how to reduce my son’s dislocated elbow (my son’s orthopedic history gets more complex by the year). There’s an old saying in medicine: “see one, do one, teach one.” I needed to “see one” again before I subjected my son to it. The procedure was successful, for what it’s worth. (Being a doctor’s kid is weird. I digress.) Are you scheduled to have your thyroid gland removed? YouTube can show you the procedure. Are you a new type 1 diabetic who wants to practice carbohydrate counting for insulin dosing? Boom. Starting chemotherapy and interested in using cooling therapy to reduce hair loss? Look no further. Recently we talked about the reliability of physician rating sites (spoiler: potentially useful, but with major caveats). How do YouTube videos stack up for general medical information? For the purposes of this post, I’m mostly ignoring obvious conspiracy-mongering about COVID vaccinations, cholesterol medications, and whatnot. Like pornography, I trust that you’ll know those when you see them.

To get an answer on the accuracy and utility of YouTube videos for medical inquiry, I looked not to YouTube, but to PubMed, the search engine of the National Library of Medicine. Here’s what I found:

YouTube contains so much information that investigators tend to categorize it by learner, generally either medical trainees or the general public. Videos for medical trainees seem to be relatively generously reviewed by researchers. Using our example of thyroid surgery from above, one study found that most YouTube thyroid surgery videos were posted by surgeons operating in academic institutions, which they took to mean the intentions of the videos were purely educational and not promotional. But the researchers also noted that surgeons who had no history of traditional academic publications–i.e., not necessarily the most respected people in the field–posted the majority of surgeon-sourced videos. This led the authors to conclude that “Trainees and educators alike should critically analyze the quality of video content,” which is the academic equivalent of throwing shade. A systematic review of studies of YouTube videos aimed at medical learners backed this up, concluding that “While videos authored by academic physicians were of higher quality on average, their quality still varied significantly,” and “Video characteristics and engagement metrics were found to be unreliable surrogate measures of video quality.” That is, a video’s slick production and millions of views did not mean it was accurate.

Videos aimed at the general public tend to be more harshly judged. One study by two emergency room doctors investigating the quality of videos pertaining to the management of low blood sugars went so far as to say that “health videos should only be uploaded by physicians,” a statement hilarious in both its confidence and its wrongness. Surely someone without a medical degree somewhere, at some point, has been filmed saying something accurate and helpful. But, in general, the quality of public-facing YouTube videos does appear to suffer in comparison to professional learner-directed videos. A systematic review from 2015, admittedly ancient history in internet years, concluded that “YouTube contains misleading information, primarily anecdotal, that contradicts the reference standards and the probability of a lay user finding such content is relatively high.” But, on the bright side, they also found that “videos from government organizations and professional associations contained trustworthy and high-quality information.” We at KBGH, who have produced and posted videos of our own, hope that we fall into that category.

Let’s bottom-line what we can take from this research. First, beware of any video that makes claims that seem extraordinary. Someone who says that removing a food from your diet is as powerful as taking cholesterol medications for preventing heart attacks, for example, better have good evidence to back that statement up. Second, pay attention to the source. Videos from academic centers, government agencies, and professional associations appear to be the most reliable. But they’re also, I suspect, the most conservative. Few such organizations are willing to put themselves out on a limb compared to their peers. Finally, beware of using the number of views or shares as a marker of the reliability of a video’s contents. As we’ve discussed before in this very blog, the internet is set up to make sure the most radical statements get the most eyeballs.

As the Medical Director of the Kansas Business Group on Health I’m sometimes asked to weigh in on hot topics that might affect employers or employees. This is a reprint of a blog post from KBGH.

Do Online Physician Ratings Actually Help?

Toward the end of my full-time clinical career, I attended a speech by a physician who encouraged doctors to “own” their online personas. He said we should actively manage our social media presence, our clinic websites, and our ratings by third-party sites like Angie’s List and Yelp. Against my instincts, I took his advice and Googled myself. Reader, I don’t mean to be histrionic. Many factors contributed to the end of my clinical career. But that innocent internet search did not, to put it lightly, make me excited to show up for work the next day:

I don’t share this anecdote as a bid for your pity. My experience with online ratings represents a tiny fraction of the “feedback” that a politician or a college football coach gets daily. I share the story as an entree to a question: do online physician ratings accurately reflect the quality of care people receive? If the ratings are accurate, then we should encourage our employees to use them. If they’re inaccurate, we should encourage employees (and practitioners) to ignore the ratings.

This is no idle inquiry. Some studies have suggested that up to 60 percent of patients consider online reviews important in choosing a provider. A recent national survey (paywall) of Americans aged 50 to 80, the heart of an internist’s practice like mine, revealed that more than 40 percent had looked up a physician’s rating for themselves at some time in their lives. Women, people with higher education levels, and (predictably) people with at least one chronic condition were more likely to have looked up a physician rating. The investigators in the recent study looked at several factors contributing to how prospective patients chose a physician, and online ratings came in only ninth, behind factors like “accepts my health insurance” and “convenient office location.” But the physician’s rating was still considered important almost as often as word-of-mouth reputation among family and friends, consistent with the results of smaller surveys.

But the ratings themselves are less influenced by clinical outcomes, like death, infection, or well-being, than they are by the patient’s experience. As we’ve blogged about before, denial of a patient request, especially for pain medications or lab tests, results in a dramatic decrease in patient satisfaction. That is surely poison for an online rating, regardless of the appropriateness of the denial. A very sophisticated study of dentist ratings showed that things like wait time were strongly associated with higher ratings, while raters barely mentioned clinical outcomes like infection or tooth loss. These experience-centric ratings may also reinforce biases that we already know exist. One study showed that, globally, male surgeons were rated higher on technical skills, while female surgeons were more highly rated for interpersonal skills.

It’s hard to tell if the ratings correlate with those harder clinical outcomes. A study of orthopedic surgeons’ online ratings found no correlation between ratings and total knee replacement outcomes. And one study found that the design of the rating website itself, like the presence or absence of advertisements for other doctors on the page, affected the quality of the data. But there is a hint of better outcomes in certain situations. A retrospective study showed that patients who had hip replacement surgery at hospitals highly ranked on physician rating sites did slightly better than patients at lower-ranked hospitals, for example.

If we can draw any conclusions from this muddled body of research, it seems that the most important lessons are, first, patients should understand the limitations of online reviews. A negative review of a highly skilled oncologist who has a gruff bedside manner may obscure the fact that his staff has experience in steering patients into clinical trials that may help complex cases. His staff’s skill may only be known by other providers. And second, doctors need to learn to use their online reviews as a source of quality improvement data. Someone who gives a doctor a lousy review may well have a valid complaint. The patient experience in American healthcare hardly has a sterling reputation. Instead of simply bristling at negative reviews, doctors should use the reviews as a tool to enact positive change.

As the Medical Director of the Kansas Business Group on Health I’m sometimes asked to weigh in on hot topics that might affect employers or employees. This is a reprint of a blog post from KBGH.

Drug prices are getting more transparent, too

We’ve covered the waves of price transparency that are washing over health care the past few weeks in the KBGH Book Club and here in the blog: no more surprise medical bills, new public tools for comparing procedure prices, no more gag clauses on cost or quality, and others. But we haven’t talked about what’s coming in drug pricing transparency. Americans pay far, far more than peer countries for prescription drugs. Drug prices account for almost a fifth of our excess health spending, even more than administrative overhead and salaries. How bad is the problem? Americans make up less than five percent of the world’s population, but we account for 80% of pharmaceutical revenues.

It is easy to cast the pharmaceutical manufacturers alone as the bad guys here; they spend far more on advertising than on research and development, they are far more profitable than any other sector in the economy, they cannibalize profits to gift to shareholders, and they lobby Congress far harder than any other industry. But manufacturers are not the only players. The manufacturers only set list prices, which are publicly disclosed. Manufacturers negotiate rebates with insurers and pharmacy benefit managers (PBMs) in order to move their drugs up the list on the insurers’ and PBMs’ formularies. Rebates and discounts like this have grown to an astonishing extent over the past few years, leading to “net” prices for many brand-name drugs that are lower than list prices. As we’ve pointed out before, insulin has a typical rebate of 66%. Because the process is so opaque, consumers have no way of knowing the actual price paid for the drugs. Payers argue that this “confidentiality” (if you’re charitable; “secrecy” if you’re cynical like me) allows them to more effectively negotiate because transparency would only allow drug manufacturers to get net prices closer to their very high list prices. This is transparently false. If secrecy were such a tool for keeping costs down, the industry would not be fighting transparency rules. Instead, the manufacturers would be demanding more transparency to allow prices for their products to rise naturally. 

Manufacturers and PBMs have reason to be concerned because of the “Transparency in Coverage” final rule that was issued in 2019 as part of the usual flurry of executive orders that precede and accompany any presidential transition. The rule, which takes effect for plan years beginning January 1, 2023, requires that:

1.     insurers disclose the 1) current list price and 2) historical net price for prescription drugs,  

2.     the data be available in “machine-readable” files (that is, not blurry .pdf scans) online to allow for comparisons, and

3.     insurers provide real-time personalized estimates of cost-sharing. 

 Legal challenges may slightly change the final product prior to 2023. But the rule has unusually solid bipartisan support: both Presidents Trump and Biden support it, along with a clear majority of congressional Republicans and Democrats. So it will be difficult to overturn completely. This is all the more reason to make sure our employees are educated shoppers for health services moving forward.

As the Medical Director of the Kansas Business Group on Health I’m sometimes asked to weigh in on hot topics that might affect employers or employees. This is a reprint of a blog post from KBGH.

Do we need to coach patients how to read their notes?

Do you know what is in your medical record? I don’t mean dry lab values or x-ray reports. I mean your doctors’ interpretations of those things, along with intimate, personal details like the results of your physical examinations and their impressions of your adherence to medications and home environment. The information is about you, but it also belongs to you. But it wasn’t always available to you. The 1996 Health Insurance Portability and Accountability Act (HIPAA) gave patients the legal right to review their medical records. But few lay people other than medical malpractice attorneys knew what to do with the information. 

And electronic health record (EHR) vendors have historically treated your data as proprietary, in spite of whatever HIPAA had to say about it. The data was treated as the EHR vendor’s property and was difficult to transfer from one health record to another. Stopgap measures like the Kansas Health Information Network popped up to try to make the data transferable from one hospital or clinic to another. But even this was suboptimal. Compare your experience with your health data to your experience with your financial data, which is probably almost as sensitive. You have undoubtedly used your ATM card from, say, Intrust Bank, to check your balance at, for example, a Fidelity ATM. We take it for granted, just like I take for granted that my USB drive from my home Mac computer will plug into my work PC. I don’t have to rely on the substantial expertise of a middle man to know that the data will transfer.

Since the 1990s several experiments have led to a movement for patients to have ready access to their doctors’ notes, be they on paper or in an electronic format. The best known organization goes by the name “Open Notes.” Now, new federal rules stemming from the 21st Century Cures Act aim to promote further patient access to their electronic health records via secure online “portals.” With a few exceptions, starting April 5, 2021, clinical notes and much other electronic information must be made available free of charge to patients. And the new rule forbids health systems or electronic health record vendors from “information blocking,” the practice of treating electronic health data as a proprietary asset and restricting access. The Annals of Internal Medicine (paywall) has a nice infographic:

Annals of Internal Medicine

To help folks transition to this new world, I think employers, insurers, and health care providers need to be proactive. To start, we should encourage our patients or employees to find their health record and to discuss it with their treating practitioner. Medical records are teeming with mistakes, due to cut-and-paste, poor user interoperability, and old-fashioned errors. Patients who find these mistakes shouldn’t run straight to the nearest malpractice attorney. Instead, both the patient and the doctor might be enlightened by a discussion of what should have been in the note.

Second, we should teach our employees and patients that what is in the record is meant to be objective. It is not a subjective judgement of anyone’s value as a human being. When I was in full-time academic practice, I remember a colleague being berated by a patient for noting that the patient smelled like urine (because she did, objectively, smell like urine). But once the patient’s embarrassment over reading the note faded, she was able to have a very meaningful conversation with her doctor about her urinary incontinence, and she was prescribed a medication that helped tremendously. Without access to her record this may never have happened. 

Finally, we need to remind patients that their record is truly private. In the era of predatory social media companies we’ve largely given up on the idea that any of our personal information should be private. But Facebook is probably not the best forum in which to litigate disagreements with doctors or nurses or to share screenshots of one’s medical record.

As the Medical Director of the Kansas Business Group on Health I’m sometimes asked to weigh in on hot topics that might affect employers or employees. This is a reprint of a blog post from KBGH.

Congress Bans Surprise Bills (mostly)

On Super Bowl Sunday my son managed, in that mysterious preteen boy way, to break his leg while snow sledding. We went to the emergency department and received good, straightforward care. His leg was splinted and his pain was controlled in time for kickoff. He’s healing up nicely.

But now my family has a pendulum swinging over its head. Will we get a bill that is as straightforward as his care was, or will we get a set of “out-of-network” bills, even though the emergency department we went to was considered “in network” (we checked)?

This is no hypothetical threat. Hundreds of thousands of Americans get stuck with out-of-network bills from emergency departments, often for tens or even hundreds of thousands of dollars, because of a sinister business model being advanced by private equity firms. Those firms have twisted this quirk of American medicine, where a doctor working in an in-network hospital can be considered out of network, into a profitable business model in which they buy physician groups and intentionally move the providers out of network. It’s exasperating not only for its shadiness, but for the fact that the out of network doctors often charge rates far above what insurance companies are willing to pay. And it works: as many as one in five ER visits have surprise bills attached to them.

But late in 2020 Congress did something that seems like an obvious bipartisan win for everyone involved, but which was kept from happening for a depressingly long time by lobbying from those same private equity firms: they banned surprise medical billing. Some are calling it “Sarah Kliff’s Law,” after the former Vox, now New York Times, reporter who asked people to send her outrageous examples of this kind of behavior over the last few years.

The law requires insurers and medical providers who cannot agree on a payment to, instead of just mailing out outrageous bills destined to be sent to collection agencies, use an outside arbiter to settle on a fair fee. The fee is based mostly on typical payments for similar services. Then the patients can be charged the same cost-sharing they would have paid for in-network services, and no more. The most powerful effect of the law may be in avoiding arbitration altogether; the New York Times reported last winter that, in the dozen or so states that have set up their own arbitration systems like this prior to Sarah Kliff’s law, most price disputes get successfully negotiated before an arbitrator is even involved.

The law is not perfect. It doesn’t take effect until 2022. And while it will apply to doctors, hospitals, and air transport (which can generate particularly huge bills), it excludes ground ambulances even though a majority of ambulance rides nationwide generates an out-of-network bill. Sarah Kliff herself reported that the omission was due to lawmakers’ fear that untangling the complex local and federal regulations around ambulance services would have delayed or killed the entire bill. If you’re an optimist, you’ll predict that Congress will take up the ambulance issue separately in the future. If you’re a pessimist, you’ll predict that private equity firms will simply move their money away from ER physician groups and toward ambulance services.

Learn more about this kind of skullduggery and what you can do to fight it in the KBGH Book Club.

As the Medical Director of the Kansas Business Group on Health I’m sometimes asked to weigh in on hot topics that might affect employers or employees. This is a reprint of a blog post from KBGH.

How to Get Your Employees to Take Advantage of Price Transparency

In the KBGH Book Club we’ve gone through the “What’s wrong with this situation?” phase, and we’re just entering the “What can we do about this?” phase. A solution that is proposed again and again in this book and in the benefits world in general for controlling costs in medical care is price transparency.

In theory price transparency works like this: since most of the medical care that we receive is non-urgent, we should have time to compare prices. So if only the price of, say, an elective knee MRI at several locations was published on a website, we could simply compare the different radiology practices, choose the lowest price, and go to that practice for our MRI. There is some evidence to support that this works. My favorite study, which I wrote about in a previous blog post, showed that parents choosing a treatment for their child’s appendicitis still mostly chose the cheaper option when they were given cost information, even though it affected their insurance payment more than their out of pocket cost.

Because of this, and because of an Executive Order President Trump signed on October 29, 2020, CMS and the Departments of Labor and Treasury have issued a final rule that will, for the first time, require most private health insurance plans to do two things:

1. They will have to provide personalized cost-sharing information to patients.

2. They will have to publicly report negotiated prices for specific health care services through an online tool. The tool initially will be required to have the ability to compare rates and out-of-pocket expenses for 500 of the most common labs, visit codes, and procedures (deadline January 1, 2023). Starting January 1, 2024, these tools must report this cost information for all health care services. Legal challenges to these rules will undoubtedly continue (not everyone believes, as we do at KBGH, that transparency = trust). But barring a truly explosive set of judicial rulings, we can expect a great deal more price transparency moving forward than what we have now.

Unfortunately, as Jeffrey Kullgren and Mark Fendrick note in a recent editorial (paywall), transparency tools have not yet been shown to reduce overall spending, even when patients are paying pre-deductible prices, when they should be most sensitive to prices. Multiple phenomena may account for this. Patients may simply have too many choices (the old “too much jam” phenomenon). Some patients may assume that less expensive options are of lower quality. Patients may simply not know when more than one option is available. Kullgren and Fendrick make several suggestions on how to make the new price transparency rule work:

1. Make sure employees know that health care services are “shoppable.” We’ll all have to sell patients on the idea that the information is “trustworthy, reliable, and worth using,” as the authors say. This will mean working with our insurance partners to make sure those things are true. Relying simply on the fantasyland “chargemaster” prices for hospital services, for example, will undoubtedly make employees skeptical or cynical about the process.

2. Many employees will need guidance on how to best use the transparency information. A specific example given by Kullgren and Fendrick is direction on when prices could be most helpful. Planning a knee replacement in a few weeks or months, for example, is a good use of pricing information. Trying to price shop after a diagnosis of a potentially life-threatening cancer requiring urgent treatment, though, is clearly not a good practice, in spite of what my favorite parents-cheaping-out-on-their-sick-kids study above may say.

3. On the provider side, we need to continue moving away from fee-for-service reimbursement models and toward quality-driven, alternative payment models. Much of this movement is happening on the public side in Medicare and Medicaid. On the employer side, a move toward more direct contracting with providers could be a good way to accomplish this.

4. Employers need to work with professional societies (like the Medical Society of Sedgwick County, with whom KBGH is allied) to continue to advocate that cost containment is a core professional responsibility of modern medical providers. Integrating cost information into the medical record like the Veteran’s Administration does for drug pricing may be a good practice.

5. We need to pressure different health systems to adopt electronic health record interoperability standards so that, when patients use price information to seek services at alternate facilities, their care won’t be fragmented between doctors that can’t access the same information.

How do you propose we nudge our employees toward taking advantage of price transparency moving forward? We’d love to hear your ideas!

As the Medical Director of the Kansas Business Group on Health I’m sometimes asked to weigh in on hot topics that might affect employers or employees. This is a reprint of a blog post from KBGH.

Introducing Advanced Primary Care

In the last couple of years, we’ve tried to drive home a couple key points about the routine medical care of your employees:

First, even though annual “check-ups” may not be that important, steady access to a primary care provider is essential. Access to primary care increases the life expectancy of a community. Primary care visits are declining, being crowded out by visits to retail clinics, urgent care centers, emergency rooms, and specialist visits.

Second, primary care is the most cost-effective form of health care, and to avoid unnecessary costs, most of your care should be coordinated through a primary care provider. American adults who have a primary care physician may have healthcare costs as much one-third lower than the costs of their peers who lack a PCP. Almost two-thirds of Medicare claims for wasteful or unnecessary care are by physicians with no relationship to the patient’s primary care practitioner.

But it’s possible that even with those assertions we’re thinking too small. KBGH is a member of the National Alliance of Healthcare Purchaser Coalitions (say that three times fast), and they have adopted the provocative stance that simple access to primary care isn’t enough. The Alliance has begun advocating for “Advanced Primary Care.”

If you’re a provider, you might cringe at the name. Isn’t the “advanced” part insulting to a seasoned, experienced, competent doctor who does “regular” primary care? Names are tricky. But the name isn’t meant to connote the achievement of a certain score on board exams or the possession of a special skill set. Instead, Advanced Primary Care, as defined by the National Alliance, describes a philosophy and commitment to seven key, sometimes overlapping, attributes in the clinic: 

1. Enhanced access. Many patients end up in the emergency department simply because they could not access their primary care practitioner during normal business hours or they got frustrated by the time it takes to schedule and complete a visit. Primary care practitioners who offer available appointments on nights or weekends can reduce emergency room utilization.

2. Increased time with patients. The average fee-for-service primary care physician carries a patient panel of roughly 2,200 patients. In models in which the physician or practice directly contracts with employers, this number may be more like 400-600 patients. This allows additional time with each patient to encourage better engagement, to better identify social determinants of health, and to relationship-build to ensure continuity of care over time.

3. Realigned payment methods. Much of the current fee-for-service model perversely incentivizes increased care or increased volume without increased quality of outcomes. Advanced primary care, which operates more frequently on a salaried or subscription model, seeks instead to incentivize patient activation, case and care coordination, accountability for health outcomes, and judicious use of downstream referrals.

4. Organizational and infrastructural “backbone” to support patient-centered leadership, additional training for staff when needed, and commitment to quality improvement over time. This may mean changes in the practice’s staffing and use of information technology.

5. Behavioral health integration in order to deliver “whole person health,” not just physical health. This can be in the form of a social worker, therapist, or psychologist on site or coordinated via telemedicine.

6. A disciplined focus on health improvement, not just reactive care, with a deep understanding of population risk factors and a strategy to focus resources within that population to where they will drive the greatest overall improvements. Advanced primary care seeks to anticipate problems like seasonal influenza, not just respond to crises that arise from those predictable problems.

7. A process of referral management to other providers or services, like specialist physicians, labs, radiology departments, and allied health, that explicitly seeks to maximize quality while moderating downstream cost.

The National Alliance has a good infographic on Advanced Primary Care below. If you’re interested in exploring direct contracting with primary care providers for your employee benefit package, please let us at KBGH know. We would love to help out.

As the Medical Director of the Kansas Business Group on Health I’m sometimes asked to weigh in on hot topics that might affect employers or employees. This is a reprint of a blog post from KBGH.

Center your care on a PCP

If you’ve been to a Kansas Business Group on Health meeting in the last couple of years, you know already that American health care is beset by “low-value” care. We spend inordinate amounts of money doing “executive physicals” that offer almost no benefit. We pay for expensive back surgeries that are sometimes no better, and often worse, than physical therapy. We fail to substitute cheaper generic or bioequivalent drugs for more expensive drugs in spite of evidence that the less expensive drugs work just as well. All these low-value services account for between $75 billion and $100 billion in annual U.S. health care spending. In a $3.5 trillion health care economy, that seems like a rounding error. But it’s a big number! $100 billion is an extra $300 per year on health care per American.

 What do most of these sins against our collective pocketbooks have in common? They mostly happen in specialist offices, not at the hands of primary care providers (PCPs). We’ve extolled the virtues of primary care often here at KBGH (although not necessarily the “annual check-up”). We’ve long known that primary care is the most cost-effective place to get your care. This was reinforced just last week in a new study looking at the sources of low value care.

 The investigators analyzed Medicare Part B claims from a 20% random sample of beneficiaries enrolled between 2007 and 2014. They excluded anyone in a given year who could not be linked to a PCP in the data, and they defined “low value services” as 31 services by various clinical guidelines:

Annals of Internal Medicine

When they looked at who ordered the low-value services, they found that PCPs accounted for a tiny fraction, 14.5%. But since many of the services you see above are not routinely done by PCPs, they looked further and found another 19.8% were performed or ordered by doctors to whom the patient was referred by the PCP, and another 5.6% was done by physicians to whom the patient had been referred by the PCP in the past.

The remaining 60.2% of low-value spending was “for services performed or ordered by a physician to whom the PCP never referred the beneficiary.” That is, almost two-thirds of the low-value spending was by physicians the PCP likely didn’t even know the patient was seeing! It’s possible the patient Googled “chest pain,” or answered a billboard for another service. The data doesn’t say.

This hurts me as a specialist physician. I wonder how many of the 31 low-value care items I’ve over-utilized in my career. Several of the items on the list, from certain thyroid tests to tests of vitamin D and parathyroid hormone, were right down my alley as an endocrine specialist. If it matters, the worst-offending non-primary care specialties for low-value spending were cardiology (27.3%), ambulatory surgical centers (8.9%), internal medicine (7.0%), orthopedic surgery (4.9%), and gastroenterology (4.8%). No endocrinology on that list. Whew!

All this isn’t to say that people don’t benefit from seeing more than one doctor. We’ve reviewed the myriad benefits of second opinions in past posts. But I do think that it reinforces the need for all of us to have a primary care physician directing our care. More than 84 percent of Americans have had contact with a health care professional in the past year, but only about half of those visits were to primary care offices, and only 75% of Americans have a primary care physician, a number that is declining over time.

None of us want to be accused of erecting barriers to good care. But I believe that adopting policies that encourage the use of primary care over, or ahead of, other services will be good for both the health of your employees and the bottom line of your company.

As the Medical Director of the Kansas Business Group on Health I’m sometimes asked to weigh in on hot topics that might affect employers or employees. This is a reprint of a blog post from KBGH.

The Robots Are Coming, Part 2

Last week we tiptoed up to some of the problems that increasing automation in health care may uncover. This week let’s talk briefly about proposed FDA action to address them.

FDA approvals of automated and artificially intelligent health care platforms have been accelerating, and in the flurry of activity that accompanies all Presidential transfers of power, the outgoing Trump administration had controversially proposed waiving much of the regulatory oversight of medical artificial intelligence tools. With a new administration in place, the original WhiteHouse.gov link I’d originally included in this post no longer exists, and the FDA has pivoted hard in the other direction, releasing a new five-part action plan laying out its efforts to regulate products that incorporate “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD).” Let’s go through them one at a time:

1. One of the big challenges in regulating artificial intelligence is that an AI program is, by definition, not a static product the way a drug or a physical device is. Once the FDA approves a drug, we know that we’ll be dispensed the same drug ten years from now that we’ll get today.

   But artificial intelligence learns over time. So as the dataset that a software platform “learns from” grows, the interpretation of that data by the program may change. We call this process of gradual improvement through multiple steps an “iterative” process. So the FDA has expressed an expectation that manufacturers and the FDA be able to transparently monitor performance through this iterative process in hopes of maximizing safety while allowing the gradual change and improvement of the platform.

2. When you go to an ATM you have the expectation that you can put any bank card into the ATM and check your bank balance, even if your ATM card was issued from a different bank than the machine. When you put a CD into a CD player, you know it will play, regardless of whether the machine is a Sony or a Panasonic. But this isn’t true of every device. Electronic health records are notoriously finicky about what data they can exchange, for example. So the FDA has asked manufacturers to use “Good Machine Learning Practice (GMLP)” to “encourage harmonization of the development of programs through consensus standards efforts.” These include harmonization of data management, feature extraction, training, interpretability, evaluation, security, and documentation standards.

3. Many artificial intelligence/machine learning platforms are trained on existing datasets. The patients who contributed their data were real, but the data is now so divorced from any living creature that it is easy to think of it in hard, mathematical terms rather than as attached to a real, living person who had thoughts, feelings, emotions, and parents. So the FDA has asked that manufacturers take a “patient centered” approach to how these technologies interact with people. What this precisely means is still under discussion, but broadly it seems to mean transparency to users (that is, you’ll know when your data is being used, and you’ll know when a machine is helping make decisions in your care), usability (meaning the operation of the software won’t be a mystery), equity (everyone gets a fair shake at representation within the software’s training dataset, for example), trust, and accountability.

4. The machines we build carry our biases. You may have read about bias in software used in sentencing for convicted criminals. The software was meant to reduce bias in sentencing, but since it was trained on a dataset that displayed the bias of past sentencing, the software itself was biased against certain groups of people. Or you may have seen news of this in facial recognition algorithms, which only become adept at recognizing faces when intentionally exposed to diverse faces. A good example of a similar phenomenon in medicine is a tool developed to predict knee pain in patients with osteoarthritis. A commonly used tool built on data from mostly white, British patients was found to be less accurate than a similar tool that was trained on data that included more Black and low-income patients. The new, more diversely trained model roughly doubled the likelihood that an evaluated Black patient would be considered eligible for surgery. With this in mind, the FDA has pledged to “evaluate and address algorithmic bias and to promote algorithm robustness,” specifically as it relates to race, ethnicity, and socioeconomic status, to avoid biases present in the health care system from seeping into algorithms.

5. Since many currently commercially available AI and machine learning products were approved based on their performance with historical datasets, not based on prospective testing on real patients the way a drug or another device would have historically been, we don’t know for certain how they’ll do in the real, nitty-gritty care of patients. But even with the traditional model of drug testing prior to approval, a need for post-approval testing is not unprecedented. Roughly a fifth of medications prescribed, for example, are used “off-label,” meaning they’re used for something other than the purpose for which the FDA originally approved them. Gabapentin, for example, is frequently used for pain relief, but it’s FDA approvals are only for seizure disorder and for a specific type of pain syndrome called “postherpetic neuralgia.” With this in mind, the FDA has pledged to monitor “Real-World Performance.” This not only allows the FDA to monitor the performance of the device in terms of accuracy of its recommendations, but it allows the FDA to monitor just exactly how the devices are being used. As far as I can tell, real-world performance data monitoring at this point is voluntary but encouraged. Depending on how well this voluntary system works, FDA intends to develop a framework for any mandatory prospective reporting in the future.

 Will any of this solidify public and physician trust in artificial intelligence? I don’t know. My hunch is that trust on the physician side will hinge more on the positive or negative effect of AI on clinics’ bottom line. And public trust of technology seems to depend more on convenience than on the good or ill intentions of the company. Few of us complain about Google, for example, because even though Google knows a lot about us it makes certain parts of our lives, like the composition of this blog post on Google Docs, better.

As the Medical Director of the Kansas Business Group on Health I’m sometimes asked to weigh in on hot topics that might affect employers or employees. This is a reprint of a blog post from KBGH.

The Robots Are Coming, Part 1

We are mostly techno-optimists here at KBGH. We have talked about the possibility of technology saving the aging primary care workforce by augmenting their skills in certain areas. But if you are a techno-pessimist, you might think more in terms of what automation or robots will do to certain jobs, the way factory automation has decreased the availability of jobs in manufacturing. (Or you may worry about safety because of bias in machines or a Tom Selleck-Runaway style robot rebellion. Great movie with Wichita native Kirstie Alley. I digress.)

My training is in endocrinology and metabolism, disorders of the finely tuned feedback loops of chemical messengers in the body. About half of most endocrinologists’ practices is the care of diabetes mellitus, a collection of metabolic defects that cause excess sugar to build up in the blood and cause blindness, kidney disease, and nerve damage, among other devastating problems. When I was in training in the mid-aughts, a big part of my day was spent managing insulin pumps, small pager-sized devices worn by some diabetic patients that deliver precise doses of insulin to meet their dietary and exercise patterns. My job was to observe blood glucose levels the patients took from fingersticks and coach patients on how to change their pump settings. For all their sophistication, insulin pumps were still pretty manual.

In the last few years, though, a new type of insulin pump has emerged. We call them “closed-loop” devices because, when paired with an implanted sensor that constantly tracks the patient’s blood sugar levels, the pumps can make adjustments to insulin infusion rates without the wearer even being involved. For now, the automation in the devices is mostly confined to rates of insulin infusion when the wearer is not eating or exercising. But pumps that can detect food intake and activity and make rapid adjustments are just around the corner. Insulin pumps will eventually use artificial intelligence, complex intelligence uninvolved with messy human emotionality or consciousness, to make adjustments in the background that are seemingly unrelated to our traditional understanding of diet, exercise, or adherence to therapy. Accidentally load your insulin pump with insulin that is slightly out of date and less potent than last week’s supply? The machine may detect it and adjust your rates of infusion to make up the difference. Have a family tragedy that increases your stress hormone levels, causing blood sugars to spike? The insulin pump’s “brain” may be able to detect this and bring your sugars back to normal without your input or recognition.

And this is just the tip of the iceberg in terms of medical technology. Already “decision support systems,” like the alert your doctor gets through her electronic health record to make sure you get your cancer screenings, show small, persistent improvements in overall care. And as we touched on in previous blog posts, robots have proved themselves to be superior to humans in a range of medical tasks, from finding diabetic eye disease to detecting bleeding in brains on CT scans.

All this will require a cultural shift. Often patients express frustration at having “only seen the PA” when they have gone to the doctor, in spite of ample evidence that physicians’ assistants and nurse practitioners provide excellent care, sometimes exceeding the quality of care of physicians in trials. Our culture currently places value on face-to-face time with the physician. And Americans are anxious about the potential safety of driverless cars in spite of the fact that human-driven cars currently kill more than 30,000 people a year. So how will we respond to robots guiding certain potentially high-risk parts of our care like insulin adjustment or detection of bleeding in radiology studies? Maybe we will give them the same brush-off we sometimes give PAs. Or maybe we will accept their input the way we have accepted advertising algorithms from Facebook and Google. It is completely possible that medical professionals will resent medical robots the way we resent automation for taking away factory jobs. To tiptoe into these ideas we will talk about a potential regulatory framework next week.

As the Medical Director of the Kansas Business Group on Health I’m sometimes asked to weigh in on hot topics that might affect employers or employees. This is a reprint of a blog post from KBGH.

Is your bedroom the new hospital?

In his book “Home Game: an Accidental Guide to Fatherhood,” author Michael Lewis tells the story of his infant son’s admission to the hospital for a lung infection with respiratory syncytial virus, commonly known as “RSV.” His son requires oxygen during his stay but gets no other treatment: no antibiotics, no steroids, no ventilator. Michael speculates that the only reason his kid was admitted was so that nurses and doctors could check on him daily in case he got worse and needed to be intubated. And so, feeling the burn of a lost night’s sleep for both himself and his son, Michael stages a minor protest to allow his son to rest. He meets every potential visitor to the room at the door and demands to know their purpose. Nurses are mostly let in. But if the visitor is a resident or medical student “checking in,” for example, he gives them an update on his son’s respiratory rate and oxygen level and shoos them away. After a couple days his son improves and is discharged home.

As of the writing of this blog post roughly 130,000 Americans are hospitalized with COVID-19, up from ~96,000 at the beginning of December, resulting in more than a third of America’s hospitals operating at at least 90 percent capacity. Some of those inpatients are like Michael Lewis’s son: they’ve been admitted because of frailty or a combination of risk factors (age, other diseases, etc.) that put them at higher risk of death, and the primary treatments they are receiving are oxygen and steroid medications that could theoretically be delivered at home.

Like telemedicine, our very idea of the purpose of hospitalization may be morphing under the pressure of a viral pandemic, prompting changes that have been smoldering for decades. CMS is exploring ways to increase hospital capacity during the COVID-19 surge. We can’t solve this problem by building new hospitals. That takes time (at least outside of China), and hospital beds are needed in relatively small numbers in the US (compared to places like Germany) when viral pandemics aren’t raging uncontrollably. CMS is instead encouraging hospitals to be more aggressive in deciding who can be cared for at home in a program they call, unimaginatively, the “Acute Hospital Care At Home” program, a waiver allowing qualifying health systems to provide hospital-level care at patients’ homes for more than 60 conditions, including common reasons for admission like asthma, congestive heart failure, and pneumonia. You can’t be “admitted” to your own bedroom via telemedicine; you have to be transferred from an in-person emergency department or traditional inpatient hospital bed after an in-person evaluation by a physician. And surgical care clearly needs to be done in the traditional setting, at least for now.

Some companies, having anticipated this need, are marketing equipment or even using artificial intelligence-based systems for monitoring “hospitalized” patients at home. And it seems to work. “Hospital at home” may be marginally better than traditional hospitalization: a study in the Annals of Internal Medicine showed that with one home hospital program, only 7% of patients had to be readmitted to the hospital within 30 days of discharge, compared to 23% of inpatients in traditional care, and the average cost of care of home was 38% lower than care in the hospital.

So the next time you’re on your way to the hospital (heaven forbid), be sure to keep your choice in the back of your mind before you hit the door: would you rather be cared for in the hospital, or would you rather convalesce in the comfort of your own bed?

As the Medical Director of the Kansas Business Group on Health I’m sometimes asked to weigh in on hot topics that might affect employers or employees. This is a reprint of a blog post from KBGH.

Is it time to re-think sick leave?

When I was a medical resident, saucy attending physicians, wanting to impress on us the importance of our work, said things like “If we’re not rounding with you, we better be rounding on you,” meaning that in order to justify missing hospital rounds we better be sick enough to need hospitalization ourselves. So it was no surprise that I once saw a residency classmate work through a night call shift with obvious symptoms of acute influenza.

In the COVID-19 era, working with patients through a febrile illness seems as dated as smoking indoors or driving without a seatbelt. But America remains one of the few developed countries that does not guarantee universal access to paid sick leave for all workers. Twenty-seven percent of all US employees and 17 percent of all US full-time employees cannot take paid sick leave. Congress tried to address this, albeit temporarily, with the Families First Coronavirus Response Act (FFCRA), which was passed on April 1, 2020 and expired on December 31, 2020. 

As a reminder, FFCRA said that employers with up to 500 employees must cover, with exceptions:

• Up to 80 hours paid sick leave at usual pay if the employee was quarantined and/or experiencing COVID-19 symptoms

• Up to 80 hours paid sick leave at two-thirds usual pay if the employee was caring for someone else in quarantine

• Up to 10 weeks of paid expanded family and medical leave at two-thirds usual pay if the employee was unable to work due to caring for a child whose school or child care provider was closed or unavailable for reasons related to COVID-19

About a quarter of US companies affected by the law used it in its lifespan; employers with 500 or more employees already overwhelmingly offer paid sick leave. FFCRA’s passage set up a “natural experiment” (we’ve talked about these before): in some states like Kansas without pre-existing laws around sick leave, workers gained the right to take paid sick leave. These were treated by researchers as the “treatment group.” Their change in COVID-19 rates were compared to changes in workers in twelve states and the District of Columbia who already had access to paid sick leave before FFCRA, the “control group.” Investigators were able to use baseline levels of infection in the few weeks before passage of the law as a baseline. 

The results? States where employees gained new access to paid sick leave had a “statistically significant decrease of approximately 400 fewer confirmed new cases per state per day relative to the pre-FFCRA period and to states that had already enacted sick pay mandates before enactment of the FFCRA.” The authors estimate that this translated into about one prevented case per day per 1,300 newly covered workers.

Given COVID-19’s roughly 2% mortality rate, 400 cases fewer per day could equals as many as eight lives per state per day saved by a simple administrative decision. This is completely in line with previous research showing that paid sick leave induces employees with contagious infections like influenza to take sick leave, thus reducing influenza activity during non-COVID-19 times.

Besides the obvious humanistic angle, is this cost effective? After all, COVID-19 hospitalizations are expensive. I tried to muddle through some math to see how much each saved life cost, but I don’t trust my numbers. So instead I’ll ask you: if you’re an employer with fewer than 500 employees, how did FFCRA affect you and your bottom line?

As the Medical Director of the Kansas Business Group on Health I’m sometimes asked to weigh in on hot topics that might affect employers or employees. This is a reprint of a blog post from KBGH.

Refusing COVID Vaccination Is Morally Indefensible

Imagine for a moment that you are stuck on an island with a few dozen other people. The island has a spring that serves as its only source of fresh drinking water. By some stroke of luck, the island also has a safe, secure, sanitary porta potty that sits a couple hundred feet from the freshwater spring (humor me; you saw Cast Away). You and the other strandees have collectively decided that the porta potty is safe and that it is open and free for everyone on the island to use.

In spite of this astonishingly lucky set of circumstances, a fellow desert-islander named Chuck tells the group that he’s philosophically opposed to using the portable toilet and that the only comfortable place for him to have a bowel movement is on a stump a few feet away from the freshwater spring. Chuck is not differently abled. There are no poisonous plants or insects in the area of the toilet. He has no history of an allergic reaction to the toilet seat in the porta potty. Everyone points out to Chuck that by doing this he will endanger the lives of everyone else through contamination of their drinking water with his feces. An epidemiologist in the group (again, what a stroke of luck!) calculates that by continuing to defecate near the spring, Chuck will give between two and three people a diarrheal illness, and given the tenuous nutritional situation on the island, one of them may die. Chuck is unconvinced, and continues to use the spring as his private latrine.

Now imagine that a vaccine to a virus that is currently the number one cause of death in the United States is available for free. It appears safe. It cannot give you the virus, as it contains no intact virus. By getting the vaccine you will drop your chance of illness by more than 90%. More importantly, you may well save someone else’s life by getting it, just as Chuck might save the health of his island-mates by pooping in the toilet. That vaccine, obviously, is one of the newly available vaccines against SARS-CoV-2, the virus that causes COVID-19.

Given this, we can only conclude that anyone who has access to COVID-19 vaccination and for whom vaccination is not medically contraindicated has a moral obligation to undergo vaccination in order to contribute to herd immunity. The end. It is a classic utilitarian problem: unless the individual cost of being vaccinated is so high that it outweighs the expected negative effect on the aggregate wellbeing of others, we are obligated to be vaccinated. And if you think a possible mild fever for two days outweighs the current death rate of more than 3,000 people per day in the United States, we operate in different moral universes.

This calculation applies not only to the elderly, whose COVID-19 infection fatality rate may be more than 10%, but to the youngest people approved to get the vaccine (sixteen year-olds) who have an infection fatality rate of less than 0.01%. Because the spread of the virus, often asymptomatically, among young people is the single biggest threat to the health and life of the elderly. Fortunately, since SARS-CoV-2 is not as easily transmissible as extremely contagious viruses like measles, and since the vaccines are extremely effective, the number of vaccinated people needed to achieve “herd immunity” is smaller than some other vaccinations: probably around 75-85%. But we’re operating on the razor’s edge right now: our drinking water-contaminating friend Chuck is the 16% of the population who still state they will refuse a COVID-19 vaccine.

If you have a known severe allergic reaction to a prior vaccine, then you should probably wait to be vaccinated against SARS-CoV-2. But true allergic reactions to vaccines are unusual. By my back-of-the envelope count, only three people out of many tens of thousands already vaccinated have reported allergic reactions.

So please get vaccinated as soon as you can. And please encourage your employees to get vaccinated. It is our only path out of the sticky mess we’ve been in since March.

As the Medical Director of the Kansas Business Group on Health I’m sometimes asked to weigh in on hot topics that might affect employers or employees. This is a reprint of a blog post from KBGH.

Amazon is a pharmacy now. Is that a good thing?

Amazon is now in the pharmacy business

Amazon announced just before Thanksgiving that it was entering the pharmacy business. On its face, this is a good thing. Amazon has grown so large that it is a de facto arm of the federal government, and it is incorporated as much as utility companies into many of our lives. The move isn’t sudden; some analysts have framed this as a natural extension of their 2018 purchase of PillPack, a pharmacy service to coordinate, organize, and deliver prefilled medication containers. So we can be confident Amazon will offer efficient, seamless delivery and good prices, two things that are often missing from our experience in American health care. It’s no surprise, then, that the announcement was catastrophic to the stock price of several pharmacies whose shares fell by a tenth or more. GoodRx, a quasi-pharmacy benefit manager (PBM) designed for discounts for uninsured and underinsured patients, lost a fifth of its value.

How it works

Amazon Prime customers will get medications delivered for free within two days. They’ll also qualify for discounts of up to 80 percent off generics and up to 40 percent off brand-name drugs. (some have pointed out that people who can’t afford Prime will be cut out of these offerings, an example of a systemic problem in American health care that Amazon won’t or can’t fix)

I did a quick road-test of Amazon Pharmacy today. The interface is, as one would expect, pretty intuitive and slick. If nothing else, Amazon has mastered simplicity. Just by seeing my routine demographics and the last four digits of my social security number Amazon was able to find my insurance information automatically, a task which I can tell you from both the physician side and the patient side is not easy. Then, after entering medications I currently take, I was given the option of transferring those prescriptions from my current pharmacy. I did not do this (my commitment to this project only goes so far), but it looked like the process would have been seamless on my end. I do not know what nightmarish snarl of paperwork it may have generated for my existing pharmacy or my doctor, though.

Allegedly, were I to have gone ahead and tried to check out, I would have been shown two prices: one with my insurance benefits, and one with my Prime discount. I would have chosen my preferred price, and the medication would have been delivered within two days. It remains to be seen how Amazon Pharmacy would handle one-off prescriptions for an infection or injury, although their same-day delivery in cities and by drone aircraft point toward that being a future feature.

Where do pharmacists fit in?

But the practice of pharmacy is more than the cheap, reliable delivery of medications. We at KBGH see pharmacists not as people who take pills out of a big bottle and put them into a small bottle to sell to you, but as highly trained medical professionals [note: KBGH has CDC funding to promote, among other things, team-based patient care including pharmacists]. Pharmacists’ training is toward the upper end of medical professional training in terms of time and testing requirements. After a minimum of two years of undergraduate classes with strict prerequisites (and some schools require additional coursework), pharmacists since 2000 have universally completed a Doctor of Pharmacy (Pharm.D.) degree, a four-year professional degree program which makes them eligible for licensure by their state Board of Pharmacy. The Pharm.D. degree is often followed by one or two years of a postgraduate residency program to increase the pharmacist’s depth of knowledge in a specific area of focus like inpatient care or chronic disease management. Pharmacists interested in research may do fellowship training beyond residency.

Pharmacists, like physicians, utilize “extenders” and technologies to increase their capacity. This theoretically allows pharmacists to spend more time on direct patient care roles like providing evidence-based medication recommendations, monitoring therapeutic responses to drugs like anticoagulants and blood pressure medications, and reconciling medications as patients transition from one care setting to another.

Pharmacists are capable of contributing to extraordinary patient outcomes. A meta-analysis of randomized trials, for example, showed that pharmacist + physician dyads are much more effective than physicians alone in treating patients’ cardiovascular risk factors. Teams with pharmacists had patients with blood pressures 8.1 mmHg lower, bad cholesterol levels 13.4 mg/L lower, and a 23 percent lower likelihood of smoking:

Some pharmacists, in collaboration with other practitioners, offer testing for high blood pressure, infections like strep throat, and markers of chronic disease management like cholesterol and blood sugar levels. In 2015 the State of Kansas authorized the creation and use of “Collaborative Practice Agreements” between pharmacists and physicians for patient care. Amazon Pharmacy has promised to try to virtually recreate the “counter conversation” with the pharmacist that many people desire, so while it is hard to see Amazon tiptoeing into the collaborative practice water any time soon, it is not impossible to imagine long-term. Amazon already offers telemedicine to its employees. Expect telemedicine for the rest of us next. And expect those telemedicine providers to work with Amazon Pharmacy somehow as the company learns what it takes to provide more comprehensive physician-pharmacy services. Maybe PillPack’s existing expertise in counseling will translate into more traditional brick-and-mortar pharmacy-style interactions. With time, it seems inevitable that Amazon will be labeled a preferred pharmacy for most health insurance plans. After that, it will surely follow CVS’s lead and become or acquire a PBM.

Staying out of stores is unquestionably safer in the COVID-19 age, a system-delivered advantage for Amazon. So if your employees begin using Amazon Pharmacy I’d make sure they know some basics, like that if they opt not to use their insurance but instead just take the Amazon Prime discount, their purchase may not count toward their health insurance deductible.

But for now, for complex patients with complex medication regimens that include potentially dangerous, potentially interfering drugs, the use of a community pharmacy familiar with your employees seems the most prudent course. Many community pharmacies already offer delivery and PillPack-like services designed for ease of drug administration, all with a more recognizable over-the-counter pharmacist interface. Grocery stores adapted when Amazon bought Whole Foods, and I would expect pharmacies to do the same.

As the Medical Director of the Kansas Business Group on Health I’m sometimes asked to weigh in on hot topics that might affect employers or employees. This is a reprint of a blog post from KBGH.