My comment submitted for Meaningful Use Stage 3 last week

This is long but if you’re interested in patient data access I hope you’ll find time to read it. Something important is afoot in federal policy.

Updated 6/4 – added a link to a doctor’s blog post

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Over on e-patients.net, the blog of the Society for Participatory Medicine, for weeks there have been blog posts about an important moment that’s happening right now in Federal health policy.  The details are complex and geeky (imagine that, with Federal policy) but here’s a tiny tiny nutshell, for readers of this blog:

• In the 2009 federal stimulus bill (not as part of Obamacare), billions of dollars were designated to help doctors and hospitals finally computerize.

• To get the money, they have to not just buy the system and let it collect dust; they have to put it to “meaningful use” – “MU,” as it’s often known.

• Not surprisingly, what you have to do to get the money is a topic of hot debate and much lobbying.
  • Remember your civics class? The Legislative Branch writes a bill, and then in the Executive Branch, regulators write the regulations that put the law into action. The regulators get to say specifically what’s legal and what’s not. (See, lobbyists aren’t just on Capitol Hill – they talk to the Executive Branch too.)

• An important part of this discussion for several years has been whether they have to give you and me our data that’s in their systems. Basically: can they use those systems to create your medical record, hoard it (keep it from you), and still get their federal reimbursement??

• Of course the patient community says “No! No Meaningful Use without ME!” That’s the badge at right, which is currently the profile picture for many of us on Twitter and Facebook.

• BUT – and it’s a big but – this is not a trivial subject, because there are many other messy messy factors about other MU regulations.

When it comes to Federal regulations, it’s easy to get drawn into the endless minutiae and sub-sub-sections and parties of the third part.  It drives me nuts; I’m grateful for people who can tolerate that work, but that’s not me.

But – and this is important – to get their money, the owners of those systems have to meet every one of the regulations, in the same way you have to obey every traffic law. Obeying everything except the speed limit will get you a ticket, and obeying 99% of MU regulations won’t get your money. In fact now, after years of working up to this, it’s about to start incurring a penalty. (In Washington policy lingo, there were years of “carrots” (incentive payments), which are now turning to “sticks.”)

And the screaming starts.

An important complicating factor is that some of the products on the market are really, really, really hard to use because they were either badly designed or were set up and configured in a way that local management wanted but which requires a ridiculous number of clicks… while the patient is sitting there waiting and the clinician’s clock is ticking. So, separate from “No MU without Me” is that other factors are making MU reimbursement miserable, many say.

Added next day: For a glimpse of this difficulty blogged by a very patient-centered physician, see this post by SPM board member Peter Elias.

Well, it’s complicated. We who’ve fought for complete access to our medical records have cheered the current rule for “Stage 2” of MU that says “You gotta show that at least 5% of your patients and families actually have looked at their records in the patient portal.” But others, like the president-elect of the AMA, have said (paraphrasing) “How can you expect doctors to interfere with their patients’ freedom of choice, if 96%+ of patients don’t want to??”

I’ve heard of doctors begging their patients to log in to the thing, as a personal favor. Docs I know and like. Yet, back in November, half the providers who’d already succeeded at this measure said that 32% of their patients are doing it! What the heck?? (I have opinions and suspicions but that’s not for now.)

Well, now the government has proposed a rule change: “Okay, you don’t have to automate it so lots of people can do it. You can get full reimbursement even if you just cobble something together so just one person – even one of your employees – looks at their data.”  (I may be slightly oversimplifying, but not much, and I believe it’s literally true.)

Our movement is livid. In USA Today last week famed advocate and widow Regina Holliday called this a “slap in the face,” a betrayal by the government. Meanwhile, a lot of people are on the doctor side are saying “But these systems SUCK!! They’re horrible to use! They made us buy garbage!” And we patient advocates say, “Um, dude, that’s a separate subject, even if it’s true. Give Us Our Data!!”

Separate or not, in many minds it’s all mixed up in one tangle. Apparently the requirement to show that 5% of patients at least looked at their data once is one of many specific items, and if any one of the measures falls short, sorry, you get penalized.  So it’s a mess, and a big argument.

What to do? What do say? I mean, I like  my doctors and nurses. I want them to have a good life. At the same time, I do not want the government to let up on the mandate to give us our data … which was, after all, created solely because we needed care.

Last week I commented officially to the government (as you can) as the public comment period expired on one specific part of this: the proposed Stage 3 rules, which are different from the current argument about Stage 2 rolling back from 5% of what we call “just one patient.”  The details are different between 2 and 3, but my thoughts are exactly the same, so below is what I pasted in to the government’s comment system.

As a citizen, you’re allowed to say anything you want at the next deadline, which is coming up this month. More on that another day. Below is the comment I posted last Friday.

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“Data Liberación!”

So said Todd Park when he was Chief Technology Officer of HHS. He knew that there’s power in knowledge and power in data. And he argued for liberation of the data, not locking it up.

I assert that anything that impedes the flow of important data – including bad system design – is functionally equivalent to locking it up.

In this comment I won’t appeal to specifics of MU3, but to the greater need, the greater human need, that brings people to the doctor or hospital: the need to be taken care of. I fervently believe something that I said in my book Let Patients Help:

“We all perform better when we’re informed better.”

This applies to patients and families (which points to the value of good data access), but it also applies to clinicians: no clinician can possibly do what they trained for if they don’t have the best information.

Simply put – and undeniably, I think – the best healthcare is simply not possible if important information exists but is not brought to the point of care. And that requires optimizing the flow of data … which requires, as its first step, getting data organized for sharing, and then making it available. It can be a tragedy if facts exist but are withheld.

We must, as a matter of federal policy, do everything in our power to encourage providers to work this way: with data sharing, not “knowingly interfering” with data flow, as ONC worded it in their report to Congress. Anything government does to reduce the consequence of dysfunctional systems will keep us short of what we could achieve.

I know this will require putting pressure on vendors to fix the problem. My feeling? They got their billions through Meaningful Use; now finish the job. Make the systems you installed workable, to get the job done: the job of taking care of patients in need.

This sentiment is not anti-provider

I know that life has been miserable for some users trying to adapt poorly designed systems to do what patients and families need them to do. The remedy for this is not to give up; it’s to fix the problem, to finish the job.

I know that some of the systems are horrible on usability, with a ridiculous number of clicks and many other sins. I’ve spoken about such problems in speeches, and I’ve heard from providers whose workflow suffers. But the family’s need – the need for healthcare, which is the only reason these systems exist – is not trumped by those products’ bad design. Fix the problem.

Follow the IOM’s advice

In their major 2012 report Best Care at Lower Cost the IOM said that one of the cornerstones of the future of medicine is science and informatics:

Science and Informatics

Real-time access to knowledge—A learning health care system continuously and reliably captures, curates, and delivers the best available evidence to guide, support, tailor, and improve clinical decision making and care safety and quality.

And:

Patient-Clinician Partnerships

Engaged, empowered patients—A learning health care system is anchored on patient needs and perspectives and promotes the inclusion of patients, families, and other caregivers as vital members of the continuously learning care team.

My primary physician, Daniel Z. Sands, MD MPH, points out that these partnerships require full data sharing: “How can patients participate if they can’t see the information??”

Let’s harvest the methods of those who’ve succeeded

At the ONC webinar last November, of those who’d already attested on MU2, the median VDT adoption was 32%. The median – half of those who’d attested. Let’s find out what they did, that others didn’t. (One hypothesis: I’d love to see if there’s a correlation with whether any given provider made use of the REC training, and how their VDT adoption is going.)

My 2010 talk to AHRQ on system usability: data quality is essential

A year ago the Wall Street Journal wrote that 80% of charts contain errors. I know from personal experience, and that of many other engaged patients, that patients are in a far better position to spot mistakes and get them cleaned up before harm happens.

In 2010, AHRQ invited me to speak at their conference of IT grantees and contractors. The air was abuzz that week with talk of early Meaningful Use rules; some users were pleading that to get certified, an EMR should meet some minimal standard of usability.

The air was abuzz with rumors that a major EMR CEO had said “Over my dead body.” So that’s what I titled my talk: “Over my dead body: why usability matters to patients.” Here are slides slideboom.com/presentations/301817 and video bit.ly/daveahrq2010. Some excerpts from the slides:

• Slide 37-39: “A radical proposal: the producer/consumer paradigm is erroneous in today’s world. Networked patients are producing value, not just consuming it. To overlook this (by not training and harnessing this highly motivated resource) would be to squander a substantial resource in a time of great need.”
  • This is an early version of “we perform better when we’re informed better.”

• Slide 52-53: “It’s self-evident: If a system is hard to use in real-world medical settings, information is more likely to be entered wrong, or calculated wrong, or read from the wrong screen. Someday that will harm someone you love. Which one will it be?”

• Slide 55: “Data errors and confusing systems can lead to accidental deaths. System usability does matter.”

Note: two years later, in 2012, my own mother’s chart got screwed up when she was transferred to rehab; her thyroid condition came across as hypo when it’s hyper. If her daughters (my sisters) hadn’t been engaged, and caught the error, it could have been a disaster. They were there in person; what if they’d been remote, with no working portal? We need to keep the pressure on, to make the systems viable.

I am not amused at the irony of this subject being greeted with a vendor attitude of “over my dead body, will usability be a criterion.” Whose dead body?? Fix the problem.

Additions from the SPM letter

I support the letter filed by the Society for Participatory Medicine. (I’m its co-chair.) In particular:

• “The agency proposes to count communications from any health care provider that is not an Eligible Provider or Eligible Hospital under Meaningful Use as “data obtained from a non-clinical setting” (80 FR at 16757, March 30, 2015), thus virtually ensuring that no provider organization will even attempt to build the interfaces necessary to receive patient-generated health data (“PGHD”) from patients.”
  • Come on: are we trying to lock doctors into a cycle of obsolescence, by blinding them to my life?? I already have a trove of data that my doctor can’t see from my Withings wi-fi scale, my Garmin wristband with heart rate monitor, and my MyFitnessPal app (which integrates them with my food data). Using these three has been a fundamental part of my losing 29 pounds for diabetes prevention in 4.5 months, a major health goal, and my doctor can’t see it. If Federal policy doesn’t force development of APIs, physicians will become increasingly un informed and increasingly irrelevant. How ironic is that?? Physicians should be screaming to the vendors for better data integration, not yelling at CMS.

• I applaud the use of APIs in Option 2. However, I note that given the nature of data delivery via APIs to smartphone applications, and the near-universal availability of cellular network coverage, broadband connectivity is not a prerequisite to its availability, and I therefore propose eliminating the rural exception for Option 2.

• I support the 35% threshold for secure messaging in Measure 2. Again, given the shift from desktop to handheld devices, and the attendant shift away from reliance on broadband networks, I propose eliminating the rural exception.

• I also support the idea of making data available to patients at no cost via APIs. In my view there is no moral and rational reason to have this be different in medicine than in any other industry. To charge for it is to think like a 1994 bank, trying to hold back the tide of data democratization.

I’ll close by citing a fictional case that must surely be an amalgamation of actual cases others have sent in as comments.

Imagine a family with a child in trouble. Imagine multiple providers doing the best they can to gather information, to diagnose and share thoughts. Imagine calling in the best specialists, or collaborating with colleagues. Imagine the family calling on friends and reaching out through their social networks, asking if anyone knows anything that might help.

Imagine – as I know has happened – one of those providers discovering a fact too late, and saying “Oh … if I’d known that, we could have done X.” And then imagine the reason they didn’t know it is because we as a nation didn’t demand that the billionaire vendors, who made their riches through Meaningful Use, were not, in the end, required to finish the job so their users can use the systems to achieve what the policy intended.

Data mobility is absolutely essential to medicine achieving its utmost for families in need. Please, do not loosen the reins; we must keep pulling healthcare into a future optimized by having the best possible data available to the providers who need it. To do anything less is to put business interests ahead of the needs of the people for whom the business exists.

For the families, please: finish the job.

Again, I know these points do not address, item by item, the rules at hand. I speak instead to the purpose of this activity in the first place: improving healthcare.

One more time I’ll emphasize that this is not just a patient-centered issue; no clinician can do their best if the information isn’t available. The cause is good, the cause is aligned with what the IOM called for. If the problem is that the systems suck (pardon my French), then the remedy is not to give up (and give a free pass to the forces of “over my dead body”), it’s to finish the job and fix the problems.