Advice to the New National Coordinator

Screen Shot 2016-08-15 at 6.51.33 AMTwo and a half years ago, John Halmaka posted an entry with this title – and I recall that it was a good summary of the state of the industry.  While I didn’t agree with all of his suggestions, I enjoyed the review and it offered a good set of guiding principles.  Since I was Acting National Coordinator for about the same duration as Vindell will serve, (Fall of 2013 – after Farzad Mostashari departed, and before Karen DeSalvo arrived) I’ll offer some thoughts from one who has been in his position.

    1. Certification.  The health IT certification program is the core of ONC’s responsibility to the nation.  While some have called for the eradication or reduction of the certification program, I would argue that this would be akin to scaling back Dodd-Frank.  Yeh – crazy.  As a product of ONC’s certification program, we now have health IT systems that do what their developers claim they do.  Before this program existed, creative health IT salespeople would assure customers that systems had functionality that simply didn’t exist, or was nonfunctional.  The program, like certification programs in other industries (telecommunications, transportation, etc.) is in place to assure the purchasers of products that these products do what developers claim.   Is the certification program perfect?  No.  Of course not.  The program needs to iterate with the evolution of the industry and the standards that are evolving.  Revisions to the certification program must therefore continue, so that the certification requirements don’t point to obsolete standards.  A focused “2015R2” certification regulation would therefore be an appropriate component of ONC’s fall work – so that something can be “shovel ready” for a new administration for ~ February release – with final rule in ~ April/May of 2017.

  1. The 2017 Spend Plan.  The 2017 federal budget appears to be on track to pass @ some point soon – and ONC’s appropriation for 2017 is looking like it will land at a steady ~ $60M ($65M if the extra $5M for narcotic abuse prevention lands).  The National Coordinator defines the “spend plan” for how the organization allocates this money – and the plan needs to be developed and executed at the beginning of the fiscal year: October, 2016.  The new National Coordinator is therefore making decisions now about how the funds will be spent over the next 12 months.  Office Directors are preparing proposed budgets for the year:  new FTEs, new projects that they want to launch.  Every year, it’s the same – just as it is in any large organization – proposals are submitted and the proposals represent 2x-3x the $$ available.  Tough calls need to be made.  The NC makes these calls. It’s hard to do this when you don’t know who your successor will be in January – or what their preferences will be.  When I was in this position in October, 2012, I worked closely with the Office Directors and the ONC Chief Operating Offer (Lisa Lewis), to identify the components of the organization’s work that were essential, and which were not.  We delayed decisions on about $2M to give Karen some flexibility to fund programs that were important to her.  As I mentioned in my response to Politico’s request for comments on the next phase of ONC’s path, my view is that it’s time to wind down ONC’s grants and health IT evangelism activity.  Perhaps it’s just my personality coming through here – as I am a well-known introvert, with little interest in quadrant 1 of the sizzle-substance 2 x 2 matrix (kudos to Janhavi for its invention), but I am concerned that it’s not government’s role to convince the public of the value/need for health IT.  If health IT has value (and I believe it does) then this value will be tangible and self-evident to the public.  If not, then no annual conference, blog post, or challenge grant will change this fact – or anyone’s perception of it.  ONC’s annual meeting – an event that costs several hundred thousand dollars and attracts the same participants every year – adds rather little to the nation’s progress toward improved health through the strategic use of health IT.  Kill the conference.  Kill the health IT flag-waving.  There’s already plenty of that to go around, and the taxpayer need not pay for it.
  2. Focus on quality.  No – not quality measures.  Quality of health, quality of care, quality of decisions.  Do these need to be measured?  Of course they do – and with the growth of value based payment in federal programs upon us, measurement of quality is imperative.  But we have conflated the concepts of quality and measurement.  As many know, I’ve long been concerned that the way that we use clinical quality measures in health care is fundamentally flawed.  Indeed, it was my concern about these flaws that led me to join ONC in the first place:  as the CMIO at Allscripts, I was responsible for helping our EHR development teams meet the requirements of Stage 1 of the EHR incentive programs (“meaningful use”) and it became clear that the accuracy of quality measure reporting would be terrible across the industry.  Why was this?  Because the 2011 certification criteria and Stage 1 meaningful use requirements were too vague about the data that would be used to measure quality.  For example, a quality measure might express that patients with “severe congestive heart failure” would be expected to be on a certain class of medications.  But there was no clarity for how “severe” was to be assessed, and many EHRs didn’t even formally capture ejection fraction, which would be an imperative component of an assessment of the severity of one’s CHF.  For Stage 2/2012 certification, we changed all of this, and while most readers don’t know or care about the details, these quiet changes represent the first important step toward improved quality measurement:  the data elements that are required for quality measures are explicitly identified in the certification regulation, and no measures are required that exceed the scope of these data elements. Read the last sentence again if you need to – as it’s very important and this guiding principle remains ignored by NQF, by many commercial health plan quality measures, and by many state Medicaid programs that are trying to implement quality programs.Simply put:  it’s impossible to report on data that was never captured.  A “quality measure” that assumes the presence of information in an IT system that is not present will be an invalid quality measure.  Period.  I thought / hoped we solved this problem in 2012.  Unfortunately, we did not.  Quality measures are still proposed without consideration for the data that EHRs have captured.  It’s now easy to know what the EHR can capture (what it can capture and what it has captured may of course differ).  Start with the NLM’s Data Element Catalog (Jesse James won the naming competition).  If the concept that you want to measure isn’t in here, then re-design your measure, because the EHRs don’t capture the data in a uniform manner.   If it is there, then the likelihood is high (but not certain) that the data can be captured, queried, and transmitted.Recall that I said our method of measuring quality is flawed.  Why is it flawed?  Because all of our focus is on quality measures rather than quality improvement, and improvement is a product of measurement and decision support.  Let’s parse this statement, beginning with the difference between measures and measurement.  A measure is an explicit logical statement about care delivery and its alignment with a very specific expectation.  For example, there is some evidence that individuals with diabetes will live longer if their blood sugar is well controlled, so there is a quality measure for this:  IF (individual has diabetes) AND (blood sugar is well controlled) THEN (quality measure satisfied).  Each of the logical expressions can be defined explicitly.  This measure can then be applied to thousands of care providers and their “scores” on the quality of care they presumably offer can be compared.  But what if blood sugar control isn’t so important?  What if there becomes a better way to measure individuals’ optimal health?  Measuring care quality in this way is like having a speedometer in your car that measures 10, 15,25, 37 and 55 miles-per-hour and nothing in between.  It’s a seat of measures -hard-coded into the system rather than measurement:  a fluid, adaptable system that enables us to see how we are doing and therefore to enable us to adjust our work dynamically if necessary.   How do we adjust?  With clinical decision support (CDS)!  As you will read in the chapter I wrote in Eta Berner’s just-published book on CDS, the federal government has done a great deal of work to build CDS capability in health IT systems, and to align it with quality measurement.  We’re not there yet – but we are well on the way.  Keep this on the front burner, and the path to the triple aim will be shorter and much less bumpy.
  3. As my friend Jerry Osheroff always says – focus on the most important things:  TMIT.  Are we helping improve the health of people?  That’s most important.  Don’t lose sight of it.  Karen DeSalvo taught me many things when I was her deputy – but the one I’ve internalized the most was something that she taught me very early in her time at HHS:  we need shift our conversation from how to improve “health care” to how we improve health.

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5 replies »

  1. I don’t mind to agree to disagree, but your team made a entire policy market that has failed physicians like me on the front lines. You guys BLINDLY made certification requirements. They were not based on any tested, proven or evidence based standards. They were based on “SOUNDS” good. That is NOT a reason for certification. Certification for glass breaking is based on a standard. Engine parts on a mean time to failure. They are based on proven methods. All you did is prove how NOT to do an EHR.

    EHRs do NOT work as the vendors claim. YOU MUST AGREE ON THAT! Are you telling me that you feel the certification system really worked to be sure these EHR products work in the real world? Based on what standard? Therefore the certification is INVALID.
    Physicians know what they would like from an EHR/IT standpoint to better care for their patients. We do NOT need a one size fits none EHR policy from ONC.

    My big beef is the penalties. You cannot penalize us that do not want to use these awful “certified” products. You did, and still do penalize me a hardworking, quality, front line physician. We use a custom EHR that does what WE want in our office, not what you want.
    We know what we need and want from our EHR to make our care better. Yet we get penalized because we do not count our clicks nor send piles of meaningless data to the US government. Tell me ONE STUDY that shows all this MU and PQRS data improved costs, value, safety, security, efficiency, usability, or reduced burden. You have 5 years of data…what happened to that? If it is so important, this data, what has it done?

    In our hospital we battled for a year on whether the MU requirements for CPOE meant that the MD had to enter every single order in the EHR because you guys called it CPOE. We had to fight back from the admins not allowing verbal or telephone orders, because our EHR would not count those into the CPOE numbers and hence if we would not meet MU and/or get audited. That is just one small example of the HUGE nightmare you caused us. As for you silly certification rules…First, they do NOT work as they say they do, there may be some 500 step process to meet a certification requirement, but it is just not possible for nonIT folks to do it, they are confusing, ambiguous, and way too complicated. Second, you MUST admit that EVERYONE feels that the current crop of certified EHRs are a nightmare and have burdened MDs, and not improved safety, quality, value, cost, usability, efficiency, and certainly not security of medical records. Third, when Lockheed Martin is now in the Health IT game, you can see where you have driven this market to…Fourth, you AUDIT us on whether we follow these arcane complex requirements. I feel ALL ONC leaders should still practice front line medicine at least 50% of time, be forced to use these EHRs, mandated to do all the PQRS, MACRA type programs, go through an audit every year, then maybe they would understand better the problems they made.

    EHR cert is the foundation of the problem you created. .Maybe you should listen to John H. The fact that you fundamentally disagree is EXACTLY why we are stuck with the major problems we have right now. Forget your roadmaps to EHR nirvana and learning health and all that other crap, ONC and EHR certification set back medicine and patient care at LEAST a decade, when it could have organically grew, you forced it. You guys all backslap each other because MDs bought computers/EHRs and yet we are still mired in the aftermath of the factory data driven mess you attempted to make…all because it “sounds good”. Now you guys are all using the puffery language of “value based”, again, will fail be costly, and heavily damage the profession. The medical profession may not be recoverable soon. It is that bad out here. Its time for ONC CMS and all the rest of you to wake up and realize it.

  2. @meltoots: I DO love a critic! 1) Thanks (I think)! 2) We’re going to need to agree to disagree on this one. Would you like to fly a plane with engine parts that aren’t certified? Drive your car with tires that don’t meet certification standards? What about that shatter-proof glass that is certified not to shatter? Or the milk in your fridge that meets quality standards? Products meet standards – and industries adopt these standards so that consumers know that they are buying safe products that work as the manufacturers claim.

    Now – does the GOVERNMENT need to run the certification program? No. If/when the industry steps up to the plate, as other industries have, with an objective, rigorous program, the government can/should step aside.

    You are correct – innovation is waning in some circles – but it’s not dead at all. Many health IT developers are innovating – and the recent FHIR work that is gaining steam is being facilitated by the government. Yes – prescriptive certification requirements CAN slow innovation (especially when the certification requirements are misinterpreted), and this certainly happens. Baby/bathwater. We may need better (focused, clear, iterative) certification, but we don’t need less of it.

  3. Probably shouldn’t have regulated just at the time when you needed creativity. The two are immiscible. I realize that government felt it needed to give medicine a shot in the arm to get IT going, but it could have done this by subsidies alone, couldn’t it?

    But, where computerization was useful, health care was an early adopter. We had a computerized lab system in 1971 using a PDP-8 mainframe. The fact that the EHR was slowly trickling into health care should have meant something to the feds: it wasn’t THAT needed.

    It was essential that it came in from the ground up. Too late now. Annals of government screw-ups Vol I, #1.

  4. If you follow any websites that deal with physicians and “burnout” this pretty much sums it up. The plane is going down in flames.

  5. OK Jacob, you get a pass since you were only roped in as National Coordinator for a few months. But I definitely agree with you that we do not need yet another huge regulatory Health IT Cheerleader Department of the US Government. Its time to stop with all the puffery language, back slapping, roadmaps to the magical interop butterflies and rainbow land, etc. Gentle nudging is all real really need from ONC and CMS. Not what we current have.
    2. You are DEFINITELY wrong on certification. Let the REAL market work. Policy markets do NOT work. I own businesses outside medicine, IT works fantastically for those. We work directly with vendors. No interference from US Government, at all. Thats how it has to be. We do not want or need a nanny state. Hate to break it to you but we are still sold on “things they say it can do” but its so ridiculously complicated to use, it just doesn’t work, and yeah they are certified. So that argument falls flat. Right now all our vendors are buried with complicated formulas and measures and objectives that constantly change. WE KNOW WHAT WE WANT AND NEED from our IT vendors. We do NOT want ONC or CMS or anyone else to get in our way. We want custom IT solutions. We cannot get that now. Every single day, I am told we HAVE to do it this way or that way because of MU, or certification, and they cannot change their software or risk being decertified. Its a HUGE problem that ONC feels that they need to watch out for us. Its lead to worse safety, definitely worse security, worse usability, worse efficiency, worse burdens on physicians…what exactly has it helped, this great certification EHR thingie? Let us watch out for us. We are big boys and girls now. MACRA and MU/PQRS/CPIA are just monstrous burdens that are getting in the way of our care. At least give us an OPTION to opt out of using a certified EHR so we do not get penalized. Let innovation back into this. Right now there is NO innovation coming. None.
    3. CMS has a very big problem attribution of cost and all these quality measurements and definitely with CDS. Really, they should just leave us alone and let us work with IT vendors to improve care. In my experience, EHR and health IT will take at least a decade to get even minor improvements. You guys asked for WAY too much WAY too fast and have lost our heart and minds and many breached records. In fact, you probably set back real improvements with health IT/EHR, outcomes, safety, security, usability, efficiency at least 10 years with MU PQRS etc. Its time to take your lumps, you guys failed, stop trying to fix it with more “less” complicated measurements.

    We are drowning so bad out here, I am surprised that anyone at CMS thinks that MACRA is a good idea. Are you ONC and CMS folks that far removed from direct care that you are not hearing us? Are you back out in the real world attesting to MU, PQRS, etc?