The AMA and 33 other organizations sent a letter to National Coordinator Karen DeSalvo last week. The letter has seven requests of ONC:
- Decouple EHR certification from the Meaningful Use program;
- Re-consider alternative software testing methods;
- Establish greater transparency and uniformity on UCD testing and process results;
- Incorporate exception handling into EHR certification;
- Develop C-CDA guidance and tests to support exchange;
- Seek further stakeholder feedback; and
- Increase education on EHR implementation.
Let?s take them one-by-one ?
Decoupling EHR certification from the EHR incentive programs. One could argue that this is already happening, and we can expect it to continue to happen. Check.
Re-consider alternative software testing methods. I?m not sure that ?re-consider? is what?s in order here. The letter asks ONC to re-consider the stance on scenario based testing. But ONC?s stance is (and always has been) that scenario based testing is a great idea. Is the goal of the letter to express enthusiasm for this model? ONC will share the enthusiasm. The harder part will be to create a framework that builds and maintains scenario-based test procedures. This is a shared responsibility. Shared by government (ONC and NIST) and industry (health IT developers) and – yes – the AMA and the 33 other organizations who sent the letter. ONC has invited everyone to participate (here?s the open test development site). So far – I don?t see much (any?) engagement from the AMA or the others who signed the letter. It?s relatively easy to write a letter saying someone else is responsible for solving problems. Time to step up to the plate and participate in the solutions, folks!
Establish greater transparency on UCD testing. Yep. I agree. ACBs need to enforce this, and ONC needs to get serious with those who don?t comply. UCD testing results not posted on the CHPL? Give them 60 days warning (more than enough!) and de-list the product.
Incorporate exception handling & C-CDA guidance and tests. These requests expresses AMA?s ambition for ONC (and NIST?) to do full interoperability testing. But as defined by congress in ONC?s authority – the certification program does conformance testing. That means the products conform to the standards. It doesn?t mean they have been tested with full end-to-end interoperability tests. If we want ONC and NIST to do that – there will need to be an expansion of ONC?s authority and budget. Asking ONC to do this is barking up the wrong tree. AMA should lobby Congress on this one, not ONC. Yes – there is some low-hanging fruit here with the C-CDA. ONC could offer more explicit guidance to limit some of the optionality that exists in the HL7 standards. I agree on this point.
Seek stakeholder feedback. I think they do a pretty good job with this. ONC?s FACAs are open to the public, transcribed, and always invite public comments.
Increase EHR implementation eductaion. Well, ARRA funds are depleted. While I agree that there is work to continue here – but ONC and the RECs and the developer community – I?m not sure that this can be increased in context of the current fiscal situation.
I?ll enable comments on this post - as I?m interested in how others view this letter.
Thanks Jacob-
What struck me was the contradictory impulses here with respect to what they want from a government regulator. It seems that they are happy to join the vendor bandwagon of “remove onerous regulations” and also slam ONC for not regulating the industry more.
We used to feel that if everybody is a little unhappy on opposite sides of an issue, we’re probably doing our job at balancing the tensions inherent in regulation. That barometer may be losing its reliability!
They want to decouple certification from MU, but they “also feel the Administration is pushing too quickly for the use of CEHRT
beyond the MU program”
On the one hand, the clinical societies complain that “MU certification has become the priority in health
information technology (health IT) design at the expense of meeting physician customers? needs, patient
safety, and product innovation”
On the other hand, they want:
-more prescriptive testing, more “in-vivo surveillance”, and more oversight on ATCBs (all good, but will increase costs for certification)
-rigorous testing against a larger “number of clinical scenarios, including ?abnormal ones,?
-enhanced security, including 2FA- which now “may help bolster vendor innovation” despite lack of consensus approach
-less optionality in interoperability specifications
-more prescriptive and far-reaching requirements for user-centered design and usability (despite lack of consensus approach)
Look- ultimately, the role of government regulations is to protect the public, and empower the customer (doctors and hospitals). The clinical societies are entirely within their rights to ask for more protections vis a vis vendors who wield a disproportionate advantage over them. But they should then stop bashing the regulator for regulating, and support them in getting sufficient funding and authority to do their job well (which I don’t recall seeing).
/endrant
Maybe I’m a bit sensitive, but it strikes me as quite a defensive posture of the 2 prior ONC leaders have to take to a comment section to “rant” their feelings about AMA and their concerns for ONC. First of all, ONC really overreached on MU and is now seeing actual miserable EP numbers attesting and their failings. The industry was moving to EHR without MU, but ONC decided to make an artificial market and they created a monster. Now, not to lose face, these ex-ONC leaders are moving from government regulator to industry insider, these prior ONC leaders are biting back at those that are left behind in their mess. We have a huge percentage of miserable caregivers, dealing with unusable, inefficient, unsafe and insecure vendor products. There is essentially no interoperability. While ONC created the MU program, designed as a a one size fits all, 100% or fail program, they let CMS pile on with PQRS, VBM, MOC, ICD-10, HIPAA, SGR failings, Sequester cuts, etc and leave providers shell shocked from overwhelming regulatory burdens and payment cuts. So Farzad and Jacob, you will get no puffery language here, you guys failed us. While you are out there living the dream, not involved in direct patient care, you left us with a huge disaster that we need to figure out now. So fire off the smug comments while you can, but it smacks of insecurity of you own professional failings. Maybe the AMA letter is incoherent, but so are your own ONC policies and procedures. Maybe you left us all so confused we don’t know what to do. One thing for sure is, no one is doing your MU program or maybe I should say 6% of EPs that can do Stage 2, are doing it, but you failed 94% of us. Take this to heart, you guys should not be proud or arrogant about pointing out the deficiencies of groups left to try to clean up the mess you made. So to be cutesy like you, Jacob and brother F, good riddance. /endrant
I see several sides to this and I can’t see how my two colleagues have failed anymore than I can be critical either of the AMA letter or of the responses made. HITECH was a highly-specified, overly prescriptive wish list that I would argue would logically have been best left out of ARRA. Many of the concerns raised in the letter were indeed influenced by ONC leaders, but the course was set in the earliest days of HITECH – and long before. The Brailer/Thompson 2004 report made a relatively mild case for certification but in the ensuring years prior to HITECH, much of the complexity of certification, quality metrics, and all of the other broader complexities of health care technology were already arguably overly-engineered, over-prescriptive, and unrealistic before HITECH emerged.
I argued in a 2009 Health Affairs piece that one can’t use a Keynesian stimulus to effect rapid cultural change, but that was the deck certainly later ONC directors were handed. Among the many flaws was the reliance in the Act on State HIEs to address interoperability for clinicians. To many of us, this was a failed strategy from the outset. Similarly the pile on of quality metrics, coding standards, and performance-based reimbursement that had enormous momentum both from within CMS and from the various powerful stakeholders within the health care industry. There was, I believe, no way to be entirely successful and there might have been ways in retrospect to make a few more changes, but I sincerely believe every effort has been made by parties across the industry to work with what one has. The law prescribed that everything the government funded should be done at once (training, research, standards development, implementation incentives). And some academic illuminati, I believe, did not help when claiming that enormous savings were to be found and that one could assume that EHRs would lesson clinician time and not extend hours to an onerous extent. Naturally, that led to turbulence.
In my own mind, ONC addressed in novel ways many of the limitations prescribed in HITECH. The Direct Project, for example, was one effort to create messaging in a more light-weight way. Yes, as the AMA letter says, the “standards” are not yet “standards” but we are seeing a great convergence among many players to rectify these issues. The rate of progress inspires some hope.
There is no doubt hat the confluence of “pile-on” programs have left the healthcare industry with “HITECH Fatigue” and sapped the energy out of many practitioners. And the AMA letter does raise tensions – not contradictions – between the need for more regulation and support of autonomy/innovation.
But none of the individuals at ONC under the tenure of these two directors “failed us.” Rather, they courageously sought to address a flawed barrage of initiatives (most not originating from ONC) and tried to use their limited authority to simply and ease.
Both the benefits and high costs of health care IT must be viewed in the context of a system burdened by excessive complexity – a system that is the product of health plans, PBMs, state government, vendors, suppliers, and the many faces of federal government.
I share the concerns about MU2 and the concerns expressed by the AMA. But I am equally concerned by all of the other complexity that is outside of the control of ONC and even other government agencies. Yes, it is indeed, a mess. Yes, it has made some individuals miserable and one only wishes that the original legislative aides who threw all of their drams into HITECH would have been constrained by the reasoned concerns of practitioners. The legislation will bring many good things (and has) but in some respects it has failed us. Hopefully the dialogue among professional societies, government, vendors, and the health care industry will continue to address legitimate concerns.
I would just – with vigor – claim that both Farzad and Jacob took on an impossible job and served us well.
Mark Frisse
Thank you “meltoots” (not your real name? Why – as an eloquent critic – do you hide behind an alias?) and Mark. I love an engaging conversation. I’ve always done my best to make the choices that best aligned with the needs of the people, and have worked tirelessly toward that end – as have many many others. Did everything work out perfectly? No. Better? Good? Yes. I’d argue that it has. My comments – and those of my former colleague – are offered with passion and integrity. Smug? No. Far from it. We care deeply and are working incredibly hard to improve the health of a nation. I’ll not debate here whether MU was an “over-reach” and whether we now have “a mess” or not. We did our best – and others in the government are currently doing THEIR best – and we all need to work together to understand what the best possible next steps are. AMA and the 33 other organizations are engaged and that is good. It’s now time for us all to engage even MORE so that we can improve health for all.
Mark, you eloquently (as usual) express how some components of the current state (and the resolutions to some of our problems) lie outside the scope of ONC and HHS. This is the point that I was trying to express in my review of AMA’s letter. They’re not wrong to bring up these issues – just barking up the wrong tree!
Finally – I’ll offer that I am absolutely “living the dream” as “meltoots” (not his/her real name) suggests, but it is not the Caribbean beach dream that is implicitly asserted. Both Farzad and I are – in different ways – living the dream of working 80 hour weeks, and taking on extraordinary personal risk – in order to help a nation find better health and better care at lower cost. Some of the “facts” you state are simply incorrect (far more than 6% of EPs are participating in MU 2) and you shouldn’t assume that I will remain “not involved in direct patient care.” I continued to see patients for much of my tenure at ONC, and will soon resume clinical work. Your attacks on our integrity represent your opinions – to which you are absolutely welcome. I’ll admit that it saddens me a bit to think that someone actually believes that I am arrogant – implying that I don’t care about the downstream impact of my work at ONC. The work of federal service is a balance between passion, vision and – yes – humility. It is the combination of these three attributes that makes a great leader – and it is such a leader that Fazad certainly was – and to which I aspired. You disagree. That’s ok.
Hi Mark! (and greetings, “meltoots”)
I think what Jacob and I are expressing is a sense of loyalty to an institution that we served to the best of our abilities, and to the many men and women who work very hard, very loyally, and very ably there to improve health for all Americans. Those people and that institution are rarely appreciated, and routinely pilloried by people who are well intentioned, and passionate in their own right. We have seen and heard and listened to their frustration (which is often misdirected) and their policy prescriptions (which are usually unworkable). But when you’re a civil servant you don’t talk back.
There is, and should be sadness at a payment system that forces doctors to squeeze more and more patients into less and less time, and pays for documentation not health. There should be frustration at badly designed and poorly implemented software. There should be dismay at “compliance” officers that over-interpret regulations and enforce absurd contortions. There should be concern about extortionist business practices. Those problems weren’t created by ONC, and usually can’t be solved by it either.
Where we might be fairly faulted is in the audacity to try to get the most out of a piece of imperfect legislation- to implement it aggressively in the face of epistemic humility. That we don’t know what we don’t know, and there will always be unintended consequences.
But while in hindsight you can always do things differently, I don’t believe that we were wrong to push as hard as possible to move healthcare into the digital age. We are in a fundamentally different place, and while all of healthcare’s problems can now be cast as an EHR problem, there are now also more opportunities for innovators to help.
Mark’s wonderful lecture (http://mediasite.vanderbilt.edu/Mediasite/Play/365ba1cab9da402398ada19419f794701d) on four decades of informatics reminded me of how long it takes for a new technology to fully come into its own, and I have to keep reminding myself of that longer lens, even as we work impatiently, urgently to make things just a bit better, together.
Farzad
On the specific matter of the clinical societies’ letter-
It’s actually mostly very good, and very thoughtful. I should have said that.
Its contradictory impulses probably come from being drafted by committee (always easier to add than subtract, as critics of MU remind me).
I am concerned that provider groups– customers– are at a disadvantage vis a vis vendors, and a strong certification program *can* help, but I do think that there is an unrealistic expectation of how much of the problems with usability, or vendor business practices on interoperability can be solved through ONC regulation or technical standards alone. And certainly little of it would be accomplished with a hobbled agency and a diminished mandate.
Farzad