Wednesday, November 4, 2015

The November HIT Standards Committee

The November HIT Standards Committee included a comprehensive review of the CMS Meaningful Use Stage 3/Modification Rule and the ONC 2015 Certification Rule.

We begin the meeting with a presentation from Robert Anthony of the Meaningful Use Stage 3 and Modification Rule 

A robust discussion followed.   Issued raised as those similar to the ones I identified in previous blog posts.

The main concern was the alignment of the CMS Meaningful Use rule with future pay for performance criteria that will be part of MACRA/Merit-based Payment Incentive programs.

Additionally there was significant discussion about the API requirement and the notion that “an API that can be used by applications chosen by the patient” implies that there cannot be curation or security review of patient selected applications.    All agreed that CMS and OCR need to clarify how patient access can be balanced with security imperatives.

The 6 public health requirements apply to providers but CMS has no authority to standardize communications on the public health side.  This could lead to significant regional variation in public health transaction flow.

The next presentation from Elise Sweeney Anthony and Mike Lipinski covered the 2015 Certification Rule  

Issues discussed included privacy and security criteria, safety enhanced design, field audits,  and the API requirements.

As I’ve stated in previous posts and articles, I believe the CMS Stage 2 modifications are good but the Stage 3 requirements could be moved into merit-based incentive programs and the Meaningful Use program eliminated.

Regarding the ONC Certification rule, the API requirement should include additional specificity for FHIR/OAuth.   I realize that it is too late, since the rule is final,  but the ONC rule includes so many criteria for so many purposes that I believe the market will find it very confusing.  It has the potential to create enormous burden beyond the intent and original goals of HITECH.    Private sector innovation in support of MACRA/MIPS is likely more powerful than certification to accelerate the functionality and interoperability we need.


Jacob Reider said...

John: First (and most important) - aside from train-watching, what is the purpose of the platforms you've built? I can imagine a peaceful lunch up there - but I suspect there is something else you've got in mind!

As the 1 year anniversary of my departure from ONC approaches, (it seems like only yesterday!) I find that my opinions are evolving closer to yours. Scary indeed. I do agree that more specificity in the ONC API certification criterion would have been of value, but of course FHIR isn't "there" yet and so the team couldn't cite a standard that's immature. You and others have beaten them up on that front before - and I'm sure it was a puddle that they didn't want to step in again (can you say "Direct?"). Yet specificity remains a double-edged sword. One of my favorite examples of this is the requirement from the Department of Transportation that cars have mirrors rather than "things that can be used to see behind you on the sides." The mirror is explicit and specific and prevents innovation. (See this request for DOT to re-visit the regulation.) So when things are standardized, we hold back innovation, but when things are ambiguous ("thou shalt have an API capability") as the 2015 certification criteria state, then 10 health IT developers might implement this 10 ways. And (perhaps) that would be bad. But the flexibility doesn't prevent the industry from aligning on FHIR/OAuth. The specificity remains an opportunity - it's just not mandated.

I also concur that there are incentive opportunities in MIPS that don't exist in HITECH. One could therefore view this a positive statement about MACRA/MIPS rather than a negative statement about HITECH and HHS' implementations of HITECH's provisions. We've all learned quite a bit since HITECH was passed in 2009. It's time to incorporate that progress into an "optimization" phase - of the regulatory framework - of the health IT implementations - and (yes) of the organizations that have been created in the government to steward this progress.

John Halamka said...

The reason for the platforms is to
1) play the Japanese flute in the tranquility of the tree canopy
2) watch wildlife which does not seem to notice folks in trees
3) watch fireflies rise from the grasses into the canopy in the summer

Regarding ONC, there are two possibilities

1. Don’t require an API unless you specify a standard
2. Acknowledge that FHIR is early today but will be mature by 2018, so ask forgiveness for including it now with an API requirement

Brian Ahier said...

The reason for the platforms and all these work we have been doing is to improve patient care and get a handle on costs. EHR incentives and penalties won't get us there. I agree with the idea of ending the Meaningful Use program and a consolidation of Stage 3 requirements within upcoming Merit-Based Incentive Programs

Michael Banks said...

I hope that all of you in ONC positions or influence actually hear from street level front line providers. MU is devastating the practicing providers, its ruining the EHR vendor - provider relationship. All resources by vendors are used to figure out, implement and program systems to achieve some massive everchanging federal regulatory burden. There is nothing left for usability, efficiency safety or security that providers are so desperately asking for.... MU fits no practice, Ok, may 10% of overachieving data entry practices, but not 99% of them. And its a complete distraction to patient care and a huge burden. Those of us out here trying to care for patients have had enough of MU PQRS CQM MIPS MACRA VBM etc. So you can have 3000 measures and or objectives or whatever you want to call it for Stage 2 and 3, but we have given up. We are going to take our lumps with penalties. And if that was your goal, congrats, you achieved some savings through penalties. But you have also disenfranchised 100's of thousands of providers. For anyone that has some influence with ONC or CMS or MU or all this data entry check boxing, pop up disaster making, please stop. Quit devaluing physicians and providers. I think the calls for action will get louder and more angry. And that is never good. You guys are leaders, please stop trying to be "yes men" to complex regulatory action and listen to your colleagues that what you are doing is terrible to both us and for our patients. Its time to end MU and get out of our way. Stop thinking for us, standardizing for us, telling us what you think is good or bad. Its beyond annoying at this point. I know John, you are trying ever so eloquently, but its not effective. I do not think they are hearing you. Its time to be much more direct and harsh. Someone has to say this stuff and you need to hear it.