Wednesday, April 1, 2015

Gathering Feedback on the Certification Rule

Over the next 3 months, the HIT Standards Committee will review every detail of the 431 page Certification rule.     We’ll also be holding calls to look at the rule as a whole.  At least one call will be open to the general public.  Think of this as reviewing the “trees” and the “forest”.

In the meantime, I’m interested in the opinion of the crowd      Feel free to post comments on this blog that provide positive and negative reaction to the rule, just as Micky Tripathi and I divided the initial analysis into the Good, Bad and Ugly.

Important questions to ask

1.  The ONC Certification rule includes a catalog of many transaction types, only a few of which are related to Meaningful Use.  Is it helpful or hurtful to publish everything now in a single large regulation?

2.   Many of the standards included lack maturity per the objective ranking of their adoption.   Should regulations include standards that are not yet in use?

3.   The regulation suggests that thousands of developer hours are required for every EHR seeking Stage 3 certification.    What effect will such a burden have on the marketplace? How is innovation impacted by the rule as written?

4.  Does certification help interoperability or are there more effective means (economic incentives, culture change, penalties etc)

5.  The Certification Rule expands the enforcement powers and requirements of the ONC authorized certified bodies, and has sanctions for vendors found not to be compliant with their certification status.  Will the prescribed approach be helpful? Related to an earlier question on standards maturity, what is the balance that will need to be struck between tough enforcement and requirements for using immature standards?

Our job, as a country of stakeholders, is to strike the right balance between regulation and market forces.  Regulation is sometimes necessary when market failures occur.  Over regulation can impede market forces.    The Standards Committee and many commenters will help ONC achieve the right balance.    ONC has significantly reduced the scope of final rules in the past based on comments.   There is hope!


Will Ross said...

[1] - It is ok for ONC to include a few transaction types that are not part of MU, but it is unhelpful for ONC to lose focus and to be distracted by many non-MU activities. The NPRM appears to squander the value of certification as a policy lever by pursuit of many inessential tasks.
[2] - "I long for the day when a Certification rule adopts no standard that is still in its infancy." -- motorcycleguy blog on 27 march.
[3] - If the certification process is abused by ONC, then EHR vendors or EPs/EHs may adopt new business models that shun certification.
[4] - Health information won't be shared until there is a business reason to share it. Certification of software does not address the health care business disincentive to share patient data.
[5] - proscribing tools for interoperability in the absence of a business incentive to share patient data is not likely to succeed

David Smith said...

Well stated. ONC and Meaningful Use should also consider specialists, which appears to have happened on some level with the new recommendations for Stage 3 in pulling back on population-based health concepts. Most procedureal-based specialists don't do preventive care.

Meaningful Use should address concepts that all healthcare practitioners should use, consequently, simplifying it and making it simpler for all to perform while encouraging interoperability.

CCD/CCDA is still not used widely. It is still largely unknown. Could CMS pay for coordinated care (where a new patient visits starts with an electronic record)? The new TCM codes pay for patients seen within 7 - 14 days from Medicare. Why not add a requirement that the visit is electronically started per Stage 3 Requirements?

I bet that would create more interest. Is there a business model for it? would it save money? Would it cut errors, save lives?

meltoots said...

1. Really ONC needs to get away from spilling out of Meaningful Use. Like EPs, no one wants to be in that playpen anymore. I feel that ONC is also trying to get away from MU. But that is really what ONC is all about. ONC has a real ADHD problem.

2.ONC needs to realize that immature or non-standard standards or infant standards are a breeding ground for discontent and disorientation and disgruntled vendors and EPs.

3. I think the SGR fix basically kills MU. (Thank Goodness). No more penalties after 2017. There is no business model that will keep EPs in the MU game. Sure MU is a part of some nebulous MIPS program, but the costs of certification will be WAY to high to keep EPs in the program. Vendors will have to pass the certification costs downstream, and if you can find one EP that feels that MU is actually meaningful, I'll give you a hug. What ONC really needs to realize is that EPs want /desire/plead is for vendors to actually program EHR for patient care, not MU not billing.
4. Current certification completely interferes with interoperability. EPs and vendors heads are spinning with the counting attesting auditing of every little measure and denominator or whatever. Interop is a pipe dream at this point.
There is really no way to force any more IT or interop or MU on EPs anymore. Penalties, as you see, do not work.
Culture change is hard to mandate. Incentives only work when they are attainable, which they are not now.
I would argue that ONC should drop ALL certification. Focus on trying to include EVERY one in the interop game, even if the office only can fax documents to the HIE or exchange. Start VERY basic, very easy. You can do APIs and HL7 and FHIR and whatever but you will lose at least 50% of the EPs with that. Make it easy, make it simple, make it worth the effort.

5. Be very weary of tough enforcement. Tough enforcement means that if I ask our EHR vendor for a custom workflow, then they will say "NO WAY" as it will jeopardize their certification with ONC. See in the current form, ONC has let MU and certification kill innovation. ONC is doing the typical government thing of making the hurdles SO high for innovative new players, that we will be only left with a Boeing and McDonnell Douglas (Epic and Cerner). And Epic and Cerner will make sure that no one can enter the market by making the usual "after ONC" we will hire you vibes.

Its actually time for ONC and CMS to let the market take over now. The artificial EHR market driven by CMS and ONC and HITECH has pushed many into EHR, but its time to let go. You will see no improvement in patient care, usability, safety security with the constant prescriptive hamstringing of the MU program. Let vendors off the leash to innovate and actually talk to EPs about how to make their IT systems better without jeopardizing certification, MU etc. Look at the Stage 2 numbers, they are terrible. And its only going to get worse. With SGR killing MU penalties, many EPs will jump ship asap.

Could you imagine a world where an EHR vendor actually came in to see you and say "how can we make your day better, easier, more efficient?" How refreshing. Instead of "Hey, we are Stage 3 certified, is that great?"