Thoughts on the MeaningfulUse Stage 2 Incentives Rule

I've spent enough time with the Standards rule this week, now I need to go over the incentives rule.  I have to say that this rule was a much easier read this time around.

The first thing of interest in the incentives rule is how CMS expects Meaningful Use to play out over time.  The definition of a meaningful user has been adjusted to include meeting the staged requirements during either a payment year, or an adjustment (penalty) year for a provider (42 CFR 495.4 (3) [see also page 23]). I've reproduced Table 2 (see page 28) showing the timeline.

TABLE 2: STAGE OF MEANINGFUL USE CRITERIA BY FIRST PAYMENT YEAR

First Payment Year	Stage of Meaningful Use
	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021
2011	1	1	1	2	2	3	3	TBD	TBD	TBD	TBD
2012		1	1	2	2	3	3	TBD	TBD	TBD	TBD
2013			1	1	2	2	3	3	TBD	TBD	TBD
2014				1	1	2	2	3	3	TBD	TBD
2015					1	1	2	2	3	3	TBD
2016						1	1	2	2	3	3
2017							1	1	2	2	3

The cells marked TBD represent a possible extension of Meaningful Use into Stage 4 or even beyond.  Note also the cell in yellow, showing that providers that started with Meaningful Use in Stage 1 last year get three years at that stage before they have to advance to stage 2, and that all other providers starting this year or later spend two years in each stage.

Note also that in 2014, providers will be required to use an EHR certified against the 2014 Certification Criteria, even if they are only attempting to meet stage 1 requirements.  Presumably they will be required to us an EHR certified against 2016 Certification Criteria in 2016, again, regardless of the stage they are at.

The stage 1 set of Menu objectives moves to Core in Stage 2 with a couple of exceptions (syndromic surveillance and recording of the existence advance directives).  I understand why Syndromic surveillance was challenging, as it got off to a rough start with respect to standards in Stage 1.  There are new "menu objectives" in stage 2 for EPs and Hospitals also.  CMS expects to follow this pattern in stage 3 also (see page 38).

EPs have 17 core objectives, and 5 menu objectives.  Hospitals have 16 core objectives and 4 menu objectives.  You can see the list of objectives mapped to the certification criteria in this table.

I have a few thoughts on some of the major areas around the objectives which I'll express below.  These are just my gut reactions after an initial read, and are my own opinions, not those of my employer, or any other organization I represent.

Clinical Decision Support

Among the objectives are the implementation of clinical decision support interventions impacting at least 5 of the quality measures for a provider.  For EPs, I don't see this linkage being difficult for most providers, although it could be challenging for some specialties.  However, for hospitals, I do see challenges, especially for Children's hospitals, or those focused on other kinds of treatment (e.g., burn centers, cancer, etc.).  The quality measures listed for Hospitals may not address what that organization sees as being the most relevant.  

Also, while the prefatory text is pretty clear on the linkage from interventions to quality measures, the regulatory text is not.  I'd like to see that be clarified.  Also a bit confusing is the wording on 5 CDS Interventions addressing 5 or more CQMs.  Is that 5 interventions each addressing 5 or more CQMs, or is that 5 interventions addressing a total of 5 or more CQMs.  I know what they mean (the latter), but they should say it.  The number of "interventions" isn't really important, and defining how to count interventions isn't really what is important, rather, it is the number of measures affected.  I'd suggest rewording that section a bit differently to address these issues.  Something like this:

Implement clinical decision support interventions which are related to five or more clinical quality measures which the EP, Hospital, or CAH believes will be effective in improving the quality, safety, or efficiency of patient care, at a relevant point in patient care for the entire EHR reporting period; and ...

View, Download and Transmit

This is a subtle but important change from Stage 1.  In stage 1, providers were obligated to give patients a copy of health information and discharge instructions.  In stage 2, providers need to make this information available to patients electronically, and will be measured upon it based upon whether A) they make it available with 24 hours for more than half of all patients, and B) more than 1 in ten patients actually do something (View, download or transmit) with the information that is available electronically.

Although the rule does include exceptions for providers in areas with low broadband penetration, I still think providers will push back on that one.  There are providers that work in specialties where this could be challenging.  While the first half isn't hard (making the informamation available electronically), the second requires engaging enough patients to meet the goal.  That could be challenging, even with an engaged patient.  For example, I probably won't bother to check with the GI specialist that I see once every 3-4 years to download my data from him.  After all, my GP will have that data in his EHR (he does today), and I can get it from him.  So my poor GI guy won't get me into his portal, it's just not worth my effort, but my GP will. I expect to see a push for a meaningful numerical count on this one, say 100 patients, rather than a specific percentage.  What we've seen in Stage 1 is that for many of the objectives, providers don't take half measures, e.g., giving patients their summaries -- they go for broke.  I expect the same would be true for patient engagement through an electronic portal if the measure population is large enough, without making it impossible for some providers to reach due to lack of ability to engage their patients.  After all, it's hard to engage with a patient who you see for all of 10 minutes while they are conscious, and get them to look up stuff online afterwards.

Smart providers will provide a way to engage patients they see to use the portal for the first time IN the office.  Showing them how to get their information in the office would count towards "View, download and transmit."

Labs

I'm thrilled with the work that the LRI workgroup has done getting consensus around Lab reporting standards, and fully support having EHR's being capable of using that standard, and objectives around receiving and incorporating structured data into the patient record.  

Where the rule could (but didn't) go a bit too far is in confusing an EHR with a laboratory information system expecting the hospital EHR to send labs out to the ordering physician (see page 153).  Many hospital labs serve the physician community around them, but the lab itself is not necessarily integrated directly with, or as part of the hospital EHR.  Making the hospital EHR be capable of performing what is essentially the function of the Lab Information System and measuring hospitals on their performance wouldn't be fair.  I'm glad CMS got that one right, even if ONC didn't (see 170.314(b)(6), which includes transmission of lab results as a requirement for hospital EHR systems in the standards rule).

Backwards Compatibility

One last challenge with the two rules is how to ensure that all the summary data presently available in CCD or CCR format as a result of the Stage 1 MU criteria, and 2011 certification criteria remains  accessible for Stage 2 providers using EHR systems certified under the 2014 criteria.  The most rational change I can think of is to modify 170.314(b)(1-2) so that the EHR must support display of Patient Summaries conforming to the standards at 170.205(a)(1) [CCD] and 170.205(a)(2) [CCR].  After all, display isn't a big lift, the certified EHR's MUST already support it, and it would be reasonable to keep it in.  It doesn't mean they have to "incorporate" data in these formats into the EHR (although some already do that), it just means that those documents already available to providers should remain accessible.

I think View, Download and Transmit might also need to be altered to allow any prior data accessible using those standards to apply to the numerator.  That way, if I view my old CCD, it still counts towards the provider's support for patient engagement.