As healthcare IT leaders pore over the details in the Notice of Proposed Rulemaking (NPRM), more informally known as the proposed rule, for Stage 2 of meaningful use, under the American Recovery and Reinvestment Act/Health Information Technology for Economic and Clinical Health (ARRA-HITECH) Act, analysts are finding different elements in the proposed rule to be of particular interest.
Most industry experts analyzing the proposed rule, as well as many of the CIOs and other healthcare IT leaders looking at the rule, have expressed broadly positive comments about it, even as they have cautioned their colleagues about some of its challenges and complexities. One of those industry experts who has come away broadly positive after a detailed analysis of the rule is Mark Segal, Ph.D., vice president, government and industry affairs, for GE Healthcare IT. The Oak Park, Ill.-based Segal spoke recently with HCI Editor-in-Chief Mark Hagland regarding his analysis of the rule. Below are excerpts from that interview.
What strikes you as most significant about the proposed rule?
At the highest level, there is a general level of continuity from the prior rule, and, in looking from Stage 1 to Stage 2, and from structured data through advanced care processes. Also, at the very highest level, there’s a sense that both CMS and ONC [the federal Centers for Medicare and Medicaid Services, and the Office of the National Coordinator for Health IT, respectively] listened [to providers’ concerns] and observed pretty carefully what’s going on, to how Stage 1 is progressing, and to what’s needed. Drilling down one level, the fact that they formalized the additional year to Stage 1 was very significant. [Health and Human Services] Secretary [Kathleen] Sebelius had indicated that they might do this, late last year, and the policy committee had recommended it. But the fact of it just drives home that, given the complexity involved, it would literally have been impossible to stick to the initial timetable.
Mark Segal, Ph.D.
In addition, there’s an increased emphasis on interoperability and health information exchange [HIE]. For example, they eliminated the single test for HIE in favor of requiring actual exchange. I think CMS really nailed this, because people had been very unclear about what they had to test; and because there hadn’t been any actual transport standards in Stage 1. So it had basically been about generating a CCD [continuity of care document] or CCR [continuity of care record], and then sending it; so it didn’t test for very much. Now, they’ve really shifted to actually having to do an exchange for 10 percent of the times when you actually have a referral or transition of care. And I think that that really is a very important move forward, because that really helps create the actual business case, not only for doing exchange, but for doing exchange in a way that integrates with your workflow.
There are things in here that really reinforce exchange: a move towards a single summary standard from the two that were in Stage 1. In Stage 1, they had the CCD or CCR; in Stage 2, you have something they’re calling a Consolidated CDA (clinical document architecture); and a CCD is a version of a CDA. The EHR, when it receives a clinical summary from another provider, needs to basically integrate the data from that summary into the EHR and structured data, whereas in Stage 1, you only needed to display it. And also, there are actual transports standards as to how you move the information from point A to point B; and that had been a very noticeable gap in Stage 1. So all those things taken together really make the prospect for health exchange really bright.
There are a couple of other areas to point out as well. In Stage 2, there is now an increased focus on patient access to their data, including the ability to view the data and actually transmit to somewhere else; as well as secure messaging between patients and their providers. Another step forward is the alignment of quality measures across different federal programs, so on the physician side, it’s aligning the measures with the PQRS system [the federal Physician Quality Reporting System under Medicare]; and it’s aligning the measures themselves, as well as aligning the reporting processes.
And finally, they’ve explicitly mentioned the role of access to images, both as images themselves, as well as imaging reports. Images and imaging reports are obviously a very important part of this. Stage 1 for the most part really didn’t address images or access to images. In Stage 2, they’re proposing that there be access to images either as embedded in the EHR itself, or as will more likely be the case, through links to PACS [picture archiving and communications systems] and other systems. And they actually reference the DICOM standard when patients get access to their own information. That’s really an important first step. They also asked for comment on creating an additional meaningful use item that would involve the exchange of images among providers.
So they’ll fashion that requirement based on comments on the proposed rule, and put it into the final rule, then?
That’s right. And a few other things: there’s more flexibility in the approach to certification. So in Stage 1—and this is something that sort of evolved through various FAQs—a provider has to ‘possess certified technology’ covering applicable areas; but in many cases, that meant you had to possess technology for items you were deferring. So ONC created a very nice framework and said, there’s a base EHR, and everyone has to have that capability, whether or not they’ve claimed exclusion for some of those items; but beyond that, you only have to have certification for items you have, and you only have to have those items if you are using those elements for meaningful use; so it provides an element of flexibility.
They also added more flexibility for specialists, in a few areas. So they continued with the general approach of having some menu items, which gives some flexibility relative to what your particular practice is. There’s an exclusion for vital signs, where there are three elements of vital signs (height, weight, and blood pressure)—and for a physician to claim an exemption, you’d have to attest that none of those were relevant in your practice—but they’ve made each element separate. And this is looking ahead to what they’re calling payment adjustments (penalties)—they’ve proposed several categories of exemptions, such as not having broadband, or being a new doctor, or if a tornado hits your town; but they’ve also asked for specialty-based exemptions. For example, the meaningful use framework really doesn’t fit with how pathologists actually work. So it wouldn’t make it easier to get the payments, but it would prevent you from incurring the penalties.
Were you surprised at all, or was it essentially what you had expected?
In the main, it was what I had expected. I was surprised that they had added imaging in Stage 2, not because it didn’t make sense, but because the HIT Policy Committee had been having discussions more about including imaging in Stage 3. Other than that, nothing really surprised me; they proceeded in a fairly logical way.
Others have said they think the Stage 2 proposed rule is reasonable, equitable, and fair. Would you agree?
Yes. Now, we have to look carefully; some of the thresholds may be too high as you look at new people coming in; but in the main, it was a positive reaction to the rule.
What would your advice to CIOs, CMIOs and other IT and clinical informaticist leaders be at this point?
They should certainly be reviewing the rule carefully, and engaging as an active participant or listener in various discussions about the rule. Number one, because it’s really important that the actual final rule reflect the experiences of those in the provider community. And second, they should really be assessing what will almost certainly survive, even if certain specifics change. So in addition to the CMS meaningful use rule, it’s important, particularly for a CIO, to look at the ONC rule, which looks at standards and certification, so that they can anticipate the kinds of technology changes and upgrades that may be coming, as well as the implications of particularly vocabulary proposals, like the sole use of SNOMED for problem lists.
And there are a couple of areas here around patient engagement: providers will be responsible for whether patients use the view-and-download capability; for whether patients actually use secure messaging. So, anticipating patient engagement and the specifics around it, will very much be a part of Stage 2. I think it would definitely make sense for hospitals, medical groups, and other providers, to take steps now in terms of patient engagement, with regard to patient portals and secure messaging, so that they’re well-positioned to hit those ten-percent thresholds; and that’s more of a business process/change management issue than it is a technology issue.
Overall, we are looking very carefully at both the CMS and ONC rules, to determine what comments to make, and to identify those steps that we need to be taking in the next few months, in advance of the final rule, to be well-prepared.