At the risk of being very “inside the beltway,” the following comments are directed at the numerous national associations, advocacy groups, and other interested organizations who are gearing up to submit comments on the two meaningful use Stage 2 notices of proposed rulemaking (NPRMs) recently published in the Federal Register by the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC).

Meaningful use is now known by many, but the NPRM comment process is still a somewhat arcane part of government for most. And while NPRM commenting can seem almost like a sport “inside the beltway,” increasing numbers of healthcare providers are realizing that these particular regulations will have a very practical impact on their everyday practices in an increasingly electronic healthcare world.

Making the technology, not just the providers, do more
There are a lot of details to digest in the hundreds of pages of these two regulations. Many of the details are dedicated to encouraging providers to use their EHRs to accomplish “meaningful” activities such as CPOE, quality reporting and health information exchange. The hope is that doing so will overcome some of the industry’s misaligned incentives and convert on the vision for health IT. Like birds evolving capabilities for flight, however, things in the middle may be ugly.

At risk is that during these intermediate stages, the burden of the meaningful use demands will not be balanced by actual capabilities of the technology to help achieve the outcomes. Nowhere is this clearer than in the area of quality measures. In most settings, technology is not really helping with the management of quality yet and we are far from automating the reporting process. The measures, however, and their huge demand for comparable data, keep on coming.

In this context, the comments herein focus on those parts of the NPRMs that can actually help make the technology reduce provider burden and make the EHRs do more for the providers instead of just asking the providers to do more with their EHRs.

A one way street
Unfortunately, the regulation and comment process is not well suited for advancing technology with the kind of specificity that it frequently requires. CMS believes that the potential commenters for Stage 2 are better informed about the process than they were for Stage I, but it is still important to note that comments on an NPRM almost never lead to anything substantial being added to the final regulation. There would be no review of the new content.  So while details may be clarified and additional descriptive text may be added, for the substance of the rules, comments can really only lead to requirements coming out and/or weakening the actual regulation.

Weakening may be useful when trying to reduce the number and burden of ever increasing numbers of measures. Weakening is not helpful, though, when advancing the technical standards and specificity that are needed to facilitate EHR interoperability, information exchange or help ease provider EHR use.

Getting specific
Stage 2 of meaningful use has an increasing number of process measures that try to encourage health information exchange between and, by implication, inside of organizations. But asking for information exchange or interoperable systems without highly detailed, implementation guide “cookbooks” for each transaction means that the costs and burden rests with each healthcare provider. As far back as 2005 when HITSP started its work in the first national health IT agenda, there was a consensus assumption that standards-based, implementation-level guidance for health-related transactions was a principal need and goal. Stage I meaningful use had almost no implementation level guidance because, according to the Health IT Standards Committee, no guidance was ready. It is not clear there is more, well-tested implementation guidance available now for Stage 2, but fortunately there is still incrementally more in the regulation.

Comments that push back on implementation level guidance, while there are still process measures that demand the transactions occur, put healthcare providers on the hook for costs and effort for making ad hoc transactions happen. When adequate specificity of implementation guidance is present, much of the burden is shifted to the software developers. Instead of provider-funded, ad hoc transactions in each clinical setting, we get closer to having transactions that that can be built once by each vendor and used in many different implementations. Clearly the advice here is don’t “comment out” the implementation guide specificity of these regulations even if the implementation guides are not as well tested as one would ideally like.

Consuming what you produce
Stage 2 should also be lauded for beginning to include measures that require EHRs to process information that is shared with them. Stage I frequently concentrated on the lower bar of producing data, or even just testing that one could produce data. Data that are produced without actual requirements for being consumed and processed tend to end up, at best, as document images that are not much better than the paper the EHR seeks to replace.

Image files, like paper, also put burden on the provider as the one who must integrate information from disparate documents and cannot natively use the data for processing or reporting. In the Stage 2 NPRM for both lab results and the Consolidated CDA, there are initial expectations for actual consumption. While this sets a much higher bar for compliance, “commenting out” this progress will not benefit provider burden either.

Increasing quality by moving it out
Hopefully the coordination of meaningful use quality measures with other quality initiatives will mean that some of the overall push back on the meaningful use NPRMs will be pointed elsewhere. If not, let’s hope that the bulk of commenters will recognize that not all push back is created equal. Sometimes pushback and weakening of regulations can create more burden not less.

John Loonsk, MD, is a CGI Initiative for Collaborative Government Fellow, with experience in health information technology spanning government, commercial and academic environments. Before joining CGI, he held the position of Director of Interoperability and Standards in the Office of the National Coordinator for Health Information Technology.