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January 03, 2010

Meaningful Use of Certified EHRs: Proposed rules come out just under the wire

Meaningful use of certified EHRs -- the long-awaited definitions were released by HHS and ONC, within HHS, before year-end, as required by law.  ("Put on display," technically.)  Filed at 4:15 pm on December 30, followed by a 5:15 pm conference call, the release was almost a parody of transparency.  Nevertheless, the rules are out, and some spent the days around New Year's reading the 500+ typewritten pages of meaningful use criteria and 100+ typewritten pages of certification standards.  (Others have called it "drivel.")  The rules will be formally published in mid-January, and at that time the 60-day comment period will begin.  David Blumenthal, National Coordinator for HIT, said on the conference call that final rules are expected in the Spring.  So, the two sets of regulations released last week are linked to from an HHS press release on meaningful use of certified EHRs; the agency sites linked to in the press release also link to FAQs, fact sheets and other resources.  (When the regulations are published in the Federal Register, there should be direct links on the agency sites linked to in the press release.)  The standards apply to three parallel incentive payment programs: Medicare, Medicaid and Medicare Advantage.

One rule is issued as a proposed rule: the HHS definition of meaningful use. 
The proposed rule would specify the -- initial criteria an EP ["Eligible Professional"] and eligible hospital must meet in order to qualify for the incentive payment; calculation of the incentive payment amounts; payment adjustments under Medicare for covered professional services and inpatient hospital services provided by EPs and eligible hospitals failing to meaningfully use certified EHR technology; and other program participation requirements.
The other is issued as an interim final rule: the ONC's certification standards and certification process:
This interim final rule represents the first step in an incremental approach to adopting standards, implementation specifications, and certification criteria to enhance the interoperability, functionality, utility, and security of health information technology and to support its meaningful use.
There are two sorts of comments engendered by the release of regulations such as these, and both sorts of comments have already started appearing in the twittersphere, blogosphere, elsewhere on the web and in the MSM. 

The first category is the sort of commentary called for in the notices:  Are the rules clear? Are the various time periods established appropriate? Are there other ways in which the ends required by the statutory scheme may be achieved more effectively? 

The second category is a broader sort of reaction, which really calls into question some of the assumptions underlying the enabling legislation, and which is therefore not really answerable by an agency whose range of discretion is limited by legislation: How do we know that the meaningful use of certified EHRs (however those terms are defined) will result in improved health status and reduced health expenditures?  Why don't we have a U.S. Patient-in-Chief?

Some comments fall somewhere in the middle; for example: Why isn't the meaningful use schema more patient-centered?  After seeing a few patient advocate comments on twitter last week from fellow tweets, I fed the proposed meaningful use regulation into Wordle, which returned the following image (size of word is directly related to frequency in the source document; click on thumbnail for full-size image):  

Wordle: CMS EHR meaningful use regulation 123009

My take on the results: The regs do what the statute requires: they deal with incentive payments for EHR use.

Browsing the documents bring to mind a few more observations and questions for me:

These rules are the beginning, rather than the end, of the rulemaking process -- and I am not simply referring to the 60-day comment period.  Last week's issuances, as long as they are, are far from comprehensive, and they contemplate significant additional rulemaking to flesh out the concepts of meaningful use and certification.  The national health information network, which we've been hearing about for quite some time now, doesn't really exist yet, so the initial rules require a number of workarounds, and future rulemaking will need to define additional standards and processes.

For example, the meaningful use regulation sets out only "Stage 1" Criteria for meaningful use.  These are drawn from the three sets of criteria contained in the working group's recommendations which formed the basis for this proposed rule.  From the regulated community's perspective, it would be preferable to know all three sets of criteria in advance of beginning an enormous investment of money and other resources, designed to entitle providers (and certain health plans) to significant dollars reimbursing some of those costs in the near future, and to exempt them from being subject to reduced payment schedules in the more distant future. 

In fairness, this criticism is perhaps more appropriately directed to the architects of the HITECH Act, who established an incredibly aggressive timeline for this portion of the stimulus package, and who therefore may be running the risk of speeding investment and spending in technology platforms and system design that ultimately prove to be less than meaningful in the broad effort to improve population health status and reduce health care costs through the deployment of HIT.

As I dig in and read more, I may have further comments on these rules. 

Update 1/3/10: For further reading, see John Halamka's posts on The Interim Final Rule on Standards and Achieving Meaningful Use.

Meanwhile, dear reader: Have you read the rules yet?  What's your initial take?  Please share your thoughts.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting


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It's very difficult to design a study that can prove something so broad as the hypothesis that EHRs have a positive impact on health care. That's because there are too many other factors, some of them unknown, that can influence the results of such studies, and for which there is no control.

Of course, doctors make decisions in the face of uncertainty like this every day in practice...most of their decisions cannot be supported by "the evidence" since the studies providing "the evidence" rarely apply at the bedside.

So just like doctors, we have to go with our gut instinct: yes indeed, wiring health care so that it comes up to speed with every other major market sector on the planet is a good thing to do.

On another matter, Blumenthal and Co. did a masterful job in crafting their Interim Final Regulation, because, by introducing the concept of "EHR Modules," they have shown a way forward for the innovators in the space and in so doing, hastened the development of EHR technology in general.

I do agree that the whole process is rushed, and that the fault there lies with the original legislation's timeframes, not with ONC or HHS generally. But I think these boys deserve some credit for setting us on a very good path, on something that is very obviously the right thing to do.

Glenn Laffel, MD, PhD
Sr. VP Clinical Affairs
Practice Fusion
Free, Web-based EHR

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