Health Law

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.

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.

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):  

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:

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