New MeaningfulUse Rule will likely impact Stage 1 Criteria

Most Health IT folks today are concerned about Meaningful Use for Stage 2, but they should also be concerned about stage 1 as well.  Under new Federal Regulation for meaningful use, it is certainly possible that the definition of stage 1 meaningful use can change.  As the Meaningful Use Standards final rule stated:

The stages of criteria of meaningful use and how they are demonstrated are described further in this final rule and will be updated in subsequent rulemaking to reflect advances in HIT products and infrastructure. We note that such future rulemaking might also include updates to the Stage 1 criteria.

The real question for many is what that will mean for vendors implementing products, and providers attesting to meaningful use at a particular stage.  For vendors, it is very clear that EHR products will need to be certified against the new criteria as soon as possible, because again, according to both the final rule for temporary certification and for permanent certification:

Regardless of the year and meaningful use stage at which an eligible professional or eligible hospital enters the Medicare or Medicaid EHR Incentive Program, the Certified EHR Technology that they would need to use would have to include the capabilities necessary to meet the most current certification criteria adopted by the Secretary at 45 CFR 170 subpart C. 

When Stage 2 becomes effective (anticipated for 2014), providers will need to upgrade to EHR technology that is certified to that criteria, regardless of whether they are attesting to Stage 1 or Stage 2 of Meaningful Use criteria.  The new incentives rule will contain criteria defined for those organizations who are a “Stage 1” Meaningful User and for those who are a “Stage 2” Meaningful User.  Stage 2 users will have more criteria to attest to, and for those capabilities already existing in stage 1, a higher degree of use of those capabilities (e.g., A higher percentage of orders performed electronically at stage 2 than stage 1).  Regardless of whether they are at Stage 1 or Stage 2, both kinds of organizations will have to use EHR technology that has been certified to support the Stage 2 criteria.  

The table below shows the current Stage 1 standards and the stage 2 standards that I’m currently projecting for the new Meaningful Use Standards rule.

	Stage 1		Stage 2
	January 2011 – December 2013		January 2014 – ?
Purpose	Standard	Implementation Guide	Standard	Implementation Guide
Generating a Clinical Summary	CCD 1.0	HITSP C32 V2.5	CDA R2.0	CCD 1.1 (Stage 1)
	CCR			CDA Consolidation Guide (Stage 2)
Viewing a Clinical Summary	Both CCR and HITSP C32 V2.5		CDA Consolidation Guide, CCR and HITSP C32 V2.5
Immunizations	HL7 V2.3.1	CDC 2.3.1 Guide
	HL7 V2.5.1	CDC 2.5.1 Guide	HL7 2.5.1	CDC 2.5.1 Guide
Public Health Lab Reporting	HL7 V2.5.1	ELR Guide		ELR Guide and/or updated LRI Guide
Disease Surveillance	HL7 V2.3.1	No Guide Selected
	HL7 V2.5.1		HL7 V2.5.1	PHIN Guide

The new certification criteria for Stage 1 and Stage 2 will almost assuredly require use of new standards, and some standards previously acceptable will be dropped.  The biggest challenge for many will be the change from CCR/HITSP C32 V2.5 to CDA® and the CDA Consolidation Guide, and that is what this post will focus upon.    The key question is how systems conforming to the new standards will address the issue of the legacy data stored using either CCR or the HITSP C32 2.5.  

Fortunately, ONC cleverly created two separate criteria for the clinical summary.  The first was generating (and subsequently transmitting) an electronic summary.  ONC allowed two formats for that capability: CCR or the HITSP C32 2.5, of which a provider need choose only one (but could support both).  However, all systems must support viewing both (and need not do any more than that).

In order to support viewing of legacy documents, I fully expect that the new certification criteria will require certified systems to support viewing of legacy content.  I also expect it to support viewing of any document found in the CDA Consolidation guide.  With the exception of the Unstructured Document, viewing is not a challenge.  IHE implementers have learned over the years to sign up for the “Content Consumer” actor for all PCC Profiles of the HL7 CDA if they can support content consumer for ANY document because you get it nearly for free.  Most implementations transform CDA to HTML or XHTML and display the results.  A good stylesheet handles all content equally well.  Thus, it is reasonable to ask these systems to support viewing of any CDA based content under the new certification criteria.  If you can view one kind of CDA document using an XSL stylesheet, you should be able to view many.  There are numerous sources of code for CDA stylesheets freely available. 

The Unstructured Document in the CDA Consolidation guide needs more work for viewing but there are plenty of viewing technologies available to support its requirements as well.  There's another whole post that I will devote to that topic.

On the creation side, I expect that systems must be able to create content using the CDA Consolidation Guide.  A stage 1 meaningful user might only be required to generated CCD 1.1 documents, but a Stage 2 user might be required to support not just CCD 1.1 but could be permitted or even required to generate other document types in the CDA Consolidation Guide (e.g., discharge summary).

Where backwards compatibility becomes a problem for organizations that are exceeding the meaningful use requirements, such as the Beacon programs.  Those organizations have been working with CCD 1.0 and will now need to support CCD 1.1.  That is one of the penalties of getting out in front.  The key for those programs will be adapting their technology that uses the HITSP C32 V2.5 to use CCD 1.1.  It may be a PITA, but this is really not a hard challenge. 

Given the origins of CCD 1.1, it should certainly be feasible to transform from CCD 1.0 to CCD 1.1 automatically.  While there are some incompatibilities between the two versions, a valid HITSP C32 Version 2.5 will almost certainly transform into a valid CCD 1.1 for the purpose of importing, reconciliation, et cetera.  The transition to CCD 1.1 even prior to its adoption as a certification requirement could be done within the context of the single system that makes use of it, enabling innovators to take advantage of it before it becomes a requirement.

Shortly HL7 will be releasing the latest CDA Consolidation template database, and the Model Driven Health Tools project will be releasing a version which includes the CDA Consolidation rules.  Those two model driven tools will provide engineers (including me) with a lot more information than we’ve ever had previously to make the transition to the new format easier.

-- Keith