Following up on my blog post in March on the proposed rules for Meaningful Use Stage 2, the final rules can now be analyzed for their impact on integration and interfacing. This blog will discuss changes from Meaningful Use Stage 1 to Stage 2, as well as changes from the proposed rules released earlier this year.

The final rule for Meaningful Use Stage 2 certification criteria define the standards used for data exchange and the required utilization of interoperability by providers. Areas most impacted by the final rule certification criteria include:

  • Patient Summary
  • Clinical Messages
  • Electronic Prescribing
  • Transport Specifications

Patient Summary

  • Meaningful Use Stage 1: HL7HL7 is a Standards Developing Organization accredited by the American National Standards Institute (ANSI) to author consensus-based standards representing a board view from healthcare system stakeholders. HL7 has compiled a collection of message form... More CCDContinuity of Care Document (CCD) The HL7 CCD is the result of a collaborative effort between the Health Level Seven and American Society for Testing Materials (ASTM) to “harmonize” the data format between ASTM’s Continuity of Care Record (CCR)... More (C32), or CCRContinuity of Care Record (CCR) is an XML-based standard for the movement of “documents” between clinical applications. Furthermore, it responds to the need to organize and make transportable a set of basic information about a patient’s health ... More
  • Meaningful Use Stage 2: HL7 Consolidated CDA (for create, transmit and display), HL7 CCD (C32) or CCR (for display only)

In somewhat of a surprise, the final rule included both standards from Meaningful Use Stage 1, as well as the new Consolidated CDAClinical Document Architecture (CDA) HL7 CDA uses XML for encoding of the documents and breaks down the document in generic, unnamed, and non-templated sections. Documents can include discharge summaries, progress notes, history and physical reports,... More standard mentioned in the proposed rules. It was stated in the final rule a desire to maintain backwards compatibility based on public comment for display purposes only. This makes the transition from Stage 1 to Stage 2 easier and more interoperable, as Stage 2 requires EHRs to display Stage 1 documents.

Consolidated CDA makes it much easier for implementers and providers alike to analyze and understand the standard. For more information on Consolidated CDA, please see 6 things to know about Consolidated CDA in Healthcare IT News.

The hurdle for providers to demonstrate the electronic transfer of patient summaries has also increased. Stage 2 requires that a provider electronically transmit a summary of care for more than 10% of transitions of care and referrals. Further, at least one summary of care document must be sent to a recipient with a different EHRElectronic Health Record (EHR), as defined in Defining Key Health Information Technology Terms (The National Alliance for Health Information Technology, April 28, 2008): An electronic record of health-related information on an individual that conform... More vendor or to a CMS test EHR.

Clinical Messages

  • Meaningful Use Stage 1: HL7 2.3.1 and 2.5.1 
  • Meaningful Use Stage 2: HL7 2.5.1 only

Many criteria which allowed for either HL7 v2.3.1 or HL7 v2.5.1 messaging in Stage 1 will now only allow HL7 v2.5.1 messaging. The criteria impacted include:

  • Clinical quality measure data import, export, and electronic submission
  • Transmission to public health agencies (surveillance)
  • Transmission to immunization registries
  • Transmission of reportable laboratory tests and values/results

In addition, a new standard will be utilized for Stage 2.

  • CDA, Implementation Guide for Ambulatory Healthcare Provider Reporting to Central Cancer: Utilized for the transmission of cancer information.

One standard included in the proposed rules, but not included in the final rules: 

  • DICOMDigital Imaging and Communications in Medicine (DICOM) is a common format for image storage. It allows for handling, storing, printing, and transmitting information in medical imaging. Visit DICOM website. Synonyms: Digital Imaging and Communicati... More PS3 – 2011: A standard for image transfer that was called out in the proposed Meaningful Use Stage 2 criteria. The ONCOffice of the National Coordinator for Health Information Technology (ONC) – Located within the Office of the Secretary for the U.S. Department of Health and Human Services (HHS), the Office of the National Coordinator (ONC) coordinates nationwide ... More stated that “the adoption of this or other standards was not necessary to enable users to electronically access images and their narrative interpretations.”

Electronic Prescribing

  • Meaningful Use Stage 1: NCPDPThe National Council for Prescription Drug Programs (NCPDP) creates and promotes the transfer of data related to medications, supplies, and services within the healthcare system through the development of standards and industry guidance. Visit the NC... More 8.1 and 10.6
  • Meaningful Use Stage 2: NCPDP 10.6 only

For electronic prescribing, only NCPDP 10.6 will be allowed for Meaningful Use Stage 2.

Transport Specifications

  • Applicability Statement for Secure Health Transport (primary Direct ProjectThe Direct Project was launched by the ONC within Health and Human Services (HHS) on March 1, 2010. It was initially called NHIN Direct. The object of the Direct Project is to replace the use of faxes, phones, and paper transactions with a simple and... More spec)
  • XDRCross-enterprise Document Reliable Interchange (XDR) – What it’s used for: The exchange of health documents between health enterprises using a web-based, point-to-point push network communication, permitting direct interchange between EHRs, PHRs ... More and XDMCross-enterprise Document Media Interchange (XDM) – What itss used for: According to IHE, XDM transfers documents and metadata using CDs, USB memory or email attachments. This profile supports environments with minimal capabilities in terms of usin... More for Direct Messaging
  • SOAP-Based Secure Transport Requirements Traceability Matrix (RTM)

As expected, the Direct Project will be the required transport for summary of care documents. Specifically, the Applicability Statement for Secure Health Transport, which is referred to as the primary Direct Project specification will be the required transport. For more information on this specification, please visit the Direct Project website.

There are optional transport standards as well. There are two choices for the use of optional standards:

  • Option 1: Certification can be performed for both the Applicability Statement for Secure Health Transport specification and the specification utilizing the XDR and XDM profiles for Direct Messaging.
  • Option 2: Certify for both Simple Object Access Protocol (SOAPSOAP (Simple Object Access Protocol) is a web services protocol used heavily in healthcare to implement IHE profiles. SOAP is an enterprise standard that is typically used by business applications to exchange information across the enterprise. See... More)-Based Secure Transport Requirements Traceability Matrix (RTM) version 1.0 standard and the XDR and XDM for Direct Messaging.

For the optional standards, the SOAP-Based Secure Transport Requirements Traceability Matrix (RTM) specification was selected instead of specific IHEIntegrating the Healthcare Enterprise (IHE) is an initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information. Visit the IHE website. Synonyms: Integrating the Healthcare Enterprise profiles. This was purposefully done by the ONC because “it serves as the baseline SOAP specification on top of which other Nationwide Health Information Network Exchange specifications (using IHE profiles) can be implemented.”

As previously discussed, the Direct Project specifications provide entry-level transport in a point-to-point fashion, while the SOAP-based IHE profiles provide for more advanced communications where healthcare facilities can query one another for patient information.

While there were a few surprises in the final rules Meaningful Use Stage 2, many health organizations still have plenty of work to do to before beginning compliance testing by July 1, 2014. Then, on to Stage 3 criteria, which will be implemented in 2016 at the earliest. 

 

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