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					CAP Policy Meeting
May 8, 2012

Jodi G. Daniel, JD, MPH
Director, Office of Policy and Planning
Office of the National Coordinator for Health IT


• HIT Regulations Overview

• Intersections: ONC Programs/Policy and Labs

HITECH Framework: Meaningful Use

Meaningful Use Program
Meaningful User of Certified EHR Technology

“Meaningful User            of      Certified EHR Technology”

    Meaningful Use
         & Measures
                                          EHR         =
                                 HIT Certified Complete Programs Regulations
                                                              Combination of
                                                          Certified EHR Modules

               Correlated                  ONC-ATCB / ONC-ACB
                                       HIT Standards & Certification
                                  Certification Criteria Regulations EHR Modules

          Pillars of Meaningful Use

 Patient &                Quality,
           Coordinated                Privacy &     Public &
  Family                 Safety &
              Care                     Security   Population
Engagement               Efficiency                  Health

Stages of Meaningful Use

          Data            processes
          and sharing

                  Office of the National Coordinator for
                     Health Information Technology
Stages of Meaningful Use
Showing Proposed Delay of Stage 2

                         Stage of Meaningful Use
     2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021
2011   1   1    1    2       2     3     3    TBD      TBD   TBD   TBD

2012       1    1    2       2     3     3    TBD      TBD   TBD   TBD

2013            1    1       2     2     3         3   TBD   TBD   TBD

2014                 1       1     2     2         3    3    TBD   TBD

2015                         1     1     2         2    3     3    TBD

2016                               1     1         2    2     3     3

2017                                     1         1    2     2     3

Incentive Program Payment Summary

  March 2012                        Providers Paid     Amount Paid
                                     Program-to-date   Program-to-date

  Medicare Eligible Professionals             44,014     $ 792,252,000

  Medicaid Eligible Professionals             29,931       628,018,995

  Eligible Hospitals                          2,667      3,064,069,772

  Total                                       76,612     4,484,340,767


Meaningful Use Stage 1
Lab-Specific Objectives and Measures

•   Objective: Incorporate clinical lab test results into EHR as structured data
    (ambulatory and inpatient menu)
     • Measure: More than 40% of all clinical lab tests results ordered during the EHR
        reporting period whose results are either in a positive/negative or numerical
        format are incorporated in certified EHR technology as structured data.

•   Objective: Capability to submit electronic data on reportable (as required by
    State or local law) lab results to public health agencies and actual submission
    according to applicable law and practice (inpatient menu)
     • Measure: Performed at least one test of certified EHR technology’s capacity to
       provide electronic submission of reportable lab results to public health
       agencies and follow-up submission if the test is successful (unless none of the
       public health agencies to which an eligible hospital or CAH submits such
       information has the capacity to receive the information electronically)

Proposed Stage 2
Lab-Specific Objectives/Measures
• Use CPOE for more than 60% of medication, laboratory and radiology orders
• Incorporate lab results for more than 55% (do not have to use standards
    proposed by ONC)
• Use CPOE for more than 60% of medication, laboratory and radiology orders
• Incorporate lab results for more than 55%
• Successful ongoing submission of reportable laboratory results
*Note that laboratory results must be included in a summary of care record and
 information that must be provided to patients (implicating other objectives)

NOT Proposed But Sought Comment

Hospital Objective: Provide structured electronic lab results to eligible

Hospital Measure: Hospital labs send (directly or indirectly) structured
electronic clinical lab results to the ordering provider for more than 40
percent of electronic lab orders received.

 This measure requires that in situations where the electronic
  connectivity between an eligible hospital or CAH and an EP is
  established, the results electronically exchanged are done so using
  Certified EHR Technology.
 The HIT Policy Committee recommended this as a core objective for
  Stage 2 for eligible hospitals.

Standards and
Certification Criteria
Certification Criteria “Editions”

 S&CC July ‘10 final rule           S&CC March ‘12 NPRM

 Proposed Revised Definition
 of CEHRT Compliance

                                  EHR Reporting Period
FY/CY 2011        FY/CY 2012        FY/CY 2013                       FY/CY2014
MU Stage 1        MU Stage 1        MU Stage 1              MU Stage 1 or MU Stage 2

                                                    All EPs, EHs, and CAHs must have EHR
 All EPs, EHs, and CAHs must have EHR               technology (including a Base EHR) that has
 technology that has been certified to all          been certified to the 2014 Edition EHR
 applicable 2011 Edition EHR certification          certification criteria that would support the
 criteria or equivalent 2014 Edition EHR            objectives and measures, and their ability to
 certification criteria adopted by the Secretary.   successfully report the CQMs, for the MU stage
                                                    that they seek to achieve.

Looking forward to 2014, an eligible health care provider will need to know 2 things:
1) The EHR technology that they have is 2014 Edition certified
2) The 2014 Edition EHR technology they have has been certified to support their achievement of the
   meaningful use stage they seek to meet (i.e., objectives & measures)

Note: There is no such thing as being “Stage 1 Certified” or “Stage 2 Certified”
2011 Lab-related Certification Criteria

Certification Criteria:
• Incorporating lab test results; includes that the test report
  information required by CLIA be displayed (42 CFR
  493.1291(c)(1) through (7))
• Capability to report lab test results to public health (inpatient
• Several other certification criteria require the reuse of
  laboratory test results (e.g., electronic copy to patient and
  summary record must include lab test results)

2014 Edition Certification Criteria - Proposed

Same certification criteria as 2011 Edition but with proposed revisions:
•   Version of LOINC to be, at minimum, version 2.38 where laboratory tests
    and values/results are required
•   “Incorporate laboratory tests and values/results” certification criterion
    (ambulatory setting) requires capability of receiving results in accordance
    with HL7 Version 2.5.1 standard & HL7 Version 2.5.1 Implementation
    Guide: S&I Framework Lab Results Interface, Release 1 (US Realm)
•   “Report laboratory results” criteria (inpatient setting)
    – Split into 2 certification criteria (capability to record, change and access
        lab tests AND ability to transmit according to the standards)
    – Requires the errata version of the ELR Implementation Guide to
        account for newly assigned OIDs identifying the message profiles
    – Requires certification to, at minimum, the January 2012 International
        Release of SNOMED-CT®
2014 Edition Certification Criteria - Proposed

• Transmission of electronic laboratory tests and values/results
  to ambulatory providers. (inpatient setting)
    • Enable a user to electronically create laboratory tests and values/results
      for electronic transmission in accordance with HL7 Version 2.5.1
      standard; HL7 Version 2.5.1 Implementation Guide: S&I Framework
      Lab Results Interface, Release 1 (US Realm); and at a minimum, LOINC
      version 2.38

 Complements the proposal for EHR technology designed for the ambulatory
  setting to be capable of receiving test results in this structured format
 Would support the MU objective/measure if adopted after consideration of
  public comment

ONC State Health Information
Exchange Program
Eligible Professionals and Lab Exchange:
Challenges and Strategies

• Policy
   •   Lack of standardized contract language
   •   Weak business case for low volume practices
   •   Little coordination among small, independent lab partners
   •   No long-term economic model for sustainability

• Transport
   • Lab results must be transported reliably from the lab to the provider
   • Challenges with bi-directional exchange

• Standards
   • Need for coordination between lab partners to support standards
   • Differences in interpretation of CLIA regulations

State HIE Examples

• Delaware – Encouraging Lab Participation

• Massachusetts - ELR Reporting

• New Mexico – ELR Reporting

• State HIE Labs Summit & Pilot Program
   • A handful of states focused on labs over Direct secure
     messaging demonstration pilots starting in May 2012.
   • Participants include Florida, West Virginia, North Carolina,
     Guam, Hawaii and Alaska.
   • Expectation is for live pilots by August 2012.

State HIE Lab Interoperability CoP

• Approximately 70 members, including State HIT Coordinators and other
  key state stakeholders working to advance lab interoperability

• Short-term objectives focus on lab results delivery, including:
    – Outreach to labs to increase adoption of Direct secure messaging tools and lab
      interfaces for hospital labs and independent reference labs
    – Assisting grantees with Quest and LabCorp implementation strategies
    – Identifying common levers for Medicaid, private payers, etc.
    – Discussing requirements of regulations (e.g., CLIA) and specific technical requirements
      to ensure the timely, accurate, and secure delivery of laboratory results.
    – Standardizing format and content specifications for results reporting by promoting the
      work of the LRI (Lab Results Interface) initiative.

• Long-term objectives focus on implementing lab orders into the HIE
  models, stage 2 MU and adoption of LOI (Lab Orders Interface) initiative

ONC Regional Extension
Center Program

Regional Extension Center (REC)
Functional Interoperability Community of Practice

• Community of Practice (CoP) focused on functional interoperability
  and HIE.

• The Lab Workgroup within this CoP is tasked with aligning the REC
  program tasks with Lab/Meaningful Use

• Current activity:
    – The appropriate role of the REC in lab interoperability
    – Connecting directly to labs for states and REC’s without an affiliation
      to an HIE
    – Practice capabilities and EHR capabilities that support lab
    – Resource: providing a compendium of results for testing (common
      ones for primary care)
    – S&I Framework’s standards development; using Direct and HL7

Standards and Interoperability Framework
Lab Results Interface (LRI) Initiative
     Laboratory Results Interface (LRI) Initiative

     The LRI Initiative aims to standardize results reporting to ambulatory primary care, in support of
     Meaningful Use objectives for decision support, quality reporting, transitions in care, and
     electronic copies of clinical summaries and Discharge Instructions. The Initiative enables results
     reporting between a laboratory information system and an ambulatory EHR system in different
     organizational entities, including incorporation of lab results into EHRs as structured data.

     •   Too many options for laboratory result interfaces result in point-to-point agreements
     •   Multiple message formats in multiple guides:
           •   Variety of “flavors” of HL7: 2.2, 2.3, 2.3.1, 2.5.1, etc.
     •   Non-standardized (and often non-electronic) custom formats
           •   Uneven usage of vocabulary & code sets, e.g., LOINC, SNOMED, etc.
     •   Differing clinical workflows and levels of EHR/LIS adoption

     Laboratory Results Interface Initiative
     Key Outputs
            Work Product                     Description                                   Value Created
                                                                         •     Provides clinical context for how results
                                •   Defines the electronic communication
                                                                               should be exchanged between an LIS and
          Laboratory Results        and dataset considerations necessary
      1   Interface                 for information exchange to support
                                                                         •     Dataset Considerations: Provided message
          Use Case                  lab results reporting to ambulatory
                                                                               content requirement for laboratory result
                                    primary care providers
                                                                               message to align with MU regulations

                                                                           •   Provides implementers with a right-sized,
                                •   Defines a list of tests recommended
                                                                               representative list of laboratory tests for
                                    for testing and usage with the
      2   In-Scope Test List
                                    implementation guide defined through
                                                                               consideration in their implementation/piloting
                                                                               of vocabularies and code sets, particularly
                                    this initiative

                                                                           •   Agreement that a single, re-designed
                                                                               implementation guide was “the right thing for
                                                                               the industry” by broad community of labs,
                                                                               EHR vendors, and other health participants
                                •   Agreement among proponents of          •   Agreement on vocabularies in line with
          Consensus on single
                                    HITSP, ELINCS, and HL7 Public              HITSC (i.e., LOINC and SNOMED)
      3   guide and
                                    Health Reporting guides on a single    •   Path forward to pilot less-proven
                                    direction for the industry                 technologies in this domain UCUM, OIDs,
                                                                               and broader use of SNOMED
                                                                           •   The approach defined through this initiative
                                                                               will drive decision-making in related
                                                                               domains, particularly lab orders

     Laboratory Results Interface Initiative
     Key Outputs
            Work Product                      Description                                    Value Created

                                                                            •   Provides flexibility for future additional
                                                                                extension for other domains, while using
                                                                                “profiles” to enable constrained guidance
         HL7 2.5.1 Laboratory
                                                                            •   Incorporation of lab results into EHRs as
         Results                •   Provides implementation guidance
     4   Implementation
                                                                                structured data enables better care by
                                    that satisfies current Ambulatory Lab
                                                                                making laboratory result data viewable
         Guide                      Reporting requirements
                                                                                alongside other clinical data
                                                                            •   Facilitating input into data analysis, trending,
                                                                                CDS, public health reporting, syndromic
                                                                                surveillance, etc.

                                Examples of pilots include:

                                • LabLynx (mdDigest)                   •        Working implementations that test and
                                • Royal Oak (Atlas Development)                 provide a feedback loop on improvements
     5   Pilots                 • RML/Sunrise Labs (Halfpenny                   and corrections needed in the new HL7
                                  Technologies)                                 2.5.1 Laboratory Results Implementation
                                • Kentucky Health Information Exchange          Guide as well as the vocabularies therein
                                • Sonora Quest (OptumInsight)

     Laboratory Results Interface Initiative - Value

     •   Engaged a broad and divided community-including clinical laboratories, EHR vendors and public
         health experts - on a neutral platform
     •   Agreement across the industry to use a standard (HL7 2.5.1) and single implementation guide
         (LRI) to drive down the cost and time required to implement a laboratory results interfaces
     •   Final standard implementation guide bootstraps on existing investments made across the
         industry, enabled by broad input
     •   Provides a platform for aligning outstanding, related national health IT needs, particularly lab
     •   Delivering technical resources, such as validation tools, to guide implementations and reduce
     •   Established a platform for testing and piloting of key elements of lab results exchange,
         including LOINC, SNOMED, UCUM and OIDs
     •   Provided forum for defining “standardized structured data” for MU Stage 2

Laboratory Orders Interface (LOI)

• Initiative Purpose:
   – An Implementation Guide (IG) for electronic ordering of laboratory tests in an
     ambulatory setting that can serve as a foundation for eventual use in in-patient and
     public health settings. Further, the design will incorporate vocabulary consistent with
     the above mentioned guides as well as support for use of the Electronic Directory of
     Service (eDOS) IG.

• Summary of Work/Current Status:
   – Consensus is OPEN on the LOI Charter
   – DRAFT Use Case is up for review

Opportunities for Input

•   Regulations comment periods
•   Comments on testing – NIST
•   S&I framework activities
•   Federal advisory committees – HIT Policy and
    Standards Committees

For More Information

  Helpful Links
   • Temporary Certification Program: http://healthit.hhs.gov/certification
   • Standards & Certification Criteria:
   • Certified HIT Product List: http://healthit.hhs.gov/chpl
   • CMS EHR Incentive Programs: http://www.cms.gov/EHRIncentivePrograms
   • Meaningful Use Grids: http://www.healthit.gov/buzz-blog/meaningful-
   • Comments? Questions? ONC.Certification@hhs.gov

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