CAP Policy Meeting May 8, 2012 Jodi G. Daniel, JD, MPH Director, Office of Policy and Planning...
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Transcript of CAP Policy Meeting May 8, 2012 Jodi G. Daniel, JD, MPH Director, Office of Policy and Planning...
CAP Policy MeetingMay 8, 2012
Jodi G. Daniel, JD, MPHDirector, Office of Policy and PlanningOffice of the National Coordinator for Health IT
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Agenda
• HIT Regulations Overview
• Intersections: ONC Programs/Policy and Labs
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HITECH Framework: Meaningful Use
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Meaningful Use Program
Meaningful User of Certified EHR Technology
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“Meaningful User of Certified EHR Technology”
Correlated
Objectives Measures&
ONC-ATCB / ONC-ACBONC-ATCB / ONC-ACB
Certification CriteriaCertification Criteria
StandardsStandardsEHR ModulesComplete
EHRs
Meaningful UseRegulations
HIT Standards & Certification Criteria Regulations
HIT Certification Programs RegulationsHIT Certification Programs Regulations
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Stages of Meaningful Use
Office of the National Coordinator for Health Information Technology
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Stages of Meaningful UseShowing Proposed Delay of Stage 2
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1st
Year
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
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Incentive Program Payment Summary
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March 2012 Providers PaidProgram-to-date
Amount PaidProgram-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
http://www.cms.gov/EHRIncentivePrograms/
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)
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Proposed Stage 2 Lab-Specific Objectives/Measures
COREEP: • 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)
Hospital: • 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)
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NOT Proposed But Sought Comment
Hospital Objective: Provide structured electronic lab results to eligible professionals.
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.
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Standards and Certification Criteria
S&CC July ‘10 final rule S&CC March ‘12 NPRM
Certification Criteria “Editions”
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Proposed Revised Definition of CEHRT Compliance
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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 certified2)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 setting)
• 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)
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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®
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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
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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
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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.
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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 recommendations
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ONC Regional Extension Center Program
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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
interoperability– Resource: providing a compendium of results for testing (common
ones for primary care)– S&I Framework’s standards development; using Direct and HL7
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Standards and Interoperability Framework Lab Results Interface (LRI) Initiative
Laboratory Results Interface (LRI) Initiative
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• Provides clinical context for how results should be exchanged between an LIS and EHR
• Dataset Considerations: Provided message content requirement for laboratory result message to align with MU regulations
• Provides implementers with a right-sized, representative list of laboratory tests for consideration in their implementation/piloting of vocabularies and code sets, particularly LOINC
• 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 on vocabularies in line with HITSC (i.e., LOINC and SNOMED)
• Path forward to pilot less-proven 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 Use Case
In-Scope Test List
Consensus on single guide and vocabularies
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2
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Laboratory Results Interface Initiative
Work Product Value CreatedDescription
• Defines the electronic communication and dataset considerations necessary for information exchange to support lab results reporting to ambulatory primary care providers
• Defines a list of tests recommended for testing and usage with the implementation guide defined through this initiative
• Agreement among proponents of HITSP, ELINCS, and HL7 Public Health Reporting guides on a single direction for the industry
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Key Outputs
•Provides flexibility for future additional extension for other domains, while using “profiles” to enable constrained guidance today•Incorporation of lab results into EHRs as structured data enables better care by making laboratory result data viewable alongside other clinical data•Facilitating input into data analysis, trending, CDS, public health reporting, syndromic surveillance, etc.
HL7 2.5.1 Laboratory Results Implementation Guide
Work Product
• Working implementations that test and provide a feedback loop on improvements and corrections needed in the new HL7 2.5.1 Laboratory Results Implementation Guide as well as the vocabularies therein
Pilots5
Description
Examples of pilots include:
•LabLynx (mdDigest)•Royal Oak (Atlas Development)•RML/Sunrise Labs (Halfpenny Technologies)•Kentucky Health Information Exchange (KHIE)•Sonora Quest (OptumInsight)
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Value Created
• Provides implementation guidance that satisfies current Ambulatory Lab Reporting requirements
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Laboratory Results Interface Initiative
Key Outputs
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 orders
• Delivering technical resources, such as validation tools, to guide implementations and reduce ambiguity
• 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
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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
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Opportunities for Input
• Regulations comment periods• Comments on testing – NIST• S&I framework activities• Federal advisory committees – HIT Policy and
Standards Committees
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For More Information