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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 1.

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Presentation on theme: "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 1."— Presentation transcript:

1 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 1

2 Agenda HIT Regulations Overview Intersections: ONC Programs/Policy and Labs 2

3 HITECH Framework: Meaningful Use 3

4 Meaningful Use Program

5 Meaningful User of Certified EHR Technology 5 “Meaningful User of Certified EHR Technology” Correlated Certified Complete EHR Combination of Certified EHR Modules = ObjectivesMeasures & ONC-ATCB / ONC-ACB Certification Criteria Standards EHR Modules Complete EHRs Meaningful Use Regulations HIT Standards & Certification Criteria Regulations HIT Certification Programs Regulations

6 Pillars of Meaningful Use Patient & Family Engagement Coordinated Care Quality, Safety & Efficiency Privacy & Security Improved Public & Population Health 6

7 Stages of Meaningful Use Office of the National Coordinator for Health Information Technology 7 Data capture and sharing Advanced clinical processes Improved outcomes

8 Stages of Meaningful Use Showing Proposed Delay of Stage 2 8 1 st Year Stage of Meaningful Use 20112012201320142015201620172018201920202021 2011 1112233TBD 2012 112233TBD 2013 112233TBD 2014 112233TBD 2015 112233TBD 2016 112233 2017 11223

9 9

10 Incentive Program Payment Summary 10 March 2012 Providers Paid Program-to-date Amount Paid Program-to-date Medicare Eligible Professionals44,014$ 792,252,000 Medicaid Eligible Professionals29,931628,018,995 Eligible Hospitals2,6673,064,069,772 Total76,6124,484,340,767

11 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) 11

12 Proposed Stage 2 Lab-Specific Objectives/Measures CORE EP: 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) 12

13 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. 13

14 Standards and Certification Criteria

15 S&CC July ‘10 final rule S&CC March ‘12 NPRM Certification Criteria “Editions” 15

16 Proposed Revised Definition of CEHRT Compliance EHR Reporting Period FY/CY 2011FY/CY 2012FY/CY 2013FY/CY2014 MU Stage 1 MU Stage 1 or MU Stage 2 All EPs, EHs, and CAHs must have EHR technology that has been certified to all applicable 2011 Edition EHR certification criteria or equivalent 2014 Edition EHR certification criteria adopted by the Secretary. All EPs, EHs, and CAHs must have EHR technology (including a Base EHR) that has been certified to the 2014 Edition EHR certification criteria that would support the objectives and measures, and their ability to successfully report the CQMs, for the MU stage that they seek to achieve. 16 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”

17 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) 17

18 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 ® 18

19 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 19

20 ONC State Health Information Exchange Program

21 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 21

22 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. 22

23 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 23

24 ONC Regional Extension Center Program 24

25 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 25

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

27 Laboratory Results Interface (LRI) Initiative Focus: 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. Challenges: 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 27

28 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 1 2 3 Laboratory Results Interface Initiative Work ProductValue 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 28 Key Outputs

29 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 Pilots 5 Description Examples of pilots include: LabLynx (mdDigest) Royal Oak (Atlas Development) RML/Sunrise Labs (Halfpenny Technologies) Kentucky Health Information Exchange (KHIE) Sonora Quest (OptumInsight) 4 Value Created Provides implementation guidance that satisfies current Ambulatory Lab Reporting requirements 29 Laboratory Results Interface Initiative Key Outputs

30 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 30

31 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 31

32 Opportunities for Input Regulations comment periods Comments on testing – NIST S&I framework activities Federal advisory committees – HIT Policy and Standards Committees 32

33 For More Information Helpful Links Temporary Certification Program: Standards & Certification Criteria: Certified HIT Product List: CMS EHR Incentive Programs: Meaningful Use Grids: use/meaningful-use-grids-quick-reference-navigation use/meaningful-use-grids-quick-reference-navigation Comments? Questions?

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