Finding Meaning for Pathology in Meaningful Use and the EHR Pathology Informatics 2014 May 14, 2014 Pittsburgh, PA

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1 Finding Meaning for Pathology in Meaningful Use and the EHR Pathology Informatics 2014 May 14, 2014 Pittsburgh, PA Walter H. Henricks, M.D. Cleveland Clinic

2

3 What is Meaningful Use? Meaningful Use is using certified EHR technology to: Improve quality, safety, efficiency, and reduce health disparities Engage patients and families in their health care Improve care coordination Improve population and public health All the while maintaining privacy and security

4 What is non-meaningful use? (out of scope)

5 ARRA (American Recovery and Reinvestment Act) includes HITECH (Health Information Technology for Economic and Clinical Health Act) implemented in CMS Rule - Defines meaningful use criteria - Establishes incentive payments for meeting meaningful use criteria (and penalties for not meeting) alignment Walter H. Henricks, M.D. ONC Rule - Establishes certification criteria that EHR technology will need to meet in order to support meaningful use (ONC = Office of the National Coordinator for Health Information Technology in HHS)

6 September 4, 2012 Walter H. Henricks, M.D.

7 EHR Meaningful Use vs. EHR Certification EHR certification criteria specify WHAT an EHR must be able to do. Meaningful use objectives specify HOW an EHR must be used to qualify for incentive and to avoid penalties. Meaningful use can be achieved only by using certified EHR technology (CEHRT).

8 CMS EHR Incentive Program Eligible Professionals (EPs) Individuals Up to $44K over 5 yrs (Medicare) $63K over 6 yrs (Medicaid) Hospital-based providers not eligible (as individuals) Hospitals $2M base payment Further payments based on formula including discharges and inpatient beddays

9 After the Thrill is Gone - Pay Now, or Pay Later In 2015, penalties kick in for those who are not Meaningful Users EPs: Reductions in Medicare physician fee schedule professional payments 1% in 2015, 2% in 2016, 3% in 2017 and after Hospitals: Reductions (%) to the standard IPPS percentage increases 25% in 2015, 50% in 2016, 75% in 2017 and after IPPS = Inpatient Prospective Payment System

10 Status of EHR Use by Physician Practices Source: CDC/NCHS National Ambulatory Medical Care Survey

11 Data as of May 13, Walter H. Henricks, M.D.

12 EHR Meaningful Use Stages Stage Data capture and sharing Stage Advanced clinical processes Stage 3 TBD Improved outcomes Requirement to meet stage 2 has been pushed back to 2014 for EPs that participated in stage 1 CMS announced it will delay development of stage 3 requirements until after program assessment

13 CMS EHR Incentive Program Requirements Eligible Professionals (EPs) Stage 1 15 core objectives 5 of 10 menu set objectives 6 CQMs CQMs = Clinical Quality Measures Stage 2 17 core objectives 3 of 6 menu set objectives 9 CQMs covering at least 3 of 6 National Quality Strategy (NQS) domains

14 CMS EHR Incentive Program Requirements Hospitals Stage 1 14 core objectives 5 of 10 menu set objectives 15 CQMs Stage 2 16 core objectives 3 of 6 menu set objectives 16 CQMs covering at least 3 of 6 National Quality Strategy (NQS) domains

15 Themes in MU Stage 2 Relevant to Labs Patient engagement active participation >5% of patients must send secure messages to EP >5% of patients must access their health information online may include lab results Electronic communication Summary of care document (CDA) for transitions of care or referrals includes placeholders for lab results Decision support e.g. rules/alerts at test order entry (CPOE)

16 MU Objective Directly Relevant to Laboratory Data in EHRs Stage 1 (menu): More than 40% of clinical laboratory tests ordered whose results are in a positive/negative or numerical format are incorporated in EHR as structured data Stage 2 (core): Requirement increases to more than 55% of such results Realistically possible only with an interface from laboratory Walter H Henricks, M.D. Walter H. Henricks, M.D.

17 MU Objective Directly Relevant to Laboratory Data in EHRs Stage 1: No CPOE requirement for lab orders Stage 2 (core): Use CPOE for more than 30% of laboratory orders Electronic transmission of orders not required but strongly encouraged CPOE: (Computerized Provider Order Entry)

18 MU Objective Directly Relevant to Laboratory Data in EHRs Stage 1 (hospital menu): Capability to submit electronic submission of reportable lab results to public health agencies Stage 2 (hospital core): Successful ongoing submission of such results Per ONC, use of HL7 v2.5.1, SNOMED-CT, and LOINC is required for this objective Options: send from Complete EHR or send from LIS certified as EHR module

19 New Stage 2 MU Menu Set Requirement for Hospitals Eligible hospitals send (directly or indirectly) structured electronic laboratory results to ambulatory ordering providers for more than 20% of electronic laboratory orders received Included as a menu option, rather than a core requirement Per ONC, use of HL7 v2.5.1, SNOMED-CT, and LOINC is required for this objective

20 Meaningful Use of EHRs can be achieved only through the use of Certified EHR Technology (CEHRT) Walter H. Henricks, M.D.

21 ONC Standards and Certification Criteria 2011 Edition Published July 2010 Supports Stage 1 MU 2014 Edition Published Sept Supports Stage 2 MU Required to support MU beginning 2014 No such thing as Stage 2 certified

22 EHR Certification Complete vs. Module Complete EHR system meets all certification criteria EHR Module meets at least one certification criterion EHR Modules can be used in aggregate to meet MU objectives LISs may be certified as EHR Module relevant to reportable result MU objective

23 ONC S&I* Framework Lab Interoperability Initiatives Electronic Laboratory Reporting (ELR): Lab Results Initiative (LRI) Lab Orders Initiative (LOI) Aim to standardize lab test ordering and result reporting to ambulatory providers Will be incorporated into regulations as Implementation Guides (IGs) *S&I: ONC Standards and Interoperability

24 ONC S&I* LRI and LOI Implementation Guides Define EHR-LIS orders and results interfaces Incorporate HL7 v2.5.1, LOINC, SNOMED- CT Adherence to LRI and LOI IGs to be required for MU objectives that involve electronic transmission of lab orders/results

25 Summary of Transition to Stage 2 Meaningful Use Menu objectives become core requirements CPOE for laboratory test orders LOINC (version 2.40) (where used) HL7 v2.5.1 LRI, LOI; more exchange of health data; More decision support Reporting of hospital lab tests to outpatient providers (menu objective) Patient engagement

26 What does all of this really mean for pathology laboratories? Increased expectations for LIS-EHR electronic interfaces As a result of broader and new EHR deployment To meet Meaningful Use requirements Shift to EHR as origin of lab orders and as mechanism for reporting results CPOE requirement will only grow Less laboratory influence unless proactive

27 What does all of this really mean for pathology laboratories? (there s more?) Hospitals may rely on lab to meet MU core objective for reportable result submission Labs must work with public health agencies Interface requires HL7 v2.5.1, SNOMED-CT, LOINC Hospital may expect lab to meet MU menu objective for electronic reporting to ambulatory providers Interface requires HL7 v2.5.1, SNOMED-CT, LOINC

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29 Toward a Broader View of Laboratory Information Domain in EHR Era Successful and accurate exchange of test results and orders between LIS and EHR Application of laboratory domain expertise to management of laboratory information in the EHR

30 Informatics is More Than Information Technology Pathology s role as steward of patients laboratory information in the EHR has dimensions of: PEOPLE PROCESS TECHNOLOGY

31 1990: Am J Clin Pathol 1990;94(Suppl 1):S2-S6 Strategically, political power accrues to those subunits of an organization that are best able to solve its strategic problems.

32 Int J Med Inform 2010;79:e It became clear that the [CPOE] project s management grossly underestimated the CPOE-L implementation project. The technical infrastructure of some laboratories proved to be enormously complex, and the large number of specialized laboratory services added to this complexity. Understanding of clinical workflow was identified as a key theme pressured by organizational, human and social issues ultimately influencing the entire implementation process in a negative way.

33 EHR Era Success Strategy #1: Advocate that laboratory-ehr issues are now part of lab operations and patient care EHR now defines order entry and results reporting channels; previously were under lab control EHR-lab issues are fundamental administrative component on par with quality management, regulatory compliance, competency, etc. These activities require resource allocation Example: metrics to monitor impact of CPOE on laboratory services Georgiou A, et al. Stud Health Technol Inform 2008: Walter H. Henricks, M.D. 33

34 EHR Era Success Strategy #2: Participate in EHR selection processes Serve on selection/implementation teams Contribute to clinical scenarios used during EHR evaluation Attend EHR vendor demonstrations and provide feedback Contribute to RFP for the EHR Describe EHR functional requirements germane to pathology Walter H. Henricks, M.D. 34

35 EHR Era Success Strategy #3: Be active in EHR implementation processes Configure lab CPOE screens and processes Provide laboratory perspective and requirements for the presentation and organization of laboratory result information Test/validate accuracy and timeliness of LIS- EHR data exchange Establish change management procedures Walter H. Henricks, M.D. 35

36 EHR Era Success Strategy #4: Get involved in enterprise-level EHR-related teams and committees EHR steering committees Physician advisory groups Issue-driven EHR task forces Medical Records Committees be at the table Walter H. Henricks, M.D. 36

37 EHR Era Success Strategy #5: Build relationships with those with enterprise-level EHR influence CIO/CMIO Medical Chief of Staff Influential clinicians Quality/Safety Officer Compliance Office EHR technical support team Walter H. Henricks, M.D. 37

38 EHR Era Success Strategy #6: Cultivate EHR-laboratory expertise in lab technical staff Activities that carry over well from LIS support to EHR issues: Test definition Interface implementation and support System testing and validation Change control practices Certification in informatics for lab professionals AACC, ASCP Walter H. Henricks, M.D. 38

39 EHR Era Success Strategy #7: Demonstrate benefits of lab s contributions to EHR projects and troubleshooting Work collaboratively with EHR support staff Document and track laboratory domain expertise and involvement in resolving or preventing EHR problems Identify risk management and patient safety issues

40 Meaningful Use and the Laboratory Summary Meaningful Use and related federal programs aim to spur uptake of EHRs by physicians and hospitals. Expansion of EHR use and future stages of Meaningful Use will increase requirements for electronic exchange of laboratory information. With EHR use increasing, laboratories will be called upon to implement more LIS-EHR interfaces. Walter H. Henricks, M.D. 40

41 May 7, 2014

42 Wednesday s hearing quickly broke down into a gripe fest and finger-pointing about the difficulty of managing the achievement of meaningful use Stage 2, from every facet of the process. Walter H. Henricks, M.D.

43 Summary Spurred by federal programs, EHR use is proliferating and transforming medical practice. The shift to EHRs poses challenges, risks, and opportunities for our specialty. Pathologists and laboratories are well positioned by virtue of experience and domain expertise to serve in the role of stewards of patients laboratory information in the EHR 43 Walter H. Henricks, M.D.

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