HIT Policy Committee

1. HIT Policy Committee Information Exchange Workgroup Recommendations on Standardizing Electronic Laboratory Transactions Deven McGraw, Chair Center for Democracy & Technology Micky Tripathi, Co-Chair Massachusetts eHealth Collaborative December 15, 2009

2. Information Exchange Workgroup Members Co-Chairs: • Deven McGraw, Center for Democracy & Technology • Micky Tripathi, Massachusetts eHealth Collaborative Members: • Connie White Delaney, University of Minnesota, School of Nursing • Paul Egerman, Retired • Judith Faulkner, Epic Systems Corp. • Jonah Frohlich, California Health & Human Services Agency • Dave Goetz, Tennessee Department of Finance and Administration • Gayle Harrell, Former Florida State Legislator • Charles Kennedy, WellPoint, Inc. • Michael Klag, Johns Hopkins University, Bloomberg School of Public Health • Martin Laventure, Minnesota Public Health • Frank Nemec, Gastroenterology Associates, Inc. • Steve Stack, American Medical Association • Latanya Sweeney, Carnegie-Mellon University ONC Lead: • Kelly Cronin 2

3. Executive Summary 3 • Electronic laboratory ordering and results delivery are key elements of meaningful use, and key enablers of better patient care through health IT • Electronic lab results delivery (along with eRX) is a pillar of 2011 ambulatory MU requirements • Quality reporting practically impossible without standards-based lab transactions • Many obstacles exist to rapid and widespread penetration of standards-based lab transactions: business, technical, regulatory • Lab market is highly decentralized • Little market imperative and no regulatory requirements exist for messaging or vocabulary standards • Federal government has a number of levers to influence the market, though decentralized nature of the market requires orchestration of a variety of levers • ARRA levers: certification, MU requirements, cooperative agreements, NHIN governance • Regulatory levers: CLIA authority • Contracting levers: CMS and FEHB contracts • IE Workgroup has a number of recommendations that, taken together, will facilitate more rapid adoption of electronic lab transactions

4. Meaningful Use Requirements 4 Electronic lab results delivery key to MU fulfillment starting in 2011 • 2011 – structured labs requirement; quality reporting • 2013 – electronic ordering Standards not necessarily required for either of these requirements, however • Without standardization will be too costly and too difficult to achieve • Quality measures and clinical decision support rely on standardized nomenclatures

5. Five Steps of Laboratory Transactions Order Result Lab service supplier Lab system Lab requisition or result Physician system Lab service demander Physician office Laboratory 5

6. Most Lab Transactions Today Are Not Electronic Lab service supplier Lab system Lab requisition or result Physician system Lab service demander Custom electronic order LIS or HIS system Paper Order Patient-carried Lab requisition Physician office Fax Laboratory Phone Paper Result Terminal or portal Terminal or portal EHR EHR Letter mail Auto-print Fax Letter mail Lab report Custom electronic result 6 LIS or HIS system

7. IE Workgroup Hearing Revealed Many Systemic Issues... • Technical • Messaging and vocabulary standards exist but are not monitored or enforced • HL7 2.5.1 released in 2007 but still not widely used • Allowable variations in HL7 standards keeps costs high; high number of optional fields • Hospital labs usually use local legacy codes; national labs closer to conforming with LOINC, but still have internal legacy-based variations • LOINC and SNOMED still too complex for routine ambulatory implementation – not “clinically relevant” • Conversion to HL7 2.5.1 and LOINC would require investment by most hospitals for interface development and upgrading of systems • No standard automated way to update compendiums; usually happens manually after fax notification • High degree of allowable variation in current messaging and vocabulary standards makes interfacing time-consuming and costly Regulatory CLIA regulation that holds laboratory responsible for how results appear in the EHR is being interpreted differently by various lab companies and hospitals CLIA Requirement 42 CFR 493.1291: “The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry to final report destination” No regulatory requirements or market imperatives currently exist for messaging or vocabulary standards either on the receiving or on the transmitting ends Patient access to lab results not established in law or regulation Interpretation of legal requirements across states and lab sources varies widely; no requirements exist for messaging or vocabulary standards, and no ability to monitor/enforce standards Business • CLIA recognizes over 200K labs • Over 75% of laboratory tests conducted by hospitals and local labs • Most lab results delivered through paper-based means (letter, fax) • Lab interfaces cost $5-$25K each • Labs typically pay EHR vendors for lab interfaces • Users typically do not pay for lab interface or delivery as long as they are high enough volume users • Interface approval process can take months, which lengthens interface time and cost Weak market incentives prevent rapid growth in standards-based lab interfacing; interfaces still not replicable and are thus time-consuming and costly 7

8. ...Which Create Barriers To Progress At Every Step Of The Way Lab service supplier Lab system Lab requisition or result Physician system Lab service demander ! ! ! ! ! Order Result Laboratories LIS or HIS system Physician office Most labs not trained for electronic lab transactions Most labs not outfitted for electronic lab transactions No nationally approved lab ordering standard Non-standard results management and display Most offices not trained for elab transactions Electronic lab management system No incentives or requirements to deploy standards-based systems Little incentive and no requirements to demand standards-based labs Little incentive and no requirements to supply standards-based labs No incentives or requirements to deploy standards-based systems HITSP-approved vocabulary and messaging standards not widely used No mechanisms for monitoring and enforcing standards even if they were adopted 8

9. Federal Government Has Many Policy Levers, Which Need To Be Orchestrated Across The Entire System • CLIA regulatory changes or interpretive guidance • HIT system certification • Meaningful use incentives/requirements • HIE and RHITEC cooperative agreements • Technical Standards • Government contracts Policy levers Lab service supplier Lab system Lab requisition or result Physician system Lab service demander Order Electronic lab management system LIS or HIS system Result Laboratories Physician office • 8,500 hospital • 5200 commercial • 400 public health • 115,000 office/clinic • Dozens of LIS systems • Dozens of HIS systems • Thousands(?) of custom interfaces • Thousands(?) of custom message formats • Thousands(?) of custom compendiums • Hundreds of EHR, HIE, and lab-specific systems • 170,000 ambulatory practices • 150,000 of which are solo or 2-physician 9

10. Orchestrated Policy Levers Can Achieve Unified Goal Lab service supplier Lab system Lab requisition or result Physician system Lab service demander Order Result Physician office Laboratories LIS or HIS system MU criteria to incent hospitals to adopt standards-based ordering & results transmission CLIA authority to push commercial labs to adopt standards-based ordering/delivery Government contracts to require lab adoption & adherance Certification of source systems on standards-based ordering & results transmission Establishment of national vocabulary and messaging standards with designated distribution channels Certification of receiving systems on standards-based ordering & results management CLIA regulatory authority to reinforce standards and standardize display of labs in user-facing systems MU criteria to incent physicians to adopt standards-based ordering & results management Electronic lab management system HIE and RHITEC funding to facilitate implementation and monitoring of standards-based ordering and results transmission 10

11. Recommendations Summary • Recommended Goals • (consistent with MU criteria for labs) • Laboratory results must be transmitted and incorporated into EHRs using nationally defined messaging and vocabulary standards, by 2011 • Laboratory orders must be transmitted and incorporated into hospital HIS/LIS systems using nationally defined messaging and vocabulary standards, by 2013 • Patients must have prompt access to their laboratory results, by 2011 • Critical issues to resolve in order to meet these goals • Critical issue #1: Which vocabulary and messaging standards should be required for lab results and orders? • Critical issue #2: How will these standards be monitored and enforced? • Critical issue #3: How to enhance patients’ ability to get prompt communication of lab results? 11

12. CRITICAL ISSUE #1:Which Vocabulary and Messaging Standards Should be Required? Discussion The Standards Committee in September approved specific messaging and vocabulary standards for lab results in 2011, with temporary exceptions for local codes and pre-existing lab interfaces in 2011 and 2012. This development was not flagged for us by the stakeholders testifying at the hearing, so the full impact of the Standards Committee recommendations may not be widely understood. Current work underway through the Standards Committee and HITSP will address other standards issues identified by the IE WG • Identification of nationally-approved standards for electronic ordering • Identification of nationally-approved standard for electronic updating of lab dictionaries • Improved implementation assistance, clear communication of requirements, and education are needed for lab vocabulary standards to be widely adopted. 12

13. BACKGROUND: Anatomy of An Hl7 Message Indicates that it is a result message Non-standard order name HL7 is the “envelope” that holds the message LOINC describes the question SNOMED describes the answer qualitatively UCUM describes the answer quantitatively Patient Order Results Units of measure (valid UCUM) Non-standard test name Quantitative result 13

14. HIT Standards Committee Recommended Use of HITSP-Approved Standards, With Specific Implementation Guidance, Phased In Over Time September 15, 2009 Clinical Ops WG recommendation to HIT Standards Committee 2011 2013 Recommended HITSP-approved standard & implementation guide for lab results Temporary exception allowed for pre-existing HL7 v2 interfaces Recommended HITSP-approved standard for lab vocabularies Temporary exception allowed for local codes except as required for quality reporting No HITSP-approved standards for ordering (not MU for 2011) – to be taken up in 2010 by HIT Standards Committee 14

15. CRITICAL ISSUE #1:Which vocabulary and messaging standards should be required? • Recommendations • ONC should require national standards for messaging, vocabulary, and measure codes, and create means for widespread availability of authorized implementation guides and code-sets. 15

16. CRITICAL ISSUE #1:Which vocabulary and messaging standards should be required? Hit the Essentials in 2011 • Make mandatory the Standards Committee recommendations proposed in September 2009 but without the allowable alternatives for local HL7 interfaces and local codes in 2011. To us this means: • Required vocabulary standards (LOINC, UCUM, SNOMED CT) cover “most frequent” results, and define a simplified “clinically relevant” vocabulary subset corresponding to those results • Required HL7 messaging standards focus specifically on meaningful use transactions for treatment, quality measurement, and public health • Reduced optional fields • Standard should be mandatory, but meaningful use compliance measures may need to be flexible to allow for time to incorporate system changes More Comprehensive approach in 2013 • The Standards Committee should define simplified “clinically relevant” lab order compendium for a national laboratory vocabulary. The Committee also should simplify other lab vocabulary standards in subsets and value sets that are “clinically relevant”. (We understand this work is already underway.) 16

17. CRITICAL ISSUE #2: How will these standards be monitored and enforced? Discussion Monitoring and enforcement of lab messaging and vocabulary standards is made difficult by: • Lack of certification and testing of lab receiving and transmitting systems • Lack of requirements to use such standards • Regulatory organizations not “in stream” of day-to-day transactions • Commercial labs are not subject to MU requirements, so alignment of CLIA authorities is essential • Monitoring and enforcement of standards-based lab transactions will be critical to success moving forward since current business processes have no “built-in” mechanism for monitoring and enforcing lab transactions. 17

18. CRITICAL ISSUE #2: How will these standards be monitored and enforced? Recommendations (1) • Enforcement regarding EHRs and Hospital Laboratories • Certification: Use of these standards by providers should be required for meaningful use (for receipt of results in 2011 and for orders in 2013). Thus, EHR (and EHR components pulled together by HIEs) certification requirements for 2011 should include the ability to incorporate lab results using these standards, and to transmit orders in accordance with these standards by 2013. Such certification should cover the interface with the laboratory, and include testing of the system/components and the interface to ensure compliance • Hospital MU requirements: Include standards-based laboratory results transmission to ambulatory physicians as a hospital (inpatient) meaningful use requirement for 2011. Hospitals should then be required to have their in-house HIS, laboratory, or interfacing systems certified to transmit according to the same messaging and vocabulary standards that ambulatory physicians and EHRs are required to receive. Allow standards-based delivery through certified HIE products (interoperability components) to satisfy this certification requirement. 18

19. CRITICAL ISSUE #2: How will these standards be monitored and enforced? Recommendations (2) Enforcement for Laboratories: • CMS CLIA Office should issue a survey and certification letter for laboratories that would include: • Interpretive guidance for presentation of lab information in user-facing applications (EHRs, HIEs, and PHRs) • Interpretive guidance for interfacing reflecting the messaging and vocabulary standards set forth above • Best practices reinforcing the above guidance • The sending of results using these messaging and vocabulary standards should be deemed acceptable for meeting the criteria of presentation of lab results in user facing applications • This survey and certification letter should deem EHR certification as demonstration of adherence to the guidance, which should eliminate the need for labs to test each EHR implementation. 19

20. CRITICAL ISSUE #2: How will these standards be monitored and enforced? Recommendations (3) Alignment of national and state rules and enforcement: • Require State HIT Coordinator to work with state CLIA administrators to align state-level lab approach with national CLIA, standards, and certification requirements. • Request NGA analysis of state variation in CLIA rules and enforcement, and recommendations on what policy levers state governments have on lab rules and enforcement. 20

21. CRITICAL ISSUE #2: How will these standards be monitored and enforced? Recommendation (4) Monitoring and enforcement for Labs: Monitoring and enforcement are critical to achieving a breakthrough in electronic laboratory transactions. ONC should develop an approach for ensuring ongoing adherence to national standards ONC has a variety of ways that this could be accomplished, some of which might be: • Require regular testing of source system through national test harnesses created for certification programs • Require state HIEs/HIOs as part of State-level HIE Cooperative Agreements to require the use of the national standards in any relevant services funded by the Cooperative Agreement (applicable to those who exchange lab data through HIEs, including hospital and state regional labs). (Note that HIEs/HIOs could also create lab transaction monitoring capabilities, such as interface testing platforms and periodic testing processes, and offer them as a service.) • Require Regional Health IT Extension Centers through their Cooperative Agreements to require the use of national standards in their procurements. RHITECs can also help with education and clear communication of standards. 21

22. CRITICAL ISSUE #2: How will these standards be monitored and enforced? Enforce and enhance federal contractual and subregulatory provisions: Enforcement Existing CMS call letter requirements that require health plans to seek contracted laboratory adoption of recognized lab result interoperability standards should be the subject of guidance letters, compliance audits and corrective action plans Existing FEHB carrier requirements to implement recognized lab result interoperability standards should be the subject of an enforcement program (States could also impose such requirements as part of state employee health benefit plans.) Enhancement When electronic systems are used, laboratory providers should be required to implement federal lab interoperability standards consistent with MU as a condition of participation in CMS programs including Medicare and Medicaid Federal contract provisions requiring adoption and implementation of clinical laboratory interoperability standards should be aligned with MU requirements and made consistent across federal departments including OPM, HHS, DoD, VA and other relevant entities, so that providers, labs and others who voluntarily contract with federal agencies are not subjected to varying requirements Recommendation (5) 22

23. CRITICAL ISSUE #3: How to ensure that patients can get prompt access to lab results? • Discussion   • A study published in the Archives of Internal Medicine in June 2009 demonstrated that patients don’t always receive their lab results, even in cases where the results are clinically significant. • The workgroup received testimony recommending changes in the law to allow patients to receive laboratory results directly from the lab (which occurs today only in states that permit patients to directly receive lab test results). • Under the Policy Committee’s Meaningful Use Matrix, objectives for 2011 include providing patients with timely electronic access to, and upon request an electronic copy of, their health information, specifically including lab results. ARRA also requires that providers using electronic health records provide patients with electronic copies upon request – and patients can have that copy sent directly to another person or entity (such as a PHR). • To ensure patients are getting timely access to lab results, Committee should consider whether the CMS meaningful use rule in 2011 and ONC interim final standards rule facilitate patient electronic receipt of lab results. 23