Meaningful Use Stage 2 Certification: A Guide for EHR Product Managers
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1 Meaningful Use Stage 2 Certification: A Guide for EHR Product Managers Terminology Management is a foundational element to satisfying the Meaningful Use Stage 2 criteria and due to its complexity, and the development costs of building and supporting such a foundation, vendors are increasingly turning to best-ofbreed Enterprise Terminology Management vendors like Health Language to support their Meaningful Use initiatives. The federal government s Meaningful Use (MU) program aims to boost the adoption of electronic health records, providing financial incentives to healthcare providers who attest to the program s standards. Meaningful Use attestation, is a process that documents an organization or individual has successfully demonstrated meaningful use and is successfully fulfilling the requirements for electronic health records (EHR) and related technology. The Centers for Medicare and Medicaid Services (CMS), which oversees Meaningful Use, reports that more than 410,000 healthcare providers have received incentive payments as of July According to CMS, more than $16 billion in payments have been issued in the Medicare side of the EHR incentive initiative, while more than $8.4 billion have been issued on the Medicaid side. 2 To qualify for those payments, healthcare providers must deploy certified EHR technology. The task of creating such a product, however, is complex. The purpose of this whitepaper is to help the EHR product manager understand the benefits of terminology management when navigating the MU Stage 2 certification process. STEPS TO CERTIFICATION The MU requirements are a bit of a moving target. The program has multiple stages, each with different criteria. Stage 1, which concluded in 2012, focused on data capture and sharing. The current phase, Stage 2, pursues more advanced clinical process, while Stage 3, scheduled for 2016, will introduce additional requirements. 3 In 2015, MU Stage 2 will have special significance for providers who began the program in 2013: the incentive payment for Medicare providers who demonstrate a full year of compliance in 2015 will be $8,000. To see where you stand, visit the CMS website s participation timeline. 4 But 2015 isn t only important from an incentive perspective. 1
2 Terminology is core to everything in healthcare, from diagnoses to procedures to outcomes. Healthcare IT systems represents clinical concepts in coded terminologies or free text. The lack of a common clinical vocabulary across disparate systems currently hinders national efforts to increase interoperability, transparency, and collaboration within the healthcare system. Medicare eligible professionals who haven t achieved Meaningful Use compliance will be subject to penalties in the form of payment adjustments starting on January 1. As a result, software vendors must comply with a shifting set of directives. The federal rulemaking process introduces an additional wrinkle: the government typically issues a proposed rule for governing a particular stage of Meaningful Use. That rule is put out for public comment and is followed by an interim rule. After additional comment and modification, the government publishes a final rule. This sequence of events generally spans several months, and the vendor must be nimble to keep up with the changing regulatory landscape. The Meaningful Use criteria, once solidified, offer additional challenges. In all, there are more than 40 criteria that apply to software vendors that hope to deliver a compliant software product. Some criteria apply to software intended for what the Meaningful Use program defines as Eligible Professionals (individual clinicians such as doctors and dentists), while others apply to Eligible Hospitals. The software requirements cover a range of technology, from computerized physician order entry (CPOE), to clinical decision support, to e-prescribing. In addition, vendors must adhere to more than a dozen standards, including HL7, LOINC, RxNorm, and SNOMED CT, to name just a few. The Office of the National Coordinator (ONC) for Health IT, which creates the MU criteria, manages the process through its Certification Program. Under the program, a vendor submits its software to an Accredited Testing Laboratory for evaluation. If the test proves successful, the software moves on to an Authorized Certification Body for approval. Certified products are then placed on the Certified Health IT Product List. 5 THE ROLE OF TERMINOLOGY IN MEANINGFUL USE AND BEYOND Terminology is core to everything in healthcare, from diagnoses to procedures to outcomes. Healthcare IT systems represent clinical concepts in coded terminologies or free text. The lack of a common clinical vocabulary across disparate systems currently hinders national efforts to increase interoperability, transparency, and collaboration within the healthcare system. The ability to translate, or map, among the terminologies used in different healthcare IT systems becomes a critical tool for Meaningful Use compliance. Stage 2 Meaningful Use, for example, designates the 2
3 By single sourcing content designed to go beyond Meaningful Use's basic terminology requirements, an EHR vendor can increase clinician satisfaction and minimize lost revenue for providers by capturing the necessary clinical documentation to support billing requirements. RxNorm drug terminology as the required vocabulary for communicating medication data. Many organizations will need to map their current pharmacy management codes to RxNorm in order to achieve compliance. Similarly, industry standard LOINC codes (laboratory data) and the SNOMED CT terminology (problem lists) are required under the Meaningful Use program. To qualify for MU Stage 2 incentives, a provider must be able to translate non-standardized lab codes and problem lists to LOINC and SNOMED CT, respectively. Terminology mapping also plays an important role in emerging healthcare delivery models such as Accountable Care Organizations (ACOs). ACOs will need to integrate clinical and claims data - often encoded in SNOMED CT and ICD - to provide an accurate picture of health across the patient populations they manage. Mapping between standards helps ACOs make the most of their data, improving patient care. BUILD VS. BUY Landing on the certified product list is the EHR vendor s objective. But to get there, a product manager must first conduct a gap analysis to see where its offering must evolve to meet the Meaningful Use criteria. Terminology management is a foundational element to satisfying the Meaningful Use criteria and due to its complexity, and the development costs of building and supporting such a foundation, vendors are increasingly turning to best-of-breed Enterprise Terminology Management vendors to support their MU stage 2 certification projects. The build (source it directly and integrate) option obviously gives the EHR vendor more control over the time to market and minimizes any upfront licensing costs. And managing the whole process in house lets the software development team account for company-specific business processes and technical requirements. On the downside, this approach often presents hidden costs and introduces risks by consuming development resources as the developers not only have to integrate the required terminologies provided by the different standards bodies, but also provide ongoing content updates when they re published. These updates could introduce unforeseen risks to the overall the EHR software platform and their customers if not managed properly. The buy (or single source from a terminology vendor) option may involve greater upfront cost in terms of software licensing in order to 3
4 single source the required terminologies to support the MU requirements. On the other hand, this approach won t tie up internal resources, or introduce product delivery risks, and may ultimately provide a better experience for clinicians by ensuring that they always have the latest updates in place. One of the key advantages of single sourcing the required terminologies is leveraging economies of scale with content designed to provide additional value above the core MU requirements. Some examples include multilateral terminology maps, value sets, and synonym libraries, as illustrated in the diagram below. For example, leveraging terminology maps designed to translate local lab catalogs or proprietary drug data to LOINC and RxNorm can enable an EHR vendor to support the interoperability requirements of their customers who have legacy information systems that don t yet support LOINC or RxNorm but still need to communicate with the EHR. CERTIFIED EMR CONTENT SET The necessary building blocks by which certified EMR vendors producing or receiving clinical and administrative data can centrally manage terminologies the nexus of data, meta-data intelligence and workflow to support semantic interoperability Code Groups/ Value Sets Health Language curates value sets for clinical quality measures, which are used for quality reporting under MU. Users can also reuse these value sets and curate local modifications for their internal analytics needs. SMOKING STATUS INDICATOR DISEASE CONDITIONS MEDICAL SPECIALTIES Synonym Libraries Health Language simplifies problems and diagnoses search within your EHR by supporting the documentation requirements for Meaningful Use and ICD-10 using the language clinician's use. This library consists of over 1M synonyms and clinical and coding attributes to support the upcoming ICD-10 transition. PROVIDER FRIENDLY TERMS CONSUMER FRIENDLY TERMS Basic Classification System Health Language provides the necessary diagnoses and procedure codes to prepare you for the upcoming ICD-10 transition. Classification & Reference Terminologies Health Language provides content to meet MU Stage 2 requirements including SNOMED CT(R), RxNorm, LOINC(R), CDT, CVX, and HL7. Multi-Lateral Terminology Maps Health Language provides maps to harmonize data from disparate sources into standard terminologies to support broader interoperability requirements for your certified EHR. ICD-10-PCS ICD-10-CM ICD-9-CM SNOMED CT LOINC RxNorm OMB UNII CVX LOCAL DRUG TERMINOLOGIES > RXNORM SNOMED > ICD-10 LOCAL LAB CATALOGS > LOINC Diagram 1 - Health Language's Certified EHR Content Set Another consideration when evaluating a build vs. buy approach is the upcoming ICD-10 transition which presents its own set of complex challenges. Taking a single source approach can help vendors tackle ICD-10 in parallel with Meaningful Use. By addressing these issues at the same time, vendors and their clients avoid reworking and duplicating coding and business processes common to each initiative. To address this challenge, EHR vendors can leverage a comprehensive synonym library of provider friendly terms with mappings to SNOMED CT, ICD-9 and ICD-10. By leveraging the language clinicians use, an EHR can simplify 4
5 problems and diagnoses search for clinicians by capturing the necessary codes behind the scenes while also supporting the documentation requirements for MU and ICD-10. By single sourcing content designed to go beyond MU s basic terminology requirements, an EHR vendor can increase clinician satisfaction and minimize lost revenue for providers by capturing the necessary clinical documentation to support billing requirements. Whichever path a company takes, however, it will still need to focus on the long list of requirements. Health Language, a leader in enterprise terminology management, provides software and content sets that support all content required under MU Stage 2 as outlined in the above diagram. The following section of this whitepaper provides a guide to the key requirements and how Health Language can help you meet them. CERTIFICATION REQUIREMENTS EHR developers must adhere to the government s Meaningful Use criteria to achieve Stage 2 certification.. From the healthcare provider s perspective, some criteria apply only to Eligible Professionals, while others apply only to Eligible Hospitals. Some apply to both. The criteria also break down according to mandatory core objectives and menu objectives. Health Language's content is intended to facilitate an EHR's certification process with respect to the following requirements: KEY: Hospital Professional Core Menu Requirement Computerized Provider Order Entry Requirement: a.1 Description How to satisfy: EHR system must enable a user to electronically record, change, and access order types including medications, laboratory, and radiology/imaging. Certified EHR Content Sets Demographics Requirement: a.3 How to satisfy: EHR technology must let a user electronically record, change, and access patient demographic data including preferred language, sex, race, ethnicity, and date of birth. Demographics Requirement: a.3 How to satisfy: EHR technology must let a user electronically record, change, and access patient demographic data including preferred language, sex, race, ethnicity, and date of birth. In addition, the system must record data and preliminary cause of death in the event of mortality. Problem Lists Requirement: a.5 How to satisfy: EHR must let a user electronically record, change, and access a patient s problem list. 5
6 Drug-Formulary Checks Requirement: a.10 How to satisfy: EHR must automatically and electronically check whether a drug formulary, or preferred drug list, exists for a given patient and medication. Record Smoking Status Requirement: a.11 How to satisfy: EHR technology must enable users to electronically record, change, and access the smoking status of a patient. Family Health History Requirement: a.13 How to satisfy: EHR must let a user electronically record, change, and access a patient s family health history. Patient-Specific Education Resources Requirement: a.15 How to satisfy: EHR system must electronically identify patient-specific education resources based on patient data from such sources as problem and medication lists., 04, 05 Transitions of Care - Receive, display, and incorporate transition of care/ referral summaries Requirement: b.1 How to satisfy: EHR system be able to receive, display and incorporate transition of care/referral summaries. Transitions of Care - Create and transmit transition of care/referral summaries Requirement: b.2 How to satisfy: EHR system must be able to create transition of care/referral summaries. e-prescribing/erx Requirement: b.3 How to satisfy: EHR system must enable a user to electronically create prescriptions and prescriptionrelated information for electronic transmission. Clinical Information Reconciliation Requirement: b.4 How to satisfy: EHR system must let a user electronically reconcile the data that represent a patient s active medication, problem and medication allergy list., 05 6
7 Receive and Incorporate Laboratory Tests and Values/Results Requirement: b.5 How to satisfy: EHR system must be able to receive results, electronically display all the information for a test report, and electronically attribute, associate or link a laboratory test and value/result with a laboratory order or patient record., 03 Provide Structured Electronic Lab Results to Ambulatory Providers Requirement: b.6 How to satisfy: EHR system must be able to electronically create laboratory test reports for electronic transmission., 05 Data Portability Requirement: b.7 How to satisfy: EHR system must let a user electronically create a set of export summaries for all patients, including data on encounter diagnosis and immunizations. Clinical Quality Measures - Capture and Export Requirement: c.1 How to satisfy: EHR technology must electronically record all of the data required to calculate each CQM. It must also be able to electronically export a CQM data file., 04 Clinical Quality Measures - Import and Calculate Requirement: c.2 How to satisfy: EHR system must electronically import a data file and calculate clinical quality measures., 04 Clinical Quality Measures - Electronic Submission Requirement: c.3 How to satisfy: EHR system must enable a user to electronically create a data file for transmitting clinical quality measurement data., 04 Patient Information Access Requirement: e.1 How to satisfy: EHR must give patients the ability to view online, download, and transmit information about a hospital admission. 01, Patient Information Access Requirement: e.1 How to satisfy: EHR technology must provide patients the ability to view online, download, and transmit health information within four business days of the information being available to Eligible Professional. 01, 7
8 Clinical Summary Requirement: e.2 How to satisfy: EHR must enable a user to create a clinical summary for a patient in human-readable format. 05 Immunization Information Requirement: f.1 How to satisfy: EHR technology must let a user to electronically record, change and access immunization information. 03 Transmission to Immunization Registries Requirement: f.2 How to satisfy: EHR must be able to electronically create immunization information for electronic transmission. 03 Transmission of Reportable Laboratory Tests and Values/Results Requirement: f.4 How to satisfy: EHR system must be able to electronically create reportable laboratory tests and values/results for electronic transmission. Transmission to Cancer Registries Requirement: f.6 How to satisfy: EHR system must be capable of electronically creating cancer case information for electronic transmission. 8
9 SOFTWARE REQUIREMENTS In addition to compliance requirements, here are 20 software requirements an EHR product manager must also address: KEY: Hospital Professional Core Menu Vital Signs, body mass index and growth charts. Requirement ( a.4) Electronic Notes. Requirement ( a.9) Image Results. Requirement ( a.12) Patient List Creation. Generation of patient lists by specific conditions. Requirement ( a.14) Patient List Creation. Identification of Patients for Reminders. Requirement ( a.14) Advance Directives. Requirement ( a.17) Authentication, Access Control and Authorization. Requirement ( d.1) Auditable Events and Tamper Resistance. Requirement ( d.2) Audit Reports. Requirement ( d.3) Amendments. Requirement ( d.4) 9
10 Automatic Log Off. Requirement ( d.5) Emergency Access. Requirement ( d.6) End-user Device Encryption. Requirement ( d.7) Integrity. Requirement ( d.8) Optional Accounting of Disclosures. Requirement ( d.9) Secure Messaging. Requirement ( e.3) Secure Messaging. Requirement ( e.3) Automated Numerator Encoding. Requirement ( g.1) Automated Measure Calculation. Requirement ( g.2) Safety-Enhanced Design. Requirement ( g.3) Quality Management System. Requirement ( g.4) 10
11 WHAT TO LOOK FOR IN A TERMINOLOGY MANAGEMENT PARTNER Stage 2 Meaningful Use requirements have raised the bar for vocabulary standards. Many vendors find it too difficult and costly to meet all of the requirements themselves. Consequently, increasing numbers of healthcare IT vendors are turning to Health Language for terminology support to satisfy all of their vocabulary requirements. This approach will help vendors save money and accelerate time to market their Stage 2- certified EHR. Here are some things to consider when selecting a partner to create a single, integrated, and trusted source of terminology truth: 1. Sourcing the required classification and reference terminologies (ICD-9-CM, ICD-10-PCS and ICD- 10-CM, SNOMED CT, LOINC, RxNorm, and others) to support the MU Stage 2 and billing requirements 2. Through the use of Multi-lateral terminology maps, ensure non certified systems who may be using local code sets interoperate with your EMR by translating local and proprietary codes to standards to support your customer's interoperability requirements with legacy information systems 3. Integrate code groups and value sets to support clinical quality measures 4. Leverage a comprehensive synonym library with mappings to SNOMED CT, ICD-9 and ICD-10 to simplify problems and diagnoses search for clinicians 5. Have access to an automated content management and update process to ensure your certified EHR provides the latest and most up to date code sets for your customers 11
12 1 Centers for Medicare and Medicaid Services (CMS), 2 CMS, 3 HealthIT.gov, 4 CMS, 5 Department of Health and Human Services, Office of the National Coordinator, 12
13 ABOUT HEALTH LANGUAGE Health Language provides software, content, and consulting solutions that map, translate, update, and manage standard and enhanced clinical terminologies on an enterprise scale - enabling the information liquidity required to support healthcare s toughest challenges, such as Meaningful Use, ICD-10, population health, analytics, ACOs, and semantic interoperability among systems. ABOUT THE AUTHOR Brian Diaz is Director of Marketing at Wolters Kluwer Health. Brian can be reached at brian.diaz@wolterskluwer.com Additional information To learn more about our solutions, visit Health Language 4600 South Syracuse Street Suite 1200 Denver, CO 837 healthlanguage.com Wolters Kluwer Health All Rights Reserved. HL-WP-MUPB
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