1. 2010 UBO/UBU Conference Health Budgets & Financial Policy Briefing: ARRA ARRAn't You Going to Make Some Changes Too? Date: 23 March 2010 Time: 1010–1100

2. 2010 UBO/UBU Conference Turning Knowledge Into Action Discussion Framework Statutory framework under ARRA – Support of EHR adoption – Requirements of federal healthcare delivery organizations Implementing the regulations required by ARRA – EHR standards and certification criteria (ONC) – EHR Incentive Program (CMS) – EHR certification bodies and processes (ONC) Definition of Meaningful Use Initial set of standards, certification criteria and implementing specifications 2

3. 2010 UBO/UBU Conference Turning Knowledge Into Action Statutory Framework Under ARRA Support for EHR Adoption The ARRA seeks to greatly accelerate the adoption of EHRs across the nation by providing substantial incentive payments for the adoption and use of EHRs. To meet the requirements to receive these incentive payments, Eligible Professionals (EP) and Eligible Hospitals (EH) must use certified EHRs in a meaningful way. Thus, the incentive program is dependent upon creating very objective definitions for this new entitlement program linked to the concept of “meaningful use.” 3

4. 2010 UBO/UBU Conference Turning Knowledge Into Action Statutory Framework Under ARRA (2) Support for EHR Adoption The general requirements set forth in the ARRA for meaningful use require that a provider/hospital 1.use “certified EHR technology” including “electronic prescribing,” 2.use standards-based electronic exchange of appropriate health information “to improve the quality of health care [and] care coordination,” and 3.report information on “clinical quality … and … other measures.” 4

5. 2010 UBO/UBU Conference Turning Knowledge Into Action Statutory Framework Under ARRA (3) Requirements for Federal HCOs SEC. 13111. COORDINATION OF FEDERAL ACTIVITIES WITH ADOPTED STANDARDS AND IMPLEMENTATION SPECIFICATIONS. (a) SPENDING ON HEALTH INFORMATION TECHNOLOGY SYSTEMS.— As each agency…implements, acquires, or upgrades health information technology systems used for the direct exchange of individually identifiable health information between agencies and with non-Federal entities, it shall utilize, where available, health information technology systems and products that meet standards and implementation specifications adopted under section 3004 of the Public Health Service Act, as added by section 13101. (b) FEDERAL INFORMATION COLLECTION ACTIVITIES.—With respect to a standard or implementation specification adopted under section 3004 of the Public Health Service Act, as added by section 13101, the President shall take measures to ensure that Federal activities involving the broad collection and submission of health information are consistent with such standard or implementation specification, respectively, within three years after the date of such adoption. 5

6. 2010 UBO/UBU Conference Turning Knowledge Into Action Statutory Framework Under ARRA (4) Requirements for Federal HCOs Interpretation of S13111 of the ARRA S13111 uses the same language as that previously stated in EO 13410 EO 13410 had been interpreted to mean that while national standards implementation did not have to be implemented internally within the departments, any information that crossed organizational boundaries (left the VA or DoD), would have to be standards compliant. 6

7. 2010 UBO/UBU Conference Turning Knowledge Into Action Statutory Framework Under ARRA (5) Requirements for Federal HCOs The implications of the ARRA and prior EO assessments are clear – DoD/VA sharing should be based on national standards – DoD/VA sharing with partners in the private or commercial communities should be based on national standards – As noted in the following section of this brief, new national standards are being proposed and the “old” standards are not necessarily the basis of plans moving forward 7

8. 2010 UBO/UBU Conference Turning Knowledge Into Action Implementing the Regulations Required by ARRA To support national HIE, the ARRA required three sets of rules – EHR standards and certification criteria (ONC) – EHR Incentive Program (CMS) – EHR certification bodies and processes (ONC) The ONC-published Interim Final Rule on EHR standards and certification criteria has the most direct bearing on Federal Health Care Organizations The CMS proposed rule on EHR incentives has strong impact on adoption of EHRs in the private sector The ONC has yet to propose its rule regarding new certification bodies and procedures to accelerate the certification of EHRs and EHR modules 8

9. 2010 UBO/UBU Conference Turning Knowledge Into Action EHR Standards, Implementation Specifications and Certification Criteria (ONC IFR) - 1 ONC published its Interim Final Rule (IFR) on 13 January 2010. As an IFR is a “final rule,” it has the force of law and became final on 12 February 2010. The “finality” of the rule is needed to support certification standards for EHRs in time for providers to qualify for Meaningful Use (MU) incentives by 2011. Although the ONC IFR is a final rule, ONC has agreed to take comments from the public through 15 March and hopes to publish a final rule by year’s end. 9

10. 2010 UBO/UBU Conference Turning Knowledge Into Action ONC IFR – 2 Stages of Meaningful Use (MU) The ARRA required that “…more stringent measures of meaningful use” be defined by HHS to “improve the use of electronic health records and health care quality over time”. Three “stages” of MU were defined in the CMS NPRM and adopted in the ONC IFR: – Stage 1: Required in 2011 – Final (for EHRs on 12Feb – Stage 2: Required in 2013 – Open for comment – Stage 3: Required in 2015 – Open for comment 10

11. 2010 UBO/UBU Conference Turning Knowledge Into Action ONC IFR – 3 Three Components of the Rule The title of ONC’s IFR is “Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology” As the name of the rule implies, it addresses: – Standards for EHR Technology – Implementation Specifications for EHR Technology – Certification Criteria for EHR Technology 11

12. 2010 UBO/UBU Conference Turning Knowledge Into Action ONC IFR Implementation Specifications (IS) – 1 The IFR defines IS as “specific requirements or instructions for implementing a standard.” Many IS have been developed by HITSP. While the IFR states, “We expect that in determining whether to recognize harmonized or updated standards from other entities, the HIT Standards Committee will look to entities such as HITSP…,” it goes on to state that “HITSP… developed implementation specifications… which …resulted in varying degrees of interoperability…. and resulted in a narrow and unique set of implementation specifications, designed for a specific architecture and well-defined exchange…. We do not believe, with the exception of the few mentioned below, that there are mature implementation specifications ready to adopt to support meaningful use Stage 1.” 12

13. 2010 UBO/UBU Conference Turning Knowledge Into Action ONC IFR IS Adopted by the ONC IFR – 2 The Physician Quality Reporting Initiative (PQRI) Measure Specifications Manual for Claims and Registry The HIPAA “IS” for eligibility for health plan transactions and health care claims The “requirements of Phase 1 of the Council for Affordable Quality Healthcare (CAQH) Committee on Operating Rules for Information Exchange (CORE)” 13

14. 2010 UBO/UBU Conference Turning Knowledge Into Action ONC IFR Certification Criteria – 1 “…the Secretary has decided not to adopt previously recognized certification criteria developed in 2006 as any of the certification criteria in this interim final rule.” The current approach is that certification criteria will be aligned with “the proposed definition of meaningful use Stage 1….” Certification Criteria are those criteria that an EHR must be capable of supporting in order to be certified Stage 1 certification criteria follow 14

15. 2010 UBO/UBU Conference Turning Knowledge Into Action ONC IFR Certification Criteria – 2 1 - Use Computerized Provider Order Entry 2 - Implement drug-drug, drug-allergy, drug-formulary checks 3 - Maintain an up-to-date problem list of current and active diagnoses based on ICD–9–CM or SNOMED CT®. 4 - Generate and transmit permissible prescriptions electronically (eRx). 5 - Maintain active medication list 15

16. 2010 UBO/UBU Conference Turning Knowledge Into Action ONC IFR Certification Criteria – 3 6 - Maintain active medication allergy list 7 - Record demographics (4, 5) 8 - Record and chart changes in vital signs: Height Weight Blood pressure Calculate and display: BMI Plot and display growth charts for children 2–20 years, including BMI 9 - Record smoking status for patients 13 years old or older. 16

17. 2010 UBO/UBU Conference Turning Knowledge Into Action ONC IFR Certification Criteria – 4 10 - Incorporate clinical lab-test results into EHR as structured data. 11 - Generate lists of patients by specific conditions to use for quality improvement, reduction of disparities, and outreach. 12 - Report quality measures to CMS or the States (7, 8). 13 - Send reminders to patients per patient preference for preventive/follow up care. 17

18. 2010 UBO/UBU Conference Turning Knowledge Into Action ONC IFR Certification Criteria – 5 14 - Implement 5 clinical decision support rules 15 - Check insurance eligibility electronically from public and private payers 16 - Submit claims electronically to public and private payers 17 - Provide patients with an electronic copy of their health information upon request 18 - Provide patients with an electronic copy of their discharge instructions and procedures at time of discharge, upon request 18

19. 2010 UBO/UBU Conference Turning Knowledge Into Action ONC IFR Certification Criteria – 6 19 - Provide patients with timely electronic access to their health information (including lab results, problem list, medication lists, allergies) within 96 hours of the information being available to the eligible professional 20 - Provide clinical summaries for patients for each office visit 21 - Capability to exchange key clinical information among providers of care and patient authorized entities electronically - Provide summary care record for each transition of care and referral 19

20. 2010 UBO/UBU Conference Turning Knowledge Into Action ONC IFR Certification Criteria – 7 22 - Perform medication reconciliation at relevant encounters and each transition of care. 23 - Capability to submit electronic data to immunization registries and actual submission where required and accepted. 24 - Capability to provide electronic submission of reportable lab results (as required by state or local law) to public health agencies and actual submission where it can be received. 25 - Capability to provide electronic syndromic surveillance data to public health agencies and actual transmission according to applicable law and practice. 26 - Protect electronic health information created or maintained by the certified EHR technology through the implementation of appropriate technical capabilities. 20

21. 2010 UBO/UBU Conference Turning Knowledge Into Action ONC IFR The Standards Supporting MU – 1 The standards are organized into four categories including: Vocabulary standards: i.e., standardized nomenclatures and code-sets used to describe clinical problems and procedures, medications, and allergies Content exchange standards: i.e., standards used to share clinical information such as clinical summaries, prescriptions, and structured electronic documents Transport standards: i.e., standards used to establish a common, predictable, secure communication protocol between systems Privacy & security standards: e.g., authentication, access control, and transmission security which relate to and span across all of the other types of standards 21

22. 2010 UBO/UBU Conference Turning Knowledge Into Action ONC IFR The Standards Supporting MU – 2 The intent of the initial set of standards was to focus on those that support interoperability and privacy & security. The IFR provides the content exchange and vocabulary standards adopted as well as privacy & security standards. This presentation focuses on the content exchange and vocabulary standards 22

23. 2010 UBO/UBU Conference Turning Knowledge Into Action ONC IFR The Standards Supporting MU – 3 Purpose Cate- gory Adopted Standard(s) to Support Meaningful Use – Stage 1 Patient Summary Record CxHL7 CDA R2 CCD Level 2 or ASTM CCR Problem ListV Applicable HIPAA code set required by law (i.e., ICD-9-CM); or SNOMED-CT® Medication ListV Any code set by an RxNorm drug data source provider that is identified by the United States National Library of Medicine as being a complete data set integrated within RxNorm Medication Allergy ListVNo standard applicable at this time 23

24. 2010 UBO/UBU Conference Turning Knowledge Into Action ONC IFR The Standards Supporting MU – 4 Purpose Cate- gory Adopted Standard(s) to Support Meaningful Use – Stage 1 ProceduresV Applicable HIPAA code sets required by law (i.e., ICD-9-CM or CPT-4®) Vital SignsVNo standard adopted at this time Units of MeasureVNo standard adopted at this time Lab Orders and ResultsV LOINC® when LOINC® codes have been received from a laboratory Drug Formulary CheckCxApplicable Part D standard required by law (i.e., NCPDP Formulary & Benefits Standard 1.0) 24

25. 2010 UBO/UBU Conference Turning Knowledge Into Action ONC IFR The Standards Supporting MU – 5 Purpose Cate- gory Adopted Standard(s) to Support Meaningful Use – Stage 1 Electronic Prescribing Cx Applicable Part D standard required by law (i.e., NCPDP SCRIPT 8.1) or NCPDP SCRIPT 8.1 and NCPDP SCRIPT 10.6 V Any code set by an RxNorm drug data source provider that is identified by the United States National Library of Medicine as being a complete data set integrated within RxNorm+ Administrative Transactions Cx Applicable HIPAA transaction standards required by law Quality ReportingCxCMS PQRI 2008 Registry XML Specification #+ 25

26. 2010 UBO/UBU Conference Turning Knowledge Into Action ONC IFR The Standards Supporting MU – 6 Purpose Cate- gory Adopted Standard(s) to Support Meaningful Use – Stage 1 Submission of Lab Results to Public Health Agencies CxHL7 2.5.1 V LOINC® when LOINC® codes have been received from a laboratory Submission to Public Health Agencies for Surveillance or Reporting (except adverse event rptg) CxHL7 2.3.1 or HL7 2.5.1 V According to Applicable Public Health Agency Requirements Submission to Immunization Registries CxHL7 2.3.1 or HL7 2.5.1 VCVX#+ 26

27. 2010 UBO/UBU Conference Turning Knowledge Into Action Conclusion & Recommendations ARRA and Implementing Regulations in the Federal Register are setting a path for Nationwide Health Information Exchange (HIE) Federal health care organizations (HCOs) must use these standards when sharing health information “between agencies and with non-Federal entities” Federal HCOs should consider undertaking an analysis of HIE at organizational boundaries and determine how to modernize these exchanges to meet national standards 27

28. 2010 UBO/UBU Conference Turning Knowledge Into Action 28 Questions?