1. Office of the National Coordinator for Health IT (ONC) Certification Program June 19, 2013 Lauren Fifield, Policy Adviser, Practice Fusion

2. TODAY’S AGENDA Introduction ONC Overview EHR Certification Discussion Topics

3. In 2009, the HITECH Act provisioned $19.2 billion to promote the adoption of EHRs As developed under the Department of Health and Human Services (HHS), the EHR Incentive Program framework has three stages: – Stage 1: data capture and sharing (2011-2013) – Stage 2: advanced clinical processes (2014-2015) – Stage 3: improved outcomes (2015-2016) Eligible Professionals (EPs) and Eligible Hospitals (EHs) earn incentives for adopting certified EHRs and successfully achieving Meaningful Use (MU).Meaningful Use (MU)

4. Two organizations within HHS jointly oversee and manage the EHR Incentive Programs – The Centers for Medicare and Medicaid Services (CMS) oversees MU and provides incentive payments to EPs and EHs who meaningfully use Certified EHR Technology (CEHRT)MU – The Office of the National Coordinator for health IT (ONC), per the HITECH Act, was charged with creating the ONC HIT Certification ProgramHITECH Act Certification vs. MU Certification establishes standard EHR Technology capabilities that enable providers to adopt and pursue Meaningful Use of the technology. Solely adopting certified EHR does not qualify an EP or EH to receive incentive payments.

5. The HITECH Act introduced a definition for health IT ‘Health information technology’: Hardware, software, integrated technologies, integrated technologies or related licenses, intellectual property, upgrades, or packaged solutions sold as services that are designed for or support the use by health care entities or patients for the electronic creation, maintenance, access, or exchange of health information

6. TODAY’S AGENDA Introduction ONC Overview ONC HIT Certification Program Discussion Topics

7. The HITECH Act also established the ONC Towards the “development a nationwide HIT infrastructure that allows for the electronic use and exchange of health information”, ONC duties include: – Standards – HIT Policy Coordination (FACAs, HIT Strategic Plan) – Measurable Outcome Goals – Publication – Certification – Reports and Publications – Assistance – Governance for Nationwide Health Information Network

8. The Office of the National Coordinator Goal: “to pursue the modernization of the American health care system through the implementation and meaningful use of health information technology”.

9. OPP and OCERT Office of Policy and Planning (OPP) Develops and coordinates policies that support market optimization and provides proactive and forward-thinking strategies that reflect open and transparent processes Office of Certification (OCERT) Accredits the testing and certification bodies that ensure health IT is certified for use by federal agencies and partners and as required for attestation by providers participating in the Meaningful Use Programs

10. ONC HIT Certification Program Overview

11. OST Office of Science and Technology (OST) Promotes the adoption of interoperable, open, standards-based technologies and architectures that ensure information can flow seamlessly and securely between interoperable health IT. By engaging a range of stakeholders through a standardized framework, OST accelerates the development and harmonization of health IT standards.

12. Standards Development, Testing, Acceleration

13. Investing in Innovation (i2) – Under ONC’s i2 Program, competitions focus on using the Challenge.gov criteria and providing incentives that will help in the development of innovations that support HITECH Act, HHS goals, RECs, and learning health system

14. TODAY’S AGENDA Introduction ONC Overview ONC HIT Certification Program Discussion Topics

15. The ONC HIT Certification Program – General Characteristics – Scope – Requirements – Process

16. General Characteristics: Tied to Meaningful Use 20112012201320142015… MU for Providers Stage 1 Stage 1 & 2 Certification Required 2011 Edition 2011 & 2014 Edition 2014 Edition Stage 2 delayed

17. General Characteristics General Characteristics: Modular

18. Scope – Currently, certification is limited to electronic health records (EHRs) and module functionality – HITECH Act grants ONC authority to broadly certify health IT – Certification was established as a voluntary program

19. Overview Certification Requirements Vocabulary & Code Sets – e.g. LOINC, RxNorm, SNOMED CT, Common MU Data Set Transport – e.g. Applicability Statement for Secure Health Transport Content Exchange/Utilization – HL7 Infobutton + Igs, Consolidated CDA, QRDA Category I & III, HL7 2.5.1+ IG Other – Automated numerator recording – Safety-enhanced design – Medication related certification criteria – Quality management system – Price Transparency – Test Result Transparency

20. Certification Standards and Criteria

21. Certification Process

22. Testing - ATLs – Certification and testing activities are performed by separate entities – Testing is performed by Accredited Testing Laboratories (ATLs) – The National Voluntary Laboratory Accreditation Program (NVLAP) has been acknowledged by ONC, by regulation, as the Accreditation Body for Testing Laboratories in the ONC HIT Certification ProgramNational Voluntary Laboratory Accreditation Program (NVLAP) – Approved test tools and test procedures are used to test Complete EHRs and/or EHR Modules in order for them to be eligible for certification by an ONC-Authorized Certification Body (ONC-ACB).

23. Certification – ONC-ACBs – ANSI accredits certification bodies, which then seek ONC authorization to certify EHR technologies in the HIT Certification Program – ONC-ACBs renew status every three years – A single organization can be both an ONC- ACB and an ATL (if they have a strong firewall between the two programs)

24. Example – Will review a test procedure and test data example

25. Certified HIT Product List – The Certified Health IT Product List (CHPL) lists Complete Electronic Health Records (EHRs) and EHR Module(s) – The website is managed by the ONC and for use by EPs and EHs to identify certified technology

26. TODAY’S AGENDA Introduction ONC Overview ONC HIT Certification Program Discussion Topics

27. Reduce Risk of Harm – Require standard drug-drug, drug allergy interaction warnings – Adoption of standards for exchange, vocabulary, reporting – Baseline privacy and security capabilities – Clinical reconciliation and exchange standards

28. Market Assurances – Standards assurances (CHPL, surveillance and revocation of certification) – Transparency into quality management system and safety-enhanced-design processes – Standard guidelines for listing of CDS intervention source

29. Promote Innovation – Modular certification – Challenges – Convening stakeholders – Acceleration of standards development – Shifting initiatives to private sector HealtheWay (formerly NwHIN Exchange)

30. Challenges/Risks to Innovation – Fine line: technology prescription vs. technology as means to end – High level of complexity – Regulatory scaling concerns – Regulatory uncertainty stage-to-stage – Universal applicability issues

31. Challenges/Risks to Innovation – Measurement Risks Emergency Access, E-Prescribing, Immunizations, Formulary check Automated measure calculation – Flexibility Allergy decision support Time to certify