Understanding Certification: Evaluating Certified EHR Technology Alisa Ray, Executive Director, Certification Commission for Health Information Technology Marisa L Wilson, DNSc, MHSc, RN-BC, Assistant Professor, Nursing Informatics, University of Maryland School of Nursing Summer Institute in Nursing Informatics Baltimore, MD July 23, 2010
Today s Topics The role of certification in HIT adoption CCHIT in brief ARRA in brief Federal rulemaking on certification bodies CCHIT s certification programs Q&A
The Health IT Adoption Deadlock Will not offer adoption incentives unless EHRs benefits are assured Payers/Purchasers IT Vendors Can not lower prices until provider adoption accelerates Providers Slow to adopt EHRs until costs and risks are lower and/or incentives higher 2010 CCHIT Slide 3 July 23, 2010
Certification as a Catalyst Beneficial effects and interoperability assured, unlocking incentives Payers/Purchasers IT Vendors Growing market attracts investment, lowers costs Providers Reduced risk and availability of incentives accelerates adoption 2010 CCHIT Slide 4 July 23, 2010
CCHIT in brief Mission: accelerate the adoption of robust, interoperable health IT by creating an efficient, credible certification process Status: independent, nonprofit 501(c)3 organization Developed certification criteria and inspection processes under contract with HHS/ONC, 2005-2009 Federally recognized certifying body since 2006 (Stark safe harbor, Medicare EHR demo, State ehealth programs, private sector pay-for-performance programs) Over 250 products certified, representing 85% of the installed market Independent development process continues to be voluntary and transparent 2010 CCHIT Slide 5 July 23, 2010
Foundations of credibility, 2005-2010 Transparent organization Strong engagement from diverse stakeholders Balance of providers, developers, other HIT experts, payers, government Number of participants has nearly doubled each year Over 250 on workgroups at present Voluntary, consensus-based criteria development Open recruitment, open development process Public comment on interim and final materials Pilot testing Robust, repeatable and efficient inspection process Zero tolerance for conflict of interest Demonstrated scalability Endorsement of professional organizations 2010 CCHIT Slide 6 July 23, 2010
CCHIT Certified Development Process Inputs: * Scope guidance from the Commission * Roadmap (from previous year) * Environmental scan: - Available standards - Market research - More Public Comment periods* Develop Draft Criteria & Test Scripts Refine Criteria and Develop Pilot Test Scripts Proposed Final Criteria and Test Scripts Final Criteria and Test Scripts Launch Certification * Length of development and number of Public Comment periods depend upon the domain and scope of work Pilot Test A consensus-based process with broad support from health care stakeholders 2010 CCHIT Slide 7 July 23, 2010
Features of CCHIT Certified Inspection Process Rigorous, objective, and consistent testing 100% compliance required Open book model all criteria and test scripts are published in advance for all vendors to use in preparation Panel of well-trained expert jurors free of financial conflicts Cost-efficient uses web-conferencing and other virtual presence tools to avoid travel expense Robust retesting and appeal processes 2010 CCHIT Slide 8 July 23, 2010
Juror-Observed Virtual Demonstration CCHIT Proctor Juror A (Practicing physician) Vendor personnel follow Test Script to demonstrate system at the vendor facility Web conferencing and concurrent audio conferencing Juror B (Practicing Nurse Inpatient Products) Juror C 2010 CCHIT Slide 9 July 23, 2010
The American Recovery and Reinvestment Act (ARRA): Financial Incentives for Electronic Health Records (EHRs)
ARRA in brief Effective Feb 19, 2009 HITECH is the section dealing with health IT Codifies the Office of the National Coordinator, and HIT Policy and HIT Standards Committees Allocates $2B for programs directly administered by ONC Major: HIT Regional Extension Centers, State HIEs Minor: Beacon Communities, Community College education, Strategic Health IT Advanced Research Projects (SHARP), others Provides ~$20B in incentive payments (and penalties for noncompliance) for Eligible Providers and Hospitals under Medicare and Medicaid For adoption and meaningful use of certified EHR technology 2010 CCHIT Slide 11 July 23, 2010
Three Steps to the ARRA Incentive Our topic today Step 1: Adopt certified EHR technology EHR is certified by an ONC-accredited certifying body against ONC-developed criteria and standards Step 2: Achieve meaningful use Hospital or Eligible Provider achieves Meaningful Use goals, objectives, and measures published by CMS Step 3: Apply for payment Hospital or Eligible Provider submits data or reports in a manner to be defined by CMS, collect payment 2010 CCHIT Slide 12 July 23, 2010
Three federal rules with strong cross-dependencies Meaningful Use (CMS) Standards & Criteria (ONC) Dec Mar NPRM IFR Analyze 2000 public comments, issued Final Rule Analyze 700 public comments; effective Feb 13; issued Final Rule Final Rule July 13 Final Rule July 13 Today 60 days until effective 30 days until effective Certification Process (ONC) Test Tools & Procedures (NIST) NPRM Analyze ~ 100 public comments, issued Final Rule Permanent program (longer schedule) Develop test procedures and test tools Final Rule June 24 Approved Procedures 30-day delay waived; in effect now Some still pending 2010 CCHIT Slide 13 July 23, 2010
Certification Final Rule NPRM published March 9, 2010 Final rules for the temporary program published June 24 30-day delay waived; effective now Taking applications for ONC- ATCBs now ONC-ATCBs will be operational by late summer Certified EHR technology will be available by fall 2010 CCHIT Slide 14 July 23, 2010
Details of Certification Final Rule: Two sequential certification programs Temporary program ONC accredits one or more Authorized Testing and Certification Bodies (ONC-ATCB) Authorization ends when the first ONC-ACB is accredited by the permanent program; certifications in process may be completed Permanent program Replaces the temporary program with a more complex structure ONC will recognize one (and only one) Approved Accreditor (ONC-AA) ONC will recognize one or more ONC-Authorized Certification Bodies (ONC- ACB); to apply for ONC-ACB a body has to first be accredited by the ONC-AA NIST will accredit one or more NIST-Accredited Testing Labs through the National Voluntary Laboratory Accreditation Program (NVLAP) An organization can be both an ONC-ACB and a NIST-ATL, or they can be separate ONC-ACBs may only use NIST-ATLs for their testing ONC-ACBs must renew their status every 2 years 2010 CCHIT Slide 15 July 23, 2010
National Institute of Standards and Technology (NIST) Conformance Test Methods for Health IT Certification Test procedures, test data, and test tools Released material in four waves eprescribing, lab submission still pending Final procedures and tools will now need to be updated to the Final Rule Available at http://healthcare.nist.gov/use_testing/index.html 2010 CCHIT Slide 16 July 23, 2010
Meeting Meaningful Use Objectives and Measures For Eligible Providers Meet 15 from a Core Set Meet 5 from a Menu Set of 10 (including at least 1 public health measure) Meet all 25 requirements in later stages For Hospitals Meet 14 from a Core Set Meet 5 from a Menu Set of 10 (including at least 1 public health measure) Meet all 24 requirements in later stages See The Meaningful Use Regulation for Electronic Health Records, New England Journal of Medicine, July 13, 2010; David Blumenthal, M.D., M.P.P., and Marilyn Tavenner, R.N., M.H.A. http://healthcarereform.nejm.org/?p=3732&query=home#printpreview 2010 CCHIT Slide 17 July 23, 2010
Update on CCHIT Certification Programs and Plans
CCHIT s Certification Programs Two distinct but complementary certification programs No cross-dependencies between the programs Taking applications, performing testing, issuing certifications CCHIT is not yet an ONC-ATCB Launching and developing new programs for special populations, special settings and specialty medicine Developing programs to meet provider certification needs for self-developed or self-assembled EHRs Applied for ONC-ATCB 2010 CCHIT Slide 19 July 23, 2010
Current Certification Programs Preliminary ARRA A choice for providers who are new to EHRs or need extra information and maximal assurance when selecting a certified EHR Inspects integrated EHR capabilities that exceed many of the HHS IFR Stage 1 certification criteria An EHR may also be certified in the ARRA program A choice for providers experienced with EHR technology who want maximum flexibility to assemble an EHR from a mix of products and technologies Inspects Complete EHRs or EHR Modules against federal minimum requirements Signals product readiness for final ARRA certification Will be replaced with a final ARRA program when ONC- ATCB programs ready 2010 CCHIT Slide 20 July 23, 2010
Understanding the Differences Preliminary ARRA Separate certification Criteria independently developed by CCHIT s broad stakeholder work groups to meet provider needs Multiple domains, plus specialty systems and optional endorsements Integrated EHR with all necessary functionality Usability tested and rated (Ambulatory) Live usage at multiple sites verified Vendor characteristics published Meets one or more federal criteria and standards (clearly labeled) Two domains: Eligible Provider and Hospital 2010 CCHIT Slide 21 July 23, 2010
Labeling for Modular Certification Program 2010 CCHIT Slide 22 July 23, 2010
CCHIT Certified Program Domains Available or in Development Base Domain Certification Options (Add-on to Base Domain) Year Launched or [Planned] Available Now Ambulatory EHR 2006 Yes Child Health 2008 Yes Cardiovascular Medicine 2008 Yes Behavioral Health (add-on) 2010 July 26 Dermatology 2010 July 26 Clinical Research 2010 Fall Inpatient EHR 2007 Yes Emergency Dept 2008 Yes Enterprise 2008 Yes eprescribing (stand-alone) 2009 Yes Behavioral Health (stand-alone) 2010 July 26 Long Term and Post-Acute Care 2010 July 26 2010 CCHIT Slide 23 July 23, 2010
Continued Growth of CCHIT s Certification Programs This month began developing two new CCHIT Certified domains: Oncology Women s Health (obstetrics and gynecology) Developing an ARRA EHR certification alternative for hospitals (opening first) and eligible providers Self-developing EHR technology Using older, uncertified EHR technology Needing gap closure due to a mix of certified and uncertified EHR technologies 2010 CCHIT Slide 24 July 23, 2010
Opportunities for Participation Learn Info at cchit.org, ehrdecisions.com, Twitter, LinkedIn Sign up for CCHIT enews at cchit.org receive announcements of all significant events and opportunities Contribute All CCHIT development work includes opportunity for public comment announcements via cchit.org and CCHIT enews Volunteer Applications open as needed for Work Group members Applications open annually for Commissioners 2010 CCHIT Slide 25 July 23, 2010
In Summary An independent nonprofit organization with a mission to accelerate adoption of robust, interoperable health IT Consensus-based process has attracted strong volunteer engagement and earned industry credibility CCHIT maintains two separate programs to meet the unique needs of the healthcare delivery system CCHIT has applied for federal accreditation We will continue to expand our independently developed certification programs to meet the needs of special patient populations, special care settings and specialty practices 2010 CCHIT Slide 26 July 23, 2010
Thank You! Q&A For more information: http://cchit.org