EHR Certification Programs              February 2012                 Carol A. Bean                 Doug Fridsma          ...
BACKGROUND & CONTEXT                       2
Outline Topics     Background Information & Context     Temporary Certification Program (TCP)     Permanent Certificat...
Telling the HITECH Story – What, Why, and How?                                                 4
How do we achieve interoperable healthcare information systems?      Enable                                               ...
How do we achieve interoperable healthcare information systems? Example Patient Scenario• A primary care doctor orders a l...
Interoperability: transport is necessary,but not sufficient   Vocabulary &   How should well-defined values be coded so th...
Health Information ExchangeTurns A CornerWe have made huge strides in Stage 1, making certain that every certified EHRcan...
The Nationwide Health Information Network The NwHIN is the portfolio of standards, services and polices that enable secur...
The Nationwide Health Information Network ONC has developed standards and specifications for Directed Exchange (secure  e...
The Nationwide Health Information Network                                            CURATINGA portfolio ofservices, stand...
ONC EHR Certification Programs                 The Division of Certification & Testing was established Establishment   to ...
How Does All This Work?  Vendors          ONC-         Certified     Eligible     EPs/EHscreate EHR      ATCBs test       ...
TEMPORARY CERTIFICATION    PROGRAM (TCP)                          14
TCP Program Achievements                                                                Test                              ...
Temporary Program GrowthTHEN – October 2010           NOW – February 2012 3 ONC-ATCBs                    6 ONC-ATCBs 36...
Meaningful Use Takes OffFifty-two percent of office-based physicians intend to take advantage of EHRincentives.The perce...
Medicare and Medicaid EHR Incentive  Payments – 100 K in 2012                                                        500,0...
Medicare or Medicaid EHR IncentivePayment - Eligible Hospitals                                                            ...
TCP Estimations vs. Realizations            Estimated                   Actual1-2 ONC-ATCBs           6 ONC-ATCBS200 certi...
CHPL Statistics   CHPL Stats                               Percent of Products   1722 Certified EHR Products             ...
Certified HIT and Vendor Trends18001600140012001000 800                                    Total Products 600             ...
CMS EHR Incentive ProgramsThousands of providers arereceiving incentive payments acrossthe country, totaling more than $2....
Program Oversight & MonitoringPurposeTo provide assurance to the community that the ONCCertification Programs conducted ov...
TCP Program SunsetONC issued an update to the Final Rule on November 3, 2011 to delaythe sunset of the TCP, originally sch...
TCP Program Sunset Timeline              Dec.                                             July              2011          ...
TCP vs. PCP      Temporary                Both Programs               Permanent     Certification                         ...
PERMANENT CERTIFICATION    PROGRAM (PCP)                          28
PCP Requirements Structure                                ONC                                               Technical     ...
PCP Key Facts                                                Testing and certificationANSI will be the ONC-               ...
Improvement Plan for the PCP          CHPL            Communications        Test Procedures• User interface      • Website...
ANSI’s Role: ONC-AAKey Responsibilities   Maintain conformance with ISO/IEC 17011   In accrediting certification bodies,...
ONC-ACBs: CertificationOverview Accredited by ANSI All interested organizations will have  to apply to ONC for ONC-ACB s...
NVLAP: ONC-ATL AccreditorKey Responsibilities   Maintain conformance with ISO/IEC 17011   In accrediting test labs, veri...
ONC-ATLs: TestingOverview Accredited by NVLAP All interested organizations will have to apply  to ONC for ONC-ATL status...
Testing and CertificationA single organization can be both an ONC-ATL and an ONC-ACB, serving as a “one-stop-shop” for tes...
ONC-APPROVEDTEST PROCEDURES                  37
ONC Test ProceduresTest Procedures ProcessThe process below highlights how test procedures are developed.Public comment is...
Test Procedure Consideration Process To submit a test procedure for ONC consideration, complete the following requirements...
A Track Record of Success More than 1,700 electronic health record  products from more than 700 vendors have  been certif...
Come Stop by ONC’s Booth!Learn more about the ONC CertificationProgram by visiting the ONC Exhibit Hall booth:          BO...
Stay connected, communicate, and collaborate•Browse the ONC website at: healthIT.govclick the Facebook “Like” button to ad...
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EHR Certification HIMSS Presentation

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The Certification team from ONC's Office of Standards & Interoperability will host an interactive session that provides information on the EHR Certification program and provides attendees the opportunity to ask questions and discuss thoughts with the panelists.

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EHR Certification HIMSS Presentation

  1. 1. EHR Certification Programs February 2012 Carol A. Bean Doug Fridsma Steve Posnack Office of the National Coordinator for Health IT
  2. 2. BACKGROUND & CONTEXT 2
  3. 3. Outline Topics  Background Information & Context  Temporary Certification Program (TCP)  Permanent Certification Program (PCP)  ONC-Approved Test Procedures Speakers  Carol Bean, Director of Certification Division  Doug Fridsma, Director of Office of Standards & Interoperability  Steve Posnack, Director of Federal Policy Division 3
  4. 4. Telling the HITECH Story – What, Why, and How? 4
  5. 5. How do we achieve interoperable healthcare information systems? Enable Curate astakeholders to portfolio of come up with standards, servic simple, shared es, and policies solutions to that accelerate common information information Team exchange Accuracy & exchange Compliance convened to challenges solve problem Solutions & Usability Enforce compliance with validated information exchange standards, services and policies to assure interoperability between validated systems
  6. 6. How do we achieve interoperable healthcare information systems? Example Patient Scenario• A primary care doctor orders a lab test and gets the test back from the lab. She schedules the patient to be seen in the office to discuss the results.• Based on the results of the test, the primary care doctor decides to send the patient to a subspecialist. She sends a summary of care record to the subspecialist electronically with a summary of the most recent visit.• When the patient sees the subspecialist, it becomes apparent that there is a missing test that was done at a different hospital that would be helpful in taking care of the patient. Rather than repeating the test, the doctor queries the outside hospital for the lab test that she needs.
  7. 7. Interoperability: transport is necessary,but not sufficient Vocabulary & How should well-defined values be coded so that Code Sets they are universally understood? Content How should the message be formatted so that it Structure is computable? NwHIN Direct and NwHIN Transport How does the message move from A to B? Exchange focus at these levels How do we ensure that messages are secure and Security private? How do health information exchange Services participants find each other? 7
  8. 8. Health Information ExchangeTurns A CornerWe have made huge strides in Stage 1, making certain that every certified EHRcan produce the standardized content that is the foundation for exchange and forreporting quality measures and lab results.The Nationwide Health Information Network (NwHIN) Direct Exchange Projectprovides a simple, secure, standardized way to send encrypted health informationto trusted recipients over the Internet, enabling providers to meet Stage 1Meaningful Use exchange requirements. To support better care coordination and advanced care processes, standardsdevelopment is focusing on NwHIN. Exchange requirements will become morerigorous in Stage 2 of Meaningful Use.Protecting the Privacy and Security of Personal Health Information is paramountto advancing Health Information Exchange. 8
  9. 9. The Nationwide Health Information Network The NwHIN is the portfolio of standards, services and polices that enable secure health information exchange over the Internet. This portfolio of tools consists of modular “building blocks” that enable users to tailor their NwHIN-based information exchange to their individual needs. In the next year, ONC will work with the communities to develop implementation SOLUTIONS that describe how these building blocks work together to solve real- world problems. Developing this portfolio is an ongoing endeavor, as new technologies, uses and users will continue to emerge. ONC will continue to support these efforts to support interoperable, standards-based health information exchange.
  10. 10. The Nationwide Health Information Network ONC has developed standards and specifications for Directed Exchange (secure email) and Query-Based Exchange (web services.) The NwHIN Exchange Coordinating Committee is developing a business and transition plan to guide the Exchange to a sustainable, scalable and efficient public-private model. ONC is committed to supporting all forms of interoperable health information exchange. Interoperability is not “one size fits all,” so we expect that multiple forms of health information exchange will occur simultaneously. (Direct-based, web services- based, etc.)
  11. 11. The Nationwide Health Information Network CURATINGA portfolio ofservices, standards and policiesthat enable secure healthinformation exchange over theInternet. 11
  12. 12. ONC EHR Certification Programs The Division of Certification & Testing was established Establishment to develop and oversee national programs for certification of Health IT as required by HITECH Providers and patients must be confident that the electronic HIT products and systems they use are secure, can maintain data confidentiality, can work with other systems to share information, and can perform a set of well-defined functions Program Goals The Certification Programs provide a defined process to ensure that EHR technologies meet the adopted standards, certification criteria, and other technical requirements to achieve meaningful use of those records in systems 12
  13. 13. How Does All This Work? Vendors ONC- Certified Eligible EPs/EHscreate EHR ATCBs test EHR Providers collect products and certify products (EPs) and incentive that meet the are posted Eligible payments the products to the CHPL Hospitals from CMS standards based on (EHs) use and those certifiedcertification criteria products incriteria set a by ONC meaningful way 13
  14. 14. TEMPORARY CERTIFICATION PROGRAM (TCP) 14
  15. 15. TCP Program Achievements Test 6 ONC-ATCBs 1,700+ procedures have been700+ vendors* have been products* authorized to have created developed in have been test and certify EHR products partnership certified EHR with NIST technology colleagues Fostering Providing New Boosting Competition Resources Business Competition in the HIT The CHPL has created a Certification has been a certification market has resource for providers to boost to small offered vendors and search for certified businesses developers a wider products to meet their selection and has 100% of ONC-ATCBs are meaningful use lowered the overall cost small businesses objectives of certification. M ore than 60% of CHPL vendors are small businesses * As of 2/3/12 15
  16. 16. Temporary Program GrowthTHEN – October 2010 NOW – February 2012 3 ONC-ATCBs  6 ONC-ATCBs 36 EHR vendors/developers  706 EHR vendors/developers 54 certified EHR products  1,704 Certified EHR products 16
  17. 17. Meaningful Use Takes OffFifty-two percent of office-based physicians intend to take advantage of EHRincentives.The percentage of primary care providers who have adopted EHRs in theirpractice has doubled from 20 % to 40 % between 2009 to 2011. ONC’s Regional Extension Centers (RECs) have signed up more than 100,000primary care providers. This means that roughly one third of the nation’s primary care providers have committed to meaningfully using EHRs by partnering with theirlocal REC. Momentum is building!Hospital adoption has more than doubled since 2009, increasing from 16 % to 35%. Most (85 %) of hospitals intend to attest to Meaningful Use by 2015. 17
  18. 18. Medicare and Medicaid EHR Incentive Payments – 100 K in 2012 500,000 400,000 300,000 200,000 Total registered: 100,000 172,972 2012 Goal: 143,637 professionals are 100,000 registered but not yet paid paid professional 0 s Total Paid: 29,335Note: Figures reflect number of unique professionals Source: Number of professionals registered andwho have received a payment from either the Medicare paid are from CMS EHR Incentive Program Dataor Medicaid EHR Incentive Payment Programs. Figures as of 12/31/2011.may be slightly different than the number of paymentsthat have been made to eligible professionals by the 18programs.
  19. 19. Medicare or Medicaid EHR IncentivePayment - Eligible Hospitals 5,000 4,000 3,000 Total registered: 3,077 2,000 1,714 hospitals are registered but not yet paid 1,000 Total Paid: 1,363 0Note: Figures reflect number of unique hospitals that have received a Source: Number of hospitals registered and paidpayment from either the Medicare or Medicaid EHR Incentive Payment are from CMS EHR Incentive Program Data as ofPrograms. Figures are different than the number of payments that 12/31/2011.have been made to eligible hospitals by the programs becausehospitals can receive payments under both programs. Office of the National Coordinator for 2/19/2012 19 Health Information Technology
  20. 20. TCP Estimations vs. Realizations Estimated Actual1-2 ONC-ATCBs 6 ONC-ATCBS200 certified 1,700+products certified products$1,500,000,000 in $2,500,000,000+ inIncentive IncentivePayments** Payments* *Includes Medicare and Medicaid 20
  21. 21. CHPL Statistics CHPL Stats Percent of Products  1722 Certified EHR Products submitted by ONC-ATCB Ambulatory Inpatient Total Drummond CCHIT 32%Complete 51%EHR 743 137 880Modular InfoGardEHR 416 426 842 SLI ICSA 11% 2% 4%Total 1159 563 1722  712 EHR Vendors/Developers *As of 2/3/2012 21
  22. 22. Certified HIT and Vendor Trends18001600140012001000 800 Total Products 600 Total Vendors 400 200 0 *As of 2/3/2012 22
  23. 23. CMS EHR Incentive ProgramsThousands of providers arereceiving incentive payments acrossthe country, totaling more than $2.5Billion between Medicaid andMedicare.Quick Facts More than 176,000 active registrations Both Medicare and Medicaid have paid more than $2.5 Billion to more than 15,000 providers 43 states are participating 23
  24. 24. Program Oversight & MonitoringPurposeTo provide assurance to the community that the ONCCertification Programs conducted oversight andmonitoring to evaluate ONC-ATCB operations.Overall Feedback ONC-ATCBs are doing a fantastic job! Many ONC-ATCBs are exceeding expectations in how they handle vendor testingAreas for Improvement Creating a consistent vendor experience across the ONC-ATCBs Working to ensure that ONC-ATCBs respond to vendor complaints in a timely fashion 24
  25. 25. TCP Program SunsetONC issued an update to the Final Rule on November 3, 2011 to delaythe sunset of the TCP, originally scheduled for December 31, 2011. Thesunset will be tied to the effective date of the final rule that ONC intendsto issue in summer 2012.Upon Sunset of the TCPONC-ATCBs are prohibited fromaccepting new requests to certifyComplete EHRs or EHR Modules, butare permitted up to six months afterthe sunset date to complete all testingand certification activities associatedwith pending or current requestsreceived prior to the sunset date 25
  26. 26. TCP Program Sunset Timeline Dec. July 2011 2012TCP (sunset in July) TCP Wind Down Period PCP Transition ONC-AA Announcement ONC-ATLs and ONC- ACB Announcements PCP Fully Operational 26
  27. 27. TCP vs. PCP Temporary Both Programs Permanent Certification Certification Program  Open application Program process  Organizations are authorized to perform  Separate testing and  Combined testing the testing and/or certification and certification certification of  Testing Labs are  Testing & certification Complete EHRs, EHR accredited by NVLAP bodies are Modules, or both  Certification Bodies are authorized by ONC  ONC approves test accredited by the ONC- procedures for use AA, ANSI  Surveillance & monitoring 27
  28. 28. PERMANENT CERTIFICATION PROGRAM (PCP) 28
  29. 29. PCP Requirements Structure ONC Technical Regulations Requirements ISO/IEC 17011 Accreditation NVLAP Bodies ANSIISO/IEC 17025 NIST 150 ISO/IEC Guide 65 NIST 150-31 ONC- ONC- CertifyingTest Labs ATL ACB Bodies 29
  30. 30. PCP Key Facts Testing and certificationANSI will be the ONC- activities are ONC-ATCBs may apply separate, but a singleAA for ONC-ACBs and NVLAP will accredit to be ONC-ACBs or organization can do ONC-ATLs or both ONC-ATLs both functions with a firewall in place Gap certification is Stage 2 Meaningful The PCP will be available for new or Use is expected to be operational on or before revised criteria implemented in 2013 the summer of 2012 30
  31. 31. Improvement Plan for the PCP CHPL Communications Test Procedures• User interface • Website • MU Stage-2• Search and filter • Social media recommendations for• Data download and • Inbox management certification criteria reporting • Outreach • Increase rigor and • Education robustness • New test tools, procedures, players 31
  32. 32. ANSI’s Role: ONC-AAKey Responsibilities Maintain conformance with ISO/IEC 17011 In accrediting certification bodies, verify conformance to, at minimum Guide 65 and ensure the surveillance approaches used by ONC-ACBs include the use of consistent, objective, valid and reliable methods Verify that ONC-ACBs are performing surveillance in accordance with their respective annual plans Review ONC-ACB surveillance results to determine if the results indicate any substantive non-conformance by ONC-ACBs with the conditions of their respect accreditations Selected every three years through a competitive processProgress To Date 32
  33. 33. ONC-ACBs: CertificationOverview Accredited by ANSI All interested organizations will have to apply to ONC for ONC-ACB status Certify EHR products Step 1: Step 2: Note: ONC-ATCBs (authorized under Certification Certification the Temporary Certification Program) Body receives Body applies to accreditation ONC for ONC- will not automatically become ONC- from ONC-AA ACB status ACBs, as a CB must first be accredited to be eligible for ONC-ACB status. 33
  34. 34. NVLAP: ONC-ATL AccreditorKey Responsibilities Maintain conformance with ISO/IEC 17011 In accrediting test labs, verify conformance to, at minimum, ISO/IEC 17025, NIST 150, NIST 150-31 Ensure the approaches used by ONC-ATLs include the use of consistent, objective, valid and reliable methods Verify that ONC-ATLs are performing testing in accordance with their regulatory, technical, and other applicable requirements To determine if the results indicate any substantive non-conformance by ONC-ATLs with the conditions of their respect accreditations Selected every three years through a competitive processProgress To Date 34
  35. 35. ONC-ATLs: TestingOverview Accredited by NVLAP All interested organizations will have to apply to ONC for ONC-ATL status Test EHR products Step 2: Test Step1: TestNote: ONC-ATCBs (authorized under Lab applies Lab receives to ONC forthe temporary certification program) accreditation ONC-ATLwill not automatically become ONC- from ONC-AA statusATLs, as a TL must first be accreditedto be eligible for ONC-ATL status. 35
  36. 36. Testing and CertificationA single organization can be both an ONC-ATL and an ONC-ACB, serving as a “one-stop-shop” for testing and certificationA firewall must exist between the Testing and Certification branches ofthe organization ONC-ATL ONC-ACB Performs testing Certifies tested against Criteria products 36
  37. 37. ONC-APPROVEDTEST PROCEDURES 37
  38. 38. ONC Test ProceduresTest Procedures ProcessThe process below highlights how test procedures are developed.Public comment is an important part of the process. NPRM includes initial NPRM Public Comment Errata (if Final Test set of test necessary) Final Rule Procedures Period proceduresOther Helpful Information: Meaningful Use and Test Procedures are separate, but related The Notice of Public Rulemaking for Meaningful Use Stage 2 and the EHR Incentive Rule and Standards and Implementation Guidance and Certification Rule is scheduled for spring 2012  The Final Rule for both of these is scheduled for summer 2012 Meaningful Use Stage 2 is scheduled to be implemented in 2013 38
  39. 39. Test Procedure Consideration Process To submit a test procedure for ONC consideration, complete the following requirements:  Identify the developer  Specify the certification criterion/a that it addresses  Explain how it would evaluate a Complete EHR’s or EHR Module’s compliance with the applicable certification criterion/a  Provide information describing the process used to develop it  Demonstrate that it is clearly traceable to a certification criterion/a adopted by the HHS Secretary  Describe the public comment process used during the development of the test tool and/or test procedure (including any opportunity for the public to comment on the test tool and/or procedure and the degree to which public comments were considered)  Be sufficiently comprehensive to assess all required capabilities  Guarantee provision of training, as required by ONC for the ONC-ATCBs and/or ATLs 39
  40. 40. A Track Record of Success More than 1,700 electronic health record products from more than 700 vendors have been certified CMS has paid more than $2.5 billion in incentives to tens of thousands of providers that “meaningfully used” certified EHR technology Driving economic growth--100% of ATCBs and 60% of vendors are small business 40
  41. 41. Come Stop by ONC’s Booth!Learn more about the ONC CertificationProgram by visiting the ONC Exhibit Hall booth: BOOTHS 14624 & 14824 41
  42. 42. Stay connected, communicate, and collaborate•Browse the ONC website at: healthIT.govclick the Facebook “Like” button to add us to your network•Contact us at: onc.request@hhs.gov•Subscribe, watch, and share:  @ONC_HealthIT  http://www.youtube.com/user/HHSONC  Health IT and Electronic Health Records  http://www.scribd.com/HealthIT/ Health IT Buzz Blog  http://www.flickr.com/photos/healthit
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