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2014 Edition
Standards & Certification Criteria
                Final Rule Edition]
       [HIT Standards Committee Special




     Steve Posnack, MHS, MS, CISSP
     Director, Federal Policy Division
S&CC 2014 Edition Final Rule
Major Themes

• Enhancing standards-based exchange
• Promoting EHR technology safety and security
• Enabling greater patient engagement

• Introducing greater transparency

• Reducing regulatory burden


                                                 1
S&CC and Meaningful Use
Complementary but Different Scopes

  • S&CC scope = “technical”
     – Specifies the capabilities EHR technology must
       include and how they need to perform in order to
       be certified.
     – It does not specify how the EHR technology needs
       to be used.

  • Meaningful use scope = “behavioral”
     – Specifies how eligible providers need to use
       Certified EHR Technology in order to receive
       incentives.
                                                          2
NPRM versus Final Rule



S&CC February ‘12                    S&CC August ‘12
§ 170.314                            § 170.314
 (a)   Clinical (n=18)                (a)   Clinical (n=17)
 (b)   Care Coordination (n=6)        (b)   Care Coordination (n=7)
 (c)   CQMs (n=3)                     (c)   CQMs (n=3)
 (d)   Privacy and Security (n=9*)    (d)   Privacy and Security (n=9*)
 (e)   Patient Engagement (n=3)       (e)   Patient Engagement (n=3)
 (f)   Public Health (n=8)            (f)   Public Health (n=6*)
 (g)   Utilization (n=4)              (g)   Utilization (n=4)


                                                     * = includes optional
                                                     certification criteria 3
“New” Certification Criteria
 Ambulatory & Inpatient           Inpatient Only             Ambulatory Only

                           Electronic medication
Electronic Notes                                          Secure messaging
                           administration record
                                                          Cancer case
Image results              eRx (for discharge)
                                                          information
                           Transmission of electronic     Transmission to
Family Health History      lab tests and values/results   cancer registries
                           to ambulatory providers
Amendments
View, Download, &
Transmit to 3rd party
Auto numerator recording
Non % based measure use
report

Safety-enhanced design

Quality management
system

Data Portability
                                                                               4
“Revised” Certification Criteria
                Ambulatory & Inpatient                       Ambulatory Only
Drug-drug, drug-allergy       Vital signs, body mass
                                                           eRx
interaction checks            index, and growth charts
Demographics                  CQMs (3 criteria)            Clinical summaries
Clinical information          Incorporate lab tests and
reconciliation                values/results
Problem list                  End-user device encryption
                              Auditable events and
Clinical decision support
                              tamper-resistance
                                                                 Inpatient Only

Drug-formulary checks         Audit report(s)

TOC – receive, display, and                                Transmission of
                              TOC – create and transmit
incorporate toc/referral                                   reportable lab tests and
                              toc/referral summaries
summaries                                                  values/results
                              Patient-specific education
Patient list creation
                              resources
                              Automated measure
Smoking status
                              calculation
                              Transmission to public
Transmission to
                              health agencies –
Immunization Registries
                              syndromic surveillance
                                                                                      5
“Unchanged” Certification Criteria
                         Ambulatory & Inpatient
       CPOE                                Advance directives
       Medication list                     Immunization information

       Medication allergy list             Automatic log-off
       Authentication, access control, &
                                           Emergency access
       authorization

       Integrity                           Accounting of disclosures

       Incorporate lab test results
                                           Smoking status
       (inpatient only)
       Vital signs, body mass index, and
                                           Drug formulary checks
       growth charts
       Patient lists                       Patient reminders
                                           Reportable laboratory tests and
       Public health surveillance
                                           values/results


• These certification criteria would be “eligible” for “gap certification.”

                                                                              6
Common MU Data Set

 (1) Patient name                     (9) Medications – RxNorm
 (2) Sex                              (10) Medication allergies – RxNorm
 (3) Date of birth                    (11) Laboratory test(s) – LOINC
 (4) Race – OMB Standard              (12) Laboratory value(s)/result(s)
 (5) Ethnicity – OMB Standard         (13) Vital signs – height, weight, blood
                                      pressure, BMI
 (6) Preferred language – ISO 639-2   (14) Care plan field(s), including goals
 constrained                          and instructions
 (7) Smoking status – 8 SNOMED CT®    (15) Procedures –
 codes.                               (i) SNOMED CT® or CPT/HCPCS.
                                      (ii) Optional. ICD-10-PCS
                                      (iii) Optional. CDT
 (8) Problems – SNOMED CT®.           (16) Care team member(s).


                                                                                 7
45 CFR 170.314(a)
Clinical
    Certification                 Changes from Proposed Version to Final Version
     Criterion
                        • Clarified that the standard for preferred language is ISO 639-2 constrained
                        to those languages represented in ISO 639-1
(3) Demographics
                        • Removed the reference to a vocabulary standard (ICD -10) for preliminary
                        cause of death
(4) Vital signs, body
mass index, and         Clarified that only numerical values can be recorded
growth charts
(5) Problem list        Adopted the most recent version of SNOMED CT® and US extension
                        • Specified that the use of the HL7 Context-Aware Knowledge Retrieval
(8) Clinical decision   (“Infobutton”) standard would be optional as part of the linked referential
support                 decision support capability (and adopted IGs)
                        • Limited configuration variations to be just based on a user’s role

(11) Smoking status     Adopted an 8-code list of SNOMED CT® codes for smoking status

(13) Family health      Adopted as alternatives, the most recent version of SNOMED CT® and the
History                 HL7 Pedigree standard for recording family health history
(15) Patient-specific
                        Adopted HL7 Infobutton standard and the URL and SOAP-based
education
                        implementation guides
resources
                                                                                                      8
45 CFR 170.314(b)
Care Coordination
Care Coordination




              Certification             Changes from Proposed Version to Final Version
               Criterion
                              • Require receipt according to the same transport standards we adopted for
                              transmit
                              • Require the capability to display previously adopted summary care record
(1) TOC – receive,
                              standards: CCD/C32 and CCR
display, and
                              • Clarified that incorporate meant that problems, medications, and medication
incorporate
                              allergies data could be processed and stored for subsequent use
toc/referral
                              • Included a general patient matching capability with the incorporation
summaries
                              capability
                              • Require that EHR technology would be able to individually display all of the
                              other CCDA section templates that were not incorporated
(2) TOC – create              Revised the transport standards referenced to require certification to the
and transmit                  primary Direct Project specification and to permit two optional approaches in
toc/referral                  addition [(1) Secure App Statement + XDR/XDM for Direct Msg’n; (2) SOAP
summaries                     RTM +XDR/XDM for Direct Msg’n]
(3) Electronic
                              NCPDP SCRIPT 10.6 and RxNorm
prescribing




                                                                                                         9
45 CFR 170.314(b)
Care Coordination
    Certification                  Changes from Proposed Version to Final Version
     Criterion


                         • Removed the erroneous reference to the main HL7 2.5.1 standard
(5) Incorporate lab      •Adopted an updated version of the LRI implementation guide and the most
tests and                recent version of LOINC®
values/results
                         • Note: This certification criterion remains “unchanged” for the inpatient setting



(6) Transmission of      Adopted an updated implementation guide and the most recent version of
electronic lab tests     LOINC®
and values/results
to ambulatory
providers
Inpatient setting only
                         • New certification criterion
(7) Data portability     • Focuses on the most current clinical information about each patient for
                         which an export summary can be created using the Consolidated CDA

                                                                                                     10
45 CFR 170.314(c)
Clinical Quality Measures
Clinical Quality Measures




                            Certification             Changes from Proposed Version to Final Version
                             Criterion


(1) Clinical quality
                                            • Revised to a per CQM approach
measures–capture
                                            • Adopted QRDA Category I for export
and export


(2) Clinical quality
                                            Adopted QRDA Category I for import to create a link between the two
measures–import
                                            capabilities
and calculate

                                            • Included the electronic submission certification criterion in the Base EHR
                                            definition
(3) Clinical quality                        • Adopted QRDA Category I and III as electronic reporting formats
measures–
electronic
submission




                                                                                                                           11
45 CFR 170.314(d)
Privacy and Security
Privacy & Security




                     Certification            Changes from Proposed Version to Final Version
                      Criterion

                                     • Adopted the ASTM standard “for audit and disclosure logs for use in
                                     health information systems” and point to specific sections within that
(2) Auditable events                 standard that mirrored the data/actions that were explicitly referenced in
and tamper-                          the proposed version
resistance                           • Clarified language


                                     • Changed the certification criterion’s name
(7) End-user device
                                     • Modified the first part of the certification criterion to more clearly express a
encryption
                                     technical capability that could be tested and certified




                                                                                                                  12
45 CFR 170.314(e)
Patient Engagement
Patient Engagement




                     Certification             Changes from Proposed Version to Final Version
                      Criterion

                                     • Included a requirement that the online access must be done through secure
                                     channel
                                     •Specified that only the primary Direct Project transport specification is
                                     required for certification
(1) View, download,                  • Adopted SNOMED CT® and CPT/HCPCS as alternative required
and transmit to 3rd                  vocabularies for procedures, but also permit additional (optional) certification
party                                to ICD-10-PCS and CDT (dental terminology)
                                     • Changed the accessibility requirement from WCAG Level AA to Level A
                                     • Removed the requirement to enable images to be downloaded and
                                     transmitted to a 3rd party
                                     • Adopted the use of RxNorm for medication allergies




                                                                                                                 13
45 CFR 170.314(f)
Public Health
Public Health




                Certification          Changes from Proposed Version to Final Version
                 Criterion


(2) Transmission to                  Adopted an updated implementation guide and the most recent
Immunization Registries              version of CVX codes

(3) Transmission to public
health agencies – syndromic          Adopted an updated implementation guide and addendum
surveillance



(4) Transmission of reportable
                                     Adopted a supplement to the implementation guide and the
lab tests and values/results
                                     most recent versions of LOINC® and SNOMED CT®
Inpatient setting only


(5) Cancer case information
                                     Designated as “optional”
Optional - ambulatory setting only
(6) Transmission to cancer           Designated as “optional” and adopted an updated/final
registries                           implementation guide and the most recent versions of LOINC®
Optional - ambulatory setting only   and SNOMED CT®
                                                                                                14
45 CFR 170.314(g)
Utilization
 Utilization




        Certification             Changes from Proposed Version to Final Version
         Criterion


                        Modified to require that EHR Modules be able to create a report or file that
(1) Auto numerator
                        enables a user to review the patients or actions that would make the patient
recording
                        or action eligible to be included in the measure’s numerator

(2) Automated
measure                 No change
calculation

(3) Safety-enhanced
                        No change
design


                        • New certification criterion
(4) Quality
                        • Requires the disclosure of whether and what QMS was used in for EHR
management
                        technology development . Acceptable approaches are: 1) a single QMS; 2)
system
                        multiple QMS’; or 3) no QMS.

                                                                                                   15
Standards Applicability
                              Vocabulary &            Content Exchange
      Purpose                  Code Sets                / Utilization
                                                                                 Transport

                          OMB Race/Ethnicity
   Demographics
                          ISO 639-2 (constrained)
      Problems            SNOMED CT® + US ext
         CDS                                        HL7 Infobutton + IGs
   Smoking Status         SNOMED CT® + US ext
    Family Health         SNOMED CT® + US ext
       History               HL7 Pedigree
Patient Ed Resources                                HL7 Infobutton + IGs
                                                                               Applicability
                                                         CCD/C32           Statement for Secure
                          SNOMED   CT®
                                   + US ext                                  Health Transport
ToC – receive, display,
                              RxNorm
    & incorporate                                           CCR            AppState + XDR/XDM
                                                                               SOAP RTM +
                                                     Consolidated CDA
                                                                                XDR/XDM
                                                                                             16
Standards Applicability (cont.)
                    Vocabulary &    Content Exchange
    Purpose          Code Sets        / Utilization
                                                             Transport

                                                           Applicability
                    [Common MU                         Statement for Secure
 ToC – Create &        Data Set]                         Health Transport
                                   Consolidated CDA
    Transmit          ICD-10-CM                        AppState + XDR/XDM
                         CVX                               SOAP RTM +
                                                            XDR/XDM
      e-Rx            RxNorm       NCPDP SCRIPT 10.6
 Incorporate Labs
                       LOINC        HL7 S&I LRI Spec
   (ambulatory)
                    [Common MU
                       Data Set]
 Data Portability                  Consolidated CDA
                      ICD-10-CM
                         CVX



                                                                         17
Standards Applicability (cont.)
                            Vocabulary &       Content Exchange
     Purpose                 Code Sets           / Utilization
                                                                           Transport

    CQM Export                                 QRDA Category I
    CQM Import                                 QRDA Category I
                                                QRDA Category
  CQM e-Submit
                                                   I & III
                                              Consolidated CDA           Applicability
  View, download,          [Common MU
                                                                     Statement for Secure
transmit to 3rd party        Data Set]          WCAG Level A           Health Transport
                           [Common MU
 Clinical Summary                             Consolidated CDA
                             Data Set]
  Immz Reporting                CVX             HL7 2.5.1 + IGs
     Syndromic                                     HL7 2.5.1
    Surveillance                              +IG (inpatient only)
                        SNOMED CT® + US ext
        ELR                                     HL7 2.5.1 + IG
                             LOINC
                        SNOMED CT® + US ext
  Cancer Registry                                CDA R2 + IG                           18
                             LOINC                                                       18
Revised Certified EHR Technology
(CEHRT) Definition
   July 2010 Final Rule Policy      August 2012 Final Rule Policy
         Static Definition              Dynamic Definition
 Driven by Certification Criteria    Driven by Meaningful Use




                                                                19
Revised CEHRT Definition
and Interdependence
  Big picture
  • The new regulatory framework provides more flexibility.
  • The potential number of 2014 Edition certification criteria to which EHR
    technology would need to be certified (for an eligible provider to have EHR
    technology that meets the CEHRT definition) could be limited to the MU stage
    needs of an EHR technology developer’s customer.

  CEHRT Interdependence – Two views of the CEHRT Definition
  • For eligible providers:
      – It is about having EHR technology(ies) certified to meet the Base EHR
        definition and just enough of 2014 Edition certification criteria to support
        their achievement of the MU stage they seek to meet.

  • For EHR technology developers:
      – This new definition presents the opportunity to rethink the scope of EHR
        technology certifications sought.
      – Now able to seek “right size certifications” for their EHR technology based on
        their customers scope of practice and/or the MU stage that their customers
        will be seeking to achieve.
                                                                                         20
General Points to Remember
• Two types of certifications can be issued:
     – “Complete EHR” (i.e., EHR tech certified to all mandatory cert. criteria)
     – “EHR Module” (i.e., EHR tech certified to less than all mandatory cert. criteria)

• The scope of a certification issued to EHR technology
  represents only the capabilities for which the
  certification was sought/granted.

• EHR technology developers get to choose the type
  of certification sought for EHR technology and its
  scope (i.e., for EHR Modules, the number of cert. criteria to which it would be certified).
     – Additional capabilities beyond those for which certification criteria have been
       adopted are not within the scope of ONC’s regulatory framework and reflect a
       business decision made by the EHR technology developer if they are included with
                                                                                       21
       an EHR technology to which a certification is issued.
So what? What’s to be excited about?
Now 3 ways to meet CEHRT definition
  • Complete EHR
     – Generally provides overall assurance.
     – EPs would still need EHR technology
       certified to cancer registry certification criteria if they
       seek to meet that MU objective.

  • EHR Module(s):
     – Combination of EHR Modules
     – Single EHR Module
  • In the case of EHR Modules, it is now possible for an
    eligible provider to have just enough EHR technology
    certified to the 2014 Edition EHR certification criteria to
    meet the CEHRT definition.
                                                                  22
2014 Edition CEHRT
Easy as 1, 2, 3 + C*
                       EP/EH/CAH would only need to have
                       EHR technology with capabilities
                       certified for the MU menu set
                       objectives & measures for the stage of
                       MU they seek to achieve.

                       EP/EH/CAH would need to have EHR
                       technology with capabilities certified
                       for the MU core set objectives &
                       measures for the stage of MU they
                       seek to achieve unless the EP/EH/CAH
                       can meet an exclusion.

       Base EHR        EP/EH/CAH must have EHR technology
                       with capabilities certified to meet the
          1            Base EHR definition.




                                                    *C = CQMs
                                                         23
Certification Criteria Assigned to
Final Base EHR Definition
• It is a definition. It is meant to be used like a checklist to meet the CEHRT definition.
• It is not “a Base EHR” or a singular type of EHR technology that has these capabilities.
• The Base EHR definition includes CQM requirements not specified in this table.
               2014 Edition EHR Certification Criteria Required to Satisfy the Base EHR Definition
          EHR technology that:                                      Certification Criteria
                                                               Demographics § 170.314(a)(3)                     
Includes patient demographic and                                 Vital Signs § 170.314(a)(4)                   N/A
clinical health information, such as                            Problem List § 170.314(a)(5)                    
medical history and problem lists                             Medication List § 170.314(a)(6)                   
                                                          Medication Allergy List § 170.314(a)(7)               
Has the capacity to provide clinical           Drug Drug and Drug Allergy Interaction Checks § 170.314(a)(2)   N/A
decision support                                         Clinical Decision Support § 170.314(a)(8)             
Has the capacity to support physician
                                                    Computerized Provider Order Entry § 170.314(a)(1)          
order entry
Has the capacity to capture and query
information relevant to health care                 Clinical Quality Measures § 170.314(c)(1) through (3)      
quality
Has the capacity to exchange electronic                 Transitions of Care § 170.314(b)(1) and (2)             
health information with, and integrate                     Data Portability § 170.314(b)(7)                     
such information from other sources            View, Download, and Transmit to 3rd Party § 170.314(e)(1)       N/A
Has the capacity to protect the
confidentiality, integrity, and availability
                                                      Privacy and Security § 170.314(d)(1) through (8)         
of health information stored and
exchanged                                                                                                      24
CEHRT: Show and Tell
              EP MUS1 min = 27 CC                            Ambulatory CEHRT = 32 CC
                *No MU core exclusions
                ** 5 MU menu deferral

2010 Final
Rule Policy




                EP min = variable                                  Ambulatory CEHRT =
                                                                   CC required by Base EHR def
                                                Reality sized      + those to meet MU stage
                                               “Right sized”
2012 Final                               certified EHR Module(s)

Rule Policy



                                                                                            25
Revised CEHRT Definition
Effective Dates and Options
                                      EHR Reporting Period

  FY/CY 2011       FY/CY 2012       FY/CY 2013                      FY/CY2014

  MU Stage 1      MU Stage 1        MU Stage 1               MU Stage 1 or MU Stage 2
  EPs, EHs, and CAHs have 3 options:
  1) EHR technology that has been certified to all
                                                      All EPs, EHs, and CAHs must have
     applicable 2011 Edition EHR certification
     criteria.                                        EHR technology certified to the 2014
  2) EHR technology that has been certified to all    Edition EHR certification criteria
     applicable 2011 Edition or equivalent 2014       that meets the Base EHR definition
     Edition EHR certification criteria      Same     and would support the objectives,
     certification criteria.                 Policy   measures, and their ability to
  3) EHR technology certified to the 2014 Edition     successfully report the CQMs, for
     EHR certification criteria that meets the        the MU stage that they seek to
     Base EHR definition and would support
                                                      achieve.
     ability to achieve MU stage 1 and
     successfully report the CQMs.
 • 2014 Edition EHR technology supports the achievement of either meaningful use stage.
 • Certification is not tied to MU stages.
 • No “Stage 1 Certified” or “Stage 2 Certified” in perpetuity.
                                                                                        26
Illustrated: Two Types of Certifications Issued
“Complete EHR” or “EHR Module”
1 Universe of EHR technology capabilities
    (e.g., all of what XYZ’s EHR technology includes)

    2014Ed Complete EHR definition
2 Generally supports MUS1 or MUS2 achievement
                                                           MUS2
    Certified to all mandatory 2014Ed CC for setting

    EHR Module certified to number of 2014Ed
3 necessary to support MUS1                             MUS1

    Inner square = EHR Module certified to number
    of 2014Ed CC less than MUS1 (or MUS2)
4   Outer square = EHR Module certified to
    number of 2014Ed CC necessary to support
    MUS2
5 Base EHR definition = certified EHR Module

6 EHR Module certified to less than
    Base EHR definition


Point to remember:
Certification’s scope does NOT address all                2014 Edition Scope Stops Here 27
capabilities included in EHR technology
A Different Look: Understanding the CEHRT Definition
and the Minimum Number of Certification Criteria
to which EHR Technology would need to be certified




                                                       28
ONC HIT Certification Program
Final Changes
• Temporary Certification Program Sunsets
   – Upon 2014 Edition final rule effective date
• Program Name Change
   – “ONC HIT Certification Program”

• Revisions to EHR Module Certification
  Requirements
   – Privacy and Security Certification Policy
      • Will not require upfront certification to P&S for the 2014
        Edition CC
      • Policy outcome now reflected in Base EHR definition (which
        includes all P&S CC)
   – Other tweaks to make certification more efficient
                                                                     29
ONC HIT Certification Program
Final Changes (cont.)
 • Application of certain new certification criteria to EHR technology
     – § 170.314(g)(1): Automated numerator recording
     – § 170.314(g)(3): Safety-enhanced design
         • 8 Medication related certification criteria: CPOE; Drug-drug, drug-allergy
           interaction checks; Medication list; Medication allergy list; Clinical decision
           support; eMAR; e-prescribing; and Clinical information reconciliation.
     – § 170.314(g)(4): Quality management system

 • Price Transparency: ONC-ACBs are required to ensure that EHR
   technology developers notify eligible providers about additional
   types of costs (i.e., one-time, ongoing, or both) that affect a
   certified Complete EHR or certified EHR Module’s total cost of
   ownership for the purposes of achieving meaningful use.

 • Test Result Transparency: The final rule requires that ONC-ACBs
   submit a hyperlink of the test results used to issue a certification to
   a Complete EHR or EHR Module.
                                                                                             30
What’s Next?
 Anticipated Timeline
• Aug 2012
   – Final rule issued
• Sept 2012 – Oct 2012
   – Weekly waves of test procedures and electronic test tools
     published
   – Test Procedures and tools available for comment
• Nov 2012 – Dec 2012
   – Testing workshop
   – National Coordinator approves 2014Ed test procedures
• Testing and certification to 2014 Edition available
  early 2013.
                                                            31
2014 Edition EHR Certification
                     Criteria                                                                          2014 Certification Criteria associated with
                                                                                                       a Base EHR:
 2014 Certification Criteria                                                                                  • CPOE (170.314(a)(1))
 associated with MU Core Stage 2:                                MU Menu                                      • Demographics (170.314(a)(3))
   • Drug-drug, drug-allergy interaction                                                                      • Problem list (170.314(a)(5))
     checks (170.314(a)(2))                                                                                   • Medication list (170.314(a)(6))
                                                                  MU Core
   • Vital signs, BMI, & growth charts                                                                        • Medication allergy list (170.314(a)(7))
     (170.314(a)(4))                                                                                          • Clinical decision support (170.314(a)(8))
   • Smoking status (170.314(a)(11))                                                                          • Transitions of care (170.314(b)(1) & (2))
   • Patient list creation (170.314(a)(14))                       Base EHR
                                                                                                              • Data portability (170.314(b)(7))
   • Patient-specific education resources                                                                     • Clinical quality measures (170.314(c)(1) - (3))
     (170.314(a)(15))
                                                                                                              • Privacy and Security CC:
   • eMAR (170.314(a)(16))
                                                                                                                o Authentication, access control,
   • Clinical information reconciliation                                                                          & authorization (170.314(d)(1))
     (170.314(b)(4))                                                                                            o Auditable events & tamper resistance
   • Incorporate lab tests &                                                                                        (170.314(d)(2))
     values/results (170.314(b)(5))                                                                             o   Audit report(s) (170.314(d)(3))
   • View, download, & transmit to         3rd                                                                  o   Amendments (170.314(d)(4))
     Party (170.314(e)(1))                                                                                      o   Automatic log-off (170.314(d)(5))
   • Immunization information                                                                                   o   Emergency access (170.314(d)(6))
     (170.314(f)(1))                                                                                            o   End-user device encryption (170.314(d)(7))
   • Transmission to immunization                                                                               o   Integrity (170.314(d)(8))
     registries (170.314(f)(2))                                                                                 o   Accounting of disclosures* (170.314(d)(9))

   • Transmission to PH agencies –
     syndromic surveillance (170.314(f)(3))                                                                  2014 Certification Criteria associated
   • Transmission of reportable lab tests                                                                    with MU Menu Stage 2:
     & values/results (170.314(f)(4))                                                                         • Electronic notes (170.314(a)(9))
                                                                                                              • Drug-formulary checks (170.314(a)(10))
                                                                                                              • Image results (170.314(a)(12))
                                                 2014 ed. certification criteria for which
                                                 certification may be required:                               • Family health history (170.314(a)(13))
                                                   •   Automated numerator recording (170.314(g)(1))          • Advance directives (170.314(a)(17))
                                                   •   Automated measure calculation (170.314(g)(2))          • eRx (170.314(b)(3))
                                                   •   Safety-enhanced design (170.314(g)(3))                 • Transmission of e-lab tests &
                                                   •   Quality management system (170.314(g)(4))                values/results to providers (170.314(b)(6))
*= optional                                                                                                                                                  32
Do you have EHR Technology that meets the new Certified EHR
  Technology definition for Meaningful Use Stage 1?
          START HERE
       Do you have a 2014                               Technology Definition for MU Stage 1

  Edition Complete EHR for the           Yes                                                                                                                                                              Yes
  Ambulatory (EPs) or Inpatient
  (EHs/CAHs) Setting?

    No
                                                                                               Yes   Is your EHR technology certified to the       Yes   Is your EHR technology certified to the          Yes
                                     Do you have EHR technology                                      following certification criteria to support         following certification criteria to support
                                     that has been:                                                  the MU1 EP Core Objectives you seek to              the MU1 EP Menu Objectives you seek to
                                      Certified to ≥ 9 CQMs                                         achieve and for which you cannot meet a             meet? § 170.314:
                                        ≥ 6 from CMS’ recommended                                   MU exclusion? § 170.314:                            (a)(10) – RxFormulary    (b)(5) – Incorp Lab
                                         core set                                                                                                        (a)(14) – Pt List        (f)(1) – Immz Info
                                        Address ≥ 3 domains from the                                (a)(2) – DD/DA    (b)(3) – eRx
                                                                                                     (a)(4) – Vitals   (e)(1) – VDTx3                  (a)(15) – Pt Edu         (f)(2) – Immz Tx
                                         set selected by CMS for EPs?                                                                                    (b)(4) – ClinInfoRec     (f)(3) – Syn Surv
                                                                                                     (a)(11) – Smoking (e)(2) – Clinical Sum

                     Yes
    Is your EHR technology certified to the               No                                                                 No                                                   No
 following certification criteria required to
 meet the Base EHR definition? § 170.314:         EP
   (a)(1),(3)&(5-8) –
    CPOE/Demogfrx/ProbList/                     No
    MedList/MedAllergyList/CDS
   (b)(1),(2)&(7) – TOC/Data Port
   (c)(1)-(3) – CQMS
   (d)(1)-(8) – P&S                                    No                                                                    No                                                  No
                      Yes
                                                                                                                                                          Is your EHR technology certified to the
                                     Do you have EHR technology                                      Is your EHR technology certified to the              following certification criteria to support
                                     that has been:                                                  following certification criteria to support          the MU1 EH/CAH Menu Objectives you
                                      Certified to ≥ 16 CQMs from                                   the MU1 EH/CAH Core Objectives you seek              seek to meet? § 170.314:
                                       CMS’ selected set for EH/CAHs                                 to achieve and for which you cannot meet             (a)(10) – RxFormulary   (b)(5) – Incorp Lab
                                        Address ≥ 3 domains from the                                a MU exclusion? § 170.314:                           (a)(14) – Pt List       (f)(1) – Immz Info
                                         set selected by CMS for                               Yes     (a)(2) – DD/DA     (a)(11) – Smoking      Yes    (a)(15) – Pt Edu        (f)(2) – Immz Tx      Yes
                                         EH/CAHs?                                                      (a)(4) – Vitals    (e)(1) – VDTx3                (a)(17) – AD            (f)(3) – Syn Surv
                                                                                                                                                          (b)(4) – ClinInfoRec    (f)(4) – ELR



Note: To meet the CEHRT definition, EHR technology will need to have been certified to:
 Automated numerator recording (170.314(g)(1)) or Automated measure calculation (170.314(g)(2));                                                                                                               33
 Safety-enhanced design (170.314(g)(3)); and
 Quality management system (170.314(g)(4))
EPs: Do you have EHR Technology that meets the new Certified
  EHR Technology definition for Meaningful Use Stage 1?
          START HERE

        Do you have a 2014                Yes                                                                                                                                       Yes
   Edition Complete EHR for the
   Ambulatory Setting?

          No




   Is your EHR technology certified to the
following certification criteria required to
meet the Base EHR definition? § 170.314:
   (a)(1),(3)&(5-8) –
    CPOE/Demogfrx/ProbList/                     No
    MedList/MedAllergyList/CDS
   (b)(1),(2)&(7) – TOC/Data Port
   (c)(1)-(3) – CQMS
   (d)(1)-(8) – P&S

          Yes
                                                          No                                         No                                                      No



                                                                            Is your EHR technology certified to the                 Is your EHR technology certified to the
                               Do you have EHR technology                   following certification criteria to support the         following certification criteria to support
                               that has been:                               MU1 EP Core Objectives you seek to achieve              the MU1 EP Menu Objectives you seek to
                                                                   Yes                                                        Yes                                                   Yes
                                Certified to ≥ 9 CQMs                      and for which you cannot meet a MU                      meet? § 170.314:
                                  ≥ 6 from CMS’ recommended                exclusion? § 170.314:                                   (a)(10) – RxFormulary   (b)(5) – Incorp Lab
                                   core set                                                                                         (a)(14) – Pt List       (f)(1) – Immz Info
                                  Address ≥ 3 domains from the             (a)(2) – DD/DA    (b)(3) – eRx
                                                                            (a)(4) – Vitals   (e)(1) – VDTx3                      (a)(15) – Pt Edu        (f)(2) – Immz Tx
                                   set selected by CMS for EPs?                                                                     (b)(4) – ClinInfoRec    (f)(3) – Syn Surv
                                                                            (a)(11) – Smoking (e)(2) – Clinical Sum




Note: To meet the CEHRT definition, EHR technology will need to have been certified to:
 Automated numerator recording (170.314(g)(1)) or Automated measure calculation (170.314(g)(2));                                                                                         34
 Safety-enhanced design (170.314(g)(3)); and
 Quality management system (170.314(g)(4))
But wait, there’s more!

 • Check back to:
 http://www.healthit.gov/policy-researchers-implementers/meaningful-use-stage-2-0
 Now:
     – CEHRT Infographic flows and Bull’s eye diagrams


 Coming soon:
     – Grids comparing MU1 and MU2 w/ 2014 Ed.
     – Standards resource page where all the adopted standards as part of
       the 2014 Edition EHR Certification Criteria will be listed with URLs to
       where you can find/access them.



                                                                                    35
Questions




            36

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Posnack scc 2014edition_hitsc_091912

  • 1. 2014 Edition Standards & Certification Criteria Final Rule Edition] [HIT Standards Committee Special Steve Posnack, MHS, MS, CISSP Director, Federal Policy Division
  • 2. S&CC 2014 Edition Final Rule Major Themes • Enhancing standards-based exchange • Promoting EHR technology safety and security • Enabling greater patient engagement • Introducing greater transparency • Reducing regulatory burden 1
  • 3. S&CC and Meaningful Use Complementary but Different Scopes • S&CC scope = “technical” – Specifies the capabilities EHR technology must include and how they need to perform in order to be certified. – It does not specify how the EHR technology needs to be used. • Meaningful use scope = “behavioral” – Specifies how eligible providers need to use Certified EHR Technology in order to receive incentives. 2
  • 4. NPRM versus Final Rule S&CC February ‘12 S&CC August ‘12 § 170.314 § 170.314 (a) Clinical (n=18) (a) Clinical (n=17) (b) Care Coordination (n=6) (b) Care Coordination (n=7) (c) CQMs (n=3) (c) CQMs (n=3) (d) Privacy and Security (n=9*) (d) Privacy and Security (n=9*) (e) Patient Engagement (n=3) (e) Patient Engagement (n=3) (f) Public Health (n=8) (f) Public Health (n=6*) (g) Utilization (n=4) (g) Utilization (n=4) * = includes optional certification criteria 3
  • 5. “New” Certification Criteria Ambulatory & Inpatient Inpatient Only Ambulatory Only Electronic medication Electronic Notes Secure messaging administration record Cancer case Image results eRx (for discharge) information Transmission of electronic Transmission to Family Health History lab tests and values/results cancer registries to ambulatory providers Amendments View, Download, & Transmit to 3rd party Auto numerator recording Non % based measure use report Safety-enhanced design Quality management system Data Portability 4
  • 6. “Revised” Certification Criteria Ambulatory & Inpatient Ambulatory Only Drug-drug, drug-allergy Vital signs, body mass eRx interaction checks index, and growth charts Demographics CQMs (3 criteria) Clinical summaries Clinical information Incorporate lab tests and reconciliation values/results Problem list End-user device encryption Auditable events and Clinical decision support tamper-resistance Inpatient Only Drug-formulary checks Audit report(s) TOC – receive, display, and Transmission of TOC – create and transmit incorporate toc/referral reportable lab tests and toc/referral summaries summaries values/results Patient-specific education Patient list creation resources Automated measure Smoking status calculation Transmission to public Transmission to health agencies – Immunization Registries syndromic surveillance 5
  • 7. “Unchanged” Certification Criteria Ambulatory & Inpatient CPOE Advance directives Medication list Immunization information Medication allergy list Automatic log-off Authentication, access control, & Emergency access authorization Integrity Accounting of disclosures Incorporate lab test results Smoking status (inpatient only) Vital signs, body mass index, and Drug formulary checks growth charts Patient lists Patient reminders Reportable laboratory tests and Public health surveillance values/results • These certification criteria would be “eligible” for “gap certification.” 6
  • 8. Common MU Data Set (1) Patient name (9) Medications – RxNorm (2) Sex (10) Medication allergies – RxNorm (3) Date of birth (11) Laboratory test(s) – LOINC (4) Race – OMB Standard (12) Laboratory value(s)/result(s) (5) Ethnicity – OMB Standard (13) Vital signs – height, weight, blood pressure, BMI (6) Preferred language – ISO 639-2 (14) Care plan field(s), including goals constrained and instructions (7) Smoking status – 8 SNOMED CT® (15) Procedures – codes. (i) SNOMED CT® or CPT/HCPCS. (ii) Optional. ICD-10-PCS (iii) Optional. CDT (8) Problems – SNOMED CT®. (16) Care team member(s). 7
  • 9. 45 CFR 170.314(a) Clinical Certification Changes from Proposed Version to Final Version Criterion • Clarified that the standard for preferred language is ISO 639-2 constrained to those languages represented in ISO 639-1 (3) Demographics • Removed the reference to a vocabulary standard (ICD -10) for preliminary cause of death (4) Vital signs, body mass index, and Clarified that only numerical values can be recorded growth charts (5) Problem list Adopted the most recent version of SNOMED CT® and US extension • Specified that the use of the HL7 Context-Aware Knowledge Retrieval (8) Clinical decision (“Infobutton”) standard would be optional as part of the linked referential support decision support capability (and adopted IGs) • Limited configuration variations to be just based on a user’s role (11) Smoking status Adopted an 8-code list of SNOMED CT® codes for smoking status (13) Family health Adopted as alternatives, the most recent version of SNOMED CT® and the History HL7 Pedigree standard for recording family health history (15) Patient-specific Adopted HL7 Infobutton standard and the URL and SOAP-based education implementation guides resources 8
  • 10. 45 CFR 170.314(b) Care Coordination Care Coordination Certification Changes from Proposed Version to Final Version Criterion • Require receipt according to the same transport standards we adopted for transmit • Require the capability to display previously adopted summary care record (1) TOC – receive, standards: CCD/C32 and CCR display, and • Clarified that incorporate meant that problems, medications, and medication incorporate allergies data could be processed and stored for subsequent use toc/referral • Included a general patient matching capability with the incorporation summaries capability • Require that EHR technology would be able to individually display all of the other CCDA section templates that were not incorporated (2) TOC – create Revised the transport standards referenced to require certification to the and transmit primary Direct Project specification and to permit two optional approaches in toc/referral addition [(1) Secure App Statement + XDR/XDM for Direct Msg’n; (2) SOAP summaries RTM +XDR/XDM for Direct Msg’n] (3) Electronic NCPDP SCRIPT 10.6 and RxNorm prescribing 9
  • 11. 45 CFR 170.314(b) Care Coordination Certification Changes from Proposed Version to Final Version Criterion • Removed the erroneous reference to the main HL7 2.5.1 standard (5) Incorporate lab •Adopted an updated version of the LRI implementation guide and the most tests and recent version of LOINC® values/results • Note: This certification criterion remains “unchanged” for the inpatient setting (6) Transmission of Adopted an updated implementation guide and the most recent version of electronic lab tests LOINC® and values/results to ambulatory providers Inpatient setting only • New certification criterion (7) Data portability • Focuses on the most current clinical information about each patient for which an export summary can be created using the Consolidated CDA 10
  • 12. 45 CFR 170.314(c) Clinical Quality Measures Clinical Quality Measures Certification Changes from Proposed Version to Final Version Criterion (1) Clinical quality • Revised to a per CQM approach measures–capture • Adopted QRDA Category I for export and export (2) Clinical quality Adopted QRDA Category I for import to create a link between the two measures–import capabilities and calculate • Included the electronic submission certification criterion in the Base EHR definition (3) Clinical quality • Adopted QRDA Category I and III as electronic reporting formats measures– electronic submission 11
  • 13. 45 CFR 170.314(d) Privacy and Security Privacy & Security Certification Changes from Proposed Version to Final Version Criterion • Adopted the ASTM standard “for audit and disclosure logs for use in health information systems” and point to specific sections within that (2) Auditable events standard that mirrored the data/actions that were explicitly referenced in and tamper- the proposed version resistance • Clarified language • Changed the certification criterion’s name (7) End-user device • Modified the first part of the certification criterion to more clearly express a encryption technical capability that could be tested and certified 12
  • 14. 45 CFR 170.314(e) Patient Engagement Patient Engagement Certification Changes from Proposed Version to Final Version Criterion • Included a requirement that the online access must be done through secure channel •Specified that only the primary Direct Project transport specification is required for certification (1) View, download, • Adopted SNOMED CT® and CPT/HCPCS as alternative required and transmit to 3rd vocabularies for procedures, but also permit additional (optional) certification party to ICD-10-PCS and CDT (dental terminology) • Changed the accessibility requirement from WCAG Level AA to Level A • Removed the requirement to enable images to be downloaded and transmitted to a 3rd party • Adopted the use of RxNorm for medication allergies 13
  • 15. 45 CFR 170.314(f) Public Health Public Health Certification Changes from Proposed Version to Final Version Criterion (2) Transmission to Adopted an updated implementation guide and the most recent Immunization Registries version of CVX codes (3) Transmission to public health agencies – syndromic Adopted an updated implementation guide and addendum surveillance (4) Transmission of reportable Adopted a supplement to the implementation guide and the lab tests and values/results most recent versions of LOINC® and SNOMED CT® Inpatient setting only (5) Cancer case information Designated as “optional” Optional - ambulatory setting only (6) Transmission to cancer Designated as “optional” and adopted an updated/final registries implementation guide and the most recent versions of LOINC® Optional - ambulatory setting only and SNOMED CT® 14
  • 16. 45 CFR 170.314(g) Utilization Utilization Certification Changes from Proposed Version to Final Version Criterion Modified to require that EHR Modules be able to create a report or file that (1) Auto numerator enables a user to review the patients or actions that would make the patient recording or action eligible to be included in the measure’s numerator (2) Automated measure No change calculation (3) Safety-enhanced No change design • New certification criterion (4) Quality • Requires the disclosure of whether and what QMS was used in for EHR management technology development . Acceptable approaches are: 1) a single QMS; 2) system multiple QMS’; or 3) no QMS. 15
  • 17. Standards Applicability Vocabulary & Content Exchange Purpose Code Sets / Utilization Transport OMB Race/Ethnicity Demographics ISO 639-2 (constrained) Problems SNOMED CT® + US ext CDS HL7 Infobutton + IGs Smoking Status SNOMED CT® + US ext Family Health SNOMED CT® + US ext History HL7 Pedigree Patient Ed Resources HL7 Infobutton + IGs Applicability CCD/C32 Statement for Secure SNOMED CT® + US ext Health Transport ToC – receive, display, RxNorm & incorporate CCR AppState + XDR/XDM SOAP RTM + Consolidated CDA XDR/XDM 16
  • 18. Standards Applicability (cont.) Vocabulary & Content Exchange Purpose Code Sets / Utilization Transport Applicability [Common MU Statement for Secure ToC – Create & Data Set] Health Transport Consolidated CDA Transmit ICD-10-CM AppState + XDR/XDM CVX SOAP RTM + XDR/XDM e-Rx RxNorm NCPDP SCRIPT 10.6 Incorporate Labs LOINC HL7 S&I LRI Spec (ambulatory) [Common MU Data Set] Data Portability Consolidated CDA ICD-10-CM CVX 17
  • 19. Standards Applicability (cont.) Vocabulary & Content Exchange Purpose Code Sets / Utilization Transport CQM Export QRDA Category I CQM Import QRDA Category I QRDA Category CQM e-Submit I & III Consolidated CDA Applicability View, download, [Common MU Statement for Secure transmit to 3rd party Data Set] WCAG Level A Health Transport [Common MU Clinical Summary Consolidated CDA Data Set] Immz Reporting CVX HL7 2.5.1 + IGs Syndromic HL7 2.5.1 Surveillance +IG (inpatient only) SNOMED CT® + US ext ELR HL7 2.5.1 + IG LOINC SNOMED CT® + US ext Cancer Registry CDA R2 + IG 18 LOINC 18
  • 20. Revised Certified EHR Technology (CEHRT) Definition July 2010 Final Rule Policy August 2012 Final Rule Policy Static Definition Dynamic Definition Driven by Certification Criteria Driven by Meaningful Use 19
  • 21. Revised CEHRT Definition and Interdependence Big picture • The new regulatory framework provides more flexibility. • The potential number of 2014 Edition certification criteria to which EHR technology would need to be certified (for an eligible provider to have EHR technology that meets the CEHRT definition) could be limited to the MU stage needs of an EHR technology developer’s customer. CEHRT Interdependence – Two views of the CEHRT Definition • For eligible providers: – It is about having EHR technology(ies) certified to meet the Base EHR definition and just enough of 2014 Edition certification criteria to support their achievement of the MU stage they seek to meet. • For EHR technology developers: – This new definition presents the opportunity to rethink the scope of EHR technology certifications sought. – Now able to seek “right size certifications” for their EHR technology based on their customers scope of practice and/or the MU stage that their customers will be seeking to achieve. 20
  • 22. General Points to Remember • Two types of certifications can be issued: – “Complete EHR” (i.e., EHR tech certified to all mandatory cert. criteria) – “EHR Module” (i.e., EHR tech certified to less than all mandatory cert. criteria) • The scope of a certification issued to EHR technology represents only the capabilities for which the certification was sought/granted. • EHR technology developers get to choose the type of certification sought for EHR technology and its scope (i.e., for EHR Modules, the number of cert. criteria to which it would be certified). – Additional capabilities beyond those for which certification criteria have been adopted are not within the scope of ONC’s regulatory framework and reflect a business decision made by the EHR technology developer if they are included with 21 an EHR technology to which a certification is issued.
  • 23. So what? What’s to be excited about? Now 3 ways to meet CEHRT definition • Complete EHR – Generally provides overall assurance. – EPs would still need EHR technology certified to cancer registry certification criteria if they seek to meet that MU objective. • EHR Module(s): – Combination of EHR Modules – Single EHR Module • In the case of EHR Modules, it is now possible for an eligible provider to have just enough EHR technology certified to the 2014 Edition EHR certification criteria to meet the CEHRT definition. 22
  • 24. 2014 Edition CEHRT Easy as 1, 2, 3 + C* EP/EH/CAH would only need to have EHR technology with capabilities certified for the MU menu set objectives & measures for the stage of MU they seek to achieve. EP/EH/CAH would need to have EHR technology with capabilities certified for the MU core set objectives & measures for the stage of MU they seek to achieve unless the EP/EH/CAH can meet an exclusion. Base EHR EP/EH/CAH must have EHR technology with capabilities certified to meet the 1 Base EHR definition. *C = CQMs 23
  • 25. Certification Criteria Assigned to Final Base EHR Definition • It is a definition. It is meant to be used like a checklist to meet the CEHRT definition. • It is not “a Base EHR” or a singular type of EHR technology that has these capabilities. • The Base EHR definition includes CQM requirements not specified in this table. 2014 Edition EHR Certification Criteria Required to Satisfy the Base EHR Definition EHR technology that: Certification Criteria Demographics § 170.314(a)(3)  Includes patient demographic and Vital Signs § 170.314(a)(4) N/A clinical health information, such as Problem List § 170.314(a)(5)  medical history and problem lists Medication List § 170.314(a)(6)  Medication Allergy List § 170.314(a)(7)  Has the capacity to provide clinical Drug Drug and Drug Allergy Interaction Checks § 170.314(a)(2) N/A decision support Clinical Decision Support § 170.314(a)(8)  Has the capacity to support physician Computerized Provider Order Entry § 170.314(a)(1)  order entry Has the capacity to capture and query information relevant to health care Clinical Quality Measures § 170.314(c)(1) through (3)  quality Has the capacity to exchange electronic Transitions of Care § 170.314(b)(1) and (2)  health information with, and integrate Data Portability § 170.314(b)(7)  such information from other sources View, Download, and Transmit to 3rd Party § 170.314(e)(1) N/A Has the capacity to protect the confidentiality, integrity, and availability Privacy and Security § 170.314(d)(1) through (8)  of health information stored and exchanged 24
  • 26. CEHRT: Show and Tell EP MUS1 min = 27 CC Ambulatory CEHRT = 32 CC *No MU core exclusions ** 5 MU menu deferral 2010 Final Rule Policy EP min = variable Ambulatory CEHRT = CC required by Base EHR def Reality sized + those to meet MU stage “Right sized” 2012 Final certified EHR Module(s) Rule Policy 25
  • 27. Revised CEHRT Definition Effective Dates and Options EHR Reporting Period FY/CY 2011 FY/CY 2012 FY/CY 2013 FY/CY2014 MU Stage 1 MU Stage 1 MU Stage 1 MU Stage 1 or MU Stage 2 EPs, EHs, and CAHs have 3 options: 1) EHR technology that has been certified to all All EPs, EHs, and CAHs must have applicable 2011 Edition EHR certification criteria. EHR technology certified to the 2014 2) EHR technology that has been certified to all Edition EHR certification criteria applicable 2011 Edition or equivalent 2014 that meets the Base EHR definition Edition EHR certification criteria Same and would support the objectives, certification criteria. Policy measures, and their ability to 3) EHR technology certified to the 2014 Edition successfully report the CQMs, for EHR certification criteria that meets the the MU stage that they seek to Base EHR definition and would support achieve. ability to achieve MU stage 1 and successfully report the CQMs. • 2014 Edition EHR technology supports the achievement of either meaningful use stage. • Certification is not tied to MU stages. • No “Stage 1 Certified” or “Stage 2 Certified” in perpetuity. 26
  • 28. Illustrated: Two Types of Certifications Issued “Complete EHR” or “EHR Module” 1 Universe of EHR technology capabilities (e.g., all of what XYZ’s EHR technology includes) 2014Ed Complete EHR definition 2 Generally supports MUS1 or MUS2 achievement MUS2 Certified to all mandatory 2014Ed CC for setting EHR Module certified to number of 2014Ed 3 necessary to support MUS1 MUS1 Inner square = EHR Module certified to number of 2014Ed CC less than MUS1 (or MUS2) 4 Outer square = EHR Module certified to number of 2014Ed CC necessary to support MUS2 5 Base EHR definition = certified EHR Module 6 EHR Module certified to less than Base EHR definition Point to remember: Certification’s scope does NOT address all 2014 Edition Scope Stops Here 27 capabilities included in EHR technology
  • 29. A Different Look: Understanding the CEHRT Definition and the Minimum Number of Certification Criteria to which EHR Technology would need to be certified 28
  • 30. ONC HIT Certification Program Final Changes • Temporary Certification Program Sunsets – Upon 2014 Edition final rule effective date • Program Name Change – “ONC HIT Certification Program” • Revisions to EHR Module Certification Requirements – Privacy and Security Certification Policy • Will not require upfront certification to P&S for the 2014 Edition CC • Policy outcome now reflected in Base EHR definition (which includes all P&S CC) – Other tweaks to make certification more efficient 29
  • 31. ONC HIT Certification Program Final Changes (cont.) • Application of certain new certification criteria to EHR technology – § 170.314(g)(1): Automated numerator recording – § 170.314(g)(3): Safety-enhanced design • 8 Medication related certification criteria: CPOE; Drug-drug, drug-allergy interaction checks; Medication list; Medication allergy list; Clinical decision support; eMAR; e-prescribing; and Clinical information reconciliation. – § 170.314(g)(4): Quality management system • Price Transparency: ONC-ACBs are required to ensure that EHR technology developers notify eligible providers about additional types of costs (i.e., one-time, ongoing, or both) that affect a certified Complete EHR or certified EHR Module’s total cost of ownership for the purposes of achieving meaningful use. • Test Result Transparency: The final rule requires that ONC-ACBs submit a hyperlink of the test results used to issue a certification to a Complete EHR or EHR Module. 30
  • 32. What’s Next? Anticipated Timeline • Aug 2012 – Final rule issued • Sept 2012 – Oct 2012 – Weekly waves of test procedures and electronic test tools published – Test Procedures and tools available for comment • Nov 2012 – Dec 2012 – Testing workshop – National Coordinator approves 2014Ed test procedures • Testing and certification to 2014 Edition available early 2013. 31
  • 33. 2014 Edition EHR Certification Criteria 2014 Certification Criteria associated with a Base EHR: 2014 Certification Criteria • CPOE (170.314(a)(1)) associated with MU Core Stage 2: MU Menu • Demographics (170.314(a)(3)) • Drug-drug, drug-allergy interaction • Problem list (170.314(a)(5)) checks (170.314(a)(2)) • Medication list (170.314(a)(6)) MU Core • Vital signs, BMI, & growth charts • Medication allergy list (170.314(a)(7)) (170.314(a)(4)) • Clinical decision support (170.314(a)(8)) • Smoking status (170.314(a)(11)) • Transitions of care (170.314(b)(1) & (2)) • Patient list creation (170.314(a)(14)) Base EHR • Data portability (170.314(b)(7)) • Patient-specific education resources • Clinical quality measures (170.314(c)(1) - (3)) (170.314(a)(15)) • Privacy and Security CC: • eMAR (170.314(a)(16)) o Authentication, access control, • Clinical information reconciliation & authorization (170.314(d)(1)) (170.314(b)(4)) o Auditable events & tamper resistance • Incorporate lab tests & (170.314(d)(2)) values/results (170.314(b)(5)) o Audit report(s) (170.314(d)(3)) • View, download, & transmit to 3rd o Amendments (170.314(d)(4)) Party (170.314(e)(1)) o Automatic log-off (170.314(d)(5)) • Immunization information o Emergency access (170.314(d)(6)) (170.314(f)(1)) o End-user device encryption (170.314(d)(7)) • Transmission to immunization o Integrity (170.314(d)(8)) registries (170.314(f)(2)) o Accounting of disclosures* (170.314(d)(9)) • Transmission to PH agencies – syndromic surveillance (170.314(f)(3)) 2014 Certification Criteria associated • Transmission of reportable lab tests with MU Menu Stage 2: & values/results (170.314(f)(4)) • Electronic notes (170.314(a)(9)) • Drug-formulary checks (170.314(a)(10)) • Image results (170.314(a)(12)) 2014 ed. certification criteria for which certification may be required: • Family health history (170.314(a)(13)) • Automated numerator recording (170.314(g)(1)) • Advance directives (170.314(a)(17)) • Automated measure calculation (170.314(g)(2)) • eRx (170.314(b)(3)) • Safety-enhanced design (170.314(g)(3)) • Transmission of e-lab tests & • Quality management system (170.314(g)(4)) values/results to providers (170.314(b)(6)) *= optional 32
  • 34. Do you have EHR Technology that meets the new Certified EHR Technology definition for Meaningful Use Stage 1? START HERE Do you have a 2014 Technology Definition for MU Stage 1 Edition Complete EHR for the Yes Yes Ambulatory (EPs) or Inpatient (EHs/CAHs) Setting? No Yes Is your EHR technology certified to the Yes Is your EHR technology certified to the Yes Do you have EHR technology following certification criteria to support following certification criteria to support that has been: the MU1 EP Core Objectives you seek to the MU1 EP Menu Objectives you seek to  Certified to ≥ 9 CQMs achieve and for which you cannot meet a meet? § 170.314:  ≥ 6 from CMS’ recommended MU exclusion? § 170.314: (a)(10) – RxFormulary (b)(5) – Incorp Lab core set (a)(14) – Pt List (f)(1) – Immz Info  Address ≥ 3 domains from the (a)(2) – DD/DA (b)(3) – eRx (a)(4) – Vitals (e)(1) – VDTx3 (a)(15) – Pt Edu (f)(2) – Immz Tx set selected by CMS for EPs? (b)(4) – ClinInfoRec (f)(3) – Syn Surv (a)(11) – Smoking (e)(2) – Clinical Sum Yes Is your EHR technology certified to the No No No following certification criteria required to meet the Base EHR definition? § 170.314: EP (a)(1),(3)&(5-8) – CPOE/Demogfrx/ProbList/ No MedList/MedAllergyList/CDS (b)(1),(2)&(7) – TOC/Data Port (c)(1)-(3) – CQMS (d)(1)-(8) – P&S No No No Yes Is your EHR technology certified to the Do you have EHR technology Is your EHR technology certified to the following certification criteria to support that has been: following certification criteria to support the MU1 EH/CAH Menu Objectives you  Certified to ≥ 16 CQMs from the MU1 EH/CAH Core Objectives you seek seek to meet? § 170.314: CMS’ selected set for EH/CAHs to achieve and for which you cannot meet (a)(10) – RxFormulary (b)(5) – Incorp Lab  Address ≥ 3 domains from the a MU exclusion? § 170.314: (a)(14) – Pt List (f)(1) – Immz Info set selected by CMS for Yes  (a)(2) – DD/DA (a)(11) – Smoking Yes (a)(15) – Pt Edu (f)(2) – Immz Tx Yes EH/CAHs?  (a)(4) – Vitals (e)(1) – VDTx3 (a)(17) – AD (f)(3) – Syn Surv (b)(4) – ClinInfoRec (f)(4) – ELR Note: To meet the CEHRT definition, EHR technology will need to have been certified to:  Automated numerator recording (170.314(g)(1)) or Automated measure calculation (170.314(g)(2)); 33  Safety-enhanced design (170.314(g)(3)); and  Quality management system (170.314(g)(4))
  • 35. EPs: Do you have EHR Technology that meets the new Certified EHR Technology definition for Meaningful Use Stage 1? START HERE Do you have a 2014 Yes Yes Edition Complete EHR for the Ambulatory Setting? No Is your EHR technology certified to the following certification criteria required to meet the Base EHR definition? § 170.314: (a)(1),(3)&(5-8) – CPOE/Demogfrx/ProbList/ No MedList/MedAllergyList/CDS (b)(1),(2)&(7) – TOC/Data Port (c)(1)-(3) – CQMS (d)(1)-(8) – P&S Yes No No No Is your EHR technology certified to the Is your EHR technology certified to the Do you have EHR technology following certification criteria to support the following certification criteria to support that has been: MU1 EP Core Objectives you seek to achieve the MU1 EP Menu Objectives you seek to Yes Yes Yes  Certified to ≥ 9 CQMs and for which you cannot meet a MU meet? § 170.314:  ≥ 6 from CMS’ recommended exclusion? § 170.314: (a)(10) – RxFormulary (b)(5) – Incorp Lab core set (a)(14) – Pt List (f)(1) – Immz Info  Address ≥ 3 domains from the (a)(2) – DD/DA (b)(3) – eRx (a)(4) – Vitals (e)(1) – VDTx3 (a)(15) – Pt Edu (f)(2) – Immz Tx set selected by CMS for EPs? (b)(4) – ClinInfoRec (f)(3) – Syn Surv (a)(11) – Smoking (e)(2) – Clinical Sum Note: To meet the CEHRT definition, EHR technology will need to have been certified to:  Automated numerator recording (170.314(g)(1)) or Automated measure calculation (170.314(g)(2)); 34  Safety-enhanced design (170.314(g)(3)); and  Quality management system (170.314(g)(4))
  • 36. But wait, there’s more! • Check back to: http://www.healthit.gov/policy-researchers-implementers/meaningful-use-stage-2-0 Now: – CEHRT Infographic flows and Bull’s eye diagrams Coming soon: – Grids comparing MU1 and MU2 w/ 2014 Ed. – Standards resource page where all the adopted standards as part of the 2014 Edition EHR Certification Criteria will be listed with URLs to where you can find/access them. 35
  • 37. Questions 36