2014 EHR FAQs

1.  How do I use the ONC CHPL?

The ONC Certified Health Product Listing (CHPL) is used by providers and hospitals to identify and select the certified EHR technologies they are using for Meaningful Use and then obtain a CMS EHR Certification ID number to use in their Meaningful Use attestation.

Instructions for navigating the CHPL and obtaining the required CMS EHR Certification ID can be found here and is also the entry point for the ONC CHPL portal: http://oncchpl.force.com/ehrcert?q=chpl

ONC has also provided further instructions on the CHPL on this page: http://www.healthit.gov/policy-researchers-implementers/certified-health-it-product-list-chpl

2.  How do I register for EHR testing and how much does it cost to test and certify with Drummond Group?

Registration for EHR testing is completed online at Register for EHR tests.

Please contact to Tracy LaRue (This email address is being protected from spambots. You need JavaScript enabled to view it. or 512-826-2938), our Client Services Coordinator for EHR, to receive our 2014 Edition Certification and Testing Decision Kit which includes our pricing.

3.  What is the 2014 Edition Criteria and how does it relate to Meaningful Use Stage 2?

2014 Edition Criteria is the name given by ONC to the new criteria required for Stage 2 Meaningful Use. You can find the final rule document here: http://www.gpo.gov/fdsys/pkg/FR-2012-09-04/pdf/2012-20982.pdf. Refer to sections 170.314 at the bottom of the rule to see the specific criteria.

Also, the list of all the required technical standards along with website references to the respective specifications is found here: http://www.healthit.gov/policy-researchers-implementers/meaningful-use-stage-2-0/standards-hub.

The previous certification was over the criteria which ONC now calls 2011 Edition Criteria (sections 170.302, 170.304, and 170.306 found in this ruling: http://edocket.access.gpo.gov/2010/pdf/2010-17210.pdf). Meaningful Use Stage 2 is developed and overseen by CMS and includes various measure thresholds required to obtain incentives. ONC has created a PDF document mapping the 2014 Edition Criteria to the Stage 2 Meaningful Use measures which you can find here: http://www.healthit.gov/sites/default/files/meaningfulusetablesseries2_110112.pdf. ONC also created a useful page containing informational presentations and documents regarding the new criteria which can be found here: http://www.healthit.gov/policy-researchers-implementers/meaningful-use-stage-2.

On this same ONC webpage, there is a PDF showing how 2014 Edition Certification can be used for Stage 1 MU.

 

4.  Where can I find the ONC test procedures?

You can find the test procedures here: http://www.healthit.gov/policy-researchers-implementers/2014-edition-final-test-method.

5.  What are Clinical Quality Measures?

Per the CMS website:

Clinical quality measures, or CQMs, are tools that help us measure and track the quality of healthcare services provided by eligible professionals (EPs), eligible hospitals (EHs) and critical access hospitals (CAHs) within our health care system.  These measures use a wide variety of data that are associated with a provider’s ability to deliver high-quality care or relate to long term goals for health care quality.  CQMs measure many aspects of patient care including: health outcomes, clinical processes, patient safety, efficient use of healthcare resources, care coordination, patient engagements, population and public health, and clinical guidelines.

Beginning in 2014, EPs must report on 9 of the 64 approved CQMs and EHs/CAHs must report on 16 of 29 approved CQMs, and the selected CQMs must cover at least 3 of the National Quality Strategy domains. Under 2014 Edition core measures are no longer required for submission in Meaningful Use attestation, but CMS does encourage use of these core set as applicable to the scope or practice and patient population: http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Recommended_Core_Set.html.

The CQM measures and further information can be found here: http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/2014_ClinicalQualityMeasures.html.

6.  Does Drummond Group offer consulting services for EHR?

Due to our ONC-required vendor neutrality, we can neither offer nor recommend consulting services.

7.  What is the difference between a Complete EHR and an EHR Module?

ONC addresses this question on their FAQ. Please refer to it at http://healthit.hhs.gov/portal/server.pt?CommunityID=2999&spaceID=41&parentname=&control=SetCommunity&parentid=&in_hi_userid=11673&PageID=0&space=CommunityPage.

8.  How do I qualify for meaningful use?

It is important to understand the distinction between certification of an EHR vendor and meaningful use attestation by an EP/EH/CAH. As this ONC website points out (http://www.healthit.gov/policy-researchers-implementers/certification-and-ehr-incentives#certification-vs-meaningful-use), an EHR product must first be certified before an EP/EH/CAH can attest to Meaningful Use. The EP/EH/CAH must then “meaningfully use” their certified EHR in such a way to meet the specific objectives required by the CMS measures to obtain the incentives as described in the CMS Final Rule for Stage 2. The CMS Final Rule goes into the necessary detail to explain what is required, but qualifying for meaningful use incentives is ultimately the responsibility of the eligible providers and hospitals. The CMS Final Rule for Stage is found here: http://www.gpo.gov/fdsys/pkg/FR-2012-09-04/pdf/2012-21050.pdf

9.  My product is certified to 2011 Edition Criteria. Does it inherit its certification for 2014?

No. Per the ONC Final Rule, no previously certified EHR Module could have its certification automatically “updated” to the 2014 Edition EHR certification criteria because it would need to be certified to at least the new quality management system certification criteria (170.314.g.4). Therefore, testing with an ONC Authorized Testing Lab like Drummond Group is necessary for any 2014 Edition Certification. Also, all 2011 Edition Criteria that have been revised must be retested as well.

However, ONC has identified several unchanged criteria which qualify for “Gap Certification” and may not need to be retested for certification. These Gap Certification criteria include:

314.a.1 – CPOE (or the individual CPOE criteria 314.a.18-20).

314.a.6 – Medication List

314.a.7 – Medication Allergy List

314.a.17 – Advance Directives (Inpatient Only)

314.b.5 – Incorporate Lab Results (Inpatient Only)

314.d.1 – Authentication, Access Control, and Authorization

314.d.5 – Automatic Logoff

314.d.6 – Emergency Access

314.d.8 – Integrity

314.d.9 – Accounting of Disclosures (Optional)

314.f.1 – Immunization Information

314.f.7 – Syndromic Surveillance (Ambulatory Only)

For Gap Certification, an ONC-ACB may accept the test results from a previous certification test administered by an ONC-ATCB or ACB for unchanged criteria. If these test results are accepted, the EHR would not need to be retested for these Gap Certification criteria.

10.  My EHR was certified by an ONC-ATCB or ACB other than Drummond Group. Can my EHR be certified by Drummond Group for the new 2014 Edition Criteria?

Yes. An ONC-Authorized Certification Body (ONC-ACB) like Drummond Group can accept test results from any ONC-ATCB or ACB. Vendors are free to use one ONC Authorized Testing Lab (ONC-ATL) for testing and a different ONC-ACB for certification, if desired.

11.  What is a Base EHR?

Base EHR is a term defined by ONC and CMS to describe the minimum criteria required by all EPs/EHs/CAHs regardless of what Meaningful measures they are attempting to meet. Its origins are traced back to the HITECH Act itself which required physicians to demonstrate meaningful use of a qualified, certified EHR to obtain incentive money. A qualified EHR was defined as an EHR capable of:

  • Including Patient Demographic and Medical History and Problem Lists
  • Providing Clinical Decision Support
  • Supporting CPOE
  • Capturing and Querying Information Relevant to Health Care Quality
  • Exchanging and Integrating Electronic Health Information with other Sources
  • Protecting the Confidentiality, Integrity and Availability of Health Information

In the previous 2011 Edition Criteria Final Rule, the term “Qualified EHR” was used. However, with 2014 Edition, ONC replaced the term “Qualified EHR” with “Base EHR” to convey the requirements in a plain language meaning. ONC then explicitly defined the 20 criteria which comprise a Base EHR:

314.a.3, 5-7 – Including Patient Demographic and Medical History and Problem Lists

314.a.8 – Providing Clinical Decision Support

314.a.1 or a.18 or a.19 or a.20 – Supporting CPOE

314.c.1-3 – Capturing and Querying Information Relevant to Health Care Quality

Minimum of 9 CQMs covering 3 domains, including 6 CQMs from recommended core set, for EPs

Minimum of 16 CQMs covering 3 domains for EHs/CAHs

314.b.1-2, 7 – Exchanging and Integrating Electronic Health Information with other Sources (NOTE – certifying on combinations of optional criteria 314.b.8 and 314.h.1 can potentially be part of Base EHR; please ask Drummond Group's technical team for more details.)

314.d.1-8 – Protecting the Confidentiality, Integrity and Availability of Health Information

EPs/EHs/CAHs, must have at a minimum certified EHRs, either through a single EHR product or using multiple EHR Products, covering the Base EHR definition. For example, even if an EP can qualify for the exclusion of the CPOE Measure, the EP must still have certified EHR technology with CPOE (314.a.1) criteria because it is part of the Base EHR.

Please note that Base EHR is NOT a separate EHR certification seal or designation. The two EHR certifications remain EHR Module and Complete EHR.

12.  My software is developed for a specialty practice (e.g., dental, etc.) and some criteria are not relevant for my customers. To be a Complete EHR, do I still need to certify over all the criteria?

To be a Complete EHR, it is still required that the EHR be certified to all required ONC Criteria for the given setting, Ambulatory or Inpatient. For Fiscal Year or Calendar Year (FY/CY) 2013, EPs/EHs/CAHs must still have certified EHR technology covering all applicable and required criteria. For example, a Dentist who never submits immunizations must still have certified EHR technology with immunization functionality (either 2011 Edition 302.k criterion or 2014 Edition 314.f.1-f.2 criteria).

However, starting in FY/CY 2014, ONC and CMS have relaxed the requirement that EPs/EHs/CAHs must have Complete EHRs or EHR Modules which collectively cover the same criteria as a Complete EHR to be a fully certified EHR technology. The definition for certified EHR technology will then be more flexible in that now it is required:

  • Certified criteria which meet the Base EHR definition and…
  • Only certified criteria necessary to meet the Meaningful Use measures which are sought to achieve.

Going back to the earlier example, a dentist would now not need his or her EHR technology certified to immunization (314.f.1-f.2) even though Immunization Submission is a Core measure for Stage 2.

Please note that all applicable 2014 Edition Utilization criteria (314.g.1-g.4) would still be required for EHR certification.

13.  Does my product have to meet all the privacy and security criteria to be certified?

For certification to 2014 Edition criteria, it is no longer required for an EHR Module to be certified to the required privacy and security criteria (170.314.d.1-d.8). However, EPs/EHs/CAHs still must have certified EHR technology over all of the required privacy and security criteria. NOTE – the Accounting of Disclosures criteria (314.d.9) is an optional criteria and not required for qualification for Meaningful Use.

14.  Are there any required criteria for an EHR Module certification?

Yes. For certification to 2014 Edition criteria, an EHR Module must be certified to the applicable criteria in the Utilization section of the criteria, 314.g.1-g.4.

314.g.4 – Quality Management System – Required for ALL EHR Modules

314.g.1 – Automated Numerator Recording – Required for EHR Modules certifying for criteria:

  • 314.a.1 – CPOE
  • 314.a.3 – Demographics
  • 314.a.4 – Vitals, BMI, Growth Chart
  • 314.a.5 – Problem List
  • 314.a.6 – Medication List
  • 314.a.7 – Medication Allergy List
  • 314.a.9 – Electronic Notes
  • 314.a.11 – Smoking Status
  • 314.a.12 – Image Results
  • 314.a.13 – Family Health History
  • 314.a.14 – Patient List Creation
  • 314.a.15 – Patient-specific Education Resources
  • 314.a.16 – eMAR (Inpatient Only)
  • 314.a.17 – Advance Directives (Inpatient Only)
  • 314.a.18 – CPOE-Medication
  • 314.a.19 – CPOE-Laboratory
  • 314.a.20 – CPOE-Diagnostic Imaging
  • 314.b.2 – Transition of Care – Create and Transmit
  • 314.b.3 – Electronic Prescribing
  • 314.b.4 – Clinical Information Reconciliation
  • 314.b.5 – Incorporate Lab Results
  • 314.b.6 – Transmission of Electronic Lab Tests and Value/Results (Inpatient Only)
  • 314.b.8 – Transitions of Care
  • 314.b.9 – Clinical Information Reconciliation and Incorporation
  • 314.e.1 – View, Download, Transmit to 3rd Party
  • 314.e.2 – Clinical Summaries (Ambulatory Only)
  • 314.e.3 – Secure Messaging (Ambulatory Only)

NOTE – 314.g.1 is not required if certifying to 314.g.2 (Automated Measure Calculation)

314.g.3 – Safety Enhanced Design – Required for EHR Modules certifying for criteria:

  • 314.a.1 – CPOE
  • 314.a.2 – Drug-drug, Drug-allergy Interaction Checks
  • 314.a.6 – Medication List
  • 314.a.7 – Medication Allergy List
  • 314.a.8 – Clinical Decision Support
  • 314.a.16 – eMAR (Inpatient Only)
  • 314.a.18 – CPOE-Medication
  • 314.a.19 – CPOE-Laboratory
  • 314.a.20 – CPOE-Diagnostic Imaging
  • 314.b.3 – Electronic Prescribing
  • 314.b.4 – Clinical Information Reconciliation
  • 314.b.9 – Clinical Information Reconciliation and Incorporation

For more details on these specific criteria, please refer to the ONC 2014 Edition Final Rule and the ONC Test Procedures.

15.  Can I view your test procedures/test scripts specific for my certification prior to testing?

Drummond Group will utilize the ONC test procedures that have been extensively reviewed as the basis for our testing. We do create test scripts,referred to as Proctoring Sheets, which clearly state the test procedures, expected results and verification steps for testing. However, our proctoring sheets in no way add additional requirements beyond what is expressed in the ONC test methods and are mapped back to the requirements dictated by the ONC test methods. Reviewing and using the ONC test methods for your test preparation will fully prepare you for the Drummond Group EHR ONC certification. The Drummond Group proctoring sheets will be issued to each applicant that has returned a signedMaster Services Agreement, provided us a purchase order or deposit, and has scheduled a test date on our calendar.

16.  How do I test my software if I use a third-party ePrescribing solution?

Third-party software is permitted to be included in your certification testing. However, any third-party software, including eRx solutions integrated within your system, must be noted in the ONC certification report which will eventually be reported within the ONC CHPL.

17.  If I use a third-party module in my software, do I need to test that module if it has been certified by an ONC-ACB?

Yes, if you want to receive certification over the criteria in question. A good example is a using a third-party e-Prescribing module. If that e-Prescribing module has been certified by an ONC-ACB, but can also be integrated within an EHR system, a Vendor’s EHR product cannot receive certification for e-Prescribing (170.314.b.3) unless they test and demonstrate compliance with that criterion. However, if you choose not to test the e-Prescribing criterion that was certified as an EHR Module in the remaining ambulatory setting criteria, your customers could still have a qualifying EHR technology by virtue of the Vendor’s EHR Module and the third-party e-PrescribingEHR Module collectively satisfying the requirements of a Complete EHR.

18.  How much assistance can I get before registering and signing-up for testing with Drummond Group?

Prior to registering and signing up for testing with Drummond Group, we will attempt to answer any questions you have, including detailed technical questions. Our technical team is very busy with our testing services, and we do assign priority in addressing technical questions to vendors who have completed registration and sign-up. However, we will work to sufficiently answer your questions and reply as quickly as possible.

19.  When will I receive proctoring sheets and be assigned to a Test Proctor?

Once you have satisfied the necessary legal and payment requirements for obtaining a firm test date, you will be assigned a test proctor and receive the proctoring sheets. The test proctor will then setup an introductory conference call to go over the test process and answer any questions you may have. You can also email the proctor with additional questions prior to your test date.

20.  Do I need to notify Drummond Group if I modify my certified product?

ONC addresses this within their Final Rule on the Permanent Certification Program. The relevant section is quoted below in italics:

Comments.Several commenters requested that we clarify whether each updated version of a Complete EHR or EHR Module would need to be recertified in order for its certification to remain valid, and whether there would be a mechanism available to accommodate routine changes and product maintenance without the need to fully retest and recertify each instantiation of a previously certified Complete EHR or EHR Module.  Some of these commentators stressed that they provide bug-fixes and other maintenance upgrades to customers on a regular basis and that those versions are normally denoted by a new “dot release” (e.g., version 7.1.1 when 7.1 received certification).

Response. We understand that Complete EHR and EHR Module developers will conduct routine maintenance.  We also recognize that at times Complete EHR and EHR Module developers will provide new or modified capabilities to either make the Complete EHR or EHR Module perform more efficiently and/or to improve user experiences related to certain functionality (e.g., a new graphical user interface (GUI)). Our main concern, as we stated in the preamble, is whether these changes adversely affect the capabilities to which a Complete EHR or EHR Module has already been tested and certified and whether those changes are such that the Complete EHR or EHR Module would no longer support an eligible professional or eligible hospital’s achievement of meaningful use.  Accordingly, we clarify that a previously certified Complete EHR or EHR Module may be updated for routine maintenance or to include new capabilities that both affect capabilities related and unrelated to the certification criteria adopted by the Secretary without its certification becoming invalid. However, we do not believe that it would be wise to simply permit a Complete EHR or EHR Module developer to claim without any verification that the routine maintenance or new/modified capabilities included in a new version did not adversely affect the proper functioning of the previously certified capabilities.  We believe that an ONC-ACB should, at a minimum, review an attestation submitted by a Complete EHR or EHR Module developer indicating the changes that were made, the reasons for those changes, and other such information and supporting documentation that would be necessary to properly assess the potential effects the new version would have on previously certified capabilities.

Therefore, if you make changes to your certified product which result in a new version release and wish to see this updated version of your product listed on the CHPL as a certified EHR technology, then you must submit a written attestation to Drummond which details exactly what was changed and how it impacts or does not impact the previously certified criteria.  Drummond will provide a document containing several questions for your use in assessing the changes and their impact. The attestation will be reviewed by the Drummond Certification Committee and either approved or not approved, thus allowing the new version to be listed on the CHPL without retesting, or your company will be asked to retest this version before certification is granted.  The first attestation is free and subsequent attestations are $1000.  If your company is asked to retest, then retesting fees will apply. You can request this attestation document by registering on the Drummond website here.

21.  What is price transparency?

One change ONC has made to the certification program is requiring vendors of certified EHR technologies to include price transparency language when promoting their certification status. These are types of costs only in addition to the costs that an EP, EH, CAH would pay to purchase the EHR technology capabilities for which certification are required. Below are some examples ONC provides in their Final Rule:

For example, if EHR technology is certified to the “view, download, and transmit to a 3rd party” certification criterion, and an EP would be expected to pay an “ongoing” monthly service fee to the EHR technology developer for it to host/administer this capability in order for the EP to meet the correlated MU objective and measure, the existence of this potential “ongoing” cost would need to be disclosed by the EHR technology developer. As another example, an EHR Module certified to the public health electronic lab reporting certification criterion (§ 170.314(f)(4)) would be able to create a valid HL7 message for electronic submission. However, for the purposes of achieving MU, a hospital may be expected to pay their EHR technology developer a separate “one-time” and/or “ongoing” interface development and configuration fee to establish connectivity between their certified EHR Module and a public health authority. In such a situation, the potential costs of the interface development and configuration fee would need to be disclosed. A final example would be where an EHR technology developer charges a “one-time” fee to integrate its certified EHR technology with a hospital’s other certified EHR Modules or a health information exchange organization. Again, just like the other examples, the potential for this fee would need to be disclosed by the EHR technology developer. Building off these examples, we would expect that an EHR technology developer could satisfy § 170.523(k)(1)(iii) by disclosing: 1) the type(s) of additional cost; and 2) to what the cost is attributed. In reference to the first example above, an EHR technology might state that “an additional ongoing fee may apply to implement XYZ online patient service.” In situations where the same types of cost apply to different services, listing each as part of one sentence would be acceptable, such as “a one-time fee is required to establish interfaces for reporting to immunization registries, cancer registries, and public health agencies.”

 

22.  Where can I find more information on CMS incentives?

For more information about CMS incentives and Stage 2, please visit the following CMS site: http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/index.html?redirect=/EHRIncentivePrograms/.

23. Which modules do I need to test for Ambulatory or Inpatient EHR?

The required modules for each setting are listed below. Please be aware that General Module criteria, which apply to both settings, may require different standards or test data according to their setting. Please refer to the 2014 Edition Certification Criteria Final Rule and associated test procedures for these details.

General Modules – Applicable for both Ambulatory and Inpatient

314.a.1 – CPOE

314.a.2 – Drug-drug, Drug-allergy Interactions Checks

314.a.3 – Demographics

314.a.4 – Vitals, BMI, Growth Chart

314.a.5 – Problem List

314.a.6 – Medication List

314.a.7 – Medication Allergy List

314.a.8 – Clinical Decision Support

314.a.9 – Electronic Notes

314.a.10 – Drug-formulary Checks

314.a.11 – Smoking Status

314.a.12 – Image Results

314.a.13 – Family Health History

314.a.14 – Patient List Creation

314.a.15 – Patient-specific Education Resources

314.a.18 – CPOE-Medication (Optional)

314.a.19 – CPOE-Laboratory (Optional)

314.a.20 – CPOE-Diagnostic Imaging (Optional)

314.b.1 – Transition of Care – Receive, Display and Incorporate

314.b.2 – Transition of Care – Create

314.b.3 – Electronic Prescribing

314.b.4 – Clinical Information Reconciliation

314.b.5 – Incorporate Lab Results

314.b.7 – Data Portability

314.b.8 – Transitions of Care (Optional)

314.b.9 – Clinical Information Reconciliation and Incorporation (Optional)

314.c.1 – Clinical Quality Measures – Capture and Export

314.c.2 – Clinical Quality Measures – Import and Calculate

314.c.3 – Clinical Quality Measures – Electronic Submission

314.d.1 – Authentication, Access Control, and Authorization

314.d.2 – Auditable Events and Tamper-Resistance

314.d.3 – Audit Report(s)

314.d.4 - Amendments

314.d.5 – Automatic Logoff

314.d.6 – Emergency Access

314.d.7 – End-user Device Encryption

314.d.8 – Integrity

314.d.9 – Accounting of Disclosures (Optional)

314.e.1 – View, Download, Transmit to 3rd Party

314.f.1 – Immunization Information

314.f.2 – Transmission to Immunization Registries

314.f.3 – Transmission to Public Health Agencies – Syndromic Surveillance

314.g.1 – Automated Numerator Recording

314.g.2 – Automated Measure Calculation

314.g.3 – Safety-Enhanced Design

314.g.4 – Quality Management System

314.h.1 – Direct Protocol Transport with CCDA (Optional)

314.h.2 – Direct Protocol Transport with XDM (Optional)

314.h.3 – SOAP Transport with XDR (Optional)

Ambulatory-Specific Modules

314.e.2 – Clinical Summaries

314.e.3 – Secure Messaging

314.f.5 – Cancer Case Information (Optional)

314.f.6 – Transmission to Cancer Registries (Optional)

314.f.7 – Syndromic Surveillance (Optional)

Inpatient-Specific Modules

314.a.16 – eMAR

314.a.17 – Advance Directives

314.b.6 – Transmission of Electronic Lab Tests and Value/Results

314.f.4 – Transmission of Reportable Lab Results

Additional Resources: - UPDATED

ONC FAQs are located at: http://www.healthit.gov/sites/default/files/pdf/onc-regulations-frequently-asked-questions.pdf

CMS FAQs are located at: https://questions.cms.gov/

 

 

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