Comparison of ONC & LTPAC EHR Functional Criteria AND Testimony to HITPC C/A Workgroup (Summary &...

Comparison of ONC & LTPAC EHR Functional Criteria

ANDTestimony to HITPC C/A Workgroup

(Summary & Detail Slides)

January 10, 2014 (Updated 1/17/2014)

Jennie Harvell, HHS/ASPESue Mitchell, Independent Consultant

Table of Contents

• Privacy and Security – Slide 3

• Summary Care Record at TOC/Referral – Slide 9

• Clinical Summary – Slide 16

• View, Download, Transmit – Slide 18

• Data Portability – Slide 20

• Patient Demographics – Slide 23

• Clinical Health Information – Slide 25

• Medication Related Criteria – Slide 29

• Incorporate Laboratory Tests & Values/Results – Slide 34

• Clinical Decision Support – Slide 36

• Advance Care Planning – Slide 40

• Clinical Quality Measures – Slide 44

• Public Health – Slide 49

• Patient-Specific Education Resources – Slide 53

• LTPAC Setting Specific EHR-S Requirements– Slide 55

Comparison:ONC, HL7 Functional Profile and CCHIT LTPAC

Criteria

• Privacy & Security related criteria:– Authentication, Access Control & Authorization– Auditable Events & Tamper-Resistance– Audit Report(s)– Amendments– Automatic Log-Off– Emergency Access– End-User Device Encryption– Integrity– Optional – Accounting of Disclosures

Privacy & SecurityComparison of ONC and HL7 and CCHIT Criteria and HITPC C/AWG Testimony

ONC 2014 Edition Comparable Criteria in either HL7 LTC FP or CCHIT LTPAC

§ 170.314(d)(1)Authentication, access control, and authorization.

•Good match on verifying that a person seeking access to electronic health information is the one claimed•Good match on establishing user access based on the unique identifier(s) and the actions the user is permitted to perform with the EHR technology

§ 170.314(d)(2)Auditable events and tamper resistance.

•Good match on record actions related to electronic health information in accordance with ONC specified standards•Poor match on record the audit log status (enabled or disabled) in accordance with ONC specified standards•Poor match on record the encryption status (enabled or disabled) of electronic health information locally stored on end-user devices by EHR •No match on EHR system set by default to perform specified audit tasks•No match on restricting the ability to disable the audit log to a limited set of users•Good match on audit log protection•No match on detection of alteration to the audit log



§ 170.314(d)(3)Audit report(s).

•Fair match on ability to create an audit report for a specific time period and sort entries in the audit log by specified data elements

§ 170.314(d)(4)Amendments.

•Poor match for select the record affected by a patient’s request for amendment•Good match for append the record for an accepted amendment•Poor match for denied patient request for amendment

§ 170.314(d)(5)Automatic log-off.

•Fair match for automatic log-off.

§ 170.314(d)(6)Emergency access.

•Good match on permitting identified users to access electronic health information during an emergency

§ 170.314(d)(7)End-user device encryption.

•No match on encryption of end-user devices after use of EHR technology on those devices stops•Fair match on use of encryption algorithms identified in FIPS Pub 140-2 Annex A•No match on default setting to encrypt end-user devices or restriction of users who can configure this feature•No match on default setting to encrypt end-user devices or restriction of users who can configure this feature•No match on prevent storage of health info on end-user devices after use of EHR technology on those devices stops



§ 170.314(d)(8)Integrity.

•No match on create a message digest in accordance with the hashing algorithms specified in FIPS PUB 180-4. •Fair match on verification of received messages in accordance with hashing algorithm specified in FIPS PUB 180-4.

§ 170.314(d)(9)Optional– Accounting of disclosures.

•Good match on compliance with HIPAA requirements for accounting of disclosures

Health IT Policy Committee Certification and Adoption Workgroup Testimony

December 2, 2013 Clinical Utility and Use in Practice: All LTPAC settings require technology with Privacy, Security and Integrity Features


ONC 2014 EditionComparable Criteria in either HL7 LTC FP or CCHIT LTPAC

December 12, 2013 •“… I would …attest that we owe the folks that we take care of the same responsibility in taking care of their digital life and their financial well-being. Data can be stolen from many areas and LTPAC software providers today are very, very small and are learning to provide safe, secure, feature rich, scalable systems. There are a few acute software vendors that are entering the [PAC] market that are trying to figure out what [PAC] means and the features and functions are very different than the acute care space. Most LTPAC providers have very small IT departments and do not have the time or skill to evaluate software at the level needed to ensure safe company and patient data. Most recently, I’d like to give a very quick example. Brookdale adopted a software package about two years ago and if my IT department did not evaluate that software—and this was a piece of software used by many of the providers today—I would've implemented a piece of software that, on a daily basis, would have been a HIPAA data breach violation…I pose to you today that many of the [LTC] providers’ IT departments don’t have the capabilities to question these software providers’ functionality. (S. Ranson)



December 12, 2013 •“Brookdale has had to subsidize some of these certifications just to make sure that our software systems are compliant with HIPAA and the regulations that we need to comply with as a public company.” (S.Ranson)•“Certification of software for a [LTC]company should include but not limited to the following categories: Secure regulatory compliance, interoperability which many of you have talked about today, third party device integration, validation—and no one has mentioned this, but validation of trusted sender data quality. We need to know the sender of the data is who they say they are and the data that they are transferring in fact is accurate for determining quality of care; core base functionality by care setting with coding standards.” (S.Ranson)•“there should be an overarching standard around security and privacy” (S.Ranson)•“One of the most powerful interventions, though, that led to our results of this grant that we have been conducting, of course, is the use of Direct, which is HIPAA compliant e-mail…”( B. Yeaman)•Surveyors need prompt access to the EHR (K. Tritz)•“we must … [ensure]care plans are in each record enabling client access—that’s patient, family, and caregiver” (J. Lynn)


Criteria

• Summary Care Record at TOC/Referral– Receive, Display, and Incorporate TOC/Referral

Summaries– Create and Transmit TOC/Referral Summaries

Summary Care Record at TOC/Referral Comparison of ONC and HL7 and CCHIT Criteria and HITPC C/AWG Testimony

ONC 2014 Edition Comparable Criteria in either HL7 LTC FP or CCHIT LTPAC§ 170.314(b)(1) Transitions of Care (TOC) – Receive, Display, and Incorporate TOC/Referral Summaries

•Good match on “receive” TOC/referral summaries.•No match on “receive” in accordance with specified transport standards•Fair match on “display” TOC/referral summaries received and formatted according to HITSP C32/ASTM CCR/Consolidated CDA•Good match on “incorporate” upon receipt of a TOC/referral summary (no content exchange standard specified)•No match on “incorporate” upon receipt of a TOC/referral summary formatted as a HL7 Consolidated CDA•Good match on properly match TOC/referral summary to correct patient•Poor match/no match on incorporate medication list/ medication allergy list expressed in RxNorm and problem list expressed in SNOMED•Poor match on display each additional section(s) of a TOC/ referral summary formatted as a HL7 Consolidated CDA


ONC 2014 Edition Comparable Criteria in either HL7 LTC FP or CCHIT LTPAC§ 170.314(b)(2) Transitions of Care (TOC) – Create and Transmit TOC/Referral Summaries

•Good match on create a TOC/referral summary •No match on summary formatted according to Consolidated CDA•Fair match on summary including Common MU Data Set and additional specified items•No match on expressing Common MU data set and additional items according to specified vocabulary standards•Poor/no match on transmit TOC/referral summary [in accordance with specified transport standards]

Summary Care Record at TOC/Referral Comparison of ONC and HL7 and CCHIT Criteria and HITPC C/AWG Testimony Health IT Policy Committee Certification and Adoption Workgroup TestimonyDecember 2, 2013 Clinical Utility: Create, transmit, receive, incorporate Summary Care

Records in all LTPAC settings

December 12, 2013 •LTPAC providers: “are pressured by receiving EHs for better information” (T. Leonard) and “getting pressure from EHs to be part of the system” (S. Chies)•“The focus of [LTPAC EHR] certification should be to support transitions of care” (J. Damgaard, D. DeVore)•“standards used in [MU], such as CCDA, SNOMED, LOINC, and RxNorm, can be and are supported within the EHR products to help obtain greater parity in the exchange of information regardless of formal certification” (K. Utterback)•“more and more individuals have and will have episodes of acute illness superimposed on chronic conditions, and the result is far more complex care provided in multiple sites by multiple clinicians across longer episodes of care… important for them are really two fundamental…processes… the first is the transition of clinical responsibility from one clinician…to another, and… from site to site or team to team…The second process is the exchange of a longitudinal care plan to align care across these multiple sites and providers and reduce the risks of omissions and duplications. … (T. O’Malley)


Health IT Policy Committee Certification and Adoption Workgroup TestimonyDecember 12, 2013 •“electronic exchange of standardized, interoperable clinical

information between different IT platforms becomes the essential tool for care integration between and among acute and LTPAC providers.” (T. O’Malley)•“at a minimum, EHR certification for both eligible providers…and LTPAC sites should include the capacity to send and receive these standardized data elements [in the HL7 CCDA] to support transitions in coordination…” (T. O’Malley)•“The [EHR] is critical to improving quality of care …Number one, interoperability. As the patient experiences care transitions, interoperability will lead to efficiencies… we anticipate …saving two hours per admission and facility staff time… This savings will be realized because of the automated entry of… orders … electronically delivered from the discharging hospital into the SNF EHR. … will …decrease keystroke entry errors, which…frequently contribute to patient harm...time saved will allow staff to focus efforts on improved data gathering and evaluation of the patient’s condition which is critical as sicker individuals are admitted (L.Harris).•“Supporting effective [ToC] should be the focus of our IT certification efforts… the establishment of a national… certification process focused on care transitions can head off… state level standards.” (J. Damgaard)


Health IT Policy Committee Certification and Adoption Workgroup TestimonyDecember 12, 2013 •“[Benedictine Health System] is expecting our software vendor to

adopt voluntary certification and other certifications…that will allow us to better use our information and…to transmit this information interoperably to other providers, including acute care... One of the visions we have going forward is to create an enterprise wide record that will cut across all …sectors of our delivery system,…from the post-acute payer…to independent living so that we can manage these individuals better.” (S. Chies)•“We're already getting …pressure from referring hospitals to exchange health information… Unfortunately, these are usually requests for ad hoc connections and not through a formal HIE…they want our facility associates to log directly into a hospital discharge system to input and receive information. That may be great for the hospital, but then [LTPAC is] left with manual input of the information into our own systems. I would like to see the standards and efforts around formal HIEs to be pushed much harder. Without this push, it’s hard to see successful interoperability any time soon…. . Due to our recent certification… we can now import lab results, submit immunization registries with HL7, submit syndromic surveillance files with HL7, provide clinical summaries in the form of a CCD, and also receive CCD/CCR format from external sources ” (T. Leonard)

• ONC requirements for ToC/Summary Care Records do not require or reference the inclusion of some clinical content important to LTPAC providers and included in the LTC FP (see bold text):– DC.1.1.4, cc#3: The system SHALL provide the ability to produce a CCD that

includes at least the following sections: Advance Directives, Problems, Alerts, and Medications

– DC.1.1.4, cc#4: The system provide the ability to produce a CCD that includes the following sections: Functional Status, Immunizations, Medical Equipment and Plan of Care.

• The LTC FP and CCHIT criteria include additional functionality related to receipt, display, incorporation, creation and transmission of summary documents and content that are not included in the ONC standards. These criteria are applicable to EHRs regardless of setting.

Summary Care Record at TOC/Referral – LTC FP & CCHIT Requirements

NOT in ONC 2014 Edition


Criteria

• Clinical Summary (Ambulatory setting only)

Clinical Summary Comparison of ONC and HL7 and CCHIT Criteria and HITPC C/AWG Testimony


§ 170.314(e)(2) Clinical Summary (Ambulatory setting only)

•Good match on create a clinical summary •No match on summary formatted according to Consolidated CDA•Poor match on Customization of clinical summary•Fair match on summary including Common MU Data Set •No match on summary including additional specified items


December 2, 2013 Clinical Utility and Use in Practice: Create clinical summary

December 12, 2013 LTPAC providers: “are pressured by receiving EHs for better information” (T. Leonard) and “getting pressure from EHs to be part of the system” (S. Chies)“The focus of [LTPAC EHR] certification should be to support transitions of care” (J. Damgaard, D. DeVore)“standards used in meaningful use, such as CCDA, SNOMED, LOINC, and RxNorm, can be and are supported within the EHR products to help obtain greater parity in the exchange of information regardless of formal certification” (K. Utterback)


Criteria

• View, download, and transmit to 3rd party

View, Download, and Transmit to 3rd PartyComparison of ONC and HL7 and CCHIT Criteria and HITPC C/AWG Testimony

ONC 2014 Edition Comparable Criteria in either HL7 LTC FP or CCHIT LTPAC§ 170.314(e)(1) View, download, and transmit to 3rd party.

•Neither the LTC FP nor the CCHIT LTPAC program include requirements providing patients with an online means to view, download, and transmit specified data to a 3rd party.


December 2, 2013 Clinical Utility and Use in Practice: Use of patient portals reported across all LTPAC provider types. Add statement

December 12, 2013 •“With every EHR system, there is a patient system reaction, so as we work towards certification in [LTPAC], it’s important to understand that a patient facing system will interact with that… As we view, download, and transfer, the provider should protect … information, but the patient should continue…to direct it, so the work being done in Blue Button would have a great application in transitions of care and [LTPAC].” (L. Kelly Hall)•“we need to figure out what the presentation layer is that is appealing to patients and families, but to have one record that all parties can tap into, upload to, download from, right through to the end of the person’s life…” (J. Lynn)


Criteria

• Data Portability

Data PortabilityComparison of ONC and HL7 and CCHIT Criteria and HITPC C/AWG Testimony

ONC 2014 Edition Comparable Criteria in either HL7 LTC FP or CCHIT LTPAC§ 170.314(b)(7) Data Portability

•Good match on create a summary •No match on summary formatted according to Consolidated CDA•Fair match on summary including Common MU Data Set and additional specified items•No match on expressing Common MU data set and additional items according to specified vocabulary standards


December 2, 2013 Clinical Utility and Use in Practice: Electronically create a set of export summaries for all patients in EHR technology formatted according to the Consolidated CDA

December 12, 2013 LTPAC providers: “are pressured by receiving EHs for better information” (T. Leonard) and “getting pressure from EHs to be part of the system” (S. Chies)“The focus of [LTPAC EHR] certification should be to support transitions of care” (J. Damgaard, D. DeVore)“standards used in meaningful use, such as CCDA, SNOMED, LOINC, and RxNorm, can be and are supported within the EHR products to help obtain greater parity in the exchange of information regardless of formal certification” (K. Utterback)

• ONC requirements for Data Portability do not require or reference the inclusion of some clinical content important to LTPAC providers and included in the LTC FP (see bold text):– DC.1.1.4, cc#3: The system SHALL provide the ability to produce a CCD that

includes at least the following sections: Advance Directives, Problems, Alerts, and Medications

– DC.1.1.4, cc#4: The system provide the ability to produce a CCD that includes the following sections: Functional Status, Immunizations, Medical Equipment and Plan of Care.

• The LTC FP and CCHIT criteria include additional functionality related to receipt, display, incorporation, creation and transmission of summary documents and content that are not included in the ONC standards. These criteria are applicable to EHRs regardless of setting.

Data Portability – LTC FP & CCHIT Requirements

NOT in ONC 2014 Edition


Criteria

• Demographics

Patient DemographicsComparison of ONC and HL7 and CCHIT Criteria and HITPC C/AWG Testimony


§ 170.314(a)(3)Demographics.

•Fair match on the ability to record, change, and access patient demographic data •No match on capture preferred language and race/ethnicity in accordance with ONC specified standard•No match on the ability to record, change, and access preliminary cause of death in the event of a mortality.


December 2, 2013 Clinical Utility and Use in Practice: All LTPAC providers need to record demographic data.

December 12, 2013 •“exchange of demographics and using some of the older ADT standards have been the primary interest…”(D. Devore)


Criteria

• Clinical Health Information– Problem List– Medication List– Medication Allergy List– Clinical Information Reconciliation

Clinical Health Information Comparison of ONC and HL7 and CCHIT Criteria and HITPC C/AWG Testimony

ONC 2014 Edition Comparable Criteria in either HL7 LTC FP or CCHIT LTPAC§ 170.314(a)(5)Problem list

•Good match on electronically record, change, and access problem list•Fair match on capturing/accessing content for duration of stay and over multiple encounters•Poor match on using specified standard [SNOMED]

§ 170.314(a)(6)Medication list

•Good match on electronically record, change, and access medication list and medication history•Fair match on capturing/accessing content for duration of stay and over multiple encounters

§ 170.314(a)(7)Medication Allergy list

•Good match on electronically record, change, and access active medication allergy list and medication allergy history•Fair match on capturing/accessing content for duration of stay and over multiple encounters

§ 170.314(b)(4) Clinical information reconciliation.

•Fair match on enable reconciliation of medication list•Poor match on enable reconciliation of problem list and medication allergy list•Poor match on simultaneous display of data from at least two list sources, create single reconciled list, and review/validate/automatically update problem/med/med allergy list



December 2, 2013 Clinical Utility and Use in Practice: Technology in all LTPAC settings would be clinically useful for: Patient Demographics, Health Information, Problem Lists, and Physician Order Entry. All LTPAC provider types use technology for: condition specific documentation and treatment records. Institutional LTPAC provider types (e.g., NHs, LTCHs, and IRFs) use technology for: medication and medication allergy information, Medication records, and exchanging information with Pharmacy and Lab information systems. Home health agencies may require: medication and medication allergy information, and Medication records.

December 12, 2013 •“…a joint project between NCPDP and HL7 for [C-CDA]…documents to meet CMS documentation requirements of an annual comprehensive med review. This structured document contains the pharmacist provided reconciled active med list, allergy list, indications for each active medication, and special instructions for the patient…can be used by pharmacists and other health care providers in all practice settings including LTPAC and behavioral health.” (S. Spiro)



December 12, 2013 •“ As many as 60% of [NH] residents are prescribed over or equal to 9 chronic medications, which is the CMS definition of polypharmacy. The potential consequences … is the development of an [ADE]…[ADEs] are difficult to predict…approximately half these events are considered preventable, and finally, most, about 80%, are associated with monitoring rather than prescribing errors” (S.Handler)•“At least two areas which are priorities [for EHR certification] from a [PH] perspective. They are medication administration data and laboratory data.” (N.Stone) •“EHR can be instrumental in reducing preventable re-hospitalizations … In the reduction of medication errors, …prescribers entering orders electronically into the EHR will decrease the chance for errors in the interpretation of prescriber orders. Now, we heard today earlier that monitoring was more important than prescribing; however, …a significant number of orders are changed today verbally or via telephone, which result in SNF staff entering the order into the software rather than the prescriber doing it. Therefore, keystroke errors are frequently identified in our business as contributors to adverse events that result in patient harm.” (L.Harris)•The electronic exchange of standardized, interoperable clinical information between different IT platforms becomes the essential tool for care integration between and among acute and LTPAC providers. (T O’Malley) •“it’s good to have voluntary certification as a helpful step perhaps, and we could require …some interoperability of at least a small set of data, the medications, diagnoses, care plans, function, mental status, likely course—that would be my list. “ (J. Lynn)


Criteria

• Medication related criteria:– CPOE– e-MAR– e-Rx– Drug-Formulary Check

Medication Related Criteria Comparison of ONC and HL7 and CCHIT Criteria and HITPC C/A WG Testimony


§ 170.314(a)(1) CPOE. •Good match on record, change and access each of the order types (i.e., meds, labs, radiology/imaging)

§ 170.314(a)(16) Inpatient setting only — e-MAR….

•Good match on verify right patient•Fair match on verify right: medication, dose, route, time, and documentation•Neither addresses use of assistive technologies nor requires synchronizing system clocks for recording date and time of clinical documentation.

§ 170.314(b)(3) Electronic prescribing.

•Good match on NCPDP SCRIPT v10.6•Poor match on use of Rx Norm for prescription content

§ 170.314(a)(10) Drug-formulary checks.

•Good match on automatically and electronically check whether a drug formulary exists for patient or drug

Medication Related CriteriaComparison of ONC and HL7 and CCHIT Criteria and HITPC C/AWG Testimony

Health IT Policy Committee Certification and Adoption Workgroup TestimonyDecember 2, 2013 Clinical Utility and Use in Practice: CPOE, e-MAR, e-Rx: Functionality

needed in NHs, LTCHs, IRFs. HHAs may require use of e-MAR.

December 12, 2013 •“…savings will be realized because of the automated entry of appropriate orders which have been electronically delivered from the discharging hospital into the SNF EHR.” (L. Harris)•“…the practice of prescribers entering orders electronically into the EHR will decrease the chance for errors in the interpretation of prescriber orders. …we heard today earlier that monitoring was more important than prescribing; however, in my experience, a significant number of orders are changed today verbally or via telephone, which result in SNF staff entering the order into the software rather than the prescriber doing it. Therefore, keystroke errors are frequently identified in our business as contributors to adverse events that result in patient harm.” (L. Harris)•“A [NF] indicated that they would discontinue a specific EMR they …implemented five months earlier as part of a plan of correction … among other problems an individual was given an excess dosage of Coumadin because the [e-MAR] kept all Coumadin orders, even when the dosage was changed. (K. Tritz)•we had to build two prescription systems; one for e-prescription outside the [MU] and the other one to be integrated with our internal pharmacy. So once we get to interoperability, some of those barriers, I hope, will fall away for us. (T. Leonard)


Health IT Policy Committee Certification and Adoption Workgroup TestimonyDecember 12, 2013 •“a 2011 survey report by the [ASCP], the QS/1, pharmacies are continuing

to move more into automation… Pharmacies surveyed have been the quickest to embrace e-prescribing automated packaging and electronic medication administration records. … In terms of electronic prescribing... the document noted the inconsistencies in LTPAC prescribing adoptions, stating the lack of direction on the LTPAC e-prescribing standard has led to these inconsistencies, leaving a void of the vendor implementation in this setting. Since the exemption is scheduled to remove November 1st, 2014, the industry is unsure how lifting the exemption will affect the e-prescribing adoption in the LTPAC setting. In addition, LTPAC settings have a higher use of controlled substances as compared to the ambulatory setting. Controlled substances represents further obstacles in the LTPAC e-prescribing adoption.” (S. Spiro)•“ As many as 60% of [NH] residents are prescribed over or equal to 9 chronic medications, which is the CMS definition of polypharmacy. The potential consequences … is the development of an [ADE]…[ADEs] are difficult to predict…approximately half these events are considered preventable, and finally, most, about 80%, are associated with monitoring rather than prescribing errors” (S.Handler) •“I don’t want to dissuade or discourage the use and development of prescribing decision support, but in the [NH], it’s important to remember to focus on monitoring as well” (S.Handler) •“[CDS] at the time of prescribing is one of the most powerful ways to change or influence physician and provider decision making” (N. Stone)


Health IT Policy Committee Certification and Adoption Workgroup TestimonyDecember 12, 2013 •“In terms of utilization of existing technology pipeline, there are existing

standards for lab, including LOINC and medications, NCPDP, and are widely available to support this safety system.” (S. Handler)

Comparison:ONC, HL7 Functional Profile and CCHIT LTPAC Criteria

• Incorporate Laboratory Tests & Values/Results

Incorporate Laboratory Tests & Values/Results Comparison of ONC and HL7 and CCHIT Criteria and HITPC C/AWG Testimony

ONC 2014 Edition Comparable Criteria in either HL7 LTC FP or CCHIT LTPAC§ 170.314(b)(5)Incorporate Laboratory Tests & Values/Results

•Good match on receive and incorporate results•Good match on display results•Poor match on requirement to display all the information, as specified, for a test report •Good match on attribute, associate, or link lab test and value/result with laboratory order or patient record


December 2, 2013 Clinical Utility and Use in Practice: All LTPAC settings reported to use/need lab tests/results in practice.

December 12, 2013 •“The [CDS] systems that we've developed use signals that require the presence of admission, discharge, transfer, lab, and medication data…there are existing standards for lab, including LOINC and medications, NCPDP, and are widely available to support [AD detection and management].” (S. Handler)•“Due to our recent certification process, we've built in some key capabilities. We can now import lab results…”(T.Leonard)•“Indeed, we find that sharing…lab results and just the exchange of demographics … have been the primary interest.” (D. Devore)


Criteria

• Clinical Decision Support– Evidence-based decision support interventions.– Linked referential clinical decision support– Clinical decision support configuration– Automatically and electronically interact– Source attributes– Drug-drug, drug-allergy interaction checks

Clinical Decision Support Comparison of ONC and HL7 and CCHIT Criteria and HITPC C/AWG Testimony

ONC 2014 Edition Comparable Criteria in either HL7 LTC FP or CCHIT LTPAC§ 170.314(a)(8)(i) Evidence-based decision support interventions.

•Fair match on enable users to select/activate CDS interventions•Good match on CDS interventions based on problems, medications, medication allergies, demographics & labs•Fair match on CDS interventions based on vital signs

§ 170.314(a)(8)(ii) Linked referential clinical decision support.

•Fair match on identify Dx and therapeutic reference info•No match on use of Infobutton standards for reference info• No match on reference info available based on each one and at least one combination of specified data

§ 170.314(a)(8)(iii) Clinical decision support configuration.

•Fair match on user configuration of interventions and resources•Poor match on electronic triggering of CDS interventions based on data incorporated in summaries

§ 170.314(a)(8)(iv) Automatically and electronically interact

•Fair match on CDS triggers occurring when a user is interacting with EHR technology

§ 170.314(a)(8)(v)Source attributes

•Poor match on all requirements related to source attributes

§ 170.314(a)(2) Drug-drug, drug-allergy interaction checks.

•Fair match on presentation of drug-drug and drug-allergy contraindications•Fair match on user adjustments to alert severity levels



December 2, 2013 Clinical Utility and Use in Practice: All LTPAC providers need CDS technology.

December 12, 2013 •“Our research group has … [worked]… to develop, test, and assess the impact of [CDS] systems to detect and manage [ADEs] in the nursing home setting. The systems …require the presence of admission, discharge, transfer, lab, and medication data… I …support of the base EHR definition… which [requires] clinical decision support as a core requirement… I …use AD detection and management as a use case …but there are many additional examples of how [CDS] rules can benefit residents in ….[NHs]…CDS can greatly improve the detection and management of [adverse consequences] and improve [regulatory compliance] and inclusion of medication specific CDS should provide alignment with and support existing federal and state programs... we should try and link [CDS rules] to those harm related events to try and reduce that ” (S. Handler)•“the level of opportunity for using “[CDS] at the time of prescribing can be quite significant. For example, …clear opportunity to optimize the way antibiotics are being used and other antimicrobials—not just in the LTPAC setting, but across all health care settings.” (N.Stone)



December 12, 2013 “the question around the need for things such as decision support reporting, medication management within the long term post-acute space—I mean, there’s no doubt whether those pieces are needed…there are some core principles around decision supports that still apply whether that individual is in a[LTC] versus in the hospital, those conditions still require that decision support to be there…” (C.Hertel)“… with respect to clinical decision support, there are core principles and good practices that can be imposed or used as guidelines in all systems, but I don't know that that is a certification issue. I see it as a competitive advantage issue, plain and simple…” (J.Damgaard)


Criteria

• Advance Care Planning

Advance Care PlanningComparison of ONC and HL7 and CCHIT Criteria and HITPC C/AWG Testimony


§ 170.314(a)(17) Inpatient setting only – Advance Directives

•Good match on indicate that advance directives exist for the patient


December 2, 2013 Clinical Utility and Use in Practice: All LTPAC settings reported to use/need advance care planning.

December 12, 2013 •“…there are three things [that EHR certification needs] to take account of. The first is, you have to make clear that the goal is to enable care plans to move across settings and time for very sick and disabled persons…we could require…interoperability of at least a small set of data, the medications, diagnoses, care plans, function, mental status, likely course…secondly—…we need to put the care plans into the records…We need advanced plans in all records, we need to know who the surrogate is, and not just a yes/no. We need to be able to code the major decisions…We need to make the core elements available to the patient, family, and caregiver. These are the most important [LTCPAC] providers, so they have to be involved in seeing the care plan, the record, the likely goals and the likely course. (J. Lynn)

Advance Care PlanningComparison of ONC and HL7 and CCHIT Criteria and HITPC C/AWG Testimony


December 12, 2013 •“we need to figure out what the presentation layer is that is appealing to patients and families, but to have one record that all parties can tap into, upload to, download from, right through to the end of the person’s life…” (J. Lynn)•need to “include anything about Social Services, …anything about housing, …include things about the capabilities of the caregiver” (J. Lynn)•“…it is becoming actually harmful and dangerous to have in the electronic record only a yes/no on an advanced directive. Now, a majority of states accept the POLST—we could readily digitize most of the POLST entries, and we could readily scan and attach to the record a real document” (J. Lynn)

Advance Care Planning –LTC FP & CCHIT 2011 Requirements Not in ONC 2014 Edition

• Indicate the type of advance directives completed (e.g., Living will, DNR)

• Capture, present, maintain and make available for clinical decisions patient advance directives documents and “DNR” orders

• Indicate when advanced directives were last reviewed

• Indicate the name and relationship of the party completing the advance directive for the patient

• See full listing in notes below


Criteria

• Clinical Quality Measures– Capture and Export– Import and Calculate– Electronic Submission

Clinical Quality Measures Comparison of ONC and HL7 and CCHIT Criteria and HITPC C/AWG Testimony

ONC 2014 Edition Comparable Criteria in either HL7 LTC FP or CCHIT LTPAC§ 170.314(c)(1)Clinical Quality Measures – capture and export.

•Fair match for the generic function of capturing data for quality reporting•Poor match for capturing data in accordance with the specified Data Element Catalog•Fair match for the generic function of exporting data for quality reporting•No match for exporting data in accordance with HL7 QRDA

§ 170.314(c)(2)Clinical Quality Measures – import and calculate.

•No match for importing data file formatted as HL7 QRDA•Fair match for calculating quality measures for which the technology is presented for certification

§ 170.314(c)(3)Clinical Quality Measures - electronic submission

•No match for creating HL7 QRDA files for reporting quality measures to CMS


Health IT Policy Committee Certification and Adoption Workgroup TestimonyDecember 2, 2013 Clinical Utility and Use in Practice : All LTPAC providers need technology to

capture and calculate QMs. All LTPAC providers use technology to report patient (assessment) data to CMS and CMS calculates QMs.

December 12, 2013 •“…e-quality measures….if [EHR]certification requirements for LTPAC… were to include… the ability to exchange…interoperable data elements required for good transitions and …longitudinal coordination of care… this could be a quality metric that could drive some of the adoption of the EHR, [and] fundamentally improve the process of care.”(T. O’Malley)•“EHR and EMR systems are critical enablers of …quality process and innovation …; the ability for health care workers to deliver excellent patient outcomes and maximize quality of life …in LTPAC settings depends greatly upon these systems.” (S.Ranson)•CMS believes that data uniformity…across settings, is critical to facilitate … transfer of information. It’s also what’s needed…to develop and implement measures that can be harmonized across settings... [Regarding CARE data elements:] a lot of data elements related to function had very high inter-rater and validity scoring…about six [QMs] have been developed related to function…function is very central to… the CMS quality strategy…. what is critical is looking at natural patient care flow and identifying data elements that…are clinically relevant and identifying what you need to help guide the patient care.”(S.Mandl)


Health IT Policy Committee Certification and Adoption Workgroup TestimonyDecember 12, 2013 •“… need to look at this as [a] strategy to get …from point A to point

B… this will be an incremental approach similar to …[MU], many … [QMs] needed to be transformed for use within an electronic environment… When and how that takes place,… needs to be assessed … some of these requirements are tied to regulatory requirements… information required for LTPAC [QM] should leverage clinical information recorded in the patient record. LTPAC clinical [QMs] should be derived from the quality data model, a framework that encompasses data from EHRs and other sources to manage measures of health. EHRs can than process these clinical [QMs] to guide the collection and reporting of LTPAC quality data. Decision support rules derived from CQMs will then prompt providers to do the right thing…. The same clinical information must be made available for transitions of care…Public and private pairs should agree on and promote consistent and efficient methods for electronic reporting of quality and health status measures across care settings…LTPAC reporting requirements should be harmonized with clinical data required for patient care. .” (C.Kallem)


Health IT Policy Committee Certification and Adoption Workgroup TestimonyDecember 12, 2013 “Lantana [is] working with … stakeholders through HL7 processes to

…. develop standards for [QM] expression and transmission formats. A lot of that work is … being used as part of …[MU] stage two …and we're ….working with a variety of stakeholders to support enhancement of those standards for …[MU] stage three.There are …differences in the existing transmission formats used in LTPAC settings, so we'll take some time and effort to help streamline those processes. …initial focus is to … help LTPAC providers get the data flowing first by using structured documents with minimum metadata requirements that …allow the information to get …to frontline clinicians and then eventually identify which of those data requirements should be structured to support …secondary uses such as quality measurement.There also needs to be some alignment and harmonization with the quality data model for those clinical quality measures that are currently used in the LTPAC setting. Certainly the quality data model is designed for use within electronic systems, and that would certainly align with the existing [MU] requirements.”(C.Kallem)


Criteria

• Public Health– Immunization information– Transmission to immunization registries. – Transmission to public health agencies – syndromic

surveillance– Transmission of reportable laboratory tests and

values/results (Inpatient Only)– Optional—cancer case information (ambulatory setting only)– Optional—transmission to cancer registries (ambulatory

setting only)

Public Health Comparison of ONC and HL7 and CCHIT Criteria and HITPC C/AWG Testimony

ONC 2014 Edition Comparable Criteria in either HL7 LTC FP or CCHIT LTPAC§ 170.314(f)(1)Immunization information.

•Good match on record, change, and access immunization information

§ 170.314(f)(2)Transmission to immunization registries.

•No match on create immunization information for electronic transmission using ONC specified standards

§ 170.314(f)(3)Transmission to public health agencies – syndromic surveillance.

•No match on create syndrome-based public health surveillance information for electronic transmission using ONC specified standards

§ 170.314(f)(4) Inpatient setting only—transmission of reportable laboratory tests and values/results.

•No match on create reportable laboratory tests and values/results for electronic transmission using ONC specified standards

§ 170.314(f)(5)Optional—ambulatory setting only—cancer case information.

•No match on electronically record, change, and access cancer case information

§ 170.314(f)(6)Optional—ambulatory setting only—transmission to cancer registries.

•No match on create cancer case information for electronic transmission using ONC specified standards




December 2, 2013 Clinical Utility and Use in Practice: Some LTPAC providers record immunization data.

December 12, 2013 •“establishing a common language for recording and sharing clinical data could dramatically improve the flow of information from health care providers…as well as to [PH] entities…In 2012, the HAI reporting program …was extended to [LTCHs] and acute [IRFs], which began reporting data to CDC in January of this year…creating the capacity to identify HAI events within EHR systems and transmit data to CDC using interoperable exchange would reduce the burden of data collection for facilities while standardizing…data submission…for all providers. Clinical data “priorities from a [PH] perspective…are medication administration…and laboratory data …data on immunizations and antimicrobials would support…efforts to prevent …transmission of vaccine preventable diseases and reduced …emergence of antibiotic resistant organisms.” (N.Stone)•defining a health IT standard for… influenza vaccine administration… would enable…information…exchanged between… providers as well as … state vaccination registries. This could reduce duplication of immunization …among different…providers caring for the same person, reduce… individual’s risk of receiving multiple vaccinations…, and provide [PH] with reliable information and vaccine coverage within communities. (N.Stone)




December 12, 2013 •“….clear opportunity to optimize the way antibiotics are…used and other antimicrobials—not just in the LTPAC setting…antibiotic stewardship literature … suggest that [CDS] at the time of prescribing is one of the most powerful ways to…influence … provider decision making. (N.Stone)

• On transitions of care: CDC has a national infection reporting data system (NHSN) that includes information on “positive laboratory identified [MDROs]; for example, [MRSA] or [VRE] or even C. diff. The presence of… infection…is incredibly important for any receiving facility… so that they can ensure… safest care…delivered to that person.” (N.Stone)

•“we…have a clinical surveillance system…across all… clinical settings, including…[NH] care… for infection prevention, control, for HAI detection management reporting, and… to exchange information about HAIs or [MDROs]…to the next care setting.” (S.Handler)


Criteria

• Patient-Specific Education Resources

Patient-Specific Education ResourcesComparison of ONC and HL7 and CCHIT Criteria and HITPC C/AWG Testimony

ONC 2014 Edition Comparable Criteria in either HL7 LTPAC FP or CCHIT LTPAC

§ 170.314(a)(15) Patient-specific education resources.

•Fair match on electronically identify for a user patient-specific education resources•Poor match on use of Infobutton standards•Good match on use of processes other than Infobutton


December 2, 2013 Clinical Utility and Use in Practice: Use of patient portals reported across all LTPAC provider types. Patient portals are available across all LTPAC provider types. However, frequency and breadth of use is unknown.

December 12, 2013 •“…all that health happens at home, that the facilities and licensed health services we've been talking about are extremely important, but 75 percent of [LTC] is provided by families in the home, and by non-licensed personnel and agencies going into the home.” (S. Atkins)•“we need to figure out what the presentation layer is that is appealing to patients and families, but to have one record that all parties can tap into, upload to, download from, right through to the end of the person’s life…” (J. Lynn)

LTPAC Setting Specific EHR-S Requirements

Federally Required AssessmentsUse in Practice

•CMS requires LTPAC providers to create, maintain, and transmit (in accordance with CMS requirements) assessment instruments assessment instruments and data sets for LTPAC: MDS 3.0, OASIC-C , IRF-PAI, CARE subset for LTCH.•LTPAC providers create and use a variety of clinical assessments for a variety of purposes (patient assessment, care planning, internal quality monitoring/improvement, support transition of care, payment, and quality assurance).

Use in Practice

EHR Criteria in either HL7 LTPAC FP or CCHIT LTPAC

Create Assessments

The EHR must allow providers to create and make available the following assessments for clinician use:• user-defined assessments reflecting assessment content and protocols;• standard assessments reflecting assessment content and protocols as per industry and professional standards of practice;•Federally-required assessment instruments or assessment data in accordance with CMS requirements.

Federally Required AssessmentsUse in Practice EHR Criteria in either HL7 LTPAC FP or CCHIT LTPAC

Maintain Assessments

The EHR SHALL provide the ability to complete, maintain, and retrieve assessments as required by:a) Federal, State, and other jurisdictional requirements,b) professional standards of practice, and c) facility policy.

Transmit Assessments

The EHR SHALL provide the ability to transmit assessment instruments or assessment data as mandated by jurisdictional regulations

Re-use Assessment Content

The EHR SHOULD provide the ability to re-use assessment data for: • various clinical purposes such as: creating a problem list, an

individual care plan, and tracking trends; and • administrative purposes such as Medicare and Medicaid payment

calculation, quality monitoring and reporting, reporting associated with survey oversight.

The EHR SHOULD support: • the creation and exchange of an interoperable LTPAC Assessment

Summary CDA document in accordance with the HL7 IG for CDAr2: LTPAC Summary Release R.1; or

• provide the ability to upload source assessment documents to a third party for the creation of a LTPAC Summary CDA document.

Federally Required Assessments


December 2, 2013 Clinical Utility and Use in Practice: All LTPAC providers: (i) must complete and electronically transmit federally required assessments /assessment data; and (ii) complete other patient assessments. Assessment data is reused for various clinical and administrative activities.

December 12, 2013 •“CARE tool data set comprised from uniform data elements was designed to standardize the assessments of patient medical, functional, cognitive, and social support status across acute and post-acute settings” (S. Mandl)• CMS requires “the minimum data set for SNFs and NFs, inpatient rehab facility Patient Assessment Instrument, the IRF PAI for IRFs - inpatient rehab facilities, the Outcome and Assessment Information Set or OASIS for home health, and the Long Term Care Hospital Continuity Assessment Record and Evaluation Data Set or the LTCH CARE data set, and a Hospice Item Set. Data is submitted to CMS electronically by providers …using our submission specifications which we post on our CMS website by provider type setting” (S. Mandl)

Federally Required Assessments Health IT Policy Committee Certification and Adoption Workgroup Testimony

December 12, 2013 •“CMS is…exploring movement and capability towards uniformity… I mean… the use of uniform, consistent data elements in multiple settings to enable consistent [QM] capabilities and … foster and facilitate data uniformity—transfer of data. Lantana is our named contractor that supports our efforts towards … a CMS assessment data element library and the data governance support, so that once we are able to incrementally move towards uniformity of data elements, the integrity of those data elements are protected” (S. Mandl)•“There are…differences in the existing transmission formats used in LTPAC settings, so we'll take some time and effort to help streamline those processes…initial focus is to try to help LTPAC providers get the data flowing …using structured documents with minimum metadata requirements that then allow the information to get flowing to frontline clinicians and then eventually identify … those data requirements should be structured to support various secondary uses such as [QM].” (C. Kallem)•“The handling of the MDS, … census data, care planning, quality assurance activities, by and large …are primarily used for internal operations of the SNF. There are a number of SNFs that would like to be able to transmit data… but the interoperability structure in the state is not terribly well developed for communicating between hospitals and SNFs, SNFs and home health or home care, assisted living. (D. Shreve)

Federally Required Assessments Health IT Policy Committee Certification and Adoption Workgroup Testimony

December 12, 2013 •“We have to have our reimbursement piece, the MDS, as part of our electronic health record…. (L. Tubbs)•“ the RAI [Resident Assessment Instrument] manual currently has some changes that can affect the electronic medical record system with no turnaround time. …the government pushed out the changes, and then the vendors have to create [the] system to integrate. It doesn’t always happen in a timely manner… recently, the RAI manual was updated in Section G with ADLs. … they wanted the cross referencing of therapy documentation along with some interdisciplinary review and comment during the seven day look back period. This causes a gap because the [EHR] currently doesn’t do a cross matrix for matching of those and the therapy documentation usually is narrative, so there has to be opportunity to change that and pull through. It just becomes cumbersome for the end user, who has to then data mine from two different systems. (L. Tubbs)•“there’s a strong need for CMS to adopt a minimum criteria for standardized patient health record information to be utilized across all providers and disciplines.” (L. Tubbs)

Survey and Certification RequirementsUse in Practice

•CMS and States conduct quality assurance and complaint surveys in certain LTPAC providers (e.g., Nursing Homes, Home Health, and Hospice Providers) and certifies providers as meeting program participation requirements.•The survey process requires resident/patient and staff interviews, observation of care and services being provided, and review the medical record.

Use in Practice

EHR Criteria in either HL7 LTPAC FP or CCHIT LTPAC

Surveyors need complete access to EHR

The EHR shall support prompt surveyor access to the complete EHR, consistent with federal requirements.

Survey Requirements Health IT Policy Committee Certification and Adoption Workgroup Testimony

Clinical Utility and Use in Practice: Federal and State quality assurance surveys are conducted in certain LTPAC provider settings.

December 12, 2013 • A NF “indicated that they would discontinue a specific EMR they had implemented five months earlier as part of a plan of correction … because the electronic [MAR] kept all Coumadin orders, even when the dosage was changed. The result was that the nursing staff didn't then trust the system and reverted back to reliance on the paper documentation and contacted the medical director frequently to verify the orders. …raise[s] the broader questions of, to what extent can an EMR certification process include disclosure and follow up of any software problems identified, whether it be through the certification program, CMS, or both.” (K. Tritz)•Surveyors need prompt and complete access to the EHR to complete surveys as required. (K. Tritz)•“It would be interesting to consider if an EMR certification program could also include certain interoperability with this QIS [Quality Indicator Survey] software.” (K. Tritz)•“it [is] imperative for the surveyors …to look across modules of the EMR to understand the timeline of how the different care components fit together.” (K. Tritz)

Survey Requirements Health IT Policy Committee Certification and Adoption Workgroup Testimony

Clinical Utility and Use in Practice: Federal and State quality assurance surveys are conducted in certain LTPAC provider settings.

December 12, 2013 • “We have to have [as part of our EHR] a regulatory component that CMS requires us to document and for surveyors to filter through during the survey process, so CMS reports as well that are required and standardized for the surveyors to review “ (L. Tubbs)

Comparison of ONC & LTPAC EHR Functional Criteria AND Testimony to HITPC C/A Workgroup (Summary &...

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