Certification / Adoption Workgroup

Larry Wolf, chairMarc Probst, co-chair

Certification / Adoption Workgroup

February 7, 2014

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Agenda

• Review of Agenda• Workforce Subgroup – Update• Patient Perspective

– Mark Savage, National Partnership for Women & Families• Requirements of 42 CFR Part 2

– Maureen Boyle, SAMHSA • HITPC Charge: Step Two

– Discussion of Potential Behavioral Health IT Certification Criteria• Next Steps• Public Comment

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Updated Call Schedule

Date Call Schedule 10/25/2013 Overview of new charge11/4/2013, 11/18/2013 Develop a framework for certification12/2/2013, 12/12/20131/10/2014, 1/17/2014

LTPAC EHR background presentation, virtual hearing, draft recommendations

1/21/2013, 1/28/2014,2/7/2014, 2/14/2014

BH EHR background presentation, virtual hearing, draft recommendations

2/21/2014, TBD Workgroup review and finalization of recommendations

3/11/2014 Recommendations to HITPC

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Patient and Caregiver Perspective

National Partnership for Women & Families

Mark SavagePROPOSED LTPAC EHR

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BH Hearing Agenda: Jan 28, 2014

Panel 1: Patient Perspective Dr. Daniel Fisher, Mental Health America

Panel 2: BH Provider Perspective Dr. Lori Simon, American Psychiatric Association Dr. Stacey Larson, American Psychological Association Roger D. Smith, Amer. Assoc. for Marriage & Family

Tx Michael Alonso, Seneca Family of Agencies

Panel 3: BH Provider Perspective cont. Paul McLaughlin, American Association for the

Treatment of Opioid Dependence Dr. Richard Rosenthal, American Academy of

Addiction Psychiatry Dr. David Gastfriend, American Society of Addiction

Medicine Mohini Venkatesh, National Council for Behavioral

Health

Panel 4: Vendor Perspective Melinda Wagner, Cerner Kevin Scalia, NetSmart Technologies, Inc. Paul LeBeau, SMART Management, Inc. Dr. Katherine Peres, Synergistic Office Solutions, Inc. Joe Viger, Software and Technology Vendors’ Association

Panel 5: HIE Perspective Wende Baker, Electronic Behavioral Health Information

Network (eBHIN) Dr. Laura Mccrary, Kansas Health Information Network

(KHIN) Charlie Hewitt, Rhode Island Quality Institute (RIQI)

Panel 6:Regulatory / Quality Improvement Perspective David Lloyd, MTM Services Justin Harding, National Association of State Mental

Health Program Directors Rick Harwood, National Association of State Alcohol

&Drug Abuse Directors Tim Knettler, National Research Institute

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Privacy ConsiderationsRequirements of 42 CFR Part 2

Maureen Boyle, SAMHSAPROPOSED LTPAC EHR

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Stakeholder Feedback: Privacy

• Need for:– Consent management

• Standards for communicating consent policies• Electronic signatures

– Consent requirements, including the need to name specific providers or provider organizations in the consent are presenting a barrier to HIE

– Standards for communicating consent obligations to the receiver

– Criteria for controlling redisclosure of information• Support for granular data segmentation– Acknowledged that the field is not ready yet– Pilot testing ongoing

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Confidentiality

• Federal and state laws protect the confidentiality of behavioral health information and other sensitive data– HIV, genetic, reproductive health

• Require patient consent to share sensitive health data

• Some, including the substance abuse treatment confidentiality regulations prohibit redisclosure without consent

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42 CFR Part 2

Confidentiality of Alcohol and Drug Abuse Patient Records The purpose of the statute and regulations

prohibiting disclosure of records relating to substance abuse treatment, except with the patient's consent or a court order after good cause is shown, is to encourage patients to seek substance abuse treatment without fear that by doing so their privacy will be compromised.

Source: State of Florida Center for Drug-Free Living , Inc.,842 So.2d 177 (2003) at 181.

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42 CFR Part 2

• With limited exceptions patient consent must be obtained before sharing information from a substance abuse treatment facility that is subject to 42 CFR Part 2

• Disclosure:– “A communication of patient identifying information, the

affirmative verification of another person’s communication of patient identifying information, or the communication of any information from the record of a patient…” (42 CFR 2.11)

– Even acknowledging that an individual is (or was) a patient at a Part 2 facility is a breach of the regulations

Source: 42 CFR Part 2

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Consent Requirements

Nine required elements of a 42 CFR Part 2 compliant consent form:

1. The specific name or general designation of the program or person permitted to make the disclosure.

2. The name or title of the individual or the name of the organization to which disclosure is to be made.

3. The name of the patient.4. The purpose of the disclosure.5. How much and what kind of information is to be disclosed.6. The signature of the patient or other person authorized to sign in lieu of the patient7. The date on which the consent is signed.8. A statement that the consent is subject to revocation at any time except to the extent

that the program or person which is to make the disclosure has already acted in reliance on it. Acting in reliance includes the provision of treatment services in reliance on a valid consent to disclose information to a third party payer.

9. The date, event, or condition upon which the consent will expire if not revoked before.

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Restrictions on Redisclosure and Use

• Each disclosure made with the patient's written consent must be accompanied by the following written statement:

• This information has been disclosed to you from records protected by Federal confidentiality rules (42 CFR part 2). The Federal rules prohibit you from making any further disclosure of this information unless further disclosure is expressly permitted by the written consent of the person to whom it pertains or as otherwise permitted by 42 CFR part 2. A general authorization for the release of medical or other information is NOT sufficient for this purpose. The Federal rules restrict any use of the information to criminally investigate or prosecute any alcohol or drug abuse patient.


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42 CFR Part 2

• Limited exceptions for disclosure without consent :– Medical emergencies (“break the glass”)– Child abuse reporting– Crimes on program premises or against program personnel– Communications with a qualified service organization of

information needed by the organization to provide services to the program

– Public Health research– Court order– Audits and evaluations


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Medical Emergencies

• “Patient identifying information may be disclosed to medical personnel who have a need for information about the patient for the purpose of treating a condition which poses an immediate threat to the health of any individual and which requires immediate medical intervention.” Any health care provider who is treating the patient for a medical emergency can make that determination that a condition which poses an immediate threat to the health of an individual exists can make the decision to “break the glass” and gain access to Part 2 records.

• Part 2 requires that when a disclosure is made in connection with a medical emergency, the Part 2 program (emphasis added) must document in the patient's record the name and affiliation of the recipient of the information, the name of the individual making the disclosure, the date and time of the disclosure, and the nature of the emergency (42 CFR § 2.51(c)).

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42 CFR Part 2 FAQs

• To help providers in the behavioral health field better understand privacy issues related to Health IT, SAMHSA, in collaboration with ONC has created two sets of Frequently Asked Questions (FAQs).

• These FAQs can be accessed at: http://www.samhsa.gov/healthprivacy/docs/EHR-FAQs.pdf and http://www.samhsa.gov/about/laws/SAMHSA_42CFRPART2FAQII_Revised.pdf

• Series of webinars by the Legal Action Center on 42 CFR Part 2 http://www.lac.org/index.php/lac/webinar_archive

.

http://www.samhsa.gov/healthprivacy/docs/EHR-FAQs.pdf

http://www.samhsa.gov/about/laws/SAMHSA_42CFRPART2FAQII_Revised.pdf




http://www.lac.org/index.php/lac/webinar_archive

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State Laws

• State laws often provide additional protections for HIV infection, mental health information, genetics, drug and alcohol abuse, minors, domestic violence.

• Mental health records are treated as ultra-sensitive in many jurisdictions.

• Each state approaches the confidentiality of mental health records from their own perspective

• EHR systems have to recognize this variability in state statutes and regulations.

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SAMHSA Priorities: Privacy

• Two elements are needed to ensure that the receiving EHR can comply with 42 CFR Part 2 and other similar regulations – Standards for communicating the obligations associated with

receipt of protected information• HL7 Privacy and Security classification system • Receiver- process and comply with codes• BH specific- apply codes to documents to be shared

– Need to be able to comply with these obligations including the prohibition on redisclosure• Can be done through granular data segmentation or data silo

– Silo- share all or nothing– Granular data segmentation- fully integrated record, more meaningful

choices for sharing some data while withholding highly sensitive information.

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Behavioral Health EHR CertificationDraft Recommendations

PROPOSED LTPAC EHR

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Review of the Proposed Areas of Certification

• Consider each proposed area of certification by:– Briefly highlighting BH hearing testimony of

relevance to the proposed area of certification– Discuss the proposal (blue box)– Determine whether the proposed area of

certification is a “key heath IT capability needed” in the BH care setting

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BH Hearing Summary

• Focus on addressing need of BH while minimizing burden and cost• Alignment of standards to foster reduced reporting

burden/alignment across state and federal programs• Key themes

– Strong support for interoperability– Systems needed to support compliance with confidentiality

requirements (balance privacy with integration)– BH setting specific needs (e.g., consent management, assessments,

DSM code set issues, group therapy )

• Support for a modular program with flexibility to meet the needs of diverse provider types

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Interoperability

“Interoperability is critical – many providers in multiple settings involved in a patient’s care”

“Implement a cert program for BH EHRs that identifies that they meet interoperability standards /criteria required for MU providers”

“The high prevalence of comorbid conditions among BH patients dictates the need for sharing information and interoperability”

“Interoperability is crucial - availability of information with these transitions in care may prevent adverse events and facilitate better determination on level of care, which contributes to faster stabilization and decreased readmission rates.”

ONC 2014 ed. CC:§ 170.314(b)(1) & (2) - Transitions of care

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

BH Hearing Testimony ONC Certification Criteria to Support

Proposed Areas for BH Certification

Support the ability to receive, display, incorporate, create and transmit summary care records with a common data set in accordance with the Consolidated Clinical Document Architecture (CCDA) standard and using ONC specified transport specifications.

Support the ability of a user to electronically reconcile the data that represent a patient’s active medication, problem, and medication allergy list.

Support the inclusion of emerging TOC and care planning standards being reconciled as part of Aug. HL7 CCDA ballot [MUWG-identified MU 3 criteria].

Potential Use Cases: Sharing information between providers (primary use case), with social services to enable service coordination (e.g., criminal justice, HUD) , Standardization of mechanisms; Transitions of Care; Clinical information Reconciliation criteria

Privacy and Security

• Federal laws protect the confidentiality of substance abuse treatment data

• Approximately half of states have similar laws protecting the confidentiality of MH information

• Need for EHR systems to support compliance with these laws:– Consent management– Standards for communicating

consent obligations – Controlling redisclosure of

information• Consent requirements, including the

need to name specific providers or provider organizations in the consent are presenting a barrier to HIE

• Support for granular data segmentation when standards are ready

ONC 2014 ed. CC:§ 170.314(d)(1) - Authentication,

Access Control, and Authorization§ 170.314(d)(2) - Auditable Events

and Tamper-Resistance§ 170.314(d)(3) - Audit Report(s)§ 170.314(d)(4) - Amendments§ 170.314(d)(5) - Automatic Log-Off§ 170.314(d)(6) - Emergency Access § 170.314(d)(7) - End-User Device

Encryption § 170.314(d)(8) - Integrity § 170.314(d)(9) – Optional:

Accounting of Disclosures

BH Hearing Testimony

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ONC Certification Criteria to Support


Support existing ONC-certified Privacy and Security requirements: § 170.314(d)(1)-(9).

Support inclusion of standards for communicating privacy policies (HL7 Privacy and Security classification system) and controlling redisclosure of protected data.

FUTURE WORK: • ONC should consider supporting

equivalent functionality in MU 3 for standards for communicating privacy policies and controlling redisclosure of protected data.

• Incorporate granular data segmentation when ready.

BH Setting Specific Criteria Consent Management

• Federal laws protect the confidentiality of substance abuse treatment data

• Approximately half of states have similar laws protecting the confidentiality of MH information

• Need for EHR systems to support compliance with these laws and to enable automated consent management• Electronic signatures• Standards for collecting and

communicating consent policies

• Standards for communicating privacy obligations

HL7 Healthcare Privacy and Security Classification System, Release 1 http://www.hl7.org/Special/committees/secure/index.cfm

HL7 Data Segmentation for Privacy (DS4P) Implementation Guide http://www.hl7.org/special/committees/projman/searchableprojectindex.cfm?action=edit&ProjectNumber=1006

HL7 Implementation Guide for CDA®, Release 2: Consent Directives, Release 1 http://www.hl7.org/implement/standards/product_brief.cfm?product_id=280

BH Hearing Testimony

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Standards to Support Proposed Areas for BH Certification

Support the following functionality: Use of the HL7 privacy and

security classification system to tag records to communicate privacy related obligations with the receiver.

FUTURE WORK: Develop consensus on standards for consent management functionality needed by BH providers to comply with diverse federal and state confidentiality laws

http://www.hl7.org/Special/committees/secure/index.cfm




http://www.hl7.org/special/committees/projman/searchableprojectindex.cfm?action=edit&ProjectNumber=1006






http://www.hl7.org/implement/standards/product_brief.cfm?product_id=280





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Clinical Health Information

“Our experience is that medical doctors are mostly interested in receiving information from behavioral health providers on medications, diagnoses, and repeat labs.”

Another panelist indicated his “agreement on the need for medication information.”

ONC 2014 ed. CC:§ 170.314(a)(3) - Demographics§ 170.314(a)(5) - Problem list § 170.314(a)(6) - Medication list § 170.314(a)(7) - Med allergy list§ 170.314(a)(13) - Family health

history§ 170.314(a)(11) - Smoking status

*§ 170.314(a)(9) - Electronic notes*§ 170.314(a)(9) - Patient lists



• Support the ability to record, change, and access the following data using ONC specified standards:

o Demographicso Problem listo Medication listo Medication allergy listo Family health historyo Smoking status

Support the ability for a user to electronically record, change, access, and search electronic notes.

Support ability to electronically and dynamically select, sort, access, and create patient lists.

FUTURE WORK: ONC should consider including DSM-5 standards.

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Clinical Decision Support

“The last certification level we recommend is around Clinical Decision Support (CDS).”

“The most needed function is linking the CDS software to managed care, primary care, and EDs.”

“There is a strong need for standardization, since CDS support mechanisms can help spur the use of EHRs as well as eliminate more labor-intensive capacity management processes, such as the use of spreadsheets to track referrals and waiting lists.”

ONC 2014 ed. CC:§ 170.314(a)(8) - Clinical Decision Support



Support the ability to have: Evidence-based decision

support Linked referential clinical

decision support Clinical decision support

configuration Automatically and

electronically interact Source attributes

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Clinical Quality Measures

“A Certification Program that supports the ability of an EHR to track and report on Clinical Quality Measures (related to behavioral health) would provide BH providers a position in their medical neighborhood that assures they can work with other organizations and focus on the same goals and population management activities.” • There are currently 14 BH

related CQMs in MU2 but they primarily focus on primary care based behavioral health services

ONC 2014 ed. CC:§170.314(c)(1)-(3) – Clinical quality measures

Note: Criteria C1 (capture and export) and C2 (import and calculate) are core functions. C3 (report) is relating to CMS reporting.

BH Hearing Testimony ONC Certification Criteria & Standards to Support


FUTURE WORK: C/A Workgroup requested that HITPC Quality Measures WG discuss clinical quality measures further and provide recommendations to C/A WG on potential LTPAC/BH CQM opportunities for EHR certification.

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Medication-related

• The majority of ineligible behavioral health providers do not have prescribing authority, however psychiatrists, psychiatric nurse practitioners and psychologists in some states are prescribers

• Behavioral health organizations providing integrated primary care will also need med-related functionality in their EHRs.

• A ‘prescriber’ module could be useful to address this diversity

ONC 2014 ed. CC:§ 170.314(b)(3) – Electronic

Prescribing § 170.314(a)(10) – Drug-

formulary Checks§ 170.314(a)(2) – Drug-drug,

drug-allergy interaction checks§ 170.314(a)(16) – eMAR (inpt)



Support the ability for a user to electronically create and transmit prescriptions/rx-related information.

Support ability to automatically and electronically check whether a drug formulary exists for a given patient or med.

Support ability to enable drug-drug and drug-allergy interaction checks.

Support electronic medication administration record.

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CPOE

• The majority of ineligible behavioral health providers do not have prescribing authority, however psychiatrists, psychiatric nurse practitioners and psychologists in some states are prescribers

• Ineligible BH providers typically do not rely on labs test or radiology. However, eligible BH providers (psychiatrists and psychiatric nurse practitioners do and there are ineligible BH providers who capture lab tests for urinalysis and other purposes.

ONC 2014 ed. CC:§ 170.314(a)(1) – Computerized

provider order entry



Support the ability to electronically record, change, and access the following order types: Medications; Laboratory; and Radiology/imaging.

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Patient Engagement

“Patients should have the opportunity to review and correct their records.”

“Certification and interoperability could greatly help patients to understand their addictions. Rigorous quantification of data across the longitudinal dimension would be very helpful in showing patients how the development of the disease affects their behavior.”

ONC 2014 ed. CC:§ 170.314(e)(2) - Clinical

summary (amb menu)

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

§ 170.314(e)(1) - View, download, & transmit to 3rd party

§ 170.314(e)(3) - Secure messaging



Support the ability to be able to electronically retrieve patient-specific education from content/ knowledge resources

Support the ability to provide secure online access to health information for patients and authorized representatives to electronically view, download their health information in accordance with the CCDA standard and transmit such information using ONC specified transport specs.

Support the ability to enable a user to create a clinical summary in accordance with the CCDA standard in order to provide it to a patient.

Support the ability to use secure electronic messaging to communicate with patients on relevant health information.

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Labs/Imaging

“Our experience is that medical doctors are mostly interested in receiving information from behavioral health providers on medications, diagnoses, and repeat labs.”

• Ineligible BH providers typically do not rely on labs test or radiology. However, eligible BH providers (psychiatrists and psychiatric nurse practitioners do and there are ineligible BH providers who capture lab tests for urinalysis and other purposes.

• A labs and imaging module would be useful to address this diversity among BH providers

ONC 2014 ed. CC:§ 170.314(b)(5) - Incorporate lab tests & values/results§ 170.314(b)(6) - Transmission of electronic lab tests & values/ results to ambulatory providers

§ 170.314(a)(12) - Image results



Support the ability for an ambulatory setting to be capable of electronically receiving, incorporating, and displaying clinical lab tests and values/results.

Support the ability for an inpatient setting to be able to generate lab test reports for e-transmission to ambulatory provider’s EHR systems.

Support the ability to electronically indicate to a user the availability of a patient’s images and narrative interpretations (relating to the radiographic or other diagnostic test(s)) and enable electronic access to such images and narrative interpretations.

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Usability and Safety

BH providers expressed “the need for usable systems that support workflow.”

“We do not believe that there should be a voluntary certification process for system usability. We do recognize that usability of EHRs and other electronic health information systems is important, however, usability is somewhat subjective.”

ONC 2014 ed. CC:§ 170.314(g)(3) – Safety-

enhanced design§ 170.314(g)(4) – Quality

management system



Support user-centered design processes which must be applied to each capability an EHR technology includes that is specified in the following ONC certification criteria: § 170.314(a)(1), (2), (6) through (8), and (16) and (b)(3) and (4).

Enable for each capability that an EHR technology includes and for which that capability's certification is sought, the use of a Quality Management System (QMS) in the development, testing, implementation and maintenance of that capability must be identified.

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BH Setting Specific Criteria Patient Assessments

“Regarding BH clients, different code sets and assessments are required.”

“There are current challenges with comparative data elements.. The “average” number of data elements collected during the intake to treatment planning process is 1,750 to 2,100. In one state alone, 1800 different diagnostic assessment forms styles or versions are in use.”

“States have differing requirements for collecting and reporting standardized assessments for BH.”

HL7 Implementation Guide for CDA® Release 2: Patient Assessments, Release 1http://www.hl7.org/implement/standards/product_brief.cfm?product_id=21

HL7 Version 3 Domain Analysis Model: Summary Behavioral Health Record, Release 1 – US Realmhttps://www.hl7.org/implement/standards/product_brief.cfm?product_id=307

BH Hearing Testimony Standards to Support Proposed Areas for BH Certification

Support the ability to create, maintain, and transmit (in accordance with federal and state requirements) assessment instruments and data sets for Behavioral Health. (e.g. ASAM Patient Placement Criteria (PPC), Child and adolescent functional assessment scale (CAFAS))

FUTURE WORK- Expand upon the existing standards to develop relevant certification criteria for this purpose.






https://www.hl7.org/implement/standards/product_brief.cfm?product_id=307



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Data Portability

ONC 2014 ed. CC:§ 170.314(b)(7)-Data portability



Support ability to electronically create a set of export summaries on all patients, formatted in accordance with the CCDA.

35

Example of Modular Certification Program

• Psychologists- A, B, C, D, E, G, I, J, K• Psychiatrists- A, B, C, D, E, F, G, H, I, J, K• Housing and Urban Development- A, B

AINTEROPERABILITY

D PATIENT

COMMUNICATION

E CLINICAL QUALITY MEASUREMENT

FLABS AND IMAGING

CPATIENT

ASSESSMENTS

BPRIVACY AND

SECURITY

GCLINICAL DECISION

SUPPORT

H PRESCRIBING

ICONSENT

MANAGEMENT

LDATA

PORTABILITY

JCLINICAL HEALTH

INFORMATION

KUSABILITY AND

SAFETY

Windows User

obviously this is a new slide :) We can leave it hidden if you don't want to go there

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Consideration of other potential criteria

• Collecting vital signs– Vital signs, BMI, & growth charts § 170.314(a)(4)

• Reporting to immune and cancer registries– Immunization information § 170.314(f)(1)– Transmission to immunization registries § 170.314(f)(2)– Cancer case information § 170.314(f)(5)– Transmission to cancer registries § 170.314(f)(6)

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

• Implementing advanced directives– Advance directives § 170.314(a)(17)

• Calculation of MU objectives– Automated measure calculation § 170.314(g)(2)

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Appendix

Behavioral Health EHR Certification HearingSummary of Testimony Received

LTPAC HEARING

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BH Hearing Summary

• Strong support for interoperability• Concerns about compliance with confidentiality requirements

– Need to balance need for information with privacy– Varying views on stigma

• Some concerns about the cost of certification• Support for a modular program with flexibility to meet the needs

of diverse provider types• Some dichotomy between vendor/provider comments: vendors

cautioning restraint, providers supporting more robust system to help …

• Need for alignment with MU but focus only on critically relevant to BH.

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BH Hearing Summary Cont.

Testimony on Setting-Specific Criteria:• Addressing needs while minimizing burden• Utility for setting standards that can ultimately foster reduced

reporting burden/alignment across state and federal programs

• Should enable increased clarity and consistency regarding standards

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BH Hearing Summary cont.

• Value of Behavioral Health Certification:– “Has the potential to improve care and care delivery within the practice

setting for a variety of stakeholders—including providers, patients, and more.” • Would allow BH providers to collaborate more effectively with primary care by

selecting a system that is truly interoperable.

– “Currently, no guidance on available EHR products have features that would make them well-suited for BH.”• While these products are available in the marketplace—and are being

purchased by BH providers—the systems' appropriateness for BH settings are unclear to policymakers and the public.

• Guidance by the ONC through a certification process could serve to demonstrate these products' suitability for our members.

– Provides a mechanism for SAMHSA to verify that EHRs purchased using federal funds meet a core set of standards and are interoperable with those being adopted by the broader healthcare system.

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Key Themes

– Modular certification to accommodate the needs of diverse set of BH providers which addresses the following domains:• Health IT privacy and security • Interoperability• Clinical Decision Support• BH setting specific needs (e.g., consent

management, assessments, DSM code set issues, group therapy )

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Next Steps

• 2nd Certification and Adoption WG Call: Behavioral Health IT Certification Criteria Friday, February 14th from 1:00-2:30pmEST

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Blank Slide

Documents

Certification / Adoption Workgroup