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Welcome to :

Confidentiality, Substance Use Treatment, and Health

Information Technology

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Confidentiality, Substance Use Treatment, and Health Information Technology (HIT)

First 3 Webinars Presented by the Legal Action Center

4th Webinar Presented by SAMHSA

Four-Part Webinar Series on…

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Use the “Question(s)” feature on the upper right-hand corner of your screens to type in your question(s).

We will answer questions at the end of the presentation.

Have a Question During this Presentation?

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Today’s Power Point presentations can be downloaded from http://www.lac.org/index.php/lac/webinar-archive

Power Point presentations and materials from the Webinar series can be downloaded from http://www.lac.org and http://www.pfr.samhsa.gov The recording of this series will be available soon at the same locations.

Maureen Boyle, PhDLead Public Health Advisor, Health Information Technology

Center for Substance Abuse TreatmentSubstance Abuse and Mental Health Services Administration

May 25, 2012

SAMHSA’s Vision for Advancing SAMHSA’s Vision for Advancing Behavioral Healthcare throughBehavioral Healthcare throughHealth Information TechnologyHealth Information Technology

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President’s Vision for Health IT

Medical information will follow consumers so that they are at the center of their own care.

Consumers will be able to choose physicians and hospitals based on clinical performance results made available to them.

Clinicians will have a patient's complete medical history, computerized ordering systems, and electronic reminders.

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“The increased use of health information technology is a key

focus of our reform efforts because it will help to improve the safety and quality of health care generally while also cutting

waste out of the system.”

Kathleen SebeliusSecretary

U.S. Department of Health & Human Services

September 29, 2009

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SAMHSA’s Strategic Initiative - Health IT

Goal: Widespread Implementation of HIT Systems that Support High Quality Integrated Behavioral Health Care for All Americans

• Ensure the behavioral health provider networks fully participate in the adoption of Health IT

• Working closely with the Office of the National Coordinator for Health IT to support inclusion of behavioral health

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National HIT Landscape

The Health Information Technology for Economic and Clinical Health Act ( HITECH Act)• Meaningful Use, EHR Certification• Large national investment in HIT• Largely excludes behavioral health providers

The Affordable Care Act Privacy and Confidentiality Regulations

• HIPAA• 42 CFR Part 2• State laws

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Health Information Exchange

HIE

EHR

EHR

Claims

Data Systems

PHR

EHR

EHR

EHR

Public Health Agency

Health Plans

Clinics

HospitalsPrimary Care

Pharmacies

Labs

Patients

EHR

Specialty Care

NwHIN

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HITECH Act

CMS and ONC define the requirements for meaningful use and certification of EHRs• Large national investment in HIT• Largely excludes behavioral health providers

Funding for Regional Extension Centers and Health Information Exchange Networks

NPRMs for Stage 2 were released on March 7th and the final rule is expected by the end of the summer• Multiple items of relevance to behavioral health

– Clinical Quality Measures– Privacy and Confidentiality

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Meaningful Use

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Stage 2

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Meaningful Use Incentive Program

https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/downloads/eligibility_flow_chart.pdf

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Useful Links

CMS: https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/index.html?redirect=/EHRIncentivePrograms/

ONC: http://www.healthit.gov/providers-professionals/ehr-incentives-certification

Certified EHR: http://oncchpl.force.com/ehrcert/EHRProductSearch?setting=Inpatient

Regional Extension Centershttp://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__listing_of_regional_extension_centers/3519

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The Affordable Care Act

Establishing patient-centered medical homes (PCMH) and accountable care organizations (ACO)

Focus on coordinating care and pay for performance Formation of an ACO is contingent upon HIT for

information exchange and quality measure reporting

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Privacy and HIT

Privacy and Confidentiality Regulations• HIPAA• 42 CFR Part 2• State specific laws

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Ensuring Confidentiality and Trust

Increased accessibility to health records raises the question of how to ensure patient confidentiality and trust.

To be sustainable, electronic exchange efforts must establish trusting relationships with all participants, including patients.

Melissa M. Goldstein, JD et al, 2010

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42 CFR Part 2

Patient consent must be obtained before sharing information from a substance abuse treatment facility that is subject to 42 CFR Part 2

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

Patient consent must be obtained before sharing information from a substance abuse treatment facility that is subject to 42 CFR Part 2

Prohibition on re-disclosure without consent Limited exceptions for disclosure without consent :

• Medical emergencies • 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

Source: 42 CFR Part 2

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MENTAL HEALTH CONFIDENTIALTY

Non-Substance Use Disorder mental health records may be treated as ultra-sensitive in many jurisdictions.

Each state approaches the confidentiality of mental health records from their own perspective• There are differences• There are similarities

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

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Critical Health IT Questions

42 CFR Part 2 and other regulations provide the ground rules. Careful analysis determines how the rules are applied to ensure effective treatment of substance use and mental health disorders. • Who needs what information when?• Who determines who needs what Information when?• How should psychotherapy notes be treated – as part

of the patient record?• How should HIT systems be designed to control

disclosure and re-disclosure of sensitive information

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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

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The Health IT Challenge

Health IT will provide powerful tool to address the quality of care

The challenge is to be ready to use those tools Only a small percentage of behavioral health

providers have adopted interoperable Health IT systems

Even if the systems are in place, many do not have the personnel trained to effectively use them.

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SAMHSA’s Strategic Initiative - Health IT

The SAMHSA is working to advance Behavioral Health through Health IT• Technologies/policies for privacy and confidentiality• Develop and test advanced functionality for Behavioral Health

– Data segmentation and consent management– Behavioral Health Clinical decision support– Patient engagement and self-management

• Development of data standards to ensure that information can be efficiently and effectively exchanged and interpreted

• Behavioral health clinical quality measurement• Deliver technical assistance to increase adoption of HIT by the

behavioral health community

SOLUTIONS FOR PRIVACY

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Solutions for Privacy

Working to identify interim solutions for electronic exchange of health information that is subject to 42CFR Part 2 using existing technology platforms• Working with technology and legal experts

Working with the ONC Standards and Interoperability Framework and the VA to develop open source technology for consent management and data segmentation to give the patient dynamic control over what information is shared

DATA STANDARDS

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Benefits of Data Standards

The integration of behavioral health and physical health is contingent upon health information exchange

It is critical that health care providers can interpret the information they receive from other providers

Standards for collection and storage of health information are needed for both interpretability and integration of data into the receiving record

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Benefits of Data Standards

The adoption of interoperable data standards can improve patient care and facilitate research• More accurate and consistent data will be

available• Quality measurement• Real time outcome tracking and surveillance• Standard information will allow programs to cross

reference and validate patient information.

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SAMHSA HIT Standards Development

Open Behavioral Health Information Technology Architecture (OBHITA) project:• Working with the International Standards Organization

Health Level 7 (HL-7) to define consensus standards for behavioral health information to be included in the standard Continuity of Care Document (CCD)

• Working with the ONC Standards and Interoperability Framework for Data Segmentation for Privacy (DS4P) to identify exchange standards for patient consent information across EHRs

QUALITY MEASUREMENT

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Quality Measurement

Quality measures have the potential to drive improvement in the healthcare system and can be used to demonstrate successful outcomes and reduced waste.

HIT performance and outcome measures will help answer the questions:• Are our goals measurable and evidence-based?• Are we reaching the right populations?• Are client and treatment properly aligned?• Are our programs successful?

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Quality Measurement

Structural Measures• Healthcare facility's organization and resources, such as nursing

staff levels, or the presence of a behavioral health provider on a care team

Process Measures• The actual techniques used to treat patients, such as screening

and brief intervention for alcohol use or depression Outcome Measures

• The consequences of a patient's interaction with the healthcare system (i.e. Did the patient’s depression score decrease with treatment)

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SAMHSA Quality Measurement Activities

Developing clinical quality measures for behavioral health that are relevant for the meaningful use program

NQF #0109, Bipolar Disorder and Major Depression: Assessment for Manic or Hypomanic Behaviors

NQF #0110, Bipolar Disorder and Major Depression: Appraisal for Alcohol or Chemical Substance Use

NQF #0111, Bipolar Disorder: Appraisal for Risk of Suicide

NQF #1385, Developmental Screening Using a Parent Completed Screening Tool (Parent report, Children 0-5)

NQF #0576, Follow-Up After Hospitalization for Mental Illness

NQF #1401, Maternal Depression Screening

NQF $1406, Risky Behavior Assessment or Counseling by Age 13

NQF #1507, Risky Behavior Assessment or Counseling by Age 18

NQF #0580, Bipolar Anti-manic Agent

NQF #1661, SUB-1 Alcohol Use Screening

NQF #1663, SUB-2 Alcohol Use Brief Intervention Provided or Offered and SUB-2a Alcohol Use Brief Intervention

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SAMHSA Quality Measurement Activities

Two contracts are working with technical and clinical experts to determine what additional quality measures need to be developed to support behavioral health care• Both in primary and specialty care• New quality measures will be developed to fill

gaps that are identified through this process

ADVANCED TOOLS

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BH Treatment Lifecycle

Patient Identification

Brief Intervention or ReferralBrief Patient

Assessment

Patient Treatment

Patient Placement

Full Patient Assessment

Outcome Tracking

Quality Data Reporting

Clinical Decision Support

Patient Education and Engagement

Shared Decision Making

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BH Treatment Lifecycle

Patient Identification

Brief Intervention or ReferralBrief Patient

Assessment

Patient Treatment

Patient Placement

Full Patient Assessment

Outcome Tracking

Quality Data Reporting

Clinical Decision Support

Patient Education and Engagement

Shared Decision Making

EHRs or PHRs can be used to: Collect patient reported information Alert healthcare providers of patients at risk Educate patient and link them to resources Positive reinforcement

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BH Treatment Lifecycle

Patient Identification

Brief Intervention or ReferralBrief Patient

Assessment

Patient Treatment

Patient Placement

Full Patient Assessment

Outcome Tracking

Quality Data Reporting

Clinical Decision Support

Patient Education and Engagement

Shared Decision Making

EHRs/PHRs can collect patient reported standard assessments

Computer adaptive testing to minimize burden

Automated Scoring to determine the level of risk

Alerts and reminders To rule out alternative diagnoses To assess contributing physical health

problems To alert provider to critical risks (i.e.

suicidality) Collect standard data on patient symptoms

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BH Treatment Lifecycle

Patient Identification

Brief Intervention or ReferralBrief Patient

Assessment

Patient Treatment

Patient Placement

Full Patient Assessment

Outcome Tracking

Quality Data Reporting

Clinical Decision Support

Patient Education and Engagement

Shared Decision Making

Checklists for evidence based care Links to clinical guidelines and

information Sharing information with patients Linking patients to community

resources Consent Management for health

information exchange Health Information Exchange tools Referral appointment scheduling Referral management and follow up

tools Care coordination tools

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BH Treatment Lifecycle

Patient Identification

Brief Intervention or ReferralBrief Patient

Assessment

Patient Treatment

Patient Placement

Full Patient Assessment

Outcome Tracking

Quality Data Reporting

Clinical Decision Support

Patient Education and Engagement

Shared Decision Making

Decision support for level of care

Treatment plan is auto-populated and modified by clinician Methods for capturing

standardized data on non-pharmacologic treatments will be needed

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BH Treatment Lifecycle

Patient Identification

Brief Intervention or ReferralBrief Patient

Assessment

Patient Treatment

Patient Placement

Full Patient Assessment

Outcome Tracking

Quality Data Reporting

Clinical Decision Support

Patient Education and Engagement

Shared Decision Making

Evidence based practice checklists Links to clinical guidelines Alerts to identify patients who are ‘falling through

the cracks’ If critical prescriptions are not refilled If appointments are missed

Patient progress monitoring Clinical decision support for adjusting treatment:

Step up to the next level of care Continue in current care level Enroll in recovery maintenance services

Data standardization to ensure interpretability across providers

Care coordination and management tools

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BH Treatment Lifecycle

Patient Identification

Brief Intervention or ReferralBrief Patient

Assessment

Patient Treatment

Patient Placement

Full Patient Assessment

Outcome Tracking

Quality Data Reporting

Clinical Decision Support

Patient Education and Engagement

Shared Decision Making

Structure, Process and Outcome measurement

Individual and community based results

Determine if evidence based protocols were used

Assess the efficacy of individual providers and healthcare systems

Public health reporting Research to improve health service

delivery

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Learning Systems

Data can be analyzed to correlate symptom profiles and treatments used with Outcomes:• Algorithm that determine the treatment plan can

be updated based on feedback loop• Creates continuous learning environment• Personalized medicine• Support research into the biological basis of

behavioral health disorders

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Patient Engagement

Capturing patient reported data in the EHR Interface with the patient through a web portal or

PHR Provide the patient with health information tailored

to their own risks and to level of health literacy Provide community and online resources Tools to support shared decision making Goal setting and tracking Link with mHealth tools

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SAMHSA HIT Activities: Patient Engagement

Mobile Health Tools• Telephone Monitoring and Adaptive Counseling program,

part of Access to Recovery:– Life: Wire – A text messaging platform that supports ongoing client

contact & a continuously updating database that can be used to evaluate service effectiveness & make program changes to support improved outcomes.

• Addiction Comprehensive Health Enhancement Support System (A-Chess) –

– Features online peer support groups and clinical counselors, a GPS feature that sends an alert when the user is near an area of previous drug or alcohol activity, real-time video counseling, and a “panic button” that allows the user to place an immediate call for help with cravings or triggers.

SAMHSA HIT GRANTS

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SAMHSA HIT Activities: Expansion Grants

SAMHSA awarded 29 Targeted Capacity Expansion (TCE)-Health IT grants.

• To leverage technology to enhance or expand the capacity of substance abuse treatment providers to serve persons in treatment who have been underserved

• Examples include Web-based services, smartphones, and behavioral health electronic applications (e-apps).

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SAMHSA HIT Activities: Expansion Grants

SAMHSA has awarded 49 supplemental funds grants for Health IT infrastructure for current primary and behavioral health care integration (PBHCI) grantees. To develop infrastructure that supports the exchange of health

information through EHR data systems.

Sub-awards support sharing of health records among behavioral health providers and general medical providers through a state HIE (ME, KY, IL, OK, RI)

• Technological infrastructure

• Privacy and Security Policies

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Conclusion

Health IT has the potential to benefit behavioral health treatment providers and their clients through increased efficiency, coordination, and patient engagement.

42 CFR Part 2 provides the ability to share protected health information, but it is the responsibility of the organizations to use that information in a way that benefits the health of the individuals.

SAMHSA is working to ensure that providers understand the benefits of integrating Health IT into their programs and that they have the training and tools to support their HIT goals.

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HAVE QUESTIONS?

Now for your questions...

Office of the Chief Privacy Officer (OCPO):

ONC Efforts to Maintain the Privacy of Health Information Protected by 42 CFR Part 2

May 25, 2012Scott Weinstein, JD

OCPO Overview

• Chief Privacy Officer position created in HITECH Act

• OCPO’s responsibilities include:

– Advise the National Coordinator on privacy, security, and data stewardship of electronic health information

– Coordinate with other Federal agencies, State and regional efforts, and foreign countries with regard to the privacy, security, and data stewardship of electronic individually identifiable health information

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SAMHSA, ONC-OCPO, and 42 CFR Part 2

• SAMHSA– Enforces Part 2– Provides Guidance to Providers on Part 2

Compliance

• ONC-OCPO– Working with SAMHSA to explore technologies

that allow exchange of electronic substance abuse clinical information while complying with Part 2

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ONC initiatives that implicate 42 CFR Part 2

• Data Segmentation for Privacy• Query Health• SHPC Behavioral Health Data Exchange

Consortium• State HIE Community of Practice Privacy and

Security Workgroup on 42 CFR Part 2

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Data Segmentation for Privacy Initiative

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Data Segmentation for Privacy Objective

• Produce a pilot project that will allow providers to share portions of an electronic health record while not sharing others

• Certain privacy laws, such as 42 CFR Part 2, already require providers to ensure that parts of a medical record will not be shared without patient consent

• Data Segmentation for Privacy provides a means for electronically implementing choices made by patients under these laws

• Several use cases developed that focus on 42 CFR Part 2

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Provider/Healthcare Organization 1

User Story Example (1)

The Patient receives care at their local hospital for a variety of conditions, including substance abuse as part of an Alcohol/Drug Abuse Treatment Program (ADATP).

Data requiring additional protection and consent directive are captured and recorded in the EHR system. The patient is advised that the protected information will not be shared without their consent.

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Provider/Healthcare Organization 2

Provider/Healthcare Organization 1

User Story Example (2)

A clinical workflow event triggers additional data to be sent to Provider/Organization 2. This disclosure has been authorized by the patient, so the data requiring heightened protection is sent along with a prohibition on redisclosure.

Provider/ Organization 2 electronically receives and incorporates patient additionally protected data, data annotations, and prohibition on redisclosure.

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Provider/Healthcare Organization 3

Provider/Healthcare Organization 1

User Story Example (3)

The Patient receives care for new, unrelated condition and is referred by Organization 1 to a specialist (Provider/Organization 3). Organization 1 checks the consent directive and sends authorized data to Organization 3.

Provider/Organization 3 electronically receives and incorporates data which does not require heightened protection.

Allergies

Allergies

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Segmentation of medical information

• Determine information covered by Part 2– Use standardized terminology to express that data

came from a covered provider (“FacilityType”)

• Determine if patient has consented to share protected information– Consent refers to documents, document sections,

or individual data elements that may be sent

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Application of Metadata

• Helps receiving EHR/HIO implement access control

• Electronic enforcement of prohibition against redisclosure of information

• Provides a reference to a consent document that controls the data

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Query Health

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What is Query Health?

Objective:

• Enable a learning health system to understand population measures of health, performance, disease and quality, while respecting patient privacy, to improve patient and population health and reduce costs.

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Improve community understanding of patient population health

Questions about disease outbreaks,

prevention activities, health research,

quality measures, etc.

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Specification Definition Standard

Query Envelope A means to package the query and results along with security/privacy requirements, as well as other instructions

PopMedNet Query Envelope

Query Format The way in which a query is constructed, its code, vocabulary etc.

HQMF- Health Quality Measures Format

Results Format The way in which a result is reported, its code, vocabulary etc.

QRDA- Quality Reporting Document Architecture

Summary: Query Health Specifications and Standards

Query Health must standardize how queries are asked, how they are returned, and how the information travels between parties.

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Notes:1.It is understood that de-identified data sets do not require a data use agreement, but in the abundance of caution, and unless otherwise guided by the Tiger Team or HIT Policy Committee, the pilot will have data use agreements for de-identified data2.For a public health permitted use, individually identifiable health information may be provided by the disclosing entity to the public health agency consistent with applicable law and regulation.3.The CDC-CSTE Intergovernmental Data Release Guidelines Working Group has recommended limiting cell size to three counts presuming a sufficiently large population. This is also reflected in Guidelines for Working with Small Numbers used by several states.

Query requests and responses shall be implemented in the pilot to use the least identifiable form of health data necessary in the aggregate within the following guidelines:1.Disclosing Entity: Queries and results will be under the control of the disclosing entity (e.g., manual or automated publish / subscribe model).2.Data Exchange: Data will be either 1) mock or test data, 2) de-identified data sets or limited data sets each with data use agreements1 or 3) a public health permitted use2 under state or federal law and regulation. 3.Small cells: For other than regulated/permitted use purposes, cells with less than 5 observations in a cell shall be blurred by methods that reduce the accuracy of the information provided3.

Query requests and responses shall be implemented in the pilot to use the least identifiable form of health data necessary in the aggregate within the following guidelines:1.Disclosing Entity: Queries and results will be under the control of the disclosing entity (e.g., manual or automated publish / subscribe model).2.Data Exchange: Data will be either 1) mock or test data, 2) de-identified data sets or limited data sets each with data use agreements1 or 3) a public health permitted use2 under state or federal law and regulation. 3.Small cells: For other than regulated/permitted use purposes, cells with less than 5 observations in a cell shall be blurred by methods that reduce the accuracy of the information provided3.

Policy Sandbox

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Query Health and Part 2

• In future, Query Health technology may be used to query identifiable patient information

• Must prevent identifiable Part 2 information from being returned in response to a query

• Privacy metadata to restrict information from being queryable

• Metadata in “query envelope” to communicate sensitivity when information allowed to be shared

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State Health Policy Consortium (SHPC) - Behavioral Health Data

Exchange Consortium

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Purpose

• Pilot the interstate exchange of behavioral health treatment records among treating health care providers using Nationwide Health Information Direct protocols

• Draft Policies and Procedures (P&P) for exchange of behavioral health treatment records

• The focus is on meeting the requirements of federal regulations at 42 CFR Part 2 and meeting mental health laws of consortium states

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Participants

• Consortium States are: Alabama, Florida, Kentucky, Michigan, Nebraska and New Mexico; representatives include legal and behavioral health subject matter experts

• Each state is to recruit Behavioral Health providers and other providers that might exchange with Behavioral Health providers to participate in the pilots

• Representatives of the ONC, Substance Abuse and Mental Health Services Administration, the Legal Action Center and subject matter technical experts on the NwHIN Direct protocols

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Workflow Scenarios for Discussion

Workflow #1: Request for info

• Alabama PCP sends referral to Florida Part 2 program

Workflow #3: referral

• At end of patient’s stay, New Mexico provider (who is a Part 2 program and a mental health provider) sends patient summary to patient’s PCP in Kentucky

Workflow #2: Update PCP

Florida Part 2 program requests patient’s records from prior stay at Michigan behavioral health provider facility (a Part 2 program)

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Workflow #1 – Request for Info

HISP HISP

Michigan Part Michigan Part 2 Program2 Program

Florida Part Florida Part 2 Program2 Program

Jane PatientJane Patient

Treatment Treatmen

t

Signs

consent

Send request for records along with patient consent

Receive request for records along with patient consent

Send patient records specified in patient consent

Receive requested patient records

1

2

3

4

5

6

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9

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Workflow #2 – Update PCP

HISP HISP

New Mexico New Mexico Part 2 Program Part 2 Program

& Mental & Mental Health ProviderHealth Provider

Kentucky Kentucky Primary Primary

Care Care ProviderProvider

Jane PatientJane Patient

Treatment

Treatmen

t

Jane submits clarifying

infoSigns consent

Sends visit summary and clarifying info

Receives visit summary and clarifying info

1

2

3

4

5

6 7

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Workflow #3 - Referral

HISPHISP

Alabama Alabama Primary Care Primary Care

ProviderProviderFlorida Part Florida Part 2 Program2 Program

Jane PatientJane Patient

Treatment Future

Treatmen

t

Sends referral

Receives referral

1

2 3 4

5

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State HIE Community of Practice Privacy and Security Workgroup on

42 CFR Part 2

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State HIE 42 CFR Part 2 Community of Practice

• Discuss compliance approaches for listing entities, including location, formatting, and effective business processes for updates.

• Present examples of “break the glass” access and the feedback loop. The focus will be on map process requirements, formatting, and efficiencies.

• Explain required notices and limitations on the re-disclosure of protected information

• Discuss data protection and how data may be shareable in a query-based HIE environment

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Thank you

Prepared in 2012 by – the Legal Action Center,

under a subcontract fromPartners for Recovery

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