qualified entity participation agreement...2013/09/10 · (rhio) - all rhios are interconnected to...

NYS Office of Health Information Technology Transformation

Qualified Entity Participation Agreement

Webinar

September 2013


Agenda

• Purpose of the Webinar • SHIN-NY Overview • Background/Process • QEPA Overview • QEPA Core Documents • QEPA Next Steps • Questions/Discussion

• Speaker:

– Steve Smith, State Health IT Coordinator, New York State Department of Health, Office of Quality and Patient Safety, Division of Health Information Technology Transformation

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Purpose of Webinar

• Provide general understanding of the SHIN-NY

• Provide information and increase understanding of the Qualified Entities Participation Agreement (QEPA) and the relationship to the SHIN-NY

• Provide context as to how QEPA fits into the Statewide Collaborative Process and proposed policy agenda

• Describe process for feedback

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THE VISION


The Vision – Connected Capabilities

• Improve quality of care, efficiency, and patient satisfaction in New York State

• Utilize health information technology tools to enable collaboration between patients, providers, public health, and payors

• Safeguard the public’s privacy, confidentiality and security

• No single entity can deliver this set of tools

IT WILL TAKE AN ECOSYSTEM WORKING TOGETHER

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Regional Connectivity

- Regional Health Information Organizations (RHIOs)

- RHIOs have the deepest understanding of local needs of providers and patients

- RHIOs provide customized services for members of their region

Statewide Connectivity

- Investments are made to link RHIOs to allow Statewide connectivity

- RHIOs connected to each other enable the Statewide Health Information Network of New York (SHIN-NY)

Integrating the Ecosystem

- Connecting all health care endpoints…hospitals, practices, labs, long term care facilities…

Getting to an Ecosystem

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THE STRATEGY


Broad Goals for NYS’s Health IT Strategy

• Build health information infrastructure to support state health reform goals: – Support clinicians and consumers with information at point of care – Advance care coordination – Strengthen public health surveillance and response – Enhance quality and outcome measures

THE OVERALL STRATEGY IS NOT ABOUT HEALTH IT…

IT’S ABOUT HEALTH SYSTEMS CHANGE

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Major Elements of NY HIT Strategic and Operations Plans

• Adoption:

- Promote broad adoption of HIT & HIE usage

• Infrastructure:

- Develop statewide HIE services and consolidate infrastructure to lower overall costs

- Establish minimum technical standards for data exchange

- Formalize Health Information Exchanges within the state to help ensure quality and consistency by designating “Qualified HIT Entities” (QEs)

• Quality of Care:

- Develop technical services and programs to support new care models

• Public Health:

- Incorporate expansion of public health and population health data services into the HIE infrastructure

• Statewide Policy:

- Support exchange of patient specific data, privacy (consent) and security

- Adherence to statewide policy: monitoring and enforcement 9


SHIN-NY Design Goals

• Broad stakeholder participation and input to decision-making Inclusive

• Prevent gaps in access to SHIN-NY (e.g., by geography, market segment, ability to pay)

• Compliant with national Health IT goals

Support Public Policy Goals

• Effectively manage potential conflicts of interest • Maintain transparency Fair

• Eliminate free riders: • Revenue strategies to address costs in short/long

term Sustainable

• Governance for roles and responsibilities of DoH, NYeC, QEs • Efficient and effective decision making • Enforcement of consistent policy adherence

Trusted

• Promote technology innovation that supports evolving health care reforms

• Encourage rapid market adoption Innovative

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New York’s Investment in the HIE Ecosystem

2006 2007 2008 2009 2010 2011 2012 2013

HITECH Signed

MU Stage 1 Released

ONC Standards & Interop Framework Initiative Launched

MU Stage 2 Released

2014

HEAL 1 HEAL 5

HEAL 10

HEAL 17

HEAL 22

ONC Statewide HIE Award

ONC REC Award

NYeC Established

EHR | HIE Interoperability

Workgroup Launched

ONC NHIN Trial Implementation

CDC Biosurveillance UPHN

ONC Beacon Award

ONC HISPC

NY

US

SHIN-NY Launched

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Statewide Health Information Network of New York

SHIN

-NY

Technology

- Network for sharing patient data across the state - Facilitates secure exchange of data

Policy Requires harmonization of policy related to patient data exchange (Consent, security, authorization, etc.)

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GOVERNANCE


SHIN-NY Governance Public/Private Partnership

- State Department of Health: • Oversees SHIN-NY through contracts and funding of NYeC and RHIOs • Ex-officio member of the NYeC board • Co-chair of all SHIN-NY committees • Additional regulatory oversight as part of new SHIN-NY regulation to be

issued later this year - RHIOs:

• 11 RHIOs each governed by a board of up to 20 people • Broad participation by local stakeholders, including providers, employers,

and community advocates. • Own policy committee that determines how to implement individual policies

- NYeC: • The NYeC Board consists of 21 people from across healthcare industry and

across New York State. • Stakeholders

• Extensive representation from stakeholder entities across the state.

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DOH’s Principles for Advancing SHIN-NY

• Public-Private Partnership - Committed to pursuing the planning, development, operation, and oversight of

SHIN-NY as a public-private partnership. • Statewide Framework.

- Fostering broad public benefit and stakeholder confidence, the SHIN-NY operates on a foundation of common policies, services, and operational parameters that are consistently applied, followed, and implemented.

• Public Health Objectives - The SHIN-NY should meet the State’s objectives with respect to public health,

health oversight, and emergency preparedness and response. • Financing

- To date, significant public funding has built the SHIN-NY infrastructure and stimulated private investment. The DOH is committed to ensuring public financing is available to support continued adoption and utilization of the system

• Full Participation − Patient consent − Indemnification of users − QE certification

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Participants Agreement Agreement

Policy Committee

Business Operations Committee

DoH NYeC QEs

Participation Agreements

Participants Participants

SHIN-NY Committees

Hospitals

Providers Long Term Care

Health Plans

Patients

Public Health Officials

Framework of Relationships

QE Certifi-cation

DoH oversees, 3rd party administ-ers, QEs comply

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Health Homes

SHIN-NY Committees develop, NYeC recommends, DoH approves, NYeC,

QEs, and all participants comply

Statewide Policy Guidance


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THE VALUE


The SHIN-NY is a Collaborative Effort

• A “network of networks” - Patient’s electronic medical records are made available to a Healthcare Provider - The Healthcare Provider connects to its local Regional Health Information Organization

(RHIO) - All RHIOs are interconnected to form the SHIN-NY

• Governed by specific policies - Protects patients’ privacy and security of their data - Patients must “opt in” to the network - No provider can access a patient’s records without patient’s explicit consent

• Governed by a statewide collaborative process among multiple stakeholders

- Department of Health, the RHIOs and other healthcare providers and advocates. - Establish standards for privacy, security and technical requirements

• NY working with 18 other states to define “standards” so electronic medical records and HIEs can become “plug ‘n play”

- Helps support “adoption” so all healthcare providers are connected to a RHIO and thus, the SHIN-NY 18


• Better Care - Facilitates patient care coordination amongst providers - Empowers patients to better manage their health - Reduces medical errors from not having full information - Access to life-saving information in an emergency - Improves public health tracking – Immunization reporting – ER admissions, discharges, transfers

• -30% fewer admissions from the emergency department 1

• -56% reduction in patient readmissions within 30 days after hospital discharge 2

– Standards for exchanging information within “Health Homes” • Greater Efficiency/Lower Costs

– Eliminates waste: duplicate or unnecessary tests, procedures and paperwork • -27% fewer repeat images within 90 days of first imaging procedure 3

• $52M in potential cost savings across NY State

SHIN-NY Benefits

1 Vest JR, Kern LM, Campion Jr. TR, Silver MD, Kaushal R for the HITEC investigators. “Association Between Use of a Health Information Exchange System and Hospital Admissions”. 2 Vest JR, Kern LM, Silver MD, Kaushal R for the HITEC investigators. “Health Information Exchange and Hospital Readmissions”. 3 Vest JR, Kaushal R, Silver MD, Hentel K, Kern LM for the HITEC investigators. “Health Information Exchange and the Frequency of Repeat Medical Imaging.” 19


• The more records that are in the network, the more valuable the network becomes

– Data can be used for patient care, care management, payers and public health uses

• Potentially “blinded” data could be used for clinical research: – To understand origins of disease (genomics) – To monitor the safety of pharmaceutical drugs on the market

• New “apps” can be built to help healthcare providers and patients use the SHIN-NY for specific needs

Consistent methods and standards needed to connect as many

Healthcare Providers as possible

The SHIN-NY’s Value Long-Term

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The SHIN-NY Today

• New York Leads the Nation Connecting Electronic Health Records – 72% of New York hospitals now participate in health information

exchange – 5.1M patients have consented to share their health information

electronically with their providers

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Key SHIN-NY Services Availability • Patient Record Look-Up • Direct Exchange of Records between Providers

Nov: 2 RHIOs

Connected to Each Other

Jan-Feb 2014 : All RHIOs connected

Mar 2014: State

Infrastructure Live

*NYS Timing aligned with national agenda for HIE 22


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SHIN-NY POLICY AGENDA


Historical Context

• RHIOs in NYS – community-based organizations – funded through the HEAL grants and community support – under contract with NY State

• NY State administered HEAL grants – establishes legal and policy framework for compliance with Statewide

Policy Guidance • As HEAL grants sunset, new “mechanism” now needed to assure

– uniform practices across RHIOs – adherence to Statewide Collaborative Process and Governance – full establishment of the Statewide Health Information Network of NY

(SHIN-NY) – Ensure public trust

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State Policy Agenda Key Regulatory Proposals

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State Policy Agenda Key Statute Proposals

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Steps to Regulation

• Review with Program/Legal and send to Commissioner for review

• DOB Regulatory Review Unit • Secretary of State

– Publishes Regulation – 45 (30) day review period

• Public Comments • Publish Regulation

– Effective upon publication and/or at future point

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The Shift from RHIOs to Qualified Entities

• Need for Health Information Organizations - Facilitate clinical data exchange in a secure/confidential manner via the

SHIN-NY, a ‘network of networks” - Connect providers to the SHIN-NY - Expand adoption of health information exchange through known and

trusted entities • Moving Forward:

- Solidify role of the Health Information Organizations through regulatory, contractual, and governance mechanisms

- Uniform adherence to statewide policy guidance - Allows for transparency that builds public trust in the system - Create a regulatory construct to ensure adherence to policy

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QEPA Part of Policy Agenda

• Key Agreements – Memorandum of Understanding (MOU)

• DOH/NYeC setting forth DOH requirements of NYeC – QE Participation Agreement (QEPA)

• NYeC/QEs, setting forth requirements of QEs, with flow-down requirements from DOH

– Participation Agreements • QEs/Participants, setting forth requirements for access to and use

of the SHIN-NY

• QEs intended to be state-funded – No QE contract signed until funding secured

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• January Summit : – Process for establishing the roles and responsibilities of QEs – Attended by RHIO EDs, RHIO Board, NYeC Board, State DOH, NYC-

DOH/MH, and other stakeholders – Tiger Teams launched – Tiger Teams comprised of RHIO EDs, NYeC staff and Board members,

DOH and other stakeholders • May Summit:

– Attended by RHIO EDs and their Board members, NYeC staff and Board members, DOH, DOHMH and other stakeholders

• September Summit: – Scheduled for September 16th, 10-3 at Pearl River

QE Development Process

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Work Streams Established to Develop QE Structure and Policy

Certification

1. Create a certification framework 2. Develop a RFP to select an

independent, third party that will certify and monitor Qualified Entities

Adoption

1. Revise incentive program proposal 2. Assess additional options to

accelerate HIE adoption

Public Health

1. Address policy and operational issues for role-based access

2. Advance public health representation on RHIO boards

3. Further develop SHIN-NY/public health utilities

Technology Road Map

1. Define Dial Tone Services 2. Define Member Facing Services 3. Develop an Operations Guide that

will be used by QEs to implement policy and be responsive to requests for guidance

Finance

1. Collect cost information for provision of SHIN-NY services

2. Develop request for HCRA funding 3. Assess viability of Medicaid MU

Matching funds for SHIN-NY 4. Continue developing financing

models

Policy Framework

1. Develop policies and procedures for QE monitoring and enforcement

2. Continue developing education and training materials

3. Develop recommendations regarding immunity and insurance for HIE participants

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Roles and Responsibilities

• Exercise overall authority for the SHIN-NY through regulation of the SHIN-NY and administration of future funding

• Serve as a partner with the private sector in its ex-officio role on the NYeC Board

• Review and approve statewide policy guidance

• Certify QEs • Support usage of the SHIN-NY

for public health and emergency preparedness

Facilitator of Policy Development • Facilitate the development of

SHIN-NY policy, technical standards and business operations

• Foster innovative usage of the SHIN-NY to evolve with healthcare delivery transformation

• Advancing interoperability through statewide presence and involvement in national efforts

Coordinate Statewide Marketing Initiatives Provider of Technical Services

• Serve as a technology vendor to QEs that wish to use NYeC’s HIE services

• Provide centralized technical services to support statewide dial tone capabilities.

• Provide a consistent set of technical “dial tone” services statewide

• Oversee and contractually enforce adherence by participants to statewide policy

• Meet annual adoption goals • Support community-based

care models • Support emergency

preparedness • Facilitate public health goals

DOH State Designated

Entity QEs

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Dept of Health/NYeC Memorandum of Understanding

• Purpose: – Establish NYeC’s role and responsibility (as the state designated entity) vis-

à-vis development/operation of SHIN-NY

• NYeC’s obligations under Memorandum of Understanding: - Policies/procedures regarding privacy, security, interoperability, financial

integrity, sustainability and governance of SHIN-NY - Transparency of operations and financial arrangements of SHIN-NY - Fiscal administrator of SHIN-NY funds on behalf of DOH - Facilitate provider adoption

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QUALIFIED ENTITIES PARTICIPATION AGREEMENT

(QEPA)


Scope Of QEPA

Policy for SHIN-NY access and use by NYeC and QEs

Allocation of risk between NYeC and Qualified Entities

Procedures for promoting reliability/accuracy of data transmitted

Roles and Responsibilities re: access and use of SHIN-NY

• Changes to QEPA made through Statewide Collaboration Process • Separate agreement to stipulate funding for participation in SHIN-NY • Data usage will be limited to clinical purposes, those allowed by law

and as agreed upon via Statewide Policy Guidance 35


QEPA Components

• Core Document Describing QEPA – Roles and Responsibilities – Governance – Transparency and Reporting – Promoting the SHIN-NY – Access and Data Usage – Insurance – Indemnity

• Exhibits – Dial Tone Services – Member Facing Services – Oversight and Enforcement – Operational Guide – Policies and Procedures – Organizational Characteristics

• QEPA components can be modified over time.

• They will be exhibits appended to the regulation and referenced.

• Allows for modification and re-publishing without revising the actual regulation.

• Provides a safety valve

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DIAL TONE SERVICES

Service Local /

Cross-Community QE Implementation Method(s) /

Requirements Potential

SHIN-NY Component Notes Patient Record Lookup Cross-Community • Local MPI

• Clinical Viewer • Interfaces to 3rd Party

Software (incl. EMR/EHR)

SHIN-NY MPI • Opportunity for greater efficiencies with statewide MPI

Secure Messaging Cross-Community • Provider Directory / Master Clinician Index

• Clinical Viewer • Interfaces to 3rd Party

Software • Email (Direct)

Statewide Provider Directory / Master Clinician Index

• Direct Project standards and protocols • Opportunity for greater efficiencies with

statewide Provider Index / Master Clinician Index

Consent Management Local • Support service and / or online tool provided by QE

• Interfaces to 3rd Party Software

Managed to allow access to patient records across the state

• Statewide policy • Local implementation details left to QE • “Break the glass” events reported cross-

community as part of Patient Record Lookup service

Notifications (Alerts) Local Support service and / or online tool provided by QE

May evolve to statewide; in the meantime, QEs must accommodate subscription requests from users at

other QEs using local processes

• QEs communicate requests for cross-community notifications to other QEs (for border providers, patients travelling for treatment, etc.)

Identity Management & Security

Local Self-service and administrative / help desk support

Statewide Two Factor Authentication services

• Statewide policy • Opportunity for cost-sharing with

statewide or shared services for Two Factor Authentication

Provider and Public Health Clinical Viewer

Local Local implementation details and features left to QE

• Minimum capabilities specified statewide

Public Health Integration Local (Statewide standards)

Local implementation details and features left to QE

In conformance with public health use cases (TBD)

• Statewide policy and standards

Results Delivery Local • Presentation in Clinical Viewer

• Interfaces to 3rd Party Software at QE’s discretion

• Email (Direct)

• Lab and radiology at minimum • Ordering provider delivery at minimum

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Member Facing Services

• Legal & Information Sharing agreements • Ongoing Monitoring and Audits • Marketing and recruitment • Support Adoption and Usage • Participant/authorized User training • User Support (help desk and online service support) • Governance

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Organizational Characteristics

• Organizational Characteristics – non profit, good standing in NYS, necessary insurance, list of

participants • Governance Structure

– Listing of Board members, availability of organizational bylaws, and inclusive decision-making process

• Availability to all Participants – Provision of Dial Tone Services and Member Facing Services

• Comprehensive List of Participants – Ability to produce up-to-date list of all participant agreements

• Participant Flow-Down Requirements – Procedures to address Participant compliance with Statewide Policy

Guidance • Insurance/Liability Coverage

– Relevant to the exchange of individually identifiable health information 39


Operational Guide

• The Operational Guide is a companion to The Statewide Collaboration Process Privacy and Security Policies and Procedures for QEs and their Participants in New York State (P&Ps).

• The Guide defines privacy and security specifications needed for information exchange via the SHIN-NY and SHIN-NY QEs.

Policy Implementation Specification

Definition » Approach/method to guide and determine present and future approach

» Instruction(s) to effectively implement a particular policy

Characteristics » High-level » Statement of intent/expectation » Provides guidance in setting objectives » Supports consistent approach over time » Basis for agreement in principle on

requirements and responsibilities

» Detailed and measurable » Often based upon industry best-

practices » Supports evolving requirements as

needs and technology advances » Supports the effective application of

policies » Supports enforcement

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Operational Guide: Implications for Participants

• Section 1 – Consent: Patient notification of Break the Glass events

• Section 2: – Authorization: Heightened hiring scrutiny for persons whose access to data may bypass or

circumvent activity logging, access control or other security controls • Section 3:

– Authentication: password strength requirements • Section 4:

– Access: Display of appropriate use warning message for Authorized Users • Section 5:

– Public posting on notice indicating date that patient information upload began • Section 6:

– Availability on request of patient audit logs • Section 7:

– A written Breach incident response plan • Section 8:

– Policies governing the administration of sanctions for violations by Authorized Users accessing the SHIN NY

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Financing Sources and Distribution

• Two potential sources identified to fund the SHIN-NY – HCRA – Medicaid Meaningful Use Matching Funds (90/10)

• Methodology for distributing funds

- Determined by DOH - Administered by State Designated Entity

QEs: Dial Tone Member Facing Services

State Designated Entity:

State Collaborative Process

Quality Incentive Pool

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Oversight and Enforcement

• QEs must: - Comply with applicable state and federal law and certification

requirements - Conduct self audits and report non-compliance - Have a complaints process in place - Participate in external monitoring and audit process

• Enforcement:

- Remedy imposed is based on nature and severity of non compliance as determined by DOH, and can include:

• Written warning • Corrective action requirements • Monitoring requirements • Temporary restriction to accessing the SHIN-NY • Permanent restriction to accessing the SHIN-NY

• QE has right to appeal; process is detailed in the Oversight and

Enforcement documents

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Certify

SHIN-NY Participation Requirements

Qualified Entities

Warning

Certification Re-Certification

Every 2 years

1. Organizational Characteristics Non-profit status, good standing in state, list of QE participants, insurance, etc.

2. Operational Requirements Infrastructure to operationalize the SHIN-NY requirements including policies and practices for non-discriminatory exchange of data, system performance, member-facing services, business plans, audit procedures, participation in statewide policy development.

3. Policies and Procedures Consent, authorization, authentication, access, patient engagement, audit, breach, sanctions, etc.

4. Technical Services Baseline technical capabilities (i.e., Dial Tone Services) and interoperability (i.e., SHIN-NY Technical Specifications) that users of the SHIN-NY can expect to be available within any region of the state.

Monitor and Enforce

Monitoring Enforcement

Corrective Action Plan Financial Penalty Suspension of Status Revocation of Status

Maintaining Trust in the SHIN-NY Requirements Through Certification, Monitoring, & Enforcement

SHIN-NY Compliance Mechanisms

Self Audit

Complaint Process

External Audit

Internal Investigation

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Certification Timing

Finalize the SHIN-NY

certification criteria

Sep – Oct

2013

Conduct provisional certification

Oct – Dec 2013

Conduct full certification of candidate

Qualified Entities

Aug ‘14 – Dec ‘14

Conduct ongoing

monitoring of Qualified

Entities

Jan ‘15 – Jul ‘16)

Conduct first re-

certification of Qualified

Entities

Aug – Dec 2016)

Conduct ongoing

monitoring of Qualified

Entities

Jan ‘17 – Jul ‘18

Conduct second re-certification of Qualified

Entities

Aug’18 – Dec ‘18)

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Next Steps

• Your feedback prior to the Public Comment period – Provide feedback via form to be distributed separately; return to

S. Smith/I.Sieben by September 12th.

• Agreement in principle for all documents – All details may not be fully ironed out – Need to include in Budget and Regulation Submission

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QUESTIONS & DISCUSSION