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Incorporating Privacy Policies and HIPAA Compliance into an Institutional Compliance Plan Shana Chung, MPH, JD Premera Blue Cross PO Box 327 Seattle, WA 98111 (425) 670-4356 [email protected] Rebecca L. Williams, RN, JD Davis Wright Tremaine LLP 1501 Fourth Ave. Seattle, Washington (206) 628-7769 [email protected] Davis Wright Tremaine LLP

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Page 1: Institutional Compliance Plan HIPAA Compliance into an ... · Institutional Compliance Plan Shana Chung, MPH, JD Premera Blue Cross PO Box 327 Seattle, WA 98111 (425) 670-4356 shana.chung@premera.com

Incorporating Privacy Policies and HIPAA Compliance into an

Institutional Compliance Plan

Shana Chung, MPH, JDPremera Blue Cross PO Box 327Seattle, WA 98111(425) [email protected]

Rebecca L. Williams, RN, JDDavis Wright Tremaine LLP1501 Fourth Ave.Seattle, Washington(206) [email protected]

Davis Wright Tremaine LLP

Page 2: Institutional Compliance Plan HIPAA Compliance into an ... · Institutional Compliance Plan Shana Chung, MPH, JD Premera Blue Cross PO Box 327 Seattle, WA 98111 (425) 670-4356 shana.chung@premera.com

2Davis Wright Tremaine LLPDavis Wright Tremaine LLP:

The HIPAA Clock Is TickingThe HIPAA Clock Is Ticking�The final transaction and code sets regulations

started the clock�Standards must be implemented by October 16,

2002 (with an extra year for small health plans)�The other regulations are not far behind

�The final transaction and code sets regulations started the clock

�Standards must be implemented by October 16, 2002 (with an extra year for small health plans)

�The other regulations are not far behind

Page 3: Institutional Compliance Plan HIPAA Compliance into an ... · Institutional Compliance Plan Shana Chung, MPH, JD Premera Blue Cross PO Box 327 Seattle, WA 98111 (425) 670-4356 shana.chung@premera.com

3Davis Wright Tremaine LLPDavis Wright Tremaine LLP:

HIPAA Compliance Strategy ProgressionHIPAA Compliance Strategy Progression

0102030405060708090

Providers Payors Vendors

No strategyOn track

©HIPAAdvisory.comPhoenix Health

Page 4: Institutional Compliance Plan HIPAA Compliance into an ... · Institutional Compliance Plan Shana Chung, MPH, JD Premera Blue Cross PO Box 327 Seattle, WA 98111 (425) 670-4356 shana.chung@premera.com

4Davis Wright Tremaine LLPDavis Wright Tremaine LLP:

Commitment to HIPAA ComplianceCommitment to HIPAA Compliance

�HIPAA compliance needs to be top-down�Start with an education process, including the

board and senior leadership�Must have commitment to compliance by the

board and senior leadership

�HIPAA compliance needs to be top-down�Start with an education process, including the

board and senior leadership�Must have commitment to compliance by the

board and senior leadership

Page 5: Institutional Compliance Plan HIPAA Compliance into an ... · Institutional Compliance Plan Shana Chung, MPH, JD Premera Blue Cross PO Box 327 Seattle, WA 98111 (425) 670-4356 shana.chung@premera.com

5Davis Wright Tremaine LLPDavis Wright Tremaine LLP:

Practical Reasons for Compliance PlansPractical Reasons for Compliance Plans

�Reduce criminal and civil liability/based on the Federal Sentencing Guidelines

�Government encouragement — Compliance Program Guidance

�Consistent with Board’s fiduciary duty�Consistent with sound business practices�Voluntary is preferable over government-mandated

plan

�Reduce criminal and civil liability/based on the Federal Sentencing Guidelines

�Government encouragement — Compliance Program Guidance

�Consistent with Board’s fiduciary duty�Consistent with sound business practices�Voluntary is preferable over government-mandated

plan

Page 6: Institutional Compliance Plan HIPAA Compliance into an ... · Institutional Compliance Plan Shana Chung, MPH, JD Premera Blue Cross PO Box 327 Seattle, WA 98111 (425) 670-4356 shana.chung@premera.com

6Davis Wright Tremaine LLPDavis Wright Tremaine LLP:

A First Step — Revisit Corporate Compliance ProgramsA First Step — Revisit Corporate Compliance Programs�Organizational commitment to integrity�Form of self-policing�Processes to effectively ensure legal compliance�Part of an organization’s day-to-day operations�Part of the health care industry

�Organizational commitment to integrity�Form of self-policing�Processes to effectively ensure legal compliance�Part of an organization’s day-to-day operations�Part of the health care industry

Page 7: Institutional Compliance Plan HIPAA Compliance into an ... · Institutional Compliance Plan Shana Chung, MPH, JD Premera Blue Cross PO Box 327 Seattle, WA 98111 (425) 670-4356 shana.chung@premera.com

7Davis Wright Tremaine LLPDavis Wright Tremaine LLP:

Integrated Compliance PlanningIntegrated Compliance Planning�For those with compliance programs, leverage

current compliance knowledge, processes, culture and resources

�For those without effective compliance plans�Use HIPAA as the lead issue�Establish structure — Expand as capabilities allow

�Integrate — Do not just layer an additional bureaucracy on top

�For those with compliance programs, leverage current compliance knowledge, processes, culture and resources

�For those without effective compliance plans�Use HIPAA as the lead issue�Establish structure — Expand as capabilities allow

�Integrate — Do not just layer an additional bureaucracy on top

Page 8: Institutional Compliance Plan HIPAA Compliance into an ... · Institutional Compliance Plan Shana Chung, MPH, JD Premera Blue Cross PO Box 327 Seattle, WA 98111 (425) 670-4356 shana.chung@premera.com

8Davis Wright Tremaine LLPDavis Wright Tremaine LLP:

Integrated Compliance PlanningIntegrated Compliance PlanningOIG Compliance Plan HIPAA Compliance Plan

Policies & Procedures Administrative ProceduresAssignment of OversightResponsibilities

Assigned Security & PrivacyResponsibilities

Training & Education Training & EducationLines of Communication Report Procedures; Event ReportingEnforcement & Discipline SanctionsAudit & Monitoring Internal Audit

Response & Corrective Action Response Procedures; Testing &Revision

Page 9: Institutional Compliance Plan HIPAA Compliance into an ... · Institutional Compliance Plan Shana Chung, MPH, JD Premera Blue Cross PO Box 327 Seattle, WA 98111 (425) 670-4356 shana.chung@premera.com

9Davis Wright Tremaine LLPDavis Wright Tremaine LLP:

Ensure Oversight —Compliance Task ForceEnsure Oversight —Compliance Task Force�Form HIPAA oversight group or task force

�Too big a job for one person

�Engage key managers and clinicians

�Don’t delegate this solely to the I/S department

�Form HIPAA oversight group or task force

�Too big a job for one person

�Engage key managers and clinicians

�Don’t delegate this solely to the I/S department

Page 10: Institutional Compliance Plan HIPAA Compliance into an ... · Institutional Compliance Plan Shana Chung, MPH, JD Premera Blue Cross PO Box 327 Seattle, WA 98111 (425) 670-4356 shana.chung@premera.com

10Davis Wright Tremaine LLPDavis Wright Tremaine LLP:

Ensure Oversight — HIPAA PoliceEnsure Oversight — HIPAA Police�Appoint privacy and security officials

�Must have real authority — Be aware of the chain of command

�Defined by organization’s need

�Who should be privacy and security officer?

�Appoint privacy and security officials

�Must have real authority — Be aware of the chain of command

�Defined by organization’s need

�Who should be privacy and security officer?

Page 11: Institutional Compliance Plan HIPAA Compliance into an ... · Institutional Compliance Plan Shana Chung, MPH, JD Premera Blue Cross PO Box 327 Seattle, WA 98111 (425) 670-4356 shana.chung@premera.com

11Davis Wright Tremaine LLPDavis Wright Tremaine LLP:

Ensure Oversight —Other HIPAA Organizational StructureEnsure Oversight —Other HIPAA Organizational Structure

Corporate Compliance OfficerCommunications

HIPAA ComplianceOperations Manager

Oversight Committee

Finance/Patient AccountsClinical/Physicians

Facilities (security) Regional Coordinators

Human Resources (training & education)

Legal

Health Information Management

Page 12: Institutional Compliance Plan HIPAA Compliance into an ... · Institutional Compliance Plan Shana Chung, MPH, JD Premera Blue Cross PO Box 327 Seattle, WA 98111 (425) 670-4356 shana.chung@premera.com

12Davis Wright Tremaine LLPDavis Wright Tremaine LLP:

Ensure Oversight — Other StructuresEnsure Oversight — Other Structures

High Level Executive Management fromEach Entity Within the System

HIPAA Oversight CommitteeMembers:

Chair: An Executive VP

Assigns a goal & issues list to Task Forces

Task Forces

Work Groups

Page 13: Institutional Compliance Plan HIPAA Compliance into an ... · Institutional Compliance Plan Shana Chung, MPH, JD Premera Blue Cross PO Box 327 Seattle, WA 98111 (425) 670-4356 shana.chung@premera.com

13Davis Wright Tremaine LLPDavis Wright Tremaine LLP:

Employee Training: Like All Compliance Efforts, Training Is CrucialEmployee Training: Like All Compliance Efforts, Training Is Crucial�Privacy and security awareness training to —

�Entire workforce�New employees

�When policies change, retrain affected employees�HIPAA certification for employees

�New certification statement at least every 3 years�May want to tie with compliance program

�Stress importance of security and privacy�Consistent enforcement

�Privacy and security awareness training to —�Entire workforce�New employees

�When policies change, retrain affected employees�HIPAA certification for employees

�New certification statement at least every 3 years�May want to tie with compliance program

�Stress importance of security and privacy�Consistent enforcement

Page 14: Institutional Compliance Plan HIPAA Compliance into an ... · Institutional Compliance Plan Shana Chung, MPH, JD Premera Blue Cross PO Box 327 Seattle, WA 98111 (425) 670-4356 shana.chung@premera.com

14Davis Wright Tremaine LLPDavis Wright Tremaine LLP:

Risk ManagementRisk Management

�Prioritize the issues facing the organization

�Priorities list should drive the compliance plan

�Fix identified problemsin priority order

�Prioritize the issues facing the organization

�Priorities list should drive the compliance plan

�Fix identified problemsin priority order

Page 15: Institutional Compliance Plan HIPAA Compliance into an ... · Institutional Compliance Plan Shana Chung, MPH, JD Premera Blue Cross PO Box 327 Seattle, WA 98111 (425) 670-4356 shana.chung@premera.com

15Davis Wright Tremaine LLPDavis Wright Tremaine LLP:

HIPAA Project ScopeHIPAA Project Scope

� Compliance for all Premera entities impacted by

HIPAA

� Modification of information systems

� Modification of business practices

� Document policies and procedures

� Draft business partner agreements

� Secure transmission & storage of all protected

health information

� HIPAA compliance monitoring

� Compliance for all Premera entities impacted by

HIPAA

� Modification of information systems

� Modification of business practices

� Document policies and procedures

� Draft business partner agreements

� Secure transmission & storage of all protected

health information

� HIPAA compliance monitoring

Page 16: Institutional Compliance Plan HIPAA Compliance into an ... · Institutional Compliance Plan Shana Chung, MPH, JD Premera Blue Cross PO Box 327 Seattle, WA 98111 (425) 670-4356 shana.chung@premera.com

16Davis Wright Tremaine LLPDavis Wright Tremaine LLP:

HIPAA Program Phases

Assessment Analysis Remediation Closeout

� High Level Assessment

� Identify impacted systems and processes

� High Level Scope� Total Project

Cost Gross Estimate

� Select HIPAA Consultant� Detailed Gap Analysis of

affected systems and processes

� Code Analysis� Transaction Gap Analysis� Operational Gap Analysis� Data Dictionary & Data

Mapping� Security Design� Privacy Analysis� Remediation Approach

Decision� Remediation Plan and

Schedule

❒ Detailed system design of remediation

❒ Detailed design of procedural changes

❒ Coding and testing ❒ Implementation of system

remediation and procedural changes

❒ Communication and retraining

❒ Trading Partner contract modifications

❒ Finalize contracts with vendors & contractors

❒ Transition project team

Jan 00 – Mar 00 Sep 00 – Mar 01 Nov 00 – Mar 03Staggered stages which begin as each ruling is published

Follows each remediation stage

Phase

Content

Timing

Decide onRemediation

Strategy

Apr 03

Page 17: Institutional Compliance Plan HIPAA Compliance into an ... · Institutional Compliance Plan Shana Chung, MPH, JD Premera Blue Cross PO Box 327 Seattle, WA 98111 (425) 670-4356 shana.chung@premera.com

17Davis Wright Tremaine LLPDavis Wright Tremaine LLP:

20018/2000 4/2003

2002 2003

Transaction Standards Remediation

Plan Design Develop SystemTest

UAT,Training,

Deployment

Rulings Published Compliance Deadlines

Ana

lysi

sR

emed

iatio

n

Unique Identifiers Remediation

Plan Design Develop SystemTest

UAT,Training,

Deployment

Security Implementation

Plan Design Develop SystemTest

UAT,Training,

Deployment

Privacy Implementation

Plan Design Develop SystemTest

UAT,Training,

Deployment

Clo

seou

tHIPAA Program Schedule

September 2000 - April 2003

26 months from final ruling publication & compliance deadline

Page 18: Institutional Compliance Plan HIPAA Compliance into an ... · Institutional Compliance Plan Shana Chung, MPH, JD Premera Blue Cross PO Box 327 Seattle, WA 98111 (425) 670-4356 shana.chung@premera.com

18Davis Wright Tremaine LLPDavis Wright Tremaine LLP:

Know the HIPAA RulesO

verv

iew

HIPAA PrivacyHIPAA Privacy

Insurance Portability

Fraud and AbuseMedical Liability Reform

PHIPHIIndividual

RightsIndividual

Rights

Minimum NecessaryMinimum Necessary Policies and

ProceduresPolicies andProcedures

Use and DisclosureUse and Disclosure Business Partners

Business Partners

Privacy Official& Training

Privacy Official& Training

Tax RelatedHealth Provision

RevenueOff-sets

Page 19: Institutional Compliance Plan HIPAA Compliance into an ... · Institutional Compliance Plan Shana Chung, MPH, JD Premera Blue Cross PO Box 327 Seattle, WA 98111 (425) 670-4356 shana.chung@premera.com

19Davis Wright Tremaine LLPDavis Wright Tremaine LLP:

Know Related RulesKnow Related Rules

HIPAA Privacy & Security Standards

State:Patient Bill of Rights•Insurance Code•Medical Records•Privileges•Sensitive Conditions•Minors

Other:•Accreditation•Government Contracts

Federal:•Gramm-Leach-Bliley•ERISA•Privacy Act of 1974•Sensitive Conditions•HCQIA

Page 20: Institutional Compliance Plan HIPAA Compliance into an ... · Institutional Compliance Plan Shana Chung, MPH, JD Premera Blue Cross PO Box 327 Seattle, WA 98111 (425) 670-4356 shana.chung@premera.com

20Davis Wright Tremaine LLPDavis Wright Tremaine LLP:

Build the HIPAA TeamBuild the HIPAA Team

CIOExecutiveSponsor

Program Manager

BusinessImpl.

Manager

EDITransactions

Lead

Transaction &Codes

ApplicationAnalysis Lead

TBD

Unique ID.Analysis

LeadTBD

SecurityLead

Privacy Lead

S. Chung

HIPAA ProgramStaff

Steering Committee

AllBusiness

Units

HR RecruiterLeadTBD

BudgetAnalyst

TBD

HumanResources Finance

Page 21: Institutional Compliance Plan HIPAA Compliance into an ... · Institutional Compliance Plan Shana Chung, MPH, JD Premera Blue Cross PO Box 327 Seattle, WA 98111 (425) 670-4356 shana.chung@premera.com

21Davis Wright Tremaine LLPDavis Wright Tremaine LLP:

Analysis Phase StaffingAnalysis Phase Staffing

Program Core Team

• Program Manager• Business Implementation Manager • 3 Project Managers • Standard Transactions Lead• Application Analysis Lead• Unique Identifier Lead• Security Lead• Privacy Lead

PMO Staff

• Project Coordinator• Project Financial Analyst• Project Administrator/Technical

Writer/Webmaster• HR Recruiter • Information Modeler• Data Analyst• Architect• Business Analyst

Subject Matter Experts

• 100 Business Experts x 16 hr (avg)• 80 System Experts x 16 hr (avg)

Page 22: Institutional Compliance Plan HIPAA Compliance into an ... · Institutional Compliance Plan Shana Chung, MPH, JD Premera Blue Cross PO Box 327 Seattle, WA 98111 (425) 670-4356 shana.chung@premera.com

22Davis Wright Tremaine LLPDavis Wright Tremaine LLP:

Conduct Assessment and AnalysisConduct Assessment and Analysis

�Inventory Data Repositories�Identify where information resides�Look beyond the obvious (palm pilots, laptops)

�Evaluate current processes�Technical�Human�Organizational

�Y2K inventories may be helpful�DON’T STOP with information systems!

�Inventory Data Repositories�Identify where information resides�Look beyond the obvious (palm pilots, laptops)

�Evaluate current processes�Technical�Human�Organizational

�Y2K inventories may be helpful�DON’T STOP with information systems!

Page 23: Institutional Compliance Plan HIPAA Compliance into an ... · Institutional Compliance Plan Shana Chung, MPH, JD Premera Blue Cross PO Box 327 Seattle, WA 98111 (425) 670-4356 shana.chung@premera.com

23Davis Wright Tremaine LLPDavis Wright Tremaine LLP:

Reporting Structure: Privacy IssuesReporting Structure: Privacy Issues

Executive SteeringCommittee

Member Information Privacy(“MIP”) Work Group

PBR: PrivacyGLB

HIPAA: PrivacyNCQA: Privacy

Other Privacy IssuesHIPAA

ImplementationTeam

GLBImplementation

TeamTBD

PBRImplementation

Team

QualityImprovement Committee

Corporate ComplianceCommittee

Executive SteeringCommittee

Executive SteeringCommittee

AccreditationCompliance

(e.g., NCQA)

Drafted: 07/07/2000

Page 24: Institutional Compliance Plan HIPAA Compliance into an ... · Institutional Compliance Plan Shana Chung, MPH, JD Premera Blue Cross PO Box 327 Seattle, WA 98111 (425) 670-4356 shana.chung@premera.com

24Davis Wright Tremaine LLPDavis Wright Tremaine LLP:

Ad Hoc Teams(Analyzes requirements

and resolves issues)

Ad Hoc Analysis & Implementation Teams

Executive Team(Sets strategy)

Steering Committee(Decides Policy)

Clearinghouse Evaluation Team

HIPAAPrivacy and

Security

StandardIdentifiers

Multiple teams work concurrently to identify and resolve issues…

Confid. Committee

Initial HIPAA

Assessment

StandardTransactions

Application Analysis Team

GovernmentRelations

Team

Provider NetworkRelations

Team

EmployerRelations

Team

Other initiatives Liaison

…then a small core team integrates their analysis and frames decisions...

… which are approved and deployed by the management and executive teams.

The results are timely, executable decisions which fulfill business requirements

and are supported by Premera management

RFPAssessment

Core Design Team(Integrates analysis and

frames decisions)

Page 25: Institutional Compliance Plan HIPAA Compliance into an ... · Institutional Compliance Plan Shana Chung, MPH, JD Premera Blue Cross PO Box 327 Seattle, WA 98111 (425) 670-4356 shana.chung@premera.com

25Davis Wright Tremaine LLPDavis Wright Tremaine LLP:

Final ThoughtsFinal Thoughts�The HIPAA clock is ticking�Start now and keep at it�Integrate HIPAA into your strategic vision�Comprehensive organizational plan�If you base HIPAA compliance decisions on

sound business practices and the best interest of individuals, you probably will meet or exceed HIPAA’s requirements

�The HIPAA clock is ticking�Start now and keep at it�Integrate HIPAA into your strategic vision�Comprehensive organizational plan�If you base HIPAA compliance decisions on

sound business practices and the best interest of individuals, you probably will meet or exceed HIPAA’s requirements