Integrated Health Care Systems Compliance Pre-Conference

Integrated Health Care Systems Compliance

Pre-Conference

April 21, 2002

HCA – Ethics and Compliance Department

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Ethics and Compliance Program Elements

◆ Setting Ethics and Compliance Standards◆ Creating Awareness◆ Exceptions Reporting Mechanism◆ Monitoring ◆ Organizational Structure ◆ Corporate Integrity Agreement (CIA)

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Setting Standards◆ Code of Conduct

• Articulates:– Our mission and values– Our commitment to stakeholders– Various standards of conduct

◆ Policies and Procedures

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Creating Awareness/Communications

◆ Training◆ Other Communication Mechanisms

• Internet (www.hcahealthcare.com)/Intranet Sites

• E-mails from SVP, COO, CEO• Press Releases• Policy Checklists• ECO Newsletter

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Exceptions Reporting Mechanism

◆ Ethics Line -- 1-800-455-1996• Allows for “exceptions” to policies, laws

and regulations to be reported• Careful and confidential investigations,

with emphasis on local management involvement and local resolution

• Feedback to callers • Highly detailed documentation process

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Auditing/Monitoring◆ Internal Audit & Consulting Services

performs compliance audits◆ Action plans to correct problems

• Re-billing• Self-reporting

◆ Trends◆ Opportunities for further policies or

education◆ Compliance Process Reviews by E&C

Department

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Organizational Structure◆ CEO/COO Support◆ Ethics, Compliance and Corporate Responsibility

Committee of the Board of Directors◆ Senior VP for Ethics, Compliance and Corporate

Responsibility (Alan Yuspeh) ◆ Corporate Ethics and Compliance Steering and

Policy Committees◆ Facility ECOs◆ Responsible Executives

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CIA -- General Terms◆ Applies to operations of HCA and its

subsidiaries that are subject to US law

◆ HCA’s compliance with the CIA is an element of HCA’s responsibility to participate in the Federal health care programs

◆ Length -- 8 years

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CIA -- Elements◆ Definitions◆ Written Standards◆ Training and

Education◆ Confidential

Disclosure Program◆ Ineligible Persons◆ Notification of

Proceedings

◆ Overpayment Reporting

◆ Reportable Events◆ Workplans and

Independent Review Organization

◆ Required Periodic Reports

◆ Penalties

POLICIES AND PROCEDURES

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Policy Development Process

• Responsible Executive (RE) drafts• Multi-disciplinary team reviews &

comments• RE presents to Policy Committee• Policy Committee approves• E&C Department distributes to ECOs

and others

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Policy Distribution Process Policy Package includes:

• Cover memo describing new or revised policy and contacts for questions

• Divider sheets include: • Policy distribution list• Distribution tracking tool, and • Questions for ECO to ask to find out if

policy has been implemented

• For revised policies, marked copies to show revisions

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Policy Distribution Process• Policy Package placed on Intranet with links to

all attached documents including summary and table of contents; links sent to ECOs

• Hard copy sent to all ECOs and CEOs

• All policies on Internet

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Policy Implementation Tools and Resources

• Summary of Policies and Procedures• Checklists

– Examples: Business Courtesies Checklist• Helplines (e.g., Billing and Coding)• FAQs• Policy-Specific Tools

– Examples: Business Courtesies Log (Intranet-based)

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Business Courtesies Log Introduction Page

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Choose Facility, the data is facility specific

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Choose physician before adding courtesy

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Choose standard courtesy or create one

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Input single courtesy information

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Accommodates same courtesy for multiple physicians

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Choose all or a group of physicians

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Input group courtesy information

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Change master courtesy information

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Change master physician information

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Related Links

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Help

COMMUNICATION AND AWARENESS

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Code of Conduct Training◆ Orientation Training:

• Orientation training within 30 days of hire• Video based:

– Facilitator led– Case study format– Discussion of Ethics and Compliance matters– Cost effective for large number of employees– Consistent message

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Training Topics◆ A Tradition of Caring – Case Studies

• ADA and Customer Service• Gifts• Use of Organization Resources• Harassment• Information Security and Confidentiality• EMTALA

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Training Topics (cont.)◆ A Tradition of Caring – Case Studies

• Emergency Medical Treatment and Active Labor Act

• Medication Errors• Patient Rights• Medical Waste and Reporting

Misconduct• Entertainment and Gifts

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Code of Conduct Training◆ Refresher Training:

• Annual Training for all employees• 2001 game show “Who Wants to Be a

Compliance Expert?”• Three versions available

– Laptop/LCD– Overhead projector– Online

• 2002 game show “Wheel of Integrity”

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Compliance Training◆ Compliance Training:

• Related to Policies and Procedures• Online modules:

– Government Relations– Ineligible Persons

• Conference calls• Newsletter (Compliance Matters)

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Learning Management System◆ Learning Management System (LMS):

• Developed by HealthStream, a Nashville-based online education company.

◆ Reasons for the LMS:• Ensure consistent method of delivering, testing

and tracking education• Meet Corporate Integrity Agreement

requirements• Utilize a cost-effective method for educating

large numbers of employees • Establish a process for assigning required

courses

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LMS◆ Key Design Features:

• Registration for classes of all types (e.g., online, instructor-led, and video classes)

• Delivery of online education• Pre and post testing of the learner’s

knowledge• Course evaluations• Comprehensive, flexible reporting

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Student Tab

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Assignment Tab

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Assignment Tab

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Classroom Tab

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Completion Report

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Completion Report

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Use of Internet/Intranet◆ Virtues of a Robust Internet Site

• Help raise ethical and compliant conduct within our industry

• Public awareness of your ethics and compliance efforts

• Easy access for your external stakeholders to valuable information

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Use of Internet/Intranet◆ Virtues of a robust Intranet site

• Consistency– Of message– Of accessibility

◆ Ease in updating information◆ Increased awareness of key issues

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Use of Internet/Intranet◆ Content suggestions:

• Code of Conduct• Policies and Procedures• Training Materials• Program structure information• Reporting mechanism information• Auditing and monitoring resources• Communication Methods

– FAQs– Speeches– Articles

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HCA’s Internet Site

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Mission and Values

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Ethics and Compliance Internet

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Code of Conduct

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Policies and Procedures

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Communication Efforts

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Reporting Exceptions

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Monitoring and Auditing

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Organizational Supports

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HCA’s Intranet Site

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Ethics and Compliance Folder

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E&C Folder Contents◆ E&C Program Development◆ CIA – Corporate Integrity

Agreement, Plea Agreement & Settlement Agreement, & Implementation Aides

◆ Code of Conduct◆ Communications &

Awareness◆ Compliance Alerts◆ Corporate Records

Management Web Site◆ ECO Quarterly Report

◆ E&C Committees◆ E&C Discussion◆ Ethics Line Investigations◆ Frequently Asked

Questions◆ Health Fraud & Abuse

Statutes◆ Monitoring & Auditing◆ New ECO Information◆ Policies & Procedures◆ Related Websites◆ Training

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E&C Committees

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Code of Conduct Training

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ECO Quarterly Report

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Frequently Asked Questions

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Ordering Materials

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Intranet Search Feature

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Search Result

Ethics Line Process and Investigations

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Ethics Line Case VolumeOpened vs. Closed by Month: Feb-01 – Feb-02

93

78 77

100

64 68

101

74

9288

66

105

79

6156

71

116

63

117

78

10297

122134

102

132

0102030405060708090

100110120130140

Feb-01 Mar-01 Apr-01 May-01 Jun-01 Jul-01 Aug-01 Sep-01 Oct-01 Nov-01 Dec-01 Jan-02 Feb-02

OpenedClosed

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Ethics Line Case Flow

C o m p lia n ce L in e S ta ff c ap tu resin fo rm atio n fro m ca lle r a cc o rd in g to

H C A p ro to co l. C a lle rs a re g iv en are sp o n se -c a ll-b ac k d a te a n d ca s e

n u m b e r.

T h e in tak e in fo rm a tio n is ta ke n b y aC as e C o o rd in a to r, C a se M a n a g er,

In ve s tig a to r, o r A V P , C o rp o ra teIn te g rity . A c as e n u m b e r is p ro v id e d

to th e ca lle r.

T h e d a ta is re triev ed b y th eE & C S ta ff.

C as es a re re v iew e d an d a ss ig n ed a C as e M an a g e r b y th e A V P .C as es p ro v id in g in s u ffic ien t in fo rm a tio n o r n o t p re se n tin g E & C

iss u es a re c lo s ed w ith o u t in v es tig a tio n .

C a ll is p lac ed to th e E th ic s L in e1 -80 0 -45 5 -1 99 6

C a ll, le tte r , em a il, e tc ., isre c e iv ed in E & C D ep a rtm e n t

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Ethics Line Case FlowThe Case Manager/Coordinator contacts the caller (if not

anonymous) to review the issues and to provide caller with theCase Manager/Coordinator’s name and telephone number for

future contact.

The caller is asked if he/she wishes to be identified in the investigative report.The caller may choose to be anonymous to the investigator by having his/her

name redacted from the report that goes to the ECO/investigator at the facility.

The case is sent to an investigator via email in a password protected Worddocument. A 21-day investigation period is normally assigned.

An investigation is conducted at facility or by corporate.Occasionally, outside resources are utilized.

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T h e C a s e M a n a g e r/C o o rd in a to r re v ie w s s u b m itte d in v e s tig a tiv ere p o rt to v e r ify a ll is s u e s h a v e b e e n p ro p e r ly in v e s tig a te d . If

n o t , th e c a s e is s e n t b a c k fo r a d d it io n a l in v e s tig a t io n .

If C a s e M a n a g e r/C o o rd in a to r f in d s in v e s tig a t iv e re p o rtc o m p le te , a C lo s e -O u t M e m o to th e A V P is p re p a re d d e ta il in g

th e p ro c e d u re a n d s u m m a ry o f in v e s tig a tio n .

A V P , C o rp o ra te In te g r ity , re v ie w s th e C lo s e -O u t M e m o a n de ith e r a p p ro v e s o r d is a p p ro v e s th e s u m m a ry o f th e

in v e s tig a t io n a n d th e c o rre c t iv e a c tio n , if a p p ro p r ia te .

T h e C a s e M a n a g e r/C o o rd in a to r c lo s e s th e c a s e a c c o rd in g lya s “ S u b s ta n tia te d ,” “ U n s u b s ta n tia te d ,” e tc . C o rre c tiv e

a c tio n , if a n y , w ill b e n o te d in th e m e m o .

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If the caller is anonym ous, an em ailm essage is sen t to the C om plianceL in e or to the caller’s anonym ousem ail address letting them know

the investigation resu lts . T he callercontacts the C om pliance L ine to

obtain the resu lts .

C ase C oord inator c loses case in E th icsA dm in istration S ystem (E A S ). H ard cop ies o f

docum ents are p laced in perm anent, secured files inthe E th ics and C om pliance D epartm ent.

The iden tified caller is contacted b ythe C ase M anag er/C oord inator and

g iven the resu lts o f theinvestigation .

C ase M anager/C oord inator advises E C O w henthe case is c losed in the D epartm ent.

W hen the C lose-O ut M em o has been ap proved by theA V P , the C ase M anager/C oord inator contacts the caller

w ith the resu lts o f the investigation .

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Anatomy of an InvestigationBusiness vs. Investigator Speak

!Conducting an investigation is similar to solving day-to-day business problems; the language is just different.

!Be fair, accurate, and unbiased.

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! Problem Analysis = Scope of Complaint• What is the issue or issues?• Narrow the scope – In other words, you often

must sift through the complaint to find out what the allegation is.

Example: There are not enough nurses at the hospital which makes the job very difficult and patients are not getting quality care.

Issue: Patient Care (the root cause may be a nursing shortage, but the issue is patient care).

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!Determine Information Needed = Prepare Investigative Plan• Identify witnesses• Identify evidence• Identify subject matter experts• Identify needed references (e.g.

policies, applicable laws)

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!Talk to Responsible Persons = Conduct Interviews• Interviews should be in private.• Address all areas of concern.• Documented in third person, singular, and

past tense (Mr. Smith stated he saw…).• Review notes with interviewee to ensure

accuracy.

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!Gather Supporting Documentation = Collect Evidence• Evidence is anything that will support or

refute the allegation.• Common Evidence in Ethics Line.

Investigations: E-mails, Documents from files, Logs (written and electronic), Invoices, Contracts.

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! Assess, Gather Additional Information = Assess and Re-interview if necessary to Eliminate Contradictions. • Review all statements/notes• Compare – where do they conflict, can the conflict

be eliminated by doing re-interviews.• Was something brought up in a later interview that

was not brought out in an earlier interview? Do you need to go back and re-interview?

• Conduct re-interviews as needed – some conflicts don’t matter, some will never be resolved.

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Anatomy of an InvestigationThe investigation is Done, Now What?

!Determine if Changes are needed – Is the event the result of a system failure?

!Implement the Changes.!Provide Feedback to persons affected. !Provide case manager with corrective

action plan or action taken.

Compliance Process Reviews

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Compliance Process Reviews

◆ Purpose of Reviews◆ Process Overview◆ Reporting◆ 2002 Program Goals

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Purpose of Reviews◆ Assess the performance and level of

engagement of the facility’s Ethics and Compliance Officer (“ECO”).

◆ Provide the ECO with guidance and examples of best practices.

◆ Communicate one-on-one with individual ECOs and become more familiar with program issues.

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Process Overview◆ Program Assessment Team

• Manager• Compliance Process Reviewers (2)

– Legal Background– Physician Practice Management

Background• Administrative Assistant

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Process Overview◆ Pre-Review Preparation

• Scheduled 2 months in advance by the Compliance Process Reviewer

• Document requested from facility• Internal resources reviewed

– Facility E&C Committee Meeting Minutes– ECO Evaluation– Ethics Line Cases– Audits– ECO Quarterly Reports

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Process Overview◆ Agenda

• Day One– ECO Introduction and Facility Tour (1 Hr.)– ECO Interview (6 Hrs.)– Document Review/Testing (1 Hr.)– Employee Interviews (1 Hr.)

• Day Two– ECO Interview Continued (7 Hrs.)– Document Review/Testing (1 Hr.)– Employee Interviews Continued (1 Hr.)

• Day Three– Conclude ECO Interview (If necessary)– Conclude Employee Interviews (If necessary)– Exit Interview with ECO (1 Hr.)

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Process Overview◆ Facility Tour

• Facility– Ethics and Compliance Posters

• Emergency Department/Labor and Delivery– EMTALA Signage

• Nursing units– Patient Confidentiality– Informal Employee Interviews

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Process Overview◆ ECO Interview

• One-on-one• Discussion driven by ECO• Checklist• Decision Tree Analysis

– Gauge ECO’s level of knowledge – Involve Department Heads if ECO’s level of

knowledge is determined to be insufficient in any one area

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Process Overview◆ Checklist

• 24 Topics• Approximately 300 discussion points

– Answer tracker– Remarks column

• Reviewer prompts• Testing• Available resources

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Process Overview◆ Checklist Topics

• ECO Visibility• Distribution of Code and Related Training• Health Information Management• Conducting Investigations• Corporate Integrity Agreement• Interaction with Various ECOs• Professional Service Agreements• Medical Office Building Leases• Monitoring Controlled Substances

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Process Overview◆ Testing

• Personnel files – Signed Code of Conduct acknowledgement cards– Proof of background check– Proof of OIG/GSA exclusion lists screen

• Physician files – Proof of OIG/GSA exclusion lists screen

• Local Vendors – Proof of OIG/GSA exclusion lists screen

• Overpayment Tracking Log– Ensure refunding is occurring within 30 days of

identification

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Process Overview◆ Testing (continued)

• Professional Service Agreements– Proper execution– Multiple Medical Directorships

• Business Courtesies– Appropriate Monitoring

• Monitoring of Controlled Substances– Existence of facility policy– Required elements– DEA 222s Log

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Reporting

◆ Executive Summary

◆ Report of Findings

◆ Corrective Action Plan Grid

◆ Quality Control Questionnaire

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Reporting◆ Executive Summary

• Provided to the ECO’s Manager• Approximately 3 pages• ECO Assessment

– Rated 1 (Poor) to 5 (Excellent)• Special Commendations• Important Issues• Explanation of rating system

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Reporting

◆ Report of Findings• Provided to the ECO and the ECO’s

manager• Length varies• Acknowledgement of well-managed areas• Opportunities for improvement

(Exceptions)• Recommendations

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Reporting◆ Corrective Action Plan Grid

• Exceptions• Root cause(s)• Operational corrective action• Responsible individual• Projected completion date• Actual completion date• Submitted to Program Assessment team

by ECO for approval

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Reporting◆ Quality Control Questionnaire

• Provided to the ECO• Assessment tool

– Process– Reviewer

• Feedback reviewed by Program Assessment team– Continuous improvement

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2002 Program Goals◆ Conduct 40 Facility Reviews

• Evenly Distributed Among HCA Groups and Divisions

◆ Seek, gather, and disseminate determined “Best Practices” to facilities

◆ Issue Summary of Findings Report to ECOs on a Quarterly Basis

◆ Issue Annual Report of Findings to SVP, Ethics, Compliance, & Corporate Responsibility

◆ Improve Communication of Discovered Issues within E&C Department

Wrap-up

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How to Contact UsAlan YusephSenior Vice [email protected]

Kathleen WhalenAssistant Vice [email protected]

Jim FinneganManager, Program [email protected]

Bill MiddletonCase [email protected]

Sara Martin-MichelsSenior Compliance [email protected]

Holly WinnCompliance Training [email protected]

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