The Integration of Regulatory and Clinical Compliance John Ciavardone, CCE Stephanie Ziegler, CCP Debra Burock, Ph.D., CCP

The Integration of Regulatory and Clinical Compliance

John Ciavardone, CCEStephanie Ziegler, CCPDebra Burock, Ph.D., CCP

Confidential - NHS Human Services - Not for Reproduction

The Obligatory Ice-Breaker


Learning Objectives

•Acquisition of knowledge pertaining to changes in the Compliance oversight environment

•Skill application in strategic processes

• Tools to use


About NHS Human Services, Inc.•Seven states•50,000 served annually•13,500 employees•Community-based behavioral non-profit•Children and adults•Intellectual/Developmental Disabilities,

mental health, autism, juvenile justice•Hundreds of service models


NHS Integrity Program Structure

Chief Compliance

Officer

Clinical Compliance

Officer

Regulatory Compliance

Officer

Regional Compliance Officers

Compliance Specialists

Compliance Technicians

Health Information

Management Specialist


Poll – What is the size of your Compliance Program?A. 2 – 5B. 5 – 10C. 10 – 15D. Are you kidding? I’m the Lone Ranger in

my organization!



The building blocks for a compliance program

•Chief compliance officer•Reporting mechanisms•Code of conduct•Integrity policy and other policies•Auditing and monitoring


Brief Review

•Compliance 101 - Investigations▫What▫Where ▫Why

•Training/education•Risk Assessment (New)


What are the areas of risk and concern?

• Laws and regulations • Payer and contractual

requirements

• Licensing requirements

• Organization Mission and Values

• Program descriptions• Quality of care

• Policies and Standards

• Sound and ethical business practices

• Code of Conduct


How the field is changing…

•Accountable Care Organizations

•Health care reform

•Office of the Inspector General (OIG) guidance



Quality and Compliance in Transition :

From Content to Process

From Dichotomous to Continuous Quality Analysis

Transition from Content to Process•Qualifications of staff

▫Credentials may work as a baseline for quality but clinical effectiveness and compliance effectiveness?

•Documentation▫Presence or absence of documentation is

not an adequate indicator of quality•Auditing

▫What? Who? Why?


Guidance for Boards – Integrated Response

•OIG/AHLA Guidance to Boards on Quality▫Board fiduciary▫“Ten” questions▫Compliance/Quality interaction


Some Key Questions For Boards to Answer

• What internal controls exist to monitor and report on quality metrics?

• How are the organization’s quality assessment and improvement processes coordinated with its corporate compliance program?

• Are human and other resources adequate to support safety and clinical quality?



What Payers Are Looking At

•Evidence of trauma screening

•Exploration of social elements in a

person’s life

•Exploration of addictive behaviors


Even more importantly… quality-based CIA’s


Quality-based Corporate Integrity

Agreements

•CO “ensures” quality of care issues are appropriately addressed and corrected

•Quality Assurance Compliance Committee

•Board “Quality Assurance Monitoring Committee”

•Multiple measures targeted to quality•Internal audit and review functions•Independent Monitor


Poll #2: Which is the burger with the best quality?A. Burger King

B. Red Robin Royal

C. Kobe Burger

D. Biltmore Veggie



Exercise: Define “Quality” as it relates to…

•A burger

•A progress note

•A process


Defining Quality in Behavioral Health

•Medical Necessity

•Prescription Practices

•Integration of treatment

•Clinical conceptualization in documentation


Quality Indicators•“Traditional”

▫Licensing▫Accreditation▫Chart reviews

•“Neo-modern”▫Staff credentials/qualifications▫Documentation


What is the Role of the Compliance Function in

Quality?


Poll: What is the nature of your relationship with Quality Improvement in your organization?A. QI and Compliance are in the same

department (or person!)B. QI has a regular contact with

Compliance departmentC. Compliance and QI collaborate when

sentinel events occurD. QI? What’s that?



Integration and Collaboration

•COMMUNICATE

•Educate

•Know what’s going on!


Quality Control Systems

•Gap analysis

•Risk Assessment

•Process development


Types of Compliance

Regulatory Compliance

• Fiduciary linkages

• Specific laws and regulations specifying standards

• Content focus

Clinical Compliance• Standard of care

• Not clearly specified

• Process focus


Synchronizing Regulatory and Clinical Compliance with

Quality Improvement


Compliance Helpline

•Structure▫Concern presented and logged▫Review for critical incident▫Case Assignment▫Coordination with external departments▫Report▫Corrective Action Follow up


Capturing compliance concerns

•Modes of communication to OCA▫Email▫Fax▫Call

•Disclaimer and information collection•Password issuance


Review of concern

•Rapid review for critical incident

•Concurrent review for regulatory and clinical concerns

•Weekly CART


Case Assignment

•Determine type of review

•Determine who has the skill and expertise to investigate – regulatory vs clinical


Collaboration

•Human Resources

•Clinical specialists

•Quality Improvement

•Legal


Report

•Determine Type:▫Regulatory:

Compliance Investigation (CI) Initial Inquiry

▫Clinical Compliance Assessment Review (CCAR)


What’s the difference between regulatory and clinical

investigations?


Regulatory Investigation

•Initial Inquiry

•Compliance Investigation


Clinical Compliance Assessment Review

•Focus on clinical and quality deficiencies•Often no clear regulation•May have history of payor focus•Results or has the potential to result in

harm


Full Group Exercise

▫What type of investigation

▫What if…


Tracking the Issues

•Compliance Case Management System (CCMS)▫Web-based database▫Report modules


CCMS – Main Intake Screen


Issue/Outcome Tab


Follow Up Tab


The next phase of synchronizing regulatory and

clinical compliance…

•Internal control systems▫Monitoring methodology used to ensure

systematic and consistent clinical compliance and quality

▫Enhance quality-based existing practices and systems

•Risk Mitigation


Identifying quality-based practices

•Systems that define procedures and processes

•Have oversight and monitoring

•Clear baselines

•Measurable outcomes


Address what matters!•Hypothesize

•Rapid Cycle Testing (NIATx)

•Determine data utility BEFORE collection!


Case Study: Pandora's Box

•Residential program


Exercise: Corrective Actions

•Based upon the allegations, investigations and findings create a corrective action plan


Control Systems To Support CAPs

1. Finding the risks

2. Addressing the liabilities

3. Measuring interventions success

4. Documenting change


Identification of Compliance Risks

•Determine scope

•Tools Gap Analysis Enterprise-wide Risk Assessment

•Disseminate


Gap Analysis

•Review of systems

•Identify indicators

•Set benchmarks▫Internal and external

•Measurement and data collection


Enterprise-wide Risk Assessment

•Comprehensive

•Participation across organization

•5-year plan


Now that you’ve uncovered the problem…

•Who is responsible for addressing the risk?

•What process is there to analyze the risk to begin to strategize how to mitigate the risk?

•Are there current mechanisms in place that could or should mitigate the risk?


Exercise: Creating a Control System

1. Based upon the allegations, investigations and findings...

a) What is the baseline frequency of the risk?

b) Strategy or processes for mitigating the risk?

c) How do you monitor efficacy of the risk mitigation process?


Interventions

•Tools▫Research and Evidence Based Practice

▫History of other interventions

▫Workgroups

•Measurement of effectiveness▫Baseline data needed


Making trial and error work for you…

•Don’t fall victim to the File Drawer Phenomenon!

•Share successes and failures at an organizational level.



Expectations for Compliance Programs are expanding

▫Synchronize with your clinical partner▫Educate your Board▫Identify risks before they bite you▫Risks are no longer black and white or

obvious▫Quality control system vs. incidents of

quality failure


On-line Resources1. Office of the Inspector General Corporate Responsibility and Health Care

Quality: A Resource for Health Care Boards of Directors (a.k.a. “The 10 Questions”) http://oig.hhs.gov/fraud/docs/complianceguidance/CorporateResponsibilityFinal%209-4-07.pdf

2. The Compliance Watch Newsletter http://www.thenationalcouncil.org/cs/compliance_watch_newsletter

3. Corporate Responsibility and Corporate Compliance A Resource for Health Care Board of Directors http://oig.hhs.gov/fraud/docs/complianceguidance/040203CorpRespRsceGuide.pdf

4. Office of the Inspector General: Corporate Integrity Agreements http://oig.hhs.gov/fraud/cias.asp

5. NIATx - http://www.niatx.net/Home/Home.aspx

http://oig.hhs.gov/fraud/docs/complianceguidance/CorporateResponsibilityFinal%209-4-07.pdf

http://oig.hhs.gov/fraud/docs/complianceguidance/CorporateResponsibilityFinal%209-4-07.pdf

http://www.thenationalcouncil.org/cs/compliance_watch_newsletter

http://oig.hhs.gov/fraud/docs/complianceguidance/040203CorpRespRsceGuide.pdf

http://oig.hhs.gov/fraud/docs/complianceguidance/040203CorpRespRsceGuide.pdf

http://oig.hhs.gov/fraud/cias.asp

http://www.niatx.net/Home/Home.aspx


•John Ciavardone▫[email protected]

•Steph Ziegler▫[email protected]

•Deb Burock▫[email protected]

mailto:[email protected]

mailto:[email protected]

Documents

The Integration of Regulatory and Clinical Compliance John Ciavardone, CCE Stephanie Ziegler, CCP Debra Burock, Ph.D., CCP