Program efectiveness a resource guide

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Measuring Compliance

Program Effectiveness:

A Resource Guide


HCCA-OIG Compliance Effectiveness Roundtable

Roundtable Meeting: January 17, 2017 | Washington, DC

Measuring Compliance Program Effectiveness ? A Resource Guide

HCCA-OIG Compliance Effectiveness Roundtable

Roundtable Meeting: January 17, 2017

Washington DC


On January 17, 2017, a group of compliance professionals and staff from the Department of Health and Human Services, Office of Inspector General (OIG) met to discuss ways to measure the effectiveness of compliance programs. The intent of this exercise was to provide a large number of ideas for measuring the various elements of a compliance program. Measuring compliance program effectiveness is recommended by several authorities, including the United States Sentencing Commission (see, Chapter 8 of the United States Sentencing Guidelines). This list will provide measurement options to a wide range of organizations with diverse size, operational complexity, industry sectors, resources, and compliance programs.

During the meeting on January 17, the participants broke into 4 groups of 10 attendees to discuss 2 elements of a compliance program at a time. During four sessions, every participant had a chance to suggest ideas about "what to measure" and "how to measure" with respect to all seven elements of a compliance program. We used the following categories, from the Health Care Compliance Association's CHC Candidate Handbook: Detailed Content Outline, as a guide to ensure that all elements of a compliance program were covered:

Compliance Program Elements:

1. Standards, Policies, and Procedures 2. Compliance Program Administration 3. Screening and Evaluation of Employees, Physicians, Vendors and other Agents 4. Communication, Education, and Training on Compliance Issues 5. Monitoring, Auditing, and Internal Reporting Systems 6. Discipline for Non-Compliance 7. Investigations and Remedial Measures

We have listed below many individual compliance program metrics. The purpose of this list is to give health care organizations as many ideas as possible, be broad enough to help any type of organization, and let the organization choose which ones best suit its needs. This is not a "checklist" to be applied wholesale to assess a compliance program. An organization may choose to use only a small number of these in any given year. Using them all or even a large number of these is impractical and not recommended. The utility of any suggested measure listed in


this report will be dependent on the organization's individual needs. Some of these suggestions might be used frequently and others only occasionally. The frequency of use of any measurement should be based on the organization's risk areas, size, resources, industry segment, etc. Each organization's compliance program and effectiveness measurement process will be different. Some may not apply to the organization's environment at all and may not be used.

Any attempt to use this as a standard or a certification is discouraged by those who worked on this project; one size truly does not fit all.

Element 1: Standards, Policies, and Procedures

A. Conduct periodic reviews of policies, procedures, and controls. B. Consult with legal resources. C. Verify that appropriate coding policies and procedures exist. D. Verify that appropriate overpayment policies and procedures exist. E. Integrate mission, vision, values, and ethical principles with code of conduct F. Maintain compliance plan and program. G. Assure that a nonretribution/nonretaliation policy exists. H. Maintain policies and procedures for internal and external compliance audits. I. Verify maintenance of a record retention policy. J. Maintain a code of conduct. K. Verify maintenance of:

1. A conflict of interest policy 2. Appropriate confidentiality policies 3. Appropriate privacy policies 4. Policies and procedures to address regulatory requirements (e.g., the Emergency Medical Treatment and Labor Act (EMTALA), Clinical Laboratory Improvement Amendments (CLIA), Anti-Kickback, research, labor laws, Stark law). L. Verify appropriate policies on interactions with other healthcare industry stakeholders (e.g., hospitals/physicians, pharma/device representatives, vendors). M. Assure policies and procedures address the compliance role in quality of care issues. N. Verify maintenance of a policy on gifts and gratuities. O. Verify maintenance of standards of accountability (e.g., incentives, sanctions, disciplinary policies) for employees at all levels. P. Maintain a Compliance Department operations manual. Q. Verify maintenance of policies on waivers of co-payments and deductibles. R. Assure governance policies related to compliance are appropriately maintained.

Source: CHC Candidate Handbook: Detailed Content Outline


Element 1: Standards, Policies, and Procedures

What to Measure Access:

How to Measure

1.1 Accessibility

1.2 Actual Access

Review link to employee accessible website/intranet that includes the Code of Conduct Survey - Can you readily access or reference policies and procedures? (Yes/No/Don't know) Survey - How and where do employees actually access policies and procedures? Test key word search (searchable) Audit and interview staff to show policies

Audit how many actual "hits" on policies and procedures

1.3 Accessible language for code, standards and policies Flesch Kincaid measuring standard ? no more than 10th grade reading level


Survey employees to determine the extent to which the code of conduct and other

Compliance program awareness and communication

compliance communications are available to employees Review to ensure the standards, policies, and awareness material is updated and distributed

within organization's guidelines

1.5 Impaired or disabled accessibility

Review accessibility options. Look at methods and speak to individuals.

1.6 Policy communication

Communication strategy of policies

1.7 Availability of policy content

Conduct surveys and observation

Accountability: 1.8 Accountability 1.9 Ownership and accountability of policies 1.10 Routine policies and procedures

Policy Coordinator designated

Audit process of how policies get enforced by chain of command when compliance is not the final approver. Is management taking responsibility for implementing and following policies?

Confirm that listed owner of each policy and procedure is the actual owner.


Review/Approval Process:

1.11 Annual review and Board approval of Compliance Plan

Audit: Review of Board minutes

1.12 Compliance documentation operations manual

Compliance or other oversight committee to review annually to ensure it is up to date.

1.13 Maintenance of policies

Check last review or revision


Number of policies reviewed and is the review timely

Process review/audit. Use checklist to ensure all basic policy elements are in place, updated consistently and reviewed/approved by appropriate parties.

1.15 Policy approvals

Checklist audit. Create list of policies, review committee and board minutes to ensure all approvals have been obtained.

1.16 Policy review process

Audit process by which policies and procedures are prepared, approved, disseminated, etc.

1.17 Process for ensuring full organizational participation Review documentation/minutes to verify input considered and solicited for policy and procedure

in policy and procedure development

development and review

1.18 Process for review and approving

Check for written process


1.19 Are policies (and procedures) as good as industry practice

Peer reviews


Integrity of Process for developing and implementing policies and procedures

Audit policy and procedure on policy and procedures

1.21 Language and reading level of policies

Are policies written in plain language, appropriate grade reading level and written in applicable languages for organization? Policy review, Word grade level review and interviews of staff to make sure they understand.

1.22 Language translation

Audit or process review. Are policies and the code of conduct translated into appropriate languages for organization?

1.23 Usefulness

SURVEY - Do department policies and procedures assist you in doing your job effectively? (Yes/No/Don't know)


1.24 Need for policies that don't exist

Interview staff to determine if they need the certain policies to strengthen internal controls.

1.25 Policies and procedures

Request review from external experts


1.26 Assessment of all company policies

Check list of policies; which are compliance and which are business

1.27 Essential compliance policies and procedures exist Can staff actually articulate policies and procedures; test staff

1.28 Existence of procedure to support policy

Audit for procedure to support policy

1.29 Fundamental policies and procedures in place 1.30


Have focus groups of work units/departments to determine whether they understand the policies and procedures necessary to do their jobs.

Index of policies available and current Numbered policies, not just titles

1.31 List of policies are applicable to employees

Supervisors to assess direct staff


Are those affected by policy given the opportunity to weigh in on policy when developed?

Focus groups and interviews of those affected by policy.

1.33 List of required policies

Create checklist to make sure minimum policies are in place and then audit against the list.

1.34 Effectiveness of policies

Effectiveness of policies based on the submission hotline calls


Policies and procedures that have been identified as part of corrective action

Process review. Conduct annual meeting with compliance and legal to look at databases and control and prioritize review to ensure implementation and ongoing compliance with policies and procedures.

1.36 Policies for high risk and operational areas


1.37 Policies, standards and procedures are based on assessed risks

Risk assessment, policy exists for each risk identified in the risk assessment (coverage of a specific risk topic)

1.38 Policy inventory to ensure no overlap and contradiction of policies

Create inventory and analyze inventory. Analyze and review past efforts. Look at various departments that might have overlapping policies.

1.39 Policy review following investigation/issue

Top policies implicated in an investigation are reviewed to determine if policy ambiguous, complex, fails to adequately safeguard issues. Validate through audit.


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