Seven Elements of a Compliance Program Toolkit

For health centers looking to build, update and/or reinvigorate their Compliance Program, our Seven Elements of a Compliance Program Toolkit includes dozens of sample policies, procedures and forms designed to help create a successful Compliance Program.

In November 2023, the Department of Health and Human Services (HHS), Office of the Inspector General (OIG) released its new General Compliance Program Guidance (“GCPG”). In the GCPG, the OIG updated its guidance on Compliance Programs for health care entities to include:

  • An emphasis on the Compliance Officer’s role as trusted advisor to senior leaders and the Board and the expectation that health care entities have a Staff Compliance Committee
  • A focus on formalizing the compliance risk assessment process to include annual assessments and annual Compliance Work Plans designed to mitigate identified risks
  • Annual review of policies and procedures and creation of an annual Compliance Education and Training Plan

For the 2024 edition, we reviewed and updated every document in the Toolkit, including:

  • Compliance Program Description
  • Compliance Officer Job Description
  • Staff Compliance Committee Charter
  • Compliance Training and Education Plan (new for 2024)
  • General and Targeted Compliance Training Agendas
  • Nonretaliation and Whistleblower Protection Policy and Procedure
  • Compliance Risk Assessment Policy and Procedure (new for 2024)

The Seven Elements of a Compliance Program Toolkit is an essential resource for health centers looking to implement, maintain, or improve their Compliance Program. For support in responding to key health center compliance issues, please see our other Toolkit subscriptions which address federal grants management, Section 330, and confidentiality or browse our training curriculum for an upcoming program.

 

    Course summary
    Course opens: 
    08/24/2018
    Course expires: 
    01/01/2026
    Cost:
    $500.00

    Table of Contents

    Element One: Written Policies and Procedures

    • Compliance Program Description: Sample
    • Standards of Conduct/Conflict of Interest Policy and Procedure: Sample
    • Preventing Fraud, Waste and Abuse Policy and Procedure: Sample
    • Record Retention Policy and Procedure: Sample
    • Exclusion and Debarment Screening Policy and Procedure: Sample
    • Board Member Screening Policy and Procedure: Sample
    • Board Member Letter and Form on Medicare Enrollment Disclosure: Sample

    Element Two: Compliance Leadership and Oversight

    • Responsibility and Authority of the Compliance Officer Policy and Procedure: Sample
    • Board Resolution Appointing a Compliance Officer: Sample
    • Compliance Officer Job Description: Sample
    • Compliance Officer Evaluation Form: Sample
    • Staff Compliance Committee Charter: Sample
    • Board Resolution Establishing a Compliance Program: Sample
    • Board Resolution Developing and Implementing a Compliance Program: Sample
    • Board Compliance Committee Charter: Sample

    Element Three: Training and Education

    • Compliance Training and Education Policy and Procedure: Sample
    • Compliance Training and Education Plan: Sample
    • General Compliance Training Agenda: Sample
    • Targeted Compliance Training Agenda for Board Members: Sample
    • Compliance Training and Education Log: Sample
    • Compliance Training Sign-In and Certification Form: Sample

    Element Four: Effective Lines of Communication with the Compliance Officer and Disclosure Program

    • Reporting Instances of Noncompliance Policy and Procedure: Sample
    • Compliance Hotline Script: Sample
    • Compliance Issue Reporting and Response Tool: Sample
    • Nonretaliation and Whistleblower Protection Policy and Procedure: Sample

    Element Five: Enforcing Standards: Consequences and Incentives

    • Enforcing Standards: Consequences and Incentives Policy and Procedure: Sample
    • Compliance Provisions for Position Descriptions and Contracts: Sample

    Element Six: Risk Assessment, Auditing and Monitoring

    • Risk Assessment Policy and Procedure: Sample
    • Auditing and Monitoring Policy and Procedure: Sample
    • Internal Auditing Report: Sample

    Element Seven: Responding to Detected Offenses and Developing Corrective Action Initiatives

    • Responding to Detected Offenses and Developing Corrective Action Initiatives Policy and Procedure: Sample
    • Responding to Allegations of Noncompliance Concerning the Chief Executive Officer Policy and Procedure: Sample
    • Responding to External Compliance Audits or Investigations Policy and Procedure: Sample

     

    About the Authors

    This Toolkit and its resources were created in response to requests from health centers across the country for compliance resources to prevent and detect conduct inconsistent with laws, regulations, and other legal requirements. Attorneys from Feldesman Leifer LLP provide a full range of health care corporate compliance counseling services for the development, evaluation, implementation, operation, and support of effective compliance programs, informed by decades of experience advising federally qualified health centers, behavioral health providers, primary care associations, and health-center controlled networks.

    MOLLY EVANS  

    A Partner in the firm’s health law practice group, Molly advises health centers on the management of clinical, employment and workforce related risks, with a particular focus on professional liability, Federal Tort Claims Act, and HIPAA matters. From her experience as both a private attorney and in-house counsel, Molly knows the importance of managing liability and risk issues in mission-driven organizations. [Full Bio]

    ADAM FALCONE

    A Partner in the firm’s health law practice group, Adam counsels a diverse spectrum of community-based organizations that render primary and behavioral healthcare services on a wide range of health law issues, with a particular focus on fraud and abuse, reimbursement and payment, and antitrust and competition matters. [Full Bio]

    DIANNE PLEDGIE

    As Partner and Compliance Counsel with the firm’s health law practice group, Dianne advises health centers on implementing effective compliance programs and on addressing top compliance risk areas. Dianne counsels health centers and other organizations on developing compliance programs that include the OIG’s seven elements, respond to identified compliance risk areas and reflect the organization’s culture.  Dianne also advises health centers and other organizations on patient privacy and confidentiality, including the HIPAA Privacy Rule and 42 CFR Part 2.  She has experience responding to privacy and security incidents, including determining whether there has been a breach, notifying patients and the government, and creating corrective action plans. [Full Bio]

     

    There are no continuing education credits or other attendance records associated with this product.

    Price

    Cost:
    $500.00
    Please login or register to take this course.

     

    Access Period

    Purchasing this Toolkit provides access for one calendar year. This access includes any updates or additions we make to Toolkit resources throughout the year at no extra charge.

    Approval Process

    We only allow community health centers to purchase Toolkits. As a result, we must review and approve all purchases to verify eligibility. We review and approve Toolkit purchases as quickly as possible, but there are occasional delays. Please allow 3-5 business days for approval.

    PCAs, HCCNs, and other membership organizations interested in purchasing Toolkit subscriptions for their health center members should Contact Us for pricing options.

    Disclaimer

    By purchasing this Toolkit, you acknowledge and agree to our Terms of Use and Privacy Policy. This Toolkit has been prepared by attorneys at Feldesman Leifer LLP (Feldesman) and includes original materials developed by Feldesman. This Toolkit is designed as a resource to assist your health center in developing and implementing an effective Compliance Program consistent with the expectations of the United States Department of Health and Human Services (HHS), Office of the Inspector General (OIG). The materials are not intended to be adopted word for word; Feldesman recommends that each organization tailor the materials to fit your health center's legal, financial, administrative, and programmatic needs. Failing to modify the original materials to the specific needs of your program may have adverse consequences. 

    By purchasing this Toolkit, you acknowledge and agree that the materials contained herein do not constitute legal advice and your purchase does not create an attorney-client relationship between you and Feldesman, nor is it intended to do so. If legal advice or other expert assistance is required, your organization should enter into an engagement agreement with Feldesman or seek the services of another competent professional. Each legal problem is different, and past performance does not guarantee future results.

    By purchasing this Toolkit, you acknowledge and agree that, unless otherwise indicated, Feldesman owns the copyright to the resources in this Toolkit. All such materials are for personal/non-commercial use only and, any other use or disclosure is a violation of federal copyright law and is punishable by the imposition of substantial fines. Unless otherwise noted, all materials in this Toolkit remain the intellectual property of Feldesman and are protected under the copyright of Feldesman Leifer LLP. Copyright is claimed in all original material, including but not limited to the sample forms, policies and procedures, and similar resources. Any and all such copyrighted materials may not be republished for or distributed to any third party at any time or in any form without written permission from Feldesman.