Seven Elements of a Compliance Program Toolkit
Health centers are faced with an array of compliance risks. As federal grant recipients, health care providers, and community partners, health centers must develop a system to ensure compliance with the applicable laws, rules, and requirements.
The Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) recommends that all health care entities develop a compliance program that incorporates seven specific elements. The seven elements include designating a compliance officer, developing written compliance standards, providing training and communication, developing open lines of communication, conducting regular monitoring and auditing, responding to detected offenses, and enforcing disciplinary standards.
While some health centers have implemented several of the compliance program elements or some components of them, many have not organized these efforts under the formalized structure of a compliance program. Increasingly, health centers are hiring compliance officers or designating an employee to develop and implement a corporate compliance program that assesses and responds to the health center's risks.
FTLF's Seven Elements of a Compliance Program Toolkit is designed to help health centers develop a corporate compliance program that incorporates the OIG's seven elements. The Toolkit includes customizable sample policies, procedures, and forms, including:
Corporate Compliance Plan
Training and Education Agendas
Standards of Conduct
Whistleblower Protection Policy
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.
Table of Contents
I. Element One: Compliance Program Structure
- Board Resolution Establishing a Compliance Program: Sample
- Board Compliance Committee Charter: Sample
- Compliance Officer Job Description: Sample
- Staff Compliance Committee Charter: Sample
II. Element Two: Written Compliance Standards
- Corporate Compliance Plan: Sample
- Standards of Conduct/Conflict of Interest: Sample Policy and Procedure
- Preventing Fraud, Waste and Abuse: Sample Policy and Procedure
- Record Retention: Sample Policy and Procedure
- Exclusion and Debarment Screening: Sample Policy and Procedure
- Board Member Screening: Sample Policy and Procedure
- Medicare Enrollment Disclosure for Board Members: Sample Letter and Form
III. Element Three: Training and Education
- Training and Education: Sample Policy and Procedure
- Training for Individuals Newly Affiliated with the Health Center: Sample Agenda
- Training for Board Members: Sample Agenda
- Training for Billing and Coding Personnel: Sample Agenda
- Training Sign-In and Certification: Sample Form
- Training Log: Sample Form
IV. Element Four: Open Lines of Communication
- Reporting Instances of Non-Compliance: Sample Policy and Procedure
- Compliance Hotline Script: Sample
- Compliance Issue Reporting and Response: Sample Tool
- Non-Retaliation and Whistleblower Protection: Sample Policy and Procedure
V. Element Five: Internal Monitoring and Auditing
- Internal Monitoring and Auditing: Sample Policy and Procedure
- Internal Monitoring and Auditing: Sample Report
VI. Element Six: Responding to Detected Offenses
- Responding to Detected Offenses: Sample Policy and Procedure
- Responding to Detected Offenses: Sample File Memo
- Responding to Allegations of Non-Compliance Concerning the CEO: Sample Policy and Procedure
- Responding to External Compliance Audits or Investigations: Sample Policy and Procedure
VII. Element Seven: Enforcing Disciplinary Standards
- Enforcing Disciplinary Standards: Sample Policy and Procedure
- Compliance Provisions for Position Descriptions and Contracts: Sample Language
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 Tucker Leifer Fidell 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.
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]
A Partner in FTLF’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]
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.
Purchasing this Toolkit provides access through the end of the current calendar year. This access includes any updates or additions FTLF makes to Toolkit resources throughout that year at no extra charge.
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.
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 FTLF, 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 FTLF 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, FTLF 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 FTLF and are protected under the copyright of Feldesman Tucker Leifer Fidell 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 FTLF.