By Michelle E. Missigman, J.D.
On November 6, 2023, the U.S. Department of Health and Human Services (HHS), Office of the Inspector General (OIG), released 91 pages of “General Compliance Program Guidance” (GCPG) on its website. This is the first compliance program guidance the OIG has released since 2008. The GCPG provides general compliance guidance, tools, and references for use by federal health care program providers.
This new guidance brings together many resources and links, making it a valuable and easy-to-read tool to keep on hand for any professional working within the healthcare industry.
The GCPG covers the following topics:
I. Introduction
The GCPG provides a thorough introduction to the OIG’s history and commitment to preventing health care fraud an abuse. It provides a roadmap for how the OIG intends to modernize and improve its publicly available resources. The OIG’s goal is to continue producing these resources, deliver information to the public in a user-friendly approach using modern technology, and produce informative and useful resources to help advance the health care industry’s compliance efforts in preventing fraud, waste, and abuse.
II. Health Care Fraud Enforcement
The GCPG provides a broad overview of federal healthcare fraud enforcement standards and laws, such as: the anti-kickback statute, physician self-referral law, false claims act, civil monetary penalties, exclusions from federal programs, criminal health care fraud statute, HIPAA privacy and security rules.
III. Seven Elements of a Successful Compliance Program
The largest section of the GCPG reinforces and provides a thorough explanation of the seven elements of an effective compliance program:
1. Written Policies and Procedures
2. Compliance Leadership and Oversight
3. Training and Education
4. Effective Lines of Communication with the Compliance Officer and Disclosure Programs
5. Enforcing Standards: Consequences and Incentives
6. Risk Assessment, Auditing, and Monitoring
7.Responding to Detected Offenses and Developing Corrective Action Initiatives
Much of the guidance in this section reflects the OIG’s prior guidance in monitoring Corporate Integrity Agreements (CIAs). Check out this article on CIAs.
IV. Compliance Program Adaptations for Small and Large Entities
Maintaining an effective compliance program can be burdensome for smaller entities that have limited resources. The OIG acknowledges this and provides guidance on how smaller entities can still implement a compliance program that meets the above seven elements of a compliance program.
For larger entities with more resources, the GCPG goes into detail about the compliance officer’s role within the organization. The compliance officer should have the authority to oversee and direct the organization’s compliance function and lead the compliance department. The organization’s board of directors and compliance office should meet periodically to evaluate the compliance department and determine whether it meets the needs of the organization.
V. Other Compliance Considerations
The GCPG considers other areas to assist entities in developing policies and procedures to reduce or eliminate potential fraud and abuse risks. Some other areas they have considered are: quality and patient safety, new entrants in the health care industry (e.g. technology companies, new investors, and non-traditional services in health care such as social services, food delivery, and care coordination services), financial incentives, and financial arrangements.
VI. Additional OIG Resources and Tools
Lastly, the CPCG lists links all of the resources available on the OIG website, including previous compliance program guidance, advisory opinions, special fraud alerts, safe harbor regulations, compliance toolkits, OIG reports and publications, corporate integrity agreements, self-disclosure information and access to OIG’s hotline. The OIG has even implemented a FAQ process to provide informal feedback to the health care community.
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About the Author: Michelle E. Missigman, is a health attorney practicing with The Health Law Firm. The firm has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 or Toll-Free: (888) 331-6620.
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Sources:
“Criteria for Implementing Section 1128(b)(7) Exclusion Authority.” U.S. Department of Health and Human Services Office of Inspector General. (2016). Web.
Dani Kass. “HHS Watchdog Lays Out New Grounds For Exclusion List.” Law360. (2016). Web.
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