Overview of the OIG General Compliance Program Guidance 2023

Overview of the OIG General Compliance Program Guidance 2023

Overview of OIG General Compliance Program Guidance 2023

In November 2023, the Office of Inspector General (OIG) of the US Department of Health and Human Services (HHS) issued a summary compliance guidance for entities operating in the healthcare industry. The General Compliance Program Guidance 2023 (GCPG) is a long-awaited update of previous guidelines published by the OIG during the years 1998-2008.

The latest guidance is a 91-page text spanning multiple fundamental aspects of compliance for healthcare businesses in the United States. Keep reading to find out why GCPG represents an important landmark for compliance teams, who it applies to and check the core areas of focus from federal authorities’ standpoint.

Why Is It Important?

In the text of the guidance, the OIG makes it clear that the current document is nonbinding guidance, which does not create any new obligations or regulations. Instead, the document aims to help various stakeholders in the healthcare industry identify red flags with respect to existing regulations and outline a roadmap for building an effective compliance program.

The GCPG 2023 is built upon the prior guidance documents issued by the OIG in the previous years and draws upon the results of prior cases and enforcement actions, as well as feedback from industry participants. The document is an important milestone in healthcare compliance, summarizing applicable regulations and outlining the evolution of processes and approaches over the last few decades, intended to help businesses streamline their compliance efforts.

Who Does It Apply To?

Before the current guidance, the OIG had developed documents directed at various stakeholders in healthcare. Unlike previous guidelines, the latest document applies to “all individuals and entities involved in the healthcare industry.” These include, but are not limited to:

- pharmaceutical manufacturers,

- manufacturers of durable medical equipment, prosthetics, orthotics,  and supplies,

- third-party medical billing companies,

- physicians,

- hospitals, hospices and nursing homes,

- home health agencies,

- clinical laboratories,

- ambulance suppliers,

- Medicare Advantage organizations.

The Scope of the General Compliance Program Guidance

The latest GCPG addresses key federal regulations applicable to healthcare businesses, outlines key elements of compliance programs and suggests their implementation for small and large entities.

Additionally, GCPG 2023 includes specific compliance considerations and provides an overview of the processes and resources of the Office of Inspector General.

Key regulations

By overviewing the primary federal laws that may apply to healthcare businesses, the OIG seeks to create awareness and offer tools and resources to enhance compliance efforts. Meanwhile, it is important to remember that the GCPG 2023 does not mention state fraud and abuse laws and is not intended as an all-inclusive summary of applicable regulations.

Specifically, the overview by the OIG focuses on the Federal Anti-Kickback Statute and False Claims Act, the Physician Self-Referral Law, the Civil Monetary Penalty Laws, the Criminal Healthcare Fraud Statute, and HIPAA Rules. The GCPG provides useful tips to detect problematic arrangements and offers practical direction on what to do when such issues are identified.

Top pillars of the compliance program framework

In the next section of the GCPG, the Office of Inspector General offers a practical roadmap for building a robust compliance agenda focusing on key areas. In doing so, the OIG underscores the pivotal role of the senior leadership and the boards in ensuring effective compliance, highlights the importance of effective communication lines within an organization and pinpoints the implementation of corrective action initiatives.

The GCPG spans seven areas of the compliance program framework, including policies and procedures, leadership and oversight, training and education, keeping effective lines of communication, endorsement, as well as risk assessment and responding to offences. Additionally, the guidance offers practical tips for implementing the suggested agenda in the context of smaller and larger healthcare businesses in a separate section of the document.

Other compliance considerations

Starting in 2024, the Office of Inspector General plans to build on the current text of the General Compliance Program Guidance and develop industry segment-specific compliance program guidance documents (ICPGs). These documents will address compliance concerns, risks and measures specific to different types of providers, suppliers and participants in the healthcare industry and ancillary sectors.

In absence of industry segment-specific guidance, the current version of GCPG offers several compliance considerations related to specific risk areas within the same document. These include quality and patient safety considerations, practical advice for new entrants, methods to check financial incentives for compliance and practical approaches for tracking financial arrangements.

 Resources and processes

Aiming to provide a practical compliance roadmap, the OIG has furnished its guidance with numerous resources, including links to toolkits,  OIG reports and publications, advisory opinions and safe harbor regulations. The guidance includes a reference to a comprehensive FAQ section covering questions from the U.S. healthcare businesses.

Additionally, the OIG offers a useful summary of its Corporate Integrity Agreements (CIA) outlining the obligations of practitioners and providers in civil and administrative settlements. This part of the guidance also features several self-disclosure processes to report potential breaches to avoid the potential disruption and penalties as a result of government-directed investigation.

How Does GCPG Help Achieve Compliance in Healthcare?

While GCPG outlines primary federal fraud and abuse laws and other regulations, it remains voluntary guidance, offering an overview of the existing regulations and practices aimed at achieving compliance. The Office of Inspector General uses the word “should” in GCPG 2023 text to underscore the nonbinding voluntary nature of the document.

The OIG achieves its objective by providing a summary of existing regulations and offering a robust agenda for achieving compliance for both large and smaller healthcare businesses. By offering links to OIG reports, decisions, answers and resources in one place, the document serves as an important tool for compliance teams in all types of healthcare organizations.

Learn More with MedCompli

This report is intended as a short overview of the latest General Compliance Program Guidance by the Office of Inspector General and mentions only key points of the document without providing a deeper analysis. Those interested in detailed information on any of the compliance aspects addressed in the GCPG are advised to check the original of the document available at the HHS OIG website.

Please stay tuned to the MedCompli blog for more analysis of the General Compliance Program Guidance 2023 and its possible applications to healthcare businesses. If you have any questions or need assistance in steering through the pathways of reporting and compliance in the healthcare sector, please hesitate to contact the MedCompli team for a free initial consultation and demo.

Disclaimer**: This article is intended for general information purposes only and does not constitute legal advice. Please consult your lawyer to address your individual or company circumstances and legal questions.