In November 2023, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its General Compliance Program Guidance (GCPG). This guidance was released as part of OIG’s Modernization Initiative, which seeks to make compliance program guidance more user friendly and accessible. The document does not include new information but instead summarizes existing guidance regarding fraud and abuse risk, serving as an up-to-date comprehensive reference guide for the general healthcare community and industry stakeholders. OIG also noted that in 2024 it will begin publishing industry segment-specific CPGs (ICPGs) which will address compliance measures for industry subsectors.
The GCPG is not legally binding on any individual or entity, but contains valuable information regarding compliance with federal fraud and abuse statutes and regulations. The OIG guidance includes information regarding key fraud and abuse laws, the primary elements of an effective compliance program, program adaptations for small and large entities, other compliance considerations, and OIG resources and processes.
The GCPG begins with an overview of the principal federal fraud and abuse laws including the Anti-Kickback Statute (AKS), the Physician Self-Referral Law (PSL; also known as the “Stark law”), the False Claims Act (FCA), and the Civil Monetary Penalty law (CMP). Their stated goal in summarizing these laws is to “create awareness and provide tools and resources to aid compliance efforts in both preventing violations and identifying potential red flags early with respect to these laws and regulations.”
AKS is an intent-based criminal statute which prohibits remuneration in exchange for federal health care program business referrals. The GCPG identifies several key categories to consider when determining if problematic arrangements exist under AKS. The guidance also provides relevant considerations for analyzing business arrangements under the Stark law, which prohibits physicians from making referrals for Medicare-payable designated health services (DHS) to entities with which the physician or an immediate family member has a financial relationship. While there are certain exceptions and safe harbors under AKS and Stark, ensuring compliance is paramount as violations can result in steep fines and suspension, termination, or exclusion from participation in federal health care programs, among other consequences.
Additionally, the GCPG describes key factors for compliance with the FCA and CMP law. Both laws may impose significant monetary penalties and other consequences for knowingly submitting false or fraudulent claims to the government. One important distinction highlighted in the guidance is that while FCA cases are pursued in federal court by the Department of Justice, CMP cases are administrative in nature and are therefore heard by an administrative law judge. CMP also encompasses a wider variety of conduct than the FCA, leading to increased potential liability under the law.
The GCPG also highlights the seven key elements of an effective compliance program. The guidance recognizes certain necessary adaptations for small and large healthcare entities and accordingly offers specific suggestions for each type, including information tailored to newly practicing physicians. Other compliance considerations discussed in the GCPG include quality and patient safety, new entrants in the health care industry, financial incentives, and tracking of financial arrangements. The guidance also notes that forthcoming ICPGs will further address subsector-specific risk areas for different areas of the industry. Finally, the guidance concludes with offering several helpful resources including links to compliance toolkits, trainings, software, OIG reports, publications, and advisory opinions.
For over 35 years, Wachler & Associates has represented healthcare providers and suppliers nationwide in a variety of health law matters, and our attorneys can assist providers and suppliers in understanding new developments in healthcare law and regulation. If you or your healthcare entity has any questions pertaining to healthcare compliance, please contact an experienced healthcare attorney at 248-544-0888 or email@example.com.