New guidance from the Department of Health and Human Services (HHS) provides descriptions of major health regulations, including the False Claims Act, and how to avoid getting ensnared by them.
The General Compliance Program Guidance (GCPG), released Nov. 6, is the first in a series of updated, voluntary, nonbinding guidance documents issued by the HHS’s Office of Inspector General (OIG), the body that enforces health regulations.
The GCPG is designed to apply generally to the healthcare industry, from doctors to pharmaceutical manufacturers, and help all such entities self-monitor their compliance and prevent waste, fraud, and abuse, the OIG said. The HHS last updated its guidance in 2008.
The OIG cautioned the GCPG and forthcoming guidance documents “do not constitute a model compliance program” and are not “one-size fits-all, completely comprehensive, or all-inclusive of compliance considerations and fraud and abuse risks for every organization.” Instead, the documents should be viewed as providing compliance tips and pointers about risk areas the OIG believes the healthcare industry should consider when creating, implementing, updating, or evaluating compliance programs.
Updated guidance will only be available on the OIG website and not be published in the Federal Register, “in an effort to produce user-friendly and accessible information and to promote greater flexibility” for future updates, the OIG said.
The agency said it expects to update the GCPG “as changes in compliance practices or legal requirements may warrant.” Industry-specific guidance will be rolled out starting in 2024.
The GCPG provides an overview of the federal authorities with oversight of healthcare, the regulations that pertain to healthcare, the seven elements of a health compliance program, ways programs can be adapted by small and large organizations, and a description of how the OIG works.
The guidance describes three federal health regulations in detail and how they apply: the Anti-Kickback Statute; the Physician Self-Referral Law (aka, the Stark Law); and the False Claims Act. It includes tips and questions to ask when considering whether your organization meets compliance requirements.
Other industry-specific guidance that might be updated include documents on ambulance suppliers, clinical laboratories, durable medical equipment suppliers and manufacturers, home health agencies, hospitals, hospices, Medicare Advantage organizations, nursing facilities, pharmaceutical companies, physicians, and third-party billing companies, the OIG said.
Industry-specific documents will be tailored to the fraud and abuse risk areas for each sector and will describe compliance steps each industry group can incorporate to reduce those risks, the OIG said. These will be updated as needed, the agency said.