In November 2023, OIG at HHS released a "general compliance program guidance," attempting to knit together the helter-skelter rules that govern compliance.
Read about it at PolicyMed.com here:
Find the OIG Home Page for the project here:
If you download "complete guidance," you get a 91 page PDF:
- Offers comprehensive compliance guidelines for healthcare stakeholders.
- Covers key federal laws like Anti-Kickback Statute and False Claims Act.
- Emphasizes the importance of an effective compliance program infrastructure.
- Provides specific guidance for both small and large healthcare entities.
- Addresses quality and patient safety, and financial incentives in healthcare.
- Highlights the significance of tracking financial arrangements.
- Includes detailed sections on OIG resources and compliance processes.
- Serves as a toolkit for understanding healthcare compliance and legal requirements.
- Updated to reflect modern healthcare industry challenges and practices.
- Aims to aid in preventing fraud, waste, and abuse in healthcare systems.
The document doesn't have anything specific to genetics/genomics, and mentions the word "laboratories" only once or twice. For example, guidance on how a lab can avoid OIG penalties around the 14 day rule or colon screening gift cards, are not here.