The U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) recently announced its plan to update the format of and public notice protocol for its voluntary, nonbinding compliance program guidances (CPGs) based on feedback it received as part of HHS-OIG’s Modernization Initiative1 and other input. The updates (summarized below) highlight the evolving nature of risk and compliance in the healthcare industry and demonstrate how HHS-OIG is taking steps to more rapidly update its guidance to address emerging risks. While this new method of offering compliance guidance may provide stakeholders with more up-to-date insights on HHS-OIG’s priorities and perspectives, stakeholders will need to devote greater resources to monitoring more frequently evolving guidance.
General CPG
By the end of calendar year 2023, HHS-OIG will publish a General CPG (GCPG) applicable to all individuals and entities involved in the healthcare industry. The GCPG will address fraud and abuse laws, compliance program basics, operating effective compliance programs, and HHS-OIG processes and resources. This effort reflects a response to criticism that, by focusing on industry segments previously, OIG has not issued guidance on important compliance issues to health care participants that are not included in those industry segments.
Industry-Specific CPGs
In calendar year 2024, HHS-OIG will begin publishing industry-specific CPGs (ICPGs) addressing fraud and abuse risk areas for each industry subsector and the compliance measures that the industry subsector participants can take to reduce these risks, likely starting with Medicare Advantage and nursing facilities. HHS-OIG intends to update ICPGs “periodically” to address newly identified risk areas and compliance measures. In a recent speech, Inspector General Christi Grimm described these ICPGs as “modern, web-based publications that are an upgrade from the stodgy, three-column Federal Register notices.”
No Notice and Comment
HHS-OIG stated in its announcement that it will update the CPGs “periodically” and “as changes in compliance practices or legal requirements warrant” and no longer publish updated and new CPGs in the Federal Register, a position that may be subject to legal challenge. Instead, HHS-OIG stated that it intends to notify the public by posting CPGs to its website.
1 https://www.federalregister.gov/documents/2021/09/24/2021-20558/oig-modernization-initiative-to-improve-its-publicly-available-resources-request-for-information.
