Recently, the United States Department of Health and Human Services Office of Inspector General (HHS OIG) published a notice in the Federal Register, outlining upcoming procedures for issuing compliance program guidance documents. The Compliance Program Guidances (CPGs) issued by HHS OIG are voluntary and non-binding guidance documents that encourage internal controls to monitor adherence to applicable statutes, regulations, and program requirements.
The changes are in response to feedback received through the OIG’s Modernization Initiative, as well as other input. The agency noted that “CPGs have served as an important and valuable OIG resource for the health care compliance community and industry stakeholders over the last 25 years” and that it has considered ways to not only update the existing CPGs but also publish new CPGs specific to segments of the health care industry that have emerged over the last 25 years.
Through the Notice, HHS OIG noted that it will not longer publish updated or new CPGs in the Federal Register, but instead all current, updated, and new CPGs will be available on the HHS OIG website. The agency will also notify the public of new and/or updated GCPG and ICPGs through its public listserv and other communication platforms.
HHS OIG also noticed that it has developed a new format for CPGs, including starting with a general CPG (GCPG) that applies to all individuals and entities involved in the health care industry. The GCPG will address topics such as federal fraud and abuse laws, compliance program basics, how to operate an effective compliance program, and OIG processes and resources. The GCPG will be updated as changes in compliance practices or legal requirements warrant and OIG plans to publish it by the end of the year 2023.
On top of the GCPG, HHS OIG will publish industry-specific CPGs (ICPGs) for different providers, suppliers, and other participants in the health care industry subsectors or ancillary industry sectors related to Federal health care programs. The ICPGs will be tailored to cover fraud and abuse risk areas for the relevant industry subsector and address compliance measures that the specific industry subsector participants can take to reduce those risks. HHS OIG intends to update the ICPGs on a periodic basis to address risk areas and compliance measures as they are identified to allow industry participants timely and meaningful guidance from the agency. ICPGs will be published starting in 2024, with the first two likely addressing Medicare Advantage and nursing facilities.
Importantly, this change does not make the guidance mandatory, nor does it constitute a “model compliance program.” The guidance will continue to be a voluntary set of guidelines and risk areas that HHS OIG believes should be considered when a compliance plan is implemented or updated for individuals and entities in the health care industry.