The Department of Health and Human Services (HHS) through its Office of Inspector General (OIG), announced plans for significant updates and modernization of OIG compliance program guidance (CPG) to improve their accessibility and usability for healthcare entities.[1] Originally issued in 1998, the CPG provide healthcare organizations across the industry with guidance on developing, implementing, and maintaining internal compliance controls. In the 25 years since, the OIG has issued multiple and specific CPGs that apply to particular segments of the healthcare industry including Medicare Advantage organizations, hospitals, home health agencies, nursing homes, and clinical laboratories. However, over time the CPGs have not sufficiently kept up with the innovations and growth of the healthcare industry.

As part of the OIG’s current Modernization Initiative, the existing CPGs will be updated and improved. The OIG also plans to develop new CPGs for emerging providers and therapies.

Changes will include the following:

  1. The OIG will issue a new general CPG (GCPG) that will apply to all individuals and entities in the healthcare industry. The GCPG will address overarching compliance elements regarding federal fraud and abuse laws, compliance program basics, compliance program effectiveness, and general process and procedures. The OIG intends to publish the GCPG by December 31, 2023.
  1. The OIG will also issue new industry-specific CPGs (ICPGs) which will apply to different types of providers, suppliers, and healthcare industry participants that participate in federal healthcare programs. The first two ICPGs are expected to cover Medicare Advantage and nursing facilities and are anticipated to be issued in 2024.
  1. The new CPGs will no longer be published in the Federal Register, but the CPGs, and any future related guidance will be available on the OIG’s website. The OIG intends to update the CPGs periodically as compliance practices, legal requirements, and risks evolve with the industry, and will notify interested parties through the OIG public listserv[2] as well as through other publicly available communication platforms.

The new CPGs will impact compliance program requirements for all healthcare industry participants and organizations will need to incorporate the resulting changes into compliance plans, operational policies and procedures, and audit protocols. For additional information, please reach out to Noreen Vergara at Noreen.Vergara@huschblackwell.com, Kelsey.Toledo@huschblackwell.com, or other Husch Blackwell healthcare regulatory attorney.

[1] Notice, 88 FR 25000, April 25, 2023 – Modernization of Compliance Program Guidance Documents (May 12, 2023).

[2] To join OIG’s listserv, visit https://cloud.connect.hhs.gov/OIG/.